Recently in Public Health Category

• China Delays Censorship Software

  The New York Times reports that China will delay their rule requiring all new PCs to come installed with the Green Dam Youth Escort" censoring software that we wrote about earlier this month.

• EPA Grants California Waiver

  The Environmental Protection Agency (EPA) granted California the waiver the state has long sought which will allow it to set emissions standards that are stricter that the federal government's. We wrote about this in several posts including "Clean, Clear Air, Nothing To See Here, Drive Through Please".

• Bisphenol A in the NYT and Journalistic Fence-Sitting That Must Hurt

  Yesterday we wrote about Nicholas Kristof's NYT article on the disturbing research on endocrine disruptors. We talked about what we called 50-50 science journalism, where you erode your science article by giving credit to the "other side", a global warming denier, for instance, or the chemical lobby if you're talking about endocrine disruptors.

  Another play in this balanced journalism practiced by media is when a publication like the New York Times or the Economist or LA Times run conflicting articles to appeal to all paying advertisers. For instance John Tierney's column in the NYT today, written by Tina Kolata, quoted STATS and stats.org to deny the dangers of bisphenol A, an endocrine disruptor, which is pretty much the opposite of what Kristof wrote yesterday.

  Both STATS and Tierney are solidly in the science and environmental deniers camp. We wrote about John Tierney's denialism in "Scientist Columnists Sell You Short". Tierney has long expressed his devotion to bisphenol A -- "if they ever try recalling it, they'll have to pry [my Nalgene bottle] from my cold dead fingers", he wrote last year, and routinely comes out against science.

  Acronym Required previously wrote about STATS in "Yotta-Yotta-Yottabytes: Content Makes Kings, Print Dies", and various posts on bisphenol A. STATS, reported on here at Sourcewatch, claims to be a "non-partisan" think tank, but they are funded by conservative sources and consistently produce reports that fly in the face of science.

• Climate Bill's Mixed Reports

  The Waxman-Markey Climate Bill passed last week by Congress received mixed reports on its predicted effectiveness. The National Resource Defense Fund sent an email screaming euphorically, "Well, we did it! And we did it because millions of people like you made their voices heard on Capitol Hill."

  On the other hand, Clive Crook, who we previously highlighted for his climate denialism had an opposing opinion. Read his "The Steamrollers of Climate Science", for instance, in which he wrote that the IPCC report on climate change was biased, and what the world needed was some opinions from people affiliated with the Marshall Institute, Fraser Institute, and Competitive Enterprise Institute (CEI) (all funded by ExxonMobil), and you think you'd know where he stood.

  But Crook, climate science denier last time we looked, said yesterday that the President was being too weak on climate change. Accompanied by a cartoon of the president ripping open a Superman t-shirt to reveal a cute little Hello Kitty, Crook said:

  "The cap-and-trade bill is a travesty. Its net effect on short- to medium-term carbon emissions will be small to none. This is by design: a law that really made a difference would make energy dearer, hurt consumers and force an economic restructuring that would be painful for many industries and their workers. Congress cannot contemplate those effects. So the Waxman-Markey bill, while going through the complex motions of creating a carbon abatement regime, takes care to neutralise itself."

  Conservatives argue that the climate bill will negatively effect the economy for a very small pay-off, whereas some environmentalists argue that the cap-and-trade regime proposed will not work, that there a giant loopholes, and that coal gets too much of a boost from the legislation.

  RealClimate, for its part, is taking a break, a little bummed out about the Groundhog Day aspect of the internet, where you explain the science that all the deniers deny, then they pop-up again. How true, though more a game of Whac-A-Mole than Groundhog Day perhaps. Tenacity wins.

  Joseph Romm of Climate Progress weighs in favorably on the bill.

Nicholas Kristof wrote about endocrine disruptors in his column this weekend. He cites some of the evidence for disturbances in sexual development -- "bizarre deformities in water animals" -- and accumulating evidence of the same disturbances occurring in humans.

Acronym Required first wrote about endocrine disruptors back in 2005, with Plastic Bottles- Protecting Your Baby, by the ACC". Hundreds of studies in the past 20 years have documented disturbing effects of endocrine disruptors, which are widely used in industry and agriculture to make the food you eat, the containers you eat out of, and the products that surround you as you sit and read this post. Endocrine disruptors act like hormones to effect physiological actions in species from fishes to humans. Here's some of the evidence Kristof cites from the research literature on different chemicals:

• "Frogs, salamanders and other amphibians began to sprout extra legs."

• "In heavily polluted Lake Apopka, one of the largest lakes in Florida, male alligators developed stunted genitals."

• Researchers found in 2003 that "in the Potomac watershed near Washington, male smallmouth bass have rapidly transformed into "intersex fish" that display female characteristics." Today 80% of these male fish lay eggs.

• Scientists are concerned with "large increases in numbers of genital deformities among newborn boys."

• "7 percent of boys are now born with undescended testicles, although this often self-corrects over time."

• "And up to 1 percent of boys in the United States are now born with hypospadias, in which the urethra exits the penis improperly, such as at the base rather than the tip."

• "DES, a synthetic estrogen given to many pregnant women from the 1930s to the 1970s to prevent miscarriages, caused abnormalities in the children."

• "evidence from both humans and monkeys [suggests] that endometriosis, a gynecological disorder, is linked to exposure to endocrine disruptors."

• "Researchers also suspect that the disruptors can cause early puberty in girls."

"research has also tied endocrine disruptors to obesity, insulin resistance and diabetes, in both animals and humans."

• "mice exposed in utero even to low doses of endocrine disruptors appear normal at first but develop excess abdominal body fat as adults."

• Kristof notes a recent statement from the Endocrine Society. The group of scientists says: "In this first Scientific Statement of The Endocrine Society, we present the evidence that endocrine disruptors have effects on male and female reproduction, breast development and cancer, prostate cancer, neuroendocrinology, thyroid, metabolism and obesity, and cardiovascular endocrinology."

• Kristof quoted Dr. Ted Schettler of the Science and Environmental Health Network, who said, "'this can influence brain development, sperm counts or susceptibility to cancer, even where the animal at birth seems perfectly normal."'

There's a lot more evidence showing that chemical disruptors produce widespread harm over the environment to produce abnormal reactions. As one John Hopkins scientist told Kristoff: "It's scary, very scary."

But in a completely curious turn, halfway through the article, Kristof capitulates to the winds of "50-50 science journalism". Here's how "50-50 science journalism" works.

1. Accumulate your evidence.
2. Make a strong case for your point, citing the evidence.
3. Then abruptly cripple your whole point, smash it across the knees, by writing a one or two statements for the "other side", thus appeasing some readers and advertisers.

Kristof writes: "The scientific case is still far from proven, as chemical companies emphasize, and the uncertainties for humans are vast." To be fair, Kristof's reference to the "other side" could be considered merely a polite and politic mention. "Vast uncertainty" for humans could mean anything. But even at best this doesn't line up with the rest of his article and all the evidence he cites. What about his lists of studies?

Scientists are "connecting the dots" he writes. I know this may sound trifling but scientists are well into the data. It's only recently that the public is realizing that this problem is real -- a realization that's more substantial, quite un-dot-like. Some journalists are farther behind, but again, the evidence is accumulating at a brisk pace.

My small reservations with his article aside, Kristof often takes on controversial issues, especially in international development, that are easy for the mainstream press to ignore. While coverage of bisphenol A is surprisingly robust, now that states and cities have initiated legislation restricting its use, the larger questions of pervasive chemical use without regulation remain largely ignored. Importantly, this topic has been very easy for federal agencies to ignore. Therefore, it's great to see coverage of endocrine receptors by an influential New York Times journalist who will help inform the public, who will in turn demand that government act more aggressively on chemical oversight.

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Acronym Required writes frequently on journalism that remains faithful to all sides of science policy issues despite the evidence, for instance Climate Change: Fueling the "Debate", "Science Editors Sell You Short", and Phthalates and Bisphenol A: Media and Politics

During the Cold War, when science still had a certain mysterious allure, Liggett used it to sell Chesterfields: "Science discovered it now you can too...No unpleasant aftertaste". The Chesterfield ad shows a man looking down into a microscope while smoking. Smoke wafts up over his face and the microscope. That was then. Now, a half a century later Congress passed a law that gives the FDA regulatory authority over how tobacco is advertised. Landmark legislation, they call it. (Does this say anything about the state of legislation?)

"Executing With Quality"

"Joe Camel has been sentenced and put away forever" say the headlines, quoting Senator Richard J. Durbin (D-ILL). The House and Senate gave broad support for H.R. 1256 last week, a bill that gives the FDA some regulatory authority over cigarettes, including advertising restrictions and limits on cigarette additives and flavorings. Naturally, some of the bill's targets are disgruntled, but surprisingly, not all of them. RJ Reynolds, maker of Camel cigarettes and the infamous "Joe Camel", calls the bill the "Marlboro Monopoly Act", while Phillip Morris, owner of Marlboro cigarettes supports the FDA regulation -- perhaps because Phillip Morris helped produce it. And as RJ Reynolds complains, so do "pro-business" advocates, who say that the bill legislates a tobacco monopoly that's bad for business. Are cigarettes done? Or has Joe Camel just lost to the Marlboro Man?

Years ago, Altria recognized the need to step-up public relations as the tobacco lawsuits and public pressure increased. Initially, they just tried to stop regulation, but a different tactic finally worked.

• In a October 1, 1998 memo, Phillip Morris proposed that tobacco was like "guns, alcohol and gambling" -- products where the government '"largely leaves it to consumers to discern the riskiness of the products by themselves"', citing perhaps its true feelings.
• But the company also saw the looming probability of an FDA role in regulating nicotine and began aggressively inserting itself in legislative efforts. In 1996 Phillip Morris and United States Tobacco proposed legislation but were met with resistance from the White House, on grounds that their offer was weaker than what the president wanted. While proposing legislation, of course, the tobacco giants simultaneously worked through the courts to minimize FDA involvement.
• In 1998, the Phillip Morris again made a bid for legislation and John McCain took on the effort. The resulting bill grew as members of each party piled on amendment after amendment until Phillip Morris wanted nothing to do with the result. So they spent "tens of millions of dollars to kill the legislation".
• In 2001, a year after winning a Supreme Court decision ruling that the FDA doesn't have the authority to regulate tobacco, Phillip Morris took up the effort again, shopping the bill around Congress looking for supporters among representatives with other things on their minds.
• In 2004, in a much noted strange pairing of allies, Altria, the newly branded parent company of Phillip Morris and the Campaign for Tobacco Free Kids relieved the parties of their opposition and paved the way for co-authoring the current bill..

Altria controls more than 50% of the total tobacco market in the US, that's half of all the cigarettes, cigars, and smokeless tobacco products sold. According to the company's 2008 annual report, that's "sixty million adult consumers participating in the total tobacco space in the United States", actually 60.4, up from 60 in 2007.

Those "participants" account for $80 billion dollars in retail sales in 2008, up from $79 billion in 2007. $80 billion dollars a year is turf worth fighting for, even at a time when tobacco use is shifting from cigarettes to smokeless tobacco, and from the US to foreign countries. Certainly Altria doesn't need US shareholders complaining about third world exploitation like they did with sneaker factories in the 1990's.

"Gee Dad, You Always Get The Best of Everything, Even Marlboro"

Those are the words Phillip Morris put in "the baby's mouth for a billboard ad in 1951", and it wasn't even Father's Day. RJ Reynolds used the authority of doctors: ""More doctors smoke Camels than any other cigarette." And as we mentioned before, 1951 Liggett's Chesterfield brand used science.

Now it's different, they say. In passing the bill, members of the Senate and Congress aim to prevent dishonest advertising and prevent kids from taking up smoking. The legislation has been in the works for decades, but has finally been passed as tobacco's clout is ebbing in the US -- "the political climate is right". It's undetermined what the legislation will bring. For instance in an effort to curb misbranding and counterfeit products, the bill says that a product will be labeled "misbranded", if it fails to contain for instance, "adequate warnings against use by children" -- in instances where the FDA requires one. This makes me wonder, what's an adequate warning? Aside from laws against selling cigarettes to young children already in place, wouldn't a warning that was "adequate" mean that the children wouldn't buy cigarettes at all?

"Altria" for Altruistic

Altria even says in its annual report: "Kids should not use any tobacco products" ;) So then, why is the legislation necessary? Let's turn to Altria. At its shareholder meeting Altria noted that it strives to implement four core strategies with "five core values guiding our behavior. These values are integrity, trust and respect; passion to succeed; executing with quality; driving creativity into everything we do; and sharing with others." Compliance is "top-of-the-mind" to all employees and leaders and "one important tool that does that is the Altria Code of Conduct". In addition Altria has "built a Library of Principles and Policies that supports our compliance efforts." Public relations?

Altria, with an eye to evolving public pressure, a burgeoning international market, and increasing profit from tobacco products that aren't cigarettes, supports the bill because it makes the company look good (while solidifying it's market). Although Cigarette industry volume has declined about 4% per year, much of the decline has been offset by growth of approximately 7% in smokeless tobacco and 4% in cigar volumes." The bill could make it more difficult for new entrants to compete with Altria's companies.

In addition to its tobacco products, Altria has alcohol interests in Miller and St. Michel Winery. While diversifying to more societally acceptable drugs, however, the company can rest assured that its tobacco business will flourish. In addition to restricting market entry of new products, the new bill also gives the FDA authority to regulate counterfeit products, which has moved some investors to list Altria's stock as a "Buy Now".

As for regulation, crafty companies have proven themselves not only good at controlling their congressional representatives but adept at outwitting the FDA. Regulation is only effective to the extent that the purse pulling the strings allows. And regulation enacted is only as good as enforcement. The FDA regulation could be the beginning of more regulation and an end to the deadly scourge -- new scrutiny is now being called for in the marketing of menthol cigarettes. Or it could mean more work for the FDA pursuing counterfeit tobacco -- for health, but as well for the cigarette industry.

In the meantime, there's always more suspense. The new rule may well be challenged as opponents say that a rule like keeping advertising outside of 1000 square feet of schools limits free speech.

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Recently Chicago and Connecticut enacted bans on bisphenol A (BPA), hinting at a trend that's making industry nervous. According to the Milwaukee Journal Sentinel last week, and Washington Post today, manufacturers of cans containing bisphenol A and their customers like Coca-Cola are "trying to devise a public relations and lobbying strategy to block government bans" of the chemical. To anyone who has followed bisphenol A news or is at all news-aware, this isn't a news flash. But several papers got a hold of some meeting notes from a industry strategy session, which point to familiar tactics the industry has been using to frustrate legislative action on BPA. As the WP wrote:

"industry executives huddled for hours Thursday trying to figure out how to tamp down public concerns over the chemical bisphenol A, or BPA. The notes said the executives are particularly concerned about the views of young mothers, who often make purchasing decisions for households and who are most likely to be focused on health concerns."

According to the Post, the meeting a Washington DC's Cosmos Club discussed their public relations goals: research, "legislative and grassroots outreach [to mothers 21-35 years old and students]", and a "clear-cut plan to defend their industry." They needed a spokesperson for their cause, and wrote in the notes obtained by the newspapers that a pregnant woman would be "the Holy Grail".

According to the Post, ideas for defending the BPA industry could include "using fear tactics [e.g. Do you want to have access to baby food anymore?]", as well as "giving control back to customers", by explaining their "choice": more expensive frozen food packaging, or food in canned packaging.

According to the Journal Sentinal, the group worried that finding a scientist to act as a spokesman would be difficult because the scientists think they would be "tainted" by industry association. Really? (Do we think industry is being modest about their ability to recruit scientists to their causes?) In that case, the papers conclude, the industry would need to depend on marketing, not science, to get push their product. Not really the motherlode of insight, but interesting enough commentary on the BPA industry's remarkable consistency.

Demerits to Elsevier

Merck joined with Elsevier to publish several issues of a "fake" journal of bone disease and physiology, called the Australasian Journal of Bone and Joint Medicine back in 2003-2004. The journal placed advertisements for Fosamax and Vioxx, two Merck products, among reprints from journals such as Lancet, and opinion pieces waxing about medical conditions that might benefit from Merck's products. Not only is this last week's news, no, six years ago news, but it's news neither shocking or revelatory in the worlds of pharmaceutical marketing and science publishing.

Looking at the PDFs of a couple of AJBJM journals -- here, and here, I can't say I would confuse this publication with a "real" medical journal, although I'm not so silly to think that some people I know wouldn't, probably the same ones who thought an newspaper editorial on MRSA was "new research". But for a semi-observant reader, what introduction to a medical journal from the Associate Editor, laid out apposing the list of "Honorary Editorial Board" members, reads like this?

"Hopefully, the recent call by the US Preventive Services Task Force for routine screening for women aged 65 and older will help promote the local Australian lobby on osteoporosis initiatives. Among other things on the lobbyists' agenda are a wider availability of Medicare Benefits Schedule rebates on bone densitometry items and drugs under the Pharmaceutical Benefits Scheme."

If you were a doctor (to whom the journal was targeted), would you confuse recycled content and a mission statement about the promotion of "lobbyists' agenda" as typical medical journal intro? Clearly this was little more than an advertising circular. But shame on you Elsevier, you fine, upstanding company. How could you?

Sullying Science

You'll erode your brand! Erode science! So some say. Really? Which brand? In addition to it's other products, Elsevier publishes about 1,900 books and about 2,000 journals a year -- anything from Neuron, to Annals of Tourism Research to Pump Industry Analyst. Elsevier is a publishing powerhouse, and I'm sure other content from those 2000 journals would crumple under close scrutiny, if people looked more than once every six years.

And Merck -- "Where Patients Come First"? How could you? Our patience is strained. Really, this incident -- which Elsevier amusingly defended by noting it happened long ago when different standards held for journalism -- is neither unusual nor unprecedented behavior.

"Real" medical journals are also pressured if not beholden or subservient to pharmaceutical advertising, as we wrote a few years ago in "Just The Facts....mmm....No! Not THOSE Facts : Science Reporting in Medical Journals". In addition to advertising which influences the outcome of medical journals, pharmaceutical money is used to influence scientific, as excellently documented by the New York Times over the past couple of years for psychology research.

Nor did Merck exactly break new ground by publishing it's own little research vanity mag. A couple of years ago Acronym Required wrote about the company Science International Inc.,which the US government contracted to evaluate chemical risks to infants and children for the NIH Department of Toxicology. SII clients also included Dupont, W.R. Grace, and Exxon Mobil, and the company published its own research in it's own journal called Risk Analysis.

Talking about the fake "Australasian" journal this won't make all the non-allopathic practitioners come crawling out of the woodwork, as some have warned, this isn't a first. Nor does this prove that the non-profit publishing model is the answer, as some have also suggested. There exists myriad ways for ways for pharmaceutical companies to surreptitiously sell their products and advocate policies that benefit them, and non-profit is by no means immune to such manipulation. No the Australasian Journal of Bone and Joint Medicine is only the tip of the iceberg.

Pandemic Pandemonium?

From the most mundane event to the greatest crisis, rumors get mixed up with facts. Science events are more complicated than other events, thus swine flu pandemics are more confusing to sort out than, say "two men argued on the corner". Proteins, RNA, viruses, human patients, birds, pigs, nations, doctors, hospitals, and of course media and politicians mix it up. Welcome the smorgasbord of facts, half-truths, rumors, and lies, all served up with mixed intentions as news.

Although there are those politicians who truly want to blame a virus on immigration, fortunately most communications to not stem from ill-intentioned motives. However that's not to say they don't often end up muddled, despite good intentions. The great response of much of the world political leadership to the recent H1N1 shows how communication and management remain can be as challenging to emergency response as science.

Perhaps pandemics are too big not to be confusing. As Mexico reports that H1N1 outbreak is perhaps easing, the first New York school struck with an outbreak of the virus announces it will reopen, schools are closing down in Maryland, Arizona, New York, California, Texas, and Illinois. In Mexico schools are closed until May 6th. What to make of it?

Pandemic Proving Ground

As days go by the public feels more at ease, since more than 1000 cases of swine flu have been verified worldwide and most of those people seem still alive. Still, there is a pandemic on, and forthright people admit that the outcomes of a contagious, fast changing, undefined virus are impossible to predict. Perhaps there will be a second wave, history teaches us. Unfortunately, such caution doesn't slow the pen of onlookers who feel compelled to say something, as well as energized to criticize public officials trying to orchestrate the appropriate response.

The critics flay on all fronts. Officials got out ahead of the current H1N1 pandemic early, but not early enough some accuse. But get out ahead too early, have the virus turn out to be a mild flu, and people accuse the officials of over-reacting -- many news outlets are up to just that. One New York Times columnist raked Joe Biden over the coals for saying he told family members to stay away from confined spaces. Gail Collins noted sagely: "semihysteria is the easy political path" and provided reasoning beyond cliched characterizations of cool Obama and hothead Biden, fact-like based reasoning such as:

"One recent survey of 1,039 physicians showed that 63 percent believed "that there is some level of risk that the swine flu will result in a worldwide catastrophic pandemic...The real key to the physicians' response is the phrase 'some level.' If you interview a scientist about almost anything, they will tell you there is some level of risk. A while back, I talked to a prominent physicist who carefully explained that although the odds against all the oxygen molecules suddenly racing over to clump on one side of the room were really, really, really high, it could happen. And that if it did, it would be most unpleasant."

Cheekily humorous, to compare the risk of the current swine epidemic with the risk of something more fantastic even than the Cern collider sucking earth into a parallel universe. But "risk" is not "risk", and the two risks are not the same. We truly don't know what the risk of viral pandemics are, especially at the beginning of an epidemic. As each day passes the ensuing outbreaks and emerging science -- like sequence data that can be used to compare the virulence of this virus with others -- make the picture clearer. But pandemic history warns us not to be too cocky.

The CDC advises the public to "follow public health advice regarding school closures, avoiding crowds and other social distancing measures", and Obama himself advised schools with sick pupils to close to be "as safe as possible".

Some adult commenters would diss attempts at public health precautions as quickly as they'd laugh at the high schooler who complains that school officials were 'totally overeacting', although "...us older kids can deal without seeing our friends, we have FaceBook and Twitter and such". But what happens to public trust when various politicians, officials, and columnists pronounce these cautionary messages "reactionary"? We know what happens -- citizens guffaw the next time officials warn us, and people hunker down before the storm and tell the press belligerently that this hurricane will be no worse than all the others they were warned of.

Does anyone really think the Obama administration (Biden included) isn't acutely aware that over-precautionary social distancing would further exacerbate the dire economic situation? Prudent caution has a tremendous economic cost -- do people think Obama et al. became numb overnight to economic costs?

Pandemic Nationalism

If nations struggle to mount a unified response to a pandemic, the world too, has had a less than a coordinated front in the current outbreak of H1N1. Nation states will never truly get over themselves (nor should they), and if globalization didn't prove that pandemics will. So while the all nations make pronouncements about working together, the US warned tourists off of Mexico and Europe warned tourists off of the US. The US said that such a travel warning is unnecessary. France curtailed flights to Mexico. India warned travelers against going to New Zealand, Spain, Mexico, US, Canada, France and UK, and will be screening travelers from infected countries and China is sequestering Mexican travelers somewhere in Hong Kong. Europe wants the flu to be called the "North American Flu", but some commentators would rather it be called "Mexican Flu". Mexico says the swine flu might will have originated in the US.

Just as we've seen a swine flu before, this response to flu is also familiar. According to a 2005 book: "The name Spanish flu came not from major outbreaks in Spain, but from high mortality among troops in France that for intelligence reasons were attributed to Spanish origins. The highest mortality from the disease occurred after the arrival of American troops in France." In a fact that was lost on most historians, "...General Erich Ludendorff, the Imperial German Army Chief of Staff, concluded that it was the virus, not the fresh troops, that ended the World War."

Adding to the confusion about who started what, mass communication facilitates faulty data transmission that helps confuse the public when caution mixes up with harmful actions on the part of officials. As Acronym Required wrote back in 2005 about the H5N1 avian flu, customs in various countries deals with these pandemics in what is truly alarming over-reaction. For instance now in Bulgaria officers are "checking the luggage of passengers arriving from Mexico, the U.S., Canada and Japan to ensure they are not importing pork products", and Egypt is killing the pigs of Christian farmers as a precautionary measure.

If you wanted to get a sense of how organized the ground response would be in a pandemic, you could have polled your doctors about their knowledge and your local situation a few years ago. Perhaps better for your peace of mind that you didn't, nor even wondered about other nations responses. Needless to say we would all be relieved if this H1N1 were only a drill -- we could use some practice runs.

Guns and Money

In Johannesburg, South Africa, supporters of presidential candidate Jacob Zuma celebrated by leaning on horns, blowing whistles and waving flags, after the National Prosecution Authority (NPA) dropped 16 charges against the African National Council (ANC) front-runner. Prosecutors had accused Zuma of taking bribes via Schabir Shaik, his adviser who connived with French arms company Thales International (Thint) to win military arms deals from the state.

Deals with the French company worth several billion dollars were in the works in 1999, when investigators began to look into the details of the transactions. The arms company then apparently worked through Zuma's financial adviser Shaik, and recruited Zuma to interfere with the investigation. Zuma, who served as deputy president under Thabo Mbeki, had faced corruption, fraud, racketeering and money-laundering charges.

In 2005, Schabir Shaik was found guilty of corruption and sent to prison to serve several concurrent sentences amounting to 15 years. In 2005 President Thabo Mbeki dismissed deputy president Zuma after the high court found Schaik guilty. The judge in the case noted the "generally corrupt" relationship between Zuma and Shaik. After serving 28 months of his sentence, mostly in private hospitals, Shaik was released on a controversial medical probation last month.

Upon hearing the charges were dropped against Zuma, hundreds of supporters danced and sang to Zuma's theme song, "Bring Me My Machine Gun", an apartheid era rally song.

Who Needs Lawyers?

Zuma's popularity assures broad support for his election April 22, despite his ripe court history not only the corruption charges, but also a rape trial in 2006. Zuma's comments during the rape trial included the assertion that he had showered to protect himself from contracting AIDS from the woman who accused him of rape, and that he knew that the woman wanted to have sex because of the type of skirt she wore. His comments of course incensed those who care about public health and women's rights. As deputy president under Mbeki Zuma served as the head of South Africa's National Aids Council and the Moral Regeneration Movement. Zuma was acquitted of the rape.

People anticipated the charges would be dropped, and now expect Zuma to win the presidential election. But the corruption case hovers in the background uncomfortably. The case dragged on for years before wiretap tapes and transcriptions emerged which seemed to show a politically motivated plot on the part of the investigators. The case against Zuma fell apart on technicality, but the prosecutor pointed out that his decision: "does not affect the substantive merits of the case against [Mr] Zuma". Some people believe the charges will taint the South African democracy, not to mention the presidency of Mr. Zuma.

Thabo Mbeki dismissed Zuma as his deputy president after Shaik was found guilty, and Mbeki was never implicated in the corruption charges. Ironically though, Thabo Mbeki habitually railed against pharmaceutical companies who offered AIDS drugs, accusing them in one tirade of being "like marauders of the military industrial complex who propagate fear to increase their profits". Of course, while thousands of Mbeki's compatriots died of AIDS, Mbeki denied the viral cause of AIDS and pursued various themes to produce AIDS drugs in Africa. During this time, while Mbeki refused to treat AIDS patients, under his administration billions of dollars of South Africa's wealth was going to foreign weapons manufacturers.

Strong-Arming Countries -- Oil For Planes

In the scheme of things, the bribes that Jacob Zuma accepted were not a big as bribes can get. Starting tonight, Frontline will air a one hour special titled "Black Money", a documentary on international corruption by military corporations. "Black Money" is based on the work of Guardian journalist David Leigh, who has been reporting on BAE corruption across the globe for more than five years. Last year Leigh wrote about BAE bribes to South African, in which BAE pressured the country to buy war planes at inflated prices. Chippy Shaik, the brother of Schabir, worked in the defense department and helped secure the deals.

"Black Money" focuses not so much on South Africa, but on BAE's bribes and the web of relationships between Britain, Saudia Arabia, and the US. BAE devised complex deals to secure £43bn in arms deals with Saudia Arabia. When British investigators at the Serious Fraud Office (SFO) started digging into the deals and Britain's part in them, Saudia Arabia threatened to break off collaborations with Britain against terrorism. Tony Blair's government abruptly curtailed the investigation.

"Black Money" follows the kingpin role of Saudia Prince Bandar bin Sultan, former Saudia ambassador to the US, who benefited handsomely from the bribes. At one point Bandar retorts to the interviewer who probes about the multi-billion dollar deals: "So What?". Filmakers also interviewed former US FBI director Louis Freeh, now a private lawyer and consultant to Prince Bandar also appears "Black Money". He admits that money transfers amounting to $2 billion dollars flowed from BAE in Britain to the US bank accounts of the Saudi prince, but Freeh denies that Bandar accepted bribes. While acknowledging that the complicated deals and payments were set up in part to avoid congressional scrutiny Freeh retorts that the commingling of Saudi accounts is none of the US's business. The narrative and exchanges portrayed in the show "Black Money" add up to no more than "reckless allegations", says Freeh.

Has globalization and unfettered money exchange made the the world as callous as "So What?" and as compromising as Louis Freeh? Corruption is a globalized problem, with some of the biggest victims being the poorest countries, like Bangladesh. Of course all citizens of all countries pay for privileges of the lawless few at the top. The US is perhaps not as corrupt as Saudia Arabia nor is poor as South Africa. But while Africa and Europe and the Middle East and Asia see plenty of corruption, the US has its fair share of nefarious deals and Seawolf-like contracts made in the name of business by self-interested companies, lobbyists and politicians. Even now, as the Obama administration announces the military budget and certain key legislators obstruct the administration's goals to protect their states' prized military contracts, it would be remiss not to acknowledge that the US has its own solid brand of backroom dealmaking and military procurement malfeasance -- not to mention a faltering healthcare system.

• GE Healthcare Marketing Push

  GE and Siemens, which has also made significant investments in healthcare, are currently lobbying Congress against the Obama administration efforts to reduce medical scanning costs in Medicare. Bloomberg News reported that Medicare imaging costs more than doubled to $14.1 billion from 2000 to 2006, according to a June 13 congressional report.

  GE plans to rollout a new healthcare products marketing campaign based on its "Eco-magination" project, which GE told the Financial Times brought in $17bn in revenue last year from the sale of products ranging from jet engines to wind turbines. The new healthcare marketing initiative will "involve numerous parts of the sprawling conglomerate, ranging from its industrial divisions to the media unit, NBC Universal", according to FT. ("GE to pitch its vision on need for healthcare", Apr. 1, 2009) Watch for it on your local TV station.

• Electronic Records

  A study in the New England Journal of Medicine recently showed that few hospitals have electronic records systems in place. Only 1.5% of hospitals who responded to the authors' survey had electronic systems in all units, while 7.6% had electronic records in some units. Another article in the same journal noted that the current records' systems are proprietary software where the lack of a single standard makes integration with other software systems infeasible.

  The Obama administration plans to infuse $19 billion into an effort to get electronic records in place, but the effort could cost up to $100 billion dollars over the next ten years. Which makes it an attractive business to enter. Wal-Mart is now joining Microsoft and Google and GE in offering digital records options. According to PC World, the retailer:

  "plans to bring its low-cost, high-volume mentality to the healthcare industry by offering a deal that includes hardware, software, installation, maintenance and training to convert a doctor's office from using paper to digital medical records."

  Walmart will coordinate the vendors to offer the $25,000 system. Doctors may get $40,000 - $65,000 federal tax write-off to install and use medical records systems.

• Cancer Screening

  A couple of weeks ago two studies came out showing that the prostate specific antigen (PSA) blood test for prostate cancer, which allowed all men to be easily screened for the disease, may or may not be helpful. Screening may result in overdiagnosis and overtreatment in some men for whom the disease would never progress.

  In a similar situation, last week, a kerfuffle in Britain motivated British health officials to promise to rewrite patient information that gave misleading information about the benefits of mammograms. A recent study also suggested that breast cancer screening also led to over-diagnosis. Part of the problem is that doctors have limited knowledge about which cancers will progress rapidly, and which won't progress.

  Such uncertainty is common in medicine. Even if doctors can access all the technology in the world, should they run another test or save the money? How do they assess a patient's most simple claims -- "it hurts?" Is the cancer aggressive? Will the patient follow the treatment protocol?

• "Real Age" Antics

  According to a recent New York Times story, RealAge, an on-line health survey that people voluntarily sign-up for and receive health tips from, is actually a marketing tool for pharmaceutical companies:

  "While few people would fill out a detailed questionnaire about their health and hand it over to a drug company looking for suggestions for new medications, that is essentially what RealAge is doing"

  Apparently the company would email people pharmaceutical suggestions based on symptoms they listed. I had other qualms with the service, like that it rated people's health based on questions about lifestyle choices which were backed up with incomplete or controversial evidence, like -- how many servings of soy do you eat a day? Clearly the privacy issues put a whole new spin on the company's service.

• Antidote

  Should you need one. The New Yorker runs a Cartoon Caption contest every week, where readers (and potential subscribers) submit captions for a cartoon. The staff picks three of the best captions, then on-line readers vote on which of the three they like best. Sort of the New Yorker's "American Idol". This week's cartoon might be science related, a rare event.

  The cartoon depicts a big hefty naked man striding out of the ocean onto the beach. He appears to be saying something and he looks excited. He's following a fish, which has leapt out of the water and is airbound, glancing behind, fish-eyes wide. Here are the three caption choices:

  • "Now that I've met your family, I want you to meet mine"
  • "Your in trouble when we get to the bicycles"
  • "Hi there! Can I interest you in some promotional material about intelligent design?"

  Vote here.

Outrage. Yawn.

59% of Americans who answered a Gallup Poll said they were "Outraged", by the AIG bonuses. This compared to 26% who were "Bothered" and 11% who were "Not Particularly Bothered". What? No "No opinion" choice? In this case, had my executive bonus ennui ebbed to the point where I actually picked up the phone when Gallup called, I could only have rallied if "No Opinion" had been presented as an option.

Outrage: Are you as fatigued from outrage as I am? If you look for "outrage" on Google Trends, which tracks keywords across the newspapers like PerthNow, the Rhinelander Daily News, and the North Wales Chronicle, you'll find that the steady state "news reference volume" of "outrage" has increased gradually since 2004. This means nothing, but despite the lack of any empirical data, my opinion is that outrage has been overdone lately. Bailout outrage, and Madoff outrage, and TARP outrage, and crooked mortgage lender outrage, now Obama's "outrage" at the bonuses. Phheww. Sell outrage someplace else, we're all stocked up here.

In September Barack Obama accused John McCain of using "lies" and "phony outrage" in reference to Obama's ill-received "lipstick on a pig comment." Now Obama's being accused of his own phony outrage.

Being that I'm bored to death of the outrage, I thought I'd return the favor and highlight some of the details of the blueberry research that we talked about in our last post. Conservatives and liberals alike zeroed in on the pork in the Omnibus Spending Bill, like the 209,000 dollar blueberry grant to Georgia.

Blueberries! Research! History! Yay!

Blueberry farming is important to Georgia, since it has a "farm gate value of $59.4 million in 2005" and production with an "economic impact of $97.4 million". The history of blueberry cultivation is told by two University of Georgia scientists in a paper posted at the International Society for Horticultural Science (ISHS). We'll highlight some of the content here.

The early history of cultivated blueberries is most well known in Florida. In the 20th century a logger in Florida who had been transplanting plants from the wild and cultivating blueberries on his farm, met up with a marketing guy, "a Yankee", and together they sold blueberry plants to other communities in Florida. "Most plants sold were transplanted from the wild without regard to fruit quality. Some of the plants sold were not even [the prized] rabbiteye blueberries but species that don't produce commercial quality fruit." However enough higher quality plants were sold to qualify as a "blueberry boom". According to a history of blueberries told by the Georgia scientists, the boom then collapsed for multiple reasons:

"due to variable fruit quality, competition from new plantings of northern highbush in northern states, poor horticultural practices, and the depression (Mowry and Camp, 1928; Horan, 1965).

A statement in a 1926 Florida bulletin summed up the nursery stock situation: 'A great deal of promiscuous experimenting will doubtless be done before the business of handling stock for this fruit will be standardized as has been done for the great stable fruits of the day' (Coville, 1926).'"

Despite the collapse of the early industry Florida scientists managed to establish some strains that worked well for the region. From the early 1900's, when there were no viable options for commercial berries, you just gathered what you could in the woods, science and research made commercial blueberry farming not only possible, but a thriving industry and livelihood for many.

Tobacco's Out. Blueberries are In

"The position was filled by Dr. Tom Brightwell, who received his initial blueberry training under the famous Mr.Stanley Johnston of Michigan State University. In the fall of 1945, the Alapaha Blueberry Research Farm was established in a section of the flatwoods district just 25 miles east of Tifton. This has proven to be one of the great decisions made by Dr. Brightwell...."

"It is of great compliment to the character of Dr. Brightwell that he stayed focused on breeding blueberries in a state where no industry existed at the time. Numerous attempts were made to entice him to switch to some 'important' crop."

"Starting in 1950 the cultivar releases began with 'Callaway' and 'Coastal', which were a large improvement over the wild types, but did not have commercial shipping quality."

Around 1970, citizens in Bacon Co. Georgia sought help from the Rural Development Center of the University of Georgia to grow blueberries as a cash crop. The US Surgeon General had targeted cigarette smoking as a risk to health, and tobacco farmers saw the future demise of their livelihoods. Science continued to improved blueberry farming in Georgia and the authors conclude"

"It appears that Georgia has a bright future in blueberry production. The foundation of the industry laid down by so many scientists and growers over the past 60 years has opened this door."

Blueberries don't grow on trees, I guess you could cornily say, it's research and science success that puts them in your energy bar.

Congress Takes on Bisphenol A

The US House and Senate introduced bills last week that would ban bisphenol A (BPA) in all food and beverage containers. The proposed bills are the latest federal legislation to try to curb the used of BPA, even as production of the chemical continues to increase worldwide.

Studies conducted by the Center for Disease Control (CDC) have found that bisphenol A is found in 92.6% of people tested. For years consumers assumed that the chemical was benign. However BPA has now been shown through hundreds of science studies to be linked to prostate and breast cancer, obesity, neurological problems including behavioral problems in children, precocious puberty, altered sperm counts, immune disorders and other problems.

For a long time, even though more and more studies showed the dangers of BPA, legislation was nowhere to be found. Now legislative efforts are starting to gain traction following increasing public awarenes and outcry on bisphenol A. In 2005 Acronym Required reported on the first bisphenol A legislation out of California, introduced by Wilma Chan, that proposed a limit to bisphenol A in childrens products. "Plastic Bottles- Protecting Your Baby, by the ACC", focused on the industry's use of misinformation about baby bottles to protect their plastics and bisphenol A market. Reporting on San Francisco's attempt to clamp down on the use of BPA in baby bottles and children's products, we wrote: "It will be interesting to watch the progress of this legislative attempt to control use of this chemical". The California legislation was swiftly defeated under industry threats.

In the four years since, the accumulation of science research attracted public attention then propelled citizen action, which in turn motivated city, state and federal legislatures to pay heed. Not coincidentally, the companies who we chronicled vehemently denying the dangers of BPA, now "voluntarily" discontinue some of their controversial uses for the chemical. Not all lobbies are so agreeable however. The Juvenile Products Manufacturers Association (JPMA), which currently owns the site www.babybottle.org that we took exception to 4 years ago, still runs under a banner of blatant lies "PLASTIC BABY BOTTLES ARE SAFE. Convenient. Tested. Trusted."

Taking a Stand on the Precautionary Principle?

Senators Dianne Feinstein (D-CA) sponsored the Senate bill S. 593, which Charles E. Schumer (D-NY) co-sponsored. Said Feinstein when introducing the bill:

"I strongly believe that the time has come to utilize a precautionary standard in all food and beverages with respect to chemical additives. If you do not know for certain the chemical is benign, it should not be used. Bisphenol A, known commonly as BPA, is one such example. It is used in consumer products all around us: plastic containers that store food, compact discs, water bottles, canned soups and other canned foods, even baby bottles. More than 100 studies suggest that BPA exposure at very low doses is linked to a variety of health problems..."

America consumers should not be "guinea pigs", Feinstein said. The bill would ban Bisphenol A from all food and drink containers, effective 180 days from enactment. The chemical is ubiquitous, found in pipes, baby bottles, infant formula cans, dental sealants, and car parts. But the Environmental Working Group commissioned research showing that half of the cans they tested had detectable levels of BPA that would not only expose adult consumers to levels of BPA considered dangerous, but could expose unborn children whose mothers eat canned food to up 200 times safe levels. Therefore a bill that targets the use of bisphenol A in food containers would help keep the chemical out of humans.

Feinstein's legislation would allow companies to petition for renewable waivers by claiming that it was "technologically impossible to replace BPA in that time frame", an interesting and potentially problematic criteria.

The language Senator Feinstein used in her statement is interesting for other reasons too. "Precautionary Standard" is similar to "Precautionary Principle", which is a sort of loaded term, one that industry and free trade organizations detest. The presumed head of the Office of Information and Regulatory Affairs (OIRA) (in the Office of Management and Budget (OMB) in the Executive Office of the President), Cass Sunstein -- unofficially nominated but at large (maybe somewhere in the bowels of OIRA) -- has periodically taken a strong stand against the Precautionary Principle. (For instance read the paper "Laws of Fear: Beyond the Precautionary Principle", the book of the same tittle, papers or the related less conciliatory CATO article on the subject. Some of these same ideas which are propagated throughout his writing including in "Nudge"). If Congress goes forward with the legislation, will it bring the US stance on chemicals closer to the European one? Will the "Precautionary Standard" edge its way into policy or become more mainstream?

Whatever the outcome, if you were to take a stand on the unfortunately named but potent and historically interesting Precautionary Principle, would the chemical bisphenol A, which has been thoroughly researched, be the chemical you'd choose? (It's not clear whether Feinstein is doing this or whether this is just convenient, casual wording.) Acronym Required has written about the disconnect between the hundreds of studies showing potential dangers of the chemical, legislative action, media coverage, and stalling action by lobbyists, in Phthalates and Bisphenol A: Media and Politics".

The research on bisphenol A does not leave very much doubt as to the dangers of this chemical. So then is this "precaution"? Or even "caution"? Or is it legislation that is very late in to the scene, slowed by chemical companies and their intense lobbying, which makes it simply "reactionary". Not to dredge up an overused cliche here, but is this that different from warnings on cigarette boxes, decades after the first health studies came out? I'm not answering, just asking.

Making this a joint congressional action, Congressman Edward Markey (D-MA) introduced the companion bisphenol A legislation in the House. Markey's bill will be known as "Ban Poisonous Additives Act of 2009".

Senator Feinstein also helped write a 2008 amendment to the Consumer Product Safety Commission which banned the sale of phthalate containing products to children under seven. California passed a similar law in 2007.

Communities Take On Bisphenol A and Companies Suddenly Choose Science

As we mentioned above, Acronym Required previously chronicled San Francisco's failed efforts to ban bisphenol A legislation. The San Francisco City Council members deleted language that would have restricted the use of bisphenol A in certain infant and children's products when sued by plastic manufacturers. We also wrote on Chicago's city legislation and Canada's, and Canadian communities' bans. Since then, more communities have taken on bisphenol A, and Suffolk County" is the latest to institute a ban on the chemical. While manufacturers can afford to take one city to court, if multiple states and cities are introducing legislation, the balance of power changes. Steve Hentges, the prolific American Chemical Council spokesman and author of editorials proclaiming BPA's safety must be spinning (as in 360s) trying to keep up.

American manufacturers are expert at stalling legislation. But at some point, they too, glance over their shoulders an realize that legislation and negative public opinion is bearing down on them. Six companies, Playtex Products, Gerber, Evenflow, Avent America, Dr. Brown's and Disney First Years said they would stop the sale of plastic polycarbonate baby bottles in the USA, in response to action by Connecticut attorney general Richard Blumenthal, and the attorneys general in Delaware and New Jersey.

In other company responses to public outcry, Sunoco wrote a letter to investors saying that they would stop selling bisphenol A to companies that can't assure that BPA won't be used in food and water products for children under 3. Sunoco noted they couldn't assure that bisphenol A was safe. Sunoco's action, though rather anemic, was in response to investor actions and queries to the company. Interviewed by the Minneapolis Star Tribune, Tom McCaney, associate director for corporate responsibility at the Sisters of St. Francis of Philadelphia, a group of about 600 nuns who petitioned Sunoco on BPA: "We thought this was a really bold step, especially for a company that's a member of the American Chemistry Council." Bold indeed. Not the adjective I would choose perhaps, since Sunoco's not guaranteeing anything, but a "smart" business move? Sure.

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• Science Budgets That Look Friendly: Barack Obama's budget proposal looks good for science although we know this will get kicked around in Congress. Science reports these proposed budget increases:

  * NIH is slated to receive $7 billion over the $70.5 billion dollar budget, including $6 billion for the National Cancer Institute.

  * NSF: The budget asks for a 8.5% increase to $7.045 billion dollars.

  * DOE: The projection for 2009 is $33.9 billion, in addition to $39 billion for energy programs under the stimulus package, and $1.6 billion for the Office of Science.

  * NASA: $18.7 billion has been requested, which is a $700 million increase over this year's figure. The stimulus package included $1 billion.

• Public Health, Thai Style: Thailand's Anti-Smoking campaign run by the Thailand Health Promotion Institute demands that all cigarette boxes be printed with one of several disconcerting graphics, to dissuade smokers from smoking. So smokers will be able to blow artful cigarette rings while regarding a box adorned with rotting teeth, a body tethered from emphysema to hospital ventilators, lung cancer, or skeletons. The country intends to run similar warnings to dissuade alcohol drinking.

• Branding Triplets: Peter Orszag started an Office of Management and Budget (OMB) blog last week. The first title announced a new slogan: "Discipline, Efficiency, Prosperity". Perhaps the OMB is signaling that branding strategists have swept through to overhaul the agency's image, and that the marketing team incredibly found a few unspoken for adjectives still available after the run of the late 90's. Or perhaps enough companies have gone out of business now that some adjectives are newly available for government agencies to use.

  The OMB promises a turnaround from the apparent Bush era slogan: Dissemble, Procrastinate and Ruin -- and offers the new blog to open up channels of communication.

  Our only experience with Cabinet blogs was reading Mike Leavitt's blog, a communique that wasn't usually a font of transparency. For instance, Leavitt traveled to Africa several times to support PEPFAR and the Bush public health agenda. During Leavitt's 2007 visit, African president Thabo Mbeki was be writing about Leavitt's endorsement of the African National Congress's (ANC) nutrition and HIV/AIDS policies (in Mbeki's usual misleading manner). However, Leavitt's blog of his trip would read like a vaguely concerned tourists introduction to the country. 'All these orphans -- that's going to be a problem....' No mention of HIV/AIDS policies. Dissembling.

  I guess there's only so much transparency allowed on a government blog.

• Paper Cuts: This map shows the distribution of 15,590+ jobs lost from newspapers since 2007. Unlike many online denizens, I actually still subscribe and enjoy paper media. Oh well.

• Poland Spring and Nestle Deterred?: The town of Shapleigh, Maine voted against Nestle in the company's bid to test the spring water in their town for possible bottling. The townspeople reject the idea of Nestle extracting water from their springs. Their vote may or may not accomplish their objective, pending likely legal challenges and the fact that the townspeople don't have say over state owned or private drilling sites in the town. The movie, "Flow" documented the extraction of water in Michigan.

• Rahm Emmanuel Runs the Republican Party: Sunday, Rahm Emmanuel told Bob Schieffer that Rush Limbaugh was "voice and the intellectual force and energy behind the Republican Party." Emmanuel explained that when Republicans "attack" Limbaugh they have to then "turn around and come back and basically said that he's apologizing and was wrong." Sure enough, a couple of days ago, RNC chairman Michael Steele told CNN's D.L. Hughly that he, Steele, not Limbaugh, was the "de facto leader" of the party, and Limbaugh merely had a show that was "incendiary" and "ugly". Today Steele apologized to Limbaugh.

• Measles -- Science In Action: Last week a man returned from Europe with measles symptoms, caught from a friend. Once home, he came into contact with 73 people, which the San Francisco Communicable Disease & Prevention (CDCP) center contacted after activating an Infectious Disease Emergency Response. The man claimed to have been vaccinated twice against measles but couldn't document this. Instead he asserted that his disease symptoms proved that vaccinations don't work. Two of the man's children were also unvaccinated.

  The aptly named Andrew Resignato, the director of the San Francisco Immunization Coalition, noted that since the average person doesn't understand vaccines or disease or science, these perennial outbreaks among the unvaccinated are to be expected. Last year a measles outbreak infected 12 people in San Diego. Earlier this year, a different man returning from India set off another Emergency Response in San Francisco.

• Octopus Are Our Friends: Nothing like an octopus that inadvertently manipulates the water flow in its pool to plunge reporters into anthropomorphic sentiment. The Los Angeles Times reported that a female octopus at the Santa Monica Aquarium "disassembled the recycling systems valve, flooding the place with 200 gallons of seawater". This octopedal dexterity motivated quite a few comparisons to humans.

  The two-spotted octopus, which if spread out, according to LA Times reporter Bob Pool, would be "the size of a human forearm", "floated lazily in the water that remained in its tank", then "watched intently through glass walls and portholes as workers struggled to dry the place out in time for the day's first busload of schoolchildren to arrive on a 9:30 a.m. field trip." (Emphasis mine) Octopus fans immediately started writing in to suggest that the aquarium should name the unnamed octopus, from "it" or "she", to "Flo". Sure, why don't we just invite "Flo" to tea and sandwiches while we're at it?

Lavished, So to Speak

The stimulus package worked out better than it seemed it might when we last wrote about the bill. In the somewhat histrionically titled, "Science Funding Gouged From Stimulus Package", we talked about proposed cuts to the package, including all the intended NSF money. In the end $21 billion dollars of the $787 billion dollar economic stimulus package were allotted to science research and infrastructure. In an article this week, the journal Science called scientists "surprised" to be "lavished" with new funding for beleaguered science institutions, including

• $10 billion to the National Institute of Health (NIH)
• $3 billion to the National Science Foundation (NSF)
• $1.6 billion to the Office of Science in the Department of Energy (DOE)

But lest there be any confusion, "scientist lavished" is quite different from "lavished" as in banking, insurance, and auto industry lavished. We're not talking corporate jets, or $86,000 partridge hunts, Ritz-Carlton junkets, or hundred thousand dollar ads to complain about crack-downs on perks, "lavished". "Scientist lavished" means, wow, we can buy a new beaker? Or -- really? I don't have to mouth pipette anymore?

Surprised scientists may be, as they were habituated to dark downward spirals or plateaus in science and science education funding. Most of the money will be spent, carefully, with what's promised to be diligent oversight, on "shovel-ready" projects -- infrastructure. And it isn't as much money as it seems. As the American Association of Arts and Sciences (AAAS) (publisher of Science) pointed out in an earlier analysis, R&D facilities funding for 2008 was $4.4 billion. Half of that went to the International Space Station. Expenses add up fast. But think of the mileage the US got by **putting a man on the moon**.

The new, use it or lose it funding fulfills intentions Congress laid out in the in the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act -- H.R. 2272, which wasn't funded. The COMPETES Act was co-sponsored by many legislators, including Barack Obama and Joe Biden and reflected years of rhetoric about making the US more competitive in science and technology.

But The Labor is Cheap

Science is a good investment. Research is expensive, true. But think of all the technology born in academic labs. Very low paid graduate students at schools and universities all over the US execute experiments towards diverse inventions like computers, life-saving drugs, space exploration, and medical technology.

Taxpayers get a good deal with scientists. $500,000 salary limits would be no problem, since the majority of scientists working in the US don't make a 20th of that. Grads in labs are paid a fraction of what a newly minted banker earns to enter your deposit onto their balance sheets. Another nice think about scientists is that they don't amass fortunes of $billions of dollars absconded from investors. Rather, shunning office Armani for denim and sneakers, the science corps work away, sometimes cheerfully, hoping for the best from every plate pulled from the incubator, until one day, somewhere down the line, a company announces a drug that prolongs the life of your loved one, and you think, wow, where did that come from? Or not -- but it most likely started as some inkling idea then was developed in a government funded lab, before being passed on to the private sector.

Some scientists have expressed concern that the mass dollar infusion won't be sustained with consistent budgets in future years. We'll hope for the best.

PCA Maneuvers

The Peanut Corporation of America (PCA), responsible for over 630 illnesses and nine deaths from reactions to Salmonella infected peanuts, filed for bankruptcy liquidation. Culpability? The Consumer's Union (CU) reports that the bankruptcy will protect the company from lawsuits. The company listed one to ten million dollars in liabilities and coincidentally, one to ten million dollars in assets.¹ The Washington Post elaborates that lawyers will move to have the stay preventing new lawsuits lifted. CU called on the Food and Drug Administration (FDA) to "oversee food processors so that unscrupulous behavior can be detected, prevented, and deterred".

But in order for that oversight to happen, the journal Nature writes, the FDA needs at least a new commissioner and more staff to replace those lost in the past 5 years. Said Michael Taylor, a former deputy commissioner for policy at the FDA: "Members on both sides of the aisle are getting that there is a system-wide problem here, that there has to be institutional change." Nature reports that even food corporations represented by 10 organizations have appealed to congress for food safety reforms enacted through the FDA. (Wadman, M. "Obama puts focus on FDA after peanut poisonings" Nature 457, 770-771 (2009) | doi:10.1038/457770a)

The agency has been significantly weakened in a worldwide spiderweb of pharma and food production companies that generate increasing threats to consumers and that need more oversight. The FDA however is failing to keep up, and has for years been routinely paraded across the news with systemic problems. The problem is cyclical. Nature's story about the weakened agency has strong similarities to the one told in 1989 by the New York Times.

In 1989 the FDA was "ailing", reported the NYT. Reagan had eviscerated the agency in his deregulatory zeal, and Dr. Samuel Thier, president of the Institute of Medicine in the National Academy of Sciences, told the newspaper: "the Food and Drug Administration is a demoralized group, being asked to do too much with too few resources.'' As was reported this week about the state of the FDA, 20 years ago the NYT reported with an air of dropped-jaw breathlessness: "the situation has gotten bad enough that the industry regulated by the agency has begun to press for a stronger agency".

In 1992 David Thessler was nominated to run the agency, which he did for six years, revitalizing the agency's regulatory authority and working to bring tobacco under FDA control, but drew ire from some businesses.

Privatizing Product Inspection: When It Doesn't Work

Reagan accelerated 'kill the FDA' policy trend, and organizations like Cato and politicians like Newt Gingrich pushed to make shrinking the FDA a public priority. One of their aims is to privatize inspections. The agency was a "monopoly", they said, responsible for millions of job losses in the US. Articles like Cato's 2001 "How FDA Regulation and Injury Litigation: Cripple the Medical Device Industry", helped convince legislators to loosen regulation and contract out important functions.

But an earlier NYT article reported that when the State Agriculture Department inspected the plant in 2007 and 2008, it found multiple problems, especially of food processing services "not cleaned or sanitized". Why was AIB's inspection lax?

When the FDA Fails, Have Your Day In Court?

Meanwhile over in the devices part of the FDA, things are also dysfunctional. A couple of weeks ago 9 FDA scientists who work in the device division wrote a letter to Barack Obama in an effort to bring problems with device testing to his attention. The scientists had first written to former FDA Commisioner von Eschenbach, then to members of the House and Senate, then to the president's transition team before addressing Obama in an effort to get their complaints heard.

The scientists maintain that the FDA has put them under criminal investigation as retribution for their public demands that the agency change how it regulates devices. The current methods for testing Class III devices are outdated, so devices like pacemakers and replacement heart valves can enter the market without adequate testing. An urgent report from the Government Accountability Office (GAO) also found device testing inadequate in an investigation it published this January.

The Minneapolis Star Tribune reported last year on a case where several hundred patients filed a suit against Medtronic for injuries suffered from faulty implanted heart valve replacement devices. A cracked lead in certain Sprint Fidelis models caused strong intermittent shocks to the heart, which apparently felt to the patient like they were getting kicked in the chest by a horse. One 68 year old woman interviewed by the Tribune said in one hour she was shocked 54 times. The Medtronic device received FDA approval as a Class III device.

The suit brought by the hundreds of patients with faulty Medtronic valve replacement with cracked leads was dismissed by a US District Court in St. Paul Minneapolis, who based his decision on a Supreme Court case that protected medical device makers from product liability cases after the products had been through FDA review. The Supreme Court ruling was for a different Medtronic product, the balloon catheter.

When the FDA Fails, Have Your Day In Court?

While regulation can hamper markets, inadequate regulation leads to dangers for citizens that also, in the end, hamper markets. Baseball with no rules would no longer a fun game that millions of fans pay exorbitant amounts of money to watch. From the Harper's Index, January, 2009:

"Number of times FDA officials met with consumer and patient groups as they revised drug-review policy in 2006: 5. Number of times FDA officials met with industry representatives: 113." (Source: FDA)

Perhaps the FDA met with business because of logistics, or because they were there, or perhaps because companies have more money than a 68 year old women with heart problems. Many would probably like to get rid of government so that companies (or as PJ O'Rourke would have it, community organizations) could save their lobby money and put it right back into shareholder's pockets the economy.

But we too will grow old and just might need such a device to continue on with our lives (to continue contributing to the economic wealth of our country). Then who do we trust so as not to get kicked in the chest by a horse 50 times an hour? The system that will revamp the FDA? Or the system that advocates handing all oversight to PCA ("I'll take the fifth, thanks") paid AIB International? Your choice.

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¹ There's the movie "The Corporation". Seen it? It's been around for a few years and is available for download on Google.

Acronym Required has been writing about problems at the FDA since 2005, including posts on BPA and the FDA; Commisioner von Eschenbach's confirmation hearings in "The FDA'S 'Medical Ideology'"; on the beleaguered organization in general -- "Resuscitating The FDA"; the FDA in the wake of various fiascoes and staff turnover, at "FDA -- Calling Off The Dogs"; and about general issues recruiting scientists in "Ethics- The NIH and FDA".

• Penguins in Peril

  More penguins are in peril from global warming. Scientists from the University of Washington report that members of the Magellanic penguin colony from Punta Tombo now have to swim 50 miles farther round-trip, to successfully forage for food -- while their mates sit on the eggs. Last month Proceedings for the National Advancement of Sciences reported on the endangered fate of the Emperor penguins. Remember the trials and tribulations in March of the Penguins that we wrote about in March On Penguins? Now it's even harder.

• Interspecies Love

  Scientists know that various forms of gene transfer occur between species, especially in prokaryotes like bacteria and certain eukaryotes like species in the plant genus Senecio. Native to Sicily, Senecio squalidus for instance, was introduced to the UK about 300 years ago. As the flower spread it, it pollinated with an indigenous flower and formed a second form of that British weed Senecio vulgaris (common groundsel). The alternate morphology of the groundsel had petals, making it look perhaps less "vulgaris" and more like a daisy drawn by a child.

  Building previous research, scientists published a paper in Science last fall, which identified a cluster of genes transferred between Senecio species by introgressive hybridization. The cluster seemed to cause the petals in the second form of Senecio vulgaris, which gave plant a genetic leg-up because it could pollinate more easily. The weed could also then be used by humans in "Loves me, Loves me not" trials -- unclear whether that's an evolutionary advantage, to any species.

  Other eukaryote species don't undergo such capricious genetic exchange although evolution seems always unpredictable. In a paper this week in Nature scientists from the University of Washington compared the genomes of macaques, orangutans, gorillas, and chimpanzees. Macaques split from the other three species about 25 million years ago. Building on previous work, scientists looking at the genome found "bursts of activity" that duplicated whole pieces of the genomes, 20,000 base sequences or more, at the same time that single gene changes were slowing down. The bursts of activity happened at key times, like before the chimps and humans diverged about ten million years ago. The duplications occurred where areas of previous duplications occurred, indicating that these areas rapidly evolve.

• Autism Ruling

  A court ruled that three patients whose children were autistic did not present enough evidence to convince the court that vaccines caused the illnesses. (Could you imagine the havoc is they had ruled the other way?) Despite the decision, parents will still be convinced that their children's autism was caused by vaccines. Or rain?.

• Bisphenol A Updates and Ultimatums

  Health Canada's Health Products and Food Branch and the FDA hosted a meeting of manufacturers and users of packaging materials to discuss strategies for understanding bisphenol A and reducing use of the chemical in consumer products. The FDA is scheduled to issue another round of BPA information on the safety of the chemical on February 24th. In the meantime, the city council of Chicago, in the US, is acting to restrict the chemical and has warned that if the FDA doesn't act by April 30th, it will. I'm sure certain chemical and toy associations are bearing down on Chicago as we speak.

The Politics of Problem Solving in the US. One: Know Your Audience

Michael Moore's 2007 film Sicko was familiar to me even before I watched it last night, because the media dissected all parts of the film with yeahs or boos when it opened two years ago. Moore's concise editorial on the US health care system didn't muddle his point about the superiority of nationalized health care by dwelling on gray areas or discussing exceptions or contradictions. It was a simple tale, US health care: bad; Canada, Cuba, Britain, France health care: good. Criticism about Moore's lack of journalistic rigor was fair, but I found the film surprisingly refreshing.

We've been living an unfolding disaster, whereby politicians meander down the middle of the road, hopping to one side or the other as dangerous objects from the other side veer too close. Always on the path to the next election, they can never stray too far from the middle. Progressive public relations 2009 dictates that you deliver uplifting rhetoric, then when your actions fail to bring the change you promise, you must call everything a giant success anyway. Journalist, activist or politician, you win support and earn money by appealing to all sides and botoxing a cheerful smile on your face.

The Democrats didn't bemoan the cuts after the House and Senate reached agreement on the stimulus package. The bill lost education and state aid, but the centrist crafters beamed on the podium. Susan Collins, Senator from Maine, toed her own Republican party line when announcing the final package of $789 TRILLION dollars. "It is a fiscally responsible number", she said brightly, without choking, sputtering, or falling backwards in a recoil effect from the force of the lie.

While politicians need to wag this way, there's none of this middle of the road stuff for Moore and his "Dog Eat Dog Films". US health care is rotten to the core, and Moore says so, pulling no stops and corralling the most unlikely players -- Cuba, Britain, and sick 9-11 workers -- to play their parts.

Moore focuses on the high profit US insurance industry and the managed care system. He tells real, scary accounts of insurance denials for services that led to the illnesses or deaths of patients. The story appealed to his select audience, but of course the problem is more complicated than greedy insurance companies. Moores' nationalization solution necessarily cuts out all the complications and idiosyncrasies implicit to delivering health care in a 21st centure US. So he was rightly criticized.

Two: Isolate the "Problem" and Develop a "Simple" Solution

But criticize away, every solution proposed for every complicated problem simplifies, whether Barack Obama proposes the solution, or Michael Moore does. When we look to solve complicated system failures, we tend to herd ourselves towards solutions that fall within the bounds of the current broken system. The solution of nationalized medicine for the healthcare problem isn't necessarily simple but Moore makes it look as simple and straightforward as an Old West movie gunfight.

Moore tried to sell a simple solution by making it look easy. Politicians, for lack of imagination, political will and guts, craft simplistic solutions. As it turns out, often the solutions involve technology, which has universal appeal and people don't know how hard it is.

What was the cause of the economic meltdown? It was people who bought mortgages that they didn't understand, like ARM's that ballooned. This caused massive foreclosures. I'll label this the "stupid homeowner" theory of economic meltdown. How do we dust our hands of this problem? Cass Sunstein and Richard Thaler come to the rescue in "Human Frailty Caused This Crisis", published by the Financial Times:

Regulators therefore need to help people manage complexity and resist temptation.... Regulators can reduce the chances of a future meltdown by making it easier to understand financial products....Fine-print disclosure should be supplemented by machine-readable files enabling third-party websites to translate hidden details of the terms.

A preposterous solution to the financial crisis.

Here's a different example, this time the media comes up with the solution. Why is the US health care system flagging? According to USA Today and ABC News, it's because of illegal immigrants. The audience tested "solution" is so self-evident that it needs no explanation. Of course the "problem" is simply not true.

Three: Shut Down Any Solution that Disturbs the Current Paradigm.

Watch no less than five CNBC commentators taking on Nouriel Roubini and Tassim Taleb, trying to force them into making economic turnaround predictions. When Bill Gates comes to listen to you at Davos, chirps one commentator, isn't that "a data point" that indicates imminent economic recovery? Roubini and Taleb persevere through this ridiculousness, counseling how we must change the banks, the compensation, the culture, and everyone running it, "that class of people" who "failed and will fail again". The five person news team clamors noisily for investment advice. The five don't and won't get it, maybe since they're actually still all employed to prattle on like this. They tell the economists that they're there as a sideshow -- Roubini and Taleb have entered the mental ward that is this CNBC show.

The problems plaguing health care are as complex as fixing finance and the solutions offered are also simplistic. For health care, Obama drives towards electronic records. There's something to this, to having all the patients records in one place and accessible, no one can deny that, and we certainly support it. But technology is not the solution, it's another layer of abstraction on top of a broken system, a pay for service (not for health), for profit, high throughput scheme that focuses on "managing" patients, privatizing care, cutting costs, and improving efficiency. This focus on efficiency may work for churning out auto parts, but you can't care for humans via an assembly line.

When It's Not About Technology

Electronic records will help doctors and patients but most of all it will help the current winners, the insurance companies and for-profit entities that stand between to doctors and the patients. Doctors who currently have electronic record systems complain that they're not give time to respond to email, to enter records or to speak with patients, never mind diagnose them. Electronic records will certainly help "manage" costs. But "managing" costs and the endless drive to "efficiency" is what brought the system to its knees in the first place. The focus is wrong and the system is broken.

The New York Times had an interesting account this week by a patient who fared very differently than Michael Moore's sick, helpless lambs. Jay Neugeboren tells the story of how he was given a clean bill of health by his doctors and cardiologist. But shortness of breath and a burning pain in his back motivated him to call on some friends who were doctors. One of them recommended he go to the hospital, where he got an electrocardiogram which showed three arteries totally blocked, and one 90% blocked. Now, ten years after his quintuple bipass surgery, he's doing fine. Neugeboren emphasizes how lucky he was. His clinical profile -- lipid panel, blood pressure, weight, diet, exercise, lifestyle -- was excellent. Without his friends who took the time to listen to his problems, he said, no test or technology predicted how close to death he was. ¹

One caveat to the author's story is this: "I had no conventional risk factors or symptoms", he writes in the NYT. However in an excerpt listed on Amazon, he says: "My father, who died of emphysema at the age of seventy-two, had had a heart attack when he was fifty-nine, but he never exercised, had been overweight, and had smoked three packs of Chesterfields a day throughout his adult life." His father had a heart attack at the same age he did. Which suggests that he did have a conventional risk factor, genetic predisposition. But the author doesn't write that. Apparently he thought his lifestyle would trump genetics, and apparently his doctor thought so too. In his case it didn't. Disease is not necessarily predictable, for patients or doctors.

Because disease is not predictable, and because on so many levels we don't understand health, we need doctors to spend time with patients, to be detectives, first to sort through the patient history, then to decide what that history demands. Is the patient understating the problem or a hypochondriac. Technology shortens time with patients, but who does that benefit? Technology will give more information, but it will most reliably improve statistics with which insurance companies place bets about patient's health and improve their bottom line.

But it's not the solution to the health care crisis, if the crisis is one about poor care -- which it is. Technology seems like a nuts and bolts solution to many people but is as ephemeral as the placebo offered to a villager who sees a doctor for the first time and wants a token to feel better.

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¹ Neugeboren wrote a book about his experience.

Public Health and the Culture Wars

In our last post, we acknowledged that the GOP attempted to derail economic stimulus efforts by studding the recovery package conversation with fear-mongering STD and condom blather. This is old shoe rhetoric. The Republicans perennial feel good tax-cut policies don't work, but when they chat it them with promiscuity and condoms, people for some reason go all woozy and vote for them anyway. So why change?

Just as evolution keeps bumping up against religion when fundamentalists gate crash the classroom, family planning based on science, statistics, and good public policy will always encounter obfuscatory politicians spurred by religious advocates.

The CDC's annual STD report released January 13th indicated that STD infections were rising in the US. That might be expected. The former president George W. Bush removed birth control education from aid programs in favor of abstinence information doled out by religious organizations. During that dark time, the Republican party amassed payback from corporations by corralling the vote of church goers whom they regaled with grisly horror stories about the godless amorality and depravity of birth control.

Still In the 80's?

The GOP strategy, honed over the preceding decades began to bear fruit during the Reagan era and reached a apex during the Bush administration. I was reminded how long ago the evil condom tirades started when I came across an editorial from a May, 1987 issue of U.S. News and World Report. (And it wasn't always a Republican effort.)

In 1987 the AIDS crisis was a looming threat, and the Mayor Koch wanted to run 30 second TV spots, as well as print ads and radio spots to encourage heterosexual women to use condoms. Half a million people in NYC were infected with HIV.

Harold Evans, a contributing editor of US News and World Report reported in "A Necessary Offense", that ABC and CBS refused to run the ads, which Brooklyn Democratic Councilman Noach Dear called "'disgusting'". The stations also opposed the advocacy of Surgeon General Koop, who also recommended using condoms in addition to abstinence and monogamy.

In 1987 religious leaders and network executives protested that advocating condoms would promote promiscuity. However Denmark and Sweden were publicly promoting condom use, as was Britain. As Evans wrote: "no widespread disorder is reported."

Beyond Fundamentalism

Evans said, "birth control is not only accepted by the majority; it is rightly advocated..." Furthermore, in the context of the AIDS epidemic:

"Minorities cannot reasonably expect to prevail when their scruples threaten not just the right of free expression of a majority but the very existence of majority and minority together."

Twenty-two years later, television stations still "parade" morals with an even steeper gradient of "ultimate hypocrisy", since TV programming has of course advanced in licentiousness beyond the "sexual soaps" and "exploitative product marketing" of the 1980's. The initial Republican vote strategy, so successful, morphed into dramatic losses and our current economic fiasco.

Disturbingly, some politicians still resort to this strategy in times when clear headed leadership is so critical. The US touts the superiority of its advanced technology. But if the nation is to be effective against pockets of global fundamentalism as well as the current global economic crisis, politicians best continue to elevate the tenor of their argument beyond reflexive smut groveling, to thoughtful negotiations and leadership. "Tax-cutting" (bolstered by cultural fear mongering) confuses consumer "choice" with democratic freedom and grinds the country down.

• USA Loves BPA

  The FDA, pressed to change its safety assessment of bisphenol A (BPA), announced this week that it needed to investigate the safety of BPA some more. It refused to defer to science on BPA, rather offered up this stalling device. Laura Tarantino, the director of the FDA's Office of Food Additive Safety said "I can't tell you when we will finalize this," she said. "There is a lot of work." Clearly the Bush administration wasn't going to besmirch its environmental record by ruling against BPA.

  Acronym Required has been following BPA in the USA for a few years. Hundreds of studies suggest BPA has negative health consequences.

• New's York's Soda Tax

  The state of New York will raise $404 million by taxing sugary sodas with an "obesity tax". The state is looking not only to raise money, but to help stem the obesity epidemic in a state where 1 in 4 citizens is considered obese by CDC standards. Although the state's obesity incidence increased by 14% since 1995, New York's obesity rates are actually lower than the national average of 1 in 3. The American Beverage Associaton decried the tax on "hard-working families", warning robotically that the new law could cost jobs.

  Acronym Required has written on the politics of the obesity epidemic, for instance in Childhood Obesity, The American Way"

• Stevia -- Safe says the FDA?

  The FDA cleared the used of a stevia extract for sodas this week, giving the substance a "generally recognized as safe" (GRAS) designation. Pepsi and Coke eagerly awaited clearance of rebaudioside A (rebiana), a compound from Stevia rebaudiana. Pepsi will start selling SoBe Lifewater nationwide next year. Coke will market rebiana sweetened Sprite Green. Coke will also begin sweetening its Odwalla fruit drinks with stevia. This has some scientists concerned.¹

  The Center for Science in the Public Interest (CSPI) is opposed to the FDA approval because the safety profile for the chemical is worrisome. Rebaudioside A is a steviol glycoside which is 40 to 300 times sweeter than sucrose. A review study by UCLA scientists notes that Rebaudioside A and its gut intermediary steviol are potentially mutagenic (PDF). Noting that the data on the chemical is sparse and conflicting, the study authors recommended:

  "the FDA should require carcinogenicity and toxicology studies in rats and in mice before accepting rebaudioside A as a GRAS substance or approving it as a food additive. Ideally, all those studies would be conducted by an independent party, such as the National Toxicology Program of the National Institute of Environmental Health Sciences."

  Consider the FDA's different regulatory approach with BPA. Over one hundred studies show deleterious effects of bisphenol A on behavior and health, yet the agency says it needs to do more research. But with rebaudioside A, there are a few conflicting and/or disturbing studies. Yet the FDA doesn't need more research. In "Phthalates and Bisphenol A: Media and Politics" we wrote:

  "If bisphenol A were a therapeutic drug going to market, instead of a chemical with an established global market, and there were 700 studies (LA Times) showing hormone effector effects in animals, but also "two dozen" human studies showing the same responses in humans -- therefore if bisphenol A, the hypothetical drug, had passed through the equivalent of Phase I safety, Phase II efficacy and was well into Phase III trials -- the stock of a certain pharmaceutical company would be skyrocketing based on the evidence. Financial analysts would be jumping up and down in their Aeron chairs predicting sales of the next blockbuster drug....But bisphenol-A is not a drug..."

  Rebaudioside A is not a drug but a sweetener that will bring in profits when kids slurp it down in their Odwalla fruit smoothies. So no holds barred by the FDA! CSPI calls the FDA's move premature and a parting gift by Bush to the soda companies.

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"Carbonated Water, caramel color, phosphoric acid, aspartame, potassium benzoate (preserves freshness), caffeine, natural flavor, acesulfame potassium, citric acid, calcium disodium EDTA (to protect flavor), Panax ginseng extract, phenylketonurics: contains phenylalamine"

I'm sure you could do more harm by adding rebaudioside A, but this isn't the most healthy assortment of ingredients to begin with. And I'm curious what "unfresh" carbonated Water, caramel color, phosphoric acid, and aspartame tastes like?

The Emperor

Obama is making infrastructure and energy a central goal of his administration. Therefore people were heartened when they heard that Obama will nominate Steven Chu, Nobel Laureate in Physics and Director of Lawrence Berkeley National Laboratory (not to be confused with Lawrence Livermore National Laboratory) to head of the Department of Energy. Chu has led LBL since 2004. He's a Nobel Laureate who has formed collaborations in the LBL, the Joint BioEnergy Institute, the Energy Biosciences Institute with Heliosgovernment, industry and universities to forward technological solutions to alternative and renewable energies.

Environmentalists like how Chu sounds because he says things like: "If I were emperor of the world, I would put the pedal to the floor on energy efficiency and conservation for the next decade", as he told Reuters last year. Business likes him because they know that the Energy Biosciences Institute was funded by British Petroleum -- Chu works with industry, of course.

Almost everyone is thrilled that Obama will nominate Chu for this position, and he gets fantastic ratings for his accomplishments to date. Of course there are always naysayers, like the U.S. Chamber of Commerce, representing business. Said William Kovacs, vice president of the organization:

"What you've got are people who are committed to moving forward with regulation of greenhouse gases under the Clean Air Act, which we believe is a huge mistake"...If we're embarking on a new infrastructure program that's going to involve building a lot of roads and bridges, the last thing we want to do is hold it up with CO2 regulations."

There's more than some gobbledygook here, but at least one aspect of his argument, that the economy is too fragile for "green initiatives" is a common kneejerk fallacy of "pro-business" camps. In today's Financial Times, for instance, Phillip Stevens wrote:

"The EU leaders have set a target of cutting greenhouse emissions in the EU by 20 per cent by 2020. They have pledged to increase energy efficiency by 20 per cent and to draw 20 per cent of energy from renewable sources...All this seemed challenging, but possible at a time of prosperity. The voters would surely accept a degree of pain to safeguard the future for their children and grandchildren. Industry had the cash (or cheap credit lines from the banks) to adjust...[but] no longer."

This is course a myth, a common one. People like Joseph Romm have long dispelled these assertions, but business persists. Mr. Chu addressed this himself in an interview last September, when he said: "if you went to an energy-efficient economy, you will kill the economy. That is just demonstrably not true." In fact it's the opposite. Businesses can become more cost efficient by becoming more energy efficient. Changing light bulbs in schools is just a start.

Mr. Chu will not be emperor, but part of Obama's climate team. The Department of Energy focuses on nuclear weapons disposal of nuclear waste and basic science. The Environmental Protection Agency (EPA) carries tremendous influence on emissions and health through its administration of the Clean Air Act, for instance -- or as we're accustomed with the Bush administration, by eviscerating the Clean Air Act.

The Chief Administrator

Not everyone is applauding Obama's choice for EPA head , Lisa P. Jackson. She has won accolades for diplomacy and her handling of various New Jersey environmental problems. However Public Employees for Environmental Responsibility (PEER) wrote a scathing review (some say unfair and uninformed) of her tenure as the Commissioner of the New Jersey Department of Environmental Protection.

PEER even went so far as to say she was worse than former New Jersey governor Christie Whitman. Ms. "your air is safe" Whitman not only launched New Jersey's path to fiscal insolvency, her state environmental policies weren't necessarily "environmental". Interesting how the "Garden State", known affectionately as the "Armpit of the Nation", or "What exit?", holds such a reservoir of EPA administrators.

Jackson has opposed the EPA's recent handling of California's bid to waive Clean Air to act its own program. She also said, "When it comes to the auto industry, the E.P.A. apparently is the Emissions Permissions Agency."

The Czar

Obama picked Carol Browner, Clinton's former EPA head, to be Climate Czar, to coordinate all the agencies involved with climate policy, such as the the EPA, DOE, the DOT, the White House Council on Environmental Quality.

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Acronym Required writes frequently on the EPA. We've also written on effective, versus ineffective government agencies in articles like

From Taiwan: BPA "Potentially Toxic"

Taiwan is considering listing bisphenol A (BPA) as a "potentially toxic substance". Companies that used BPA would be required to notify the Environmental Protection Agency (EPA) of Taiwan. Taiwan is one of the primary manufacturers of BPA in the world. ¹ The country produced 635 megatons of BPA in 2005, compared to about 2260 megatons produced in the US during the same year. Japan, Western Europe, Korea and South American also manufacture large quantities of BPA. (Chemical Week, October, 2005.)

From Canada: CBC's "Disappearing Male"

The Canadian Broadcasting Company (CBC) recently aired a program on bisphenol A called "The Disappearing Male", available here and at CBC. The program broached a subject that hasn't been discussed too much in the media, the effect of certain chemicals on male sexual development, both in humans and other species.

The report reviews the effects of plastics on health and environment according to scientists who have long sought to bring attention to the deleterious effects of endocrine disruptors. The film also reports on a Canadian town called Aamjiwnaang Canada, that sits by a toxic chemical plant, where girl babies outnumber boy babies by about 2:1.

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¹ We previously looked at the response of politicians to citizens' safety concerns in terms of the economics of bisphenol A in Canada and the US.

² The film also provides a brief demo on mouth pipetting.

The New England Journal of Medicine reported yesterday in two on-line publications, that a malaria vaccine in clinical trials called RTS,S passed a round of tests. If further trials prove successful, the vaccine would help protect against Plasmodium falciparum

The Presidential Universe of Me

Another year passed and today's World AIDS Day finds us with many of the same struggles as last year. However there's also been progress.

For instance this year brought funding for Bush's PEPFAR program for drugs and prevention. Bush had said at the ceremony for H.R. 5501, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008:

"...I wish every single America '[sic]' could have seen the tens of thousands of people who lined the streets during our visit, and they were cheering and waving American flags in gratitude to the generosity of the American people..."

We all wish we could have seen it. Instead Bush will have to settle for some crowd appreciation today from President-elect Obama, who congratulated Bush for his efforts on PEPFAR. In response, first Lady Laura Bush said: "That's sweet, so sweet." Bush had been having a blue day, saying in various interviews that he was "unprepared" for war, (but noting there was no war on during his campaign.), that he was "sorry it's [the economic meltdown] happening", and that "some people voted for Barack Obama because of me." Some in the media called this an apology.

On the AIDS front, Bush established PEPFAR, but also ignored family planning which is effective at preventing the virus from spreading. The Obama administration, ever diplomatic, intends to loosen the Bush administrations restrictions on funding, which dictated abstinence only teachings for grantees.

From Failures, New Directions

In other AIDS news this year, the major vaccine initiative came up negative in clinical trials, motivating HIV/ADS programs re-focused their goals.

And in very optimistic developments, the South African interim government chose Barbara Hogan to work as Minister of Health until the new government takes office. See: "New Minister of Health For South Africa. Change Afoot?" Hogan recognizes both the crisis of AIDS as well as underlying issues such as public health infrastructure. Today, Hogan led a minute of silence in South Africa.

Some are Hungry

Last weekend the Los Angeles Times ran a story about the overwhelming number of people lining up for free food at food banks. It was the type of story that newspapers seem to specialize in -- a story that confirms a hunch you have -- the media equivalent of comfort food.

It's a Thanksgiving tradition for TV and print media to feature stories on food banks. But times are rough, you might be thinking, I wonder how food banks are handling the Thanksgiving rush? The answer? They're overwhelmed the Los Angeles Times reports last weekend. as you rightly expected.

No surprise. But two photos accompanying the LA Times print edition caught my eye. Those in line were ample people. No sunken cheeks, no starving, pleading eyes. These wasn't the prototypical collection of hungry people, all bones and rags and outstretched hands with empty porridge bowls -- a sight seen in depression era or developing country photos that makes you wonder about the state of the world. Instead the LA Times photographer snapped groups of predominantly chubby, fat or obese people with shopping carts -- which made us wonder about the state of the world. Not to say overweight people can't be poor or malnourished, and not to say the photo didn't editorialize. But it stll gave us pause.

Some Feast

We may be a poorer nation today, but we're not on-average underfed. For the luckier Americans not standing in the food bank line there's Thanksgiving dinner and lots of choices. Which vegetables, what stuffing, how will you prepare the turkey? Will it be free range? Organic?

Smart Money featured an article recently, "Organic Thanksgiving: What You'll Really Pay", about how much you would spend on groceries if you served an all organic Thanksgiving dinner. You'll know exactly where they're going with this by looking at the link URL: ".../spending/rip-offs...". "Hold on to your wallet", they write.

You'd better hold on to your stomach too. The magazine shopped for organic and non-organic Thanksgiving food in Manhattan, to serve "eight people". Here's excerpts from their list: A 20 pound turkey, 5 pounds of yams, stuffing, 8 cups of chicken broth, a bag of cranberries, arugula, and an orange, large amounts of flour and sugar, three pears, 2 cans of pumpkin pie filling, croutons, a bottle of salad dressing, not to mention 3 bottles of wine. In addition this burdened group of 8 people will eat lots of dairy:

"3 quarts of vanilla ice cream (12 US cups), 1 gallon of milk, 2 pints of heavy whipping cream, 1 can of evaporated milk, 8 sticks of butter [1 per person], and a dozen eggs."

Oh, and 5 cups of broccoli.

The group of 8 will be all set to don they're stretchy pants and go on the dole next month.

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Acronym Required wrote on obesity previously in these posts and others:
"Childhood Obesity, The American Way"
"News of Lightweight Study: "Obese Should Walk Slowly"
Why So Fat? It's System Wide", "Obesity, Worlds Collide" and others, as well as on organic food at
"Organics Disdain in the Media -- Surface Tension"

• Outsiders in a Networked World: In Bangkok, protesters brought airport traffic brought to a halt. In Mumbai terrorists attack. Indian newspapers have jumped to blame the attacks on Pakistan, India's nuclear armed neighbor, while the Prime Minister has said it was the work of "outsiders". Outsiders -- the universal troublemaker.

  Whoever it was, sought out people with British and American passports. [update 11/29/08, this is now disputed] The majority of people killed were Indians.

• Actions Have Consequences: South African president Thabo Mbeki spent his entire administration denying the link between the HIV virus and AIDS. Even when drugs were available, he encouraged people to fortify their immune systems with beetroot and garlic. A group of Harvard researchers reports (PDF) that Mbeki's failure to invest in antiretroviral drugs cost the country 365,000 lives, and 35,000 babies lives, a total of 3.8 million human years from 2000 to 2005. Says the soft-pedaling New York Times:

  : "the report has reignited questions about why Mr. Mbeki, a man of great acumen, was so influenced by AIDS denialists."

  Mbeki was so influenced by AIDS denialists, because he was so influenced by economists of a certain philosophy. Public health is almost always a casualty of a neoconservative-like agenda. Mbeki clearly rationalized how some lives were worth saving, while others weren't. A philosophy that can be born out by people of fine acumen.

  Barbara Hogan who is now the Minister of Health stated that the age of denialism is over.

• Living in Financial Times: We previously wrote about the plight of the underpaid, overqualified science-post doc. A recent Science feature explores financial careers for scientists. Scientists are still being hired in "droves" as quants and advisors for technology and science investments, notes the introductory article. Go forth to Wall Street armed with a Ph.D. How's that for optimism and opportunity? Also try film making, a low paying career with very few opportunities that we profiled last year.

• Turtles -- Swimming Out of Their Shell: Nature reports on an interesting paleontology find in Southeast China. The turtle fossil dates a new species of basal turtle, Odontochelys semitestacea, to 220 million years ago. This turtle is 14 million years older than than the oldest turtle fossils found in Germany. Analysis of previous fossils suggested that turtles had a land based evolution. These new fossils provide a different hypothesis for turtle evolution, that they were water creatures first. The researchers deduced this from evidence of a fully developed plastron (the lower belly shell), but no carapace (the upper flat part of the shell). The turtle of this fossile also had teeth. Scientists will chew over these new findings for a while.

• Crackberry Presidency: Obama's trying to convince various agencies to allow him to keep his Blackberrry, according to various news reports, and as he told Barbara Walters last night. He said he doesn't want to become isolated, surrounded only by a few advisers.

Representative Henry Waxman (D-CA) won the vote to displace Representative John Dingell (D-MI) as chair of the House Energy and Commerce Committee.

Waxman won the 137-122 vote to take over the leadership role that Dingelll held sine 1981. Waxman told reporters after the vote: "Seniority is important, but it should not be a grant of property rights to be chairman for three decades or more." The committee rules on health care, energy and telecommunications, all key issues for the incoming Obama administration. Nancy Pelosi named Dingell "chairman emeritus", which, as the Washington Post puts it: "is an undefined title".

Dingell has been instrumental in protecting the auto industry from higher fuel economy while couching his reasons for doing so in the same terms that the auto industry and its lobbies use. As we wrote in "Congress on CAFE: Detroit misled us", Dingell said last summer about the American consumer's car tastes: "He likes it sitting in his driveway, he likes it big, he likes it safe". The American consumer at that time was clamoring for more fuel efficient vehicles. His wife was a senior executive at GM and her family started the company.

Representative Dingell was also overseeing FDA issues. Dingell and another Michigan Democrat, Representative Bart Stupak were taking the FDA to task over their handling of bisphenol A, and vetting the potential conflict of interest of Martin Philbert. Philbert is a University of Michigan researcher who heads a Risk Center that is largely supported by a private grants from a retired manufacturer who thinks BPA is being maligned by "mothers' groups and others who don't know the science."

Dingell fought to keep his position, emphasizing his work on the FDA issues. Indeed a flurry of recent communication from the House Energy and Commerce Committee underlined the committee's work in this area. Dingell and Stupak said yesterday that they would review "compelling evidence" that the FDA approved some medical devices despite safety concerns. They released an October 14th letter by FDA agency employees who said their managers "ordered, intimidated and coerced FDA experts to modify their scientific reviews", in order to release medical devices despite safety concerns. The October 14th letter described "corruption, illegality, gross mismanagement and retaliation at the hands of FDA managers."

While Dingell might have released the letter to emphasize the important work his committee is doing, FDA employees also have an interest in airing their grievances now, while change is in the air.

Some recent news:

• Plastic Bombastic In Everything You See -- In Your Soup, In Your Turkey Dinner, Even In Your Tea:

  Like the San Francisco Chronicle before them, the Milwaukee Journal Sentinal recently sent some plastic products to the lab for independent testing. In 2006, the Chronicle reported the bisphenol A and phthalate lab analysis results for a couple of dozen toys it had tested at an independent lab.The Chronicle's lab found that toys like a rubber duck, a Baby Einstein rattle, and a Goldberger doll had high levels of phthalates or BPA.

  The Milwaukee Sentinel sent products labeled "microwave safe" to a lab to see if the plastic products leached BPA. They did. The American Chemical Council denied the results of this study (and hundreds of others), saying there's no research whatsoever that shows anything bad about BPA.

• Plastic Classics:

  900,000 pounds of Lean Cuisine frozen chicken dinners will be recalled by Nestle Prepared Foods Co. because customers found chunks of blue plastic in Cafe Classics Pesto Chicken with Bow Tie Pasta, Spa Cuisine Chicken Mediterranean and Dinnertime Selects Chicken Tuscan. A USDA spokesperson warned that "a piece of plastic could cut your mouth, it could scratch your throat."

  Consumers are left to speculate about what happened as they toss their TV Dinners and pull into the Old Spaghetti Factory. Did someone on the assembly line pull the blue dye lever instead of the green one that gives that authentic look to the oregano and basil flecks? Nestle traced the plastic to one mean Lean Cuisine facility but hasn't divulged what piece of machinery dissassembled into their cuisine.

• Melamine and Me:

  While the US lambasts China for a regulatory system that allows melamine into the food chain, the New York Times reports that melamine is all around us in products made in the US, cleaning products, plywood, plastics, ink and paint all contain melamine. However yes, the author concedes, "[t]o be sure, in China some food manufacturers deliberately added melamine to products to increase profits."

• FDA in China: "An Ant Standing Against a Flood":

  That's what one company executive told the Washington Post in response to news that the FDA is opening offices in three cities in China to more closely oversee some of the regulation functions. The agency will post thirteen inspectors to the country this week.

• There's Research...Then There's "Research":

  The Federal Reserve Bank of Philadelphia surveyed 51 economic forecasters who unanimously conclude that the United States is in a recession. The gloom and doom predicted by economists however, isn't matched with by stock analysts research according to a report by Thomson Reuters Starmine.

  US analysts rated 48.6% of the stocks they cover as "buy", compared to 49% last year. Only 6.7% of US analyst ratings were sell, the lowest of all countries surveyed, and the rest -- about 45% were "neutral" or "hold." According to the Financial Times article which reported on the overly "rosy" predictions, William Herkelrath, StarMine's US sell-side specialist said: "'the use of the word 'neutral' here really does mean: 'stay away.'"

The Bush administration is busy trying to push through 90 new laws with abbreviated public comment periods and accelerated rule-making procedures. Many of these last-minute laws would benefit industry by reducing regulation. Earlier this month OMB Watch summarized some of the action items the Bush administration is trying to roll out before the end of the 43rd presidential term. Some of the alarming changes would devastate certain environmental protections and affect the EPA's oversight of the environment. The proposed changes include:

• Allowing mining companies to dump refuse into rivers and streams.
• Weakening the Endangered Species Act.
• Allowing factory farm run-off to pollute streams.
• Loosening regulations on placing power plants near national parks.
• Exempting factory farms from reporting air pollution.
• Loosening ocean fishing management regulations.
• Doing nothing about oil refinery toxic emission control which Congress mandated.

In other odious news, a Department of the Interior rule proposed at the beginning of the year would get rid of the ban against carrying loaded firearms in National Parks. 77% of retired National Park Service employees oppose this change. The Park Service might be thinking along the lines of, how would you like to run into a retired Vice President Cheney taking popshots at birds while you're hiking with your family though the Grand Tetons? The other danger is that lifting the ban would increase "impulse" kills of wildlife by gun-toting hikers.

Some more Bush rules, these from the Department of Health and Human services, would allow healthcare workers to deny certain services that they morally oppose, and would strengthen the requirements on certain HIV and AIDS grantees to explicitly oppose prostitution and sex trafficking. These populations are the very populations that most need the services and education about HIV/AIDS, and who are at risk of spreading the disease throughout the population.

The only good news is that some of these rules are the type of regulations that the Obama administration plans to reverse. The administration appointed Susan Wood to be co-chair of the president-elect's advisory committee for women's health. She recently told Bloomberg News: "We have been going in the wrong direction and we need to turn it around and be promoting prevention and family-planning services and strengthening public health."

However OMB Watch warns:

The next president will be unable to repeal or reverse any Bush-era regulations that are final and in effect. Short of actions taken by the courts in the face of potential lawsuits, the new administration's only option would be to restart the rulemaking process. A typical rulemaking can take years to complete.

The Washington Post reports that the Obama team is targeting administrative actions and executive orders that would be quickly undone "to reverse White House policies on climate change, stem cell research, reproductive rights and other issues, according to congressional Democrats, campaign aides and experts..."

---------------------

Acronym Required Wrote on Susan Wood's resignation from the FDA over the agency's handling of Plan B in 2005 and 2006 in "FDA -- Calling Off The Dogs" and The FDA's Medical Ideology". Acronym Required writes often about environmental regulation, or the lack thereof, and about the EPA.

YAY!

It's a new day.

"...His triumph was decisive and sweeping, because he saw what is wrong with this country: the utter failure of government to protect its citizens. He offered a government that does not try to solve every problem but will do those things beyond the power of individual citizens: to regulate the economy fairly, keep the air clean and the food safe, ensure that the sick have access to health care, and educate children to compete in a globalized world..." (NYT)¹

Yes, there's work to do. Yes, it will be difficult. But today we recognize how much America's just accomplished.

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¹Obama won despite warnings about possible GOP ballot fraud stemming from information dribbling out of the Ohio trial concerning 2004 Ohio ballot fraud. In the latest episode, Michael Connell, a consultant whose firm has been accused of computer manipulation, denied knowing anything about GOP rigging the 2004 Ohio election results. Connell works for Randy Cole. Cole owns 15 companies that work simultaneously on GOP election campaigns (Bush/Cheney 2000/2004, McCain 2008, many others), anti-Abortion groups and churches, GOP mass mailings, government contracts, etc. Stephen Spoonamore, a key witness in the trial brings the allegations, explains in a multi-part series starting here.

Happy Halloween. Over 23 million people have voted in early elections across the United States. People are now driven to distraction by the election, even Acronym Required at times. But we're also distracted by science topics.

• Decidin'

  For instance take the cartoon that accompanied an article in last week's New Yorker. It was a drawing of a TinTin looking character, eyes wide, eyebrows arched, finger to his pursed lips, puzzling over two choices on a wall chart. On the left I saw a rooster. On the right I saw a Drosophila.

  The accompanying article "Undecided", by David Sedaris, discussed the baffling group of supposedly undecided voters:

  "I look at these people and can't quite believe that they exist. Are they professional actors? I wonder. Or are they simply laymen who want a lot of attention?"

  He placed the dilemma in terms of airline food (he probably flies in the class where the still have that):

  "The flight attendant comes down the aisle with her food cart and, eventually, parks it beside my seat. "Can I interest you in the chicken?" she asks. "Or would you prefer the platter of shit with bits of broken glass in it?"

  It still took me a while to figure out that the cartoon character was standing in a voting booth. The choice was not a silly Rooster or Drosophila but "chicken" or "shit with bits of broken glass" in it. The Drosophila wasn't that at all, just a giant red-eyed other type of more fuzzy fly, standing on a small brown mound that represented Sedaris' subject, "shit". In an effort to explain my confusion, I'll just say I was writing about C. elegans at the time, another model organism, so perhaps that's why I saw Drosophila melanogaster.

• Buggin'

  It was a Drosophila kind of week. Scientists and many knowledgeable Americans (and French) were angry that V.P. candidate Sarah Palin dissed fruit fly research as waste. Of course she wasn't talking about Drosophila melanogaster, but olive fruit flies in a completely different taxonomic family. But the outrage over her perfunctory dismissal of California agricultural research is warranted.

• Poisonin'

  Updating our melamine coverage from previous posts, this week brought China and Hong Kong melamine contaminated eggs, thus widening the scandal. The culprit may be melamine laced grain which has spread the toxic chemical throughout the food chain. China is now culling chickens. The past year has seen the demise -- through culling and dumping -- of some major protein sources, pigs, milk, eggs, chicken -- hopefully there's some unadulterated beans and soy and rice around.

• Labelin'

  India passed the Prevention of Food Adulteration (Fifth Amendment) Rules, 2008, which will require food product labels starting in March, 2009. Fruit products cannot be labeled as such unless they contain fruit, etc. Cardiac conscious customers will now be able to identify transfats such as "vansapati", hydrogenated vegetable cooking oil which is commonly found in packaged food.

• Trick-or-Treatin'
  The cost of drugs to treat type 2 diabetes doubled between 2001 and 2007, according to a report in the Archives of Internal Medicine, from $6.7 billion dollars in 2001, to $12.5 billion dollars in 2007. The higher cost is due to new drugs, which can be 10 times higher than old drugs, as well as increased numbers of patients. The number of patient visits increased from 25 million in 1994, to 36 million in 2007.

  But today's Halloween. So here's a carbohydrate chart (PDF!) from "DLife" (For Your Diabetes Life!") For example:
  - 3 Musketeers 16 gram fun-sized bar: 12 grams
  - Gummy Bears 11 pieces: 30 grams
  - M&M's "Halloween" mini box: 10 grams
  - Tootsie Roll midgets 12: 30 grams
  - Heath Bar 1.4 oz. bar: 20 grams
  

• Cravin' Palin

  One of this year's most popular costumes is a Sarah Palin costume. This would be a challenging one to pull off for three reasons. One, it's just gonna' be an icky couple of hours sitting in that particular suit. Two, do you really have her style down? Sarah Palin is hot, according to, well, everyone, which may be hard to live up to. I recently got an explanation of this relative hotness -- it's "niche hot". Therefore if she doesn't win the vice presidency maybe she'll vamp through Playboy, with a "hot" politician theme, and if not that, then she actually already has her Palin calendar awaiting your purchase.

  But she's a tricky act to follow, which brings us to your third challenge. You might be able to cackle "you betcha!" with the best of them, you might be able to wink wildly, you might be able bend the elite right wing news staff of the Weekly Standard, the National Review, The Hill, and the New York Times to your side by leading them around by the front of their pants, as a recent New Yorker article describes¹.

  But do you really have her diction down? Can you remember to drop the "g" on pallin', and lyin' -- like Palin'? Maybe, but can you remember to leave the "g" on the word when necessary? Can you remember to say "cravING", as she does? As in, American's are craving that straight talk"? And Americans are craving something new and different..." You're not hearing "I'm Sarah and I'm cravin'". Americans are cravinG.

  Sure "it's genuine, not affectation", just like she's genuine in every other way, an outsider, didn't hire lobbyists to buff her image as Alaskan governor. I think it's a tough Halloween costume to pull off.

• Swoopin' & Spookin'
  Merriam Webster's Word of the Day is Chiropteran:

  "Chiroptera" is the name of the order of the only mammal capable of true flight, the bat. The name is influenced by the hand-like wings of bats, which are formed from four elongated "fingers" covered by a cutaneous membrane. It is based on the Greek words for "hand," "cheir," and "wing," "pteron." "Cheir" also had a hand in the formation of the word "surgery," which is ultimately derived from the ancient word "cheirourgos," meaning "doing by hand."

  Acronym Required wrote a little about bats in "Bats, Riddles, and Viruses."

• Mappin' not Spyin'

  The town of Molfsee, Germany, is rebelling against Google's "Street View". Google would dispatch vehicles with camera's to map the town's streets, but the 5,000 citizens have laid down the law. The company would need a special permit to photograph the city's streets, which the town politicians refuse to grant. The town's concerns about privacy are shared by state and federal privacy experts, according to Spiegel.

• Votin'

  As for the election, some, like Larry David, are pacing and suspicious. There's been a steady stream of alarming reports about voting machines, it's no wonder that everyone's a bit on edge.

  There's apparently a trend now, everyone's droppin' their g's. On the positive side, voting turn-out so far is great. Pray; no Hope; no Work for the most honest, cleanest result.

--------------------------------

¹ This article also contends that this one young Republican started a blog advocating Sarah Palin for Vice President, and that blog precipitated a lot of conservative enthusiasm: "In the month before Palin was picked by McCain, Brickley said, his Web site was receiving about three thousand hits a day". To put this in perspective Daily Kos gets about 2,604,779 page views a day, so if there's about 3-4 hits per page view, DKos gets about 6 million hits a day. Brickley was getting about 1000 pages a day -- not too much.

Subcommittee to FDA: Room For Improvement

The FDA subcommittee reviewing the FDA's August 2008 draft report has released its first recommendations(PDF) on the draft BPA report. The subcommittee brought lots of suggestions for improvement.

They wrote that the draft did not adequately provide scientific support for their method of choosing which studies to include: "Specifically, the Subcommittee does not agree that the large number of non-GLP studies should be excluded from use in the safety assessment."

The subcommittee also questioned the use of "no observed adverse effect level" (NOAEL) standard the FDA employed to determine the safety of exposure. The panel pointed out that so many studies show effects in neurobehavioral development, prostate gland, mammary gland and puberty in females, that it seems BPA must bind to gonadal hormone receptors during development. The panel said this suggests safe exposures "at least an order of magnitude below the 5 mg/kg/bw/day NOAEL identified in the draft assessment." The panel authors suggest several alternative ways to measure dose response that would model findings across the many studies that the FDA excluded in its draft.

The subcommittee offered additional point by point criticism and noted that the studies cleared by the NTP's Center for the Evaluation of Risks to Human Reproduction (CERHR) indicate that the FDA standard should be "substantially below (i.e., at least one or more orders of magnitude lower than) the 5 mg/kg bw/day level selected in the draft FDA assessment."

Living Through Chemistry -- U. Michigan and Dow

The FDA panel released their draft at an opportune time. Philbert was under increasing pressure about his role on the panel given appearances of conflict of interest. Acronym Required wrote a couple of weeks ago on Philbert's directorship of the University of Michigan SPH Risk Science and Analysis program, founded and heavily contributed to by Charles Gelman, a retired manufacturer and tireless critic of chemical regulation. Had the subcommittee's report dared reach the opposite conclusion than the pressure would have increased.

Following our post Martin Philbert wrote a letter to the editor of the Milwaukee Journal Sentinel protesting the paper's allegations that his work would be influenced by the donations he accepted from Gelman: "This simply is not true", he said.

To illustrate his point he described in his letter the $15 million dollar grant the Risk Science Center took from Dow Chemical for a dioxin study. Philbert told how, given the grant, his colleagues "still found that people living near the Dow plant had higher levels of dioxins in their bodies."

Nobody found Philbert's assurance about his work for Dow Chemical comforting since Dow manufactures bisphenol A and takes political action to protect its market when necessary. For instance at (http://dowaction.com/grassroots/notice-description.tcl?newsletter_id=30665022), you can read Dow's letter thanking their employees for their "Best in Class", 31.5% "grassroots" effort in defeating California SB 1713 Bisphenol-A Ban.

The University of Michigan task in the Dow study was to measure blood dioxin levels of home-owners in different geographic areas -- not to investigate health affects. In that sense the dioxin study is not an analogous situation to the BPA panel. But even if were comparable, the University of Michigan results got Dow off the hook in a way, by finding that the variation in dioxin levels was due to things like age and body mass index (BMI), not levels of dioxins in the air or soil.

Media, politicians, citizens and scientists criticized the study because Dow had long been under pressure from the EPA to clean up dioxin contamination ¹ and the study was seen as a stalling technique. The EPA had this to say in one memo: "the study was initiated at the request of Dow in order to downplay the risks of exposure to dioxin contaminated soils." The EPA went on to say:

"public presentations of the preliminary results have emphasized how little effect living on contaminated soils has one an individual's dioxin blood level. This emphasis has resulted in numerous media stories, an understanding by some members of the public, that remediation of dioxin contamination is unnecessary."

The BPA memo on the FDA draft will no doubt assure the doubters in the public that Philbert's panel has their best interests in mind. ² If not, Philbert warns that he will "think long and hard" before taking time to "perform this kind of public service".

Stay on your toes...

-------------------------------------

¹ Burnham, D. "1965. Memo Show Dow's Anxiety on Dioxin.", NYT 1983)

² Perhaps Dow's BPA economy is not at stake in Michigan? John Dingell (D-MI), bulldog for the auto-industry, has also taken on BPA.

Methods Suspect. Evidence of BPA Harm Swept Under the Rug?

In their August 2008 draft evaluation (PDF) on the safety of bisphenol A (BPA), the FDA used industry studies to reaffirm that an older, no observed adverse effect level (NOAEL) for humans. Their evaluation that BPA was safe flew in the face of hundreds of peer-reviewed studies that show low doses of BPA has potentially damaging affects on human development. In our last post we described how congress is closing in on the FDA, criticizing their methods for evaluating the safety of BPA and questioning FDA conflicts of interest.

Last week, 36 bisphenol A researchers also called into question the FDA's procedure for evaluating BPA science. In their published paper Myers et al analyzed an industry study authored by Tyl et al, (including authors from Bayer, Dow, ACC, TRI, and SABIC Innovative Plastics) paper ¹, used by the FDA in their draft assessment, earned ten pages of criticism from Myers et al.

Neurobehavioral Affects Swept Under the Rug?

Two recent NIH reports, the 2008 NTP report, and Chapel Hill Consensus Statement indicate that the "greatest level of concern [for BPA] was directed towards possible neural and behavioral effects caused by BPA exposure in utero." Low dose bisphenol A is implicated in "changes in brain structure, brain chemistry and behavior represent the largest portion of the published low-dose BPA literature."

The NTP is supposed to advise the FDA on regulatory matters, but the FDA's draft report did reflect NTP conclusion that there was "some concern" about neurobehavioral effects. Instead, the FDA draft said that there was no evidence to support such a warning. Included in " documents on the FDA site is a research review of neurobehavioral studies contracted by The American Chemistry Council's (ACC) to Exponent ¹, a consulting company in San Francisco, California. Exponent unsurprisingly found "no consistent adverse effects of perinatal exposures to low doses of BPA on neurobehavioral endpoints based on the 18 studies," a decision reflected in the FDA draft.

Good Laboratory Practice: "FDA's Misguided 'Gold Standard'"

The many, many low dose studies should convince anyone that BPA is not safe. Yet the chemistry industry keeps coming up with its own studies, one after another, which show the opposite results of non-industry scientists. The 2008 FDA draft gave the most weight to two industry studies that followed Good Laboratory Practice (GLP) standard.

Myers et al explain that the FDA designed the GLP standard to stop widespread private lab fraud in the 1970's, following a federal investigation of private lab practices. Scientists in the 1970's investigation needed to re-run 4000 tests by 235 companies and re-examine safety profiles of 15% of all U.S. pesticides on the market. Several men from one company were sent to prison for doctoring data. The Myers et al authors note:

"...fraudulent results were possible because contract lab studies used in the regulatory process are rarely subject to the checks and balances that peer-reviewed, replicated scientific findings undergoes."

The FDA's resultant industry GLP standards require extensive record-keeping to halt the type of fraud that Myers et al say is largely prevented in peer-reviewed research conducted under NIH grants. Another impediment of using GLP in academia is that GLP standards require large sample numbers of rats. 8000 rats were killed in a 2002 industry BPS study (a distressingly gross pile of dead rats). Such a large number of sacrificed animals would violate the animal care guidelines under the NIH grants.

GLP Trumps Good Methodology?

Among the supporting documents for the FDA draft here on the FDA site, you can find the ICF consulting product that Acronym Required mentioned in our last post, the neurobehavioural review contracted by ACC to the consulting company Exponent², and various other reviews and communications.

There's obviously industry involvement in the FDA review. However, it is the government agency's job to consider the arguments of all constituents. I challenge anyone who doesn't know BPA research very well to make too much out of the content of these documents. However, given the FDA's conclusion you can's help infer that some of the industry sponsored research on the site influenced their decision. One you suspect that the FDA is influenced by industry, every document could look suspect.

For instance in one document ("Bisphenol A - Review of studies conducted by Vom Saal et al, Nagel et al, and MPI Research"), an FDA scientist, Dr. Sprando, compared low-dose studies on prostate development from Frederick Vom Saal's lab to an industry study where the scientists tried (and failed, with much public ado) to repeat Vom Saal's results. The MPI study used more animals in its experiments, which Sprando says makes the industry study "more powerful", an assertion that's not necessarily true.

More disconcerting, MPI's positive control failed. The FDA noted the lack of positive result, dismissed it, and concluded that all the results conflicted on neurobehavioral affects, therefore no decision was warranted.

Who To Trust?

On one hand you have several studies from Vom Saal's labs, as well as a later study from another academic lab showing negative affects of BPA on prostate development. On the other hand you have the MPI study sponsored by The Society of the Plastics Industry, Inc. which finds nothing. As with every other endpoint, the FDA compares NIH studies to an industry study, a "GLP" study, and favors or heavily weighs the industry result.

Myer's et al have concluded that the industry studies used by the FDA are "invalid":

"The fact that the U.S. regulatory community is willing to accept these industry-funded, antiquated and flawed studies as proof of the safety of BPA, while rejecting as invalid for regulatory purposes the findings from a very large number of academic and government investigators using 21st century scientific approaches, is of great concern."

"Industry research" shouldn't be code for "fraudulent", but it's difficult to read through these documents and not be suspicious. The GLP standard intended to lend credence to industry research which is not peer-reviewed, research that is subject to conflict of interest and historically littered with fraud. Now GLP is ironically being used for an important health decision on BPA to exclude over a hundred peer-reviewed studies.

Not only does this blemish industry research, it makes you wonder about academic research. Taxpayers invest in unbiased, peer-reviewed research on issues like whether BPA is safe for human consumption. The far wealthier chemical industry can fund a study showing some opposite result every time it sees something that might impede business. The FDA appears as if at times to be in cahoots with industry -- no? But what about the people? There's got to be a better way.

--------------------------------

¹ Tyl et al: Two-Generation Reproductive Toxicity Study of Dietary Bisphenol A (BPA) in Mice. April, 2008: Toxicol Sci 104: 362 - 384.

² Exponent is chemical consulting company located in San Francisco. Elizabeth Anderson, who is on the management team, was previously the president of Sciences International, the company fired for conflict of interest from the NIEHS bisphenol A contract, which we wrote about here and here, founded the journal Risk Analysis.

Charles Gelman, retired from Gelman Sciences, now donates his wealth through the Gelman Educational Foundation. Gelman is a vocal critic of chemical regulation and supporter of free-market organizations that fight regulation. The foundation gave a 5 million dollar gift to the University of Michigan School of Public Health Risk Science and Communication Center, which Gelman has called his "legacy". That center is directed by the head of the FDA panel which will review the safety of bisphenol A (BPA). Will the decision of the FDA committee be compromised?

Canada just announced its plan to place BPA on its toxic or hazardous chemical list, which will give the government unprecedented authority to ban the sale of bisphenol A containing polycarbonate baby bottles and to demand bisphenol-A-free packaging from baby formula makers.

The US lags behind Canada in the regulation of bisphenol A for a number of reasons, like the different politics and economics of BPA in each country; therefore the US moves ahead on regulating BPA more slowly, in a sort of two step forward, one step back pattern.

Last week, the Attorneys General from Connecticut, Delaware, and New Jersey asked 11 manufacturers of baby bottles and infant formula to stop using bisphenol A. Yet the federal Food and Drug Administration (FDA) steadfastly maintains that Bisphenol A poses little risk for humans. The agency contends that the estrogen related chemical is not dangerous in the doses the FDA predicts people will ingest, despite research showing otherwise.

In the FDA's last review, issued last April, the agency used industry sponsored studies to make its decision. People tend to jump to conclusions about the validity of industry data, using a study's funding source as a proxy for trustworthiness rather than examining the data. But their correct to be concerned about industry research in the case of BPA because hundreds of government and university studies show very different, more alarming results.

The House Energy and Commerce Committee plans to interview FDA Commissioner Andrew von Eschenbach to question him about the agency's procedure for rating the safety of BPA. While the first FDA results are under congressional investigation, a second committee chaired by Martin Philbert was also set up to review the first FDA decision.

Last week, in the continuing saga of bisphenol A policy, the Milwaukee Journal Sentinel revealed that the University of Michigan center that Martin Philbert heads received a $5 million dollar gift coincident to his appointment to the FDA BPA review committee. (The FDA would not be the first government agency to have a conflict of interest on BPA, recently an NIH subcommittee studying BPA was also found to have controversial links to industry.)

The donation was given to the University of Michigan's School of Public Health (SPH) Center for Risk Science and Communication by Charles Gelman, a retired manufacturer with strong views on regulation and chemical safety. The Sentinel reports that Gelman told them in an interview that bisphenol A was perfectly safe, despite the opinions of - in his words - "mothers' groups and others who don't know the science." According to the Sentinel's report, Gelman passed his opinions about bisphenol A on to Philbert, who claims to have refused to discuss the issue with his benefactor. Philbert's conflict of interest statement for the FDA did not list the donation.

Industry Secret: Can't Beat the Law? Make The Law.

Acronym Required dug around a little more. Charles Gelman is a well known figure in Michigan. He made his fortune founding and running Gelman Sciences, a maker of plastic filtration devices. For several decades the company polluted groundwater and aquifers in Michigan with 1,4-dioxane, (PDF!) listed in California as a known cancer causing chemical. The pollution was discovered in wells near the plant in the mid-eighties and the state's Department of Natural Resources (DNR) rated the Gelman Sciences site the second worst industrial waste site in the state. The DNR then took regulatory steps to ensure that the company cleaned up the waste. In response, Charles Gelman launched an offensive that included everything from suing one of its main customers, Dow Chemical for 'falsely advertising' that it stewarded its chemicals "cradle to grave" (dismissed in court); to staging a boisterous parade through town with local business leaders when the DNR was scheduled to meet.

While settling homeowners lawsuits against the company, Gelman Sciences staged an epic fight with the state documented extensively by the local media. The company commissioned its own $50,000 study from the University of Michigan to show that other commercial products also contained the chemical. Gelman Sciences installed their own copier at the DNR while it tried to dredge up evidence against the state. The company also ran smear campaigns against people and non-profits involved with any actions against the company. Several years into the battle, the company had spent more on lawsuits against the state than it would if it had cleaned up its pollution, according to a September, 1991 article in Corporate Detroit (Waldsmith, L.,The revenge of Charles Gelman.; Gelman Sciences' legal battle with the Department of Natural Resources).

Then Gelman began pouring efforts into public policy, as he told the Corporate Detroit reporter:

"One thing I've learned is that business has some responsibility to participate in drafting legislation and being active in the legislative process, rather than paying no attention to it at all. That's the way bad laws are written."

Charles Gelman has stuck to his belief that he was wrongly accused, in his experience with the state set a course for his future actions. In 1994 while criticizing the state's lack of science knowledge, Charles Gelman told a state hearing on natural resources that 1,4-dioxane is not harmful, and no scientific evidence proved it was. When Charles Gelman's Foundation gave the $5 million dollar gift to the university last summer, Gelman noted that his gift was driven by his experience with the state on 1,4-dioxane.

I have Five Million Dollars. Would you Like some Job Security?

In gifting his millions to the university center, according to announcements the University published, Gelman noted that chemicals are complicated, and "our vision is to help inform industry, government and the public about how to properly assess the benefits and hazards posed by technology (and chemicals in particular) in our society." His wife Rita added that they were particularly interested in assessing the risks versus benefits of chemicals.

The gift establishes an endowed professorship for the UMRSC Director (Philbert is now the acting director), and will pay for two new faculty, scholarship support for students, and the Risk Science Master's in Public Health curriculum.

The gift from Gelman Education Foundation to the Risk Center certainly wasn't an out of the blue. The U. Michigan risk center was originally established with a $2.9 million dollar grant from the Gelmans, which David Garabrant, the director at the time called, "the foundation upon which the center will be built". The Gelmans also make frequent smaller (hundred thousand dollar) donations. According to Gelman, the center is his "important legacy", something that "will make a difference" as the Gelmans noted when they gave the initial 2.9 million dollar grant.

It would be a quandary. If you were a professor, in times when grants are tight, and someone offered to give you that amount of money what would you do? Perhaps you'd open the center too, while promising on your home page that your work "adheres to the highest standards of academic and professional integrity", and secure your employment security. Would the money change your politics? Even a little? One can suspect that a five million dollar donation might sway a recipient, but there's no real proof. Furthermore, it's not clear what sort of FDA opinion the $5 million dollars to the center could buy. But distrust seems warranted in this case.

Spreading the Wealth Around

Gelman's education foundation gives hundreds of thousands of dollars yearly to various religious, education, medical and political organizations. Aside from the Risk Center, his science and political donations are a nominal slice of the pie, a thousand dollars here or there which amounts to a nod to a cause or ideology. But do these donations portend an agenda that belies a neutral mission for the Risk Center? Gelman's only political donations are predictable neoconservative organizations dedicated to free-market proliferation and opposed to regulation. These are the organizations listed on the Gelman Foundation's 2007 990:¹

• The CATO institute
• The Competitive Enterprise Institute
• CFACT
• The Heartland Institute
• George Mason's Tyler Cowen, who runs the Mercatus Foundation, the Center for Public Choice, and the James Buchanon Center for Political Economy.
• The Mackinaw Center for Public Policy
• The Manhattan Institute for Public Policy
• Reason Foundation
• American Counsel on Science and Health
• The Science & Environmental Policy Project (SEPP) (Fred Singer's Global Warming Skeptism organization)
• Capital Research Center
• The Independent Institute

Incidentally, FDAreview.org is also a project of the Independent Institute. FDAreview.org advocates that "FDA control over drugs and devices has large and overlooked cost that almost certainly exceed the benefits." FDAreview.org "favors adult freedom and hence the repeal of all forms of premarket approval."

Gelman is clear about his mission to fund the Risk Science and Communication and as he says, to provide the Risk Center with contacts that will help its mission. When Gelman gave the originating grant to the center he referred to Gelman Science's protracted fight with the state's Department of Natural Resources "a case in public confusion", which would have benefited from the center's 'neutral' science.

But is an organization really "neutral" towards public policy if one person with a very clear agenda establishes it, funds the director, the professors, the students and the post-docs, and provides the contacts to help define the mission? If you're a professor doing science and didn't share Gelman's strong ideological stance, could you endure the pressure? Would Gelman endow with his legacy an organization that didn't share his views? What say does the founding funder have in the backgrounds of the professors whom he funds?

Congress is asking whether this donation will sway the the FDA's bisphenol A committee chair. Members of the Energy and Commerce committee plan to investigate the donation, and House Appropriations agriculture subcommittee members are calling on Philbert to recuse himself from the committee. If Philbert remains on the FDA committee, and then goes on to OK BPA, can that decision be trusted by US citizens? Can the University of Michigan's School of Public Health Risk Science and Communication be trusted?

¹ Acronym Required has previously written about a number of these organizations and you can find more information at Sourcewatch, ExxonSecrets.org and other websites.

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Acronym Required has written numerous articles on BPA, starting with the 2005 article "Plastic Bottles: Protecting Your Baby, by the ACC"

Change, Change, Change

People chant for change, yet some political observers say change in presidency is of over-rated importance. Nevertheless, the US electorate has basically thrown George Bush out in their excitement to welcome a new chief executive. For his part, Bush addresses the nation with familiar threats about the nation's security and citizens' well-being, but he delivers them with such monotonic disassociation you'd think he'd been drugged.

Anxious to move on, the voters gather their remaining hopes and dreams in bundles and strew these along the campaign trail like flower petals at the feet of the new king and they vie for the attention of the incoming administration. The electorate anxiously tracks the presidential campaign and chooses, gaffe by gaffe, who to entrust with their future.

But there is a certain mystery to this all. People clamor for change but most of them just want security -- to work in the day and scurry to safety back at the den for food and sleep and family; they want their hunger abated and to be warm. With their fundamental securities established, the gold watch of yore really was icing on the cake. Today many people can't count on a job or a home. The change people yearn for is to feel more secure.

Of course it's never that simple. US presidential candidates also court constituents who would like to be assured that the dinosaurs roamed around with the humans 5000 years ago and that there's no such thing as evolution. Preachers urge parishioners to vote according to the bible, which of course means no evolution, no modern social awareness that reflects new science knowledge, no change. Perhaps being able to read your future from The Good Book feels secure for it certainly promises no change. To these people McCain also paradoxically promises "change", as he embraces the religious right via Palin. Those mavericks.

Change in the US, Change in the World

The US population is not alone in being seduced by the "change" promised by new leaders. In South Africa last month, Thabo Mbeki resigned as he was being ousted from his post of the last eight years as president representing the African National Congress party (ANC). As the successor to Mandela, the West considered Mbeki a steady leader of a nascent democracy on a continent with too few democracies. The west did well by the president who advocated neoliberal policies and expanded the economy with predictable policies.

In Mbeki's place, the ANC installed Kgalema Motlanthe as the interim president until Jacob Zuma, the presumed future winner of the 2009 election and future president is elected into office. Zuma was the populist choice to lead the ANC and has strong support of unions and the Communist Party. He was imprisoned during apartheid and still revels in the glory of liberation movement, singing "Bring Me My Machine Gun" at gatherings.

Zuma's strong populist appeal and support from unions makes investors and middle class South Africans very nervous and so to them, he promises no change. But his populist message appeals to many voters who were disenfranchised under Mbeki. Mbeki's South Africa was a fragile economy which created glaring gaps between extreme wealth and extreme poverty. The Mail & Guardian wrote of South Africa's growing discontent with Mbeki:

"the mounting failure of the criminal justice system to prosecute and convict criminals, the increasingly disturbing nature of violent crime, burgeoning inequality and unemployment, the HIV/Aids catastrophe and the culture of impunity for corrupt and incompetent public officials."

Change is needed on South Africa's domestic front, and Zuma's message promises a forum for the poorer populations. But will Zuma deliver this change? And can his policies at the same time appeal to international investors the way Mbeki's did?

Barbara Hogan, New Minister of Health for Africa

Before Zuma_The_Unnerving takes office, there is a chance for interesting, perhaps positive and real change in the form of the new interim government of Kgalema Motlanthe. Motlanthe has already appointed a new Health Minister, Barbara Hogan, to replace the infamous "Dr. Beetroot" -- Manto Tshabalala-Msimang -- who ably and stridently propagated Mbeki's AIDS denialism. Dr Molefi Sefularo is the new Deputy Minister of Health.

The proactive organization Treatment Action Africa (TAC) and the AIDS Law Project, along with many others both inside and outside of Africa -- scholars, public health communities, researchers and NGOs around the world -- have embraced the new choice for Minister of Health. TAC and the AIDS Law project joined to serenade Hogan at her Cape Town flat last Friday, toasting her appointment with champagne. Her neighbors wondered what all the ruckus was about, then joined the party. TAC expressed their opinion of Hogan on their website:

"We are confident that Hogan has the ability to improve the South African health system. She has been one of the few Members of Parliament to speak out against AIDS denialism and to offer support to the TAC, even during the worst period of AIDS denialism by former President Thabo Mbeki and former Health Minister Manto Tshabalala-Msimang. 0n 14 February 2003, she received the TAC memorandum to President Mbeki for a treatment plan. She was removed as Finance Portfolio Chairperson by Mbeki in part for her stand on HIV/AIDS. She has a reputation for being hard-working, competent and principled."

The new minister has her work cut out for her. Various groups clamor that she should work to clean up the "rot in public hospitals", to "protect us from toxic foods", and to intervene and uncover the truth beneath the secrecy surrounding "tragic deaths of 142 babies in the Eastern Cape" at Frere Hospital. They ask that Hogan stop the brain drain of medical personnel in South Africa and restore confidence in the public health system.

In an interview with News24 radio last week, Barbara Hogan acknowledged the amount of work that needs to be done in her new post as Minister of Health and warned that with such a short tenure she can only focus on a couple of things. Top of her list was the "morale of healthworkers" and revamping healthcare to a "system that is functional and responsive to people who are using it". Hogan said the "biggest challenge is HIV/Aids and all the strains that it places on the health system." None of these seem like low-hanging or modest, easily achievable goals for Hogan's short tenure, nevertheless, she seems sincere, which is why there is so much hope.

Change You Can Believe In?

However last week the science journal Nature cautioned in Nature News that a new law passed by the South African parliament may hamper the country's adoption of more progressive HIV policies. ("Incoming South African health minister raises hopes on HIV" (doi:10.1038/news.2008.1138))

The law creates a regulatory authority (South African Health Products Regulatory Authority (SAHPRA)) which will oversee all medicines including "medicine, medical device or cosmetic in respect of which a medical claim is made". The Minister of Health will become the final arbiter of which drugs get to market according to criteria that includes nebulous goals like "public interest", the experience of other countries, and consideration of whether the product is "supportive of national health policy goals". The agency is not independent, rather its under the thumb of the Health Minister.

The previous Minister of Health had had run-ins with the former science based drug regulatory agency, so the law seems tailored to Manto Tshabalala-Msimang's reign and Mbeki's intense suspicion of Western pharmaceuticals. As Nature sees it, the concern is that the new bill gives the new minister "sweeping authority over the approval of new medicines and a remit to regulate traditional medicines alongside of conventional pharmaceuticals", Considering all the enthusiasm for the new Health Minister, Nature's observation seems almost ill-conceived. Or does it?

Mbeki's Legacy

Hogan has a lot of obstacles to overcome with the standard Mbeki set for public health. When he emerged from prison after apartheid with strong ideas about African solutions. The growing HIV/AIDS epidemic must have seemed cosmically unfair as the nation finally sloughed off apartheid. AIDS treatment is costly, especially for a country with a fledgling public healthcare system. Yet rather than approaching the national crisis head on, Mbeki for years refused to acknowledge that HIV was the viral cause of AIDS. As a result, according to the Mail & Guardian, "Death certification by Stats SA shows more than 1.5-million deaths in the ages 0-49 and more than two million new infections during his rule." Now, almost 30% of pregnant women in antenatal clinics screen positive for HIV and best estimates show that approximately 50% of patients with Stage IV AIDS who need AIDS drugs, do not receive anti-retroviral treatment (ART).

Throughout his tenure, Mbeki steadily dragged his feet on the HIV/AIDS crisis. He juggled the tensions of his mixed world-view -- his South African heritage, his survival during apartheid, and his education as an economist in Europe. He mixed up neoliberalism, anti-colonialism, and crony politics, and ended up intensifying public unrest during his tenure as his policies created increasingly stressful social conditions. These tensions were apparent in the long, oblique letters he wrote to the citizens published by a weekly newspaper and at the website of the African National Congress (ANC). Here he spent considerable energy trying to diffuse serial national outcries.

Last year Acronym Required wrote about Mbeki's mini-skirt memo, in which he took the media to task for their criticism of the infant death cover-up at the Frere Hospital in Eastern Cape. At the time of that August 2, 2007 memo, Mbeki had just fired the assistant health minister Nozizwe Madlala-Routledge who had been addressing the AIDS crisis and who had devised an HIV/AIDS strategy while she stood in for Manto Tshabalala-Msimang. Tshabalala-Msimang had received a liver transplant and newspapers were reporting that she was a heavy drinker before and after the transplant, had skipped the organ donor cue, and was abusive to hospital staff during her transplant operations.

Mbeki addressed the outcry of the public health situation again in his 6000 word August 31, 2007 memo. The memo shows his cunning ability to twist the facts around, to say first one thing, then the opposite. He accused anyone who criticizes Manto Tshabalala-Msimang (("cadre of the revolution") of being a traitor or weakling:

"...some, at home and abroad, who did nothing or very little to contribute to the immensely difficult and costly struggle to achieve our liberation, have chosen to sit as judges over who she is, what she has done for the welfare of our nation, and what she represents, today, with regard to the pursuit of the goal of a better life for all our people."

He defended his administration's handling of HIV/AIDS and railed on national and international papers for questioning his stance, including The New York Times, BBC and The Guardian. He eviscerated all media for distorting his and Manto Tshabalala-Msimang's position on nutrition as it relates to AIDS:

"Manto Tshabalala-Msimang's mortal sin in the eyes of our opponents, in which regard she has faithfully represented the convictions of the ANC and the ANC directive to those we had deployed in government, is that she upheld this view, insisting that it must constitute an important and integral part of our national response to the serious challenge of HIV and AIDS....they [her critics] will continue to do their best to denigrate a principled fighter for a democratic, non-racial and non-sexist South Africa, who has dedicated her entire life to the achievement of this outcome, Dr Manto Tshabalala-Msimang, whom history will honour as one of the pioneer architects of a South African public health system constructed to ensure that we achieve the objective of health for all our people, and especially the poor."

His extensive rationale for promoting nutrition to help prevent AIDS included citing the judgment of everyone from small babies to Romans, all who he claims understand, as he does, the importance of nutrition.

"they [the critics] have deliberately falsely presented the arguments of our Minister of Health about the known nutritional (and micro-nutrient) value of olive oil, lemon, beetroot, garlic, and other foods, as well as the efficacy of traditional medicinal prescriptions based on herbs and other natural plants, as an argument against the use of modern drugs and medicines, including antiretrovirals (ARVs)."

He wrote that the media and critics contorted his message to represent that he proposed nutrition and opposed ARV's. Mbeki criticized the national Cape Times for reporting the Minister of Health's own words:

"Nutrition is the basis of good health and it can stop the progression from HIV to full-blown Aids, and eating garlic, olive oil, beetroot and the African potato boosts the immune system to ensure the body is able to defend itself against the virus and live with it."

He didn't deny that Manto Tshabalala-Msimang said that, but recruited to his side a doctor who wrote in a letter to the editor that good food bolsters the immune system. Mbeki quoted the doctor, then re-established his party's position: "It is our sustained opposition to the fundamentally wrong proposition that in our response to HIV and AIDS we must rely almost exclusively on ARVs." He added that because of "our poverty", the country had "fallen victim to three pernicious influences", as he put it:

"One of these is the medicalisation of poverty. Another is the politicisation of disease. The third is the commercialisation of health care, in all its elements. As a revolutionary movement we have fought against all these, and must continue to do so.

Mbeki recruited the US as an ally for his position:

"US Secretary of Health Mike Leavitt had the courage and honesty to acknowledge this reality, fully understanding the need to respond to the health needs of our people, liberating our health care obligations from the dictates of partisan political and commercial interests."

Secretary of Health Leavitt, who now has his own disapproval to face on a controversial contraception bill, unsurprisingly didn't mention anything about "liberating South African from commercial interests" on his blog back in 2007 when he visited South Africa.

Mbeki managed to play all angles in his August 31, 2007 memo. He bragged about the excellent modern health care system, describing at length the surgical excellence and technology afforded to the Minister of Health during her liver transplant. Meanwhile his administration was busy covering up the Frere baby death scandal and mounting evidence of a failing public health care system. He accused anyone who complained about Tshabalala-Msimang of being either a traitor, someone who wanted to see South Africa fail, or someone who would "have allowed Manto Tshabalala-Msimang to die." He accused the media and any critic of misrepresenting the ANC's position on AIDS drugs vis a vis nutrition. Then he defended the importance of nutrition to the immune system and his government's advocacy of nutrition in AIDS, recruiting to his side a letter to the editor and the US Secretary of Health.

Neoliberal Economic Policies or Public Health -- One or the Other?

Despite outcry from the international public health community for his AIDS policies, Mbeki built relationships in the West because of his adherence to neoliberal economic policies. He welcomed foreign investment and freed up capital from the demands of deteriorating infrastructure in order purchase goods abroad and foster national participation in the world economy. Supporters from the west, including many consultants, would argue that Mbeki made progress with his motions to rebuild shantytowns and provide better healthcare. They will point to Zimbabwe, which roils at South Africa's northeast borders, and note that similar unrest that could just as easily overflow into S. Africa -- as it recently did. Some of these business leaders talk about the new struggling capitalist economy and say -- 'isn't it obvious? Public health just couldn't be the highest priority with the economic stakes so high'. People are apparently able to look past the charges against Zuma for extortion for http://en.wikipedia.org/wiki/Jacob_Zuma_rape_trial">raping a woman who had AIDS, and see someone who's "change" promise's more security.

In the meantime, will the interim government and Minister Hogan be able to balance international economic pressure for open markets with the yawning gap in public healthcare and carry through her stated mission? Were Mbeki and Manto Tshabalala-Msimang merely carrying out the demands of the ANC as Mbeki always emphasized? Will party politics of the ANC to which Barbara Hogan is so loyal to allow reform? Or will the ANC continue to let laggard public health policies associated with Mbeki's reign prevail? Or will the ANC give the people reason to trust in the ANC and reason to hope -- as they did during the short tenure of Nozizwe Madlala-Routledge, before Zuma takes office? Can you grow a liberal state without tending to the population's basic needs for shelter, security and healthcare? Will change really come to Africa's public health system? We remain hopeful.

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Acronym Required previously wrote on this subject in these posts:

"Mbeki's AIDS Legacy and Ours"

"South Africa: Peddling Beetroot, Courting AIDS"

""Not in Paradise Anymore - AIDS in Africa - Reason for Optimism?"

It's the Economy and the Election...

When US citizens wake up each morning wondering what they might have lost from their retirement accounts overnight, and what they inadvertently gained: i.e., one morning you learn you're part owner of a gargantuan mortgage business, the next you find yourself lassoed into a giant insurance collective -- no one knows what's next. Will there be a knock on your door tomorrow AM and someone waiting to press a hoe into your hand?

When congress says they're reeling, they're "stunned" from the news delivered by the Fed at their big powwow last night, and when the press is overwhelmed with the ups and downs of an off-the-charts financial crisis and the back and forth poll numbers for McCain and Obama, we completely understand that you can't give science your usual riveted attention. With the Fed sucking up all these great liabilities and throwing the whole the "government needs to get out of the way of business" idea out the window -- or did we just all misunderstand what that really meant -- we agree that reading up on monetary policy and investigating your own sense of what "full-scale panic" means might be your highest concern.

Sure the future of permafrost is interesting, cell culture research and science curriculum really important, and yes, these things should definitely claim our attention and that of all four candidates. But I'm distracted wondering why GOP VP nominee Sarah Palin canceled more appearances in the last few days than the number of heavyweights the Republicans have pulled in to play defense in Troopergate. Palin's appearances have been canceled in Seattle & the Eastside, Virginia Beach, Dayton, Jackson Hole, Wyoming, Tampa and Central Florida, Virginia Beach, Cincinatti, Jackson Hole, and all of California, as well as other places. Did McCain shoo her off-stage with Fiorina to be seldom seen and not heard? Is she cramming for a American Politics 101 final? Dental work? Did she she see a Russian tanker trawling the water out her dining room window? Nervous breakdown? Sure the also "hot" Cindy McCain will replace Palin at some events, but there's got to be some disappointed Palin admirers.

Anyway, we tear ourselves away from those massive shim-sham distractions (for the moment), in order to glance at some recent science-ish news.

Some Science Headlines

• Thousands Tens of thousands of babies are sick and several have died from Chinese baby formula contaminated with melamine that compromises kidney function. This is the same chemical that was found in pet food imported from China to the U.S. last year. Officials in Singapore, Hong Kong and Bangladesh Yemen, Gabon, Burundi and Myanmar express concern that the tainted products might be available to consumers their countries also.

  Melamine has also be found in milk, yogurt and ice cream in China and Hong Kong. In 2007 the FDA found that US manufacturers of animal feed had also adulterated their product with melamine.

  Earlier this year, contamination of US supplies of heparin led the FDA to investigate and find myriad problems in the oversight process of the imported product. The agency discovered quality control issues, ranging from agency confusion about the real name of a Chinese plant that went un-inspected; to the crude processing methods of the pigs intestine in family-style workshops". Experts admonished drug makers (after the fact) that the shortage of pigs in China due to blue-ear disease should have served as a red flag to the possibility of spiked heparin.

  Heads will certainly roll (figuratively if not literally) in China over the milk scandal, but an overall plan about how to prevent the next batch of fatalities has yet to emerge. In this instance, neither US and Canadian health agencies have found melamine contamination in their milk products.

• In other news, the FDA has banned 31 drugs manufactured for export to the US by the Indian company Ranbaxy, based on an inspection of the company's Dewas plant that revealed cracked equipment, unsterilized and unclean preparation areas, inadequate procedure specification, and sporadic documentation of testing and cleaning.

  Yesterday, in response, Ranbaxy announced that it had hired Rudy Giuliani, last seen speaking on behalf of McCain at the GOP convention, to help lobby the US agency.

• Also: Environmentalists cheered last year when Florida penned an agreement to buy land in the Everglades from the sugar industry. Interestingly, some of those who pressed hardest for the move were free-market conservatives and groups such as the Cato Institute. Sugar subsidies were instituted back in the 1930's, but the industry has since shrunk, and been monopolized by a few firms whose prices were kept artificially high with the subsidies, crowding out foreign competitors. The Fanjuls, an entrepreneuring family originally from Cuba, own one of two Florida companies that control most of the sugar consumed in the US. Last Sunday the New York Times ran a great article about the buyout, digging deeper into some of the issues complicating the deal, and questioning whether the company actually arranged for their land to be lucratively bought out by the state when its business began to suffer in the downturn.

• In infectious disease news: The CDC estimates that 90,000 people die in the US each year from institution acquired infections from antibiotic-resistant bacteria. Science reports this week that the "perfect storm" of antibiotic resistance and diminished reserves of medicines portends trouble The situation not only demands new drugs, according to Science, it requires new drug targets.

  The journal summarizes two recent studies that work in this direction. In the first, a group of scientists created a class of synthetic antibacterials effective against staphylococci including methicillin and multi-drug resistant Staphylococcus aureus.(D. J. Haydon et al., Science 321, 1673 (2008)) The chemicals target specific proteins responsible for cell division. The August 22nd issue of Sciencecontained a report from another group who found a molecule that inhibits the gene which causes virulence and is turned on when certain conditions occur as the host responds to the infection. (D. A. Rasko et al., Science 321, 1078 (2008))

  On the prevention side of things, researchers at the University of Illinois found that tetracycline resistance genes can most likely be transferred from animal to animal in large hog containment areas into groundwater that feeds the public water supply. This could be one way that antibiotics used in feed to prevent infection and promote growth are adding to the overall problem of antibiotic resistance.

  And to get a sense of how far our understanding about microbes and mechanisms of infection, read up on Stanley Falkow from Stanford University, who was one of five scientists honored with a Lasker prize for his work on microbes and aspects of antibiotic resistance.

• Iran has detained AIDS doctors Dr Kamiar Alaei and his brother Dr Arash Alaei since late June. (via Nature News) The two were known world-wide for working to prevent and treat the disease, and for tackling issues around HIV/AIDS in model ways, for a country which long denied that HIV/AIDS was anything but a "Western Disease". Their disappearance in late June has drawn global concern and calls from various physician groups for the Iranian President to answer questions about the whereabouts of the AIDS doctors. Mahmoud Ahmadinejad is scheduled appearance at a UN meeting next week.

• In other news: Both McCain and Obama have now submitted answers to questions about their science policy gathered by ScienceDebate2008. Some of their statements have been published here at the LA Times also. Several other science groups have submitted a document for both campaigns that lays out strategy for the incoming president on science and technology policy. Obama has named five science advisers who would serve his administration.

• Now for some old news: Last May the Anchorage Daily News (ADN), Sarah Palin tried to obfuscate the contents of report written by state scientists that supported the federal scientists' decision of list polar bear as an endangered species. Palin wrote in an editorial in the New York Times January 5, 2008: "I strongly believe that adding them to the list is the wrong move at this time. My decision is based on a comprehensive review by state wildlife officials of scientific information from a broad range of climate, ice and polar bear experts." But the state's biologists agreed with the federal assessment. Palin is has also been criticized for her positions on global warming, oil and gas drilling, Exxon Valdez oil spill damages, and the Endangered Species Act. Why does this sound so familiar to me?

Oops, we've inadvertently gone full circle, escaping politics with science then allowing ourselves to get whooshed back into the politics. But why not wonder about Palin? There's no outro to this post. We wonder what science policy would really be like in a McCain government, or in an Obama government? More like China? More like India? More of the same? Same, same but "different"? Science and technology depends on politics and government. We may think we know what science and technology looks like in an "extreme" market economy, we've seen its penultimate apex during the Bush administration. ¹ But lets not forget that we didn't anticipate Bush's actions. Now's the time to think beyond the rhetoric. I'm not sure I buy what many people insist -- that the candidates will be very alike on science issues. Now's the time wonder why McCain chose Palin if their philosophy is so different. Now's the time to learn more about Obama's science advisers.²

Perhaps we can have some government involved before the next giant catastrophe...? Before the energy investment bubble, the imminent infectious disease outbreak, the next bunch products consumed by citizens because manufacturers successfully slipped drugs cut with toxic proteins past the FTC or the FDA, the next species goes endangered, the growing storm of global warming, or the EPA....does whatever they do? There aren't too many science problems that won't be directly influenced by the new administration's policies.

¹ The book Supercapitalism by Robert Reich was interesting.

²Though it's certainly nice to see he has any now.

Canada, Painting the Country Green

When a group of US senators including Richard J. Durbin (D-Ill.), Dianne Feinstein (D-CA), John F. Kerry (D-MA) and Robert Menendez (D-NJ), joined Charles Schumer (D-NY) last spring to sponsor a bill that would disallow the sale of products containing bisphenol A (BPA) for children under 7, a Canada newspaper commented that the US must have been "emboldened" by Canada's recent action on Bisphenol A (BPA). Two weeks before, on April 19th, Health Canada and Environment Canada had jointly proposed a ban on products like polycarbonate baby bottles made with bisphenol A. Canadians proudly declared themselves "the first country in the world to take such action to limit exposures to bisphenol A".

Canadian retailers quickly hopped on a growing bandwagon to stop selling BPA containing products. Walmart and three other major retail groups announced they would stop selling polycarbonate baby bottles, thus joining ranks with Canadian retailers who had already volunteered to stop their sales. Individual towns also caught the BPA ban spirit; Canadian municipalities from Vancouver to the "model town" of Kapuskasing, Ontario began pulling bisphenol A containing plastic containers off the shelves.

Canada's First Mover Status. Oh, Sacrifice

There's plenty of room for congratulating Canada on its first regulator status, but there's also some background. We've followed the science and politics of bisphenol A for a few years and with BPA (and everything else, as you very well know), politicians seem violently allergic to being "the first" to suggest regulating any product or chemical. For obvious reasons, no politician is a maverick. The economy, business, personal reputation, and lack of comfort with science, combined with lack of attention from the public, give politicians a handy (and sometimes reasonable) excuse to lag several paces behind the leading edge of science. Real mavericks don't get second terms.

When the public brings an issue like bisphenol A to the attention of cities like San Francisco, states like California, and US regulatory agencies like the FDA, these entities promise to limit the sale of bisphenol A. They quickly back down when faced with industry threats or lawsuits. At state, city and federal levels, when curious reporters ask politicians later why they backed down BPA, they tend to mumble incoherently into their hands, if they answer at all.

Last year for instance, San Francisco, California proudly proclaimed itself the "first city to ban bisphenol A". The chemical and toy lobbies promptly sued, whereupon San Francisco's political bravado melted away like gelato on the 110 degree day that its legislators will never encounter in their town. San Francisco immediately dropped the legislation, but maintained their elevated reputations as protectors of children's health because the press headlines heralding their fleeting bravery stuck in black and white. (Except at Acronym Required where we amended the titles and introductions of all our blog posts to accommodate the city's mercurial fortitude).

I don't doubt that Canadian politicians are just as calculating as American politicians. For the past 15-20 years, Bisphenol A research showing convincing deleterious health effects has accumulated. Although Canada's "first" is commendable, it could taken with a grain of salt.

And is being "first" even relevant? The US and Canada have entirely different economic considerations that influence and shape political will. Consider Canada's overall economic investment in bisphenol A, compared to that of the US. According to the Canadian April 19, 2008 report, in 2003, worldwide production of BPA was about 3 billion kilograms per year. As recently as 1986 Canada manufactured or imported 12 million kilograms of bisphenol-A per year. However, today, Canada only uses .5-1.5 million imported kilograms(kg) a year and the country has stopped manufacturing bisphenol A altogether. By contrast, in the US production increased from 7.3 million kg in 1991, to 1 billion kg in 2004. It's not surprising that Canada would be less reluctant to ban BPA, they have less of a commercial stake in the chemical.

On BPA, The US and Human Health vs. Canada's Health and Environment Concerns

One notable difference between Canada's approach to BPA and that of the United States is the separation of agencies that decide US policy. The Canadian ministers from two agencies, Health Canada and Environment Canada, issued a joint statement of concern in April, based on the research on health and the environment, stating that bisphenol A was a "toxic chemical".

The weight of the environmental evidence against BPA is strong. Researchers can measure BPA that collects in brackish low-oxygen waters and see the direct effects on species that live in those waters. By contrast, human health data is sparse. There are few studies in humans because of the obvious barrier to "testing" humans by asking them to ingest a obviously toxic chemical. In rats, there are lots of studies and the conclusions are more solid. At very low doses scientists find BPA causes deleterious developmental effects.

Canada'a decision rests heavily on environmental data in addition to the health concerns. This is different from the US, where the government's primary focus, at the National Toxicology Program (NTP), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA), is how BPA effects human health. While the expert panel of 38 scientists who evaluated bisphenol A research published in 700 of studies was sponsored in part by the EPA and was significantly alarming, the results focused on humans and were quickly confused when other agencies published simultaneous conflicting results.

Critics quickly linked the different results to the institutions affiliations of the researchers -- industry or academic or government. These differing results have become a hot-button issue for many people. Industry research in bisphenol A frequently arrives at the opposite conclusion of government research and is sometimes not peer-reviewed or has control problems.Indeed, some commenters skip over real scientific uncertainties involved with BPA research, the diversity of various experiments and the difficulties in determining effects, and unilaterally cast blame on "industry research". However damning this pattern seems, all "industry research" should not be tainted.

It's more important to keep focus on the evidence and for the public to grapple with the real uncertainties yet be able to recognize the relentless BPA industry fronted marketing for what they are. Subtle and confusing perhaps, but key to understanding the real dangers of BPA and other toxins.

BPA research is fraught with experimental difficulty which effects the interpretation of results. Bisphenol A shows biphasic effects depending on the dose, so high doses show dramatic negative effects, and low doses show subtle but important effects, while medium doses often show fewer effects, presumably because the receptors are overwhelmed or the effects masked. Additionally there is uncertainty based on arcane experimental criteria -- the delivery method for bisphenol A dietary or injected, the type of experiment -- cell culture or rat, if rat, the breed, the brand of rat chow its fed, the type of labware used to do the experiment, the source of BPA tested -- blood, breast milk, urine, tissues, air, water, dust. That's only the beginning.

But there's a consistent pattern of BPA research showing widespread effects on health. In the past couple of years ordinary citizens who care about their own exposure have aggressively asked questions of industry, legislators and science, and are concluding that the growing body of bisphenol A research shows consistent and disturbing implications for on systems such as behavior, neurobiology, development, and other systems.

No matter how fast the evidence piled up, plastic lobbyists have leveraged the different results from disparate agencies adeptly. Animal data shows toxicity of BPA which persists in the environment. But industry lobbyists actually use the prolific animal results to bolster their claims by saying that deleterious BPA studies have only been shown in animals, but not humans. In the US there's not a lot of public talk about the effects of BPA on species other than humans.

Canada's Minister Baird said in his statement about the BPA decision:: "When it comes to Canada's environment, you can't put a price on safety". However this too can be evaluated differently depending on your perspective. Canada has heartily embarked on other projects such as the Alberta oil sands, that aren't so congenial to the environment. Baird's statement presents a conflicting image for the country's true commitment to the environment, given the economics of BPA.

At least for a moment last spring, though Canada was proudly "first" on BPA. Hopefully the rigors of comment periods, legislation drafting, and enforcement follow-through will cement its place. In the meantime, Europe and the US follow haltingly along.

US Agencies Dither

Despite the necessary constraints to doing toxicity research on human subjects, studies in mice and cell cultures show myriad changes to genital tract development, breast and prostate tissues, sexual differentiation, endocrine and immune systems, behavior, and neural development, all at doses below what the FDA deems safe. Yet an NIH interagency group assures us doesn't cause human health effects.

At the same time Canada issued it's dual agency warning, the US National Toxicity Program released their April, 2008 (NTP) report, stating the agency's reconsideration of BPA safety. The US National Toxicology Program's (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) announced a slightly revised conclusion about BPA from their November, 2007 report, criticized by experts in the field. The April report reconsidered their 2007 report (just finalized this September) and concluded there was "negligible" concern for many exposures, and "some concern" for neural and behavioral effects in fetuses, infants, and children.

However the April, 2008 report added: "the possibility the bisphenol A could alter human development cannot be dismissed". The authors repeated the statement 3 times, which is pertinent, given the otherwise understated tone. The report included papers that the previous group had left out because of methodology, with the explanation that scientists could get meaning from the research even if the questions addressed in studies were not necessarily aimed at discerning overall BPA safety to humans. It was also much more accessible to non-science readers then the previous report.

Despite the overall reassuring stance of the April NTP report however, it's clear that ample concern (or action), and further research is justified. Take for instance the conclusion of "negligible concern" that exposure to bisphenol A would cause birth defects. The evidence is based on, as the NTP scientists put it: "results from several animal studies provide evidence that bisphenol A does not cause birth defects such as cleft palette, skeletal malformations, or grossly abnormal organs." If you get past the reassuring "negligible" stamp, the actual data is not reassuring. These particular birth defects are the most conspicuous ones that could effect fetal mice, aside from quick death. However the results don't prove that less conspicuous but serious and debilitating birth defects would not occur.

While the chemical industry likes to point out that the results in mice wouldn't occur in humans, you could just as easily argue that not observing a "gross organ malformation" in a fetal mouse would not rule out the possibility of other very serious birth defects could occur in both mice and humans and not appear as gross malformations. The dearth of more conclusive safety evidence in humans, therefore, more than warrants the NTP's April warning, however understated, that "the possibility that bisphenol A may alter human development cannot be dismissed". Nevertheless, their authoritative opinion assures people that the chemical is safe. This opinion serves as a nice soundbite and marketing fodder for the Chemical and Plastics industries.

JAMA Steps In

We should point out that the hesitation to take precautions about BPA in light of extensive (animal) research extends beyond politicians. Several recent books detail the dangers of many environmental toxins but exclude any mention of bisphenol A. Scientists' warnings about bisphenol A have been countered vehemently by seemingly trustworthy organizations like the American Dental Association. To confuse matters more, the press takes a less than informative approach in covering bisphenol A, regularly calling on the ultra-self-interested American Chemical Council lobby group for plastics to answer safety questions. All of this befuddles citizens, who don't know whether to invest in glass baby bottles or just keep microwaving the trusty plastic ones they've depended on all these years.

Because of all the questions surrounding BPA and pressures from citizens, quite a few representatives in congress are tripping all over themselves to investigate the chemical and the agencies which should be overseeing its use. At some point the momentum of an issue catches up with those who stall and demands unified response. Congress is starting to question the FDA about its procedures for evaluating BPA.

While Canadians make small jabs about the newly "emboldened" Americans, who, it's true, only now, are beginning to introduce new legislation, most of which has been resoundingly defeated. However US politicians are quickly catching up.

Adding medical weight to the issue this week, the Journal of the American Medical Association, (JAMA), yesterday published what was billed by some as the "first human data on BPA". The study looked at urinary levels of BPA and found increased incidence of cardiovascular disease, type 2 diabetes, and liver-enzyme abnormalities in adults with elevated BPA levels. The study was by no means the robust proof needed to show long term effects from BPA exposure indicated in the low-dose research, however the researchers and accompanying editorial by BPA expert Frederick S. vom Saal emphasize that these results are consistent with animal and cell culture data and will hold up with more conclusive longitudinal studies.

In the meantime, this study gives one of the most prominent group of physicians something to wrap a stance around, in light of increasing attention that Congress and the public is paying to the issue. It also gives Congress some medical evidence to base their demands on. We expect growing attention to and action on bisphenol A. The ACC won't be able claim so dismissively that there are no human studies.

Sell Your Own Data

There's a market for your prescription data. The Washington Post reported this week that insurance companies are buying prescription data collected from companies like Milliman Intelliscript and Ingenix to help them make insurance coverage determinations. Patients with particular drug profiles and whether to pay claims for other patients. Drug profiles are determined by the insurance companies, who assign them scores or color codes. In a red, yellow and green schema, red would correspond to an AIDS patient, who needs lots of drugs. Milliman Intelliscript, part of the Milliman company, collects data from Pharmacy Benefit Managers (PBMs) that are not covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II). Then insurance companies pay a small fee to obtain the data, which they use to deny or approve claim requests.

The Washington Post interviewed "an entrepreneur who built the database system that Ingenix acquired", who explained how it works. If someone is taking a high dose of cholesterol lowering medicine, said Richard Dick, then the insurance company would "know you had an intractable cholesterol test" and could deny "an expensive blood test".

Electronic records are necessary and will deliver a lot of the benefits and efficiencies. However as described, I'm sure doctors and patients are alarmed.

Richard Dick is an electronic medical record pioneers and electronic consent advocate who contributed to this Institute of Medicine (IOM) publication on the subject in1997. He currently serves as the Chief Technical Officer at You Take Control (YTC), which sells an electronic consent management system. He has a Ph.D. in Medical Biophysics and Computing from "the University of Utah's world-class Medical Informatics M.D./PhD program (equates to a Ph.D. in CS + first 2 yrs Med School)."

ACLU Concerns

The American Civil Liberties Union (ACLU) brought attention to this issue last month, voicing concern over H.R. 6357, the PRO(TECH)T Act of 2008. The ACLU says that

"Virtually all the pending bills lack important privacy and security protections for the online databases that would store patients' electronic health records and prescriptions."

Suggesting that lobbyists for the systems don't want privacy concerns to slow down system implementations, the ACLU asks Congress to "require strong privacy and security standards" to prevent "identiy theft; accidental publication of patients' sensitive or embarrassing personal information; discriminatory review by insurance companies or potential employers so they can avoid paying for people who might be expensive to insure or employ; invasive direct marketing to patients or doctors by competing drug companies; and commercial resale or misuse of personal health information." These concerns are clearly warranted.

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Acronym Required wrote about the probable fluidity of forthcoming genetic information in What's Your Sign Code?"

More Money for PEPFAR

Last week George Bush signed into law a bill to increase global HIV/AID, tuberculosis and malaria funding. The bill had been delayed while the Senate negotiated aspects of the funding, questions like how much would be allocated to drugs, versus infection prevention. After legislative deliberation and compromise, the House approved the bill and the president signed it last week. H.R. 5501, known as the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, sets out to expand the President's Emergency Plan for AIDS Relief (PEPFAR) by increasing funding to $48 billion dollars for the three diseases and some miscellaneous appropriations. Further deliberations will determine whether the Act is fully funded.

In his remarks at the ceremony Bush said "Laura and I saw the hope on our trip to Africa. I wish every single America '[sic]' could have seen the tens of thousands of people who lined the streets during our visit, and they were cheering and waving American flags in gratitude to the generosity of the American people." (Bush made the same statement after visiting Ghana and four other African countries earlier this year.) He continued that he thought it "important for our fellow citizens to understand that PEPFAR is saving lives...showing the good heart of our nation...earn[ing] us respect and thanks around the world."

US HIV Infections

In other HIV/AIDS news, the Centers for Disease Control and Prevention released rates of infection information, based on revised methods used to determine time of HIV infection more accurately. As a result the CDC reports greater numbers of HIV infections in the US than previously reported. Previous data showed that 40,000 new infections occurred in the US every year, now the CDC has adjusted that number up to between 55,000 - 58,500 new cases each year. The full CDC report by Hall et al, "Estimation of HIV Incidence in the United States", is published in JAMA's August 6th issue. The CDC announced the news ahead of the international AIDS conference that started today in Mexico City. Funding for HIV/AIDS prevention has reportedly fallen relative to inflation.

The NIH narrowed an AIDS vaccine trial planned for U.S. testing. The trial, called Partnership for AIDS Vaccine Evaluation (PAVE 100) will be pared down to focus on the question of whether the vaccine lowers amount of HIV virus in the blood of those who are subsequently infected after vaccination. Scientists questioned the sense of moving forward with this larger trial last year in light of the failure of the multi-country Merck vaccine trials, as we commented in "New Directions for AIDS Research Funding".

In other AIDS research news,Weijing He and a team of colleagues in the US and UK found that a protein called DARC (Duffy antigen receptor for chemokines), that makes some African people resistant to malaria may influence HIV infections and AIDS outcomes. The small study published by Cell Host & Microbes shows that the existence of certain DARC mutations enables resistance to some malaria parasites -- though not Plasmodium falciparum, the most prevalent and deadly parasite.

The DARC mutation that prevents infection by some malaria parasites also seems to influence how successfully HIV invades and attacks the immune system. DARC codes a receptor on the surface of red blood cells that binds or tethers the HIV virus. The researchers found that a particular mutation of DARC increases the odds of acquiring HIV-1.

However the mutation also seems to increase the DARC protein's interactions with chemokines. Chemokines are proteins in the immune system that trigger inflammation, and they interact with HIV virus. Researchers have shown that the DARC protein acts by scavenging, retention, or transporting chemokines, and mutated DARC protein seems to lower levels of chemokines. In this study, once infected, people with the mutated DARC lived 2 years longer than those with the normal copy of the protein. While the study helps pave an outline of these interactions the authors predict (with understatement) that future research will show "the net effect of the relationship between DARC and chemokines on HIV disease in vivo is likely to be much more complex."

Court Declares Clean Air Interstate Rule (CAIR) Not Patchwork Enough

Back in December, 2007, the EPA denied California the waiver the state requested under the Clean Air Act (CAA). The state wanted to set its own tougher emissions standards, which at least 18 other states would have adopted. However the auto and energy industries lobbied successfully against the waiver to an administration as dedicated as they were to denying global warming. EPA administrator Stephen Johnson defended the denial, saying the waiver would have created a "patchwork quilt" of regulation.

At the time, Bush had just signed the new Corporate Average Fuel Economy (CAFE) mileage standards passed by Congress under the National Highway Transportation Safety Act, and he defended the EPA's denial, saying: "Director Johnson made a decision based upon the fact that we passed a piece of legislation that enables us to have a national strategy, which is the -- increasing CAFE standards..."

Last week, the administration might have had another opportunity to point to the success of its own brand of environment legislation, while once again shooting down the Clean Air Act. The EPA announced its decision to ignore the Supreme Court order in Massachusetts v. EPA to regulate greenhouse gases and instead decided to issue an Advance Notice of Public Rulemaking (ANPR)¹. But unlike the CAFE standards which Congress passed and Bush signed into law, the Bush administration's Clean Air Interstate Rule (CAIR) aimed at regulating sulfur dioxide and nitrogen oxides from stationary polluters was challenged by the state of North Carolina and rejected by a three judge panel of the U.S. Court of Appeals District of Columbia Circuit.

CAIR was a cap and trade system for large stationary polluters in the framework of Bush's "Clear Skies". It required 28 eastern states to reduce sulfur dioxide (SO2) and nitrogen oxide (NO_x) emissions (not carbon) that contribute to air pollution. The D.C. court disputed the EPA's regional plan: "The EPA's approach, region-wide caps with no state-specific quantitative contribution determinations or emissions requirements, is fundamentally flawed....the trading program is unlawful, because it does not connect states' emissions reductions to any measure of their own significant contributions."

Environmental groups thought it ironic that the conservative court overturned what some considered the best-of conservative Bush legislation on greenhouse gases.Although attempts to project the exact effects of CAIR fell short of providing a thorough understanding of outcomes and overall there was very little reaction from either science and environmental groups, almost everyone, including utility companies, agreed that effort was worthy. The projected benefits to health and air quality under CAIR would have improved acid rain and air quality on the eastern seaboard. According to the EPA CAIR would reduce SO₂ emissions by over 70% and NO_x emissions by over 60% from 2003 levels.

While people were taken aback that the court struck down CAIR in its entirety, no one was surprised that the EPA's Stephen Johnson announced the Advance Notice of Proposed Rulemaking (ANPR) instead of working to create new Clean Air Act regulation. He had responded to Representative Waxman (D-CA) several months ago with his intention, as we wrote in "The EPA: Mulish Days, Staring out to Pasture".

At that time, many saw the Office of Management and Budget (OMB), especially the Office of Information and Regulatory Affairs (OIRA) headed by Susan Dudley, as in the "catbird seat" over federal regulation as Public Citizen put it, and therefore overlord of the EPA's actions. People weren't sure that "Director Johnson" really had too much choice in the issue. Susan Dudley had a long history in conservative think tanks of advocating the types of cost benefit analyses that the Bush administration sought to impose, as we described in "EPA, OMB and OIRA: The Biggest Kid on the Block is Back". The OIRA footprint was evident under the Bush administration, especially in the EPA's lack of action on the environment.

When the EPA released its several hundred page document last week, it of course included a statement from the OIRA head Susan Dudley, who rejected the EPA's staff's recommendations, writing: "the [EPA] draft cannot be considered Administration policy or representative of the views of the Administration", but then magnanimously added that given the Supreme Court ruling the EPA could go ahead and seek public comment.

Considering the previous repudiation of the OMB/OIRA from critics who called the agency on its interference with the EPA's mandate to protect clean air,², it's not surprising that the OMB recruited additional support from the secretaries of Agriculture, Commerce, Transportation, and Energy. They too denounced the EPA draft in 75 pages of testimony, saying:

1. The Clean Air Act (CAA) is "fundamentally ill-suited to the effective regulation of GHG emissions" because the US cannot control emissions from other countries, so state or regional reductions could be "replaced with emissions increases elsewhere"
2. CAA would hurt international competitiveness
3. The EPA draft "suggests that regulating GHGs under the Clean Air Act would be workable. We disagree. The draft offers a number of legal constructs to support its position but there is no certainty of how those theories will work out in actuality, or whether they would be unheld by the courts."

The Secretaries cited the "burdens, difficulties, and costs, and likely limited benefits" of CAA. Of course this is familiar Bush rhetoric, delivered with orchestral cohesion. However if the Clean Air Act is ill-suited for the task, shouldn't the reasons be grounded in fact rather than fear laden claptrap?

The Wall Street Journal described Johnson as being stuck in between his staff and the White House, and as if to illustrate the dysfunction, Johnson disagreed with the conclusions of his staff, calling CAA "ill-suited for the task of regulating global greenhouse gases."

The Administration's Gut

The document was a product of "career EPA's" critics said, with the hint of a sneer they might use for "teacher's unions". Piling on the hyperbole, William Kovacs, vice president of the U.S. Chamber of Commerce in Washington told the Wall Street Journal "This is a classic example of EPA staff saying we can manage the economy of the United States better than the president." (WSJ July 11, 2008) (To which some economists gasped -- Aha, the president's running the economy?)

The Bush administration has led a sustained attack on the Clean Air Act and the EPA. Last fall Bush publicly conflated the Clean Air Act emissions standards with CAFE standards, acting as though they were the same thing. But they're not. The NHTSA in the Department of Transportation (DOT) sets gas mileage standards through (CAFE). The energy bill that Congress passed and Bush signed (H.R. 6) last December improves long term mileage standards (barely).

The EPA regulates carbon emissions that contribute to global warming, through the Clean Air Act. Several industries argue that the EPA should not regulate emissions because of "regulatory overlap" between the NHTSA and EPA, but the Supreme Court rejected that argument in Massachusetts v. EPA. Said the court, the EPA "has been charged with protecting the publics 'health' and 'welfare'", whereas "DOT sets mileage standards".

The legislative goal of CAA was to protect considerations about healthy air and water from being corrupted by private interests and business. Its this goal that industries resent. As we described in previous posts, the petroleum and auto industries petitioned the EPA and the Bush administration to deny the California waiver. Industries argued that the EPA should adopt the notion of "maximum feasibility", and "set standards that take account of the limits on the investment capabilities and product cycles of the industry, just as NHTSA does...", as Chrysler put it in a memo last year.

One-Two Punch

There are legitimate criticisms of Clean Air Act, however the auto industry simply wants to continue its 30 year run of little to no regulation, despite the evidence that this damages health, the environment and the auto industry. The Bush administration now seems more brazen about criticizing the EPA document directly. Bush chose the familiar war theme when he called the EPA outline a "'command-and-control' regime that would regulate virtually every aspect of American life from cars to factories, hotels and lawnmowers". "Command and control" is a conservative slur you run across scanning the conservative op-eds, as in "command and control communism", "command and control socialism", and "enemy of the free-market".

The push by the OIRA, the administration, industry, and much of congress for measures that considers projected costs to industry when determining whether or not to regulate of course has valid points, but is subject to abuse. If the cost to industry is used to determine whether industry should clean up the mess it makes of air and water, then why shouldn't industry make a really BIG mess and what incentive is there to accurately estimate either costs or benefits?

An example of how costs and benefits can be manipulated is n the latest report from the EPA on CAA. The Los Angeles Times reported that the benefits section of the current draft was "sharply revised" from a May draft that calculated savings to consumers of up to $2 trillion dollars.

"$2 trillion in savings to consumers at the gas pump and elsewhere could be achieved if greenhouse gas regulations were implemented.. [In the current draft], that number was slashed to $830 billion, and the price of gas was calculated at $2 a gallon for the next 30 years.

According to the LA Times EPA press secretary Jonathan Schradar said "he did not know why the numbers had been changed". Or perhaps he knew why but didn't know how or who or when? An inherent danger of such analyses?

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¹ (ANPR) Advance Notice of Proposed Rulemaking: Regulating Greenhouse Gas Emissions under the Clean Air Act.

² Congressman Waxman's Committee of Oversight and Government Reform has a long running investigation of the OMB and EPA's actions on the environment/. He held the two agencies in contempt of court for refusing to release documents related to decisions about the ozone and the California waiver, to which President Bush claimed executive privilege.

Making Grad Work Easier

In "The Companions of Mad Cows" a couple of years ago we mentioned that veterinarians in Alabama had diagnosed mad-cow disease, bovine spongiform encephalopathy (BSE) in a downer cow. According to the Wall Street Journal article, officials had buried the cow on a farm in Alabama, but refused to divulge where. They were also searching for the bovine's "companions", to assure the disease was confined to one cow and hadn't been contracted through feed eaten by many cows. (Scientists don't think BSE is transmissible from cow to cow.) We wrote in that post: "we suspect that perhaps someday when the BSE stricken cow has long since been forgotten and decayed, some inquiring grad student will be stunned by the number of prions they unearth in a random soil sample of the unidentified burial site."

Now, a recent study indicates that prions could be made more infectious via certain soils. From the University of Wisconsin, Madison, Christopher Johnson et al. tested prions' ability to bind to different minerals that could then be orally transmitted to grazing animals. They published their results in PLoS Pathogens. According to the study, transmissible spongiform encephalopathies (TSEs), (which include BSE, scrapie in sheep, and Creutzfeldt-Jakob disease, and chronic wasting disease) not only survive in some soils, but because prions selectively bind to certain minerals, clays containing these minerals might be more infectious.

Researchers in another study found that prions remain in biowaste after sewage treatment. Glen T. Hinckley and fellow scientists at University of Wisconsin published research in ASAP Environmental Science and Technology (via Nature News) showing that prions survive activated sludge treatment and anaerobic sludge digestion that's used to degrade waste in waste water treatment plants.

Lurking on Your Portabellos?

Nature News suggested forebodingly that we should assume prions are in biosolids leftover from wastewater treatment, and since "biosolids are often used as crop fertilizer, this raises the prospect of small amounts of prions being present on the surfaces of the crop plants - and without careful washing, they could therefore be ingested when the food is consumed." (Taken at face value this is bad and good. Bad for obvious reasons. But think how much less work grad students would have to do in gathering their specimens? -- straight from the dining hall salad bar to the bench.)

But really? Prions on your crudités? So far prions have not been found in wastewater, only in biosolids, and aside from the current research they haven't ever been found in routine tests -- although the authors of the wastewater paper point out that the the tests aren't sensitive enough to detect them. Prions would occur at very low levels since they are rarely found in humans, so the possibility that they would somehow end up on salad is not impossible, but according to an EPA scientist interviewed by New Scientist is quite remote. She added that alkaline treatment used by some treatment plants, though not the Madison one, would deactivate the prions.

Prions are know to be resilient to conditions that would kill viruses and bacteria, but studies have also shown prions sensitive to extremes in PH. For instance researchers found that prions that mice were less susceptible to prions than cows, because mice digestive systems contain greater amounts of hydrochloric acid. Authors of the first paper above hypothesize that when prions attach to minerals in soil this might protect them from acid and explain their enhanced ability to infect the host.

China's Transparency

China's 7.8 earthquake continues to bring bad news with heart-breaking collapses of schools and too many people trapped under fallen cement. However by all counts, China has improved its handling of the earthquake compared to previous disasters. Communication is critical in a disaster but difficult. During Hurricane Katrina, even in the middle of the worst of the storm, a few intrepid residents and journalists hunkered down in New Orleans and provided on-line updates. The US government responded, but governments' ineffective communications held up disaster efforts. Even with the most modern technology, medical and logistics support, in accessible terrain and with an outpouring of support, Katrina proved challenging. In countries with less infrastructure and less effective government the communication situation is measurably or immeasurably worse. In lieu of information, rumors run rampant.

The dearth of information is a breeding ground for rumors. Not too ago death tolls were considered a state secret in China. China has been notoriously non-transparent dealing with critical problems like infectious diseases, such as SARS, Avian Flu, Streptoccocus Suis, and even the "blue-ear disease" that killed millions of pigs and contributed to the pig shortage considered to be one part of the world-wide heparin contamination fall-out.

While China was at first guarded in dealing with this earthquake, it has since invited foreign aid from Taiwan, Japan, South Korea, and Australia, some of whom have sent specially trained groups to China. China's new acceptance of outside help defies a tradition of doing it all themselves. Their initial nationalist reaction seemed to be on display in the beginning, when China announced: "Faced with the disaster, we have become still more united, still more cohesive, still more composed and still more sure of ourselves, and such spirit and strength constitute the invincible, priceless assets of the Chinese nation" Then they seemed to move from their defensive starting position.

China spent considerable effort informing citizens about the progress of the recovery. But when the disaster struck, rumors about the cause of the disaster clogged the internet and they continue today, rumors that the Chinese government failed to warn about the earthquake, that a chemical plant blew up, a damn broke, that tap water was turned off by the government -- a rumor a minute. Yesterday, China punished 17 "rumormongers" with anything from reprimands to jail terms. The country urges people to stop spreading rumors, saying that "[r]umours will stop at those who are brave and upstanding". China tells people to listen to the government: "We have the most accurate and authoritative information. Believe only what we say." So much government information has previously been faulty though these new message seem a touch unrealistic.

Many observers think the upcoming Olympics provides incentive for an effective leadership front. China is aiming to improve its record for dealing with disasters, and so tries to be transparent, or look transparent, even as disturbing news continues -- 2 dams are in danger of bursting and 391 dams are in "dangerous condition".

The Washington Post writes today that China's control of communications tightened on Thursday, with the government all be blocks access to the worst hit regions. Especially unwanted were foreign reporters.

In Poor Taste

Unlike China, Myanmar is trying not to be transparent, so although rumors abound, the country is so closed that we never even hear most of them. All access is now blocked to the Irrawaddy delta and military checkpoints are increasingly difficult to circumvent. The International Herald Tribune reports that the World Food Program delivered thousands of high-energy biscuits to the south, but that many had "been stolen, or replaced with cheap crackers". The story is somewhat confirmed, but there are conflicting reports. Myanmar does have a 400,000 strong army to feed and no one wants a hungry army, especially if your feeling like an endangered junta.

The biscuit rumor had it that Myanmar was passing out "low-quality" biscuits and stashing the World Food Program's donated High Energy Bisquits (HEB). This is unfortunate, especially since HEB's don't have a culinary standard you'd want to descend too far from. The biscuits are packaged in "strong cardboard cartons in which packages of 100 individual packages "100 of these are to be stuffed in one carton box". Here's the ingredients of one HEB:

Composition: Energy: 450 kcal, Moisture: 4.5% minimum, Protein: 10-15 g, Fat: 15 g Sugar: 10-15 g maximum. "10 to 20 g each, shelf life of 18 to 24 months, manufactured in conformity with US or EU food legislation....fit for human consumption."

These are valuable for their emergency purpose, containing calcium and magnesium, as well as vitamins. But why would Myanmar switch out these biscuits when they have their own (celebrated) biscuit factories? When the Myanmar Biscuit Factory of the Circus Foodstuff Cooperative Ltd had it's grand opening, according to a government website news item, the Auditor-General, deputy ministers, departmental heads, officials of the Ministry of Cooperatives and Secretary-3 of the State Peace and Development Council Lt-Gen Win Myint attended. Wouldn't their own biscuits store nicely? In the context of western governments' relative transparency, technology, convoys of aid, and trucks that run all by themselves without being pushed by a team of monks, we can only imagine how dire Burma has become. How can a country that's trying to deploy aid to a couple of million people with six helicopters be so defiant?

According to reports the death toll may be greater than 200,000 at this point, and the international community has become increasingly apoplectic. A group of Nobel Laureates recently requested that western governments provide humanitarian aid. France has warned that Burma is committing a Burma then called France's big ship carrying aid sitting of its coast a warship, in what the Bangkok Post called a "clear sign of paranoia". A UN emissary, John Holmes will travel again to Burma with a third letter from UN Secretary-General Ban Ki-moon to the Myanmar senior general, who refuses to talk to Ban. Thailand has sent a small team of doctors to Burma and an international team of disaster assessors is also on its way. As the crisis becomes worse, not a few people hope for assertive action on behalf of the Burmese citizens. Lack of transparency leads to rumors, paranoia, secrecy, lack of accountability, lack of humanity.

For many years, the defense ministries in allied states like the US, Canada and the UK have denied that exposure to depleted uranium (DU) could produce negative health effects. Depleted uranium is a byproduct of uranium 238 (U238) enrichment, and contains a higher percentage of U235, a more fissile isotope that makes DU useful in the production of nuclear weapons and energy. This depleted byproduct is 1.7 times the density of lead, and because of its durability, has been used extensively by militaries for things like armor piercing projectiles and anti-tank weapons. During the Iraq and Balkans wars, when vehicles and weapons clashed together, dust from depleted uranium was released. Bullets made with the depleted uranium were scattered in battle, and shrapnel was strewn about and embedded in wounds. Depleted uranium ordnance now lays scattered throughout previous war zones where children play and civilians attempt to carry on their lives.

Civilians and other species are exposed to depleted uranium not only during war, but via dust in the air around weapons factories and in groundwater near firing test ranges like in Solway, Scotland, where scientists find worms that carry uranium isotopes. All of this exposure could prove toxic to animals and humans.

Depleted uranium is not as radioactive as U235 but it is suspected of causing various illnesses, from cancer, immune disorders like Gulf War Syndrome and even birth defects in offspring born of soldiers who inhale or ingest it. Research shows that in lab animals, depleted uranium is an immunotoxin, neurotoxin, and teratogen and carcinogen. Although the deteriorations in the health of some soldiers seems to show the the dangers of DU, there's limited government recognition of these dangers, from military, medical, and science establishments. Even in the face of accumulating evidence and significant public outcry about depleted uranium, militaries give mixed messages about DU safety. The US Department of Defense says:

• "The health effects of uranium have been studied extensively for over 50 years."
• "The Department of Defense has comprehensively studied the environmental fate of depleted uranium both before and after the Gulf War."
• "Fortunately, DU is only mildly radioactive emitting alpha and beta particles, and gamma rays.....The risk of chemical toxicity is also minimal because there is little likelihood that sufficient quantities of DU could be inhaled or ingested to cause a heavy metal concern."
• "Since the Gulf War, the DoD has dramatically stepped up its emphasis on increasing soldier and leader awareness of the hazards associated with the battlefield use of depleted uranium..." through training, handbooks and "support materials".
• "...there is no reason to believe that other exposed Service members have any elevated risk to their health due to their DU exposures."

Similarly, the Ministry of Defense (MOD) for the UK has repeatedly asserted minimal health effects from exposure to depleted uranium, but the MOD also gave warning cards to all UK servicemen deployed to Iraq stating possible health effects of DU. The Ministry of Defense suggests that it's reducing use of DU, noting cryptically of all the accounting of the depleted uranium used by the military: "In 2003, during the recent Iraq conflict, UK tanks expended 1.9 tonnes of DU ammunition and none has been fired since the official ending of the conflict." The MOD urged soldiers to get monitored for depleted uranium, but after testing the urine of returning servicemen the Ministry of Defense told papers in 2006 that "no evidence of DU was found in their urine". Critics question the sensitivity of their tests.

Clearly, the effects of depleted uranium are still disputed and perhaps not a problem, but new research suggests a potential solution. Scientists have discovered a fungus that will break down depleted uranium to a less toxic mineral, research sponsored in part by the Ministry of Defense, produced by scientists at the University of Dundee in Scotland and published in the recent issue of Current Biology. They describe how a plant symbiotic fungus can be grown on the surface of depleted uranium, where it will transform the depleted uranium into uranyl phosphate minerals, a more stable form of the metal that is less likely to be absorbed into plants, animals and water. The mycorrhizal fungi usually lives in the roots of plants, where it transforms carbon into nutrients that plants use. When colonizing uranium, moisture in the air helps the fungi cover the surface of the metal, where the fungi helps accelerate the corrosion process of the uranium into products that can be take up by the fungi or broken down to less toxic uranium holding minerals. The fungi could be used for various bioremediation projects in uranium polluted soils.

Can market solutions to an intractable public health problem like AIDS work? Can paying people for intrinsic choices motivate better choices?

AIDS, Malaria and Public Health

Public health requires persistence and creative solutions. Public health is tenuous, and a mutation in a virus responsible for avian flu or a malaria parasite that can drastically change the course of a disease -- change who gets infected, where, and how.

Many other changes, in politics, economics, leadership, geopolitical stability, funding, even weather can impact progress treating and preventing diseases. Technology also changes the course of disease, although talk about technology advances sometimes provides more promise than the actual technology once it comes to fruition. In the fight against AIDS, for instance, promises of vaccines trumped promises of retroviral treatment for all or prevention. It was as if public health gave up on any solution accept a vaccine.

It's morbid to think there may never be a silver bullet for the HIV/AIDS crisis, but its also damaging to over-promise a technical solution like the vaccine that's so speculative. Despite global discouragement about the AIDS vaccine's recent setback, there are always optimistic moments, like ten years ago when education and prevention through condom use and social marketing was the crux of HIV/AIDS fight.

AIDS Long Road

The AIDS crisis seems so untenable however, that its understandable that the AIDS vaccine be touted with such determined optimism. In September, 1998 Washington Post reported on the "remarkable success" of the new prevention strategies. Across the world, the paper said, HIV infection rates were decreasing. In places like the Dominican Republic, Brazil, and Uganda, and the Ivory Coast, and in Tanzania,, where a three year trial aimed at decreasing sexually transmitted diseases had "reduced HIV transmission by 40 percent". An administrator from the AIDS Control and Prevention (AIDSCAP), Brian Atwood, told the paper: "this agency has made a global contribution....over the years, we've learned so much about this..."

Learning about the risk of AIDS doesn't necessarily change sexual practices or result in long term success. The AIDSCAP program ran through the 1990's and despite the successes, suffered many obstacles. As with many of these programs, success can easily be derailed by staff turnover, sociological shifts such as stigma around disease or misunderstanding of disease etiology, uneven programming, funding shortages, interruptions, and politics.

According to the report, today in Tanzania infection rates are lower than places like South Africa, averaging at about 8%, but overall life expectancy in the country has decreased by 8 years due to AIDS. While HIV infection in urban areas declined by 16.65% from 2000 to 2005, in rural areas infection rates have markedly increased.

Other critical economic development measures have also regressed in Tanzania, for instance literacy rates dropped from 80% in 1980, to 60% today. In one survey of adults, 52% of women and 62.5% of men believed that a teacher who has "the AIDS virus but is not sick should be allowed to continue teaching."

Rewarding Behavior

Now, an experimental trial in Tanzania will attempt to attack this complex knot of problems underlying the HIV/AIDS epidemic with a market solution. The Financial Times wrote last weekend about a project in Tanzania that would pay people who practiced safe sex. The trial participants would take regular tests for sexually transmitted diseases like gonorrhea, and be paid about $45 if they remained disease free. The control arm of the trial would not be paid. All would be treated for any infections. Sexually transmitted diseases increase the risk of becoming HIV infected and Tanzania has long focused on this connection.

The project is sponsored by the World Bank, William and Flora Hewlett Foundation, the Population Reference Bureau and the Spanish Impact Evaluation Fund (affiliated with the World Bank). The Financial Times quoted Carol Medlin, a researcher on the project from the University of California, San Francisco, who said: "We hope this 'reverse prostitution' will make people think hard about the long-term consequences of their short-term behaviour."

The move is controversial -- can paying people for intrinsic choices motivate them? Can the complex set of problems underlying AIDS epidemics, involving everything from public health infrastructure, to politics, social norms, economics, and leadership, be resolved by motivating personal choices with money? In an accompanying editorial ("Cash for safe sex; Bribing Africans to be careful is bizarre - and worth a try"), the Financial Times suggested that the scope of the problem warrants such an attempt: "In the face of an appalling Aids epidemic, we should overcome our unease." Should we?

When Merck's AIDS vaccine candidate failed in clinical trials, the National Institute of Allergy and Infectious Diseases (NIAID), in the National Institutes of Health (NIH) called a summit. The drug candidate did not reduce HIV infections, in fact the adenovirus based vaccine seemed to increase the risk of infections.

The meeting of scientists on March 25th in Washington focussed on the future of HIV/AIDS research in light of the fallout of Merck vaccine trials. Scientists including Anthony Fauci, who heads the NIAID, agree that funding needs to be redirected towards a broader research agenda and ideas beyond drug development and vaccines. Science last week noted that the decision about whether to proceed with the large NIH clinical trial planned for its HIV vaccine is still pending. ("Review of Vaccine Failure Prompts a Return to Basics" DOI: 10.1126/science.320.5872.30)

Nature also reported on the summit last week, pointing out that these clinical AIDS trials went forward not necessarily based on the strength of the science -- one of the vaccine candidates had a unimpressive track record -- but because programs needed to "show the public that progress is being made, thereby justifying the millions of dollars from philanthropists and taxpayers". ("Broken Promises" doi:10.1038/452503a).

The Nature editorial offers analysis of this HIV-AIDS vaccine experience, noting that ambitious commitments made in a flush funding environment in the early part of this decade short-changed basic research. These choices to heavily fund drug development are regarded less forgivingly in light of the trial failures and the budget shortfalls of recent years, according to the journal. Nature warns other fields, for instance stem-cell research, autism, and Parkinson's disease, are repeating these same mistakes.

The business approach comes with a high stakes mentality and ample, vigorous marketing that can ratchet up expectations both within the organization, the field and the public arena. The business-oriented nature of many philanthropic organizations influences the focus on development and can distort public expectations. But investors can and do influence the direction of an entire field. When a field becomes dominated by a few foundations it can gather tremendous productive momentum, but it can also stampede so hard down a particular path with such strong momentum in a particular direction. If that direction proves to be less fruitful than hoped research cannot turn around on a dime.

Each high-funded disease has its own idiosyncratic pitfalls, but behind the good works and fine intentions of charities, but the science research rarely responds to pressure, unlike many entrepreneurial ventures. When scientists request research funding, the results don't always yield answers as quickly as businesses might hope -- research is the mythical man myth on steroids. Some people investing in biotech and international public health come from businesses very unlike public health with its vagaries of not only politics and human behavior, but biology.

In today's fast paced communications and computing climate, intense focus on "results" is inherent to our culture. Expectations carry over from the successful and extraordinarily speedy progress of the genome sequencing. Scientists and politicians built hopes during that time that drug development and an accelerated understanding of human disease would follow. It has, but did we expect more? TV drug advertising gives the impression that scientists are developing a pill for every insignificant hangnail, when many of these drugs aren't new, just the subjects of new marketing campaigns. Meanwhile tougher diseases and conditions remain elusive.

High profile funding can influence the research environment and lead to a very public dead end. In the larger picture, despite the wisdom that should be accruing from these experiences, politicians, technology leaders, and pundits sometimes wax-on about technology's potential to produce solutions not only for specific diseases but for extremely complicated social problems such as global warming and healthcare. But while science research may yield pharmaceuticals and oil extraction techniques but one cannot look to science or technology to solve the healthcare crisis in the United States. Science and technology contextualize these problems and are integral in our lives but despite heady declarations, they are not central to the solutions.

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Acronym Required has written previously about these subjects, AIDS and research directions, and vaccines. Here are a couple of our vaccine articles:

Vaccinations -- Why Worry?
Polio Vaccinations - The end of a scourge?
Group B Strep Vaccine Development
Vaccine Development For Infectious Diseases

A couple of years ago in "The Microbes Win", Acronym Required wrote about research done by Wright et al at McMaster University, who found that many species of microbes isolated from soil samples had significant antibiotic resistance to clinically useful antibiotics. Last week researchers at Harvard published a study in the journal Science (Dantas et al, "Bacteria Subsisting on Antibiotics":Vol. 320. no. 5872, pp. 100 - 103), advancing research in this area a step further.

The scientists managed to culture a significant number of soil isolates using antibiotics as the sole source of carbon. The bacteria that proliferated most proficiently on a diet of antibiotics were from the Pseudomoniale and Burholderiale orders. Bacteria in the genuses Pseudomonas or Burkholderia, like Pseudomonas aeruginosa and Burkoholderia cepacia are responsible for infections involved in meningitis, skin, lung and bone infections, swimmer's ear, and opportunistic infections in immunocompromised patients and those afflicted with cystic fibrosis.

The Harvard group suggest that the large genomes of Pseudomonas and Burkholderia species give them many diverse mechanisms of resisting bacteria and adaptive versatility, and that catabolism of antibiotics is just one tool in their arsenal of antibiotic resistance mechanisms.

These bacteria are very relevant clinically but scientists haven't observed utilization of this antibiotic catabolism, probably because there are many sources of carbon at infection site therefore catabolism of antibiotics isn't the most useful method of resistance. Since soil residing bacteria are exposed to natural sources of antibiotics, the research isn't extremely surprising, but may lead to further understanding of shared and unique antibiotic resistance mechanisms.

EPA: The Dog Ate Our Homework

Last week 18 states sued the EPA after the agency refused to act on last year's Supreme Court ruling in Massachusetts v. EPA. The court had ordered the EPA to determine whether greenhouse gases presented a danger to public health and welfare, and if so to plan how to regulate them. The states' action was the latest move in the long tussle between the EPA and the states, the EPA and multiple Congressional committees, the EPA and various non-profits speaking on behalf of citizens, even the EPA and businesses who have a keen interest in slowing climate change.

On March 27th (PDF!), EPA administrator Steven L. Johnson sent a letter to Congressman Henry Waxman's (D-CA) Oversight Committee, outlining his plan to seek public comment on greenhouse gases and potential regulation. It was a short, simple letter but an elaborate Victorian lacework of excuses. The decision, he wrote, involved sifting through "options", "potential effects", "pending petitions","possible regulations", "careful considerations", "comment periods", "relevant data","drafts", "solicit[ations]" and "extensive briefings".

The Supreme Court ordered a ruling on the implications of CO2 from mobile sources, but administrator Johnson chose to expand his review to include as many stakeholders as he could think of -- "experts", "schools", "hospitals," "factories", "power plants", "aircraft and ships", "on-road vehicles", "off-road vehicles", "petroleum refineries", "Portland cement", "authorities", "power plants" and "industrial boilers". Procrastinators and students of the dog-ate-my-paper temperament should study his document for inspiration.

The 300 Page EPA Reports Had Already Found C02 Endangers Public Health

The science on CO2 is conclusive and the EPA knows it. The agency has already followed up on the 2007 Supreme Court ruling with a thorough investigation of their own. They recruited 60-70 experts to look at the greenhouse gas effect on public welfare (summary, PDF). The large EPA team found that, yes, global warming did endanger public welfare and detailed their result in a 300 page report. To note, this wasn't news to them, the EPA worked through the issues at stake in Massachusetts v. EPA back in 1999 and in other investigations which documented the same health findings.

Following their 300 page report, Johnson signed a proposal that would have reduced carbon dioxide from motor vehicles and brought fleet fuel economy to 35 mpg by 2018, a proposal which bested by two years the time-line in the energy bill recently signed by President Bush. Unfortunately Johnson's proposal for emissions regulation, the endangerment finding, and the 300 page document got lost somewhere between the EPA and the White House and NHTSA, leaving Congressman Waxman and his committee investigating what became of these EPA decisions and plans.

Now in 2008, nearly ten years after the initial request was given to the EPA, Johnson decides that rather than "rushing to judgment", as he put it in his latest memo, the EPA must continue to look at "complex issue[s]", "interconnections" , "lawsuits", "deadlines", possible "changes" and "ramifications", "permits", "thresholds", "requirements", "relevant information", "complexity", and "implications". The world is anxious for action on global warming. Why now, with the pressing urgency of climate change bearing down, is the EPA is overtaken by omphaloskepsis? Or is it mendacity?

Stalling: EPA Extends Public Comment and Oil Companies Weigh In

Congress wrote the Clean Air Act in 1970 to safeguard public health and welfare. Air quality regulation deserves public comment. But Johnson is proposing a comment period in the Advance Notice of Proposed Rulemaking (ANPR), despite having already received 50,000 public comments in 5 months, when the EPA previously solicited comment. This new "public comment period", seems like nothing but an unnecessary stalling mechanism, one that will only solicit "public" comment from organizations who have already weighed in loudly.

Before Bush signed the energy bill and the EPA denied the California waiver, the EPA, OMB and the White House met regularly with many stakeholders including those from the petroleum and auto industries. The Detroit News reported last year that Cheney and/or Bush met with "Detroit's three automakers" multiple times in 2006 and 2007. Public Citizen wrote a 54 page report last August (PDF) documenting how from 2001 to 2003, senior administration officials met with Department of Transportation's (DOT) National Highway Traffic Safety Administration (NHTSA) 45 times in order to produce an attributes model for determining fuel economy. Their considerations were incorporated into the CAFE standards.

As well, according to meeting records, the OMB held five "20-in-10" meetings last year and more in 2006, when the (OMB), the EPA and DOE and the DOT/NHTSA gnashed over the President's proposal to raise fuel economy by 20% in 10 years. Stakeholders who attended these meetings included Shell, the American Petroleum Institute, Frontier Oil, Occidental Petroleum, BP, ExxonMobil, Chrysler, Honda, Toyota, Nissan, Hyundai, and Porsche.

The LA Times wrote in a March 28th article that Johnson's suggestion for more comment followed a memo circulated by the Heritage Foundation, an industry lobby group or "think tank", to "everyone that we could think of" in the White House and Congress. The memo urged decision makers to pressure the EPA for the ANPR because this would make legislators look like they were doing something. As the lobby group put it, the public comment session:

"would allow all interested parties to send the EPA relevant information and start a record on important topics such as the cost and burden of carbon caps and Clean Air Act expansion without triggering the costly new regulations."

When the EPA found on endangerment (that GHG were a public health hazard) last year, it conducted "extensive analysis....about costs and benefits", according to Waxman's letter, before producing the plan that Johnson signed off on.

Now, the industry and its agent, the EPA, propose to expand the pool of stakeholders in order snag the regulatory process in a morass of bureaucracy. What's fascinating to us here at Acronym Required, is how quickly interested parties drop their typical ideological attachment to "efficiency" and "small government" when advocating an obstructive process that suit their ends.

Industry Meet and Bleat: EPA, NHTSA and the OMB

If we want to know what more "public comment" might look like with respect to "costs and benefits", we could get insight from glancing at a memo presented to the OMB and its Office of Information and Regulatory Affairs (OIRA) in a meeting November 15, 2007 with Chrysler executives. (The document we will be discussing doesn't have an author noted, but there's various fingerprints from oil companies, lobby groups and car manufacturers. Since the only company attendees at the meeting were Chrysler executives I will call it the document the "Chrysler document", the "meeting document", or the "document")

There are hundreds of other memos to the EPA, of course, but this one, the anonymous authored "Regulation of Motor Vehicle Greenhouse Gas Emissions under the Clean Air Act and the Energy Policy Conservation Act", (Whitehouse.gov/omb..) reads like an industry directive to the EPA role for how they should regulate greenhouse gases emitted from moving vehicles. After reading this it doesn't take a vivid imagination to see the industry's prints on the EPA's current actions. The "simplest" solution, the authors of this document say, "...is for the EPA to abstain from attempting to set carbon dioxide standards" from vehicles "already subject to the NHTSA regime." [emphasis ours]

To quickly explain: The two government agencies that regulate motor vehicles are the National Highway Traffic Safety Administration (NHTSA) in the Department of Transportation (DOT). NHTSA sets gas mileage targets through CAFE standards, and the EPA is charged with regulating motor vehicle emissions.The energy bill that Congress passed and Bush signed (H.R. 6) last December pertains to mileage standards. Carbon dioxide emissions are primarily responsible for global warming. Industry argues that the EPA should not regulate emissions because of "regulatory overlap" between the NHTSA and EPA, but this was already defeated by the Supreme Court, who rejected this overlap argument.

The meeting document defines the EPA's "primary mission" under the Clean Air Act as determining the "requisite technology", that will "address the potential problem of climate change" -- as if technology were the only solution (and the entire thrust of the Act). A quick aside: Politicians use the word "technology" because of its magical properties. It's modern, smart, and forward leaning. "Technology" solves unsolvable problems and no one argues with it, it offends no one. "Technology" inevitably translates to more *business*, and business is always good, therefore "technology" is probably the only noun in the world that remains nonpartisan. But in actuality it often means absolutely nothing. The "technology" argument has been quite successful in staving off progress on global warming, as we mentioned in a previous post.

The document advises that if the EPA find endangerment, which they did, then the agency should coordinate with NHTSA "a series of clearly defined steps, each of which involv[es] public participation", and successive "public comment" periods. The document precisely describes the very political maneuvering we see today, so no one today should be surprised at the EPA's announcement.

But long after this document was made public, the press and politicians expressed shock over EPA actions like the agency's denial of the California waiver. Sometimes the press should pay more attention to the evidence. There was no room for surprise given the very public history of the climate change tussles.

Cues: "Technological Feasibility, Economic Practicability, Maximum Feasible"

The meeting document repeatedly cites the NHTSA's Energy Policy & Conservation Act of 1975 ("EPCA" or "the 1975 Act"), and its "balanced goals". The reason for the auto industry's adoration of the 33 year old NHTSA standard over the Clean Air Act and the EPA's updates to the Clean Air Act, is because the 1975 Act considered things like "technological feasibility" and "economic practicability", which allow for more input from the industry.

A favorite concept from the "1975 Act" is "maximum feasibility". "The document" insists that the EPA carbon dioxide standards should be "no more stringent" that the "maximum feasible" standards for fuel economy set under the NHTSA. Although the phrase "maximum feasible" seems straightforward, it's anything but. To be clear about what they mean, the authors spell out their own definition. It's not, they write, "the highest level of fuel economy that can be achieved by a single vehicle, or even by a fleet of vehicles, through the application of available technologies". "Maximum feasible" they say, gives the auto industry leeway to consider sector employment, consumer choice, and the overall health of the industry. In other words, "maximum feasible" is entirely subjective and by their interpretation, the fantastic 1975 Act, "ensured wide consumer choice by leaving maximum flexibility to the manufacturer". To be clear, the industry theorem therefore takes "maximum feasibility", and neatly redefines it as "maximum flexibility to the manufacturer".

The authors emphasize the part of the Clean Air Act 202(a)(2), that says the EPA should give "appropriate consideration to the cost of compliance". The document predicts that costs like "investment in tooling engineering research, and development" are a "primary constraining factors on the industry's ability to achieve higher average fuel economy levels on a fleet-wide basis", and that "NHTSA's own standard setting process under EPCA would...be the upper limit of what EPA could properly determine to be the most stringent standards". In other words, gut the intention of the Clean Air Act, and instead follow NHTSA's 1975 standard.

The document says the Clean Air Act should allow the EPA to: "set standards that take account of the limits on the investment capabilities and product cycles of the industry, just as NHTSA does...". The document advises the EPA to consider the financial resources of the industry, and weigh the "potential trade-offs between more stringent requirements in the near-term, and investments in longer-term strategies that seek to commercialize vehicles that do not require" carbon fuels. Of course, the industry has for 30 years spent all its effort undermining "longer-term strategies", so this is a bit of a canard.

Citing a petroleum industry case, the document recommends that whatever the EPA does, standards shouldn't require costs and if "additional technology" is needed, than the EPA can "properly decide to not adopt standards under the Clean Air Act". So first the EPA should define "requisite technology", then once it's defined, then the auto industry waive action. The Chrysler document outlines all the ways the EPA can not regulate greenhouse gases, including "abstain from attempting..." regulation, a request that the EPA under Stephen Johnson seems quite agreeable to.

Automotive "Modernization" -- Back to the 70's?

Of course if we look back 30 years ago we get an idea of how antiquated and stuck the American auto manufacturing industry really is. In the 1970's the fuel efficient cars looked like the Plymouth Duster or the Chevy Chevette, and the impetus to innovate for customer choice was real because those rattletrap choices were truly dire. Today, "customer choice" is an encrusted artifact of advertising cynically used by auto manufacturers, especially when faced with regulation. Despite seductive rhetoric about "new technology", the auto industry is clinging to the good 'ole days and the loose regulatory framework of the NHTSA's 33 year old standard.

The document presented to the EPA in November, 2008 directs "what the Congress sought to achieve in the [1970's] EPCA and how those objectives should shape EPA's action under the Clean Air Act." The authors on last year's document quote Phil Sharp, former D-IN (now the president of Resources for the Future, an energy policy think-tank) who sponsored the 1975 Act. Apparently, three decades ago, during a congressional debate, Sharpe noted: "Serious unemployment in the auto industry" called for considerations to "preserve this important segment of the economy". Sharp urged the EPA to maintain "the health of the industry."

Back to the 1970's. We know that "mid-century" is all the rage in fashion and home decorating, but while we tolerate (for the sake of argument) scaly old orange plastic chairs and brown shag rugs as retro fashion statements, we're not so keen on mid-century policy for 21st century problems. We need an evolved policy to "preserve the auto industry". Plus, if you think back, the Chevy Chevette got 40mpg highway, 28mpg city, better than many cars today. Surely we can do better with mileage and emissions in 2008, then in 1970 -- given our technology-centric society?

Today in 2008, the auto industry is swamped with losses. In the 1980's, when one auto company president suggested controlling the regulators, Reagan replied "Get control of them? We need to get rid of them."

Per Ronald Reagan and successive White House leadership, for the last 35 years deregulation spared the auto industry manufacturers, who chose to use the government's leniency and improvements in fuel efficiency to innovate gas consuming features rather than mileage standards that surpassed the "1975 Act" mandate. When sales sink up to 18%, as they now have, unemployment follows. Would today's crisis have been averted if a less permissive policy had been pursued?¹

The auto industry would love to live forever in the 1970's. But if "the health of the industry" is truly still a goal, maybe the government's kindest move would be to shoot the industry, or drown it in the bathtub, or whatever libertarian types do these days with ponderous, surly sectors.

The Prognostications of New York Times

In a post last week we questioned the New York Times assumption that Congress would never alter the Clean Air Act to include cost benefit analysis.² But perhaps they don't have to, if the Heritage Foundation is successful at urging members of legislator to bog down EPA action on global warming.

When legislation leaves it to industry to decide whether a particular environmental regulation to mitigate pollution or toxins, the process towards resolution is well-rehearsed and elicits a predictable response -- YES, yes; way, way too costly! This is the problem. Costs and benefits must be considered, even though some people unilaterally criticize cost benefit analysis for public health and welfare. But on the emissions arguments and the Clean Air Act provisions, analysts correctly point out that costs are often overestimated. This is because the industry doesn't approach this exercise fairly, rather they seek to torpedo all regulatory initiative to preserve and enhance today's profits.

The document prepared for the Chrysler/OMB meeting underlines one of the points of our previous post: that costs and benefit analysis done by industry will prioritize industry profits; and forsake clean air, water, health and welfare.³

To run out the clock, the EPA broadened the emissions issue addressed by the Supreme Court to all greenhouse gas emitters. Expanding the Supreme Court's mandate so promiscuously will allow corporations and their lobby groups, maybe even some newly minted ones with deceptive names like 'Citizens For Fresh Air', (I made this up) to make wide, swinging estimates of costs in an attempt to freak the public out about lost jobs, economic gloom and doom and the exorbitant cost of regulation. This is a 30 year old trick though, and where did it lead the auto industry?

Consumer Choice, Sea to Shining Sea

In the US, school children sing national songs about the country's natural resources. Indeed, the country is famous for its natural beauty, the mountains, forests, canyons, fields and azure oceans. Children learn "America The Beautiful" early on. But once they grow to adults, the children naively adapt their thinking. They accept rhetoric from industry that rejects the idea that resources are really the citizens', rather they belong to industry, which uses and pollutes air, water, land, trees. Somehow citizens think that yes, what's good for industry trickles down to them. Then when pollution burdens public health, as with smog in California, industry reacts as if fouling the public's air and water is its right -- how dare citizens overstep their rights by demanding we control our pollution?

Trotting out the "costs" of regulation, industry rebuffs citizens as if they were encroaching, trying to steal its property. Regulation is hurting business, they cry! Once citizens and politicians subscribe to this rhetoric, regulation is easily overturned in the name of freedom. And subscribe they do, paying daily, yearly, for industry to pollute the nation's resources. If that doesn't work for businesses and their lobbies, they drag "jobs" onto the set.

When industry puts "jobs" onto the national bargaining table they present a coercive choice. Regulation or jobs? Clean air or jobs? Water or jobs? Glaciers or jobs? Species or jobs? Your health or jobs? Your kids health or jobs? Would most citizens walk up to a slouch on the street and ask to play 3-card Monte with them? No. But in just as obvious a con, citizens instinctively recoil from the "jobs threat" and snatch desperately at the "jobs" hand -- just as if it were really a "choice"! Addressing global warming is good for the economy, not bad.

Global warming is not a simple problem, but the Supreme Court has many times laid the groundwork for how the EPA needs to act. But the Environmental Protection Agency, in the name of its citizens but in the service of "free-markets" flouts the court, congress, states and constituents.

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¹Deregulation that impacted environmental resources didn't start in the 1980's, but Reagan amassed huge gains in this direction, including cost benefit considerations. Many politicians are attentive to these analyses and some ascribe to more radical sentiments. Senator Tom Delay and Senator James Inhofe would dismantle agencies like NOAA, NEH, DOE, OSHA and the EPA, which they liken to the "Gestapo". (See for instance Delay, T., "No Retreat, No Surrender: One American's Fight" (p13)). Inhofe puts out regular press releases as ranking minority member of the Committee for the Environment and Public Works (EPW) which is led by Barbara Boxer stating that any global warming measure will cost jobs and wreak economic havoc.

²We previously wrote about Johnson's request to Congress that the Clean Air Act be "refurbished" to include "benefits, costs, risk tradeoffs, and feasibility in making decisions about how to clean the air".

³A 2007 draft report for Congress on costs and benefits of government legislation used Heritage Foundation information and the example of failed communist states to show how regulation can wreak havoc on an economy. Of course the Soviet Union was famous for disasters like Chernobyl and for leaving a devastating, costly pollution legacy, so the example is flawed on many levels. Not to mention how ludicrous it is to write a 2007 report to Congress which stoops to waste even one sentence linking clean air and water security with communism.

Flipping a Nation

The press, scientists, and commentators were instinctively indignant yet unsurprised by the Environmental Protection Agency's (EPA) new ozone rules, which of course came out below science and public health recommendations. The agency changed the ozone levels from 84 parts per billion (ppb) to 75 ppb, although scientists said that 60-70 ppb would decrease deaths and smog levels dangerous to children, the elderly, and those with asthma and respiratory disease.

Of course industry and the Bush administration weighed in on the matter, killing a secondary standard that EPA staff had recommended. The EPA's standard would have allowed agency discretion in setting standards in the event of certain conditions like weather in order to protect vegetation and wildlife from ozone exposure during growing seasons. Despite the agency's flaccid ruling, the EPA held a press conference to give agency heads the opportunity to beat their brave, intrepid, heroic chests. There, administrator Stephen Johnson spoke of standard as, "the most health-protective eight-hour ozone decision in the nation's history".

A New York Times editorial focused on another thing Johnson said during the conference:

"The big surprise was Mr. Johnson's proposal to rewrite the Clean Air Act to allow regulators to take costs into account when setting air quality standards. Since this would permanently devalue the role of science while strengthening the hand of industry, the proposal has no chance of success in a Democratic Congress."

What? The Bush administration whittles away government regulation? It marches "forward", privatizing various common assets like air, natural resources, forests and health that the administration acts like it inherited for the America public? Shocking. So all the spin we hear about the redistribution of this resource bonanza as the principled, constitutionally sound, economically ideal (market driven) thing to do is -- well, spin? Surprise.

We can count the ways that our government ignores science in its decisions -- astute observers attend to this problem. The EPA itself attempts to gut the Clean Air Act at every opportunity, for instance after Hurricane Katrina (pdf). But to the editor's point, is Johnson's cost/benefit proposal outlandish? Not a chance of passing?

The EPA Saves "Living" Things: Documents

In his March 12th comments Johnson called the Clean Air Act a "living document" that needed to be "refurbished", "overhaul[ed] and enhance[ed]", "modernize[d] and upgrade[d]". There's really nothing to complain about on the face to this statement. Johnson announced his four "principles" for a Clean Air Act, including, to"allow decision-makers to consider benefits, costs, risk tradeoffs, and feasibility in making decisions about how to clean the air." The Clean Air Act was not "a relic to be displayed in the Smithsonian", he said.

The Times editor pointed out that Johnson's proposal would "cut to the very heart of the Clean Air Act", which was written to protect science from special interests by mandating rule-making based on health, not economic costs.

As we have witnessed, when the first hint of pollution regulation arises, any energy company worth its salt begins wailing about "technology not being available", about the exorbitant cost of the proposal, and about all the risks of complying when there is such scientific "uncertainty". Companies did just this when they held the nation in a decades long trance while they chanted about global warming uncertainty. Recognizing hints of recent history in his statement, and knowing how Johnson's incredulous suggestion could easily put estimates about cost and feasibility squarely in industry's park to the detriment of clean anything, we should become alarmed, perhaps leap to action, maybe phone our legislator.

However the NYT editor's tone soothed, calling Johnson's pronouncement a "revelatory moment", one that signaled the administration's "cry of frustration at being largely unsuccessful in undoing three decades of environmental law". Like the wolf frustrated in mid-hunt? One last guttural, spine chilling howl before giving up its prey -- and the fawn darts into a thicket of brambles just in the nick of time, a small defiant flick of its white tail?

Can we argue so optimistically, as the NYT editor did, that the Bush administration attempts have been "largely unsuccessful"? Knowing that standards should be set according to science can we be assured that, "the proposal has no chance of success in a Democratic Congress"? We love this view, can we share the optimism?

Ozone Decisions, Sunset Regulations and the Doyenne of Death

In Johnson's ozone ruling he said he followed the letter of the law and ignored "costs, net benefits and implementation challenges of more stringent standards" as required by the Act. Despite his words, scientists say that his new 75ppb standard was in deference to industry. Rogene Henderson, who chairs the Clean Air Science Advisory Committee, told Platts Energy: "I think [Johnson] is responding to the pressure of the industrial groups about the cost". The record also shows influence from the Office of Management and Budget (OMB), and its Office of Information and Regulatory Affairs (OIRA).

A series of memos between Susan Dudley, the OIRA administrator and the EPA, detail the Administration's influence in crafting the rule (available online www.regulations.gov). Over a couple of exchanges, the EPA refused to back down on the secondary standard. Then administrator Dudley issued a 'President-says-so' order March 12th: "The President has concluded that, consistent with Administration policy, added protection [Orwellian doublespeak?] should be afforded...by strengthening [more OD?] the secondary ozone standard and setting the secondary standard identical to the new primary standard..." Thus, the EPA was over-ruled.

Before Susan Dudley was chosen by Bush to head the OIRA, she distinguished herself by attacking what she saw as over-regulation, and she decried the diminished role of the OIRA and OMB in overseeing the regulations that agencies enacted. In the 1990's she roundly criticized the effect of a Clinton executive order, which shifted regulation out from under executive control to science agencies like the EPA. Dudley said the OIRA and OMB under Clinton had been made impotent and she urgently advocated for cost benefit analysis, especially for ozone and particulate matter rules. She chafed at how OIRA had lost its standing as the "watchdog for social welfare". (Regulation, Fall, 1997) As Reagan and H.W. Bush did before him, the current Bush administration has now spent the last 8 years pulling authority back into the executive branch. Dudley's interests are clearly aligned the administration's.

When Bush considered Susan Dudley to run OIRA, according the the Washington Post in 2006, "'Frank O'Donnell of Clean Air Watch called Dudley 'a true anti-regulatory zealot' who 'makes John Graham (previous OIRA head and Mercatus executive) look like Ralph Nader.'" In 2006 Public Citizen and OMB Watch published a report about Susan Dudley on the eve of her appointment to the OIRA, titled "The Cost Is Too High: How Susan Dudley Threatens Public Protections". The two groups argued against Dudley's appointment to the OIRA -- because her approach to regulation, they argue, was laden with "extreme-antiregulatory ideology". Public Citizen and OMB Watch went on to detail her background at the neoliberal Mercatus Center and her dedication to "embedding cost considerations in all laws that authorize agencies to protect the public, including...'safety first' laws" (like Clean Air Act).¹

Of course cost/benefit calculations involve valuing health, the environment, and quality of life. When considering the cost/benefits of smog then, here's a question: what's an acceptable threshold for the number kids who are forced to stay inside on high ozone days to prevent asthma attacks? Thousands? Millions? Particular cost-of-death calculations are often seemingly arbitrary, and long-term injury or morbidity that may or may not truncate a life are even more speculative. What does this say about how the US values its citizens, its children?

At the other end of the age spectrum, according to the OMBWatch/Public Citizen report "Dudley has supported a senior death discount that counts the lives of seniors for less than the lives of the young". While this may be standard actuarial practice, pollution is more dangerous to the elderly, which make her calculations seem savage. For the prospects of regulations protecting our welfare the report pulls no punches in painting Dudley as the doyenne of death.

What Happens in "The Catbird Seat"

The report's authors also point out that not all "costs" have the same moral and ethical value. With government doing "regulatory budgeting" they say "industry can knowingly expose the public to grave harms, enjoy the financial benefits of failing to take the steps necessary to protect the public, and then use compliance costs -- the costs of finally doing the right thing -- as a shield against being forced to comply with new protective standards."

Another impediment to forming guidelines for clean air or water, as well as workplace safety is sunset regulation. Dudley favors sunset regulation, which 'imposes automatic extinction to regulatory policies then puts agencies in the position of having to justify regulations'. As we can see from global warming, environmental damage accrues with indecision. By the time a piece of the Antarctic the size of seven Manhattan's drops off, well, too little has been done too late.

Finally, as Public Citizen notes: "Dudley would impose "regulatory budgets": fictional budgets of industry compliance costs, with a cap. Once an agency like the EPA hits its cap, it would be forced to stop promulgating any new protective standards, no matter how great the need."

As part of its regulatory oversight OIRA invites industry to suggest changes to federal rules. The Washington Post reported that shortly into President Bush's first term, when the OMB asked for public input on which regulations should be revised or killed, Mercatus submitted 44 of the 71 proposals the OMB received and the OMB approved 15 of them according to the National Journal. In 2002, 267 regulations were targeted, 80 from business associated organizations and a couple dozen from Mercatus. As a result, in 2001 and 2002 the Clean Air Act and the Clean Water Act were changed by proposals that benefited industry sponsors like BP Amoco, ExxonMobil and Koch Industries and other Mercatus donors.² The Public Citizen/OMB Watch analysis predicted that when Dudley headed the OMB she "will sit in the catbird seat, overseeing the entire executive regulatory process...able to slow, stall, weaken regulatory proposals" to the detriment of public health and the environment.

Ozone Rulings and Regulatory Agencies

Bush worked around the nervousness surrounding Dudley's nomination by appointing her during Congress's recess, and she immediately began to reclaim more ground for the OIRA. Specific to the smog ruling, Dudley had long advocated against smog regulations on behalf of industry. In 1997 testimony before the Senate Committee on Environmental and Public Works on the Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety she argued incorrectly as the Vice President of Economists Incorporated that smog was beneficial because it protected individuals from ultraviolet radiation. In the same presentation she asserted preposterously that since research showed that asthma rates were associated with poverty a smog ruling would have the "perverse effect" of costing communities money which would in turn increase poverty and asthma. While she now works for government and on behalf of citizens instead of industry, she employs this line of thinking.

The OMB for its part has the EPA in its sights for what it deems as engaging in misguided rule-making based on unreasonable scientific uncertainty and high costs. In the 2007 annual report to Congress The Costs and Benefits of Federal Regulations, OMB criticized the EPA for its determinations of the health effects of particulate matter: "the degree of uncertainty in benefit estimates for clean air rules is large. In addition, the wide range of benefits estimates for particle control does not capture the full extent of scientific uncertainty."

The authors single out six EPA rules on drinking water which they say cost state, local, and tribal governments or the private sector "over the threshold" of one hundred million dollars annually. The Clinton/Bush II Executive Order 12866, especially Bush's two recent amendments, strengthened the OMB/OIRA's authority over the agencies, including putting executive appointed regulatory policy positions into each independent agency.

Of course this OMB analysis doesn't expound on the enumerable benefits of clean drinking water free of cleaning agents, disinfectants or arsenic. And why one hundred million dollars? How much administrative consideration is justified for solvent free water? Some Senator's houses cost nearly that much. Needless to say this is a drop in the bucket compared to the Iraq war, the costs accruing at $341.4 million per day with some mighty uncertain benefits.

The 2007 OMB costs and benefits report grounds its analysis in the philosophy that economically well-off countries have strong property rights and minimal regulation. The draft document veers to ideology at times, citing the Heritage Foundation for information and stooping to past arguments by citing Communism as an example of regulation gone wrong.

No More Neighborhood Wimp

In an issue of Regulation in 1997 Dudley wrote before she was administrator about a previous OIRA administrator who had bragged that OIRA was the "biggest kid on the block", so other agencies had to respond to its agenda. She complained that the OIRA under Clinton was the neighborhood wimp. So although Dudley's perch at OIRA may be short-term, she had been preparing her tenure for decades and when nominated by Bush strode in to the post with a clear agenda.

To aid Dudley's smooth tenure, executive orders and congressional laws paved the way, for instance in the 1990's, rules such as the Unfunded Mandates Reform Act (1995), the Government Performance and Results Act (1993), and the Small Business Regulatory Enforcement Fairness Act (SBREFA) (1996), all addressed regulatory and reporting costs without expanding definitions of benefits. SBREFA, for example, spares businesses from what could be burdensome regulatory costs.

But the idea that agencies need to consider the costs of clean water and air rulings on "small business" can be interpreted in such a way that hobbles the goals of clean air and water. This also leaves small businesses susceptible to lobby manipulation by groups like the National Coalition of Petroleum Retailers, who may officially represent "small business", but whose aims may appeal most strongly to huge business. Look for example, at San Francisco's attempt to limit bisphenol A, and the immediate lawsuit which of course included BPA manufacturers, but also listed as parties to the suit local toy stores.

Johnson's proposal to rewrite the Clean Air Act is not out of left field, rather something urged for decades by industry, various government agencies, congressman and lobby groups. Furthermore, it's no more surprising then his smog ruling, if more appalling, since the changes he speaks of have been in the works for years and in fact progress towards the goals he articulated is well underway.

Health and the Environment: The Public's Standing

You'd think Johnson wouldn't even mention to Congress rewriting the Clean Air Act, given the spotlight on the EPA's recent record on the environment and the vocal admonition of members like Senator Boxer (D-CA). But Congress, though recently vocal against the EPA's refusal to move on environmental laws, has at times acquiesced eagerly to business deregulation and cost benefit guided rulemaking. Thus the current ease and confidence of Dudley in thwarting the goals of the EPA. Congress of course touts progress on all fronts, business, environment, and health, but business generally comes out the biggest winner.

Our intent is not to focus entirely on Susan Dudley, anymore than it is to focus on Stephen Johnson, or George W. Bush. They're all accomplices to a larger agenda which seems outmoded and outdated, that needs to be "overhauled" and "modernized". We are not in competition with Soviet ideology, capitalism is not merely ascendant, it's dominant -- so arguments in last year's OMB report to Congress about regulations on Clean Air and Water being nigh to Communism are absurd.

We live in a time when kids can't play outdoors because of smog, when business pollutes with abandon then screams about a rule that mildly asks, please don't pour oil into streams. We live in a time when the UN warns monthly about climate change and rising seas. This is the state of our nation today. This administration's decades old way of thinking deserves only to be encased in Plexiglas in a museum.

We live in a time when business calls the shots in Congress, in the White House and in the Judiciary, and we should all wake up to that truth. Yet voters still respond to "red phone" imagery with a knowing nod of utter naivete. There is no threat bigger than ourselves -- we are the traitorous monsters in our midst.

When the phone rings -- red, blue, yellow or green -- in the White House, in your Congressperson's office, or at the court house, it's not some nameless international threat, but an American industry whose TV advertisements you hum to and whose brand you endorse, and the person on the other end is calling to murmur in the lawmaker's ear about less regulation. One hand of the caller is slipping dollars into the decision-maker's pockets while the other waves fanatically to citizens about the economic doom of Clean Air and Clean Water, about the unemployment that will follow, and balance sheets that will run red. That's what happens when the red phone rings in the White House in 2008. Let's get real.

So what will elected representatives do for Clean Air? What they always do? Should the world have faith that Congress will protect Clean Air and Water? Sure, as long as somehow business benefits. But citizens have a choice, and always a voice, so we'll veer positive here. The NYT editor's right. The US evolves. Congress will see Johnson's clumsy marionette arms and legs being yanked by OIRA, his mouth voicing the agreed upon words from the decades old script. And your Congressman will answer the phone when citizens call, skip the form letter reply, and renounce Johnson's quest to rewrite Clean Air considering such things as costs, feasibility, and trade-offs.

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¹The report details how during seven years in the 1990's, Koch Industries (a petrochemical company) was found by the EPA to have spilled 3 million gallons of oil (300 unstopped leaks) into waterways in 6 states, and was fined $30 million dollars as a civil penalty (Koch founded Mercatus and is its largest contributor).

² Incidentally, Mercatus donors included Merrill Lynch, JP Morgan Chase, NYSE, Fanny Mae, and Freddie Mac. A quarter of the proposals the Mercatus submitted to OIRA in 2001 and 2002 were for financial services deregulation.

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Acronym Required has previously written about the EPA, the environment, and public policy.

BPA -- Here to Stay (In the Environment)

Bisphenol A (BPA) is a chemical used in plastic products we all use, everything from dental resins to household products, canned foods, plastic food containers, and baby bottles. Since the chemical gives plastic products useful properties, its ubiquity means that most of us have traces of it in our bodies -- 93% of populations tested have BPA in their blood. Chemists originally developed BPA as a possible synthetic estrogen so it binds to estrogen receptors, is potent at low doses, and as such it can cause deleterious health effects such as decreased sperm count, enlarged prostate, cancers, diabetes, early puberty, and immunological and developmental effects.

Legislators for the city of San Francisco recently proposed bans on bisphenol A and phthalates, however in the final bill, after the legislators had probably duly considered circumstances such as a lawsuit against the city by bisphenol A manufacturers and toy retailers, as well as sustained lobbying from chemical company lobbies, they removed bisphenol A from the bill. The states of California, Maryland and Minnesota all produced bisphenol A bills that died in process. The America Plastics Council rigorously lobbied against all these bills and is relentless in its efforts to convince the public that there's no scientific evidence to support the dangers of health effects of bisphenol A. In fact, there are hundreds of government sponsored research studies showing health effects of BPA.

Chem Link Love: BPA-->EPA--> FDA--> APC--> RTI--> PPG

Now Congress has taken interest in Bisphenol A. The U.S. House of Representatives and Committee on Energy and Commerce chaired by John D. Dingell (D-MI), and its Subcommittee on Oversight and Investigations, launched an investigation of Bisphenol-A in January. The subcommittee is focusing on BPA found in products made for infants and children like infant formula, where BPA is used in the epoxy liners of cans.

The subcommittee has sent out a series of letters requesting more information about the safety of BPA from the makers of infant formula, the EPA, the FDA, and others, including the consulting firm the Weinberg Group. The manufacturers of infant formulas responded variably that BPA was not found in formula, was found at levels considered safe, and/or BPA epoxy was the only option for lining cans*.

In a letter to the FDA the subcommittee questioned what evidence the FDA used to deem BPA safe, to which the FDA wrote back citing two studies both "sponsored by the American Plastics Council". Both of these studies were done by Research Technologies Inc. (RTI) and scientists have cited problems with at least one of the studies' methodology's. (The president and CEO of RTI Victoria Haynes coincidentally cut her teeth at Monsanto, rising to the post of director of their plastics division. In addition to her RTI post she was an adviser to the Homeland Security Advisory Committee and is a director at several companies, including PPG Industries, a company whose products include epoxy resins for cans as well as *'non-epoxy liners for the European market.')

Government and Industry Consulting, a Lucrative Formula Perhaps?

Last year Acronym Required wrote about Sciences International Inc. (SII), a small consulting firm that was fired for conflicts of interest from its contract running the NIH Center for the Evaluation of Risks to Human Reproduction's (CERHR) assessment of Bisphenol-A's safety for neonates and infants. We wrote that SI's mission included public education, such as publishing their own research on chemical safety in their own scientific journal headed by their own company executives. They cited this as "peer reviewed" research on their website and in white papers perhaps to increase their scientific credibility and assure people of chemicals' low safety risks.

The Sciences International website touted the company's abilities to leverage government contacts for corporate benefit, and their history of producing favorable regulatory outcomes and public opinion. For example SII described their risk analysis work used to influence lower regulatory standards for clean air for the EPA. On one version of their site, SII wrote: "Sciences' methods development work is often sponsored by public agencies, such as the U.S. EPA, while applications work is most often for the private sector where agents of particular concern need to be addressed."

In that post in 2007, Acronym Required wondered about the nature of regulation in Washington when the company NIH chose to assess the safety of BPA for neonates and infants that seemed to be more focused on industry objectives: "[Sciences International scientists]...have applied a biologically-based model approach to coke oven emissions for the industry and derived an alternative cancer potency factor which has been accepted by the EPA. We believe that our ability to utilize accurate dosimetry and pharmacodynamic models in tandem in risk assessments provides unique opportunities to the chemical industry",

Acronym Required is heartened to know Congress is paying attention. Similar to the SII example, the subcommittee explored the marketing website (since removed) of the chemical industry consulting company the Weinberg Group. As per the subcommittee's quotes in their request for more information, the Weinberg site was a virtual rodomontade of feats pulled off by Weinberg on behalf of chemical companies versus government regulatory agencies, all of which seemed to skew scientific integrity in favor of client "results".

The subcommittee sent a letter to the Weinberg Group asking about a series of case studies that included verbiage about various projects, such as swaying an FDA decision on a drug with "life-threatening adverse events", and being "at the forefront" of public relations addressing endocrine disrupting chemicals "leaching from food containers", and contained in "children's toys". (the latter sounding a lot like bisphenol A.)

The subcommittee requested information on details of another letter from the Weinberg Group to DuPont de Nemours referring to their work on the chemical perfluorooctanoic acid (PFOA), a carcinogenic chemical used to manufacture Teflon. Weinberg says they produced scientific papers on "PFOA, junk science and the limits of medical monitoring", handled scientific testimony and expert witnesses for court cases, and "[reshaped] 'the debate by....analyzing existing data, and/or constructing a study to establish not only that PFOA is safe over a range of serum concentration levels, but that it offers real health benefits.'" PFOA Dupont has been fined by the EPA and sued for its PFOA activities including suppression of safety information for 20 years.

The committee has now widened its scope beyond BPA. Their letter to the EPA's Stephen Johnson requested information about the dismissal of Dr. Deborah Rice as the chair of an external review panel that was investigating a type of polybrominated dephenyl ether (PBDE), decabromobiphenyl ether (deca) used as a flame retardant. Rice's sacking followed a letter the EPA received from the American Chemistry Council (ACC) complaining that she had testified for the State of Maine on the dangers of deca. The ACC called her expertise a "conflict of interest". The subcommittee's letter challenged the EPA's firing and included 9 incidences of people from industry who testified on various EPA chemical safety panels despite real conflicts with obvious pecuniary connections in the chemical industry.

It will be interesting to see where this goes beyond the obvious -- subcommittee members burnish their environmental credentials while giving companies serving both government and chemical industries another lesson on the pitfalls of producing zealous marketing material for the company websites. We remain optimistic that the inquiry will produce results and anyway, the public outing of information is always useful. Happy belated Sunshine Week.

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Acronym Required wrote about bisphenol A in the following posts:
"Phthalates and Bisphenol A: Media and Politics" (November, 2007)
Plastic Bottles- Protecting Your Baby, by the ACC (July, 2005)
"Bisphenol-A and Phthalates Bill in California" (January, 2006)
"San Francisco Bans Bisphenol A, Phthalates" (July, 2006)
"San Francisco Phthalates & Bisphenol A Ban" (November, 2006)
"Sports Retailers Stop Selling Polycarbonate Bottles" (December, 2007)
We wrote about PFOC in these posts:
"PFOC: Likely Carcinogen" (January, 2006)
"Dupont, The Teflon Company" (December, 2005)
"Slick Company Stands behind Teflon"(July, 2005)

Lung Cancer, No Worries?

The New York Times reported today that a study promoting CT scans for early lung cancer detection published in the New England Journal of Medicine was supported in part by a cigarette company. Funds for the research came from the Foundation for Lung Cancer: Early Detection, Prevention & Treatment, a group funded by $3.6 million dollars from the Vector Group, the parent company of the Liggett Group.

The New England Journal of Medicine published the study by Dr. Henschke et al, "Survival of Patients with Stage I Lung Cancer Detected on CT Screening The International Early Lung Cancer Action Program Investigators" in 2006. The authors concluded that "annual spiral CT screening can detect lung cancer that is curable", which was optimistic on two fronts. 1) The idea that lung cancer is detectable would be well received by doctors and patients because lung cancer is not usually detected in time for successful treatment. 2) If lung cancer were treatable, that is if Stage I cancers were "curable", as the authors concluded, this was very positive news considering that the mortality rate for all lung cancer is high. Both of these ideas could quell fears of some concerned smokers and health workers. More and more, cancer is considered a chronic disease not necessarily a fatal one, but lung cancer is still one of the deadliest.

The study results, if repeatable, could potentially change (some people's) perceptions about the dangers of smoking, and the paper got a lot of attention. The study authors compared CT scans to mammography scans and concluded that you could prevent 80% of deaths from lung cancers in at risk populations. If the results were that significant, if CT scans helped treat cancer, and if policy followed from the authors' conclusions, one might see an increase in the number of routine CT scans performed in the US.

Not. But What About a CT Scans?

As with most science everyone wants to see more studies done, especially since eyes are on Cornell-Weill study's methodology and conclusions. The idea to test greater numbers of people from risky populations also has also interests doctors and public health practitioners. But doctors have also expressed concern that if its recommendations were enacted patients could risk overdiagnosis since the testing produces false positives and there are concerns about exposing populations to CT radiation. To this end the NIH is funding the a $200 million dollar National Lung Screening Trial which tracks 50,000 smokers using CT scans through the agency's National Cancer Institute, .

But that study has also been dogged by some concerns. The Wall Street Journal wrote an article last October suggesting that two of the researchers in the multicenter study also had conflicts of interest for work they had done for tobacco companies testifying about the safety of CT scans. The Lung Cancer Alliance wrote letters to the NIH calling their attention to possible bias. The Lung Cancer Alliance is supported by donations and grants including $100,000 from General Electric, the company that makes CT scanners.

Two researchers, Dr. Denise Aberle of UCLA and Dr. William Black of Dartmouth, each testified on behalf of tobacco companies in state lawsuits. The defendants in the cases wanted the tobacco companies to pay for CT diagnostic screens. Aberle earned $30,750 from American Tobacco by testifying against the state of Louisiana, saying that CT scans were "reckless or irresponsible to promote". Black reportedly earned $700 from Phillip Morris for testimony for that company against the state of New York. He said CT screening "may do more harm than good."

The NIH asks that researchers involved with government studies report conflicts of interest to the institutions that employ them. Most of those institutions, as Acronym Required has discussed before, refuse to impose restrictions on research funding sources, and in fact aren't eager to divulge their policies on controversial funding from industries like tobacco. CT scanning is a powerful tool, but the most appropriate use for lung cancer detection is still under study. With the forthcoming NIH study results due next year, the investigation of these important research questions is clouded by contentions of conflict of interest on both sides.

My House or Yours?

One evening about 5 years ago I learned of "chicken pox parties". There on a news group, a dozen people chatted about sending their kids to a "party" with such nonchalance you'd have thought they were planning holiday shopping and $5.95 lunch special afterwards. Perhaps they'd spent hours thinking over the pros and cons. But on the public forum those do-it-yourself infectors didn't question the public health risks, the possible complications, or the ethics of purposefully exposing your kids and family to highly infectious diseases that fortunate people in western countries get immunized against. If they had doubts they masked them with derring-do.

I was taken aback by this parental concept of fun and thought it some new and bizarre fad. Naturally I was curious. How would it work? "OK kids, now we're going to pass the communal drink cup around, then we'll play the kissing game..."? (I also rethought my entire childhood in a positively idyllic way, though I never forgot the sting of merthiolate.¹)

These modern parental dalliances with infectious disease seem ironic. Public health's largest successes include the vaccination campaigns that eradicated or significantly reduced loathsome diseases such as smallpox, polio, yellow fever, measles, diphtheria, and tetanus. The UN reported last November that measles vaccination efforts, especially in Africa, have helped decrease measles deaths by two-thirds across the world since 2000.

Scientists and doctors toil to develop vaccines for ugly scourges like HIV and malaria, which are each responsible for mortally infecting up to 30% of some populations and when a recent AIDS vaccine trial failed, the collective global dismay was palpable. For diseases where vaccinations aren't available, citizens in developing countries latch on to promises from the public health community that millions of people's lives will someday be saved by immunization. Against this backdrop, suburban parents in western countries shun vaccinations, because in their country, in this day and age, the injections themselves seem more dangerous than the diseases.

It's tempting to think of these "chicken pox parties" as the privileged reserve of parents of a certain age who never saw the ravages of disease that previous generations knew intimately. Maybe if they saw a man crippled by polio; maybe if they had lived through the smallpox epidemics in New York at the end of the 18th century, where one in five victims died and in milder cases victims were left left blind. Maybe their mother or grandmother never described what it was like caring for a family during an outbreak of chicken pox as it swept through infecting each of six children.

But doubts about vaccines are perennial. Now parents air their vaccination suspicions via the web. Before the web, they talked on the phone, or at work, or in between hauling water from the well. This is not the fad of a select cohort of modern parents, convinced that a case of wild chicken pox is safer than a vaccine because they've never known anyone who died of the disease.

These unique "social events" seem shocking when they appear in your inbox. Go to any online article about any part of the whole wide topic of vaccination and peruse the comments section for horrifying rumors, misunderstandings, and cavalier-bordering-on-criminal pronouncements about never vaccinating kids. It's enough to make anyone shudder -- doctor, scientist, parent or casual reader. It's easy to see how those who claim that thimerosal is responsible for every imaginable childhood tic are dangerously misguided. It's less acceptable to question an authority who tags as crazy anyone who questions any aspect of vaccinations.

For Your Own Good -- Smallpox in New York

Naturally, vaccinations have an interesting and controversial history, like much of medicine. The tussle between public health campaigns and fearful citizens is part and parcel of that history. The first vaccinations introduced a wound with a sharp implement of some sort, then infected the area with a bit of virus from a sick neighbor or perhaps some pox in a jar. Vaccination became more sanitary, but the concerns about safety persist as with all cutting-edge medicine.

Along with the health worries, there has always been questions about the government's power to compel vaccination. When vaccinations arrived in the US from England in the early 1800's, people balked at what they saw as encroaching boundaries of government. At the time, American public health initiatives were more about trying to convince people not to do things, like "[let] their privy overflow into the street" says James Colgrove in "Between Persuasion and Compulsion:Smallpox Control in Brooklyn and New York, 1894-1902 (Bulletin of the History of Medicine 78.2 (2004)). As Colgrove's book title indicates, public health officials walked a fine line between persuading, cajoling and forcing public compliance, for many years without legal authority.

Health officials contained smallpox outbreaks by vaccinating households within a circumference of an infected household. If someone refused to receive the vaccine, authorities would station couple of policemen, the "Sanitary Police", to enforce a quarantine on the household. There are stories of people who made involved escapes from quarantined New York residences, only to be caught in New Jersey and hauled back for punishment.

While libertarians thought the government was overstepping, even when vaccinations became safer there were concerns about the deleterious effects of vaccinations. During several outbreaks of smallpox in New York in the late 18th century and early 19th century, rumors spread that the vaccine contained tetanus, despite significant efforts by health professionals to dispel such notions.

Arthur Allen writes in "Vaccine: The Controversial Story of Medicine's Greatest Lifesaver" that "Raggedy Ann", was named for a rag doll handed down from writer Johnny Gruelle's grandmother to his daughter Marcella and memorialized in Gruelle's books. Marcella died at 13 after receiving two smallpox vaccinations in school -- some fears were justified. According to Allen, the Raggedy Ann doll then became symbol for the anti-vaccination effort.

At the beginning of the 20th century, anti-vaccination advocates successfully brought two high profile cases to court to challenge the government's right to make vaccinations compulsory. In 1904, the New York state court decided in Viemeister v. White that the state could mandate laws curtailing individual liberties in order to protect public health. In 1905 the Supreme Court decided that all states have the right to legally enforce public health measures, in the infamous Jacobson v. Massachusetts precedent. This helped solidify government authority, and continued medical advances and quality control assured safety. However real and perceived hazards remain.

The same issues (legal, moral, individual liberty, public safety, medical safety) churn in the public arena today as during the smallpox vaccination campaigns of 100 years ago. People erroneously think modern issues are unique to our era but the underlying questions are the same. Is HepB really necessary for newborns they ask? Can I infect my own child with chickenpox? Can I skip vaccinations altogether and depend on herd immunity? States struggle with how to keep populations safe.

Additionally, people understand the profit incentives of pharmaceuticals and ask questions like: Is a cervical cancer vaccination really necessary for my 9 year old daughter? Since so many vaccinations are enforced by law there's an uncomfortable nexus of profit motives (pharmaceutical companies), individual health concerns (what are the risks of taking or not taking the vaccine), and public health concerns (how to prevent scourges and keep the public safe).

While vaccination is one of medicine's greatest coups there are still many issues and questions about vaccinating. Nevertheless among all the doctors, commentators and public health authorities who speak out, there's always one subset of the chorus who authoritatively treat all questions and concerns with the same universal knee-jerk dismissiveness. Is their approach the best public health strategy?

"Same, Same But Different" - Polio in Nigeria

Vaccination doubts are not the exclusive domain of "naive" westerners. Polio persists in countries like India, Afganistan, Pakistan and Nigeria where many people know first hand the crippling effects of the disease, yet still occasionally resist vaccination. In 2003, Nigerians in some northern states thought that polio vaccines contained HIV virus and/or sterility drugs, and began refusing vaccinations. Here's how the CDC described the problem (brackets mine):

False rumors about OPV [oral polio vaccine] safety adversely affected SNIDs [Subnational Immunization Days], with the greatest impact in Kano, where 25% of all Nigerian WPV [wild polio virus] cases occurred in 2003. Citing vaccine safety concerns, state authorities in Kano (which last conducted a SNID in April 2003) decided in August 2003 to suspend all SIAs [supplementary immunization activities]. Statewide suspension of SIAs at different times during 2003--2004 also occurred in Kaduna, Zamfara, and (to a limited extent) in Niger state. As a result of these rumors, public health managers and frontline health-care workers found it increasingly difficult to improve microplanning, training, and implementation of SIAs.

Unlike the New York Times, the CDC is not in the business of humanizing disease. The agency categorized the events but of course gave no hint as to where the false rumors may have come from. However it's worth looking at because Nigeria's history with vaccinations provides some insight into the quandary of public resistance to vaccination. For instance take these three recent events:

1) As Western AIDS denialists like Peter H. Duesberg influenced South Africa's Thabo Mbeki, some say a book by Edward Hooper published in 1999 called "The River: A Journey to the Source of HIV and AIDS" (Little, Brown) fed rumors throughout Africa that AIDS was spread to humans via a related simian virus contained in a oral polio vaccine (OPV) given to populations in the 1950's. Hooper theorized that OPV was developed when scientists used primary chimpanzee kidney cells as a substrate for the vaccine. The polio vaccine was tested in mass trials across Africa, Poland and Russia, but Hooper claimed that in Africa OPV led to HIV.

Hooper's book was well received. Reviewers from most major newspapers gave the book good reviews, and even more skeptical reviewers gave partial accolades. Robin Weiss of Science called the book "a towering achievement; right or wrong in its main conclusion, there is much to learn from Hooper's exposition" (Vol. 286. no. 5443, pp. 1305 - 1306). John Moore, in a Nature review called the book, "in many ways, superb. It is scholarly, thoroughly researched, well (if densely) written and deserves, indeed demands, to be taken seriously." ("Up The River Without a Paddle", 401, 325-326 (23 September 1999) | doi:10.1038/43778) However both journals disagreed with the central tenet of the book because Hooper based his conclusion on circumstantial evidence. Shortly thereafter no less than three research groups disproved Hooper's hypotheses in research that was published in Nature and Science. Nevertheless there's enough residual interest and belief in Hooper's book (and he continues to publicize and update his hypotheses), that the ideas he introduced persist today.

2) Africa has long been a place where clinical trials are conducted unlike the way they are in the US. When these trials don't work out the fallout hurts subsequent public health efforts. For instance take the recent example of Pfizer's Nigerian clinical trial of Trovan in 2006. Half the kids were given the antibiotic Trovan (Trovafloxacin) during a meningitis outbreak, and half were given ceftriaxone, the drug normally used to treat the disease. Kids from both groups died, but the focus was on the eleven of the kids in the trial on the test drug and others in the experimental cohort who remain permanently impaired.

The Washington Post covered the story in a series called the "The Body Hunters". Marcia Angell also outlined the trial in a New York Review of Books article, also called "The Body Hunters". Investigators who followed up on the clinical trials charged that the company breached medical ethics and said the trial wouldn't have been allowed in the US because it's unethical to do a trial of an unproven drug during an active epidemic. Among other issues, doctors gave inadequate or no informed consent to patients, and the dosage for the established (control) treatment was reportedly too low, which could have made the experimental drug (Trovan) look better.

National outrage over Pfizer's actions brought a group of Nigerian plaintiffs to New York where they unsuccessfully attempted to try the case in the US. Nigeria's suit against Pfizer continues to this day, and a lawyer for Nigeria recently testified about the US red tape complicating his attempts to summon to Pfizer executives.

3) In 2003 the idea that vaccine campaigns were nefarious sterilization efforts gained momentum after scientists reported that polio vaccines contained estrogen. A Muslim leader, Dr Ibrahim Datti Ahmed, secretary general of the Supreme Council for Sharia in Nigeria, claimed he had research proving western goals to "depopulate" Africa and introduce "adulterated" vaccines. Throughout history, the west has championed family planning, which has elicited abject suspicion, and led to occasional rumors about devious plots by western forces to decimate populations via birth control and vaccinations. Public health workers have diligently tried to solidify trust of vaccinations among Nigerians for decades.

But in 2003 the Nigerian polio vaccination program was forced to shut down so that politicians could test the vaccines suspected of being birth control agents and provide public proof of their safety. Such an interruption can have devastating health consequences. Vaccination rates fell to 30%. and the disease spread to Muslim communities around the world. Muslims tended to mount resistance to vaccinations people say, because they were wary of the war in Iraq and perceived animosity from the US to Muslims. Eighteen countries previously declared polio free incurred polio flare-ups and countries that hadn't seen polio since the 1980's had outbreaks.

Any of these incidents could have help spread fears about vaccinations. Hooper's ideas have been dispensed with and Trovan may have not have caused deaths, but the effect of these incidents has a far-reaching negative impact. Furthermore, when clinical trials are conducted in countries under circumstances that wouldn't be legal in the US, suspicion is not without foundation.

10 Billion Doses, 200 Side Effects.

During the interrupted 2003 polio vaccination effort, many Nigerians went unvaccinated, and the population became susceptible to another uncommon occurrence. The polio vaccine, made of attenuated virus, can occasionally mutate to a wild non-attenuated virus that causes infection. But the chance of this occurring increases when a large number of unvaccinated people give the virus more opportunity to replicate and mutate to the wild form.

The journal Nature reported that an outbreak of this type last fall ended up paralyzing 69 children. This is a rare occurrence -- the WHO expert interviewed by the journal pointed out that "10 billion doses of oral polio vaccine...administered worldwide were implicated in 9 outbreaks, accounting for fewer than 200 cases of disease" (Michael Hopkin, "Health officials fear Nigeria Polio setback" 12 October 2007 | Nature | doi:10.1038/news.2007.163). Despite how rare these occurrences, or the fact that they often occur when many people refuse to get vaccinated, the incidents feed suspicion.

Time reported that Nigeria's 2007 outbreak due to the wild-type virus was contained via collaborative public health messaging between religious, health and political leaders. However sometimes mischievous anti-immunization authors, politicians, organizations or religious leaders stir trouble by either malevolently or innocently blaming such an outbreak on vaccinations.

There are risks to vaccinations. There are risks to clinical trials. There are mistakes, and sometimes medical malfeasance. And there's a public disconnect when it comes to understanding risk, 200 side effects in 10 billion doses is very safe, but no one's content when their child has the adverse reaction. There's always the possibility that a few aberrant reactions to a vaccination can innervate fears in hundreds of people and derail a whole vaccination effort.

Some percentage of the population will always distrust vaccinations, no matter how good the messages. But another percentage of civilians have legitimate concerns. Public understanding of reasonable risks is further complicated by public health, pharmaceutical and political hesitation to admit errors for fear that people will shun vaccinations (or pursue litigation). So what do these suburban American families have to do with Nigerian villagers? People harbor distrust of government mandated vaccinations produced by for profit pharmaceutical companies. If all resistance, chicken-pox parties as well as questions about the necessity of cervical vaccines receive the same reception from authorities, as they do sometimes, this can lead citizens to distrust public health authorities and more vehemently shun vaccinations, ironically.

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¹ Merthiolate is a trade name for thimerosal and was widely used as a topical antiseptic for children. You'd fall down scrape your knee, and then into the wound mom would pour this reddish-orange-pink stuff, a toxin, as it turns out that really burned and smarted. Barbaric.

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Senate Consumer Product's Bill Includes Phthalates Amendment

The Senate and House are both working on bills to provide more oversight for imported toys. The bills follow several toy recalls last year that resulted in the deaths of children exposed to lead laden toys, and seeks to raise the civil penalty caps from thousands to millions of dollars. The legislation also aims to bolster the Consumer Products Safety Commission (CPSC) and establish a public database of consumer complaints.

Nancy Pelosi (D-CA) and several Democrats have called for the ouster of CPSC head Nancy Nord, who opposed the bills to strengthen the CPSC despite the surge in product recalls. Sen. Sherrod Brown (D-Ohio) told reporters unsurprisingly: "She's an acting chairperson, but we've seen more inaction than action."

The Senate Bill also contains an amendment by Senator Dianne Feinstein (D-CA) that would ban phthalates in children's toys and products. Following California's state law last year Feinstein vowed to work nationally to get phthalates out of kid's products.

No Christmas, Just Chunks of Coal to Kick Around

Following California's vote to limit phthalates last year, several states have followed suit, including Washington. The press predicted that the senate wouldn't pass the bill. One lawmaker, worse than Ebenezer himself, had warned in a vile deceit that Christmas would be canceled, and the Toy Industry Association spent $50,000 at the last minute working to undermine the bill. The state senate bill passed March 7th, 40-9.

Europe and other countries have banned phthalates, and Walmart, Toys-R-Us, Target, and other stores have volunteered to stop selling toys with phthalates. The chemical makes toys pliable and their are alternatives to its use.

In the meantime, the research on phthalates continues to pile up. Researchers last month found that infants had elevated levels of phthalate metabolites in their urine when their parents self-reported using baby lotions and shampoos, and that the link was strongest in the youngest infants.

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Acronym Required also wrote about phthalates in the following articles:

Phthalates and Bisphenol A: Media and Politics" (November, 2007)

Plastic Bottles- Protecting Your Baby, by the ACC (July, 2005)

Bisphenol-A and Phthalates Bill in California (January, 2006)

San Francisco Bans Bisphenol A, Phthalates (July, 2006)

San Francisco phthalates & Bisphenol A Ban (November, 2006)

FDA Leader Criticized

We wrote the "State of the FDA" about a couple of reports documenting FDA management shortcomings compounded by budget shortfalls that compromise the health and safety of US citizens. Now Rep. Bart Stupak (D-MI), who heads the Subcommittee on Oversight and Investigations in the House Energy and Commerce Committee has called for FDA commissioner Andrew von Eschenbach to be replaced. Eschenbach has been in the post a little over a year.

In a press release Feb. 1, 2008 on the FDA, Stupak said the agency was no longer a "pending" crisis, but rife with problems and fresh off a formidable record of "378 recalls last year on everything from peanut butter to pet food to drugs". Stupak's goal "is to help identify what went wrong and implement changes to minimize negative health effects on the American people." Stupak even has a replacement candidate in mind according to the Wall Street Journal.

Firecracker Appointees

However some politicians see the Michigan Democrat as a little too aggressive. Rep. Joe Barton (R-TX) says that firing the commissioner is a bad idea and told the journal that Dr. von Eschenbach is a "dedicated public servant," who has "certainly not done anything unethical or illegal". (Gold Star commendable these days, but shouldn't we be throttling for a higher standard?)

Some news agencies scurvily suggest that the death of Stupak's son from suicide, a reaction to the acne drug Accutane, motivates his attention to the FDA's problems. However the congressman points out that while the incident gave him insight into the FDA, if people knew how little oversight the agency had on some products they'd be "marching in the streets." (like the Sixties?)

It's too bad Stupak wasn't in on the Senate confirmation hearings in August, 2006, since perhaps he could have guided the leadership choice at the beginning of the process. The Senate deliberated during von Eschenbach's confirmation hearings, voicing reservations about his suspected attention to politics over science. The commissioner is a family friend of President Bush's who had what Newsweek at the time called "a history of generating controversy".

Prior to his FDA tenure he worked at the National Cancer Institute (NCI), where he "introduced prayer to commission meetings", unrealistically set a goal of eliminating death from cancer by 2015, and was called a "disaster" by some staffers. Senators Murray and Clinton balked on his confirmation over the stance the FDA was taking on Plan B, the birth control pill. In what seemed like a sort of a quid pro quo deal, once Plan B got passed von Eschenbach got confirmed.

The interesting thing about Bush's political appointees to science agencies is that the lifecycles between Senate confirmation and given appointees' agencies' disasters has become quite short, in a way that nicely matches the current pace of news. The predictability and familiarity of it all gives us a sense of reassurance in a day when little else is predictable. Reporters aren't like - von Eschenbach who? It's just - oh yeah, that guy everyone worried about a year and a half ago.

But again, as with many of the science agencies it's not all about the commissioner. Stupak acknowledges that the FDA has entrenched problems that preceded Eschenbach's short tenure.

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Acronym Required wrote about von Eschenbach's confirmation hearings in "The FDA'S 'Medical Ideology'"

We wrote "Resuscitating The FDA", about the FDA in the wake of various fiascoes.

"FDA -- Calling Off The Dogs", is about Plan B and FDA staff turnover.

"Ethics- The NIH and FDA", discusses conflicts of interests among scientists in these two agencies.

"...Except for Prisoners and Students"

"Grade D Beef, Unfit For Human Consumption (Except for Prisoners and Students)". That's an urban legend -- there is no such label, says Snopes.com. But apparently there's a witness outside the loading zone of every college cafeteria who reports that workers are hauling in boxes labeled with this very dicey standard.¹

It may be a funny story and an urban legend, but reading the news lately you wouldn't necessarily believe that the beef we're being served matches the USDA's quite delicious sounding quality ratings: "prime", "choice", "select", "standard" and "utility". (OK "utility" sounds a little iffy). The USDA bases the ratings on things like marbling and maturity grades, and for all the various grading parameters they employ, you'd hope that whatever ended up on your plate jived with the image you have of the happy cow in the grassy field, mouth full of clover and switchgrass -- an image that's widely dispersed by the beef industry. Unfortunately the Humane Society recently videotaped downed cattle being "urged" to slaughter, which swiftly and cruelly dispossessed us of our happy cow images.

The Humane Society sued the US Department of Agriculture (USDA) yesterday in an attempt to force the agency to close a loophole in beef slaughter guidelines. Last year the USDA loosened a 2004 regulation aimed at preventing diseased cows from entering the food chain. The USDA allows "downer" cows (ones that had fallen down and can't get up) into the food chain , if they have made it through an initial inspection then collapsed, but are subsequently examined and cleared by a veterinarian on call. Iffy. Apparently the veterinarians don't always get called.

Downed cows that can't walk themselves to the slaughter line are often not fit for human consumption because of disease -- especially what's commonly referred to as "mad-cow disease" -- bovine spongiform encephalopathy (BSE). This is worrisome because BSE, the result of a prion infection, is fatal. BSE is infrequently transmitted to humans who eat the infected meat, where it manifests as Creutzfeldt-Jakob disease -- also fatal.

The Humane Society filmed workers abusing cows at the Hallmark slaughter plant and released a video in January. The widely publicized video shows fallen cows being prodded, hosed, rolled and dragged to slaughter with farm equipment. The release of the video prompted the USDA to shut down the plant, which supplies Westland Meat Co. This was no doubt a blow to Westland, a company that in 2005 received USDA's Livestock and Seed Program Industry Recognition Award, for "Outstanding Performance and Commitment in the Production and Delivery of Quality Beef Products". Westland supplies the USDA's Commodity Procurement Branch providing meat to elder homes and schools and other organizations in 36 states. The USDA subsequently recalled 143 million pounds of ground beef.

Common-Sense Provisos

Most of the beef had already been eaten but the USDA assured diners that the health risks to humans were small. In the aftermath of the recall USDA accused the Humane Society of holding back its video evidence, an accusation that some found absurd. Rosa DeLauro, (D-CT) noted: "It is the height of irony that the U.S.D.A. is now trying to blame the whistle-blower for the agency's own irresponsible behavior."

The USDA tightened the rules in 2004 in response to several cases of Creutzfeldt-Jakob, but then last year loosened the rules when the meat industry complained that the mandates condemning non-ambulatory disabled cattle were too broad. Industry advocates wanted the USDA to allow cows downed after the initial inspection to be examined and possibly cleared by a veterinarian. Otherwise they reasoned, an non-diseased cow with a broken leg might be wasted.

A vice president from the American Meat Institute called the industry's request "a proviso founded in common sense." However the New York Times reports that 20/29 cattle in 9 months of USDA inspections had no indications of physical injury that would explain their "downer" status, suggesting that downer cows are less often found to have a sprained ankle, and more often sickly beasts with suspected BSE. (The paper doesn't give the number of total cattle processed.)

The Federal Meat Inspection Act (FMIA) was signed into law in June, 1906 by President Theodore Roosevelt. The USDA recently celebrated its 100 year history of "protecting consumers" -- a perennial challenge.

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¹ I thought it was true until this very moment.

Acronym Required previously published Cow Rendering - Ingenuity Gone Mad", and "The Companions of Mad Cows".

On the front page of the "Sunday Styles" section of the New York Times Sunday was a grand photo of three of Charlize Theron's stylists and fashion consultants considering long flowing gowns for the Oscars festivities. Also an article about Gardasil vaccinations for boys, titled "Vaccinating Boys For Girl's Sake?" So it's pretty much like this. Your eyes are first drawn to the photo of the women with their leggings and boots and fashionable outfits and hairstyles. Then your eyes automatically drift to the left to read "Protect yourselves against the human papillomavirus, or H.P.V., which causes cervical cancer."

The article explains the idea of extending the vaccine to boys in 2009 which is to "slow the rates of cervical cancer". Some controversy here of course. Says the paper, "Public health folks charmlessly call this 'herd immunity'". Speaking of charm school, and charm is relevant not only to "Sunday Styles" but to vaccinations for sexually transmitted diseases -- taking "science is culture" to heart -- what about that page layout?

Update: The New York Times reported March 3, 2008 that David L. Allison resigned as the incoming president of the Obesity Society. He said in his email statement that "I stand behind the scientific statements I made, my right to make them, and the manner in which I made them", however he apologized for the "distress" he might have caused the Obesity Society. The economic tensions that interfere with frank science presentation and reporting remain.

Conflict of Interest?

Would you believe a nutrition researcher working for Coca-Cola who said that restricting foods might backfire in preventing obesity because 'birds put on weight when food is scarce'? Would you choose him to be president of your "Obesity Society", if your club's mission was to "be the leader in understanding, preventing and treating obesity and in improving the lives of those affected"?

A recent New York Times article, "Conflict on the Menu", threw light on the "food fight among the nation's obesity experts". The New York State Restaurant Association hired the president-elect of the Obesity Society, Dr. David Allison, to support their suit against New York City's regulation requiring chain restaurants to list the kilocalorie values on menu items.

Allison submitted an affidavit warning that listing calories on menus might encourage overeating. According to the NYT he suggested the regulation would either tempt patrons with "the forbidden-fruit allure of high-calorie foods", or leave them so hungry they'd "later gorge themselves".

Somewhat less creatively, the American Medical Association, the American Academy of Pediatrics, the American Heart Association, the American Diabetes Association, the American Public Health Association, the California Center for Public Health Advocacy, the Medical Society of the State of New York, the Trust for America's Health, and many other organizations back the city's regulation.

Obesity & Personal Freedom

While the New York Times keeps the focus of the story on the skirmish within the Obesity Society, many stakeholders have a foot in this game. Public interest groups of all stripes, including "consumer freedom and choice" advocates, fight tooth and nail over the city's plan.

The Center for Consumer Freedom (CCF) is a group that lobbies against government regulation. They wrote histrionically about New York City's labeling plan in "Menu Labeling Meltdown", warning that "the food cop campaign will plaster our nation's menus with warning labels.." Their consolation was Dr. Allison's "damning evidence" that labeling "might be harmful". CCF reveled in the idea that Allison's affidavit dealt a "major blow" to the city's plan and that Burger King might not have to label their Whopper with its energy value: 670 kilocalories.

CCF claims to fight for Americans' right to "guilt free eating". Their stated mission is "promoting personal responsibility and protecting consumer choice" and their especially belligerent towards specific targets, individuals or groups like the Center for Science in the Public Interest (CSPI) -- "the food cops". Sourcewatch offers a more blunt profile of CCF, calling them "a front group for the restaurant, alcohol and tobacco industries". Phillip Morris started the organization under the name "Guest Choice Network" years ago for the purpose of organizing restaurants against government smoking bans.

CCF wields the same arguments that tobacco lobbyists used to oppose government smoking bans by supporting the claim that the city's rules violate the First Amendment. However Sandra Wootan, director of nutrition policy at the Center for Science in the Public Interest (CSPI), says: "The restaurant industry isn't concerned about defending the First Amendment, as its lawsuit laughably claims. It just wants to keep its customers in the dark. People need nutrition information to exercise personal responsibility and to feed their children healthy diets."

It seems like "personal freedom" stands for "corporate freedom" in this context. While personal freedom is important, governments are obliged to work on behalf of the community, for instance by mandating vaccinations, sanitary conditions in restaurants, anti-smoking laws, etc. The city regulation basically requires chain restaurants that have caloric information elsewhere, like on a website, to post in on the customer menus. This is not the cumbersome requirement that CCF makes it out to be.

Science & Policy

Despite the Center for Consumer Freedom's approval of Allison's recent position they haven't always been so friendly. In 2001 the group contested Dr. Allison's 1999 finding that obesity caused 300,000 deaths a year, calling the research "bogus". The organization accused him of "voicing support for an onerous and unnecessary 'Twinkie Tax'", and having "ties to the weight-loss industry". In 2004 and 2005 the group opposed Dr. Allison in articles like "Hypocritical Food Cops Preach 'Integrity'", accusing him of conflict of interest and citing Allison's many industry affiliations to discredit his research.

In 2005 Allison was one of ten authors on a New England Journal of Medicine paper showing that the average lifespan in the US would decrease because of the obesity epidemic. (Olshansky et al, "A Potential Decline in Life Expectancy in the United States in the 21st Century", March 17, 2005 Vol. 352:1138-1145.) The accompanying editorial said the group's assumptions were "excessively gloomy", but scientists generally thought the findings important despite the data estimates.

Although this was a science research paper, the authors pointed out policy implications, as they often do. There were possible up-sides to the research, for instance: "the U.S. population may be inadvertently saving Social Security by becoming more obese". The findings were grim, but policy interventions might reverse the death trends, they said: "Unless effective population-level interventions to reduce obesity are developed, the steady rise in life expectancy observed in the modern era may soon come to an end and the youth of today may, on average, live less healthy and possibly even shorter lives than their parents."

An accompanying editorial gave more detail. "Deadweight? --The Influence of Obesity on Longevity", by Samuel Preston, Ph.D., mentioned other research showing that only "30 excess calories a day during an eight-year period for Americans 20 to 40 years of age" produced the obesity epidemic. (NEJM Volume 352:1135-1137). Given the morbid implications of small increases in daily calories, Dr. Preston said: "reversing the increase in body mass might be accomplished through small behavioral changes...the food and restaurant industries would be valuable allies in this effort..."

So the authors recommended that government interventions were critical to maintaining current longevity, and that nominal calorie reduction might help reduce obesity if restaurants cooperated. Which makes it particularly ironic that Allison, the co-author, chooses the role of a hired gun fighting calorie labeling on behalf of restaurants.

In contrast to their opinion of Allison since 2001 CCF's coverage of the current NYC regulation does an about face. Now, abruptly, his "facts showed" and "the evidence was damning". They decided not to fill their story about his affidavit for the Restaurant Association with long lists of "conflicts of interest", which served as the meat and potatoes of their previous irate stories about his research.

News of Allison's affidavit supposedly caused a fracas among members of the Obesity Society, who got ''completely mad that a president-elect of [an] organization that cares about obesity and cares about healthy eating, wants to hold back information from people that helps them make healthy choices'', according to the NYT. This forced the current president of the Obesity Society to put out a separate statement opposing Dr. Allison's that supported the city's labeling rules.

Which made me wonder -- if Allison's position is so disagreeable, why did the nominating committee and 2,000 members in the society select him to be their future president? His consulting positions were a significant piece of his resume. He has been a paid industry consultant for at least 15 years. There must be more to this story.

When Truth Pays

A professor at the University of Alabama, Dr. Allison is an obesity statistician with a background in psychology. He's more than just a statistician with an affidavit that appears to be a conflict of interest. He's has published over 300 papers and 5 books. His home page shows him clad in a sporty warm-up jacket as if back from a jog, rather than posing with the more traditional professor air, before a pile of books or a math covered blackboard . He regards the camera a little too ravenously, as if he had picked the Veggie Delite Salad (51 kcal) at Subway, instead of the Footlong Meatball Marinara (1160 kcal), and was photographed hungry, about to grab the Ben & Jerry's New York Super Fudge Chunk from the freezer. [Although, if he wasn't getting paid to introduce doubt, we wouldn't be wasting our time here because he would have sensibly chosen the 6 inch Turkey Sandwich (280 kcal) instead of the Delite.(Subway lists their calories on menus)]

For his efforts and accomplishments Dr. Allison was honored by George Bush last year in a White House ceremony for recipients of the Presidential Award for Excellence in Science, Mathematics and Engineering". The award recognizes mentoring of women, minorities, and persons with disabilities.

Dr. Allison noted that the award was not just about mentoring but also about making sure the students "understand the ethical foundation on which science is based." It's a mission he apparently takes seriously, as The Birmingham News reported: ''In science, we are not just doing a job,'' he said. ''I was chosen. I think of it like a calling. It is a special and sacred profession. Our sacred duty is truth.''

When he was questioned by the New York Times about his support of the restaurant industry he said, "I'm happy to be involved in the pursuit for truth....Sometimes, when I'm involved in the pursuit for truth, I'm hired by the Federal Trade Commission. Sometimes I help them. Sometimes I help a group like the restaurant industry."

Speaking his truth though he may, Allison remains agnostic in his choice of client. He's widely consulted by government, industry and the media for his expertise in obesity, science, and integrity. When Eric Poehlman, the University of Vermont obesity professor was accused of falsifying data on metabolism and aging in research papers and federal grant applications, Dr. Allison interviewed the media in his defense: "I believe he's innocent, and I believe that he is being broken financially to the point where he's ready to give up the fight because he has no more money to fight with, and that's the way the game works", (Boston Globe, March, 2005). Poehlman served a year in jail, paid fines and recieved penalties.

Dough Boy

The Center for Consumer Freedom discredited any research Allison was involved in except when it ran in their favor. They accused Allison repeatedly of conflict of interest especially with companies selling "weight control product and services". CCF may be a bottom feeder, but it doesn't exaggerate Allison's impressive industry ties. In the 2005 NEJM paper about obesity longevity, nine authors disclosed zero financial interests or affiliations. Dr. Allison however, gave new respect to warm-up jackets and statistics by listing about 150 organizational affiliations in a three page single spaced PDF, attached to the paper.

Dr. Allison's list of grants, monetary donations, donations of product, payments for consultation, contracts, honoria and commitments include consulting assignments for numerous parties, like lawyers engaged in litigation, pharmaceutical companies including Pfizer, Eli Lily, Wyeth Ayerst, Glaxo, as well as Corning, Frito-Lay, Coca-Cola, the Wheat Council, Kraft Foods, Nabisco, the FDA and ILSI. He has impressive experience doing everything from serving on the United Soybean Panel's Nutrition Advisory Board, to being an expert witness for defendant Lockheed Martin at $350 an hour in a groundwater contamination lawsuit.

Much of this was listed in Allison's resume, which I assume the Obesity Society recieved prior to selecting him to their leadership council. If not it was summarized at the Integrity in Science project at CSPI, or in disclosure documents in his publications. His insouciant transparency, extensive network (I assume), precocious achievement. and ethically unencumbered attitudes to choosing clients no doubt secured him a Obesity Society leadership position.

Hungry Scientists, Money

Sometimes when you travel or walk down the sidewalk you encounter kids so poor they come running up, dozens of them -- "pen"? "dollar"? "cigarette"? Science seems like this sometimes these days. It seems there's no party that doesn't have an interest in this obesity science/business -- pharmaceutical companies, lawyers, labs, product companies, insurance companies, NGO's, government. Science results create more work and profits for some, and/or less work and profits for others. You can imagine the repercussions of some of the science results we mention above.

Allison co-authored a study published in NEJM, where the policy implications proposed are the opposite of the "expertise" Allison now sells. This costs the state in legal fees and customer choice, not to mention making a mockery of science. Poehlman's false data of age related metabolic depreciation affected policy. Doctors and researchers based study and clinical practice on his results, and granting Poehlman funding, other scientists were denied money for their research. Then there was the CDC study in 2004 which incorrectly calculated the statistics and overestimated the annual deaths from obesity. This created false public perceptions and policy implications, and raised the ire of public health advocates in other areas who eying the competitive pie of public health money (especially anti-smoking advocates who were nervous that the results would make obesity public health priority number one).

Some people think that science should remain separate from policy -- like an old TV dinner, the cut vegetables separate from meat product and the syrupy peaches, each one in its own plastic mold -- compartmentalized, never mixed. Combining "science and policy" confuses the public they say. Others, claiming pragmatism, suggest everything is already mixed up, a big stew. Indeed, this seems true when scientists recommend policy, or when results are seized upon by lobbies. In many fields results have direct policy and/or business implications.

The media impedes the first approach, separating science from politics, by blending everything together in their stories, the science, the policy, the personalities, the business, the lobbyists. This mush is extracted by the press, drained of color and interesting nutrients and doled out as an equally portioned product of pro and con, like symmetrical freeze-dried blocks. We're fed an easily digested story with the predictable arch of a food fight and a neat two part conflict: "Scientists found this...but others found that".

Unfortunately, one of the largest problems resulting from this information processing by media and various lobbies, politicians, and interest groups, is that many of us -- citizens, reporters, politicians, scientists out of their field... have not clue as to who's the lobbyist, who's the "unbiased researcher", who's the expert, and who is an apostate. If headline news runs a "science piece", separating the chaff doesn't always matter because it might ruin the storyline, and anyway, who could be bothered? But this is not and never has been an isolated conflict of interest problem, a media problem, the scientists' problem, or a government agency problem. It's a larger more thorny economic conundrum that affects us all.

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Acronym Required has previously written about obesity in public health.

When Media Swooned In the Arms of Tobacco

Cigarette peddlers lethally succeed in convincing people to suck smoke into their lungs non-stop, decade after decade. There's mountains of evidence for this, millions of publicly available documents on the subject, court proceedings, leaked internal industry documents, as well as movies, articles and books. One in five deaths in the US is smoking related, according to the Center for Disease Control (CDC) -- preventable deaths, tragically wasteful. Most of us, in and out of public health arenas understand the deceptive business strategies that the cigarette industry uses to reap profits from its killer product. Tobacco is the standard by which deception around other science issues is measured. Despite the evidence the tobacco is the culprit of a major health problem, however, we're forever embattled trying to dissuade people from smoking.

Tobacco industry history informs current discussion on other health concerns such as global warming, diabetes, asbestos and cell phones. Like tobacco, all seem to have a single corporate culprit. Comparisons between the issues are frequent, sometimes pertinent, but too often facile. In order to successfully continue profiting from cigarettes, many parties collaborate, including stockholders, legislators, presidents, and the media. Tobacco captured the media for decades, from movies that romanticized smoking to prolific cigarette advertising, to dubious reporting on the safety hazards that insured the sale and marketing of cigarettes.

One of many interesting stories in the history of tobacco is how the industry influenced investigative news reports back in the 1990's when reporters started uncovering the "dirty secrets" of the cigarette business. Investigative reports from major TV stations were squelched when reporters revealed the tobacco companies' knowledge about the health dangers of smoking. Tobacco companies took advantage of the networks' business aspirations and fears about getting sued, while certain media companies, motivated by profit, complied by shutting down controversial investigative reporting. Together, the tobacco industry and the media industry stifled public knowledge about the risks of smoking.

The 1990's was only last decade...but people tend to forget. Pieces of this story can be found on internet, for instance here and here and here. In his recent book The Cigarette Century: The Rise, Fall, and Deadly Persistence of the Product That Defined America (2007).¹, Allan Brandt chronicles the story of how two major television stations capitulated to the tobacco industry.

Tobacco Wars

In 1994 ABC News show Day One, aired a report called "Smoke Screen". The trailer for the segment told how companies "spiked" cigarettes with extra doses of tobacco. The show detailed how tobacco companies added reconstituted tobacco plant stems and leaves along with extracted nicotine to its cigarettes. This doctoring effectively controlled the dose of nicotine in cigarettes, and incidentally maintained the level of nicotine in "low-tar" cigarettes, assuring addiction. Jack E. Henningfield, an expert on addiction from the National Institute on Drug Abuse at the NIH, called cigarettes the "crack cocaine form of nicotine delivery". This wasn't stunning news. The Surgeon General had declared nicotine additive in 1988.

However Phillip Morris promptly sued ABC for libel and $10 billion dollars in compensatory and punitive damages. Phillip Morris was particularly defensive about ABC's assertion that cigarettes were "spiked". The company insisted that nicotine was not a drug. Even though the company's own scientists had said their "product" gave people "a pleasing sensory experience with mild pharmacology".

Many experts thought the network would win the case. ABC's report hadn't specifically implicated any company, and Phillip Morris's libel claim was not obvious, since the company would need to prove both intent and malice. ABC defended Day One in court for months, spending millions in legal fees.

Meanwhile, Lowell Bergman of CBS's 60 Minutes was putting together another story, this one featuring Jeffrey Wigand, a biochemist from Brown & Williamson. Wigand was one of many company whistleblowers who had begun to speak out about the tobacco industry, working with the FDA on their investigation of the industry.

When Mike Wallace interviewed Wigand for CBS, the CEO's of seven major cigarette companies had just testified before Congressman Henry Waxman's (D-CA) Subcommittee on Health and the Environment. Each had said in almost identical statements that "nicotine is not addictive". But Wigand had headed up various research projects at Brown & Williamson and lobbied within B&W for safe cigarettes. He told Wallace that the CEO Thomas Sandefur had lied to Waxman's committee. B&W management knew that cigarettes were addictive, Wigand said, and used every opportunity to leverage research data that proved the addictiveness to sell their product. He also described how scientists added ammonia to the cigarettes to assure that the lungs absorbed the nicotine more easily, and how carcinogenic additives like coumarin (one of 700 cigarette additives at the time) were added to cigarettes despite known toxicity.

The Weak-Kneed Fourth Estate

Right before CBS aired its show, ABC shocked its employers, its lawyers, and onlookers by settling its lawsuit with Phillip Morris. The surprise settlement was motivated by ABC's pending business deal with Walt Disney Company. Disney wanted the liability of the lawsuit off the table. Phillip Morris had also threatened to pull advertising worth $100 million dollars a year.

Many in and outside the media agreed that the Phillip Morris lawsuit was about intimidation and that it effectively dampened investigative journalism. As part of the settlement, ABC apologized to R.J. Reynolds and Phillip Morris and paid 15 million dollars in legal fees. Phillip Morris took out full page ads in national publications to advertise the network's apology. Shortly after ABC's settlement with Phillip Morris, CBS canceled the 60 Minutes show featuring the interview with Wigand. CBS revealed that they were in the midst of finalizing a $5.4 billion dollar merger with Westinghouse Electric Corporation.

Business interests had once again prevailed. Coincidentally or not, Laurence Tisch, the CEO of CBS, was the father of Andrew Tisch, CEO of Lorillard, who testified at the Waxman hearings. In the industry's well established pattern of denying science and math when it was inconvenient, Tisch told the subcommittee that he did not believe that cigarettes caused death, because death rates were generated by computers and are only statistical".

The CEO's sworn denials of their knowledge of tobacco's dangers were wearing thin and did not endear them to legislators. When James Johnston, CEO of R.J. Reynolds, compared cigarettes to ordinary sweets like Twinkies, Waxman tersely pointed out the stark difference between the two, "death". Waxman was not swayed then and of course today cigarette company denials elicit aghast indignation across the world, especially in the US and EU. We're wise to deceptive marketing, legislative finagling, and payments to scientists in mid-life/career crises made pliable about science with money. Cigarette companies lie, obviously.

But this is not obvious to people who aren't educated about tobacco's addictive and dangerous nature, or to those who smoke to possess prosperity, joie de vie and independence, the illusions that cigarette marketing sells -- or to those who are simply addicted, illusions or not. Many people have quit smoking and many people never start, but many more people continue to inhale and die. True, this is a devastating public health problem, but its also an undying, successful business strategy.

Tobacco Industry Solutions for Today's Business Executives: A Case Study

Tobacco's marketing strategies are highly successful, as Harvard Business Review highlighted in their February 2008 issue. Michael Sheehan wrote in "Understanding Opposition", about a few handy business techniques: "[s]omewhere between co-option and tug-of-war lies what I call a deflection strategy."

The tobacco industry used "deflection strategy", Sheehan wrote, to deal with pressures to reduce second hand smoke in the 1980's. The industry reframed the issue as a "sick-building" problem, caused by energy efficient buildings. Cigarette companies blaming the buildings for trapping indoor pollutants from things like office machines and carpets. Instead of banning smoking, Sheehan says the tobacco industry reframed or "deflected" the issue: "The solution was to engineer efficient ways of bringing more fresh air into facilities", he wrote, and although the "strategy wasn't ultimately successful", it successfully "stymied [smoking] bans for several years."

It's all about business, and all is fair. "Understanding Opposition" was on page 24 of HBS. Three pages before this article, on page 21, was an article on ethics, titled "How Honest People Cheat", a report on "honest" people's propensities towards dishonesty. It was nice to have close at hand, because it explained some of the rational of both the cigarette companies who deceived, and their would be emulators.

"It's clear that we have an incredible ability to rationalize our dishonesty and that justifying it becomes substantially easier when cheating is one step removed from cash. Nonmonetary exchanges allow people greater psychological latitude to cheat -- leading to crimes that go well beyond pilfered pens to backdated stock options, falsified financial reports, and crony deals."

The Harvard Business Review editors ironically and neatly compartmentalize tobacco industry's "deflection" on page 24, from "cheating", on page 21. Your average businessman should now be able to successfully walk this line. It's fine to "stymie a ban on smoking"; but one should never, ever, "backdate stock options".

Worldwide Opportunities

The tobacco story spans a hundred years and is a complex mix of sociology, science, business and politics. While the number of smokers in the United States began to decrease in the 60's, there are still large numbers of addicts especially among poorer populations and those in inner cities who are especially susceptible to tobacco's marketing. The companies long ago saw the writing on the wall in the US with the rash of lawsuits and public health activism and adapted to the business challenge by expanding their global strategy.

Companies today market aggressively in foreign countries, skillfully navigating each country's laws, and seducing young smokers using the same tools they perfected during the 20th century in the US. Advertisements spin notions of individuality, prosperity, freedom and cool factor. The messages appeal to the poorest populations who are naive to the addiction and health consequences. Tobacco thrives through wily marketing, a favorable trade atmosphere and the dueling motives of public health and profit. At every stage, cigarette makers seem to master all the tricks. Yesterday, the organization Corporate Accountability accused Phillip Morris, British American Tobacco and Japan Tobacco of colluding with smugglers to gain entry into markets.

According to The World Lung Foundation, a contractor for the World Health Organization, in 2000 there were approximately 2 millions cigarette deaths in developing countries and 2 million in developed countries from cigarettes. By 2030 they project there will be 3 million deaths in developed countries and 7 million deaths in developing countries, totaling 10 million deaths worldwide from cigarettes.

In moment of enthusiasm once in 1996, former Senator Jesse Helms (R-NC) said to a reporter, "I was with some Vietnamese recently, and some of them were smoking two cigarettes at the same time. That's the kind of customers we need!" Then perhaps realizing how that sounded, he added: "Well, not exactly". A Vietnamese official queried by the same reporter said, "We'll smoke for 10 more years, until we are a more developed country." Then, perhaps not realizing the power of addiction he added, "Then we'll quit, just like you." (NYT April 12, 1996) More realistically, one doctor commented a decade ago about China's growing tobacco addiction: "If the Chinese smoke like Americans, then they will die like Americans"

For all the hand-wringing about tobacco's health effects, it remains highly profitable, capable of keeping potential naysayers at bay. China illustrates this dichotomy. The state owned tobacco industry in China contributes $30 billion to government coffers a year in tax revenue which is estimated to be 7% of government revenue (a decrease from a few years ago when it was 12-14%). 350 million people smoke in China, and 1 million people a year die. The country racks up $5 billion in medical costs per year. But government officials have balked at tobacco control, noting that it would "destabilize" the country. A recent WHO study found that "governments around the world collect 500 times more money in tobacco taxes each year than they spend on anti-tobacco efforts."

It's easy to find a primary culprit to blame problems on. But while society struggles with smoking at the same time it allows complex business, government, civilian, and not-for profit arrangements to pervade the media that informs us, the rule-making governments, and society itself. These arrangements thrive, albeit cancerously, because they are entwined in and reinforced by the very public health problems.

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¹ This post is not a review of the book, which is excellent, captivating, and highly recommended. Brandt's analysis and perspectives on the tobacco industry are thorough and insightful. The Cigarette Century: The Rise, Fall, and Deadly Persistence of the Product That Defined America (2007)

Acronym Required previously wrote about tobacco industry funding of science research in "My Lab Thanks You For Smoking", and UC Senate Smokes RE-89. Lowell Bergman was one of the producers of last years four part PBS Frontline series called "News War" that we wrote about here. We've also written several posts about corporate advertising and the global warming debate.

The FDA, Hanging by Its Fingertips

The Food and Drug Administration is "barely hanging on by its fingertips", said Peter Barton Hutt, former chief counsel of the agency, when he spoke before the Subcommittee of the Committee on Energy and Commerce in the House of Representatives last week. The FDA's problems are not new, they're cumulative. In an interview with The Hill last year, Hutt expressed his frustration with Congress, which continues to pile statutes on top of the 1938 law without providing extra funds. He noted that the Food, Drug and Cosmetic Act "has been amended well over 200 times and now reads something worse than the Internal Revenue Code"

The congressional subcommittee heard dire testimony from the Goverment Accountability Office (GAO) and various members of the FDA's self-assessment committee who conducted a review of the agency in 2007 at a time when product recalls were continuous and frequent. The self-assessment, "FDA Science and Mission at Risk", and an Institute of Medicine (IOM) report, "The Future of Drug Safety", highlighted systemic problems with the FDA that inevitably trickle down to the public as food safety and drug safety risks.

Leadership Unstable

Those who testified said the FDA leadership was politicized and unstable. They pointed out organizational dysfunction, lack of coherent management structure, paucity of vision and competence, and problems with recruitment, retention, and morale. Others spoke out about major gaps in science expertise, nonexistent peer review, and scientists who are disengaged with the broader scientific community. Of course large government agencies inevitably need better information technology capabilities, but one former CDC employee who now works in consulting focused his report exclusively on the FDA's technology needs.

Andrew C. von Eschenbach, the commissioner who heads the agency, didn't think it was all that bad. He noted that the FDA had proven, "state-of-the-art applied sciences", a "commitment to peer review", and that a he had hired a new CIO. He opposed majority opinion by pointing out that the "collaborative relationship among the Agency participants was an excellent model for other government programs".

The FDA ensures the safety of about 80% of the US food supply, according the GAO, $417 billion of domestic food, and $49 billion of imported food. The GAO noted that there were fewer that 100 inspections of 190,000 foreign food firms in 2007, which is half the number of inspections as 2001. Of all the areas that need attention, food inspection is a high priority area that suffers in part from a lack of user fees that fund other areas, like drugs and medical devices, which receive millions of dollars. According to Hutt and others who met with the subcommittee, the agency urgently needs more money from Congress in order to meet its charge of assuring the safety of food and drugs. Hutt recommended that the Congress increase FDA employees by 50 percent and double FDA funding.

This week, the FDA announced the agency's budget request for 2009-- which given the state of the agency seems paltry, a mere 5.7 percent increase over this year's budget. The 2009 budget proposal includes important increases for food safety and medical product safety and development. The one area that the FDA proposed cutting is in Administrative Savings and Management Efficiencies. We hope, as is sometimes the case in larger institutions, that this function title is a euphemism for something else and is somehow part of the larger problem. Otherwise, it's not intuitive, given the state of the agency's organization troubles, that funds directed in this area should be "redirected to higher priority items".

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Acronym Required wrote about von Eschenbach's confirmation hearings in "The FDA'S Medical Ideology"

"Resuscitating The FDA", about the FDA in the wake of various fiascos.

FDA -- Calling Off The Dogs, about Plan B and staff turnover.

Ethics- The NIH and FDA, about conflicts of interests among scientists in these two agencies.

The New York Times has launched what I can only assume is an inadvertent pro-vegetarian campaign. Last week an article featured pictures of cattle, shoulder to shoulder in a pen, up to their cattle knees in "mud", accompanying an article about beef consumption in the US. You could almost smell the repugnant odor, especially if you've ever driven by one of these vast cattle pens. Even at 50mph/80kph, the smell is mind-alteringly revolting, capable of singeing the hair off the inside of your nostrils. Today the paper provides lurid details from the investigation of a neurological illness that affects workers of hog manufacturing plants, especially one in Austin, Minnesota. (Denise Grady, "A Medical Mystery Unfolds in Minnesota")

The Center for Disease Control (CDC) in Atlanta reports that at least 12 people at the Austin, Minnesota plant have been affected with symptoms ranging from weakness on both sides of the body that gets worse over time, mild pain, numbness, tingling and heaviness in their legs and feet, to acute paralysis. While the illness generally resolves and some workers were affected for only 8 days, others were affected up to 213 days.

Investigators on the case recognize common symptoms and although they don't yet know the exact cause, they're making progress. The Washington Post, in its story yesterday,noted that the translator who accompanied the patients recognized common symptoms between some of her clients. Once several victims were identified, investigators learned that the majority of the affected workers had harvested brains from the swine.This is a stomach churning job that the journalists seem lucky enough to not have actually witnessed, since reporters are not allowed in the plant. We try not to revel in the details that follow, but queasy readers, be forewarned.

When the state epidemiologist toured the plant with the owner, they observed workers at the "head table", whose job was to remove the brain and skeletal muscle from the swine. Brains were removed with an air hose in a process that called "blowing brains". After studying workers from various stations at the plant, the CDC found that 7 of the 10 head table workers in their study were affected by the disease. These workers didn't wear long sleeves or face shields. Possibly as a result they inhaled aerosolized brains or head muscle from the spray that caused their symptoms. Once the plant owners realized that the illness was related to brain blowing, say all the news stories, they stopped the process.

The interesting part of the story to some people may be the gross-out factor, but to doctors and scientists it's the question of what causes the disease. It wasn't clear from the first patients that the symptoms were work related, since many of the symptoms are common to other diseases. Tests for various parasites, viruses and bacteria came back negative. More testing revealed that the patients had what doctor's think is a new disease, progressive inflammatory neuropathy (PIN) ¹. This label distinguished the condition from doctors' original assessment earlier last year of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare, but known disease.

Doctors ran tests for inflammation, and "electrodiagnostic tests" of the nervous system, such as measurements of nerve conductivity. One of the things that showed up is evidence of axonal and peripheral nerve cell demyelination. Myelin covers the axon part of the nerve cell, and allows the small electric impulse, the action potential, to be conducted very quickly through the nerve cell. Healthy myelinated nerves transmit signals to and from the spine to the periphery of the body.²

Doctors hypothesize that the patients' immune systems became unable to distinguish foreign proteins of the pigs that they inadvertently ingested, from their own body's proteins. In this autoimmune ("auto"- self) response, the immune system attacks the body's own proteins, perhaps in the myelin. When the myelin is damaged, as with different autoimmune disorders such as Multiple Sclerosis (which also effects the central nervous system ³), or in Guillain-Barre Syndrome, the nerve signals don't transmit properly, causing numbness or tingling, numbness, foot droop, or more severe symptoms.

One avenue of research scientists are following according to the NYT is comparing the pig to human myelin DNA sequence to understand the extent of the similarities. Knowledge as what exactly happens in the immune system to cause the neuropathy, and what agent triggers the reaction will someday be determined.

The workers respond to treatment differently, as would be expected from their different pathologies. Some workers responded to steroid treatment. Other workers responded to IVIG treatment, which is given intervenously. This uses donated IgG immunoglobin products from the plasma of pooled blood from many donors, either to boost the antibodies in an immune compromised individual, or as in these cases, to suppress the autoimmune response and control inflammation. Some have recovered quickly, while others have a longer road ahead.

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¹When news outlets say, "CDC is calling the condition progressive inflammatory neuropathy", it's not complicated. Doctors observe that the symptoms get worse over time, progress, "progressive". Tests show evidence of "inflammation"². Disease of the nerves -- "neuropathy" -- in this case of the peripheral nerves. Thus, "progressive Inflammatory Neuropathy".

²The nervous system is amazing and can be visualized in the actions of the neuromuscular system. Complex and intricate physiology allows you score a goal or dip your toe in the water and recognize it as cool, or warm as the nervous system communicates that back to the brain. To briefly summarize the process, which you can find in more thorough detail elsewhere, when you kick the ball, the thought originates in the CNS -- through the motor cortex of your brain, then as a nerve impulse transmitted down your spinal cord. At that point the somatic nervous system transmits the signal from the spine to the muscles of your foot and leg. At the muscle, a biochemical reaction at the site where the nerve cell meets the muscle cell triggers muscle contraction. Think of this happening for all the muscles, in the exact right order, when athletes pass a football, or perform an uneven parallel bar routine, or swim.

³ In the body there is the peripheral nervous system (PNS), and the central nervous system (CNS). The CNS is the brain and spinal cord, and the peripheral nervous system consists of the somatic and autonomic nervous systems. The somatic nervous system innervates skeletal muscle, skin, and sense organs.

The Jungle is Upton Sinclair's book about meatpacking conditions in the early 20th century.

Acronym Required wrote other posts about livestock related diseases that were infectious, which PIN is not. We wrote about BSE (mad-cow disease), caused by an infectious agent called a prion, in "Cow Rendering - Ingenuity Gone Mad", and "The Companions of Mad Cows". We've also covered the bacterial infection of Streptoccocus suis in Chinese pigs, and the Coxsackie virus in Britain's Foot-and-Mouth Disease. We wrote several posts on the H5N1 virus known as avian flu.

There seems to be a new trend among sports retailers. Many large chains are discontinuing the sale of polycarbonate bottles. These popular drink bottles contain bisphenol A, an endocrine disruptor. Nalgene bottles, made by Thermo Fisher Scientific Inc., are ubiquitous among athletes, and the company has successfully cultivated a new market for its colored plastic bottles to augment its labware market. However as awareness about the health risks of bisphenol A containing polycarbonate spreads, it makes sense that the bottles would lose favor among sports enthusiasts who comprise some of the most health conscious and environmentally aware consumers.

Last week, Canada's Mountain Equipment Co-Op (MEC), announced that it would discontinue the sale of polycarbonate bottles including Nalgene bottles. MEC is sports co-op started in Vancouver, similar in theory to Seatle's REI (Recreational Equipment Inc.). The company has followed the bisphenol A research for three years, a MEC spokesperson said, and will continue to follow the research. For now, however, they won't be selling the bottles.

Today, Lululemon, another Canadian retailer specializing in workout gear, announced that it plans to stop selling the polycarbonate bottles in January. Lululemon is an international retail chain with stores in the US, Australia, and Japan. The company last gained attention when it denied a New York Times investigation which found that the company's seaweed fiber yoga clothes didn't have seaweed in them.

Patagonia, the North American sports retailer, also does not sell polycarbonate bottles, but instead sells metal drink containers.

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Acronym Required has been following various aspects of the bisphenol A story for a few years.

The good news on World AIDS Day is that the UN changed the 2006 estimate of the number of people living with HIV from 34.1 - 47.1 million people, to 30 - 35.3 million people. The more precise number comes largely from revised numbers for India, as well as Angola, Kenya, Mozambique, Nigeria and Zimbabwe. Two-thirds of the people living with AIDS are in sub-Saharan Africa, where the number of infected women is now 61%.

The theme for this 20th observance of World AIDS Day is leadership.

When Fear of the Internet Manifests as a Desire to Throw Cheerios?

In Time magazine's "When the Patient is a Googler", Dr. Scott Haig constructs a straw lady for our entertainment. His female patient "brandish[es]" information during an office visit and her unruly child spews chocolate milk and Cheerios about his office. Haig holds up his caricature of a harried mom and compares her to his ideal patient, the engineer who is "accustomed to the concept of consultation". The engineer's kids are no doubt being cared for somewhere else, and his Mr. or Ms. "Logical" probably sports a pocket protector to prevent ink from the Pilot Extra Fine Point permanent marker from accidentally marring the doctor's fine upholstery. Kudos to engineers for knowing their rightful place.

To be fair, Haig likes nurses too. They're his "favorites", because "they know our language and they're used to putting their trust in doctors. And they laugh at my jokes."

The doctor holds a seemingly exalted position in New York's medical circles. He teaches, runs a private practice, and "punts" his undesirable patient, her "mispronounced words and half-baked ideas", after only one short visit. Such skill! Such fortune! Hospitalists, emergency docs, managed care docs, brilliant and dedicated private practice doctors, nurses, lab techs, physical therapists, administrators and medical workers are often stuck with their clients -- even when said individuals taunt outrageous anti-medical ideas like "yin-yang", or "nutrition"! But imagine Haig's scenario. Imagine if after a mere twenty minutes of your insufferable patient, co-worker, doctor, or boss, you could simply opt out? You could just bid that arrogant pill adieu and never have to endure whatever blah, blah, blah, blah...again? Without sacrificing your (let's say) $500,000K+ salary? Oh, should such a world be mine! To hell with compassion.

For a man of his stature, Haig's stereotyped "brainsucker" female protagonist with her wayward toddler provokes a strong reaction -- "I soon felt like throwing Cheerios at her too", "I couldn't dance with this one". Why such indignation? In Haig's telling she knows his address, but it's hard to imagine any real rage or paranoia built around that. It's easy enough to keep an address private, and she's obviously harmless.

Haig did not write 'Googler Patient' for Acronym Required's rhetorical amusement. If we were to hazard a guess, we'd suspect there's something more, and the doctor didn't diagnose his problem correctly. We'd suggest that it's psychological. That he's upset, unsettled perhaps, thinking about how the internet might further disrupt the cozy information asymmetry implicit in doctor patient relationships. Does Google masquerade in Haig's tale as some pushy female, "rude" and "too personal"? Does "she" jostle the power structure? Does "she" psychophysiologically unnerve the doctor?

An Apple a Day....More Pablum For Busy, Distracted Minds

When patients visit the doctor they generally get one 10-30 minute office visit with the "expert". Doctors are pricey, even if insurance buffers the $200-$500 bill. "Personalized" medicine? Patients are often lucky if the doctor gets their name and age right. Stressed by whatever ails them, patients don't see doctors for a living, as doctors do patients, so they could be forgiven their unpracticed manner. Think of your dear grandmother, born in a time not too long after the town doctor made patient rounds with his horse-drawn carriage. Does she have to ape the behavior of a dispassionate engineer in order to avoid the scorn?

Many doctors agree that patients should be as informed as possible for their own health. We all acknowledge that American medicine is often a broken system. Sure "experts" abound, but complacent doctors are easy to find too. Medical errors occur in "44,000 to 98,000" patients a year according to the FDA (via Google). Patients, being human, aren't all equally subtle or adept at integrating their new found internet information with the doctor's expertise. But doctors should be able to adjust to this. They should be able to relate to inevitable unevenness in "bedside manners", and the variable ability of patients to see the body in the same way that the well-trained and indoctrinated doctor does.

There's a phenomenon at work here concerning the internet, medical information, and doctor/patient relationships. Unfortunately this Time column doesn't get around to exploring the more subtle and interesting aspects of the story.

'Fessing Up For Health

In a related piece, Tom Delbanco, M.D., and Sigall K. Bell, M.D write in "Guilty, Afraid, and Alone - Struggling with Medical Error", (New England Journal of Medicine NEJM Volume 357:1682-1683, October 25, 2007), about mutual fear on the part of patients and doctors that exacerbates suffering due to medical mistakes. They note that "because of the power dynamics between physicians and patients, questioning the expertise or skill of an authority figure is particularly fraught for the least empowered members of society". The authors have made a film for third year medical students and suggest that in the case of medical errors, there should be a forum for some sort of reconciliation: "patients and families will bring ideas to the table that expand the horizons of health care professionals".

Summary:

Just a thought: If bisphenol A were a therapeutic drug going to market, instead of a chemical with an established global market, and there were "700 studies" according to LA Times showing hormone effector effects in animals, but also "two dozen" human studies showing the same responses in humans -- therefore if bisphenol A, the hypothetical drug, had passed through the equivalent of Phase I safety, Phase II efficacy and was well into Phase III trials -- the stock of a certain pharmaceutical company would be skyrocketing based on the evidence. Financial analysts would be jumping up and down in their Aeron chairs predicting sales of the next blockbuster drug... But bisphenol-A is not a drug. It's a chemical used in mostly polycarbonate products such as baby bottles and sport's drink bottles, but ubiquitously in toys, dental epoxies, food cans... 2.8 million tons of bisphenol A were produced globally (PDF) in 2002. Manufacturers, politicians and organizations like the American Dental Association deny that the animal studies mean anything. They insist that bisphenol A is safe. Is it? If not why did city legislators in San Francisco decide not to restrict its use in products?

Plastic People

Chemical & Engineering News published an article August 6, 2007, titled "More Concerns Over Bisphenol A: Human Exposures are Usually as High as Those Causing Profound Effects in Rodents". The article presented evidence from four toxicology studies that "bolstered" the link between "bisphenol A (BPA) and adverse health affects". Bisphenol A is used extensively in producing certain hard plastics made into many products. It is an endocrine disruptor that in mice causes a myriad of deleterious physiological effects, and when scientists do corresponding studies in humans, those experiments produce the same results as in mice.

Makers of bisphenol A and the chemical industry label anyone who questions the safety of chemicals a "green activist" with "anti-chemical agenda". But the American Chemical Society hardly fits into this category. When the American Chemical Society notes the "profound effect" of bisphenol A, won't industry lobbyists and Fox news temper their caustic comments? Will they realize how out of date and trenchant they sound? Doubtful. As the American Chemical Society also notes, "despite growing evidence of toxic effects in lab animals, manufacturers of BPA insist that their product is safe."

It's curious that the chemical industry has manage to conceive and manufacture hundreds of thousands of chemicals for millions of "better living through chemistry" applications, but seems hamstrung when challenged to create less toxic options. Instead, they vehemently oppose the idea of taking a toxic product like bisphenol A off the market.

Once production is in place and market share is established, removing a product from the market is as much an anathema to industry as it is to the politicians and media who represent (in part) that industry. Of course there would be "economic repercussions" to any change in production. But industries remove consumers favorite products all the time when it benefits their bottom line. In fact isn't "planned obsolescence" part and parcel of capitalism? But rather than focusing on the potential profit that would come from a new, less toxic product, these industries cling to their old product like a child whose parent tries to remove a toy from their grasp.

Chemical & Engineering News doesn't need to tell us that the Chemical, Plastics and Toy Manufacturing industries might not be the most reliable source of information for toxicity of chemicals.This is not strange or unprecedented business practice, rather a predictable one. The car industry bucked the notion of seatbelts for years, the tobacco industry denied that dragging on cigarettes caused cancer, and the oil industry launches vigorous attacks against all science and scientists who observed and predicted climate change and global warming.

We've come to expect this of industries. They bombard the market with new and exciting products on their own terms. They find infinite new uses for chemicals; for phthalates and bisphenol A that make plastic products pliable or rigid or just plastic-y so. They create and manufacture plastic products en force, to strong demand, with impressive budgets that buy marketing, press releases, opinion pieces, disclaimers, liability notices, and a bevy of braying lobbyists and complicit politicians.

When it comes to our health, consumers are learning not to depend on industry information. Since Acronym Required first started reporting on bisphenol A and phthalates a couple of years ago, public awareness of the potential dangers and the lack of industry transparency about them has grown tremendously. Despite their self-determination, however, as consumers we remain dependent on the media to inform us and the legislature to protect us.

Consumers are the largest constituency of politicians, and the largest consumer group of newspapers, and TV networks, however we don't necessarily have the clout to match the sheer number of us. To the media and politicians, citizens are just one of many constituencies -- not necessarily the loudest, the most consistent, or the most financially generous. Politicians and the media are also indebted to their own bottom line; to donors, partner businesses, trade groups, and advertisers, not only readers and voters. Health and environmentally conscious citizens sometimes discover that their influence is relatively small, just one line on a whole balance sheet of competing interests.

The Press and Poison, The Press and Pills

Media coverage on potential toxins can be good, as in a USA Today article on October 30th about bisphenol A, but it can also be confusing if not downright bad. Consider the editorial decisions that Los Angeles Times made last month, in publishing an article lengthily titled: "Some Chemicals May Affect the Reproductive System, Growing Research Suggests. But as Consumers seek Alternatives, Scientists Point out that Human Studies are Few."

Discussing the bisphenol A, the article relayed the warning of a panel of 38 scientists working for a EPA and NIH panel on bisphenol A, who surveyed "700 studies of bisphenol A". The scientists concluded:

"human exposure to BPA is within the range that is predicted to be biologically active in over 95% of people sampled. The wide range of adverse effects of low doses of BPA in laboratory animals exposed both during development and in adulthood is a great cause for concern with regard to the potential for similar adverse effects in humans."¹ [emphasis ours]

Said the Los Angeles Times "the vast majority of studies" looked at BPA effects in animals, but "only two dozen studies measured levels of the chemical in people, and three have examined the health effects of everyday exposure to the chemical" "Hundreds of studies" in lab animals, the article notes, found that "bisphenol A damages the reproductive system by interfering with the effects of reproductive hormones. Male rats have reduced sperm counts and enlarged reproductive glands; female rodents have altered mammary