Recently in Public Health Category

Some recent news:

• Plastic Fantastic 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. Would you want to run into a retired Cheney taking popshots at birds while hiking though the Grand Tetons? The other danger is that lifting the ban would increase "impulse" kills of wildlife.

Other 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 good news is, some of these rules are the type of regulations that Obama is planning 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..."

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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.

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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...

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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.

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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 long held up the Senate negotiated aspects of the funding, for instance how much would be targeted to drugs and prevention, and the legislators finally reached a compromise. The House then approved the bill and the president signed it last week. H.R. 5501, 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 green