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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.

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

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?"

Notes on Science in a Mixed Market Economy

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.

The Politics of Everyday Bisphenol A (BPA)

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 for following along several paces behind the leading edge of science.

Cities like San Francisco, states like California, and US regulatory agencies like the FDA repeatedly back away from promises to limit the sale of bisphenol A when faced with industry threats or lawsuits. Last year for instance, San Francisco, California proudly proclaimed itself the "first city to ban bisphenol A". Then 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. They 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).

At the state, city and federal levels, when curious reporters ask politicians why they backed down BPA, they tend to mumble incoherently into their hands, if they answer at all.

I don't doubt that Canadian politicians are just as calculating as American politicians. Bisphenol A research showing convincing deleterious health effects has accumulated for 15-20 years, so 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's April 19, 2008 report, in 2003, worldwide production of BPA was about 3 billion kg/year. However Canada only uses .5-1.5 million imported kilograms(kg) a year. It has stopped manufacturing bisphenol A altogether, although as recently as 1986 it manufactured or imported 12 million kg. By contrast, 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

But 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 of Health Canada and Environment Canada issued a joint statement of concern in April, based on both agencies' research stating that bisphenol A was a "toxic chemical" based on both environmental and health research.

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. Doses that some researchers have discovered cause deleterious developmental effects are very low.

But the research is still fraught with experimental difficulty. 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.

The affiliation of researchers -- industry or academic or government -- has become a source of contention for many people. Indeed, some commenters skip over real scientific uncertainties, the diversity of experiments, and the difficulties in determining effects, and unilaterally cast blame on "industry research". Industry research in bisphenol A frequently arrives at the opposite conclusion of government research and is sometimes not peer-reviewed, or has control problems. This pattern shouldn't taint all "industry research", it's more important to keep looking at the evidence and for the public to grapple with the real uncertainties yet be able to recognize the relentless industry fronted marketing for what it is. Subtle and confusing perhaps, but 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 health.

Canada'a decision rests heavily on environmental data in addition to the health concerns, and its position is based strongly on the environmental data. 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 by conflicting results from other agencies that were simultaneously published.

Plastic lobbyists have leveraged these disparate agency results adeptly. Animal data shows toxicity of BPA which persists in the environment. But industry lobbies use the prolific animal results only to bolster their claims 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. This statement presents a conflicting image for the country's true commitment to the environment.

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 and neural development, all at doses below what the FDA deems safe and 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". It repeated the statement 3 times. 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 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." While the "negligible" conclusion is reassuring, these particular birth defects the most conspicuous ones that could effect fetal mice. Less conspicuous birth defects might also 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 possiblility that bisphenol A may alter human development cannot be dismissed". Nevertheless, their authoritative opinion assures people that the chemical is safe and provides great 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 the press and the questions and citizen pressures however, 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 study. Longitudinal studies are necessary.

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.

Your Prescription Data Roams Free

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?"

Global AIDS Funding to Pep the US Up

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.

AIDS Trial Narrowed, Research Progress

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 (NOx) 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 NOx emissions by over 60% from 2003 levels.

Ill-suited, Ill-suited, Ill-suited

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

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

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

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

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

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

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

The Administration's Gut

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

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

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

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

One-Two Punch

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

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

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

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

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

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

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

Prions at Large

Making Grad Work Easier

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

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

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

Lurking on Your Portabellos?

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

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

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

Aid for China and Myanmar

China's Transparency

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

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

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

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

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

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

In Poor Taste

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

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

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

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

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

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

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

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

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

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

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

Tanzania Safe Sex: Pay for no Play?

Public health requires perseverance. A mutation in a virus responsible for avian flu or in the parasite that causes malaria can instantly change the course of a disease -- who gets infected, where, and how. Many other changes, in politics, economics, leadership, geopolitical stability, funding, even weather can impact progress treating and preventing diseases. Technology also changes the course of disease, although promises of technology advances sometimes provide more sustained satisfaction than the actual technology fulfillments. In the fight against AIDS, for instance, [romises vaccines one-upped promises of retroviral treatment for all, which in turn supplanted promises of prevention through education and condoms. Ths means that progress on the ever devastating HIV/AIDS pandemics takes even more perseverance than many less lethal threats. It's morbid to think there may never be a silver bullet for the HIV/AIDS crisis, but at the least, many more strategies will be tested en route to stanching the devastation of the virus.

Despite global discouragement, there are always optimistic moments, like ten years ago when education and prevention through condom use and social marketing was the crux of HIV/AIDS fight. In September, 1998 Washington Post reported on the "remarkable success" of the new strategies.

Across the world, the paper said, HIV infection rates were decreasing. In places like the Dominican Republic, Brazil, and Uganda, and the Ivory Coast, and in Tanzania,, where a three year trial aimed at decreasing sexually transmitted diseases had "reduced HIV transmission by 40 percent". An administrator from the AIDS Control and Prevention (AIDSCAP), Brian Atwood, told the paper: "this agency has made a global contribution....over the years, we've learned so much about this..."

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

Today in Tanzania infection rates are lower than places like South Africa, averaging at about 8%, but overall life expectancy has decreased by 8 years due to AIDS. While HIV infection in urban areas declined by 16.65% from 2000 to 2005, in rural areas infection rates have markedly increased. Other critical economic development measures have also regressed in Tanzania, for instance literacy rates dropped from 80% in 1980, to 60% today. In one survey of adults, 52% of women and 62.5% of men believed that a teacher who has "the AIDS virus but is not sick should be allowed to continue teaching."

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

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

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

New Directions for AIDS Research Funding

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

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

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

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

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

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

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

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

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

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

Bacteria Flourish on Antibiotics

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

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

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

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

Flipping a Nation

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

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

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

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

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

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

The EPA Saves Living Things: Species and Documents

In his March 12th comments Johnson called the Clean Air Act a "living document" that needed to be "refurbished", "overhaul[ed] and enhance[ed]", "modernize[d] and upgrade[d]". Johnson announced his four "principles" for a Clean Air Act, including, to"allow decision-makers to consider benefits, costs, risk tradeoffs, and feasibility in making decisions about how to clean the air." The Clean Air Act was not "a relic to be displayed in the Smithsonian", he said.

The Times editor pointed out that Johnson's proposal would "cut to the very heart of the Clean Air Act", which was written to protect science from special interests by mandating rulemaking based solely on health, not economic costs. As most people can attest, when the first hint of pollution regulation arises, any energy company worth its salt begins wailing about "technology not being available", about the exorbitant cost of the proposal, and about all the risks of complying on account of scientific uncertainty. Companies did just this when they held the nation in a decades long trance while they chanted about global warming uncertainty. Recognizing this, and knowing how Johnson's incredulous suggestion would put estimates about cost and feasibility squarely in industry's park to the detriment of clean anything, we should become alarmed, perhaps leap to action, maybe phone our legislator.

However the NYT editor's tone soothed, calling Johnson's pronouncement a "revelatory moment", one that signaled the administration's "cry of frustration at being largely unsuccessful in undoing three decades of environmental law".

Like the wolf frustrated in mid-hunt? One last guttural, spine chilling howl before giving up its prey -- and the fawn darts into a thicket of brambles just in the nick of time, a small defiant flick of its white tail? Can we argue optimistically, as the editor did, that the Bush administration attempts have been "largely unsuccessful"? Knowing that standards should be set according to science can we be assured that, "the proposal has no chance of success in a Democratic Congress"? We love this view, can we share the optimism?

Ozone Decisions, Sunset Regulations and the Doyenne of Death

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

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

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

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

Inevitably cost/benefit calculations involve valuing health, the environment, and quality of life. When considering the cost/benefits of smog then, here's a question: what's an acceptable threshold for the number kids who are forced to stay inside on high ozone days to prevent asthma attacks? Thousands? Millions? At the other end of the age spectrum, according to the OMBWatch/Public Citizen report "Dudley has supported a senior death discount that counts the lives of seniors for less than the lives of the young". While this may be standard actuarial practice,pollution is more dangerous to the elderly, which make her calculations seem savage. For the prospects of regulations protecting our welfare the report pulls no punches in painting Dudley as the doyenne of death.

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

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

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

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

Ozone Rulings and Regulatory Agencies

In the end she was appointed by Bush during Congress's recess, and she began to reclaim ever more ground for the OIRA. Specific to the smog ruling, Dudley had long advocated against smog regulations on behalf of industry. In 1997 testimony before the Senate Committee on Environmental and Public Works on the Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety she argued incorrectly as the Vice President of Economists Incorporated that s