Recently in Public Health Category

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Administration's Gut

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

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

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

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

One-Two Punch

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

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

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

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

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

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

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

Making Grad Work Easier

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

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

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

Lurking on Your Portabellos?

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

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

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

China's Transparency

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

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

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

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

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

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

In Poor Taste

Unlike China, 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.

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?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 smog was beneficial because it protected individuals from ultraviolet radiation. In the same presentation she asserted preposterously that since research showed that asthma rates were associated with poverty a smog ruling would have the "perverse effect" of costing communities money which would in turn increase poverty and asthma. While she now works for government and on behalf of citizens instead of industry, she employs this line of thinking.

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

The authors also single out six EPA rules on drinking water which they say cost state, local, and tribal governments or the private sector "over the threshold" of $100 million dollars annually. This was Ted Stevens 1996 amendment directing the OMB to submit to Congress cost benefit analysis of "economically significant" rules. Of course this OMB analysis doesn't expound on the enumerable benefits of clean drinking water free of cleaning agents, disinfectants or arsenic. And for reality's sake, please, a $100 million dollars? High cost for solvent free water? There are houses that Congresspeople reside in that cost nearly that much. And needless to say this is a drop in the bucket compared to the Iraq war, the costs accruing at $341.4 million per day with some mighty uncertain benefits.

The OMB costs and benefits report grounds itself in the philosophy that economically well-off countries have strong property rights and minimal regulation. Even with consideration to the fact this is a draft, the document veers to ideology at times, citing the Heritage Foundation for information and stooping to past arguments about Communism being an example of regulation gone wrong.

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

To aid Dudley's smooth tenure, executive orders and congressional laws paved the way, for instance in the 1990's, rules such as the Unfunded Mandates Reform Act (1995), the Government Performance and Results Act (1993), and the Small Business Regulatory Enforcement Fairness Act (SBREFA) (1996), all addressed regulatory and reporting costs without expanding definitions of benefits. SBREFA for example spares businesses from what could be burdensome regulatory costs. But the idea that agencies need to consider the costs of clean water and air rulings on "small business" can be interpreted in such a way that hobbles the goals of clean air and water. This also leaves small businesses susceptible to lobby manipulation by groups like the National Coalition of Petroleum Retailers, who may officially represent "small business", but whose aims may appeal most strongly to huge business. Look for example, at San Francisco's attempt to limit bisphenol A, and the immediate lawsuit which included BPA manufacturers and local toy stores.

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

Health and the Environment: The Public's Standing

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

Our intent is not to focus entirely on Susan Dudley, anymore that it is to focus on Stephen Johnson, or George Bush. They're all accomplices to a larger agenda which seems outmoded and outdated, and needs to be "overhauled" and "modernized". We are not in competition with Soviet ideology, capitalism is not even ascendant, it's dominant -- so arguments in last year's OMB report to Congress about regulations on Clean Air and Water being nigh to Communism are absurd. We live in a time when kids can't play outdoors because of smog, when business pollutes with abandon then screams about a rule that says mildly, please don't pour oil into streams, and when the UN warns monthly about climate change and rising seas. This is the state of our nation today. This administration's decades old way of thinking deserves only to be encased in Plexiglas in a museum (perhaps the Smithsonian if the Republicans have donated enough for a display).

We live in a time when business calls the shots in Congress, in the White House and in the Judiciary and we should all wake up. Yet voters still respond to "red phone" imagery with a knowing nod and utter naivete. We are the traitorous monsters in our midst. When the phone rings -- red, blue, yellow or green -- in the White House, in your Congressperson's office, or at the court house, it's not some nameless international threat, but an American industry whose TV advertisements you hum to and whose brand you endorse, and the person on the other end is calling to murmur in the lawmaker's ear about less regulation. One hand of the caller is slipping dollars into the decisionmaker's pockets while the other waves fanatically to citizens about the economic doom of Clean Air and Clean Water, about the unemployment that will follow, and balance sheets that will run red. That's what happens when the red phone rings in the White House in 2008. Let's get real.

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

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

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

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

BPA -- Here to Stay (In the Environment)

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

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

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

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

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

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

Government and Industry Consulting, a Lucrative Formula Perhaps?

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

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

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

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

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

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

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

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

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

Lung Cancer, No Worries?

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

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

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

Not. But What About a CT Scans?

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

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

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

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

My House or Yours?

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

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

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

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

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

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

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

For Your Own Good -- Smallpox in New York

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

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

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

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

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

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

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

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

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

"Same, Same But Different" - Polio in Nigeria

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

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

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

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

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

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

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

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

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

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

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

10 Billion Doses, 200 Side Effects.

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

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

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

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

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

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

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Senate Consumer Product's Bill Includes Phthalates Amendment

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

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

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

No Christmas, Just Chunks of Coal to Kick Around

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

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

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

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Acronym Required also wrote about phthalates in the following articles:

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

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

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

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

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

FDA Leader Criticized

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

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

Firecracker Appointees

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

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

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

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

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

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

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

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

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

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

"...Except for Prisoners and Students"

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

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

The Humane Society sued the US Department of Agriculture (USDA) yesterday in an attempt to force the agency to close a loophole in beef slaughter guidelines. Last year the USDA loosened a 2004 regulation aimed at preventing diseased cows from entering the food chain. The USDA allows "downer" cows (ones that had fallen down and can't get up) into the food chain