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August 13, 2007

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Integrity in Science Watch

Week of 08/13/2007

Consumer, Enviro Groups Protest Nominees to EPA Acrylamide Panel

Consumer and environmental groups this week blasted the Environmental Protection Agency for larding its proposed acrylamide review panel with scientists with close ties to industries with a stake in the outcome of the committee's deliberations. The August 13 letter from the Center for Science in the Public Interest, the Environmental Law Foundation, and seven scientists warned the EPA that the final panel will likely violate both the conflict-of-interest and balance provisions of the Federal Advisory Committee Act since at least six of the 21 scientists being considered for slots on the panel have either worked or consulted for companies or trade groups that produce or use the compound. Moreover, one nominee, a Harvard-based epidemiologist, has already written that acrylamide poses little or no cancer risk to humans. "The EPA needs to do a lot more work before the public will be assured that the final roster is balanced and free from conflicts of interest," the letter noted. "EPA’s failure to do so will cast a permanent cloud over the integrity and reliability of the committee's work."

Acrylamide, a commonly used industrial compound that is also produced by frying starchy food, is already listed as a neurotoxin and probable human carcinogen. The update to the EPA's risk assessment, which is due out September 15 and will be peer-reviewed by the panel, may impact a 2005 lawsuit by the California Attorney General, which is seeking cancer warning labels on acrylamide-containing foods. Food processors are looking forward to the review since they believe recent science would downgrade the chemical's danger thresholds and thus void the lawsuit, according to a May 8 Risk Policy Report published by Inside Washington Publishers (subscription required). "I suspect that the calculation of risk will be less than the existing [EPA] assessment," said Robert Fensterheim, president of RegNet Environmental Services, which provides consulting services to the chemical industry.

The panel's 21 candidates include Harvey Clewell and Timothy Fennel, who are current and former employees of CIIT Centers for Health Research, a group that conducts research for the chemical industry. Ernest McConnell, current president of ToxPath, Inc., is a former consultant to the North American Insulation Manufacturers Association; acrylamide is a component of some fiberglass insulation materials. Abby Li, a former Monsanto science fellow, is now with Exponent, Inc., which provided expert testimony for Procter & Gamble Company, one of the defendants in the California lawsuit. And Jeffrey Fisher and Penelope Fenner-Crisp have worked with the International Life Sciences Institute, a research foundation whose board is dominated by food and beverage corporations.

In addition, candidate Lorelie Mucci of Harvard Medical School has authored several epidemiological studies in recent years that suggest there is no link between acrylamide and some cancers. Her first study was harshly criticized by experts in the field. "[Mucci's] published conclusions and public statements indicate excessive confidence in insensitive epidemiology studies to detect acrylamide's possible carcinogenicity. . . and a strong bias in favor of acrylamide’s non-carcinogenicity," the consumer and environmental groups noted in their letter. Putting her on the EPA committee would put her in the position of evaluating her own research.

Comments on the proposed list are due today, August 13, and can be sent to shallal.suhair@epa.gov.

Avandia Panel Chair Spoke for Glaxo; FDA Waives Waiver

The chairman of the Food and Drug Administration advisory panel that voted last month to allow Avandia (rosiglitazone) to stay on the market with stricter heart risk warnings did not receive a conflict-of-interest waiver despite having recently earned a $2,000 speaking fee from the drug’s manufacturer, GlaxoSmithKline. Clifford Rosen, an endocrinologist and professor of nutrition at the University of Maine, told the agency about that relationship as well as his clinical trial work for Glaxo competitors Eli Lilly, Merck and Novartis, which was revealed on the New England Journal of Medicine website last week in an essay entitled "The Rosiglitazone Story – Lessons from an FDA Advisory Committee Meeting." "I listed it all on the FDA sheet, and they never saw it," Rosen said. "They told me, 'I'm sorry. We missed it.'" An FDA spokeswoman, contacted by email about the oversight, claimed that "Dr. Rosen did not have any interests relevant to the meeting topic that rose to the level that would require a waiver."

OMB Casts Cloud of Confusion on Ozone Risks

Using its own interpretation of the science, the White House’s Office of Management and Budget downgraded the health effects of ground level ozone in the Environmental Protection Agency's economic impact analysis of proposed new air quality regulations, an OMB Watch investigation revealed. The move served to increase the costs of the health benefits of the new standard and may undermine the agency's ability to enforce the tighter rules when they go into effect. The EPA’s original economic analysis assumed that ozone concentrations above the proposed standard of 0.07 ppm led to increased human mortality, a conclusion unanimously backed by the Clean Air Scientific Advisory Committee in March. OMB rewrote the analysis to downplay the association between ozone and premature mortality.

Scientists Challenge NIH Findings on Bisphenol A

Ignoring challenges that it overly relied on industry-funded research, the 12-member expert panel set up by the National Institute of Health's Center for the Evaluation of Risks to Human Reproduction last week downplayed the health risks of bisphenol A, a widely used component of plastics. The panel’s finding that the health risks of BPA were "negligible" was in sharp contrast to a consensus statement published by the journal Reproductive Toxicology on August 2, where 38 scientists warned that the compound may be responsible for serious human reproductive disorders. The scientists' statement was accompanied by a study showing reproductive damage in newborn animals exposed to the compound.

The government report has a checkered history. The Los Angeles Times revealed that the original 2006 draft had been written by a consulting group with ties to companies that manufacture the chemical. Though this consulting group was subsequently fired from the panel, independent scientists who have reviewed the most recent version of the draft contend that the report still relies heavily on industry-funded studies, USA Today reports. The Environmental Working Group also charges that there are hundreds of inaccuracies in the panel's report, which the nonprofit contends call into question the objectivity of the report's findings.

House Panel Presses White House on Global Warming Science

Representatives Henry Waxman (D-CA) and Tom Davis (R-VA) of the House Committee on Oversight and Government Reform have asked the White House Council on Environmental Quality to turn over 56 documents as part of its ongoing investigation into political interference with government climate science. The latest request came after the CEQ withheld the documents by claiming in a letter that their release would violate "core confidentiality interests of the Executive Branch."

Odds and Ends

The Boston Globe has editorialized on the need for FDA reform legislation currently being considered by Congress to limit the number of conflict-of-interest waivers allowed for FDA advisory committees to one. While the FDA objects by claiming that tighter rules would limit the pool of experts from whom it forms committees, the Hartford Courant points out that there are hundreds of thousands of unconflicted experts at university medical centers and government agencies within the U.S.

Cheers and Jeers

  • Cheer: to Newsweek for its August 13 cover story"The Truth about Denial." It documents how industry-funded scientists are still sowing doubts about global warming.
  • Jeer: to Newswise, an online news service that publishes press releases on research news from the nation's universities and research institutions, for reprinting a press release from the University of Alabama that cited researcher John Christy to cast doubt on the accuracy of the Newsweek article. The service failed to mention Christy's association with the George C. Marshall Institute, Competitive Enterprise Institute and Independent Institute - conservative think tanks that receive funding from ExxonMobil and other energy companies.