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September 17, 2007

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Integrity in Science Watch

Week of 09/17/2007

Groups Decry Broken Peer Review Process at EPA

Citing the Environmental Protection Agency's violation of its own rules governing peer review, four consumer and environmental groups last week asked the EPA to withdraw a proposed regulation that would loosen the rules governing incineration of some hazardous wastes. The groups want the EPA to re-review the science and, if necessary, rewrite the proposed rule. The groups, which include the Center for Science in the Public Interest, the Environmental Integrity Project, the project on Scientific Knowledge and Public Policy, and the Natural Resources Defense Council, charged that the EPA’s subcontractor violated the agency's conflict-of-interest guidelines on peer review of scientific documents. The contractor allowed an employee of ExxonMobil, which produces large quantities of hazardous wastes, to sit on a panel that reviewed the EPA's "tool" for determining which chemicals would be eligible for the Comparable Fuels Exclusion, which, as currently proposed, would allow an additional 107,000 tons of hazardous waste per year to be burned in ordinary industrial boilers without the safeguards currently imposed by the Resource Conservation and Recovery Act.

The groups pointed out that the appointment of an ExxonMobil employee to a peer review panel was part of "a pattern of undue agency tolerance of conflicts of interest in its rulemaking process." In 2005 the agency appointed three employees of utility companies to review a report on coal combustion waste management. In 2003 the agency’s update of the health risks of ethylene glycol monobutyl ether (EGBE or 2-butoxyethanol), then listed as a “possible human carcinogen,” was peer reviewed by a panel that included two scientists whose industry-funded studies were the basis for the agency’s proposal to remove EGBE from the hazardous air pollutants list. After the scientists helped review their own conclusions, the EPA removed the compound from the list.

Tie-Breaking Vote on Conflicts at FDA Recorded Wrong

A key senator has informed the Senate leadership that his vote was incorrectly recorded last May when the full Senate voted 47-47 to reject an amendment to Food and Drug Administration reform legislation that limited conflict-of-interest waivers to one per committee meeting. If recorded properly, the measure would have passed. In a letter written June 22 and revealed for the first time last week, Sen. Arlen Specter (R-PA) told Senators Ted Kennedy (D-MA) and Michael Enzi (R-WY), the chairman and ranking member of the Senate Health Education Labor and Pensions Committee, respectively, that he in fact had voted yes on the amendment sponsored by Sen. Richard Durbin (D-IL) and Jeff Bingaman (D-NM). “As you move to conference on this legislation, I urge inclusion of the Durbin amendment in the final bill,” he wrote. Since the House included that language in its version of the bill, the issue is still on the table. Last week House and Senate conferees met to hammer out the final details of the reauthorization of the Prescription Drug User Fee Act. Despite Specter’s turnaround, sources say the Senate conferees are still pushing for a provision that would substantially weaken the intent of the House-backed measure, which would allow just one adviser with a conflict of interest to participate or vote at an advisory committee meeting.

Judge: EPA Must Base Lead Review on Science, Not Politics

A federal court in Missouri has ordered the Environmental Protection Agency to use an assessment written by staff scientists in the agency’s review of national ambient air quality standards (NAAQS) for lead. The Bush administration had sought to change the agency’s review process to rely more heavily on a risk assessment written by political appointees. The ruling was part of a Missouri Coalition for the Environment lawsuit seeking to compel the EPA to review the lead NAAQS, which has not been updated since 1986. A spokesman for the EPA’s Clean Air Scientific Advisory Committee welcomed the order.

Group Highlights Suppression of Cancer Research

OMB Watch has released a report that reveals extensive industry influence over the National Toxicology Program, a program within the National Institutes of Health entrusted with disseminating information on toxic chemicals to the public. The report charges that industry uses the Data Quality Act (DQA) to suppress or delay the release of cancer-related information through information quality challenges that slow regulatory action on chemicals. NTP publishes the biennial Report on Carcinogens (RoC), which is used by local, state and federal authorities to set environmental policies, regulate dangerous substances and establish protective health measures. The report documents how the latest RoC has been delayed for more than a year due to numerous DQA challenges from industry groups such as the Chemical Products Corp., the Nickel Development Institute, and the American Chemistry Council.

The report comes just as Congress is investigating allegations of mismanagement, industry influence, and suppression of whistleblowers at the National Institute of Environmental Health Sciences and the NTP. Robin Mackar, media relations officer with the NIEHS, says that the institute is preparing a response to the letter by House Oversight & Government Reform Committee Chairman Henry Waxman (D-CA) asking NTP Associate Director John Bucher to prepare "a plan for conducting an assessment of actual or potential conflicts under existing NTP contracts that does not rely on the self-certifications of contractors."

Odds and Ends

A 2005 paper by epidemiologist John Ioannidis of the University of Ioannina School of Medicine in Greece, which shows that "the majority or even the vast majority" of peer-reviewed research papers contain false findings, has become the most heavily downloaded scientific paper in the journal PLoS Medicine's history, the Wall Street Journal reported last week . . . . The British government's chief scientific advisor David King outlined a universal ethical code for scientists that includes an exhortation to "prevent corrupt practice and declare conflicts of interest". . . . Purdue University is investigating accusations of research misconduct against professor Rusi P. Taleyarkhan, who claims to have generated nuclear fusion in a tabletop experiment. . . Jan W. Poling, the Bush Administration's top Forest Service lawyer, is joining the American Forest & Paper Association, the timber industry's leading lobbying group. Earlier this year, Dave Tenny, deputy undersecretary of agriculture, became a vice president at AFPA . . . . The EPA last week released hazard characterizations for 101 high-volume chemicals, the first data released by industry under the agency's voluntary toxics testing program . . . .

Cheers and Jeers

  • Cheer: to Shannon Brownlee, author of Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer, for pointing out in an "On the Media" segment with Brooke Gladstone that the drug companies that manufacture sleep aids funded the National Sleep Foundation's survey that found that 75 percent of all Americans suffer from insomnia.
  • Jeer: to Jeremy Laurance of the London Independent, for failing to report that pharmaceutical companies that make birth control pills funded a study that found women who take the Pill experience elevated levels of cervical cancer but reductions in ovarian, uterine, and bowel cancers.
  • Jeer: to Alex Berenson and Benedict Carey of the New York Times; in an article questioning the validity of a study that showed an increase in child suicide rates was associated with a Food and Drug Administration warning about the use of antidepressants in minors, they failed to note two of the study's authors had ties to manufacturers of antidepressants.