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March 10, 2008

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Integrity in Science Watch

Week of 03/10/2008

EPA Staff Unions Challenge Science Overrides

After accusing the Environmental Protection Agency’s top political appointee of overriding staff scientists to favor regulated firms, the agency’s unionized employees suspended participation in the agency’s National Labor-Management Partnership Council, a cooperation agreement set up during the Clinton Administration to resolve disputes between agency management and staff. In a letter sent last week to EPA administrator Stephen Johnson, the presidents of 19 local unions accused the agency of repeatedly violating the spirit of the agreement, which was designed to increase employee participation in agency decisions.

The letter cited Johnson’s refusal to allow California to regulate greenhouse gas emissions and his decisions involving fluoridation of water that ignored staff objections. “EPA ignores the advice of its Labor Union Coalition and its own Principles of Scientific Integrity whenever political direction from other federal entities or private sector interests so direct,” the letter said. William Evans of the EPA’s Office of Pesticide Programs and president of the EPA headquarters chapter of the National Treasury Employees Union said that political appointees at the agency have increasingly withheld important information about pesticide risks from the public. They have also discounted the input of agency scientists on these risks. “There’s a refusal to work collaboratively on decisions,” Evans said. “Unless we see a willingness to work with us, we’re just not going to meet.”

Obesity Society Prez-Elect Quits after Conflict of Interest Storm

After weeks of criticism from peers, University of Alabama at Birmingham biostatistician David B. Allison has stepped down as president-elect of the Obesity Society. Allison, who was slated to assume leadership of nation’s largest group of obesity researchers later this year, came under fire for providing paid expert testimony in January in support of the New York State Restaurant Association’s (NYSRA) lawsuit seeking to overturn a city ordinance requiring calorie labeling on restaurant menus. In his declaration, Allison claimed that there was insufficient evidence that “providing restaurant patrons with calorie information on menu items will reduce individual or population levels of obesity” and that menu-labeling could also increase obesity levels. The Obesity Society, on the other hand, supported the New York City initiative in its February newsletter.

In his resignation letter dated February 29, Allison said that “while I stand behind the scientific statements I made, my right to make them, and the manner in which I made them, I realize now that participating in this case while in the presidential sequence in TOS was a serious political error.” Other obesity researchers criticized Allison’s testimony as a selective reading of the academic literature. In addition to his relationship with the NYSRA, Allison has a long history of financial ties to the food and drug industries, according to the Integrity in Science database. He has served as a consultant to Frito-Lay, Coca-Cola, Bayer, Pfizer and Amgen, and served on advisory boards for the Wheat Council, Kraft Food and Nabisco.

IOM Urged to Recommend Conflict-Free Zone for Medicine

The Institute of Medicine panel developing rules for managing conflicts of interest in medicine will be told this week that there need to be strong boundaries between researchers who conduct industry-funded research and any body that helps determine how medicine gets practiced. “The system for reviewing the body of evidence in a field; deriving best practices through systematic reviews; writing clinical practice guidelines; conducting and evaluating comparative research; and, vitally important, evaluating evidence for regulatory purposes should be entirely free from conflicts of interest,” Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, will tell the 17-member panel on March 13. The Conflict of Interest in Medical Research, Education, and Practice panel is charged with designing policies to manage conflicts of interest “without damaging constructive collaboration with industry.”

With an estimated 70 percent of clinical trials now funded by industry, it is inevitable that numerous physician-researchers will have ties to industry, Goozner will note. But it is crucial to find unconflicted scientists to evaluate that evidence since there is a demonstrated correlation between the outcomes of research and the funding source of the researchers. CSPI will also call for the nation’s 700,000 physicians to wean themselves from dependence on industry support for their continuing medical education, and to stop taking gifts from industry salespersons, a near ubiquitous practice that clearly influences prescribing patterns.

Goozner will compare medical evaluators on guideline writing committees and regulatory advisory panels to financial journalists, who are strictly prohibited from having any financial relationship with the companies they cover, and the Federal Reserve Board, whose officials and staff are strictly prohibited from having financial relationships with the banks and financial institutions they regulate. “Why should medicine be held to a lower standard than either of those professions?” Goozner will ask. “Where there is total financial independence, there can be no questions about objectivity.” CSPI also called on the IOM to tighten its own conflict of interest policies. Numerous scientists with financial ties to industry serve on its advisory panels without disclosing those ties since the agency only considers ongoing financial arrangements as a conflict of interest, not those that took place in the recent past.

Enviros Charge Border Fence Behind Jaguar Decision

Conservationists last week warned the Fish and Wildlife Service that it could wind up in court if it continues to refuse to develop a recovery plan for the endangered jaguar, a feline species native to northern Mexico and the southwestern U.S. A coalition of environmental groups and scientists notified the agency of their plans to sue after the FWS’s January announcement that a recovery plan was unwarranted and would not assist conservation of the species because the fast cats do not have a separate breeding grounds within U.S. borders. The Center for Biological Diversity, which filed the formal notice of intent to sue on Feb. 29, said that the agency’s unwillingness to develop a recovery plan may have to do with Bush Administration plans to construct a fence along the U.S.–Mexico border, which would inhibit recovery.

The Endangered Species Act allows the FWS to forego the development of a recovery plan for species that occur wholly within foreign countries. Scientists with the American Society of Mammalogists said that a study conducted between 2001 and 2007 in Arizona indicated that the species is well-established within U.S. borders.

Odds and Ends

CSPI is joining a coalition of consumer and public interest groups protesting the removal of toxicologist Deborah Rice from an Environmental Protection Agency panel charged with evaluating the safety of the flame retardant Deca-BDE. The groups’ letter, which will go to EPA administrator George Gray this week, charges that the agency “capitulated to the demands of the American Chemistry Council” in removing Rice from the panel. Rice had successfully pushed the state of Maine to ban use of the chemical, and was removed from the panel after the chemical industry trade group accused her of bias. . . .Chief Justice John G. Roberts Jr. could not participate in a significant pharmaceutical pre-emption case last week because of a financial conflict of interest. The case involved whether 27 diabetes patients who suffered liver damage from taking Rezulin can sue the drug’s manufacturer, Warner-Lambert. According to his 2006 financial disclosure form, Chief Justice Roberts owns $15,000 to $50,000 of Pfizer stock, which is Warner-Lambert’s corporate parent. Robert’s decision to abstain resulted in a 4-4 tie, which automatically affirmed the lower court’s judgment allowing the plaintiffs’ lawsuit to proceed . . . .The Food and Drug Administration granted a conflict of interest waiver for an upcoming Anesthetic and Life Support Drugs Advisory Committee meeting to Wake Forest University anesthesiology professor James E. Eisenach for the $10,000 he recieved in consulting fees from Schering-Plough Corp., whose drug Bridion will be discussed at the meeting. . . . CSPI today joined a coalition of organizations calling for enhanced protections for federal whistleblowers. The coalition, led by the Union of Concerned Scientists asks that current bipartisan whistleblower protection legislation be strengthened to include federal scientists who report distortion or suppression of their work.

Cheers and Jeers

  • Cheer to Andrew Martin of the New York Times for a story exposing that a new lobbying group called American Farmers for the Advancement and Conservation of Technology was organized and partly funded by Monsanto to lobby for state laws prohibiting labels on milk cartons declaring when it is free of synthetic bovine growth hormone. A Consumers Union survey showed 88 percent of Americans want that information on the milk containers.
  • Jeer to Juliet Eilperin of the Washington Post for failing to disclose Patrick J. Michaels' many ties to coal and utility industries and also incorrectly describing Michaels as Virginia's State Climatologist. Michaels’s resigned from the post late last summer and is now only a part-time research professor on leave from the University of Virginia.
  • Cheer to Donald G. McNeil Jr. of the New York Times for noting that Sir Richard G. A. Feachem directs the Global Health Group, which receives funds from the Gates Foundation. Feachem was quoted in McNeil’s story supporting Bill Gates’ call to launch a malaria eradication campaign, which has drawn criticism as quixotic and setting unrealistic expectations from the World Health Organization’s top malaria official and others.