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October 1, 2007

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Integrity in Science Watch

Week of 10/01/2007

Protest Prompts EPA to Postpone Pesticide Approval

The Environmental Protection Agency (EPA) has temporarily delayed registering the fumigant iodomethane after 54 scientists and physicians, including five Nobel laureates, protested its approval to director Stephen Johnson. The agency had quietly renewed efforts to approve the compound, also known as methyl iodide, as an alternative to methyl bromide, which is being phased out because it depletes the stratospheric ozone layer. The agency "will address recent questions prompted by the pending registration of iodomethane," said James Gulliford, assistant EPA administrator for pesticides and toxic substances. A year ago the EPA had to abandon efforts to approve iodomethane, which is manufactured by Tokyo-based Arysta LifeScience Corp., after a wave of protests from its own scientists, the California EPA and public health and environmental advocates.

Iodomethane is classified as a possible human carcinogen by the EPA and a known carcinogen by California, where it would be heavily used by fruit growers if approved. "[In the chemistry lab] this substance is always used in tiny amounts and with major protections. The thought of using it as a fumigant is frightening," said Roald Hoffman, a Nobel Prize-winning chemist at Cornell University. The Pesticide Action Network of North America asked the chemists to write the letter after government scientists complained anonymously that EPA higher-ups had warned them not to tell opponents about its pending approval.

Privately-held Arysta LifeScience, which wants to sell iodomethane under the trade name Midas, is currently for sale. Last month, the company announced it had received an EPA permit to use iodomethane experimentally on 1,000 acres in Florida, Georgia, Michigan, North Carolina, South Carolina, Tennessee and Virginia.

FDA Fails to Monitor Clinical Trials - OIG

The Food and Drug Administration monitored just one percent of clinical trial sites between 2001 and 2005 and almost never reviewed the performance of Institutional Review Boards, which are supposed to protect human subjects, a report released Friday by the Health and Human Services Inspector General found. Moreover, nearly three-quarters of inspections had nothing to do with protecting patients, but instead involved checking the validity of trial data long after the trial had been concluded. In the few cases involving patients that resulted in warning letters, the agency almost never conducted follow-up investigations to ensure compliance. Congress demanded the study after a November 2005 Bloomberg News investigation found several instances where clinical trials that resulted in patient deaths and injuries had not been evaluated by the agency.

The report recommended that the FDA create a database for tracking clinical trials, a registry for IRBs, and a database for tracking inspections; the report also said that the FDA should seek legislative authority for policing the colleagues and subordinates of principal investigators if they participate in the trials. FDA deputy director Janet Woodcock, in a response dated July 30, 2007, agreed the agency should establish a non-public database for clinical trials (the law signed by President Bush last week created a public registry for late-stage clinical trials, but not the early stage safety or proof-of-principle trials that have sometimes resulted in patient harm). She also said the FDA and Office of Human Research Protection had proposed an IRB registry in 2004, and were "working diligently" to complete it. But, citing "limited resources," Woodcock suggested the FDA should only target the riskiest trials for inspections.

CMS Okays Journals without Disclosure, Registry Policies

The Center for Medicare and Medicaid Services next month will nearly double the number of journals that oncologists can use to justify payment for the off-label use of anti-cancer drugs and procedures. At least one of the 11 cancer journals added by CMS (Bone Marrow Transplantation) doesn't require publishing authors' conflict of interest disclosure statements, and more than half do not require registration of clinical trials prior to publication of results, a Center for Science in the Public Interest survey found. CSPI and Consumers Union had asked CMS to make any journal on the list used to justify off-label use payments -including the 15 journals already on it - adhere to such policies.

In comments submitted to CMS, the American Society of Clinical Oncologists, which represents the nation's 20,000 cancer physicians, balked at adopting the requirements, even though it moved quietly in the wake of the protests to adopt both policies at its own journals. "The best way to identify those journals is through the considered opinion of the physician specialists who treat patients with cancer," said Joseph Bailes, co-chair of the government relations panel for ASCO. "In the abstract, ASCO agrees that these two criteria are among the appropriate indicia of quality in scientific or medical journals, but they are not the only significant criteria, and they should not be utilized to foreclose otherwise appropriate coverage." In two letters to CMS, ASCO had recommended 14 journals be added to the approved list. Six of the ASCO-nominated journals were rejected, including the Journal of Thoracic Oncology and Breast Cancer Research and Treatment, neither of which have conflict-of-interest disclosure policies.

NAS Reconsiders Fuel Economy Panel

The National Academy of Sciences has reopened the comment period for its panel charged with assessing technologies for improving automotive fuel economy, which previously drew protests for including seven nominees with ties to the automobile and engine manufacturing industries. Two of these members, former executive director of science for General Motors research and development Larry J. Howell, and former vice president of research and development for Garrett Engine Boosting Systems, Syed Shahed, have been replaced with John J. Moskwa, who has worked for Cummins Engine Co., General Motors Research Labs, and Ford Motor Co. The panel has also been criticized by business interests for its inclusion of David Friedman of the Union of Concerned Scientists and Robert Sawyer, former chairman of the California Air Resources Board.

Climate Skeptic Leaves U. VA

Global warming skeptic Patrick J. Michaels has left the climatologist's office at the University of Virginia, generating relief among university faculty who lamented the politicization of the office resulting from Michaels' industry funding and contrarian views on global warming. Though the state of Virginia funds the climatologist's office at the university, the state has repudiated Michael's oft-repeated claims that he was the official "state climatologist," and the governor's office made clear that Michael's views on global warming do not represent those of the state. Michaels says that state funding of the climatologist's office made his position there "untenable," and says that he relishes the ability to "speak more freely" in his work as a Senior Fellow in Environmental Studies with the libertarian Cato Institute.

Odds and Ends

The Food and Drug Administration granted waivers to five scientists with conflicts of interest to serve on the Circulatory System Devices Advisory Committee that will evaluate Medtronic's application for a new drug-eluting stent. Three of the waivers, including one for chairman Clyde Yancy of Baylor University, involved consulting relationships with Medtronic. . . Professor Sir Leszek Borysiewicz, the incoming director of Great Britain's Medical Research Council (the equivalent of the U.S. National Institutes of Health), has assured scientists that his pledge to focus on commercializing research will not shortchange basic science financed by the agency, the London Times reports . . . A National Academy of Sciences panel will review the Bush administration's use of data in the Climate Change Science Program (CCSP). An earlier NAS review of CCSP called the program delayed, inefficient, and a failure because it hadn't addressed climate change's impact on local communities.

Cheers and Jeers

  • Cheer to the to the Wall Street Journal for disclosing that recent studies showing that apple juice contains more beneficial nutrients than previously thought were partially funded by trade groups for the apple juice industry.
  • Jeer to the New York Times, the Los Angeles Times, the Chicago Tribune and numerous other publications for failing to report that 4 of 17 co-authors of a Centers for Disease Control-funded study downplaying the neurological risks of thimerosal-containing vaccines had consulting relationships with vaccine manufacturers. The New England Journal of Medicine, where the study appeared, disclosed that information as well as the fact that CDC lead author William Thompson was previously employed by Merck, although that relationship ended in 1998, according to the CDC.
  • Jeer to the American Dental Association for awarding its acceptance seal to sugar-free gum brands Orbit, Extra and Eclipse based solely on studies funded in part by Chicago-based Wm. Wrigley Jr. Co., which manufactures the brands. Cheer to the Associated Press for raising the issue in its story.
  • Correction: The International Journal of Food Sciences and Nutrition, jeered last week for failing to disclose the food industry ties of authors of a study showing no direct correlation between soft drink consumption and childhood obesity, did disclose that fact in the acknowledgements section of the article. We apologize for the error.