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September 2, 2008

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Integrity in Science Watch

Week of 09/02/2008

Integrity in Science Conference Audio Now Available!

Audio recordings from the Fourth National Integrity in Science Conference are now available online. Click here to hear the major presentations!

EPA Hides Data; Bayer Offers Flawed Studies

The Natural Resources Defense Council last month accused the Environmental Protection Agency of withholding information about the possible role of pesticides in Colony Collapse Disorder (CCD), a mysterious ailment that has destroyed one third of the U.S. honeybee population since 2006. The Freedom of Information Act lawsuit demanded immediate access to all EPA data on the toxicity of pesticides to bees after the EPA posted limited information on its website in response to an earlier request. The EPA’s posting failed to disclose any details about the association between the recently approved pesticide clothianidin and the health of bees. In May, clothianidin was banned in Germany for its role in bee deaths, and NRDC claimed the EPA has evidence establishing the link.

The pesticide is the subject of another lawsuit in Germany, where a coalition of beekeepers and consumer protection advocates has accused Bayer CropScience, the manufacturer of the chemical, of submitting flawed studies to mask its effects on bees. “Bayer, despite serious environmental damage, is fighting against any application prohibitions,” said Philipp Mimkes, spokesman for the Coalition Against Bayer Dangers. “Bayer's …management has to be called to account since the risks of . . . clothianidin have now been known for more than 10 years." A spokesman for the company said “studies available to us confirm that our product is safe” if used properly.

Firm Fires Docs Who Spotted Workers' Ills

The South African mining company Assmang Ltd. last week fired a team of doctors who diagnosed manganism in 10 of its workers, according to the South African daily IOL. The workers were suffering from a host of neurological symptoms after working at a manganese processing factory near the southeastern coast of South Africa. The new team of medical experts hired by Assmang revised the workers’ diagnoses to suggest they suffered from drug abuse and other maladies, according to Susan Tager, who testified before the South African Department of Manpower. Tager, who was on the original team of physicians that diagnosed manganism, said that the new Assmang expert panel never examined the patients.

Meanwhile, U.S. manganese manufacturers have paid more than $12.5 million to 33 researchers and 25 organizations that published papers downplaying the link between manganese and health effects, Mother Jones reports. The bulk of the industry-funded studies have been published after an Illinois jury in 2003 awarded $1 million to welder Larry Elam, who sued three companies, Hobart Brothers, Lincoln Electric, and Airco, over his manganese poisoning. Robert Park of the National Institute for Occupational Safety and Health (NIOSH) said there is strong scientific evidence linking manganese in welding fumes to speech impediments, tremors, and gait disturbance. NIOSH’s official report on the health effects of manganese and welding is four years overdue.

Study: BPA Threatens Adults, Too

A new study in Environmental Health Perspectives claims that the widely used chemical bisphenol A (BPA) may cause obesity, type-2 diabetes, and other disorders linked to metabolic syndrome in adults. The study is the first to link the chemical to effects in adults, and appeared just days after the FDA issued a report alleging that the chemical was safe for human consumption. The chemical has generated controversy ever since the National Toxicology Program (NTP) used contractors with ties to industry to perform a literature review for its report on the chemical, which also found the chemical to be safe. Nira Ben-Jonathan, an author of the Environmental Health Perspectives study, said that her team also found that small exposures to BPA reduce the efficacy of chemotherapy in breast cancer cells.

A number of states are considering proposals to ban the chemical, particularly in products intended for children age 3 and under. In the wake of the FDA report, the California legislature defeated such legislation, prompting some environmental groups to accuse the agency of playing politics with the timing of its release. The FDA, which denied the charge, will hold an advisory committee hearing on its report on September 16 featuring testimony from both NTP and University of Missouri scientist Frederick vom Saal, who is considered a leading researcher into the potential ill-effects of BPA.

Stanford Restricts Drug Industry Financing

Stanford University announced last week that it will no longer let drug and device companies specify which continuing medical education courses they wish to finance. Instead, companies will be asked to contribute to a medical school pool that can be used to pay for any class, even ones that never mention a company’s products, reports the New York Times. This announcement comes after a congressional investigation of Stanford professor and psychiatry department chair Alan Schatzberg, who recently resigned as principal investigator of an National Institutes of Health-funded research project after it was disclosed that he simultaneously took money from the company whose product he was studying for NIH.

Editorial Board of Psychiatric Times to Disclose COIs

The ongoing congressional investigation into conflicts of interest in medicine has prompted Psychiatric Times to begin disclosing its editorial board’s conflicts of interest to readers. In an editorial, Ronald Pies, editor-in-chief of Psychiatric Times, said "it is the editor-in-chief's job to know of potential conflicts and to make executive decisions accordingly." However, the move only raises further questions about who is calling the shots at leading psychiatric journals. The International Committee of Medical Journal Editors' “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” says “editors who make final decisions about manuscripts should have no personal financial involvement in any of the issues they might judge.” Top editors of psychiatric journals, though, frequently have such ties and include Jan Fawcett, medical editor of Psychiatric Annals, and Alan J. Gelenberg, editor-in-chief of the Journal of Clinical Psychiatry, both of whom receive education grants or consulting fees from pharmaceutical companies that sell psychiatric medicines. In 2005Pies disclosed that he received grants for educational activity from Abbott Pharmaceuticals, Janssen Pharmaceuticals, and GlaxoSmithKline.

Critical Cell Phone Studies Get Poor Reception

The two leading European studies showing that cell phone use may cause DNA damage are under investigation for relying on falsified data, Science magazine reports (subscription required). The senior author, Hugo Rudiger of the Medical University of Vienna, has agreed to retract one of the papers, but says the other remains valid. He also accused his critics of being funded by the cell phone industry.

After receiving complaints earlier this year, a university ethics committee investigation found both a 2005 study in Mutation Research and a 2008 paper in the International Archives of Occupational and Environmental Health contained errors in the data collected by a lab technician who was one of the paper’s coauthors. The chair of the ethics committee was a lawyer who had worked for a telecom company, Rudiger charged. Meanwhile, Alexander Lerchl of Jacobs University Bremen in Germany, who led the call for retracting both papers, has received funding from an umbrella organization funded by cell phone operators and manufacturers. The papers are the only two peer-reviewed studies showing DNA breakage from the electromagnetic fields emitted by cellular phones.

Odds and Ends

Academic health centers should be more open and sharing of biomedical data, a new study in PLoS Medicine suggests. . . . The National Institutes of Health has launched an independent study of a sepsis treatment after physicians questioned the validity of some of the data in the original study, published in 2001 in the New England Journal of Medicine by Emanuel P. Rivers of Henry Ford Hospital in Detroit. The original study also failed to reveal Rivers’ financial ties to Edwards Lifesciences, a firm that makes a catheter used in the treatment, the Wall Street Journal reports . . . . The Bush administration has proposed new rules that will make it harder to limit worker exposure to carcinogens and other toxic materials . . . . Vice President Cheney senior aide F. Chase Hutto III is angling to become assistant secretary at the Energy Department. Hutton played a key role in overriding endangered species protections for whales and to promote oil drinking in Alaska, according to the Washington Post . . . . Seven senators led by Barbara Boxer (D-CA) and John Kerry (D-MA) wrote Interior Secretary Dirk Kempthorne asking him to withdraw proposed changes to the Endangered Species Act . . . . A new Center for Progressive Reform report calls for nine legal reforms to protect scientific integrity in regulatory decision making. . . . .

Cheers and Jeers

*Cheer to Harold Sox of the American College of Physicians and Drummond Rennie of the Journal of the American Medical Association for their editorial in the Annals of Internal Medicine calling on doctors to “just say no” when approached by pharmaceutical companies to participate in so-called seeding clinical trials, whose primary purpose is to encourage doctors to prescribe the tested drugs rather than answer pressing clinical questions. The editorial was a response to a study based on internal Merck emails showing top company officials feared that a large trial involving Vioxx, later withdrawn from the market for safety reasons, lacked a strong scientific rationale.

*Jeer to Alex Berenson of the New York Times for failing to disclose in today's story about the cancer risk associated with the popular anti-cholesterol drug ezetimibe that quoted critic Steven Nissen of the Cleveland Clinic has conducted numerous clinical trials for manufacturers of rival anti-cholesterol drugs and routinely discloses that fact in the medical literature with the disclaimer that he donates all proceeds to charity. Media should follow a similar protocol.