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October 14, 2008

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Integrity in Science Watch

Week of 10/14/2008

BPA Panel Chief's Center Took Anti-Reg Zealot's Cash

The chairman of the Food and Drug Administration panel that is weighing the human health effects of bisphenol-A directs a University of Michigan center that recently received $5 million from a retired businessman who considers the chemical "perfectly safe," the Milwaukee Journal-Sentinel reported. When questioned about the gift, Charles Gelman, a retired medical supply manufacturer, told the newspaper that he has had several conversations with FDA panel chair Martin Philbert, who is a professor of environmental health sciences at the University of Michigan's Risk Science Center. "Philbert denied that," the paper reported.

Gelman, whose former company Gelman Sciences makes syringes and medical filtration devices, "is an antiregulation activist and an outspoken supporter of organizations including JunkScience.com, the Cato Institute and the Competitive Enterprise Institute," the paper reported. These organizations frequently attack independent scientists who find environmental toxins harm human health. Gelman's anti-regulatory activism dates from the mid-1980s when the Michigan Department of Natural Resources forced the company to clean up 1,4-dioxane discovered in groundwater near its plant.

Despite Gelman's gift to the Risk Science Center, the FDA did not consider it a conflict of interest. Philbert's own research is government-funded and has largely focused on the toxicology of nanoparticles. Another FDA panelist drawn from the Risk Science Center, Howard Hu, is studying fetal lead exposure on a $1.8 million grant from the Centers for Disease Control. However, the Michigan center does house a number of scientists conducting industry-sponsored research, according to University of Michigan records. They include environmental health science professors Alfred Franzblau and David Garabrant, who have received more than $8.2 million from Dow Chemical Co. in this decade for a dioxin exposure study.

Lawsuit: Pfizer Hid Negative Neurontin Studies

Pfizer, maker of the anti-seizure drug Neurontin, suppressed studies showing negative results for its off-label use in neurological and psychiatric conditions, a class action lawsuit filed in U.S. District Court in Boston charged. Health insurers and consumers who are seeking refunds alleged that “Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions,” the Wall Street Journal reported. In 2004, Pfizer's Warner-Lambert unit pleaded guilty to felony charges that it promoted Neurontin for uses not approved by FDA, including bipolar disorder and chronic nerve pain. The company settled the charges by paying $430 million.

The alleged suppression of research results drew fire from public health scientists. Kay Dickersin, a professor of epidemiology at Johns Hopkins University in Baltimore, wrote in a brief supporting the suit that patients who agree to participate in clinical trials are short-changed when companies refuse to release data from negative trials. “Patients are told they are contributing to human knowledge,” she said. “Ethically, one is compelled to publish results.” Dickersin’s fee for writing the brief will be donated to Johns Hopkins to house Pfizer's documents and make them publicly available.

Report: CDC Demoted Scientist for Whistle-Blowing

The House science panel investigating the Centers for Disease Control and Prevention released a report last week charging the CDC demoted Christopher De Rosa, former director of the agency's Division of Toxicology and Environmental Medicine, “in retaliation for his persistent attempts to push the agency's leadership to take more substantive actions to protect the public's health," the Los Angeles Times reported. De Rosa raised early alarms about dangerous levels of formaldehyde in the trailers used to house refugees from Hurricanes Katrina and Rita. The CDC responded by pointing out that “no federal regulation or standard exists for formaldehyde levels in residential settings.” The statement did not address the whistleblower accusation.

Inspector General: NIH Needs Ethics Overhaul

A new report on the National Institutes of Health’s management of ethics violations called on the agency to adopt clear rules for reporting and policing conflicts of interest. The report, issued last week by the Health and Human Services department’s Inspector General, charged the agency lacked a formal, written policy on how to handle allegations of conflicts of interest and ethics violations at its more than two dozen institutes and centers. In addition to adopting an agency-wide policy, the agency should document ethics allegations and maintain a record of how they are ultimately resolved, the report said.

Scientists Fault Endangered Species Act Rewrite

Three scientific societies concerned with wildlife and habitat conservation have protested the Bush Administration's most recent proposed changes to the Endangered Species Act, which would eliminate the role of the Fish and Wildlife Service and National Marine Fisheries Service in determining whether federal actions harm listed species. The changes, proposed in August, would allow agencies wishing to engage in mining, timber sales, development, and other projects to determine whether those projects have the potential to harm vulnerable species—a task formerly assigned to biologists with species-specific expertise. The Society for Conservation Biology, the Wildlife Society, and the Ornithological Council write that the “proposed rule sacrifices effectiveness for the sake of efficiency because it bypasses the science that is critical to the consultation process.”

Odds and Ends

A Government Accountability Office report released last week said the Food and Drug Administration could avoid conflicts on its advisory committees by expanding its outreach efforts.... The Environmental Protection Agency published its final hazardous waste rule. The rule drew praise from the American Chemical Society, but environmentalists charged it removes safeguards and will lead to more pollution.... Energy conservation and resource protection were ranked 1st and 2nd as top priorities for innovation by the National Academy of Engineers annual conference.... Skeptics question an Icelandic biotech company’s claim to have created a genetic test that can predict a woman’s risk of developing breast cancer, the Washington Post reported, while the Food and Drug Administration informed LabCorp that its $1,600 ovarian cancer test did not meet FDA standards for approval, the New York Times reported....

Cheers and Jeers

  • Jeer to the United Kingdom’s Multi-Science Publishing Co., publisher of 15 on-line journals including Energy & Environment, Low Frequency Noise & Vibration and Wind Engineering. The company’s author instructions do not include requirements for conflict of interest disclosure, and its published papers disclose neither research funding sources nor individual author conflicts of interest.

  • Cheer to Shirley Wang at the Wall Street Journal for disclosing in a story on genetic testing that a study by Eric Topol, director of the Scripps Translational Science Institute, was funded by Navigenics, Affymetrix, and Microsoft.