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September 24, 2007

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Integrity in Science Watch

Week of 09/24/2007

FDA Bill Slightly Reduces Advisor Conflicts of Interest

The Food and Drug Administration reform bill passed by Congress last week freezes the number of conflict of interest waivers that the agency can grant scientists who sit on its food, drug and device advisory panels, and will reduce that number by 25 percent over the next five years. About a quarter of all advisors currently get waivers, according to FDA reports. Consumer groups had pushed to prohibit the practice entirely. "This mild limitation doesn't go far enough," said Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest. "The FDA can find scientists without ties to industry if it truly wants to, and we will continue to push for banning a practice that gives regulated firms undue and unseemly influence over the regulatory process."

Drug safety advocates did win some major victories in the bill. Besides requiring company and government-funded researchers to register clinical trials in a publicly available database, the sponsors will now have to post the results of those trials a year to 18 months after their conclusion. This will aid researchers who want to sift for safety clues in data scattered among a large number of clinical trials, some of which in the past had been hidden from the public by the firms that sponsored the trials. The legislation also provides additional protection to scientists inside the FDA who want to speak out or publish their own reviews. On the down side, the legislation maintains the FDA's dependence on drug industry user fees, which are primarily earmarked to speed the review of new drug applications, although some of the money will now go to hire more safety experts and review direct-to-consumer ads.

Arnold Fires Game Official for Stance on Lead Ammo

Gov. Arnold Schwarzenegger last week forced California's top fish and game official to resign from his post after a consultant's report sponsored by the National Rifle Association claimed the state's endangered condors weren't threatened by lead ammunition, which the official had tried to ban. Game and Fish Commissioner Judd Hanna had backed a bill recently sent to the governor's desk that relied on a scientific consensus that a major factor in the condor's decline was lead poisoning caused by eating the carcasses of animals killed with lead ammunition. Schwarzenegger is expected to veto the bill.

Republican lawmakers pressured Schwarzenegger with a report prepared by Thomas Wright and Richard Peddicord of Dick Peddicord & Co., a consulting firm that works primarily for the shooting sports industry. The study's conclusions were immediately disputed by 44 scientists and activists, who defended Hannaís efforts to pass the law. "Taken as a whole, the chain of evidence from all sources, including peer-reviewed journals, supports the conclusion that California condors are suffering lead exposure primarily due to the ingestion of lead ammunition from game," they wrote. "Lead exposure is the major, preventable obstacle to the success of the condor reintroduction."

Dueling Cell Phone Reports Suggest Funding Effect

Does funding source effect research outcomes? A new study out of the United Kingdom on mobile phone safety found no adverse health effects from short-term cell phone use. The report, funded by the mobile phone industry and the British government, said that further research is needed to determine if long-term use leads to cancer, Parkinson's disease and Alzheimer's. Meanwhile, the Bioinitiative Working Group, an international team of non-industry scientists, researchers, and public health workers, conducted a meta-analysis of studies on the health effects of electromagnetic radiation and found that "chronic and uncontrolled exposures" to power lines, cell phones, and cordless phones "can reasonably be presumed to result in adverse health effects and disease. Children may be particularly vulnerable." The report led the European Environment Agency to urge immediate reductions in exposure limits to electromagnetic radiation as necessary "to avoid plausible and potentially serious threats to health."

U. Investigates Researcher for Mining Company

In what appears to be a clear breach of academic freedom, the provost of Idaho State University investigated the outside activities of a scientist after a mining company lodged a complaint with the school, the Chronicle of Higher Education reported. Officials at the J.R. Simplot Co., which has extensive phosphate mining operations in Idaho, contacted the university after math modeler Robert W. Van Kirk received $8,867 from the Greater Yellowstone Coalition to determine the safe level of selenium, a byproduct of phosphate mining, in the Blackfoot and Salt rivers. Van Kirk's study found the safe level was above a proposed federal regulation, but below what was already in most trout, including the endangered Yellowstone Cutthroat trout. After completing its investigation, the university assured Simplot officials that Van Kirk did not belong to the environmental group that sponsored the study, and the study had undergone peer review at the journal where it was eventually published. However, university officials did reassign Van Kirk's co-investigator, his wife Sheryl L. Hill, to another job and said her contract would not be renewed after this year.

Climate Skeptic Refuses to Disclose Funding

Global warming skeptic Patrick J. Michaels withdrew as an expert witness in a high-profile Vermont court case rather than disclose his funding sources, the Society of Environmental Journalists reported. Michaels was set to testify in the auto industry's lawsuit against the state of Vermont over the state's efforts to regulate greenhouse gas emissions from cars, but withdrew when told by lawyers for the automakers that he might have to disclose his sources of funding. During the trial Michaels had revealed that he was dependent for his livelihood on income from his consulting firm, New Hope Environmental Services, Inc., and that many of the firmís clients provide funding on condition of anonymity. Last year, ABC News and the Associated Press revealed that the Intermountain Rural Electric Association, an electric utility company in Colorado, paid $100,000 to New Hope. Michaels revealed that this disclosure had cost him $50,000 in fees from another Colorado utility, Tri-State Generation & Transmission Association, Inc.

Odds and Ends

Cloning expert Xiangzhong "Jerry" Yang violated conflict of interest policies by failing to disclose that he was running a private company, Energen, at the same address as his University of Connecticut laboratory, a university audit has found. Yang, who was the first in the U.S. to clone a calf using adult cells, has also been found to have used research grants to purchase supplies from his own company and to have applied for grants from a state program he helped oversee . . . A House Oversight subcommittee chaired by Rep. Dennis Kucinich (D-OH) will hold a hearing on Tuesday to examine whether the National Institute of Environmental Health Sciences is adequately prepared to safeguard public health in the wake of the temporary suspension of its director, David Schwartz . . .

Cheers and Jeers

  • Cheer to the AP for reporting on conflicts of interest within a National Academy of Sciences panel charged with updating a 2002 study on fuel economy. While the panel contains two scientists with ties to environmental and public health organizations, they are far outnumbered by the seven members who are current and former employees of the automobile and engine manufacturing industries. The panel also includes three scientists who worked on the 2002 report the panel is to review.
  • Jeer: to the International Journal of Food Sciences and Nutrition for failing to disclose that Sigrid Gibson and Deborah Neate, authors of a study showing no direct correlation between soft drink consumption and childhood obesity, are consultants to manufacturers of sugary foods and beverages.