Integrity in Science Watch|
June 19, 2006
Groups Protest EPA Choices for Evaluating Pesticide
The Environmental Protection Agency's candidates for reviewing a staff analysis of the carcinogenicity of a common sterilizing agent drew a sharp protest from 15 health and labor advocacy groups last week. The Natural Resources Defense Council, Service Employees International Union, and the Center for Science in the Public Interest among others asked EPA to remove three scientists who co-authored an industry-funded study on ethylene oxide (ETO) risks. The letter suggested they be replaced with independent health and occupational experts to balance the other industry consultants tentatively named to the committee. In 2004, Christopher Kirman and Michael Gargas from The Sapphire Group and Mary Jane Teta from Exponent conducted an industry-funded study recommending values for cancer risk about equal to those that were generated from the EPA's draft three years earlier, which those same authors helped write. The EPA is reviewing the carcinogenicity of ETO for its Integrated Risk Information System (IRIS) database, which numerous government agencies in the U.S. and around the world use to determine health risks.
Meanwhile, the EPA's Office of Pesticide Programs is conducting its own risk assessment of ETO in order to meet an August deadline for re-registering the chemical. Comments submitted last fall by producers and users of ETO slammed the OPP's draft risk assessment. The industry groups complained that the OPP's preliminary standard, 180 times stricter than the Occupational Safety and Health Administration's standard of 1 ppm for exposed workers, is impossible to achieve.
Time Runs Andrew Weil Advertorial
This week's Time Magazine includes a column by Dr. Andrew Weil touting the benefits of fish oil supplements. The column was sparked by a recent report in the Journal of the American Medical Association showing that fish oil supplements did not reduce the risk of serious abnormal heart rhythms. The article failed to disclose that Dr. Weil sells his own brand of fish oil supplements on his website.
NIH Researcher on Pfizer Payroll Gave Firm Tissue Samples
A top-ranked National Institutes of Health researcher who failed to comply with the agency's conflict-of-interest disclosure policy provided pharmaceutical giant Pfizer government-owned tissue samples. In a report released last week, House Energy and Commerce Department investigators concluded Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, failed to tell agency officials about his arrangement with Pfizer Inc. after sending the company thousands of NIH fluid samples he had worked on for Alzheimer's research. Sunderland received over $500,000 in consulting fees from Pfizer. The House investigators were tipped off by a former NIMH scientist who had worked with Sunderland and was unable to locate spinal fluid samples she had collected in the 1990s. Sunderland pleaded the fifth amendment when called by the committee last week. He had previously blamed his failure to disclose the conflict of interest on his office staff. The case has caused NIH to clarify its rules for managing tissue samples. "All transfers of human samples will require an appropriate agreement signed off by a senior official," said NIH spokesman John Burklow.
Texas Crony Sought White House Help to Weaken Rule
Four years after Texas oilman Ernest Angelo made a special appeal to hunting buddy Karl Rove, the EPA last week approved a weakened rule that aims to decrease groundwater contamination from oil drilling and construction sites, the Los Angeles Times reports. Angelo, a former mayor of Midland, told the White House's top domestic adviser that a more comprehensive groundwater rule from an early EPA draft would cause "our strongest supporters to openly express doubt as to the merit of electing Republicans when we wind up with this type of stupidity." Rove promised Angelo that the administration would consider the "economic, energy and small business impacts" of the rule. In 2005, the EPA draft was changed by the White House's Office of Management and Budget (and now finalized) to allow sediment from energy production sites to flow freely into streams and underground water. "We can't say that Karl Rove walked over to OMB and demanded these changes," said Sharon Buccino, director of the Natural Resources Defense Council's land program. "But it is clear that there was direction coming from the top of the White House."
Industry Asks OSHA to Limit Access to Documents
Industry groups have asked the Occupational Safety and Health Administration to deny a former high-ranking employee access to its data on OSHA inspectors' exposures to toxic beryllium, according to Inside OSHA. Adam Finkel, who resigned from the agency in January, wanted the documents for an academic research project. Industry officials claimed turning over the documents would disclose confidential commercial or trade secret information, threaten national security and initiate new lawsuits. Finkel, now a professor of environmental and occupational health at the University of Medicine and Dentistry of New Jersey, has filed a Freedom of Information Act suit against OSHA.
FDA Opposing Conflict-of-Interest Waiver Ban
Top FDA officials continue to speak out against an amendment to the agency's appropriations bill that would ban physicians with direct ties to drug and device manufacturers from sitting on FDA advisory panels. That amendment, sponsored by Rep. Maurice Hinchey (D-NY), passed the House last month and is now before the Senate. Center for Devices and Radiological Health director Daniel Schultz told a Medical Device Manufacturers Association meeting in Washington last week that the bill "could present major, major problems for the agency" by denying it needed expertise, according to the online publication FDA Webview. The Center for Science in the Public Interest, which backs the bill, says there are numerous experts without financial ties to regulated firms that could serve the agency equally well.
Odds and Ends
The House of Representatives Science Committee rejected an amendment to the National Oceanic and Atmospheric Administration appropriations bill that would prohibit NOAA supervisors from punishing employees who disseminate scientific research. . . The British Medical Journal is reporting that the International Obesity Task Force, which is closely affiliated with the World Health Organization and became part of the non-profit International Association for the Study of Obesity in 2002, draws two-thirds of its funding from Hoffman-La Roche, which makes the antiobesity drug orlistat (Xenical), and Abbott Laboratories, which makes sibutramine hydrocholoride (Reductil). . . The revolving door is swinging at the Food and Drug Administration as deputy commissioner Steve Niedelman departments the regulatory affairs office for a job at Quintiles, the clinical trials consultancy. . . The Energy Department's National Coal Council defends its lack of environmentalists by claiming none wanted to be associated with the coal industry officials who dominate the advisory panel. The Natural Resources Defense Council told Inside EPA it would likely accept an offer to join.