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Integrity in Science Watch Week of 11/20/2006


Headlines
EPA Names ExxonMobil Scientist, Industry Consultants to Review Panel

USDA's Committee on Grain Skirts Law

Tougher CMS Policy on Clinical Trials Urged

FDA Warns Against Using Guidelines Backed by National Kidney Foundation

Climate Skeptic Misleads Viewers About Funding

Odds and Ends

EPA Names ExxonMobil Scientist, Industry Consultants to Review Panel

The Environmental Protection Agency has placed ExxonMobil scientist Robert Schnatter and two industry consultants on the 16-member panel that will review the agency's risk assessment for ethylene oxide, despite protests from the Natural Resources Defense Council, the Center for Science in the Public Interest, and other health and environmental advocacy groups. EPA's draft risk assessment recommends reclassifying ethylene oxide to "carcinogenic to humans" from a "probable human carcinogen. "It also proposes tighter restrictions on the chemical, which is used to make antifreeze and polyester and is emitted in vehicle exhaust. The risk assessment review panel, whose deliberations could affect future air pollution and occupational safety and health regulations, meets Jan. 18-19, 2007.

In addition to Schnatter's employment in the oil industry, James Klaunig of the Indiana University School of Medicine and James Swenberg of the University of North Carolina at Chapel Hill have financial ties to companies or industry groups that have a stake in the outcome of the ethylene oxide reassessment. Klaunig has received research support from ethylene oxide manufacturer DowAgro and the American Chemistry Council, and Swenberg has received funding from the Chemical Manufacturers Association and the International Institute of Synthetic Rubber Producers.

USDA's Committee on Grain Skirts Law

Despite a 2004 Government Accountability Office study calling for reform, the Agriculture Department continues to ignore the Federal Advisory Committee Act (FACA) when staffing its outside advisory panels. The Grain Inspection Advisory Committee includes numerous industry stakeholders who vote on scientific and technical issues such as the best way to measure the nutrient content of grain. For instance, a scientist with ties to Monsanto, which manufactures a test for measuring the linolenic acid content in soybean oils, sits on the committee as an industry "representative" and earlier this year voted on the test's scientific validity. The representative designation allowed the USDA to skirt FACA's conflict-of-interest and bias rules. In a letter sent today to the Grain Inspection, Packers and Stockyards Administration (GIPSA), the Center for Science in the Public Interest called on USDA to establish an independent committee made up of scientists without ties to the regulated industry. CSPI also called on USDA to appoint a designated ethics officer to monitor the agency's compliance with FACA. GIPSA's Grain Inspection Service establishes standards for grain and related agricultural products.

Tougher CMS Policy on Clinical Trials Urged

The Center for Science in the Public Interest last week asked the Center for Medicare and Medicaid Services to strengthen its registration and conflict-of-interest disclosure requirements for clinical trials that are used to justify payment for the off-label use of anticancer drugs. Physicians and their patients can be reimbursed for a non-Food and Drug Administration approved use of a chemotherapy drug as long as a study suggesting the use is effective has appeared in a peer-reviewed journal that lacks publication bias and has a conflict-of-interest disclosure policy.

CMS currently lists 15 journals as acceptable outlets for those studies. It is considering adding eight more. But a CSPI Integrity in Science survey found that none of the eight proposed additions requires clinical trial registration prior to publication, which helps eliminate publication bias; and three of the eight do not automatically publish conflict-of-interest disclosure statements. Several of the 15 journals already in use by CMS have similar gaps in their policies. CSPI asked CMS to strengthen its guidelines by prohibiting payment for the off-label use of a drug if the prescription is based on a trial that had not been registered prior to enrolling patients. It also asked CMS to require all journals to publish conflict-of-interest disclosures if necessary, and require authors to declare the presence of such statements in the abstracts that are submitted to the National Library of Medicine's PubMed.

FDA Warns Against Using Guidelines Backed by National Kidney Foundation

The New England Journal of Medicine last week published a Johnson & Johnson-funded clinical trial showing that patients with failing kidneys who were given high doses of Amgen's anti-anemia drug Epogen suffered 34 percent more heart attacks and strokes than patients given lower doses nearer to the FDA-approved standard. A comment that appeared in the Lancet online pointed out that the higher dose achieved in the study was within guidelines recently issued by the National Kidney Foundation, which received 57 percent of its $19.7 million budget in 2005 from corporate and organizational partners, including $4.1 million from Amgen and $3.6 million from J&J. Amgen and J&J compete with variants of Epogen sold as Aranesp and Procrit, respectively, in the oncology market. The Food and Drug Administration late last week warned physicians not to exceed agency-approved prescribing levels for Epogen, Aranesp and Procrit.

Climate Skeptic Misleads Viewers About Funding

Global warming skeptic S. Fred Singer denied that he has received substantial funding from the oil industry, despite evidence of his long-standing ties to energy companies. In an interview during the Canadian documentary program "The Fifth Estate," Singer claimed he didn't remember whether the oil industry had given him money. "I donít think so," he said. When reporter Bob McKeown pressed Singer further, relying on ExxonMobil documents showing the company gave $10,000 to Singerís Science and Environmental Policy Project (SEPP) and $65,000 to a foundation located at the same address as Singer's office for a climate change conference featuring Singer, he admitted receiving a one-time donation of $10,000 that "came in over the transom." Singer gave similar answers during an interview on E&ETV's "OnPoint" interview program, which also aired last week. In a telephone interview with the Center for Science in the Public Interest, Singer said he only remembered receiving one check from ExxonMobil "10 or 12 years ago" for $10,000.

Yet, the Science and Environmental Policy Project, which Singer founded and leads, has received at least two $10,000 grants from ExxonMobil, in 1998 and 2000. In a 1993 sworn affidavit, Singer also admitted to receiving consulting fees from the Global Climate Coalition Ė a now defunct group of businesses including Exxon, Shell, Texaco and BP that opposed implementing mandatory greenhouse gas emission reductions -- and doing climate change research on behalf of oil companies. SEPP's website claims it does not solicit support from government or industry and that it receives contributions from charitable foundations and individuals. The project's most recent tax filings show the organization received $102,260 in contributions and $14,700 for lecture fees last year. (Singer has also served as a fellow or adviser for several organizations that receive funding from ExxonMobil, including the Advancement of Sound Science Coalition, American Council on Science and Health, Cato Institute, Frontiers of Freedom and Heritage Foundation.)

Odds and Ends

Federal Communications Commissioner Jonathan Adelstein last week called for an investigation into local TV stations that used video news releases (VNRs) in news stories without alerting their viewers, after a report by the Center for Media and Democracy turned up such practices by 46 stations in 22 states. One story aired by a Missouri TV station used footage from an oil industry VNR featuring global warming skeptic William Gray . . . Hydro-Quebec cut the funding of a team of researchers whose findings on hydro reservoir greenhouse gas emissions weren't to the utility's liking and tried to persuade the scientific journal Lakes and Reservoirs Management not to publish their findings, according to a commentary by the International Rivers Network's Patrick McCully in Friday's San Francisco Chronicle . . . The Baltimore Sun reported today that Ira Wainless, author of an Occupational Health and Safety Administration advisory which warns auto mechanics about lethal asbestos fibers in brakes, is facing 10 days of unpaid suspension by the agency after he refused to alter the warning.


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