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Integrity in Science Watch Week of 02/09/2009

Industry Controls USDA Role in Peanut Safety

Kohl-Grassley to Seek Disclosure from NIH Grantees

Montana Methane Mining Justified with Corporate Science

Odds and Ends

Cheers and Jeers

Industry Controls USDA Role in Peanut Safety

The Agriculture department's advisory committee charged with ensuring the safety of exported peanuts is comprised entirely of industry representatives, including the chief executive of the firm responsible for the massive Salmonella-outbreak that has been linked to at least eight deaths and sickened more than 500 in the U.S. The Peanut Standards Board, which was exempted from federal conflict-of-interest rules in the 2002 Farm Bill, advises the Secretary of Agriculture on designing safety and handling rules that are designed to minimize aflatoxin contamination. USDA, which usually has no role in non-meat food safety, gets involved in peanut safety because high levels of aflatoxin, which can cause developmental abnormalities and increases liver cancer risk, make peanuts unsuitable for export.

The 18-member Peanut Standards Board has no consumer, public health or environmental health representatives. But, as reported by the Atlanta Journal-Constitution, it does include Stewart Parnell, president of the Peanut Corporation of America, which faces a possible criminal investigation for the ongoing-Salmonella-related outbreak. The Agriculture department removed him from the committee last week. The board recently recommended peanut handling practices that would lower industry costs when drying peanuts to meet export standards. It's never taken up safety standards to prevent Salmonella contamination.

Kohl-Grassley to Seek Disclosure from NIH Grantees

Sens. Herb Kohl (D-WI) and Charles Grassley (R-IA) are pushing an amendment to the economic stimulus package that would require all National Institutes of Health grantees who receive over $250,000 a year from the government to report "significant" financial ties with private sector firms. The recovery bill would add an estimated $3 billion to the almost $24 billion that NIH awards each year to "extramural" scientists at the nation's universities, medical schools and non-profit research institutes.

Besides reporting the amounts of the primary investigator's financial interest, "estimated to the nearest one thousand dollars," the amendment would require the investigator's institution to report how it plans to manage the conflict of interest. A recent Government Accountability Office report found that NIH does almost nothing to monitor how well universities manage conflicts of interest. "The goal of this initiative is to establish transparency and the accountability that comes from disclosure," Grassley said. "It's become clear that the federal rules in place to manage conflicts of interest in research aren't enforced as they ought to be."

It's unclear if the proposal would cover intellectual property rights that have yet to generate revenue, or institutional conflicts of interest. Large pharmaceutical firms are increasingly turning to major universities to generate new drug leads since their own efforts have come up empty in recent years. For instance, Vanderbilt University last month signed an exclusive $10 million licensing and commercialization deal with Johnson & Johnson's Janssen unit that involves potential anti-schizophrenia drugs developed by P. Jeffrey Conn, who heads the school's drug development program. Conn has received well over $1 million from NIH in recent years, and has at least one pending patent on the technologies developed with those grants.

Meanwhile, the movement among leading medical schools to limit conflicts of interests is moving ahead in fits and starts. Harvard Medical School will bar its faculty or their family members from holding any equity in companies that sponsor their research or from receiving more than $20,000 a year in consulting or other fees from companies that sponsor their research. According to the Boston Globe, David Korn, Harvard's vice provost for research, is overseeing the 19-member committee conducting a yearlong review of the university's conflict-of-interest policies. But University of Minnesota Medical School Dean Deborah Powell has watered down a task force proposal calling for strict disclosure standards, according to the Minnesota Daily. Powell's proposal sets a threshold at $500 before reporting was required. The task force proposal had no threshold

Montana Methane Mining Justified with Corporate Science

The Bureau of Land Management in late January opened over five million acres in Montana to coal bed methane extraction based on an environmental impact statement (EIS) that relied on a report from the Petroleum Association of Wyoming, which dismissed concerns about the waste water produced by the drilling. The EIS argued that the water could be either injected into the ground or used for livestock or industry.

Those uses were criticized by the Environmental Protection Agency. Still, the decision was published in the federal register last month. The EPA critique also called for greater stakeholder involvement in air quality mitigation and monitoring. The Washington Post reported that Congress will start reviewing Bush administration public land regulations this week.

Odds and Ends

The Food and Drug Administration last week excluded cardiologist Sanjay Kaul, a researcher at Cedars-Sinai Medical Center in Los Angeles, from the advisory committee that unanimously recommended approving prasugrel, a new blood thinning medicine. The FDA accused Kaul, a frequent industry critic, of having an intellectual conflict of interest, according to the Wall Street Journal Health blog. ... President Obama is reviewing a Clinton Administration Executive Order that gave the Office of Management and Budget oversight of all federal regulations, and revoked Bush Administration executive orders that solidified that power. The president's memo to OMB chief Peter Orszag asked for recommendations for a new executive order. ... Former Environmental Protection Agency toxicologist Linda Birnbaum was named director of the National Institute of Environmental Health Sciences, an agency wracked by controversy during the term of former director David Schwartz. ... The EPA's Science Advisory Board Drinking Water Committee wrote EPA administrator Lisa Jackson to complain about lack of transparency in setting the agency's list of drinking water contaminants. ... A little-noticed parting gift by the Bush Administration gave DuPont three more years to conduct tests to determine whether C8, or PFOA, is leaching from Teflon, Stainmaster, and other products in drinking water supplies surrounding a Dupont plant in West Virginia. ... Public Employees for Environmental Responsibility warns that Dow Chemical and the EPA are nearing a "non-enforcement" approach to cleaning up dioxin contamination surrounding the company's Midland, Michigan plant. An agreement would sidestep regulatory action required under the Superfund law and "would constitute a precedent-setting abdication of public health protection to a polluter."

Cheers and Jeers

  • Cheer to Laurie Talkan of the New York Times for disclosing in a story about oral cancer testing that Joel Epstein, a professor of oral medicine at the University of Illinois, Chicago, received research funding from Zila Pharmaceuticals, which makes an oral cancer test.

  • Jeer to Stephanie Nano of the Associated Press for failing to point out in an article about a New England Journal of Medicine study challenging the effectiveness of colon cancer drugs made by Eli Lilly and Genentech that the study was funded by Roche, Merck Serono and Sanofi-Aventis, which make competing colon cancer drugs.

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