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November 19, 2007

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Integrity in Science Watch

Week of 11/19/2007

FDA To Use Simultaneous Voting at Advisory Meetings

The Food and Drug Administration announced last week it plans to use simultaneous voting at advisory committee meetings when new drug and device applications are considered. Advisory panels, which are usually made up of a dozen or more outside experts, previously went around the table when recording votes, with each adviser allowed to comment and the choice of the first speaker left to the panelís chair. Critics claimed this allowed more outspoken panel members, who sometimes had conflicts of interest, to influence the vote.

Meanwhile, the FDA simultaneously released new guidelines implementing the recently passed law requiring disclosure and posting of conflict-of-interest waivers 15 days ahead of any advisory committee meeting. The law also requires a 25 percent reduction in the number of waivers issued over the next five years. The FDA also released a study by the Eastern Research Group, which primarily conducts government-funded research, suggesting it is difficult for the FDA to find outside advisers without conflicts of interest and the ones who receive waivers are "significantly more qualified" than advisers who do not receive waivers.

OMB Throws Back Krill Protection Rule

The White House Office of Management and Budget (OMB) last month rejected the National Oceanic and Atmospheric Administration's (NOAA) proposed rule that would have protected krill, the organisms that form the foundation of the marine food web. The proposed rule sought to prohibit the commercial fishing of krill off the West Coast of the United States. Krill are used commercially as fishing bait and feed for the aquaculture industry, as well as by the pharmaceutical industry in fish oil supplements. Although no large-scale krill fishery currently exists in the U.S., the Pacific Fishery Management Council (Council), an independent regional advisory panel of fishery experts and local government officials, recommended the rule to NOAA to protect stocks of krill and the species dependent upon them from future fishery development.

According to the rejection letter from OMB Administrator Susan Dudley, formerly of the industry-funded Mercatus Center, krill stocks within United States waters are as yet unexploited so no basis exists for their protection. Council scientists had hoped that the rule could go through quickly, given the lack of existing economic interests that might oppose it. "This was a proactive measure to protect the ecosystem, [but] aquaculture is a big-ticket item with the current administration," said Mike Burner, an officer with the Council.

U.S. Failed to Question Industry Data on Gassed Meat

To get government approval for a process banned in Europe, Japan and Canada, scientists at Cargill and Hormel Foods submitted data that showed reduced microbe counts in under-refrigerated meats that had been gassed to retain redness even though other indicators showed spoilage rose. Agriculture Department officials failed to question the counter-intuitive data in approving the process, the Washington Post reported. Even the industry scientists knew something was wrong. "Quite honestly, this test seemed to raise more questions than what [sic] it answered," a Hormel scientist wrote in an email to a colleague. The email was revealed last week at a House Energy and Commerce Subcommittee on Oversight and Investigations hearing chaired by Rep. Bart Stupak (D-MI), whose district, according to Republicans on the subcommittee, includes a company whose meat treatment business was threatened by the process. Asked by Stupak if the e-mails raise concerns about the approval, the Agriculture Department's lead reviewer, Robert Post, said: "Based on this information, I think this leads to some questions, yes." A Food and Drug Administration official said the process was not a safety concern and would remain "generally recognized as safe."

Exxon-Backed Group Attacks State Climate Policies

A nonprofit organization of scientists and policy analysts is in the business of assisting state efforts to curb greenhouse gas emissions, but faces growing attacks from foundations funded by the petroleum industry. The Center for Climate Strategies (CCS) in Harrisburg, PA was created in 2004 to assist the development of state and regional "Climate Action Plans," or policy recommendations to cut greenhouse gas emissions and energy use. The group has been accused of having only "the most extreme and alarmist views on global warming" by the North Carolina-based John Locke Foundation. According to the progressive Institute for Southern Studies, the Locke Foundation has received hundreds of thousands of dollars from foundations with ties to ExxonMobil and other fossil fuel interests. The Locke Foundationís founder, James Pope, has also served on the boards of the Exxon-funded Atlas Economic Research Foundation and Citizens for a Sound Economy. A spokesman for CCS said that the scientists with his organization work in a "sensitive but neutral environment," and prefer not to respond to such attacks.

Meanwhile, an exhibit on the Arctic at the Smithsonianís National Museum of Natural History was altered to tone down its emphasis on recent climate change, documents obtained by the Washington Post reveal. The opening panels of the exhibit, which originally described Arctic temperature increases at a rate double the global average over the past 50 years, were changed after being reviewed by former interior secretary Gale Norton's science adviser and the museum's acting director, CristiŠn Samper, to read simply "The Earth's climate is changing -- and it always has." The Post reports that the Smithsonian has in the past altered exhibits to respond to political pressures, as when a 2003 photo display of the Arctic National Wildlife Refuge was moved to a less prominent position when the Bush administration was considering oil and gas drilling in the region. Of the current changes to the Arctic exhibit, NASA scientist Waleed Abdalati said "For the focus to be shifted from scientific content to political content, I found disturbing for a museum. . . .[These changes were put in place] to avoid a political backlash."

Senator Feinstein (D-CA) sent a letter on Friday to the chairman of the museum's Board of Regents asking that the "Smithsonian take steps to reassure Congress and the public that the exhibitís representation of the threat of global warming was not toned down because of political pressure." The same day the Post covered the controversy, the American Petroleum Institute withdrew its $5 million offer to help finance another Smithsonian exhibit on the oceans; the gift had been opposed by two members of the institution's Board of Regents who worried that the "Ocean Initiative" exhibit could be tainted by the oil and gas money.

Occ-Docs Seek Retraction, Threaten Journal with Libel Suit

The American College of Occupational and Environmental Medicine (ACOEM) is threatening the International Journal of Occupational and Environmental Health with a libel suit if it doesnít retract a recent article accusing the ACOEM of being a "professional group in service to industry." The journal's publisher immediately fired back a letter accusing the ACOEM of refusing to open its files for fact-checking purposes, and noting that its article had passed traditional peer review. "The editor and the publisher welcome information that will correct any errors that may have been made," wrote Sandra Lovegrove, president of Abel Publication Services, publisher of the IJOEH. In a message to ACOEM members that included a link to a refutation of the article, president Robert F. McLellan said the group "will explore all options, including legal action if necessary to set the record straight in matters that are libelous or factually incorrect."

The original IJOEH articledescribes the ACOEM's membership as largely industry-employed doctors and recounts its history of opposing government regulations on lead, beryllium, and a number of other environmental toxins. The articleís authors, led by Joseph LaDou of the University of California School of Medicine, accuse the ACEOM of taking "industry positions on virtually all issues" and state that its journal, the Journal of Occupational and Environmental Medicine, is "decidedly pro-industry in its editorial policy and publications." The journal has published many studies funded by Dow, Lockheed, and other industry sponsors, and has been implicated in several cases of scientific fraud.

Odds and Ends

Environmental groups are renewing their calls for a ban on bunker fuels used by the shipping industry in the wake of last week's accident that dumped 58,000 gallons into San Francisco Bay. A recent article in Environmental Science and Technology estimated that shipping emissions led to 60,000 additional deaths from heart and lung disease around the world in 2002. . . . A new analysis of meta-analyses of antihypertensive drug trials shows that when industry funds the meta-analysis, the authors are much more likely to favor their funder's products. The study appeared in the British Medical Journal. . . . The Bush administration again tried to water down the latest report from the United Nations Intergovernmental Panel on Climate Change, seeking the removal of a section on "Reasons for Concern" that included melting of ice sheets. It remained in the report, the New York Times reported.

Cheers and Jeers

  • Jeer to the non-profit Lung Cancer Alliancefor nominating oncologist Richard Miller of Stanford University to fill one of the patient advocacy slots on the board of the Food and Drug Administration's Reagan-Udall Foundation, which will be looking for ways to expedite drug development. In a short biographical sketch attached to Miller's Huffington Post article lauding the Foundation, he revealed that he is the president and CEO of Pharmacyclics and a former vice president of IDEC Pharmaceuticals.