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September 29, 2008

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Integrity in Science Watch

Week of 09/29/2008

DOT Ties to Sleep Aid Industry Riles Truckers

A recently formed Department of Transportation medical advisory committee charged with establishing health standards for truckers includes a panelist who sits on the board of the National Sleep Foundation, which receives funding from numerous manufacturers of sleeping pills and sleep-aid machines. The DOT’s Federal Motor Carrier Safety Administration Medical Review Board is considering new rules that would make transportation companies test all drivers for sleep apnea and require drivers to use forced air CPAP machines while sleeping if diagnosed with the condition.

Some trucking companies are already requiring sleep apnea testing for all truckers over the age of 50. The American Trucking Association, which represents the industry, has funded research that promotes routine screening. According to a recent analysis funded in part by the sleep aid industry, people with sleep disorders are two-and-a-half times more likely than the general population to be involved in vehicle accidents. Less than five percent of all highway fatalities are related to sleep disorders.

The medical board’s five members include Barbara Philips of the National Sleep Foundation, which receives funding from several manufacturers of sleep drugs and CPAP machines and has endorsed mandatory screening and treatment. At its January meeting, the medical board heard from Allan Pack, who runs the Center for Sleep and Respiratory Neurobiology at the University of Pennsylvania. Pack recommended mandatory testing for truckers with certain risk factors including age and obesity. In his presentation, Pack did not reveal that his newly created post at the University of Pennsylvania is funded by Philips Respironics, which manufactures CPAP machines.

If diagnosed with sleep apnea, truckers would have it noted on their licenses and could receive citations if caught sleeping at roadway rest stops without CPAP machines. Truckers fear the designation will limit their ability to get or change jobs in the industry. “This is disguised age discrimination without benefit of unemployment,” said Linda Sunkle-Pierucki, a disabled trucker. According to a 2002 study by Pack, sleep apnea affects about 28 percent of truckers, about the same percentage as the general population. The Medical Review Board will hold a public meeting on October 6 in Alexandria, VA to consider the issue.

Pharma-Connected DTC Ad Group Strips Website of Info

The Georgia-based non-profit helping the Food and Drug Administration educate consumers about direct-to-consumer (DTC) drug advertising has stripped its website of the names and affiliations of its governing committee after consumer groups revealed its connection to a pharmaceutical public relations firm. Michael Shaw, executive director of the non-profit EthicAd, is also president of Shaw Science Partners, a drug industry marketing and consulting firm that claims to have helped launch over 25 pharmaceuticals, including Viagra, Celebrex, Zoloft, Cymbalta, and Rezulin, a drug later withdrawn from the market because of safety concerns. Earlier this month, the FDA and EthicAd launched a website aimed at educating consumers about DTC advertising.

The rebuilt EthicAd website now acknowledges that its members have connections to the pharmaceutical industry. But, the site claims, none does work for entities that are involved in any form of DTC advertising. However, Marc Scheineson, general counsel for the Georgia-based EthicAd and a former FDA official, acknowledged in a telephone interview that he does in fact work on DTC advertising. “It’s what I do,” he said. Scheineson is a partner with the law firm Alston &Bird, whose Washington-based lobbyists represent numerous drug and health-care-industry clients. In a letter to Capitol Hill last week, the Center for Science in the Public Interest requested Congress to investigate the matter and ask the FDA to contact legitimate consumer groups when developing consumer education materials.

Grassley Pounces on More NIH Conflicts of Interest

Senator Charles Grassley (R-IA), ranking member of the Senate Finance Committee, last week raised new questions about the National Institutes of Health’s use of outside advisers with ties to the drug and medical device industries. In a letter to NIH director Elias A. Zerhouni, Grassley asked why the agency last January hired Tufts University Medical Center professor Marvin Konstam as a senior advisor to the director of the National Heart, Lung and Blood Institute. Konstam simultaneously worked for a private heart-device company. A month later, Konstam submitted an article in support of devices produced by Orqis Medical, where he is listed as a medical director. The Boston Globe also reported that Konstam switched his affiliation from NIH to Tufts Medical Center after being named in a Journal of the American Medical Association article about ghost writing. He is expected to return to Tufts as chief physician in January.

The same day he received Grassley’s letter, Zerhouni announced that he will step down from his post at NIH at the end of October to “pursue writing projects and explore other professional opportunities.”

Lilly, Merck to Reveal Some Payments to Physicians

Starting late next year, Eli Lilly and Merck will begin voluntarily disclosing payments to doctors over $500, the Los Angeles Times and other papers reported last week. The disclosures will only apply to payments for consulting relationships or speaking at company functions. While agreeing to public disclosure, Lilly CEO John Lechleiter defended the practice of routinely making payments to physicians at academic medical centers and in community practice. “These services help to advance the science related to medicines and are important to both current and future patients who rely on pharmaceuticals as an integral part of their therapy,” he said. The companies’ disclosure plans are similar to requirements contained in the proposed Physician Payments Sunshine Act, which is now before Congress and would require disclosing the payments in a national registry. Neither the voluntary disclosures nor the PPSA require industry to list payments to continuing medical education providers, or payments to professional societies and patient advocacy groups that write clinical practice guidelines.

GAO: EPA Lax on Livestock Pollution

The GAO has charged the Environmental Protection Agency with failing to gather enough information to regulate air and water pollution from concentrated animal feeding operations. The report, delivered last Wednesday to the House Energy and Commerce Committee, questioned the EPA’s proposal earlier this year to exempt livestock farms from reporting air pollution from their operations. The Wall Street Journal reports that the proposal was a result of pressure from livestock industry lobbying groups such as the National Chicken Council and the U.S. Poultry & Egg Association. A spokesman for the EPA says that the goal of the proposal is “reducing reporting burdens and protecting public health and the environment.”

Odds and Ends

The Department of Justice is investigating charges that EPA Administrator Stephen Johnson committed perjury in testimony before the Senate Environment and Public Works Committee about EPA's denial of California's request to regulate greenhouse gas emissions from motor vehicles, Environment and Energy Daily (subscription required) reported . . . . The former senior legal counsel for a unit of Medtronic Inc. alleged in a lawsuit that the medical-device maker provided surgeons with regular entertainment at a Memphis strip club, trips to Alaska, and patent royalties on inventions, the Wall Street Journal reported. . . . Michael H. Glantz, a political scientist who studies the societal impacts of climate change, will move the Center for Capacity Building to the University of Colorado after the National Center for Atmospheric Research defunded the agency, the New York Times reported. . . . A new study of clinical trials submitted to the FDA for new drug approvals revealed that most studies that fail never appear in medical journals, and over half of all trials for FDA-approved drugs remain unpublished . . . .

Cheers and Jeers

  • Jeer to CBS Healthwatch for allowing its online news website to be used as a conduit for functional food hucksterism. A video interview on functional foods with “Early Show contributor” Keri Glassman only identified her as a registered dietitian and did not reveal that Glassman markets her own brand of functional foods. The accompanying online article also contained a link to Glassman’s website, where she offers weight loss programs, fortified food products, and dietary advice.

  • Cheer to Alicia Chang of the Associated Press for reporting that a study of the stroke medication TPA was funded by Boehringer Ingelheim Pharmaceuticals, which markets TPA as Actilyse overseas.