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January 14, 2008

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Integrity in Science Watch

Week of 01/14/2008

Organized Medicine Warned on "Entrepreneurial” Guidelines

Professional medical societies should actively oppose legislative health care mandates that rely on clinical practice guidelines produced by “entrepreneurial activity,” a commentary in last week’s Journal of the American Medical Association argued. The article was triggered by the Screening for Heart Attack Prevention and Education (SHAPE) Task Force Report, which appeared in a Pfizer-funded supplement to the July 2006 American Journal of Cardiology. The SHAPE guideline called for non-invasive screening for “subclinical atherosclerosis” through tests such as ultrasound or CT scans for all men 45 to 75 and all women 55 to 75 who are considered more than minimally at risk for a heart attack or stroke. Legislation has been introduced in Texas that would require insurance companies to cover the tests.

The SHAPE task force was created by the Houston-based Society for Heart Attack Prevention and Eradication, which was created in 2001 by Morteza Naghavi. He advises and receives research support from Pfizer, manufacturer of cholesterol-reducing Lipitor, and consults for and owns stock in Endothelix, which makes a fingertip thermal measuring device that purports to reveal heart attack risk. The FDA approved the device last November even though it has never been studied in a randomized clinical trial. Naghavi was also the lead writer on the SHAPE guideline. Twelve of 26 co-authors disclosed ties to drug and imaging equipment manufacturers. While the others claimed they had no financial ties to "a corporate organization or a manufacturer of a product discussed in this supplement," many had industrial ties on related subjects or are radiologists, who have a financial stake in increasing the number of cardiac imaging tests.

In his commentary, University of Michigan law professor Peter Jacobson called on the American College of Cardiology (ACC) to convene a consensus panel to determine the objectivity and scientific efficacy of the SHAPE guidelines. Previous reviews have concluded CT scans for measuring atherosclerosis are not superior to other diagnostic tests and generate a high rate of false positive results. After reviewing the conflicts of interest among the writers of the guideline, Jacobson called on organized medicine to develop criteria for acceptable clinical practice guidelines. "Only those guidelines that meet the criteria should be endorsed," he wrote. However, in an email to Integrity in Science Watch, he opposed banning conflicts of interest on CPG-writing panels. "I'm dubious that it's possible to find an expert committee to draft guidelines that has zero conflicts of interest," he said.

New EPA Assessment Reduces Acrylamide Risk

The Environmental Protection Agency’s newly released toxicological assessment for acrylamide says that the chemical is less toxic than previously thought, and may assist the restaurant industry in its efforts to fight off state regulation of the chemical. Acrylamide, a commonly used industrial compound also formed from baking or frying food starch, is currently listed as a neurotoxin and probable human carcinogen. The California attorney general has sued to require labeling of fast foods under Proposition 65, the state’s toxics labeling law. The assessment would raise the level of ingested acrylamide considered safe by a factor of 15 based on new studies that the agency claims prove acrylamide is less harmful than the agency reported in 1988. The assessment will be reviewed by a panel to which six scientists with ties to acrylamide-producing industries or other conflicts of interest have been nominated. The agency is expected to announce the committee’s final membership this month and complete the assessment later this year.

Scientists Blast Proposed Change to Lead Standard

The Environmental Protection Agency’s new proposal for changing the airborne lead standard has been harshly criticized by the agency’s own scientists as lacking adequate scientific analysis, Science magazinereports. Rogene Henderson, chair of the agency’s Clean Air Scientific Advisory Committee (CASAC), called the options contained in the proposal a "disaster" because they include industry’s call to end the regulation of lead as an air pollutant under the agency’s National Ambient Air Quality Standards (NAAQS). That proposal had already been floated by the agency in 2006 and rejected by EPA and CASAC scientists. The new proposal resurrects the idea without offering any scientific rationale.

The proposal is part of a five-year review of NAAQS pollutants required under the Clean Air Act. In 2006 the agency overhauled its process for completing the reviews. Members of CASAC and environmentalists, citing the lead proposal, maintain that the new process allows undue influence by industry and political appointees and excludes proper scientific analysis.

Ban on Wildlife Poisons Sought

The Environmental Protection Agency, prompted by environmental groups’ petition backed by wildlife scientists, is considering a ban on two poisons used by the U.S. Department of Agriculture's Wildlife Services to kill wild mammals. The proposal would prohibit the agency from using sodium cyanide and sodium fluoroacetate to kill livestock predators such as coyotes and wolves. The livestock industry opposes the ban, although the environmental groups contend that predation accounts for only 0.18 percent of livestock losses. Rep. Peter DeFazio (D-OR) also has introduced legislation banning the poisons, citing their potential use as bioterror agents and their threat to humans, pets, and nontarget wildlife. Scientists say using poison is indiscriminate and ineffective at controlling predators in the wild.

Wildlife Services kills nearly 13,000 mammalian carnivores annually using the poisons, and spends nearly $109 million every year on lethal control of wildlife. Last fall the office, a unit within the Animal and Plant Health Inspection Services, announced that it is undertaking a nationwide safety review of its operations, prompted in part by safety audits by USDA’s Office of Inspector General. Comments on the EPA proposal are due tomorrow and may be filed under docket number EPA-HQ-OPP-2007-0944 at http://www.regulations.gov.

Congress Probes Jarvik’s Role in Pfizer Lipitor Ads

The House Energy and Commerce Committee last week demanded Pfizer turn over all documents related to the company’s use of Dr. Robert Jarvik in print and broadcast ads promoting its anti-cholesterol drug, Lipitor. Jarvik became a household name in 1982 as co-inventor of the world's first artificial heart. According to the Wikipedia, the University of Utah medical school graduate never completed his internship or residency and isn't licensed to practice medicine in the U.S. "Dr. Jarvik’s appearance in the ads could influence consumers into taking the medical advice of someone who may not be licensed to practice medicine in the United States," said Rep. Bart Stupak (D-MI), who chairs the investigations subcommittee. "Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break." Though Lipitor was the world's best selling drug in 2006 with $12.9 billion in sales, use is declining, and its basic patent expires in 2010.

Odds and Ends

Letters published last week in the British Medical Journal claim last fall's Royal College of General Practitioner’s study showing women taking oral contraceptives are not at risk of cancer misinterpreted the data by excluding some women during the follow-up phase of the study. The study received funding from Wyeth Ayerst International, Ortho Cilag, and G.D. Searle, all one-time producers of oral contraceptives for women. . . .The U.S. Fish and Wildlife Service has postponed delivering its recommendation to Interior Secretary Dirk Kempthorne on whether the polar bear should be listed as an endangered species; the polar bear would be the first species listed because of climate change. . . . A federal judge has imposed restrictions on the use of military sonar to protect endangered whales off the coast of Southern California, calling the Navy’s existing mitigation measures “grossly inadequate to protect marine mammals from debilitating levels of sonar exposure.” An article in Science magazine last week says that the ruling leaves many whales still vulnerable.

Cheers and Jeers

  • Jeer: to The Providence Journal for failing to disclose in an op-ed article that Robert Goldberg, and his organization, the Center for Medicine in the Public Interest (CMPI), receive financial support from the pharmaceutical industry. The article attacked the Center for Medicare and Medicaid Services for limiting reimbursement for anti-anemia drugs in cancer patients when they raise mortality. The co-founder of CMPI is Peter Pitts of Manning, Selvage & Lee, a p.r. firm with numerous pharmaceutical industry clients.
  • Cheer: to Alex Berenson of the New York Times for disclosing that the National Fibromyalgia Association receives some of its funding from the pharmaceutical industry and that supporter Dan Clauw, a professor of medicine at the University of Michigan, consults for Pfizer, Eli Lilly and Forest Laboratories, which sell or are developing drugs for treating the condition. The story, headlined "Drug Approved. Is Disease Real?", focused on the sales surge of Pfizer's Lyrica since the FDA approved it for the condition last June.