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July 21, 2008

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Integrity in Science Watch

Week of 07/21/2008

Pediatrics Fails to Disclose Industry Ties in Lipid Guide for Kids . . .

The American Academy of Pediatric’s new cholesterol guidelines for children did not reveal the industry ties of three of the six authors despite its policy requiring conflict of interest disclosure in its flagship journal. The recommendations, which appeared in the current issue of Pediatrics, caused a national uproar by recommending statin drugs for children as young as eight if suggested dietary interventions, including the use of foods fortified with fiber, stanols, and sterols, proved ineffective in lowering lipid levels in overweight children.

The lead author, Stephen R. Daniels, a professor of pediatrics at Cincinnati Children's Hospital, has served as a consultant to Abbott Labs and Merck. Abbott makes baby food, while Merck markets Mevacor, a statin. Co-author Nicolas Stettler, an assistant professor at Children's Hospital of Philadelphia, consults for numerous firms, including Wyeth Nutritional and the Dannon Institute, a non-profit wholly funded by Dannon Yogurt.

Co-author Jatinder Bhatia, a professor at the Medical College of Georgia, has commercial ties to Mead Johnson, Ross Labs, Forest Laboratories, Dey Labs, and Inhibitex. Mead Johnson, a unit of Bristol-Myers Squibb, produces fortified foods for infants and young children.

. . . While Journal of Lipidology Also Ignores Disclosure Rules

Despite a policy on disclosure of conflicts of interest in submitted manuscripts, the Journal of Clinical Lipidology in a forthcoming article by Peter Toth, a Sterling, IL-based physician-scientist, and Kevin Maki, a consultant with Provident Clinical Research of Glenn Ellyn, IL, fails to disclose the authors’ ties to drug manufacturers and related firms. Toth has received research support from AstraZeneca and served on speakers bureaus or consulted for AstraZeneca, Kos Pharmaceuticals, Merck, Pfizer, GlaxoSmithKline, and Takeda. Maki's firm consults for food and drug companies and offers investment advice. The in-press article, which was obtained by the Center for Science in the Public Interest, will critique a trial recommending limiting the combined use of anti-cholesterol drugs Ezetimibe and Simvastatin.

Grassley Probes Biz Ties at American Psychiatric Association

The Senate Finance Committee is demanding that the American Psychiatric Association turn over all financial records that document industry support over the past five years. The request for information comes three weeks after committee ranking member Charles Grassley (R-IA) accused Stanford University of failing to monitor APA president-elect Alan F. Schatzberg’s ties to industry. According to the New York Times, Schatzberg has multi-million dollar investments in pharmaceutical companies including Corcept Therapeutics, maker of the “morning-after” pill Miferpristone. Schatzberg’s research on Miferpristone is funded by the National Institutes of Health, which requires institutions receiving government funds to police their faculty members’ conflicts of interest.

Mugs, Pens Out; Consulting, Speaking In

The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry’s powerful trade group, has issued new guidelines for how its member companies should conduct door-to-door sales visits at physicians' offices. The voluntary marketing code includes a ban on showering doctors with free pens, mugs, and other small gifts branded with medical advertisements and logos. The code also prohibits drug companies from providing restaurant meals to doctors and restricts some industry support of continuing medical education (CME). According to PhRMA these restrictions reflect their support for “appropriate transparency” in the health-care system.

While Merck, GlaxoSmithKline, Amgen, and AstraZeneca immediately announced support for the new guidelines, according to the San Diego Union Tribune, the voluntary code does not restrict speaking and consulting fees, nor ban free breakfast and lunches within the office. At least one financial analyst, Seamus Fernandez of Leerink Swann, suggested the voluntary code is unlikely to end industry influence over physician prescribing patterns. Meanwhile, a Massachusetts effort to ban gifts to doctors stumbled last week in the wake of PhRMA's releasing its voluntary code. Beacon Hill’s lower chamber stripped the provision out of a bill that would also restrict drug companies from getting individual patient and physician prescribing data, according to the Boston Globe.

Odds and Ends

Paul Blackburn, a GlaxoSmithKline executive, resigned from the United Kingdom education watchdog agency following public criticism of a potential conflict of interest. The British government recently signed a $200 million contract to purchase Glaxo’s HPV vaccine for young girls. . . . Nature Publishing Group announced that it will join 366 journals in submitting manuscripts to PubMed Central’s free digital archive six months after publication. Critics had sought an immediate release. . . . Jason K. Burnett, who resigned in May as chief adviser on climate to Environmental Protection Agency administrator Stephen L. Johnson, claimed Vice President Dick Cheney and the White House Council on Environmental Quality sought to delete sections of a draft report describing health risks from global warming. The final report, released late last week, contained the warnings.

Cheers and Jeers

*Cheer to Shirley Wang of the Wall Street Journal for disclosing that Charles Natanson, a senior investigator and chief of the anesthesia section at the National Institutes of Health, failed to reveal in a paper in the Journal of the American Medical Association about the dangers of blood substitute products his part-ownership of a pending patent aimed at making blood substitutes safer. After manufacturers of existing blood substitute products complained about the lack of disclosure, Natanson apologized and said he had forgotten about the pending patent.

*Jeer to Jay Hancock of the Baltimore Sun for failing to disclose that Patrick Moore, a co-founder of Greenpeace, now co-chairs a nuclear industry funded organization advocating nuclear power. In a Nov. 2007 Wired Magazine interview Moore admits the Clean and Safe Energy Coalition is funded by the Nuclear Energy Institute, an industry trade group. Hancock cited Moore in explaining how “the risks of nuclear energy are lower than the risks of continuing to use carbon energy.”