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Why Howard Dean, MD, would be the best Health Secretary or FDA Commissioner

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Dr. Howard Dean III is the best candidate for FDA Commissioner. Further, I strongly support legislation elevating the FDA job to a Cabinet position, since, after all, it oversees in a regulatory capacity 25% of the US Economy, and as such, deserves to be at a Cabinet level.

Drug makers and Big Pharma are promoting Dr. Janet Woodcock, presently head of the Food & Drug Administration's drug division, but consumer advocates favor FDA critics like Dr. Stephen Nissan or Baltimore's Health Commissioner, Joshua Sharfstein.

Current FDA Commissioner Andrew von Eschenbach is offering his resignation before President-Elect Obama takes office in January. The current commissioner has been criticized as (at best) being too hands-off in his leadership. Over the past 8 years, drug scandals like Vioxx and Heparin, dangerous side effects from other medicines, plus recalls of peanut butter, spinach and other foods, have ravaged the FDA's already tainted and flawed reputation.

Woodcock has been at the FDA since 1986. Before directing the FDA's drug division, she served as deputy commissioner and chief medical officer. has noted that drug maker's representatives are advocating that Woodcock be chosen to serve as commissioner on either an acting or permanent basis. Woodcock is also among a number of candidates supported by Ellen Sigel, chairwoman of Friends of Cancer Research, based in Arlington, Virginia. The group receives some funding from drug makers.

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Critics of the FDA have questioned whether Woodcock should get the job, as she wouldn't be seen as someone who would significantly change the agency. While she wouldn't comment on any possible FDA candidate - including Woodcock - directly, Representative Rosa DeLauro, a Connecticut Democrat, and frequent FDA critic, told "You need to have someone who changes the culture at the agency.''

Several consumer groups, including the National Research Center for Women & Families, are said to favor cardiologist Stephen Nissen. Nissen disclosed heart risks associated with the diabetes drug Avandia in a May 2007 study, and he has criticized the agency's handling of drug safety.

Joshua Sharfstein is another favorite of consumer groups, having gained prominence last year after petitioning the FDA to ban marketing of over-the-counter cough and cold medicines to young children.

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According to Scientific American, the science community is aflame with speculation about who President-elect Barack Obama's picks will be to run this key agency that consumer groups charge buckled to industry pressure during the Bush administration. Enviros, researchers and company execs are promoting candidates to lead the Food and Drug Administration when Obama takes over.

Associated Press reports that more than a half-dozen names are circulating for the top FDA job, including the Cleveland Clinic's Steven Nissen, a cardiologist and prominent whistleblower who was an early critic of Vioxx, the blockbuster drug that Merck pulled off the market amid concerns that it dramatically ups the risk of heart attacks in vulnerable patients. Another public advocate mentioned by AP is Joshua Sharfstein, commissioner of Baltimore's health department. Sharfstein, a former aide to California Rep. Henry Waxman, took up a high-profile fight to curb young children's use of over-the-counter cough medicines, according to the Wall Street Journal.

Another candidate: Susan Wood, George Washington University occupational and environmental health Professor, who directed the FDA's Office of Women's Health until "she resigned on principle over the continued delay in approving emergency over-the-counter contraception" in 2005, according to her bio on the university's Web site.

Diana Zuckerman, president of the National Research Center for Women & Families, told Bloomberg that her organization is discussing the possibility of recommending FDA candidates with a coalition of groups," but notes that she would back Nissen, Sharfstein or Wood.

>From Kaiser Medical's point of view:

Democratic congressional staffers and others have begun floating names for top health posts in the administration of President-elect Barack Obama that include several possibilities for HHS secretary, the Wall Street Journal's "Washington Wire" reports. According to staffers, possibilities for Health Secretary include former Senate Majority Leader Tom Daschle (D- S.D.); former NIH Director Harold Varmus; and Democratic National Committee Chair Howard Dean, a physician ("Washington Wire," Wall Street Journal, 11/5). Daschle has written a book that calls for an independent agency to oversee the health care system.

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Some individuals in contact with the president-elect's health care advisers have cited Kansas Gov. Kathleen Sebelius (D) as a possibility for HHS secretary. Sebelius tried passing health care reform legislation and in 2003 became the first state insurance commissioner to reject a proposal for a BlueCross BlueShield Association plan to convert from a not-for-profit organization to a for-profit company.

Former HHS Secretary Donna Shalala said that Obama will "want someone with stature and management experience. It's a complex, wide-ranging agency. If you don't know anything about health going in, it's a big problem."

Democratic congressional staffers said that possibilities for FDA commissioner in the Obama administration include in addition to Dr. Nissen, Mike Taylor, a former deputy FDA commissioner; Duke University cardiologist Robert Califf; Mary Pendergast, a former FDA official and a consultant to the pharmaceutical industry, and FDA Center for Drug Evaluation and  ResearchDirector Janet Woodcock.

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