Time Magazine has offered up an article to let us know how many heads of organizations are out there, appointed by Bush or his staff, and are in similar league of competence as Michael Brown. One such agency is the FDA, however, although Scott Gottlieb, is not necessarily as under qualified as Michael Brown is, he certainly falls under the “croney” category with his ties to the large pharma companies like Eli Lilly, Roche, Pfizer and Proctor & Gamble. Read the whole story.
His official FDA biography notes that Gottlieb, 33, who got his medical degree at Mount Sinai School of Medicine, did a previous stint providing policy advice at the agency, as well as at the Centers for Medicare and Medicaid Services, and was a fellow at the American Enterprise Institute, a conservative think tank. What the bio omits is that his most recent job was as editor of a popular Wall Street newsletter, the Forbes/Gottlieb Medical Technology Investor, in which he offered such tips as “Three Biotech Stocks to Buy Now.” In declaring Gottlieb a “noted authority” who had written more than 300 policy and medical articles, the biography neglects the fact that many of those articles criticized the fda for being too slow to approve new drugs and too quick to issue warning letters when it suspects ones already on the market might be unsafe.
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Would he ever be involved in determining whether an individual drug should be on the market? “Of course not,” Gottlieb told Time. “Not only wouldn’t I be involved in that … But I would not be in a situation where I would be adjudicating the scientific or medical expertise of the (FDA) on a review matter. That’s not my role. It’s not my expertise. We defer to the career staff to make scientific and medical decisions.” Behind the scenes, however, Gottlieb has shown an interest in precisely those kinds of deliberations.One instance took place on Sept. 15, when the FDA decided to stop the trial of a drug for multiple sclerosis during which three people had developed an unusual disorder in which their bodies eliminated their blood platelets and one died of intracerebral bleeding as a result. In an e-mail obtained by Time, Gottlieb speculated that the complication might have been the result of the disease and not the drug. “Just seems like an overreaction to place a clinical hold” on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication “seems very clearly a drug-related event.”