"How many more Mike Browns are out there?" asks Time. Meet the FDA's pharmacy-tied Scott Gottlieb, 33, for one:

...What [Gottlieb's] 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. FDA Commissioner Lester Crawford, who resigned suddenly and without explanation last Friday, wrote in response to ?e-mailed questions that Gottlieb is "talented and smart, and I am delighted to have been able to recruit him back to the agency to help me fulfill our public-health goals." But others, including Jimmy Carter-era FDA Commissioner Donald Kennedy, a former Stanford University president and now executive editor-in-chief of the journal Science, say Gottlieb breaks the mold of appointees at that level who are generally career FDA scientists or experts well known in their field. "The appointment comes out of nowhere. I've never seen anything like that," says Kennedy.

Gottlieb's financial ties to the drug industry were at one time quite extensive. Upon taking his new job, he recused himself for up to a year from any deliberations involving nine companies that are regulated by the FDA and "where a reasonable person would question my impartiality in the matter." Among them are Eli Lilly, Roche and Proctor & Gamble, according to his Aug. 5 "Disqualification Statement Regarding Former Clients," a copy of which was obtained by Time. Gottlieb, though, insists that his role at the agency is limited to shaping broad policies, such as improving communication between the FDA, doctors and patients, and developing a strategy for dealing with pandemics of such diseases as flu, West Nile virus and sars. 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." Two days prior, when word broke that the FDA had sent a "non-approvable" letter to Pfizer Inc., formally rejecting its Oporia drug for osteoporosis, senior officials at the FDA's Center for Drug Evaluation and Research received copies of an e-mail from Gottlieb expressing his surprise that what he thought would be a routine approval had been turned down. Gottlieb asked for an explanation.

Gottlieb defends his e-mails, which were circulated widely at the FDA...

A big hint as to why Lester Crawford was forced to resign, perhaps. And more on how Safavian got the GSA job in the first place, as well as on the anonymous tip to the feds about the Safavian-Abramoff business deals that Safavian withheld from investigators. "In 2002, Abramoff invited Safavian on a weeklong golf outing to Scotland's famed St. Andrews course (as Abramoff had done with DeLay in 2000). Seven months after the trip, an anonymous call to a government hotline said lobbyists had picked up the tab for the jaunt. That wasn't true; Safavian paid $3,100 for the trip. But the government alleges that he lied when he repeatedly told investigators that Abramoff had no business dealings with the General Services Administration, where Safavian worked at the time." Something's rotten in Denmark, indeed.

Posted by Laura at September 25, 2005 01:39 PM