How Many More Mike Browns Are Out There?

A TIME inquiry finds that at top positions in some vital government agencies, the Bush Administration is putting connections before experience

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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. "Part of my job is to ask questions both so I understand how the agency works, and how it reaches its decisions," he told TIME. However, a scientist at the agency said they "really confirmed people's worst fears that he was only going to be happy if we were acting in a way that would make the pharmaceutical industry happy."

The Oporia decision gave Pfizer plenty of reason to be unhappy: the drug had been expected to produce $1 billion a year in sales for the company. Pfizer's stock fell 1.4% the day the rejection was announced. The FDA has not revealed why it rejected the drug, and Pfizer has said it is "considering various courses of action" that might resuscitate its application for approval.

Health experts note that Gottlieb's appointment comes at a time of increased tension between the agency and drug companies, which are concerned that new drugs will have a more difficult time making it onto the market in the wake of the type of safety problems that persuaded Merck to pull its best-selling painkiller Vioxx from the market last year. The agency's independence has also come under question, most recently with its decision last month to prevent the emergency contraceptive known as Plan B from being sold over the counter, after an FDA advisory panel recommended it could be. That Gottlieb sits at the second tier of the agency, critics say, sends anything but a reassuring signal.

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