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Welcome to STop, the Seattle Times Opinion blog where our editorial writers and editors share their evolving thoughts on a variety of issues. STop is a place where opinion writers and readers can exchange views and readers can learn more about how editorial positions are formed.

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Jim Vesely
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Jim Vesely
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Lee Moriwaki
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Lee Moriwaki
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Joni Balter
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Eric Devericks
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Lance Dickie
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Lance Dickie
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Bruce Ramsey
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Kate Riley
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Lynne Varner
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Ryan Blethen
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Ryan Blethen
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August 24, 2005

Our Man at the F.D.A.

The Timesí page one story today on Scott Gottlieb, the Wall Street analyst hired by the Food and Drug Administration is an editorializing storyóa story with a message. We can tell he story straightóand our reporter, Alicia Mundy, tells it pretty straight, but the premise of it, the definition of it as a story, carries a message of the fox guarding the henhouse or ďregulatory capture,Ē meaning an industry influencing its regulator.

Our reporter has put in a resume of Mr. Gottlieb, and so we can have a rough measure of his attachments to Wall Street. He ran a Forbes investment newsletter for about half a year, also participating as a policy guy at the American Enterprise Institute, a right-of-center policy shop. He has previously worked for the FDA in medical policy under the Bush administration. He has worked for George Gilder, who writes about investments and policy from a pro-technology view. He has been a medical internist at a hospital. In the Clinton years he wrote for the Journal of the American Medical Association and worked in the investment firm Alex. Brown. His degree is in economics.

My question is: For a policy job, would it have been preferable to hire a person who had been in the bureaucracy for an entire career? Certainly there are people like that, and probably lots at the FDA. Probably the lifetime regulators are more pro-regulation than Mr. Gottlieb will be. The unspoken assumption of this story is that thatís what the public should want.

Itís not what I want. I want innovation, I want information, and I want choice. I want new drugs to be tested and reviewed, but I donít want the system to be so safety-conscious that I canít get the drugs I need. The fact is, people are suffering and dying now. New medicines may be able to help them. If you insist on a drug-approval system of near-zero risk, you delay the new medicines and more people suffer and die. You can die from taking a drug that should have been studied longer and you can die from not getting a drug that should have been approved earlier.

There is also the question of whether people who are sick should be allowed to make these choices themselves. If you have cancer, and itís going to take five years to review a new drug to a zero-risk standard, maybe you donít want to wait five years. Maybe you want the drug now. I think the system should allow thatóand (judging from one newspaper article) Mr. Gottlieb is more likely to consider that point of view than someone who has been a regulator all his adult life.

Respond to Bruce.

 
Posted by Bruce Ramsey at August 24, 2005 11:07 AM



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