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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« How Much is the PI To Blame? | Main | Blogroll Update »

August 27, 2010

Not Your Usual FDA Hearing

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Posted by Derek

You always had to wonder how the move of appointing Sidney Wolfe to the Drugs Safety and Risks Management Committee at the FDA was going to work out. The signs of friction are appearing. I'm with the InVivo Blog: this is the first time I've heard of an FDA committee cutting off the microphone on one of its own members. And you'd think that everyone involved would be able to manage things so that didn't happen - wouldn't you?

Comments (7) + TrackBacks (0) | Category: Regulatory Affairs


COMMENTS

1. retread on August 27, 2010 1:01 PM writes...

God help us all. You're all probably too young to remember this, but Sidney and his PIRG (Public Interest Research Group) strongly opposed the use of CT scanning (too expensive, not useful) when they first became available in the 70s. Their arguments made one of the journals, but I don't have the reference. Like Paul Ehrlich (of the population bomb) he's been wrong about a lot of things -- but never in doubt.

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2. Anonymous BMS Researcher on August 27, 2010 5:28 PM writes...

Here's a little item that may really provoke political controversy whenever some politician notices it:

http://invivoblog.blogspot.com/2010/08/pediatric-exclusivity-for-viagra-its-no.html

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3. Ben A on August 28, 2010 8:32 AM writes...

I'd be grateful for the cite, retread.

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4. retread on August 28, 2010 3:45 PM writes...

#3 Ben A: Sorry, I don't have it I'm pretty sure it was before 1980 when I got my first computer (an AlphaMicro) and started taking notes on what I'd read. Prior to that, my notes had been on 4 x 6 index cards (which are long gone). Like most things from the past we remember, his articles had an emotional kick for me.

Here's why. Anything that could replace the angiogram and the pneumoencephalogram with their morbidity and mortality would be incredibly useful to neurologists and their patients. His objection seemed to be the expense, but as I recall he seemed to argue that the technique just wasn't that good as well. As soon as clinicians began using the CT, it was obvious to all what a huge advance in care they represented.

I'm not sure if the journals still exist, but back then there were journals devoted to CAT scanning (Computerized Axial Tomography), and I think it appeared in one of them. Also I think he made the same points in multiple places and at multiple times back then, some in the popular press. Sorry I can't be of more help.

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5. Kevin on August 29, 2010 12:40 AM writes...

#3 Ben A: I did a Google scholar search and came up with a couple of interesting refs: (i); Bogue T, Wolfe SM: CAT Scanners: Is Fancier Technology Worth a Billion Dollars of Health Consumers’ Money? Washington, D.C., Health Research Group, 1976, and (ii); HL Abrams and BJ McNeil: Computed tomography: cost and efficacy implications, American Journal of Roentgenology, Vol 131, Issue 1, 81-87

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6. Eskimo on August 30, 2010 9:48 AM writes...

Wolfe's behavior might be weird, but I was still surprised to learn that GHB is approved for narcolepsy. Seems counterintuitive. Apparently, you're supposed to take it together with modafinil if you have narcolepsy.

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7. Kent G. Budge on August 30, 2010 11:14 AM writes...

I looked at your Wikipedia link for Wolfe and saw that he had written Good Pills, Bad Pills. I could be mistaken -- it has been a long time -- but I think I stumbled across this in my local library once and, out of curiosity, looked up what he had to say for metformin for type 2 diabetes.

He panned it.

That really piqued my interest, so I looked up all the other oral antihyperglycemics.

He panned them all.

Now, I could be thinking of a different book. As I said, it's been a long time. But if I'm remembering correctly, then the man is a menace and is unfit to sit on any FDA committee.

Please tell me I was looking at a different book.

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