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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

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March 22, 2007

FDA Advisory Panels: Pay, No Play

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Posted by Derek

Jim Hu has a good post on some proposed new FDA rules for its advisory panel members. Some sort of changes have been coming for a while now - here's an op-ed that I wrote on the subject back in 2005. I argued that many of the best scientists and clinicians in a given field already work with the industry (which isn't such a bad thing when you think about it), and that restrictive requirements for serving on advisory panels could do more harm than good.

Well, here's the new proposal: the cutoff is $50,000 in the previous 12 months. At that or above, you won't be allowed on the panel. Between $1 (presumably) and $50,000, you can sit on the panel, but won't be allowed to vote. My guess is that that's going to have a pretty big impact if it goes through, and that we're going to see some very different committee rosters.

Or, of course, maybe we're going to see some new forms of relationships between drug companies and their consultants. That's what happens whenever efforts are made to regulate money in the political world, and it wouldn't surprise me a bit here. There are two ways to look at this: if you're suspicious of the FDA's motives (like, say, Rep. Maurice Hinchley of New York, who has a bill mandating these changes and more coming along), then you'll probably see the whole process as a form of organized bribery, wheel-greasing to get defective drugs past the regulatory authorities. Another way to look at it, though, is that outside experts have something that the drug companies need (expertise, and more importantly, expertise from another point of view than the one from inside the company), and that they're willing to pay for it. This may seem odd, but these consultants don't always tell us what we want to hear.

The tough part is when a drug is on the edge of getting approved or not - it has some good points, some bad ones, and the decision could go either way. That's when suspicions are raised that an extra $50,000 here and there is what tipped things over to approval. I don't see that happening, myself (although readers are invited to submit counterexamples). Many approvals can be honestly argued either way, because these medical questions are inherently one big grey area.

The media reaction to this story is rather more toward the former point of view, though. The Washington Post's take on the story is that ". . .the new guidelines implicitly acknowledge what critics have long said -- that it is possible to find enough qualified experts who do not have ties to drug and device manufacturers." And Gardiner Harris in the New York Times gives one sentence to someone at the American Enterprise Institute, while leaving plenty of space for words from Rep. Hinchley and my own representative, Rosa DeLauro, both of whom are good places to go for "corporate poisoners" quotes.

Well, this is the first act of a rather long session of political theatre. There are 60 days of public comment on this proposal, then more wrangling comes along after that. Then there are the bills in the House, which if things go on long enough will get thrown into the next election cycle, and on it goes. It's worth watching, but be ready for a protracted show.

Comments (5) + TrackBacks (0) | Category: Clinical Trials | Drug Development | Press Coverage | The Dark Side | Why Everyone Loves Us


COMMENTS

1. Anonymous on March 22, 2007 11:42 AM writes...

The British system has been more on the lines of, everyone has to declare his/her interests. I think it's smarter: you aren't cut off from the expertise of the guys who have worked on that or similar materials, but everyone's aware, if you got $40000 from the maker. The US system just assumes corruption.

Permalink to Comment

2. SP on March 22, 2007 12:09 PM writes...

Perhaps they could come up with some sort of a blind system or collective reimbursement. The suspicion arises when scientist A is paid by company B and company B has drug C up for approval- people are concerned that's too direct a conflict of interest. If advisers could be hired by some group of industry members, paid for collectively by companies who use their consulting services, they wouldn't be working directly for a company who needs approval (and Dr. A may even be getting paid simultaneously by company D who would like to see drug C go down in flames to make room for their drug E.)

Permalink to Comment

3. qetzal on March 22, 2007 12:38 PM writes...

Jim Hu wrote:

Disqualifying someone who gets $50K per year sounds reasonable at first. But note that this is 50K from the industry as a whole, not from a company that is actually having a product under review by the specific panel....I hope the reporting on this is screwed up, but I fear it's not.
After skimming the actual guidance, I don't think that's right. Only direct financial interests related to a "particular matter" (FDA's term) that will have "a direct and predictable effect on financial interests of the affected organization or organizations" are potentially disqualifying for a committee member. Permalink to Comment

4. Jim Hu on March 24, 2007 12:10 AM writes...

Thanks for the link, Derek, and thanks for finding the actual proposal, qetzal. I've updated the post.

Permalink to Comment

5. WEL on November 4, 2008 4:23 PM writes...

MAXIDEX WARNING

I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS

Two days later I was BLIND

Use Google and enter EPOCRATES MAXIDEX REACTION to verify

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