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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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March 23, 2009

And While We're Talking About Industry-Sponsored Studies. . .

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Posted by Derek

Last week's discussions around here about the merits (and demerits) of pharma-industry research seem to be coming at what's either a really good or a really bad time. Take a look at this Washington Post article on the handling of clinical data at AstraZeneca.

These details have come up during a large array of lawsuits over Seroquel (quetiapine). And if they're as represented in this article, it doesn't make AZ's marketing folks look very good, and (by extension) the rest of the industry's. We shouldn't be doing this sort of thing, on general principle. But if that's not enough, and it probably isn't, here's a more practical concern: does it take much imagination or vision to think that, with all kinds of health care reform ideas in the air, this sort of behavior might just make Congress want to reform our industry really good and hard?

Comments (6) + TrackBacks (0) | Category: Clinical Trials | Press Coverage | Regulatory Affairs | The Central Nervous System | Why Everyone Loves Us


COMMENTS

1. Hap on March 23, 2009 12:10 PM writes...

Perhaps I'm wrong, but it seems like when you give the marketing folks the keys to the car, and tell them to get you good financials (and you don't really care how), you may not like where the car ends up, or the numerous pictures of your tire tracks appearing in lawsuits or red-light photos of your car sent in the mail.

If the people running the industry are in it for the short-term (or the investors) then the possibility of "reforming the industry good and hard" isn't so much of a threat, because they won't be around to pay the financial costs. Goodwill means nothing to short-timers other than as an asset to be cashed in, and it has been, mostly.

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2. pete on March 24, 2009 10:46 AM writes...

I'd just take some issue with the idea that the buck stops with Marketing. It seems to me that even in the most 'good-science' driven bio/pharmas, the mentality that sets in when you get to actually sell your drug is not just a reflection of who happens to run the Marketing department.

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3. Hap on March 24, 2009 11:54 AM writes...

I don't know (because I haven't done it, or even worked in the process, so, the correct mileage may be different), and some of the overmarketing might be a lack of knowledge, but trying to expand the indications for your drug without a whole lot of data to support them (or paying people for studies that seem designed to yield a particular result) doesn't seem like a science-driven mode of action. It may not be an economically sound one, either, if the (potential) probability of adverse effects in the expanded population and the consequent loss of goodwill and cost of lawsuits is larger than the added revenue of the expanded market. So why do it? Either 1) the added revenue is sufficient to outweigh the potential losses, or 2) the decisions are being made for short-term revenue (the losses will be seen later) and the long-term is irrelevant.

The decision to do things like the above doesn't seem science-driven, and it may not be in the long-term interests of the company (it could be though). If it isn't in the company's long-term interests, whose interests is it in?

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4. pete on March 24, 2009 2:25 PM writes...

Hap -
I'm in complete agreement with what you say. My point was that even strong science driven companies may stray off the straight-and-narrow when they start selling drugs -- and that the decisions to do so probably aren't all due to those fast talkin' guys n' gals in Marketing.

If memory serves, about 10 yrs ago Genentech got told by the FDA to cool it in regard to they way they were marketing Growth Hormone. I'd guess that warning came as an embarrassment to Genentech scientists, who'd built a well deserved reputation for high scientific standards and ethics. But I can't believe it was a total surprise to the former CEO.

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