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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

« CMPI Conference: Lunch With the FDA | Main | CMPI Conference: Critical Path »

February 21, 2007

CMPI Conference: CATIE and ALLHAT

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Posted by Derek

The third conference is on the CATIE and ALLHAT trials, the large comparative studies of antipsychotic and hypertensive medications. These studies are taking a real beating, I have to say. Herbert Meltzer of Vanderbilt took on the CATIE work, saying that its design was too complex and tried to do too many things at once. He pointed out that the study's results - that older and newer antipsychotics were essentially equivalent - is very much at odds with evidence-based medicine. He says that its conclusions haven't had that much effect with clinicians, because it's so at variance with their experience.

Michael Weber of SUNY-Downstate has a lot of bad things to say about the ALLHAT study, too. He points out that the HAT part stood for "Heart Attack Treatment", and that although the diuretic treatment group showed somewhat better blood pressure data, the heart attack outcomes were no different. His other surprising claim was that a large number of African-American trial subjects ended up in groups that did not meet the best standard of care for that population, and asked what would have happened if a drug company ran a similar trial. He was clearly frustrated with the initial coverage of the results in places like the New York Times, which he said were the result of a very well-planned press offensive by the study's authors.

Ralph Snyderman of Duke spoke about the problem of working on complex diseases that aren't driven by a single molecular defect (which, more and more, is what we're left to work on). These things are terribly heterogeneous, on more than one level - for instance, referring to his specialty, he said that as far as he's concerned rheumatoid arthritis is at least three diseases, and perhaps as many as six or seven.

Susan Horn of the Institute for Clinical Outcomes Research made the case for "practice-based medicine", trying to work out the real-world effects of compounds after they've been launched. Meltzer wasn't so sure about how well these sorts of studies replicate, though.

In other news, Matt Herper of Forbes has reluctantly admitted that he doesn't find medical journals to be the most exciting reading in the world - his challenge is turning these results into things that people will read voluntarily. He had a great quote about the difficulty of turning ambiguity into a story, mimicing an editor: "What you you mean these experts don't know? Call them back and get them to tell you!"

Post updated in sections - I've been recharging my laptop batteries - DBL

Comments (4) + TrackBacks (0) | Category: Press Coverage | The Central Nervous System


COMMENTS

1. Hap on February 21, 2007 2:41 PM writes...

What evidence does CATIE contradict - if there was a body of evidence saying that the newer drugs worked better in actual use, then why was the study done? Put another way, what evidence supports the "evidence-based medicine" of current clinical practice?

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2. Derek Lowe on February 22, 2007 8:08 AM writes...

Hap, some people seemed to think that these studies were set up in such a way that the older, cheaper medications were much more likely to come out on top. I'm not an antipsychotics drug guy per se - I last worked in the field sixteen years ago - but I can send you to a couple of references on potential problems with the study:

http://ajp.psychiatryonline.org/cgi/content/full/163/3/554

http://psychservices.psychiatryonline.org/cgi/content/full/56/12/1489
(Reply here: http://www.psychservices.psychiatryonline.org/cgi/content/full/57/1/139)

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3. Jim Hu on February 22, 2007 1:18 PM writes...

I wonder if new drugs ever benefit from a newness placebo effect.

Conferences like these should provide more power strips!

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4. steve on February 24, 2007 1:31 AM writes...

CATIE is a good study. Not perfect. Much of the belief that 2nd gen APs are better has to do with the influence of big PHARMA and the desire to have better treatments.

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