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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

« Say It Again! | Main | By a Nose in a Head to Head »

September 21, 2005

No Clear Winners

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Posted by Derek

You've probably seen the headlines about the recent NIH-sponsored "CATIE" study comparing five anti-psychotic medications. The result, which is what made the whole thing newsworthy to the popular press, was that it was hard to distinguish among them, with the oldest generic working as well as (or better than) the newer drugs.

But I think that people outside of the medical world are going to learn the wrong lessons from all this. Does this study mean that everyone taking anti-schizophrenia medication should switch to the old generic? Not at all, although if they need to try a different medication, they should definitely consider it. Does it mean that all these newer drugs are unnecessary? No, again. There's an awful lot of patient-to-patient variation in central nervous system drugs. Says the study's principal investigator, Dr. Jeffrey Lieberman of Columbia:

"There is considerable variation in the therapeutic and side effects of antipsychotic medications. Doctors and patients must carefully evaluate the tradeoffs between efficacy and side effects in choosing an appropriate medication. What works for one person may not work for another."

But I think that this study does make clear that the newer antipsychotics aren't as good as they should be. The field is a tough one, as I know from personal experience, having played a small role in helping a company spend I've-no-idea-how-many millions of dollars to find out that a potential schizophrenia medication didn't do squat. There's a lot of room for improvement, and we haven't been able to improve things very much.

It's important to emphasize that this was a surprising result. No one expected the side effect profiles of the four "second-generation" drugs to be so similar to the older one (perphenazine), and so similar to each other. That's one reason that a study like this is so valuable - huge clinical trials that tell you something that you already knew aren't too wonderful. I think that this is an excellent thing for the NIH to be doing. Tomorrow: what this says about head-to-head trials in general.

Comments (4) + TrackBacks (0) | Category: "Me Too" Drugs | Clinical Trials | The Central Nervous System


COMMENTS

1. NJbiologist on September 22, 2005 10:08 AM writes...

I know it's a little unfair to ask a chemist this question, but... is it really appropriate to do random assignment of patients in clinical trials of drugs, considering how many people rotate drugs until they find one that works? Don't trials like this just prove that doctors and patients need to think about whether the meds are working?

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2. Morten on September 22, 2005 11:14 AM writes...

My thoughts exactly: When 3 out of 4 patients during the 18 month trial changed from the drug they were originally prescribed to something else and they were testing only 5 different drugs... then how can they really tell that they had equal efficiency? Isn't it more like equal inefficiency?
Then again I don't really know much about what they do in clinical *shrug*

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3. Still Scared of Dinosaurs on September 25, 2005 8:06 AM writes...

I think that the appropriateness of randomization and the likelihood of failure are independent. The former is based on sufficient doubt as to which treatment is the best at the time of treatment assignment. The latter, in this case, makes "treatment assignment" mean "first treatment in the path to finding the best treatment for this patient at this time". No trial can force a patient to stay on a medication when it has proven to fail, but the decision to switch is usually left to the patient and MD.

Though my only knowledge of the trial comes from Derek's posts, one thing that stands out to me is the apparent lack of any clear LOSER in the trial. This is something that is very hard to do without the benefits of random assignment, and if one had appeared in the trial it would have likely given great insight into what it means when "doctors and patients...to think about whether the meds are working".

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4. Insider on September 27, 2005 12:59 PM writes...

CATIE has shown the following is possible for HMOs and other prescribers:

1 Try perphenerzine first (10x cheaper than atypicals)
2 Then try olanzapine at a high dose, but watch for metabolic/weight gain side effects.
3 Then try the others, one by one
4 Last chance; clozapine

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