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More about Unreported Side Effects of Powerful Drugs

Posted Jul 30 2008 4:07pm

A few days agoI blogged about how Tim Lundeen, via careful  and repeated measurement — let’s call it self-experimentation — uncovered a serious and previously-unreported side effect of a drug he was taking. Tim’s example illustrates an important use of self-experimentation: discovering unreported side effects, which I believe are common.

By coincidence today I came across a talk about the very subject of unmentioned side effects: Alison Bass speaking about her new book,Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial.Near the end, Bass said,

It’s not the just the antidepressants, it’s not just the antipsychotics. This is happening with a lot of other drugs. With Vioxx, with Viturin [?], an anti-cholesterol drug, with Propries [?] and Marimet [?], anti-anemia drugs. Where again and again the drug companies know that there are more severe side effects and they’re not letting the public know about that. It just keeps happening, unfortunately.

Just as it would be foolish to think the problem is limited to mental-health drugs, it would be foolish to think the problem is limited to side effects, that drug company researchers do everything right except fail to report side effects. Tim’s example shows how hard it is to learn about unreported side effects — so it is only realistic to think that there are other big problems with drug company research we don’t know about. Bass mentioned one I didn’t know about. A company did a clinical trial of Paxil. The goal was to see if the drug helped with Measures of Depression A and B. Turns out it didn’t: no effect. So the company changed the measures! They shifted to reporting different measures that the drug did seem to improve. Creating the hypothesis to be tested after the data supposedly supporting that hypothesis had already been collected. Without making this clear. (Which I presciently mentionedhere, in response to an interesting comment by Andrew Gelman.) And if you think that drug companies do research like this — in ways that seriously damage people’s lives — but everyone else, such as academia, is really good, that is as realistic as thinking the problem with drug company research is restricted to side effects. Self-experimentation has all sorts of limitations, yes, but (a) you know what they are and (b) it is cheap enough so that you can gather more data to deal with the problems. Drug company research and lots of other research is too expensive to fail — or even be honest about shortcomings.

This is an aspect of scientific method that scientists rarely discuss: the effect of cost on honesty. Is there an economic term (aVeblen good, perhaps?) for things whose quality goes down as their cost goes up?

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