More about Unreported Side Effects of Powerful Drugs

A few days ago I 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 Vytorin, 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 mentioned here, 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 (a Veblen good, perhaps?) for things whose quality goes down as their cost goes up?

8 Replies to “More about Unreported Side Effects of Powerful Drugs”

  1. hm, are there database of self experimentation available to and created by the public regarding drugs (and i suppose anything self experimentation could help on)? would such a thing be useful if it existed, as a supplement or check on more expensive studies with problematic biases? i guess this database might be a kind of wikipedia of self experimentation.

  2. Is this the place to repeat my mother’s report that 1000 IU Vitamin D supplements caused all-over itching in herself and (later) in my father, mitigated by reducing dosage?

    Or the place to complain that the huge study skewering vitamin E as increasing cancer risk used a synthetic alpha- acetate formulation, despite that nowhere in nature do you find only alpha-, and that the acetate compound interferes with some people’s (e.g., my) digestion? Where is the study using mixed alpha, beta, gamma free-form natural extracts as they appear in, you know, food?

    OK, never mind.

  3. Seth,

    Why do you say “let’s call it self-experimentation”? If he’s doing an experiment on himself, that’s self-experimentation, right? What do you mean by “let’s call it”?

  4. I can’t speak for all pharma’s, but several have a transparency policy.
    http://www.lillytrials.com/results/results_by_ta.html
    Ms. Bass can search to her hearts content through the adverse events reports: rule of thumb- the bigger the number the more there are, help her look for those ‘severe’ adverse events that are ‘woefully underreported’. In regards to vaccines, you’re not part of the “Green Vaccine Team” are you now? http://thestatsblog.wordpress.com/2008/07/17/hurrah-for-amanda-peet-and-salon/
    Finally, not that long ago, big pharma was looked upon as a good business model, now they are vilified, why the sudden change? Perhaps it’s the same phenomena that Tierney speak about with information cascades: http://tierneylab.blogs.nytimes.com/2007/10/09/how-the-low-fat-low-fact-cascade-just-keeps-rolling-along/

  5. BBroley, if you think I’m wrong that serious side effects are “woefully underreported”, could you explain why?

    Ms. Bass said that it was the way drug companies would shift the endpoints after the trial was over that led to the current requirement that clinical trials be registered.

    Andrew, he didn’t take the drug to see how it would affect his weight. He took it because he thought it might help something else. Which it did. He didn’t measure his weight because he thought the drug might affect it. He measured his weight for other reasons. So he was doing two ordinary things. To say anytime anyone takes a drug it’s self-experimentation is going a bit far. To say anytime anyone keeps track of their weight it’s self-experimentation is probably going too far. That’s why it’s a borderline case.

  6. Speaking of side effects of powerful drugs, here’s an excellent post about statins on the blog of Dr. Michael Eades, co-author of Protein Power:

    http://www.proteinpower.com/drmike/statins/statin-disaster/

    It tells the story of a man with no health problems other than a set of numbers — triglycerides and cholesterol — that his doctor didn’t like. His subsequent slide into medicalization and suffering is chilling, and revealing. Lots of great comments, also.

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