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September 8, 2004
I haven't been covering all the twists of the clinical-trial-disclosure story, because there have been so many of them. The drug industry is proposing its own plan, various companies are jumping out with theirs, the big medical journals have another one, and it won't be long before Congress sticks its oar in, too. Clearly there's still some wrangling to come - but equally clearly, we're going to get some sort of meaningful clinical trial data repository.
And as I've blogged here, I don't necessarily have a problem with that, although some of the ">details concern me. My problem, speaking as someone who pays his mortgage with ill-gotten loot from the rapacious drug industry, is with how we've handled the whole thing: poorly.
The verb that almost every story has used is "bury." The drug makers will no longer be able to bury their failed trials, the buried data will now have to be made public, and so on and so on. That's right, we take the data and stick it in a hollow tree stump. You would never know that every clinical trial in the US has to be registered with the FDA (or the equivalent authority in the case of offshore studies.) And you'd never guess that if we want the FDA to act, we have to submit all our clinical data, bad and good.
(Now, a situation where we could indeed use more transparency is when a trial is run, but the company decides that the results weren't good enough to support some new FDA action (a labeling extension, most of the time.) Then the results don't see the light of day, although I think that they should. But even then, the FDA knows that a trial was run.)
Where has my industry been while we've been pummeled in the press? Issuing press releases that nobody believes or even reads? Our industry organization's home page is a sinkhole of grinning publicity head shots and soft-focus stock pictures of cute babies. Find someone who can stand to look at it for two minutes, and I'll show you someone with a stronger stomach than I have. Why isn't our side of the story getting out?
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