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Wednesday, February 14, 2007The government warned on Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea. The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago. The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year _ the so-called background rate, the FDA said. I've been reluctant to use the RotaTeq vaccine because of just this possibility. Not that I thought it would cause more intussusceptions (the preliminary studies showed that the indicence of this particular side effect was no different than spontaneous cases), but because the FDA was likely to issue a warning such as this. In the public's eye (and the eye of the plaintiff's bar), a warning from a government agency says that there's a problem, not that there "might" be a problem. When the Weather Service issues a tornado or flood or winter storm warning means the tornado, flood, or winter storm is happening now - not that it might happen. Maybe the FDA should initiate a "watch" category, just like the weather service, instead of making everything a warning. But one suspects that the real goal of the FDA's warnings against harms that have not occurred is to prove to the public that they aren't in bed with the pharmaceutical companies. We now have big black box warnings on anti-depressants that warn not against an actual increase of suicide with their use, but a slight increase in thoughts of suicide. But the RotaTeq warning is an even more egregious example of baseless warnings. If intussusception is happening in vaccinated children at the same rate that it's happening in unvaccinated children, then what's the beef? More thoughts on the FDA's risk aversion. posted by Sydney on 2/14/2007 11:35:00 AM 1 comments 1 Comments:
Part of the issue here is the recent problems with a number of drugs and the governments response to these situations. In today's WSJ we find under Vaccine Draws FDA Warning the following information:
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