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Adverse Event Reporting

medlaw Industry experts are proclaiming victory in getting a law passed that requires dietary supplement (and OTC drug) manufacturers to report all serious “adverse events” to their products to the FDA, which will, of course, make those reports public. The idea is that this will be seen as a “responsible” act by industry and help stem the tide of negative publicity about supplements. Oh really? With the obvious bias in the media against supplements, each reported (but not proven) “reaction” will likely be used to hammer dietary supplements. Does anyone think that reports of OTC “adverse events” will get the same exposure? Face it, another aspirin overdose or a liver destroyed by Tylenol is simply not news. Especially to media outlets heavily sponsored by drug companies. Besides, a supplement manufacturer has no right to ask for a customer’s medical records, to see if she already had a health condition or risk factor that might explain the apparent reaction to a supplement. Marketers of supplements simply can’t fully investigate complaints, which may or may not be related in any way to the supplement. I’m reminded of the infamous case of a fatality attributed by the Texas Health Department to an ephedra supplement. Yes, the ephedra supplement user died, but the coroner blamed the knife wound. In another “ephedra fatality” it was probably the extreme blood alcohol coupled with the head on auto collision. Chaparral was said to be so dangerous it had caused a rash of liver failures. There have been none before or since. Same with kava. And scullcap, that turned out to be germander, itself probably innocent. Again, no problems before or since. Maury Silverman, a literature researcher and staunch supporter of supplements argued unsuccessfully to have the language of the new law require the disclosure of simultaneous drug use, which may better explain the “adverse event”. For example, if someone takes an herbal supplement and a Tylenol, seriously, which one is more likely to have caused that liver toxicity?

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