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Sen. Durbin continues his misleading statements about supplements, AERs 09/22/2008 14:03
Since it became mandatory for dietary supplement companies to report Serious Adverse Events Jan. 1, there have been 604 such reports filed according to a story in the USA Today. Compared to the 400,000+ annual adverse events reports for drugs, that is a pretty low number. Check that, a very low number. Unfortunately, the USA Today story does not do a very good job of explaining what adverse event reports are (and what they are not). They sound pretty scary, but AERs do not establish any causal relationship between a product and a adverse outcome. This is clearly explained on the FDA's web page about adverse event reporting for drugs. But with 400,000+ AERs each year, some explanation is probably due. My point today is not that USA Today did a mediocre job of covering this story ... or non-story. It is that Sen. Dick Durbin (D-IL) is still telling his tales. In the USA Today article, he imples that these 604 AERs are really something serious. Thanks to his legislation (no mention that Sens. Hatch and Harkin and the supplement industry supported the AER bill), we now know that there are hundreds of serious problems each year, many involving hospitalization and death. Come on Senator. Do you understand what an Adverse Event Report is? It it not proof of any causal relationship. It is simply a system to look for big trends and red flags. Or if you are Sen. Durbin, an Adverse Event Report is something you can use to mislead the public about dietary supplements.
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