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Monday, February 27, 2006

How Broad a Net for Adverse Events?

An FDA advisory panel earlier this month recommended a black box warning for ADHD drugs like Ritalin based on cardiovascular risks. 

Much like the concerns about SSRIs and suicidal thoughts, however, a number of people argue that these drugs increase risks of violence among those taking them.  From MediaMonitors.net, for example:

The numbers cited by the Food and Drug Administration (FDA) for possible attention deficit drug-related deaths and injuries represent a gross understatement of statistics. The truth is that these drugs are responsible for and [sic] endless stream of deaths and injuries all over the country.

* * *

For instance, on November 20, 1986, after being on Ritalin since the third grade, fourteen-year-old Rod Mathews lured a classmate, Shawn Ouillette, into a wooded area near his home in Canton, Massachusetts, under the pretense of a plan to build a snow fort, and beat him to death with a baseball bat.

Now, this seems like a bit of a cheap shot at the FDA report, which was presumably prepared specifically about CV risks.  And it is difficult to attribute causation in any of the cases cited in the article (and there are a number) -- what else happened between third grade and 1986 in Mathews's life?  (The article notes that he had no history of violence, but that's hardly enough to connect up -- no history of violence before third grade is not unique, even, I reckon, among murderers.)

Even with all of that, it's an interesting question -- if these were submitted to the drugmakers and FDA in the MedWatch system, how were they evaluated by their various recipients?  How should they be evaluated?  Is there a structure for monitoring third-party risks?

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