Testing Risk Management

J0321067_1 Last night, ABC News carried a report that teen suicide has increased since the Black Box Warning was labeled for anti-depressants.  It is very unpleasant news.  The ABC News Report states that:

"According to the Center for Disease Control and Prevention’s Annual Summary of Vital Statistics released Monday, the suicide rate rose more than 18 percent in those 1 to 19 years old, from 2.2 per 100,000 in 2003 to 2.6 per 100,000 in 2004."

That increase is staggering.

Since the post-COX-2 revelations, there is no question that the focus on new drugs has shifted from the benefit to the risks.  There is no disagreement in this quarter that the risk of new drugs has to be weighed against benefit.

That said, there is a heavy standard put against benefit.  Sponsoring companies have to put a great deal of time, expense and effort in demonstrating the benefit of a drug, anti-depressants included.  But, if one is going to place risk interventions to that drug, should not risk be held to the same standard as benefit?  The FDA has a responsibility to demonstrate that risk interventions also meet a risk/benefit standard. 

But that is not what happens.  There is precious little research to demonstrate that risk intervention imposed on a drug can yield the same desired outcome in risk avoidance that companies have to show in the benefit.  At the end of January, the FDA announced a new initiative to focus on drug safety.  Where is the focus on risk interventions?

I have long written on the fact that risk interventions are slapped onto drugs without consideration as to whether or not those interventions achieve the outcome desired.  Do Black Box Warnings serve their purpose?  What is their impact?  Do we know?

In this case it is not conclusive that putting black box warnings on anti-depressants for teens has resulted in the increase in teen suicide, but there is also no conclusive evidence that a black box warning achieves the desired outcome. 

The rate of teen suicide before anti-depressants existed should be compared to the rate after they were available. This might give us insight as to their usefulness.  And, before putting a black box warning on a product like anti-depressants, the FDA should be putting that intervention to the same rigorous standards that it puts sponsors claiming a benefit.  Will the intervention result in the desired outcome?  I don’t think there has been the same investment to that end by those imposing such a standard as there has been to the sponsors of drugs for showing the benefit. 

That is something that yesterday’s statistic perhaps demands. 

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