PHARMA: Debating Risks And Benefits: The Case Of Tysabri
May 22nd, 2007
by
Jane Hiebert-White
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The readers and authors of the new Health Affairs paper “What’s More Dangerous, Your Aspirin Or Your Car? Thinking Rationally About Drug Risks (And Benefits),” by Joshua Cohen and Peter Neumann [1-week free access], have entered into a lively discussion on assessing the risks versus benefits of the drug Tysabri for patients with multiple sclerosis (MS). For the full exchange, see the journal’s eLetters [free access]. Some excerpts are highlighted here:
Howard Katlin: There clearly is significant confusion when talking about Tysabri and the “risks vs. benefits” scenario….I cannot begin to emphasize adequately just how significant this issue is. Prior to the “PML [progressive multifocal leukoencephalopathy] scare,” Tysabri was considered to be the most significant breakthrough in the treatment of MS since the introduction of Betaseron. With the PML issue now causing so much worry and concern amongst MS patients and their neurologists, such an impartial evaluation of the facts would be greatly appreciated by all. Thank you.
Joshua Cohen and Peter Neumann: We want to clarify that the intent of our article was not to portray Tysabri as unacceptably risky. Instead, our purpose was to point out that even when some drugs do pose notable risks, their substantial benefits must also be taken into consideration. We thought that Tysabri was a good example of a treatment that especially deserved this type of analysis. As it turns out, an article published two weeks ago [subscription required] [Dorsey ER et al., Neurology 2007; 68:1524-1528] has conducted exactly the type of analysis we have called for in our article. The recent article by Dorsey et al. suggests that the benefits of Tysabri far exceed its risks. Interestingly, this analysis assumes virtually the same mortality risk that we reported in our work. We encourage people to keep in mind the broader point of our article, which is that there should be a thoughtful discussion of risks and benefits of all interventions, including Tysabri.
Chris Chan: I commend Cohen and Neumann on an informative article, and I believe the article’s intent is timely and warranted. Indeed, it is quite clear that the paper’s primary intent is to put the risk profiles of drugs in a proper perspective, and for the most part I believe that Cohen and Neumann succeed in doing so. However, it would have been better to have selected a different example than Tysabri to illustrate drug risk, as the basis for determining a reasonably precise risk for this new drug is still quite limited….
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