Drug safety recommendations lack scientific evidence

February 21, 2007

During the past several years, there has been a perceived drug safety crisis in the United States. The Institute of Medicine (IOM), recently released it final recommendations for reforming the U.S. drug safety system, but an editorial published today in Health Economics by Tomas Philipson and colleagues at the University of Chicago finds little evidence of a drug safety crisis and no scientific evidence to back up the IOM's recommendations.

The current drug controversy is largely due to the withdrawal of Vioxx from the market, but the decrease in drug approval times thanks to the Prescription Drug User Fee Acts (PDUFA), and undue influence from the pharmaceutical industry that these acts may have invited have also played a role. Yet the scientific basis that too many unsafe drugs enter the market is lacking.

The IOM report does not document, for example, whether the reductions in approval times for bringing drugs to the market negatively affects the well-being of consumers. The editorial points to a study that the social benefit from reducing drug approval times from 1979 to 2002 --a sum estimated at $16 to $32 billion dollars--substantially outweighed any decrease in safety. Although a lengthier approval process might reduce the number of drug withdrawals, this doesn't necessarily mean that too many drugs are withdrawn. Removing a few drugs from the market may be a necessary price to pay for bringing a larger number of medications more quickly to the public.

The report recommends a two-year ban on advertising drugs directly to consumers because it may lead to increased exposure to unsafe drugs, but it would also mean that fewer consumers would benefit from these medications. Also, it is not clear if restricting this advertising would limit consumption since it represents only a 15% share of total advertising expenditures.

The authors agree with the report's recommendation that extensive testing should be done after drugs are on the market. "The science of approval is far more elaborate than the science of withdrawal, many times done under great political pressure," they note. They point to a strong need for FDA-mandated post-approval studies, since pharmaceutical companies have little incentive to undertake this research on their own, as it could potentially lower their profits. The FDA has picked up on this point; at the end of January, the agency announced a new policy to comprehensively assess drugs 18 months after they are introduced.
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Wiley

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