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Commentary

Editorial: Looking for Adverse Drug Effects
The New York Times, 11-27-04

This editorial posits that drug approval is essentially a zero sum game when it comes to pharmaceutical innovation and patient safety. Push the pendulum too far towards innovation, and patient health inevitably suffers. The Vioxx debacle shows that the FDA is too quick to approve new medicines, and thus must be reined in with onerous new regulations.

While the Vioxx withdrawal does indicate some gaps in the FDAs drug safety process (particularly postmarketing), we should remember that all drugs have adverse effects in addition to benefits. The goal should not be to completely withdraw valuable drugs with rare side-effects, but to keep them away from high risk patients. Building a better drug safety system will require the FDA to employ more and better datamining technology, and embrace new tools (like pharmacogenomics) that will help both FDA and industry to segment treatment more effectively.

Both of these reforms, however, are a win-win for industry and patients: they encourage better, safer, and more powerful drug treatment without compromising public health. Creating a false dichotomy between innovation and safety will only slow the pace of medical progress and cause more harm in the long run as patients are deprived of valuable new medicines.



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