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Prescription for Confusion
The New York Times, 12-28-04

It is, the Times notes “no surprise that many people who rely on painkillers to ease their way through the day feel lost at the moment. Not only have Vioxx, Celebrex, and Bextra, the only three drugs in a class thought to be exceptionally safe, been found to cause heart attacks and strokes in some patients, but an over-the-counter painkiller, Aleve, has too. It makes one wonder whether anything out there is really safe.”

The main lesson the Times takes from the confusion is that: “all medicines carry risks as well as benefits”, and that “risks may not show up in clinical trials that are used to decide whether a drug is effective enough and safe enough to be marketed in this country. But if the drug is used by vast numbers of people for extended periods of time, adverse effects may emerge.”

However, after making these very valid points the editorial jumps to the conclusion that doctors and the FDA are “in thrall to drug companies” and have compromised their public obligations as a result. Says the Times: “Now that exquisitely calibrated judgments must be made as to which patients can truly benefit from what drugs, doctors will have to reassert their independence.”

We should point out that as science advances more “exquisitely calibrated judgments” will be available that allow us all to second guess companies and regulators who are only doing the best they can with the facts – and regulations - at hand. After all, we know very little about the risks of generic drugs that have been on the market for decades, and not even aspirin might pass FDA muster if it was presented to the agency now, despite its many benefits.

Getting to the outcome everyone wants (the right balance between safety and benefit, or risk and innovation) depends primarily making sure that outdated technologies – for instance, the clinical trials that the Times deprecates – are supplemented by state of the art screening technologies and datamining that improve patient safety.

Making sure that FDA regulations are driven by the latest science and technologies will help the agency make the right decisions on the first go round – and leave us all with less opportunity to second guess the agency and its stakeholders.

Project FDA.
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