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Learning from Vioxx
The Globe offers its perspective on how Congress can help to improve the FDA's drug safety efforts:
Post market monitoring [of new drugs] is crucial because pre approval testing rarely includes enough subjects to turn up harmful side effects that can arise when millions of patients start using a drug once it is on the market. In the case of Vioxx, trials were for no more than 12 months, even though the drug is prescribed for a chronic condition, arthritis. Problems often arose with Vioxx among patients taking it for longer than 18 months.
We agree in principle, but with some very important caveats. Some drugs have very apparent side–effects, like liver failure, that are very rare in the public at large and thus are relatively easy to catch through post-market surveillance.
Other drugs, like Vioxx, have rare side–effects like heart attacks, whose background rate in the population at large is relatively high, making them very hard to pick out from the background "noise" of natural disease. The only way—using existing technologies—to sort out signal from noise in these cases is to require large, post market trials that are extraordinarily expensive and time consuming, and which will slow down the utilization of what may be very effective therapies. This is a serious challenge for the FDA and the industry, and it would be shortsighted to impose blanket regulations on every drug in a vain attempt to rule out rare side effects.
Perhaps an effective compromise might entail a moratorium on direct to consumer advertising for the drugs that pose the highest potential risks until enough data can be collected and analyzed to identify rare problems. In return, companies could receive some additional patent time at the end of a drug's patent life. This way, the FDA and physicians would get access to better real world data and companies could recoup some revenues lost as a result of slower drug utilization.
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