The Experts’ Verdict on Painkillers
The underlying problem with these drugs is that they have been heavily promoted and thus prescribed promiscuously to patients who did not need to take them. The presumed advantage of the cox-2 drugs is that they may provide the same pain relief as older painkillers like ibuprofen without causing the gastrointestinal bleeding and ulcers that occur in a minority of patients taking the older remedies. Although there are doubts that the drugs actually do cut the rate of bleeding and ulcers (only Vioxx has shown that ability to the F.D.A.’s satisfaction), the panelists clearly felt that they benefit some patients, if for no other reason than that different patients respond well to different drugs. Some experts also complained that there was too little safety information available on the alternative painkillers.
In making its final decision on the cox-2 class, the F.D.A. ought to ensure that the drugs are aimed only at the patients most likely to benefit and least likely to be harmed, and are taken in doses and for durations that limit the unavoidable risk. For the long run, the agency needs to find better ways to assess the safety of drugs once they are on the market.
Sometimes the NY Times gets it exactly right. In this case they did. We can only hope that this “crisis” will stimulate a better overall process. We do need more restrictions on direct to consumer marketing. We do need better processes for post-marketing surveillance. I hope we move forward with positive steps.
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