Ilena Rose
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SAC BEE: Editorial: A toothless FDA Agency has lost half its watchdogs
Editorial: A toothless FDA
Agency has lost half its watchdogs
http://www.sacbee.com/content/opini...-12584495c.html
Published 2:15 am PST Wednesday, December 8, 2004
The Food and Drug Administration over the past decade has shifted its
budget away from monitoring the safety of drugs on the market,
focusing more and more on approving new medicines. That policy has an
obvious side effect. Time after time, the agency has been slow to
respond to evidence about the dangers of drugs on the market.
The FDA has wandered from its central mission. Patient safety should
always come first, whether it's a new drug or an old drug.
The troubles surrounding Vioxx, once one of the nation's most
prescribed arthritis and pain relief medications, bring into focus a
problem inside the FDA that has been apparent for some time. It took
the FDA four years to respond to evidence that Vioxx increased the
risk of heart attacks. Why so long? A recent New York Times story,
examining the flow of funds inside the FDA, explains it this way:
Roughly a decade ago, about half of the agency's money went to drug
safety and other areas, the other half to approving new drugs. Now,
nearly 80 percent of the money goes to approving new drugs.
With that shift in priorities, something had to give. Inside the FDA,
that turned out to be the FDA's Center for Drug Evaluation, which
monitors the safety of drugs on the market. The FDA cut in half the
ranks of scientists who perform that vital mission. When the drug
companies are slow to respond to internal reports of problems, it
falls to those FDA researchers to double-check the safety of approved
drugs.
There is a growing chorus of voices, from the Journal of the American
Medical Association to outgoing Health and Human Services Secretary
Tommy Thompson, who suggest that the best solution is a new and
independent agency. It would monitor the safety of the drugs that the
FDA approves and remove from the market those with problems that come
to light after FDA approval. Given the cozy relations between the Bush
administration and the drug industry, that solution is likely to go
nowhere. But starving the watchdog wing of the FDA is no palatable
solution, either.
A slow response isn't in the narrow financial interests of this
industry or in the interests of the public at large. The FDA must show
it is more than an efficient reviewer of new drugs. One way to start
is to reorder priorities, and that means restoring the ranks of FDA
monitors who are watchdogs for drugs already on the market.
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12-29-2004 01:26 PM
