Dr. Andy

Reflections on medicine and biology among other things

Wednesday, April 06, 2005

What to do with the FDA

is the subject of a good perspective piece in the NEJM several weeks past (I'm behind in my reading, so shoot me), which is probablly only available to subscribers (for academics, most medical schools give you on-line acess).

Several interesting points, including that unlike previously, most new drugs are now approved first in the US.

Two good criticisms of the curent process are that

1. Once a drug is approved, the FDA has no authority to order more safety trials

2. Long term studies are not required, even for drugs that will be used long term:
Bruce M. Psaty, a professor of medicine, epidemiology, and health services at the University of Washington in Seattle, believes that for drugs that patients are likely to take for years, companies should be required to initiate long-term trials before approval and to continue them after the drugs are marketed. "For drugs that are going to be used by millions of people for many years, six-week studies are not adequate to assess the trade-off between risks and benefits," he said.
The article goes on to point out that for statins, there are actually additional benefits to long term use not seen in shorter trials

The article goes on to give a balanced discussion over whether safety oversight of approved drugs should be done inside or outside the FDA, with the Alastair Wood of the outside camp getting the best line:
"When a plane crashes, we don't turn over the investigation to [the airline] and the air-traffic controllers," Wood said. "We get someone else to do it."
Finally, the article makes the point I (and many others) have made previously, that going from approval to mass marketing is a disaster waiting to happen. The disaster with Vioxx is not that it was approved. For patients with arthritis and history of gastric ulcers it is a good medicine. The disaster is it was successfully marketed to everyone with a backache or sore knee.


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