 With
the FDA dropping the ball in detecting harmful side effects of drugs,
some wonder what steps must be taken in order to rectify this problem.
Medical researchers and editors of The Journal of the American Medical
Association (JAMA) suggest the development of an independent drug
safety board -- completely separate of the FDA -- to detect
harmful effects of drugs already on the market.
JAMA editors claimed it was unreasonable to expect the FDA to both
approve drugs as well as "be committed to actively seek evidence
to prove itself wrong."
Proposals similar to these were made after the surfacing of recent
drug scandals surrounding the withdrawal of the painkiller drug,
Vioxx, from the market. These recommendations provided no protection
to the public because they were never implemented. A deputy director
of the FDA's Office of New Drugs argued that a new system was
unnecessary because of the evident separation between the agency's
office of new drugs and office of drug safety.
Editors also explained how the nation's
current system for tracking adverse side effects of drugs was inadequate.
These shortcomings, according to JAMA, can be linked to:
- Drug makers collecting and evaluating data on the side effects
of their own products. This presents the possibility that companies
may be temped to conceal unfavorable, yet vital, data.
- The system's reliance on doctors' voluntary reports,
meaning that most negative side effects are most likely unrecorded.
- The inabilities of the system to pick up on a drug-related increase
in a common disease such as heart attack or stroke.
- Incomplete "promised" studies, as well as those that
have not even begun yet.
The
Lakeland Ledger November 23, 2004
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