| Topic: |
Politics > Politics-USA |
| User: |
"!Harry Hope!" |
| Date: |
27 Nov 2004 09:43:27 AM |
| Object: |
Weakened FDA Under Bush Can't Ensure Safety Of Drugs On Market |
From a New York Times editorial, 11/27/04:
http://nytimes.com/2004/11/27/opinion/27sat1.html
Looking for Adverse Drug Effects
As the Food and Drug Administration continues to draw fire for its
handling of various drugs and the flu vaccine crisis, one lesson is
inescapably clear: the agency lacks enough power to ensure the safety
of drugs after they are approved and on the market.
That defect needs to be corrected before countless Americans are
killed or hurt by dangerous side effects that did not show up in the
original clinical trials and only became apparent when the drugs were
in widespread use.
Not many years ago, the F.D.A. was routinely criticized by the drug
industry and conservative commentators for being too nitpicking in
demanding proof of efficacy and safety before allowing new drugs on
the market.
A result, that line of argument went, was that valuable new drugs were
first introduced abroad and long delayed here, depriving American
consumers of their benefits.
Now the balance has shifted.
Approval times for new medicines have been cut sharply, and new drugs
often go into use first in this country.
Whereas disastrous consequences once showed up first in Europe
(witness thalidomide babies), now they are more likely to show up here
first.
That makes postmarketing surveillance of drugs increasingly important,
but the F.D.A.'s authority in this area is shockingly weak.
The system relies on doctors to make voluntary reports to drug
companies about any adverse side effects they spot.
Only a small fraction of the bad outcomes are actually reported.
Even more problematic, the prime responsibility for collecting and
evaluating data from postmarketing studies rests with the
manufacturers.
It defies belief that any company whose fortunes are riding on a
blockbuster drug will be hard-nosed when assessing unexpected
consequences.
The typical pattern - shown in cases like Vioxx and Baycol, both
ultimately withdrawn from the market - is that manufacturers cling to
any rationalization that might explain away hints of danger in their
products until the evidence becomes too strong to ignore.
The F.D.A., alas, has no power to order a manufacturer to test for
possible dangers after a drug is being sold.
Indeed, the agency is so impotent that manufacturers mostly fail to
complete even the postmarketing trials they have pledged to conduct as
a condition for their drug's approval.
Critics have proposed a wide range of reforms - a more active search
for adverse consequences, increasing the power of the safety office
within the F.D.A., ending the agency's reliance on user fees from the
industry and establishing a wholly independent drug safety board to
monitor drugs after they are on the market.
The F.D.A. itself has asked the Institute of Medicine of the National
Academy of Sciences to study the effectiveness of the drug safety
system.
As the institute proceeds with this task, it needs to determine
whether the pendulum has swung too far in favor of the manufacturers
and should be pulled back in favor of consumer safety.
_______________________________________________________________
Weakened FDA Under Bush Can't Ensure Safety Of Drugs On Market. That's
gotta make you happy.
Harry
.
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