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Study faults drug approval system
http://www.msnbc.com/news/745698.asp#BODY
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‘...
it is incorrect to describe the introduction of unsafe drugs as frequent.’
—
ROBERT TEMPLE AND MARTIN HIMMEL
FDA
physicians |
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THE RESEARCHERS
went so far as to suggest that doctors should prescribe older drugs when
possible, unless the new one is truly superior.
“It’s like playing Russian roulette when a doctor prescribes a newly
approved drug that doesn’t have a big breakthrough,” said Dr. Sidney Wolfe
of Public Citizen Health Research Group, one of the researchers who worked
on the study.
Pressure from pharmaceutical companies and doctors’ failure to
closely read warning labels are partly to blame, the researchers said. They
said the findings should prompt the Food and Drug Administration to consider
raising its threshold for approving new drugs when safe and effective
alternatives exist.
The findings are based on an analysis of 548 drugs approved from 1975
through 1999. Of these, 56, or more than 10 percent, were later given a
serious-side-effect warning or taken off the market for safety reasons. The
number climbed to approximately 20 percent when researchers took into
account drugs that were approved toward the end of the period studied.
The study, led by Dr. Karen Lasser of Cambridge Hospital and Harvard
Medical School, appears in Wednesday’s Journal of the American Medical
Association.
An accompanying editorial by two FDA experts said the analysis
overstates the problem.
FDA SEES DIFFERENT RESULT
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Advertisement
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In an opinion
piece in the same issue, Robert Temple and Martin Himmel, physicians with
the FDA’s Center for Drug Evaluation and Research Policy, agreed that
doctors should be cautious in prescribing new drugs.
But, they added, “it is incorrect to describe the introduction of
unsafe drugs as frequent; the analysis of drugs (in the study) actually
demonstrates that adverse drug reactions of sufficient importance to change
the role of a drug in practice are uncommon.”
And Jeff Trewhitt, spokesman for the Pharmaceutical Research and
Manufacturers of America, told Reuters that “the U.S. FDA has the best
safety record of any regulatory agency in the world. The recall rate is
really quite small — 2 to 3 percent. The vast majority of medicines are
still on the market and doing what they are supposed to do.
“There is no such thing as zero risk,” he added. “If you want zero
risk you’re not going to get any new drugs.”
PROBLEMS SHOULD BE
ANTICIPATED
Safety studies that are conducted before a drug wins approval
typically involve a few thousand patients and may not detect all side
effects, especially relatively rare ones, Drs. Robert Temple and Martin
Himmel said.
“Frequent post-marketing label changes are therefore inevitable and
should be anticipated,” they wrote.
Temple also noted that some medications cause side effects in only
certain groups of patients, such as pregnant women, which does not mean a
drug is dangerous for everyone. |
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The study analyzed what are known as “black-box” warnings published
in the Physicians Desk Reference, a compendium of drugs and labeling
information published annually. Black-box warnings highlight the most
serious side effects.
Sixteen drugs studied were withdrawn from the market, nearly half of
them more than two years after they had won approval.
They include the diabetes drug Rezulin, which was approved in 1997
but has been linked to dozens of cases of fatal liver damage. Lasser said
doctors continued to prescribe it an unsafe manner even after it was given a
black-box warning, and it was ultimately withdrawn from the market in 2000.
Two allergy drugs, Seldane and Hismanal, were linked with potentially
fatal heart problems in certain patients but were not removed from the
market until several years after receiving black-box warnings.
OLDER CAN BE BETTER |
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Most troublesome new drugs do not
represent any advance in treatment and are at best no better than older,
safer drugs already on the market, Wolfe said.
“The safety of new agents cannot be known with certainty until a drug
has been on the market for many years,” said the study.
Unless a new drug is a breakthrough, it should be avoided until its
safety record is better known, the researchers said.
“When a drug that comes on the market has a 1-in-5 chance that it’s
going to have to be banned or get a black-box warning is pretty worrisome,”
Wolfe said.
He said the FDA is correct in saying doctors do not pay enough
attention to warning labels, but that is “all the more reason to do the
right thing on the front end. The remedy should be don’t put the drug on the
market unless it’s a breakthrough drug.”
The FDA has said that while its drug review process has gotten
shorter in recent years, the procedure is still adequate. But the agency has
expressed concern over doctors not reading drug warning labels closely.
The Associated Press and Reuters contributed to this report.
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