U.S. Drug Recalls Won't Slow FDA Approvals: Medical Market
Bloomberg News
July 1, 1998, 8:44 a.m. PT
U.S. Drug Recalls Won't Slow FDA Approvals: Medical Market
Washington, July 1 (Bloomberg) -- The record number of drug
recalls in the U.S. in the past year probably won't slow down
approvals for new treatments.
American Home Products Corp. decided last week to remove
Duract, a pain reliever, from pharmacy shelves less than a year
after it was introduced, due to toxic effects on the liver that
may have played a role in four deaths. It was the sixth
withdrawal of a drug due to safety concerns in the last 12
months, after only 10 between 1980 and 1996.
The recalls put pressure on the U.S. Food and Drug
Administration. Congress last year told the agency to accelerate
its approval process. Now, critics of the FDA worry that there
will be more cases like Duract and claim that the agency, which
approved 92 new drugs in the past two years compared to about 25
annually in the past, doesn't screen new drugs carefully enough.
''We're going to see a lot more of this,'' said Raymond
Woosley, chairman of the pharmacology department at Georgetown
University. ''When we're doubling the number of new drugs
approved every year, there will be problems that will show up.''
The FDA and its supporters counter that many side effects
are so rare they don't emerge in clinical trials, no matter how
thorough they are. Also, new drugs may interact with other
therapies in unforeseen ways. This underscores the need to
monitor drugs closely once they go on sale.
The number of drug withdrawals actually proves that the
monitoring system works, they claim.
''A recall isn't a sign that anybody made a mistake, it's a
sign that there's increased scientific knowledge about a
product,'' said Richard Samp, general counsel for The Washington
Legal Foundation and a sometimes ardent FDA critic.
Side Effects
Common sense suggests that if more new drugs are approved,
more will be recalled. A side effect that only occurs in about 1
in 10,000 patients will sometimes be missed in clinical studies.
''It isn't like the FDA has been asleep at the switch all
these years,'' said Ira Loss, an analyst who covers the FDA for
HSBC Washington Analysis, a division of HSBC Securities.
The agency has identified dangerous risks from some
blockbuster drugs, such as Warner-Lambert Co.'s diabetes drug
Rezulin, Johnson & Johnson's heartburn drug Propulsid and potent
HIV treatments made by Agouron Pharmaceuticals Inc., Merck & Co.,
Abbott Laboratories and Roche Holding AG.
The benefits of those drugs are so powerful, however, the
agency chose to strengthen their warning labels to highlight
concerns rather than pull them off the market entirely.
''For serious and life-threatening illnesses, we're willing
to take a higher safety risk,'' said Murray Lumpkin, deputy
director of the FDA's Center for Drug Evaluation and Research.
Other Countries
The FDA's critics complained for years that other countries
had access to new therapies first.
In the past, many drugs were on the market in Europe and
elsewhere before winning approval in the U.S. Sometimes they
turned out to be too dangerous and drugmakers withdrew them
before they were ever sold in the U.S.
Now, Americans are getting the benefit of first access to
many new drugs and they, instead of the Europeans, are the guinea
pigs for their first large-scale use. It's a mixed blessing,
because some risks only emerge with wide use of a drug.
''We're willing as a country, Congress said, to take the
chance that there will be unfortunate side effect developments in
some products'' in return for faster approvals, said HSBC's Loss.
Roche's Posicor drug for high blood pressure, for example,
was prescribed to some 200,000 Americans before the FDA and
company decided its potential to dangerously interact with other
drugs was too great and Roche removed the drug from the market in
June.
Congress
Vermont Republican Senator James Jeffords, chairman of the
Senate committee that oversees the FDA, is investigating how the
FDA monitors new drugs and may hold hearings. He isn't
questioning the review process itself, however.
''We don't think that the problem is that drugs are being
pushed out on the market too quickly,'' said Joe Karpinski,
spokesman for Jeffords. ''You always have to keep remembering
drugs are potentially dangerous -- that's why they are
administered under the supervision of a trained professional.''
In fact, Congress passed its FDA overhaul bill last year
just weeks after the notorious withdrawal of two diet drugs.
The sudden, wide-scale use of American Home's fenfluramine,
an obesity drug, in an unapproved combination with another drug,
phentermine, in the popular ''fen-phen'' diet treatment, and the
quick sales of American Home and Interneuron Pharmaceutical
Inc.'s Redux left thousands of patients subject to potential
heart-valve problems.
The FDA recommended the recall of the drugs in September and
the companies promptly complied.
Like Roche's Posicor, Hoechst AG's allergy drug Seldane was
withdrawn from the market earlier this year because of the risk
from interaction with other drugs.
Pfizer's Viagra, the first pill to treat impotence, met with
unprecedented demand when it was introduced in April. From the
start, the blockbuster drug had a strong warning not to use it
together with nitrate heart medicines. The drugmaker reinforced
the warning about nitrates with letters to physicians after
reports of deaths of men who had taken Viagra.
Prescriptions for Viagra slowed down after the reports,
though there was no evidence directly linking the drug to any
deaths. The recalls of Posicor and Duract in June also may have
dampened enthusiasm for Viagra and other new drugs.
''There's no question recalls are a negative,'' said Martin
Bukoll, an analyst with Northern Trust, which owns several drug
stocks. ''It's not going to stop this great engine of industry
growth, but it particularly could dampen new products' growth and
acceptance.''
--Kristin Jensen in Washington (202) 624-1843 and Michelle Fay |
