CRITICS QUESTION FDA SAFETY NET AFTER DRUGS GET YANKED
Sunday, July 12, 1998 ; Page
WASHINGTON(DC) -- Delicate balancing act: Agency faces various
obstacles ... political and otherwise
WASHINGTON (AP) - Almost as many prescription drugs were yanked
off the U.S. market in the past 10 months as were banned in the
entire previous decade, a spate that has critics questioning if
the Food and Drug Administration's safety nets are breaking down.
A senator has persuaded Congress' General Accounting Office to
investigate whether the FDA - under political pressure to speed
approvals - is doing enough to safeguard against risky medicines,
or is passing drugs that once would have been held up for further
study. One longtime FDA pharmacologist told The Associated Press
that she just left the agency in frustration with pressure to skim
over safety concerns.
The message was that "one should be approving things, not
questioning problems that arise, and ... give the drug company the
benefit of the doubt," said Elizabeth Barbehenn, who spent 13
years at FDA monitoring the safety of certain experimental drugs.
"The red flag is up," said consumer advocate Dr. Sidney Wolfe
of Public Citizen, who noted experts had questioned some of the
five recently banned medicines before they were ever sold.
"Whoever is responsible for creating the attitude at the FDA that
they have to approve drugs even with serious safety concerns is
starting to see the bloody results."
Dr. Michael Friedman, FDA's acting commissioner, vehemently
denies that outside pressure influences drug-safety decisions.
"What drives the agency is not political or commercial or any
other interest short of scientific," said Friedman. "It is not a
responsible position ... to suggest the agency would ... do
anything less than our very best to make public health decisions."
The FDA appropriately approved the later-banned drugs because
the full scope of side effects did not show up at first - and the
system worked by catching them as soon as they did appear,
Five drugs have been pulled off the market since September: The
painkiller Duract for causing liver failure, including four deaths
and eight liver transplants; the blood pressure drug Posicor,
after 400 injuries and 24 deaths when it interacted dangerously
with other medications; the diet drugs fenfluramine and Redux for
damaging hearts; and the antihistamine Seldane, which interacted
lethally with a long list of other drugs.
In the previous 10 years, the FDA had banned just six other
The FDA performs a complex balancing act: Getting the promising
new drugs to desperately ill patients quickly, at the same time
hunting the often subtle clues that signal which drugs will cause
dangerous side effects.
Drugs are approved based on studies in a few hundred to a few
thousand carefully chosen patients. That means rare problems may
not emerge until tens of thousands of patients, or sicker ones,
Over the past three years, Congress intensely pressured the
once-backlogged FDA to speed approvals. Critics even accused FDA
of killing patients by delaying potentially lifesaving therapies.
Attempts to force a drastic speedup ultimately failed. Still,
by charging new fees to drug makers, FDA hired hundreds more
reviewers and approved a record 92 unique new drugs in 1996 and
1997, up from 50 the previous two years.
Faster approval of lifesaving therapies is good, Wolfe said -
but just 20 percent of FDA-approved products are medical
Most instead are "me-too" drugs like the just-banned Duract and
Posicor. Wolfe lists at least 18 similar painkillers and 30
blood-pressure alternatives, questioning why the two were approved
last year. The FDA knew that Duract, for example, caused serious
liver damage if taken for longer than 10 days.
And there's a separate problem: How to inform doctors of the
side effects that come with every drug.
Some 2 million Americans are hospitalized annually for side
effects, and 100,000 die, Thomas J. Moore, a researcher at George
Washington University, reported this spring.
The FDA has to upgrade safety warnings on more than 20 drugs
But doctors aren't required to report side effects to FDA so it
can warn the public, and many don't. The agency has about 80
employees to monitor more than 3,000 drugs, but is working to
improve surveillance, Friedman said.
Nor can the FDA force doctors to heed warnings. Duract, the
painkiller, had to be banned because doctors ignored FDA's warning
not to prescribe it for longer than 10 days, Friedman said.
Sen. Edward Kennedy, D-Mass., asked the GAO to quickly
investigate how well the FDA handles drug safety and side effects.
Republicans, too, are making inquiries, but agree with Friedman
that the drug bans actually may mean the system is working by
There's no easy answer, because every drug approved is
ultimately a judgment call, stressed Moore. He wants Congress to
establish a scientific panel that judges how the FDA handles drug
controversies, much as the National Transportation Safety Board
investigates plane crashes.
Articles appear as they were originally printed in The
Telegraph Herald and may not include subsequent corrections.
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