CRTITICS QUESTION FDA AFTER DRUG BANS

Health: Five prescription medications have been pulled off shelves since
September,raising concerns about safety standards.

Washington-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 frustrated over
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 the FDA monitoring
the safety of certain experimental drugs.

"The red flag is up," said consumer advocate Dr. Sidney Wolfe of Public
Citizen, who noted that 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, the 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.

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, Friedman said.

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 fenfluranmine 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 drugs.

The FDA performs a complex balancing act: getting the promising new drugs
to desperately ill patients quickly while at the same time hunting for the
often subtle clues that signal which drugs will cause dangerous side effects.

Over the past three years, Congress intensely pressured the once-backlogged
FDA to speed approvals. Critics even accused the 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, the 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 breakthroughs.

Instead, most 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.

Health: Five prescription medications have been pulled off shelves since
September, raising concerns about safety standards.

Washington -- 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 frustrated over
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 the FDA monitoring
the safety of certain experimental drugs.

"The red flag is up," said consumer advocate Dr. Sidney Wolfe of Public
Citizen, who noted that 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, the 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.

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, Friedman said.

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 fenfluranmine 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 drugs.

The FDA performs a complex balancing act: getting the promising new drugs
to desperately ill patients quickly while at the same time hunting for the
often subtle clues that signal which drugs will cause dangerous side effects.

Over the past three years, Congress intensely pressured the once-backlogged
FDA to speed approvals. Critics even accused the 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, the 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 breakthroughs.

Instead, most 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.

Checked-by: Mike Gogulski