REVIEW BOARD SOUGHT FOR DRUGS GONE AWRY

When an airplane crashes, scores of investigators descend on the site,
searching for the ``black box'' and piecing together the wreckage in a grim
effort to find out what went wrong.

The investigators work for an independent government agency, the National
Transportation Safety Board -- not for the company that built the plane,
not for the airline that flew it and not for the Federal Aviation
Administration, which gave its stamp of approval to both the manufacturer
and the airline.

By contrast, when a drug harms patients, there is no independent agency to
find out what went wrong. There is not even a formal program or system in
place to require that early signs of trouble be reported.

Instead, the government relies on doctors to report problems voluntarily,
and the job of investigating then falls to the same people who put the drug
on the market in the first place: the Food and Drug Administration, which
approved the drug, and the pharmaceutical company that manufactured it.

Writing in a recent issue of the New England Journal of Medicine, three
doctors -- Raymond Woosley of Georgetown University, and Alastair J.J. Wood
and C. Michael Stein of Vanderbilt University in Nashville -- compared
airplane safety and drug safety, noting that adverse reactions to
medications kill 100,000 Americans a year -- far more than die in plane
crashes.

The doctors suggested that the United States needs an independent
drug-safety agency, analogous to the transportation board, to investigate
drug ``crashes,'' and a mandatory reporting system to catch adverse drug
effects as early as possible.

The diet drug Redux is a case in point. It was taken off the market in
1997, because as part of the weight-loss combination fen-phen, it was found
to cause heart-valve damage.

Millions of people had taken fen-phen, but because of the lack of rigorous
post-marketing surveillance, the authors said, there was little information
about how many people were harmed, how the damage occurred and whether
other drugs might cause similar problems.

A safety board might have been able to make better sense of what happened,
Woosley said, ``so that when we approve the next obesity drug, we might not
be creating the same problem again.''

Another drug, Posicor, prescribed for high blood pressure, was taken off
the market earlier this year after only 10 months, because of dangerous
interactions with more than 25 other drugs. The FDA had received reports of
400 health problems and 24 deaths among the 200,000 Americans who had taken
it, though it was not known whether these problems had actually been caused
by the drug.

The allergy drug Seldane was also taken off the market because its
interactions with other drugs caused serious heart problems. It had been on
the market for five years and had been used by tens of millions of people.
(Late last year, it was reformulated and released as Allegra-D.)

The proposal to turn over investigations of drug mishaps to a new safety
board has not been well received at the FDA. Officials there issued a
statement saying that the agency was best equipped to handle the job.

``FDA scientists who review marketing applications,'' it said in part,
``have extensive knowledge of the products and families of related
products, which significantly benefits the agency's ability to monitor the
products once they are on the market.''

But Woosley said that the article was not meant to criticize the agency or
the drug industry.

``Our intention was not so much to find fault as to improve the process,''
he said.

Checked-by: Pat Dolan