MEDICATION ISN'T MONITORED

PHILADELPHIA --- A study published in the lournal of the American Medical
Association this month found that more than 100,000 Americans die each year
from adverse reactions to medication. If the report is accurate, these
reactions are the fourth leading cause of death in the country.

And the problem might even be worse than that. The study took into account
only hospitalized patients. Plenty of people have reactions to medication
at home.

We have not known just how bad the problem is because so little money and
effort are devoted to monitoring or researching the safety of drugs after
they have been approved by the Food and Drug Administration. Since 1992,
the FDA has increased spending by $335 million to speed up the approval of
new drugs but it has provided little additional money to monitor drugs
after approval.

Medications are tested on only 3,000 to 4,000 volunteers during clinical
trials. Much of whar we need to know about a drug's safety can be
determined only once it has been approved and is taken by hundreds of
thousands of patients under varied circumstances.

The FDA has been able to speed up approvals because pharmaceutical
manufacturers must now pay six-figure "user fees'? along with their drug
applications. But when the companies agreed in 1992 to pay these fees, they
also tacked on a rule that none of the money generated---about $36 million
this year---could be used to track adverse reactions after the drugs were
approved.

The FDA currently allots only $140,000 a year from its budget for the
Medwatch system, which is responsible for monitoring reactions to all drugs
sold in America. Until last fall, Medwatch was not even computerized.

Doctors are not required by law to report patients' drug sensitivities to
the FDA, and rarely do. The FDA estimates thatfewer than 10 percent of all
drug reactions are reported.

Once a new safety problem is discovered, it is hard to get unbiased
research on the subject. The FDA's small budget for studying drug reactions
has shrunk even though the number of new drugs approved has increased. That
leaves manufacturers as the main source of financing to study problems with
their own drugs.

Last year Congress passed legislation creating a pilot program to conduct
independent research on adverse drug reactions and provide safety
information to doctors and patients. But the current White House budget
proposal allocates only a third of the $3 million needed to create the
first center.

There have been exciting discoveries in predicting which patients will
react badly to certain drugs---particularly in the new field of
pharmacogenetics, in which DNA analysis is used to identify genetic
predispositions to medical sensitivities. The technology that allows
doctors to analyze a drop of blood for DNA markers already exists. But we
need to finance research to flnd the markers that indicate possible drug
sensitivities, or the technology will be wasted.

Pharmaceutical companies have given us plenty of good news about the
benefits of their products. It is important for us to learn not only what
these drugs can do for us, but also what they can do to us.

The writer, author of "Bitter Pills: Inside the Hazardous World of Legal
Drugs," contributed this comment to The New York Times.