REPORT CITES PRESCRIPTION DEATHS

WASHINGTON (AP) - The Food and Drug Administration must find new ways to
learn when Americans are injured or killed by prescription drugs because
doctors and hospitals don't alert regulators to problems quickly enough,
concludes a new report by a government oversight agency.

Studies have estimated that 2 million Americans are hospitalized annually
from drug side effects, and 100,000 die.

Part of the FDA's job is to track side effects of the medications it
approves for sale so that health officials can take action if unexpected
problems arise and hunt ways to prevent drug-related injuries.

But the FDA learned of just 9,961 medication-related deaths and 33,541
hospitalizations in 1997, said a report by the Department of Health and
Human Services' inspector general, obtained Tuesday by The Associated
Press.

The problem is not that the FDA isn't trying - it's that the
injury-reporting system is largely voluntary, the report said.

The FDA can only require drug manufacturers to report the injuries they
learn about that involve their drugs. The FDA does not have the authority
to require doctors and hospitals to report injuries, either to the
government or to manufacturers who can pass on the word.

But unless the FDA finds proactive ways to uncover patterns of injuries, it
can't take the next step of helping to prevent them, the inspector general
concluded. A chief recommendation: The agency should ask Medicare to
require that hospitals accepting Medicare patients report all serious side
effects directly to FDA.

``We need to do more to correct the serious problems revealed by this
report,'' said Sen. Edward Kennedy, D-Mass., who requested it. ``It's a
tragedy that so many of these 100,000 deaths a year are preventable. Many
of them could be avoided by more effective oversight. ... Clearly, Congress
has a responsibility to give high priority to these important reforms.''

The report comes weeks after the announcement by another organization, the
prestigious Institute of Medicine, that medical mistakes kill 44,000 to
98,000 hospitalized Americans a year.

The two issues are related: Some deaths caused by prescription drugs occur
when doctors make a mistake in prescribing them. However, some dangerous
drug side effects are simply a consequence of taking medicine, like the
fact that cancer chemotherapy leaves patients vulnerable to infection.
Other drug-caused deaths occur not with hospitalized patients, but among
those taking medicines at home.

The FDA recognizes the problem.

``We can't just sit here in Washington and receive reports (from drug
makers) and know what's going on in the community,'' said FDA drug chief
Dr. Janet Woodcock.

The agency wants to set up ``sentinel hospitals'' that would specially
track and investigate side effects, helping find ways to prevent them.

President Clinton had asked Congress to give the agency an additional $15.7
million to improve side-effect reporting, including adding the sentinel
hospitals. But Congress refused, keeping the agency's funding to track
problems with thousands of drugs level at about $12 million, officials
said.

``There's no doubt the toll of deaths and injuries, and the economic costs
of adverse drug reactions, is really staggering. It really does cry for
investment,'' Woodcock said.

Every medication, even aspirin, has some risks.

Some are a surprise. New drugs are tested on only a few hundred to a few
thousand patients before they're sold to millions, meaning rare side
effects that didn't show up in small clinical trials can wind up hurting
hundreds of people.

The FDA says its passive side-effect reporting program actually works
fairly well in detecting those. But the inspector general recommended
better coordination to ensure that when such injuries are reported, the
separate branch of FDA responsible for warning the public learns about them
quickly.

In addition, a proactive side-effect program would uncover patterns of more
common injuries. For example, some drugs cause deadly side effects only if
patients take them for too many days, a pattern that ``sentinel hospitals''
could uncover so the FDA could issue warnings to use the drug properly.