August 27, 2001
HEALTH CARE
THE anti-cholesterol drug Baycol is gone, voluntarily withdrawn from the
market this month after being linked to 31 deaths. But the problems exposed
by this latest recall will linger until doctors and federal regulators take
meaningful action.
In an eerie repeat of failures that prompted the withdrawal of the diabetes
drug Rezulin last year, federal officials sent several warning letters to
doctors over the last 18 months advising them about potential problems with
Baycol and suggesting strategies to prevent them. But the alarm apparently
went unheeded, as it did when four separate warning letters were issued on
Rezulin. Side effects are inevitable with any effective drug. But without
stepped-up requirements for reporting medication problems, and an improved
system for ensuring doctors receive and heed warnings, future tragedies are
inevitable.
An estimated 12 million Americans take one of the class of
cholesterol-lowering drugs called statins, of which Baycol is a member.
Statins are an important new weapon in the fight against heart disease, the
nation's leading killer. They block formation of cholesterol. But it has
long been recognized that they can cause serious side effects. In a small
percentage of users, statins cause the breakdown of muscle tissue. When that
happens, waste floods the bloodstream. That can shut down the kidneys,
causing death.
No one knows how many people died after taking statin medications. Drug
makers are required to report so-called adverse reactions to federal regula
tors, but doctors and hospitals are not. Drug companies don't see patients.
Changing the rules to require doctors or hospitals to report suspicious
illness or deaths would give regulators more accurate and timely
information.
But even that is only useful to a point, because federal regulators don't
prescribe drugs. Doctors, often overwhelmed with information about new
studies and breakthrough treatments, are sometimes slow to heed warnings
about potential problems. They often rely on drug company sales r
epresentatives for information.
The solution is to create a federal drugs database, where information could
be easily obtained and readily updated. Doctors could consult it for updated
information about drug warnings and potential interactions.
Deaths linked to Baycol, Rezulin and several other recalled drugs have
exposed shortcomings in the system for regulating medications. The U.S. Food
and Drug Administration has an obligation to act now, before the next
tragedy inevitably occurs.