Is anyone watching the store?
Consumers ask that question when it appears that no one is
accountable for how a business is being managed. It's a question many now
ask about how the Food and Drug Administration (FDA) monitors drug safety.
On Friday, the maker of Celebrex announced that the pain
reliever might be linked to increased risks of heart attacks and strokes -
the same issues that caused Vioxx, a drug in the same class, to be
withdrawn. More than a dozen of the world's most popular medicines have
been challenged this year by new studies and scientists who say the FDA is
failing to protect the public.
The stakes couldn't be higher. Vioxx alone may have caused
more than 30,000 deaths, David Graham, an FDA whistleblower and safety
expert, told Congress last month.
To be sure, all drugs carry risks. But how much trust can
Americans have in the FDA when a government survey finds that two-thirds
of its scientists lack confidence that the agency adequately monitors
safety, and 18% say they'd been pressured to recommend a drug over their
reservations?
The FDA's job is to make sure the benefits outweigh the
risks and that physicians and patients are aware of both. But the agency
often operates in the dark, particularly after a drug is approved, putting
the public at risk. It has seven times the number of employees working on
new-drug approvals than it does on safety issues after a drug is OK'd.
Potentially lifesaving new drugs ought to get fast review,
but several changes in the system are needed:
Give FDA authority to demand targeted studies to resolve
safety questions and funds to perform adequate research. Adverse effects
of drugs may not be known for years. Yet the FDA waits for drugmakers to
volunteer data instead of demanding that they track how drugs perform.
Create an independent drug-safety board. Critics say the
FDA is too cozy with drugmakers and has a conflict of interest in
monitoring safety. The attitude is that "they approved the drug, so there
can't possibly be anything wrong with it," Graham says.
Bring stability to FDA leadership. The agency has had a
permanent chief only 17 months of the past four years. The lack of stable
leadership means the agency doesn't move as quickly and efficiently as it
should.
The first step in a cure is acknowledging the problem.
Instead, the FDA is in denial. Some strong medicine will be needed to
regain public confidence.
