What ails the FDA? Payola
By Marcia Angell | March 10, 2005
LET'S FACE it. The FDA is doing a poor job of ensuring that
prescription drugs are safe and effective. It approves drugs that
offer only minimal benefit, and then sometimes leaves them on the
market long after they've been shown to be dangerous.
Take Vioxx, the hugely popular arthritis drug that was taken off the
market in September and now might return if an FDA advisory panel has
its way. This is one of a class of drugs called COX-2 inhibitors
(Celebrex and Bextra are the others) that are supposedly easier on the
stomach than over-the-counter remedies like Advil or Aleve. It was
rushed to market in 1999 even though it was never shown to be any
better for relieving pain than the older drugs.
The FDA then let it stay on the market for four years after a clinical
trial showed it was probably more likely to cause heart attacks or
strokes than to prevent stomach ulcers. It could have insisted that
the manufacturer, Merck, immediately conduct a large-scale study to
better define the risks and that the company add a warning in its
direct-to-consumer ads that made Vioxx sound like a miracle drug
(think Dorothy Hamill skating effortlessly to ''It's a Beautiful
Morning"😉. The FDA is now implying it doesn't have that authority, but
it does.
Why is the nation's most important regulatory agency appeasing the
pharmaceutical industry instead of protecting the public? One answer
is that it is on the industry's payroll. Literally.
Since 1992, by an act of Congress, drug companies pay the FDA ''user
fees," which are earmarked almost entirely for speeding up drug
approvals. Consequently, the agency now behaves as though that were
its main job, not ensuring safety and effectiveness.
Even worse, the 18 standing advisory committees of outside experts who
help the agency decide whether drugs should be approved include paid
consultants to drug companies. They are supposed to recuse themselves
from decisions that directly affect the companies they work for, but
that rule is regularly waived on the dubious grounds that their
expertise is uniquely valuable. (Imagine judges not recusing
themselves from cases in which they have a financial stake on the
grounds that their expertise is invaluable!) The advisory committee
that originally recommended approval of Vioxx, for example, consisted
of six people, four of whom had received waivers because of their
''potential for a conflict of interest."
Last month a special advisory panel (two of the standing committees
combined) held public hearings on the safety of COX-2 inhibitors and
decided that the benefits outweighed the risks. What was not publicly
disclosed was that at least 10 of the 32 panel members (we don't yet
know the exact number) were paid consultants for the companies that
make the drugs. If their votes had been discounted, the panel would
have recommended that Vioxx and Bextra be removed from the market. No
wonder drug companies hire members of FDA advisory committees.
Drug companies and the FDA sometimes respond to critics by reminding
them that nearly all prescription drugs have side effects. Even so,
one of the FDA's most important jobs is to make sure the risks don't
outweigh the benefits. When potential benefits are great, as with many
cancer treatments, it is acceptable to run substantial risks. But when
there are few benefits over drugs already sold, as in the case of the
COX-2 inhibitors, it is not.
Vioxx is estimated to have caused tens of thousands of heart attacks
or strokes. It is hard to see how the panel could have concluded that
the benefits were worth those risks, especially given the fact that
taking over-the-counter Prilosec in addition to an older pain reliever
would probably have provided as much protection from stomach ulcers.
The fact is, this was a public health disaster.
To prevent such disasters in the future, the FDA must be made
independent of the industry it regulates. First, the legislation that
authorized user fees should be repealed and the money replaced and
augmented by appropriations that restore a better balance between drug
approval and safety monitoring. The public is the primary ''user" of
the FDA, not the industry, and funding should reflect that. Second,
FDA advisory panels should not include paid consultants for drug
companies. Their conflict of interest is real, not ''potential." The
excuse that they are indispensable is not only self-serving but
insulting to the experts who don't consult for industry.
The FDA is vital to our public health. We need to strengthen it as an
independent watchdog, not an industry lapdog.
Dr. Marcia Angell is a senior lecturer in social medicine at Harvard
Medical School and author of ''The Truth About the Drug Companies: How
They Deceive Us and What to Do About It."
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TC