JUDY NORSIGIAN AND DIANA ZUCKERMAN
Adding bite to FDA screening
By Judy Norsigian and Diana Zuckerman  |  April 17, 2007

SENATOR EDWARD M. KENNEDY is leading efforts in Congress to pass
legislation to overhaul the Food and Drug Administration. Such reform
is needed, because the FDA has repeatedly failed to protect the public
from drugs and medical devices that prove dangerous to patients.
Unfortunately, the proposed legislation is so weak that it is unlikely
to save any lives.

http://www.boston.com/news/globe/editorial_opinion/oped/articles/2007/04/17/addi
ng_bite_to_fda_screening/

We hoped for more. Last year, Mike Enzi, a conservative Republican
from Wyoming, was in charge of health legislation in the Senate, and
Kennedy was in the minority party. The two senators introduced a drug
safety bill that pleased the pharmaceutical industry considerably more
than consumer advocates. This, supposedly, was the best these
advocates could get from a Republican Congress.
The bill was delayed, luckily, and much has happened since then.
Kennedy is now in charge of health legislation in the Senate.
Nevertheless, he and Enzi introduced the same bill this year.

When drugs are allowed into the market before their side effects are
fully evident, the potentially deadly results are all too familiar:
think of drugs like Vioxx, Trasylol, and Ketek, and devices such as
drug-eluting stents and defibrillators.

Preventing unnecessary deaths will take more congressional muscle. For
example, when new drugs are widely advertised to consumers before the
risks are known, thousands of those who take them may be harmed. Most
could have been treated by older, safer, cheaper drugs. That's why the
American Medical Association, most physicians, and the Institute of
Medicine -- a respected nonprofit that offers advice on biomedical
issues -- recommend a two-year moratorium on direct-to-consumer
advertising of all new drugs.

That sounds like a great idea, but the Senate bill rejects it.
Instead, it would allow (but not require) the FDA commissioner to
impose a moratorium only when there is clear evidence that advertising
to consumers would harm patients. This is hard to prove because new
drugs lack data on widespread use. Even worse, Kennedy's bill doesn't
even require the FDA to review new drug ads for accuracy.

The Institute of Medicine also calls for reducing conflicts of
interest among FDA advisory panel members. A few weeks ago, the FDA
adopted some of those suggestions. It proposed to exclude from
advisory panels all doctors and scientists with financial ties of more
than $50,000 in the previous 12 months to the products under review;
those with a lesser financial interest could still serve on the
committees, but only as nonvoting members.

Having any advisers with a financial interest is like having referees
who bet on their own games -- an obvious conflict of interest. Yet the
Senate bill allows paid consultants, scientists with stock in the
companies, and other financially conflicted experts to vote on FDA
advisory committees -- as long as their financial ties are made public
and the FDA grants a waiver. And, the bill would also create a new
foundation, also funded by drug companies, to do the kind of drug
safety research that the FDA should be doing.

This month, Kennedy is expected to attach provisions of his drug
safety bill to another measure that, among other provisions, expands
the user fees that are charged to pharmaceutical companies to pay for
drug reviews. Meantime, the FDA itself proposed several changes that
Congress should build on -- but hasn't. For example, the FDA proposed
that $29 million of the almost $400 million dollars in user fees paid
by drug companies should be spent to "ensure the safety of medications
after they are on the market." But the Institute of Medicine has said
$100 million is needed for this purpose.

Much more -- almost $370 million in user fees -- would be spent to
speed up the review process, so companies can get their drugs to
market more quickly. Although new medications can potentially save
lives, most "new drugs" approved by the FDA in recent years are merely
newer, more expensive versions of equally effective drugs. Speeding up
their approval translates to millions of dollars for pharmaceutical
companies, but usually no lives saved.

It's a sad day when the public good is completely overshadowed by
pharmaceutical companies' lobbying. A strong reform bill would protect
the health of all Americans. We hope Senator Kennedy will fix this
bill before it's too late.

Judy Norsigian is executive director of Our Bodies Ourselves, a
women's health advocacy organization. Diana Zuckerman is president of
the National Research Center for Women & Families.