Posted on Wed, May. 11, 2005
Duluth News Tribune and other Knight Ridder newspapers
 



FDA needs to start putting consumer safety first

Commentary by DIANA ZUCKERMAN

Food and Drug Administration scientists point out that silicone breast
implants can break inside a woman's body and leak silicone into their
lymph nodes and subsequently to their livers and other organs. They
agree that Vioxx, Celebrex and Bextra can cause fatal strokes and
heart attacks. Despite these concerns, FDA advisers recommended that
the FDA let the public make "an informed choice" to buy them anyway.

Does this make sense to you? Or are you left wondering who these FDA
advisers are and whether they have your best interests in mind?

FDA is having a bad year, and it isn't going to get any better if its
advisers keep recommending FDA approval for questionable products. Of
course, FDA advisers are selected by the FDA, which raises concerns
about the process, not just the individuals.

It may be too much to expect "outside advisers" to spend the scores of
hours necessary to read thousands of pages of safety data before a
public meeting, in their spare time. They are then told to carefully
weigh hours of public testimony by patients and experts they know
almost nothing about, as well as data presented by company scientists
who are paid to persuade them that their product is safe.

Still, at the Vioxx and breast implant FDA advisory meetings, as I sat
watching many advisory panel members ignore the concerns expressed by
FDA scientists and other panel members, I was left wondering: Why do
they seem so convinced by obviously biased information and so
oblivious to the scientific findings that are presented?

Financial and professional ties to the companies and the experts
testifying may be part of the problem. After FDA advisers recommended
that potentially fatal painkillers remain widely available, we learned
that many of those advisers had financial links to the companies
making those products. FDA disregarded those recommendations.
Similarly, the plastic surgeon on the breast implant panel had a
financial relationship with at least one of the companies (he voted
yes), and the two breast surgeons on the panel seemed much more
concerned with patient choice than with any scientific evidence
indicating that the choice might not be safe.

The painkiller and breast implant advisory panels had something else
in common: Members who voted for approval assuaged their concerns by
piling on numerous conditions for FDA approval. Many of the conditions
are not under the jurisdiction of the FDA, such as restricting access
to silicone implants to board-certified plastic surgeons. Most of the
conditions that the FDA could impose, such as requiring long-term
research, have never been enforced by the FDA.

It is no small task for the FDA to make sense of the often conflicting
advice it is getting from its advisers. Unfortunately, the problems it
faces are much more overwhelming than that. The FDA needs to take a
leadership role, but it seems to be playing defense instead. For
painkillers and many other drugs, it needs to decide what kind of
studies could help patients compare the risks and benefits of various
medications, and it needs to make sure those studies are completed as
quickly as possible.

Meanwhile, our government also needs to find a way to prevent
advertisements, junkets and other PR efforts from persuading doctors
to prescribe medications that could kill their patients. For breast
implants, the FDA needs to listen to its own scientists, who have been
saying since the late 1980s that the implant companies' claims of
safety are not supported by research or FDA adverse reaction reports.
Implant makers are now flooding medical journals with articles on
breast implants, but most of the studies are checkbook science --
designed to prove that their product is safe, rather than to determine
whether their product is safe.

If reading this article is giving you a headache, I can only say that
after six days of watching these FDA meetings, (three for painkillers,
three for breast implants) I share your pain. When the FDA is in
trouble, we're all in trouble. It is simply unacceptable that there is
no useful information about the long-term safety of most drugs and
medical implants being sold in the United States.

FDA laws pertaining to long-term safety are hopelessly lax, lacking
the teeth necessary to protect consumers. Until this is changed,
millions of us will continue to buy medical products that have never
been studied to determine whether they are truly safe to "use as
directed."

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DIANA ZUCKERMAN is president of the National Research Center for Women
& Families in Washington, D.C. This essay was distributed by Knight
Ridder/Tribune Information Services.  

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www.BreastImplantAwareness.org
For updates to this unfolding controversy