Diana Zuckerman dz@center4research.org

Dear Friends,

This article appeared in a Minnesota newspaper today, and probably other Knight Ridder newspapers.

Diana

Diana Zuckerman, Ph.D.
President
National Research Center for Women & Families
1901 Pennsylvania Ave, NW, Suite 901
Washington, DC 20006
(202) 223-4000
www.center4research.org

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