FDA needs to start putting consumer safety first

May 11, 2005

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."


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.


(c) 2005 Duluth News Tribune and wire service sources. All Rights Reserved.