Op-ed on Plan B and the FDA - from Zuckerman

[Guest guest]

Note: forwarded message attached.

My latest op-ed -- which is published in the Houston Chronicle and probably other Knight Ridder newspapers -- spells out why I think the Plan B decision is symbolic of greater problems at the FDA, including what is going on with implants. Science is losing, politics is winning.

Best wishes,

Zuckerman, Ph.D.PresidentNational Research Center for Women & Families1701 K Street, NW, Suite 700Washington, DC 20006(202) 223-4000www.center4research.org

HoustonChronicle.com -- http://www.HoustonChronicle.com | Section: Viewpoints, Outlook

Sept. 4, 2005, 1:19AM

NO PLAN B

Will you swallow political safety?

FDA's changing standards may end up hurting us all

By DIANA ZUCKERMAN

IF you're a woman or care about the health of women you know, you rely on the FDA and people like Dr. Wood, a woman you've probably never heard of and never met. She was in charge of the Office of Women's Health at the Food and Drug Administration — one of those nameless, faceless bureaucrats in the alphabet soup agency world of Washington. Your tax dollars paid her salary and she really cared about making your world safer. And that meant safer medications, safer vaccines, safer implants and safer food.

You can't rely on her anymore. She's gone. She quit the FDA last week, explaining that the FDA is making too many decisions that are based on politics rather than science. She was especially upset that the agency did not approve nonprescription access to Plan B, the emergency contraception that can prevent pregnancy for rape victims and other women who have unprotected sex.

The FDA's refusal to approve the use of Plan B without a prescription is a rallying cry for the millions of Americans who believe that contraceptives are good, not evil. Plan B consists of several birth control pills, taken together to prevent — not to end — pregnancy. It has nothing to do with abortion, but you'd never know that from hearing the arguments against it.

But, if you, or someone you love, were raped at gunpoint, for example, Plan B could help make sure the rape victim doesn't get pregnant as a result. The problem is that Plan B only works during the first few days after unprotected sex — usually 72 hours. Every year, thousands of date rape victims, rape victims and other women who desperately need the pills find it difficult to get a doctor's appointment and fill a prescription during those crucial first three days.

Plan B is not fun to take — it causes nausea and other unpleasant side effects. That's why it is not the kind of medication that is likely to be abused or misused. In fact, it's been used safely for years, and even the FDA commissioner admits in his official statement that it is safe for women over 17. The American Academy of Pediatrics says it is also safe for adolescents.

For more than a year, the FDA refused to decide whether or not to approve the use of Plan B without a prescription. It was only when two U.S. senators, Hillary Rodham Clinton and Patty Murray, courageously refused to allow the Senate to vote on President Bush's choice to head the FDA that the administration promised a decision would be made by September. Rather than waiting to make sure the promise was kept, the two senators allowed the Senate to vote on the new FDA commissioner.

As a result, Lester Crawford, a veterinarian who worked at the FDA, has been commissioner for several weeks. While he was waiting for Senate confirmation, Crawford had avoided any controversial decisions. Almost as soon as he was confirmed, however, he got busy. Under his leadership, the FDA announced its intention to ignore its own scientists by approving silicone gel breast implants for the first time. Soon thereafter, the FDA announced that it would ignore its own scientists by not approving Plan B.

In her letter of resignation, Wood pointed out that the FDA commissioner ignored the science, ignored the agency's scientific staff and made the political decision to do nothing. Women across the country will be harmed as a result. In addition to dissing his own scientists and harming women across the country, the FDA betrayed the senators' trust by failing to make a decision.

Why'd he do it? Why embarrass himself, his agency, and the senators who trusted him? The commissioner made lots of excuses about how complicated the issue was, but the real reason was clear: to please religious extremists who oppose birth control — even in cases of rape — and avoid making a clear decision at least until after the next election.

The FDA's outrageous decision about Plan B is just the latest cry for help from that flailing agency. And, it is yet another sign that the Senate is confirming candidates who, despite their friendly demeanor and ah-shucks manner, are too ideological for their own good — and certainly too ideological for our own good.

Maybe you will never need Plan B, but this is not only about this one product. Every time a new medical product is approved by the FDA from now on, whether a vaccine, a painkiller, a heart valve or an implant, you can no longer assume that it is proven safe scientifically. All you can assume is that it is deemed to be safe politically. The standards have changed, and that is going to hurt all of us.

Zuckerman is president of the National Research Center for Women & Families. Readers may write to her at dz@....

HoustonChronicle.com -- http://www.HoustonChronicle.com | Section: Viewpoints, Outlook This article is: http://www.chron.com/cs/CDA/ssistory.mpl/editorial/outlook/3337768