Healthy Skepticism Library item: 1542

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Kolata G.
A Contraceptive Clears a Hurdle to Wider Access
The New York Times 2003 Dec 17
http://www.nytimes.com/2003/12/17/us/a-contraceptive-clears-a-hurdle-to-wider-access.html

Full text:

In a 23-to-4 vote, two expert advisory committees to the Food and Drug Administration recommended Tuesday that a so-called morning-after pill to prevent unintended pregnancies be sold over the counter.

The F.D.A. usually follows its committees’ advice, although the final decision rests with its commissioner, Dr. Mark B. McClellan. But the overwhelming vote by the agency’s outside advisers led proponents as well as opponents to expect that Dr. McClellan would go along with the committees, making his decision within weeks to months.

The drug is an emergency contraceptive known as Plan B, to be taken when regular contraception either fails or is skipped. Consisting of two high-dose birth control pills, Plan B is meant to be used within 72 hours after unprotected sexual intercourse and may prevent up to 89 percent of unplanned pregnancies.

If approved, widespread availability of Plan B could have an impact second only to the advent of the birth control pill, advocates say. The proponents, including groups like Planned Parenthood, argued to the panel that Plan B was safe and could prevent as many as half of the three million unintended pregnancies in the United States each year.

Kirsten Moore, president of the Reproductive Health Technologies Project, an advocacy group, said she was delighted but feared that political considerations would have held more sway. “I guess I just didn’t have a lot of faith that people would let the facts speak for themselves,” Ms. Moore said.

The Bush administration is an opponent of abortion and has been more conservative on birth control than the Clinton administration, which in 2000 approved a pill that induces abortion in the early weeks of pregnancy.

Opponents of the morning-after pill, including religious groups, told panel members that over-the-counter sales could encourage irresponsible sexual behavior. They also say that women may not understand how this type of pill works. While it usually acts by preventing ovulation, it also may prevent a fertilized egg from implanting. Those who believe that pregnancy begins with fertilization say the pills in doing this can induce abortions.

The company that will market Plan B, Barr Laboratories, says it will provide detailed information to women on what the pills do and on how to use them. It wants to sell the drug only in stores with pharmacies but adds that it plans to advertise widely to women and doctors. The prescription now sells for $25 to $35, the company said but added that it had not decided what to charge for over-the-counter sales.

If the F.D.A. agrees, both sides say they expect enormous medical and social consequences.

Dr. James Trussell of Princeton, a member of the advisory committee who voted for the motion, said he had waited for years for this day to arrive. “It’s hard to believe it actually happened,” Dr. Trussell said. Allowing Plan B to be sold over the counter, he added, “sends a signal to women that it is safe.”

But Dr. W. David Hager of the University of Kentucky, one of four committee members who voted against the motion, said he was worried about the implications for sexual behavior. Dr. Hager said Plan B would have a similar effect to the birth control pill, which he said ushered in “a new day and age for the expression of sexuality among young people.”

“What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences,” Dr. Hager said. He said he was worried in particular that it would encourage sexual activity among adolescents, who could just buy the drug on their own.

While Plan B and a similar drug, Preven, made by Gynétics Medical Products N.V. of Belgium, were in theory available to women by prescription, medical experts say the drugs are underused, even in five states that passed laws to make them easier to obtain. Those states – Washington, California, Alaska, New Mexico and Hawaii— allow pharmacists to provide emergency contraceptives to women without a prescription.

Dr. Carole Ben-Maimon, the president of Barr Laboratories, which is in the process of buying Plan B from Women’s Capital Corporation, its current owner, said that even with publicity directed at consumers and health care professionals in California, only 14 percent of pharmacies and pharmacists in the state provide the drugs without a prescription.

“In a state as large as California, finding emergency contraception without a prescription is still an enormous challenge,” Dr. Ben-Maimon said. Another obstacle for women, she said, is that they are required to talk to the pharmacists, who decide whether emergency contraception is indicated. “In my pharmacy, there aren’t any areas where I can hold a private conversation with my pharmacist,” Dr.Ben-Maimon said.

At the meeting on Tuesday, two F.D.A. committees, the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs, heard evidence from F.D.A. staff members; Barr, the company marketing the drug; and the public. The panels consist of experts in a variety of fields, including obstetrics and gynecology, pharmacology, pediatrics and internal medicine. They also represent a spectrum of views on birth control.

The company provided data from studies that showed the label to women ages 12 to 50 in shopping malls and then assessed their comprehension. It also provided a study of more than 500 women in family planning centers who took the drug, asking whether they followed instructions. The studies, the company argued, indicated that women could understand the label and take the drug as intended.

Extensive studies with contraceptives also indicate that side effects, like nausea and vomiting, were limited and minor, the company said, adding that it knew of no deaths.

“Women deserve access at any time, at any age, for any reason,” a young woman from the Gainesville, Fla., area chapter of the National Organization for Women told the panel. “I braved football-game traffic to go to the campus infirmary,” she said, but it was closed. “I had no idea where I could get it,” and so, she said, she just hoped for the best.

Opponents said the data did not convince them that the drug was safe enough to be so freely available.

Judy Brown, president of the American Life League, said, “The pill acts to prevent a pregnancy by aborting a child.”

Ms. Brown added that while Plan B may be called emergency contraception “the emergency in this case is a baby.”

Committee members urged that the drug’s actions be described so that women understood that a fertilized egg might be disrupted.

Others argued that for teenagers pregnancy was a far worse alternative.

“It is the rare adolescent that ever comes to see me before she has sex the first time,” said Dr. Abby B. Berenson, a professor of obstetrics and gynecology at the University of Texas Medical Branch in Galveston. “Usually that’s because she hadn’t planned to have it in the first place. It just happens, usually on a Saturday night when I’m not available.”