By Darryl McGrath
Thursday, December 18, 2003
Two advisory panels for the Food and Drug Administration recommended this week in a 23-4 vote that Plan B--an intensive, short-term dose of birth control pills known as the morning after pill--be made available over the counter.
(WOMENSENEWS)--Margaret Toulouse was asleep one morning 18 months ago when a man broke into her home, kidnapped her at gunpoint and raped her.
In what Toulouse calls a miracle, her attacker returned her home after the assault instead of killing her. Less than two weeks later, the same man was abducting another woman when that victim seized his gun and killedhim.
Toulouse, a 27-year-old political consultantwho lives near Albuquerque, N.M., is still terrified by the memory of the rape.
"It's something that I live with every day," she said in a recent interview with Women's eNews.
What she did not have to live with was a pregnancy. Toulouse was treated at a hospital in Albuquerque where the staff had special training in helping rape victims. There, Toulouse received the emergency contraception known as Plan B. Consisting of two high-dose birth control pills, Plan B is highly effective if taken within 72 hours of unprotected intercourse and may prevent about 89 percent of unplanned pregnancies.
At the time, New Mexico was six months away from making emergency contraception available over the counter and requiring hospitals to provide it to rape victims. The hospital offered Toulouse emergency contraception and Toulouse would have known to ask for it even if it had not been offered. But, she said, women should not have to ask.
"Dealing with an unplanned pregnancy is very difficult," Toulouse said. "It's a life-altering experience. To lay that experience on top of that trauma--being sexually assaulted--I can't imagine how one would have dealt with that."
Throughout the country, reproductive-health advocates agree that emergency contraception should be readily available to all women--not just rape victims--facing the prospect of an unplanned pregnancy. They say Plan B could prevent over one million of the unintended pregnancies in the United States each year.
The debate moved from individual state legislatures to the national arena on Tuesday when two advisory panels for the Food and Drug Administration recommended in a 23-4 vote that Plan B be made available over the counter.
Food and Drug Administration Commissioner Dr. Mark B. McClellan will make the final decision, which is expected within weeks to months. But the overwhelming vote is a strong indication that McClellan will agree with the committees.
A number of national organizations--such as the United States Conference of Catholic Bishops, the conservative public policy group Concerned Women for America and nearly four dozen members of Congress--object to the measure. They say Plan B--originally marketed by the Women's Capital Corporation, a research and development firm for women's reproductive health products in Washington, D.C.--is an abortion-inducing pill such as RU-486.
RU-486 inhibits the embryo's ability to absorb progesterone, a naturally produced hormone essential to maintaining a pregnancy, explained Dr. Stephen Cohen, director of gynecology at Albany Medical Center in Albany, N.Y. Plan B can work in two known ways: by interfering with ovulation or by impeding the sperm from reaching the egg. It may also work by preventing the fertilized embryo from implanting in the uterus, although the medical opinion on that is mixed, Cohen said.
"To most of us, we consider it as interfering with fertilization, not interfering with implantation," Cohen said. The view that pregnancy begins at the moment the sperm fertilizes the egg is "really more of a religious definition than a medical definition."
"It's a crime victims' issue and it is a women's health issue," said Lois Uttley, vice president of the Education Fund of Family Planning Advocates of New York State. "It's not an abortion issue because it's not an abortion drug."
The Education Fund has been working with two other national organizations--the National Sexual Violence Resource Center in Enola, Penn., and the Clara Bell Duvall Reproductive Freedom Project, a Philadelphia-based organization dedicated to the need for safe, legal, and accessible reproductive health programs--to pass state laws that would make emergency contraception available to rape victims in hospitals.
So far, California, Washington, New Mexico and New York have such laws. The movement to make emergency contraception available to rape victims has garnered unexpected support, because even staunch opponents of abortion have been willing to make exceptions in the case of rape. In New York, for example, the New York State Catholic Conference supported the emergency contraception bill, citing church teachings that endorse a woman's right to protect herself against pregnancy from a rape.
But the proposal before the Food and Drug Administration has been more controversial because it would allow women access to emergency contraception after unprotected intercourse or the failure of other birth control methods.
Currently, Alaska, Hawaii, California, Washington and New Mexico allow pharmacists to provide emergency contraceptives to women without a prescription.
The National Right to Life Committee did not take a position on the Plan B proposal. The United States Conference of Catholic Bishops, however, filed a lengthy objection to the proposal with the Food and Drug Administration.
The bishops also said they feared that women would face health risks from unsupervised use of emergency contraception. And, the bishops warned that emergency contraception would promote high-risk sexual behavior, especially among minors.
"The Administration, if anything, should be encouraging physician involvement and parental notification, not thwarting it as this proposal, if adopted, would do," the bishops wrote in their letter.
Barr Laboratories, headquartered in Pomona, N.Y., is in the process of buying Plan B from the Women's Capital Corporation and will market the drug. The company 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 will also advertise widely to women and doctors.
Sharon Camp, president and chief executive officer of the Alan Guttmacher Institute in New York City--a national public policy and research center on reproductive health--said that non-prescription status for Plan B is long overdue. She says many European countries have made emergency contraception available without a prescription for years.
"Opposition is beginning to come from groups opposed to all forms of contraception, but that is not a mainstream view, so it is unlikely to get much traction, even in the current political climate," said Camp, the founder and former chief executive officer of Women's Capital Corporation. "The real point, of course, is that drug regulation is not and should not be driven by politics."
Barbara Seaman has not participated in the formal debate over selling Plan B in drug stores, but she has followed the debate. Seaman is a journalist who has dedicated herself to the health hazards of hormonal medicine and the pursuit of medical and pharmaceutical irresponsibility toward women. Her latest book about the Pill, "The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth," was published this year. The point of it all, she says, is that for women not to expose themselves unnecessarily to a new hormonal drug.
While she does not align herself with the bishops, she joins their stated concerns about women not taking unnecessary health risks if Plan B does become available over the counter. If Plan B is made available over the counter, she notes, a number of women may be take it who aren't actually pregnant and may therefore expose themselves to unnecessary risks.
"I'm always cautious about taking any drug if you don't really need it," she said. "I think in a real emergency situation, we're all inclined to take chances."
Darryl McGrath is a writer in Albany, N.Y., who has reports often on reproductive health issues.
The Clara Bell Duvall Reproductive Freedom Project:
Alan Guttmacher Institute--
"FDA Committees Strongly Support Over-the-Counter Status for Emergency Contraception":
United States Conference of Catholic Bishops: