Local doctors are concerned the Food and Drug Administration's move to allow nonprescription sales of the emergency contraceptive Plan B will likely increase sexual abuse of women and also deny women their right to "informed consent" about the drug's abortifacient action.
"My concern is that statutory rape will be greatly facilitated," said Dr. T. Murphy Goodwin, USC professor and chief, maternal-fetal medicine. Sexual abusers of women, including perpetrators of incest, could "go into a pharmacy and get Plan B," he asserted. "It's a grave disservice in that regard."
On July 31, the FDA said it would work with Duramed, a subsidiary of Barr Pharmaceuticals that manufactures the drug marketed as Plan B, to develop a "framework for moving emergency contraception medication to over-the-counter status" for women 18 and older.
The following day, the U.S. bishops' pro-life secretariat criticized the FDA's decision, saying that making the morning-after pill available over the counter could damage women's health and put more pressure on pharmacists conscientiously opposed to dispensing the drug.
On Aug. 9, the bishops' Secretariat for Pro-Life Activities reiterated its opposition to the FDA's action, after the FDA asked Barr Pharmaceuticals to resubmit its application for over-the-counter marketing of the Plan B pill.
"The morning-after pill may prevent fertilization, or it may interfere with the implantation of the embryo in her mother's womb," said Deirdre McQuade, Secretariat director of Planning and Information. "Such interference is best understood not as contraceptive but as a very early abortifacient action."
'At increased risk'
USC's Goodwin said he is concerned that women purchasing Plan B over-the-counter will not have medical oversight. "They're not going to be tested for sexually transmitted diseases. They'll clearly be at increased risk for future infertility and future cervical disease," he pointed out.
According to Goodwin, studies of Plan B users show only 75 percent understand they shouldn't take the emergency contraceptive in case of vaginal bleeding. Less than 50 percent, noted Goodwin, understand that Plan B is not a regular contraceptive. Plan B is made up of two progestin-only pills containing levonorgestrel delivered in a much higher dosage than a single birth control pill.
Side effects for Plan B listed in the Physicians' Desk Reference include nausea, abdominal pain, fatigue, headache, heavier (or lighter) menstrual bleeding, dizziness, breast tenderness, vomiting and diarrhea. Women who take Plan B are also at greater risk of ectopic pregnancies. According to research furnished by the USCCB Secretariat for Pro-Life Activities, an FDA Postmarketing Safety Review on Plan B yielded 116 adverse events, including convulsions and 28 cases of ectopic pregnancy.
"I have very grave concerns regarding the so-called morning after pill for use in anyone," said Dr. Kathryn Watson, board certified in family practice. "Drugs which cause very small increases in coronary artery disease, such as Vioxx, are off the market and have thousands of lawsuits pending. But, for Plan B, there is no way to assess the true rate of side effects or even deaths.
For one thing, Watson stressed, "it takes years or even decades to know these things. Even for abortions, we don't have this data. In the state of California, for all other surgical procedures, there are mandatory statistics kept for complications. Only for abortion, a physician is not required to report complications, even death. It could be reported as 'secondary to bleeding.' Can we expect any more accurate reporting with Plan B?"
Both Goodwin and Watson have a problem with Plan B in the area of "informed consent." According to Goodwin, the "fine print" labeling is insufficient in making consumers aware that two of Plan B's four main mechanisms of action could interfere with survival of the early embryo depending on the time in a woman's reproductive cycle that the drug is taken.
"It can serve as an early abortifacient; that's a very big problem," said Sister of Social Service Paula Vandegaer, a licensed clinical social worker and founder of International Life Services educational and counseling centers located in 32 sites across the U.S. When the centers get calls asking for emergency contraception, the volunteers ask the caller to come in for counseling.
"We use the calls as a bridge to help the woman look at what's happening, at what she's doing with her life and relationships," said Sister Vandegaer, who noted International Life Services centers provided pro-life counseling services to 22,000 women last year. She finds it ironic that women need a prescription for birth control pills, but may soon obtain higher-dosage emergency contraceptives over-the-counter.
"It could undermine the recent decrease in teenage sexual activity," she said, referring to a survey report issued Aug. 10 by the Centers for Disease Control and Prevention showing a drop in sexual activity among teens from 54.1 percent in 1991 to 46.8 percent in 2005.
Many women 'unaware'
Plan B uses large doses of birth-control pills to prevent conception up to 72 hours after unprotected sex. "But even its proponents admit that it works both before and after conception," said McQuade, adding that many women are "unaware of (the pills') abortifacient action."
McQuade also said FDA approval of over-the-counter sales would "place additional pressure on pharmacists who conscientiously object to dispensing drugs that kill humans at their earliest stages of development." Barr Pharmaceuticals originally had sought approval for over-the-counter sales of Plan B to anyone 16 or over.
"A number of studies have shown that readier access to emergency contraception does not lower unintended pregnancies or abortions," said McQuade. "Such access may also lead to an increased risk of ectopic pregnancy and of contracting a sexually transmitted disease. Plan B fails the test of addressing an urgent medical need --- a new human life is not a disease - and may expose women to greater harm."
Catholic News Service contributed to this story. For additional information, visit http://www.usccb.org/news.
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