Morning-after pill labels questioned

Excerpt from "Morning-after pill labels may be wrong about implantation," MSNBC by Pam Belluck. June 6, 2012--Labels inside every box of morning-after pills, drugs widely used to prevent pregnancy after sex, say they may work by blocking fertilized eggs from implanting in a woman’s uterus. Respected medical authorities, including the National Institutes of Health and the Mayo Clinic, have said the same thing on their websites. Such descriptions have become kindling in the fiery debate over abortion and contraception.

Based on the belief that a fertilized egg is a person, some religious groups and conservative politicians say disrupting a fertilized egg’s ability to attach to the uterus is abortion, “the moral equivalent of homicide,” as Dr. Donna Harrison, who directs research for the American Association of Pro-life Obstetricians and Gynecologists, put it.

But an examination by The New York Times has found that the federally approved labels and medical Web sites do not reflect what the science shows. Studies have not established that emergency contraceptive pills prevent fertilized eggs from implanting in the womb, leading scientists say. Rather, the pills delay ovulation, the release of eggs from ovaries that occurs before eggs are fertilized, and some pills also thicken cervical mucus so sperm have trouble swimming. It turns out that the politically charged debate over morning-after pills and abortion, a divisive issue in this election year, is probably rooted in outdated or incorrect scientific guesses about how the pills work. Because they block creation of fertilized eggs, they would not meet abortion opponents’ definition of abortion-inducing drugs. In contrast, RU-486, a medication prescribed for terminating pregnancies, destroys implanted embryos.

While scientific and political disputes over emergency contraception may persist even if labels change, both sides consider the wording on labels central because it summarizes scientific consensus and shapes what medical authorities say. “F.D.A. labeling is important to us, it’s very important,” said Jeanne Monahan, director of the Center for Human Dignity at the Family Research Council, a conservative group.

“I would be relieved if it doesn’t have this effect,” said Richard Doerflinger, associate director of the Secretariat of Pro-Life Activities for the United States Conference of Catholic Bishops. “So far what I see is an unresolved debate and some studies on both sides,” he said, adding that because of difficulties in ethically testing the drugs on women, “it’s not only unresolved, but it may be unresolvable.” Several scientists acknowledged that absolute proof may be elusive; in science, as James Trussell, a longtime emergency contraception researcher at Princeton, said, “You can never prove the negative.” But he and others said the evidence from multiple studies was persuasive. Full story can be found here.

CMDA Senior Vice President, Gene Rudd, MD: “This article highlights a concern raised by CMDA in the early days when hormonal emergency contraception was first approved for prescription use and later as OTC. The science lacked an adequate explanation of the mechanisms of action. We also knew the science lacked the support for the industry assertions that Plan B was as effective as advertised (e.g., the claim of a 89 percent reduction in pregnancy). Nevertheless, driven by the unproven promise that these products would reduce unintended pregnancies and subsequent abortions, Plan B was approved. The underlying political agenda to remove restraint from reproductive choices overshadowed the science.

“The story began to unwind when actual experience with the product failed to alter healthcare statistics. Even in population studies where these products were freely and readily available, pregnancy and abortion rates were unaffected.¹ Some in the pro-abortion community began to doubt the efficacy of the products.
“Keep in mind that these revelations unfolded during a time when healthcare professionals lost their jobs for refusing to prescribe these products because of their abortifacient potential (as confirmed by the FDA product literature). Employers, medical universities, medical academies, courts and even a state governor tried to coerce pharmacists and prescribers into drinking the Kool-Aid.

“CMDA raised these concerns:

1. If the product is as effective as claimed, it must have a post-fertilization effect, not simply suppression of ovulation.
2. Deceptive language used to describe the product to patients (e.g., it does not affect an “established pregnancy”), resulted in users being improperly informed -- a breach of medical ethics.
3. Now, as some claim, if there is no post-fertilization effect, then patients have been and are being sold a bill-of-goods -- an inadequate product. This is also a breach of medical ethics.

“So why is the Times raising this issue now? I suspect it has to do with the “contraception mandate” being promulgated by HHS. The government seeks to force religious organizations to pay for sterilizations and contraceptives against their moral teaching. Many Americans are not aware of how this undermines the right of conscience and religious freedom for all. In addition, the majority of Americans may have trouble identifying and supporting those whose religious teaching prohibit contraceptives. But the dynamics are different for abortion. The country is clearly divided on abortion. To have these products linked to abortion is damaging to their cause.

“Do these products have post-fertilization effect? For Plan B, it remains questionable. For Ella, it almost certainly does. But the pro-abortion community cannot have it both ways. Post-fertilization effects are necessary for these products to be effective as claimed. There is either deception about how they work, or how well they work.

“It is a small skirmish in a greater cultural war. We must beware; those with a social agenda will deceive to achieve.”

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Raymond EG, Trussell J, Polis CB. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol. 2007 Jan;109(1):181-8.

CMDA Ethics Statement: Hormonal Birth Control
Is Ella an Abortifacient