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Molecules to Medicine

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Plan B: My politically incorrect take on the news


Protest over Savita Halappanavar's death - separation of Church and State

Sometimes I feel like Alice in Wonderland, staring into distorting mirrors. The ongoing fight over Plan B has again precipitated this disquieting feeling. There is such a disconnect between some stated outcomes that are claimed as being desirable and actions that don't support that. In this case, probably most people would agree that elective abortions are unfortunate and not a desirable outcome. But how different sides would approach this problem are at polar opposites.

For example, conservative folks on the political right are using draconian measures of banning abortions—even if the mother's life is at risk—and attacking clinics and murdering health care workers, at the same time as euphemistically proclaiming themselves “pro-life.” Small government proponents want to insert themselves into every aspect of a woman's life and health, including via intrusive, medically unnecessary vaginal ultrasounds, psychological duress, and insanely stupid debates about legitimate rape. In contrast, many of us who are more liberal, focus our efforts on reducing the need for abortion, aiming to achieve this goal by providing education and family planning services.

Also, on the one hand, we are asking physicians to practice more evidence-based medicine, at the same time as, in the area of women's reproduction at least, politicians are tying their hands.

Memorial rally in Dublin for Savita Halappanavar and women's rights

This issue has resurfaced in recent weeks, first with the tragic and senseless death of Savita Halappanavar, a 31 year old Hindu woman who had the misfortune to have a miscarriage “treated” in an Irish hospital imposing barbaric and antiquated Catholic doctrines on her. As well described by Dr. Jen Gunter, physicians did not perform a medically necessary abortion on a non-viable fetus, instead choosing to let a woman die painfully and needlessly from overwhelming sepsis.

Last week, the The American College of Obstetricians and Gynecologists called for birth control pills to be sold over the counter, noting that the cost and difficulty of seeing a physician to obtain a prescription is a major barrier to use of contraception.

This week, Plan B is again making headlines, as the American Academy of Pediatrics (AAP) just recommended that pediatricians provide prescriptions for Plan B to teenagers to have on hand “just in case.” Don't get me wrong—I think this is a great step forward for health care for teens. But it falls short of what is rational, evidence-based, and necessary practically.

The battle over men's control of women's bodies has been going on for years, though has certainly heated up with this election cycle. Before, we even saw access to science-based information being limited through censorship and distortion even in government sources (e.g., data regarding the efficacy of condoms in preventing HIV infections and STDs were removed from the CDC’s Web site). This helped neither the rates of abortions, the teen birthrate, nor STDs and HIV to go down. At the same time as HIV prevention programs and NIH funding has been cut, funding for abstinence-only programs rose from $20 million to $167 million, despite any lack of evidence of effectiveness. To reiterate, No federal money is spent on comprehensive sex education. Even worse, since 1982, “Over $1 billion in government funding has been granted to abstinence-only programs…[which] are expressly forbidden from discussing contraception…and often contain factually inaccurate and distorted information. Those who design and operate these programs are often inexperienced, religiously-motivated and frequently have close ties to the anti-abortion movement.”

So why are we tolerating this? (For more history related to the FDA and reproductive politics, see my previous post here.)

Note that several years ago, Susan F. Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, resigned because of the politicization of the agency—specifically, having the approval of Plan B emergency contraception denied, despite scientific evidence of the pill’s safety and recommendations from the FDA’s own advisory committee. Yet the same battles are still taking place.

Plan B Perspective

The irrational decision to overrule the recommendation of numerous experts appears to be based on the idea that young girls would be buying the pill without parental consent, and that such girls could not do so safely. They ignore that kids can readily buy Tylenol, which has significant liver toxicity and is often a component of deadly drug overdoses. Plan B is far safer—and also unlikely to be used routinely because, at ~$50, it is relatively expensive. They ignore the dangers of pregnancy, which are far greater...or the dangers of a teen suffering from rape or abusive parents, who certainly doesn't need the added trauma of an unwanted pregnancy.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. It does not cause an abortion. Taken within 72 hours of unprotected sex, it reduces the risk of becoming pregnant to only about 1 to 2 percent—the sooner taken, the more efficacious.

Given the clearcut and overwhelming data, I was tremendously disappointed by last fall's decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17. This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Clearly, that wasn't the case.

President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. That may be true in an ideal world, but it is neither practical, nor does it bear any resemblance to the realities of many teens' lives. The US has a higher teen pregancy rate than any other developed western country, with five times the teen birthrate in France and 2 1/2 times the rate in Canada. “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty,” according to “Sacrificing ‘Change We Can Believe In’ for Expediency?” According to a pediatrician author of the new AAP policy, teen pregnancy perpetuates a cycle of poverty and problems, as these babies perform more poorly in school and tend to have ongoing behavior problems.

Given the safety data, the lingering educational and economic harm and the huge personal toll of unexpected and unwanted pregnancies, I am disappointed that the AAP did not go further in their recommendation. It is unrealistic to expect teens to be able to get a prescription from their physicians for emergency contraceptives. Many teens do not have access to regular medical care. Instead, the AAP and ACOG should strongly back the FDA, who already recommended OTC status for the drug for teens. And we should all send a strong message to President Obama: decisions should be based on science, not politics. You have been re-elected. Stand up and don't overrule the FDA and data on this public health and economic issue. Make emergency contraception available to all, regardless of age.

Updates 11/30/12:

See my comments in response to a reader for further information about the application of the Catholic religious directives during miscarriages.

Also, to encourage HHS Secretary Sebelius to take action, the Union of Concerned Scientists has a new petition up, "Tell HHS Secretary Sebelius: Allow the FDA to Revisit its Plan B Decision."

Credits & Links:

Molecules to Medicine banner © Michelle Banks

Savita protest images by infomatique (William Murphy)/Flickr

Small portions of this post appeared previously in Plan B: The Tradition of Politics at the FDA.

see also:

Plan B’s ad: “I chose a condom but it broke. Now I Have A Second Chance.”

and a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

The views expressed are those of the author and are not necessarily those of Scientific American.

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