By Randall K. O’Bannon, Ph.D. NRL Director of Education & Research
While a lot of folks are sharing their Christmas wish lists, abortion advocates are already telling us what they want for next November – a president who will support over-the-counter access to abortion pills.
On the heels of a study that inadvertently exposed safety problems with mifepristone, the first of the two drugs used in the two-drug chemical abortion technique, advocates of the abortion pill are still continuing their push for unregulated, unsupervised do-it-yourself chemical abortions.
Prominent advocates, such as Daniel Grossman clearly understand that the success of that venture depends a great deal on who holds political power in Washington.
Dems Declare Abortion Pill Allegiance
Around Thanksgiving, the New York Times queried the Democratic candidates who were then running for president on abortion. Most of the major candidates responded. Among the questions they asked was one about whether they would support making misoprostol and mifepristone (the current chemical abortion regimen) available over the counter, that is, available for consumers to pick up at retail or drugstores without a prescription.
Seven of the then eleven candidates who responded said they would support making the abortion pills available for over the counter sale: Michael Bennet, Cory Booker, Pete Buttigieg, Tom Steyer, Elizabeth Warren, Marianne Williamson, and Andrew Yang
Two candidates – Amy Klobuchar and Joe Sestak – said they were unsure at this point about making these drugs available OTC. Two others – former vice president Joe Biden and Bernie Sanders — provided no direct answer on this, though all four affirmed their support for Roe v. Wade, repealing the Hyde amendment, and funding Planned Parenthood (NY Times, 11/25/19).
Which brings us back to Daniel Grossman, long time chemical abortion researcher and promoter from the University of California at San Francisco (UCSF). Grossman wrote a column in USA Today (12/18/19) applauding the candidates’ consideration of the issue and their promises to make chemical abortifacients available over the counter.
Decrying the increase in “restrictive abortion laws,” Trump reproductive health policies, and a potential loss on an abortion regulations case to be heard in the Supreme Court next year, Grossman says “two key factors will help determine the future of abortion in the United States” – the outcome of the 2020 presidential election and the success of efforts to make abortion pills easier to get.
Presidential politics may be a new venture of Grossman’s, but the promotion of abortion pills is something he has been a part of for some time. By way of preview, the ultimate goal from the beginning was to assure that women could independently access chemical abortifacients from the internet, or her neighborhood drugstore, without having to go to a clinic, see a doctor, or even consulting with a pharmacist.
Fighting against reasonable limits
When first approved by the U.S. Food and Drug Administration in 2000 as an alternative to surgical abortion, mifepristone came with several pre-conditions: among other things, its use was limited to women who no more than 49 days pregnant (seven weeks LMP, after her last menstrual period); it was to be used in combination with misoprostol (to increase efficacy to expel the child); it was to be taken under the supervision of a physician; and it involved three visits to the abortionist’s office.
Almost immediately, abortion pill advocates complained. They insisted that three visits weren’t necessary, that a woman could take misoprostol, the second drug, at home, and that it really wasn’t critical to have the doctor present to examine the woman and deliver the pills.
Within just a few years, by July 2008, they were performing web-cam abortions in Iowa. Here the woman visits a store front clinic, interacts with the abortionist via a computer screen who in turns releases pills in a drawer after a brief video conversation.
Fast forward to March of 2016, when Beverly Winikoff, one of the early promoters of mifepristone, announced her new group, Gynuity, would be conducting a trial making abortion pills available by overnight mail.
It should be noted that word of Gynuity’s study came on the heels of announcement by the FDA that it would be loosening requirements on the abortion pill. It would extend the cut off to ten weeks LMP, allow women to take the misoprostol at home, and reduce the supervisory requirements to a “certified healthcare provider.”
However, abortion pill advocates found even these much reduced requirements onerous. They sought to be allowed to bypass clinics entirely and eliminate any regulations that would stand in the way of women’s ready access to these killing pills.
That’s where Daniel Grossman comes in. Grossman thinks that these deadly drugs ought to be available for sale over-the-counter at your local pharmacy.
OTC access trumps safety concerns
The column in USA Today is not the first time Grossman has mentioned this. In 2015, he told a reporter from National Public Radio that “It would really be quite easy for women to actually use this on their own.” He specifically added, “It could almost be eligible for the kind of medication that could be available over the counter” (NPR 3/11/15).
Grossman gives assurances “As a practicing OB-GYN,” that “I have few concerns about the safety of making medication abortion available without a prescription or clinical evaluation.”
To make this breathtaking declaration, Grossman blithely ignores the history of mifepristone, which as of 2017, had put more than a thousand patients in the hospital and had been linked to at least 22 deaths in the U.S. and 11 more overseas. Most of these were young, otherwise healthy women.
Why the “adverse events”? Mifepristone works not only by blocking progesterone, the hormone responsible for maintaining the safe, supportive environment of the early embryo, but also by triggering bleeding as the nutrient lining breaks down. That bleeding was so severe in a recent trial of mifepristone that two of five women who did not receive a progesterone follow-up had to be rushed to the hospital to deal with hemorrhage.
Women have bled to death. Women have had their uteruses ruptured from undetected ectopic pregnancies (which are not affected by mifepristone). Women have died from rare bacterial infections thought to be introduced into the reproductive tract by self-administered vaginal administration of misoprostol, another deviation from the FDA protocol introduced by the abortion industry.
Relaxed FDA regimens bring added risks
It is a simple fact that the pills decrease in lethal effectiveness the farther along the woman is. This was one of the concerns when the FDA bumped up the time when the protocol could be employed from 7 week to 10 weeks. But if made available over the counter, the willingness of women to abide by this limit, or to even know their gestational date, is very much open to question.
And the later the chemical abortion, not only the greater likelihood of failure, but more pain, more bleeding, more risk.
Bleeding and cramping are part of every successful chemical abortion, though, and it can be intense, copious, painful, and frightening. Grossman seems to be ok with letting women pick up these pills from their nearest store or pharmacy and going through this terrible ordeal at home, alone.
Maybe not ready yet?
Despite his enthusiasm and long time advocacy for OTC abortion drugs, Grossman admits that “the reality is that this is not an immediate panacea.” He grants “more studies are needed” and thinks it will be years before the FDA will consider an application for over the counter mifepristone and misoprostol.
That doesn’t mean Grossman won’t continue to try and prepare the way for that day.
His chief concern appears to be then how well women can accurately estimate their gestational age. Conveniently, Grossman says he is now conducting just such a trial to determine how well that can be done.
Grossman assures us that studies in Asia and Latin America “suggests that women can safely and effectively use abortion pills they obtain without a prescription,” but expects the FDA to seek more proof.
What is needed for FDA approval of OTC sale of these abortifacients, Grossman says, is that “a pharmaceutical company would need to perform specific research showing that women can safely and effectively use the product without medical supervision.”
He is confident that can be done in “three to five years, assuming the studies go well and there is no political interference in the FDA approval process.”
Grossman wants changes
In the meantime, he wants the FDA to lift its Risk Evaluation and Mitigation Strategy (REMS) restrictions. These limit distribution to certified prescribers and keep mifepristone from being stocked and sold by pharmacies (restrictions put in place by an FDA aware of the deaths and injuries associated with these pills).
And Grossman also wants some sort of legislative or judicial fix for regulations requiring a doctor to examine the pregnant women and dispense the drugs in person (rather than by webcam or mail) and state rules allowing only physicians (rather than nurses, midwives, practitioners, etc.) to perform or facilitate abortions.
Not surprisingly, Grossman has conducted or is conducting several studies designed to address these encumbrances and advance the OTC agenda.
It is worth noting that the chief aim of such an agenda is not to enhance the health or safety of women, but to advance the abortion cause, to make abortion easier to obtain and less dependent on clinic abortionists and staff.
Revealing is this statement from Grossman: “An FDA move toward approving OTC would help decriminalize and destigmatize self-managed abortion.”
The problem with “self-managed” abortion is not that it is a crime or stigmatizing, but that it is dangerous.
That is particularly so when a woman – now alone, abandoned by the abortion industry, bleeding, terrified, doubled over in pain, not knowing if she is bleeding to death, or dealing with a ruptured ectopic pregnancy – comes face-to-face with the reality of her aborted child.