By Randall K. O’Bannon, Ph.D. NRL-ETF Director of Education & Research
A little less than a year ago, the U.S. Food and Drug Administration (FDA) eased restrictions on the use of the abortion pill RU-486 (miferpistone), reducing required dosages, extending the cutoff time, reducing office visits, and loosening the qualifications for prescribers. It was not enough for the abortion lobby.
On February 23rd, a group of doctors calling themselves the Mifeprex REMS Study Group (mifeprex is the U.S. trade name of mifepristone) published an article in the New England Journal of Medicine titled “Sixteen Years of Overregulation: Time to Unburden.” They called for an end to remaining special restrictions on the drug, asking that it be made available by prescription at retail pharmacies.
As we discuss later in this article, this is not a call of America’s family physicians or pediatricians or even the majority of the country’s Ob-Gyns. This is a publicity ploy of some of America’s top abortion academic activists, trying to pressure the FDA to go even farther than they felt comfortable going just eleven months ago.
Currently, even with the new FDA label, mifepristone is only supposed to be dispensed in clinics, private doctors’ offices, or hospitals by or under the supervision of a “certified healthcare provider” (it used to specify “physician’). This certification is minimal. It requires only that the “provider” possess the ability to accurately date the pregnancy (the efficacy of the drugs decreases as gestational age increases), diagnose ectopic pregnancy (the drugs do not work in these circumstances, which could prove fatal), and either have the ability to surgically address complications like severe bleeding or incomplete abortion, or have plans in place for patients to obtain such care from others.
“Providers” also have to sign a document saying that they have read and understood the prescribing information for Mifeprex before ordering the drugs. They also must give every patient a “Medication Guide” which details the process and mentions some of the risks and obtain the patient’s signature on a Patient Agreement Form that distills some of the that same information into a single page format.
The Mifeprex REMS Study Group finds even these minimal safeguards too much for a drug that has been associated with at least 19 known deaths and thousands of hospitalizations. They call these measures “unnecessary.” They say the skills to which it asks providers to attest are “common to all women’s health care providers” and that providers “already give women the information they need” (Statement by Gynuity, “Experts Call for an End to Overregulation of Mifepristone,” 2/22/17 at gynuity.org/news/).
Even under previous regulations saying the drug had to be dispensed by or under the supervision of a physician, they were interpreted so loosely that drugs were being prescribed to patients by web-cam. Yet the Study Group is concerned that the current regulations impede the abortion drugs being sold at retail or on-line pharmacies.
A Gallery of Rogues
Though portrayed by the media as just “a group of doctors and public health experts” (AP, 2/22/17), the Mifeprex REMS Study Group is actually an assemblage of a lot of the same tired old pro-abortion all stars and a few up and coming ones.
The media has and will report their commentary without question, but is highly unlikely to share much about the background of this particular group. Certainly the early stories covering the commentary didn’t. But even a quick scan of published biographical information of these folks will show they are hardly just an ordinary group of concerned doctors.
Elizabeth G. Raymond is a “scholar-activist” working for Gynuity who received the Guttmacher Institute’s first Darroch award in 2005 for her work on “emergency contraception.” At the time, it was also noted that she worked as a practicing obstetrician-gynecologist at her local Planned Parenthood.
Kelly Blanchard, another of Guttmacher’s Darroch Award recipients (2009), works for Ibis Reproductive Health, a group that focuses on “increasing access to safe abortion… around the world.” Her Ibis bio says that one of the things she has focused on in her research is “improving contraception and abortion technologies, including medication and surgical abortion.”
Paul D. Blumenthal is listed as the Director of the Division of Family Planned Services and Research at Stanford University. But he has a long record of work with international abortion-promoting organizations such as IPAS, Pathfinder, and Gynuity, and was the 2008 recipient of the Kenneth J. Ryan Leadership Award from the Physicians for Reproductive Choice and Health. He has been the medical director for Planned Parenthoods in Chicago and Maryland and is the author or coauthor of numerous research articles on abortion.
Kelly Cleland is a younger, new member of the academic abortion establishment, on the research staff of the Office of Population Research at Princeton University. Executive Director of the American Society for Emergency Contraception, she found time to coauthor a study on the “Safety and efficacy of medical abortion in a pediatric population” (Contraception, October 2015) with Planned Parenthood’s Deborah Nucatola and Mary Gatter whose cavalier remarks about aborted babies and dickering over prices for fetal tissue were caught on camera in an undercover investigation.
Angel M. Foster hails from Health Sciences faculty of the University of Ottawa and has also worked with Ibis, specifically working on “reproductive health issues” in the Middle East and Northern Africa. She is a member of the Board of Directors for the National Abortion Federation.
Marji Gold of the Albert Einstein College of Medicine is hailed as a doctor who “wrote the first curriculum for training non-obgyn clinicians in early abortion practice.” She added abortion training to the clinical experience of residents at the medical school in 1982, and “trained residents in first-trimester procedures in the outpatient setting at Montefiore and also at Planned Parenthood in New York City.” She was the recipient of the Society of Family Planning’s 2014 Robert A. Hatcher Family Planning Mentor Award. (www.societyfp.org/About-SFP/SFP-awardees/Dr-Marji-Gold.aspx)
Mary K. Pendergast is not a doctor, but an attorney who has been involved in pharmaceuticals with both the government and private sectors for more than twenty years. She just happened to be Deputy Commissioner and Senior Advisor to the FDA when the marketing application for mifepristone was submitted and sat in on the advisory committee that first publicly considered its approval in July of 1996.
Carolyn Westoff has been part of the faculty at Columbia University since 1986 and is the Medical Director of New York’s Presbyterian Hospital and Columbia’s Family Planning Clinics. A one-time chair of the Planned Parenthood Federation of America, her Society of Family Planning bio says that “She has published over 100 scientific articles, as well as many abstracts, relating to safety and effectiveness of contraception and abortion.” Her bio also mentions her involvement in clinical trial of RU-486 and legal challenges to the Partial-Birth Abortion Ban Act of 2003 (www.societyfp.org/About-SFP/SFP-awardees/Dr-Carolyn-L-Westhoff.aspx).
Beverly Winikoff is currently the president of Gynuity, but worked for 25 years at the Population Council where she played a critical role in bringing mifepristone to the United States. She has served on the boards of numerous abortion advocacy groups, including the National Abortion Federation, the Society of Family Planning, and Physicians for Reproductive Choice and Health, where she was a founding member. Winikoff is currently part of a group studying mail-order abortion in four states, precisely one of the new methods that the dropping of the regulations would supposedly allow (see here) .
Daniel Grossman, listed as being with ANSIRH (Advancing New Standards in Reproductive Health) and the Department of Obstetrics of the University of California, San Francisco is a name regular readers of the National Right to Life News Today may easily recognize. Grossman has written numerous articles defending the safety of abortion and the impact of abortion “restrictions” over the past few years. Grossman was a key figure in series of reports issued by the Texas Policy Evaluation Project that claimed there were disastrous consequences from Texas’ limits on abortion and the funding of abortion performing family planners like Planned Parenthood.
Grossman, here calling for the loosening of restrictions on mifepristone, raised the specter of regulations in Texas driving more women to self-abort and the risks that would entail (see www.nationalrighttolifenews.org/news/2015/11/activists-study-threatens-more-self-induced-chemical-abortions-if-pro-life-laws-prevail/#.WLB7AvkrLIU). In fact, if self-abortions are increasing, the more likely explanations are the Abortion Industry’s blithely repeated claims of the drugs’ safety and its own non-stop “how-to” discussions. Grossman’s confidence here that women can safely abort with minimal supervision seems at odds with his own original dire assessment.
Why all the fuss?
Abortionists are harder to find and clinics are expensive to keep open and the old guard is anxious to use the webcam, mail and the internet to get around any legal or logistical obstacles that stand between them and their potential customers.
Chemical abortion has taken off, to the point where it now is responsible for close to 30% of the abortions performed in the United States. But this is apparently not enough for some people, with most abortions still being performed at traditional abortion clinics and both clinics and abortions overall in a steep decline in the country.
Even the producer of Mifeprex told one reporter that her company is unlikely to push for the removal of the FDA REMS limits any time soon, given the expense already involved in making the 2016 labeling change (Revelist.com, 2/22/17).
Making chemical abortifacients available at your local pharmacy, by mail, or by on-line order? It’s something that only the most rabid abortion activists want and no one really needs.