Abortion-inducing drugs: wrong for women and pharmacists

By Dr. John O'Keeffe

A new rule is expected this month from the Supreme Court of the case of U.S. Food and Drug Administration vs. Alliance for Hippocratic Medicine. The case concerns the safety of Mifepristone and Misoprostol for medical abortion. Mifipristone is a drug used to block progesterone for a developing fetus ending its life and Misoprostol is used to induce uterine contractions to expel the dead tissue. What is the controversy?

First some background: RU-486 — Mifepristone — was developed in the 1980s as the “abortion pill.” The developer, Dr. Etienne-Emile Baulieu, saw this drug as a way to curb the population in developing countries. The rights to Mifepristone were later sold to the Population Council, a group also committed to limiting births in developing countries. The Population Council ran only one study — non-blinded and non-randomized without pediatric (under age 18) subjects — to show the safety and effectiveness of Mifepristone. This study was used in 2000 by the FDA to fast track the drug’s approval under an emergency ruling in the auspice of the AIDs epidemic for the treatment of serious or life threatening illness — pregnancy! At the time, three physician visits were required: the first to confirm gestational age less than seven weeks and rule out ectopic pregnancy, the second to administer misoprostol, and the third to confirm complete passage of tissue.

Typically the FDA requires two randomized placebo-controlled studies showing significant efficacy and minimal risks of the drug in question. Typically, approval also hinges on followup by the prescribers plus a post-approval study confirming safety and efficacy. None of these were mandated by the FDA for these drugs. Their approval for these pills was for medical abortion at less than 49 days of gestation and a physician visit. The only complication required to be reported was the death of a patient.

In 2016, FDA gained approval for lengthening gestational age to less than 70 days without the previously-mandatory three physician visits. In 2021, restrictions were relaxed further, allowing the drug to be prescribed by Telehealth with non-physician prescribers and mailed to the patient. 

Are these medications safe for women? Twenty percent of women who take these pills have complications that can include excessive bleeding, infection, and retention of tissue. Surgical intervention is necessary in most of these cases, especially if the pregnancy is more than seven weeks gestation. The prescriber is rarely the one to provide follow-up care, so patients are seen by gynecologists or emergency room doctors for an average of three post-abortion visits. The medical code for these visits is invariably “incomplete miscarriage”. This usually prevents reporting to the FDA of Mifepristone for bleeding, infection, or hospitalization.

Treating a woman with a drug with such a high risk for complications and surgery at a minimum should require the involvement of a physician who has admitting privileges at a hospital to handle complications. This physician should also be required to examine the patient to confirm gestational age and rule out ectopic pregnancy. This physician should also monitor the patient when giving Misoprostol and confirm evacuation of the dead fetus. We would expect no less from a physician who does invasive care for any other malady — whether it be urologic or orthopedic or general surgery. 

An additional factor involves the effect on pharmacists who are filling these prescriptions. Imagine the ethical challenges of a pro-life and pro-safety pharmacist when dealing with these potentially online prescriptions. Will the government respect their conscience rights to not prescribe a dangerous abortive? At present, Walgreens and CVS pharmacies are prepared to dispense these abortion pills.

Mifepristone and Misosprostol are wrong for women and pharmacists. The Supreme Court at a minimum should reinstate prior safety requirements for the abortion pills. The medical profession should adhere to one of its guiding principles: “Primum non nocere” — first do no harm.

(Dr. John O’Keeffe is a family practice physician and a member of St. Francis of Assisi Parish in Colorado Springs.)