In December, the Supreme Court overturned a lower court ruling that allowed abortion drugs to be mailed. Since then, women who want to end a pregnancy with the combination drug containing mifepristone and misoprostol have had to see a doctor personally.
However, in many states and in Washington, DC, this personal requirement is not required. A study has been conducted since March 2016 to follow the participants who have consumed the medication and to assess the safety and tolerability of the medication. The sponsor of the study is Gynuity Health Projects; The study completion date on clinicaltrials.gov is June 2022. The participating states are listed here.
This clinical study on medical abortion is called TelAbortion. Tara Shochet, project leader, told Medical Daily, “TelAbortion is an FDA-approved study evaluating the safety, effectiveness, and feasibility of medical abortion using telemedicine and mail. The study works under one [investigational new drug] with the FDA, which allows the study sites to send the drugs to the study participants. “
The safety data from the TelAbortion study could help remove mifepristone from the FDA’s list of dangerous drugs called REMS. A drug that lands on the REMS (Risk Evaluation and Mitigation Strategy) does so because it is suspected of causing serious harm.
Due to REMS, mifepristone is not available in any retail pharmacy in the United States. It is only available through a certified provider in a clinic, doctor’s office, or hospital. Although some states would allow mifepristone to be mailed, drugs on the REMS list are subject to federal law.
Providers participating in the study must be licensed to practice under the laws of their state. Ms. Shochet stressed that TelAbortion is not in violation of the recent Supreme Court decision. She stated that “vendors will not be able to sign up to participate in the study and the FDA restriction banning shipping of mifepristone will apply across the country.”
TelAbortion has 9 site partners offering TelAbortion services in 17 states and Washington, DC. She added that TelAbortion does not offer services in any state outside of the locations approved by the study.
Refuting a REMS listing
The FDA put mifepristone on their REMS list when it was first approved in 2000. A look at studies from then on seems to suggest that taking this combination after a pregnancy of 9 weeks not only reduces its effectiveness, but also causes serious medical problems. A 2005 study examining adverse events discussed viability during the second trimester, which starts well after the current prescribed cut-off of less than 10 weeks. There was no breakdown of when the adverse events occurred.
However, a 2015 study of 13,373 women that lasted no more than 63 days or 9 weeks found that the rate of women with infections that required hospitalization was 0.01%. for transfusions 0.03%. The 2005 study, which involved 607 events with mifepristone over a four-year period, listed 513 cases where surgery was required and 43 cases where parenteral antibiotics were required.
In 2016, the FDA changed the original regulatory indication for mifepristone by lowering the gestational age for use and changing the dosage.
Nowadays, many providers believe that REMS is unnecessarily restrictive as there are now more than 20 years of data. Daniel Grossman, MD, director of Advancing New Standards in Reproductive Health at the University of California’s Bixby Center, San Francisco, told Medical Daily, “There is no medical reason to require patients to come to a clinic in person for the pills for medication to obtain abortion – especially because patients are not required to take the medication in the office. This requirement creates an obstacle to care and increases the risk of coronavirus transmission during the pandemic. “An article in the NEJM reported that by 2016, mifepristone was used by more than 3 million women in the US and 19 deaths were reported to the FDA. Now, pregnancy-related deaths are 14 times higher in the United States. In 2018 there were 17 maternal deaths per 100,000 live births – almost 32% of all deliveries in 2018 were by caesarean section.
The breakdown of pregnancy-related deaths in 2018:
- Almost 33% occurred during pregnancy
- 17% occurred on the day of delivery
- 52% occurred after delivery caused by infection, bleeding, etc.
For a woman to qualify as a participant, the pregnancy must be less than 10 weeks and verified by ultrasound, which can be done on site. There is a video appointment between the patient and the provider. If the woman is approved as a study participant, the pills will be sent by post and must be taken while the pregnancy is less than 10 weeks.
Ms. Shochet said the pills have been mailed to approximately 1,500 study participants since the project started in 2016.
There are several reasons someone might choose medical abortion, especially during the pandemic. Privacy and control over the timing of an abortion are two reasons women seek medical abortions.
Current information suggests that health risks associated with pregnancy and childbirth outweigh the risk of medical abortion. Removing mifepristone from REMS can improve access to a safe and effective alternative for early abortion if an unplanned pregnancy occurs.
Scheduling an appointment with an abortion provider often involves arranging time off and childcare. Other barriers to obtaining a medical abortion are transportation and travel expenses.
Yvonne Stolworthy MSN, RN graduated from Nursing School in 1984 and spent many years in critical care and as an educator in a variety of settings including clinical trials.