Abortion pill ruling puts politics ahead of medical evidence | Opinion
Putting lives at risk for political gain is completely unacceptable
(Phil Walter/Getty Images)
By Jennifer Smith
American healthcare just took a backseat to American politics.
U.S. District Judge Matthew Kacsmaryk, of Texas, sided with the conservative Christian legal advocacy group, Alliance Defending Freedom, and issued an injunction on the Federal Drug Administration’s 2000 approval of mifepristone on the grounds that the FDA did not adequately evaluate its safety before approval. If this injunction is allowed to go into effect, mifepristone will no longer be available throughout the United States.
Safe and effective, in combination with misoprostol it is branded as Mifeprex, and is used for over 50% of abortions under 10 weeks gestation in the United States. This injunction has the potential to impact tens of thousands of pregnant people across our country.
After the ruling, Erik Baptist, senior legal counsel for Alliance Defending Freedom, stated that “this is a significant victory for …. the health and safety of women and girls.”
Contrary to his statement, Mifeprex has been used safely and effectively for over 20 years.
Its approval and safety is based on numerous medical studies, and it is successful in 95-98% of cases depending on gestational age. The risk of serious complications from the two drug protocol (mifepristone and misoprostol) is less than 0.3%.
By comparison, the risk of serious complications from a surgical abortion is about 0.4%, and the risk of serious complications in childbirth is 1.3%. Despite this safety record, Mifepristone is also subject to “REMS”, risk evaluation and mitigation strategy. REMS requires pharmacies and physicians who carry and prescribe this drug to become certified. No such requirement is in place for Penicillin or Viagra, even though a person is four times more likely to die as a reaction to Penicillin, and nearly ten times more likely to die as a reaction to Viagra, than to die from taking mifepristone.
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Tylenol, available over the counter, is also not subject to REMS, even though it can cause severe liver damage when taken in excess. The REMS mandates on mifepristone limit access to medication abortion, despite its proven safety compared to pregnancy and these commonly used medications.
If this injunction goes into effect, mifepristone will no longer be available anywhere in the United States. As a result, the only option for medication abortions will be to use the drug misoprostol alone. The misoprostol only regimen, already used in some other countries, has a significantly lower success rate of 80%.
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In some cases this means the pregnancy continues. In others, this results in complications such as an incomplete abortion, hemorrhaging, or sepsis at a higher rate than the two drug regimen with mifepristone. The lower success rate and higher complication rate will drive more women to have surgical abortions, significantly increasing wait times, exhausting already stressed resources, and delaying some first trimester abortions to the second trimester where the risks are higher. This will also deepen economic inequality as patients without means to travel for in person care will be disproportionately affected, continuing the cycle of poverty.
A victory for the health and safety of women and girls? I think not.
The legal attacks on mifepristone deny women evidence-based medicine and care by their physicians who have spent many years training to become true experts in the field. Putting lives at risk for political gain is completely unacceptable.
Dr. Jennifer Smith graduated magna cum laude with a BS in biology from UCLA. She moved to St. Louis and graduated with her MD from Washington University in St. Louis and then completed her residency in obstetrics and gynecology at Barnes Jewish Hospital. She is in private practice. She wrote this piece for the Missouri Independent, a sibling site of the Pennsylvania Capital-Star, where it first appeared.
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