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“It was absolutely groundbreaking,” says Dr. Marguerite Cohen, an obstetrician-gynecologist in Portland, Oregon. Dr. Cassing Hammond, an obstetrician-gynecologist in Chicago, Illinois, describes it as a “radical change – a godsend for so many patients who needed it.”
These doctors are referring to the advent of mifepristone more than twenty years ago, a drug that has been approved by regulatory bodies in more than 90 countries as part of a pregnancy termination regimen. Since the United States Food and Drug Administration (FDA) approved its use in 2000, mifepristone has been shown to be over 98% effective in its designated use as part of a two-way medical abortion protocol. medications. It has also proven to be effective in easing the process of a miscarriage.
But on April 7, U.S. District Judge Matthew Kacsmaryk decided to suspend FDA clearance for mifepristone, finding the drug unsafe and its initial regulatory approval had been rushed. The Fifth Circuit Court of Appeals has since agreed to temporarily block the stay while it considers the case, but limited the use of 10 weeks’ gestation to seven, even though the World Health Organization advises that mifepristone can be used safely for 12 weeks. “It’s just made up of whole fabric,” Cohen says of the shortened window. “There is no medicine behind it.”
The court also reinstated a rule that would require patients to have three clinic visits with a doctor to be prescribed the drug, a requirement that for many pregnant women could prove to be a burden.
“It’s really hard to know that you have the scientific expertise to take care of people and to know that it’s been completely undermined by an individual,” said Dr. Gabriela Aguilar, regional medical director for Planned Parenthood of Greater New York. , “or in this case, the policy of an individual.
At the request of the Biden administration, the United States Supreme Court intervened on Friday and temporarily suspended all restrictions on mifepristone until Wednesday evening. Anyone can guess what happens next: the Supreme Court could say that restrictions on mifepristone are suspended until the Fifth Circuit issues its final decision, or the Supreme Court could decide to reconsider the case itself- even in its entirety. If the restrictions are finally enforced, it could take months for mifepristone makers to update their labels to meet the new guidelines: a period during which the drug may not be available. Meanwhile, the availability of a drug that has revolutionized abortion care and the management of miscarriages is at stake, even in states where abortion is legal.
But what would reproductive health care in America look like without mifepristone? To answer this question, Mother Jones interviewed five doctors and reproductive health experts. Abortion would still be safe without the drugs, they said, but their patients would have to choose between more invasive surgical treatments or a more uncomfortable and less effective drug option. Today, medical abortions – usually by the combination of mifepristone and misoprostol – account for more than half of all abortions in the United States.
“The patient experience is going to be terrible,” says Amy Hagstrom Miller, founder of Whole Woman’s Health, a network of independent abortion clinics. “People deserve better.”
Mifepristone is a pill that works by blocking a hormone called progesterone, which the uterus needs to prepare for and maintain pregnancy. Without enough progesterone, the lining of the uterus breaks down and the pregnancy stops growing. The standard regimen for medical abortions in the United States and other developed countries is to take a 200 mg dose of mifepristone, followed 24 to 48 hours later by 800 mg of misoprostol, which causes the softening, dilation and contraction of the cervix, expelling the contents. of a pregnancy.
It will still be possible to have a medical abortion using more doses of misoprostol alone. Misoprostol-only regimens are often the only option for women in developing countries because they are inexpensive. It is also taken to prevent stomach ulcers, making it easy to get even in countries where most abortions are illegal.
The other alternative is a surgical abortion, in which a healthcare provider inserts thin rods into the vaginal canal to manually dilate the cervix, followed by metal instruments or a suction tube to remove pregnancy tissue. Surgical abortion has long been the alternative and was effectively the only option when Roe vs. Wade first became law.
Misoprostol-only regimens are safe and reasonably effective: a review published by the International Journal of Gynecology and Obstetrics in 2007 found that taking misoprostol alone before 9 weeks of gestation was successful in terminating a pregnancy between 84 and 96% of the time. But it’s less effective than the two-drug regimen, which is around 98% effective in patients up to nine weeks gestation.
Patients using the single-drug regimen will usually need to take 2-3 doses of misoprostol, at three-hour intervals, to complete the pregnancy termination, but the process takes longer than with the combined method. “NOTHaving to use a multiple-dose regimen of misoprostol alone would delay this process,” says Aguilar. “It will also be more difficult for people.”
Aguilar was referring to the fact that when using misoprostol alone, patients tend to suffer more side effects. Symptoms may include heavier bleeding, more cramping, nausea, diarrhea, and fever.
Dr. Daniel Grossman, an obstetrician-gynecologist at the University of California, San Francisco, said that if mifepristone were completely taken off the market, “we could switch to using misoprostol only… But that’s not ideal”. He, too, pointed to the larger doses of medication that were needed and the increased likelihood of unpleasant side effects. Also, because misoprostol is slightly less effective on its own, Grossman says more patients may need aspiration procedures to finish expelling uterine contents that haven’t passed with misoprostol.
Surgical abortions are the other alternative. They are extremely safe and have additional benefits: they may require fewer in-person clinic visits, the procedure itself can take as little as five minutes, and the method is slightly more effective than medical abortions, especially as the gestational age increases. But surgical abortions can also be more laborious and expensive than medical abortions and come with their own health risks: infection, heavy bleeding, tearing of the lining of the uterus, and damage to the cervix.
Mifepristone is used not only for abortions, but also to manage miscarriages and stillbirths. A 2018 article in the New England Journal of Medicine showed that patients having a miscarriage were 17 percentage points more likely to expel the entire contents of the pregnancy when they received mifepristone and misoprostol than when they received misoprostol alone. The higher success rate meant that fewer of them had to undergo an aspiration to clear their uterus of remaining pregnancy tissue.
If a miscarriage occurs early in pregnancy, the combination of mifepristone and misoprostol can be taken at home, an option, Grossman says, that may be helpful for patients who “have a lot of emotions around pregnancy loss. “. Pregnancy losses occurring at a higher gestational age sometimes need to be transmitted in a clinical setting. Also in these cases, mifepristone is helpful in hastening the delivery of fetal remains.
“It can literally take days for someone to be induced, and during those extended periods their risk of bleeding and other complications increases,” Hammond says. “When I was in training in the late 1980s, we saw that. We were trying older induction agents all the time and some patients delivered well, but for other patients, it was a long and agonizing process.
Misoprostol, originally designed to prevent NSAID-induced stomach ulcers, began being used off-label as an induction agent in the 1990s. This shortened the time needed to pass pregnancy remains to 12 -6 p.m., Hammond recalls. But adding mifepristone shortened the duration even further: “If you treat with mifepristone before giving misoprostol,” he says, “the average induction intervals are about halved. It’s more like six to nine hours. He estimates that the inductions would be “at least twice as long” if they went back to the misoprostol-only diet.
Since medical abortions using misoprostol alone tend to generate more symptoms, some doctors expect patients to be more likely to contact their practice after taking the drug. That would mean more follow-up appointments at the clinic and more phone consultations, putting a strain on already overworked clinic staff.
If mifepristone is limited, Aguilar also expects more people to opt for surgical procedures in hopes of avoiding the side effects of treatment with misoprostol alone. “We are also preparing for the fact that people might hear this information and no longer be interested in medical abortion,” she says, “so we are preparing for having to do more procedures if the interest in medical abortion decreases”.
Despite currently suspended court restrictions on mifepristone, the workload for OB-GYNs and their clinics is already increasing as they try to deliver safe and effective care plans that keep patients as comfortable as possible. while complying with increasingly strict standards and often uncertain legal codes. But depending on the decision of the courts, these two objectives may no longer be compatible.
“Doctors are caught between what the law is and what medical practice is,” Cohen says. “It is a disaster.”
Additional information was provided by Madison Pauly.