Well, it must be a day ending in a Y, because the US is currently losing its mind over safe and well-established medical procedures to end pregnancies.
Earlier this month, Matthew Kacsmaryk, a Trump-appointed federal judge in Amarillo, Texas, brought a drug called mifepristone storming into the headlines with a 67-page ruling to halt the Food and Drug Administration's (FDA) longstanding approval of the medication. If the ruling stands, it could lead to a nationwide ban on the drug – which is why the US Justice Department filed an emergency appeal to the Supreme Court on Friday aiming to preserve access to the treatment for patients across the country.
“If allowed to take effect, the [Texas] court's order would thwart FDA's scientific judgment and severely harm women,” the Justice Department said in a statement, reports Sky News. “Particularly those for whom mifepristone is a medical or practical necessity.”
Meanwhile, a competing ruling from a federal judge in Washington state – one which specifically orders the FDA to preserve access to mifepristone in 17 states and the District of Columbia – only adds to the confusion. And while the ruling has been put on hold by the Supreme Court for now, as Justice Samuel A. Alito Jr. granted the government’s request for a stay until Wednesday, legal experts say there are no guarantees on which way the conservative-heavy bench will eventually decide.
But here’s the thing. According to – well, just about everyone, actually – this case is about much more than just abortion. This is why.
What is mifepristone?
Mifepristone, a medication used by some 5.6 million Americans since it was first made available, is the drug at the center of this furor. For decades, it’s been recommended by doctors around the world for use in medical abortions: it was first approved for such treatments by the FDA back in September 2000 and in Great Britain nearly a decade before that, with more than 60 countries and the World Health Organization following suit since 1988, when the drug first became available in France.
In all of that time, mifepristone has been shown to be extremely safe: per FDA figures, there are just five deaths per million users of the medication. To put that in context, it’s less than one tenth the rate of fatalities attributed to “baby”, or low-dose, aspirin – and, in the USA, approximately one sixty-sixth the risk of death from being pregnant at all.
Despite being generally thought of as an “abortion pill”, mifepristone does not necessarily terminate a pregnancy on its own. It’s also not only used for terminating pregnancies: it’s a fairly common treatment for conditions caused by high blood sugar, like Cushing’s syndrome or type 2 diabetes, as well as helping with the management of miscarriages and painful uterine conditions such as non-cancerous tumors and endometriosis.
The drug works by acting as a steroidal hormone blocker: it binds to the body’s progesterone receptors, disrupting the ability of the hormone to reach the placenta and uterus. Without progesterone, the endometrial lining within the uterus breaks down, until eventually – especially within early pregnancy, when virtually all abortions in high-income countries are carried out – it can no longer support the pregnancy at all.
Within 48 hours of taking the mifepristone, the patient will take a second medication: misoprostol. This drug has many uses – it’s often prescribed to treat and prevent stomach ulcers, among other things – but when it comes to pregnancy, it’s primarily used for its ability to induce labor. In other words, when used in a medical abortion, it’s this drug that makes the uterus cramp up and evict the no-longer-viable pregnancy from the patient’s body.
While the drug’s effect is irreversible, should a patient change their mind about the abortion after taking mifepristone, there’s a non-zero chance that they can continue their pregnancy with no lasting effects to them or their fetus. There’s not a lot of data to say just how likely that is – and it depends heavily on how far along in the pregnancy you are – but one 2015 review put the chances of staying pregnant after taking mifepristone on its own at just over one-half.
Why is the judgment so controversial?
Kacsmaryk’s ruling was controversial for quite a few reasons, with commenters such as Scott Lassman, a lawyer with over 30 years of experience in FDA law and policy, calling the decision “more of an ideological or religious tract masquerading as a judicial opinion.”
Medical experts quickly pointed out that many of the supposedly scientific arguments employed in the ruling – for example, the judgment’s claims of mifepristone being unsafe and unreliable, and the plaintiffs' position that the FDA had failed to follow proper protocols when it originally approved the drug – were completely false.
“I can assure you that that approval process was both comprehensive and quite thorough and was done according to the standard procedures at FDA,” confirmed Jane Henney, who led the agency when mifepristone was approved, during a news conference last Monday.
Others highlighted the spurious research underlining the ruling, noting that, for example, a major part of the judgment relies on a tiny, poor-quality analysis of anonymous blog posts on a pro-life website. Other “evidence” relied on flawed data from antiabortion groups such as the Charlotte Lozier Institute – an organization known for its misuse of medical terminology and methodology, University of California, San Francisco, professor and expert in reproductive health and abortion safety Ushma Upadhyay told the Washington Post.
Meanwhile, real researchers who have found their work cited in the judgment have already publicly distanced themselves from the ruling. Oskari Heikinheimo, an author of one such study and a professor of obstetrics and gynecology at the University of Helsinki, said in an interview that the plaintiffs and Kacsmaryk were willfully misinterpreting his work, overemphasizing “adverse events” and ignoring the overwhelming evidence – also highlighted in Heikinheimo’s study – of the drug’s safety.
“The correct scientific way would be to look at the whole body of evidence,” Heikinheimo said. “If you just pick the results that you personally like, then that’s pure nonsense.”
So the problem is just with the science?
Put simply, no. If this were just about methodology or data, the case would be simple, since the evidence is overwhelmingly in favor of mifepristone’s safety and reliability.
But this is a legal ruling, not a peer-reviewed paper – and as such, it has real-world implications that experts fear may permanently change the face of drug regulation in the US.
“This could have precedential value that could apply well beyond abortion medication to standard drugs that the FDA is constantly reviewing,” Lawrence Gostin, a professor of global health law at Georgetown University, told the BBC.
“It's a slippery slope to try to second-guess the scientific judgments of career FDA scientists,” he cautioned.
The fear is that, should the ruling stand, it would mean the opinion of a federal judge, with zero medical training, could override the expertise and conclusions of experts in the field. “The implications of this ruling go far beyond mifepristone,” reads a statement of opposition signed by 30 patient advocacy organizations representing those with serious health conditions.
“If this judge’s ruling is allowed to stand, patients may no longer have the security of knowing that determinations about drug safety ultimately lie with the experts.”
And with the current onslaught of reactionary legislation against trans healthcare and COVID-19 treatments, such an outcome is especially worrying. “It's going to trickle down,” warned I Glenn Cohen, a Harvard Law School professor, to the BBC. “[It will] be the worst for drugs that are needed sometimes by discrete and insular minorities.”
Theoretically, though, virtually any drug or treatment approved by the FDA would be up for grabs – with the authority of the agency being massively undermined as a result. And the implications may extend even further than that, with legal experts warning that the ruling may affect the ability of other regulatory agencies, such as the Environmental Protection Agency and the US Centers for Disease Control and Prevention, to make scientifically informed decisions to protect Americans’ health.
“If they're unable to use the very best scientific evidence, then America is going to be far less safe and far less healthy,” Gostin said.
Will the ruling stand?
While the current US Supreme Court is known for its pretty antagonistic attitude towards abortion science, there are still reasons to hold out hope that Kacsmaryk's ruling will not become federal law.
These mostly come down to legal issues rather than scientific ones: for example, Adam Unikowsky, an attorney who previously clerked for conservative Supreme Court Justice Antonin Scalia, called the decision “indefensible,” and based on “egregiously… [and] profoundly wrong” arguments which are “disconnected from reality.”
“Vague speculation that someday, somewhere, some unspecified doctor will be overwhelmed by an onslaught of patients coming into the [emergency room] after taking mifepristone does not establish that these particular doctors face an imminent risk of a concrete and particularized harm,” he wrote, attacking the idea that the plaintiffs have suffered the legal injury required to justify the case.
Further, the Supreme Court has shown a tendency to defer to scientific agencies’ expertise in the past. This is true even when it comes to medical abortions: in January 2021, the conservative Chief Justice John Roberts technically sided with the FDA in a case surrounding abortion medications, saying that “courts owe significant deference to the politically accountable entities with the background, competence and expertise to assess public health.”
That may be crucial in this case. After all, as Gostin told the BBC, “if the FDA can't approve [mifepristone], I'm not sure what the FDA can approve… It's been on the market for over two decades, [and] it's got an impeccable health and safety record.”
Will medical abortions still be legal in the US if the ruling holds?
Yes – at least at the federal level.
While mifepristone is commonly thought of as “the” abortion drug, it’s misoprostol that empties the uterus – and doctors are able and willing to perform misoprostol-only abortions if mifepristone becomes outlawed in the US.
While this route can have slightly more side effects, and be slightly less reliable, than the two-drug regimen, it’s still “incredibly safe and effective,” Kristyn Brandi, a New Jersey family planning specialist and spokesperson for the American College of Obstetricians and Gynecologists (ACOG), told NPR.
Multiple organizations, including the ACOG and the World Health Organization, have ruled that the misoprostol-only protocol is an acceptable choice, particularly when mifepristone isn't available. And, perhaps ironically, it’s misoprostol which is the faster-acting and more accessible drug, since it’s already subject to fewer regulations than mifepristone.
“Medication abortion and miscarriage management will not go away with the loss of mifepristone, but it may look a little different,” Brandi said.