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With the legal challenge against the abortion pill mifepristone still making its way through the courts, AMA president Jack Resneck Jr., MD, joins to check in on the case and discuss what it could mean to patients, physicians and the future of medicine. AMA Chief Experience Officer Todd Unger hosts.
Find out more on "Next steps in mifepristone court fight: What doctors should know."
Read Dr. Resneck's viewpoint "Judge’s ruling on mifepristone has no basis in medical science."
Speaker
- Jack Resneck Jr., MD, president, AMA
Transcript
Unger: Hello and welcome to the AMA update video and podcast series. Today we're checking back in on the legal challenge against the abortion pill mifepristone. With me to discuss the case and what it could mean to patients, physicians and the future of medicine is AMA President- Dr. Jack Resneck, Jr. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Resnick, thanks so much for joining us today.
Dr. Resneck: Thanks, Todd, for inviting me back.
Unger: We've been closely following the case against mifepristone and there have been some big developments since we last discussed it here on the update. Why don't you just start by catching us up on where the case currently stands?
Dr. Resneck: Well, let me wind things back initially to November, when this case started. And at that time, a coalition called the Alliance for Hippocratic Medicine filed a lawsuit that argued, pretty absurdly, actually, that the FDA did not follow proper protocol in approving mifepristone 23, I think, years ago and arguing that the pill is unsafe.
But neither of those things are actually true. This drug has been used safely and effectively for decades in medication abortion, and it's also been used as standard of care for miscarriage management. And the FDA actually used processes just like it has for many, many other drugs that doctors and patients rely upon.
The physician plaintiffs in this case, as best I can tell, Todd, had never even prescribed the drug. So the AMA basically briefed in court at every step along the way.
But the federal judge in this case, who had really no background whatsoever in medicine, issued a temporary ruling ignoring all of that scientific evidence. And that ruling halted or stayed the FDA's approval of the drug. This was really, in my opinion and the AMA's opinion, a profoundly dangerous step backwards on access to mifepristone.
In this decision, the judge really substituted speculative pseudoscience for the experience and the expertise of the FDA. And he intervened in really highly personal decisions that belong to patients and physicians.
So the FDA immediately appealed and the case has been making its way through the courts ever since, initially in the Fifth Circuit court of Appeals, and ultimately in the Supreme Court. And the latest development really came on April 21, when the Supreme Court said mifepristone would remain available for uses where it's legal in states while an appeal moves forward in the Fifth Circuit, up until it really comes back to the Supreme Court, which I think is pretty likely.
Unger: Well, this case is certainly far from over. A lot of back and forth already, and we're going to keep a close eye on developments. Shouldn't be surprised if folks out there. Because Dr. Resnick, we've seen you on the news a lot about this. But just for the benefit of folks out there, can you give us AMA's position on this issue?
Dr. Resneck: Yeah, Todd. I mentioned that the AMA has briefed, really at the district, appellate and Supreme Court levels. And first of all, that's because we do have very clear policy on this. Now that policy is debated and voted upon by our House of delegates, which is a really large and diverse group of physicians, representing every state medical association and every national specialty society in the country, doctors from red, blue and purple states, small and big practices, urban and rural areas.
And those physicians came together and stated really clearly that government, whatever branch, should not be interfering in access to the full spectrum of reproductive health care.
The second reason we're engaged is that the efficacy and safety of methylprednisolone are backed by overwhelming evidence. It's been used by millions of people. The studies are extensive. And frankly, it has fewer side effects than a lot of other drugs that are approved that we use on a regular basis.
This is really a brazen attack on access to evidence based health care. And as physicians, we know that it would harm our patients. In addition to that, it undermines informed decision making that we do with patients every day. It erodes patient trust in important institutions. It exacerbates social divides and health inequities, and really places the health of the nation at risk.
We can't be a country where access to the care each of us needs is determined by the whims of ideologically driven judges and lawmakers who don't have the medical and scientific training that physicians do.
Unger: And those words ring so true. And read them first in your op-ed in the New York Times. This legal challenge, if it ultimately manages to restrict access to mifepristone or remove it from the market entirely, what implications would that have on access to reproductive care?
Dr. Resneck: It's a great question. I think first of all, medications like mifepristone and misoprostol are used in more than half of abortions in the United States. And while there's really no evidence that patients are harmed by mifepristone, there is abundant evidence that denying care and taking the drug off the market takes a toll.
We know, for example, that patients who are turned away from care and forced to carry unwanted pregnancies experience worse physical health, worse mental health, negative economic consequences, more intimate partner violence.
And we know that these kinds of restrictions, Todd, fall hardest on historically marginalized and minoritized communities. And mifepristone is not only used in termination of pregnancy. It's also used as really just standard of care, everyday treatment in many miscarriages.
So removing access to this drug causes needless suffering, and really puts women experiencing early pregnancy loss at further risk for dangerous infections, for hemorrhage and other complications. So at a time when we already have an unacceptable maternal mortality crisis in this country, I just can't think of a crazier and worse thing to do than to take this drug off the market and take it away from our patients.
Unger: So clearly, huge and negative impact in the realm of reproductive care. But I think one of the points that you have really been focused on is that this case could also have massive ramifications beyond that. And in your op-ed in the New York Times, you wrote that the case has seriously jeopardized our nation's 85-year-old drug regulatory system. Let's talk about that.
Dr. Resneck: Yeah, I did really focus on that in the New York Times op-ed piece. And I was so happy that the New York Times accepted it, and that it got so much national attention in the days leading up to this recent Supreme Court decision.
So this case, as I mentioned, really introduces what's unprecedented, the danger of courts stepping in and upending our FDA approval process that has worked so well, as you said, for 85 years. So if the lower court's rulings aren't ultimately reversed entirely, it really would throw our health care system into chaos that would extend way beyond mifepristone itself.
So upholding any parts of these rulings, in all likelihood, would almost immediately prompt a series of additional challenges to other FDA approved drugs that physicians and patients rely upon every day. You can imagine the things that would follow next in this train of lawsuits, like vaccines, contraception, drugs that we use to treat cancer and arthritis, that just incidentally, if you happen to unintentionally get pregnant while you're on them, can cause issues with those pregnancies, drugs that prevent or treat HIV, new drugs that are being developed with stem cell technology to treat Parkinson's or Alzheimer's or diabetes, or even existing over-the-counter medicines for allergies or heartburn or pain that were developed or tested using stem cells that could be at risk.
So this would really be a dangerous, and frankly reckless step backwards.
Unger: The stakes are clearly really high here. What are you hearing from physicians on this issue?
Dr. Resneck: Well, physicians across the country are deeply concerned, and I would even say dismayed, as they imagine trying to do the work that my colleagues do on the front lines every day. Imagining doing that in a country where a single ideologically driven judge can just take drugs off the market that we and our patients have depended on for years or decades.
And physicians know that they would suddenly have patients who would be living sicker and suffering more, and even dying younger. This just conflicts so deeply with our code of ethics and the things that drew us to medicine in the first place. So there is this sense of urgency.
And that's why the American Medical Association, in partnership with state medical associations and specialty societies, is fighting back, is speaking out. And physicians and our organizations are showing up in legislative bodies around the country, and we're briefing in the courts as well. We cannot let this attack on medicine and on our patients go unchallenged.
Unger: Dr. Resnick, I just want to say thank you for being out there and communicating this particular situation, and representing medicine and physicians and their patients. Thank you so much for joining us today.
If you want to hear more from Dr. Resnick on this issue, we've included links to the New York Times op-ed and an AMA viewpoint article in the description of this episode. We'll be back soon with another AMA Update. In the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this podcast are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
