GREENSBORO, N.C. (WGHP) – There is a chance that the safest, most effective and most preferred method for women in North Carolina to have abortions might be off the market by Saturday.

Dr. Beverly Gray of Duke Health (DUKE)

You likely have seen the ruling by U.S. District Judge Matthew Kacsmaryk in Texas on Friday that called for the Food & Drug Administration to remove the abortion medication mifepristone from the market. He gave the FDA a week to respond.

And although a separate decision on the same day by another district judge – Thomas O. Rice in Seattle – set aside any changes in 18 states that had sued to protect access to the pill, the onset of confusion and conflict have left many searching for answers about this week and the future of abortion access beyond. The U.S. 5th District Court of Appeals has received appeals.

A couple of things to know before the questions begin. Mifepristone, prescribed by physicians for both miscarriages and elective abortions, is part of a two-drug cocktail that allows women to have abortions at home and in private and to avoid the timing and side effects of more dangerous and invasive procedures that were required before 2000.

Jolynn Dellinger of Duke Law (DUKE)

The second drug in the cocktail – misoprostol – was not affected by Kacsmaryk‘s decision, and it is the drug that actually causes the abortion. But without mifepristone, its efficacy would decrease and its side effects would increase (more on both of those later).

Since the Dobbs decision in the U.S. Supreme Court last June, North Carolina’s long-delayed restriction on abortions after 20 weeks of pregnancy – the controversial Roe v. Wade had limited procedures at about 24 weeks – went into effect. Lawmakers have talked about tightening that window, and a bill was filed in March in the NC House to eliminate abortions in all cases.

Data about abortions is slow to be compiled, but research by the Guttmacher Institute and the Centers for Disease Control and Prevention for 2020 found that 31,850 abortions were performed in North Carolina. That was about 1 out of every 5 pregnancies (21.4%) at a rate of 15.3, which was higher than the national average of 14.4.

U.S. District Judge Matthew Kacsmaryk listens during his confirmation hearing before the Senate Judiciary Committee on Capitol Hill in 2017. (Senate Judiciary Committee via AP)

“In 2020, 60% of patients seeking abortion care [in North Carolina] sought a medical abortion,” Dr. Beverly Gray, a gynecologist from Duke, said during a conference call.

With all of that as a background, Gray and a fellow faculty member, Jolynn Dellinger, stepped up to offer insight and clarity. Dellinger teaches privacy and ethics at Duke Law and is an adjunct at the University of North Carolina Law School. Gray is the chief of women’s health in the Department of Obstetrics and Gynecology at Duke Health.

North Carolina is one of the states that is fighting the ban on mifepristone. Attorney General Josh Stein joined a group of 24 AGs who challenged Kacsmaryk’s decision. Its seven Democratic members in Congress were included among 240 who signed an amicus brief imploring the 5th District Court of Appeals to toss Kacsmaryk‘s decision because “it has no basis in law.”

But, as Gray pointed out, mifepristone already was under severe restriction in North Carolina, where physicians are required to be present to administer that first dose before sending home the patient with the follow-up misoprostol and subsequent doses.

That’s but one nuance to many aspects of the potential effects from Kacsmaryk‘s ruling. We collected the responses that Gray and Dellinger provided to many questions during their call. They are paraphrased and repackaged here to provide clarity, with some direct quotes sprinkled in.

Q: How does Kacsmaryk‘s ruling affect the use of mifepristone and the decisions that patients make about their health care?

A: Mifepristone is “one of safest drugs that we prescribe. It increases the reception of misoprostol by about five times,” Gray said. Mifepristone primes the uterus and the cervix for the second dose, which is misoprostol. She said that if a patient had to choose a medical solution that is less effective and has more side effects, the patient might choose to have a procedure. Misoprostol has more side effects and less efficacy. Mifepristone is also for miscarriages, and about 1 in 5 pregnancies end in miscarriages. This might require those who had miscarriages to have a procedure. She cited its use for fibroids and other gynecological procedures. There are a “lot of downstream effects if this is taken away as an option,” Gray said. She also noted that at the same time that the FDA was considering mifepristone, it also was evaluating Viagra, a process that took two years vs. four for mifepristone. “And mifepristone is much safer than Viagra,” she said. “They took their time in approval. … We have 20 years of data … millions have used it in the U.S. and more worldwide. It absolutely can be taken in the safety of the home.”

Q: Is misoprostol an acceptable option?

A: Gray said physicians would be comfortable with misoprostol, but she cited “low 90% efficacy in abortion or miscarriage. … For a long time it was only used for miscarriage. We practice evidence-based medicine. This is a good alternative, not best. It’s best to use the two together. It’s more effective and less side effects.” She said mifepristone has no side effects and that its usage limits those in misoprostol, which, she said, included nausea and diarrhea. And without mifepristone, the number of doses of misoprostol would increase.

Q: What would be the effect of outlawing mifepristone for those who are dealing with miscarriages?

A: Gray said that having to use a medication that is less effective could increase the number of procedures for miscarriages, returning to the typical process before the turn of the century. “Patients want to do this in the privacy of their own home. … If a drug is less efficacious, there’s more of a chance the patient would need a procedure.” She also said that the change would change the calculus for patients who were planning to travel.

FILE - Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., March 16, 2022. Health and Human Services Secretary Xavier Becerra on Sunday, April 9, 2023, stressed that women for now continue to have access to the abortion medication mifepristone after the Texas judge stayed his ruling for a week so federal authorities could file a challenge. The drug was approved by the FDA in 2000. (AP Photo/Allen G. Breed, File)
Boxes of the drug mifepristone (AP Photo/Allen G. Breed, File)

Q: What would happen for patients if Saturday were to arrive and the drug had been removed from the market?

A: The Department of Justice has appealed, and a court could stay the judge’s ruling pending a hearing of the case based on its merits or toss out the ruling on some legal precedent. This situation was complicated somewhat by the ruling in Washington on a suit filed by 17 “blue” states that enjoyed the FDA from “making any changes to the status quo.” In North Carolina, there also is an ongoing federal suit brought by a doctor for UNC Healthcare to protect mifepristone and lift restrictions on access. Dellinger said if Kacsmaryk‘s decision goes into effect, the FDA would have to take action to enforce it against any manufacturer or pharmaceutical company that creates the drug. Or the FDA could take no action.

Q: What kind of conversations are Dr. Gray and her colleagues having about the possibilities?

FILE - Bottles of the drug misoprostol sit on a table at the West Alabama Women's Center, March 15, 2022, in Tuscaloosa, Ala. White House officials warned on Wednesday, April 12, 2023, that access to nearly any medication is in jeopardy after a federal judge ordered that mifepristone, a pill commonly used for abortions, be pulled off the market, and they said they're consulting with lawmakers, doctors and pharmacies to fight the ruling. (AP Photo/Allen G. Breed, File)
Bottles of the drug misoprostol. (AP Photo/Allen G. Breed, File)

A: Gray said that they are working on a “variety of scenarios” that included understanding how state law might be impacted. How they might use “off-label medications. Are we able to use medication on the shelf or order more medication? We hope the legislative dust will settle … give us more time to determine this.” She said doctors are consulting with lawyers and are “looking at the protocols for using misoprostol if we have to.” Patients are unsure, she said, and are coming to her clinic and trying to move up scheduled appointments to this week “because they want to have a medication abortion. We are trying to see what’s going on while at the same time practicing medicine. As a physician in the family planning world, it’s frustrating and confusing at the same time.”

Q: If mifepristone were to be banned, what could that mean for other drug approvals by the FDA?

A: Dellinger called this “a great point to raise” and said she thought the pharmaceutical industry was “all over that. They’ve already written a letter with more and more signatures all the time about the consequences of what could happen. It’s unprecedented for a judge to use his medical knowledge to overrule those we’ve charged to evaluate” the effectiveness and safety of drugs. She cited the different responsibilities of the branches of government and that the “FDA is charged by Congress to do this.”

Q: Didn’t the Supreme Court grant abortion decisions to states?

A: Medication abortion is good for privacy. It can be ordered online, received in the mail and taken in the privacy of the patient’s home. It’s also a “less physically invasive option,” Dellinger said, emphasizing that you should “focus on the word ‘choice’ in relation to privacy.” The ruling is “unprecedented” and has effect not just in states that have banned abortions. The argument in Dobbs that it returns to states the regulation of abortion is “misleading. States have been regulating abortion this whole time,” Dellinger said. “Dobbs is an evisceration of the right to privacy … to criminalize abortion … to disregard the interest of women and women’s lives.” She said this is not really up to states but “up to people and their elected representatives and the democratic process.” She mentioned the 13 states where there are total abortion bans and said this is ”not just a states rights issue. She mentioned Associate Justice Brett Kavanaugh’s words in the Dobbs case, in which he said that “the nine unelected members of this court don’t possess right to override democratic policy … can’t determine policy for all 330 million people.” The removal of mifepristone would be across the country and “would decree a pro-life approach for all 330 million. That attempt by one person to decree this new way of life is really inconsistent with some of the language in Dobbs.”

Q: What are other legal possibilities? Could the distribution of mifepristone by mail be banned under the Comstock Act?

A: Dellinger said there were many questions about the viability of Kacsmaryk’s decision. There is the question of whether those who brought the court case had standing to do so. There could be issues with the statute of limitations, given that mifepristone has been on the market since 2000. She said that she thinks an appellate court would get rid of the ruling based on one of those before getting to the Comstock Act, an 1873 obscenity law Intended to prohibit the mailing of contraceptives.

Q: If abortion medication by mail were to be halted, what would that mean for access in states where abortion is outlawed?

A: Gray said in North Carolina physicians are unable to prescribe mifepristone by mail or by telehealth. “In North Carolina, we are required to give the first dose in person,” she said. “North Carolina is a very hostile state for abortion procedure.” Dellinger said patients in some states may be able to get access through programs called Plan C or AidAccess, which distribute the pills online. But depending on the state where they live, patients “need to be aware of criminal laws and how abortion is criminalized,” Dellinger said. “I see this as a feature and not a bug of the situation.” She cited bans that were based on laws on the books since the 1800s, the trigger laws that have been in place since Roe v. Wade in 1973 and the laws passed by states since Dobbs, including homicide codes that “define a fetus as a person. … Sometimes all of those are in one state. … In states that are criminalizing abortion, people are really struggling about what this means. Who can be held liable? … There are huge liberty and freedom aspects.”

Q: What are those broader legal ramifications of Kacsmaryk’s decision? Doesn’t the Constitution protect an individual’s privacy?

A: Dellinger has described the current situation as “pre-1970s law with 2020 surveillance capabilities.” She cited the patchwork of laws that emerged across the country and said that the “criminalization of abortion in 2023 is a whole different ballgame. Part of that equation is medication abortion,” that potentially liberating side of it.” But she noted that we now live in “a surveillance economy suffused with surveillance technologies … driven by data.” She said because of those changes in society that “any laws that prohibit abortion affect physical privacy. … Dobbs and its intersection with digital reality really raise the issue of information privacy.” She said that most people believe that their personal medical data is protected by the HIPPA laws that prohibit the release of information about illness and treatment. But that doesn’t cover anyone but physicians and insurers and in criminal procedures other data habits could be accessed and used. “With cellphones, it would be child’s play for people,” she said. Searches for information about topics such as laws and pregnancy tests create a data trail that makes not only a patient susceptible to legal entanglement but also anyone from a state with a ban who may advise and assist. She called it “criminalizing a bodily function, criminalizing health care.” She said that protected health info via HIPAA is very small. She noted fitness apps, health apps and period trackers, all of which women use to track their reproductive cycles. “Any of those services online that are not providers are not covered under HIPAA [Health Insurance Portability and Accountability Act of 1996],” she said. “When you put in your first day of your last period into Femtech, you are creating a digital record of your reproductive process. That creates a data trail on your phone.” Dellinger said the 4th Amendment of the Constitution that protects against search and seizure in some cases is no help, either. She mentioned the Griswold v. Connecticut ruling, which prevented the state from banning contraception as a matter of privacy. She said in that case law enforcement would have to look into a couple’s home and their marital bed. But if in a state where abortion has been criminalized, “law enforcement can go before a magistrate, get a warrant and check out your device. … The 4th Amendment is not going to prevent searches in states that are criminalizing abortion. … Even if the provider is the target [of the investigation], your body is the place where the ‘crime’ is happening.”

Q: Some of those states with tight abortion bans are in the Southeast. Could a pill ban mean more pressure for states where abortions can be accessed, such as in North Carolina?

A: Gray said she is “worried about the coming weeks.” She cited that Florida provides more abortion care than any state, and it has a 6-week ban that is working its way through the legislature. She said if that goes into effect, physicians were “looking at a tidal wave of pushing patients to nearest states where they can get care.”

Q: How might this ruling affect the long-term future of obstetrics, health care deserts and the availability of reproductive care?

A: Gray said there is a research project underway to determine how abortion laws were factoring into decisions by medical students and where they might go to school and establish practices. “Those we talked to, it did factor in,” she said. “People will be drawn to a field because they have fire in their belly. More will make decisions about ‘where’ they are. If we change laws in North Carolina, we think we might have trouble attracting students. … Where people do residency, usually they stay there and put down stakes.” She said there already is a mortality rate crisis and that she had heard from a physician in North Carolina specializing in high-risk OBGYN treatment who was not planning to stay in the state because laws potentially “hindered her from practicing evidence-based care.” Dellinger pointed to Tennessee, where abortions are banned even in cases where the mother’s life is in jeopardy. “An OBGYN in Tennessee may be committing a felony just by going to work every day,” she said. “If you do an abortion to save the life of the mother, you are able to offer that as a statement” against felony charges.” Said Gray: Being pregnant is like running a marathon. If you are young and healthy, it’s mostly OK. … Pregnancy puts life at risk, even if you are healthy. If you have heart disease, kidney disease, some other critical illness, it’s hard to run that marathon.” She said sometimes there are conditions that could mean an acute risk of death, some with 50% risk but that in Tennessee you are “hindered” from delivering evidence-based care, “even if the risk is 10% which I would say is too risky.” She said doctors support patients who want to continue pregnancy in those situations. “There are many who don’t want to take that risk with their lives,” she said. “They are put in a difficult position.”

Q: Is this purely a civil rights issue?

A: Dellinger said that you must think of “intimate privacy as a civil right.” She mentioned an upcoming book, “Fight For Privacy.” She said candidates for medical schools, law schools and other professional schools are deciding where to live and where to work. If you take “25 states off the table because you can’t rely on evidence-based health care … that’s not equality by any measure.”

Q: Are there any benefits to this ruling?

A: Gray’s response was simple: “For the practice of medicine, there is no benefit. I’m not a lawyer … I don’t’ read opinions often. …. But I read most of this one. … There is a lot of [personal] opinion.  … It doesn’t use scientific language. … I felt it was very disrespectful in reading it.” She said the benefit would be to inspire people to get involved, to get out and vote, to mimic what proponents had seen in Wisconsin’s Supreme Court election last week. She cited the 57% in a Meredith College poll that people wanted “continued or expanded” access to abortion. “People are so happy we are providing care,” Gray said. “We all know and love people in our lives who have had abortions …. You realize people in your lives have needed this care. … Most people seeking abortion already have a family. When they are turned away from care, there is a risk of staying in poverty and being with an abusive partner. … We are going to see people’s everyday lives impacted. … We keep moving and keep caring for people, caring from a deeply moral place.”