The Challenges of Innovating Access to Abortion

 

Medical abortion should make access easier, but some of the more recent state restrictions also make getting abortifacient drugs, which are already constrained by the REMS, more difficult. Seventeen states require that a clinician be physically present when the mifepristone is taken. Thirty-four states require those clinicians to be licensed physicians. Women who obtain and self-administer abortifacients outside the traditional medical establishment, typically from an Internet pharmacy, may be subject to arrest and imprisonment. In 2013, a woman in Pennsylvania who had ordered them online for her teen-age daughter was sentenced to a nine-to-eighteen-month jail term for "providing abortion without a medical license, dispensing drugs without being a pharmacist, assault and endangering the welfare of a child." It is now possible to order these medications through Aid Access, a program overseen by a doctor in the Netherlands. So far, no one has been arrested, but the promulgation of fetal-homicide laws—thirty-eight states now have them—and aggressive prosecutors puts women at risk of arrest if they obtain them this way. According to the Guttmacher Institute, "these laws are even being used to pursue women who are merely suspected of having self-induced an abortion but in fact had suffered miscarriages."

https://www.newyorker.com/science/elements/the-challenges-of-innovating-access-to-abortion

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A year ago, when Kanuʻuhiwa Thomas, a twenty-four-year-old who lives in Hawaii, found out that she was pregnant, she decided to terminate the pregnancy. (Kanuʻuhiwa Thomas is an alias.) "I don't have any type of support system," Thomas told me. "I'm still trying to finish my schooling, which is really important to me because a lot of girls here don't finish their education—they just get pregnant and maybe get married and have kids and have to live off the system. I'm just kind of adamant about making sure I can take care of a child before I have one."

Hawaii has one of the most liberal abortion policies in the country, but, like many rural and geographically expansive states, services are hard to come by. At the time, only two of the Hawaiian Islands had abortion providers—Maui, which is a hundred miles from the Big Island, where Thomas lives, and Oahu, two hundred miles away. She began to make phone calls. "All I wanted was someone who could help me do it," she said. "I was afraid they were going to scold me on the phone and hang up." Eventually, she heard about a service called TelAbortion, which uses video conferencing to connect doctor and patient. Once an ultrasound confirms that the pregnancy is no more than ten weeks along and the TelAbortion physician gives the O.K., the patient is sent medications that, essentially, induce a miscarriage, ending the pregnancy.

Telemedicine—obtaining medical services over the phone or through the Internet—is not a new phenomenon. In the U.S., it began to take off in the late nineteen-fifties, and a 2016 federal grant to increase access to health care in rural areas has made it more mainstream. Medical abortion (as distinct from surgical) relies on a drug protocol that was approved by the Food and Drug Administration in 2000. What makes TelAbortion unique is the coupling of the two technologies. It enables a woman to terminate a pregnancy in the privacy of her own home, but with medical oversight.

The F.D.A. protocol, which involves two drugs—mifepristone and misoprostol—now accounts for thirty-one per cent of all non-hospital abortions in the United States, according to a 2014 study from the Guttmacher Institue, a nonprofit reproductive-health research and advocacy organization. When the two medications are taken together, they work between ninety-five and ninety-nine per cent of the time, depending on gestational age. Medical abortion has also proved to be safe. According to the Guttmacher Institute, complications from medical abortion result in hospitalization 0.4 per cent of the time. By contrast, a study published in the New England Journal of Medicine, in 2017, found that women are fourteen times more likely to die from pregnancy-related complications than from taking mifepristone for a medical abortion. (Mifepristone can be taken by itself, but it is more effective taken in tandem with misopristol.)

The TelAbortion service that Thomas hoped to use is part of a five-state trial that the reproductive-health initiative Gynuity launched, in 2016, in response to the ever-diminishing availability of abortion services in the United States. As of the end of January, two hundred and eighty-three women had received TelAbortions, a hundred and fifty-eight of them in Hawaii. The Gynuity trial, which is also available in New York, Oregon, Washington, and Maine, is not the first or the only medical-abortion protocol. More typically, women are required to visit a clinic and take the abortifacient drugs in the presence of a clinician. What makes the TelAbortion protocol so unusual is that once a woman consults with a physician, she is on her own.

Dr. Bliss Kaneshiro, an ob-gyn at the University of Hawaii, who is one of four physicians in her practice participating in the Gynuity trial, told me that consulting with patients over the Internet has been surprisingly intimate. "I was worried that the video visits wouldn't be as personal as they are in the office, but I've found it's very personal," she said. "I get to glimpse into people's lives. I see kids in the background and a partner listening. I see patients in their bedrooms. I get a sense of how this is playing out in their lives."

So far, Kaneshiro has done about eighty telemedical abortions. "So many patients have vocalized how much they've preferred this de-medicalized process," she said. One patient who lived a mile from the office simply preferred to communicate screen-to-screen. But most of the women in the trial, like Thomas, are hampered by geography, finding it expensive and often logistically impossible to access distant services. "I didn't have to get a hotel or buy a flight to Oahu," Thomas told me. "I got to be home, which was not just financially efficient, it was just comforting and private." The total cost of her abortion was less than three hundred dollars.

Leah Coplon, who runs the Gynuity trial in Maine, said, "For some folks, it's a scheduling issue. Even though we have very good access here in Maine, it still can be hard if somebody works nights or they only have child care on weekends." This flexibility is vital, Coplon told me, but so is the opportunity to avoid the gauntlet of protesters who routinely show up at clinics that provide abortion services.

Although the five states in the TelAbortion trial have some of the most accommodating abortion laws in the country, Gynuity is only able to run the trial with a waiver from the F.D.A., which has put onerous restrictions on the distribution of abortifacients. Mifeprex, the trade name of mifepristone, is one of only seventy-five F.D.A.-approved medications (out of thousands) controlled through its Risk Evaluation and Mitigation Strategy (REMS), and only one of fifty with its most stringent restrictions. According to the F.D.A., REMS, which regulates such drugs as Clozapine, an antipsychotic medication, and Thalidomide, which is known to cause birth defects, is a drug-safety program for "medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks." The REMS mandates that Mifeprex only be dispensed to a patient in a clinic, medical office, or hospital. A doctor can't send a patient to her local pharmacy with a prescription for the medication, because pharmacies are not allowed to carry it. This limits the ability of physicians to administer the medication and of patients to obtain it, despite nearly twenty years of evidence demonstrating its safety and efficacy, which is why the American Congress of Obstetricians and Gynecologists has recommended eliminating the REMS altogether. An F.D.A. panel of experts recommended eliminating one aspect of the REMS in 2016 when the Mifeprex REMS came up for review. It was overruled by the F.D.A. commissioner, an Obama appointee.

In 2017, the American Civil Liberties Union sued the F.D.A. over the REMS on behalf of the California Academy of Family Physicians; the Society of Family Planning; Pharmacists' Planning Services, Inc.; and Dr. Graham Chelius, the chief of staff at Kauai Veterans Memorial Hospital, who is the named plaintiff. "While many of my patients have much-wanted pregnancies, a substantial percentage choose to end their pregnancies and come to me seeking abortion care," he wrote in his sworn testimony. "Most of these women are medically eligible for the FDA-approved medication abortion regimen." The problem, according to Chelius's lawyer at the A.C.L.U.'s Reproductive Freedom Project, Julia Kaye, is that the REMS makes this impossible because "rather than writing a prescription for the patient to fill at a retail pharmacy, you have to get multiple layers of approval. It has to go through the pharmacy therapeutics committee and you may need the chief resident to sign off and the nursing committee and all the way up to the chief medical officer." As Chelius wrote in his testimony, "If I were to comply with the Mifeprex REMS, I would be doing more than just supporting access to abortion in my individual professional capacity. I would also have to involve, and win the approval of, multiple colleagues and staff members in the process of procuring, stocking, dispensing, and billing for Mifeprex." For Dr. Chelius, who practices in a small, tight-knit community, there are also privacy concerns. Almost everyone knows someone who works at the hospital. He is also concerned for his and his family's safety.

As the A.C.L.U. lawsuit wends its way through the legal system, Republican members of Congress, the President, and a number of state legislatures continue to whittle away at the constitutional right to abortion established by Roe v. Wade. In late February, the Trump Administration said that it would eliminate family-planning funding for organizations that refer patients to abortion services. A few days later, legislation introduced by Senate Republicans which would have placed criminal liabilities on doctors who failed to save the lives of babies born alive during abortions was narrowly defeated. (Opposition to so-called late-term abortion has become a public relations strategy of anti-abortion advocates—most recently, Donald Trump accused pro-choice Democrats of encouraging infanticide—even though third-trimester abortions are extremely rare and live-birth abortions even rarer.)

Meanwhile, a number of state legislatures are passing laws to ban abortions in the event that Roe is overturned by the Supreme Court, while simultaneously making them increasingly difficult to obtain: more than four hundred new abortion restrictions have been passed since 2011. An Iowa law, which was struck down at the beginning of the year, sought to ban abortions as soon as a fetal heartbeat could be heard, sometimes as early as six weeks, before many women know they are pregnant. Arkansas passed a comparable law, in 2013, that was also struck down, but other states—Florida, Kentucky, and Missouri among them—are considering similar bans. There are now six states—Mississippi, Missouri, North Dakota, South Dakota, Kentucky, and West Virginia—with only a single abortion provider. In states like Texas, where the number of abortion clinics has been halved, some women have to travel up to three hundred miles to a clinic and then are forced, by law, to wait twenty-four hours after their first appointment before receiving an abortion.

Medical abortion should make access easier, but some of the more recent state restrictions also make getting abortifacient drugs, which are already constrained by the REMS, more difficult. Seventeen states require that a clinician be physically present when the mifepristone is taken. Thirty-four states require those clinicians to be licensed physicians. Women who obtain and self-administer abortifacients outside the traditional medical establishment, typically from an Internet pharmacy, may be subject to arrest and imprisonment. In 2013, a woman in Pennsylvania who had ordered them online for her teen-age daughter was sentenced to a nine-to-eighteen-month jail term for "providing abortion without a medical license, dispensing drugs without being a pharmacist, assault and endangering the welfare of a child." It is now possible to order these medications through Aid Access, a program overseen by a doctor in the Netherlands. So far, no one has been arrested, but the promulgation of fetal-homicide laws—thirty-eight states now have them—and aggressive prosecutors puts women at risk of arrest if they obtain them this way. According to the Guttmacher Institute, "these laws are even being used to pursue women who are merely suspected of having self-induced an abortion but in fact had suffered miscarriages."