Illustration: Angelica Alzona (Gizmodo)
A woman contacted Dr. Ghazaleh Moayedi’s team on a Friday afternoon, nine weeks and three days into an unwanted pregnancy. Although she butted right up against the Food and Drug Administration’s 10-week regulatory deadline, the patient wanted a medication abortion—a difficult request to satisfy on any doctor’s busy schedule, but especially tough in this case: Moayedi, a family planning fellow with Physicians for Reproductive Health, works at the University of Hawaii in Honolulu. The patient lived on a neighboring Hawaiian island. If she wanted to see an abortion provider in person, she’d have to spend a few hundred dollars on a last-minute flight to Oahu or Maui, one of the two islands with physicians authorized to dispense the requisite medication.
This scenario is not unusual: Six weeks into a pregnancy might be just two weeks after a missed period for many people, and terminating a pregnancy early often requires overcoming a financial and logistical nightmare for the average U.S. abortion seeker, who tends to be low-income and often has other children at home. “They still have to work, they still have to take care of their kids, they still have to go to school, they have responsibilities on their home island,” Moayedi explained.
Timely specialist care of any kind can be difficult to procure in an island state, and Hawaii has a solution: Telemedicine, or, the provision of services via a video conference connection on a HIPAA-certified platform. Moayedi’s office used that tool to confirm the woman’s pregnancy, walk through the consultation exactly as they would have in-office, and express ship the medication—along with a full set of the instructions that had already been verbally explained to her—to the patient’s home. The two pills arrived just in time for the woman to terminate her pregnancy within the prescribed 10-week window that the FDA deems effective for outpatient medication abortion.
“There’s really no reason for anyone to be in-person with us, for any of this,” Moayedi said. But while people might beam themselves into a physician’s office to secure a prescription for cold medicine or a yeast infection or even contraception, medication abortion is only available in a few U.S. states. It remains subject to tight restrictions and politically motivated overregulation that make the model implausible for many practitioners across the country, despite its repeatedly demonstrated benefits.
“There’s really no reason for anyone to be in-person with us, for any of this.”
Among U.S. patients, the overwhelming majority of abortions—89 percent, according to the Guttmacher Institute—occur within the first trimester, or 12 weeks, of pregnancy, and 66 percent happen within the first eight weeks. Yet aggressive legislative regulations on the procedure mean women (most often, low-income women) have to put off termination until they’re later along in their pregnancies: They need time to raise funds not just for the abortion (which costs about $500 in the first trimester and becomes more expensive thereafter), but also for transportation to the nearest clinic, for child care, and potentially for lodging if they live in one of the 14 states that mandate a multi-day waiting period between in-person counseling and procedure. They’ll likely have to take time off work, and account for that missed income as well.
Especially for women living in remote areas—at least, those with access to a webcam-enabled device—telemedicine abortion packs huge promise: A 2017 study that followed 20,000 abortion patients in Iowa over seven years suggests that medication abortion is as safe when you see your doctor onscreen as it is when you see your doctor in person. The ability to terminate early, and to visit a provider for pre-procedure screenings in a closer-to-home location, radically cuts down on logistical costs and makes for a relatively more comfortable experience.
Yet despite medication abortion’s demonstrated safety and limited legal availability, stringent FDA regulations mean it cannot be prescribed through a pharmacy or—with the exception of one program New York-based Gynuity Health Projects is piloting in five states—shipped to patients. Only doctors who have registered with the drug’s manufacturer can dispense medication abortion, in their offices, at hospitals, or through their clinics, thereby complicating a process that advocates argue could be accomplished almost entirely within the privacy of a patient’s home. In at least nine state with telemedicine abortion services, technology presents a welcome workaround for situations in which no nearby providers are registered and able to dispense the medication.
Telemedicine abortion operates along two basic models. The direct-to-patient approach on offer in Hawaii is part of a research effort by Gynuity Health Projects. A technical assistance organization, Gynuity helps design and pilot programs that expand access to reproductive health care. The Food and Drug Administration is permitting its “TelAbortion” study to proceed, and Gynuity aims to compile enough evidence to convince the FDA that mailing medication abortion is safe and effective. Currently, Gynuity’s model is only available in Hawaii, Maine, New York, Oregon, and Washington by extension: One of the abortion providers in Oregon also happens to be licensed in Washington State, and in order to provide a telemedicine abortion across state lines, the doctor in question must be licensed in the state where their patient resides.
At Moayedi’s hospital, a patient schedules a video consultation with a physician, which both parties can access from any convenient location on a smartphone, laptop, or tablet—any device that lets them log into the teleconference platform, Zoom. The consultation proceeds along the same lines it would in the doctor’s office: They discuss medical history to pinpoint any drug allergies, bleeding disorders, porphyria, use of blood thinners or chronic steroids, or presence of an IUD. The physician also explains the process: Follow the first drug, oral mifepristone, with misoprostol either six to eight hours later, if inserted vaginally, or 24 hours later, if wedged between cheek and gums. Mifepristone blocks the production of the hormone progesterone, which the body needs to continue a pregnancy. Mifepristone causes the uterine lining to start detaching and softens the cervix; misoprostol triggers uterine contractions that actually expel the pregnancy. Within a few hours of taking the second pill, patients can expect to see blood and to experience heavy cramping, as with a particularly intense period. Cramps can last for hours or even a couple of days (although the pain should dull after the pregnancy passes), and spotting can follow for the next few weeks.
Although first trimester abortion generates major complications about 0.5 percent of the time, the provider runs through the risks before the procedure beforehand, warning the patient about infection and the fever or discharge that might announce it; hemorrhage, and how much blood is too much blood; dizziness and fainting. Then, they make a plan for aftercare—whether the patient will get an ultrasound or blood test to make sure the pills worked—and both parties electronically sign consent forms.
Before the abortion can take place, the patient will need to visit the nearest facilities that offer ultrasounds and bloodwork. Those results route back to the abortion provider, who reviews them for abnormalities—like an ectopic pregnancy, or anemia—before shipping out the medication package: one dose of mifepristone, two doses of misoprostol (one as a back-up, in the rare instance the first dose doesn’t work), and meticulously detailed instructions. According to Gynuity, all packages have arrived on schedule so far.
The second model, a doctor-to-clinic setup piloted by Planned Parenthood in Iowa, is now on offer at Whole Woman’s Health in Peoria, Illinois, and at Maine Family Planning affiliates. It works much the same way, but the teleconsultation happens at the nearest participating reproductive health center, which also handles the patient’s blood work and ultrasound. The patient takes the first pill on-site under the provider’s supervision, but because of the extreme regulations surrounding mifepristone, the actual dispensation comes with a whiff of Hollywood drama: The pills might be presented in a pre-loaded lockbox that the physician opens remotely, or, as is the case at Maine Family Planning, a patient might receive an envelope the providing physician previously packed and sealed with the medication. It’s a big production for two tiny pills but, MFP Program Director Leah Coplon told Gizmodo, it ensures that no one touches the medication between doctor and patient. It’s also miles more convenient for people living in the 81 percent of Maine counties without abortion clinics, who may otherwise have to travel hundreds of miles to reach one of the three cities with providers. In a state with large rural populations, where getting around demands a car, the ability to terminate a pregnancy quickly and without leaving town is crucial.
Since Maine Family Planning implemented telehealth in 2014, the service has taken off: About a quarter of its abortions happen over teleconference, according to Coplon. Among both patients and providers, Coplon said, satisfaction runs high.
“Providers all said that they find that it sometimes creates a more intimate connection with the patients,” she explained. “In the home, the kids are running around in the background, you get to see her in her setting.” And when the provider is at home “instead of the white lab coat in the office,” she added, “you get to see that the provider’s actually a person.” On top of the convenience, there’s “a humanizing element to it.”
And still, enough stigma to stand as a barrier.
The FDA approved mifepristone, pharmaceutically known as Mifeprex, for use in 2000; at the time, Elizabeth Nash—Senior States Issues Manager at the Guttmacher Institute—recalled, advocates hoped that taking the procedure out of its clinical setting would “put abortion where it belongs, squarely within medical care, and [help people] see it as part and parcel of the services that were provided to women. That was the hope, [but] that hasn’t borne out in reality.”
In 2011, the FDA placed Mifeprex in the Risk Evaluation and Mitigation Strategy (REMS) program for, in the administration’s own words, “certain medications with serious safety concerns.” Seven years later, Mifeprex hasn’t budged—despite substantial evidence demonstrating its relative safety. A 2015 study involving more than 11,000 medication abortions found fewer than one third of 1 percent resulted in hospitalization for complications, and as of 2016, the manufacturer’s own numbers showed that just 14 of the 2.8 million people who had taken mifepristone died from complications related to its use. By contrast, the mortality rate for surgical abortion is about .7 deaths for every 100,000 procedures.
In lieu of a comment for this story, the FDA provided links to an informational page on Mifeprex and the associated FAQ page that describe when and by whom it can be prescribed. A spokesperson also reiterated that the REMS designation exists to “help ensure that the benefits of Mifeprex outweigh its risks” and with respect to telemedicine, specifically, stated that “neither the prescriber agreement form nor any of the other Mifeprex labeling addresses the use of telemedicine.” And that omission isn’t particularly surprising—telemedicine is a relatively new technology.
Abortion advocates suspect one plausible explanation for the FDA’s cagey stance on Mifeprex: politics.
In the mid-aughts, telemedicine appeared as a “new, shiny tool that [was] reshaping medical care” across the country, Nash said: Reproductive health care providers spotted an opportunity to make services more widely available to women in communities without accessible clinics. In 2008, Iowa’s Planned Parenthood of the Heartland launched its doctor-to-clinic program, which an anti-abortion organization called Operation Rescue quickly challenged, filing a complaint with the Iowa Board of Medicine in 2010. The board banned telemedicine abortion, but in 2015, the Iowa Supreme Court intervened, ruling that outlawing procedure constituted an “undue burden” on women who want to terminate. Further, they noted, “It is difficult to avoid the conclusion that the board’s medical concerns about telemedicine are selectively limited to abortion.”
That is the case pretty much everywhere legislators go after telemedicine abortion, which they’ve attempted with increasing frequency since local governments shifted dramatically to the right in 2010. That’s when, according to Nash, “you started to see abortion restrictions fly through state legislatures,” some of which targeted telemedicine abortion—often indirectly. One popular maneuver was requiring a physician to be in the same room as the patient for any termination procedure: Currently, 19 states have these de facto bans on the books, even as general practice telemedicine gains traction in state legislatures nationwide.
“Telemedicine is being used more and more in all aspects of healthcare, from connecting specialists to primary care providers, to even doing remote surgery, to doing mental health care with patients directly in their homes,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health and a professor in the department of obstetrics, gynecology, and reproductive sciences at the University of California San Francisco. Culling abortion from the herd “just doesn’t make sense from a medical perspective.” It also contradicts all available evidence—which Grossman suspects could be opponents’ undoing.
In 2016’s Whole Woman’s Health v. Hellerstedt decision, the United States Supreme Court held that legislators can’t curtail or deliberately place hurdles in the way of abortion access without demonstrating that restrictions improve patients’ health and safety. When it comes to medication abortion, multiple sweeping studies show that it does not matter whether a doctor hands pills to their patient directly or dispenses them via telemedicine: health outcomes are overwhelmingly positive. Cut from its red tape cocoon, telemedicine could transform abortion into a procedure performed almost entirely at home.
The ACLU of Hawaii is currently challenging FDA restrictions on medication abortion, pushing for patients’ right to purchase prescription Mifeprex at retail pharmacies, eliminating the shipping requirement and streamlining the process. Gynuity Health Projects is also working with the international mail-order abortion service Safe2Choose on a pilot program that includes two sophisticated pregnancy tests in its drug package. Taken before and after the procedure, the pregnancy test would allow the patient to judge whether or not the abortion took, without obligating them to spend more money and time on an ultrasound or lab work. The overarching goal is to make the process more accessible, so that one day, obtaining abortion services may be almost as simple as taking a trip to your local pharmacy.
Correction: Mifepristone’s effect on the uterine lining, not the uterus, has been specified. We regret the error.
By Claire Lampen
Source: Gizmodo