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World These Start-Ups Could Make Abortion One Click Away

12:35  16 may  2021
12:35  16 may  2021 Source:   thedailybeast.com

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In California right now, you can get an abortion without speaking to a single other human being. You log onto a website—mychoix.co—put in your health information, answer some questions, and wait for an email from a clinician letting you know if you’ve been approved. If you are, an online pharmacy will ship you a package of mifepristone and misoprostol—a two-pill regime that is safer than many prescription drugs and 98 percent effective at terminating early-stage pregnancies. You will take it, you will bleed, your pregnancy will—in all likelihood—end.

mychoix © Provided by The Daily Beast mychoix

This particular configuration is available in only one state, for a limited time, due to an emergency declaration issued by the Food and Drug Administration during the pandemic. But make no mistake: This is the future abortion advocates want.

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Medication abortion has been available in the U.S. since 2000, when the FDA approved a mifepristone-based drug called Mifeprex for use in ending early-stage pregnancies. At the time, the administration also attached a set of restrictions known as an REMS to the product’s distribution—something it has done for less than 0.01 percent of the 20,000 drugs it’s ever approved for use. The REMS required Mifeprex—which is safer than both penicillin and Viagra, and 14 times less dangerous than giving birth—to be prescribed and dispensed in-person, by a certified prescriber, at a clinic or hospital. That meant the medication could not be obtained at a pharmacy, but had to be obtained from a physician willing to register with the drug manufacturer and stock the medication in their office. The result was that abortion pills—the most common way to end a pregnancy in several other countries—were harder to access in the U.S. than fentanyl or oxycodone.

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Ever since then, advocates have been pushing to get the REMS on Mifeprex reduced or repealed entirely. The American Medical Association, American Public Health Association, and American College of Obstetricians and Gynecologists (ACOG) have all called on the agency to lift the restrictions. The ACLU sued the Trump administration over the restrictions in 2017; ACOG signed onto the suit last year. The agency eventually updated the medication’s label, extending how long into a pregnancy it could be used, but it refused to alter the dispensing restrictions.

Then, in July of last year, a federal district court in Maryland did what no advocate or medical group had been able to do: It ordered the FDA to lift the in-person requirement on mifepristone for the duration of the COVID public health emergency—clearing the way for providers to see patients remotely, and to send abortion pills by mail.

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“By causing certain patients to decide between forgoing or substantially delaying abortion care, or risking exposure to COVID-19 for themselves, their children, and family members, the InPerson Requirements present a serious burden to many abortion patients,” Judge Theodore Chuang wrote in the 80-page decision. “Particularly in light of the limited timeframe during which a medication abortion or any abortion must occur, such infringement on the right to an abortion would constitute irreparable harm.”

In Washington state, Dr. Jamie Phifer—an abortion provider who has worked at abortion clinics for 10 years, and in telemedicine for two—heard the news and sprang into action.

“I called one of my colleagues who does brick-and-mortar [abortion] practice and I was like, ‘I got an idea,’” she told The Daily Beast. “‘I think we could do this.’"

Phifer launched her company, a telemedicine abortion service called Abortion on Demand, in April. And she wasn’t alone. In the months between July—when the in-person requirement was lifted—and today, at least five other companies across the U.S. started offering abortion pills by mail. Several brick-and-mortar abortion clinics, including one Planned Parenthood affiliate, started offering direct-to-patient abortions, too. (Four Planned Parenthood locations were offering the service before last year through an experimental research study.)

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The launch of these companies signaled a sea change in the way Americans can access abortion. Some of them look familiar, with the bright color schemes and slightly mind-numbing technical language of a local health clinic, but others boast the sans serif fonts and twee illustrations of a typical millennial startup. (“Your body. Your health. Your time,” reads the tagline for Choix, which notes that the “x” on the end of its name “allows for more gender neutral language.”) All offer online visits with a licensed provider, same or next-day appointments, and overnight shipping. There are no exam tables, no hospital gowns, no throngs of angry protesters.

Most of the companies require patients to speak with a provider for at least 10 minutes before receiving their prescription. (Choix can offer prescriptions by email because of the more relaxed telehealth laws in California.) But the process is less time-intensive and more automated than going into a clinic or doctor’s office and meeting with a provider. “Everything that doesn't require a human being to gather information is functionally done by a robot,” Phifer said.

The automation allows the companies to keep prices low—four of the five companies charge less than $250 for the entire service—and serve a high volume of patients. Choix would not release exact numbers, but said they’d served several hundred patients since launching the service in October; Minnesota-based company Just The Pill served over 100 between October and January.

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While the numbers are low compared to the more than 600,000 people who get abortions in the U.S. each year, they are reflective of a growing trend. Already, the percentage of patients choosing medication abortion has jumped from 14 percent in 2004 to nearly 40 percent in 2017.

“I do think this is the future of medication for abortion for most folks,” said Dr. Colleen McNicholas, Chief Medical Officer at Planned Parenthood of the St. Louis Region. “It’s meeting them where they are, in their homes.”

Especially in the early days of the pandemic, the need for the service was obvious. No one wanted to go to a doctor’s office—and even if they could, many had kids at home or sick families to care for. The Planned Parenthood that McNicholas oversees in Illinois was the first to start offering pills by mail last year, and it quickly started receiving requests from as far away as Texas. (Texas Gov. Greg Abbott paused abortion services at the beginning of the pandemic, claiming he wanted to save medical resources for COVID patients.)

Leah Coplon, program director at Maine Family Planning, said she received multiple requests to ship abortion pills to New York—including from a woman whose partner was working overtime as an ER doctor and couldn’t find anyone to take care of her kids.

“She was like, ‘I can’t leave and I can’t bring my kids to any clinic… I don’t have a way to get an abortion right now,’” Coplon said. “There were several people in similar situations who really felt that they didn’t have another option.”

Despite the high demand, the rollout wasn’t exactly seamless. On Jan. 12, six months after the in-person dispensing requirements were lifted, the U.S. Supreme Court overturned Judge Chuang’s ruling. Overnight, Trump’s FDA was free to enforce the restrictions, and the providers were barred from providing abortions by mail.

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Julie Amaon, the medical director for Just the Pill, said her company went back to basics after that, securing a mobile clinic and driving 1,200 miles around Minnesota each week to deliver abortion pills in person. Phifer, meanwhile, suspended the launch of her business entirely, canceling contracts with service providers and calling off a pre-planned article in Marie Claire. On the day the decision was announced, she had already ordered thousands of dollars worth of mifepristone from an online pharmacy—medication which she could no longer ship. “I called the owner of the mail order pharmacy and was like, ‘Do not accept! Do not accept!’” she recalled. She joked later: “I’ve lost about 10 pounds of weight in stress in the last four months.”

The providers sat in limbo for three months, waiting to see what the Biden administration would do. On April 12, to their relief, the FDA announced it would voluntarily rescind the in-person requirement—at least for the duration of the public health emergency. Several companies told The Daily Beast they started shipping pills again the next day.

But the FDA had a final surprise in store: Just last week, the agency announced it would launch a full-scale review of the REMS—a move many advocates believe is the first step in repealing them entirely.

“The scientists, the medical reviewers, are being tasked with: ‘OK, you assess the evidence and you tell us what to do,’” said Kirsten Moore, director of the Expanding Medication Abortion Access (EMAA) Project. “From our perspective, the data all points in one direction: The REMS are outdated and should be lifted.”

The driving force behind the expansion of medication abortion is ease of access. The hundreds of abortion restrictions passed by state legislatures since 2011 have made getting an in-clinic abortion a headache at best, and impossible at worst. Dozens of clinics have been shuttered by these regulations in recent years; six states have only one clinic left, and 11 million women live more than an hour’s drive from the nearest abortion provider. Even when they get to the clinic, abortion-seekers face mandatory 24-hour waiting periods, forced ultrasounds, and required counseling on fetal pain.

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A medication abortion by mail, by contrast, feels simple: all you need is an internet connection, a mailing address, and about a day to recover. Multiple providers told The Daily Beast they often saw patients who were in their cars, fitting their telehealth visit between class or errands. McNicholas said a number of patients took their appointments on their lunch breaks. “They could schedule their appointment at 11 o'clock, go out to their car or close their office door, have their health-care visit and then move on with life,” she said.

Mail-order abortions are especially helpful in rural areas—93 percent of the patients at McNicholas’ clinic who used the service last year lived in a rural community—but they are also useful for people with children, who are in an abusive relationship, or who simply want privacy around their decision. Phifer said her own job was pretty much the same whether she was prescribing in-person and online, but the difference in her clients was noticeable. “I think because they’ve gone through less steps to get an abortion, when I do see them on their video they seem more relaxed, or they just seem more…” she paused. “They didn't have to walk through a line of protesters. So that’s been really meaningful.”

Advocates are quick to point out that medication abortion is not a silver bullet for access. Besides the logistical issues—needing an internet connection and a consistent mailing address, to start—there are medical ones. Medication abortion is only available up to 11 weeks into pregnancy, and is not recommended for people with severe anemia or who are at risk for an ectopic pregnancy. For people who are further along in their pregnancy, who have medically risky pregnancies, or who simply want to see a provider face to face, Abortion Care Network Deputy Director Erin Grant said, “we'll always need in-clinic abortion."

And conservatives are already moving to limit access to medication abortion as quickly as they did with surgical procedures. Thirty-two states have passed laws requiring a doctor to dispense the abortion pills, despite recommendations from the World Health Organization and other medical groups that mid-level providers like nurse practitioners be allowed to prescribe it. Nineteen states require that the prescribing clinician be physically present with the patient when they take the abortion pills, thereby banning abortion by telemedicine.

Anti-abortion activists, meanwhile, have seized on the false notion that most women regret their abortions, setting up clinics and hotlines to promote an unproven method of “abortion reversal.” The method’s proponents claim they can stop a medication abortion in its tracks if the patient consents to taking a high dose of progesterone instead of the second abortion pill. There is no concrete evidence that this procedure is either safe or effective—the only major study on it had to be stopped halfway through after several participants were hospitalized—but eight states passed laws requiring physicians to tell their patients about it anyway.

The irony is that brick-and-mortar clinics are the institutions most likely to challenge restrictive laws like these in court. (Every challenge to an abortion restriction heard by the Supreme Court since 1973 was filed on behalf of a clinic or provider.) They are also more likely to be engaged and politically active in their communities, and provide crucial services like STI testing, contraception, and the kind of medical counseling needed to combat false ideas like “abortion reversal.”

For these reasons, advocates say, the fight to expand access to abortion pills cannot come at the expense of brick-and-mortar clinics.

“When we treat pills like they’re a silver bullet for our conversation about access to abortion in this country, we’re just forgetting that all options should be on the table, and these are two different procedures that work for different people,” said Grant.

“I feel like we're in this moment right now where it's like, ‘Why can't we have both?’” she added. “Why not dream big?"

Most of the providers who spoke to The Daily Beast were confident that telemedicine abortion is here to stay. (Other clinicians were, after all, shipping pills across the country before it was even legal.) Several of them were in a group WhatsApp, where they shared advice on how to manage their text lines or which online consent forms were best. The group meets every few months by Zoom.

But the providers also know that the future of medication abortion—of abortion in the U.S. in general—is precarious. The current hold on the REMS lasts only until the end of the federally declared public health emergency, which could end at any time, and the result of the FDA’s review isn’t expected until November.

Phifer said that’s one of the reasons she didn’t take investor money or partner with an existing clinic when launching her business.

“If something happens with my company it will be awful for me, and it will be awful for my financial wellbeing, but it won’t take down a clinic or an entire group of clinics,” she said.

Later, she added with a laugh: “I don't think this is going to be my retirement plan. I just would be really mad at myself if I didn't try.”

Read more at The Daily Beast.

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usr: 17
This is interesting!