WENY News - Abortion pills now available by mail in US -- but FDA may be inv

Abortion pills now available by mail in US -- but FDA may be investigating

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By Jessica Ravitz, CNN

Signaling a new chapter in the battle over abortion access in the United States, a European organization is providing Americans a way to get doctor-prescribed pills by mail to medically induce abortions at home.

Aid Access says it uses telemedicine, including online consultations, to facilitate services for healthy women who are less than nine weeks pregnant. If a woman completes the consultation and is deemed eligible for a medical abortion, the organization's founder writes a prescription for the two pills used to terminate the pregnancy, misoprostol and mifepristone. Prescriptions are sent to a pharmacy in India, which fills and mails orders to the US.

There are other ways to get abortion pills by mail in the US, but Aid Access is the most affordable option at $95 and one that offers the possibility of financial help, as stated on its website. Plus, Aid Access is the only company to offer physician oversight, according to a report card issued by the grassroots group Plan C, which seeks to educate women about self-managed abortion.

The US Food and Drug Administration, however, warns against buying mifepristone over the internet and says consumers who do so bypass distribution safeguards in place to protect them. As a result, the FDA announced in mid-October that it was evaluating the practices of Aid Access "to assess potential violations of U.S. law."

The agency was more measured this week, saying it was "not able to confirm or deny the existence of an investigation."

Advocates for abortion access say restrictions on mifepristone distribution serve to prevent women, girls and transgender men from getting the medical care they need and want.

Aid Access's founder, Dr. Rebecca Gomperts, said this week that she had not heard from the FDA. She said that the agency's handling of the drug is "based on politics, not science," and that the safety concerns the agency points to are "totally unfounded."

"That's the problem," she said. "I have no worries. Everything I do is according to the law."

'To serve women who don't have access'

Gomperts is not new to this work. Twelve years ago, her site, Women on Web, went live to offer a similar service to women living in countries where abortion is illegal. Each month, she says, the Women on Web help desk receives 10,000 emails in 17 languages.

Not everyone who reaches out needs or gets prescriptions. Women on Web mails out about 9,000 abortion pill packages each year, Gomperts said. Among those she's served: women in the US military who are serving abroad and have nowhere to turn, she said.

The organization is available to answer questions about self-managed abortion and refer women to local clinics or resources they may not know are available to them. Women on Web -- and now Aid Access -- is "not intended to replace existing services" but "to serve women who don't have access," Gomperts said.

Since being quietly introduced in April, Aid Access has fielded 3,000 requests for help from within the US, Gomperts said. And she's written prescriptions for 600 women.

Those numbers are likely to jump after the initiative went public several weeks ago, a move spurred by the recent confirmation of Supreme Court Justice Brett Kavanaugh. Abortion rights activists, including Planned Parenthood, have argued that Kavanaugh will usher in the end of Roe v. Wade, which legalized abortion in the US and made it a constitutional right in 1973.

A 'moral obligation'

Interest in and use of medical abortion in the US has risen in recent years. A study published in 2015 showed the regimen to be about 97% effective.

The protocol combines two drugs. Mifepristone blocks progesterone, a hormone that allows a pregnancy to continue. Misoprostol stimulates the uterus, causing it to cramp, bleed and contract -- thereby ending the pregnancy in what is essentially a miscarriage, Aid Access explains on its website.

Even as the overall number of abortions declined, medical abortions grew from 6% of nonhospital abortions in 2001 to 31% in 2014, according to the Guttmacher Institute, a reproductive rights think tank. And in 2014, 45% of abortions before nine weeks of gestation were abortions induced by medication.

Searches online for ways to self-manage or self-induce abortions also indicate a growing demand for alternatives perhaps driven by barriers to clinic access due to financial hardship, geographic distance, fear of being publicly shamed or other reasons. Research published this year showed that in a one-month period in 2017, nearly 210,000 Google searches in the US were for information about self-abortion.

Gomperts says the need to give women in the US a safe option became increasingly clear as state restrictions to abortion access continued to mount. The election of President Donald Trump sounded yet another alarm, she said, as her hopes for improvement under a Hillary Clinton presidency were dashed.

Over the past year, Women on Web, which was never set up to help those living in the US, began receiving approximately 1,000 emails every month from people in the country. The organization heard from women who threatened to harm themselves or who had thrown themselves down stairs to try to end their pregnancies, Gomperts said. It heard from hopeless pregnant women who were living with their kids in cars.

Gomperts knew that women might take pills or ingest other substances that weren't safe or turn to online pharmacies that aren't always reliable and that many women weren't getting the medical guidance they wanted and deserved.

"I realized it was time," she said. "Something had to be done."

Calling it her "moral obligation" as a doctor, Gomperts said, "It's not acceptable to stand by and watch the desperation of women that are in need of a normal medical procedure and they can't get access to it."

'A disaster waiting to happen'

The response to this new service from anti-abortion activists came quickly, as soon as an October news release about Aid Access began to circulate.

"Handing out deadly drugs through the mail is a disaster waiting to happen," Kristan Hawkins, president of Students for Life of America, said in a statement.

"We know that women have died using chemical abortion drugs," she said. "Risking women's lives to make a political point and a quick profit makes no sense, and we sadly anticipate horror stories when inevitably something goes wrong."

Americans United for Life weighed in with an emailed list of talking points from Catherine Glenn Foster, the advocacy group's president and CEO.

Foster called Gomperts' latest initiative "reckless and irresponsible." She pointed out that without an ultrasound, a woman can't know whether she has an ectopic pregnancy, "a dangerous and potentially life-threatening condition that no abortion clinic would try to manage."

She warned that the pill doesn't necessarily work and that women for whom it backfires face the risk of infections and complications that may require surgical abortion procedures.

She added that for women who can't have surgical abortions, "engaging in chemical abortion ... is like playing Russian roulette with their health, because an unsuccessful chemical abortion may lead to a far riskier surgical one."

Lastly, Foster mentioned that her organization is looking into ways to stop Aid Access.

"Because Gomperts' plan is dangerous to women's health and safety, the act of sending unregulated prescription abortion pills through the mail should be the subject of federal regulation," she said. "For this reason, Americans United for Life is exploring the possibility of Congressional intervention to protect women."

Foster has since added that her organization is researching the subject and is "in discussions with potential sponsors of federal legislation relating to the matter."

What the numbers say

These criticisms from anti-abortion groups, which are couched in concern about women, don't faze Gomperts. She says that people who fixate on the risks of medical abortion "don't believe in science" and that the research she adheres to and the regimen she follows show that the procedure is "very safe."

"Less than one in every 100,000 women who use a medical abortion die, making medical abortions safer than childbirth and about as safe as naturally occurring miscarriages," she posted online.

According to the FDA, of the 3.4 million patients who'd taken mifepristone to medically terminate their pregnancies since the agency approved it in 2000 through December 2017, 22 people died. That amounts to one in about 155,000 women.

Meantime, each year, more than 700 women in the US die as a result of pregnancy and childbirth, and more than 50,000 face life-threatening complications, according to the Centers for Disease Control and Prevention. There were more than 3.9 million births in 2016, and based on CDC calculations, that would mean approximately one in 5,600 women died as a result of their pregnancies.

Concerns about using telemedicine to prescribe abortion pills are unfounded, say Gomperts and others -- including Dr. Daniel Grossman, a professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at University of California San Francisco and the director of the school's research group, Advancing New Standards in Reproductive Health.

"After more than 15 years of use in the US, we know medication abortion is extremely safe and effective," he said in a statement. "When it comes to self-managing abortion, research shows that when people have accurate information and high-quality medication, they can use the abortion pill safely and effectively on their own."

Medical abortion has "benefited millions of women," according to the American Congress of Obstetricians and Gynecologists, which warns against efforts to limit access to or criminalize use of the evidence-based regimen. The professional association also points to the value of telemedicine.

In the group's guidelines for managing first trimester abortions, it says, "Medical abortion can be provided safely and effectively via telemedicine with a high level of patient satisfaction; moreover, the model appears to improve access to early abortion in areas that lack a physician health care provider."

Safeguard vs. barrier

From the time the FDA approved Mifeprex, a brand name for mifepristone, nearly two decades ago, the agency attached to the drug "Risk Evaluation and Mitigation Strategies." These restrictions, known as REMS, are "necessary to ensure the safe use of Mifeprex," the FDA said in a statement.

"As required by the REMS, Mifeprex is only available to be dispensed in certain health care settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber," the FDA said. "Mifepristone, including Mifeprex, for termination of pregnancy is not legally available over the Internet."

What Aid Access is doing may not be in compliance with the REMS instituted by FDA 18 years ago, but clinicians and researchers in reproductive health "have been providing evidence that the REMS is unnecessary for many years," said Abigail Aiken, an assistant professor at the LBJ School of Public Affairs at the University of Texas at Austin who has done extensive research on the topic.

"In all honesty, I think the REMS really doesn't serve much purpose in terms of mitigating risk to people having medication abortions. In fact, it's actually one of the biggest barriers to the widespread use of a very safe and effective medication," Aiken said. By requiring a "prescriber registry," the drug has been made "expensive and out of reach for many."

It turns out too that in 2016, the FDA approved a limited study by Gynuity Health Projects, a nonprofit research group focused on reproductive health, to explore the safety of using telemedicine and mailed medications to induce abortions at home. The TelAbortion Study is available only to women in Hawaii, Oregon, Washington, New York and Maine -- while Aid Access is available to people in all 50 states.

Dr. Beverly Winikoff, president of Gynuity, has been working on research around mifepristone since 1988, she says. She explained that while there's a "tacit understanding that people are allowed to bring into the US drugs for their own use," the FDA has a list of drugs on an "import alert" list that aren't afforded the same leeway. Mifepristone, she said, was placed on that list "in a political move."

She said its inclusion on that list could be challenged, because it was placed on the list before numerous studies showed how safe and effective mifepristone is.

The TelAbortion Study uses drugs registered in the US and distributed by a registered US provider, with the approval of the FDA, which is monitoring the study's progress. As a result, Winikoff said, Gynuity's work is not under threat.

What the work has shown is that of the 200 women who've enrolled in the study, there have been no problems with medical abortions, and the women have been satisfied with the results, Winikoff said.

"The results are equivalent to what's happening in clinics," she said.

Laws in 19 states make it hard for many women to get medical abortions, Winikoff said. These laws require women to be shown ultrasounds of fetuses or sit down with doctors in order to be issued the medications. If they can't get to or can't afford a clinic visit, medical abortion might not be an option.

Suggesting that Gompert's Aid Access may be in violation of the law "brings into focus the utter folly of the FDA's medically unnecessary regulation of abortion pills that keeps people in the US from being able to get the care they need here," added Jill Adams, founder and chief strategist of the SIA Legal Team.

This week, the legal team launched a confidential helpline and website to help people understand their legal rights and the risks they face in pursuing self-managed abortions. Adams' group is working to "transform the legal landscape so people who end their own pregnancies can do so with dignity and without punishment," according to its main website.

"Government agencies ought to look at the evidence and lift these harmful restrictions," according to recommendations by the American Congress of Obstetricians and Gynecologistsand other experts, she said.

Gomperts points to language in a study released by the Guttmacher Institute, which called the restrictions "not justified": "Even a warranted REMS must be tailored to address specific risks and cannot be unduly burdensome. Yet the limits imposed on mifepristone are both burdensome on those seeking to access medication abortion and ineffective in addressing any risks associated with the medication."

Facing reality

A study published last year looked specifically at Gomperts' work serving women in Ireland and Northern Ireland. (This was before Ireland's recent repeal of its abortion ban.) It analyzed data and self-reported outcomes from 1,000 participants who'd used Women on Web to self-manage their abortions. The findings, published in BMJ (formerly the British Medical Journal), showed that about 95% of the women in the study terminated their pregnancies without any surgical intervention.

It was a result that mirrored the success rates of medical abortion in general, as reported by the FDA in 2015.

The study did more than this, though, said lead author Aiken, of the LBJ School of Public Affairs at the University of Texas at Austin.

"Following waves of restrictive legislation in the United States, the parallels between women seeking abortion in the US and Ireland and Northern Ireland are striking," she said in a release.

"Women in Ireland and Northern Ireland have three options when faced with a pregnancy they do not want or feel they cannot continue: travel long distances to access in-clinic abortion care, remain pregnant, or self-source their own abortion outside the formal healthcare setting," Aiken said. "For many women throughout the South, Appalachia and the Mid-West, where state laws have forced clinics to close, these are the same three options.

"Safe, supported, and effective at-home medication abortion," she continued, "could be an option for these women too."

At least for now, that option is available.

Filling what she fears will be a growing void for women in the US is precisely why Gomperts introduced Aid Access. She hopes the data gleaned from her work will open people's eyes to the reality for many women in the US and promote the sort of change that will someday make her organization unnecessary.

"I hope that with exposing the restriction to access, this will eventually lead to better policies and better access," she said, "so that I don't have to provide this service anymore."

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