10 years after its approval by FDA, abortion pill faces new turmoil over telemedicine

By David Crary, AP
Sunday, September 26, 2010

After 10 years in US, abortion pill still divisive

NEW YORK — Ten years ago, after long and bitter debate, the U.S. Food and Drug Administration approved use of the abortion pill by American women. It is hailed as safe and effective, but new turmoil may lie ahead as the pill’s proponents consider using telemedicine to make it more available.

Already, a pioneering telemedicine program in Iowa has provided the pill to about 1,900 women — with a doctor able to consult with a faraway patient in a video teleconference, then unlock a container by remote control to release the pill. To the alarm of anti-abortion activists, abortion providers in other states are pondering whether similar programs would enable them to serve more women, especially in rural areas.

“There are many affiliates that are carefully considering this option, within the confines of their state laws,” said Dr. Vanessa Cullins, vice president for medical affairs of the Planned Parenthood Federation of America, the nation’s leading abortion provider.

Initially known as RU-486, the pill was introduced in France in 1988, and anti-abortion activists fought doggedly over 12 years to keep it out of the U.S. The FDA finally gave its OK on Sept. 28, 2000, and nearly 1.4 million American women have used the pill since then.

Affording women more privacy than a surgical abortion, the pill marketed as Mifeprex now accounts for about one-quarter of U.S. abortions performed in the first nine weeks of pregnancy and about 15 percent of all U.S. abortions. In 2008, about 184,000 American women used the pill — up from 55,000 in 2001 even though the overall number of U.S. abortions wasn’t rising.

The pill’s manufacturer, Danco Laboratories, says it is effective about 95 percent of the time, with surgical procedures needed in most of the other cases to end the pregnancy or stop heavy bleeding. According to Danco, since approval in 2000 there have been eight deaths from sepsis, a bloodstream infection, among women taking the pill — a death rate of roughly 1 in 168,000 that’s far lower that the rate of women dying in childbirth.

Dr. David Grimes, a North Carolina obstetrician/gynecologist who formerly headed the abortion surveillance branch at the Centers for Disease Control and Prevention, said the pill’s impact has been overwhelmingly positive.

“I just don’t see any downsides,” he said. “For those women who don’t like the invasiveness of surgery, it gives them a very important option.”

He noted the option enables a woman to undergo an abortion in the privacy of her home after getting the pill from her doctor, avoiding the need for surgery at an abortion clinic that might be targeted by protesters.

Some of the pill’s opponents “said this would make it too easy for women,” Grimes said. “That implies that the procedure should be punitive. I don’t buy that.”

The procedure, which works during the first nine weeks of pregnancy, involves swallowing Mifeprex, known chemically as mifepristone. The pill causes an embryo to detach from the uterine wall, and a second pill, misoprostol, is used two days later to cause contractions and push the embryo out of the uterus.

Unquestionably, the pill has made abortion more accessible for many women outside major cities. Ten years ago, Planned Parenthood offered surgical abortions at 151 sites, according Cullins; now the organization has 322 centers providing abortion — nearly half of them relatively small clinics that offer the pill but not surgery.

Among those clinics are the Iowa facilities engaged in Planned Parenthood of the Heartland’s telemedicine program. Women seeking the pill can go to one of 16 clinics, have an ultrasound, be examined by a nurse, then talk to a doctor by a secure Internet connection. The doctor has the woman’s medical records and, if no complications are detected, can remotely open a container to provide the pill.

Abortion opponents have asked the Iowa Board of Medicine to block the program, saying it violates state medical standards and poses a health risk to women because it doesn’t entail a face-to-face meeting with the doctor. The board has formed a review committee, but hasn’t said when it might rule.

Jenifer Bowen, executive director of Iowa Right to Life, said there’s been no verified health emergency among the telemedicine patients served thus far, “but we think the risk is still there.”

She said efforts would be made in the next legislative session to pass a law ending the program.

Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists, assailed the Iowa program as “vending-machine distribution. … that takes a cavalier attitude to a new dimension.”

Both in Iowa and nationally, there has been too little rigorous research into the impact of the pill, Harrison contended. Yet she expects that the telemedicine concept will spread to other states unless cases of serious health problems emerge in Iowa.

Planned Parenthood of the Heartland’s CEO, Jill June, has been getting numerous queries from across the country asking about the program — and whether in might be feasible in other states.

Her advice: Get a good health care lawyer and carefully consider how to tailor a program that would comply with state laws on abortion and telemedicine.

“There are states that have passed laws that make accessing abortion virtually impossible, and they will try to curtail use of telemedicine,” June said. “But I think the genie is out of the bottle — technology marches on, regardless of the ways we human beings accept it or reject it.”

She said abortion opponents see the telemedicine concept as a particular threat because it would make abortion services more decentralized.

“They feel like they’re losing ground big-time, and they want to nip it in the bud,” June said. “But they really have no case to be made that it’s bad medicine, or bad for women. They’re fighting against the tide.”

The pill’s journey to the U.S. began in 1994, when French manufacturer Roussel-Uclaf turned over U.S. rights to the drug to the nonprofit Population Council. The New York-based council began clinical trials needed for FDA approval and created Danco Laboratories to market mifepristone.

Danco doesn’t disclose how much it earns from sales of the pill and, as evidenced by its unlisted phone number and office address, remains wary of possible harassment from abortion foes. However, Abigail Long, Danco’s director of marketing and public affairs, said the company is proud of its role in making the pill available.

“Its use has increased as women — and providers — have become more comfortable with it,” she said. “We’ve given them a safe, effective option.”

The pill’s active ingredient is manufactured in China, according to Danco, while the tablets are produced and packaged in the U.S. Danco says the facility in China is subject to regular inspections by the FDA.

Vicki Saporta, president of the National Abortion Federation, said availability of the pill seems to be prompting more women to have abortions early in their pregnancy — a trend that abortion-rights supporters welcome.

“While abortion is safe anyway, the earlier it’s done, the safer it is,” Saporta said.

To date, mifepristone has been approved for use in more than 35 countries, most of them affluent and industrialized. Several U.S.-based groups are part of a push to make the pill more widely available in developing countries, in hopes of reducing the number of deaths from unsafe abortions.

Planned Parenthood: www.plannedparenthood.org/

Iowa Right to Life: iowartl.org/

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