Pill chill: Politics and weak demand keep RU-486 on the shelf

Columbia College Chicago

A 1999 New York Times article called it “the little white bombshell.”

Seattle doctor Suzanne Poppema said it was “the best means we’ve had yet for defusing the abortion conflict.”

And Columbia University ob-gyn Carolyn Westhoff predicted, “It will help get abortion back into the medical mainstream and out of this ghettoized place it’s been in.”

Eleanor Smeal of the Feminist Majority Foundation said that it would cause the number of abortion providers to “double overnight.”

They were all talking about the abortion pill, mifepristone — long known by its French name, RU-486 — which was supposed to revolutionize abortion in America by greatly increasing the number of physicians who would provide abortions and broadening the options available to women wanting to end a pregnancy.

But in the year since mifepristone was approved by the Food and Drug Administration and made available commercially as Mifeprex by Danco Laboratories, the reality has not lived up to the hype.

From the political to the medical

“People thought all these doctors were going to come out of the woodwork to offer the pill,” said Ron Fitzsimmons, executive director of the National Coalition of Abortion Providers in Alexandria, Va. “It hasn’t happened.”

While abortion clinics have been relatively quick to offer the “early option pill,” as Danco tags it, gynecologists and general practice physicians have lagged behind.

A tortuous FDA approval battle and restrictive labeling have made mifepristone expensive to offer to patients. Meanwhile, state laws put a burden on doctors seeking to provide medical abortions and open them up to harassment by anti-abortion activists.

A 1998 Henry J. Kaiser Family Foundation study reported that 45 percent of family practitioners polled said they would be “very” or “somewhat” interested in offering mifepristone once it was approved and available.

However, a new Kaiser survey released in September showed that only 6 percent of gynecologists and 1 percent of general practice physicians were offering the drug. An additional 16 percent of gynecologists and 7 percent of general practitioners said they were “likely” to begin offering the drug next year.

“Expectations were high,” Fitzsimmons said. “What happened was that for many years [mifepristone] was a political issue. So pro-choice activists were real excited about it. They had visions of this being something that would be almost a social revolution.

“That’s fine,” Fitzsimmons added, “but sometimes the political doesn’t connect with the reality of the clinics, necessarily. It was political, then it became medical.”

According to the Kaiser survey of 790 randomly sampled physicians, 40 percent of gynecologists and 37 percent of general practitioners said that they would not offer mifepristone because they personally opposed abortion.

But for those who were not personally opposed to abortion, the following were identified as “important” reasons they did not offer abortions:

  • 62 percent — lack of patient demand
  • 51 percent — concerns about protest or violence
  • 49 percent — lack of interest in performing abortions
  • 48 percent — office space not set up to offer medical abortions
  • 47 percent — too much political controversy surrounding abortion

Though mifepristone has been available in France since 1988 and according to the Population Council has been used safely by more than 620,000 European women, Fitzsimmons argues that American doctors are still becoming familiar with the drug.

“You want your physicians to be conservative,” he said. “You want them to take their time and read studies. You want them to feel totally comfortable. Slowly, but surely, the use is increasing.”

Fitzsimmons said that half of the 150 independent abortion clinics which belong to NCAP are offering the drug. Half of the National Abortion Federation’s members — about 200 healthcare facilities — are offering mifepristone.

And through September 2001, 5,000 women had medical abortions through Planned Parenthood clinics. There are about 1.2 million abortions in the United States annually, according to the Kaiser Foundation.

Nonprofit clinics like Planned Parenthood and clinics affiliated with the National Abortion Federation make up 65 percent of sales of Mifeprex, according to Danco, a private company which would not release exact sales figures.

Private practices and independent clinics together account for the other 35 percent of sales, said Pamela Long, a Danco media relations officer. Long said there was no breakdown of how much of that 35 percent was accounted for by clinics and how much by private physicians.

Not easy to offer

Fitzsimmons said that a lot of preparation goes into offering mifepristone. “It’s not just a pill that you can just start offering. You have to start setting up protocol and get staffing situations resolved.”

This is precisely what Chicago’s Planned Parenthood Near North Health Center, 1200 N. LaSalle St., has done.

“We have been preparing for approval for over a year,” explained Vasyl Markus, Planned Parenthood Chicago Area’s vice president for public policy.

The Near North Health Center took part in one of the many training sessions offered by the National Abortion Federation, which has trained more than 3,400 healthcare professionals in how to provide mifepristone counseling to women.

“Forty percent of women at our clinic choose the early option pill,” Markus said. “It’s very popular, and our staff is very well trained to answer women’s questions.”

Markus said he was not surprised that more physicians weren’t jumping on board. “For physicians, it’s too new and they don’t know how to incorporate it into their practices. It was pretty predictable, particularly in hindsight, that it would not be offered right away.”

Heather Boonstra, senior public policy associate at the Alan Guttmacher Institute in New York City, echoed this sentiment. “A big part of why mifepristone isn’t more available yet has to do with bureaucratic inertia on the part of abortion providers,” she said. “They have to set up a different system for medical abortion.”

Boonstra also said that lack of demand for the early option pill accounted for its limited availability. Indeed, it was the reason most offered by doctors for not offering the pill.

“It seems a lot of women don’t know that it’s been available, and they need to know that so they can request it,” said Christina Horzepa, a public information specialist with the Population Council. “And even among doctors, they’re not aware of it.”

This lack of demand comes in spite of a six-month, $2 million National Abortion Federation advertising campaign in magazines popular among women.

The group’s executive director, Vicki Saporta, claimed that 70 percent of women between 18 and 49 were exposed to the ads, which ran in magazines like People, Glamour, Self, Fitness and Essence.

In the months following the ad campaign, the group’s hotline volume increased from 2,000 to 4,000 calls, and 40 percent of callers were inquiring about medical abortion.

Meanwhile, Danco has targeted thousands of healthcare providers in a huge direct-mail campaign to let them know about Mifeprex and how to provide it.

While Danco would not release information about how much was spent on the direct-mail campaign and other efforts such as medical conferences and advertising in medical journals, a September 2000 Wall Street Journal story year sheds some light on things.

Journal reporter Rachel Zimmerman obtained two internal Danco documents which showed that the firm had raised about $34.7 million — including $23.4 million from its nonprofit partner, the Population Council — through March 2000.

This included a $10 million loan from the David and Lucille Packard Foundation and a grant from the Buffett Foundation. In addition, the company hoped to raise $2 million to operate through the first quarter of fiscal year 2001.

‘Early option’ arrives late in U.S.

In spite of all this investment by Danco and abortion-rights supporters, mifepristone has not yet had the impact many thought it would have. First, let’s retrace why abortion-rights supporters struggled for so long to get mifepristone approved.

Though the Supreme Court’s 1973 decision in Roe v. Wade gave American women a constitutional right to choose to end a pregnancy, exercising that right has never been easy.

The number of surgical abortion providers has been steadily declining due to harassment from anti-abortionists, less emphasis on teaching abortion in medical schools, and state laws which make providing abortions a costly and dangerous endeavor by requiring that abortion providers give certain information about their practices to the government and comply with regulations no other doctors must deal with.

In Illinois, for example, 90 percent of counties have no abortion provider, and between 1992 and 1996, the number of providers fell from 47 to 38, a 19 percent loss.

A July 11, 1999 New York Times article reported that 59 percent of abortion doctors are at least 65 years old. Most abortion doctors are trained in obstetrics and gynecology, and the percentage of ob-gyns willing to perform dropped from 42 percent in 1983 to 33 percent in 1995.

Furthermore, fewer and fewer hospital residency programs are teaching surgical abortions. For these reasons, nine out of 10 abortions are performed not in private physician’s offices but in clinics.

And the cost and inconvenience of operating clinics is foreboding. They remain a flashpoint in the ongoing debate over the speech rights of anti-abortionists outside and their isolation from the mainstream medical community increases costs and discourages new doctors from entering the field.

Mifepristone, which was first synthesized by researchers at the French pharmaceutical firm Roussel Uclaf in 1980, works by blocking progesterone, a naturally produced hormone that prepares the lining of the uterus for a fertilized egg and helps maintain pregnancy.

Without progesterone, the lining of the uterus softens, breaks down and bleeding begins. This usually occurs about two days after the drug is taken, and it is followed by another drug, misoprostol, which causes the uterus to contract, completing the abortion process.

Mifeprex is called the early option pill because unlike surgical abortion, it can be used earlier in the pregnancy. It can be taken anytime up to seven weeks, and of course the procedure is non-invasive.

“I just think having another option, especially one that’s earlier, is better,” said Heather O’Neill, director of public affairs at Danco. “Earlier tends to be safer.”

Women who have had medical abortions rate their experiences more favorably than women who have had surgical abortions, according to a recent study which appeared in the June 2000 issue of American Journal of Obstetrics and Gynecology.

Women who had medical abortions reported less anxiety during the process, which can be completed at home. And while only 58 percent of women having surgical abortions said they would choose the method again, 91 percent of women who chose medical abortions said they would choose the same procedure.

By 1988, mifepristone was available in France, but testing and even importation of the drug into the United States was banned.

Sweden and the United Kingdom approved mifepristone for use in the early ’90s, and in 1992 the New England Journal of Medicine concluded that mifepristone was a safe and effective contraceptive. Yet approval was still eight years away.

Only after President Bill Clinton was elected did FDA testing begin in earnest. After a series of attempts by anti-abortion activists to severely limit the availability of mifepristone, the FDA finally approved the drug on Sept. 28, 2000. Danco began shipping Mifeprex to providers in late November.

FDA places limits on availability

But abortion-rights supporters didn’t get everything they wanted from the FDA. First, the FDA required that a doctor, or someone directly supervised by a doctor, administer the drug.

“The FDA basically says that you need to assess gestational age, diagnose ektopic pregnancy and have backup in case the mifepristone doesn’t work,” NAF’s Saporta said. “We felt that advance practice clinicians — nurse’s assistants, physician’s assistants, nurse-midwives — could do that.”

Planned Parenthood Chicago’s Markus said that this would not prevent a nurse from administering the drug, but the nurse would have to be in the same office as a physician. So, for example, the Near North Health Center is the only office in Chicago capable of providing such service, and so it is the only Planned Parenthood clinic which offers mifepristone.

“Nurses already do ultrasounds,” Markus said. “That requires more skill than counseling someone about mifepristone.”

Also, three doctor’s visits are required: the first to be counseled and take the mifepristone, the second to come back two days later to take the misoprostol, and a third visit 14 days later to make sure that the pregnancy has been terminated.

“According to the literature I’ve read, it’s not medically necessary for the woman to come back in for the second treatment,” claimed Bonnie Scott Jones, staff attorney at the Center for Reproductive Law and Policy in New York City.

“She can just take [the misoprostol] with her. There’s no need for her to come into the doctor’s office for that.”

Safety or sabotage?

Others see the requirements as part of an attempt by anti-abortionists to make medical abortions more expensive to provide.

“All of that is just a deliberate attempt to drive up the cost,” said Glen Whitman, an associate professor of economics at California State University, Northridge.

“It’s a deliberate attempt to drive up the cost. So much of it is transparently unnecessary. Other equivalent procedures don’t require that level of involvement. It’s apparent that there’s no reason for these restrictions on this treatment, except to make it more difficult to access.”

Cost should definitely not be overlooked as an explanatory factor in mifepristone’s disappointing popularity thus far. More than half of women seeking abortions are under the age of 24, and mifepristone costs about $75 to $100 more than surgical abortions, which usually cost $325 to $350, according to the Guttmacher Institute.

While many clinics are charging the same for surgical and medical abortions so as to give women as much choice as possible, users of the abortion pill still bear the higher cost.

“The medication cost alone is so high, and when you add the physician fee and the cost of ultrasound, the price is prohibitive,” one Bergen County, N.J., abortion provider told the Bergen Record on Sept. 25, 2001. “Once we presented it to our patients, they all said. ‘No.’ ”

Also, many young or low-income women do not have schedules flexible enough to allow them not one but three visits to oftentimes inconvenient clinic locations, pointed out Toni Bond, executive director of the Chicago Abortion Fund. CAF has not yet funded any medical abortions for its clients because of the cost, Bond said.

“We simply cannot afford RU-486,” Bond said. “The clinic we work with charges $500, which is more than a surgical abortion. And this requires more than one visit, which means taking off of work, making arrangements to get childcare, getting to the clinic and so on.”

Danco’s Long and O’Neill both said that Mifeprex’s cost was “within range” of surgical abortions. It was designed to be “affordable to women while helping us recoup the cost of bringing the drug to market,” O’Neill said.

And there is the culprit, said economist Whitman. “RU-486 is an extreme example of what happens all the time,” he said. “The protracted FDA approval process substantially increases the cost of going through the research and development process.

“When firms are deciding what kind of R&D projects to go into, they have to pick the very best bets. Only if it promises great profits is it worth the cost of the approval process.”

Strengthen choice by reforming FDA

FDA reforms allowing for more free choice for patients to risk possible side effects of drugs in order to get experimental treatments or, in the case of RU-486, end a pregnancy without invasive surgery, would be an improvement, according to Dale Gieringer, California coordinator for the National Organization for the Reform of Marijuana Laws. Gieringer has written extensively about FDA investigational regulation of pain medications.

The high price of mifepristone is “caused by the FDA regulatory system where you have a government agency that dictates what is safe and effective for everybody,” Gieringer said.

“Unfortunately, these are subjective concepts. Most people choose what is ‘safe’ and ‘effective’ according to their own values. The normal way a free society deals with this is to place these decisions in a market context.

“Instead, today you have bureaucrats making these choices on their own political grounds. They are influenced and pressured by all these different special-interest groups, as happened in the case of RU-486, and it all becomes this big political football based on someone’s religious superstitions.”

Keep your laws off my doctor

Finally, there are intense hurdles at the state level which make becoming an abortion provider a tremendous sacrifice for any gynecologist or general practitioner, according to CRLP attorney Bonnie Scott Jones.

“Let me put it this way: It’s much more difficult to be an abortion provider than to be in regular practice,” Scott Jones said. In regular practice, as long as a doctor has a license and performs a quality standard of care, he or she will be left alone by the government.

“But if you’re an abortion provider,” Scott Jones said, “you’re probably going to have to register with the state.” Providers may have to perform tests that aren’t required. For example, South Carolina requires that a Gonorrhea test be performed before the abortion procedure is done.

Regulations determining the width of doors, the flow of air and other trivia may now apply to an abortion provider — regulations which do not apply to other doctors, Scott Jones said.

An especially harmful requirement is that a registered nurse be hired on at a first trimester abortion facility. This is because RNs are in high demand and often will opt to work at hospitals where pay and benefits are better.

“The purported intent of these laws is to protect the health of abortion patients,” Scott Jones said, “but the true intent is to achieve the [anti-abortionists’] goal of making abortion legal but impossible to get, by making it difficult to be an abortion provider and making abortion so expensive that it will be out of reach.”

Scott Jones said that all laws which apply to surgical abortion providers would also apply to medical abortion providers. So even if a gynecologist only wanted to offer medical abortion to current clients, he or she would still have to register with the state and comply with all applicable laws and regulations.

The most ominous of these, Scott Jones argued, were those requiring abortion providers to give the government information about themselves and their employees. This information is often obtainable through Freedom of Information Act requests.

“And it’s not like nobody cares,” Scott Jones said. “The information is routinely requested by anti-choice activists so they can harass abortion providers.”

A difference, but only in kind

Ultimately, the legal infrastructure is hostile toward abortion providers, Scott Jones said, and a different type of abortion is not going to make much of a dent in that.

“There was the implication that a lot of doctors were going to start offering the pill,” NCAP’s Fitzsimmons said of the hopes abortion-rights supporters had for mifepristone. “In many ways, that minimizes what this is about.

“We’re not just dealing with possible terrorism. This is more than just a procedure or a pill. If a doctor starts thinking about it, he has to consider whether he wants to expose himself to anti-abortion activists … Is it really worth it?”