By Pete Kotz
By Michael Musto
By Michael Musto
By Capt. James Van Thach told to Jonathan Wei
By Kera Bolonik
By Michael Musto
By Nick Pinto
By Steve Weinstein
The year is 1990. George Bush (no "W") is president. MC Hammer is number one on the pop charts. Ghost is in the theaters. And a woman in the early stages of pregnancy can have a safe, legal, medical abortion with RU-486in France, anyway.
Flash . . . forward? Here in the 21st-century United States, RU-486 is still unavailable, caught in a gnarly tangle of politics. With several expected approval dates already come and gone, the Food and Drug Administration recently set yet another deadline by which it promises to rule on the drug: September 30. But even if the agency keeps to its scheduleby no means a sure betRU-486 is already long overdue. In international use and American clinical trials, the little yellow tablet has proved to be just as safe as many drugs already approved by the FDA. Even so, the agency recently let on that if it does finally approve the abortion pill, it may do so with serious restrictions that could destroy most advantages the drug has to offer. With the FDA deadline perilously close to election day, and a chip off the first anti-choice Bush pushing toward the White House, there is no better time to take a good, hard look at the pill that could irrevocably transform abortion in the U.S. Will RU-486 finally make it into the average American doctor's office so that a woman can easily end an unwanted pregnancy in its first weeks? Or will government-mandated restrictions and strategically placed legal hurdles ultimately render the first big innovation in abortion meaningless?
many women report feeling "less guilty" about medical abortion. some even say it feels more like bringing on a late period or taking the morning-after pill than having an abortion.
Western medicine's first approved nonsurgical abortion method, RU-486which is also known as mifepristoneis in many ways a successor to the teas and tinctures women have used for centuries. (For a look at an underground abortion drug, see "The Star Pill.") When taken with misoprostol, an ulcer medication that's already approved and available in the United States, RU-486 blocks the hormone that gets the body ready for pregnancy; within hours after a woman takes the two pills (one 24 hours after the other), the lining of the uterus breaks down and the pregnancy ends. But, because it works from the very earliest stages into the seventh week, many see RU-486 as a method that can prevent pregnancy from beginninga distinction that could prove huge. For women who have taken it, RU-486 often sidesteps the stigma of having an abortion; a pill, many of them say, feels more natural and less invasive. Most doctors, too, seem to be more willing to prescribe a medication than to perform a surgery, however minor.
That's certainly been the case in France, where some 25 percent of abortions are now done with RU-486, which is widely available in French doctors' offices. France, it should be noted, is not some sort of women's rights mecca, where toilet seats are welded down and tampons are free. The country has its own history of strife over reproductive rights, its own bands of zealots bent on forbidding abortion at all cost.
In fact, a few such abortion opponents were at the helm of Roussel Uclaf, the very company that developed RU-486 back in 1980. (1980!) In late 1989, two years after the safety and efficacy of the drug were established in French clinical trials, these executivesas well as the Roussel's head of security, who was recruited into the effort because of his strong antiabortion beliefstried to overpower their pro-choice colleagues within the company and force Roussel to abandon the drug. The antiabortion faction of the company had already written a press release announcing the decision, when an 11th-hour countercampaign saved the first major abortion breakthrough from oblivion. A petition with more than 2000 signatures and a flurry of press coverage quashed the anti-RU-486 rebellion. Despite political opposition, the French minister of health declared RU-486 "the moral property of women." By April of 1990, the drug was on the French market.
imagine. instead of facing a phalanx of picketers and being called a murderer, a woman could simply go to her regular doctor's office and, depending on the specific regimen the FDA approves, even abort at home.
Since the French started stocking RU-486 in their drugstores, a steady stream of countries have followed suit. RU-486 (which pro-choicers sometimes call the "early option pill" and the pope likes to refer to as "the pill of Cain") is now approved in Great Britain, Sweden, Switzerland, Austria, Belgium, Denmark, Spain, Finland, Greece, Germany, the Netherlands, and Israel. Even China has manufactured its own version of RU-486. As the years have ticked by, more than 500,000 women have had abortions with the drug in Europe alone. (For a history of RU-486, see "Time Marches On.")
Exactly why is the moral property of women still not in our doctors' offices? It's a story of blatant political maneuvering, some well-intentioned bungling, and more politics. American antiabortion activists first put out the unwelcome mat even before RU-486 was approved in France, pushing Reagan and then Bush to prevent the FDA from reviewing the drug. Bush issued an "import ban" in 1989. Then, in 1994, abortion opponents organized a boycott of American subsidiaries of Roussel Uclaf, targeting big moneymaking products, such as the allergy drug Allegra. Sufficiently spooked, the company bolted the American abortion controversy, andunder pressure from President Clintondonated its U.S. patent to a nonprofit organization, the Population Council.
The Population Council, which was set up almost 50 years ago by John D. Rockefeller III to address the problem of overpopulation, had a seemingly simple mission for mifepristone: to conduct a U.S. clinical trial, file a new drug application with the FDA, and arrange for a manufacturer and distributor in this country. But nothing having to do with mifepristone happens quite so smoothly. The first attempt at raising money to launch the drug played out like a bad B-movie. Patent securely in hand, the Council proceeded to hire Joseph Pike, a shady, disbarred lawyer, to raise funds for the drug. After Pike went public with having a criminal record, a legal mess between the Population Council, Pike, and other investors ensued, eating up almost two years of time when mifepristone might have been fighting its way toward American women.
Most people chalk up the Pike chapter of the RU-486 story to unfortunate circumstances rather than politics. But while bad luck clearly had something to do with the choice of a petty criminal to head a sensitive medical project, the dearth of better business partners that led to that choice can be tracedonce againback to abortion politics. Mifepristone promises to be in great demand; one-third of the more than 1.3 million abortions in the United States are performed in the first 49 days of pregnancy, and so could be done with RU-486. With the cost of the whole regimen, doctors' visits and all, expected to be about the same as surgical abortion (which averaged $316 in 1997, when statistics were last tallied), this could mean a profit of tens of millions of dollars for whoever is willing to produce and market the drug. Yet fear of protests and boycottsnot to mention bombings and shootingshas meant that big pharmaceutical companies won't go near it with a 10-foot test tube.
The same is true for investors. "You have no idea how frightened people are to contribute money," says Richard Hausknecht, medical director of Danco, a group of investors that formed to market RU-486. "The company that's doing this is tiny," Hausknecht says of Danco. "It's literally a mom-and-pop store." Without bigger, wealthier sources, Danco has been operating on a shoestring budget, which may partly explain its snail's pace toward approval. For many bigger potential financial backers, the business is simply too volatile. "If you're an investment banker, even if your heart's in the right place, your wallet's not," says Hausknecht. "They're afraid [approval] is just not going to happen."
Bankrollers aren't the only ones afraid mifepristone will never happen. Since 1997, when the Population Council ousted Pike and rearranged its investment team, the ball has mostly been in the Food and Drug Administration's court. And women have been waiting and waiting, and waitingfor the agency to hit it back. The FDA seemed poised to approve the drug in '96, when the agency issued its first letter declaring mifepristone safe and effective. But then it requested additional information. And shortly after, the Hungarian company that had agreed to manufacture the drug in the U.S. pulled out, derailing the process.
Since then, times at the FDA have been somewhat turbulentthe agency has spent much of that period without a commissioner and under scrutiny for approving drugs both too quickly and too slowly. And mifepristone has faced one delay after another. First, it was supposed to be approved in 1998. Then, it seemed likely to get the nod at the end of '99, but when that time came, the agency instead issued another set of questions. Most recently, FDA watchers were sure RU-486 would be approved by the beginning of this year. But in February, the agency once again asked for more information and then announced its new September deadline.
This last might have been just another in the line of frustrating delays if not for news leaked at the same time to The Washington Post: The FDA was considering imposing restrictions that could snuff out the potential of RU-486. We now know mifepristone may be limited to physicians who are specially trained to use it and also have admitting privileges in hospitals within an hour of their offices. Perhaps the most stifling of the FDA's proposed restrictions would allow only doctors who have fulfilled the special training required to provide surgical abortions to prescribe mifepristone.
If pro-choice advocates didn't think politics were mucking up a supposedly scientific process before, there now seem few other possible explanations. "Since there is no scientific basis, it has to be about restricting access to this medication that holds the promise of making early abortion available without violence and harassment," says Wendy Chavkin, professor of public health and OB-GYN at Columbia University. Chavkin calls the proposed restrictions "unheard of." And several medical organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Medical Women's Association, have also weighed in against the restrictions as an intrusion into the practice of medicine.
To understand how extreme these restrictions are, realize thatwith very few exceptionsthe FDA has no say as to who gets to prescribe drugs. The agency doesn't require doctors to be able to do bypass surgery in order to prescribe heart medications. A dermatologist could prescribe it if he or she felt like it. For that matter, a dermatologist could also prescribe Viagra, the drug for erectile dysfunction, which took far less time to gain FDA approval, despite the fact that it can cause heart problems.
Nevertheless, the FDA denies its treatment of mifepristone is political. "We look at applications on a scientific basis, and we look at all applications for how products can be used safely," says one FDA official who declines to comment further, citing an agency policy of not discussing drugs that are not yet approved. The Population Council is also reluctant to acknowledge the role of politics. "We're not calling it political in the sense that other people are," says the Population Council's Sandra Waldman, adding that the organization isn't "exactly sure what prompted the FDA to list its requirements."
While no one may know for sure exactly where to pin the blame for the possible restrictions, some have pointed to the influence of the agency's new, more circumspect leader, Jane Henney, and to a general jitteriness at an agency increasingly under siege. A more charitable explanation is that the FDA, known for its scientific integrity, is simply inoculating the drug against anti-choice attacks that are sure to follow its approval.
But, overtly political or not, the proposed restrictions threaten to destroy precisely the most exciting potential of RU-486: to weave abortion into the normal fabric of the medical system. If mifepristone ends up going only to those doctors who already provide abortions, harassment and intimidation can continue unchecked. If, on the other hand, OB-GYNs, internists, and family practitioners who don't already provide abortions start using it, abortion protesters won't know where to take their posters, plastic fetusesand bombs.
Imagine. Instead of facing a phalanx of picketers and being called a murderer, a woman could simply go to her regular doctor's office and, depending on the specific regimen the FDA approves, even abort at home. That's how it was for Amy, a 35-year-old woman who had a mifepristone abortion last October as part of a clinical trial. After taking RU-486 in her doctor's office, she was given a second drug to take at home 24 hours later. When the cramps began half an hour after that, she was in bed with her husband beside her, rubbing her back.
"The pill form allowed me to be in charge of the abortion," says Amy, who adds she would choose it again if she were ever to have another abortion. "Privacy is a lot of it. I like to be able to do this on my own. I don't need doctors to be jeopardizing their lives. And I don't have to be jeopardizing my own life." Amy, who works in a biological laboratory and has a five-year-old son, decided to abort her unintended pregnancy after she realized she had been exposed to some fairly toxic chemicals during the first weeks. Choosing RU-486 meant she could have her abortion as soon as she made the decision, rather than having to wait until she could have a standard, surgical abortion.
overtly political or not, the proposed restrictions threaten to destroy precisely the most exciting potential of RU-486: to weave abortion into the normal fabric of the medical system.
Indeed, mifepristone can be used at the very earliest stages of pregnancy. The drug works as soon as a woman discovers she's pregnant, while the surgical methods most often performed now require waiting until at least the sixth week of pregnancy. The difference can spare a woman the early, uncomfortable days of an unwanted experience. And many women report feeling "less guilty" about medical abortion. Some even say it feels more like bringing on a late period or taking the morning-after pill than having an abortion.
Politically, that shift in perception could turn RU-486 into one of the pro-choice movement's most important weapons. Repeated surveys have shown that the American public finds relatively early abortions more acceptable than later ones. Pro-lifers have played on that tension by focusing on abortion procedures that take place in the second and third trimesters of pregnancy. Mifepristone has the power to shove that dialogue back in the other direction. When RU-486 abortions take place, the product of conceptionas doctors sometimes refer to the clump of embryonic cellsis no bigger than a grain of rice.
This swiftness and simplicity also appeal to doctors. According to a recent survey by the Kaiser Family Foundation, 31 percent of gynecologists and 31 percent of family-practice physicians who had not performed abortions within the last five years said they were at least "somewhat likely" to prescribe mifepristone. But nearly half of those gynecologists and 40 percent of the family-practice physicians said they would be deterred from prescribing it if they had to go through a training program, which the FDA may now require.
For Ruth Lesnewski, a physician who works for the East 13th Street Family Practice in the East Village, the restrictions are the deciding factor. "If they come out as they're proposed, I won't be able to offer my patients this option because I'm not fully trained in the surgical procedures they [would] require," says Lesnewski. "Doctors I work with closely would be happy to take care of the failed medical abortions, but the FDA wouldn't consider that adequate."
If restrictions on mifepristone will keep the number of abortion providers down in cities, they will be felt even more strongly in rural areas. The vast majority of rural counties have no abortion providers. Keeping abortioneven medical abortiona secret from local pro-lifers may prove difficult in such rural settings. In 1998 in one Bible Belt town, a single abortion performed with methotrexate (a less effective abortion drug that's FDA-approved for cancer treatment, though not for abortions) caused an uproar that set off a staff resignation, letters from area ministers, and a petition signed by 8000.
The protests might have been brushed off as mere annoyance. Instead, the hospital where the abortion was performed forbade the doctor involved from doing any more medical abortions, citing an increase in its malpractice insurance rates. Insurance prices likely did play a part in the hospital's decision. With standard rates for medical abortion not yet set, some doctors report being quoted prices that are higher for medical abortion than for delivering babies, which is far riskier.
Abortion opponents see such bureaucratic deterrents as the next frontier in the war against RU-486. "I don't think your average doctor is really going to want to be getting into this when he realizes the kinds of logistical problems involved," says Laura Echevarria, spokesperson for the National Right to Life Committee. "Do doctors really want to set themselves up for the possibility of lawsuits?"
Whether they want to or not, pro-choice attorneys are steeling themselves for the legal battles many think would inevitably follow approval. "They'll pull out their bag of tricks, try to obfuscate and intimidate and obstruct access to it," Donna Lieberman predicts of her pro-life opponents. Lieberman, who directs the New York Civil Liberty Union's Reproductive Rights Project, also expects that medical abortion will prove easier to defend against legal challenges than traditional surgical abortion, which is already regulated as to how and where it's performed. "What are they going to saythat you have to have a 600-square-foot operating room to give out a pill?" asks Lieberman. "That's just ridiculous. I think any judge would agree."
Until they do get to the courts, both sides are focusing on the upcoming election, which may determine whether the drug is even available to fight over. "A chief executive opposed to RU-486 would significantly decrease the chances that mifepristone would be approved," says Simon Heller, director of the Center for Reproductive Law and Policy's domestic program. If RU-486 isn't approved by election time, Heller says the president could influence the FDA through his choice of secretary of health and human services. If the drug were already approved, the president "might get the FDA to issue special, discriminatory restrictions on its distribution, saying that it can only be given out in hospitals, for example." Beyond that, Heller declined to comment, not wanting "to give them any ideas."
But ideas about how to stop RU-486 already abound. Both last year and this one, Oklahoma representative Tom Coburn, a Republican, sponsored amendments to the agricultural appropriations bill that would have banned the FDA from developing and approving mifepristone or any other abortifacients. The most recent amendment was voted down in July by a five-vote margin. Though he hasn't said how, George W. has also made it clear he'd do his best to stop RU-486. "It's abortion," Bush has explained.
Well, exactly. Opposition to abortion is what has kept RU-486 out of reach. And those who support women's right to choose may want to put up a big, French-style fuss until they get access to this simple medical innovation. Petitions and angry letters worked when RU-486 seemed doomed in France. If such an outcry doesn't get mifepristone approved here by September 30, pro-choice Americans can take the fight to the voting booth.
The Star Pill
An Abortion Drug Goes Underground While we're waiting around for RU-486 and its promise of safe and legal medical abortion, some American women have been using another pill without supervision or a prescription to end pregnancies. In its unregulated state, at least, this underground medication turns out to be not that safeand not that legal. Cytotec is the brand name of misoprostol, a drug approved as an ulcer treatment in the U.S. and more than 72 other countries. It's also the pill taken (both orally and vaginally) along with RU-486 in U.S. clinical trials to induce abortion. If and when the FDA approves an RU-486 regimen, Cytotec is expected to be included as part of it to help make the uterus contract. Indeed, it turns out that Cytotec can often make the uterus contractand cause an abortioneven without RU-486, a discovery that has made it one of the hottest drugs on the black market. Almost a third of more than 600 women recently interviewed in a Washington Heights clinic said they were familiar with Cytotec, which is known on the street as the star pill (because the tablet has five sides). Five percent of women in the study, which was published in the Journal of the American Medical Women's Association, said they had used Cytotec. Buying the star pill is perfectly legalif you have a prescription for it. Without one, some women have been paying their pharmacists between $5 and $7 for a pill that costs about 35 cents when sold with a prescription. (RU-486 isn't approved for any purpose in the United States, so it doesn't show up on drugstore shelves.) In New York City, much of the Cytotec use seems to take place among immigrants from Latin America, where women have been inducing abortion with it for much of the past decade. Risking an unsupervised abortion with a black-market pill makes some sense in countries where abortion is illegal and women don't have better options. In fact, Cytotec is widely credited with bringing down Brazil's rate of complications from illegal abortions induced with herbal teas and inexpert attempts to get through the cervix. But taking Cytotec without knowing how to proceed or what to expect causes its own complications. Some women have taken too much of the drug, according to Brazilian reports; others took it too late in pregnancy, causing serious bleeding, incomplete abortions, and sometimes premature delivery. The star pill has caused its share of problems in the U.S. as well. Mark Rosing, the OB-GYN who conducted the JAMWA study, says he decided to investigate Cytotec after treating almost 50 women with post-Cytotec problems in only three months as an emergency-room resident. "I saw a number of patients coming in hemorrhaging, or with incomplete abortions, with portions of the pregnancy inside," says Rosing. "A lot of my colleagues saw and heard the same thing." Given the problems it's caused, Cytotec seems more of a hazard than a help in a country where other methods are legal. But, whether for financial reasons or because they were afraid to go to their doctor or just wanted to avoid the minor surgery involved in other types of abortions, some women seem to be taking the risk. For those without other options, Rosing hesitantly acknowledges a role for the less-than-perfect star pill. Says Rosing, "I'd rather see a 16-year-old who doesn't have access to a safe abortion use this than try something more drastic like a coat hanger or some sort of weird tea." S.L. Time Marches On
A Chronology of RU-486 1980: Roussel Uclaf, a French company, synthesizes mifepristone, which it dubs RU-486.
1981: First RU-486clinical trial is undertaken in Geneva.
1983: The U.S. Food and Drug Administration gives the Population Council, a nonprofit organization, a permit to test RU-486 as an early-abortion method in the U.S.
1987: A complete set of safety and efficacy information on RU-486 is compiled.
1988: A French application for RU-486 is approved.
1989: The FDA (under George Bush Sr.) puts RU-486 on the import ban list; individuals are allowed to bring other drugs into the country for their own use, but not RU-486.
1990: RU-486 becomes commercially available in France.
1991: The United Kingdom approves mifepristone.
1992: Sweden approves mifepristone. JulyFederal agents seize a single dose of mifepristone from Leona Benton, a pregnant 29-year-old who tries to bring it into the United States from London. Benton isunsuccessful in her attempt to get the courts to order the pill returned to her and eventually has a surgical abortion.
1993: Upon entering office, President Clinton lifts the import ban and orders the Department of Health and Human Services to "promote the testing, licensing and manufacturing" of RU-486.
1994: The National Right to Life Committee launches a consumer boycott of Roussel Uclaf's American subsidiaries. Roussel Uclaf, having decided it does not want to get tangled up in American abortion politics, donates the licensing rights for RU-486 to the Population Council.
1994-1995: The Population Council conducts clinical trials involving more than 2000 women in the U.S.
1996: MarchThe Population Council submits a new drug application to the FDA for RU-486. The agency issues an "approvable letter," declaring the drug safe and effective but requesting additional information about labeling and manufacturing.
NovemberJoseph Pike, a businessman hired by the Population Council to head the effort to arrange for manufacture and marketing of mifepristone, admits he has been convicted of fraud and forgery.
1997: Gedeon Richter, the Hungarian manufacturer that had agreed to produce mifepristone in the U.S., backs out.
1999: Mifepristone is approved in Switzerland, Austria, Belgium, Denmark, Spain, Finland, Greece, Germany, the Netherlands, and Israel. The Population Council and Danco, a group of investors formed to market mifepristone, submit the requested information to the FDA. Approval is widely expected by early 2000.
2000: FebruaryThe FDA issues another approvable letter for the use of mifepristone in early abortions, but says more information is still needed. JuneThe Washington Post reports that the FDA is considering approving mifepristone with stringent restrictions. The agency sets another approval deadline for September 30. JulyRepresentative Tom Coburn's amendment to an agriculture appropriations bill, which would forbid the approval of mifepristone, is voted down. September 30By this date, if it holds to its schedule, the FDA will have approved, rejected, or requested still more information about mifepristone. S.L.
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