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Biomedical Politics (1991)

Chapter: A Political History of RU-486

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Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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A Political History of RU-486

R. Alta Charo

RU-486, a drug that interferes with uterine implantation of fertilized eggs, is a safe and effective alternative for early abortions. But it is not available in the United States. In fact, it is unavailable everywhere except France. The reason is not its cost, its side effects, or lack of consumer interest.

In fact, RU-486 is a captive of the abortion debate that has recently engulfed a number of tangentially related issues, such as appointment of the new director for the National Institutes of Health, the reconstitution of an Ethics Advisory Board to oversee federal funding of in vitro fertilization research, and the federal funding of fetal tissue transplant research for relief of Parkinson's disease symptoms. RU-486 is but the latest addition to this list.

Like the birth control pill, RU-486 has encountered strong resistance from moralists who fear it will trivialize sex, life, and human relations by “bolster[ing] the comparison between taking the drug and swallowing an aspirin” (Glasow, 1990i). These objections often contain statements of concern over women's health or the potential for contraceptive genocide in developing countries. But it is the moral opposition of a minority of Americans that underlies the so far effective campaign to keep this drug from coming to market. “When pro-lifers have the opportu-

R. Alta Charo holds a joint appointment at the University of Wisconsin Law and Medical Schools.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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nity,” wrote Richard Glasow, education director for the National Right to Life Committee (NRLC), “they should emphasize how RU-486 both cheapens the value of human life even more than surgical abortion and contributes to a general decline in moral standards” (Glasow, 1986).

RU-486 is available in France during the first 49 days of amenorrhea for the purpose of terminating a pregnancy, provided that (1) it is taken under a physician's supervision and in conjunction with a follow-up dose of prostaglandin derivative; (2) there is no contraindication to mifepristone (adrenal insufficiency, long-term administration of glucocorticoids, clotting disorders) or to prostaglandins (asthma, severe hypertension); and (3) it is taken in accordance with French abortion law, which requires a one-week waiting period between the request for an abortion and the procedure.

Anecdotal reports of only 90 percent effectiveness and some side effects (including two cardiac complications) were made by Meredeth Turshen of Rutgers University at an October 1990 meeting of the American Public Health Association (Contraceptive Technology, 1990). Turshen reported on conversations with French government researchers unaffiliated with Roussel whose preliminary data had not yet been peer-reviewed or published (Contraceptive Technology, 1990; Voelker, 1990). This was consistent with comments by an inquiry commission chaired by French researcher de Vernejoul that concluded that the prostaglandin follow-up to RU-486 administration posed potentially life threatening complications (Le Quotidien du Médecin, 1990).

Peer-reviewed studies, however, show that RU-486 is safer than suction techniques for early abortion. According to a 1990 study by researchers affiliated with the drug's manufacturer and published in the New England Journal of Medicine, pregnancy terminations reach 98.7 percent effectiveness when 600 milligrams (mg) of mifepristone is followed three days later with a 0.5-mg intramuscular injection of the prostaglandin analogue sulprostone. Side effects were minimal.

Of 2,115 French women using the drug in 1988, in various dosages of prostaglandin analogues, failures included persisting pregnancies (1.0 percent), incomplete expulsions (2.1 percent), and the need for hemostatic procedure (0.9 percent). The average time to expulsion ranged from 4.5 hours to 22.7 hours depending upon the dose of prostaglandin, and on average uterine bleeding continued for 8.9 days (range, 1 to 35 days). Use of the drug was characterized by transient abdominal bleeding after receiving prostaglandin, but few other side effects. One woman of the 2,115 received a blood transfusion. Incomplete abortions were completed by suction technique (Silvestre et al., 1990).

Besides being safer than suction abortions and causing few side effects, RU-486 is relatively inexpensive. An abortion performed by a pri-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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vate physician in the United States costs $500 to $1,000. Clinics usually charge $200 to $300 (Abrams, 1988). In France, the cost of an abortion using RU-486 is approximately $233. This includes the RU-486, the prostaglandin, and three medical visits. Roussel receives $44 for the RU-486. French social security covers 75 percent of the cost, so the client pays $58 (Aubény et al., 1990).

In France, more than 100 women a day (accounting for a third of all abortions) take RU-486 (Herman, 1989). More than 40,000 women in France (Herman, 1989) and 4,000 women in Britain, China, the United States, and elsewhere have also tried it on an experimental basis (Greenhouse, 1989a). China currently allows women to use RU-486. The drug will probably not, however, play a leading role in the country 's contraception and abortion services. Other countries use the drug only on an experimental basis, although it is hoped that it will become widely available in Britain and Scandinavia by mid-1992. It may also become available in other European countries. Although the drug is effective only within the first seven weeks following conception, experts estimate that it could replace one-half to two-thirds of the 30 to 40 million surgical abortions performed annually worldwide (Stein, 1988).

The prospects for RU-486 in the United States are dim. At best, it could be available by 1997, but that would require several actions that do not seem very likely to occur. A U.S. pharmaceutical company would have to open negotiations almost immediately to obtain the rights to produce and market the drug in this country. Soon thereafter, the firm would have to begin the process of obtaining Food and Drug Administration (FDA) approval. No U.S. company has yet been willing to take on the expense, an estimated $50 million, and difficulty of obtaining FDA approval, especially in light of concerns about FDA's ability to withstand pressure from the Bush administration and to review the drug dispassionately. Another obstacle is the drug 's 5 percent failure rate, which is perceived as a significant potential liability. Finally, and most importantly, marketing this drug in the United States would undoubtedly be a public relations nightmare. Boycott threats at the retail and investment level are real—and so far, effective.

It seems that only a small, single-product company could withstand these pressures. Family planning and feminist health groups have discussed starting a company devoted to bringing RU-486 to the market, but no concrete progress has been made. Ironically, the biggest stumbling block is the drug's French manufacturer, Groupe Roussel Uclaf, which has refused to license it in the United States. At least six groups of financiers have expressed serious interest in forming a company for U.S. development and distribution, and a coalition of interested feminists, lawyers, and researchers have combined under the name “Repro-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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ductive Health Technologies Project” to develop wider public support for the drug. Roussel and its German parent company, Hoechst, however, fear an organized retail and investment boycott in the United States, and not only will not license the drug in the United States but even hesitate to supply it for research on nonabortion applications.

The company's fears are not groundless. The lives of Roussel executives and their families have reportedly been threatened. Organized campaigns to boycott Roussel products, to block investment in Hoechst, and to seek out potential product liability claims against both have dogged the companies ever since Roussel announced it had developed an “ abortion pill.”

Reassurance from the U.S. government may be a precondition to persuading Roussel to license the drug here. The company refused to market the drug in France without a direct order from the French Ministry of Health. Roussel has announced it will license RU-486 only to companies in countries whose governments have specifically requested the drug. In the United States, such a request is unlikely, despite the drug 's other possible applications in the treatment of Cushing's syndrome, breast cancer, menangioma, endometriosis, and even obesity (Carey, 1990; Ullman et al., 1990). “It would be a tragedy to deny cures to Americans with life threatening diseases because of an ideological agenda,” says Congressman Ron Wyden (D-Ore.) (Carey, 1990). But that is just what may happen unless there is a surge of support in the United States for the drug's abortion applications. “[Roussel] wants a groundswell of doctors who will run interference for them,” says one researcher. “Then the company, with a Gallic shrug, can tell antiabortion protestors that it was forced to distribute the drug” (Carey, 1990).

For the moment, limited clinical trials have been completed in the United States; for example, small-scale trials were conducted at the University of Southern California (USC) under the auspices of the New York-based Population Council. Progress toward FDA approval will be slow, however, because the prostaglandins used in the United States in conjunction with RU-486 are different from those used in the European protocols. Even with new trials, once the studies are completed the patent on RU-486 will be close to expiring. Once that happens, the question of licensing (although not FDA approval) becomes moot.

In the end, it appears that American women are going to be denied this safe, effective form of early abortion for at least the next decade. As shown by the early history of the controversial birth control pill, it appears that in the United States there is a need for much patience.

The purpose of this case study is to trace the network of political, economic, and historic forces that have converged to slow the introduction of RU-486 into the U.S. market. It is a study of the absence of a de-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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cision, that is, the absence of FDA consideration of the drug, the absence of a U.S. license issuance, and the near absence of any government hearings. It is also a story of perceptions: the perception that RU-486 will trivialize abortion, that the abortion controversy makes any new contraceptive or abortifacient commercially risky, and that contraceptive development proceeds without full regard for women 's health and safety.

One persistent theme in this story is that members of the women's health and family planning communities, the pharmaceutical industry, or the antiabortion movement have publicly questioned the sincerity of the public statements made by each other. The NRLC, for example, has consistently complained of distortions in press coverage and scientific journals (Andrusko, 1991). As a result, there is no single authoritative source of information on the motivations of those who have worked to promote or to discourage the development of the so-called abortion pill. It is therefore difficult to present the “truth” about why RU-486 is not likely to be on the U.S. market in the near future.

This article is based largely on the published statements of official representatives of these various groups and published rebuttals by their opponents. Most of the research is based on a full-text review of over 500 articles in leading newspapers and news services, as reproduced in the Mead Data electronic NEXIS service. Additional sources include the National Right to Life News (which itself relies heavily on popular press articles), leading medical journals, and recent congressional hearings. Those hearings have not yet been published by Congress and are described in this article on the basis of New York Times coverage. Because leaders of the various interest groups have often reacted to one another on the basis of these news articles, newspaper coverage has become not only a source of news reporting but a news event in itself.

INTRODUCING CONTRACEPTIVES TO THE UNITED STATES

Family planning is now an accepted part of American life. Planned Parenthood, for example, is supported by 250,000 donors and has 24,000 volunteers and staff, “by any measure a mainstream organization ” (Steinbrook, 1988). Supreme Court Justice Sandra Day O'Connor's husband was the emcee for two of its events in Phoenix, and her sister has sat on its board in Tucson. Dwight D. Eisenhower and Lyndon Johnson were once members of its honorary national board (Steinbrook, 1988). Today it is one of several organizations supporting access to RU-486.

Yet only a relatively short while ago in this country, contraceptives were considered obscene. They were also illegal, and there were several vigorous campaigns in the 1950s and 1960s to keep them that way.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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The battle in the United States was lost, however, when the Supreme Court ruled—first in Griswold v. Connecticut in 1965 and then in Eisenstadt v. Baird in 1972—that there is a constitutionally protected zone of privacy that extends to the purchase and use of contraceptives.

It would be a mistake, however, to view that battle as simply one centered on contraception or even on sexual morality. Rather, it was part of a larger debate about the power of women to control their reproductive capabilities and their lives. It began with nineteenth-century “voluntary motherhood” organizations fighting for contraception. This movement did not reject the idealization of motherhood; it fought merely to make the timing one of discretion rather than chance. The twentieth-century family planning movement went further, supporting a broader effort to ensure equal opportunity and independence for women. Personal control of reproduction was a crucial first step toward women's rights (Gordon, 1976).

This mix of concerns over immediate reproductive freedom and long-term creation of equality for women has affected past development of contraceptive options for women, and today its impact is being felt in the development of RU-486. The early birth control pill trials in Puerto Rico, for example, were heatedly attacked by feminists who accused the trial sponsors of paying inadequate attention to the safety of the study participants. Although directed toward a worthy goal—contraceptive choice—the trials appeared to violate the health and autonomy of the subject women (Seaman and Seaman, 1977).

Feminist health organizations often assert that supporters of “population control” put slowing global population growth ahead of protecting women's health and choice, and that commercial interests in contraceptives sales exacerbate this problem (Gordon, 1976). There is little question that A. H. Robins resistance to complaints about its Dalkon shield hardened skepticism of contraceptive development within the feminist community, which resulted in pitched battles over Depo-Provera (see the later discussion) and even a less than enthusiastic initial response to RU-486. “As women, we have learned that we cannot trust assurances given to us by doctors,” activist and Harvard biology professor Ruth Hubbard has been reported to say (Glasow, 1988a).

But the autonomy offered by RU-486 overcame feminist skepticism of contraceptive innovations. The drug offers the prospect of performing abortions in any physician's office and even at home. The prospect of eliminating abortion clinics, which are easy targets for picketing and bombing by the radical antiabortion movement, has made feminists enthusiastic supporters of the drug. This alarmed abortion opponents, who characterized RU-486 as ushering in an era of “guilt-free, responsibility-free, carefree living—better killing through chemistry, so to speak”

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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(Andrusko, 1991). “Let's have the courage to say so openly,” stated the Vatican, “a way of killing with no risk for the assassin has finally been found ” (Reuters, 1989c).

THE EARLY DEVELOPMENT OF RU-486

The central actors in the RU-486 history are Etienne-Emile Baulieu, a 62-year old endocrinologist with a “breezy, almost brash manner and hyperkinetic nature [that] give him the air more of a populist politician than of a meticulous medical researcher” (Greenhouse, 1989a), and Edouard Sakiz, chairman of Groupe Roussel Uclaf, a $1.7 billion French pharmaceutical group. A native of Turkey who arrived in Paris at age 20 to pursue his studies, Sakiz is described as reserved and cautious (Greenhouse, 1989a). Although much attention has been paid to Baulieu's involvement in developing RU-486, it was Sakiz who played the instrumental role in determining the future of the so-called abortion pill in France.

Baulieu started investigating fertility control in 1961 as a postgraduate researcher at Columbia University in the United States. While at Columbia, Baulieu developed a relationship with Gregory G. Pincus, who had worked during the 1950s to develop a birth control pill. Pincus helped Baulieu obtain a sizable grant from the Ford Foundation for his basic research on hormones—even though Baulieu did not want to work on refining the birth control pill (Rosenfeld, 1986). Back in France, however, Baulieu became a member of the government committee appointed during the administration of Charles de Gaulle that was instrumental in getting birth control legalized in 1966. The tremendous social implications of hormonal control research were not lost on Baulieu (Greenhouse, 1989a).

In 1966, Baulieu recommended Sakiz for the position of director of biological research at Roussel. Just returning from a teaching position at Baylor Medical School, Sakiz took up the post and worked with the company during the turbulent 1960s. During that time Roussel decided not to pursue production of the contraceptive pill because it did not want to risk offending the Catholic Church. “We lost the market for contraceptives even though we were the most important steroid company in the world,” Sakiz said regretfully in a 1989 New York Times interview. “And now contraceptives are considered natural; they aren't controversial at all” (Greenhouse, 1989a).

In 1970, Baulieu and his team at the University of Paris were the first to identify receptors within the uterine cells that receive messages from progesterone. They realized that it might be possible to use this knowledge to create a method for blocking or terminating pregnancy.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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“The receptors are like a keyhole,” explained Baulieu, “and we were trying to produce a false key” (Greenhouse, 1989a). Baulieu in turn gave the idea to Roussel, which had the facilities and know-how to turn the concept into a pill (Rosenfeld, 1986). (Baulieu was ineligible for financial rewards from any commercial sales.) He also suggested to the Roussel chemists that they try to graft a molecular cluster onto a progesterone-like molecule. In 1980, George Teutsch succeeded.

Clinical tests of the pill, dubbed R(oussel)U(claf)-486, began in Switzerland in 1982 under the direction of Walter Herman, a long-time friend of Baulieu (Rosenfeld, 1986). In 1983 Gilbert Schaison and Beatrice Couzinet at Bicêtre Hospital in Paris also began tests. There was little opposition to the tests because they had been cleared by the French national bioethics committee (Nayeri, 1987).

The drug rapidly showed promise. Eighty-five of the 100 women taking the drug had complete abortions. Subsequent tests showed that the drug should be followed with prostaglandins to raise the effectiveness rate from 80 percent to 96 percent.

Sakiz quickly became an enthusiastic supporter of RU-486. The discovery was hailed as a breakthrough, especially for developing countries where physicians and sanitary conditions are in short supply. Further research was initiated, although it remained almost exclusively in Europe because of a generally hostile climate for contraceptive innovation in the United States.

The most striking recent victim of this hostility was Depo-Provera, an injectable contraceptive developed by the Upjohn Company. Despite favorable test results, the compound showed some minimal indications of a tendency to induce cancer in certain laboratory animals when given in extremely high doses (Rosenfield et al., 1983). The result was a tortuous FDA regulatory review. Its problems were also attributable in part to an article in the journal Women and Health asserting that the U.S. Agency for International Development (USAID) was dumping dangerous contraceptives, most notably Depo-Provera, on markets in developing countries. This and other articles asserted that Depo-Provera was just the latest in a series of contraceptives that were being tested and marketed in developing countries with little regard for the health of the women using them (Gordon, 1976; Minkin, 1980; Seaman and Seaman, 1977).

Others argued that the charges being leveled at Depo-Provera were unfounded. They cited safety data and noted that USAID was not distributing the drug in developing countries. At least half of all Depo-Provera distributed abroad from any source, they maintained, had been directed to the markets of developed countries (Rosenfield et al., 1983).

Nevertheless, the Women and Health article was widely distributed to ministries of health in developing countries. A cover letter signed by

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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a number of physicians maintained that Depo-Provera was unsafe (Rosenfield et al., 1983). Unpersuaded by these assertions, some U.S. politicians began lobbying FDA to approve the drug. House Agriculture Research and Environment Subcommittee Chairman James Scheuer wrote to FDA Commissioner Frank Young, expressing his surprise that Depo-Provera, approved in the United Kingdom, Sweden, and West Germany, was not being approved by the FDA (F-D-C Reports, Inc., 1985a).

Despite congressional interest, however, FDA rejected Upjohn's efforts to compare Depo-Provera carcinogenicity data with data for oral contraceptives that had already been approved. It strongly criticized Upjohn's reliance on World Health Organization (WHO) studies, calling them “seriously flawed” (F-D-C Reports, Inc., 1985b). In August 1986 the FDA refused to reopen its Public Board of Inquiry record so that new data could be submitted. To justify the action, Commissioner Young asserted that Upjohn had failed to show that additional studies were relevant. Finally, in October 1986 Upjohn announced it would seek a wholly new approval procedure. That, too, eventually failed (F-D-C Reports, Inc., 1986).

The long, expensive, and ultimately unsuccessful effort to get Depo-Provera approved helped fuel charges that the U.S. regulatory system and the women's health movement made this country a hostile environment for contraceptive research and development. Contraceptive and abortion research continued in Europe, however. In December 1984, Baulieu and his Swedish colleague Mark Bygdeman of the Karølinska Institute in Stockholm reported that their method of combining RU-486 with follow-up prostaglandin treatments resulted in a “100 percent” success rate for inducing abortions and, further, that there were no significant side effects (Reuters North European Service, 1984).

During this time, RU-486 was billed as a sort of “morning-after” pill (Reuters North European Service, 1984) that acted as a “contragestive” as opposed to a contraceptive. Within a month, newspapers reported that the inventors had suggested RU-486 might become a once-a-month contraceptive. “Its main target is the one billion women in Third World nations who should be using birth control,” the Washington Post quoted Baulieu as saying. “Eventually it could be used protectively in developed nations, like a monthly contraceptive pill” (Berg, 1985).

COMMERCIAL INTEREST IN RU-486

By the spring of 1985, the commercial and political potential of RU-486 was being discussed in popular business magazines. Business Week, for example, ran a piece on Roussel's RU-486 and Sterling's Epostane (a progesterone formation inhibitor), describing the clinical trials that

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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were being conducted in the United States (under the guidance of Daniel Mishell, Jr., chair of the obstetrics and gynecology department at USC), and in China, India, and Europe (Rhein et al., 1985). Other European companies were working on similar products. Schering, a German company, had been working on two antiprogestins called ZK 98.734 and ZK 98.299. Only the former, however, had been tested in animal and human trials (Klitsch, 1989).

Portraying RU-486 and Epostane as morning-after pills, the Business Week article said they were better than three Upjohn prostaglandin products that could be used for abortion. (Those drugs, unlike Epostane and RU-486, produced severe uterine contractions and other side effects.) Sterling's senior vice president for medical and scientific affairs, Monroe Trout, discounted reports of nausea caused by Epostane: “ It's possible it was morning sickness.” Similarly, Baulieu discounted reports of excessive bleeding associated with RU-486: “While bleeding can sometimes be excessive, in most cases it is the same as a regular period or a spontaneous abortion ” (Rhein et al., 1985). (Discounting complaints of side effects brought on by contraceptives was nothing new: it had also been a problem associated with the birth control pill and the IUD, or intrauterine device.)

Both companies saw a major market for their drugs as an alternative to approximately 50 million surgical abortions each year, including the nearly 1.5 million abortions in the United States. Securities analysts thought RU-486 and Epostane could also compete in the $697 million oral contraceptive market. In 1985, this market was the exclusive domain of Ortho Pharmaceutical's Ortho-Novum and Wyeth Laboratories ' Ovral (Rhein et al., 1985).

Analyst David Crossen noted that safety fears had caused a 2 percent decline (to 51.7 million) in birth control pill prescriptions in the early 1980s (Rhein et al., 1985). RU-486 might suffer fewer problems. In January 1987, the New England Journal of Medicine published the results of a study led by Lynette Nieman of the National Institute of Child Health and Human Development. The study confirmed that RU-486 had few serious side effects (Stein, 1987).

Roussel officials, even before all the necessary dosage studies were completed, were optimistic about French government approval. “The Ministry [of Health] will examine the question on a scientific basis, not on a moral basis, because abortion is already legal in this country, ” said Maurice Ullman, who supervised clinical studies at Roussel (Nayeri, 1987). Analyst David Crossen concluded that “the oral contraceptive market is clearly tremendously ready for an alternative.” Thinking of RU-486 as an at-home morning-after method of contraception, Crossen estimated that at $2.50 to $3.50 per pill, a $1 billion market for

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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the drug would be created in the United States alone (Rhein et al., 1985).

But the United States was not an open market: political and religious opposition managed to keep that market closed. At the end of 1986, Congressman Robert Dornan (R-Calif.) called RU-486 a “death pill” (Rosenfeld, 1986). John Willke, NRLC's president, worried about the pill's effect on his organization's campaign. “We're really a very simplistic, visually-oriented people. And if what [abortions] destroy in there doesn't look human, then it will make our job more difficult” (Rosenfeld, 1986). Cal Thomas, former associate of televangelist Jerry Falwell, publicly urged the FDA to reject RU-486 partly because “the United States has never had a national debate on abortion.” This was angrily denied by several readers of the Los Angeles Times (January 17, 1989), who complained in “Letters to the Editor” that antiabortion forces had long dominated the political scene.

Baulieu was nevertheless ready to enter the fray. He chose what he saw as the high road of scientific objectivism: “I believe to work scientifically and to bring this thinking to the debate is very important, ” he said. “People know that scientists make a point to remain basically honest, because if you cheat in science you are dead. So if people give us the credit that we are fair, I am ready to use that credit for a cause of this sort” (Rosenfeld, 1986).

Using that credit, Baulieu argued that preimplantation interference with reproductive processes cannot be characterized as abortion. Pregnancy, he argued, does not commence until full implantation of the fertilized egg in the uterine wall. (This view is held by most U.S. scientists and has been adopted by the U.S. government for the purpose of defining “fetus” in its regulations governing research on human subjects [U.S. Congress, Office of Technology Assessment, 1988].) The result, according to Baulieu, is that, for the sake of public discussion, “the whole concept of abortion must change” (Rosenfeld, 1986).

The hope that RU-486 might become a once-a-month contraceptive led gynecologist Raymond Faraggi to predict: “If it works, it will be the end of contraceptives and the end of abortion. No more daily pills, no more IUDs, you take a pill on the 25th to 28th day of your menstrual cycle regularly, every month. It means the end of abortion, anyway, and an end to all our problems” (Nayeri, 1987). William Crowley, Jr., an endocrinologist at Harvard Medical School, hoped RU-486 would lessen opposition from antiabortionists. “If you look at drugs that have changed the history of society,” Crowley said, “. I think RU-486 is another significant advance” (Stein, 1987).

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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THE GROWING THREAT OF ANTIABORTION GROUPS

Viewing RU-486 as a once-a-month pill or a menstrual regulator did not lessen opposition from antiabortion organizations. In mid-June 1987, antiabortionists held a three-day conference in New Orleans at which they attended workshops on, among other things, political action strategies for resisting RU-486 (Emiling, 1987). Among these strategies was a plan to lobby Congress to stop the FDA from authorizing clinical trials of RU-486, such as those under way at USC under the auspices of the not-for-profit contraceptive research organization the Population Council (Sheler, 1987). On June 12, 1987, the NRLC proposed guidelines for amending FDA regulations for testing contraceptives. They recommended that no FDA funds be used “to perform any function with respect to” the investigational new drug application in effect for RU-486. In another effort to slow RU-486 development, they also recommended that all oral contraceptives and devices have mandatory 7- and 10-year dog and monkey trials prior to initiation of clinical trials (F-D-C Reports, Inc., 1987).

In February 1988, a WHO task force announced the results of clinical studies in Britain, China, France, and Sweden. They found that RU-486, when administered in conjunction with prostaglandin therapy, was 95 percent effective and free of significant side effects (Steinbrook, 1988). Sensing a growing enthusiasm for the drug, the NRLC and other antiabortion organizations threatened to boycott any drug company that decided to develop the drug—just as Upjohn had been boycotted several years earlier for its development of prostaglandins that had abortifacient qualities (Kolata, 1988b). Publicly, pharmaceutical companies claimed they were not concerned by the boycott threat. Privately, however, according to the New York Times, the message was different. “The reasons are obvious,” said one unnamed company executive, “and we don't want to get into it” (Kolata, 1988b).

One strategy that might have been employed to avoid the public relations problems raised by developing and marketing RU-486 for early abortions would be to approve it in the United States under another guise, for example, as a drug to widen the cervix and help avoid cesarean sections. Once a drug is approved for marketing by the FDA, it can be prescribed by physicians at their discretion for any condition. But NRLC's education director Richard Glasow said his group would not be fooled by such an action. The group's thousands of local chapters, he said, would organize to boycott any company making the drug—unless it were the only drug available to treat a life-threatening disease. “Our basic position,” said Glasow, “is that death drugs designed to kill babies have no place in America ” (Kolata, 1988b).

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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The boycott threat was real because previous boycotts had been effective. In 1985, after NRLC had boycotted Upjohn products for two years, the company stopped all research on drugs to induce abortions or prevent pregnancy. An Upjohn spokesman said that the company decided to stop because of the “adverse regulatory climate in the United States” and the “litigious climate.” Glasow, however, insists it was the boycott (Glasow, 1988b). Wayne Bardin, vice president and director of biomedical research at the Population Council, and several others agree (Kolata, 1988b).

In light of this history and the threats to boycott companies involved with RU-486 development, Irving Spitz of the Population Council characterized the power of U.S. antiabortion groups as “very upsetting”: “Because of the possible political backlash, we have kept a low profile. We have not really encouraged studies in this country. We feel that our hands are tied. It's a question of political realities” (Kolata, 1988b).

Ironically, little more than a month later the NRLC joined forces with women's groups and consumer activists to oppose certain provisions of proposed legislation that would reduce manufacturer liability for defective products. Consumer groups opposed the entire bill; NRLC encouraged an amendment, sponsored by Congressman Gerry Sikorsky (D-Minn.), that would have removed all drugs or medical devices used as contraceptives or to facilitate abortions from the broad protections of the bill. In its efforts on the amendment, NRLC sent letters to members of Congress complaining that the original version of the bill “would severely curtail the ability of women to obtain recompense for injuries inflicted on them and on their unborn children” (Gladwell, 1988b). Uppermost in NRLC's thinking was RU-486. “It's in our interest to keep the law the way it is,” said Douglas Johnson, legislative director for NRLC. Without limitations on liability, the 5 percent failure rate posed a problem for the drug's manufacturers (Gladwell, 1988b). Should the drug fail to terminate a pregnancy, and the mother then decide to carry the child to term rather than seek a surgical abortion, the manufacturer could be exposed to enormous liability if the child were born with health problems traceable to RU-486 exposure. Although exceedingly unlikely, the magnitude of the liability and “bad press” that might be associated with even one such birth defect might be enough to curtail serious interest in the drug.

Women's groups also opposed the original version of the bill, not to hinder RU-486 production but rather for the very reasons stated in the NRLC letter: fear of restricting women's access to damages for injuries resulting from contraceptive use. Not wishing to join too closely with NRLC, women's groups fought the entire bill on the ground that it was unfair to consumers. NRLC set its sights much lower and aimed only to

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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pass the Sikorsky amendment. Passage of the amendment would make the bill fairly useless to pharmaceutical companies and help break the business coalition supporting overall product liability reform (Goodman, 1989). With this kind of opposition, the bill was eventually defeated in Congress.

NRLC's public statements of concern for women's safety did not end with the fight over the product liability bill. In his April 23, 1988, letter to the editor, for example, Richard Glasow protested the New York Times editorial stance in favor of the drug. Comparing it to the ill-fated Dalkon shield, he noted that IUDs had also been viewed as safe and effective when they first were put on the market. NRLC asserts that RU-486 might cause cancer, citing a chemical structure with some similarities to the carcinogenic compound diethyl stilbestrol, or DES (Harris, 1991). The claim is dismissed as preposterous by David Grimes of the USC Medical School (Stein, 1988).

The NRLC letter to the New York Times concluded as follows: “[Our] opposition to RU-486 arises out of a concern for the life of the unborn child and the life and health of the mother. If any pharmaceutical company attempts to manufacture or market such a killer drug in the United States, it would face so massive a boycott by right-to-life organizations, church groups, and pro-life hospitals that RU-486 profits would be swallowed up many times over by the loss of other business. American women aren't looking for a chemical Dalkon Shield. Neither are we.”

NRLC continued to draw connections between RU-486 and the failed IUD when it critiqued a peer-reviewed study of the drug: “The French study offered nothing to calm fears about the possibility of long-term adverse side effects, such as damage to the aborted woman 's later children. This is especially important in light of the abysmal track record many of those advocating RU-486 in the United States (such as Planned Parenthood) had in promoting such dangerous products as the Dalkon Shield IUD” (Glasow, 1990a).

By May 1988, RU-486 was making its way into the general public's debate over abortion rights. A Virginia mail handler, for example, wrote in The New Republic (Fagen, 1988) that:

[P]ro-lifers like to compare their struggle with the fight against slavery. In fact, it has more in common with prohibition. Abortion is like alcohol abuse—it pervades our whole society. The idea that abortion can be stopped by reversing Roe is prohibitionist romanticism, as naive and foredoomed as that of the Anti-Saloon League. The issue is not whether women theoretically should be the ones making abortion decisions. As a matter of fact they are, and in the future, with RU-486 or the equivalent, their decision making capacity is likely to increase. Faced with this reality, the only practical way to decrease abortion is to influence the decisions they make.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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There is no way to overstate the anger that abortion, and RU-486, can generate. When asked whether he'd prefer his daughter be forced to use the riskier suction technique rather than use RU-486 should she become pregnant, one antiabortion demonstrator said “I don't think it makes much difference if she kills her baby or kills herself” (ABC News, 1990).

The political controversy surrounding RU-486 soon took its toll on Roussel. By June 1988, Sakiz's support for RU-486 began to wane in the face of taunts outside his window and as many as 25 threatening letters a day. The protesters claimed he was “changing the uterus into a death oven” (Greenhouse, 1989b). “Assassins, stop your work of death,” read some letters. Others contained threats: “Your pill kills babies and you will suffer the consequences.” Handbills were distributed calling RU-486 a “chemical weapon” that would “poison a billion third world children.”

In addition, other pressures began to build. On June 22, 1988, the eve of Roussel Uclaf's annual meeting, NRLC executive director David O'Steen released a letter the organization had sent to the French ambassador (PR Newswire, 1988b) protesting the French government 's involvement with RU-486 through its minority shareholder position in Roussel Uclaf:

[A] lethal drug has no place in America or anywhere else. We are especially incensed that the abortion pill's proponents have announced that they intend to make women of Third World countries a special target for the death drug's use. If Roussel Uclaf or any other pharmaceutical company attempts to manufacture or market RU-486, [the] National Right to Life Committee would seriously consider joining with other pro-life groups around the world to initiate a boycott of the products of Roussel Uclaf and firms affiliated with it through the parent company Hoechst.

This letter, like the congressional lobbying over the product liability legislation, demonstrated NRLC's ability to borrow arguments and language from the women's health movement. This movement often cited inadequate testing of new products and exploitation of women in developing countries as reasons to oppose many contraceptive innovations. The promise of RU-486 was so great, however, that it encouraged the women 's health movement to join with the “population controllers” whom they bitterly opposed—Planned Parenthood Federation and the Population Council—in support of the drug (Fraser, 1988).

Now ambivalent about RU-486, Sakiz arrived at Roussel's annual meeting on June 23, 1988, to be met by hundreds of abortion protesters on the Boulevard des Invalides. Instead of focusing on the company's recent increase in profits, the meeting was dominated by anatomy pro-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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fessor and abortion opponent Xavier Dor, who excoriated Sakiz for 20 minutes (Greenhouse, 1989a). Yet despite this growing internal and external pressure, Sakiz was unwilling to repeat the company 's mistake of the 1960s, when it chose not to produce oral contraceptives for fear of a public and religious backlash. He hoped that the protests would disappear after France's minister of health, Claude Evin, ruled on Roussel's application to market the drug. He believed the protests were directed more at the government than at the company (Greenhouse, 1989a). Meanwhile, Baulieu also lobbied colleagues within the company, urging them not to give in to the right-to-life movement and to support the clinical trials beginning in Great Britain (Facts on File, 1987).

CORPORATE PRESSURE FOR WITHDRAWAL

Although antiabortion forces clearly were having some effect on Sakiz, they were having their greatest effect on Roussel's parent company. A spokesman for Hoechst acknowledged that the company had received threats of boycotts against all of its products and that the director had “decided it [proceeding with RU-486] was simply not worth the risk” (Ricci, 1988).

According to the following excerpt from a New York Times Magazine article (Greenhouse, 1989a) written by Paris-based reporter Steven Greenhouse on the basis of interviews with unidentified Roussel employees and their friends (S. Greenhouse, personal communication, February 6, 1991), it was the resulting intra-company pressures that finally persuaded Sakiz to withdraw support for the drug.

Sakiz's friends say it was not the anti-abortion protestors but intra-company pressures that finally caused him to cave in. Roussel, after all, had a parent company to answer to. Hankering for what the French call a “petite danseuse,” a little dancer, Hoechst A.G., the stolid West German chemicals giant, had first bought a stake in Roussel in 1968; it has since grown to 54.5 percent. Hoechst was attracted by the smaller company 's expertise in biochemistry, and by its creativity and impulsiveness. But in the RU 486 affair, it appeared that Roussel was too creative and impulsive. Hoechst made it clear that RU 486 was no longer welcome, when the company's chief executive officer, Wolfgang Hilger, stated that an abortion pill violates the company's credo to support life.

Hoechst also feared that boycott threats by the American anti-abortion movement could cripple Hoechst's $6-billion-a-year American subsidiary. “Officials at Hoechst's American subsidiary asked headquarters to get Roussel to cease and desist,” says Sheldon Segal, director of population sciences at the Rockefeller Foundation and a hard-fighting advocate of RU 486.

Privately, Roussel officials said colleagues at Hoechst were dismayed by the right-to-lifers' taunts that Hoechst and Roussel were doing to fetuses what the

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Nazis had done to the Jews. I.G. Farben, Hoechst's ancestor company, manufactured cyanide gas for the death camps.

The key development that seemed to force Sakiz's about-face came when Alain Madec, an ambitious 41-year-old executive vice president, the No. 3 man at Roussel, announced that he was against RU 486. He was the third of Roussel's five-man executive committee to throw his weight against the pill, joining two other executive vice presidents. Sakiz had withstood their opposition because they were due to retire soon. But with Madec 's announcement, he began to worry that Madec might be currying favor with Hoechst to stage a palace coup. (Greenhouse, 1989a)

Still, Sakiz held out. On September 23, 1988, French Minister of Health Evin approved the pill for marketing (Foreman, 1988a). But instead of the protests dying down, as Sakiz had hoped, they escalated. The influential Archbishop of Paris Jean-Marie Cardinal Lustiger condemned the pill (Greenhouse, 1989a). Even Judy Norsigian of the National Women's Health Network in the United States was less than completely supportive of the decision: “Women think this is a great idea and it does offer an option to women ambivalent about abortion, but it's too early to say if it is a good thing until it has been around longer” (Foreman, 1988a).

Norsigian's ambivalence was noted and her remarks repeated in the National Right to Life News (Glasow, 1988c), in which NRLC's education director Richard Glasow echoed this safety theme: “We are opposed to marketing of RU-486 in the U.S. or any other country because it kills unborn babies and it can injure if not possibly kill women. It is a very dangerous drug. It causes every woman who takes it to experience a miscarriage with excessive bleeding. Women in the United States and other countries should not be guinea pigs to determine its long-term adverse side-effects” (Foreman, 1988a). These were the same kinds of charges made earlier by women's groups who opposed Depo-Provera, and they reflect the continued mistrust generated by the early birth control pill trials.

In the week that followed, Dutch researchers announced that another drug, Epostane, was about 84 percent effective at inducing abortions. Glasow announced that NRLC opposed Epostane as strongly as it opposed RU-486 (Stein, 1989).

With attention beginning to focus on prospects for U.S. marketing of either Epostane or RU-486, U.S. pharmaceutical companies, seemingly in an effort to ward off boycotts and bad publicity, began to deny interest or involvement. John Wood, vice president for public affairs at Searle, which owned the rights to Epostane in the United States, announced that the company had no plan to market it. “The drug is not a suitable candidate for our overall objectives,” he said (Stein, 1989). GynoPharma,

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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a New Jersey company, announced that, despite Roussel's statements that discussions were taking place between the two companies (Technology Newsletter, 1988), it did “not have an agreement, nor is the company involved in negotiations with Roussel Uclaf” (Foreman, 1988c). Glasow of NRLC asserted that GynoPharma had “backpedaled immediately, pull[ing] itself out of this debate” following the French government's approval of the drug (Foreman, 1988c).

In an October 6, 1988, editorial entitled “Pills and Parallels,” the Boston Globe noted the parallels between the introduction of the birth control pill and the introduction of RU-486:

Historic parallels between the two pills are remarkable in the extent to which American pharmaceutical companies fear political and religious backlash against the new abortifacient, just as they did 30 years ago against the contraceptive. Such fears about “the pill” turned out to be groundless, as they should about the abortifacient.

To test the waters of social acceptance, the contraceptive pill was first presented as a medicine for menstrual regulation, a legitimate use but not the pill's primary purpose. The same ruse—menstrual regulation—is being used today to try to gain approval of the abortion pill.

In the 1950s, America's mightiest drag companies did not dare to market the contraceptive pill, fearing they would become the target of boycotts over the “immorality” of birth control. The identical fear now—of a vast boycott threatened by the National Right to Life Committee over the “immorality” of abortion—has cowed the pharmaceutical industry. No United States company is seeking federal permission to market RU-486 as an abortifacient or for any other medical purpose.

The presumed power of anti-abortion groups should be challenged. When the G.D. Searle company finally plunged ahead with the marketing of the contraceptive pill, it experienced no adverse reaction. .

History's lesson is that society was way ahead of politicians, federal agents, and socio-religious groups in its acceptance of the birth control pill. Today, Americans widely approve the option of abortion; the earlier, the better.

The editorial's point about public attitudes was accurate. A Louis Harris survey, released on October 12, 1988, found that 82 percent of Americans supported government spending on research and development of new contraceptives and 59 percent thought that RU-486 should be made available in the United States (PR Newswire, 1988d). Even America 's oldest advice columnists, Abigail Van Buren and Ann Landers, supported the drug. At an October 17 dinner to honor them with Planned Parenthood 's 1988 Margaret Sanger Award, Van Buren said: “[RU-486] is said to be safe and effective. Hallelujah sisters. But what will the politics of this medication be? Will the FDA approve it? And who's going to manufacture it? Between my sister and me I am told we are read by an estimated 100 million people daily. Thank God,” she

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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continued (borrowing the religious rhetoric of the antiabortion movement), “we are on the right side of this issue” (PR Newswire, 1988c).

Nevertheless, despite this evidence of public support in the United States, corporate pressures and local demonstrations began to take their toll on Roussel's Sakiz. Roussel had been inundated with letters of protest and threats of boycotts (Associated Press, 1988); Hoechst, with 25 percent of its $23 billion in sales located in the United States, made it clear that it strongly favored suspending sales of the drug (Greenhouse, 1988b). On October 21, 1988, Sakiz called a meeting of the management committee. After two hours, he called for a vote, and he raised his hand to withdraw RU-486 from the markets both in France and abroad (Greenhouse, 1989a), despite having already contracted with China, Spain, Britain, and the Scandinavian countries to supply the pills (Tempest, 1988b). “We have a responsibility in managing a company,” he explained in an interview. “But if I were a lone scientist, I would have acted differently,” thus summing up the conflicting priorities of business and science (Greenhouse, 1989a).

Baulieu was traveling and did not hear of the decision until the following week. When he did, he returned to Paris to protest privately, in Sakiz's office. Reportedly, Baulieu's Roussel colleagues felt at times that he was too outspoken, as when he suggested investigating the use of RU-486 as a once-a-month pill, thus blurring the lines between contraception and abortion. Nonetheless, Sakiz encouraged Baulieu to go public. “You're independent, ” he said, “you can go out and speak freely” (Greenhouse, 1989a).

The next day, October 26, 1988, Roussel informed the press it was pulling RU-486 off the market because of the “outcry of public opinion ” and the “polemic” surrounding the pill. “Side effects were in no way a problem,” said Arlette Geslin, director of medical relations for Roussel Laboratories. “The problem was that there were protests, letters threatening to boycott, and demonstrations in front of our headquarters. We didn 't want to get into a big moral debate” (Greenhouse, 1988a).

Roussel vice chairman Pierre Joly commented, “We believed that after the French government approved the product, everybody would be influenced by that decision and we could forget the problem. But that was not true. The trend, the threats kept increasing ” (Tempest, 1988c). For example, a militant French antiabortion group, the Committee to Save Unborn Children, called for the “destruction of all stocks of the chemical weapon RU-486” (Tempest, 1988c).

Roussel officials were concerned about protests not only in France but in the United States, citing the NRLC letter to the French ambassador and American threats of boycotts against all Roussel and Hoechst products (Greenhouse, 1988a). “We witnessed an orchestrated cam-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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paign that became more and more powerful,” said Joly (Greenhouse, 1988c).

There have also been personal threats. Baulieu once traveled with a bodyguard during a U.S. visit (United Press International, 1988). David Byrd (a Scottish researcher), Joly, and a number of Roussel officials also received threats (Atwood, 1988; Gruhier et al., 1988; Reuters, 1988). Minister of Health Evin later commented, “Their children and their wives were threatened through anonymous letters. This is totally inadmissible and utterly cowardly. It is difficult to say who these people are, since they are acting anonymously, but they are basically those same religious fundamentalists who in the early 1970s campaigned against the abortion law” (Naughton, 1988b).

U.S. pressure was particularly influential. “The pressure groups from the United States are very powerful, maybe even more so than in France,” said Pierre de Rible, Roussel's deputy financial director. “We see that in the American presidential campaign, abortion is a major subject of debate, but in France people speak less and less of it” (Greenhouse, 1988c). But, he added, the introduction of the abortion pill had begun to revive that debate in France (Greenhouse, 1988c). French physicians were writing to the company, threatening not to prescribe any of its products to their patients (Laurenson, 1988).

NRLC agreed that public pressure must have caused Roussel to take RU-486 off the market. “Roussel Uclaf expended millions of dollars to promote their abortion pill,” said John Willke, president of NRLC. “If they've decided to halt their distribution, we can be sure the ‘public outcry' must have been massive and worldwide. They evidently concluded that peddling death drugs was not in their best interests” (PR Newswire, 1988a).

One unnamed Roussel employee said, “We cannot put the group's development at risk. Public opinion is not ready for this product ” (Naughton, 1988a). Although Roussel's exports to the United States represented only 7 percent of its annual $1.7 billion in sales, financial analysts said the company was worried that a boycott over RU-486 might cripple its ambitious plans to increase American sales.

According to another Roussel employee, concern about its international image had been more important than the short-term economic effects of a boycott when Roussel made its decision to pull the drug from the market. “We decided more than five years ago that we didn't want to make money on RU-486,” said Joly. “We decided to sell it at cost” (Tempest, 1988c). Although protests in France itself had been fairly weak, NRLC asserted that there had been demonstrations against the drug at 40 French embassies worldwide. Although Agence France Presse reported it had no such information (Foreman, 1988d), “the

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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company acted to preserve its image abroad,” according to a Roussel employee (Tempest, 1988c).

Roussel's decision met with mixed reactions within the French government. Michèle André, minister for women's rights, called the decision disagreeable. Junior Minister for Family Affairs Hélène Dorlhac, however, said, “I am pleased by this withdrawal, as by the decision to take pornographic films off prime-time television” (Greenhouse, 1988c).

Roussel's decision came at a time of tension in France during which religious conservatives and the secular society were publicly and privately at odds. For example, the Roussel announcement was made three days after a firebombing of a Paris cinema showing the film “The Last Temptation of Christ.” A Hoechst spokesman denied any connection between the cinema fire and the decision to stop making RU-486. He did say, however, that both events “stemmed from the same thinking ” (Ricci, 1988).

The French Movement for Family Planning issued a statement drawing attention to the link between the political opposition to RU-486 and the political opposition to the film: “After setting the fires of intolerance with the Scorsese film, the traditionalists and Catholic reactionaries want to impose their outdated laws on women. When will we start seeing women burned alive at the stake as in the Middle Ages?” (Ricci, 1988). Scientists and leftist politicians also drew parallels between the withdrawal of the drug and a Catholic fundamentalist campaign to drive the controversial film from theaters. Only one Paris cinema showed the film after the protests and arson attack (Naughton, 1988a).

THE RETURN OF RU-486

On the same day Roussel announced its decision to withdraw RU-486 from the market, nearly 10,000 physicians and researchers were gathered in Rio de Janeiro for the World Congress of Gynecology and Obstetrics. Roussel's decision turned the meeting into a rally to rescue the drug. It could appear that Roussel had timed its announcement to coincide with this meeting to generate support for the drug, and to lay the groundwork for subsequent events that allowed Roussel to market the drug without appearing to endorse its development or use.

The Roussel decision was widely criticized at the Rio meeting. Sheldon Segal attacked Roussel for “betraying its partnership with the medical profession” (Greenhouse, 1989b). Elisabeth Aubény, a Parisian gynecologist, carried a 2,000-name petition of protest back to France. Baulieu called for women to organize: “It's not enough for women to show a simple desire for the pill. There must be a public mobilization to demand it be made available” (Reuters Library Report, 1988). He also

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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said, “Sakiz told me he hopes there is pressure to counteract this decision ” (Simons, 1988). Indeed, such pressure was building. A group of American and European university professors began preparing a list of Roussel 's products and said they would ask physicians to boycott them. A protest campaign was planned that included placing advertisements in newspapers and sending letters to Hoechst. “Medical groups and family planning clinics should protest the decision to show that we too have a voice, not only right-to-life groups,” one professor said (Simons, 1988).

Other organizations also issued statements of protest. The National Abortion Rights Action League (NARAL) said, “A fringe group of anti-choice extremists, having failed to halt legal abortions through the courts and the legislature, is holding a large multinational drug company hostage” (Ricci, 1988). The French minister of women's rights, Michèle André, said the action might encourage an attack on abortion rights in general: “We are witnessing a return to morality. And who are the victims of morality?—women. Always. It's as old as the world” (Naughton, 1988a).

An October 28, 1988, New York Times editorial entitled “Abortion, Intimidation, and Death” also focused on the women who would be affected by the decision: “By capitulating to activists who regard abortion as immoral, a French company called Groupe Roussel Uclaf may be committing a larger immorality, ordaining the death of tens of thousands of women around the world. It is they, and not a corps of noisy intimidators, who should have the company's ear.”

Planned Parenthood Federation called Roussel's move a “tragic display of cowardice and a shocking blow to women around the world” (PR Newswire, 1988d). It accused Roussel of “buckling to the political pressure exerted by a small but vocal anti-family planning minority, with total disregard for the health benefits this drug could have had for millions of women worldwide. We hope that another manufacturer, one truly devoted to improving the health of the world's people, will step in and make available this much-needed product” (PR Newswire, 1988d).

In fact, physicians, scientists, feminists, and family planning organizations began to work almost immediately to bring RU-486 to market without Roussel. “We're worried about the rise of Catholic fundamentalism and the blackmail exercised against Roussel,” said Catherine Lesterpet, the national coordinator of the French Family Planning Association (PR Newswire, 1988d). One suggestion was to set up a nonprofit company to buy the patent because, as a single-product enterprise, retail boycotts could not harm it. Another suggestion was to have China, the only country besides France to approve the drug, buy the patent

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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and manufacture the pill for the whole world. A third suggestion was that WHO, which had sponsored many tests of RU-486's safety and effectiveness, distribute the pill (Greenhouse, 1988a). But WHO would face problems in manufacturing and marketing on such a scale, asserted José Barzalatto, then director of WHO human reproduction research, “because we are not a pharmaceutical company” (Greenhouse, 1989b). In addition, obtaining the patent from Roussel would not be easy because of the drug's promising uses in other areas, such as fighting breast cancer or dilating the cervix to avoid cesarean sections in cases of prolonged labor.

There was also the chance Roussel might change its mind. Pierre Joly, Roussel's vice chairman, hinted at this the day following the announcement: “We might resume distribution of RU-486 if the atmosphere becomes peaceful again” (Greenhouse, 1989b). Within the French government, efforts were under way to force Roussel to make such a change. Mich èle Barzach, former health minister under conservative Jacques Chirac, was the first to attack the company's decision and to criticize the Socialist government for remaining silent (Izbicki, 1988). Two days later, Claude Evin summoned Joly to his office. Evin was angry that the company had pulled RU-486 only four weeks after the government had defied the Church and antiabortion pressure groups and approved the drug. “[I am] astonished by such a decision, which is contrary to the industrial policy pursued up to now on this product,” he said (PR Newswire, 1988a).

Evin feared that if the antiabortion movement was triumphant in its crusade against Roussel, it would begin fighting for a repeal of the 1975 French law legalizing abortion. The government did not wish to enter such a fray. Bitter controversy had preceded passage of the 1975 law, as well as the 1984 Socialist government decision to reimburse abortion costs under the national health plan (Naughton, 1988a). “I was doing what I could,” said Evin, “to make sure France did not surrender to pressure groups animated by archaic ideologies” (Greenhouse, 1989a). Roget Bouzinac, a distinguished French commentator writing in Le Var, pointed to another aspect of the controversy. Noting the violence surrounding “The Last Temptation of Christ” and RU-486, he asked whether France might not be on the verge of another religious war. “We must be careful that the affair of this abortion pill does not recreate the anti-clerical movement which at another period did our nation so much harm” (Izbicki, 1988).

Evin told Joly that, if necessary, the French government would use its status as 36 percent owner of Roussel (and some special provisions of French law) to transfer the patent to another company in order to serve the public good. In light of this threat, Roussel issued a statement

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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on October 28, agreeing to put the drug back on the market (Associated Press, 1988). Explaining his decision to force the company to change its mind, Evin said, “I could not permit the abortion debate to deprive women of a product that represents medical progress. From the moment Government approval for the drug was granted, RU-486 became the moral property of women, not just the property of the drug company” (Greenhouse, 1989a, 1989b).

Baulieu echoed this sentiment: “It is a good reaction in the face of demonstrations of intolerance that constituted a grave precedent. Medicine is at the service of patients and goes beyond other considerations” (J. Phillips, 1988b). He added, “Intolerance cannot be introduced into choices made between a patient and her doctor. That would be something of incalculable consequences” (Atwood, 1988).

Prime Minister Michel Rocard's Socialist Party praised Evin's decision: “This is in accord with the morals, needs, and mentality of medical science. The majority of public opinion, and especially most women, expected it” (J. Phillips, 1988a). This perception was accurate: an October 1988 survey found 64 percent of the French public in support of the drug. Fifty-six percent believed that Roussel had violated women's rights by withdrawing it (Gruhier et al., 1988). Representatives of conservative parties disagreed: “It is in the interests of public health to favor life, not to kill it with a chemical product” said Christine Boutin, a deputy of former President Valery Giscard d' Estaing's Union of French Democracy federation (J. Phillips, 1988a).

The French government's stance was also supported by interested medical and political groups around the world. José Pinotti, president of the International Gynecological and Obstetrics Federation, said, “France has made a courageous decision, one that shows science cannot be blocked by narrow-minded politics ” (Atwood, 1988). Scottish gynecologist David Byrd called the decision a “mature response to pressure from people who are not opposed to this drug but to any kind of abortion” (Atwood, 1988).

Sakiz was delighted with the government order because it took the onus off his company and shifted responsibility to the Ministry of Health. “The Government's order helped us,” he said, “because it showed the Government was on our side.” Joly added, “We are relieved of the moral burden weighing on our group. For us, the problem is now solved” (Greenhouse, 1989a). Some opponents suggested that Evin and Sakiz had orchestrated the series of events to shift blame from Roussel to the government, but both men denied the charge (Greenhouse, 1988a, 1989b; Gruhier et al., 1988).

Hoechst, however, also denied any allegation of collusion: “This is a purely political decision of the French government and we have always

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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said that we would respect such political decisions” (Naughton, 1988b). The Hoechst spokeswoman also sought to distance the company from events by noting that “Roussel Uclaf is totally independent and the decision they made has nothing to do with whatever Hoechst thinks” (Foreman, 1988b). But, she added, the pill would not be put on the market in West Germany.

The leading French weekly Nouvel Observateur, however, hinted at collaboration between the government and the company. It noted that Roussel had responded far more quickly to the government threat than would be expected, especially in light of the legal questions raised by the government's minority stockholder status (Gruhier et al., 1988). (France would sell its shares in July 1990 to Roussel 's competitor Rhône-Poulenc, for $700 million) (Dawkins, 1990; Glasow, 1990d, 1990e). American observers agreed. Based on conversations with Sakiz, the director of population policy work at the Rockefeller Foundation, Sheldon Segal, said: “I personally believe that this was a joint decision on the part of Groupe Roussel and the Ministry of Health ” (Tempest, 1988c).

The antiabortion movement also rejected Hoechst's denials of collusion. Judie Brown, president of the American Life League, said she was not surprised by the French government's decision: “We originally thought the whole thing was a public relations gimmick ” (Tempest, 1988c). The NRLC stated that “the withdrawal was all for show, a carefully staged ploy to take the heat off of the manufacturer by placing the blame on the French government” (Glasow, 1988d). Its president, John Willke, said, “We hold Roussel-Uclaf and its parent company, Hoechst AG in Germany, 100 percent responsible” (Glasow, 1988d). In another interview he said: “We cannot rule out a massive worldwide boycott against Hoechst and every other subsidiary. The attempt by the French minister to take the blame and absolve the company is a charade and we will directly hold the company totally responsible for release of this drug” (Foreman, 1988b).

These organizations and the Catholic Church denounced the French government's move. Msgr. Albert Decourtray, president of the French Bishops Conference, called it “a victory for savage liberalism” (United Press International, 1988). He also asserted that the reason for the government's intervention was financial, not ethical: “There are huge sums at stake and I am afraid that economic considerations weighed heavily in this decision ” (Tempest, 1988a). In Washington, Victoria Leonard, executive director of the National Women's Health Network, said she was “relieved” by the French government's decision. She called it courageous and predicted that “this drug's entry into the United States is inevitable” (J. Phillips, 1988b).

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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THE CONTINUING OPPOSITION

With the drug's marketing in France assured, concern switched to the possibility of a dangerous black market in RU-486 in countries where the drug was not available. Evin said that precautions to prevent abuse and black market sales had been taken. “These pills will only be administered in the presence of a doctor and sales will be subjected to the same rigorous restriction as those which apply to hard drugs,” he said (Reuters, 1988). Others, however, like Louise Tyrer of Planned Parenthood, predicted that a black market would appear in the United States (Thomas, 1988). “It's coming,” agreed Planned Parenthood president Faye Wattleton. “The question is whether it will come unsupervised and unsafe, or supervised and safe” (Goodman, 1988a). Joseph Speidel and Victoria Leonard also thought that women would smuggle the drug to obtain it. “Women smuggle contraceptives into Ireland, where they are illegal, and women are going to smuggle RU-486 into this country,” said Leonard (Stein, 1988).

The feminist leadership were concerned that a black market in RU-486 would make lay abortions dangerous. Recently, a number of groups have sprung up to teach women to do lay abortions using the relatively safe suction technique lest the medical community become unwilling or unable to provide the service (Japenga and Venant, 1989; Kolata, 1989). Some have already talked of trying to smuggle in RU-486, although none as yet have been successful. But if taken too late by someone with contraindications, or without follow-up prostaglandin therapy, RU-486 could produce complications. To prevent a black market from developing, feminists began working to get the drug into the country, either through an established company or by organizing a new company (Goodman, 1989). The groups began by visiting Roussel in Paris and its New Jersey subsidiary, hoping in both instances to get the companies interested in U.S. marketing. To date, they have been unsuccessful (Sherman, 1989).

Legal access to RU-486 in the United States does not appear likely in the near future. At the moment, the companies most likely to take on testing and development of the drug are keeping a low profile. In January 1989, Victor Bauer, president of Roussel's U.S. subsidiary, HRPI, asserted that its decision not to pursue testing and licensing of the drug in the United States had nothing to do with “extremist pressures.” Rather, RU-486 “lies outside the experience and medical expertise of this company. HRPI does no research in the birth control area” (Savage and Tumulty, 1989).

At this same time, however, controversy began over drugs not destined for the birth control or abortion markets, such as Searle's antiulcer drug, Cytotec. While the drug was under review by the FDA, antiabortion

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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groups began petitioning the federal government to prevent its production because it could be used to induce miscarriages. Richard Glasow of NRLC asserted that the drug would be “on the streets” within days of approval as a black market source for abortifacients, and antiabortion groups threatened to boycott Searle should it market the drug (Kolata, 1988c). Despite these threats, the FDA approved the drug.

SUCCESS OF THE BOYCOTT THREAT

In late 1988, a new opposition group, the RCR Alliance, registered with Congress as lobbyists. The registration stated that RCR was interested in abortion-related legislation. In fact, the group was formed solely to persuade the French government, Hoechst, or Roussel to pull RU-486 off the market (Ciolli, 1989a). Its strategy is partly revealed by its name. The initials stand for Robins-Carbide-Reynolds, referring to three companies that have faced extensive product liability litigation (Sarasohn, 1988).

“We feel the pill is devoid of conscience. It is nothing more than a human pesticide,” said Kenneth Dupin, pastor of the Valley View Wesleyan Church in Roanoke, Virginia, and a director of the RCR Alliance (Sarasohn, 1988). Legal abortions in the United States are handled by the medical community, which, according to Dupin, has a conscience. But women in the third world generally would use the drug without such supervision (Sarasohn, 1988).

Although Dupin's RCR Alliance is centered at his church, its membership includes others as well. The church has already organized a boycott of such high-visibility French products as Perrier and Michelin tires. RCR Alliance plans to back the boycott if other efforts at persuasion fail. Its immediate goal, however, is to negotiate with the French government, Hoechst, and Roussel. “We're not trying to be corporate terrorists,” Dupin says. “We're willing to compensate this company for its research ” (Sarasohn, 1988).

In September 1988, the unknown RCR Alliance tried unsuccessfully to set up a meeting with Hoechst. “We were just another telex,” Dupin said (Ciolli, 1989a). So the group tried a more indirect method. With an anonymous donor covering their costs, the alliance spent thousands of dollars in computer time examining documents in Europe and the United States to get a detailed profile of Hoechst and its owners. A source in Frankfurt provided them with the U.S. global money market funds, European banks, and other financial institutions that held stock in Hoechst. RCR then sent a courier to hand-deliver the document to the chairman of Hoechst in Frankfurt with an outline of their three-pronged strategy (Ciolli, 1989b).

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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First, it would organize a boycott of any U.S. financial firm that was holding Hoechst stock in its international funds. Fearing that Hoechst would divest itself of Roussel to avoid controversy, RCR Alliance sent letters warning against such an action to 75 of the world's brokerage houses able to finance such a sale (Ciolli, 1989b). RCR also said it would solicit media attention through Operation Rescue and threatened to picket Hoechst's New York headquarters and other locations.

The group also said it would focus public attention on Hoechst's South African assets and its predecessor, I. G. Farben, which had produced cyanide gas for the Nazi death camps (Ciolli, 1989b), a threat made good in 1991 with a lengthy article on the drug's “Nazi connection” (Brennan, 1991) in a special issue of the National Right to Life News. The article was accompanied by a cartoon depicting shower heads spewing forth both deadly gas on trapped naked victims in a concentration camp and RU-486 pills on a well-developed fetus in utero.

Further, the group threatened to tie Hoechst up in litigation by finding plaintiffs in developing countries where the drug might be distributed. RCR retained a French law firm that was ready to go forward with the litigation. It also identified religious organizations that would look for any woman who could claim to have been harmed by taking the drug (Ciolli, 1989b).

While RCR focused on the private sector, other groups focused their efforts on Washington. At a news conference regarding his confirmation hearings, Health and Human Services Secretary-designate Louis Sullivan was asked specifically whether he would oppose FDA review and approval of the drug. He declined to respond (States News Service, 1988).

In February 1989, Congressman Robert Dornan (R-Calif.) introduced H.R. 619, a bill to prohibit federal assistance for investigation of Roussel Uclaf's antiprogesterone steroid. No federal funds may be used for abortion research, but this bill would have prohibited federal funding even for non-abortion-related applications, such as treatment of Cushing's disease. The bill died in committee (F-D-C Reports, Inc., 1989); however, White House Chief of Staff John Sununu ordered aides to research RU-486 in case a decision was needed about U.S. availability (Walsh, 1989).

In addition to U.S. groups, several international bodies joined the campaign against RU-486. In mid-March 1989, the International Right to Life Federation (IRLF) urged consumers to boycott Roussel and Hoechst (Greenhouse, 1989b; Reuters Library Report, 1989). IRLF said it would join its Canadian affiliate, Alliance for Life, and call for extending the boycott to other French products, such as wine or perfume, if France did not stop its “chemical warfare against unborn children” (Reuters Library Report, 1989).

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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The IRLF and the Moral Majority, a conservative U.S. political/religious group, asserted that using RU-486 could devastate African populations by drastically cutting birth rates while failing to reduce mortality rates. The statements echoed those charges from the political left that U.S. population policy and family planning programs are a covert form of colonialist genocide. IRLF claimed that “[t]he effect on agrarian cultures could be their very elimination” (Arch, 1989). The statement, however, made no reference to likely rates of use nor to reduced maternal mortality from avoidance of illegal, unsanitary abortions or overly short birth intervals. Each year approximately 500,000 women a year die from pregnancy-related complications, an estimated 200,000 of whom die from illegal abortions (Yinger, 1990).

Later that month, Jerry Nims, president of the Moral Majority, claimed that his group had reached a “milestone” agreement with Hoechst and Roussel to prohibit marketing and distribution of RU-486 outside of France. Nims said the companies also agreed not to begin any new tests, limiting trials to those already under way (Glasow, 1989). Finally, the companies had agreed not to offer the drug to WHO for other medical applications (Arch, 1989). According to Nims, the agreement came after “several months of dialogue” among the companies, the Moral Majority, RCR Alliance, and other antiabortion groups. Nims implied that the threats of economic boycott, picketing, and “social action” by groups currently associated with Operation Rescue “clearly communicated” to Hoechst that they had to be “taken seriously” (Arch, 1989).

The agreement was outlined in a telegram from Hoechst's spokesman Dominik Von Winterfeldt to Nims (Arch, 1989). Von Winterfeldt, however, denied that there was an agreement: “We exchanged various messages since January [1989] and it seems that our last message in which we restated our former policy satisfied them and led them somehow to the conclusion that what they had discussed with us constituted an agreement” (Sachs, 1989). RCR's Dupin replied that Hoechst's freedom to make this claim was part of the agreement (Ciolli, 1989a).

Von Winterfeldt asserted that Hoechst had decided years ago never to sell an abortifacient under its own name because its directors did not want to decide whether abortion was morally correct (Sachs, 1989). “The board does not want the company to get involved in a decision of whether you are interfering with life itself” (Ciolli, 1989a).

THE FEMINIST AND MEDICAL COMMUNITY RESPONSE

U.S. support for legalizing RU-486 was demonstrated again in an April 1989 Associated Press poll. It found that 51 percent of Americans supported legalization, a figure similar to the 59 percent support-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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ing availability in the earlier Louis Harris survey (Associated Press, 1989). Indeed, public support was considered so strong that some prochoice supporters, such as Congresswoman Pat Schroeder (D-Colo.) were considering legislation to offer federal funding for RU-486 research (Walsh, 1989).

In June 1989, feminist leaders announced a campaign to bring RU-486 to the United States (United Press International, 1989). “We intend to visit the pharmaceutical leaders, the medical health leaders to urge them to rise up against this know-nothing movement that is denying the best of medical research and the best that modern medicine can provide for the modern woman,” said former National Organization for Women (NOW) president Eleanor Smeal (Reuters, 1989b). “RU-486 can help save so many lives that we are determined to build a network both nationally and internationally to ensure that its research and development proceeds as fast as possible,” announced NOW's current president, Molly Yard (Anderson, 1989).

Following the July announcement of the Supreme Court's decision in Webster v. Reproductive Services, in which the Court expanded state powers to curtail even privately funded abortion services in state facilities, Eleanor Smeal renewed calls for testing and distribution of RU-486 (Goodman, 1989). An office-based technique such as RU-486 was now more crucial than ever, given the Illinois case concerning restrictive abortion clinic licensing statutes that might drive most clinics out of business (Goodman, 1989). Maintaining that there are no serious side effects from RU-486 and that the new drug was a needed contraceptive option, Smeal added that RU-486 was also promising for the treatment of endometriosis. “The irony is, this [Supreme] Court just said you should favor childbirth, yet RU-486 could help cure one of the leading causes of infertility ” (Federal Information Systems Corporation, 1989).

Fury over the Webster case fueled the national abortion debate and filled the coffers of abortion rights as well as antiabortion organizations. Pro-choice groups such as NOW and NARAL experienced sizable increases in donations and membership, as supporters felt threatened by receding constitutional protection from legislative action. The American Civil Liberties Union, already relatively flush from the 1988 presidential election, received another wave of support. Antiabortion organizations also began to receive more donations. They started subscription drives to gear up for a push in state legislatures nationwide. The attention given to the abortion issue in the 1989 local elections was extraordinary (Kornhauser, 1989).

When in July 1989 the NOW membership endorsed the idea of a third party, they made abortion rights a centerpiece of that party's

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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platform, and specifically listed bringing RU-486 into the United States as part of their agenda (Black, 1989). Two months later, Eleanor Smeal called on NOW to make RU-486 availability a “top priority.” She also urged women to organize counterboycotts and lobby Congress to ensure that the next FDA commissioner (Frank Young had resigned in mid-1989) was not ideologically opposed to the drug (Arnst, 1989a).

The medical community also urged Roussel and the FDA to make RU-486 available in the United States. In June 1990, at its annual policymaking session, the American Medical Association (AMA) unanimously supported testing and possible use of RU-486. “The abortion issue, pro and con, should not interfere with our ability to conduct all kinds of investigations for all kinds of problems,” noted Dr. Charles Sherman, who chaired the AMA committee recommending support for RU-486 (St. Paul Pioneer Press, 1990).

INTERNATIONAL RU-486 AVAILABILITY

As a result of the governmental intervention discussed earlier, Roussel is currently distributing RU-486 to 350 hospital clinics in France. Since it was first introduced, more than 40,000 women worldwide have taken the drug (Herman, 1989; Ullman et al., 1990). Projected annual sales in France are $3.3 million (Laurenson, 1988). With RU-486, abortion is a four-step process: (1) an initial interview; (2) after a one-week waiting period, administration of RU-486; (3) administration of prostaglandin therapy several days later; and (4) a follow-up examination approximately one week after that (Klitsch, 1989).

Roussel is not distributing the drug outside France; as Sakiz says, “We're not eager to start a new debate” (Greenhouse, 1989a). Neither the French government nor WHO, which cosponsored clinical trials of the drug, is pressing Roussel to release the drug abroad. WHO, citing data from more than 10,000 women who participated in tests over the past seven years, has confirmed that RU-486 is safe and effective. But the agency, which has the right to commandeer the drug and supply it to developing countries at cost, has cautiously decided to await further trials. It wants the drug to be “discredit-proof” (MacFarquhar, 1988). Some have suggested that WHO fears its U.S. funding would be cut off if it were to promote the drug, just as the United Nations Fund for Population Activities lost U.S. contributions for supporting family planning services in China, which the United States contends has a coercive population policy (Glasow, 1990c).

The most likely market outside France is Britain (Arnst, 1989b), where physicians endorsed the drug in October 1989 (Arnst, 1989a). Roussel filed an application for a license in September 1990, and while denying

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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that the application was “fast-tracked,” a Department of Health spokeswoman did say it was “quite high in the pile” (The Independent Staff, 1991). According to the spokeswoman, the application would be going to the Committee on Safety of Medicines by early to mid-1991. It usually takes the committee about 18 months to process an application (The Independent Staff, 1991). The British Society for the Protection of the Unborn has made clear the importance of resisting U.K. approval of the drug, lest it become widely available in Britain and pave the way for introduction in other European Community countries (Françoise, 1991).

Another likely market is China, where the drug is already being used on an experimental basis, and the government need only make a request to the company for supplies to distribute it more widely (Arnst, 1989b). As a nonsignatory to the International Convention on Patents, China could produce the drug on its own. Yet even if it were to become a signatory, it could continue to manufacture the drug for domestic consumption without a license from Roussel (Klitsch, 1989).

Although plans to license RU-486 in the Netherlands and Scandinavia were scuttled in 1988 when Roussel temporarily pulled the drug off the market, research there is continuing. At the Karølinska Hospital in Stockholm, RU-486 is being administered to 30 women over a period of six months to determine if it can be used as a once-a-month contraceptive (Reuters, 1989a). There are indications that Roussel will seek licensing in all European countries that approve the drug (Holmes, 1989).

In Europe, however, the Webster decision in the United States is stirring up what generally had been settled debates on abortion. It encouraged renewed activity by antiabortion groups in Britain and Italy that want to slow the introduction of RU-486 (LaFranchi, 1989). In Italy, for example, the deputy party leader of the antiabortion Movement for Life, Christian Democrat parliamentarian Carlo Casini, said his group would consider calling on Italians to boycott Roussel products if the pill were introduced. Roussel's Italian subsidiary consequently has announced it has no plans to introduce the drug—because of a lack of “technical guarantees” (Holmes, 1989).

Elena Marinucci, a Socialist party senator and undersecretary at the Health Ministry, has instead proposed making the pill available. She calls the subsidiary's response an insult to Italy's health service. The secretary of health, Liberal party member Francesco de Lorenzo, has distanced himself from Marinucci's campaign, asserting that it is not the ministry's job to invite drug companies to market their products in Italy (Holmes, 1989).

Commenting on efforts to expand distribution in Europe, NRLC's Glasow wrote: “Roussel-Uclaf's policy of introducing the abortion drug

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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into one country at a time can also be viewed as a test of how pro-life advocates in Europe and America will react. Evidently Roussel-Uclaf and Hoechst A.G. have decided to see how far they can go before provoking retribution by the U.S. right-to-life movement” (Glasow, 1990c).

Outside Europe, Roussel may find easier markets. India's official Bombay Council for Medical Research in 1988 recommended that RU-486 be investigated for use, but use in other developing countries may be limited. The need for physician supervision and for a second office visit to obtain the follow-up prostaglandin may make RU-486 difficult for the millions of women living in countries with poor doctor-patient ratios.

Pharmaceutical industry analysts point instead to Eastern Europe as a potentially huge market. In general, Eastern bloc countries have poor contraceptive availability and abortion is more frequent there than in the West. (The Soviet Union has one of the highest abortion rates in the world.) U.S. protests are unlikely to have much weight should these countries approve RU-486. In fact, opening these markets, say analysts, may provide a sufficient profit motive to get Roussel back into the business of aggressively marketing its discovery (Arnst, 1989b).

GETTING RU-486 TO THE UNITED STATES

In late September 1989, Etienne Baulieu received the Albert Lasker Clinical Medical Research Award, the United States' most prestigious medical award and often a forerunner to a Nobel Prize (Specter, 1989). Scientists and family planning organizations praised the choice; antiabortionists were outraged and accused Baulieu of waging chemical warfare against the unborn (Specter, 1989). “Where does the demented imagination of abortionists end?,” demanded R. Alvarez in a letter to the editor of the Washington Times on October 18, 1989. Apparently unaware of Hoechst's link with I. G. Farben, Alvarez continued, “With such a mentality, those responsible for making this presentation will next be awarding the Medal of Honor to the developer of Zyklon B gas used to exterminate millions of Jews in Nazi Germany.”

With the exception of recreational drugs that could also be used for pain relief, there seems to be no modern precedent for withholding a proven drug on moral grounds. Inadequate return on investment is a far more common reason for such an action, but in the case of RU-486, it is the commercial and public relations consequences of the antiabortion groups' moral outrage that seem to underlie the decision of so many pharmaceutical companies to avoid the drug and of Roussel to limit its distribution and licensing. Hoechst continues to deny that it is concerned about a boycott. Its chairman says that it simply is not Hoechst policy

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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to sell abortifacients. Company insiders suggest that Hoechst directors may have agreed to the research because they never expected it to succeed. They are now torn between pride in the discovery and their own antiabortion sentiments. “What we need is a company psychiatrist, ” says one researcher (MacFarquhar, 1988).

Yet concern about the financial aspects of marketing RU-486 can have played only a small role in the decision to withhold the drug. There is little doubt that it could be a moneymaker. At $100 per treatment, RU-486 could generate $8 million in sales by replacing only a third of France's annual 250,000 surgical abortions. Globally, it could become one of the few billion-dollar drugs (MacFarquhar, 1988). NRLC knows this: “Our weapon in a democracy is to sting them financially and make it unprofitable for them. If we can keep them from making money they won't market it,” says Willke (ABC News, 1990).

There are ways to circumvent Roussel's self-imposed ban on exports. Some countries, such as Britain, have compulsory licensing laws to deal with reluctant pharmaceutical manufacturers. If necessary, the government can give away an unused patent for the public interest. The catch is that Roussel cannot be compelled to produce its testing data, which is necessary for licensing approval. A would-be distributor would have to repeat Roussel's trials to get the drug approved, which would take about two years (MacFarquhar, 1988).

Another route is moral suasion. This strategy seemed to help in October 1988 when the scientists and physicians at the Rio conference joined to denounce Roussel's decision to pull RU-486 off the market. But Roussel says it will respond only to direct appeals from foreign governments. The most likely country to make such an appeal is China. Beijing has had the largest clinical trials—more than 3,000 women —outside France; it also runs the world's largest national abortion service, with more than 11.5 million abortions performed annually (MacFarquhar, 1988). China has approved the drug but has not yet asked Roussel for supplies (Herman, 1989; MacFarquhar, 1988). Private groups can also appeal. In 1990, the Fund for the Feminist Majority sent a delegation to Roussel carrying 115,000 petitions and a list of 250 medical researchers supporting RU-486 importation to the United States.

It may be possible to obtain the drug in the United States with a prescription from a French physician who perhaps has been contacted by a sympathetic American doctor. But U.S. customs and postal officials can intercept drugs for examination by the FDA, and current FDA policy has authorized inspectors to seize RU-486 because the agency considers it dangerous (Lunzer, 1989). In the past, FDA has issued regulations allowing patients to ship unapproved drugs into the country to treat life-threatening conditions. On September 26, 1988,

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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however, it announced that these regulations do not apply to RU-486 (Kolata, 1988a).

In May 1989, noting that RU-486 was omitted from the list of drugs specifically excluded from the United States, Congressman Robert Dornan (R-Calif.) and a group of his antiabortion colleagues in the House wrote FDA Commissioner Frank Young requesting clarification, and expressing concern that importation of RU-486 and other abortifacients might be occurring (letter from Congressman Robert Dornan to Dr. Frank Young, commissioner of FDA, May 5, 1989).

Young responded by updating the import alert on June 6, 1989, instructing field personnel to prevent the importation of unapproved abortifacient drugs such as RU-486. He explained: “[U]napproved drugs may be imported only if there is no unreasonable safety risk or evidence of fraud, and other criteria are met relating to personal use, quantity, and other factors. We do not believe this policy can be appropriately applied to the importation of RU-486 because use of the product could present unreasonable safety risk. ” (letter from Dr. Frank Young, commissioner of FDA, to Congressman Robert Dornan, June 9, 1989). Young did not explain how a drug with such a low incidence of side effects might be considered unreasonably dangerous.

Congressman Ted Weiss (D-N.Y.) became so concerned by the appearance of inappropriate political judgments entering FDA's scientific evaluations of RU-486 (Diana Zuckerman, staff member, Subcommittee on Human Resources, Committee on Governmental Operations, personal communication, August 6, 1990) that he asked the agency for a formal explanation of its findings. Meanwhile, however, the drug cannot be legally brought into the United States, even with a French prescription and under an American doctor's supervision.

Although seemingly aimed only at users, the import ban also affected researchers studying nonabortion uses of RU-486 (Hilts, 1990a). Testifying at a November 19, 1990, hearing held by Congressman Ron Wyden (D-Ore.), chair of the Small Business Subcommittee on Regulation, Kathryn Horwitz (a breast cancer and hormone specialist at the University of Colorado) said that an FDA official had told her she could no longer import the drug by mail or in person for her breast cancer research (Hilts, 1990b). Federal researchers at the National Institutes of Health (NIH) announced they were shutting down research on RU-486 treatment for Cushing's syndrome, a potentially fatal illness affecting 5,000 Americans, because they could no longer be assured a supply of the drug (Hilts, 1990a). An NIH official said, “It is wrong to say that politics were the only reason to stop the work, but that was a major factor in our decision” (Hilts, 1990a).

At the Wyden hearing, FDA blamed the application of the import

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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ban to researchers on “poor communication,” and said researchers need only ask for permission (Hilts, 1990b). Roussel, however, appears to be hesitating to guarantee supplies even for non-abortion-related research due to the FDA's evident opposition to abortion and continued pressure from antiabortion forces who support the import ban (Hilts, 1990a, 1990b). NRLC, however, maintains that the hearings were biased and failed to document the side effects of RU-486 and prostaglandin therapy or to emphasize the preliminary nature of the data supporting its nonabortion applications (Glasow, 1991a). NRLC also charges that interest in the drug's nonabortion uses is simply an effort to provide political cover for those physicians and politicians who want it brought to the United States (Glasow, 1991b) and not part of an overall strategy to discuss the drug on all its merits (Ciolli, 1990).

Congressional interest following the Wyden hearings remained strong. In early February 1991, Wyden introduced H.R. 875 to rescind the FDA import ban. Two days later, Congressman Dornan introduced H.R. 798 to prohibit use of federal funds to investigate any aspects, abortifacient or otherwise, of RU-486. His bill also proposed that drugs derived from materials from human fetuses be labeled as such, and set forth a scheme for regulation of storage and interstate transportation, importation, or exportation of human fetal tissue.

Of course, there is always smuggling and patent infringement. The Chinese could re-create the drug quite easily, but their manufacturing facilities are inadequate. Black markets in RU-486 pose the danger of unsupervised use without the necessary follow-on prostaglandin therapy and backup availability of surgical abortions. The only way to prevent this situation may be to make the pill legally available under a less threatening name (e.g., as a menstrual regulator) in countries where it is likely to be controversial (MacFarquhar, 1988).

Currently, Roussel is holding discussions with nonprofit organizations from the United States, Great Britain, and Sweden that would like to buy the pill at minimum cost and distribute it in their home countries. Of course, the appeal of this arrangement is that these organizations, rather than Roussel, would become the target of activities by antiabortion groups. In the United States, however, RU-486 also faces the hurdle of FDA approval, a process that takes five to seven years at best. With a strong antiabortion lobby supported by the administration, many supporters of the pill worry that the FDA will never approve the drug.

Nonetheless, research continues at USC under the original Population Council permit, which is the only ongoing work on RU-486 in the United States (Ciolli, 1989b). In December 1988, USC researchers announced that a single dose of RU-486 alone could provide an effec-

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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tive chemical abortion for 81 to 100 percent of women using it within 49 days of their last menstrual period. Effectiveness was 100 percent with further dose adjustment (Grimes, 1988). In the past four years, 300 women have used RU-486 alone, and another 30 have tried it with follow-on prostaglandin therapy. USC researchers used the last of their supplies of the drug on a study of 16 women (Stein, 1990). It demonstrated that women taking RU-486 alone were no more likely to experience cramps, heavy bleeding, nausea, vomiting, or other side effects than the control group of women taking Tylenol (Stein, 1990).

Another possible route toward U.S. introduction of the drug is through individual states. Although states usually cannot review or approve a drug independent of the FDA, there are exceptions. In California, for example, there is a Food and Drug Bureau, a so-called mini-FDA, that was set up in 1987 to bypass the FDA so that AIDS drugs could be tested more rapidly in the state (Miller, 1990). Under state law, the bureau can approve the sale of drugs not approved by the FDA provided they have been tested and are manufactured and distributed solely within California (Miller, 1990).

In early March 1990, Attorney General John Van de Kamp, then candidate for the Democratic nomination for governor, publicly called on the state's health department director, Kenneth Kizer, to authorize importation and testing of the drug (Scott, 1990) and to resist “non-medical political pressure” (Van de Kamp, 1990). His campaign opponent Diane Feinstein questioned his motives, asserting he was just “trying to one-up me with the female vote” (Scott, 1990), a view that reportedly was held even by some of those close to the campaign (V. Rideout, Issues Director, Van de Kamp for Governor Campaign, personal communication, February 19, 1990).

Abortion opponents were also angry, with NRLC's associate western director Jan Carroll calling it a “desperate political maneuver to out-pro-abort two other pro-abortion candidates ” (Glasow, 1990b), and education director Richard Glasow writing that “right-to-life supporters should recognize that preventing U.S. tests of the abortion pill [is] a very important objective. Without testing in the U.S., it will be much more difficult to have the death drug licensed and marketed here” (Glasow, 1990b).

The head of California Right to Life, Camille Giglio, sent a letter to Kizer opposing California review of the drug in the strongest possible terms, once again connecting the drug with concerns about genocide. “The RU-486 is a radical departure from the normal routes to controlling the size of one's family. Does your department consider the human population of this state to be such a threat to the environment that the procreation of human babies must be prevented with such a sweeping

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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pesticide approach to reducing the size of the human population Is this the Health Department's ‘medfly approach' to the human condition?” (PR Newswire, 1990).

While Van de Kamp did not go on to win the nomination nor did the health department accede to his request, he was not alone in this idea. Carol Ruth Silver, a former member of the San Francisco Board of Supervisors, formed an organization called “Every Child a Wanted Child,” devoted solely to bringing RU-486 to the United States (Miller, 1990). The medical advisory group for the organization was formed from among those interested in testing the drug, and on April 2, 1990, a group of doctors unveiled a plan to test the drug in San Francisco (Herscher, 1990). Board of Supervisors member Terence Hallinan introduced a resolution calling on the governor and the state legislature to pay for the tests and support clinical trials with 200 women subjects at San Francisco General Hospital, Children's Hospital, and the University of California at San Francisco (Herscher, 1990). The cost was estimated at $60,000 to $100,000 for three months of work.

The California state regulators reportedly looked favorably on the proposal, but were unable to give final approval without information about the drug that only Roussel could supply. Roussel, still unpersuaded that the political climate was receptive, continued to refuse to ship the drug to the United States for abortion-related clinical trials (Glasow, 1990g). Marie Bass, codirector of the Reproductive Health Technologies Project, a Washington-based organization working to promote RU-486, emphasized in the press and technical journals that with legislative and private sector support in place, grassroots political pressure was now needed to persuade Roussel to take a chance on licensing the drug in the United States (Glasow, 1990g).

The California example did not go unnoticed. By November 1990, New York City was discussing the same tactic. Mayor David Dinkins was receiving “options memos” from Deputy Mayor Steisel, Consumer Affairs Commissioner Green, Health Commissioner Myers, and Hospital Commissioner Carillo because, as Green said: “The federal government, the natural jurisdiction on this issue, is so anti-choice that it's forcing a congressional-urban alliance to cut this Gordian Knot” (Carroll, 1990). Within weeks, Green and mayoral advisor Rivera had developed a plan for Dinkins and other U.S. mayors to lobby everyone from George Bush to FDA to WHO on the issue of RU-486 (Barth, 1990), and to bring the drug to New York City under a state law that would allow testing (although not sales) of non-FDA-approved drugs (Barth, 1990). While Linda Sachs, spokesperson for Green's office, told the National Right to Life News that the health and consumer affairs departments were merely “evaluating” their options (Glasow, 1990f), she was quoted in the Village

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Voice as saying that the departments are researching the drug to “come up with a possible plan to provide for the women in New York City” (Hancock, 1990).

Oregon, too, has considered taking an independent stance, although there the proposals are coming with a different political flavor. Then Governor Neil Goldschmidt released a December 1990 report of the Oregon Task Force on Pregnancy and Substance Abuse, recommending that RU-486 be offered to welfare-dependent women who have a history of drug abuse (Rarick, 1990). Goldschmidt endorsed the proposal (Seattle Times Staff, 1990). The 10-member board of lawyers, doctors, and state legislators also recommended that the state encourage such women to use Norplant, a recently approved five-year implantable contraceptive, and that it relax restrictions on the ability of doctors to perform publicly funded sterilizations (Rarick, 1990). Newly elected Governor Barbara Roberts, while not commenting on the merits of the proposal, did say that Oregon could pass legislation permitting RU-486 testing if it wished: “We believe that if California can do it, Oregon can do it” (Rarick, 1990).

Under the auspices of the American Society of Law and Medicine, David Grimes, of USC, and Rebecca Cook, of the University of Toronto Law School, are organizing a December 1991 conference on RU-486. With presentations on its latest safety and efficacy data for abortion and nonabortion uses, explanations of regulatory issues by FDA officials, and discussions by Congressman Wyden, Weiss, and Dornan on its political repercussions, the meeting is likely to create the most complete public record to date on the prospects for this drug in the United States (personal communication with Rebecca Cook, November 2, 1990).

INDUSTRY CONSTRAINTS ON RU-486 DEVELOPMENT

No matter how much good research is done in the United States on RU-486, certain pharmaceutical industry constraints will slow or prevent its production and distribution. One of the most important such constraints is corporate profitability. Even such strong supporters as Edouard Sakiz view corporate responsibility to maximize profits for shareholders as a paramount consideration. To that end, pharmaceutical companies examine the profitability of a new drug like RU-486 from four standpoints: (1) the size of the market and the likely price of the product; (2) the difficulty and expense of obtaining FDA approval; (3) the costs associated with product liability claims; and (4) the costs associated with loss of public good will.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Market Share and Price

Early presentations to security analysts misrepresented RU-486 as a “morning-after” pill to be taken at home in lieu of contraception prior to intercourse. Characterized as such a product, the drug would be aimed at the global birth control pill market of 51.7 million users. Later statements made it clear, however, that RU-486 could at best replace first-trimester surgical abortions, which are performed at the annual rate of a little under 1.5 million in this country. This distinction is important. “If drug companies don't see it as enough of a moneymaker to offset their liability costs, they aren't interested,” says Allan Rosenfield. “The pill makes lots of money, so companies make it. The IUD doesn't, so we have a new FDA approved IUD, the best ever made, that no one will make” (Rosenfield et al., 1983). Joseph Speidel, vice president of the Population Crisis Committee, commented, “It is ironic that the American consumer is denied the IUD, which costs less and is generally safer than the pill, principally because IUD sales in the U.S. have totaled only about $12 million annually whereas the pill generates about $600 million.”

Because RU-486 would be taken at most for a few days a year, potential profits are probably less than from the daily contraceptive pill —that is, unless the drug were priced extremely high. Such markups are not unheard of, of course. (The U.S. government, buying in bulk shipment for distribution overseas, can obtain a month's supply of birth control pills for about 18¢, whereas consumers pay $12.) Another option is for companies to wait until patent protection on RU-486 expires in 1999. U.S. companies could then manufacture the drug and save a considerable amount of money by avoiding licensing fees (Klitsch, 1989). The hurdle of FDA review would still, however, pose a substantial disincentive.

FDA Review

Upjohn tested RU-486 in its laboratories but has no interest in pursuing it (Rosenfeld, 1986). “FDA standards are so high, and the chances of getting something approved are so low, it just isn't worth it, ” said a company representative (Rosenfeld, 1986). Upjohn, it may be recalled, was unable to get FDA approval for Depo-Provera. Having already experienced the difficulties that arise from the combination of a politically sensitive drug and the lengthy review required for contraceptive products, it is unlikely to enter the fray.

As an editorial in the October 28, 1988, edition of the New York Times noted, even working with an already developed and tested drug, FDA

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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approval can cost as much as $50 million over the four- to seven-year process required for action. The agency's notoriously slow and methodical review process has been cited with approval by many who recall that thalidomide, which caused thousands of birth defects in Europe, was never approved for use in the United States. But pharmaceutical industry spokespersons complain that FDA is too slow and too unwilling to accept studies and government approvals from other countries. However, in the case of RU-486, even if FDA were to accept foreign test data, it would be necessary to run extensive clinical trials using prostaglandins available for use in the United States because the European prostaglandins used in the French and WHO-sponsored trials are not licensed for use here (Klitsch, 1989).

Product Liability

Liability for injuries caused by contraceptive drugs and devices has also generated considerable concern among pharmaceutical companies. Many of them assert that this is the single most important factor in their decisions to leave the field of fertility control. Jacob Stucki, vice president for pharmaceutical research at Upjohn, said his firm, like several other major pharmaceutical firms, has discontinued all fertility control research because liability insurance is so expensive. Fifteen years ago, there were 19 firms with research staffs working on birth control. Today, there is one. There is also 25 percent less money available for contraceptive research than there was in the 1970s (Goodman, 1988b; Institute of Medicine, 1990).

The IUD has been the object of much of the recent liability activity, and manufacturers have responded accordingly. G.D. Searle & Company pulled its IUDs off the shelves in 1986, although it continues to manufacture birth control pills. The firm dropped its IUD line after what it perceived as unwarranted lawsuits over its products following the uproar over the A. H. Robins Dalkon shield. “It's not conducive to making you think of developing new things in an area where there is so much interest in litigation,” said Kay Bruno, Searle 's senior director of public affairs (M. Phillips, 1988). Other companies, however, cite different reasons for avoiding contraceptive research and development: a saturated and well-served contraceptive market (Syntex Corp.), availability of European research and patents (Warner-Lambert Co.), and lack of any truly revolutionary innovations (GynoPharma, Inc.; M. Phillips, 1988). Henry Gabelnick, director of extramural programs and product development of the Eastern Virginia Medical School's Contraceptive Research and Development (CONRAD) program, however, supports Searle's view: “The reason the major companies have pulled out is quite simple:

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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dollars. They are afraid to take the risks because of the giant lawsuits that have come up” (M. Phillips, 1988).

Until recently, ALZA Corporation was the only remaining U.S. company to sell IUDs (Gladwell, 1988a). Furthermore, ALZA seemed unenthusiastic about its sudden monopoly following Searle's 1986 withdrawal from the market. With the Searle exodus, ALZA narrowed the focus of its marketing, suspended much of its contraceptive research effort, raised the price on its product, and began to insist on informed consent by users (all purchasers had to read and sign an eight-page statement concerning the risks and benefits of the IUD) at least in part to protect the company from liability claims. These seemingly un-business-like decisions reportedly were aimed at “avoiding new people and more problems” (Gladwell, 1988a).

In this cautionary climate, RU-486 was viewed warily by most firms. “We never even got to a serious examination of the [RU-486] pill's properties,” said one pharmaceutical company executive. “As soon as our attorneys learned that it is only 95 percent effective, they began to scream. The other five percent could involve defective children—and that, in terms of liability suits, could blow us out of the water. They wouldn't let us touch this product” (Abrams, 1988). Although three children have been born without health problems following in utero exposure to RU-486, physicians acknowledge that if a woman carries her pregnancy to term following an unsuccessful attempt to abort with RU-486, the child might suffer birth defects (Abrams, 1988; Klitsch, 1989).

Even producers of good products with few side effects are fearful, according to Louise Tyrer of Planned Parenthood. Consumers are willing to take risks when they are sick and in need of medicine, but they are outraged by any side effects to contraceptives, which are taken when they are healthy (M. Phillips, 1988). And manufacturers' concerns on this score are not ill founded; Ortho, for example, lost a $4.7 million jury decision in Atlanta in a 1987 case brought by a woman claiming, on very weak evidence, that her child's birth defects were caused by Ortho Gynol spermicide.

Public Relations

Ortho, the only company currently conducting research on a wide range of contraceptive products, wants nothing to do with RU-486. “I cannot elaborate on our decision,” said spokesman Richard Salem, who noted that the 40-year-old company intends to stay in existence. “It is a matter of proprietary information” (Abrams, 1988). However, Neil Sweig, drug industry analyst for Prudential-Bache Securities, says “it

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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just isn't worth the hassle. The market for a manufacturer of RU-486 in this country would be between $200 and $250 million annually. And that is minuscule compared to the markets for antibiotic, antihypertensive and anti-arthritic drugs. Those markets are worth billions, and they don't involve political controversies and other problems created by social or religious groups” (Abrams, 1988).

NRLC's president John Willke builds on that equation. “We have told them that if one of these companies gives a license to any company in the United States, we will unleash a boycott, supported by tens of millions of people. It will have the support of all 50 state and 3,000 local right to life groups, of major church bodies etc. It will include every product produced by any of these companies. It is this, plus the threat of medical liability law suits, that has kept the pill out of the United States so far” (Willke, 1990).

With both abortion foes and women's rights groups highly critical of new contraceptives, firms have begun to view the field of reproductive health as a public relations nightmare. “There's a lot of pressure that builds over time to devote research money where you gain positive public image,” says Roderick MacKenzie, former president of Ortho and current chairman of GynoPharma (M. Phillips, 1988). “I've looked at the books,” he said, “and people have not been driven out of this business by financial reasons. It's simply that the companies working in this field have become exhausted by the continuous stream of adverse publicity in the press. They've decided to direct their marketing efforts and research dollars toward areas that don't result in such negative publicity” (Gladwell, 1988a).

“Look,” said one drug company executive of RU-486, “if this is going on in France, do you have any idea what will happen in the United States if the drug were being distributed? The market is potentially huge and the drug appears worthy. But who needs the headaches?” (Specter, 1988).

Thus, contraceptive research these days is largely found in European pharmaceutical companies, in U.S. or European government-sponsored programs, and in small firms such as GynoPharma, which recently introduced a copper IUD (ParaGard) in the United States. It may be that only smaller companies will find working with abortifacients to be worth the risk. As Forrest Greenslade, senior consultant to the Population Council, says, “There are entrepreneurial opportunities there” (Kolata, 1988a). If a company markets a drug developed abroad or by a nonprofit organization, the need for long-term capital investment in research and development is vastly reduced. Moreover, although profits may be small for a pharmaceutical giant, they might be quite significant for a small, one-product company. Finally, by focusing on one

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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product, the company is immune to boycotts against collateral product lines (Kolata, 1988a).

At present, except for Johnson & Johnson's Ortho, responsibility for developing new forms of contraception is almost entirely in the hands of nonprofit, government-funded research institutions, whose budgets are far smaller than those of for-profit drug companies. The combined budget of the three most important nonprofit companies doing contraceptive research, the Population Council, Family Health International, and CONRAD, is only $16 million. From $60 million to $100 million are routinely spent by major drug companies to bring a new product to market. ParaGard was developed by the Population Council, a New York nonprofit firm that receives considerable funding for contraceptive research from, among other sources, the U.S. Agency for International Development. It then licensed the technology to GynoPharma (Abrams, 1988).

But even this solution has its limitations. “We can spend money developing products, but eventually to make the products available to the public, we have to entice manufacturers to do so,” said CONRAD's Gabelnick, whose program is funded entirely by the USAID. “It ends up with things that have reached a certain point, and are ready to be tested more widely, sitting on the shelf” (M. Phillips, 1988).

AMERICAN ACCESS TO RU-486 IN THE 1990s

RU-486 is a drug with substantial market potential that is not likely to be available in the United States in the near future. This delay in access to what many consider a proven drug is primarily due to the vociferous boycott threats and effective private and public sector lobbying of U.S. antiabortion organizations. Product liability exposure and frustration with FDA review procedures are also obstacles to development and marketing, but these factors are only background to the public relations nightmares and boycott possibilities that loom large as serious disincentives to production.

RU-486 is not the only contraceptive drug held hostage to the abortion debate. The most advanced contraceptive, HCG vaccine, has been tested by WHO in Australia, the Dominican Republic, Finland, and India. It has not been tested in the United States because it acts by stimulating the immune system to attack the outer cells of a pre-embryo. Thus, abortion opponents classify it as an abortifacient rather than a contraceptive, although it works on embryos prior to implantation (Foreman, 1989).

RU-486 has many promising applications: dilating the cervix, to help avoid cesarean sections; treating certain breast cancers that grow in

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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response to sex hormones; treating endometriosis, the third leading cause of infertility in the United States; and controlling Cushing 's syndrome, a hormonal disorder in both men and women that is currently treated by removing the adrenal glands. Forrest Greenslade says, “There obviously are all kinds of major hurdles to overcome in producing and marketing this drug [but] somebody almost certainly will be willing to take a chance” (Abrams, 1988).

And who will that be? “Somebody with guts,” said a high-ranking official at NIH. “Somebody who will see the need, step in, and without describing himself as the savior of American women, simply do the work. But at present, I don't know anyone who would do it” (Abrams, 1988). Neither does Joseph Speidel, who thinks the immediate prospects are pretty dim. “But,” he continued, “the potential for this product is so great that I have to believe an American distribution eventually will come” (Abrams, 1988).

Some think that the people “with guts” are already out there. USC researcher David Grimes says at least half a dozen groups of financiers have discussed production with him. Cindy Pearson of the National Women's Health Network says that the women's health community is serious about forming a company to develop and market the drug. And Erin Van Heenin of Planned Parenthood Federation of America says the financing, the personnel, and the will are there.

But Roussel refuses to license RU-486 to any company in the United States because it considers the drug to be a political and commercial minefield. Nothing short of governmental intervention seems capable of persuading the manufacturer to change this policy. Planned Parenthood and other family planning groups will continue their campaign to persuade Roussel to license the drug here. If they are unsuccessful, it will be years before the patent expires. Even then, the domestic obstacles of public pressure, regulatory review, product liability, and inadequate revenue will make the introduction of RU-486 into the American market a risky business. For the moment, then, politics seem more likely than medical merit to determine the availability of this particular drug aimed at enhancing women's choices and women 's health.

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Grimes, D. 1988. Early abortion with a single dose of the antiprogestin RU-486. American Journal of Obstetrics and Gynecology 158:1307-1312.

Gruhier, F., L. Joffrey, P. Romom, and C. de Rudder. 1988. RU486: Echec a l'intolerance. Nouvel Observateur 1252(November 3-9):49-51.

Hancock, L. 1990. RU 486 hits Manhattan? The Village Voice, September 25.

Harris, C. 1991. RU 486—A chemical time bomb? National Right to Life News, January 8, p. 8.

Herman, R. 1989. In France—oui!; in the U.S.—not yet. Washington Post, October 3, at sec. “Health,” p. 12.

Herscher, E. 1990. San Francisco doctors propose testing controversial abortion pill San Francisco Chronicle, April 3, p. A1.

Hilts, P. 1990a. Abortion link helps to kill research. New York Times (national edition), November 16, at sec. A, p. 12.

Hilts, P. 1990b. FDA says it allows study of abortion drug. New York Times (national edition), November 20, at sec. B, p. 9.

Holmes, P. 1989. French abortion pill sparks storm in Catholic Italy. Reuters Library Report, November 4.

The Independent Staff. 1991. Abortion pill high on list for licences. The Independent (U.K.), January 3.

Institute of Medicine. 1990. Developing New Contraceptives: Obstacles and Opportunities. Washington, D.C.: National Academy Press.

Izbicki, J. 1988. Holy war on abortion pill. Sunday Telegraph, October 30, at sec. “International,” p. 9.

Japenga, A., and E. Venant. 1989. Underground army. Los Angeles Times, November 30, at part E, p. 5, col. 2.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Klitsch, M. 1989. RU 486: The Science and the Politics. Washington, D.C.: Alan Guttmacher Institute.

Kolata, G. 1988a. Boycott threat blocking sale of abortion inducing drug. New York Times, February 22, at sec. A, p. 1, col. 3.

Kolata, G. 1988b. U.S. may allow anti-ulcer drug tied to abortion. New York Times, October 29, at sec. 1, p. 1, col. 5.

Kolata, G. 1988c. Any sale in U.S. of abortion pill still years away. New York Times, October 30, at sec. 1, p. 1, col. 1.

Kolata, G. 1989. As new tactic, do-it-yourself abortions taught. New York Times, October 23, at sec. B, p. 12, col. 1.

Kornhauser, A. 1989. Abortion case has been boon to both sides. Legal Times, July 3, p. 1.

LaFranchi, H. 1989. Turbulent forecast: There's a storm brewing over abortion in Europe. Chicago Tribune, September 10, at sec. “Tempo,” p. 5.

Laurenson, J. 1988. France mandates drug sale. Chemical Week, November 9, p. 14.

Le Quotidien du Médecin. 1990. RU 486: Roussel adresse une lettre aux gynecologues des centres d 'IVG. April 30, p. 11.

Lunzer, F. 1989. When the corner drugstore falls short. U.S. News & World Report 106(6):82.

MacFarquhar, E. 1988. Horizons: Health. U.S. News & World Report 106(3):54.

Miller, M. 1990. Plan to test abortion pill in California sparks fierce debate. Reuters, March 15.

Minkin, S. 1980. Depo-Provera: A critical analysis. Women and Health 5:49-69.

Naughton, P. 1988a. Anger as French Catholics force withdrawal of abortion pill. Reuters, October 27.

Naughton, P. 1988b. French government orders company to go ahead with abortion pill. Reuters Library Report, October 28.

Nayeri, F. 1987. An abortion pill may soon be on the market in France. United Press International, March 28.

Phillips, J. 1988a. Abortpill. United Press International, October 28.

Phillips, J. 1988b. Abortion pill decision stirs debate. United Press International, October 29.

Phillips, M. 1988. Birth control. States News Service, January 3.

PR Newswire. 1988a. National right to life on French abortion pill. June 22.

PR Newswire. 1988b. Planned Parenthood gives Margaret Sanger Award. October 17.

PR Newswire. 1988c. Halt in distribution of new French pill declared. October 26.

PR Newswire. 1988d. Planned Parenthood statement on RU 486 pill decision. October 26.

PR Newswire. 1990. Pro lifers reject tests of abortion pill. March 22.

Rarick, E. 1990. Abortion pill urged to prevent drug abuse. United Press International, December 20.

Reuters. 1988. French government orders company to go ahead with abortion pill. October 28.

Reuters. 1989a. NOW presses for U.S. tests of morning-after pill. June, 1.

Reuters. 1989b. Abortion pill to be tested as contraceptive. As reprinted in the Chicago Tribune, October 3, at sec. “News,” p. 5.

Reuters. 1989c. Vatican newspaper says abortion pill a chemical bomb. November 11.

Reuters Library Report. 1988. Abortion pill creator calls for action to get it on the market. October 27.

Reuters Library Report. 1989. Anti-abortion movement calls for boycott of French pill. March 15.

Reuters North European Service. 1984. New substance to induce abortion. December 1.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Rhein, R., D. Hunter, and A. Hall. 1985. A pill that might defuse the abortion issue. Business Week, April 1, at sec. “Medicine,” p. 85.

Ricci, E. 1988. Abortpill. United Press International. October 27.

Rosenfeld, M. 1986. Conception and controversy: The French doctor and his pill to prevent pregnancy. Washington Post, December 18, at sec. C, p. C1.

Rosenfield, A., D. Maine, R. Rochat, J. Shelton, and R. Hatcher. 1983. The Food and Drug Administration and medroxyprogesterone acetate: What are the issues? Journal of the American Medical Association 249:2922-2928.

Sachs, S. 1989. Abortion in America. Newsday, April 24, at sec. “News,” p. 31.

St. Paul Pioneer Press. 1990. AMA backs abortion pill. June 22, at sec. A., p. 7A, col. 1.

Sarasohn, J. 1988. Oddly named group fights abortion drug. Legal Times, December 5, at sec. “Lobby Talk,” p. 4.

Savage, D., and K. Tumulty. 1989. French abortion pill stirs behind the scenes battle. Los Angeles Times, May 14, at part 1, p. 1, col. 5.

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Seattle Times Staff. 1990. Task force favors French abortion pill. Seattle Times, December 21.

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Sherman, J. 1989. Molly Yard: New Jersey and Virginia key in abortion battle. United Press International, August 28.

Silvestre, L., C. Dubois, M. Renault, et al. 1990. Voluntary interruption of pregnancy with Mifeprestone (RU 486) and a prostaglandin analogue. New England Journal of Medicine 322:645.

Simons, M. 1988. Doctor's protest company's action on abortion pill. New York Times, October 28, at sec. A, p. 1, col. 1.

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Specter, M. 1989. French researcher wins top U.S. medical award, angering abortion foes. Washington Post, September 28, at sec. A, p. 12.

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Stein, R. 1989. Abortion pill appears promising. United Press International, September 29.

Stein, R. 1990. Abortion pill ‘well-liked' in U.S. study. United Press International, October 1.

Steinbrook, R. 1988. Wide use of non-surgical abortions is called likely. Los Angeles Times, February 4, at part 1, p. 3, col. 1.

Technology Newsletter. 1988. An abortion drug is approved. Chemical Week 143(14):26.

Tempest, R. 1988a. French drug company bows to protest, halts abortion pill. Los Angeles Times, October 27, at part 1, p. 1, col. 5.

Tempest, R. 1988b. Reaction bitter on health of abortion pill. Los Angeles Times, October 28, at part 1, p. 6, col. 1.

Tempest, R. 1988c. France orders company to distribute abortion pill. Los Angeles Times, October 29, at part 1, p. 1, col. 5.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Thomas, O. 1988. New abortion method hit by safety and moral questions. Christian Science Monitor, November 16, at p. 3.

Ullman, A., G. Teutsch, and D. Philibert. 1990. RU 486; drug used to abort pregnancies has many possible applications Scientific American 262(6):42.

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Van de Kamp, J. 1990. Letter to the editor. Los Angeles Times, March 29, p. B6, col. 4.

Voelker, R. 1990. Researcher suggests side effects of RU-486 may be underreported. American Medical News, October 26, p. 8.

Walsh, K. 1989. The Bush administration's modest plan to help pro-life backers. U.S. News & World Report 106(16):26.

Willke, J. 1990. The abortifacient RU 486: Gathering clouds? National Right to Life News, September 17, p. 3.

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Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Commentary

William N. Hubbard

RU-486, used in sequence with a prostaglandin (PG), was developed collaboratively by Hoechst-Roussel in France and the World Health Organization (WHO). The latter has sponsored wide clinical trials with an emphasis on developing countries. Swedish data, and those from other developed countries, contributed to the research, which still continues. Although no commercial licenses are available from Hoechst-Roussel at this time, WHO has research contracts with a few academic institutions in the United States.

Although the Food and Drug Administration will accept well-developed data from other countries in reviewing an investigational new drug (IND) or new drug application (NDA), these are generally supplementary to, not a substitute for, data required from the sponsor. A recent Institute of Medicine publication, Science and Babies offers a short discussion of these issues. Because RU-486 is intended for convenience use by healthy young women rather than as a therapy for an incapacitating or life-threatening disease, the criteria for judging risks of use compared with demonstrable benefits may be expected to be relatively more demanding.

The fact that the drug is registered in France does not dilute the requirements for U.S. registration. The good laboratory practices and specific protocol

William N. Hubbard, currently retired, was formerly dean of the Medical School at the University of Michigan, and president of the Upjohn Company.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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requirements for animal studies that must be completed before clinical registration studies can begin make it probable that two or more years of animal work would be needed before an IND would be approved.

Since RU-486 is not used alone because of its relatively low effective rate of 80 percent, but rather is used in sequential conjunction with a second unapproved drug—a member of the PG family—the designs of both animal and clinical protocols are complicated and nearly unprecedented. The result can reasonably be expected to include a longer period for development.

The usual standard of two well-controlled clinical trials demonstrating clinical endpoint differences at a 95 percent confidence level cannot be applied because neither a placebo group nor either single or double blinding would be ethical or feasible. These considerations suggest the probability that long-term follow-up of patients from the trials would be needed, and further, that a system of close monitoring of outcome of use after approval would be required. Absent the statistical analysis from randomized controlled clinical trials, it is reasonable that a relatively much larger number of patients would be required in order to make a reasonable “epidemiologic” judgment of safety and efficacy.

Conservatively, five to seven years would be required to recruit for two approved clinical trials, collect and analyze the data, and compile and submit a completed NDA. The review process is not predictable, but in light of poor experience with drugs in the nontherapeutic group used in healthy people for a significant part of the fertile years, it is prudent to expect an extensive and very critical review lasting at least three to five years. Ten years from beginning the registration protocol to final approval of the NDA is probably an optimistic estimate of the time required.

Legal liability and the costs of insurance against personal injury and punitive damages have been a major factor in limiting the availability of intrauterine devices and oral contraceptives as well as frustrating the recovery of costs of developmental research. In this case, the risks include failure to abort—now about 5 percent of cases—and putative causal relationship of treatment to any birth defect if a failed abortion is carried to term delivery. So great is this potential liability that it could effectively cripple if not bankrupt a large company. Such liability risks could be better managed by a small company funded by stock ownership at a distance, perhaps by a limited partnership. In this case the liability would not change, but the recoverability would be limited.

Because a few patients may have excessive bleeding after a completed abortion by RU-486/PG use, surgical resources for emergency dilatation and curettage must be available when this combination is used. Because there is a discrete rate of failure of complete abortion of approximately 1 out of every 20 patients, arrangements for surgical evacuation of the failed abortus must be available. Furthermore, the patient must be prepared in advance for this

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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procedure because the degree to which the fetus has been compromised by the failed procedure cannot be known but may be extensive.

In estimating cost-benefit of RU-486 use, the costs of physician supervision and care as well as the standby costs of intervention for complications or failure must be included. The tort liability and insurance costs against damages will be a significant portion of the fee for physician services.

The total market is confined to the fertile years of women on the occasions of an unwanted pregnancy, limited to those areas where the surgical backup described above is available and where induced abortions by nonsurgical methods are legal (currently, for example, this excludes Japan—a major market). The exact number of users is not predictable, but it is not reasonable to assume that suction curettage would fail to continue as a method of choice for many women. In comparison with drugs affecting infectious diseases, cancer, heart disease, mental disorder, pain, arthritis, and metabolic disorders, the market is minuscule. Since unwanted pregnancy is unlikely to be termed a disease by the Congress of the United States, the so-called orphan drug act is unlikely to apply.

The role of boycott of the company providing abortifacients by those who oppose abortion products has been widely discussed. There are no data that would limit the freedom of opinion in this matter. It is banal to acknowledge that no company enjoys either this publicity or the loss of sales that is implied by a boycott. On the other hand, it is unlikely that an indicated medication will be withheld from a patient because of its source. There is no way to measure objectively the occurrence of sales that are not made.

Finally, in making a decision to undertake the development of RU-486/PG, a company must consider the lost value of opportunities for development of other drugs that were displaced. The irrevocable decision is the one not to develop an entity; the decision to develop is always conditional on progress. Drug candidates are more numerous by far than the number of products that can be developed. Future financial support of research depends on a choice of future products whose market will repay costs and provide for growth. Whether RU-486/PG will compete successfully for product development will depend on the number and quality of other product candidates, their therapeutic significance, the extent of need for the agent, and the time-cost of money needed for their development and distribution.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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Commentary

Peter F. Carpenter

This case study is a factual, if biased, discussion of why RU-486 is not presently available in the United States. The conflict in this instance is between individuals who want access to a particular drug and some members of the broader society who feel that such access would be morally (rather than scientifically) wrong. It is difficult but still far easier to balance differences of scientific opinion than to balance differences of moral values. Most of the participants and constituencies involved in the RU-486 controversy appear to have defined the issue in terms of requiring a yes or no answer to the question “Should RU-486 be available in the United States?” That question is based on the hidden assumption that an appropriate decision-making process already exists, or that no such process is desired because the decision will be made on the basis of a moral, political, or economic point of view. There was little agreement as to a mutually accepted way of dealing with the issue.

The RU-486 decision was clearly not a stand-alone issue; it was deeply embedded in the larger abortion rights issue, and this greatly impeded and obscured the decision process.

The foreign events of this case are well documented. The domestic events are not so well documented, but that may be inevitable because many of

Peter F. Carpenter, a former pharmaceutical company (ALZA) and federal government (Office of Management and Budget) executive, is a visiting scholar at the Center for Biomedical Ethics at Stanford University.

Suggested Citation:"A Political History of RU-486." Institute of Medicine. 1991. Biomedical Politics. Washington, DC: The National Academies Press. doi: 10.17226/1793.
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those events were, in fact, “nonevents” (i.e., things that did not happen or negative decisions not [yet] subject to public analysis). Because the case dealt with nondecisions or non-public decisions regarding U.S. availability of RU-486, the actual decision-making process was difficult to describe; only limited information about this process was available to the author for presentation in the case study.

The formal French approval process was predetermined, but the subsequent decision by the French government to require product marketing was an ad hoc process. To the extent that there was a U.S. decision-making process, it was totally ad hoc. This ad hoc process was evolutionary, but without either a guiding principle or any attempt to construct a rational process to directly address the issue from multiple perspectives. This “decision-making process” consisted of well-organized public relations campaigns. The threat of boycotts supplanted reasoned scientific and political debates, and will probably become an inappropriate model for “deciding” difficult decisions that involve both biomedical innovation and moral questions.

The question about whether RU-486 should be available in the United States has evolved into a highly polarized debate between vocal and economically powerful constituencies on opposite sides of the issue with practically no participation by larger and more broadly based constituencies. The absence of a formalized decision-making process allowed the issue to be decided, albeit temporarily, without input from all of the affected constituencies and as a result the current (non)decision is unlikely either to be a stable decision or, absent new actors, to lead to a better process the next time around.

A gradual softening of Roussel's position not to make the product available for sale outside of France will eventually remove a significant obstacle to availability in the United States. However, at that point someone or some institution will need to take responsibility for creating a process whereby this issue can be properly addressed by all affected constituencies.

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The abortifacient RU-486 was born in the laboratory, but its history has been shaped by legislators, corporate marketing executives, and protesters on both sides of the abortion debate.

This volume explores how society decides what to do when discoveries such as RU-486 raise complex and emotional policy issues. Six case studies with insightful commentary offer a revealing look at the interplay of scientists, interest groups, the U.S. Congress, federal agencies, and the public in determining biomedical public policy—and suggest how decision making might become more reasoned and productive in the future.

The studies are fascinating and highly readable accounts of the personal interactions behind the headlines. They cover dideoxyinosine (ddI), RU-486, Medicare coverage for victims of chronic kidney failure, the human genome project, fetal tissue transplantation, and the 1975 Asilomar conference on recombinant DNA.

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