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BIOMEDICAL POLITICS 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.
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BIOMEDICAL POLITICS 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-
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BIOMEDICAL POLITICS 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-
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BIOMEDICAL POLITICS 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-
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BIOMEDICAL POLITICS 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.
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BIOMEDICAL POLITICS 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”
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BIOMEDICAL POLITICS (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.
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BIOMEDICAL POLITICS “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
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BIOMEDICAL POLITICS 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
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BIOMEDICAL POLITICS 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
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BIOMEDICAL POLITICS 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).
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BIOMEDICAL POLITICS Arnst, C. 1989a. British doctors backing acceptance of French abortion pill. Reuters, October 26. Arnst, C. 1989b. French abortion pill gaining support from world's doctors. Reuters, November 7. Associated Press. 1988. France orders drug firm to market abortion pill. As reprinted in the Los Angeles Times, October 30, part 1, p. 1, col. 5. Associated Press. 1989. An abortion ban would accomplish little. As reprinted in the Chicago Tribune, April 18, p. 4. Atwood, R. 1988. Doctors laud French order to go ahead with abortion pill. Reuters, October 28. Aubény, E., D. Cossey, and M. Tearse. 1990. The French experience with RU-486 and the outlook for Great Britain A report to the Reproductive Health Technologies Project, Washington, D.C., August. Barth, I. 1990. Fear and politics versus a safe abortion pill. Newsday, December 17, p. 74. Berg, P. 1985. New pill would be taken after conception. Washington Post, January 16, at sec. “Health,” p. 5. Black, C. 1989. NOW backs call to form a feminist party. Boston Globe, July 24, p. 1. Brennan, W. 1991. Chemical warfare on the unwanted: The I. G. Farben-Hoechst connection National Right to Life News, January 8, p. 6. Carey, J. 1990. Can the ‘abortion pill' save lives? Business Week, December 17, p. 56. Carroll, M. 1990. Abortion issue a bitter pill for Dinkins? Newsday, November 23, p. 19. Ciolli, R. 1989a. U.S. school expands abortion pill research. Newsday, February 28, at sec. “News,” p. 2. Ciolli, R. 1989b. The abortion pill controversy. Newsday, May 29, at sec. “News,” p. 6. Ciolli, R. 1990. Campaign for abortion pill. Newsday, July 2, p. 4. Contraceptive technology: Promises and politics. 1990. A workshop at the Annual Meeting of the American Public Health Association, October 2. (Session 3063, transcribed from audio tape by Mobiltape Company, Valencia, California.) Dawkins, W. 1990. Rhône-Poulenc raises 4.7 billion French francs. The Financial Times, July 16. Emiling, S. 1987. Anti-abortionists see graphic film. United Press International, June 18. Facts on File. 1987. Other medical news. World News Digest, December 31. Fagen, C. 1988. Fetal distraction: Pro-lifers reconceived. The New Republic 198(22):21-25. F-D-C Reports, Inc. 1985a. The Pink Sheet: Trade & Government Memos 47(8):T&G-10. F-D-C Reports, Inc. 1985b. The Pink Sheet: Trade & Government Memos 47(18):T&G-4 to T&G-5. F-D-C Reports, Inc. 1986. The Pink Sheet: Trade & Government Memos 48(40):T&G-2 to T&G-3. F-D-C Reports, Inc. 1987. The Pink Sheet: Trade & Government Memos 49(July 20). F-D-C Reports, Inc. 1989. The Pink Sheet: Trade & Government Memos 51(February 27). Federal Information Systems Corporation. 1989. Press conference on the Webster decision with Molly Yard and Eleanor Smeal, July 3. Foreman, J. 1988a. France OK's use of new abortion pill. Boston Globe, September 24, p. 1. Foreman, J. 1988b. New drugs could change US debate on abortion. Boston Globe, October 2, p. 1. Foreman, J. 1988c. Under fire, French firm halts distribution of new pill. Boston Globe, October 27, p. 1.
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BIOMEDICAL POLITICS Foreman, J. 1988d. France orders sale of abortion pill. Boston Globe, October 29, p. 1. Foreman, J. 1989. Abortion: An American divide. Boston Globe, April 23, p. 1. Françoise, C. 1991. Pro-lifers overseas gear up to fight RU 486: Great Britain next target National Right to Life News, January 8, p. 6. Fraser, L. 1988. The abortion pill: Why America trails Europe. Newsday, July 5, at sec. “Viewpoints,” p. 49. Gladwell, M. 1988a. Enemies join hands to gut provisions in bill. Washington Post, April 10, at sec. H, p. H4. Gladwell, M. 1988b. Birth control makers weary of controversy. Los Angeles Times, May 3, at part 4, p. 15, col. 1. Glasow, R. 1986. Heavy reliance on new abortion pill marks shift in pro-abortion strategy and rhetoric, National Right to Life News, March 27. As reprinted in Omen of the Future?: The Abortion Pill RU 486, R. Glasow and J. Willke, eds. (Original copyright: National Right to Life Committee, 1986; recent copyright: National Right to Life Educational Trust Fund, 1989.) Glasow, R. 1988a. Abortion pill advocates map new strategy in 1987 and 1988 to win U.S. approval of RU 486; hurdles remain (part 1). National Right to Life News, June 2. As reprinted in Omen of the Future?: The Abortion Pill RU 486, R. Glasow and J. Willke, eds. (Original copyright: National Right to Life Committee, 1986; recent copyright: National Right to Life Educational Trust Fund, 1989.) Glasow, R. 1988b. Abortion pill advocates map new strategy in 1987 and 1988 to win U.S. approval of RU 486; hurdles remain (part 2). National Right to Life News, July 7. As reprinted in Omen of the Future?: The Abortion Pill RU 486, R. Glasow and J. Willke, eds. (Original copyright: National Right to Life Committee, 1986; recent copyright: National Right to Life Educational Trust Fund, 1989.) Glasow, R. 1988c. Abortion pill RU 486 approved for use in France, China; pro-life spokesmen condemn death drug. National Right to Life News, October 6. As reprinted in Omen of the Future?: The Abortion Pill RU 486, R. Glasow and J. Willke, eds. (Original copyright: National Right to Life Committee, 1986; recent copyright: National Right to Life Educational Trust Fund, 1989.) Glasow, R. 1988d. French abortion pill backers' ploy keeps death drug on market. National Right to Life News, November 17. As reprinted in Omen of the Future?: The Abortion Pill RU 486, R. Glasow and J. Willke, eds. (Original copyright: National Right to Life Committee, 1986; recent copyright: National Right to Life Educational Trust Fund, 1989.) Glasow, R. 1989. Company claims RU 486 will not be marketed outside France; prolifers adopt wait and see attitude, still oppose death pill. National Right to Life News, April 6. As reprinted in Omen of the Future?: The Abortion Pill RU 486, R. Glasow and J. Willke, eds. (Original copyright: National Right to Life Committee, 1986; recent copyright: National Right to Life Educational Trust Fund, 1989.) Glasow, R. 1990a. Latest abortion pill study finds same adverse side effects. National Right to Life News, March 15, p. 8. Glasow, R. 1990b. Pro-aborts plans to try to test and market RU 486 outside normal channels in California. National Right to Life News, April 26, p. 9. Glasow, R. 1990c. Marketing abortion pill outside France key policy shift. National Right to Life News, August 16, p. 5. Glasow, R. 1990d. RU 486 strategy requires influencing key groups. National Right to Life News, September 17, p. 1. Glasow, R. 1990e. Three companies manufacture drugs for RU 486 abortion technique. National Right to Life News, September 17, p. 10. Glasow, R. 1990f. Abortion pill tests proposed for New York City. National Right to Life News, October 2, p. 10.
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BIOMEDICAL POLITICS Glasow, R. 1990g. Advocates turn up pressure to bring RU 486 to U.S. National Right to Life News, October 17, p. 12. Glasow, R. 1990h. Supporters admit serious underreporting of abortion pill side effects National Right to Life News, November 19, p. 11. Glasow, R. 1990i. RU 486: The prostaglandin connection. National Right to Life News, December 13, p. 7. Glasow, R. 1991a. House hearing used to mask safety concerns over RU 486. National Right to Life News, January 8, p. 4. Glasow, R. 1991b. Hypothetical ‘therapeutic' uses vs. real complications. National Right to Life News, January 8, p. 9. Goodman, E. 1988a. Birth control goes back to the past for progress. Newsday, May 27, p. 92. Goodman, E. 1988b. The abortion debate enters a new and climactic phase of conflict. Boston Globe, November 3, p. 17. Goodman, E. 1989. Abortion: By pill. Boston Globe, July 29, p. 17. Gordon, L. 1976. Woman's Body, Woman's Right: A Social History of Birth Control in America. New York: Grossman Publishers. Greenhouse, S. 1988a. Drugmaker stops all distribution of abortion pill. New York Times, October 27, at sec. A, p. 1, col. 6. Greenhouse, S. 1988b. Maker says pressures could revive pill. New York Times, October 28, at sec. A, p. 9, col. 1. Greenhouse, S. 1988c. France ordering company to sell its abortion drug. New York Times, October 29, at sec. 1, p. 1, col. 6. Greenhouse, S. 1989a. A new pill, a new battle. New York Times Magazine, February 12, at sec. 6, p. 23, col. 1. Greenhouse, S. 1989b. Fears confine pill to France. New York Times, March 26, at sec. 4, p. 18, col. 1. 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.
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BIOMEDICAL POLITICS 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.
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BIOMEDICAL POLITICS 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. Scott, J. 1990. Van de Kamp requests tests of abortion pill. Los Angeles Times, March 15, p. A3, col. 4. Seaman, B., and G. Seaman. 1977. Women and the Crisis Sex Hormones. New York: Rawson Associates. Seattle Times Staff. 1990. Task force favors French abortion pill. Seattle Times, December 21. Sheler, J. 1987. New abortion drug to stir confrontation. U.S. News & World Report, June 1, at p. 31. 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. Specter, M. 1988. French abortion-inducing pill adds twist to medical ethics debates Washington Post, October 30, at sec. A, p. 6. Specter, M. 1989. French researcher wins top U.S. medical award, angering abortion foes. Washington Post, September 28, at sec. A, p. 12. States News Service. 1988. Sullivan hearings, December 23. Stein, R. 1987. Drug promising as birth control pill. United Press International, January 22. Stein, R. 1988. Abortion pill sparks hope, fear, controversy. Los Angeles Times, November 27, at part 1, p. 3, col. 1. 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.
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BIOMEDICAL POLITICS 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. United Press International. 1988. France tells drug firm to resume abortion pill sales. As reprinted in the Los Angeles Times, October 28, at part 1, p. 1, col. 1. United Press International. 1989. NOW leaders open campaign to bring abortion pill to U.S. As printed in the Los Angeles Times, June 1, at part 1, p. 2, col. 6. U.S. Congress, Office of Technology Assessment. 1988. Infertility: Medical and Social Choices. OTA-BA-358. Washington, D.C.: U.S. Government Printing Office. 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. Yinger, N. 1990. Focus on maternal mortality. Population Today 18(May):6.
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BIOMEDICAL POLITICS 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.
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BIOMEDICAL POLITICS 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
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BIOMEDICAL POLITICS 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.
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BIOMEDICAL POLITICS 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.
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BIOMEDICAL POLITICS 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.
Representative terms from entire chapter: