Biomedical Politics (1991) / Chapter Skim
Currently Skimming:
A Political History of RU-486
A Political History of RU-486
Pages 43-98
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From page 43... ...
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 '~olsterting]
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From page 44... ...
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reported on conversations with French government researchers unaffiliated with Roussel whose preliminary data had not yet been peer-reviewed or published (Contraceptive Technology, 1990; Voelker, 19901. 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 Medecin, 19901.
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From page 45... ...
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 drugs French manufacturer, Groupe Roussel Uclaf, which has refused to license it in the United States.
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From page 46... ...
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.
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From page 47... ...
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.
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From page 48... ...
This mix of concerns over immediate reproductive freedom and longterm 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.
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From page 49... ...
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, 19861.
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From page 50... ...
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., 19831.
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From page 51... ...
"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, 19851.
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From page 52... ...
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., 19851. (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.)
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From page 53... ...
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.
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From page 54... ...
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, 19871. 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, 19871.
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From page 55... ...
. 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.
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From page 56... ...
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.
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From page 57... ...
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, 19881.
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From page 58... ...
was simply not worth the risk" (Ricci, 19881. According to the following excerpt from a New York Times Magazine article (Greenhouse, 1989a)
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From page 59... ...
. 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.
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From page 60... ...
. 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.
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From page 61... ...
. 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.
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From page 62... ...
Baulieu once traveled with a bodyguard during a U.S. visit (United Press International, 19881.
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From page 63... ...
The French Movement for Family Planning issued a statement drawing attention to the link between the political opposition to RU486 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?
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From page 64... ...
. 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....
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From page 65... ...
"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, 19881. 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)
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From page 66... ...
. The French government's stance was also supported by interested medical and political groups around the world.
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From page 67... ...
Msgr. Albert Decourtray, president of the French Bishops Conference, called it "a victory for savage liberalism" (United Press International, 19881.
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From page 68... ...
At this same time, however, controversy began over drugs not destined for the birth control or abortion markets, such as Searle's ~ntiulcer drug, Cytotec. While the drug was under review by the FDA, antiabortion
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From page 69... ...
In fact, the group was formed solely to persuade the French government, Hoechst, or Roussel to pull RU-486 off the market (Ciolli, 1989a)
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From page 70... ...
, a threat made good in 1991 with a lengthy article on the drug's "Nazi connection" (Brennan, 1991) in a special issue ofthe National Right to Life News.
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From page 71... ...
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.
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From page 72... ...
In June 1989, feminist leaders announced a campaign to bring RU486 to the United States (United Press International, 19891. 'Eve intend to visit the pharmaceutical leaders, the medical health leaders to urge them to rise up against this .
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From page 73... ...
. Neither the French government nor WHO, which cosponsored clinical trials of the drug, is pressing Roussel to release the drug abroad.
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From page 74... ...
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, 19891.
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From page 75... ...
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.
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From page 76... ...
Beijing has had the largest clinical trials more than 3,000 womenoutside France; it also runs the world's largest national abortion service, with more than 11.5 million abortions performed annually (MacFarquhar,19881. China has approved the drug but has not yet asked Roussel for supplies (Herman, 1989; MacFarquhar, 19881.
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From page 77... ...
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, 19891.
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From page 78... ...
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.
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From page 79... ...
, and education director Richard Glasow writing that "right-to-life supporters should recognize that preventing U.S. tests of the abortion pill [is]
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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, l990f) , she was quoted in the Village
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From page 81... ...
the difficulty and expense of obtaining FDA approval; (3) the costs associated with product liability claims; and (4)
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From page 82... ...
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.
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From page 83... ...
G.D. Searle & Company pulled its IUDs off the shelves in 1986, although it continues to manufacture birth control pills.
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From page 84... ...
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.
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From page 85... ...
" (Specter, 19881. Thus, contraceptive research these days is largely found in European pharmaceutical companies, in U.S.
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From page 86... ...
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.
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From page 87... ...
United Press International, March 24.
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From page 88... ...
United Press International, June 18. Facts on File.
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From page 89... ...
1988b. Birth control makers weary of controversy.
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From page 90... ...
1988a. Birth control goes back to the past for progress.
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From page 91... ...
United Press International, October 28. Phillips, J
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From page 92... ...
1987. Drug promising as birth control pill.
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From page 93... ...
:42. United Press International.
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From page 94... ...
. The latter has sponsored wide clinical trials with an emphasis on developing countries.
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From page 95... ...
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.
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From page 96... ...
The tort liability ancl 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 describecl above is available and where induced abortions by nonsurgical methods are legal (currently, for example, this excludes Japan—a major market)
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From page 97... ...
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.
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From page 98... ...
availability of RU486, the actual clecision-maki ng process was d ifficu It to describe; on Iy I i m ited 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.
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