Great Opportunity to Refute Myths about
the Non-Abortion Uses of RU 486

An Update

U.S. marketing of the dangerous RU 486/Cytotec prostaglandin (RU 486/PG) abortion technique continues to be stalled over the lack of a manufacturer, according to the latest public statement from the organization that controls the U.S. patent. The June 1997 status report on the Internet website of the Population Council states that all of the appropriate documentation has been filed with the U.S. Food and Drug Administration (FDA), but "additional information on manufacturing still has to be provided before the drug can be approved." On May 9, 1997, the Council filed a breach of contract lawsuit against a Hungarian drug company that backed out of a deal to provide bulk quantities of RU 486, and that dispute has apparently not been resolved. The Pro-Life/Pro-Family boycott of the Hoechst Marion Roussel drug company is still underway because the company bears great responsibility for the testing and approval of RU 486 for abortion in the U.S.

Meanwhile, U.S. tests continue on two other chemical abortion techniques. One test, under the auspices of Abortion Rights Mobilization (ARM), utilizes a "Chinese clone" of RU 486 plus Cytotec prostaglandin. The other experiment being conducted by Planned Parenthood affiliates uses the anti-cancer drug methotrexate plus Cytotec prostaglandin. (See the July 1997 RU 486 Report for details.)

Seizing an Opportunity

This lull in the pro-abortion supporters’ push to market RU 486 offers Pro-Life and Pro-Family advocates an outstanding opportunity to do some public relations efforts of their own. In the past five years, we have heard virtually nothing about the non-abortifacient uses of RU 486. Yet, because of the hype created in the late 1980s and early 1990s and slavishly accepted by reporters, news accounts still act as if there are proven uses outside abortion for RU 486. In truth, such claims were not borne out then or later. In many cases, they have been disproved. At the very least, such purported uses remain unsubstantiated.

Such allegations were always intended to provide cover for abortion. So, too, were charges that pro-lifers in general, and the Bush Administration in particular, did everything they could to stop research into non-abortifacient uses. The attack focused on the Bush Administration’s wise decision to not allow RU 486 in for personal use.

This edition will provide the reader with information to address two major items that still come up:

a. A brief overview of the media events that proponents engineered (1) to plant the seed that there were non-abortion uses and (2) to portray pro-lifers as attempting to stop research into those areas.

b. An overview of the research to date demonstrating that there is no evidence RU 486 can be used, for example to cure breast cancer, or any other disease.

The Crucial Period, 1989-1992

In retrospect, it’s clear that the crucial period for the development of the "accepted knowledge" about the non-abortion claims for RU 486 was 1989 through 1992. After the drug was licensed for abortion in France in late 1988, U.S. abortion advocates became increasingly frustrated and upset. The European companies controlling RU 486 refused to license or even test it here for abortion. Moreover, the pro-life Bush Administration was unwilling to either put pressure on the companies or cut corners on drug approval, and on June 6, 1989 the U.S. Food and Drug Administration (FDA) issued an "Import Alert" formally banning importation of RU 486 by individuals for personal use for abortion on safety grounds.

The RU 486 supporters tried an indirect approach to bringing RU 486 into the U.S. for abortion. Adeptly using their access to opinion leaders, control of Congress and scientific associations, and cooperation from the media, abortion advocates attempted to build public support for importation by claiming that RU 486 was a "potential" cure for diseases or conditions affecting millions of Americans, such as breast cancer and endometriosis. Virtually in the same breath, the RU 486 supporters tried to discredit Pro-Life and Pro-Family organizations and the Bush Administration by claiming that they had blocked U.S. research on these beneficial uses. The FDA issued the Import Alert in response to political pressure from pro-life Congressmen and had been responsible for discouraging the Europeans from conducting any research, abortion supporters asserted. One of the media’s most important but unspoken assumptions has been that the pro-RU 486 forces have scientific credibility while the anti-RU-486 forces have none.

Since 1992, these Trojan Horse claims have remained basically unchallenged because the focus of the controversy has been on using RU 486 for abortion. Now in 1997 five more years of medical data provides even stronger evidence to refute the myths.

Talking Points Against RU 486

In order to counter these claims, Pro-Life and Pro-Family advocates should use the following three general themes.

• First, the "conventional wisdom" that RU 486 is useful to cure many conditions and diseases is either completely wrong, grossly exaggerated, or unproven.

In public debates, rather than rebutting each one of the claims individually, one of the best techniques is to list them collectively. Soon the list becomes ridiculously long since no drug could ever cure everything from AIDS to hypertension, and even arrest aging!

Since RU 486 was first discovered in 1980, researchers have conducted dozens of test-tube and clinical experiments on a wide variety of diseases or conditions. Those experiments have not uncovered any miraculous curative properties for this powerful synthetic steroid. U.S. marketing of RU 486 for anything except abortion is still years away and will require much more extensive animal and human testing. In short, the "potential" uses of a decade ago remain largely unsubstantiated, unproven, or completely false.

The most noteworthy claim made by RU 486 advocates that RU 486 was a potential cure for breast cancer. Three clinical trials conducted on women with breast cancer have proven authoritatively that RU 486 is not a cure for breast cancer.

Moreover, if there had been some validity to the claims made since the mid-1980s that RU 486 cured breast cancer, why didn’t the manufacturer put enormous effort into research and marketing such a potentially profitable drug? The obvious reason is the company recognized early on that RU 486 was not a cure. In fact, the U.S. National Cancer Institute said so publicly five years ago during a controversy over its refusal to fund tests in this county.

And finally, if RU 486 is supposed to be so valuable for non-abortion purposes, then why would the manufacturer give away the patent? Acting on instructions from its German parent company, the French owner of the patent "donated" the U.S. rights to the Population Council in 1994, and then gave the rest of the world-wide patent rights to a new start-up company in April 1997. The obvious answer is that RU 486 was too much trouble for them as an abortion drug, and they did not believe that it would be profitable for any other use in the foreseeable future.

• A second major theme is the strong evidence that Pro-Life and Pro-Family advocates did not and could not block U.S. research on the non-abortion uses.

In fact, during the late 1980s and early 1990s, the non-abortion uses of RU 486 were not a research priority because both scientists and the company controlling RU 486 realized that it had limited potential and they had more promising projects to pursue. The lack of progress since 1992 using RU 486 for non-abortion purposes documented below verifies their judgment.

The strongest evidence supporting the validity of the FDA’s decision in 1989 to issue the Import Alert to protect the health and lives of women comes ironically from the Clinton Administration, which has politicized the drug approval process in favor of RU 486. On President Clinton’s first full day in office, he ordered the FDA to reevaluate the scientific basis for the Import Alert. Nothing was heard for over a year. On May 14, 1994, at a congressional hearing about the licensing of the RU 486 patent for abortion, FDA Commissioner Dr. David Kessler stated that the Import Alert would remain in effect to protect the health and lives of American women. This startling admission that the Bush Administration had been right all along received no press coverage.

Moreover, as a practical matter, since most drug testing in this country is confidential and done by private companies and organizations, there was no way for the opponents of RU 486 to prevent research. For example, testing of RU 486 for abortion at the University of Southern California in Los Angeles in the 1980s was entirely secret until the researchers published their findings several years later.

• The third theme is that the events of the past five years show that abortion advocates misrepresented and manipulated the scientific facts for political purposes. After a three-year-long campaign trumpeting the alleged importance of non-abortion uses for RU 486, they precipitously dropped the issue when Clinton took office. Better public understanding of the RU 486 advocates’ cynical strategy might undermine their credibility in the present debates.

Let’s review the origins of "conventional wisdom" and then compare the claims with the latest medical evidence.

Establishing The Claims, 1985 - 1993

1985

The initial media accounts naturally had focused on its novelty as a method of chemical abortion and its potential to transform how abortions would be performed. RU 486 blocks the action of the natural hormone progesterone, which is vital to maintaining the nutrient lining of the uterus during pregnancy. When RU 486 blocks the action of progesterone, the lining disintegrates, which starves the unborn baby to death.

However, scientists also had legitimate reason to be interested in RU 486's theoretical properties as an unique anti-hormone for a variety of applications beyond abortion. In addition to being an antiprogesterone (or anti-progestin), RU 486 was the first antiglucocorticoid to become available for clinical testing. The American Medical Association’s Encyclopedia of Medicine states that glucocorticoids are hormones produced by the adrenal glands that "affect carbohydrate metabolism by increasing blood sugar level and the amount of glycogen in the liver." According to Dr. L. Michael Kettel writing in the December 1995 Clinical Obstetrics and Gynecology, RU 486 is a much less potent antiglucocorticoid than it is an antiprogestin.

While media accounts have seldom explained or differentiated between these two properties, most of the research has focused on RU 486 as an anti-progesterone (or anti-progestin).

The first extensive claims by RU 486 advocates that the drug had beneficial medical uses surfaced in late 1985 during the initial big burst of media attention. The occasion was the publication of a book summarizing the results of the research on RU 486 up to that time. The co-editor of the book and chief media spokesman for the pro-RU 486 campaign from 1985 through 1990 was Dr. Étienne É. Baulieu, the key consultant to the French manufacturer of RU 486, Roussel Uclaf. In Baulieu’s chapter in the book, he asserted that—in addition to abortion—RU 486 would be tested for "advanced breast cancers," "brain tumors," "extra-uterine [ectopic] pregnancies," and Cushing’s Syndrome (a disorder of the adrenal gland).

1989

After the French government licensed RU 486 for abortion in December 1988, U.S. abortion advocates immediately stepped up their campaign to market it here. Behind the scenes, the largest pro-abortion lobbying organizations formed a key "working group" named the Reproductive Health Technologies Project (RHTP) to coordinate strategy. Using foundation grants, RHTP spearheaded the media campaign. Many of the projects mentioned below required months of preparation before they were ready to go public.

A video named "Abortion for Survival" released in April 1989, by the radical pro-abortion organization, Fund for a Feminist Majority, escalated the list of potential benefits. It asserted that the drug had "potential" use for "labor at term delivery, treatment of ulcers, endometriosis, prostate cancer, and breast cancer." The narrator then claimed that "pressure from anti-abortion forces threatens the research and use of RU 486 in this country, and internationally." The video was aired on Ted Turner’s TBS cable network without any time for rebuttal.

In the fall of 1989, heavier promotion started when Baulieu repeated the claims in articles appearing in two prestigious U.S. scientific journals, which received national publicity.

1990

The tempo of the public campaign escalated dramatically in 1990. In January and February, Planned Parenthood, the nation’s largest provider and promoter of abortion, sponsored a nationwide series of press conferences, headlining Dr. Baulieu. The media gave them front-page coverage. On June 26th, the House of Delegates, the policy-making body of the American Medical Association, endorsed a resolution supporting more research and possible use of RU 486. This vote by the nation’s largest organization of physicians also generated widespread media coverage.

The abortion proponents’ political strategy behind the frequent mention of the beneficial "other" uses became public during a July 11, 1990, news conference by Joanne Howes in New York City. Howes served as director of the Reproductive Health Technologies Project, an organization identified in the July 12 Newsday as "spearheading the drive" to bring RU 486 into the U.S. "By targeting the [U.S.]medical community, Congress, women’s groups and the media, proponents of the [abortion] pill say they hope to pressure the pharmaceutical industry and the Bush administration to test and license the drug," reported Newsday. The story explained that the "key to their success, Howes said, may be to stress other possible medical benefits of RU 486, such as in treatment for breast cancer, and to cast the issue in ‘freedom of research’ terms."

Just over a month later, a two-page article cataloging a sweeping list of non-abortion uses for RU 486 appeared in the August 22/29, 1990 issue of the influential Journal of the American Medical Association (JAMA) written by cancer researcher Dr. William Regelson and two others. The article claimed that RU 486 has "potential" to cure patients with advanced breast disease, inoperable meningiomas, Cushing’s disease, hypertension, a broad range of tumors, viral infections, and even AIDS.

On November 19, 1990, then-U.S. Representative (now Senator) Ron Wyden (D-Oregon) held a Congressional hearing stacked almost entirely with RU 486 advocates promoting its "beneficial" uses. In his opening statement, the pro-abortion Wyden attacked the FDA’s Import Alert and claimed that "Many scientists now believe that the drug can successfully treat debilitating and life-threatening illnesses such as breast cancer, brain cancer, diabetes, and Cushing’s Syndrome." The event generated extensive national media coverage, including two stories in the New York Times.

At the hearing covered by the national media, a parade of witness and former patients who had used RU 486 asserted that "recent studies have shown" that the drug "is a promising treatment of a variety of medical disorders," including infertility and hypertension, reported the November 20 Philadelphia Inquirer. Dr. Regelson repeated his assertion from his JAMA article that RU 486 "has possible value in the treatment of AIDS" and the prevention of aging.

The lone dissenting voice against these unsubstantiated claims came from an unlikely source: the representative of the American Medical Association (AMA), which had adopted a pro-research policy on RU 486 the previous June. Dr. P. John Seward, an AMA trustee, asserted that the "published conjecture" that RU 486 may be an effective treatment for a variety of illnesses was not based on "any substantiated tests of the drug."

As for the allegations that the Bush Administration was impeding research, the federal government has "placed no barriers in the way of research," asserted a senior official of the U.S. Food and Drug Administration at the hearing. Associate Commissioner for Regulatory Affairs Ronald Chesemore explained that the agency had issued a formal policy called an "Import Alert" prohibiting importation of RU 486 for personal use, a position supported by the AMA, for good reason: protecting women from unsupervised use of a unproven and potentially dangerous drug. Scientists could obtain RU 486 for testing by following appropriate procedures, he asserted.

During 1991 and 1992, Wyden continued to badger the FDA about the "lack of research" because of the Import Alert.

1991

In February, 1991, pro-RU 486 speakers at two workshops at the annual meeting of the nation’s largest scientific society, the American Association for the Advancement of Science (AAAS), promoted its supposed non-abortion uses. One speaker received nationwide press coverage by claiming that RU 486 and similar drugs have been shown to slow or stop the growth of some kinds of breast tumors. Later in the meeting a committee of the organization passed a resolution calling for more research. The headline of an article about the meeting in a leading scientific magazine was typical of the type of coverage that announcements such as this received: "RU-486: Abortion Controversy in U.S. Clouds Future of Promising Drug - Progesterone antagonist developed in France and used to terminate pregnancy is potential anticancer and anti-Cushing’s agent, but efforts by antiabortion forces have impeded research on it in the U.S."

Meanwhile, a new facet of the pro-RU 486 campaign kicked off when an abortion supporter introduced a resolution into the New Hampshire state legislature. This resolution, which was subsequently used throughout the country in virtually the same wording, inaccurately claimed that RU 486 had "shown considerable efficacy in treating certain kinds of breast cancers and brain tumors, Cushing’s syndrome, and other diseases." The resolution, which was passed on May 12, 1991, called for introduction of RU 486 "for its significant medical value" and offered New Hampshire as a clinical test site. These assertions depended on the "big lie" technique, and proponents counted on busy legislators not having the time to research the true picture.

Over the following year and a half, the pro-RU 486 campaign received enormous media coverage as state legislatures all over the country debated—and sometimes passed—similar measures. The states where the resolutions were introduced included Arkansas, California, Florida, Hawaii, Illinois, Kansas, Maine, Minnesota, New Jersey, New York, and Wisconsin.

In July 1991, one of the nation’s most prestigious scientific agencies jumped into the RU 486 controversy on the side of the abortion advocates. The Institute of Medicine of National Academy of Sciences released a book-length study titled Biomedical Politics. One chapter devoted to "A Political History of RU 486" described the important developments and insisted that "politics " rather than "medical merit" was preventing introduction. RU 486 had "many promising applications, dilating the cervix, to help avoid cesarean sections; treating certain breast cancers that grow in response to sex hormones; treating endometriosis, the third leading cause of infertility in the United States; and controlling Cushing’s syndrome," claimed the author R. Alta Charo.

On December 5, 1991, then-Representative Wyden held another congressional hearing timed to provide a lead-in for a two-day national strategy meeting of leading RU 486 supporters. The principal theme running throughout the testimony of top RU 486 researchers was the claim that all of the scientific evidence was in favor of RU 486. Abortion "politics" (i.e. Pro-Life and Pro-Family resistance to abortion) was keeping it out of the U.S., they insisted. Once again, the hearing generated more pro-RU 486 publicity. (For example, the headline in a New York Times editorial on December 26, 1991 was "Fight Cancer, Not RU-486.")

The two-day conference held across the Potomac from Washington, D.C., brought together RU 486 activists from Europe and this country both to discuss the status of research and to plot their campaign. One of the top U.S. abortion supporters revealed publicly for the first time just how vital promoting the "other beneficial uses of RU 486" was to their campaign. Kate Michelman, head of the National Abortion and Reproductive Rights and Action League (NARAL), disclosed that public-opinion polling from the previous March indicated that "informing people that RU 486 can have other possible medical uses significantly increases the belief that the drug must be introduced into this country." She noted that "Perhaps the most powerful argument that we found for testing and licensing of RU 486 is its possible use for treating other diseases." In other words, the best way to get RU 486 into the country for abortion is to stress how it could cure non-abortion-related medical conditions.

1992

In January, 1992, Dr. Baulieu generated media coverage over the release of his book about the "abortion pill." On January 22, leaders of the largest pro-abortion organizations took the occasion of the anniversary of Roe v. Wade to announce intensification of their campaign to bring RU 486 into the U.S. During the ensuing months, RU 486 advocates continued to receive a lot of press coverage about the state legislative resolutions demanding "freedom of research." And in March at the annual meeting of the American College of Physicians in San Diego, a group of California physicians announced the formation of a new organization, Physicians for RU 486. Their leader told the press that their aim was to encourage the European companies to supply RU 486 "for all appropriate research."

On July 28, 1992, just a few months prior to the presidential election, Wyden held his third congressional hearing to investigate the status of medical research on RU 486. In his opening statement, Wyden criticized the federal government for allegedly blocking testing for RU 486 and especially expressed his outrage that RU 486 was not being testing for breast cancer in this country.

The opening witness, actress Cybil Shepherd, attracted unusually large media attention. Like all but one of the other witnesses, she urged testing of RU 486 for non-abortion uses. "Shepherd said the drug can help cure brain tumors, endometriosis and depression, as well as breast, ovarian and prostate cancer," reported the July 29 San Francisco Chronicle.

Representing the National Right to Life Committee, I testified that "no one, including pro-lifers, opposes research on the non-abortion-related uses of RU 486." I also rebutted the previous witnesses’ claims by stating that "There is no scientific evidence showing that RU 486 has any proven use except abortion."

Wyden followed up the hearing with an August 10 letter to the key agency for cancer research, the U.S. National Cancer Institute (NCI), to express his distress that the agency had turned down an opportunity to test RU 486 for breast cancer. Wyden was disturbed by NCI’s "failure to pursue much-needed research on an important new drug for a disease that claims tens of thousands of American lives each year." The Congressman noted that the research project had gone to Canadian researchers instead, (discussed in detail below).

The agency’s reply to Wyden was highly instructive. In a 6½-page, single-spaced letter, Dr. Bruce Chabner, director of NCI’s Division of Cancer Treatment, reassured Wyden that scientific—not political—considerations had governed NCI’s decision not to pursue RU 486 research. In support of this contention, Chabner made the following points, which in large measure are just as valid now as they were five years ago:

• "Clinical trials of RU-486 in human breast cancer are very limited."

• "At this point, there is little preclinical or clinical data to suggest that RU-486 will offer any advantage over other currently available hormone therapies."

• "RU-486 is not novel, has not demonstrated a potential for cure, and at this time offers, at best, the possibility of only modest, transient benefit to a fraction of the women with advanced breast cancer."

• "In short, RU-486 did not, and does not now, appear to have the potential to improve significantly on available hormone therapy for breast cancer. This decision was based solely on the scientific judgment of NCI staff."

Unfortunately, amid the hubbub of the presidential campaign, the media did not pick up on this authoritative and direct refutation of claims that RU 486 could cure breast cancer.

Since 1992

Only one major report on the beneficial uses of RU 486 has appeared since Clinton took office. Obviously planned months in advance, the Institute of Medicine (IOM) of the National Academy of Sciences convened a by-invitation-only conference in April 1993, to discuss the clinical applications of RU 486. The attendees were a virtual "who’s who" of abortion advocacy organization’s representatives, and naturally the book published later in the year, titled Clinical Applications of Mifepristone (RU 486) and Other Antiprogestins, reflected their point of view which recycled previous claims based on fragmentary and inconclusive research. Even Leslie Z. Benet, Ph.D., the chairman of the IOM committee that wrote the book, admitted in the September 9, 1993 Philadelphia Inquirer that "in breast cancer and other areas, ‘the research is very spotty.’"

During the five-year period since President Clinton’s election, the abortion advocates’ strategy has been markedly different from the three-year period just preceding it. Once they took over key federal posts in 1993, they changed from an "outside" to an "inside" political strategy—from promoting the "potential" non-abortion uses of RU 486 to praising the safety, effectiveness and ease of RU 486/PG abortion—and from creating a steady stream of media events to publicizing just major developments.

Unfortunately, although the rhetoric about "other uses" toned down considerably after January 1993, the damage had been done. Through constant uncritical repetition by the media, very preliminary research findings on cells in test tubes became exaggerated into firm projections that RU 486 was a miracle drug. Those claims became the conventional wisdom, which is still currently used by the media and RU 486 proponents.

For example, a fact sheet dated June 1997 on the Internet website of the Population Council, which controls the patent and is seeking licensing, made the following assertion that summarizes many of the claims that have been made:

"Mifepristone [RU 486] is believed to have the potential for use in treating a wide range of conditions related to pregnancy (induction of labor and cervical ripening), gynecological disorders (infertility, endometriosis and uterine fibroids), and other medical problems (Cushing’s disease [probably means Cushing’s syndrome], meningioma [non-malignant brain tumor], and breast cancer."

Current Status of Non-Abortion Uses of RU 486

In contrast with the sweeping claims by the Population Council, the following section describes the status of each non-abortion use in alphabetical order using sources either favorable to or neutral on using RU 486 for abortion..

In general , the "potential" uses of a decade ago still remain largely unsubstantiated, unproven, or completely false. The information compiled below reveals that RU 486 is currently only licensed in the world for two uses: (1) abortion in France, the United Kingdom, Sweden, and the People’s Republic of China, and (2) expulsion of a dead unborn baby (only in France).

This status report utilizes the six sources that are cited in brief with each item and listed in detail at the end of the article.

AIDS

"The use of RU 486 (or analogues) has been suggested in premenstrual syndrome, postmenopausal flushes, Alzheimer’s disease, and AIDS, but there is currently no firm scientific background to justify trials (emphasis added)." (Baulieu, 1993, p. 105)

Abnormal uterine bleeding

"No clinical experience in this venue has been published." (Morales et al. 1996, 458)

Breast Cancer

As described in detail above, from 1989 through 1992 RU 486 advocates heavily promoted RU 486 as a possible cure for breast cancer, and the media picked it up uncritically.

Yet, as recounted above, in 1992 the NCI stated quite clearly that RU 486 was not a cure for breast cancer. Ironically, that conviction was affirmed by the final report of the clinical trial in Canada that Congressman Wyden was so upset did not get conducted in the U.S.

In October 1996, a team of researchers headed by Daniele Perrault published an article "Phase II Study of the Progesterone Antagonist Mifepristone in Patients With Untreated Metastatic Breast Carcinoma: A National Cancer Institute of Canada Clinical Trials Group Study" in the Journal of Clinical Oncology (vol. 14, no. 10, pp. 2709-2712). Note that the study was under the auspices of the NCI of Canada.

This article recounted the results of the two previous clinical trials on 11 women in the Netherlands and 22 women in France. It noted that evaluation of the results was "made difficult" by the inclusion of women who had failed prior therapy. In the Canadian trial "of recurrent breast cancer patients, mifepristone produced only three partial responses in 28 patients." This 11% response rate was comparable to the previous two European studies where the response rates were 9% and 13.6%.

In conclusion, the authors stated quite categorically that "We do not feel that mifepristone should be pursued as a single-agent therapy for breast cancer" (p. 2711). They suggested testing RU 486 in conjunction with other drugs, but cautioned that "before embarking on such combination trials, more complete laboratory information should be obtained on the nature of the interaction and the optimal scheduling of the two agents."

Cushing’s Syndrome

After describing the results of three case reports and one research study on a total of 21 people, the authors state that "Exploration of mifepristone in the treatment of Cushing’s syndrome is in its infancy. The cases reviewed in this report comprise the entire medical literature." (Sartor and Cutler, 1996, p. 509)

Ectopic pregnancy

"There is only one study reporting on the use of RU 486 (200 mg day for 4 days) in women with laparoscopically confirmed ectopic pregnancy. . . .The role of antiprogestin in the medical therapy of ectopic pregnancy remains to be clearly defined. Certainly, the timing, dosing, and efficacy of RU 486 treatment in this scenario awaits future studies." (Morales et al 1996, p. 458)

Endometriosis

Although pilot studies indicate that RU 486 "may prove useful of endometriosis and uterine leimyomatas, larger trials are necessary to confirm its efficacy." (Ulmann et al. 1995, p. 257)

"The efficacy of RU 486 in endometriosis awaits a randomized clinical trial." (Morales et al. 1996, p. 455)

Glioma (malignant tumor of

the central nervous system)

"No studies of mifepristone have been reported in clinical trials with glioma patients." (Sartor and Figg, 1996, 503)

Intrauterine fetal death

Tests show that RU 486 alone is able to induce labor in women with intrauterine fetal death and the expulsion "takes place significantly earlier than in patients given a placebo." RU 486 is approved for that purpose in France. (Ulmann, et al. 1995, p. 253)

Labor induction

The authors cite the results of one study and state that "dose-finding studies are currently in progress to determine the minimal dose." (Ulmann et al. 1995, p. 256)

"Much more work into efficacy, secondary benefits, and safety as well as cost comparisons of various regimens using mifepristone would be beneficial and are necessary before any clinical use should be considered at this time." (Edwards, 1996, p. 472)

Meningioma (rare non-malignant, benign brain tumor)

"At this time, there are no reports of controlled trials of mifepristone in the treatment of patients with meningiomas." (Sartor and Figg, 1996, p.503)

Premenstrual syndrome (PMS)

"There have been two clinical studies of RU 486 treatment of PMS. . . .Studies to date suggest that RU 486 in large doses or administered only during the luteal phase is not a valid therapeutic intervention for women with PMS." (Morales et al, 1996, 457-458)

Prostate cancer

"No studies of mifepristone have been reported in patients with prostate cancer."

(Sartor and Figg, 1996, p. 504)

Uterine leiomyomatas (benign pelvic tumors, also known as fibroids)

Although pilot studies indicated that RU 486 "may prove useful for treatment of endometriosis and uterine leimyomatas, larger trials are necessary to confirm its efficacy." (Ulmann et al. 1995, p. 257)

"The mechanism of action of RU 486 in reduction of leiomyomata growth remains to be fully elucidated." (Morales et al. 1996, p. 457)

Conclusion

From 1989 through 1992, Pro-Family and Pro-Life advocates pointed out that the RU 486 advocates’ claims about these non-abortion uses were either widely exaggerated or just plain wrong and that research was not being held up, but the media generally ignored us.

Unfortunately, during the past five years,. these unsubstantiated claims have gained the status of "common knowledge" or "accepted wisdom," and they continue to surface. They need to be refuted, and the current lull in the news about RU 486 offers an excellent opportunity.

The public needs to know that despite over a decade and a half of research, the primary (and almost exclusive) use for RU 486 is abortion. RU 486 is not a "miracle" drug and is years away from marketing in the U.S. for any purpose except abortion. For example, it is not a cure for breast cancer.

Also Pro-Life and Pro-Family organizations and the Bush Administration have had a "bum rap" about blocking research. From the beginning, the organizations categorically denied opposing testing of RU 486 for non-abortion purposes and pointed out that RU 486 research was not being pushed because the drug’s owner realized that the results would not be worth investing the time or money.

And finally, the public needs to know that the abortion advocates cynically distorted the scientific facts about the non-abortion purposes of RU 486 to gain support for their campaign to import the drug for abortion.

Sources on Status of Non-Abortion Research

• "Baulieu, 1993" -- Étienne-Émile Baulieu, M.D., Ph.D., "1993: RU 486—A Decade on Today and Tomorrow," Clinical Applications of Mifepristone (RU 486) and Other Antiprogestins (Washington, D.C.: Institute of Medicine, National Academy of Sciences, 1993, pp. 71-119).

• "Edwards, 1996" -- Michael S. Edwards, M.D., "Mifepristone: Cervical Ripening and Induction of Labor," Clinical Obstetrics and Gynecology, volume 39, no. 2, pp. 469-473.

• "Morales, et al. 1996" -- Arlene J. Morales, et al, "Mifepristone: Clinical Application in General Gynecology," Clinical Obstetrics and Gynecology, volume 39, no. 2, pp. 451-460. They note that "Clinical trials of non-abortion uses of RU 486 have been few, but there are data to suggest multiple clinical gynecologic applications" (emphasis added).

• "Sartor and Cutler, 1996" -- Oliver Sartor, MD and Gordon B. Cutler, Jr. MD, "Mifepristone: Treatment of Cushing’s Syndrome", Clinical Obstetrics and Gynecology, volume 39, no. 2, pp. 506-510.

• "Sartor and Figg, 1996" -- Oliver Sartor, M.D. and William D. Figg, Pharm.D., "Mifepristone: Antineoplastic Studies," Clinical Obstetrics and Gynecology, volume 39, no. 2, pp. 498-505.

• "Ulmann et al. 1995" -- André Ulmann, Rémi Peyron, and Louise Silvestre (senior-level employees of the French manufacturer and distributor of RU 486, Roussel Uclaf), "Clinical Uses of Mifepristone (MFP)" in Steroid Receptors and Antihormones, volume 761 (Annals of the New York Academy of Sciences, June 12, 1995, pp. 249-260).