AN UPDATE FROM LIFE ISSUES INSTITUTE

APRIL/MAY 1999

By Richard D. Glasow, Ph.D.

RU 486 Edges Closer to U.S. Market
Tests of “Chinese Clone” of RU 486 Continue

After months of silence about the status of plans to sell the dangerous RU 486/Cytotec prostaglandin (RU 486/PG) abortion technique, two recent press reports indicate that the company holding the patent rights expects to have it on the U.S. market “by the end of the year.” Of course, abortion advocates have made similar predictions before, and nothing happened. But this claim may be more credible because the firm has apparently started promoting sales among abortionists.

One of the media accounts also provided a valuable update on the on-going test of a “Chinese clone” of RU 486/PG at 15 sites around the country sponsored by Abortion Rights Mobilization (ARM). Since ARM does not control the U.S. patent for RU 486, this experiment is unlikely to lead directly to an attempt to market the abortion method. But the test gives the clearest indication yet of how abortionists might change the method of administration if the RU 486/PG technique were to be marketed in this country.

RU 486 On U.S. Market in 1999?

RU 486/PG will be on the U.S. market “by the end of the year” predicted a spokesman for the company handling the manufacturing and distribution. In the March 23, 1999 Washington Post, Heather O'Neill of the Danco Group stated that the company has found a manufacturer and is working to get final approval from the U.S. Food and Drug Administration (FDA). Likewise, in an article in the January-February, 1999 issue of Mother Jones, Laura Fraser, a reporter who has followed the development of RU 486/PG for a number of years, stated that “Danco has, at long last, found manufacturers—which it would not identify—willing to do the job. `We expect to make [mifepristone] available to women in the U.S. sometime in 1999,' says Danco Group's O'Neill.” Eleanor Smeal of the Feminist Majority Foundation, one of the strongest advocates for RU 486/PG abortion, observed that “It appears that everything is finally in order,” reported the Post.

Danco Group (also known as NeoGen in some press accounts) is handling the commercial aspects of RU 486/PG under the auspices of the U.S. patent holder, the non-profit Population Council, a pro-abortion research and development organization based in New York City. The Population Council conducted the U.S. test of RU 486/PG on 2,121 women and has an application for a license pending before the FDA.

Danco's announcement received very little media attention, probably because of so many false starts during the past two-and-half years. In September, 1996, the FDA completed an extraordinarily short review process and declared RU 486/PG “safe and effective.” Final approval would depend on the agency's review of the manufacturing facilities and distribution arrangements. (See the October, 1996 The RU 486 Report). The technique seemed to be on a fast track, but was suddenly stopped cold in late October, 1996, by bitter disputes among the financial backers over control of the marketing.

Settlement of the lawsuits forced months of delay. Then in February, 1997, the prospective manufacturer, Gideon-Richter in Hungary, backed out of its contract. Another lawsuit ensued. (See the Jan.-Feb., 1998 The RU 486 Report). About a year ago, O'Neill told the media that Danco was “working with manufacturers toward production.” But final approval by the FDA has not occurred.

Now the project is apparently back on track. O'Neill “said her company is confident enough of its timetable that it has begun contacting doctors to discuss how best to prescribe and administer” RU 486/PG, reported the Washington Post. Interestingly, both the Post and Mother Jones stated that “manufacturers” (plural) had been found, which would indicate that more than one company would be making RU 486. (The second drug in the abortion process, the prostaglandin Cytotec, is already on the U.S. market as an anti-ulcer drug. It is legal for a physician to use an approved drug for a non-approved use.)

New Regimen in Tests of “Chinese Clone”

Meanwhile, “largely unnoticed by the public, some women are already using RU-486 in a special research program,” reported the Post. ARM received the FDA's approval in May, 1996 to test a “clone” from the People's Republic of China that ARM claims is a chemical equivalent to the French drug. In January, 1998, ARM's president, Lawrence Lader, announced that 1,600 women had been aborted. And the recent Post article indicated that more than 3,000 women had participated in the test during the last 18 months. Press accounts have stated that ARM's goal is to eventually abort 10,000 women.

According to the Internet web site of the Feminist Majority Foundation, the number of test sites has increased during the past year from 10 to 15 (see Table A). One site in Germantown, Maryland was dropped from the list, and the following six sites were added: Brooklyn, NY; Atlanta, GA; South Bend, IN; Baltimore, MD; Cherry Hill, NJ; and Cleveland, OH.

Two important non-profit organizations, the John Merck Family Foundation and the George Soros Foundation, provided funding for ARM's test, explained the Post. Previous media accounts have indicated that the abortionists associated with ARM were distributing the drug free because ARM does not have the patent rights to sell RU 486. But Dr. Paul D. Blumenthal, a gynecologist and abortionist at Johns Hopkins University in Baltimore, said in the Post article that “the cost is equal to that of a surgical abortion,” which would seem to indicate that the researchers are charging women.

The protocol of ARM's test indicates that women are still being used as guinea pigs to find the “optimum” way to administer RU 486/PG. (See Table B.) When RU 486 first burst on to the scene in the early 1980s, researchers aborted women using RU 486 alone. But dissatisfied that the effectiveness did not match surgical abortion, European researchers added a prostaglandin (either the injectable prostaglandin Sulprostone, or the prostaglandin Gemeprost administered vaginally) to increase the rate of abortion. The French government approved that regimen in September, 1988.

But after the Sulprostone killed a French women and caused heart attacks in several others, the French switched in 1991 to a different prostaglandin, Cytotec (misoprostol). The Population Council used data from France about the RU 486/Cytotec combination along with data from the U.S. test in 1994-1995 of the same regimen as the basis for its licensing application with the FDA. The Post article pointed out that when the FDA gave its tentative approval of RU 486/PG in 1996, “the agency addressed not only the safety and usefulness of the drug[s], but the whole process of administering the pills under a doctor's care.” The woman took RU 486 at the abortionist's office, returned two days later and took the Cytotec orally, waited four hours at the abortionist's office for the drugs to take effect, and returned two weeks later for a mandatory follow-up visit. “In clinical trials, this process required three trips,” noted the Post.

Other regimens were in use elsewhere. Licenses were granted for the RU 486/Gemeprost prostaglandin technique in the United Kingdom (1991) and Sweden (1992). And since the 1980s, the Special Programme of Research, Development and Research Training in Human Reproduction (HRP) of the World Health Organization (WHO) sponsored extensive testing of a wide variety of procedures with RU 486/PG. Those tests apparently formed the basis for ARM's changes in how RU 486 and PG are administered. ARM's medical director for the project, Dr. Eric Schaff of the University of Rochester, explained to the Post that the ARM's goal is to “increase the flexibility of the drug, make it more user-friendly and less expensive,” Moreover, “the potential is here to make abortions more private and accessible, and to allow nonsurgeons to provide it,” he said.

ARM's changes to the protocol proposed to the FDA by the Population Council are important. The University of Rochester web site states that the study is being done to determine:

! whether a 200 mg. dose of RU 486 is as “safe and effective” inducing abortion as a 600 mg. dose in women pregnant up to 9 weeks;

! whether the Cytotec is “safe and effective” when “self-administered vaginally at home;” and

! whether Cytotec used 1 and 3 days after RU 486 is “as effective as two days after.”

Under the Population Council's proposed protocol currently before the FDA, women will wait for four hours in the abortionist's office after taking the PG, which requires an area set aside with chairs, couches and extra bathrooms. But in ARM's protocol, if the woman takes the PG at either her home or office, then the abortionist does not need special facilities for that purpose. Moreover, the new regimen of taking the PG vaginally at home gives women more control and privacy, asserted Dr. Blumenthal in the Post. Another important issue not mentioned in these recent press accounts is that cutting the RU 486/PG procedure down to two visits may encourage more general practitioners to use it, which has always been one of the major long-term goals of the RU-486 advocates.

Be Prepared

If the past experience of how Danco and the Population Council handle media events is any guide, the public announcement that RU 486/PG has received the FDA's final approval and is on the market will come without any warning. Pro-Life and Pro-Family supporters need to be completely prepared to give the press their perspective about the dangers and effects of the abortion technique.

If the chemical abortion technique does go on the market, abortionists will probably follow the Population Council's protocol of administering the Cytotec orally at their offices—at least initially. But that may change quickly. ARM's test is being conducted with the FDA's approval and is evidently laying the groundwork for adoption of a new regimen for women to administer Cytotec vaginally at home. Now is the time for Pro-Family and Pro-Life advocates to evaluate this revised regimen, particularly in terms of the increased dangers to women. For example, this new arrangement may “benefit” the abortionist by simplifying his routine and cutting costs, but women using RU 486/PG will be even more isolated from medical care when the worst short-term side effects, such as excessive bleeding, occur.

Table A

ARM's sites for the test of “Chinese Clone” of RU 486/PG
(listed alphabetically by state)

San Francisco, CA Dr. Bernard Gore, Ob-Gyn Associates

Atlanta, GA Feminist Women's Health Center

South Bend, IN Women's Pavilion

Baltimore, MD Johns Hopkins University

Kalispell, MT Dr. James Armstrong

Bellevue, NE Dr. Lee Carhart, Abortion & Contraceptive Clinic

Cherry Hill, NJ South Jersey Women's Center

Brooklyn, NY (phone number: 917-837-3368 to leave a message, researcher not identified)

New York City, NY Dr. Carolyn Westoff, Columbia- Presbyterian Hospital

New York City, NY Montefiore Hospital

Rochester, NY Dr. Eric Schaff, University of Rochester

Westchester, NY Dobbs Ferry Clinic

Cleveland, OH Preterm

Burlington, VT Vermont Women's Health Center

Seattle, WA Dr. Suzanne Poppema, Aurora Medical Services

Note: Reproductive Health Services in Germantown, MD was dropped from a previous list of Jan. 1998.

Source: Internet web site of the Feminist Majority Foundation, “Mifepristone [RU 486] Trial Sites in the U.S.” : http:/www.feminist.org/rrights/mifeptrials.html

Table B

The Changing Nature of “RU 486" Abortion

* Note: U.S. tests included abortions through 9 weeks of pregnancy, but the current plan is for 5-7 weeks.