Document Reveals Plans for Abortion Pill

Today, America, Tomorrow, the World
By Randall K. O'Bannon, Ph.D., NRL Director of Education and Research

A document recently obtained by NRLC details plans by the national and international promoters of the abortifacient RU 486 to use American approval of the drug as a stepping stone to use worldwide of this two-drug1 abortion technique.

The document, entitled "Towards Safe and Effective Use of Medical Abortion," is the report of an international gathering of population and abortion activists, researchers, and sponsors that met January 10-13, 1998, in Bermuda to discuss the status and future of chemical abortions, most notably RU 486, which is also known by its trade name "mifepristone."

Predictably, there were numerous presentations maintaining that RU 486 is safe; that it ought to be readily available to adolescents in developing nations; that there should be fewer steps (i.e., safeguards); and casual assurances that if women do have complications in nations with sparse medical facilities they can just go to another "neighboring community" for attention.

Intriguingly, however, there were implicit and explicit concessions that the precise extent of the pill's side effects was still unknown and staunch resistance from the company created to handle European production and distribution to suggestions that it might be acceptable to employ a double standard of medical care for women in developing nations.

The underpublicized gathering was sponsored by the Population Council, RU 486's U.S. patent holder, and the Wellcome Trust, a British charity supporting medical research (including population studies). The conference brought together 47 delegates from 13 countries, doctors, public health officials, pharmaceutical industry representatives, and public policy advocates, along with representatives from International Planned Parenthood and the World Health Organization, the United Nations agency which seeks to set and carry out international health policy. Representatives from wealthy American foundations such as the David & Lucille Packard Foundation and the Buffet Foundation, known for their support of international population control, were also in attendance.

On the Agenda: Mifepristone for Minors

Participants in the Bermuda conference announced an intention to promote use of the abortion pill among minors and expressed resistance to any barriers that might prevent adolescent usage. One presenter, Malcolm Potts, a researcher from the University of California School of Public Health and long one of the most prominent proponents of abortion on the international scene, was reported as saying, "women who need abortion, including adolescents, should be entitled to safe, early, and private methods and the new medical technologies, particularly mifepristone-misoprostol, are ideal when assessed against these criteria" (emphasis added). [Misoprostol is a prostaglandin sometimes used in conjunction with RU 486.]

Suzanne Poppema, a Seattle-area abortionist who participated in U.S. trials of RU 486, observed that in developing countries, most pregnancies are to teenagers and said a cutoff age (the minimum age at which a girl/woman might use RU 486) of 18 might affect these teens' use of chemical abortion methods. The report does not make clear whether Poppema was referring to parental involvement laws or the possibility that the U.S. Food and Drug Administration (FDA) might propose limiting use of RU 486 to women 18 or older.

Evidence of Uncertainty Regarding Side Effects

Despite the repeated assertion by Potts and several other presenters that RU 486 is safe, there was actually evidence presented that some participants were concerned about some of the pill's side effects. For example, delegates urged the creation of a centralized registry for the reporting of "adverse events" (the promoter's name for side effects ranging from fatal heart attacks to extensive blood loss to severe cramping) to establish a database of the drug's side effects and teratogenicity (the drug's tendency to provoke congenital malformations).

The representative from the World Health Organization reported three cases of anaphylactic shock, a hypersensitive reaction to the drug which can involve acute respiratory distress, swelling, and other symptoms which may range from mild to fatal. This was a side effect which has not previously been associated with RU 486. In addition, Poppema cited the case of lawsuit brought in the United Kingdom on behalf of a baby born with a congenital malformation. Concern was raised that failure to report or investigate such complications could result in the drug being blocked.

Efforts to Relax Safety Standards

Several delegates complained that the complex "protocol" (the prescribed procedure for the safe administration of the drugs) associated with RU 486 might inhibit the drug's introduction into developing countries. Currently, that protocol involved, at a minimum, a woman making three visits to the abortionist over a two-week period. In her first visit, after an ultrasound to eliminate the possibility of ectopic pregnancy and a medical exam to determine that she does not have any medical conditions that might precipitate a fatal reaction, she is given and ingests the RU 486 pills.

The RU 486 molecule blocks the activity of the natural hormone progesterone which, in pregnancy, is one of the hormones responsible for maintaining the protective and nourishing environment for the developing baby. Deprived of this essential hormone, the baby's "life support" system is shut down, and the baby starves or suffocates.

Two days later, at her second visit, the mother receives a prostaglandin which initiates powerful uterine contractions to expel the by-then emaciated baby. This visit is usually scheduled to last about four hours and involves a great deal of pain and bleeding. Between 50% and 70% of women typically abort during this visit while the remainder who do abort do so elsewhere - - at home, at work, on the bus, etc. A third visit, two weeks after the first, confirms whether the abortion is complete.

In U.S. trials the "failure" rate was between 8% to 23%: 8% for those women less than 49 days pregnant [seven weeks] and 17%-23% for women 50-63 days pregnant [8-9 weeks]. The process was considered a "failure" anytime follow-up surgery was required.

Such surgical back-up is required not merely for those women who "failed" to abort yet who still want abortions, but also for those women who may hemorrhage or retain other tissue after aborting their babies.

All these additional steps, equipment, and capacities cost not just time but money. Few developing nations have the money, equipment, or personnel to put these safeguards in place. This explains why several delegates raised the question whether there were some "unnecessary barriers" that might be removed.

Roy Karnovsky is the new president of Advances/The Neogen Group, the company formed by the Population Council to handle marketing and distribution of the drug in the United States. Karnovsky was one of the presenters raising the issue of whether the controls might be too strict.

The Bermuda report paraphrases Karnovsky raising the following question: "One key question to come to terms with is: does unmet need for abortion and the morbidity and mortality from unsafe abortion in developing countries merit relaxation of the stringent requirements for quality in place in developed countries?"

Certain presenters said they did not always utilize ultrasound when they used RU 486 and questioned whether ultrasound was even necessary. Others attempted to argue that immediate surgical back-up was also not essential, saying, according to the report, that women could travel to "neighboring communities" if that became necessary.

Another safeguard that came under attack was how far along in pregnancy a woman could be and still use RU 486. Some questioned the limitation that women be no more than seven weeks pregnant - - proposed by the FDA. Still others claimed they had been successful allowing women to take the pills (at least the prostaglandin) on their own at home.

A Different View from the Pill's European Producer

But the French firm now responsible for the pill, which would be one of those bearing the legal consequences if women were injured or died, was much less ready to cut safety corners. European distribution is now managed by Exelgyn, a new company founded by Edouard Sakiz, a former head of Roussel Uclaf, the original developer of RU 486. Remaining rights to RU 486 were supposed to have been transferred to Sakiz and Exelgyn once Roussel Uclaf decided to distance itself from the controversial drug in 1997. Exelgyn is now said to be in the process of contracting new manufacturers who will take over production of the pill once Roussel-supplied stocks run out (expected to be in early 1999).

Regina Sitruk-Ware, head of medicine and research and development for Exelgyn, warned conferees that Exelgyn would not support reduced standards. "It is in the interest of Exelgyn to have this product used safely," Ware is paraphrased as saying. " There must be back up facilities and there must not be a double standard for developed and developing countries."

Ware said that among Exelgyn's conditions for introducing RU 486 into a country were strict distribution controls and the availability of medical and surgical care, presumably to handle serious complications that women may experience after taking the drug.

The Future of Chemical Abortion

The report has the Beverly Winikoff, program director for the Population Council, asserting that approximately 500,000 women worldwide have used the combination of RU 486 and a prostaglandin to abort their babies. This number is two and half times larger than the number mentioned in most recent press accounts.

Delegates see RU 486 as part of an increasingly abortion- saturated culture. Malcolm Potts predicted that because of a larger population of women reaching reproductive age and trends toward smaller family sizes, the coming decade will see "more abortions than any other in history." "Thus," the report paraphrases Potts, "abortion continues to be an inescapable aspect of women's daily lives."

Against that prediction is the fact that the number of abortions has been declining in the United States and RU 486 still does not have final FDA approval.

There were 1.6 million abortion in the United States in 1990, according to the Alan Guttmacher Institute. Now, that number is estimated to be less than 1.4 million a year. Still too many, by any counting, but a positive trend.

Meanwhile, things have also not gone smoothly for the abortion pill's U.S. promoters. Internal legal squabbles have set back financing for the project. A would-be manufacturer from Hungary pulled out of a deal.

And despite their scientific pretense and grand rhetorical " concern" for the lives and health of the world's women, nothing changes the fact that RU486's promoters are peddling an abortion pill,2 and no respectable pharmaceutical company wants anything to do with it.

When the truth gets out, experience proves that this does make a difference. Effective educational and legislative campaigns are helping Americans to understand that RU 486 abortions, just like surgical abortions, stop beating hearts. Each day, women at thousands of crisis pregnancy centers across the country are learning that there are life-giving alternatives to abortion. And amidst crisis pregnancies, more American women today are choosing life for their unborn babies.

Despite all the plans and talk of the abortion promoters, slowly, but surely, the culture of life is gaining ground on the culture of death.