Although Canadian media have generally been silent on the issue of the RU-486 abortion “pill” for some time, a number of developments have taken place, and reports been issued (particularly in the U.S.), concerning the drug. These developments reflect the see-sawing nature of the debate over whether the drug is safe, effective and appropriate for widespread distribution and use.
Although the pill was indeed deemed “safe” and “effective” by the U.S. Food and Drug Administration in 1996, the San Francisco Examiner reported in January of this year that trials for RU-486 are continuing and no major U.S. pharmaceutical firm has agreed to produce it. The newspaper suggested one reason for this is economic. Each pill costs $20 to produce, and the market is small. Another reason is liability.
As long ago as 1991, however, feminists took opposing sides on whether RU-486 should be introduced in the U.S. That year, three feminist researchers – while declaring that they were not joining forces with pro-life groups – held a news conference at the Massachusetts Institute of Technology to denounce the drug as a dangerous and cumbersome medication that should not be used to replace surgical abortions.
“What has been missed in all the political debate is that this is not one drug, but two dangerous chemicals,” said Lynette Dumble, a medical scientist at Australia’s University of Melbourne. She joined Renate Klein, a lecturer in women’s studies at Deakin University in Victoria, Australia, and Janice Raymond, a medical ethicist at the University of Massachusetts, at the conference.
Prostaglandins were rejected as abortifacients in the 1970s and now they, together with RU-486, are being reintroduced to us as the abortion drug of the 90s. That’s ludicrous,” added Dimble.
At about the same time, on the other side, the Feminist Majority Foundation, with the backing of powerful medical associations, issued six reports touting the alleged effectiveness of RU-486 both as an abortion drug and a treatment for a host of ailments, including breast cancer and endometriosis.
Two years ago, the Philadelphia Inquirer newspaper sent a reporter to the Marie Stopes Fairfield Clinic in suburban London, England to examine RU-486 in action. Reporter Fawn Vrazo noted that as the hours ticked away at the clinic for two women who had taken the drug, “the downside of the RU-486 method became more apparent.”
“There was pain, considerable pain, something the two women described as worse than bad menstrual cramping and a bit closer to labour,” wrote Vrazo.
“A lot of women had the idea that using RU-486 was much simpler than it was,” observed Ann Furedi of Britain’s Birth Control Trust, a pro-abortion advisory group. They thought “it was a matter of taking a couple of tablets and that would bring on your period and that was the end of it.”
But in four to five per cent of cases, wrote Vrazo, RU-486 fails. One of the two women was still cramping and pregnant after eight hours of waiting, and faced a surgical abortion.
The other woman, for whom RU-486 was reported to have worked “perfectly,” didn’t give the drug high marks. “I’d give it a five or a six (on a scale of 10),” said the woman, who requested anonymity. “I think it would be very frightening for a young person who hasn’t had a baby. It is very painful.”
A spokesperson in France for Roussel-Uclaf, which developed the drug, noted that many women are avoiding the medication worldwide because “when they take a pill, they have the feeling they are truly responsible for the abortion … (There can be) more psychological pain.”
Reporter Vrazo said that of 800 women per month who underwent abortions at the Marie Stopes Clinic, only about a dozen opted for RU-486.
In April of this year, the Boston Globe carried a report that noted while RU-486 used to be hailed as a drug that would irrevocably alter one of the biggest debates of our time by making abortions “easier” and “less traumatic,” it has now slipped into limbo.
The Globe noted that German manufacturer Hoechst AG closed its manufacturing plant this spring amid protests from pro-life groups. No other company has stepped in to fill the gap, leaving just a year’s supply of the drug for Europe. Meanwhile, the U.S. Population Council’s four-year effort to bring the drug to this continent has become mired and the group will not say when the drug will become available.
Not a single drug company in the free world is taking up offers from the Abortion Rights Mobilization group, which supplies the drug to a network of 10 “clinics” that treat 1,800 women a year. Margaret Catley-Carlson, president of the Population Council, noted that further complications have been caused by the fact that the number of pharmaceutical companies making contraceptives has dropped from 13 to four. “This is not because of threats,” she emphasized. “When you look at the risks and benefits and profits associated with these products, you decide to go on to other product lines.”
Roussel Uclaf previously assigned the U.S. patent for the drug to the Population Council.
Further impeding the goals of those who want to see widespread distribution of RU-486 is the fact that most American women are uninformed about non-surgical abortion methods. A recent survey conducted by the misnamed Henry J. Kaiser Family Foundation found that 58 per cent of 1,000 American women between the ages of 18 and 44 were unaware of medications that could be taken to induce abortion. Just 40 per cent were reported to have heard of RU-486 and 10 per cent knew about methotrexate.
The Foundation claimed that in a second survey it conducted of more than 700 medical personnel, about half indicated they would be likely to prescribe mifepristone if it became available within the next year.
The survey results drew a predictable reaction from Felicia Stewart, director of reproductive health programs for the Foundation. “Increasing options for early abortions makes sense for two reasons,” she said. “One is that anything that encourages women to seek care early also protects their health because that’s the time when risks and complications are lowest. So improving those options for women could be an important contribution to public health.”
In April, the New England Journal of Medicine reported on a Population Council study that while RU-486 may not be quite as effective as earlier research suggested, it was still “a viable way to end a pregnancy.” The study claimed that the unborn child is expelled in 92 per cent of women who were pregnant for less than 50 days, versus earlier tests that showed rates of 96 to 99 per cent.
Irving Spitz and his research colleagues found that the longer a woman was pregnant, the greater the risk that the drug would fail. The “success” rate dropped to 83 per cent for women who were pregnant for 50 to 56 days, and 77 per cent for women who were pregnant 57 to 63 days.
Side effects – such as abdominal pain, nausea, vomiting and the need for hospitalization – were also greater among women pregnant for more than 50 days. It was reported that four women bled so severely, they needed blood transfusions and 65 women had complications severe enough to warrant hospitalization, surgical intervention or the reception of intravenous fluids.
The study was conducted at 17 sites on 2,121 women between 18 and 35 years old between September 1994 and September 1995.
Helen M. Alvare, director of planning and information for the U.S. Catholic bishops’ Secretariat for Pro-Life Activities, said after the study was published that news reports were incomplete and failed to examine the “appalling psychological ordeal” that the use of RU-486 causes. She noted that just 892 of the 2,121 women studied completed the whole abortion process. The claimed 92 per cent success rate referred only to those 892 women, she said.
“There was no discussion of the devastating psychological effect of sending people home after halfway-aborting a child,” she added. “It’s my worry that abortion will seem like no big deal.”
An April 1995 study conducted by Dr. Hazem El-Refaey found that RU-486 failed in five to 13 per cent of its subjects and that serious side effects occurred up to 70 per cent of the time. Such findings raise “serious questions about the safety of RU-486,” said El-Refaey.
The Population Council is reported to be working with the Danco Group, a private consortium of investors who aim to bring RU-486 to the U.S. “We are focusing on identifying manufacturers, tableters and distributors,” said Danco spokesperson Heather O’Neill. “We do expect to make the product available some time in 1999 … (But) We are keeping a low profile on purpose.”
The Population Council study makes it a “realistic possibility” that RU-486 will be available to the American public within a year, said Cory L. Richards, vice-president of public policy for the Alan Guttmacher Institute, the research arm of the Planned Parenthood organization.
A major blow to this goal took place in June, when the U.S. House of Representatives voted 223-202 to prohibit the FDA from testing, developing or approving drugs that result in abortion. The move was introduced by Oklahoma Republican Tom Coburn, who said federal approval and regulation of abortion drugs would mean killing babies and so violated the FDA’s mandate to approve only drugs that are safe and effective.
Coburn was predictably attacked by pro-abortion adherents, who said he was putting “ideology ahead of science” and interfering with a woman’s “legal right” to choose an early abortion.
Coburn’s attackers were rewarded in part recently when Republicans in Congress dropped their insistence for a ban on the use of federal dollars to develop or approve drugs that induce abortions. The Clinton White House and many Democrats were reported to be “pleased” with that development.
But the Republicans’ backing out drew a stinging rebuke from American Life League president Judie Brown, who said that the value of an innocent human being “is apparently of no interest to party leadership. The integrity of a person who is vulnerable and desperately needs legal protection is ignored by the party of Lincoln.”
While acknowledging the efforts of eight “heroic” senators who stood up for the unborn, Brown added that, “Enough is enough. May no one in the real pro-life movement ever again attempt to convince a voter that the entire Republican party is the party of life.”
The July-August issue of Archives of Family Medicine carried a report that almost all the women involved in the Population Council’s trials would recommend RU-486 to others and would choose it again for themselves.
But the July issue of Citizen magazine carried an account of an Iowa woman, whose name was given only as “Lori,” who in 1995 was brought to a Waterloo, Ia. hospital emergency room in shock, suffering from a massive loss of blood. It turned out that two weeks earlier, she had participated in an abortion drug trial.
Her physician, Dr. Mark Louviere, reported the episode to Planned Parenthood, which supervised that drug trial. Yet, some time later, Louviere read that the clinical trial in which Lori had participated had “no complications reported among 238 women who ended unwanted pregnancies without surgery.”
Louviere, who is pro-abortion, was astonished. “If near-death due to the loss of half of one’s blood volume, surgery and a transfusion of four units of blood, do not qualify as a complication, I don’t know what does,” he told a newspaper.
The president of Planned Parenthood Iowa responded that the term “no complications” referred to the trial itself and not the conditions of the participants. Planned Parenthood failed to return a newspaper’s calls after that.
Louviere eventually travelled to Washington, where he testified at government hearings on RU-486.
Citizen added that numerous other complications have been reported from RU-486. Doctors in Singapore said that one woman lost 20 per cent of her blood volume – or 761 millilitres – after undergoing a chemical abortion. And in a French study, 21 women were admitted to hospital to control bleeding, 15 required surgery and four needed blood transfusions.
Among the French victims was 31-year-old Nadine Walkowiak, a mother of five who in 1991 was given RU-486 and died two days later of a massive coronary thrombosis. Her death followed warnings more than three years earlier from the director of pharmacy and medicine in the French Health Ministry, who warned that there were “difficulties” with RU-486.
“It seems desirable to realize an exhaustive evaluation of the technical, judicial and ethical aspects of any definitive decision about the authorization to put on the market (RU-486),” said the director. However, the evaluation was never performed and RU-486 went into mainstream use in France.
Although most media reports harp about the alleged safety and effectiveness of RU-486, one observer pointed out that if RU-486 replaced surgical abortion, about 15,000 U.S. women would suffer hemorrhaging and require blood transfusions each year. “These are not ‘safe and effective’ numbers,” said Douglas Kmiec, a law professor at the University of Notre Dame.
‘A disaster waiting to happen’
Dr. Thomas Hilgers, president of the Paul VI Institute for the Study of Human Reproduction in Omaha, Neb., said RU-486 is “a disaster waiting to happen” if 500,000 women a year use it. “RU-486 is a potent progesterone antagonist. It affects every cell in a women’s body where progesterone is a factor – the reproductive system, the breasts and, to some extent, the bones. In the midst of a national breast cancer epidemic, we can’t afford to be ignoring these implications.”
“Nobody is asking what are the long-term results of using RU-486,” added former abortionist Bernard Nathanson. “Is there reproductive failure subsequently? Are the women who use RU-486 able to get pregnant again? What is the story with their female children? Are there transgenerational effects?”
Lawrence F. Roberge, a bio-ethicist and bio-medical researcher who has researched RU-486 for the American Life League, says a common side-effect of the drug is infections, usually in the genital or pelvic tract. “Whenever the RU-486 treatment led to an incomplete abortion (thus requiring a dilation and curettage for a followup), up to 29.4 per cent of the women reported an infection requiring antibiotic treatment.” He says these infections occur because RU-486 acts to suppress the immune system by causing a woman’s cortisol level to rise.
Laberge also quotes medical studies that report up to 79.1 per cent of women receiving RU-486 experience pain, and up to 80.5 per cent suffer severe uterine cramps, to the extent that many require opiate-based painkillers.
One pharmaceutical industry analyst suggested that the tenacity of pro-life forces is the main factor in the failure of RU-486 to make a widespread appearance in the U.S. “The question is whether the financial gain is worth the political headache,” observed Hemant Shah. “And for most pharmaceutical companies, the answer is no.”
At a July meeting in New York, 42 “experts” in women’s health and population issues concluded women in developing countries need “better access” to RU-486. In their report, co-authoured by Wendy Ewart of The Wellcome Trust medical charity and Beverly Winikoff of the Population Council, the “experts” concluded that RU-486 “has come of age for use in early medical abortion” and is ready for use in resource-poor environments.
Ewart and Winikoff added that “health advocates” must work hard to focus opinion on “the social injustice of unsafe abortion” in order to “hold governments and their legislative processes accountable.”
The June issue of the American Journal of Obstetrics and Gynecology, meanwhile, reported that though proponents have claimed mifepristone is a valid treatment option for endometriosis (menstrual pains, and cyst formations and adhesions in the uterus), the opposite is the case. In a study of seven women over a two-year period, no change in the state of the membrane lining the uterus was found.
Nonetheless, Abortion Rights Mobilization announced last month that RU-486 will soon be tested against endometrial cancer. ARM president Lawrence Lader claimed tests have already been conducted against brain tumours, with “promising results,” and that the drug will also be used to induce quicker labour, in order to reduce the number of Caesarian procedures.
Lader said ARM is pledging to administer RU-486 to 10,000 women at 15 hospitals and clinics across the U.S., including New York’s Columbia-Presbyterian and Montefiore hospitals.
Dr. Joel Brind, a professor of biology, chemistry and endocrinology at Baruch College, City University of New York, warns that other drugs similar to RU-486 are waiting in the wings. Onapristone (also known as ZK-299) has been tested as a treatment for breast cancer, but can induce abortions. The Dutch drug giant Organon, meanwhile, has a number of drugs in various stages of testing under “ORG” code names.