The French Correction

...There appears to be no published work at all on RU-486 and endometriosis, the uterine-lining overgrowth that makes menstruation painful for many women, although there apparently have been some small trials...

...In June 1989, the Food and Drug Administration, apparently taking those threats of a black market seriously, issued an "import alert" barring admission of the drug into this country for personal use, while allowing it for research purposes, including clinical trials...

...Sure enough, one of the witnesses produced a petition from 1,000 scientists begging the FDA to lift the ban...

...drug manufacturer willing to produce or apply for FDA approval of RU-486, despite a vigorous campaign...

...Finally, independent studies in France indicate that the lengthiness and complexity of an RU-486 procedure can exact an emotional toll on the woman, who has to see the 3/4-inch-long embryo so that she will know she has aborted...

...N ow, however, there is a new round of RU-486 hype, and it's taking the exact opposite tack of the campaign two years ago predicting a black market for the drug...

...Business Week's John Carey and the New Republic's Dorothy Wickenden declined to take at face value the extravagant non-abortion therapeutical claims proponents are making for RU-486...

...I support abortion," she told me...

...Although the Department of Health and Human Services bans federal funding of abortion research, the FDA does allow RU-486 into the country for privately funded research, both abortion and non-abortion related...

...Ron Wyden, the strongly pro-choice Oregon Democrat who leads the House Small Business Committee's subcommittee on regulation, called a hearing on November 19 to investigate the need for legislation to address this matter, subpoenaing countless FDA documents and summoning the personal presence of Ronald Chesemore, the agency's associate commissioner for regulatory affairs, and two associates...

...If she has not aborted, she gets a shot of prostaglandin and stays in the hospital another two days or so until an abortion occurs or she has to have a surgical procedure...

...V he liability issue is likely to be the 1 core of the next round of hype...

...Then he launched into a tirade against what seemed to be the real source of his annoyance, Roussel, whose representatives he has been unsuccessfully lobbying for cancer research funding...

...Roussel blamed the death on the prostaglandin and immediately switched to a different brand for its French protocol...

...subsidiaries of Roussel's German parentcompany, Hoechst, A.G., if RU-486 comes to this country as an abortifacient...

...The aim of the bill, Wyden's press secretary Wendy Horwitz informed me, is to "send a signal" to Roussel that American public opinion supports the drug...

...That fall, Dr...

...A study published in 1985 in the Journal of Clinical Endocrinology and Metabolism of a single patient with Cushing's syndrome—an endocrine disorder that afflicts mostly women and brings on osteoporosis, loss of memory and strength, and other indicia of premature old age—showed remarkable improvement after nine weeks on RU-486...

...A three-month study of twenty-two postmenopausal women with breast cancer published in 1986 in the Bulletin of Cancer, a French journal, showed improvement or stabilization in twelve of the women after six weeks, but by the end of the study eight of those had suf'No one mentions the black market nowadays except the hapless Mark Green, who declared in his Newsday interview: "If it stays on a blacklist in the U.S., it will inevitably lead to a black market here...

...This, in turn, "sends a signal" to Roussel that the right-to-lifers have more power than they actually have, and Roussel refuses to export the drug to America for any reason, including scientific ones not covered by the import alert...

...under import restrictions, proponents now say the drug is being kept from scientists eager to cure a host of diseases...

...Some reporters, however, have been more skeptical this time around...

...About 2,000 Frenchwomen a month had been procuring abortions via RU-486 since October 1988...

...She has a pregnancy test...

...But Public Citizen is lying low in the battle over RU-486, as is the Consumer Federation of America...

...I pointed out that in France—the only country where it is available to the general public—taking RU-486 required three to four visits to an abortion hospital and careful medical supervision in a sophisticated First World setting, that heavy bleeding was a near-certain side effect, and that the chief aim of RU-486's promoters was to get the drug onto the U.S...

...it's the drug's parent company that wants it kept out...

...We need good contraception," he said, noting some research indicating that RU-486can function as an ovulation inhibitor...

...Similar charges began to appear in the popular press...

...Needless to say, non-abortion related research on RU-486 in the US.—about ten ongoing projects—and abroad has been sparse and the published results inconclusive...

...Etienne-Emile Baulieu, the French physician who invented the pill in 1982, won the prestigious Lasker prize for developments in medicine...

...An op-ed piece signed by Wyden appeared in the New York Times on April 10, touting his bill and complaining once again that politics was getting in the way of "unfettered scientific research...

...But the drug's supporters seem to expect, even demand, sympathetic press coverage...

...Meredeth Thrshen, a Rutgers University psychology professor who heads the network's New Jersey division, voiced concerns about the drug's side effects at a panel discussion sponsored by the American Public Health Association...

...Indeed, Roussel started marketing the drug in France in October 1988 only under orders from the French government, which owns a 36 percent interest in the company...

...The media now routinely note that the drug, when used alone, is only 60 to 80 percent effective in producing a complete abortion, far less efficient than themost common form of surgical abortion, vacuum aspiration, which has a 98 percent success rate...

...The timing of the article was not good...

...So is the Women's Health Network, which a few years ago raised questions about the drug...

...Wyden was also unable to get full support from the medical community...

...And RU-486 lobbyist Marie Bass refused to speak to me, complaining about my 1989 story: "You made me look as though I didn't care about women's health...

...It was a quick, non-traumatic way for a woman to rid herself of pregnancy with the help of a glass of water...

...About the only old-style burbler still on the scene is Mark Green, commissioner of consumer affairs for New York Mayor David Dinkins, who is trying to spearhead a mayors' crusade to bring the pill to the nation's large cities, along with an "education" campaign to bombard Americans with favorable propaganda...

...Roussel, not right-to-lifers, holds the key to the stand-off, and some observers have suggested that the threatened boycott has nothing to do with Roussel's intransigence...

...Hoechst's chairman, Wolfgang Hilger, is a devout Roman Catholic, and there is evidence that Hoechst made the decision not to market RU-486 in the United States long before the threat of a boycott...

...When I spoke with Regelson, he complained vociferously about FDA bureaucracy and about the right-to-lifers, who, he said, "are against sex for fun...

...But a study of seven more patients published in the same journal the next year led to such equivocal results that researchers concluded the drug was not yet a "routine" treatment for Cushing's patients...

...government that RU-486 can be offered some protection from liability in any lawsuits that arise...

...In fact, the FDA does allow importation for research...

...The French government tightened its restrictions on who can take the pill...

...It was harmless...

...The RU-486 promoters have been among the supporters of federal product-liability reform bills, which would strictly limit a drug manufacturer's financial exposure in injury suits...

...When I asked Wyden's press secretary Horwitz whether the feminists' prediction of a black market didn't make it logical for the FDA to issue the import alert, her temper flared...

...That means wealthy women will have access, but the poor 16-year-old will not, or worse, may use it without adequate medical supervision...

...I f the FDA's alert does not apply to RU-486 imports for worthy research projects, what is the problem...

...20 THE AMERICAN SPECTATOR JULY 1991...

...Writing in the Journal of the American Medical Association last September, Dr...

...In January, Wyden introduced a bill that would specifically forbid the FDA from barring the import of RU-486...

...The proponents of RU-486 have constructed a Rube Goldberg chain of causation: The right-to-lifers persuade the Food and Drug Administration to slap an import alert onto the drug...

...After all, that dead woman in France would have an estate worth millions in the litigious United States...

...Prostaglandin has too many adverse side effects to be used alone, but it lessens the risk of hemorrhage that RU-486 seems to entail...

...The sameday, the Times reported on the first death from RU-486 in France...

...Embarrassingly, the American Medical Association, strongly pro-choice and on the record as favoring the legal availability of RU-486 for research, took the position that the FDA "acted responsibly in issuing import restrictions" for the drug...

...William Regelson, an oncologist on the faculty of the Virginia Medical College, accused right-to-lifers and the FDA of colluding to impede basic scientific research on life-threatening diseases...

...The purpose of the new hype is to force the FDA to drop its import alert...

...The problem is Roussel-Uclaf...

...The import alert applies only to personal use of the pill...

...The American Medical Association, strongly pro-choice and on the record as favoring the legal availability of RU-486 for research, took the position that the FDA "acted responsibly in issuing import restrictions...

...Its value is strictly abstract, like the "right" to an abortion, the most abstract of all rights anyone has ever read into the Constitution...

...Nonetheless, practically every time you opened a newspaper in 1989, you could read Molly Yard or Eleanor Smeal or a house editorialist direly predicting a widespread "black market" in RU-486 if the FDA did not approve the drug for general use immediately...

...As 1989 drew to a close, the pill crested in repute...

...Roussel has decided that American attitudes toward abortion are not acceptable...

...till, Wyden's marshaling of re-1,3 searchers and cancer patients to fight the pro-choicers' import lobbying battle has paid off with sympathetic newspaper reports and a coast-to-coast slew of editorials...

...But in California, then-Attorney General John D. van de Kamp offered the entire state to RU-486's manufacturer, Roussel-Uclaf, as an abortion-pill laboratory, with the drug to be available to all takers...

...For population control, you need contraception, not abortion...

...Now she says that a report of her remarks published in the AMA News misquoted her...

...The right-to-lifers may look numerous with all their churches, but there really aren't more than one or two of them, maybe five or six...

...Because RU-486 is a powerful steroid (it causes the uterine lining to dissolve, flushing out the embryo) with long-term effects that may include birth defects if the abortion fails, the campaign had all the earmarks of the first stage of a medical and litigational disaster on the order of those accompanying the first generation of birth-control pills and the Dalkon Shield...

...The aim of the RU-486 proponents is to persuade Roussel that this chaotic scene somehow means that the whole country is almost 100 percent pro-choice, ready to elect Molly Yard president, except for a microscopic percentage of "lonely hecklers," as Dinkins calls them...

...Today, promoters claim that, because Roussel monitors the drug so carefully, there's no black market in RU-486 whatever and not likely to be one in the future.' Similarly, proponents no longer tout RU-486 as a "miracle" abortifacient...

...Laboratory studies of human cells, rats, and mice indicate that RU-486 and others in its steroid family could be useful therapies for tumors and immunosuppressive diseases such as AIDS, but they have not been followed by published clinical studies...

...A week later—because France has a week-long waiting period for abortions —she goes back to the clinic to take the pill, then returns in forty-eight hours for another test...

...Rumored to have his eyes on the Nobel Prize as well, Baulieu pubCharlotte Allen is a contributing editor of Insight...

...It was painless...

...Their strategic approach to this drug is bizarre...

...As medical ethicist Arthur Caplan told Business Week, RU-486 "would be just another interesting substance" were it not for the abortion controversy...

...I can't understand their philosophy...

...In French clinics, the women reportedly meet in support groups while they wait the long hours for the prostaglandin to work...

...It would solve the Third World's population problems...

...An interest in product-liability reform would under normal circumstances leave the pill's supporters on a collision course with consumer groups, usually their natural allies...

...THE AMERICAN SPECTATOR JULY 1991 19 fered a relapse...

...Green did not return my calls...

...The media now also note that RU-486 is effective only during the brief window between when a woman suspects she is pregnant and the seventh week after her last menstrual period...

...You sound like you're on the other side," she declared...

...market fast, bypassing the Food and Drug Administration's decade-long approval process...

...Besides bleeding, common side-effects include pain, vomiting, diarrhea, and—in about 5 percent of the cases—an incomplete abortion or failure to expel the placenta, which also necessitates surgery...

...instead, they hail it as a "miracle" cure for a variety of afflictions having nothing to do with pregnancy: breast cancer, Cushing's syndrome, endometriosis, and AIDS...

...When the article appeared here and in reprint in the Wall Street Journal, I was roundly ridiculed in letters to the editor...

...AMA trustee P. John Seward testified, "We do not believe that there has been adequate research to establish that this drug is a safe and effective therapeutic modality...

...The New Hampshire legislature recently followed suit with a similar offer...

...For RU-486 has come to be viewed by almost everyone, supporters and critics alike, as largely symbolic, its value rooted in nothing having to do with concrete experience—not ease of administration, not women's health, not the well-being of Cushing's and cancer sufferers...

...In October 1989, I wrote an article for this magazine chronicling the wishful hype surrounding the French abortion pill, RU-486: It was a "morning-after" remedy...

...In a January interview with New York Newsday, Green characterized the heavy bleeding that RU-486 induces—about nine days' worth on average, with about one percent of recipients needing transfusions—as "just like menstruation...

...Even when used with the labor-inducing abortifacient prostaglandin, as Roussel-Uclaf's protocols require in France, the drug has a 5 percent failure rate...

...It should be noted at the outset that neither the FDA nor any other federal agency forbids research on RU-486...

...So if your sister dies of breast cancer, you know who's to blame...

...It could be taken in the privacy of ones home (no more demonstrators...

...lished an explanatory article simultaneously in Science and the Journal of the American Medical Association...

...Since December 1988, the French company has refused to allow the export of the drug for any purpose to any country that does not meet four rigid criteria: (1) availability of prostaglandin, (2) tight control of distribution, (3) the woman's signing a form binding herself to a surgical abortion if the RU-486 does not work, and, most crucially, (4) an atmosphere in which abortion is not only legal but "accepted by public opinion...

...There have been plenty of physicians and patients ready to play their roles in an elaborate pantomime of finger-pointing...

...Abortion is not where it's at...

...Dinkins's administration had earlier announced it was considering offering Roussel the use of New York's public hospitals for RU-486 clinical studies, but rejected the idea when it realized that the main users of those hospitals are poor blacks and Hispanics...

...Roussel-Uclaf's protocols require RU-486 to be administered at a hospital, where the woman is supposed to be carefully screened as a likely candidate: healthy, middle-class, and committed enough to her abortion plans not to change her mind...

...Wyden hectored the FDA officials as if they were on trial for their lives, all the while preaching that the FDA should consult scientists, not "politics...

...Scientists, physicians, and pro-choicers have been flying to France in droves to beg for the drug for more than two years, but Roussel has not budged...

...T rue, Smeal, Yard, and others were I unable to find a U.S...

...As Roussel president Edouard Sakiz himself says, a pill-induced abortion is "an appalling psychological ordeal...

...Part of the problem may be that the National Right to Life Committee has threatened to boycott the chemical and industrial products of two US...

...Although Wyden was the sole subcommittee member present, the hearing proceeded like all congressional hearings presided over by Democrats when a Republican administration is in power...

...Encomia to the ease and privacy of taking RU-486 are rare these days...

...The other hypothesis is that Roussel is playing hardball, holding out for a specific assurance from the US...

...Since then, my 1989 observations about the less pleasant aspects of RU-486 seem to have crept into the press vocabulary...

...The European press has reported at least two instances of heart failure, and in April a Frenchwoman died, apparently in response to the prostaglandin...

...Mark Green, who voiced his support for liability limits in the Newsday interview, worked five years for Ralph Nader, whose Public Citizen consumer organization has categorically opposed any liability limits whatsoever...