French ‘Abortion Pill’ Stirs Behind-the-Scenes Battle

WASHINGTON â€”  The availability of safe, early abortions for pregnant American women may depend less on the Supreme Court, the Bush Administration or the relative political muscle of activists on either side of the issue than on the future of a tiny French pill.

While the morality and legality of abortion has provoked an intense public debate, the struggle over whether the so-called French “abortion pill� will be sold here has been a quiet, behind-the-scenes battle. Officials of U.S. drug firms and the federal regulatory agencies prefer not to comment publicly on the issue.

But in the long run, the outcome of this fight may prove more significant than any other aspect of the abortion issue.

Medical experts and women’s rights activists are confident that the abortion pill cannot be bottled up in France once it has been used safely there by tens of thousands of women. Within 10 years, they predict, American women who want to end an early pregnancy will be able to do so in the privacy of their own homes, thanks to the French pill or a similar offshoot drug.

They are equally certain that the availability of a safe abortion pill will do much to quell the volatile debate over abortion. For abortion rights advocates, fearful that the Supreme Court soon may limit the right to end pregnancy, the development of the French pill has been the silver lining in a darkening cloud.

“This will totally change the politics of abortion,� said Sharon Camp, vice president of the Population Crisis Committee, a Washington-based group that promotes population control in underdeveloped nations. “This pill blurs the distinction between contraception and abortion. Most Americans, even if they are concerned about the surgical abortion of a fetus that looks like a miniature baby, are not so troubled by the idea of a woman taking a pill at home when the embryo is the size of a pea.�

The developer of the French pill, Dr. E. E. Baulieu, says that release later this year of research results on the first 10,000 women to use it in France will spark support for bringing it to the United States. The pill will be available here “sooner than most people expect,� he said in an interview in New York. “I am fully confident in the power of medicine when it is good.�

But as confident as backers of the abortion pill sound when discussing its eventual arrival in the United States, they are far less certain of how it will happen or when. Anti-abortion activists have pledged to fight any move to make the pill available here, regardless of whether it is shown to be entirely safe.

Dornan Assails Drug

Using the pill to abort a tiny embryo involves “attacking innocent human life,� just like a surgical abortion, says Richard D. Glasow, education director of the National Right to Life Committee. Rep. Robert K. Dornan (R-Garden Grove), another staunch anti-abortionist, calls the drug the “French death pill.�

Leaders of the anti-abortion movement say that they will organize a consumer boycott of all the products of any U.S. drug firm that tries to distribute the pill.

To researchers in the field of reproduction and contraception, however, the French pill is seen as the biggest advance since the development of the birth control pill in the 1950s. Chemists had learned then that the hormone progesterone prepared the uterus to receive and hold a fertilized egg.

In 1980, Baulieu and chemists at the Parisian firm of Roussel-Uclaf discovered a compound that would block the action of progesterone, thus prompting the uterus to shed the egg in a menstrual cycle. They nicknamed their new compound RU-486.

Early Tests Show Success

In its early tests, RU-486 induced abortions in 85% of women who took the pill during the first seven weeks of pregnancy. Then, the fetus is less than half an inch in length, about the size of a fingernail. After seven weeks, however, the pill is generally ineffective and not recommended.

Doctors later discovered that when taken in combination with a drug that causes contractions of the uterus, RU-486 is 95% effective. For the remaining 5%, surgery is the only method of abortion that will work.

Last September, Roussel-Uclaf received government permission to begin marketing the pill widely in France. But on Oct. 26 its top executives issued a stunning announcement: in a change of heart, they had decided to suspend distribution of the pill.

Edouard Sakiz, the chairman of Roussel-Uclaf, blamed the move on the “emotional climate� created by vehement anti-abortion activists, especially those from the United States. Others said that the decision reflected a reluctance by Roussel’s parent firm, the West German chemical company Hoechst A. G., to market an abortion drug.

Stunned by Attacks

Officials of Hoechst were said to have been stunned by attacks that linked RU-486 to the actions of its ancestor firm, I. G. Farben, which had manufactured cyanide gas for the Nazi death camps.

Three months earlier, National Right to Life Committee Executive Director David O’Steen had issued a warning to Roussel and Hoechst that it would lead a worldwide boycott of all the products made by both companies if Roussel “attempts to manufacture or market RU-486.� In a statement, O’Steen referred to the pill as a “death drug� and said: “Our basic proposition is that such a lethal drug has no place in America or anywhere else.�

But French Health Minister Claude Evin refused to let Roussel bow to pressure from the anti-abortion activists. The government owns more than a third of Roussel’s stock and has the authority to give its patent to another company.

Orders Distribution

Calling RU-486 the “moral property of women,� the health minister ordered Roussel to distribute the pill to hospitals and qualified physicians throughout France. About 2,000 women a month are now using the abortion pill in France, Baulieu said.

There, however, the story stops. Roussel-Uclaf has not moved to sell the drug outside France. And its U.S. subsidiary, Hoechst-Roussel Pharmaceuticals Inc. of Somerville, N. J., has declined to seek government approval to market it here.

Victor Bauer, president of the U.S. firm, said in a Jan. 12 letter to the Planned Parenthood Federation that “extremist pressures� had nothing to do with the decision against marketing RU-486. Rather, the pill “lies outside the experience and medical expertise of this company. HRPI does no research in the birth control area,� Bauer said, and instead will concentrate its efforts on drugs to treat Alzheimer’s disease and cancer.

Some Blame Threats

No other U.S. firm has stepped forward. Some advocates of the new pill say that companies are intimidated by threats of a consumer boycott. Others say that the biggest hurdle facing the abortion pill is not political or medical but the risk of huge liability judgments in American courts.

Few industries have been harder hit by multimillion-dollar court awards, stock analysts say, than those involving contraception and reproduction. The A. H. Robins Co. of Richmond, Va., was driven into bankruptcy by lawsuits over its Dalkon Shield, an IUD which was found to cause pelvic infections in women.

But even products that are considered safe have been hit with big court judgments. In 1985, for example, a federal judge awarded a Georgia woman $4.7 million in damages against the Ortho Pharmaceutical Corp. after she claimed that her child’s birth defects were caused by her use of a spermicide made by Ortho. Medical studies published before then, and since, have found no link between spermicides and birth defects.

Carl Habermaf, a Wall Street analyst who tracks the pharmaceutical industry, said that he does not expect any major drug firm to distribute the abortion pill.

“I can’t see that the profit would be worth the controversy and the loss of good will,� Habermaf said. “It’s not worth it, especially for a company that has a large consumer franchise.�

But if no U.S. drug firm shows an interest in RU-486, it could still be marketed here, its advocates say. A small group of venture capitalists may see a chance for big profits, or a nonprofit organization, akin to Planned Parenthood, could distribute the pill. If Roussel refuses to sell RU-486 overseas, U.S. researchers believe a similar abortion-inducing pill will be developed here.

“Given the current state of product liability in this country, I don’t think any large firm would want to take on RU-486,� said Camp of the Population Crisis Committee. “We need somebody without deep pockets.�

If those routes are blocked, too, RU-486 likely will be sold illegally here, said Camp and other backers of the new pill. If tons of cocaine can be shipped across the nation’s borders despite the best efforts of thousands of federal and local law enforcement agents, they ask, how can a small pill like RU-486 be kept out?

Meanwhile, anti-abortion activists are trying to raise doubts about the safety of RU-486. Glasow of the National Right to Life Committee calls RU-486 “very dangerous� because its ultimate effects are unknown. He points out that products such as the fertility drug DES and the IUD appeared safe at first. Their potential hazards became apparent only later.

“There is no information about the long-term side effects of this pill,� he said. A young woman who takes the abortion pill may not be able to have children later in her life, he suggested in an interview.

Drug Called Safe

In the United States, the only testing of RU-486 is being done by USC researchers at Los Angeles County-USC Medical Center. Dr. David Grimes, a co-director of the study, dismisses the warnings of the anti-abortion activists as “complete fiction . . . and a bunch of smoke. The drug is very safe and effective.�

The USC researchers have administered the pill to 300 women in the last four years, he said. RU-486 is given in a single 600-milligram dose and requires monitoring and a follow-up examination by the doctors. The only serious complication reported so far is that some women bleed heavily, Grimes said.

The U.S. Food and Drug Administration, which must approve new drugs, has had little to say so far about the abortion pill, largely because no one has applied to sell RU-486 or a similar abortion-inducing drug.

One FDA official involved in drug approvals, who asked not to be identified by name, said that the fate of RU-486 will depend on testing data. “As long as abortion is legal in this country and the test data look good, then it seems to me we would be obliged to approve it,� he said.

But FDA Commissioner Frank E. Young sounded much more cautious in a recent interview. Young said that he does not expect RU-486 to be available in the United States “in the immediate or near future.� Even if a firm applied now to distribute the pill, it would be “two to four to five years� before the agency could decide whether to approve its sale, Young said.

Cites Deaths of Thousands

Nevertheless, supporters of the right to abortion, both in the United States and the Third World, remain undeterred. Sheldon Segal of the Rockefeller Foundation points out that thousands of women die each year in Third World countries because of botched surgical abortions.

That’s why the abortion pill “is shaping up as such a very important advance,� Segal said, noting that it could make abortion inexpensive, safe and private. “This is a development that is not possible to suppress.�

David G. Savage reported from Washington and Karen Tumulty from New York.