Among Those Wary Of Abortion Pill Is Maker's-Parent Firm

Germany's Hoechst Is Facing Pressure From Clinton To Sell RU-486 III U.S.

By BARRY Newman

Staff Reporter- WALL STREET journal 01-30-93

FRANKFURT - Hoechst AG has never kept close -tabs on every new pill that appears in the laboratories of Roussel Uclaf SA, the French drug company it controls. Not until 1988 did the German chemicals colossus learn how hard one of them would be to swallow.

"If we applied our own principles to that molecule, we would never have developed it," says Hoechst lobbyist Dieter Brauer.

"It was supposed to be for cancer," says Felicitas Feick, a Hoechst press officer. "The other thing was a side effect."

The molecule at issue is known as RU-486. The "side effect" is abortion. For reasons that seem to mix money, morals and Nazi-era corporate memories, chemically induced abortion is one industry niche these Germans want no part of. In the five years since its French subsidiary, with $2 billion in sales, introduced the world's first abortion pill, Hoechst has been a $30 billion company stuck with a product it doesn't want to sell.

Enter President Clinton

Under official pressure, it has agreed to distribute RU-486 in just three countries France, Britain and Sweden - though 75% of the world's population lives in lands where abortion in some form is legal. (China has gone ahead and copied the compound without permission.) But Hoechst hasn't felt obliged to put its production the shelves elsewhere- least of all in the U.S., where the abortion pill would be sure to make the most money, and also take the most heat.

Until Bill Clinton was elected president, Hoechst stood pat for strong reasons. Presidents Reagan and Bush had made their dislike of the pill plain enough. The U.S. didn't have to ban it; Hoechst never even applied for a license from the Food and Drug Administration. But two days after taking office, President Clinton hauled down the red flags, 14e told Health and human Services Secretary Donna Shalala to "promote the testing, licensing and manufacturing" of RU-486 in the U.S.

Now Hoechst is in a fix. America's abortion rights lobby says the Germans have no choice at all - they must release the pill - and small drug companies have come forward with proposals to distribute it. Yet America's antiabortion lobby tugs the opposite way - one of its leaders calls RU-486 an "anti-human pesticide" - and securities analysts, predicting ruinous publicity, counsel a strategy of "risk avoidance."

Weighing Options

"It's their product," says an analyst who follows the chemicals industry in London. "They can do with it as they damn well choose. Nobody can force you to make and sell a product if you don't want to."

Steve Jenning, a congressional staffer, doesn't see it that way. His boss, Oregon Democrat Ron Wyden, has been hounding Hoechst for years. "This country shouldn't be on its knees to these guys," says Mr. Jenning. "They ought to get out of their bunker and bring the drug over."

Hoechst is thinking it through, It can withhold the pill, sell it, license someone to sell it or sell the patent and be rid of it. Whatever the company does, it looks as if Americans won't see how the abortion pill works anywhere near as readily as three young women do on a blustery Scottish day at the Royal Infirmary of Edinburgh.

"It's bad luck," Laura is saying. "My first romance since my divorce. My first chance. I kind of felt it was the wrong basis for a new relationship." She is 29, a sales rep for a food company.

Ann, who is 27 and already the mother of a boy and girl, sits in the easy chair to Laura's right. She had been using an intrauterine device. "I never thought it was possible to get pregnant with an IUD," she says.

One White pill

The wind rattles the windows in the corner lounge of the quiet ward. A Koran and a Bible lie on the sill. On the television, a game show plays faintly. Looking up, Charlotte says, "I told my mum. She stood by me. I'm too young to have a child,' Charlotte is 17.

The three first came here two days ago, 11 less than nine weeks pregnant. A nurse unlocked the cupboard where dangerous drugs are kept and gave each a white pill. they went home and waited for RU-486 to o its job: blocking the action of the hormone progesterone that binds an embryo to the uterine wall. They felt queasy, had cramps and began to bleed. The feeling was worse than a menstrual period, hey say, but not much worse.

This morning they have returned for a dose of prostaglandin, a drug that makes he uterus contract and causes something akin to a spontaneous miscarriage. It will happen in about four hours.

"I feel a bit detached now," says Ann. 'All the anguish was last week, when I hadn't really decided what I wanted to do." She has heard nothing of Hoechst, or its -reluctance to send its French pill to the U.S. "They sound like a powerful lot, this company," she says. "Why are they so worried?" 

Roussel-Uclaf has been asking itself hat question for a long time. In 1987, after even years' work, it applied to license U-486 in France. At its annual meeting~ he next June, antiabortion protesters raised a fuss - and Hoechst woke tip. Its response was "extremely hostile," says tienne-Emile Baulieu, the scientist who first seized on the molecule as an abortion rug. Under fire from its owners in Frankfurt, Roussel withdrew its application.

Chairman's Position

Wolfgang Hilger, Hoechst's chairman, hen made his one and only personal pronouncement on the abortion pill.

"It is my conviction that Hoechst should not market RU-486,- lie wrote in a letter to the International Federation of Gynecology and Obstetrics. "Commercialization of a drug facilitating- and easing abortion is against Hoechst's corporate credo. "

But it wasn't against the French government's credo, and at the time the state owned 3617,, of Roussel. The health minister declared RU-486 "the moral property of women," and essentially ordered Roussel to market it. Roussel complied. And Hoechst set about making sure the French contretemps wasn't repeated elsewhere.

In Frankfurt, it hired a consulting firm to convene an elaborate "round table" of 20 German groups, from feminists to lawyers. By 1990,.the company had received a policy paper, welling withJ,

~concern for "the existential question of man's being," that; soon received the imprimatur of the Hoechst board.

The paper laid out Hoechst ~bound conditions Wolfgang Hilgerfor giving a country,its pill: a "definitive" law on abortion;~"strictly controlled distribution"; an invitation from a "representative" body; and, above everything, a public consensus "recognizable to Hoechst" that "pregnancy-termination is tolerated by society."

The conditions are "a mirror of what ,the company is," says Robert Geursen, Hoechst's head of health-care policy. "We aren't a monolithic bloc." Yet, for some particularly German reasons, the bloc is obviously weighted against abortion.

Bad Memories

During World War II, Hoechst was part of IG Farben. Like Hoechst, Farben owned a quasi - independent subsidiary. it was called Degesch, and it made Zyklon-B, the "anti-human pesticide" that murdered Jews in the gas chambers of Auschwitz. The echo must have an especially harsh r1ng for Hoechst's chairman, Dr. Hilger. A chemist who has been with the company for 35 years, he is a devout Roman Catholic. And as chairman of Hoechst, he has an absolute veto over company policy.

: "Hoechst wants to stop the compound Everywhere it can," says Dr. Baulieu, "and when I say Hoechst, I mean Hilger." the pill's developer and most persistent Proponent has reason to be miffed: He has never once met the chairman, who also doesn't give newspaper interviews on the subject. Neither does Roussel, at this Sensitive juncture, though one source at the subsidiary says, "I can assure you that Hoechst's whole board wants to do something with RU-486. Except the chairman. He's a funny man, Hilger. A man alone."

But Dr. Hilger relented when two countries - Sweden last year and Britain in 1990 - met Hoechst's demands. France's record may have made a difference. though one woman died in unusual circumstances, 120,000 others there have felt no untoward effects, and RU-486 did its job for 96% of them. The most telling French statistic is the rate of abortion. It hasn't changed. Having the pill in reach, it appears, doesn't affect a woman's decision to end a pregnancy. It does make going through with it a far cry from surgery under anesthesia.

'Quite Casual'

"You wake up and you're sore and You're empty," Ann says of her one surgical abortion. Now she's sipping tea from a plastic cup. "I know more about it today. I'm more in control.''

Two hours have passed at the Royal Infirmary. The young women have talked of marriage, gardening, restaurants.

"I don't feel I'm in hospital," says Laura, who also has had an abortion before. "It's quite casual."

Charlotte, the 17-year-old, stands and Says, "I'm getting some twinges." She goes out to ask the nurse for an aspirin.

 "I wonder when we'll be getting some twinges," says Laura.

Women having abortions in Austria, Holland and Canada don't usually look forward to lunch. Hoechst has deflected all shots at bringing RU486 into those places * the same goes for Germany itself, where a law melding the West's tight abortion restrictions and the old East's loose ones is locked up in the constitutional court. Until the rules are reconciled, Hoechst says, "we do not wish to intervene."

 The Third World does without the pill for another reason: Eleven years ago, Roussel gave rights for testing and possibly distribution in poor countries to the World Health Organization. But apart from passing samples to China, WHO did nothing. If it had acted to distribute the pill, the U.S. probably would have held back a big installment of WHO's budget.

President Clinton won't do that. Under the Republicans, the U.S. clearly flunked Hoechst's RU-486 test. Now the new president is restoring funds for fetal-tissue ,research, for counseling and population programs that touch on abortion. The abortion pill will soon be off the list of ,drugs people can't import for their own use. And Hoechst can expect some jawboning from HHS Secretary Shalala.

Short of an engraved  invitation, the administration has run out of enticements. "The government has gone about as far as it can," says Mr. Jenning of Rep. Wyden's office. "Doing anything more begins to get unseemly."

But Hoechst still isn't sure. 

Very Little Appeal

The birth-prevention business in the U.S. doesn't have a lot of allure. In 1970, 13 big companies did contraceptive research; today four do, just one of them American. Product-liability suits cost more to fight than the Profits justify. Add the prospect of boycotts and bombings, and the abortion  pill field is leveled.

G.D. Searle & Co. makes the prostaglandin pill taken with RU-486 to complete the abortion process. Searle sells it as an ulcer medicine. Only after the fact did it agree to the drug's British and French use in abortions, Just one other company, Schering AG in Berlin, is at work on a drug similar to RU-486, but for treatment of breast cancer. One British scientist suspects Schering will someday apply it to abortion - after Hoechst catches all the flak over marketing in the U.S.

That would be a pretty pass for Hoechst. This is the wrong time for it to turn pioneer. With pharmaceutical sales of $5.4 billion, it has slipped in recent years to seventh in the world, from second. Its U.S. numbers are worse: sales, $635 million, market share, 1%.

"They aren't introducing enough new products fast enough," an analyst says Hoechst has put its money on Mentane, an Alzheimer's disease drug whose earnings could eclipse those of any antipregnancy pill. "The last thing they want," says Martin Glen, who tracks Hoechst at Shearson Lehman Brothers, "is a product that raises their profile in a bad way."

Requisite FDA Testing

Not even a letter from the White House seems likely to tip the scales for Hoechst Just after the election, Mr. Clinton did send a letter to Dr. Baulieu. In it, he said he wanted RU-486 treated "like any other drug that requires testing" by the FDA Hoechst's health-policy chief, Mr. Geursen, calls that "spongy."

With the U.S. Supreme Court of several minds and antiabortion activists mobilizing, Hoechst says America's abortion debate "still bears the traits of an irreconcilable conflict." As its policy. says, no consensus, no pill. Daniel Stone, a Los Angeles doctor who advocates RU-486,figures the company likes it that way "Hoechst established its criteria." he says, "because they can't be fulfilled.

He and others mobilizing their own campaigns (one group is threatening to bring in the pill's Chinese version) think that it is time for Hoechst to sell its product or give it up. "The holding game has to end," says Halfdan Mahler, head of the International Planned Parenthood Federation. "if they are so embarrassed about owning this patent, why don't they get rid of it?"

Hoechst doesn't dismiss that idea. "We have plans in the drawer, of course," Mr. Geursen says. At least 20 U.S. companies are raising their hands to bid, but they are all too small to impress Mr. Geursen. If Hoechst gives RU-486 to anyone, he insists, the method of distribution must conform to Hoechst's own rules.

Abortion as Birth Control

The company's great fear is that in the U.S. RU486 would turn abortion into a form of birth control. France and Britain don't allow it, but in the U.S. the drug could be issued in a doctor's office and taken at home. It could become even more easily obtainable if it were cleared for use as a morning-after pill. "It could lead to safety problems and black markets," Mr. Geursen says.

He doesn't point out, as others do, that abortion would also pass beyond the focus of protests at hospitals and clinics, and out of the public eye. "You can't stop a woman from visiting a' doctor," says Hermant Shah, a securities analyst in New Jersey who follows Hoechst closely. "It becomes a private transaction. And that's the end of the abortion battle."

Hoechst doesn't want that to happen. If t does release the patent, or at least the marketing rights, it will narrowly restrict 'the places where abortions are performed," Mr. Geursen says. The Population Council, a research organization, has spoken with Roussel about' distributing RU486 in the U.S. The council "doesn't have the reservations we do," says Mr. Geursen, yet Hoechst has no qualms at all about discussing the abortion pill's American future-at length.

"The pragmatic way is for people from different sides to come together and talk about it," he says. "It's still a long process. It's not short-term. No way."

But in Edinburgh, it only takes four hours.

A nurse has asked the three women into a small adjoining room. They've stayed away 15 minutes, on beds behind green curtains., Charlotte is the first back in the lounge.

"My stomach feels better," she says. "I'll go to my mum's now and watch TV or something."

Laura comes in next and says, "So. We're unpregnant now. I don't feel emotional, like I did last time. I feel I've had a little problem that's been seen to. I feel lighter."

Ann returns after they leave. She makes herself a cup of tea and sits, quietly contemplative, for a few minutes. Then she puts on her coat, and goes home to care for her children.