‘Abortion Pill’ Sparks Hope, Fear, Controversy

The world’s first “abortion pill” is back on the market in China and France but women in the United States and elsewhere cannot expect to have access to the controversial drug anytime soon--except perhaps on the black market.

Fierce opposition from anti-abortionists, the high cost of getting new drugs approved and fears of being sued, experts say, are making pharmaceutical firms reluctant to market the pill and similar agents.

“I believe it will happen, but I don’t think it will happen very soon,” said Dr. Louise Tyrer of the Planned Parenthood Federation of America.

Family planning activists such as Tyrer see the drug, RU 486, as a potentially revolutionary advance in fertility control, offering women a safer, easier, less traumatic and much more private way to abort a pregnancy.

Right-to-life proponents, who call the drug a “death pill” and “chemical warfare on the unborn,” assert that it may be unsafe, increasing a woman’s risk of cancer and a baby’s chances of being born deformed.

The drug has intensified the battle between these adversaries, both of whom believe that it could be a watershed in the debate over abortion by making the early termination of pregnancy so much easier and less public.

Work Curtailed

The fate of the drug also highlights the status of fertility research in the United States, where fear of liability lawsuits and the expense of developing new approaches has severely curtailed work in this field, experts say.

RU 486 has been approved for marketing only in China and France, where in October it was withdrawn by the drug’s maker, which cited opposition from anti-abortionists. The French government ordered it back on the market two days later after an uproar from doctors and family planning proponents.

Although approval may also be sought soon in other countries, such as Britain, the Netherlands and Sweden, there are no plans to market it in the United States or, of course, countries where abortion is illegal.

But many experts believe that the benefits of the drug compared to surgical abortions could quickly create a thriving underground illegal marketplace, raising fears that it may be used without adequate medical supervision.

“There will be a black market,” said Joseph Speidel, president of the Population Crisis Committee in Washington. “There’s a tremendous demand.”

“Women are going to smuggle it. Women smuggle contraceptives into Ireland, where they are illegal,” said Victoria Leonard, executive director of the National Women’s Health Network in Washington. “And women will smuggle RU 486 into this country.”

Developed by the Roussel Uclaf drug company in Paris, RU 486 is the most thoroughly tested of a group of drugs known as anti-progesterones because they interfere with a hormone produced by the ovaries called progesterone.

Progesterone is needed for the lining of the uterus, the endometrium, to develop properly and offer an environment that can nurture the developing fetus.

Also known as mifepristone, the drug is a synthetic steroid whose chemical structure resembles progesterone’s. An imposter, the drug fits like a key in a lock into receptors for the hormone in the uterus, blocking the real hormone.

Because RU 486 does not function like progesterone, the lining in the uterus breaks down and is expelled as in a normal menstruation, taking the fertilized egg with it. In essence, the drug triggers a miscarriage.

Studies have shown RU 486 alone causes a miscarriage in at least 80% of women, and in up to 95% of cases when accompanied by the hormone prostaglandin, which enhances the action by causing the uterus to contract.

Some women who take the drug experience fatigue and nausea. And some bleed so much they require transfusions. But studies indicate that those side effects are rare and not life-threatening, experts say.

The drug is only effective for up to about seven weeks into the pregnancy. But experts estimate RU 486 could replace more than half to two-thirds of the 30 million to 40 million surgical abortions performed worldwide because most are performed that early.

Other Uses Explored

RU 486 is also being tested as a possible treatment for breast and other cancers, the sometimes fatal adrenal abnormality Cushing’s syndrome, glaucoma and possibly as a monthly contraceptive pill. But its use as an aborting agent has generated the most excitement.

“I think it’s the most major breakthrough in the area of medical fertility control since the birth control pill,” Tyrer said. “It has a tremendous potential impact on the lives and health of women of the world.”

“We believe it’s going to have a big impact,” agreed Dr. Paul Van Look of the World Health Organization in Geneva, which is testing the drug in at least 10 countries, including Sweden, Hungary, Britain, Italy, Cuba and India.

In developed countries such as the United States, the primary benefit of the drug is it would allow women to abort their pregnancies more conveniently and privately, proponents say.

There would be no need to drive far distances required in many areas to an abortion clinic, where women may have to skirt anti-abortionists carrying pictures of aborted fetuses and pleading with them to change their minds.

The drug would also allow women to avoid the vacuum procedure involved in a surgical abortion that many women find disturbing, the advocates say.

After having her pregnancy confirmed, a woman would simply go to her doctor, get a prescription, fill it, go home and wash down a single 600-milligram pill like an aspirin. She would also get an injection of prostaglandin.

Within a few days, the woman would begin bleeding as if she were having her normal--albeit slightly heavier--menstrual period. The bleeding would continue for a week to 10 days.

After the bleeding stops, the woman would return to her doctor to make sure the fetus had been completely expelled. In the rare case that it had not, she would have to undergo the normal surgical abortion.

Fears about black market use center on women for whom the drug does not work or for whom it works only partially. If a woman fails to undergo a surgical abortion, unexpelled fetal remains could cause an infection. If the baby is carried to term, it could be born with a defect.

But if used properly, the drug could save thousands of lives in countries where quality abortions are not accessible, proponents say. And because it is expected to be cheaper than the $250 for a surgical abortion in the United States, it could save lives here too for women who seek cheaper, illegal abortions, some say.

As many as 200,000 women are estimated to die from botched abortions worldwide.

“It certainly beats using slippery elm sticks, massage, knitting needles and illegal abortionists who use unsterilized instruments,” Tyrer said. “It’s going to save many, many lives.”

But Dr. John Willke, president of the National Right to Life Committee in Washington and the International Right to Life Federation in Rome, questions the drug’s safety.

“This thing has potential for incredible disaster for babies. We have no business laying a chemical time bomb out there for the babies. . . . We think it is beyond conscience to release this drug,” Willke said.

In addition to possibly leading to birth defects in infants and infections in women, Willke claims that the drug has a chemical structure similar to the cancer-causing hormone diethylstilbestrol (DES), suggesting that it could cause malignancies.

He also argues that the drug could be more--not less--traumatic for women.

“When a woman gets a surgical abortion there is a psychic defense mechanism. Yes, she walked in there but now she lays on the table and she can distance herself in a way from this because, ‘He is doing this to me.’ It’s out of her hands. It’s being done to her,” Willke said.

“Now we have a different story going on. This different story is she went to the doctor. She got the prescription. She filled it. And she took the pills and she is the one who is directly responsible for the destruction. I think the psychic aftermath in terms of guilt from this will be very severe,” he said.

Need for Supervision

Experts acknowledge that they do not know how the drug may affect babies born to mothers who take it. But they argue that is why women who take it would be required to abort if it does not work. And that is all the more reason why the drug should be approved to ensure its use only under a doctor’s supervision, they say.

Roussel Uclaf issued a statement after the drug was returned to the French market restating the theoretical risk of proceeding with pregnancies after taking the pill. But the company denied claims that a baby was born with multiple birth defects after the mother took RU 486 during her pregnancy.

Dr. David Grimes, a professor of pediatrics and gynecology at the University of Southern California’s medical school, dismissed Willke’s claims that the drug may cause cancer.

“To suggest that because it has a ring structure that is somewhat analogous to DES is a misstatement. Biologically it’s not similar to DES. It’s very, very different,” said Grimes, the only U.S. researcher studying the drug as an abortion pill.

Leonard of the National Women’s Health Network acknowledged that the drug should undergo further safety tests, but scoffed at Willke’s psychological argument.

“If he doesn’t think a woman calling up and driving over and walking into the clinic is taking control of herself, that’s nonsense. She’s a woman making the decision,” she said.

Motives Ascribed

Leonard and other family planning advocates charge that Willke and other opponents raise unfounded fears about the drug because they are afraid that the drug will devastate their efforts by robbing them of one of their most effective weapons--picketing abortion clinics.

“They’ll have no way to harass users,” said Speidel of the Population Crisis Committee. “That’s why they are desperately trying to keep it off the market.”

But even if opposition from anti-abortionists was nullified, supporters are pessimistic about the drug’s availability in the United States anytime soon.

“We have multiple obstacles to overcome before this drug would ever be developed in this country,” said Marie Bass, a political consultant in Washington who has studied RU 486.

One major obstacle is the high cost of getting any drug, especially those involved in reproduction, approved by the Food and Drug Administration. Experts project that it would take at least five years to get RU 486 approved if efforts began today.

Drug companies, stung by huge damage awards over other birth control methods, are also wary of liability lawsuits from such drugs, which tend to be less profitable than those for cancer and heart disease, for example.

Research Lacking

Such barriers account for the nearly total lack of any research on new birth control devices being done in this country, experts say.

Bass believes that a groundswell of public demand for the drug will be needed to encourage a drug company to take it on. And Tyrer said she believes that recent publicity surrounding the drug in France may help trigger such demand.

“We’ve gotten several calls from people who want to know, ‘How can I get it? Is it on the black market? When is it going to be marketed?’ ” Tyrer said.

Getting the drug back on the market in France was very important because success there could encourage Roussel or other companies to market the drug or similar ones elsewhere, Tyrer said.

Other companies are testing similar drugs, including a drug called epostane developed by Sterling Drug Inc. of New York and two other drugs from the West German drug company Schering AG. But Sterling has said it has no plans to market epostane and Schering AG has just begun testing its drugs on humans.

Meanwhile, Willke, who believes that the pulling and the returning of the drug in France was a ploy to take pressure off the company, said his group is considering a worldwide boycott of all products made by Roussel and its West German parent company, Hoechst AG.

Willke claims that such a boycott begun in 1973 forced the Upjohn Co. of Kalamazoo, Mich., out of the birth control field.

Upjohn spokeswoman Jessyl Bradford maintains that Upjohn has seen “no measureable impact on sales” from the boycott. The company shut down its fertility program in 1986, but only because of the expense of getting such drugs approved, she said.

But Jeffrey Warren, a spokesman for the Pharmaceutical Manufacturers Assn. in Washington, said public pressure does play a major role in drug-marketing decisions. “I don’t think there’s any question that a company would factor that in,” Warren said. “It’s got to be part of the equation.”