Mon, 30 May 1994

Abortion rights activists say pill is a victory

By Joanne Kenen

WASHINGTON (Reuter): Abortion rights activists saw another goal accomplished with a breakthrough that will make the controversial RU 486 abortion pill available to U.S. women in clinical trials.

In a deal that took over a year to negotiate, the French manufacturer of the drug, Roussel Uclaf, announced Monday it was turning over all U.S. patent rights to the New York-based nonprofit Population Council, which will seek a manufacturer.

Roussel's parent company, Germany's Hoechst AG, does a multi- billion-dollar business in the United States, mostly with products unrelated to medicine. A Roussel lawyer declined to comment on fears of a boycott but confirmed the company had been reluctant to enter the politically-charged U.S. abortion arena.

Clinical trials for 2,000 women at 12 sites should start in early autumn, and the Food and Drug Administration said approval should come in 15 to 22 months, FDA commissioner David Kessler told a subcommittee of the House Small Business Committee.

"Medical science is finally winning out over politicized science," said subcommittee chairman Oregon Democrat Ron Wyden. More than 150,000 women have used the so-called abortion pill in France, Sweden and Britain. A similar drug is also widely used in China.

Research is also under way to see whether RU 486 can combat a range of diseases, including diabetes, breast cancer and endometriosis.

Though an alternative to surgical abortion, the abortion pill is more complicated than merely popping a pill.

Used in the first seven weeks of pregnancy, the procedure involves two types of medication, RU 486 and a prostaglandin. The woman must typically go to the doctor three times, and be monitored for side effects including excessive bleeding.

But unlike traditional abortions, it does not require surgery, which carries risk of damage to the cervix or uterus. And it does not require anaesthesia.

As abortion rights groups celebrated a victory, anti-abortion forces such as the National Right to Life Committee denounced Roussel's decision. The American Life League Inc issued a statement calling RU 486 a "human pesticide."

"It's baby poison," said New Jersey Republican Chris Smith of New Jersey, one of three members of Congress who circulated a letter to other lawmakers criticising the drug.

But for abortion rights activists, it was a long awaited victory, made sweeter by coming just days after passage of bill that restricts violent or intimidating protests outside abortion clinics.

"This has been an historic day and an historic week," said Colorado Democrat Patricia Schroeder, saying the clinic access law and the RU 486 trials marked the end of "medical censorship." President Clinton is expected to sign the clinic access bill into law soon. Since his very first week in office, he has taken several measures to expand access to abortion, including allowing abortion counselling at federally funded clinics and urging U.S. studies of RU 486.

Since the medication will be administered in a doctor's office instead of at an abortion clinic, advocates hope the emotional protests will subside.

"This is the beginning of the end of the abortion war," said Planned Parenthood president Dr Pamela Miraldo.

"This is definitely going to change the debate. It's going to change everything," said Ellie Smeal of the Fund for the Feminist Majority.