U.S. Ban on ‘Abortion Pill’ Said to Hurt Research on Cancer, Other Dread Diseases

The chairman of a House subcommittee Monday accused federal regulators of threatening valuable research into cancer and other diseases by limiting access to RU-486--France’s so-called abortion pill.

“Americans with breast cancer and other dread diseases have become the innocent victims of this Administration’s political brinkmanship with the pro-choice movement on abortion,” said Rep. Ron Wyden (D-Ore.), chairman of the regulation, business opportunities and energy subcommittee of the House Committee on Small Business.

However, representatives of the Food and Drug Administration testified at a subcommittee hearing that the agency’s 1989 ban on the importation of the drug for personal use was not intended to restrict researchers’ access to it.

Some medical researchers echoed Wyden’s charges, but others said that they had overcome bureaucratic hurdles and obtained adequate supplies for their research.

Recent studies have shown that, in addition to use as a non-surgical means of ending pregnancy, RU-486 is a promising treatment for a variety of medical disorders, including breast cancer, brain cancer, infertility, hypertension and Cushing’s syndrome.

But Wyden charged that the U.S. government has created a climate that discourages the manufacturer from supplying American researchers.

The manufacturer, Roussel Uclaf, has not applied for permission to market the drug in the United States because of the political controversy over abortion. The FDA ban applies to individuals who attempt to bring the drug into the United States for personal use.

However, the agency routinely authorizes use of the drug “for . . . research when the proper application comes to our attention,” said Ronald G. Chesemore, associate FDA commissioner for regulatory affairs.

The drug, which has been available in France since 1988, is a synthetic steroid that induces abortion by blocking the action of progesterone, a hormone necessary to sustain pregnancy.

Researchers who testified before the subcommittee described a wide variety of other uses for the drug’s hormone-blocking properties.

In the case of Cushing’s syndrome, tiny tumors cause a sometimes fatal overproduction of the hormone cortisol, causing weight gain, muscular weakness, hypertension, depression and diabetes.

Dr. George Chrousos, a pediatric endocrinologist at the National Institutes of Health, described to the subcommittee how RU-486 has removed patients’ symptoms, allowing them to regain sufficient strength to undergo corrective surgery.

But, despite tremendous successes to date, Chrousos said, he has halted some of his research because Roussel Uclaf will not guarantee delivery of an adequate supply of the drug.

Kathryn B. Horwitz, a molecular endocrinologist at the University of Colorado School of Medicine, told the panel that RU-486 has tremendous potential to block the progress of progesterone-stimulated breast tumors.

But she said her research has been hampered by the fact that the FDA’s application procedure is designed for clinical studies, not the kind of laboratory research Horwitz conducts.

“Enforcement of the import alert means that I no longer can obtain RU-486 for basic research,” she told the panel.

The FDA said after the hearing that the intent of the FDA policy is not to deny drugs to researchers like Horwitz and that it would look into her situation.

Other researchers pointed to potential benefits in treating meningioma, a type of brain cancer stimulated by progesterone, and to the possibility of developing a once-a-month contraceptive for women.

The American Medical Assn. has supported the “legal availability of RU-486 for appropriate research and, if indicated, clinical practice.” An AMA representative who testified before the subcommittee stressed that “the actual impediment to research on RU-486 is the manufacturer’s unwillingness to make the drug available in the United States.”

Some anti-abortion groups have charged that new attention to non-abortive uses for RU-486 is a smoke screen to change the image of what abortion opponents consider “a death drug.”

Richard Glasow, education director of the National Right to Life Committee, said that, although “the sole proven use of (RU-486) is to kill unborn babies whose heart has just begun to beat,” his group does not oppose research into other medical uses of the drug.

“When there is conclusive evidence of other uses,” he said in a telephone interview Monday, “we will review it at that time.”