It was classic congressional melodrama, replete with passionate witnesses and hostile questions. But in the end, no one knew who the villain was.
"We're talking at cross purposes," complained Solomon Sobel, director of the Food and Drug Administration's Division of Metabolism and Endocrine Drug Products.
They did so for 3 1/2 hours yesterday in an often-contentious hearing at which the chairman of a House subcommittee charged that the FDA's ban on importation of RU 486, the French "abortion pill," is "arbitrary, political and unscientific." Rep. Ron Wyden (D-Ore.) also accused the FDA of truckling to antiabortion prejudice in the Bush administration and thereby causing "needless suffering" for Americans denied access to the drug.
FDA officials countered that their policy is mandated by U.S. law, which prohibits the import of unapproved drugs. The agency, said FDA counsel Sandra Barnes, "has no other choice but to enforce the statute -- which Congress has not seen fit to change." Ronald Chesemore, FDA associate commissioner for regulatory affairs, stressed that agency officials "place no restrictions on research."
At issue was a year-old import ban on personal use of RU 486, a drug available in France to induce abortion, but which is also thought to have exceptional promise in treating breast cancer, endometriosis, meningioma (a form of brain cancer), an adrenal gland disorder called Cushing's syndrome and many other maladies involving hormonal effects on the body.
William Regelson of the Medical College of Virginia told the hearing that more study of the effects of RU 486 could lead to "major medical breakthroughs" in treating diseases as diverse as hypertension and AIDS. But, he said, "we're stymied by this emotionalism related to fertilization. I get the feeling that the FDA got carried away by the pressures of Right-to-Lifers."
Regelson dismissed arguments about the personal hazards of unsupervised use of RU 486: "We don't deny patients morphine because people on the street are abusing narcotics."
FDA officials responded that, in fact, the compound can be imported legally for FDA-approved clinical trials, several of which are under way. Chesemore kept reiterating that the agency's ban extends only to individual use of the drug for abortion. The personal-use ban, Chesemore said, was implemented after the agency became concerned that "publicity about the use of these drugs overseas would lead to unsupervised use or clandestine distribution" in this country.
But Wyden, chairman of the House subcommittee on regulation, business opportunities and energy (and the only committee member present at the hearing), blamed the FDA for ignoring evidence of the drug's safety and creating a climate of regulatory "resistance" to RU 486 through the import ban instead of performing as an "active advocate" for medical research.
As a result, he said, the drug's manufacturer, Roussel Uclaf, has made it difficult, and often impossible, for U.S. researchers to get reliable supplies of RU 486.
Kathryn Horwitz of the University of Colorado, who studies the actions of sex hormones on cancer, testified that she can no longer obtain the drug for basic research because her test-tube studies of its effects on cancer cells don't fit the requirements for clinical trials.
Several other witnesses criticized the FDA policy while emphasizing the drug's therapeutic promise. Myron Allukian Jr., past president of the American Public Health Association, testified that the FDA's "bureaucratic barrier" demonstrates "profound ignorance of the potential of RU 486" and "sends the wrong message to researchers, academics, health professionals and the public." He urged the FDA to disregard RU 486's ability to cause abortions "and treat it like any other drug that has demonstrated potential to improve the quality of life."
Representatives of various patients' groups, including Cancer Patients Action Alliance (CANACT) and the National Cushing's Association, testified to dramatic improvements they had experienced after being treated with RU 486 and decried what they said was anti-abortion bias in restricting the drug. "I am a practicing Catholic who is unalterably opposed to abortion," said Helen Byrne, a breast cancer victim and vice president of CANACT. "But the issue here is not abortion. The issue is life or death of women with breast cancer."
Two researchers from the National Institute of Child Health and Human Development testified about the drug's potential in treating Cushing's syndrome (caused by an overabundance of cortisol, a hormone whose receptors are blocked by RU 486) and as a therapy for infertility.
The American Medical Association, however, submitted a statement declaring that the FDA "has acted responsibly," and noting that RU 486 "poses a severe risk to patients unless the drug is administered as part of a complete treatment plan under the supervision of a physician."
Moreover, several witnesses testified that the chief obstacle preventing clinical access to the drug is its manufacturer. Between the FDA and Roussel Uclaf, Regelson said, "we're being whiplashed on both sides." The drug company "is trying to whip up sentiment in those women who have breast cancer" so that they will put pressure on the government, he said.
So what is the FDA going to do "to turn this situation around?" Wyden demanded. In fact, he asked, why not get get Health and Human Services Secretary Louis W. Sullivan on the phone to Roussel Uclaf?
"It is not in the authority of the FDA," Chesemore said wearily, "to make corporate decisions."