The field of reproductive medicine needs more oversight, data collection, and boundaries to prevent scientific practices that lead to diminished human dignity, said Leon Kass, M.D., chairman of President Bush's Council on Bioethics. But others in the field warned against imposing more layers of regulation that cause financial stress on patients whose treatments are not covered by insurance.
"Effective oversight -- and I exaggerate only slightly -- does not exist at all," Kass said while speaking Friday at a genetic and reproductive ethics conference sponsored by the Center for Bioethics and Human Dignity at Trinity International University in a Chicago suburb.
Kass, who noted that he was speaking for himself and not the council, said compliance with regulations is mostly voluntary and that the U.S. lags behind countries like Canada, Germany and Great Britain in regulating assisted reproduction. He said Germany has the strictest regulations and, while Britain's laws are more liberal, the government "knows the whereabouts and fate of every embryo" created by reproductive technology.
In contrast, he said the U.S. has very little monitoring and oversight of the children reproductive technology helps create.
American Society for Reproductive Medicine spokesman Sean Tipton, however, noted in an interview that the field has just gone through several years of working with the Food and Drug Administration to revise egg and sperm donor regulations. Also, he said statistics on the number of patients and the number of successful pregnancies from every in vitro fertilization clinic in the country are reported by the Centers for Disease Control and Prevention.
"You can't go to an orthopedic clinic and find out how many fractured femurs they've set," Tipton said.
David Adamson, M.D., director of Fertility Physicians of Northern California, Palo Alto, and a past president of the Society for Assisted Reproductive Technology, said in an interview that compliance with reporting requirements adds $25 to $50 to each assisted pregnancy attempt or "cycle." And, he said that with about 100,000 cycles performed annually in the U.S., these costs add up.
"Some would argue that's a good use of the money . . . but very commonly these costs are borne by the patient," Adamson said, stating that additional regulations may hinder access to care. "We see patients all the time who drop out because they can't afford it."
Adamson said he wasn't necessarily disagreeing with Kass' call for more reporting and regulation, but he said someone other than patients should cover the associated costs. But he did disagree with Kass concerning his comments that the field is under-scrutinized.
"Certainly the argument that we're under-regulated is a misconception -- especially when compared to other fields," Adamson said. "Reproductive medicine is unique, I recognize that. But I think it's important to dispel the myth that we're under-regulated."
He added that any new regulations should be developed from within the profession to ensure that they are instituted for the benefit of the patient and not for political gains. For example, Adamson criticized a bill proposed by a Kentucky legislator that would limit IVF clinics to using only one embryo per cycle.
"We've always been opposed (to legislation) regulating the practice of medicine because patients are (all) so different," Adamson said. He said the profession has responded to concerns over multiple pregnancies and has acted to limit their occurrence.
At the conference, Kass joked that most people favor regulation, "but only on their own terms." He then said how people on the left object to any kind of regulation of reproductive technology that may have a basis in religion, and those on the right oppose regulation out of concern that it may be viewed as a government sanction of something they oppose.
Kass praised Canada for passing laws regulating the use of reproduction technology, for creating the Assisted Human Reproduction Agency to enforce those laws, and for citing "concern for human dignity" as a founding principle behind these actions.