PHILADELPHIA — Recommendations on assisted reproductive technologies issued by the President's Council on Bioethics in 2004 aim to prevent “renegade investigators from doing unethical procedures” and are unlikely to meet with opposition from most fertility experts, according to Marian Damewood, M.D., immediate past president of the American Society for Reproductive Medicine.
“The government regulation that has been proposed is on specific targeted legislative measures, such as preventing human/animal combinations from being born. And I don't think anyone would disagree with those measures,” Dr. Damewood said in an interview after the council's chairman, Leon Kass, M.D., discussed the recommendations during a presentation at the ASRM's annual meeting.
The council's recommendations—published as part of a report, “Reproduction and Responsibility: The Regulation of New Biotechnologies,” released in March, 2004—fall into three categories:
▸ The pursuit of longitudinal studies and data collection to monitor the health and well-being of women affected by assisted reproductive technology procedures.
▸ The strengthening of monitoring systems to track success rates and adverse events and ensure compliance with professional guidelines.
▸ A moratorium on “questionable” practices, such as the creation of human/animal hybrids. This category prompted the report's strongest recommendations, with calls to prohibit mixing of human and animal gametes for the purpose of procreation and the transfer of gametes between humans and animals.
“We are also concerned about overly burdensome regulation and its possible costs and drawbacks,” said Dr. Kass, a biomedical ethicist at the University of Chicago. Although the council believes it understands a great deal about today's assisted reproductive technology landscape, “it would be premature to recommend dramatic legal or institutional change” until it gathers more information.
The recommendations in the report were unanimously supported in “an otherwise very divided council,” Dr. Kass added.
Despite unanimous agreement within the council on these points, several ASRM members told this newspaper that they had some concerns about the report.
“You see time and time again how legislation may initially look fairly harmless, but by the time people have tacked more and more things onto it, can become a very serious issue with long-term consequences,” said J. Michael Putman, M.D., of the Baylor Center for Reproductive Health, Dallas.
“Everything suggested so far has been unanimously supported. These are things that you really don't argue with. But there are concerns any time you try to legislate medical and ethical issues that once you have a legislative body in place, what looked like it wasn't an issue may suddenly become one,” he said.
Dr. Putman gave the example of how the long-term acceptance of egg donation may evolve, an issue also raised by Kutluk Oktay, M.D. “We don't want legislation that targets extreme cases to be overinterpreted and expanded to limit routine procedures,” he told this newspaper.
Dr. Damewood emphasized that having a formal body oversee the general practice of infertility treatment would not be desirable or necessary. “We feel that the ASRM and other professional societies, as well as individual practitioners, are ethical people and will continue to practice in that domain without having a formal body to oversee 99% of their activity,” she said.
But government involvement in the field should not be seen as entirely negative, she added. “We also need to note the positive side in that the report calls for government-funded longitudinal studies of children born from various types of assisted reproductive technologies, which would be very good.”