Yet another question arises around the self selection of physicians to perform the controversial transplants. Several transplant specialists--many doctors at Harvard affiliated hospitals among them--have questioned whether doctors like Bailey, who are relatively unknown and unpublished, should be allowed to conduct such dangerous and widely-publicized operation on a child.
Bailey says he had consulted the parents of Baby Fae and "completely informed them of all other possibilities to save their child's life." And the Loma Linda Ethics Board, made-up of citizens and doctors, reviewed and gave approval to the operation, says spokesperson Baker.
State medical regulators, however, criticize these informal processes as archaic. "Bailey is in the forefront on technology but he is 30 years behind on guidelines," says Jogan M. Georga, special assistant for medical planning in the Massachusetts State Health Department.
If the operation were to take place in this state, Bailey would have had to apply for a certificate of need (CON), she says. "We would have asked: will the operation take money and time away from patients who stand a much better chance of survival? Is it too expensive? What would be the quality of life afterwards? What would all the drugs do to her tiny body?"
Georga says to her knowledge no such forum took place at Loma Linda. "No such novel operation should happen in a suprise manner as it did there," she says.
A Boston University professor goes further in calling for special guidelines for transplants on children. Professor of Health Law George T. Annas, who headed up a task force earlier this month which set the guidelines for heart transplants in Massachusetts, advocated a more widespread use of the Nuremberg code of ethics for human experimentation. "There should be absolutely no risky experiments performed on children until the same experiments have been successfully applied to adults," he says.
The medical ethics expert lebels Bailey's work on Baby Fae "child abuse."
Annas added that unreasonable operations should be strictly forbidden. "Everyone gave up, on xenograph transplants ten years ago, and I have found no new literature to suggest any improvement in the technique."
He added that Bailey's peers haven't had the chance to review his work, a process vital to good medical practice. "Bailey's work boarders on the reckless-he won't tell us anything and we suspect the worst."
But Dr. Joseph Vicanti, assistant professor of medicine and administrator of transplant operations at Children's believes that doctors are out to do their best for the community. "I am not in favor of further regulation because it layers things and stifles creativity. In situational review is enough."