Face transplant plans renew ethical debate

News that the Cleveland Clinic Foundation has moved one step closer to the world's first facial transplantation has reignited the ethical debate about the surgery among physicians and ethicists.

A clinic spokeswoman confirmed that its institutional review board has approved the surgery and that 12 facially disfigured candidates for the procedure will travel to the clinic in the next few weeks for screening, a process that could last months or years.

Ethicists say that with a surgery like this, doctors must weigh the potential of tremendous quality-of-life improvements for transplant recipients against the grave risks and potential social consequences of an early failure. There is also a debate about just how forthcoming researchers should be before undertaking a controversial and often misunderstood procedure.

Cleveland Clinic spokeswoman Angela Kiska said the plastic surgeon who will likely perform the surgery, Maria Siemionow, MD, PhD, was traveling and unavailable for comment. The clinic did not make other members of its institutional review board available for interviews.

The clinic has come under some criticism from bioethicists because it would not release IRB documentation or characterize the board's year-long decision-making process.

"Once they start talking, my comment is they have more talking to do," said Arthur Caplan, PhD, director of the Center for Bioethics at the University of Pennsylvania and a leading researcher on transplantation research ethics. "It's the Desi Arnaz rule of ethics: 'You got more splainin to do.' Making an announcement and then shutting down is not the best way to secure public support."

The surgical techniques for the proposed face transplant are similar to those in facial reconstruction, but the ethical considerations are much greater, experts say.

For the procedure itself, surgeons would remove the facial tissue and musculature of a donor cadaver and connect it to the musculature of the recipient's face. The recipient would receive immunosuppressive drugs.

The lifelong drug regimen costs about $1,000 a month, can be difficult to adhere to and increases the risks for life-threatening infections and cancer. Some ethicists say these risks may be too great for a procedure that is not life-saving.

If the procedure failed, the surgeons would have to remove the face and cover the wound with skin grafts, according to Carson Strong, PhD, a professor of medical ethics at the University of Tennessee College of Medicine. Dr. Strong argued this would be psychologically devastating and possibly life-endangering for the patient.

Also, if the surgery's results are visually disturbing and gain notoriety, it could repulse the public and discourage organ donation, Dr. Caplan said.

Critics argue that it would be difficult to select a patient psychologically and emotionally stable enough to properly consent to the surgery's risks, which will likely include unwanted public attention.

Furthermore, there are legal and ethical impediments to the use of donated facial tissues, according to Dr. Caplan. Most organ donors do not explicitly consent to such use, and the sudden appearance of a dead relative's face on a recipient could cause a nightmarish public backlash, he said.

Clinic says open debate unnecessary

Experts say that it is not unusual for scientists to refrain from public ethical discussion about clinical research, usually to protect patient privacy as well as proprietary research findings.

But the Cleveland Clinic's approach stands in stark contrast to the course taken by researchers at the University of Louisville, who also are aiming to do the world's first facial transplantation. A team of 11 medical, psychological, social and ethical researchers from the University of Louisville in Kentucky and the Netherlands' University of Utrecht published an article in the American Journal of Bioethics a year ago laying out its ethical rationale for proceeding with the surgery.

"It was really prescient of these guys at Louisville to do that," said Glenn McGee, PhD, the journal's editor-in-chief. "It was a step in the right direction for bioethics to allow researchers who do controversial things to expose their rationale as early as they want to." Dr. McGee said the Cleveland Clinic's refusal to comment was "a huge mistake on their part."

The Louisville researchers are still searching for a hospital to approve the procedure, and the university's IRB also will have to give its OK for the medical staff to participate in the operation. The University of Utrecht hospital is reviewing the team's application, according to John Barker, MD, PhD, director of plastic surgery research at Louisville.

Science has reached a stage where it shouldn't proceed behind closed doors, said Osborne Wiggins, PhD, a professor of philosophy at Louisville and lead author on the AJOB article. "Science is really part of the public realm, and scientists should make known what they're doing so the public can discuss this in advance."

Dr. Wiggins, who did not directly criticize the Cleveland Clinic's approach, cited the cloning of Dolly the sheep as an archetypal example of how the public may overreact to a scientific advancement if there has been no prior public ethics discussion.

But the Cleveland Clinic's approach was foreshadowed. In a commentary published in AJOB last year in response to the Louisville team's article, Cleveland Clinic researchers argued forcefully that prior public discussion of an innovative surgery was not ethically required.

Dr. Siemionow and bioethicist George Agich, PhD, wrote that the Louisville team's view that "we are obligated to release to the public basic clinical and surgical information about facial transplants" could be accepted "as a statement of belief, but no sound ethical argument is offered to support this conclusion."

And Dr. Siemionow and the Cleveland Clinic have not been completely close-mouthed. Dr. Siemionow discussed the procedure with The New York Times in a story published in July. She told the paper that the patient should decide whether to proceed with a face transplantation.

"How can people who are normal decide for burn victims, 'This is not right for you'?" she asked.