First, the entire process, especially since it is experimental, has to be transparent — that is, never in isolation from approval and step-wise evaluation of the public and medical profession. In this regard, it is interesting that both the Royal College of Surgeons and French National Ethics Advisory Committee recently stipulated that a red light be given to face transplantation, at least at this time.3 The British and French opinions were both concerned over the potential adverse consequences of graft failure (10% in the acute period and another 30 to 50% over the ensuing 5 years). The groups left a yellow light for a later time, when immune-suppression would progress to a stage wherein rejection would be less prohibitive. In contrast to the French enterprise, in 1997, the first International Symposium on Composite Tissue Transplantation was attended by experts in immunology, transplant, research, and ethics from all over the world. They were there to openly discuss any issue relevant to hand transplantation.4 Critical questions were debated such as whether adequate animal research had been performed to progress non-vital organ transplants to human subjects. Unfortunately, in the instance of Isabelle Dinoire, the disregard for "transparency" and healthy debate, as well as the impartial opinions of two respected professional organizations, is bothersome.
The next important issue is informed consent. The informed consent process has to be iterative, comprehensive, and forthright about what is really unknown and unpredictable. Face transplantation may be accurately characterized as experimental. As an example, with the first larynx transplant, exhaustive efforts were made to inform the patient over an extended period (exceeding the 7-month duration in Dinoire's instance) about the pros and cons of a revolutionary and risky therapy. Any coercion based on unrealistic expectations or reward has to be completely absent for consent to be authentic. Was only 7 months enough time for a woman who may have attempted suicide? Did she know about the risk of cancer from immune-suppression, or about a 10% risk of diabetes from her medications? Were alternative, approved treatments (grafting, flaps) tried so that transplant was a last resort? Furthermore, recent disclosure of substantial monies ($177,000) contracted to the patient and surgical team for a documentary is, if true, problematic.5
In addition, how vulnerable will this particular individual become now that she is under the glare of inordinate publicity? A fragile psyche may lead to a discontinuation of anti-rejection medications and stimulate the disfiguring results of rejection. Severe depression will inevitably follow. Were even these basic requirements to proceed enforced by unbiased individuals (that is, people solely concerned about the patient's welfare and reasonably independent of the surgical team and the profitable documentary) on an institutional review board? Although there is more to examine on an ethical checklist, the aforementioned topics are essential.
The ethical issues that have surfaced after the world's first face transplant are both substantive and valid. The red light recommended by expert consensus should be enforced for any future attempts that proceed in such a vacuum, immune from well-intentioned debate and genuine concern for the recipient. That the first face transplant occurred under the particular circumstances that it did is yet another black eye for Post-Hippocratic medicine. It appears, unless evidence surfaces to the contrary, that the proverbial foxes may have been caring for the chicken coop! Unfortunately, the recipient was a very vulnerable human being, and the rest of her story may qualify as a tragedy.
Gregory W. Rutecki, M.D., is Director of Medical Education, Mount Carmel Health System, Columbus, Ohio; a Clinical Professor of Medicine, The Ohio State and Wright State University Medical Schools; and a Fellow of CBHD.
References
- John Ward Anderson, "French Doctors Defend Ethics of First Face Transplant," The Washington Post, December 3, 2005 www.washingtonpost.com/wp-dyn/content/article/2005/12/02/AR2005120201787.html (accessed December 14, 2005).
- Adam Sage, "Face Transplant Woman To Profit From Picture Sales," TimesOnline, December 8, 2005, www.timesonline.co.uk/article/0,,13509-1915330,00.html (accessed December 14, 2005).
- Carson Strong, "Should We Be Putting A Good Face On Facial Transplantation?" American Journal of Bioethics 4, no 3 (Summer 2004): 13-14.
- Osborne Wiggins, John Barker, Serge Martinez and others, "On the Ethics of Facial Transplantation Research," American Journal of Bioethics 4, no 3 (Summer 2004): 1-12.
- Adam Sage, "Face Transplant Woman To Profit From Picture Sales."