Putting the public at risk.

Of the many important points discussed by Daar, I shall address only one: the ethical issues raised by the fact that xenotransplantation will put the public at risk of an infectious epidemic. My emphasis on this one point should not detract from other ethical concerns related to xenotransplantation. I have been and continue to be in general agreement with Daar's writings and comments regarding xenotransplantation. This one area I shall discuss from my own perspective. The possibility that xenotransplantation, such as from pigs to humans, could lead to an infection that spreads to the human population, possibly not unlike the AIDS epidemic, is generally accepted. Earlier in 1998, we wrote an article suggesting that a moratorium be declared on clinical trials involving xenogeneic organs, tissues and cells that involve such a risk (1). That moratorium, we felt, should be in place until the public has been informed about the risk to which it will be exposed if xenotransplantation proceeds, and has had an opportunity to participate in a meaningful way in making the decision on whether and how to proceed. This is not different from Daar's view. He states "Since the community is in a sense being put at risk, there is a real argument to consider some form of community consent." The suggestion for public involvement in the decision-making process is analogous to "informed consent" as it is obtained from individual patients undergoing an experimental procedure. We urged that research on xenotransplantation should continue actively (1). In that article, we discussed the question of how the "public" might be involved in the decision-making. I return to that topic below. While supporting the desirability of community consent, Daar wonders whether we should "push this point", in view of two factors: first, "our inability to quantify the ... risk", and second, the fact that "there is little experience in obtaining such community consent". I would like to take up both of these points. Our lack of knowledge about the quantitative aspects of the risk of xenotransplantation does not detract from the pressing ethical need to involve the public now. One of the most important steps in our progress regarding the ethics of medical experimentation was to insist that informed consent be obtained from the patient undergoing a procedure. Our proposal that the public must have a voice in deciding under which conditions one could proceed with xenotransplantation essentially extends this concept of informed consent. Such an approach attempts to ensure that the public is truly represented on this ethical issue. Daar's argument that we should not push public discussion now, given our uncertainty about the risk, will achieve the same result as the approach proposed by some who are against a moratorium. They have argued that since we do not know the extent of the risk of xenotransplantation, we must do a number of xenotransplants so that it can be assessed. This argument repudiates one of the most sacred tenets of informed consent: that consent must be obtained before any part of the procedure is performed. We often do not know how much risk we impose on an individual patient when asking for informed consent, and we make that fact clear to the patient in the process of obtaining informed consent. We do not say to the first patients undergoing a new procedure that we have to go ahead without informed consent so that we can assess the degree of the risk. By that logic, we would only ask patients undergoing the new procedure for informed consent after we had performed the procedure on a sufficient number of patients without such consent, in order to understand the extent of the risk. The fact that the magnitude of the risk is not known does not justify proceeding in order to find out. The decision by the individual patient, and in the case of xenotransplantation by the public, must be made while realizing that the risk exists, even though we cannot quantify it. …