March 1985 VI/7
THE ARIZONA HEART TRANSPLANTS
In early March 1985, Thomas Creighton had four hearts in three days. Two of the hearts were human transplants and one was artificial. In spite of the best efforts of the surgical team at the University of Arizona lead by Jack C. Copeland, MD, Mr. Creighton died shortly after the transplant of the second human heart. Because the artificial heart used in the surgery (the Phoenix heart) was not approved by the Federal Food and Drug Administration (FDA) and because Dr. Copeland and his team were not approved for research with the artificial heart, there was an aroused reaction on the part of health care professionals, ethicists and the media. Was the use of the artificial heart ethical? Was it legal? Should Creighton have been given a second human heart with others waiting in line? Should the FDA penalize the Copeland team? While not attempting to answer these questions, the Creighton case does offer a background for discussing the role of federal agencies in relation to the ethics of human research and emergency health care.
If all people were perfect, we would not need federal regulatory agencies. But given the evidence of weakness and sin, and such evidence exists even in the field of medical research, (l) society needs to establish agencies which will limit the effects of such weakness and sin. When establishing agencies, however, society has the responsibility to make sure that the agencies do not interfere with or suppress the actions and goals of people being regulated.
The Federal Food and Drug Administration (FDA) is an agency with the responsibility to "regulate products that have a direct effect upon human health and welfare and is concerned with the research on and the use of drugs, biologies, medical devices, radiation emitting equipment, food and color additives." (2) In order to protect people who will be research subjects of new drugs or medical devices, the FDA works through Institutional Review Boards (IRBs). The IRB monitors the informed consent of the subject as well as the scientific worth of the research protocol insofar as it might place the human subject at risk. Approval of test articles is a step-by-step process based upon scientific evidence. Though some complain about the time necessary to approve drugs or devices, the FDA has a good track record. Unlike other federal agencies which utilize the IRE for internal review of research protocols, the FDA sends investigating teams on routine or for-cause inspections.
Wisely, the FDA regulations stipulate explicitly that there may be exceptions to both the informed consent on the part of the subject and approval of the IRE if, in the investigator's opinion, immediate use of the test article is required "to preserve the life of the subject." (3) If an emergency occurs the physician or researcher in question must notify the IRE and have the use reviewed later. But the point is clear: the FDA regulations do not exclude legally the life-saving therapeutic actions which occur in emergency situations. Such decisions, however, should also be well-grounded ethically.
What are the ethical norms upon which an emergency decision to use a device or unapproved drugs should be based? Clearly, an emergency decision, just as any other medical decision, should be backed by scientific evidence that the procedure will be beneficial to the patient. As readers of these essays will recall, prolonged biological existence is not automatically beneficial to the patient. Given the condition of the patient, will the patient regain his or her creative function; will he or she be able to think, love, remember the past and plan for the Future; relate to family and friends? Will excruciating pain be a continuing presence for the patient? Will scarce resources be utilized in the most beneficial manner? These questions and others constitute the basis for an ethical decision concerning routine or emergency medical cases.
To date, the media reporting the Creighton case have not mentioned the possibility of exemption from FDA regulations in emergency cases. Thus the questions about legal penalties for the Copeland surgical team are groundless. When the first human heart transplant failed, the Copeland team acted in accord with the FDA regulations in trying to save Creighton's life.
Whether or not the Copeland team made a decision which is ethically acceptable is more difficult to discern. Dr. Copeland said after Mr. Creighton's death, "My conscience is clear." But the painful fact is that many people have a clear conscience thought their actions are ethically unsound. What is needed for ethical decisions is a "well-formed" conscience. A well-formed conscience requires that there be scientific evidence that the device in question, given Creighton's condition, had some chance of "saving his life in a beneficial manner." Moreover, there should be some evidence that the rights of other potential transplant patients were not violated. The fact that Creighton died later is irrelevant to the ethical decision that was made. But the length of time he had spent on the heart bypass machine, the reasons for rejection of the first heart, the evidence substantiating effectiveness of the Phoenix heart and, finally, whether one person should receive two human hearts in such a short time are all relevant issues. The Phoenix heart had been used in animal research and an approved mechanical heart(e.g., Jarvik heart) was not readily accessible. Thus there was some evidence that the device might save Creighton's life if used as a temporary measure.
The object of reviewing the decisions of the Copeland team is not to second guess but to delineate clearly the ethical issues in order to learn from the past. If the Copeland team had determined that the condition of the patient would not tolerate use of the artificial heart, would it have been unethical to disconnect the heart and lung machines and allow Mr. Creighton to die? Not at all. Their decision would have been based upon the condition of the patient and his future ability to strive for the values of life. This is the basis of ethical decision making.
The Creighton case offers some valuable lessons. First, the regulations of the FDA are more enlightened than many realize; second, there is more involved in an ethical decision than merely prolonging physical function. And, most important of all, the Creighton case reflects that ethical decisions must often be made by physicians in emergency situations. Thus physicians must be aware of the ethical norms associated with patient care even before emergencies arise.
Kevin O'Rourke, OP
1. "Scientific Misconduct in Investigational Drug Trials," Shapiro and Charnow; NEJM, Vol. 312, n.11, March 14, 1985; p.731-736.
2. "An Overview of FDA, IRBs and Regulations, IRB, Vo1.3, No.10, Dec.1981; p.1ff.
3. "FDA, Protection of Human Subjects;" FEDERAL REGISTER, Vo1.46, n.17; Jan.27, 1981; p.8951-89-76.
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