Ethics in Research and Surgical Practice LaSalle D. Leffall, Jr., MD, Washington, DC

The topic “Ethics in Research and Surgical Prac- tice” appears most appropriate for the 1997 Claude H. Organ, Jr. Honorary Sandoz Nutrition Lecture. With the increasing numbers of ethical problems facing clinicians today, greater empha- sis on ethics is demanded. This lecture focuses primarily on the clinical applications of basic sci- ence and ethics certainly plays a major role in this regard. Ethical principles espoused by the American College of Surgeons and the American Medical Association will be emphasized. Further, the results of the deliberations of the Advisory Committee on Human Radiation experiments will be discussed. Certainly, the Tuskegee experiment debacle will be mentioned. Ethics remains impor- tant if we are to give our patients the best care. We must always keep in the vanguard of our thinking that the welfare of our patients comes first. High ethical principles emphasize our obli- gations and responsibilities to our patients. Am J Surg. 1997;174:589-591. 0 1997 by Excerpta Medica, Inc.

I want to express my great thanks to the members of the Southwestern Surgical Congress for the honor of invit- ing me to deliver the 1997 Claude H. Organ, Jr. Hon-

orary Sandoz Nutrition Lecture. A valued friend and col- league of mine for almost 40 years, Claude Organ merits the high esteem that this Lectureship bestows upon him. With the increasing complexity of diagnostic and thera- peutic measures in medical and surgical practice, clinicians are confronting even more daunting ethical issues than in the past. Since this lecture focuses specifically on the clin- ical applications of basic science, I have chosen to speak about the relationship of ethics in research and surgical practice. This lecture then is a fitting tribute to Dr. Organ, a superb academic and clinical surgeon, who espouses and exemplifies the highest ethical principles in his teaching and practice.

The principles upon which the American College of Sur- geons was founded in 1913 were high quality care for the surgical patient and the ethical and competent practice of surgery. High ethical standards have always been an integral part of the College’s philosophy.

From the Department of Surgery, Howard University Hospital, Washington, DC.

Requests for reprints should be addressed to LaSalle D. Leffall, Jr., MD, Charles k. Drew Professor of Surgery, Howard University Hospital, 2041 Georgia Avenue, NW, Suite 4000-Tower, Wash- ington, DC 20060.

Presented at the 49th Annual Meeting of the Southwestern Sur- gical Congress, Ranch0 Mirage, California, April 13-16, 1997.

Since its founding in 1947, the American Medical Asso- ciation (AMA) has had as one of its primary goals a code of ethics. The 150th Anniversary Edition of “Current Opin- ions with Annotations” of the Council on Ethical and Ju- dicial Affairs is one component of the AMA’s Code of Ethics. The other components are the “Principles of Med- ical Ethics,” “ Fundamental Elements of the Patient-Physi- cian Relationship,” and the “Reports of the Council on Ethical and Judicial Affairs.” “Current Opinions with An- notations” reflects the application of the principles of med- ical ethics to more than 135 specific ethical issues in med- icine, including health care rationing, genetic testing, withdrawal of life-sustaining treatment, and family vio- lence. No one principle of medical ethics shall measure eth- ical behavior of the physician.’ Thus in this lecture, no attempt will be made to give ethical opinions of various problem areas but rather attention will be given to errors made in the past and principles that should guide us in whatever ethical decisions are rendered now.

Glaring examples of ethical lapses occurred in the United States with our human radiation experiments and the Tus- kegee syphilis study,-all representing moral blots on our so- ciety. A brief review of these projects will underscore the despicable transgressions that were committed in the name of scientific inquiry.

Buchanan believes that the investigation of radiation ex- periments conducted on human beings under the auspices of several agencies of the federal government between 1944 and 1974 provides a concrete focus for the problem of ret- rospective moral judgment. The Advisory Committee on Human Radiation Experiments was asked to evaluate the ethics of these experiments and make recommendations on how to avoid abuses in the future. To answer this question, the Committee had to take a stand on the problem of ret- rospective moral judgment. In some cases, those who au- thorized or conducted the experiments violated general moral principles that were widely accepted at the time and that we continue to endorse today. Among these are pro- hibitions against deceit, against harming innocent persons without their consent, against treating persons as mere means, and against exploiting the vulnerable.*

All of these general principles were violated during the course of an experiment conducted under the auspices of the U.S. government at the Femald School in the late 1940s and early 1950s. With the complicity of the school’s highest administrator, physicians tricked the parents of re- tarded children at the school into giving permission for their children to participate in a “science club.” Whether the ingestion of the isotopes posed a significant physical risk is perhaps disputable. What is beyond dispute is that these children and their parents were treated as mere means for others’ ends, that they were exploited, and that they were chosen for exploitation because their powerlessness made them vulnerable. It is of some interest to note that it was

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THICS IN RESEARCH AND PRACTKWLEFFALL ) E

the need to avoid legal liability and public outrage that the participants invoked to justify their deceptions and manip- ulations. The same was true in the plutonium injection ex- periments conducted at the University of Rochester and the University of California between 1947 and 1950 and the total body irradiation experiments conducted at the Uni- versity of Cincinnati Medical Center, which continued for over a decade until 1972.2

The Advisory Committee on Human Radiation Experi- ments was convened by President Clinton in January I994 in response to allegations of unethical practices in radiation experiments involving human subjects that were sponsored by the US government between 1944 and 1974. The Com- mittee’s Final Report was released in October 2995. In ad- dition to analyzing the history of the ethics of medical re- search involving human subjects, the Committee reviewed current federal policies and procedures for protection of hu- man subjects. Although the Advisory Committee focused on human radiation experiments, a key finding of the com- mittee was that, in the past as well as today, there was no evidence of any difference in the ethics of the conduct of human radiation research and other areas of biomedical ex- perimentation. Thus the final report concerned all biomed- ical research involving human subjects, and not specifically human radiation research.’

The Advisory Committee identified 6 basic ethical prin- ciples as particularly relevant to its work: 1) One ought not to treat people as a mere means to the ends of others; 2) One ought not to deceive others; 3) One ought not to inflict harm or risk of harm; 4) One ought to promote welfare and prevent harm; 5) One ought to treat people fairly and with equal respect; 6) One ought to respect the self-determina- tion of others. The Committee was unanimous in its view that scientists of the future must have a clear understanding of their duties to human subjects and a clear expectation that the leaders of their fields value good ethics as much as they do good science. This far-reaching, wide-ranging re- port received national recognition further emphasizing the role of ethical principles in medical and surgical research and practice.

In his book “Bad Blood,” Jones states that the Tuskegee study of untreated syphilis in the Negro male is the longest nontherapeutic experiment on human beings in medical history.4 The original study population consisted of 399 Black men with syphilis and 201 controls. The study was intended to last for 6 to 9 months. However, as Jones dem- onstrates, the drive to satisfy scientific curiosity resulted in a 4O-year experiment that followed these men to “end point” (autopsy). In the final analysis, it was Peter Buxtun who stopped the Tuskegee Syphilis Study by telling his story to a reporter with the Associated Press. On July 26, 1972, the Washington Star ran a front page story about the ex- periment. This too is another example of scientific inves- tigation gone awry. So often today we hear of the lack of adequate numbers of African-Americans in various clinical research trials. It is believed by many in the scientific com- munity that the national outcry and sense of shame in 1972 concerning the history of the Tuskegee Syphilis Study with its failure to educate the participants and treat them ade- quately was a major factor in Blacks’ lacking faith in con- trolled trials.5

Yet clinical trials are absolutely essential if we are to gain information about diagnosis and treatment that have clin- ical significance. One of our nation’s leading cancer re- searchers, an ardent proponent of clinical trials, is Bernard Fisher who states “that clinical trials are mechanisms (tech- niques) used in the conduct of experiments to obtain data (facts) that can result in clinical problem solving. Such tri- als are components of science. The design and conduct of clinical trials and the analyses of results obtained from them are complex endeavors.‘lh It is well to keep Fisher’s thoughts in mind as we conduct clinical trials lest we arrive at pre- mature conclusions about the validity and significance of some study.

Ethics is defmed as the science of human conduct. Ed- mund Pellegrino, a noted medical ethicist, states that med- ical ethics refers to the entire medical and surgical arena- including prevention of illness, care of the sick, research with integrity and cultivation of health for individuals and society. Further, he believes that medical ethics must be based on the one irreducible foundation of all clinical med- icine-the relationship between rhe one who is ill and the one who professes to help and to heal. The concept of the “good of the patient” is the final criterion of whether a decision is morally sound. The principles he emphasizes are I) to protect the vulnerable, powerless, easily exploitable patient; 2) to be true to the ideal of the 2500 year old Hippocratic oath; 3) to weigh the possible risks and benefits to the patient; 4) to consider the impact of the patient’s illness on the family unit; 5) to remember that medicine is a moral enterprise; and 6) to be aware always of the primacy of the patient’s well-being.7lH

Michael Josephson, founder and president of the nonpar- tisan, not-for-profit Joseph and Edna Josephson Institute of Ethics, states that the Institute was designed to gather and focus the moral energy of people. Since its founding in 1987, the Institute has advocated that our American cul- ture was built upon a foundation of 10 consensual ethical values that form the basis of an ethical society: honesty, integrity, respect, caring, fairness, promise-keeping, pursuit of excellence, civic duty, accountability, and loyalty. The Institute contends that these 10 core ethical values form the philosophical basis for ethical judgment and define the moral duties and virtues implicit in ethical behavior. In July 1992 the Institute, in what is now termed the Aspen Dec- laration, called for character education based on six core values: trustworthiness, respect, responsibility, justice and fairness, caring, and civic virtue and citizenship. The Insti- tute emphasized that these values-called the Six Pillars of Character-transcend cultural, religious, and socioeco- nomic differences.’ Of these six values, the first five have definite applicability to the practice of surgery, emphasizing the special relationship that exists between patients and their surgeons.

In his scholarly American Surgical Association presi- dential address, “The Surgical Scientist,” Sam Wells” states that “the young scientist realizes that the key to academic success comes through laboratory or clinical research yet clearly the integrity of our specialty depends primarily on how well we care for our patients.” There are few character traits that exceed loyalty in importance. Loyalty is one of man’s highest virtues. It implies integ- rity and honesty, and integrity is the essence of our being.

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We must be loyal to high ethical principles as we treat our patients, but loyal to individuals only if they embody these same high principles.”

We must never forget that the object of our affection is the surgical patient. I f we ever forget that, then this Lecture and all other similar lectures will amount to naught for we will have forgotten the most important person-the pa- tient. We know that it is not just that we live but how we live. The quality of life remains most important. Probity and moral rectitude will always be vital assets. High ethical principles represent the grace notes of our profession and involve not so much intellectual rigor but a disciplined spirit.

While giving our patients the best possible care which must be combined with the highest ethical and moral stan- dards, we must continue to be powerful advocates for our patients justifying our roles as surgeons who are guardians of our populace’s health. And perhaps Sir Berkeley Moy- nihan, the venerable British surgeon, stated it aptly when he said, “Ours are not the mild concerns of ordinary life. We who like the happy warrior are doomed to go in com- pany with pain and fear and bloodshed have a higher mis- sion than other men, and it is for us to see that we are not unworthy.“l’ And I submit to you, if we keep high ethical principles in the vanguard of our thought coupled with high quality care to our patients, we will not be found unworthy as members of our noble and honorable profession.

REFERENCES 1. Code of Medical Ethics. Current Opinions with Annotntions. 150th Anniversary Edition of American Medical Association, Council on Ethical and Judicial Affairs, 1997. 2. Buchanan A. Judging the past. The case of the human radiation experiments. Hastings Center Report. 1996;26(3):25-30. 3. Research ethics and the medical profession. Report of the Ad- visory Committee on Human Radiation Experiments. JAMA. 1996;276:403-409. 4. Jones J. Bad Blood: The Tuskegee Syphilis Experiment. A Tragedy for Race and Medicine. New York: The Free Press; 1981. 5. Thomas SB, Quinn SC. Public health then and now. The Tus- kegee Syphilis Study, 1932 to 1972. Am ] Public Health. 1991;81:1488-1504. 6. Fisher B. The evolution of paradigms for the management of breast cancer: a personal perspective. Cancer Res. 1992;52:2371- 2383. 7. Pellegrino ED. The medical profession as a moral cbmmunity. Bull NYAcad Med. 1990;66:221-232. 8. Pellegrino ED. Toward a reconstruction of medical morality: the primacy of the act of profession and the act of illness. J Med Philos. 1979;4:32-56. 9. Josephson M. Making Ethical Decisions. Los Angeles, CA: The Josephson Institute of Ethics; 1992. 10. Wells SA Jr. The surgical scientist. Ann Surg. 1996;22:239- 254. 11. Leffall LD Jr. Medical ethics in today’s society. Am Coil Surg Bull. 1994;79(2). 12. Moynihan B. Essays on Surgical Subjects. Philadelphia: WB Saunders; 192 1.

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