Ups and downs in the history of medical ethics

Ethics is defined as norms of conduct that distinguishes between desirable and undesirable behavior. Ethics related to medical practice research and public health policies for health care delivery had always been considered to be of paramount importance from the beginning of the history of human civilization. India has a rich heritage in this regard. During the "Ayurvedic period" between 600 BC and 800 AD, ethics in health care delivery and medical education were most judiciously enforced. In Europe, the Greek physician, Hippocrates, first came out with a three-worded phrase "DO NO HARM," which was subsequently converted to 181-worded Hippocratic oath recited by medical students at graduation ceremonies. But, till renaissance, there were no regulatory mechanisms to control the ethical violations in medical practice and research. Subsequently, in 1803, Thomas Percival published his creation "Code of Medical Ethics." Codes were revised and replaced when ethical issues arose and caused public concern from time to time. A brief description of some important ethical issues in history and the regulatory mechanisms that came up is given in this article. Ethical guidelines for medical practice and their violations are as old as the history of human civilization. During the phase of River Valley Civilizations and Agrarian Civilizations, the people in general were morally stronger and medical practice and medical education were also ethically strong-based. When we look through the history of India, one can easily say that the golden age of Indian System of Medicine was between 600 B.C. and 800 A.D. The renowned historian, Mr. P. C. Ray called this period as the "Ayurvedic Period."[1] The ethical conduct in both healthcare delivery system, medical education and medical research was most judiciously enforced. Any lapse invited strong social disapproval. Arthashastra written by Kautilya prescribed death penalty for some of the worst forms of unethical practices in medicine.[1] Before admitting the students to the School of Medicine in Nalanda University, the students were meticulously screened to determine whether he had the right aptitude and attitude to learn the art of "Healing the Ailing." In Europe, during the time of Hippocrat and Gallen, the father figures in the history of modern medicine, there were surgeons like Hirophilus Erasistratus, etc., who dissected live human bodies, mostly the victims of war, without anesthesia to study the human anatomy. Hippocrats (460 BC to 377 BC) vehemently opposed this cruelty, which resulted in the origin of the famous "Hippocratic Oath."[2] The essential component of the Hippocratic code of ethics was based on the principle of non-maleficence and came out as a three-worded phrase "DO NO HARM," which subsequently evolved into the 181-worded Hippocratic Oath recited at Graduation ceremonies. Invention of anesthesia, aseptic surgery etc. changed the situation. During the intellectual revolution of 18th century (Renaissance), Thomas Percival published "Code of Medical Ethics" in 1803.[3] In 1846, the American Medical Association came out with its own Code of Ethics, which was modified in 1897. In 1858, the General Medical Council (GMC) of U.K. came out with a code of Ethics through a Parliament Act, and in 1898, Germany came forward with its Ethics of Science and medicine. In 1956, Medical Council of India enacted its regulations on Code of Medical Ethics, which was revised in 2002 and 2007. In 1972, a separate Code of Medical Ethics for practitioners of Indian system of medicine came into being. The Code of Ethics originated so far can be chronologically arranged as shown in Table 1.Table 1: History of the evolution of the code of ethicsEverybody believed that a new generation of medical practitioners committed to Hippocratic Oath was coming up. The greatest blow to this belief occurred with the Nuremberg Trial. Nuremberg Trial[45] was conducted in the city of Nuremberg in Germany to try war criminals between 20th of November 1945 and 1st of October 1949 where case was heard by an international Jury. This was followed by Doctors Trial conducted by U.S. Jury in the same city of Nuremberg in the palace of Justice against 20 doctors including Karl Brandt, the personal Physician of Adolph Hitler, who used the innocent prisoners in concentration camps, mentally retarded children, terminally ill patients etc. for human experimentation without their consent and ultimately killed them under the guise of Euthanasia. Seven were sentenced to death, seven were acquitted, and the remaining were sentenced to imprisonment from ten years to life time. Nuremberg Code[45] is a set of ethical principles for human experimentation in medical research framed in the year 1948 following the verdict in the Doctors Trial on August 20th 1947. There were ten important clauses in the Nuremberg Code. The code explains how to take a valid informed consent from an experimental human subject and explains the different phases of clinical research to make sure that human subjects are used only after successful completion of lab and animal experimentation. The code also insists that human experimentation should be done only by qualified scientists and doctors. Nuremberg Code was the first international document that advocated voluntary participation and informed consent for all human experimentation in medical research. Unfortunately, though Nuremberg Code had a regulatory mechanism to control unethical human experimentation in medical research, incidences of ethical violations continued. A few examples of such incidences are narrated below: Gautemala Trial (1946-48)[6] was a project of the U.S. Public Health Department to study the transmission of syphilis through direct contact and effect of Penicillin against syphilis. One thousand three hundred innocent people consisted of prisoners of Indiana soldiers, sex workers, mentally handicapped and orphans; 83 of them died at the various stages of syphilis. Dr. Cutler was the main person behind this ethical tragedy and he went to Tuskeejee after this cruel trial, which was described by Obama's Bioethics Commission as ethically impossible because all the four principles of ethics viz, Autonomy, Beneficence, Non-maleficence, and justice were violated. Thalidomide Tragedy of 1950:[6] Thalidomide was a drug used to control sleep, nausea, and vomiting, associated with morning sickness in pregnant women. Soon it was proved that the drug causes severe congenital anomalies. But, the medical community never revealed the new invention to the patients and continued to use the drug. Later, it was found that 12,000 babies were born with severe congenital deformities. This became a major issue in United States and led to further enactment in the form of "KEFAUVER AMENDMENTS" to the food, drugs and cosmetics Act of U.S.A. Tuskeejee Syphilis Study 1932-72:[6] The notorious Tuskeejee Syphilis study was conducted by the United States Public Health Service to study the natural history of syphilis. Four hundred low-income African Americans who were infected by syphilis were observed for 40 years consecutively without giving any treatment inspite of the fact that definite curative treatment was available from 1950 onwards without informing the patients or their relatives. In 1973, this was noticed by the public and became a political issue, and the Government was forced to withdraw the study in 1973 due to political pressure. In 1977, President Clinton apologized to the participants and their families and said "What was done cannot be undone, but we can end the silence-we can stop turning our heads away, we can look at you in the eye and finally say, on behalf of the American people, what the U.S. Government did was shameful and sorry. U.S. Govt. disbursed 119 billion as compensation. Belmont Report:[7] This incident also resulted in the genesis of a new Act viz., National Research Act of 1974. As per provisions of the Act, a National Commission was constituted for the protection of human participants in bio-medical research, behavioral research. The Commission drafted the historic "BELMONT REPORT" in 1979 April 18, which is now considered as the landmark document on ethics of human participants in medical research. The three principles that highlighted in Belmont Report are (i) Respect for persons and informed consent, (ii) Beneficence, and (iii) Justice. The content of the Belmont Report can be summarized as depicted in Table 2.Table 2: Ethics principles and application of the Belmont reportHelsinki Declaration of 1964[8] Contain ethical regulations governing the medical research involving human experimentation. World Medical Association took the initiative in bringing out this landmark declaration on ethics related to bio-medical research. The declaration spells out the rules related to the various ethical issues in clinical and non-therapeutic medical research. The issues addressed in Helsinki declaration are: Research in human should be based on research from lab and animal experimentation. The research protocols should be reviewed by an independent and competent committee prior to the initiation of research. Informed consent from human participants is mandatory. Research should be carried out only by medically/scientifically qualified persons. The risk involved in the research should not exceed the benefits. Helsinki Declaration could bring down the incidence of ethical violations in bio-medical research to considerable extent. But, we can see the animal instincts of man again prevailing over all these regulations. One of the major ethical violations that was brought to light after the Helsinki declaration was by Beecher of Haward Medical School. Hospitalized patients were injected with plutonium without their consent to study the toxicity of plutonium. Beecher brought out 12 similar instances of unethical practices in medical research. Several other examples of similar nature can be n

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