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Background reading material by Professor Omar Hasan Kasule Sr. for Year 1 Semester 1 Medical PPSD session on Wednesday 12th November 2008.
EARLY HUMAN EXPERIMENTS
Experiments on humans are as old as history. Early humans experimented with several plants and by trial and error found some to be useful as medicines and others to be poisonous. Such trials have continued throughout human history giving rise to a corpus of traditional medicine. Many medical systems including tibb nabawi represent empirical knowledge accumulated over time by many informal and often un recognized medical experiments. These early experiments were not planned in a systematic way neither were they documented.
Planned medical experiments are quite recent. Galen is credited with being the founder of experimental medicine before 200 CE. In 1747 CE James Lind found out by experimentation that lemon juice prevented scurvy. Dr Edward Jenner found in 1798 that material from cowpox lesions prevented small pox. In 1914 Goldberger discovered the prevention of pellagra. Experiments were sometimes carried out on whole communities such as the study of vitamin C in the prevention of the common cold, the Salk and HBV vaccine trials, the multiple risk factor intervention trial (MRFIT) against cardiac disease, and fluoridation of community water supplies to prevent dental caries. Some trials are therapeutic such as the randomized study of aspirin myocardial infarction study. One of the earliest clinical trials was the use of streptomycin in the treatment of tuberculosis in 1948. Preventive studies such as the women’s health study in which vitamin C and low dose aspirin were given to prevent cancer and cardiovascular disease or the use of alpha-tocopherol and beta-carotene to prevent lung cancer among smokers. Modern sophisticated research on humans in search of new drugs is an outgrowth of these early efforts. Modern medicine would not have progressed as it has without some form of experimentation on humans. If a new drug is to be used on humans, it has to be tried on humans because animal experiments are not adequate and may not be relevant to humans.
HUMAN TRANSGRESSION
Humans are wont to transgress against other humans. Human transgression has manifested in several forms of human experimentation. The search for new cures using human experimentation showed extreme forms of human transgression and disrespect for human life in the Nazi and Japanese inhumane medical experiments on prisoners in the Second World War. These were extreme but not isolated incidents. Despite the horror of the details revealed at the Nuremberg trials of Nazi medical experiments, unethical medical experiments without informing the subjects or getting their consent continued after the second world war.
In the 1950s LSD and other drugs were used in experiments to discover drugs that could control human behavior. In 1953 a CIA employee used in an experiment on LSD without consent developed psychiatric symptoms and committed suicide. In 1953 Harold Blauer, a hospitalized psychiatric patient in a research project funded by the US Army, died after injection of mescaline. In the period 1940s to 1960s the US Atomic Energy Commission conducted experiments on unsuspecting subjects including children to study the effect atomic weapon irradiation. In 1954-56 elderly patients at the Brooklyn Jewish Chronic Diseases Hospital had cancer cells injected directly into their veins. In the period 1932-1972 under the Tuskegee Syphilis Study, 400 Black American men with syphilis were deprived of any treatment in a study of the natural history of syphilis without their informed consent. In 1946-1956 retarded teenage boys in Massachusetts had radioactive iron and calcium put in their breakfast cereals. In the early 1950s in Massachusetts pregnant women had radioactive iron injections to study fetal circulation. Some of the pregnant women involved in the thalidomide disaster were not informed of the experimental nature of the drug.
NUREMBER CODE 1946
Twenty-five physicians were charged at Nuremberg after World War II for Nazi inhuman experimentation on humans. Seven were acquitted, 9 were imprisoned, and 9 were sentenced to death. The Nuremberg code was laid down in 1946 in response to the criminal Nazi experiments on humans during the war. The main provisions of the code were: (a) Voluntary informed consent (b) No random or unnecessary experiments (c) Animal experiments and survey of disease natural history before subjecting humans to similar experiments (d) Avoiding unnecessary physical and mental suffering (e) The researchers must be scientifically qualified (f) subjects can withdraw at any time (g) the investigation is stopped if the patient is in danger. There was however no mention of experiments involving children.
HELSINKI DECLARATION
The World Medical Association drew up the Helsinki Declaration, incorporating the Nuremberg code, in 1964. The latest version (1996) was approved by The 48th Assembly of the World Medical Association held in South Africa in 1996 approved the latest version. The code is divided into three sections: Introduction, Basic principles, clinical research, and non-clinical research.
The introduction asserted that the primary duty of the physician was to act in the best interests of the patient. It pointed out the role of research in advancing knowledge of diagnosis, therapy, or prophylaxis with the caution that such research always carries a risk to the subject. A distinction was made between clinical research involving search for new treatment and diagnostic modalities and purely scientific research that had no direct benefit to the patient. This distinction is however questionable because clinical research in based on prior basic scientific research. The code also alluded to environmental concerns and the welfare of animals used in research.
The following basic principles were included in the code. Research on human subjects must conform to generally accepted scientific principles and must be preceded by laboratory and animal experiments. A competent and independent committee must approve the research protocol, setting out all details of the research and a statement of adherence to the Helsinki declaration. The research is carried out by qualified researchers and under the supervision of a medically qualified person who must assume full responsibility for the welfare of the research subjects. The research must be preceded by careful risk-benefit assessment. The research can be carried out only if its risks are predictable, the objectives are important when considered with the potential risks, and the benefits outweigh the risks. Research subject integrity in the form of privacy, physical, and mental welfare must be respected. Research subjects are entitled to full disclosure that covers the aims, methods, and potential hazards of the research before they give their voluntary informed consent. They should be informed that they are free to abstain from the study or to withdraw at any stage. Proxy consent is obtained for the legally incompetent, children or the mentally retarded. Results of the research will be accepted for publication only if they are accurate and conform to the principles of the Helsinki Declaration.
The declaration defined and approved clinical research as medical research combined with medical care. The physician is free to use a new therapeutic or diagnostic measure that in their judgment has hope of improving life and alleviating suffering. The potential benefits, hazards, and discomfort of the new method must be weighed against the best current and available diagnostic and therapeutic methods. Use of a placebo in a control group is allowed if no better method is available.
The declaration defined non-clinical biomedical research as non-therapeutic research involving humans carried out only on volunteers either healthy volunteers or patient volunteers. In case of patient volunteers the experimental design should not be related to their illness. The lead physician in the research team retains responsibility for subject welfare. The research is terminated as soon as is judged harmful to the research subjects. In any case the interests of science and society should never take precedence over the welfare of the research subjects.
CRITIQUE OF THE ETHICAL CODES
The Nuremberg and Helsinki codes on experimentation have not been successful in stopping unethical research on research subjects who are weak members of society. As mentioned above, many unethical experiments were carried out in the US soon after Nuremberg. The basic failure is that these codes lack a clear identity. They are neither law that is enforceable using the normal legal procedures nor are they moral standards that are enforced by the inner conscience of the experimenter. These codes are a reflection of the secularization of society in which morality was divorced from law and public affairs. Ethical codes are a bad attempt to mitigate the bad effects of a divorce.
Islam looks at problems of human experimentation as purely legal issues. The Law provides adequate guidelines and safeguards. Islamic Law, unlike western law, incorporates morality in its fabric. There is therefore no need to have special ethical codes outside the Law.