REBECCA S BUSCHAdvances in modern medicine have seen many fatal conditions eradicated from society. Yet we remain plagued by the threat of life threatening and often debilitating illnesses such as cancer. In the age of medical technology and extensive knowledge on the human body and physiology there is an expectation from society that the medical fraternity should have a solution to all conditions. Alas, the reality is that there are still many unknowns and incurables that human beings have to contend with. The moral dilemma now exists where the need for advances in research and clinical trials are called for (especially among those impacted by these conditions), whilst there is recognition of the fine line drawn when trying to avoid questionable ethics in the use of human subjects to achieve these results. In the aftermath of World War II and the Nuremberg trials that followed, it was determined that ethical guidelines needed to be developed to define the parameters within which medical research could be conducted in a morally acceptable manner. In 1947 the Nuremberg Code was written in an attempt to formulate universal standards for research with human subjects.
However this ten point code was not very extensive, it offered merely guidelines for researchers and their funding institutions. Modern researchers tend to frown upon some of the practices of historical studies in their subject selection and what they deem abuse of human subjects. This perceived disgraced period of medical research has come under light recently with the documentation of the history of medicine. In his research, Robert Aronowitz, a historian of medicine, stumbled upon the research of Dr. Perry Hudson, famed for his role in the transformation of the clinical approach to Prostate Cancer. At the time of his research in the 1950s, prostate cancer was only diagnosed post-mortem and was perceived to be a fatal condition of men over 50, with very limited chance of survival. Dr. Perry Hudson believed that early detection and treatment in living men was possible and key to improving survival rates. He set out to prove the efficacy of early detection procedures and resulting early treatment protocols. However this required human subjects willing to undergo invasive screening by performing an open prostate biopsy to test for prostate cancer. A prostate biopsy is a procedure in which prostate gland tissue samples are removed with a special biopsy needle. As with any surgical procedure, complications can occur, in this case bruising and discomfort, prolonged bleeding and Infection near the biopsy site, and difficulty urinating were a few examples.
As can be expected finding subjects willing to endure this procedure proved difficult at first. It is documented that while treating an alcoholic down and out Princeton Professor who had become homeless, Dr. Hudson had the idea to approach other homeless men to participate in the study. As the men were from the Bowery neighborhood of New York City, his research became known as the Bowery series. While the outcomes of the Bowery series has been acknowledged as vastly improving the attitude toward early detection and consequent treatment of prostate cancer, the methods used to obtain this knowledge has retrospectively been criticized for being riddled with questionable ethics. Bowery men are classified as a vulnerable group due to the prevailing poverty, alcoholism, and mental and physical illness that characterized these men.
The early 1950s was a period of rapid change in cancer care and clinical research. There was urgency for cancer research which led to combined research and clinical initiatives. In the 1950s virtually all cancer treatment could be viewed as experimental as there had not been robust clinical trials into chemotherapeutic or radiation practices widely used today. This meant that there was widespread administrative and resource support for cancer research, making Dr. Hudson’s research objectives a viable pursuit. The argument against the ethics of the Bowery series is that the vulnerability of the Bowery men was exploited in order to obtain consent. However one could argue that by available standards, Hudson and his fellow researchers had abided by the ethical guidelines of that time. The Nuremberg code in essence spoke of Autonomy, Beneficence and Justice as key guiding principles. Dr. Hudson claims that Autonomy by way of informed consent was observed, in that all participants were voluntary subjects of the study. He also maintains that while the biopsies were invasive, the benefits of participation in the study far outweighed the risk. Subjects who tested positive to cancer underwent the radical prostatectomy in an attempt to cure the men, which Dr. Hudson maintains was effective thereby saving these men’s lives. Those ‘patients’ who tested negative were still offered holistic health care at the hospital where the study was conducted. It was only much later, in the 60s that these ethical principles were further extended with more rigorous and specific guidelines and definitions.
Today, informed consent does not only refer to a person’s voluntary participation, but outlines specific information that must be presented to the individual to their full understanding before consent can be granted. Information such as potential risks and discomforts, rights of the research subjects and consequences of withdrawal from the study are a few examples. By this definition of informed consent, the Bowery series falls far short of achieving this ethical principle. However, to make Hudson’s Bowery series synonymous with the atrocities carried out by doctors under the Nazi regime is superfluous and unfair, because while on both counts vulnerable groups were used as human subjects, the Nazi doctors did not attempt to obtain any form of consent nor did they seek to provide any care or advantage to their subjects.
Hudson’s interpretation of the Nuremberg guidelines may have been very superficial, but he argues that his subjects were not coerced into participation and that they greatly benefited from it. While Aronowitz’s historical account of the Bowery series paints a dark shadow over Dr. Hudson and the funding institutions that supported his research, he acknowledges that this study played a fundamental role in changing the pessimistic and fatalistic attitudes toward prostate cancer and hence improved the overall clinical approach and hence survival rates of this previously hopeless condition.
Bottom Line:
Advancements in medical research must always parallel a discussion on prevailing ethical standards.
Thanks for reading! Have a story to share? Feel free to send me a note at rbusch@mbaaudit.com.
Rebecca S. Busch, RN,
Healthcare Advocate
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