Friday, October 18, 2013

Unethical Skid Row Prostate Cancer Experiment Condemned Decades Later

Advancing Honest and Ethical Medical Research


The New York Times reports that in the 1950s and 1960s more than 1,200 men living in flophouses on the Bowery in New York City were subjected to an "abhorrent" high risk, invasive experiment involving surgical biopsies--cutting a slice of their prostate.

The principal researcher, Dr. Perry Hudson of Columbia University who sought to test experimental treatments for prostate cancer, insisting that the biopsies posed no risk was supported with government grants.  In fact, the experimental biopsies caused  many of the men "serious complications, including rectal lacerations. A third of them became impotent and another third had diminished sexual function." 
At age 96 Dr. Hudson has no remorse.

Furthermore, the experiment lacked scientific validity inasmuch as: "Dr. Hudson did not set up a control group of Bowery men who did not get the biopsies and treatment. As a result, he had no way of comparing the men who got the interventions with those who did not or of documenting whether the men he treated lived longer."

The Times reports that about 100 of the 1,200 men recruited were found to have cancer and were aggressively treated with surgery and estrogen--experimental treatments that left them impotent, incontinent, and at increased risk of heart attacks and strokes.

This unethical experiment was widely cited in medical journals and textbooks--yet, no one in the medical community objected to its gross ethical violations--in complete disregard of the 1947 Nuremberg Code.  The impoverished human beings whose meal tickets at the city-run flophouse were withheld until they kept their surgical bipsy appointment, were not accorded their human right to voluntary informed consent--they were clearly regarded by the researchers as inferior beings.

The experiment is the subject of two papers by Dr. Robert Aronowitz published in the American Journal of Public Health and the Bulletin of the History of Medicine.
Although the efficacy of Dr. Hudson's approach--screen-and-treat surgically--has never been established, it became the prostate treatment paradigm for decades. 

The Bowery experiment is NOT an isolated instance: the American academic research establishment has closets full of skeletons--the unacknowledged casualties of unethical, high risk experiments conducted mostly on impoverished vulnerable persons whom researchers regarded as inferior beings.

AGAINST THEIR WILL, by Allen Hornblum, is a compendium of unethical medical experiments conducted on disabled children at state institutions.  Researchers viewed these children as "raw material for medical research." They subjected them to high risk, painful non-therapeutic experiments. 

For example, 1,100 children at Sonoma State Hospital who were disabled by cerebral palsy served as experimental subjects in experiments testing high radiation doses in order to learn how much radiation a human being can tolerate.  The researchers, led by Dr. Nathan Malamud, a prominent psychiatrist at the University of California, SF conducted experiments in which the child subjects were put through extremely painful procedures such as a psneumoencelphalogram in which air is injected into the brain before a series of X-rays.

How much have we really progressed?

The language has changed since then, but not the underlying culture of research supremacy.
For example, the controversial oxygen SUPPORT experiment sponsored and vigorously defended by the National Institutes of Health, was conducted between 2005 and 2009 on 1,316 extremely vulnerable premature babies whose parents were deceived about the nature of the experiment and the risks.  For babies randomized to receive restricted low oxygen supplements, the foreseeable risk was death and brain damage--but those risks were concealed from the parents. 

How much progress if government sponsored academic researchers violate federal informed consent disclosure requirements with impunity?

As a result of the public controversy, extremists within the medical research community, led by the Director of NIH, are lobbying for a waiver from informed consent requirements for experiments testing treatments they define as "comparative effectiveness research."

An unprecedented public hearing on August 28 focused primarily on the SUPPORT violations of federal informed consent requirements. 
However, like the Bowery prostate experiment, the scientific validity of SUPPORT was undermined by the lack of a control group of babies receiving individualized titrated oxygen supplements--as they would have in standard care. 
Videos of presentations here:
Public Comments here:!docketBrowser;rpp=25;po=25;dct=PS;D=HHS-OPHS-2013-0004

The Alliance for Human Research Protection strongly objects to a waiver from informed consent which is the very bedrock of medical ethics: 

Informed consent should never be abrogated for any research involving human subjects, under any circumstances, in any country, regardless of local standards and regardless of the type of research.

 Vera Sharav
October 17, 2013
Decades Later, Condemnation for a Skid Row Cancer Study 

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