Academic Medicine (2000) 75 999

By Melissa Reed,2014-04-30 07:41
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Academic Medicine (2000) 75 999 Academic Medicine (2000) 75 999

Academic Medicine (2000) 75: 999.

    ? 2000 by the Association of American Medical Colleges


    Addeane S. Caelleigh

     The social consensus today is that people who take part in medicalresearch must be protected. Research proposals must be scrutinizedin terms of their potential for benefit and harm, for example,and the research participants must give fully informed consent. Many today are unaware, however, that legal protections forresearch subjects have grown from concerns about, and investigationsof, research conducted on prison inmates.

     Prison inmates have long been a particularly vulnerable groupof potential research subjects, and their use in medical experimentshas a troubling past. U.S. physicians used inmates for medicalresearch in the early decades of the 20th century, usually withovert or at least tacit approval of their colleagues. Thesewere mainstream investigators, even prominent in their fields.Dr. Richard P. Strong, a graduate of Yale and of Johns Hopkins Medical School, is an example. He was head of the GovernmentBiological Laboratory in the Philippines in the early 1900s,when that country was controlled by the United States and whenboth the U.S. Army and civilian scientists were researchingtropical diseases. In 1906 Dr. Strong tested a cholera viruson prison inmates in Manila; the Philippine governor had apparentlyagreed to the experiment but the inmates were not asked for consent. Later, it was claimed that all the inmates were awaitingdeath sentences, but there is doubt about that. After inmateswere injected with cholera virus, 13 died. A few years later,Dr. Strong conducted a beriberi study that resulted in the deathsof more inmates. He left the Philippines soon afterward to becomeprofessor of tropical medicine at Harvard. Lest this examplegive the impression that such experiments were unusually extremeor were restricted to overseas populations, the case of Dr.L. L. Stanley shows otherwise. Dr. Stanley, the physician at SanQuentin, performed testicular transplants on hundreds of inmatesbetween 1919 and 1922, first transplanting the testicles ofthe newly excuted and later the "animal glands" of goats andrams in order to test whether elderly, even senile, men couldregain their potency. The results were published in a major endocrinology journal.

     Even one of the most famous stories in U.S. research involvesinmates. Many textbooks tell of U.S. Public Health Service researcherDr. Joseph Goldberger, who in 1914 proved that pellegra, thena scourge of the poor, especially in the South, was caused bya nutritional deficiency. Some of the inmates in the study beggedto be removed from it once the rigors of the disease gripped them,but Dr. Goldberger denied their requests until the disease hadrun its course sufficiently to prove or disprove his theory.

     Most disturbing, however, is that even after the United Statesadopted the "Nuremberg code" in 1946, U.S. physician researchersdid not quit using inmates in research, despite the code's prominentprohibition against it. (Ironically, several high-ranking German

physicians at the Nuremberg Doctors' Trial were hanged specificallyfor conducting medical research on prisoners, and a chief defensehad been similarities to U.S. research using prison inmates.)Two factors probably were at workthe use of inmates as patrioticvolunteers for research during World War II, and the growthof academic- pharmaceutical connections for testing productsto meet FDA requirements. During World War II, the U.S. militarydesperately needed to find treatments for diseases afflicitingtroops fighting in the Pacific and needed to improve the abilityto handle trauma cases (better blood supply, skin grafts). Themilitary appealed to the inmates of major men's prisons to becomepart of the war effort by taking part in medical tests for newdrugs to treat malaria and dengue fever, for example. Inmatesin several prisons took part in difficult, often dangerous experiments.In the process, research programs in state prisons were transformedfrom small, even quixotic endeavors into broad, well-run, cutting-edgeprograms run by some of the best researchers. After the war,there seemed no reason to forego the excellent source of medicalsubjects, and the prisoners saw the research favorably.

The other aspect that affected U.S. physicians' use of inmateswas the AMA's apparent endorsement of prisoners as researchsubjects. Dr. Andrew C. Ivy, the vice president of the Universityof Illinois Medical School and a highly respected researcher,was the AMA's official representative at the Nuremberg Doctors'Trial and the prosecution's chief witness on U.S. medical ethics.He strongly defended U.S. physicians' use of inmates in research, believingthat coercion was not a necessary feature of the penal research environment.His principles for such research, published in JAMA in 1948,gave the sanction that opened state and federal prison populationsfor a wide range of clinical studies conducted by major academicmedical centers and the government.

Once the FDA instituted regulations for testing new drugs inthe 1960s, pharmaceutical companies formed alliances with academicmedical centers and private research institutes to have productstested. A major site for the studies was prisons. And the studiesshifted from syphilis and hepatitis, malaria and influenza,to include cosmetics, detergents, psychotropics, and warfareagents. The apogee was probably the elaborate system at the Holmesburg Prison in Philadelphia, where for decades thousandsof inmates were involved in studies, most of them under thedirection of Dr. Albert Kligman of the University of Pennsylvaniaand his residents. Only in the 1970s did the sloppy design and conduct of the studiesnot the use of inmatesendDr. Kligman's work at Holmesburg and his years of governmentand private grants. But it was as information about the nature of the studies, the inmates' circumstances, and the prison conditionscame out, and as the intensity and seriousness of the ethicalquestions rose, that the U.S. medical establishment and theAmerican people re-examined the ethical standards for researchusing inmates. The protection of all human research subjectsbecame a principal value of medical research, and medical researchin prisons soon ended.

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