Blog RSSBlog.

11/21/2017

Attica Leprosy Study: Ethical Issues In What Little We Know

by Craig Klugman, Ph.D.

We are indebted to the inmates of the Attica Correctional Facility who participated in this study and to the warden and his administration for their help and co-operation. – (Bullock, Fields, and Brandiss 1972)

Like most bioethics instructors, I begin my classes with cases and studies to link the theoretical material to the applied world. When teaching research ethics, this means discussing examples such as Tuskegee, Nazi War experiments, Radiation Studies, MKUltra, Milgram, Stanford Prison, Willowbrook, Holmesburg, and more. Preparing this material often leads me to wonder two questions: “Will we discover another case of human research subjects abuse from our past” and “Will what we consider to be acceptable research today be viewed as abuse 40 years from now?”

The answer to the first question is a new revelation by author Heather Ann Thompson who wrote 2016’s Blood in the Water about the Attica prison uprising in 1971. She was contacted by another writer, Eric Beaumont, who asked about a single paragraph in her 752-page book that discussed medical experiments being done on prisoners. Beaumont also provided her with a 1972 journal article about the study:

An Evaluation of Transfer Factor as Immunotherapy for Patients with Lepromatous Leprosy” was published in The New England Journal of Medicine in 1972. Three physicians with grants from the U.S. Public Health Service and the NIH conducted immunological tests on prisoners with Hansen’s Disease (leprosy). The article has been cited 128 times (according to PubMed), most recently in 2017.

Given the history of human research subject abuse in prisons, Thompson was interested in how the study related to Attica prison and “which of Attica’s nearly 2,400 prisoners, I wondered, was the subject of experiments relating to this crippling disease, without… adequate consent?”

According to the NEJM article, “Healthy adult male volunteers, inmates of the Attica Correctional Facility, New York, served as normal control recipients of immune-transfer studies after giving informed consent in writing.” Nine prisoners took part, 5 males and 4 females, spanning in ages from 18-50. Six of them were newly diagnosed and had not been treated. All of the prisoner-subjects were subject to physical exams, photographs, blood tests, skin reactivity tests, and skin biopsies. Five also had lymph node biopsies and three had liver biopsies. The intervention appears to have been a transfer of white blood cells from normal adult males to determine if the immune reaction would treat their disease. There was a period of two weeks when they did not receive treatment for their underlying disease. Subjects were studied for 350 days, often examined twice per day. Follow up occurred 18-36 months after the interventions. At the conclusion of the study, all were given treatment “assumed to be effective.”

The big questions this study raise revolve around consent, autonomy and coercion.  In a footnote, the authors note that there was university review of the study. “Permission for this study was given by the New York State Department of Health and Corrections, and the University of Rochester Clinical Investigation Committee.”  NY State permission would have been necessary to gain access to the prison and prisoners. I called the University of Rochester IRB to learn whether this clinical investigation committee would have been only a scientific review group or if there was human subject review as well. I suspect the latter because the above quote is a footnote in the article to a statement that all subjects gave “informed consent in writing.” What was included in such consent is unknown at this time. As of posting, those calls have not been returned. Perhaps the records do not even exist.

While the consent process is unknown, consenting in 1972 was brief compared to the long and detailed processes and documents of today. We also do not know the circumstances of the consent process: Did it take place in a separate room, the clinic, or the warden’s office? Were potential subjects just given a paper to sign? Who talked to them about consent? Did they understand what was to be done to them? Was this presented as “experiment” or as “treatment” (as was done in Tuskegee)? Was the warden or other prison official in the room with them? If so, was there any coercion or pressure to sign?

Thompson suggests that prisoner-subjects did not receive special treatment, housing, food, or other privileges as did happen in the Holmesburg trials. The NEJM article reports that “The only benefit given to the volunteers was financial.”  We do not know is how much money they received. If the amount was more than an inmate would have received in a standard prison job, then the money could have been a coercive factor. In addition, it is possible that the inmates did gain an important benefit, spending time at a university facility instead of the prison. A final note in the article states: “We are indebted…to the nurses of the Clinical Investigation Unit, University of Rochester School of Medicine, for their support and care of patients involved in this study.” Were the prisoners housed at the Unit (in a separate space from the general population) or did the nurses visit the prison? Was testing done at the prison or were prisoners transferred to the Unit for their twice-a-day examinations? The fact that the prisoner-subjects had access to the nurses, to additional health care, and perhaps to a research-clinic environment may have had an influence on their decisions to participate.

For the standards of 1972, that there was written informed consent and that the article reported on potential coercive factors (even if incomplete) is remarkable. On the surface, the study leaves questions with few answers. The NEJM article was published in November of that year, 4 months after Jean Heller’s July exposé on the Tuskegee study, and 3 months after the U.S. Department of Health, Education and Welfare appointed an ad hoc panel to review that study. Given publishing timelines, it is unlikely that those events had an effect on the Attica study write-up.  This study offers a number of questions which will require investigation into the papers of the study authors, university, and NY State department of corrections in order to answer. It is possible that such records no longer exist and many of the people involved are deceased.

The lesson, according to Thompson, is not in seeking (and maybe finding) wrong-doing but in being concerned about lack of transparency and working with a vulnerable population: “But this latest revelation is a wake-up call for all of us. Prisons are public institutions, and we must insist on knowing what takes place behind the walls. It is past time for New York finally to open all of its records on Attica.“

Comments are closed.