Tuskegee Redux

An amazing story broke in the news yesterday regarding human experimentation studies with syphilis in Guatemala in the late 1940's. At the Center of this was John Cutler, who went on to play a central role in the infamous Tuskegee study, followed by a long career in Public Health at the University of Pittsburgh. While Cutler's role in the Tuskegee (and Sing Sing)  study has been explored extensively, his earlier role in syphilis studies in Guatemala had evaded detection until Dr. Susan Reverby stumbled upon his writings when reviewing Dr. Cutler's papers. While Cutler came into the Tuskegee study decades after it had begun, his role in the Guatemalan study was much more damning. The study subjects were prisoners and mentally ill and the rationale for their choice appeared to be specifically because Dr. Cutler knew such studies could not be done in the US.

The revelations are a public relations nightmare for the PHS. Furthermore, they also create all sorts of problems for the University of Pittsburgh where he served as chairman of Pitt's department of health administration and was acting dean of the Graduate School of Public Health in 1968 and 1969. He retired in 1985 from the University although he reportedly remained active until shortly before his death in 2003. Since 2005, the John Cutler Global Health Lecture and Award has been bestowed upon candidates annually. I am not sure I would want to include such an award on my CV going forward.

However, we all should all be wary of judging Dr. Cutler for what he did unless we really think hard about understanding what specifically about his undertakings was so reprehensible. Do not get me wrong. In my estimation, what he did early in his career, particularly the studies in Guatemala are so unacceptable that his subsequent accomplishments provide hardly any cover.

One principle which trumps virtually all other principles is that of autonomy. With very rare exceptions, patients and research subjects have unquestionable control over their own bodies. No matter what our intentions as individual clinicians and researchers, we must respect the autonomy of others who we interact with. All other goals and aspiration that we have as clinicians and researchers must be subservient to the principle of autonomy.

If the reports are correct regarding Guatemala, Dr. Cutler grossly ignored the principle of autonomy. However, he was not alone as evidenced by later work by Dr. Beecher published in the NEJM. http://whqlibdoc.who.int/bulletin/2001/issue4/79(4)365-372.pdf  Although he was criticized for his role in Tuskegee during his lifetime, his legacy was left pretty much intact, as evidenced by the lecture and award at University of Pittsburgh which bears his name. My guess is it will not survive these revelations.

While this particular revelation has substantial shock value and I do not think there are ongoing and gross violations in federally sponsored research programs now of this magnitude , I would venture to say that we still don't have this autonomy thing fully worked out. That is because our general perception of the "wrongness" of what Dr. Cutler did is based upon gut and shock value and not a true understanding of the specifics.

At the very heart of the problem is the process of informed consent. People should have control over their bodies and control means the ability to agree to partake in various activities. That is the consent part. We all know that means to get permission and agree to something, whether test, treatment, or participation in a study. However, in my estimation it is the informed part is where the problem lies. We all know that what Dr. Cutler did was wrong because we all know there is no way he could have convinced that number of people to participate in such studies if they were actually informed sufficiently to let them know what they were getting into.

In the present, patient and subject participation is generally within contexts where reasonable people well informed might decide either way, to participate or to not participate. Under these conditions, how can we tell if patients/subjects have been adequately informed? I would argue that the infrastructure we have put in place will protect against the most grievous transgression, but primarily serves the needs of the clinicians and research sponsors. It constructs a legal framework and paper trail  which serves as a charade for patient protection, a perfect example of regulatory capture.

As I march through my days on those that I function as a clinician, I am struck by the the hurried decisions I make, recommending diagnostic and therapeutic interventions which are based upon little or no hard data. Because of my particular awareness and sensitivity to this issue,  I at least make a serious attempt to focus on the informed part of the equation. However, it is very difficult to assess who is truly informed. No good tools have been developed to help us with this process. Does the patient understand what is at stake? How should we frame the question?

I suspect that my practice in my particular specialty is not very different from other practices. The clinical scenarios might be different but virtually all are marked by hurried decisions made with insufficient data, limited time for reflection, and patients who haven't a clue as to what they have agreed to. This is important for both procedural endeavors (where historically there has been the most emphasis) and for diagnostic tests, (For an interesting spin on this see http://getbetterhealth.com/the-american-cancer-societys-hype-prostate-cancer-screening-clearly-saves-lives/2010.10.02). It does not matter whether someone has signed a piece of paper. Consent is basically meaningless unless it is informed consent.

Let us roll the clock forward fifty years and I can see the outrage. Dr, Cutler never made an attempt at obtaining consent from his subjects and it could be said that he misled them, particularly those involved int he Tuskegee study. Few questioned these actions at the time but he is currently (and appropriately) judged harshly for these transgressions. It could be argued that we in the present world make only feeble efforts at true informed consent. This may not be viewed as a serious transgression through our present day lenses but will this be viewed with similar outrage to Tuskegee in the future?