- BIOETHICS FORUM ESSAY
After the Media Frenzy, Preventing Another ‘Guatemala’
I opened the boxes. There was almost nothing about Tuskegee, just a published article I already knew quite well, and nothing about the many studies and work he had done over a long distinguished career. There were just one study’s findings he left behind. I noticed the title on the unpublished research report: “Experimental Studies on Human Inoculation with Syphilis, Gonorrhea and Chancroid.” I read on and my jaw kept dropping.
The experiments being described all took place in Guatemala between 1946 and 1948. They were funded by a grant from NIH to the Venereal Disease Research Laboratory of U.S. Public Health Service (PHS) with the cooperation of the Pan American Health Organization and the Ministry of Health, the National Army, the National Mental Health Hospital and the Ministry of Justice in Guatemala. The purpose was benignly described as determining methods of prophylaxis against syphilis, understanding the effects of penicillin in treatment, questioning serologic tests, and enhancing knowledge of the biology and immunology of syphilis in man. What happened was anything but benign.
Cutler, with the assistance of Juan M. Funes, the leading Guatemalan venereal disease (as it was then called) specialist in their Ministry of Health, proposed a study involving prostitutes, because prostitution was legal in Guatemala and because prostitutes were allowed to visit men in penal institutions. “It was thought,” Cutler wrote, “that the prostitutes serving the penitentiary could furnish a means of securing the desired information.” What this meant was sending in a woman infected with syphilis or gonorrhea, allowing sex to occur, and then providing the “volunteers” with prophylaxis to see if it prevented infection.
When this did not provide enough of a pool of infection, Cutler and Funes moved on to repeating studies that had primarily been done with rabbits and chimpanzees. They created inoculums; they began abrading arms, faces, and penises. They began infecting subjects: not in the penitentiary, but in the country’s only mental hospital. They did blood draws (no infecting) at an orphanage to test various serology protocols and deal with the problem of false positives. They did provide treatment, but I could not really tell if everyone was cured. I could not believe what I was reading.
Even more amazing was that they knew this was on an ethical edge. Deception was seen as necessary. Cutler, writing to famed penicillin researcher and Public Health Service physician R. C. Arnold in 1947, admitted that they were not really telling very many people that the inoculums contained the syphilis bacteria. “As you can imagine,” Cutler reported to his colleague, “we are holding our breaths, and we are explaining to the patients and others concerned with but a few key exceptions, that the treatment is a new one utilizing serum followed by penicillin. This double talk keeps me hopping at times.” In a second letter, he repeated his concerns that “a few words to the wrong person here, or even at home, might wreck it or parts of it.” Cutler was not worried about his subjects; he was concerned with how his Guatemalan sponsors would see it and others at home.
Arnold was worried. Eight months after the Nuremberg trials of Nazi doctors had ended, he confided to Cutler, “I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent. Maybe I’m too conservative. . . . Also, how many knew what was going on. I realize that a pt [patient] or a dozen could be infected, develop the disease and be cured before anything could be suspected. . . In the report, I see no reason to say where the work was done and the type of volunteer.”
The studies finally did not amount to enough to warrant publishing. As penicillin was proving so successful, the Public Health Service had little money for this kind of work. Cutler was told to pack up, leave supplies for the Guatemalans, and come back to be assigned elsewhere.
I brought my notes home and thought about putting this information in the Tuskegee book. I did not want the two studies confused, however. Guatemala was an inoculation study where men and women were given a disease. Tuskegee was a study where the men already had the disease (despite the many myths I have spent nearly two decades trying to counter). In Guatemala they proffered treatment (even if maybe not to everyone). In Tuskegee they tried to keep everyone from treatment (even if they did not succeed). I decided to leave the Guatemala story out of the book. It would be too confusing and too complicated to explain.
I did not forget it, however. I went back to Pittsburgh in June of 2009 to look at the materials again and take even more careful notes. I finally wrote a paper based on it in March 2010 and gave it in May at the annual meeting of the American Association for the History of Medicine at the Mayo Clinic in Rochester, Minnesota. I was on the last session of the last day. There were 20 people in the audience. The discussion was lively, but not overwhelming. After the semester ended, I wrote the paper up and sent it to the Journal of Policy History because it was planning a special issue on human subjects. It will be out this coming January 2011. (For a prepublication copy, see my Web site.)
What might have been buried in an historical journal, however, took another step. To make sure I had the medicine right, and because we had briefly discussed it, I sent a copy off to Dr. David Sencer, the former director of the Centers for Disease Control and Prevention whom I had interviewed about his role in the responses to the study in Tuskegee. Duly disturbed by what I had written, Sencer asked if he could send it to current CDC officials before it came out. I agreed.
This is when my discovery took on another life. CDC officials were concerned enough to ask me for more notes and then to send their leading syphilis expert to Pittsburgh. His report confirmed my findings and by examining the medical records more carefully determined that not enough penicillin was given to everyone. After that my paper and the story went up the chain of command. It took some convincing along the way to explain to officials outside the CDC how important this was. By early September, this realization had clearly permeated various sectors of the government as far as Department of Health and Human Services and even the White House.
By October 1, I agreed to post my pre-copyedited article, and the official apologies by Secretaries Hillary Clinton and Kathleen Sebelius were arranged, the Guatemalan government was alerted, NIH and the State Department held a joint press conference, and President Obama called President Colom in Guatemala. The administration has asked for an Institute of Medicine report and the Presidential Commission for the Study of Bioethical Issues is set to examine how we protect individuals now, especially in studies done by Americans outside our borders.
The press coverage and reaction has been overwhelming, crossing the world in just more than a nanosecond. As I have been called upon by now countless media outlets to discuss this all, it has been difficult to do what historians do best: explain details and context.
Most reporters want the most salacious details that fit a trope from a bad science fiction film or our worst nightmares of what medicine can do. I am asked to “rate” which one is worse: the study in Tuskegee or this one in Guatemala. I am being besieged with people who have their own fears and stories, a couple of nasty e-mails, and one person who hopes that my family and I die. Some seem amazed that I did not just blog about this the minute I found it. Somehow careful thought and consideration, not to mention how to influence policy, is not part of this mix.
This experience is, in the end, a chance for all of us to consider the role that these kinds of exposures play in our work. Once the initial shock is over, what do we want the Guatemala revelation to do? The debate on the necessity for protections in the developing world continues and perhaps this will be a reminder of why they matter. I have tried to emphasize that Cutler was not just some aberrant monster. He thought the war on syphilis required these kinds of sacrifices. He thought he was doing good science.
I invite your thoughts on what we do with all this now.
Susan M. Reverby is the Marion Butler McLean Professor in the History of Ideas and Professor of Women’s and Gender Studies at Wellesley College. Her latest book isExamining Tuskegee: The Infamous Syphilis Study and its Legacy. Her last article in the Hastings Center Report was “More than Fact and Fiction: Cultural Memory and the Tuskegee Syphilis Study,” in 2001.
Posted at 10/06/2010 05:08:50 PM |
Published on: October 6, 2010
Published in: Clinical Trials and Human Subjects Research