- BIOETHICS FORUM ESSAY
Still “Ethically Impossible”? The Presidential Commission’s Report on the STD Inoculation Studies in Guatemala
Nearly a year ago, on October 1, 2010, after I shared my research and article with the Centers for Disease Control and Prevention and its subsequent inquiry, the U.S. government apologized to Guatemala for the U.S. Public Health Service’s sexually transmitted diseases studies done between 1946 and 1948. President Obama asked his bioethical issues commission to investigate the historical details and contemporary international human subjects protections.
As news of the studies spread worldwide, bioethics added another seeming horror story to its pantheon, since the studies involved the deliberate infecting of prisoners, sex workers, mental patients, and soldiers with no consent, much effort at secrecy and deception, some gruesome inoculations, and the use of U.S. taxpayers’ dollars to pay for sex in a prison.
Last week, on September 13, the commission’s 202-page report on the history was released (its proposals on human subjects protections will be finalized by December). The bottom line: the report provides broader historical context, a greater sense of the deceptions, and more medical details, and it takes a strong ethical stand of blameworthiness toward the physicians who ran the studies. The outlines of the story remain the same as in my initial article and thereport of the CDC’s syphilis expert, John Douglas. What will now be remembered is uncertain, and the myth making is well under way.
I awaited the commission’s final report with some scholarly anxiety (what if I got something really wrong) and delight that professionals with skills both similar to and different from mine would be using the power of a government agency to find more answers. The commission examined 125,000 pages and 550 secondary sources. Its report, Ethically Impossible, the ironic title taken from a 1947 New York Times article that said such research was not morally possible, is a detailed accounting of the chain of command and institutional structures that made this study possible.
The report makes clear that John Cutler, the Public Health Service’s principal investigator on the research, was not a deranged physician adrift in the heart of darkness. With well-designed charts of the personnel on the NIH grants committees and within the PHS, and citation of much of the correspondence, it is obvious that Cutler, who was just 31 when this began, had support at NIH and up to the office of the Surgeon General. With the names provided, it is also obvious that many Guatemalan officials and doctors were knowledgeable of the studies.
Yet when the commissioners discussed the report at their public meeting on August 29, the need to have a name to focus on returned the discussion to Cutler himself (with an occasional effort to utter the names of some of the others). No story such as this can so easily be blamed just on the nature of doing cutting-edge scientific work or a faceless bureaucracy. There had to be names. Subsequent media accounts have now called Cutler a “monster” or Dr. Mengele.
Numbers are always an issue when we try to wrap our minds around a finding like this and weigh its effects. Based on the general statistics in the written reports that I had found in the University of Pittsburgh archives (where Cutler had deposited them), I argued that the study involved many hundreds. The CDC’s Douglas had his staff go more systematically through the medical records, and notebooks and came up with 1,560: “696 exposed to syphilis . . . 722 to gonorrhea . . . and 142 to chancroid, ” although this may refer to number of inoculations or sexual encounters, and not individuals. Douglas’s analysis suggests that 14 percent of those in the syphilis studies (97) may not have received what was defined as “adequate treatment,” while the percentages cured from the gonorrhea and chancroid were 99.5 percent and 93 percent, respectively.
The commission’s report is simultaneously clearer and vaguer. Redoing Douglas’s counting (and with a detailed methodological statement but no acknowledgement of his work), it concluded, “of the 1,308 subjects exposed to a STD, the researchers documented (italics added by me) some form of treatment for 678 subjects” (p. 6). This is a much higher number left untreated than Douglas found. On the last page of the commission’s narrative, however, in a section called “limitations,” it notes missing information and argues that “ . . . the Commission did not attempt to identify how many people were clinically infected or how many people received adequate treatment” (p. 154). There is no explanation of this internal contradiction, or why their numbers differ from the Douglas report. The commission also counted all those included in diagnostic testing and came up with 5,128 subjects.
Even more importantly, the commission reported that Cutler had noted 83 deaths during the course of the research. It also stated, “The exact relationship between the experimental procedures and the subject deaths is unclear” and said that Cutler thought many of them were from tuberculosis and other ills (p. 42). In discussing the report in August, Stephen Hauser, a member of the bioethical issues commission, also used this number and cited the vagueness of the causes. However, this public discussion of the numbers made the deaths more vivid. Once the number of deaths was out, however, it was everywhere in the media. Some more responsible media reports said the causes were not known; others just got this plain wrong and claimed the study had caused these deaths.
To make the invisible subjects visible, the report published both some of the photographs taken during the studies and sidebars with individual “subject profiles.” The most horrific is “Berta,” a mental hospital patient who developed skin rashes, was not treated for her inoculated syphilis for more than three months, and then was given both gonorrheal pus and syphilis spirochetes as she lay dying. The callousness of this story is stunning even though it is unclear what actually caused her death.
The commissioners in public emphasized how badly the science had been done, with little follow-up, ad hoc experimentation, and failure to publish. There did not seem enough acknowledgment of the lack of scientific infrastructure, as the late historian Harry Marks so skillfully details for this time period in his The Progress of Experiment. Calling it “bad science” also provides some distance from what the NIH and PHS granters obviously thought was a necessary, if somewhat ethically challenged, research project.
In making its ethical judgment that those who ran the study were blameworthy, the commission makes much of the contrast between the informed consent obtained by some of the same researchers (including Cutler) in 1943 at a penitentiary in Terre Haute, Ind., where gonorrhea was given to prisoners (also to test prophylaxis) and the failure to do this in the international setting. Yet how much “informed consent” such prisoners can give is left unanalyzed. The time frame of their research leaves open as well the question of what was done when some of the same team ran syphilis inoculation/vaccine studies at Sing Sing penitentiary in New York State between 1954 and 1956, a study that was published in Medicine, a major medical journal. Cutler dates his unpublished report on the Guatemala materials to 1955, nearly seven years after it was completed and presumably while he was in the middle of the Sing Sing work. Whether these two events are related still needs to be explored.
The question of whether there are any records of note still in Guatemala also remains unanswered. There was an investigation in that country, but the report has yet to be released and may be awaiting the results of its presidential election this November. The U.S. report carefully thanks Guatemala for its cooperation but remains neutral on why this report has not been made available.
For bioethicists, the question remains how this history will be used in the future. My worry is that it will again just become another case study of the “barbarians” from a land and time “far far away.” The materials should demonstrate, however, that Cutler and his colleagues thought they might be making a great contribution to understanding this dreadful disease. Caught at the beginning of a paradigm shift in the disease’s impact on humans—for penicillin was just then making its scourge seem less frightening—they believed they were doing the right thing even while acknowledging the risks and discussing the ethical edge they crossed. This should never be forgotten.
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 is Examining Tuskegee: The Infamous Syphilis Study and its Legacy.
Published on: September 22, 2011
Published in: Clinical Trials and Human Subjects Research