Column: FOREIGN INTEL
For the past year, it has been bioethical bow, scrape, and grovel time in Washington, D.C. After learning that American public health researchers had infected hundreds of Guatemalans with venereal diseases between 1946 and 1948, President Obama had to telephone his Guatemalan counterpart to apologize. He then asked the Presidential Commission for the Study of Bioethical Issues to investigate the appalling story of coercion and deception. The commission did so, and a detailed report of its findings, titled "Ethically Impossible: STD Research in Guatemala from 1946 to 1948,"1 was published on September 13, 2011.
The tale came to light long after the doctors and participants had passed away. After World War II, thousands of STD-infected servicemen were being demobilized. American public health officials needed to know more about the effectiveness of the new miracle drug penicillin to control the spread of STDs in the U.S. After conducting research on volunteers in an Indiana prison, they went to Guatemala.
With the cooperation of local officials, Dr. John C. Cutler, a Public Health Service physician, first selected men in the Guatemala National Penitentiary as research subjects, then men in an army barracks, and then both men and women in the National Mental Health Hospital. The commission concluded that he and his fellow researchers had deliberately exposed about 1,300 inmates, psychiatric patients, soldiers, and commercial sex workers to syphilis, gonorrhoea, or chancroid. Permissions were obtained from government authorities but not from individuals.
Initially, the doctors used prostitutes with the disease to infect the prisoners (since sexual visits were allowed by law in Guatemalan prisons). When "normal exposure" failed to infect enough men for their research, they did direct inoculations, pouring a serum made from syphilis bacteria onto the men's penises or onto the lightly abraded skin of their forearms and faces. In some cases, they used spinal punctures. The subjects were given penicillin after they contracted the illness.
In the 1950s, Dr. Cutler also worked on a project that became an even bigger scandal, the Tuskegee syphilis study.2 Starting in 1932, black sharecroppers in Macon County, Alabama, about 400 with the disease and 200 without it, were told that they were being treated for "bad blood" and were given free medical care. But they were not told about their syphilis, and they did not give "informed consent." Public Health Service doctors withheld treatment to observe the effects of the progression of the disease—even though penicillin was available to cure it. These experiments went on for 40 years, until an Associated Press journalist exposed it in 1972.
Despite this background, Dr. Cutler eventually became "a much beloved professor" in the Graduate School of Public Health at the University of Pittsburgh. He died in 2003. The findings of his research in Guatemala were never published, and his notes gathered dust in university archives until they were unearthed by a historian at Wellesley College, Susan M. Reverby.3 Like most of the research done by Nazi doctors, Cutler's studies proved to have been a waste of time. "What stings the most in terms of bad science is that it never passed peer review and was never published," one member of the commission later said.4
Wrong & Reprehensible
Even by the standards of the time, the Guatemalan project was regarded as unethical. After all, only a few months before, Nazi death-camp doctors had been condemned to long prison terms, some even to death, for conducting medical experiments without their subjects' informed consent. Principles later formalized as the Nuremberg code of medical ethics had been published in the Journal of the American Medical Association in 1947. In April of that year, New York Times science editor Waldemar Kaempffert observed, as if it were universally accepted, that deliberately injecting human subjects with syphilis microbes was "ethically impossible."
Dr. Cutler pushed ahead anyway. "The attitude toward the Guatemalan people was pretty much what you'd expect if they were doing research on rabbits," said a member of Obama's commission, bioethicist John Arras, of the University of Virginia.
Failure to obtain consent from the research subjects was bad enough, but Dr. Cutler was also deceitful. In a 1947 letter to a colleague, he admitted that he was deceiving the research subjects. "As you can imagine," he wrote, "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 doubletalk keeps me hopping at times."
The higher-ups in the public health bureaucracy were more squeamish, but they did not stop the project. Cutler's superior confided, "I am a bit, in fact more than a bit, leery of the experiment with the insane people. They cannot 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." When the U.S. Surgeon General, Thomas Parran, was told of the project, he commented, "You know, we couldn't do such an experiment in this country." But he did not stop it.
For Dr. Arras, a single anecdote was enough to show how immoral the research had been. One of Cutler's subjects was Berta, a psychiatric patient who had been injected with syphilis and not given treatment for three months. On August 23, 1947, Cutler observed that Berta was dying (why is not clear). That same day, he put gonorrhoeal pus from a male subject into both of Berta's eyes, as well as in her urethra and rectum. He also re-infected her with syphilis. Several days later, Berta's eyes were filled with pus and she was bleeding from her urethra. She died on August 27.
Bioethics today tends to be more concerned with protocols than with harshly judgmental words like "right" and "wrong." But President Obama's bioethics commission did not hesitate to describe the Guatemalan experiments as "reprehensible" and "morally wrong."
Lessons & Follow-Up
What lessons from this shameful episode can be applied to contemporary medical research?
One, says the commission with great common sense, is "never to take ethics for granted, let alone confuse ethical principles with burdensome obstacles to be overcome or evaded." Another is that "the quest for scientific knowledge without regard to relevant ethical standards can blind researchers to the humanity of the people they enlist into research."
The commission is following up its historical investigation with a report to President Obama on how well human research subjects are protected nowadays. With the proliferation of clinical trials by drug companies in countries like Russia, India, and China, there is certainly a need to ensure that people's health does not suffer because of lax oversight or dangerous experiments. A National Institutes of Health database currently lists 113,717 trials being conducted in 176 countries. Some of them are bound to be deadly.5
However, now that this dark chapter in medical history has been exposed, shouldn't it provoke broader questions about ethical standards in reproductive health research, the field in which Dr. Cutler worked throughout his career? Abortion, assisted reproduction, and population control programs were all started by men and women whose utilitarian philosophy was much the same as Dr. Cutler's.
In fact, in vitro fertilization (IVF), a burgeoning field of reproductive medicine, was developed without the standard clinical trials we take for granted today. One of the most popular techniques, Intracytoplasmic Sperm Injection, was never tested on animals. Now it appears that it is associated with a small percentage of birth defects.
The commission did not follow this up. That is a pity, because Dr. Cutler almost certainly brought with him the pragmatic inhumanity that had corrupted his work in Guatemala and elsewhere.
After leaving the Public Health Service in 1967, Cutler helped establish a public health program at the University of Pittsburgh. His wife, Eliese, served on the board of Planned Parenthood, and "he worked tirelessly to find better ways to provide affordable reproductive health-care services to women who need them," according to his obituary.6
The university named a lecture series after him (but dropped it after his scandalous research became public). One of the lectures, "John Cutler's Quiet Legacy" lauded him for making "sexual health . . . a vibrant field at University of Pittsburgh" and for "embracing new public health challenges, no matter how controversial." "John Cutler is smiling!!" was the message on the final PowerPoint slide.
Smiling about what, exactly? •
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