Transcription
My lecture is on the Tuskegee Study, the 50th anniversary of its uncovering, the story, and lessons. This is a story that needs to stay forever on the moral horizon of doctors.
The Tuskegee Study was initiated by the Public Health Service, the PHS, in 1932. The CDC was founded in 1946 and served as the titular supervisor of the Tuskegee Study for two-thirds of its 40-year duration, from 1932 to 1972.
Like all research, the idea for the study began in the brain of one person, Dr. Clark, director of the Venereal Disease Division of the PHS CDC. When analyzing data from an earlier study, the thought came to me that the Alabama community of Macon County offered an unparalleled opportunity for the study of the effects of untreated syphilis. In the 2000 census, blacks constituted 84.6% of the population of Macon County. In 1932, the percentage was higher.
It's well known that all enrollees were black. That they were desperately poor, sharecroppers, and mostly illiterate is less well appreciated. Sharecroppers rented small plots of land from large white planters, landowners on farmer plantations. A sharecropper's unit rented from the planter was the land a man could cultivate with a mule and a one-horse plow. Sharecroppers also rented from the planter mules, farm tools, seeds, and housing. After the planter subtracted the furnish, mules, tools, seed, clothes, and food, only 20% of sharecroppers earned any profit, and then 9 to 48 cents a day. Food and items for living were bought through credit at the company store, often owned by the planter. Money rarely changed hands between the planter and sharecropper, as the entire system was built on credit debt peonage. Sharecroppers paid the loans by pledging a percentage of the crop, often two-thirds or more, at harvest time to the planter. Sharecroppers were forbidden by law from leaving the land until all debt was paid. That P.H.A. picker was paid 50 cents for a hundred pounds of cotton. A hundred pounds of cotton weighs like a hundred pounds of feathers, and as a reminder, 50 pounds is the airline baggage allowance. That P.H. turned the sharecropper into an effective slave of the planter. The system persisted in the deep South into the 1940s.
The Surgeon General wrote to the principal of the Tuskegee Institute: "The study offers an unparalleled opportunity for carrying on this piece of scientific research which probably cannot be duplicated anywhere else in the world." Presumably, Dr. was not intending any irony. The PHS CDC investigators enrolled 399 men with syphilis and 201 non-syphilitic controls. The PHS CDC doctors deceived the men into thinking they were being treated for "bad blood," a colloquialism for several ailments. The PHS CDC doctors intentionally withheld effective therapy for 40 years against syphilis and then life-threatening illness and misled the men into thinking the medications they received, aspirin and vitamin tonic placebo, were effective against their disease.
Once baseline measurements were obtained, the future CDC director, Dr. Vonderlehr, decided to check for evidence of neurosyphilis. Dr. Vonderlehr realized the men might refuse lumbar puncture if they knew it was solely for diagnostic purposes. To entice cooperation, Dr. Vonderlehr told the men he would give them a special therapy, "free spinal shots," deceiving them into thinking the lumbar punctures were therapeutic. The final step in data collection was to obtain pathological specimens at autopsy. Dr. Wenger, another PHS investigator, wrote to Dr. Vonderlehr: "As I see it, we have no further interest in these patients until they die. If the colored population become aware that accepting free hospital care means a postmortem, every will leave Macon County." To coax enrollees into hospital when severely ill, the PHS CDC doctors promised to pay their burial expenses, a very strong inducement given the importance of funeral rites in the cultural life of rural blacks.
Dr. Parran served as Surgeon General from 1936 to '48, critical years of the Tuskegee Study. He launched a vigorous campaign to eradicate venereal disease using mass screening and mobile treatment clinics. A protégé of F.D.R., Dr. Parran featured on the cover of Time, and he was the creator of the NIH extramural grants program. When Dr. Parran's mobile treatment unit reached Macon County, PHS staff instructed local doctors: "He's under study and not to be treated."
Dr. Heller was chief of the VD Division of the PHS CDC and supervised the Tuskegee Study between 1943 and 1948, which time penicillin was introduced and the Nuremberg Code promulgated. Dr. Heller subsequently served as director of NCI, the National Cancer Institute, and president of Sloan Kettering. At his death, the New York Times published a glowing obituary without mentioning Tuskegee.
Within a year of being hired by the PHS to interview patients with venereal disease, Peter Buxton, a 29-year-old Czech-born social worker, wrote to Dr. Brown, chief of the VD Division of the CDC, expressing grave moral concerns about the Tuskegee Study. After several exchanges between Peter Buxton and the CDC, the director, Dr. Usdin, informed the former social worker that a blue-ribbon panel of 17 non-government medical experts decided against stopping the Tuskegee Study and treating the men. Buxton's continued efforts were met with indifference until he reached an AP journalist who published the story on the front page of the New York Times on July 26, 1972.
Several physicians continued to defend the study. Dr. Campmeier blasted journalists for their "abysmal ignorance," arguing that "treatment was not purposely withheld. The subjects were not deterred from obtaining treatment if they desired it or bothered to get what was available." In October 1972, an ad hoc advisory panel of the Department of Health advised that the experiment be terminated and the men receive immediate medical care. In February 1973, Senator Kennedy conducted congressional hearings, which led to passage of the National Research Act with later establishment of IRBs, Institutional Review Boards, and principles of informed consent. In 1997, President Clinton finally tendered the government's apology: "What the United States government did was shameful to our African-American citizens. I am sorry that your federal government orchestrated a study so clearly racist."
There are several misconceptions about the Tuskegee Study. First, that CDC doctors did not administer penicillin once it became standard therapy in 1944. But Salvarsan had already been known to decrease morbidity and mortality from syphilis since the 1920s. Any effective medication, not just penicillin, would have violated the rationale of the experiment, which was to plot the natural course of untreated syphilis until death and autopsy. By 1969, at least 28, and perhaps 100, of the men had died as a direct result of syphilis.
Second, informed consent as we know it today did not exist. But back in 1907, the most widely read doctor in the world, William Osler, had published that full consent of subjects was a necessary condition for human experimentation. More importantly, the Tuskegee men never saw themselves as volunteers in a scientific experiment. They were told and believed they were getting free treatment from expert government doctors for a serious disease.
It's wrong to believe that the PHS CDC bears sole responsibility for continuation of the study across 40 years. The first report was published in JAMA in 1936, and PHS CDC doctors published a total of 15 articles at intervals of four to six years until 1973. For those who did not read an entire article, the titles were sufficient to have aroused suspicion. Yet countless doctors around the world saw 15 articles in reputable medical journals spread across 36 years detailing the ravages of untreated syphilis, and not one of them published any criticism of the experiment.
It is tempting to look at the young field researchers as mere functionaries following orders. This is wrong. These doctors consciously lied to the men about the withholding of effective therapy and other details. They were perpetrators.
When the Tuskegee Study was uncovered in 1972, it was difficult to imagine that the PHS CDC NIH could contain a worse chapter in its history. In March 1946, the first ever NIH study section approved a proposal for "Transmission of Syphilis to Human Volunteers and Improved Methods of Prophylaxis" to be conducted in Guatemala. The Guatemala principal investigator was Dr. Mahoney, recent recipient of the Lasker Award for demonstrating that penicillin eradicated syphilis. Two other 1946 Lasker Awardees, Kolmer and Landsteiner, also received the Nobel Prize. In 1946, 31-year-old Dr. Cutler, assisted by other CDC PHS physicians and staff, arrived in Guatemala City to conduct the experiments. The original plan was to induce syphilis in prisoners in the central penitentiary through sexual intercourse with infected prostitutes. Prostitution was legal in Guatemala, and it was also legal for prostitutes to visit men in prison. These experiments proved largely unsuccessful.
Next, the CDC doctors tried to induce infection by inoculating psychiatric patients and children in an orphanage. The investigator notebooks contain vivid details. When women remained uninfected, NIH-funded physicians described moistening a cotton-tip swab with gonorrhea pus, inserting it into the cervix, and swabbing it around with considerable vigor. Over 1,300 individuals were intentionally exposed to infection. 61 to 87% showed evidence of disease. The American doctors studied other modes of transmission. When one psychiatric patient, Bertha, had syphilis injected into her arm, only bumps resulted. On August 23, 1948, Dr. Cutler put gonorrhea from a male participant into Bertha's eyes, urethra, and rectum. Her eyes filled up with pus, and four days later, Bertha died.
It's wrong to perceive Dr. Cutler as a Dr. Mengele-type scientist acting autonomously. The principal investigator, Dr. Mahoney, was the preeminent physician-scientist of the day. He was kept fully informed, wrote frequent encouraging letters to Dr. Cutler: "Your show is already attracting rather wide and favorable attention up here." Another CDC investigator wrote to Dr. Cutler about a conversation with the Surgeon General: "He's very much interested in the project and a married twinkle came into his eye when he said, 'You know, we couldn't do such an experiment in this country.'"
How can it be that problems splashed on a newspaper are clear in retrospect, yet previously extremely accomplished physician-scientists had seen no problem? Lack of imagination, rationalization, and institutional constraints are formidable obstacles. Only moral imagination, the ability to imagine ourselves in the shoes of an endangered individual, can alter our outlook.
A common misperception is that moral judgment is linked to education. Peter Buxton had far less conventional education than many Surgeon Generals and CDC directors who had intimate knowledge of the Tuskegee Study. Intelligence and education are not enough. In human affairs, character and conscience come first.
Another misperception is that group effort is more effective than the action of an individual. But correction of the great ills of society has always started in the heart of one individual. Looking back at the Alabama and Guatemala stories, we risk falling into the trap of placing ourselves on the side of the angels. Hindsight is comforting, but it's also misleading. Only one Peter Buxton stood up across 40 years.
Given the actions of the PHS CDC researchers, who did much good in other parts of their professional lives, we need to approach today's ethical challenges with "fear and trembling," Kirkegaard's phrase, and remember to pause and think, reflect and examine our conscience. Have the courage to speak, and above all, the willpower to act. Thank you.