United States President Barack Obama recently convened a panel of experts known as the Commission for the Study of Bioethical Issues following the revelation that despite more than 1,000 regulations covering how clinical studies are conducted, unethical medical studies are still possible.
Obama first thought about creating this panel last fall when a 65-year-old study surfaced accusing federal doctors of infecting Guatemalans with syphilis without their consent or knowledge. This study lasted from 1946 to 1948. American scientists infected patients in a Guatemalan mental hospital with the terrible disease to test whether penicillin could prevent some sexually transmitted diseases. The study was hidden for many years after it produced no useful information.
The Guatemalan study was completely unethical for several reasons. Infecting the patients with syphilis alone is unethical, but the participants did not understand the study and were not capable of giving their consent. The study was hidden from the public and was only just exposed last year.
While the Guatemalan study is horrifying, perhaps the most well-known unethical medical study, at least to Americans, was the Tuskegee experiment, a syphilis study conducted between 1932 and 1972 in Tuskegee, Alabama. Six hundred poor, rural black men were tracked by the U.S. Public Health Service to study the progression of untreated syphilis. These men were not given the adequate treatment even once penicillin became available. The participants believed they were receiving free healthcare from the U.S. government.
Extensive research by the Associated Press found more than 40 other unethical studies.
In the 1940s, there was a federally funded study in which researcher Dr. W. Paul Havens Jr. exposed men to hepatitis in a series of experiments. Havens’ study used patients from mental institutions in Middletown and Norwich, Conn. The experiments left eight healthy men chronically ill. Havens, a World Health Organization (WHO) expert on viral diseases, was the first scientist to differentiate types of hepatitis and their causes. This study, however, broke no new ground in understanding the disease or how to cure it.
Also in the 1940s, a University of Minnesota study caused 11 public service employees to be injected with malaria and then starved for five days. Some of the participants were also subjected to hard labor and they lost an average of 14 pounds. They were later treated for malarial fevers with quinine sulfate.
In the 1950s, government researchers attempted to infect two dozen prison inmates with gonorrhea. The inmates were from a federal penitentiary in Atlanta. The bacteria was pumped directly into the urinary tract through the penis. The men developed gonorrhea, but the study was deemed ineffective. It was decided that since this is not how men would normally contract gonorrhea (which is by having sex with an infected partner), the results were not comparable. The participants were eventually treated with antibiotics. This study was never reported in the news.
In the late 1940s and 1950s, there was a dramatic increase in prisoners participating in studies. By the 1960s, about half of the United States allowed prisoners to be used in studies and experiments. It wasn’t, however, until a 1973 congressional hearing that pharmaceutical industry officials admitted they used inmates for their studies, because it was cheaper than using chimpanzees.
In a 1915 study, Mississippi inmates were offered pardons if they participated in a study where they were required to go on special rations. U.S. Government’s Dr. Joseph Goldberger established the study to prove that pellagra, a systemic nutritional wasting disease, was caused by a dietary deficiency. Goldberger is remembered as a public health hero.
These studies, and the countless others, violate the fundamental medical principle of “first do no harm.” “When you give somebody a disease – even by the standards of their time – you really cross the key ethical norm of the profession,” said Arthur Caplan, Ph.D., director of the University of Pennsylvania’s Center for Bioethics.
Unethical medical studies, as Obama and his panel feared, did not end with the 1960s. There were two international studies in the last 15 years that raised outrage and concern. One case involved U.S.-funded doctors who neglected to give an AIDS drug (AZT) to all HIV-infected pregnant women in an Uganda-based study. The medicine would have protected their newborns had the women received it.
The other study was done by Pfizer Inc. The company gave a powerful antibiotic, Trovan, to Nigerian children infected with meningitis. The drug was given to the children even though there were known doubts about its effectiveness for this disease. The deaths of 11 children were tied to this study. While Pfizer ultimately settled a $75 million lawsuit with Nigerian officials, the company admitted no wrongdoing.
The goal of the newly constructed presidential panel, Commission for the Study of Bioethical Issues, is to not only ensure that unethical medical studies will not continue, but to examine past studies. The panel is set to report back to the president in September. Their main objectives are to examine federally funded international studies to ensure all research is ethical, and to take a more intense, comprehensive look at the Guatemalan syphilis case. There is a 14-member expert panel assigned to study if international studies are ethical, and a 12-person commission of investigators to look through hundreds of boxes of old government documents related to the Guatemalan study.
It is plausible that with less than a year to do its work, the panel may not produce any substantial new information. “They face a really tough challenge,” Caplan said.