More than three decades after the shutdown of the notorious Tuskegee study, a team of Johns Hopkins physicians has found that Tuskegee's legacy of blacks' mistrust of physicians and deep-seated fear of harm from medical research persists and is largely to blame for keeping much-needed African Americans from taking part in clinical trials.
In a report to be published in the journal Medicine online Jan. 14, experts in the design and conduct of medical research found that black men and women were only 60 percent as likely as whites to participate in a mock study to test a pill for heart disease. Results came from a random survey of 717 outpatients at 13 clinics in Maryland, 36 percent of whom were black and the rest white.
The survey is believed to be the first analysis showing that an overestimation of risk of harm explains why blacks' participation in clinical trials has for decades lagged that of whites. The results come at a time of increased recognition of racial differences in disease rates and treatments. Researchers point out that some kidney diseases, stroke, lung cancer and diabetes all progress more quickly in blacks and kill more blacks than people of other racial backgrounds.
“There is enormous irony that without African-American subject participation in clinical trials, we are not going to have tested the best therapies we need to treat African Americans,” says study senior researcher, Hopkins internist and epidemiologist Neil R. Powe, M.D., M.P.H., M.B.A. “So long as the legacy of Tuskegee persists, African Americans will be left out of important findings about the latest treatments for diseases, especially those that take a greater toll on African Americans and consequently may not have ready or equal access to the latest medicines.”
The infamous Tuskegee study, named after the Alabama town where its participants lived, enrolled several hundred sharecroppers, mostly poor, illiterate blacks, into a study they believed would help treat their syphilis infections. Instead, health care workers denied them available drugs to cure the disease in a secret plan to study the “natural course” of unchecked syphilis. The health care workers were predominantly white.
The government-sponsored experiment ran for 40 years until a leak to the press exposed the deception and the study was shut down in 1972. The resulting public outcry and federal clampdown led to the establishment of federally regulated committees at all American academic centers, so-called institutional review boards, to oversee how clinical studies are designed and to ensure informed consent of all patients.
When the Hopkins researchers probed the perceptions and beliefs behind the decision to participate or stand back among their survey subjects, they found that blacks harbored a strong distrust for physicians when compared to whites:
- 25 percent of blacks thought their physician would be willing to ask them to participate in a study even though the study might harm them, while only 15 percent of whites thought the same;
- 28 percent of blacks, but 22 percent of whites, felt their physician would willingly expose them to unnecessary risk;
- 58 percent of blacks, and 25 percent of whites, thought that physicians use medications to experiment on people without the patient's consent;
- 8 percent of blacks did not feel comfortable about questioning their physician, while 2 percent of whites were similarly inhibited.
When researchers removed respondents who had feelings of distrust toward physicians from the analysis, the numbers of blacks and whites willing to participate in medical research became the same, at roughly a third of those asked.
“Our results strongly suggest that the problem is the lack of trust and that it may be fixable by communicating better with patients and taking actions that improve mutual respect and understanding,” says Powe, a professor at the Johns Hopkins University School of Medicine and director of its Welch Center for Prevention, Epidemiology and Clinical Research.
What is not known, says Powe, is how much of the problem is anchored in blacks' mistrust of society in general and how much of it is influenced by interactions with physicians.