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.
Powe adds that historically low numbers of minority physicians might also play a role in fostering mistrust. Currently, he points out, 12 percent of the U.S. population is black, but only 4 percent of physicians are black. Other studies done by the Hopkins team show that having a physician from the same race fosters patient trust and improves health care satisfaction scores. At Hopkins, the percentage of black medical students since 2000 has ranged between 8 percent and 11 percent.
Joel B. Braunstein, M.D., a research fellow at Hopkins who led the study, says the responsibility for improving the situation rests with physicians and medical schools to reduce the disparity “for the benefit to all of our patients, not just African Americans, but also for medical science in general.”
Braunstein, now a consultant to scientists and investors starting up biomedical companies, recommends, aside from the personal strengthening of relationships between physicians and patients during check-ups, more institutional programs, such as cultural competency programs. He says community projects to promote interaction of academic medical center staff with local neighborhood and business groups might also help.
“The academic medical system exists to help people through discovery and testing of new treatments, and unless people - regardless of race - see research conducted on all types of patients and through their own eyes, they won't necessarily believe it,” says Powe, whose team plans further research into what types of intervention - physician or patient training, or various community programs - work at improving trust in physicians.
Results from the survey, in which a total of 1,440 people of all races were asked to fill out a questionnaire while they waited for a regularly scheduled check-up, were later broken down so that only the views of blacks and whites could be compared. Every patient was asked by a physician, either white or black, to participate in the mock trial, but only after an in-depth explanation of the risks and benefits involved in joining, including the type of drug under study, possible drug side effects, study length and rules for participants. It was after this vigorous process of simulated informed consent that patients were asked to join up and to explain their rationale for participating or not participating.