Blacks and clinical trials
By Manny Otiko From Our Weekly
Many still distrustful of such studies, but are we hurting our-selves?
Common knowledge holds that African Americans are reluctant to take part in clinical trials for the pharmaceutical industry, and some say for good reason. Such horrific experiences as the Tuskegee Study of Untreated Syphilis in the Negro Male have made many African Americans wary of such testing.
The Tuskegee study was an infamous 40-year experiment carried out by officials from the U.S. Public Health Service from 1932 to 1972. It involved 600-some poor, mostly illiterate Black sharecroppers in Macon County, Ala., many in the late stages of syphilis. Three hundred ninety-nine of the men had the disease (201 were part of a control group), but were led to believe they were receiving treatment for “bad blood.” They were never told they had syphilis and had no idea of the severity of their condition, for which there was no known cure. In reality, they were not being treated at all and there was never any intention by those leading the study of curing them. They were being used as human guinea pigs to observe what the long-term effects of the disease would be on Black males.
In the late stages, syphilis can damage the brain, nerves, eyes, heart, blood vessels, liver, bones, and joints. Symptoms include difficulty coordinating muscle movements, paralysis, numbness, gradual blindness, and dementia. This damage may be serious enough to cause death.
In return for their participation, the test subjects received free “healthcare,” meals and burial services. U.S. Public Health Service officials also carried out similar experiments on human subjects in Guatemala.
On May 16, 1997, President Bill Clinton formally apologized for the experiment. “The United States government did something that was wrong—deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens . . . clearly racist.”
Oddly, Black doctors and nurses were involved in the study, though not in control, and it was done on the campus of the famed Tuskegee Institute. The Black professionals also never revealed to the men what was going on.
By the time the experiment was concluded, 28 men had died from the disease, another 100 from related complications, 40 of their wives had been infected, and 19 children had been born with congenital syphilis. Penicillin became available as the standard treatment for disease before the end of World War II and more than two decades before the end of the study, but the men were deliberately denied the drug.
The last survivor of the experiment, Ernest Hendon, survived until 2004 and died at age 96.
“Among many African Americans, the idea of clinical drug trials invokes the Tuskegee Syphilis Study, in which poor Black men participated in a research study for 40 years without ever being told they had syphilis,” wrote Tennessee State Rep. Antonio Parkinson in a guest editorial for the Memphis Commercial Appeal in 2012. “This atrocity led to additional infections and untreated cases of syphilis, and many of the participants died,” Parkinson wrote. “That study, and the distrust it helped create, had a significant impact on the participation of African Americans in clinical drug trials in the 40 years since its end.”
Even before the Tuskegee study, 10 Black elementary schoolchildren in 1927 became the unwitting subjects of an experiment by local healthcare officials to remove ringworms. The children, residents of Lyles Station in Gibson County Indiana, were subjected to massive dosages of radiation. One of the victims,Vertus Hardiman, experienced the slow dissolving of his skull, producing a massive hole in his head, a condition he lived with until his death in 2007. [See story, “Radiation and the young: like sheep to slaughter,” OurWeekly, April 21, 2011.]
Still, there are indications that the distrust of such studies may be changing. According to the University of Florida, many Black Americans are open to the idea of participating in clinical trials.
“Researchers talked to nearly 6,000 people in five cities: St. Louis, Mo.; Davis, Calif.; Ann Arbor, Mich.; New York City; and Rochester, N.Y.,” said a statement released by the school. “Interviews were held in places such as barbershops, parks, bus stops, churches, grocery stores, laundromats and health fairs. The results showed that 91 percent of Black Americans who were interviewed expressed an interest in participating in medical research, compared with 85 percent of Whites, 84 percent of Hispanics and 79 percent of Asians.”
However, the statement also acknowledged that although many African Americans were willing to be part of tests, they were often left out.
“For years, African Americans have been underrepresented in research,” said lead investigator Linda Cottler, chair of epidemiology at the University of Florida College of Public Health and Health Professions and the College of Medicine. She said it was important to have African Americans participate in these trials.
“If we’re not getting the participation of diverse groups when we’re studying medications or interventions, then we don’t know how those treatments will work in real life in different populations,” Cottler explained. “It’s very important for people to have a voice and be represented.”
Crystal Kendrick, president of The Voice of Your Customer, a certified minority-owned marketing firm that specializes in reaching out to diverse populations, believes there are several reasons why a disconnect exists between African Americans wanting to be clinical trial candidates and the pharmaceutical industry.
Her company has extensive experience working with the African American community and health issues. Since 2007, the company has completed at least 10 studies with African Americans regarding their healthcare. Many of these studies include questions regarding participation in medical research projects.
Kendrick, a resident of Cincinnati, believes the legacy of the Tuskegee experiment is still a major barrier.
“A small but significant percentage of African Americans (especially males) are concerned that medical research is a conspiracy to reduce the number of African Americans in the country,” said Kendrick. “Others believe that medical research confirms that there is little concern for the African American male population, and that they are disposable. A small percentage of African Americans also think that White men created HIV and intentionally injected Africans to either study the virus in human life and/or to reduce the African population.”
Neven Gibbs, a retired drug counselor from Washington state, said the Black community has a good reason to be concerned about drug testing. He is also wary.
“I have no desire to be a lab rat for live testing,” he said. “There again look to historical drug testing and mind control experiments of the 1960s as one example,” Gibbs said “The recent Iraq War Desert Storm is another example. Most of the people who received vaccinations and questionable drugs were not expected to survive the war.”
Many troops who served in the first Gulf War came back home with physical problems that have been traced back to a multitude of sources such as exposure to nerve agents, exposure to oil fumes and pesticides. According to the Boston Herald, between 175,000 to 210,000 are suffering from Gulf War syndrome. The Herald added that many of these soldiers were given pyridostigmine bromide pills, to ward off nerve agents.
Joyce Riley, spokesperson for the American Gulf War Veterans Association, is one who was affected by the inoculations. Riley, a former flight nurse in the Air Force Reserve, said that during the build-up to the Gulf War she received 10 shots in one day. Six months later she became ill from a nerve disease similar to multiple sclerosis.
Riley eventually had to leave her job as a nurse and the Air Force. And when she applied to the Veterans Administration for help, she was told that she had not been in the military long enough to qualify. She was also told by conventional medical practitioners that there was nothing that could be done for her condition, and is now relying on alternative medicine.
Riley said that she never actually served in the Gulf, so her illness cannot be attributed to other causes such as toxic fumes from oil well fires or exposure to nerve agents. But she is convinced that she was experimented upon.
Riley now hosts a radio show called “Hour of Power,” which deals with cover-ups and alternative medicine. She has also produced a documentary called “Beyond Treason,” which deals with the government’s history of cover-ups and experimentation. She gives DVDs to anyone planning on enlisting in the military.
She offers this warning to people who are thinking of joining up: “If you are willing to be an experimental guinea pig, go ahead and join up,” Riley said.
Although such fears are still prevalent among African Americans, Kendrick says that the pharmaceutical industry is also reluctant to engage African Americans.
“Another challenge is that many of the medical research firms do not engage the African American community, do not employ significant numbers of African Americans to work for their companies and do not have relevant marketing campaigns targeted to African Americans with well-respected spokespersons,” she said. “Many of the company names are not familiar to the African American community and thus African Americans are less likely to trust the company or the project.”
The technological gap may also be another issue, Kendrick added.
“Many of the medical research firms have highly-technical registration processes that typically require timely access to email, computers, Internet and telephone connections,” she said. “Some African Americans are not as comfortable with the electronic registration processes and may only have a limited amount of time to use public resources. Completing the registration processes in a timely manner can often be a challenge.”
In addition, geography may also be a reason why African Americans are not called into these studies. Kendrick pointed out that many of these research facilities are located in suburban areas.
“These communities are not easily accessed by public transportation and can sometimes be difficult to access by car, if the participant is not familiar with the area,” she said. “Also, some of these communities are not as welcoming to African Americans so some simply choose not to visit the locations.”
However, it may all boil down to a lack of effort on the part of the drug industry. Kendrick said that her company has found that many research companies are just not reaching out to the African American community.
“In general, we have found that so many organizations say that it is difficult to attract and recruit diverse populations for medical research projects and other opportunities,” Kendrick said. “Because this is a common misbelief, many project leaders simply accept the fact that African Americans and other diverse populations will not participate in the medical research and just move forward with their projects. Participation of African Americans in medical research will only increase when project leaders begin to demand their participation. Doing so will spur creative recruiting practices, engagement and marketing approaches that resonate with the African American community.”
Gibbs warned that there are several downsides to drug testing. “Death, deformities, decreased health, reduced longevity, anal leakage, to name just a few side effects,” he said.
But there is also an upside: “… early identification of side effects, effectiveness, dosage requirements, genetic differentiations,” Gibbs said. This is important in the African American community, which often has different reaction to drugs than other races.
Gibbs said that African Americans who decide to participate in clinical trials need to do their research and also consult a medical professional.
“Be knowledgeable about the reliability and veracity of the tester,” he said. “Know where [the drug] comes from, what it is being used for and what aftercare policies are before participating. There are benefits and downsides so be sure it is moderated by a personal physician who can act when there is the possibility of disreputable practice. Some of those (studies) up into the 1970s would test a drug or disease then close their doors leaving the subjects to either die or find other medical help to recover.”
Parkinson said that there are valid reasons why African Americans need to get involved in clinical trials. He pointed out that many of the clinical trials focus on diseases that are common in the African American community.
“Of the 3,700 clinical trials conducted in our state [Tennessee] since 1999, nearly one-third—more than 1,000—took place in Memphis. Nearly two-thirds of those trials focused on six major diseases: diabetes, heart disease, cancer, asthma, mental illness and stroke,” Parkinson said. “The effects of many of those chronic diseases on African Americans are well-documented. We are nearly twice as likely as Caucasians to develop diabetes. We are at greater risk for major complications from diabetes, including kidney failure and amputations. One in four African American women older than 55 years is diabetic.”
“We must also acknowledge that there is a need for more African Americans willing to participate in the clinical drug trials that could provide insight into treating the diseases that hit us hardest,” said Parkinson’s editorial. “Here in Memphis, institutions like Baptist Memorial Hospital are vital partners in conducting such research. Meharry Medical College, a historically Black medical college in Nashville, conducts clinical research while working with University Medical Center to identify African American candidates for additional trials.
“Participation in clinical drug trials is part of a larger effort that includes breaking down barriers to quality healthcare, closing gaps in education and income, and making healthy food accessible and affordable.”