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PART II: Doctors Find Ways to Stop African-American Resistance to Clinical Trials

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By Pharoh Martin, NNPA National Correspondent –

(NNPA) - One of history's most glaring violation of medical ethics occurred in Tuskegee, Ala. That was when federal researchers experimented on close to 400 impoverished African-American sharecroppers who suffered from syphilis. The experiments started in 1932 and lasted for 40 years.

Early in the study, researchers found that penicillin was an effective treatment for the disease; yet the U.S. Public Health Service purposely withheld the treatment from its Black participants for decades.

The fallout from that controversial study not only led to a total reform of medical ethics as well as an avalanche of new federal laws and regulations regarding protections for participants in clinical studies but that study and similar incidents shattered whatever trust the Black community had for such research.

“I can tell you as a researcher at a major university that that sort of thing is highly unlikely and almost impossible to happen now,” said Dr. Elijah Saunders, professor of cardiology and medicine at University of Maryland School of Medicine. “But to try to convince the Black public, especially many of the not very well educated part of the Black public, is still very difficult. That distrust is still out there and it still carries over.”

For many African-Americans, clinical trials run deep as a stigma. Their fear is of being turned into human guinea pigs or being recast in another experiment similar to Tuskegee.

According to Saunders research colleague, Dr. Stephen Liggett, professor of medicine at University of Maryland School of Medicine, even though there have been great advances in the field bioethics and protections for participants of clinical trials the general mistrust of the African-American community has led to an under-representation of Black participants in medical research, which can have a substantial effect on findings.

“We know the risk of having certain diseases and their response to therapy is dependent upon a person’s genetic makeup,” said Liggett, who works in pharmacogenetics, the relationship between a person’s genetic makeup and their response to drugs. “The African-American community represents a unique genetic makeup that must be considered when one is designing a clinical trial. For example, we would need to know if a treatment for high blood pressure really works to save lives in those of African descent, of Asian descent, of European descent, etc.

Otherwise, what will happen, and this is unfortunate, if a trial gets approved but doesn’t have proper ethnic representation, once it’s approved, it will be prescribed to everyone.”

Saunders has spent more than half of his 20 year career in research specifically working with African-Americans. He said that there are some cases where drugs may not work the same way in Blacks as they do in Whites. The change can show up as a side effect, as a different response to the drug or may even work at all.

"I don’t want you to think that this is extremely common but it’s common enough, especially in my area, I do studies and clinical trials in hypertension and high blood pressure,” Saunders said. One example that Saunders pointed out is regarding his research involving ACE inhibitors, a popular drug to treat high blood pressure. His research team found that these drugs don’t work the same for Black as it does for Whites.

They had to use a higher dose in order for it to be effective and even found a side effect in the form of a persistent severe cough that was found more consistently in Blacks more than with their White counterparts. Saunders, who is African-American and well-known in his Baltimore community, fortunately, does not have as hard of a time finding Black participants for his trials as other researchers.

He has developed a special way of recruiting participants from the African-American community. He carried a blood pressure program to community churches and barber shops. These church workers and barbers would be trained to screen local residents for high blood pressure and could refer them to doctors for treatment.

“It sounds simple but if Black people didn’t have that kind of screening readily available for them in the community they would never know that they had high-blood pressure,” said Saunders. Since the program started in 1985 thousands of people in Baltimore were referred, according to Saunders.

“High-blood pressure is so common and it’s killing so many Black people that every effort should be made to get them into clinical trials because the drugs is going to be used on them whether or not they are in the trials and the more researchers know about the drugs before it gets to market the safer it would be and probably the more effective it will be,” said Saunders.

“So we want to encourage Black people and let them know that the chances of them being hurt or being used as guinea pigs is almost nil in this day and time.” Africans-Americans suffer from high-blood pressure at a significantly higher rate than other racial groups. According to the Center for Disease Control, more than 44 percent of Black women suffer from hypertension compared to 28 percent of White women. The rates for Black and White men share a similar trend though not as great. Clinical trials are now regulated and approved by a governing body called the Institutional Review Board (IRB), which is empowered by the Food and Drug Administration and the Department of Health and Human Services.

Participants in clinical trials should only volunteer for IRB-approved studies, Liggett said. All sanctioned studies carry an IRB number that can be verified. Participants must see an informed consent document that must be read in-depth and understood before signed. "Read the informed consent document completely," Liggett advises. "If they have questions they should be able to have them readily answered by a physician before they sign the form. Anything that deviates from that should send up a red flag.” Federal guidelines stipulate that an informed consent form is written simply enough so that a person with a fourth or fifth grade education could read and understand it.

“The pendulum is just about where it need to be,” said Liggett. “You can go so far in one direction and you can never get anyone enrolled and it would be a bureaucratic problem from the beginning. But you don’t want it to be too loose and not give the patients the proper protections and informed content for a study. I think we are right where we need to be and that’s after many years of ethical discussions.”

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