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Saying we are all the same beneath the surface is entirely untrue - and not for the obvious reasons. Just take a look at recent clinical trial data. Studies show that blacks respond to medicines, such as cardiovascular drugs, differently than whites. Yet recruiting minority groups to participate in drugs trials and therapies is a challenge in itself.
Different Responses
In November 2004 at the American Heart Association Scientific Sessions in New Orleans, researchers reported two clinical drug trials of cardiovascular disease drugs in black patients that have shown promising results, and at least one drug maker is conducting clinical trials that target treatments in minority groups.
According to FDAnews.com, AstraZeneca found that 20 mg of its cholesterol-lowering statin, Crestor (rosuvastatin), reduced LDL-cholesterol levels in 774 black adults by an average of 46 percent.1
The ARIES (American Rosuvastatin Investigation of Efficacy and Safety) trial is the first to demonstrate the superiority of Crestor in lowering LDL cholesterol in the black population, noted Keith Ferdinand, lead investigator of the trial. Blacks have higher rates of cardiovascular disease and stroke deaths than whites, and roughly 40 percent of blacks older than age 20 have high cholesterol.1
In the African American Heart Failure Trial, researchers found black patients with heart failure experienced a 43 percent improvement in survival after taking drugmaker NitroMed's investigational drug, BiDil, compared to those in the trial taking standard heart-failure therapy plus placebo.1,2
The study, supported by the Association of Black Cardiologists (ABC), has implications for marketing a drug to one race. For now, the focus is on recruiting minority groups to drug trials. In a Nov. 8 ABC press release, Malcolm P. Taylor, MD, chair of the ABC Heart Failure Committee, described the issue: "Clinical trials are the hallmark of evidence-based medicine, but [black] participation has been appallingly inadequate," he stated. "So, we have been fervent about increasing the number of [black] patients and physicians so proper treatment and therapies can be applied for better outcomes."
Deep Mistrust
But getting to that point takes more than just signing up members of a minority group. Many minorities feel a general distrust of the government and clinical trials - and for the right reasons. A July 26, 1972, New York Times report exposed the Tuskegee experiment, which allowed nearly 400 poor, black sharecroppers with syphilis to go untreated for 40 years. The Alabama men were told they were being treated for "bad blood," when scientists actually were studying the progression of syphilis.3
Practitioner Involvement
Many health care providers who assist with clinical drug trials know the far-reaching effects they have today. Other factors such as a shortage of minority health professionals and economic and education gaps between minority groups and medical practitioners may compound the issue.4 Several organizations are doing something about it.
A recent Wall Street Journal article described how Johns Hopkins University in Baltimore tries to build trust with and recruit members of East Baltimore's black community to clinical drug trials. A Hopkins faculty member and former nurse, Diane Becker, ScD, MPH, is a key player in bridging the gap.
According to the article, Dr. Becker communicates the public health benefit to trial participants and gives leaders in black neighborhoods a say in the clinical trial.4
A Tennessee nurse also is doing her part. Yvonne Carroll, JD, RN, manager of professional development at St. Jude Children's Research Hospital, Memphis, is part of the hematology division that treats children with sickle cell disease, hemophilia and immune thrombocytopenic purpura, among others. St. Jude is one of 10 U.S. centers with a 5-year NIH grant to research sickle cell disease, which impacts mostly blacks.
The division recruits children who are in their care for the study, as well as children throughout the United States and abroad. If the family agrees to participate, a St. Jude's ombudsman advocates for the patient during the clinical trial. For Carroll, the issue of scarce minority involvement in healthcare is not limited to clinical drug trials; many do not give blood.
"The lower percentage of blacks who give blood really affects us, because sickle cell is a disease where blood transfusions are given a lot," she said. "African-Americans are going to be a better match for African-American patients."
Carroll said that with minorities representing approximately one-third of the population, yet a mere 7-8 percent of those participating in clinical trials, so much can be learned from focusing on them.
"You have to study what is different in this group, why it is different and how we can get a medication that will help this group," she said. "Otherwise, you are leaving them out entirely and ignoring what could potentially be a great benefit."
Erin James is assistant editor at ADVANCE.
References
1. FDAnews. (2004). Minority patients focus of recent clinical trials. Retrieved Dec. 14, 2004 from the World Wide Web: http://www.fdanews.com/cgi-bin/udt/im.display.printable?client.id=wbi-drugdaily&story.id=32021
2. Taylor, A.L. (2004). Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. New England Journal of Medicine, 351(20), 2035-2037.
3. Davis, K. & Biro, F. (2001). Clinical trial diversity: The need and the challenge. Retrieved Dec. 14, 2004 from the World Wide Web: http://www.netwellness.org/centers/aahealth/tips/tuskegee.cfm?printit=yes
4. Windham, C. (2004, Aug. 9). How a hospital works to gain trust of blacks. The Wall Street Journal.
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