February is Black History Month--an opportunity to reflect not only on our social and economic history, but also on the history of poor health status for America’s minority populations and the potential of using 21st century health information technology to assure optimal care for everyone.
The disparity in health status between minorities and white Americans was not new when it was so well documented in the 1985 Secretary's Task Force Report on Black and Minority Health (U.S. Department of Health and Human Services, 1985). In 1906, W.E.B. Du Bois edited a volume, The Health and Physique of the Negro American, that call attention to the disparities. In 1914, Booker T. Washington, founder of the Tuskegee Institute, addressed the issue by offering up some startling facts concerning excessive illnesses and death among blacks and the cost to the nation that were a result of this disease burden. A hundred years later we find ourselves still wrestling with disparities in health outcomes for blacks and other minorities.
We have inherited a health care system in which subsets of Americans, many of whom are African American, Hispanic Americans and Native Americans, are having their lives adversely affected by health disparities, higher rates of disease when contrasted to the general population. These health disparities degrade life’s quality while raising risk for premature death.
One of the great challenges for those working to eliminate health disparities in minority communities is their underrepresentation in clinical trials. Increased diversity in clinical trials helps researchers find better treatments and better ways to fight diseases that disproportionately impact certain populations and may be important for safe and effective use of therapies. For example:
- African American men are twice as likely to die from prostate cancer as Caucasians, but represent only 4 percent of prostate cancer clinical trials participants;
- Asian Americans have a higher risk of developing diabetes than Caucasians, but from 1998-2001, no Asian Americans were represented in diabetes clinical trials; and
- Mexican Americans and Puerto Ricans have more than double the prevalence of diabetes than Caucasian, non-Hispanics, but represented only 4 percent of clinical trial participants from 1998-2001.
As noted by the Food and Drug Administration’s (FDA) Office of Minority Health, genetic differences can make a cancer treatment more toxic in one ethnic group than it would be in another. These variations can also make drugs like antidepressants and blood-pressure medications less effective in one group than another. For this reason, it is vitally important that the process used to test the effectiveness of new medicines accurately reflects the patient population that will eventually take them.
Clinical trials are also an important piece of the scientific framework of evidence-based medicine, which inform clinical guidelines and quality measures that direct how we manage most medical disorders. Unfortunately, the underrepresentation of African Americans, Hispanic Americans, Native American and Asian Americans in clinical trials can mean that those guidelines and quality measures are frequently silent or must rely on lower levels of evidence to determine their benefit for minority patients.
There is also a paucity of databases (registries) drawn from clinical practices from which we can learn the benefits and risks of using many important, new therapies in minority populations, further compromising the ability of health care systems to make definitive statements and recommendations about optimal care for people of color.
This latter information gap was hard to overcome in the age of analog medicine when medical records were recorded in ink, stored in paper file folders, which were hard to access for medical research. But we live in the digital information age and the reality of digital medicine is here. Minorities own mobile personal digital devices – smartphones, tablets, e-readers. They are using apps to plan, monitor the inner workings of their bodies, and communicate with their health provider. Healthcare providers record information on electronic health records. Every day we are purchasing networked, biometric devices for our homes and to wear on our person that can continuously monitor and capture information about our health status. All of this health information can be stored “in the cloud”, making it readily accessible by the consumer, and the health care providers and researchers they designate. This growing body of information (big data it is called), coupled with new knowledge about genetics, biochemistry and molecular biology, can help pioneering companies create innovative medicines to improve the quality of care that is available. Digital medicine holds out many promises that can do a lot to remedy the health disparities that Dubois, Washington and the Secretary's Task Force Report documented.
The Pharmaceutical Research and Manufacturers of America (PhRMA) and my organization, The National Minority Quality Forum, have given considerable thought to the problem of underrepresentation of minority in clinical trials and we are taking two bold steps to rectify the problem. First, we are launching a public engagement initiative, designed to raise awareness and educate about the importance of diversity in clinical trials, overcome distrust in the minority community, and encourage minorities to enroll in a patient registry. Secondly, we have collaborated on the development of the Clinical Trial Engagement Network (CTEN) to enhance diversity in participation in clinical trials. The CTEN is envisioned to be a cloud-based, life-long community of patients, patient advocacy organizations, medical providers and researchers built around data warehouses, and state-of-the art analytic and communications systems.
CTEN will take advantage of many health information technology programs initiated by the Department of Health and Human Services such as the Blue Button Movement, Meaningful Use, View Download and Transmit, Clinical Trials.gov, and the Health Data Initiative. Taken together these programs, coupled with the unprecedented health care access that is guaranteed by the Affordable Care Act, create the opportunity to build a 21st health care system that is disparities free.
 National Cancer Institute at the National Institutes of Health. “Cancer Health Disparities” Fact Sheet. 2008. http://www.cancer.gov/cancertopics/factsheet/disparities/cancer-health-disparities. [Accessed 2013 Sept 19].
 Food and Drug Administration. “FDA Report: Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products, August 2013.” Available from here. [Accessed 2013 Aug 20].
 Evelyn B, Gray K, Rothwell R (Office of Special Health Issues US FDA). US Black participation in clinical trials: a review of selected new molecular identities approved 1998-2001. Presented at the NMA meeting, 2002, Honolulu, Hawaii.