Biodiversity and Health Care Quality: The 21st Century Challenge
Minorities comprise a growing segment of the U.S. population, but accounting for biodiversity and quality in health care remain significant challenges for minority populations, noted panelists at an April 20 town hall discussion hosted by the National Minority Quality Forum and Congressional Black Caucus Health Braintrust.
Minority populations are under-represented in clinical trials and genomic studies, which limits the information available to providers and patients in making treatment decisions. This matters because there are biologic factors such as race, age, genetics and comorbidities, and non-biologic factors such as diet and geography, that influence patient health outcomes, noted Dr. C. Daniel Mullins, professor in the Pharmaceutical Health Services Research Department at the University of Maryland School of Pharmacy. Recognizing these factors, accounting for them in research studies and raising awareness about them can help to address some of the challenges associated with providing treatment to diverse populations, said Dr. Mullins.
Enrolling more minority patients in clinical trials is a priority for Dr. Gary Puckrein, president and CEO of the National Minority Quality Forum. Dr. Puckrein’s organization has been leading the Clinical Trial Engagement Network, an effort with PhRMA to address a critical need in drug research—improving the representation of diverse populations, including African Americans, Asian Americans and Hispanics, in clinical trials.
“By 2020, 40 percent of the U.S. population will be minorities,” Dr. Puckrein said. “This will require our citizens to participate and build a health care system that has the capability to provide care to all Americans.”
Engaging diverse patients in clinical trials and other studies could help to ensure that study results are not solely based on what works for the “average” patient. Given the biologic and non-biologic factors described by Dr. Mullins, while the “average” patient may respond best to a particular treatment, some patients may experience little to no benefit from it, so other treatment options may be best for them. These differences in how patients respond to treatments are known as “heterogeneity,” or “individual treatment effects.”
National Pharmaceutical Council President Dan Leonard, who moderated the panel discussion, said that heterogeneity matters because if a medical professional is providing a patient care based on how the “average” person typically fares on that treatment, then that patient might not be getting the most ideal treatment for them. It also matters because most insurance companies design their policies to meet the needs of the majority of people, so those who may respond differently may have a more difficult time getting other treatment options covered, he said.
Genomic studies also can play a key role in understanding why a treatment may work well in some patients and not others, explained Dr. Georgia Dunston, who is a full professor and former chair of the Department of Microbiology in the College of Medicine at Howard University. She also is the founding and interim director of the National Human Genome Center at Howard, where she led efforts to study human immunogenetics and human genome variation in African Americans and other populations of African ancestry.
Dr. Dunston acknowledged that diversity in the genome project was nonexistent in 2003, but the early research provided a reference point that will be important for precision medicine initiatives going forward. In particular, President Obama announced during his State of the Union address a $215 million Precision Medicine Initiative “to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.”
“The community should decide what needs to be studied and work with researchers,” said Dr. Dunston. “Research is the bedrock of raw material for knowledge.”
Adolph Falcon, senior vice president at the National Alliance for Hispanic Health (NAHH), agreed on the importance of engaging minorities in research. “Genes, culture and health—that’s the environment together that we really need to be talking about,” he said.
Human genome research is important, yet only 4 percent of the representation in genome-wide association studies is from people of non-European descent, Mr. Falcon said. “Gene variants found in less than 5 percent of the population may be the most significant in understanding disease risk and therapy response.”
Genes, Culture and Health: Exploring the Best Health Outcomes for All is also the title of a publication the NAHH published this year to highlight the need for diversity in study populations. Advances in personalized medicine from determining the most effective medicine and dose to new biologic therapies tailored to the individual require inclusion in research, the publication noted.
There are other efforts underway to engage more minorities in research. Among those activities, the Patient-Centered Outcomes Research Institute has funded a research portfolio on Asthma Treatment Options for African Americans and Hispanics/Latinos. It also is encouraging the identification and assessment of patient heterogeneity and participant subgroups to inform real-world practice, as well as encouraging the selection and recruitment of study participants representative of the full spectrum of the population. In addition, the draft 21st Century Cures Act that was developed by the House Energy and Commerce Committee specifically mentions the importance of including patient experience data into its processes.