WASHINGTON (May 25, 2016) – Shawneequa Callier, J.D., assistant professor of clinical research and leadership in the GW School of Medicine and Health Sciences, is a co-author on a Perspective article featured in the May 26 edition of The New England Journal of Medicine titled, “Will Precision Medicine Move Us beyond Race?” The Perspective article addresses issues related to prescription medications that fall within the category of precision medicine.
The authors identify challenges associated with racial and genomic data based on a self-reported data collection model - creating potential for detrimental prescription drug outcomes.
“Precision medicine is a burgeoning field of study that is slowly being translated into clinical practice. Along the way, questions about the use of race in medicine will need to be addressed to ensure that we are treating people in the most strategic way,” says Callier. “Identifying the genetics of a patient through science is an area in need of more research and refinement. We are concerned that people who could benefit from certain drugs may be excluded from receiving them and others may be given treatments that are not effective when doctors use race as a proxy for genetics.”
The article explains that geographical ancestry can be a major determinant of genomic variation which can influence reactions to certain drugs. The authors note that “prescribing medications on the basis of race oversimplifies the complexities and interplay of ancestry, health, disease, and drug response.” The authors describe the first race-based drug called BiDil, which is a treatment for self-identified black patients who are experiencing heart failure. Those who supported the approval of BiDil believed that this was a step toward personalized medicine, while others believed that race alone should not determine who could or could not benefit from the drug.
Another scenario that the authors outlined describes the use of angiotensin-converting-enzyme (ACE) inhibitors that are not as likely to be prescribed to black patients as white patients, based on physician reports that hypertension is less responsive to ACE inhibitors in black patients. The authors believe that using race to dictate therapy may prevent a drug from being offered to a patient, despite the fact that the drug could be effective.
A third example outlined by the authors focuses on the sale of Plavix or clopidogrel bisulfate in Hawaii –the subject of a 2014 lawsuit filed by Hawaii’s attorney general for false, deceptive and unfair marketing and promotion of Plavix. It has been found that clopidogrel is less effective in East Asians, Native Hawaiians, and other Pacific Islanders; therefore, the plaintiff contends that a large portion of the Hawaiian population was using a drug that was not beneficial based on their genetic make-up.
The authors found that there are several major challenges that need to be addressed in the use of precision medicine, including: 1. Greater inclusion of patients of diverse ancestry in genomic and other biomedical research can improve understanding of intrapopulation and interpopulation diversity; 2. Drugs that are found to be effective only in subpopulations are likely to be more expensive, therefore, making precision medicine unavailable for all populations. Including a diverse global population in prospective cohort studies will establish an evidence base regarding the effectiveness of drugs for individual patients – and advance equitable distribution; and 3. Moving the drug selection process beyond race to more accurate indicators of drug response will depend on the ease and usefulness of implementing a precision medicine approach. As health care advances, caregivers will be inundated with genomic, environmental, lifestyle, and social data. These new data, coupled with appropriate resources and training, may help guide clinical care.
The authors concluded that upon addressing these challenges, the use of “precision medicine could reduce and ultimately eliminate the use of crude racial and ethnic census categories in drug prescribing.”
Other co-authors of this Perspective article include: Vence L. Bonham, J.D., from the Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD; and Charmaine D. Royal, Ph.D., from the Department of African and African American Studies and Center on Genomics, Race, Identity, Difference, Duke University, Durham, NC.
To view a copy of the Perspective article, visit the New England Journal of Medicine.
