/ by UK HealthCare
In an editorial published in CNS Spectrums, Dr. Jay Avasarala of UK HealthCare's Kentucky Neuroscience Institute takes the research community to task for its lack of minority representation in Phase III clinical trials for drugs to treat multiple sclerosis (MS).
Since the 1970s, science has documented that MS among African Americans is clinically distinct in its progression and presentation, according to Avasarala, but research into treatments that address their particular phenotype has not kept pace.
"The scientific community has published reams of data, but all that matters to a patient is, 'OK, doc, how can you treat me? What drugs would you recommend?' And we fall short for African Americans because we simply don't have the data," he wrote.
Why minority representation is crucial
Noting that the disease course of MS in African American patients is more aggressive, he urged researchers to make more efforts to put an end to the persistent slide in minority representation, which he believes skews efficacy and disability data and prevents physicians' ability to find out whether drugs are effective in these populations.
"The MS phenotype in the African American patient is an ideal model to study drug efficacy since the disease follows a rapidly disabling course," he wrote. "African American MS patients admitted to U.S. nursing homes are six years younger but more disabled compared to Caucasian patients with MS. Since phenotypes between Caucasians and African Americans can be clinically distinct, it is remarkable that not a single study has compared how drugs perform in such diverse groups."
According to Avasarala, a neurologist specializing in multiple sclerosis and neuroimmunology, minority recruitment for clinical trials for MS drugs declined from 7.7 percent in 2002 to about 2 percent in 2013.
In 2014, the FDA's Center for Drug Evaluation and Research (CDER) launched the Drug Trials Snapshots initiative that works to increase minority representation in drug trials and improve public transparency by providing drug trial data online. While Avasarala acknowledges that the initiative was a good first step, he emphasizes that it does not require drug package inserts to include efficacy data from minority populations, which makes it difficult for prescribing physicians to determine whether the drug will help patients from minority ethnicities.
Advocating for change
In the editorial, Avasarala proposed several changes to help spur minority recruitment, which will in turn improve the quality of data for minority populations and make it easier for physicians to treat their African American patients.
"First, I believe we should require pharmaceutical companies to collect post-marketing data in all minority groups who receive FDA-approved drugs for management of MS and classify responsiveness based on ethnicity," he wrote, noting that the FDA has required manufacturers to provide post-marketing data on drug safety for many years.
Avasarala also advocates for a requirement that package labeling include efficacy data from minority populations and that no publication should accept study data without a clarifying statement that acknowledges the lack of sufficient data to make reasonable conclusions in non-Caucasian minorities.
"I feel powerless to help them," he wrote. "There needs to be a change. And change ought to begin in the form of a policy shift."
Avasarala's research at UK will focus on the translational aspects of MS, datamining, the application of retinal imaging techniques to advance disease diagnosis and the study of in vitro blood-brain barrier models to facilitate drug transportation.