“I feel powerless to help them. There needs to be a change. And change ought to begin in the form of a policy shift.”

These are Jay Avasarala’s words in regards to finding more effective treatment options for African-Americans living with Multiple Sclerosis (MS).

For years, the scientific community has understood that African-Americans living with the disease progress at a much faster rate and deal with more aggressive symptoms of the condition. However, minority representation in clinical trials for MS is still extremely lacking, and therefore physicians are not provided the information they need to best prescribe treatments for their patients.

The Current State

In the United States, African-Americans living with MS move to nursing homes 6 years before Caucasian American individuals. Additionally, African-Americans are more disabled when they enter these homes. Although phenotypes between the two groups of patients are clinically distinct there remains to be a severe gap in the research for African-Americans. This leads to ineffective treatment options for this population of patients.

Researchers simply cannot clearly state the effect of a drug for populations who they do not specifically study. Despite knowing this, minority representation in clinical trials for MS has actually declined in recent years. In 2002 it was 7.7% but 11 years later in 2013 it dropped to an astounding 2%.

It is clear we need reform. But attempts to do so have not been very successful. An initiative started in 2014 by the FDA’s Center for Drug Evaluation and Research attempted to increase representation by being more transparent about current data. The initiative was called the Drug Trials Snapshot and it published trial data online. While a good start, it didn’t do much for prescribing physicians who ultimately need to consult the efficacy data when determining the best treatment option for their patients. Therefore this information is needed not just online for the public eye but on drug package inserts themselves.

Avasarala’s Recommendations

Avasarala is advocating for two specific changes in the way we work with minority populations. The first would be to require that pharmaceutical companies collect data on responsiveness for MS drugs with FDA approval post-marketing for minority groups. Currently, they are required to provide data in regards to drug safety, but reports regarding efficacy for minority populations is not a necessity.

Secondly, Avasarala says that companies should be required to include efficacy information from minority groups on their drug labels themselves. Likewise, he states that if a company does not have sufficient data on minority populations, they should be required to explicitly state their inability to conclude efficacy for those groups. He further explains that no publication should accept study data which does not include such a statement.

Avasarala’s hope is that these changes would ultimately help to increase rates of minority recruitment in clinical trials for MS.

Ultimately, we know that MS is represented differently in minority populations than it is in Caucasian Americans. But we have failed to find adequate treatments yet for these individuals. Hopefully, we will see changes such as Avasarala’s recommendations implemented soon and begin to find solutions for these patients.

By improving representation, we will be able to improve care for African-Americans living with MS and that’s truly what it’s all about.

You can read more on Avasarala’s take on representation and his suggested solutions here.