Medicines Are the Starting Line for Racial Equality

By Dr. Joan Fallon, CEO, Curemark Pharmaceuticals

Photo by National Cancer Institute on Unsplash

If you’re a minority, there’s a good chance you have fewer opportunities for quality healthcare than your white counterparts. As the CEO of a biopharma company, I see bias built into the system that goes far beyond basic access.

There are also tremendous ethnic and racial disparities in the development of the tools of healthcare, specifically drug development. History shows that minority participation in drug development trials has been disproportionately low.

We need to get live-saving and life-enhancing medicines into the hands of Blacks, African Americans, Latinos and other minorities. If minorities are not appropriately included in trials for conditions that affect them, the outcomes ultimately may not apply to them. There is systemic racism built into drug development under the cover of “good science”.

Examples abound.

Caroline Chen wrote a strong piece in ProPublica about the lack of participation in clinical trials entitled: Black Patients Miss Out on Promising Cancer Drugs. It’s a must read. She cites multiple examples of company sponsors of clinical trials that excluded Blacks and African Americans.

Since 2015, the FDA has produced a yearly report called the Clinical Trials Snap-Shot, which. shows demographics from clinical trials for drugs that were approved in a particular year. The last 3 years of Snap-Shots show a dramatically lower percentage of Blacks and African Americans participating in clinical trials vs the population in the US. (https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots)

The 2019 FDA Clinical Trials Snapshot shows a drug known as trifarotene approved for acne vulgaris. Acne is a condition that affects Blacks and African Americans slightly more than whites or Hispanics. Somehow, the clinical trial subjects were 7% Blacks or African American and 87% White.

Why would a trial that has 2,400 participants in 200+ clinical sites enroll only 7% Blacks and African Americans? In a study that large with so many sites, African Americans could certainly be found as participants.

According to the 2018 Snap Shot, the drug moxetumomab pasudotox-tdfk was approved for Hairy Cell Leukemia (HCL), a rare type of cancer that is more prevalent in males than females (4:1) and whites versus Blacks (3:1). There are approximately 600–800 cases a year in the United States.

However, Blacks and African Americans have a much higher mortality rate from HCL than whites. Two-third of whites survive 10 years with HCL. Only half of Blacks and African Americans do.

In the clinical trial that led to approval, only 1% of the trial participants were Blacks or African Americans.

Overt exclusion is even more obvious in drug discovery for hypertension. In hypertensive clinical trials, subjects with diabetes and/or heart disease are most often excluded. Common reasoning is that those with co-occurring diabetes and/or heart disease — which includes a high number of Blacks, African Americans and Hispanics — could mute or muffle the “data signal” (the relationship of the drug to the result) when given with co-occurring diseases.

As a result, few of the trial subjects will have these co-occurring conditions. However, the hypertensive drug, once approved, will likely be prescribed for people of color who suffer from them even though it hasn’t been tested on them. How can these patients make an informed decision as to whether to take the drug?

This issue needs to be addressed NOW. The responsibility to ensure that individuals with unmet medical needs get the medications they need falls on those with control of the process. The FDA, clinical trial sponsors both in industry and academia and private physicians bear responsibility. Patients rely on those who make the rules and set the standards. Inclusion needs to be considered as an essential part of a clinical trial.

Ethical research serves as part of the way in which individuals can understand if a particular drug or research outcome applies to them. If minorities are not appropriately included in trials for conditions that affect them, the outcomes, no matter how stellar, ultimately may not apply to them.

There is much work to do. It will take a collective effort and a willingness from big and small pharma, biotech companies, the FDA and doctors to find a middle ground.

I suggest these items as a starting point:

  1. Sponsors need to be willing to collect real-world data, with the understanding that negative outcomes are still outcomes.
  2. FDA needs to encourage sponsors to collect this data and design outcome measures that target real life symptoms and meaningful outcomes.
  3. Both FDA and Sponsors need to understand that efficacy can look like many things, not just one primary chosen outcome measure.
  4. Doctors need to demand clinical trials and drug discovery that reflect treatments for the diseases and conditions that plague their patients.
  5. Stop blaming minority patients for their lack of participation.
  6. Continue to educate patients from minority groups about the importance of clinical trials.

Medical research exists for the benefit of all Americans. It’s time to fulfill that promise.

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