Insights

The light we don't shine

Written by Mike Rea — 2021-08-12.

The issue of inequity and inequality in healthcare has become an important conversation. As Kathy Giusti points out: Most clinical trials are not representative of the general population or of those with a particular disease. Clinical trials primarily enroll white, male patients, with consistent underrepresentation of women, the elderly, and people of color — especially Black and Hispanic patients. While people of color make up about 39% of the U.S. population, these groups represent from 2% to 16% of patients in trials.

These issues have been flagged before. From under-representation within a disease, to underpowered claims, we know that we are failing to include.

From a piece in STAT:

The 257 participants in a recently published Phase 2 study of Eli Lilly’s plaque-clearing Alzheimer’s drug donanemab included just 3% who were Black, 3% who were Hispanic, and 1% who were Asian. In one Phase 3 trial for another Lilly drug, solanezumab, just 1.6% of 2,129 participants were Black. For the global aducanumab trials, information released by Biogen includes only Asian people, who made up roughly 10% of participants, and white individuals, who made up 80%, a lack of diversity that was criticized in an Institute for Clinical and Economic Review report about aducanumab released last month.

However, these insights, while critical, are only one piece of the picture. These are the studies we are doing. What about the ones we're not? Running a study in Multiple Myeloma or Alzheimer's and excluding groups is an active decision - however, we can see those statistics. Our studies are excluding people who should be included, but our non-studies are excluding even more.

There are a thousand reasons we might not run studies, but choosing to focus our pipelines on diseases that primarily affect insured Americans means we never capture these statistics. If we're not even starting those studies, we are certainly not measuring the representation. The industry's addiction to failed metrics like the eNPV perpetuate this blindness.

The conversation is essential: we can address, must address, underrepresentation or lack of inclusion in the studies that help us bring products to market - for a hundred reasons, including that we cannot know how our drugs work, or how well they work, in important populations. But perhaps we need a new conversation, about our responsibility to represent the burden of disease in general? Covid certainly focused minds on global disparities in healthcare, but it might be too comfortable to leave that focus for the pandemic-like challenges that threaten (or eventually threaten) affluent populations. The light we don't shine is felt in the studies we don't start. If we maintain our debate on what is in pipelines, we miss what is not.

I don't know many answers to this challenge, but I'd be interested to hear your thoughts

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