Is Compassionate Use in Clinical Trials a Popularity Contest?

Written by: Leah Jeunnette, Ph.D.(c)

Have you heard about Josh Hardy? He is a 7-year-old boy with kidney cancer whose parents requested compassionate use of the drug , brincidofovir by Chimerix. Compassionate use is an FDA approved option, but not a requirement. Compassionate use of a drug is agreed upon by four stakeholders: the patient (or patient’s family), the physician overseeing patient’s care, the drug company, and the FDA.  The FDA is clear that a drug company is in no way required to provide compassionate use of drugs. There are multiple reasons to reject a request for compassionate care including too many requests but not enough medication, and too high of risk for patients.

Chimerix said no to compassionate use for Josh Hardy. I understand the parents’ plea, and sympathize with their desire to help Josh. When the media latched onto the story of this cute, sick kid, Chimerix caved in to pressure and decided to provide the drug. The problem is that the media sensationalized a common situation in research. This media tactic makes compassionate use into a popularity contest. Who can draw the most attention to their patient or get the most likes on Facebook? Who gets the most airtime on the cable news networks?  I am sure there are others who want the compassionate use of brincidofovir. Where is their media push? Shame on the media for only focusing on the small, personal issue here instead of also drawing attention to the greater issue of resource allocation in the United States in the realm of medical research – a problem that many, many, individuals have a stake in.