Lessons from a compassionate use firestorm

Arthur Caplan assesses the impacts of the 2014 campaign to get Josh Hardy compassionate use 

On the tenth anniversary of a viral media campaign that extended a boy’s life, bioethicist Arthur Caplan reflected in an interview with The BioCentury Show on how the experience reshaped public views, corporate policies and legal requirements associated with providing access to unapproved therapies. 

In March 2014, physicians told the family of a six-year-old boy named Josh Hardy that brincidofovir, an unapproved antiviral drug being developed by Chimerix Inc. (NASDAQ:CMRX), was his only hope for fighting off a deadly infection. The company, citing resource constraints and a policy that had led it to reject similar requests, declined to provide the drug.

As BioCentury reported at the time, a campaign to force the company to change its policy caught the public’s attention. Working with FDA, Chimerix decided to immediately launch a new Phase III trial and enroll Hardy as the first participant.

The case raised questions about equity, illuminated flaws in the compassionate use system and provided a catalyst for change.

Caplan discussed how the Hardy case led to the establishment of new policies on access to unapproved drugs, including the establishment of an independent committee that he chairs advising Johnson & Johnson (NYSE:JNJ), as well as legal requirements for biopharma companies to publicly disclose their policies on access to unapproved therapies.

The wide-ranging conversation also touched on the need for scientists to receive communications training that could help reduce the impacts of medical disinformation, Caplan’s concerns about the lack of transparency about Neuralink Corp.’s experimental implantable brain chip, and the benefits of teaching biopharma CEOs about ethics.