ICBioethics Blog 

An Update on the Josh Hardy Story

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

I had the privilege of talking with the CEO of Chimerix, Inc., Mr. Kenneth Moch, on Wednesday. After he read my most recent blog post, we had a chance to chat about the case of Josh Hardy from the perspective of the drug company involved.

First, I need to make a few clarifications as a follow-up to my previous posting. Instead of offering compassionate use of the drug brincidofovir to Josh Hardy, Chimerix collaborated with the FDA to establish a clinical trial that Josh is now enrolled in. I commend Chimerix for addressing the challenge that the media gave, but instead of just offering compassionate use, they found a way to provide brincidofovir, while gaining useful data as part of a trial. By creating this pilot trial, other patients, as well as Josh, are being provided with this experimental drug. While the media continued to point their fingers at the “big bad drug company,” those directly involved with the debate addressed the bigger issues here: compassionate use, resource allocation, access issues, and fairness. They sought to find a resolution that benefited not only Josh, but other patients, too. According to the SaveJosh Facebook page, the medicine is working, and I truly hope that this is just the happy beginning of Josh’s continued progress report.

I still stand by my original conclusion: shame on the media! And what is their follow up chatter? Many are applauding themselves for their success in getting Josh Hardy the medicine. Sounds bites have focused on Chimerix giving in or backing down. But did they really?!  Technically, they sought an alternate resolution that genuinely reflects the broader discussion–a broader discussion that the media is still not addressing . . .

I challenge the media: broaden your focus; think bigger picture, longer term; become willing to ask the tough questions, but also discuss solutions beyond one singular case.

To date, there are no ethical standards for compassionate use in clinical trials. Without ethical standards in place, cases like Josh’s will continue to make headlines, some of them inciting and/or misleading.  Will the opportunity for a media popularity contest inevitably circle around again? Of course . . . but in the meantime, I think it is time for a change. Concerning this particular issue at hand, appropriate ethical standards need to be put into place to correct and resolve this problem.

Mitch GennusoComment