I read with interest, as I’m sure many of you did, the story of Josh Hardy, the critically ill seven-year-old from Virginia whose family petitioned Chimerix, a North Carolina biotech company to extend an unapproved drug to their son under the compassionate use regulations. You can read the story here.
What a heartbreaking story about a young boy who was diagnosed with cancer four times since the age of nine months. The good news is that Chimerix, a small biotech company with no approved drugs in its pipeline, was able to negotiate with the Food and Drug Administration (FDA) to launch a small pilot study of 20 patients in Josh’s indication. This allows the company to collect data for product launch and also provides access to the drug for Josh. It seems like a win-win…or is it?
The Washington Post published an interesting story discussing the ethical dilemma this case, and others, have brought to light.
What do you think? I’m interested in hearing the thoughts of our readers on this topic. What are your thoughts on this story?
Until next time,
th
ACRP Blog 