Seven-year old cancer survivor Josh Hardy is in intensive care with a virus, heart failure and kidney failure. His parents have asked Chimerex, Inc., for an experimental antiviral drug, brincidofovir, that could help him fight the virus but Chimerex has denied their request. The denial has caused a national uproar, escalating to threats against the company's executives. Still, Chimerex is holding its ground. Chimerex claims that allowing one child to have the experimental drug wouldn't be fair because it could delay getting the drug on the market and available to everyone. Under a "compassionate use" provision, FDA allows someone with a serious or immediately life threatening disease who has tried and failed other available treatments to ask a drug company for an experimental drug before the drug has been FDA-approved. However, because companies are required to report any poor outcomes on their applications to market the drug, companies are reluctant to delay or jeopardize the approval progress. An outraged public has turned to the social media with Facebook pleas and angry tweets to @chimerix.
[1] Cohen, E. "Company denies drug to dying child", CNN Health (March 11, 2014).
Update: Chimerex has reversed its position and agreed to give the drug to Josh Hardy and 19 others with compromised immune systems as part of a pilot trial. 03/13/2014
[1] Cohen, E. "Company denies drug to dying child", CNN Health (March 11, 2014).
Update: Chimerex has reversed its position and agreed to give the drug to Josh Hardy and 19 others with compromised immune systems as part of a pilot trial. 03/13/2014
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