Seven-year-old Josh Hardy made headlines when drug manufacturer Chimerix refused to donate an antiviral drug - still in the experimental phase - to the cancer-stricken child. However, the company has now reneged on its original decision, announcing Tuesday that Josh would form part of a new pilot study where he would be required to test the medication. Josh will be the first of 20 patients involved in the study.
A Facebook campaign (#Savejosh) saw thousands of supporters rising to the occasion, putting pressure on Chimerix to donate brincidofovir to Josh. The drug is still undergoing clinical trials and is yet to be approved by the Food and Drug Administration (FDA), hence the need for the donation on compassionate grounds by the manufacturer. However, 'compassionate grounds' proves to be a difficult and morally fraught scenario for drug manufacturers, who believe that giving the drug to one patient opens floodgates to all patients with similar conditions. In the case of brincidofovir, its effectiveness and safety haven't yet been verified in children, leaving the company with several initial reservations about giving it to Josh.
Josh, a four-time cancer survivor, requires the antiviral due to a bone marrow transplant that left him with an attack of adenovirus infection, with the child suffering from serious heart and kidney failure.
Ken Moch, CEO of Chimerix, explained the process of a compassionate donation, saying that his company has not participated in such a program for some two years. "Making an experimental drug, which currently has limited clinical evidence, available outside of controlled clinical trials has the potential to slow or derail our ability to make brincidofovir available as soon as possible to the thousands of patients each year who might benefit from it," Moch told PEOPLE Magazine. "This is why we are focused on demonstrating the safety and efficacy of brincidofovir in our ongoing Phase 3 clinical trial."
In deciding to allow Josh access to the drug, St. Jude Children's Research Hospital, where Josh is being treated, has urged his family and supporters to remain realistic about the results. "This drug is experimental and has not yet been approved by the FDA and the safety and effectiveness of the medication has not yet been established for use in children," the hospital said in a statement. "It is also important to understand that this remains a critical and complex medical situation."
Josh's mother, Aimee Hardy, expressed her gratitude in a Facebook post: "Glory to GOD! They are releasing the drug for Josh!!!!!!!!!"
