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Drug Company Denies Medication to Dying Boy

Tuesday, 11 Mar 2014 01:29 PM

A 7-year-old Virginia boy who has survived kidney cancer, heart failure, and a bone marrow transplant is once again fighting for his life, after a drug company denied him access to a drug that could cure him of a deadly virus, Fox News reports. 
Josh Hardy's mother, Aimee, has launched a campaign to encourage drug manufacturer Chimerix to allow her son to have the medication, in an effort to save his life.
"I want to be by his bedside, holding his hand, telling him, 'It's going to be okay,' but because of this unwillingness to release this drug, I have to leave him and come talk to you and it infuriates me," Hardy, from Fredericksburg, Va., told Fox and Friends.

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She said Josh had been cancer-free for two years. In January, he underwent chemotherapy and a bone marrow transplant at St. Jude Children's Research Hospital in Memphis, Tenn., but he later developed adenovirus — an acute infection that can be deadly in people with compromised immune systems.
"Normally, Josh's immune system would be able to handle the adenovirus if his immune system was set free," Hardy wrote on her son's CaringBridge.org page. "The challenge is his immune system can’t be set free yet because his body is still trying to adapt to the new bone marrow cells. So to keep the body from killing the new cells, they have to suppress the immune system, thus creating ideal conditions for adenovirus to advance. Catch 22."
She said doctors at St. Jude recommended Josh be treated with Brincidofovir — an antiviral drug that has been proven to clear up adenovirus in children within two weeks.  But the drug has not yet been approved by the U.S. Food and Drug Administration, so Josh hasn't been able to gain access to the medication.
Chimerix, the company that manufactures Brincidofovir, has given hundreds of patients the medication, but they have since stopped this practice saying they cannot afford it, Fox reported, noting Chimerix has received more than $72 million in federal funding to develop the drug.
"As we progressed to larger and more complex safety trials, we made the decision two years ago to stop the program and focus resources on earning FDA approval," said Kenneth Moch, the CEO of Chimerix.
The Hardy family has launched a campaign to convince the company to allow Josh to receive the drug through a "compassionate use" program — in which a drug company can allow a seriously ill patient to receive access to an unapproved drug.

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