After weeks of intense media scrutiny, a pharmaceutical firm has agreed to provide life-saving drugs to seven year-old Josh Hardy who will die of a bone marrow disorder if he does not receive them soon.
Fox News is reporting that the drug manufacturer, Chimerix, has agreed to provide brincidofovir to Josh, a Fredericksburg, Virginia boy who was first diagnosed with a rare form of kidney cancer at nine months of age. He beat it, but the cancer turned up three more times – in his thymus, lung, and bone marrow. Each time, Josh managed to overcome it.
However, a bone marrow transplant left him with a weak immune system and he was diagnosed last month with an adenovirus that had spread throughout his body.
Josh’s doctors at St. Jude’s Children’s Research Hospital in Memphis had been part of the studies on a new drug, brincidofovir, which has been very effective in treating this particular virus. The problem is that it’s not yet approved by the FDA and can only be used on a “compassionate use” basis. When doctors called Chimerix to request this use for Josh, they were told by Dr. Herve Mommeja-Marin that the company was not “in a position to provide drug for this and other subjects in similar circumstances due to a limited inventory and our limited resources.”
Repeated attempts to secure the drug failed, with news breaking earlier this week that the company’s CEO, Kenneth I. Moch allegedly hung up on a representative from a charity that had called to offer to pay for Josh’s medication.
Meanwhile, Aimee Hardy, Josh’s mother, launched a grassroots campaign to flood Chimerix with phone calls and emails in support of Josh and the hashtag #savejosh has been trending on Twitter. Some supporters even chartered buses with plans to protest outside the company’s headquarters.
It was all very encouraging for his long-suffering parents, but their son’s time is running out and expected to have only days to live if the medication is not started soon.
“It’s horrible for us as parents to see, because he’s a vibrant, strong little boy, and even though he is frail, he has a very strong will about him,” Hardy told Fox News. “But things just keep stacking against him, and we just want to do everything we can to give him the opportunity to make a full recovery.”
Last evening, Moch issued a statement saying the company would provide the drug and start Josh on the medication today as part of a 20-patient open-label study.
“This . . . study underscores Chimerix’s mission to develop innovative antiviral therapies in areas of high unmet need — for everyone,” Moch said. “Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections.”
Dr. Robert Hariri, CEO of the biotechnology company Celgene, applauded the decision and told FoxNews.com that colleagues in the industry “look to a company like Chimerix to provide an example of being heroic in these situations for the best interest of society.”
“We all run into problems where potentially life-saving therapies which are in development and under investigation are called upon by people who have no other choices, and who will die whether they receive the experimental therapy or not,” he said. “And we’re often facing the very complicated decisions on whether to potentially jeopardize the development of a drug or product because there’s need for compassionate use.”
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