A drug company is facing flak for refusing to donate a potentially lifesaving albeit experimental drug to a dying kid. Chimerix, a drug company based in Durham, North Carolina, is receiving unwanted national attention for refusing to donate an antiviral drug called brincidofovir to seven-year old Josh Hardy.
Josh was diagnosed with kidney cancer when he was just nine-months old. He also had cancer in his thymus, lung, and bone marrow but he survived all of them. A bone marrow transplant, however, left him with a weak immune system and this raised a concern when doctors found adenovirus spreading throughout his body. Adenovirus is an acute infection that can be fatal for people with a compromised immune system.
"Normally, Josh's immune system would be able to handle the adenovirus if his immune system was set free," Josh's mother Aimee Hardy wrote on CaringBridge.org. "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."
Doctors recommended that Josh receive the oral form of the antiviral drug brincidofovir as it was found effective in clearing up adenovirus in children in as little as one to two weeks. The problem, however, is that drug has not yet been approved by the FDA so the doctors would have to ask for the drug from the company that makes it, Chimerix, Inc. The drug company, however, didn't grant the request.
Chimerix used to give brincidofovir to patients who needed the medication in the past but it already stopped the practice. In a statement posted on its website, the company pointed out the implications of making the drug accessible while still in its experimental phase.
"Making an experimental drug available outside of controlled clinical trials has the potential to slow or derail the approval of that drug," Chimerix said. "Providing brincidofovir in any of these situations, where there is currently limited evidence to suggest that our experimental medicine would be helpful, could very likely place the entire development program at risk. The successful completion of SUPPRESS is the primary focus and mission of our small company."
In an effort to convince Chimerix to allow Josh to receive the experimental drug under a so-called compassionate use program, in which a seriously ill patient is granted access to an unapproved drug, the Hardy family launched a campaign asking people to help them persuade the company to provide Josh the much needed drug.
"Our son will die without this drug," said Josh's father, Todd Hardy. "We're begging them to give it to us."
Chimerix, however, apparently stands firm on its decision. "We've had employees who ask for the drug for family members who are close to death, and the answer has been no," said Chimerix executive Mommeja-Marin.