A pharmaceutical company has denied a 7-year-old the drug that could potentially save his life. The boy, Josh Hardy, has been held in an intensive care unit at St. Jude's Research Hospital in Memphis, afflicted with a potentially fatal adenovirus. Although Josh’s parents have requested the drug — called brincidofovir — from Chimerix, the pharmaceutical company says helping the boy would slow the time it takes to get the drug on the market (which, in turn, would help others more quickly).
Josh, who has been diagnosed with an adenovirus since February after a long battle with kidney cancer, has already been given an intravenous form of brincidofovir during his treatment. Doctors at his hospital, however, claim that test studies have shown Chimerix’s oral form of brincidofovir can cure an adenovirus without resulting in the extra damage caused by the intravenous form.
The recent film Dallas Buyers Club highlighted the relationship between pharmaceutical companies testing experimental drugs and the desperate patients that need that medicine. Even if a drug exists that could potentially help a sick individual, hospitals and medicine companies operate on a grander scale.
There is an FDA policy known as “compassionate use,” in which individuals can request drugs in a manner similar to Hardy’s family, but companies have the right to deny them. According to CNN, the FDA approved 974 compassionate use requests in 2013.
Josh’s father Todd Hardy was straightforward about the importance of obtaining this new drug.
“Our son will die without this drug. We’re begging them to give it to us,” he said.
The Hardys’ request even captured the attention of Chimerix president Kenneth Moch, who remained adamant that the company could not help Josh.
“If this were just one patient wanting this drug, then this would be a very different question. But it’s yes to all or no to all,” Moch said.
Moch explained that a compassionate use request typically costs a company about $50,000 because it is not covered by insurance. It would also mean more communication and paperwork to be filed with the FDA, which could slow their progress in getting the drug approved and on the market for the rest of the individuals throughout the world that need it. It would also mean higher risk of liability, especially because Josh is already so sick. Even though the company is aware of Josh’s situation, administering the drug to one individual would be detrimental to their company.
According to the Fredericksburg News, members of the Hardy family’s community have been demonstrating their support for Josh by reaching out to the drug company and politicians alike. At least two politicians, U.S. Rep. Rob Wittman and State Sen. Bryce Reeves, expressed their support for Josh and the Hardys through Twitter. The Chimerix president himself even commented on the situation, claiming he is “heartbroken.”
Update: They have changed their mind.