Drug company changes course, gives drug to sick boy
A North Carolina drug manufacturer will give a potentially life-saving medication to a 7-year-old boy whose case led thousands of people to apply pressure to the company.
Josh Hardy, of Fredericksburg, Va., who is fighting an adenovirus infection after a bone marrow transplant, will get the experimental antiviral drug brincidofovir as the first patient in a new pilot study, according to the company, Chimerix, of Durham, N.C.
Josh's family, who are with him at St. Jude Children's Research Hospital in Memphis, immediately thanked supporters on Facebook: "You did it. You Saved Josh. Thank you Chimerix and Josh's Army." The family had recruited support through social media and news stories over the past few days.
In a statement, the hospital confirmed that the company has promised to send the medication within 48 hours. The company previously turned down multiple requests from Josh's doctors to provide the medication outside of a study — under so-called "compassionate use" rules.
On Monday, Chimerix president and CEO Kenneth Moch said that saying yes to Josh would mean having to say yes to other similar patients, straining the resources the company has available for clinical trials that could lead to the drug's approval and ultimately get it to many more patients. And he said Josh did not qualify for the study the company had underway in adults with a different infection.
Under the plan announced Tuesday, Josh will get the medication as one of 20 people in a new study, Chimerix says. It says the plan has been approved by the Food and Drug Administration.
In the statement, Moch says: "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."
In its statement, the hospital expressed some caution: "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. ... It is also important to understand that this remains a critical and complex medical situation."
Josh is a four-time cancer survivor who needed the bone marrow transplant because of complications of his cancer treatment, his family has said. The viral infection has been tough for Josh to fight off because he is taking medications that suppress his immune system.