recently reported on the case of Josh Hardy. When Josh was nine months old he developed cancer. He got through this thanks to a bone marrow transplant. Unfortunately he later contracted an adenovirus, which causes respiratory problems. Due to his weak immune system, Josh is very ill and is intensive care.
Josh's family has been running a campaign
to have a drug called Brincidofovir released for Josh's use (this is permissible in the U.S. under a proviso called “compassionate use.” The drug is an antiviral drug made by the pharma company Chimerix
Despite a successful Twitter campaign
, Chimerix did not immediately respond. Aimee Hardy, Josh's mother, has given Digital Journal an update. This is that the company have now responded and it is not good news for Josh.
According to Aimee, Kenneth Moch, the company’s president and CEO, has said that Chimerix officials are “acutely aware of the situation faced by this patient.” He added: “There are no words to express this compassion, what he and his family are going through. We understand the complexity here.”
Moch said that because the drug is in phase-three clinical development, they cannot allow it to be used by patients through the compassionate use program.
A few years ago the company did fulfill a small number of requests; however, they have not stopped doing so, according to Josh's mother Aimee.
“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,” Moch said.
Therefore, if the company continues to release the drug for needy patients it will hamper the process of gaining U.S. FDA approval. For the company this is its priority. With this decision, it appears that the company will not have the drug available until at least 2016.
Meanwhile Josh's family and friends continue to fight for access to the medication.