Company Denies Drug to 7-Year-Old Boy Struggling Against Curable Virus
Peter Johnson Jr. reported this morning on a harrowing story pitting the family of a seven-year-old Virginia boy against a drug company. Josh Hardy was stricken with an infection called an adenovirus after undergoing a bone marrow transplant in January.
Josh has been fighting and winning his battle against cancer, along with heart and kidney issues, since he was less than a year old. Now, his mother, Aimee Hardy, says he will die if the curable virus is not treated soon.
Doctors believe the adenovirus can be cured with a drug named Brincidofovir, which is in the trial stage and has not been approved by the FDA. Doctors say the drug has been used successfully on kids with Josh's infection.
Aimee says the drug maker, Chimerix, has so far refused their urgent pleas to give doctors the drug on "compassionate use" grounds. Kenneth Moch, the company’s president and CEO, said Friday that the company cannot approve "compassionate use" of the drug right now because it is in phase-three of the clinical development process.
“We understand this great need.That’s what drives us to focus on getting it available. It creates these really difficult complex situations where the need to pursue the formal clinical development under the FDA process takes precedent over other needs. 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," said Moch, who added that his company is “acutely aware of the situation faced by this patient.”
Fox and Friends pointed out this morning that Chimerix has received $72 million in federal funds. Aimee called on the company to change its position, saying "there has got to be some other way to make this available to everyone."
"To me it's almost a crime not to make it available to everyone who needs it and I definitely am going to keep fighting for my son until they give it," said Hardy.
Johnson said he was in contact with Moch over the weekend, asking him whether it might change his mind if he were to visit Josh at the Memphis ICU. Moch maintained that a visit would not change his mind, Johnson explained.
Hardy detailed that her son is very frail right now and has trouble staying awake because of all the pain medication he's being given.
"Because of this unwillingness to release this drug, I have to leave him and come talk to you and it infuriates me," she said.
For more on Josh, you can visit his Caring Bridge page. Hardy asked people to take to Twitter and Facebook and voice their support using #savejosh.
Below is information on how you can contact Chimerix. Watch Johnson's interview with Hardy above.