Seven-year-old Josh Hardy of Virginia has spent his short time on Earth battling kidney cancer four times. The boy has refused to lose. In these battles Josh has experienced and beaten heart failure, and most recently a bone-marrow transplant. So that the new bone-marrow cells will not be refused by his body, his immune system has had to be suppressed using medication, making it very easy for the boy to catch common, normally very treatable infections. Josh is currently battling the adenovirus, a virus that is not usually dangerous. In the case of someone with a compromised immune system, this virus, normally associated with colds, rash, conjunctivitis, cystitis, bronchitis, etc., can cause death. Despite the fact that Josh is dying and a specific medication could save him, the manufacturer of the drug, Brincidofovir, has refused to give it to the boy.
Brincidofovir is manufactured by Chimerex, a relatively small company based out of Durham, North Carolina. Chimerex has received over 72 million in federal funding towards the research and manufacturing of this drug, which is not yet FDA approved. The company’s CEO and president, Kenneth Moch, says that Chimerex cannot give Josh the drug due to financial reasons. Although Brincidofovir is not FDA approved, under something called a “compassionate use” program, others in the past have received the drug and still do, but in a much narrower category now than in the past. The company stopped giving Brincidofovir away across a wide category of medical issues two years ago. In very specific instances, they will give it to people who have previously been administered the drug in clinical trials, and will additionally give it to babies with the herpes simplex virus. Aside from one of these conditions being present, Moch says giving the drug to Josh would open the door to again giving it to too many, and this would drain resources away from what the company is currently trying to achieve for the drug: FDA approval.
Arthur Caplan, a medical ethicist and professor from New York University’s Langone Medical Center, says he understands the company’s viewpoint. Caplan states that he has sympathy for the boy and his family, and knows they must do whatever they can to overturn Chimerex’s stance refusing the medication to Josh, who will die without it. That said, he simultaneously expresses support for Chimerex, recognizing possible delays in the FDA-approval process should the company have to spend time and money on giving the drug away for free. Additionally, Caplan warns that should anything go wrong in a case where trials did not support giving the drug to someone, this could seriously impede or possibly even stop altogether the company’s bid for approval, proving detrimental to many future patients.
Doctors at St. Jude Children’s Research Center in Memphis where Josh is being treated recommended Brincidofovir because the other drug they are giving him to fight the adenovirus is damaging his kidneys. They thought of Brincidofovir because they had used it for children in a previous study at the research center. Josh’s father Todd Hardy reports that their doctor told him Brincidofovir would cure his son. Josh’s father Todd, mother Aimee and older brothers all hope Chimerex will alter their decision to refuse the drug, and will release the medication to the dying boy. A caravan going from Josh’s hometown to Chimerex in peaceful protest is being organized by a family friend, Duane Adams. The caravan will leave the Central Park Wal-Mart in Fredericksburg, Virginia, this coming Thursday.
By Julie Mahfood
Follow Julie Mahfood on Twitter @Julie11153717
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