Chimerix, Inc. has refused to administer an antiviral drug called, brincidofovir, to a dying seven-year old boy despite pressure from thousands of protestors. The company reasoned it is not yet approved by the U.S. Food and Drug Administration (FDA).
Josh Hardy is a cancer survivor with a life-threatening viral illness that he got after a bone-marrow transplant. His doctors in the St. Jude Children's Research Hospital, in Memphis, believe that Chimerix' antiviral drug is the boy's cure. The doctors recommend the drug as they have used it and worked for other children.
The doctors, along with Josh' family and thousands of supporters, have made requests for the production of the drug for the boy.
However, numerous requests to get the unapproved medication were turned down by the pharmaceutical company.
Chimerix president and CEO Kenneth Moch said that they have been receiving several e-mails and calls from thousands of people that urge them to produce the drug for the boy. However, they can't give it a go as that would mean saying yes to more patients. That situation could hinder the completion of a formal study of the drug.
"We have great compassion for this family," said Moch to USA Today. "But this is not just about a single boy."
The rules of FDA permit companies to give unapproved drugs to patients under certain circumstance, which is called "compassionate use," as long as the drug has in clinical testing already. But, for a patient to get such drug, he must meet a couple of criteria first. To qualify for the use of brincidofovir, the patient who will use it must have been on the drug in a previous trial, or must be a newborn with herpes simplex virus.
Unfortunately, Josh didn't meet any of those criteria. Furthermore, Chimerix has no current study for kids like him.
Without the drug, the hospital and its medical practitioners are left with no choice but to go on with providing Josh with a state-of-the art treatment.
"We're trying to save our son," who is turning eight this coming March 31, said Todd Hardy, Josh's father to USA Today.