Family of sick boy 'begging' for use of experimental drug
Posted March 11, 2014
Durham, N.C. — The family of a critically ill Virginia child is putting pressure on a Durham biotech company that is developing a drug they believe could save his life.
Seven-year-old Josh Hardy is in the intensive care unit at St. Jude Children’s Research Hospital in Memphis, Tenn., where relatives say he’s trying to fight off a virus contracted while undergoing treatment for cancer.
Josh’s mother, Aimee Hardy, has said an experimental drug being developed by Durham-based Chimerix could be her son’s best chance for survival.
They have asked the company for what is known as a “compassionate dose” of brincidofovir, but Chimerix has denied the request because doing so could slow down the process of getting the medicine to market.
“Making an experimental drug, which currently has limited clinical evidence, available outside of controlled clinical trials has the potential to slow or derail our ability make brincidofovir available as soon as possible to the thousands of patients each year who might benefit from it,” Chimerix Chief Executive Ken Moch said in a statement. “ This is why we are focused on demonstrating the safety and efficacy of brincidofovir in our ongoing Phase 3 clinical trial.”
The Food and Drug Administration allows someone with an immediate life-threatening illness to ask for permission to use experimental drugs that have not yet received the agency’s approval. Last year, the FDA agreed to 974 such uses, according to CNN.
Moch said the company has received hundreds of requests over the past few years for compassionate use of brincidofovir. The company also pointed to industry-established ethical guidelines that state a patient’s right to treatment does not come before a company’s responsibility “to develop and market safe and effective products as fast as possible.”
The Hardy family is undaunted, and they’ve taken their plea around the country. The story has gained a wider audience in recent days following reports by CNN, CBS, Fox News, Huffington Post and USA Today. A Facebook page created for the cause less than a week ago has more than 18,000 “Likes.”
"Our son will die without this drug," Todd Hardy, Josh's father, said to CNN. "We're begging them to give it to us."