Company Decides to Give Unapproved Drug to Sick Boy
After thousands of people petitioned a drug manufacturing company based in North Carolina to provide a potentially life-saving drug to an ailing seven-year-old boy, the company has decided to comply.
The patient, Josh Hardy from Fredericksburg, VA, is suffering from an adenovirus infection that manifested after a bone marrow transplant. The young boy is a four-time cancer survivor and after the bone marrow transplant, his immune system was too compromised to fight off the infection. Due to this predicament, his doctors had asked the company, Chimerix to provide the medication, brincidofovir, outside of a study setting.
The company initially turned down the doctors' request. They stated that if they agreed to give Josh the experimental antiviral drug, they would have to provide the drug for other similar cases. By providing the drug without any approval, the company expressed concerns about losing resources that could be used for clinical trials that would help get the drug approved and distributed to more patients.
"Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir," the company's president and CEO, Kenneth Moch said according to USA Today.
After Josh's family took to social media to gain support, Chimerix changed its course and decided to provide brincidofovir to the young boy. The drug will be sent over to the St. Jude Children's Research Hospital in Memphis, TN within 48 hours. The company's new plan, which has already been approved by the U.S. Food and Drug Administration (FDA), is to provide the drug to 20 patients. Josh will be the very first.
"This drug is experimental and has not yet been approved by the FDA and the safety and effectiveness of the medication has not yet been established for use in children. ... It is also important to understand that this remains a critical and complex medical situation," the hospital stated.
It added, according to CNN, "St. Jude will continue to pursue state-of-the-art treatment for Josh and all of our patients. We are grateful for the efforts of Chimerix, the FDA and many others who worked to achieve this outcome. We ask that you continue to keep Josh and his family in your thoughts."
On the family's Facebook Page, they had expressed their gratitude and wrote, "You did it. You Saved Josh. Thank you Chimerix and Josh's Army."