The story of 7-year-old Josh Hardy has brought to light the issue of “compassionate use” of experimental drugs and the willingness of drug companies to provide them.
The pharmaceutical company Chimerix said Tuesday that Josh would receive medicine that doctors hope will help him as part of a pilot trial of the drug brincidofovir for the treatment of adenovirus infections in certain patients. Josh got his first dose of the drug on Wednesday.
The boy has been battling cancer since he was 9 months old and recently received a bone marrow transplant at St. Jude’s in Memphis. In the days leading up to the new treatment, Josh has been in the ICU ravaged by a virus. His heart and kidneys are failing him.
“Josh has a long road to recovery,” Todd Hardy, Josh’s father, told CNN in an e-mail Thursday.
In a campaign that went viral, the parents pleaded with the pharmaceutical company Chimerix to provide a compassionate dose of brincidofovir for Josh. Chimerix initially rejected the request.
Chimerix CEO Kenneth Moch had said that if the company spends too much time and money on “compassionate use” cases it would greatly hinder its effort to get brincidofovir, on the market and available to everyone. But the company changed course in the wake of the publicity the Josh Hardy case had generated.
“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 that will inform its use in adenovirus and other serious DNA viral infections,” Moch said as part of a statement on the final decision to provide the drug.
If someone faces a life-threatening disease and has tried and failed other available treatments, they can ask a drug company for an experimental drug. These drugs are usually still under review and have yet to be approved by the U.S. Food and Drug Administration.
Sometimes the drug companies say yes. According to CNN, 974 compassionate use arrangements in fiscal year 2013 were approved.
With every “compassionate use” arrangement a drug company approves, the longer it takes to get a drug out to the general public.
The FDA says that if someone has a life-threatening disease and has tried and failed other available treatments, they can ask a drug company for an experimental drug, one that they’re still studying and has not yet been approved by the FDA.
You can visit the “Save Josh” Facebook page.
- Top 10 Most Expensive Cars of 2014. No. 10 is Only $215,500
- Home Remodeling: Cost vs. Resale Value Report Shows Big Returns on Small Projects