A pharmaceutical company has finally granted a dying child the medication that could heighten his chance of survival. In Memphis, Tennessee, Josh Hardy, 7, lies in an intensive care unit with heart and kidney failure caused by an adenovirus infection. His family convenes in a vigil, helplessly watching him vomit blood several times an hour. Chimerix, a pharmaceutical company in Durham, North Carolina, initially refused to give him the drug based on the reason that helping Josh would hinder the procedure to get this drug on the market. Under the compliance of the Food and Drug Administration (FDA), if an ill patient has exhausted all other treatments, they can supplicate a drug company for an experimental drug that is still under study and not FDA-approved. When drug companies allow patients to have access to a developing medication, it is referred to as “compassionate use.”
Amid an avalanche of social media outcry from the family and an enraged public, Chimerix has finally surrendered to the pleas of thousands and will release the drug to aide in the recovery of Hardy. The pressure from unfavorable public attention on Chimerix quickened a meeting between the drug company and the FDA to immediately start Phase 3 of the clinical studies to evaluate the reaction of adenovirus infection with the treatment of the drug brincidofovir. On Wednesday, March 12, the study is to begin with Josh enrolled as the first patient.
Kenneth Moch, president of Chimerix, was asked why he did not want to grant the medication to the dying child. He responded that if Josh was the only patient it would have been a different situation, but saying yes to Josh Hardy means saying yes to all in need of the drug. Moch also stated that each “compassionate use” case cost $50,000 which insurance companies will not cover due to the medication not being FDA-approved. In addition to financial reasons, releasing the drug will inevitably divert the 50-person staff of Chimerix to handling the arduous task of addressing requests, obtaining patient records, and doing follow-ups, all of which are mandated by the FDA. Moch also added that the approval of the 20-patient open study by the FDA will subvert Chimerix’s objective of cutting-edge research and development of antiviral medicines that would be beneficial to everyone.
Josh Hardy has fought since he was nine months old and diagnosed with a rare form of kidney cancer. In the ensuing years, cancer has spread through other parts of his body. He was able to overcome it, but after a bone marrow transplant his immune system was left disintegrated. In February, doctors diagnosed him with an adenovirus infection. However, the doctors at St. Jude Children’s Research Hospital had hope, since they were part of a brincidofovir study. The results they saw with the clinical trials of the medication indicated that when taken orally, it eradicated adenovirus within a time frame of one to two weeks. The only thing left to do was ask the pharmaceutical company for the drug. The St. Jude doctors called a Chimerix executive and asked for permission to use the medication on the dying child, however the executive replied with a “no.” The executive stated that they were not in a position to provide the drug to Josh and other patients who were in a similar situation because the company had limited supply and limited resources.
With the hope and persistence of the Hardy family, St. Jude initiated an accelerated crusade to have Chimerix give in and issue the medication to Josh Hardy. Their request caught the public’s attention across the nation. A Facebook page devoted to Josh’s supplication had over 21,00o likes and garnered 1,000 likes in 22 minutes. With the fervent dedication of Team Josh, Chimerix finally granted the dying child the medication.
By Isriya Kendrick