It appears that a dying boy in Memphis, Tennessee will receive the treatment he needs thanks to the compassionate use clause. This clause allows drug makers to provide unapproved drugs to individuals with life-threatening illnesses.
In Josh Hardy’s case, this clause will be used to provide him with medicine to combat an infection that might otherwise prove to be deadly. While allowing someone access to life-saving medicine might seem like a no-brainer, drug regulations don’t always make that possible. Below is a discussion of Josh’s case and the usage of the compassionate use clause.
Josh Hardy is a seven-year-old boy who is currently suffering from an adenovirus infection at St. Jude’s Children’s Research Hospital. Since he was nine months old, Josh has struggled through various illnesses and cancers, including kidney cancer. Given his weakened immune system, his current health problem could prove to be fatal if it isn’t addressed.
This is where controversy arose, as the Food and Drug Administration does not currently approve the medicine that Josh needs. This led to a national campaign seeking to raise awareness for Josh’s situation and get the drug released in time to treat him. At long last, a little volunteer management and individual dedication allowed Josh to receive the medication.
This goal was realized as an agreement was reached between the FDA and pharmaceutical company Chimerix Inc. under the compassionate use clause. This agreement will allow Chimerix to administer brincidofovir to Josh, a drug used to treat adenoviruses.
Why This is an Issue
Cases of this nature appear to exist in a gray area between what the law prohibits and what seems humane and right. FDA laws and regulations exist to protect people from substances that may be harmful or that haven’t been properly tested yet. On the other hand, situations in which an individual can be helped by an unapproved drug tend to serve as arguments against drug regulations.
In Josh Hardy’s case, people on both sides of the drug regulation debate seem to have met in this gray area and reached an agreement. While it is certainly a risk allowing a patient to receive this virtually untested drug, in Josh’s case, it’s hard to suggest that it’s inappropriate. Given Josh’s dire health situation, this unproven drug might be his only hope of mounting any type of recovery or experiencing any level of comfort as he hangs on for his life.
The “compassionate use” clause serves as a buffer between strict drug regulation and the needs of human beings. It would be difficult for legal professionals or government officials of any capacity to argue against giving a dying boy the medicine he needs. Cases of this nature transcend legal opinion and cause people to act compassionately.
In Josh’s case and others with a similar situation, the compassionate use clause is a legal loophole that allows people to receive the treatment they need. Despite the importance of operating within the confines of the law and maintaining consistent regulation, in Josh’s case, this clause was the right choice for lawmakers.