Thousands Beg For Medication On Behalf Of 7-Year-Old Josh Hardy

Since Thursday, thousands of people have been begging a drug maker through countless emails, phone calls, and social media, asking for medication on behalf of an ailing 7-year-old cancer survivor named Josh Hardy.

While the young boy from Virginia has managed to overcome cancer, he is still suffering from a life-threatening infection that many believe can be treated if only the medication was made available.

The Hardy family’s plea to gain access to the necessary drugs for Josh Hardy has inspired thousands of compassionate individuals to beseech the drug maker Chimerix on his behalf, requesting they distribute an otherwise unapproved drug, an antiviral called brincidofovir.

@chimerix where is your compassion? Please approve the use of this experimental drug for little #JoshHardy.

— Rachel Adams (@racheladams63) March 11, 2014

@chimerix As a pharmaceutical company, you are devoted to patients. Please release the drug to #JoshHardy. Do the right thing.

— B. Marshall (@greencoffin72) March 11, 2014

Unfortunately, the North Carolina-based company, who makes the drug, says it can’t distribute the experimental antiviral to Josh Hardy as it could jeopardize the drug’s approval process, further delaying the availability of the drug for others.

In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet – and that’s if it passes preclinical testing, human trials, and meets FDA regulator’s standard of quality control, explains Medicine Net.

In the US, the Food and Drug Administration (FDA) governs this process. The FDA requires the following sequence of events before approving a drug:

• Preclinical Testing: A pharmaceutical company conducts certain studies before the future drug is ever given to a human being. Laboratory and animal studies are performed in order to demonstrate the biological activity and efficacy of the drug against the targeted disease. The drug is also evaluated for safety. This process can take up to three or more years.
• Once a drug has undergone successful preclinical testing – pharmaceutical companies are required to file an Investigational New Drug Application (IND) and other similar forms before they can begin human testing trials.
• Phase I Clinical Trials are usually tested in 20 to 80 healthy volunteers. The tests determine a drug’s safety profile, including the dosage, absorption, and metabolization. Phase I trials can take a year.
• During Phase II Clinical Trials the drug is distributed in a controlled manner to 100 to 300 applicable patients afflicted with the target disease. This phase is usually designed to identify what are the minimum and maximum dosages and efficacy. Phase II typically takes about two years.
• Phase III Clinical Trials are large-scale randomized trials, typically involving 1,000 to 3,000 patients, who are given either the experimental drug or a placebo. This phase further examines the effectiveness and potential adverse effects of the drug. Phase III takes on the average three years.

Thereafter, the drug continues to filter through additional months, even years, of a regimented process of applications and testing before it is ever made available on the market. Therefore, delays in the process can be costly, both monetarily and time-wise.

However in the case of Josh Hardy, his family says he needs the unapproved medication being made by Chimerix now in order to fight off a viral infection he picked up after a recent bone-marrow transplant.

Josh’s parents, Todd and Aimee Hardy are urging supporters, on social media and in the news, to pressure the company to provide brincidofovir to their son. The company has already turned down multiple requests from the boy’s doctors, reports USA Today. Still people continue to contact Chimerix, imploring them to make the drug available to Josh.

But the case illustrates the ethical, medical and financial dilemmas that surround compassionate use – the use of medications that have not been approved by the FDA, but are in earlier stages of development.

FDA rules do allow companies to provide such drugs to some patients under certain circumstances. KTLA explains. According to the Food and Drug Administration, if someone has a serious or immediately 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.

While representatives for the company voice being sympathetic for the Hardy’s plight, they continue to refuse, citing that alongside not meeting certain criteria for compassionate use, if they did give Josh Hardy the meds they’d be obligated to dole out the drug to other similar patients. This would drain the company of the resources it needs to complete a formal study of the drug, seek FDA approval and potentially help many more future patients.

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