Wednesday, March 12th, 2014
A 7-year-old Memphis boy who is suffering from heart and kidney failure has been denied an experimental drug that could very well help improve his condition. The drug company, in denying the drug to Josh Hardy, says its efforts to get the drug to market–with full FDA approval–will be severely impeded if the medication is given to patients at this stage. More from CNN:
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Here’s the way it works: 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.
Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013.
But pharmaceutical companies often say no, as they did to Josh Hardy.
“Our son will die without this drug,” said Todd Hardy, Josh’s father. “We’re begging them to give it to us.”
So now, like many families, the Hardys have turned to the media, Facebook, and change.org to pressure the drug company to change its mind.
Countless members of “Josh’s army” have responded with angry tweets to @chimerix, telling them to “open their hearts,” asking the executives how they can sleep at night.
“Everyone is watching,” one tweeter warned the company. Others have tweeted out the e-mail addresses of the company’s board members. Chimerix executives say they’ve received physical threats.
Moch, the company president, has read these tweets and said he is heartbroken, but the issue is complex and unsuitable for a 144-long character debate.
At its very simplest, this is it: Chimerix is going full speed ahead to get the drug on the market hopefully by the end of 2016, and if they spend time and money on compassionate use cases, it would greatly hinder their effort to get the drug, brincidofovir, on the market and available to everyone.
The company would have to dish out $50,000 per compassionate-use patient, since insurance doesn’t usually pay for experimental drugs, Moch said. And perhaps even more important than the money, it would divert manpower in this 50-person company, since they’d have to handle the requests and then get the patient’s records and follow up with them, as required by the FDA.