Durham Based Drug Company under Pressure to Provide Experimental Drug to Critically ill 7-Year-Old
By Parismita Goswami | March 12, 2014 6:35 PM EST
A Durham-based drug company has recently grabbed national attention as it has declined to donate its potential lifesaving drug to a critically ill 7-year-old boy.
Durham Drug Company Under Pressure to Provide Experimental Drug to Critically ill 7-Year-Old (Representational Image)
Chimerix, a drug company that has none of its products available in the market, has been developing a virus-killing drug for the past 13 years, which is desperately required by the family of an ailing boy, Josh Hardy. Josh has been fighting from the fatal adenovirus after undergoing a bone-marrow transplant.
The drug - Brincidofovir (CMX001) is not expected to win approval for public use until 2016 and Chimerix has not confirmed as to how much the drug might cost per dose, according to a report in Sacramento Bee.
Between 2009 and 2012, Chimerix has distributed the drug to as many as 430 patients. But since then it have stopped its compassionate care program as the drug has reached advanced stages of testing and development.
"Getting the drug approved - to where it would be widely available and covered by insurance - must be a drug developer's priority, even if it means turning down requests from people who need the drug. This is an ethical dilemma of substance. We are heartstricken about this child," said Kenneth Moch, Chimerix CEO.
The Hardy family, who was one of the trending topics on Twitter on Monday, intends to telecast a protest at the headquarters of the drug company with an aim to break the company's corporate will.
"This is the first time people have tried to use this kind of pressure. If we were to make this drug available for Josh Hardy, then others could make the same request. Could we say 'no' to them? Wouldn't they start a similar campaign?" said Moch.
The family is requesting Chimerix to continue with their established compassionate care program through which pharmaceutical companies used to distribute under developing medications to critically ill patients who have no other option left for treatment. However, the treatment carries risk as these medicines may lead to severe side effects or may be ineffective.
The US Food and Drug Administration (FDA) has the authority to permit such an emergency in less than a day, but to qualify the grant, the patient has to suffer a life threatening disease with no treatment options.
"Compassionate use involves unidentified risk and may create a false sense of hope in patients," according to the standards set by the Eli Lilly pharmaceutical firm. "Compassionate use also can negatively impact the operations of new or ongoing clinical studies and subsequently delay the approval of a new medication." He added.
Brincidofovir is available only to limited number of patients. Patients who have previously undergone clinical trials on the drug were only the ones suffering from pox viruses or newborns infected with herpes simplex virus, the drug company clarified.
Josh's infection raised another obstacle with the use of the drug Brincidofovir, as the antiviral drug was developed to prevent infection and not treat them. On that ground, it is not clear whether the drug would help Josh recover, explained Moch.
Agreeing to public appeals could undermine the growth of experimental drugs and hamper the health care system that favors some over others, according to Arthur Caplan, Head of the Medical Ethics Division, NYU Langone Medical Center.
(Edited by Anu James)
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