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Company withholds experimental drug from dying 7-year-old boy to preserve profits

By Travis Gettys
Tuesday, March 11, 2014 9:27 EDT
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Josh Hardy
 
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A drug company refuses to give a dying 7-year-old boy experimental medication because doing so would cut into its profits.

Cancer survivor Josh Hardy is fighting a viral infection he developed after a recent bone-marrow transplant, and his family has turned to social media to pressure pharmaceutical maker Chimerix into providing the antiviral drug brincidofovir.

The North Carolina-based company has already turned down multiple requests by Josh’s doctors for the unapproved drug, and it has so far remained unmoved by thousands of requests made by friends, family members, and other supporters.

“Our son will die without this drug,” said the boy’s father, Todd Hardy. “We’re begging them to give it to us.”

But the company’s CEO, Kenneth Moch, said Chimerix cannot agree to provide the drug for compassionate use because it would then be obligated to share the drug with other patients – and he said that would be too costly.

“If this were just one patient wanting this drug, then this would be a very different question,” Moch said. “But it’s yes to all or no to all.”

Chimerix hopes to begin marketing brincidofovir by the end of 2016, and Moch said the 54-person company cannot afford to spend $50,000 on each compassionate-use patient or divert workers to handle the requests, patient records, and follow-up required by law.

The Food and Drug Administration permits drug manufacturers to share experimental drugs still awaiting approval with patients who have serious or life-threatening illness and unsuccessfully tried other treatment options.

The FDA approved 974 compassionate use arrangements in the last fiscal year, but pharmaceutical companies often turn down those requests.

Chimerix has already shared brincidofovir with more than 430 compassionate-use patients and is still accepting newborn patients with the herpes simplex virus who have used the drug in a previous trial, and the company would also share the antibiotic in the event of a smallpox bioterror attack.

But Moch said the company has no current studies under way for other children.

“We have great compassion for this family, but this is not just about a single boy,” said Moch, who admits he would feel “horrible” if Josh dies.

A medical ethicist said he understands both viewpoints.

“I have huge sympathy for the family,” said Arthur Caplan, of the New York University Langone Medical Center. “I think they are right to try and see what they can get for their child.”

But he said Chimerix, like many other small pharmaceutical companies, has limited resources and a responsibility to its investors.

“We can’t ask the company to turn into a philanthropy or their investors will back out,” Caplan said.

There’s no guarantee the drug will work, he added.

“It’s always a long shot that it will help and not make things worse,” Caplan said.

But Josh’s parents are willing to take that risk in hopes of saving their son’s life.

“He holds our son’s life in his hands,” Todd Hardy said. “This is just beyond belief to me.”

Update, 9:19 p.m EST: CNN reported that Chimerix had reached an agreement with the Food and Drug Administration to provide Josh with brincidofovir as part of a new pilot trial.

Watch this video report posted online by WJLA-TV:

 
 
 
 
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