Fight for potential life-saving drug continues for Va. boy - DC News FOX 5 DC WTTG

Fight for potential life-saving drug continues for Va. boy

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Josh Hardy Josh Hardy
WASHINGTON -

Tom and Aimee Hardy are holding out for a miracle. Their 7-year-old son Josh has beat cancer four times, but now a virus he contracted following a bone marrow transplant is threatening his life.

The Fredericksburg, Va. family’s quest for access to a drug that could turn it all around has gained national attention. The potentially breakthrough anti-viral drug, Brincidofovir, is still in the trial phase, but doctors treating Josh at St. Jude's Children's Research Hospital are convinced it could have him on the road to recovery in a matter of weeks.

The maker, Chimerix, stopped releasing it for "compassionate use" to patients like Josh two years ago.

CEO Kenneth Moch says it's a decision he had to make in order to help more patients down the road. He says the small company lacks the resources to handle all of the requests, while at the same time, conducting research to gain approval by the Food and Drug Administration.

Medical ethicist Arthur Caplan, a professor at New York University Langone Medical Center, says he understands both sides, telling FOX 5, "The company's main worry is if they give this drug to Josh, the flood gates are going to open and they're not going to be able to handle all of the people who might line up and say my child has a problem too."

He says it shines a spotlight on what he calls a national problem.

"Where is Congress?" asks Caplan.

He continued, "Where in the health care debate do we have the creation of a program for compassionate use?"

For Josh, time may be running out. His mother tells FOX 5 the Adenovirus is spreading to his lungs, which is very dangerous. She has been pleading with the company and spreading her son's story through social media.

"It's getting harder and harder, so we really need to get this drug," says Hardy.

It's all too familiar for Frank Burroughs of the Abigail Alliance. He started the Lorton, Va.-based organization 13 years ago after his daughter passed away. Abigail was also denied access to drugs that could have saved her life.

Burroughs suggests Chimerix give the release of the drug to the Hardy family, and at the same time, ask for a "Breakthrough Designation" for Brincidofovir. He believes that should allow it to be fast-tracked for approval for patients in a life-or-death situation, bringing in some income and potentially more resources for Chimerix, while still allowing them time for research and testing to achieve complete FDA approval by their goal of 2016.

Moch says it's a wonderful idea in theory, but he does not believe it will work. He says while a “Breakthrough Designation” for this drug would increase federal oversight of the process, in effect, "adding more coaches on the sideline," it would not be a guarantee to faster approval for the patients who need it now.

HOW YOU CAN HELP
Josh’s family is asking everyone to help share his story.  Here’s how you can join them:

Like the Save Josh Facebook page

Follow them on Twitter @wrbesq

Tweet his story and use the hashtag #SaveJosh

Tweet Chimerix @chimerix

Get updates on his CaringBridge page:
http://www.caringbridge.org/visit/joshuahardy

A petition has been started to get the White House to intervene in the quest to get Josh the drug.  Click here to sign it.

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