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Drug Company Reverses Drug Decision for 7-year-old Cancer Patient

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Drug company reverses decision for 7-year-old who has cancer PS Productions/PhotoSpin

Josh Hardy is a critically ill 7-year-old boy from Fredericksburg, Virginia with a rare form of metastatic kidney cancer. He will get the experimental antiviral drug, brincidofovir, after his family pleaded with the pharmaceutical company.

On March 11, 2014 the Chimerix pharmaceutical company announced that Josh would receive the medicine his doctors hope will save his life as he becomes the first patient in a new clinical trial that started March 12, 2014.

The company had previously denied desperate appeals from the boy’s family to give him the experimental drug. At the time they cited that focusing time on helping Josh and others like him would slow down efforts to get the drug to market to treat so many more with similar conditions.

After the decision reversal, a spokesman for the drug company said he hopes that the government-approved trial will help Josh and many other patients like him.

Josh's story drew national attention as his parents and thousands of supporters pushed the company to change its mind in online and media campaigns.

After learning her son would receive the drug, mother Aimee Hardy praised the company’s decision in an emotional Facebook post.

"Glory to GOD!" she wrote. "They are releasing the drug for Josh!!!!!!!!!"

The little boy’s journey started at 9 months when he was diagnosed with the rare cancer. Over the years, cancer spread to his thymus, lung, and bone marrow, and each time Josh beat it.

But the bone marrow transplant compromised Josh’s immune system and in February, doctors diagnosed him with an adenovirus that has left him in critical condition in an Intensive Care Unit.

Josh Hardy is in heart and kidney failure and vomits blood several times a hour, CNN reported.

His doctors at St. Jude Children's Research Hospital in Memphis had also been pushing the company to provide the drug under a U.S. Food and Drug Administration (FDA) policy known as "compassionate use".

The policy allows someone with a serious or life-threatening disease to ask a drug company for an experimental drug.

According to WTVR, a Richmond, Virginia television station, the hospital released a statement on Tuesday saying that it expected to receive the medication within 48 hours. The statement noted, however, that its safety and effectiveness has not yet been established for use in children.

"It is also important to understand that this remains a critical and complex medical situation," the hospital said.

“St. Jude will continue to pursue state-of-the-art treatment for Josh and all of our patients. We are grateful for the efforts of Chimerix, the FDA and many others who worked to achieve this outcome. We ask that you continue to keep Josh and his family in your thoughts."

A Facebook page dedicated to the online campaign to help Josh get the medicine posted a thank-you message to supporters shortly after it was learned that he would receive the medicine.

"Thank you to every member of Josh's Army. The world has heard you and because of you Josh and many others will have the opportunity to receive CMX001 (Brincidofovir) the life saving antiviral drug made by Chimerix."

Lynette Summerill is an award-winning writer and watersports junkie who lives in San Diego with her husband and two beach loving dogs. In addition to writing about cancer-related issues for EmpowHER, her work has been seen in publications internationally.


Drug company: Ailing 7-year-old Josh Hardy will get medicine. Catherine E. Shoichet and Elizabeth Cohen. CNN. 14 March 2014.

Grandma talks about experimental drug she hopes will save grandson’s life. Jake Burns. WTVR. March 12, 2014.

Reviewed March 12, 2014
by Michele Blacksberg RN
Edited by Jody Smith

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