Local News

Family of sick boy 'begging' for use of experimental drug

Posted March 11

— The family of a critically ill Virginia child is putting pressure on a Durham biotech company that is developing a drug they believe could save his life.

Seven-year-old Josh Hardy is in the intensive care unit at St. Jude Children’s Research Hospital in Memphis, Tenn., where relatives say he’s trying to fight off a virus contracted while undergoing treatment for cancer.

Josh’s mother, Aimee Hardy, has said an experimental drug being developed by Durham-based Chimerix could be her son’s best chance for survival.

They have asked the company for what is known as a “compassionate dose” of brincidofovir, but Chimerix has denied the request because doing so could slow down the process of getting the medicine to market.

“Making an experimental drug, which currently has limited clinical evidence, available outside of controlled clinical trials has the potential to slow or derail our ability make brincidofovir available as soon as possible to the thousands of patients each year who might benefit from it,” Chimerix Chief Executive Ken Moch said in a statement. “ This is why we are focused on demonstrating the safety and efficacy of brincidofovir in our ongoing Phase 3 clinical trial.”

The Food and Drug Administration allows someone with an immediate life-threatening illness to ask for permission to use experimental drugs that have not yet received the agency’s approval. Last year, the FDA agreed to 974 such uses, according to CNN.

Moch said the company has received hundreds of requests over the past few years for compassionate use of brincidofovir. The company also pointed to industry-established ethical guidelines that state a patient’s right to treatment does not come before a company’s responsibility “to develop and market safe and effective products as fast as possible.”

The Hardy family is undaunted, and they’ve taken their plea around the country. The story has gained a wider audience in recent days following reports by CNN, CBS, Fox News, Huffington Post and USA Today. A Facebook page created for the cause less than a week ago has more than 18,000 “Likes.”

"Our son will die without this drug," Todd Hardy, Josh's father, said to CNN. "We're begging them to give it to us."

20 Comments

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  • josephlawrence43 Mar 11, 7:24 p.m.

    but meanwhile the adults have to make the real ethical decisions. The hard decisions. TRI1234:
    Ethical decisions?? don't you mean economic decisions, protecting the investors?? What kind of ethics would deny a 7 year old child a chance to live??

  • sunshine1040 Mar 11, 7:22 p.m.

    I hope he can beat the virus and the cancer but giving him this experimental drug that they have not yet proven to have no serious side effects will not guarente him a healthy life.

  • beachlvr0804 Mar 11, 7:21 p.m.

    Shame on Chimerix. This drug could potentially save this little boys life. Slowing or derailing the ability to make the drug is hogwash. What if it was a child that belonged to one of the so-called "decision makers?" Bet they wouldn't be denied......

  • tri1234 Mar 11, 7:03 p.m.

    The charity offered to pay for one photogenic kid with media savvy parents. Who pays for the next kid? Who takes responsibility for for the kids who can't get insurance coverage for the drug because approval isn't completed? Pretending this is simpler than it is might make you feel like your halo is on tight, but meanwhile the adults have to make the real ethical decisions. The hard decisions.

  • josephlawrence43 Mar 11, 6:49 p.m.

    If, as the company states, there have been limited clinical trials of the medication--did not reveal how successful or unsuccessful those trials were. The child, if he receives the medication may well die--but at least the medication will give him a chance. Without it, the company is condemning this little boy to death. They have to be lower than whale snot on the bottom of the ocean not to give the boy the chance to live.

  • freedomrings Mar 11, 6:42 p.m.

    If you read other articles you will see this greedy drug company HAD ALREADY GIVEN the drug to other people but said it was TOO EXPENSIVE to continue giving it away. A charity has stepped in and said they will pay the $50,000 for this child's treatment. The boy is in ICU in very critical condition and St. Jude Hospital recommended this treatment for their son. Fox News just reported the CEO of the drug company hanging up on the charity offering to pay for the treatment. This is greed defined because it's really about them being afraid to be sued. Good for me, the company is in Durham and I now have a protest I will happily attend.

  • no contest Mar 11, 6:41 p.m.

    If it wasn't for government bureaucrats, unpredictable government regulations, unpredictable government enforcement of laws (think Eric Holder and his ilk) and lawyers that chase people and convince people to sue, sue, sue THIS would NOT be an issue.

    We live in a world where everyone wants to legislate safety and stupidity. We also live in a world where more and more people feel entitled to what others have worked for and EARNED. When an entitled person gets what they want and has bad results they file lawsuits and or spread BAD publicity.

    No good deed go unpunished and IF this company were to hand over this drug the unintended consequences would be devastating. I would NOT do it.

  • Pseudonym Mar 11, 6:12 p.m.

    Who accepts liability if the company backs down, the drug is administered to Josh, and he (God forbid) dies within 24 hours? The parents, who were so insistent and took this to the media, or the company, who was reticent for good reason?

  • scubagirl2 Mar 11, 6:11 p.m.

    This may sound harsh but after hearing this on the news with a bit more info, it seems this little boy is very, very sick having survived 3 times. I so understand the parents desire and no words will give them comfort but it's just not an easy thing regardless. I can so see both sides of this.

  • SaysWhoNC Mar 11, 6:03 p.m.

    If it could save the boy's life, give it to him, what alternative does he have? Bottom line,... View More

    — Posted by scarlett2

    What if that meant other children would die because FDA approval was delayed?

    What would you say to their parents? Seriously.

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