UPDATE: Drug Company Will Send Experimental Drug To Dying St. Jude Patient

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Josh Hardy (Photos: Family)

(CNN) — After days of pleading with drug company executives, Josh Hardy’s parents got what they’d been praying for: a chance to get medicine that could help their son survive.

The Chimerix pharmaceutical company said Tuesday that the ailing 7-year-old will receive medicine that doctors hope will help him when he becomes the first patient in a new trial set to start Wednesday.

Josh Hardy (Photos: Family)

Josh Hardy (Photos: Family)

Todd Hardy, Josh’s father, said he got the call from Chimerix president Kenneth Moch about a half hour before the public announcement was made.

“It was wonderful,” Hardy said. “Truly wonderful. It was overwhelming.”

In an emotional Facebook post, mother Aimee Hardy praised the company’s decision.

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

The company had previously denied calls from the 7-year-old’s family to give him the drug, brincidofovir, arguing that spending the time to help Josh and others like him would slow down efforts to get the drug on the market.

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

CNN told Josh’s story Sunday night, describing his parents’ desperate pleas for help from Chimerix.

Josh’s journey began when he was diagnosed with a rare form of kidney cancer at 9 months old. Over the years, cancer turned up in his thymus, lung, and bone marrow, and each time Josh beat it.

But a bone marrow transplant left Josh without much of an immune system, and in February doctors diagnosed him with an adenovirus that spread through his body.

Now he’s in critical condition in an intensive care unit as the virus ravages his body. Josh is in heart and kidney failure. He vomits blood several times an hour as his family gathers in vigil.

His doctors at St. Jude Children’s Research Hospital in Memphis had also been pushing for the company to provide the drug.

In a statement Tuesday, the hospital said it expected to receive the medication within 48 hours, but noted 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.”

An FDA policy known as “compassionate use” allows someone with a serious or life-threatening disease to ask a drug company for an experimental drug.

Though it’s called compassionate use, sometimes it feels anything but compassionate.

Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013.

But pharmaceutical companies often say no, as Chimerix did at first to Josh Hardy.

Moch previously told CNN he wouldn’t back down from his decision not to give Josh the drug.

He said Tuesday that he hopes the new FDA-approved study will help other patients as well.

“I’m happy for Josh and I’m happy for many patients,” Moch said. “We’ve come up with a way of helping not just Josh, but helping other patients in need, and there are many.”

Over the past two years, the company has received more than 80 requests for compassionate use of brincidofovir from patients like Hardy, according to Moch.

Todd Hardy hailed Moch as a hero.

“He’s a super man. He worked diligently on behalf of everybody,” Hardy said. “His integrity was unquestioned. He was utterly professional.”

A Facebook page dedicated to the online campaign to help Josh get the medicine posted a thank-you message to supporters Tuesday night.

“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. ”

Past report by WREG-TV:


  • Wake Up

    If you want to see who controls health care and interferes with your doctor, you do not need to look at Obamacare, you need to look at these types of companies that really control things! The ACA leaves big pharma and insurance companies in control of health care in America. As a liberal, that is my criticism of Obamacare!

    • Rebekah Alexander

      If they had any compassion, they would use this drug on the child!! Everyone need 2 get on the band wagon 2 help this child,PLEASE!!!!

    • machine_gunner

      No defending the company, however it is funny how folks on here will blame the company and not the government. The question that needs to be ask is, why hasn’t the FDA approved this drug. Why does the process take longer here in the US when compared to other countries. Again, not defending the compay. Maybe both the company and the government is to blame here.

      • Wake Up

        Machine_gunner, you are defending the drug company. The article clearly says that the drug company could enroll the child in an experimental program — but refuses to do so. This is not about the government. The FDA has a program that the child could be in if the drug company approved. As I said, this story shows who is really calling the shots in the American health care system. Hint: it is not Obama!

      • machine_gunner

        Wake up, I am not defending the company. There have been other articles about this on other websites that stated the FDA has not approved the drug and no where did is state that the FDA approved the campassoniate for the use. It did state that the FDA approved 974 cases last year. No where does it say tha the FDA approved for this case. Also, where do I state obama. This has been going on with the FDA for years where it takes a very long time to approve a drug based on other countries track record. Maybe a little research on the time it takes FDA to approve a drug would help you understand. And I guess you did not read my last sentence where I stated “Maybe both the company and government is to blame”.

      • screw aarp

        What if Obama had a son ,would the drug company give it to him? oh thats right Zimmerman shot Obamas son.

      • Lindsey

        I think that the intentions are in the right place when considering the processes that the FDA requires the pharmaceutical companies to go through. They want to see what the king term effects arer of third rugs as well as the short term “fixes”. Most of the drugs that come out on the market now have worse side effects and health issues of prolonged use than the problem it fixed in the first place! I would like to think that the FDA is just being cautious. As far as the company not wanting to release the medication for use in this situation, at the end of the day it is theirs… Right or wrong, they are at liberty to choose what they do with it. They don’t care what we think, ultimately the people that will need this wiuldnt have a choice about which company to go with or what drug to choose anyway. It’s a sad world we live in where the almighty dollar wins out every time and no human compassion is left…

      • Wake Up

        America has the safest drug system because we take time to get it right. President Bush signed laws to “fast track” drug research and we ended up having consumers being guinea pigs. President Obama put a stop to that and reinstated a more secure process. Everything you need to know about this story is in the article.

      • screw aarp

        RIGHT, James! Discussion board, all you do is give people false information,from your socialist view point, and when you are caught, lying ,you go and hide, until another topic comes along ,and again you claim your an expert on the topic, and your cycle starts over, lying ,and hideing. over,over and over. people are sick of you!

      • Wake Up

        Bob (or whatever name you are now using), I have never run and hid. I only use one name. You are the one with the multiple personalities. Since you are actually about half of the replies on these discussions, using different names, you must mean that you are getting sick of me calling out your BS. Keep up the good work!

      • screw aarp

        Wakeup,james ,I will call you out everytime you start your socialist lying garbage BS. each time I call you on your socialist garbage ,you go and hide on ANOTHER LIBERAL web site .

    • Red

      Are you out of your mind? With the resistance being what it is already with the ACA trying to change ANYTHING, do you honestly think that the people with the money that are controlling you peoples opinions and oppositions to the ACA as it stands would allow the president to change it to the effect that it removes the power of the drug companies? Your issue with the ACA is that it “leaves something as it was?” Seriously? Most of the comments on this article are insanely stupid.

      A drug can’t skip the requirements of the FDA just because somebody desperately needs it. However, the drug company most likely refuses to allow this kid to take their experimental drug because they KNOW it would not help him!! The purpose of MOST drugs approved in this country at this present time is to MAKE MONEY. If they help people at all… that’s just a bonus selling point.

  • Nick

    The drug company is making the right decision. Any life lost is a tragedy, but the lives of numerous other people are at stake by diverting resources and energy from getting the drug onto the market.

    It’s painful, but you shouldn’t save the one at the risk of the many.

  • Taco Tuesday

    Unfortunately he is not special, just because he has some heavy publicity and beat cancer several times, does not mean he is an exception. I’m pretty sure there are hundreds requesting this drug at the same time in their near death scenarios without the help of publicity. People in Third world countries have died in worse deaths than this.


    What a bunch of BULL. The drug companies are the richest companies in this country, next to Insurance comp.!!! What if it was his son??? Bet that would be a different story!!!

  • Skillpot

    The Blog is a little difficult to understand, but, if someone is will to take the risk to help anyone, especially a child, then release it! It would be good for business! Maybe!

  • sld

    I have worked for drug companies, even tested drugs for chimerix. I have been a part of the compassionate use of a derivative of this drug for a child who would die without it. The child was given it and died of the cancer that had weakened its immune system to cause it to need the drug. That slowed the drugs approval bc a child died that had taken it. Other people died bc this child was given the drug. This isn’t a black and white issue, I was grateful the child got the drug but I knew it would ultimately lead to others deaths. This company is actually quite small and that 50K will hurt them. That being said I hope that now that chimerix has sent the drug that the child has a 100% recovery from the virus and the cancer and that it doesn’t delay the release of the drug.

  • Victor

    It was about cost and greed. I am glad they gave in and a little boy will be given a chance at life. As far as it being delayed I don’t believe that ,corporations lie and care about nothing but saving a couple $ s. No child should die because of some company decided to play God and not help . I’m sure the delay part is just an excuse as anyone who has worked for corporations know money is the only thing important as people are desposable in their eyes. I am glad they finally found their heart and did the right thing as if it works it could benefit them too.

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