Father Begs Company: ‘Our Son Will Die Without This Drug’

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(CNN) — In an intensive care unit in Memphis, a virus ravages the body of a 7-year-old who’s in heart and kidney failure. He vomits blood several times an hour as his family gathers in vigil.

In a cabinet in Durham, North Carolina, there’s a drug that could likely help Josh Hardy, but the drug company won’t give it to him. They’re adamant that spending the time to help Josh and others like him will slow down their efforts to get this drug on the market.

Helping Josh, they say, means hurting others.

When asked how he will feel if Josh dies — and he’s in critical condition, so sadly that could happen soon — the president of the company that makes the drug doesn’t hesitate to answer.

“Horrible,” said Kenneth Moch. He would feel horrible and heartbroken.

But still, he said there’s no way he’s going to change his mind. There’s no way he’s going to give Josh this drug.

‘We’re begging them’

It’s called “compassionate use,” but sometimes it feels anything but compassionate.

Here’s the way it works: According to the Food and Drug Administration, if someone has a serious or immediately life-threatening disease and has tried and failed other available treatments, they can ask a drug company for an experimental drug, one that they’re still studying and has not yet been approved by the FDA.

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

But pharmaceutical companies often say no, as they did to Josh Hardy.

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

So now, like many families, the Hardys have turned to the media, Facebook, and change.org to pressure the drug company to change its mind.

Countless members of “Josh’s army” have responded with angry tweets to @chimerix, telling them to “open their hearts,” asking the executives how they can sleep at night.

“Everyone is watching,” one tweeter warned the company. Others have tweeted out the e-mail addresses of the company’s board members. Chimerix executives say they’ve received physical threats.

Moch, the company president, has read these tweets and said he is heartbroken, but the issue is complex and unsuitable for a 144-long character debate.

At its very simplest, this is it: Chimerix is going full speed ahead to get the drug on the market hopefully by the end of 2016, and if they spend time and money on compassionate use cases, it would greatly hinder their effort to get the drug, brincidofovir, on the market and available to everyone.

The company would have to dish out $50,000 per compassionate-use patient, since insurance doesn’t usually pay for experimental drugs, Moch said. And perhaps even more important than the money, it would divert manpower in this 50-person company, since they’d have to handle the requests and then get the patient’s records and follow up with them, as required by the FDA.

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

From 2009 to 2012, the company did give out the drug under compassionate use to 451 patients, Moch said, but at least at that time, the information gleaned from those 451 compassionate use patients was helpful to the Chimerix study and helped move the science along. But currently doctors don’t really learn very much, if anything, from compassionate use patients, so the patients don’t help get the drug to market.

Beat cancer four times

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.

They gave him an antiviral drug, an intravenous form of brincidofovir, but it ravaged his kidneys.

His doctors at St. Jude’s Children’s Research Hospital said not to give up hope. Since they’d been part of the brincidofovir studies, they’d seen how in sometimes just a week or two, the the oral form of the drug could get rid of an adenovirus without damaging the kidneys. Now all they had to do was ask the company that makes brincidofovir: Chimerix, Inc.

On February 12, the St. Jude’s doctors called a Chimerix executive, Dr. Marion Morrison, and asked for permission to use brincidofovir. She said no.

On March 5, the doctors asked again. Two days later they got an answer by e-mail from another executive, Dr. Herve Mommeja-Marin, who said the company was not “in a position to provide drug for this and other subjects in similar circumstances due to a limited inventory and our limited resources.”

‘He holds our son’s life in his hands’

Moch wants you to know that he has children of his own, and if his child had an aggressive adenovirus like Josh, he’d be doing the same thing as Todd and Aimee Hardy.

“There are no words to express our compassion for this young boy and his family and what they’re going through,” he said.

Art Caplan, a bioethicist, said he feels for both the Hardys and for Moch.

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

It’s not just the $50,000 per patient that might make investors squeamish, Caplan said, but compassionate cases can make a drug look bad. By definition, compassionate use patients are extremely sick, and might not do well with the drug. Companies have to report that poor outcome to the FDA in its application to market the drug.

Perhaps there’s another way to handle compassionate use requests, Caplan suggests. Perhaps a company like Chimerix could agree to give the drug only to the very most dire cases, and put a cap on the number of patients they help.

“They might want to open the door a little more broadly,” he said. “They might want to show a little compassion.”

But right now, Chimerix stands firm that their compassionate use program is almost completely over.

“We’ve had employees who ask for the drug for family members who are close to death, and the answer has been no,” said Mommeja-Marin, the Chimerix executive.

But that’s not good enough for the Hardys.

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

38 comments

  • phil

    Run this company out of business,greedy pigs. I hope someday this mans son or daughter or grandchild is in this predicament and someone gives him the same answer. I hope he has night terrors for the rest of his miserable life

    • beverly main

      You know in my opinion They are making drugs to try to help people I think they’re afraid of losing money that’s what I’m getting out of this story So there isn’t any lives worth billions of dollars To them but they are supposed to be trying to help people that’s sad but that’s the world today

    • Julie

      Totally agree. Although I dont agree with what is going on here, I would never wish the same disease or harm, pain, or anything else negative on a poor helpless child who has nothing to do with this situation. I am sure whoever is responsible, (and Im sure its more than just 1person) will have endless days and nights of self doubt, torture, and remorse for what is happening. Heaven forbid another child should have to suffer. Thats just cruel.

  • Tina Bellino

    Maybe they know their drug is not any good! So many people donatecancer research! Get a pardon from the FDA to exempt this child from your research! Then they can say WOW IT DID CURE THIS YOUNG MAN, A CHILD OF GOD THAT THEY SHOULD NOT TURN THEIR BACK ON!

  • 0301adriana@gmail.com

    praying for Josh and family and hoping the drug company finds it beneficial to give this angel the drug he needs – God Bless all

  • Mommy 2

    It is a shame that the compassionate law is so horrible. Instead of blaming a company who is trying to help others (a small company trying to get a drug in the market ASAP with limited resources). Go after the government for a change!!! As a nurse I have seen cases like this and its devastating to all those involved (especially the family). Most people/families don’t understand the law and just think that the company is being selfish and mean. But that is not always true. If this small company would give in to one the. They can’t say no to anyone else then they would go out of business and no one would ever receive this medication… Ever. So before you start judging imagine that your family has this illness and needed the drug but it didn’t ever be produced… Or there was an epidemic and many lives where at stake because this drug never came to be. Also, it’s not guaranteed that it will work… Sadly. Please people start petitions and write letters to change the law so these smaller companies can help a few people without going out of business!!!

    • Jackie Grooms Hester

      Thank God there is a sense of reason in this crowd. What has happened to America? Most of these posts sound like bad children wrote them. I’m afraid bigots and conspiracy theorists are winning in this country. I’m glad Compassionate Use was not given to my mother so she could have used the Thalidomide that was available in other countries when she carried me.

  • Diane Steele

    My thoughts and prayers are with you all !!I I pray for Gods peace and strengh to be with you all God Bless

  • tracey

    I don’t know how they can sleep at night knowing the condition of this precious angel who can’t speak for himself but rely on us to help him.I too was born ill…given a 40 percent chance at life….given non fda approved drugs to save my life and here I am 34 yrs old because of it. Everybody’s body reacts different to drugs than others…what may hurt one …may help others….

  • Heaven Hepner

    So in other words, we will not give you a drug that will cost us thousands of dollars and extra man-time, just so your son, who means nothing to us, can live. There is NO amount of justification that this selfish company can use that makes it better. If it were your child, would you use it? Would you be OK sacrificing your son for the “greater good”?

  • Hosfac

    Everybody wants to blame the company for this, but it’s not entirely their fault. They have to follow the rules laid out for them just like anyone else. Sure, they want to turn a profit, but so what? Without a profit, there is no business, and if there is no business there is no product. And in this particular case, if there is no product, ALL people live shorter lives of diminished quality. Every last person posting here has taken a drug that almost certainly kept them from dying. Without those drugs, a lot of us would be dead right now.

  • ms-a-Peggy

    What is it about life? Your telling me the production of this drug is more important then a childs life. A company creates a drug that can save a life but now there’s a reason not to let him have it. What’s wrong with this picture?

  • Tabitha Marie Knipp

    The needs of the many outweigh the needs of the one.

    – Spock.

    Very true though. The company could give it to this one boy and know later that the delay caused thousands of other to die. It is sad, but this is a sad world we live in.

  • Debbie

    Will it really cost them $50,000 per patient or is it that it’s just $50,000 per patient that they won’t be able to put into the pockets of their investors…..shame on them for putting a higher priority on money than the life of a child or any life for that matter.

  • Charles

    Can the parent call me? I will pray for healing to the boy. I feel sad that he is lying helpless…waiting to die but in Jesus Name the boy wont die he will live. All tnings are possible to those who believe. By Jesus stripes josh is healed Isa 53:5.
    Get in touch with: pastorserve2000@yahoo.com

  • sara

    this is crazy and heartbreaking i wouldnt know what id do if i was he oarents perdictament and yes i do belive they are being selfish in this for not wanting to help that boy i honestly belive its all about the money thats what this world has become all about money if you dont have money you get nothing basically I couldnt sleep at night knowing that i hold the drug that could save a childs life and i seriously belive if it was there child they would use the drug i dont care if they claim they wouldnt there lying these are innocent children who depend on adults to care and help them in this world and for someone who can help a child but wont may you get whatever comes your way because you deserve it…my prayers goes out to the boy and his family…

  • Barbara caticchio

    If they (the pharmacutical company) does’t give the child the medicine free they’re scared of SOmething

  • cc

    Family needs to sue obama. Thought he was all about healthcare for everyone. So what if drug is experimental. Thats the goverments fault too. Fda will never ever approve a drug that cures cancer.

  • Jack Brown

    I know the CEO must have anguished over this, but God made an exception for us. There isn’t an easy answer, only an incredibly generous one.

  • Kim Shaver

    I am angry and heartbroken hearing all the comments by viewers siding with the company that could provide the drug to that little boy to save his life. What is wrong with you people. This is a precious life. Who cares about big wig investors. It makes me sick to think there are people out there thinking more of the bottom line then a life. Shame on all of you. If it’s a money issue won’t some corporate entity come forward and pay this company so they can’t use money as an excuse to refuse providing this drug to this little angel. If it’s a concern over FDA approval and something going wrong then the drug shouldn’t be out there, right? How contradictory. To his family…you are in my prayers.

  • Cherie

    My 8 yr old son woke up to this story. He said “he’s sick just give him the medicine!” He was very upset hearing this story and wants to know his name so he can send him a card and a stuff animal. I prayer for the family and the drug company can resolve this together. Also is there another company that a drug that could help this little boy?

  • ieva

    just give him the medicin im starting a repetition so any one how wants to do something write ur name in 1 comment

  • Tara Ladawn

    Truly sad that they don’t care about saving lives… only care bout money. I pray to god that they lose their business and profits over this. SEVEN YEARS OLD AND THAT POOR LITTLE BOY MAY LOSE HIS LIFE CAUSE THEY ARE BEING SO SELF INDULGED. People like that I call MURDERS… knowing that the boy needs meds and help and doesn’t receive the help he deserves…
    P.S.
    Not helping your business any when people finds out your a murderer. You have the medicine that may help that 7 yr old, but instead YOU choose to just let him die. Your just going to kill that boy cause you have NO heart… you heartless pos. This is how I was taught… FLIP IT. Flip the situation and think about this for a second… what if it were your child laying there and dying and it was you who needed to help Your kid and you asked DESPERATELY for help and you was turned away and then your child died over selfishness. You would be broken hearted.

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