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Company denies drug to dying child, family turns to social media

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MEMPHIS, TN — 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.”

By Elizabeth Cohen, Senior Medical Correspondent

CNN’s John Bonifield, Nadia Kounang and intern Arianna Yanes contributed to this report.

The-CNN-Wire
™ & © 2014 Cable News Network, Inc., a Time Warner Company. All rights reserved.

52 comments

  • J Bauer

    I do hope that some day the world and its people will hold drug companies accountable for their actions. The bottom line is how much money can we make on this drug, NOT how many people can we help. Shame on you.

    • Val

      It’s the damned truth… my son gets an injection every three weeks for the rest of his life, it costs $1500.00. Thank God I have insurance for him, or he would not be able to get it… ridiculous prices for medications that people need. Pisses me off. Prayers to the family.

      • L Pam

        So you would rather they were limited in what they can charge for a medicine, so they never would have developed that one keeping your son alive. You care that little for him?

    • L Pam

      …or actually the exact opposite in this case. They are specifically doing this so they can help the most people, as the article states.

    • Vincent King

      Dont get me wrong I want this little boy to get the medicine he needs and I agree it is about the money but if he got the medicine and still died it could keep the drug from being approved and more people that need it could die. That is their point besides the money. I do hope they change their mind and try to save this child.

  • joan

    Maybe someone out there with a lot of money to give them
    would change their minds. My prayers for this family.
    It is sad that money runs this world.

  • momma of 3

    It sounds like the FDA reporting requirements are the real reason they won’t give out the drug. If they do and the boy dies anyway, it would be reported as a death while on the drug. If the FDA would change the way things are reported in these extreme, last chance cases, maybe drug companies would be more willing? I can’t imagine knowing that there is a chance at saving my childs life but not being able to get to it. So sad. I hope this family gets their miracle!

  • Ruby Crowley

    Shameful! Greed! I knew of an old fellow that dug roots and found other things in the woods to sell the drug company. These items were the basis for many medications that they made billions selling,, He had to wash and dry these items, so they weighed nearly nothing., He was paid pennies for the roots and his hard work, This fellow was probably never able to afford any of the meds for which he worked very hard to provide the basis.Shame!

    • Tay

      And if the roots alone could have saved lives, he’d probably be very rich now. Don’t get me wrong, I think drug companies inflate their prices but there is a lot of knowledge, work, and expense that goes into developing these drugs. Not to mention insurance/legal premiums for when people eventually try to sue them.

  • Ashley V

    And exactly who do they think will use the drug after they refuse to help a dieing child the only people would be selfish arrogant. Idiots who think their lives are. More valuable than a child. You don’t. Know who or what that child will grow up to be i hope he grows up and becomes someone above these idiots so karma can take a stab at them ! a child’s. Life ia worth more than aALL the money in the world!!!

    • Tay

      I would imagine anyone who needed the drug to have a chance at survival would still use it. I mean, lets not be blind here. If a drug company had a drug that would save your life, but years ago they refused to give it to a dying child, are you telling me you would refuse to take it?

  • Dani

    I wouldnt be able to live with myself knowing I had a way to save a child’s life, but didn’t do so because of greed and selfish reasons. These drugs are created to heal and help the sick, right? Then do it!

  • Deb

    Clearly, I see both sides. Yes, I would (and have done) just about anything to save a loved one. However, please keep in mind that it is not a matter of compassionate use for just one child. Once a company opens the door for compassionate use at this or any stage, it is available for others as well.
    And yes, drugs get to market because of investors, and if investors go broke and don’t see a return on their investment, they won’t finance the next break-through drug.
    I think this little guy is a fighter and he has fought a good fight. His family and physicians have literally done everything in their power to help him recover. Perhaps the drug would help, but more likely not, given his bone marrow and immune compromised status. This is a sad reality of a fallen world and a continuation of breathing and heartbeat are not the same as “recovery” and “survival”.

  • Jennifer

    If I was investor in this company what would make me pull out is seeing how greedy they are. I would want to see some compassion here. I mean that’s suppose to be the reason for making the drugs in the first place right? All I can say is shame on this company. This is a child who has yet to live his life. Help him fight.

  • L Pam

    It is interesting to see so many nasty, hateful people with nothing better to do than villianize people they don’t know and situations they don’t (or refuse to) understand. Not one has proposed to raise funds to support a program at this small drug company to fund such situations. People pat themselves on the back for hating and not offering help. Some world…

    • mel

      Well done for speaking out, L Pam. This drug company is doing what is best for the greatest number of people. If there was an equal media coverage of every person who will be saved by hurrying this drug to market rather than stopping to deal with compassionate use, I wonder if people would get so upset about this one case.

  • how many billets dies take to stop a drunk? 2

    Yeah, and when the kid dies anyway then the family falls back to the good ole this is ‘merica’ I’m gonna sue their a$$.

  • Tay

    This medication would (potentially) help with the virus but is not a cancer medication. So to say it would “save his life” is a bit misleading. Yes, it has a chance to cure the virus and perhaps he would still make a full recovery with ongoing cancer treatments (though that doesn’t sound likely), but this medication is not going to single-handedly cure him. It is a very complicated situation they are all in but I would probably do the same as these parents if I was in their place.

  • Cindy Linck

    My heart is breaking for this precious child.  I doubt very seriously that if one of the “poets that be” of this drug company would withhold this medicine from one of their children if they needed it. May God have mercy on their souls.  Praying for this sweet baby and his family 

  • angie

    I cant believe there is companies out their that are so heartless . SHAME ON THEM !!!!! I can only imagine how outraged these parents are , i would be pissed . 50,000 dollars isnt nothing compared to a precious life . This little boy has been through so much already . Praying by a miracle this little boy gets what he needs to have a fulfilling , long life . This story needs to go viral ! And i pray for him and his family . So disgusted right now !

  • Catherine Hoffman

    Thank you for telling us the name of the company. I will stride to never use any drug manufactured by them. This isn’t about all or none, so the company claims…. this is about the all mighty dollar. Heaven forbid you do the right thing and save a dying boy.

    • L Pam

      …like trying to help? (which you have specifically stated you won’t) The company, if you read the article, is trying to stay on a path to get their drug to market to help people. No one yet has proposed to fund a side business there to help these ‘compassinate use’ cases. Your proposal is hate. You can bet you will be the first hypocrite in line when you need a drug, this company or other.

  • D. McDonald

    Think about the situation in these terms. You’re driving down the street and you see an obviously sick person holding up a sign. The sign reads, “Please provide a ride to the dialysis clinic.” Your first impulse is to stop, but then you read the small print on the sign. The small print reads, “By giving me a ride today, you are legally obligated to give me a ride whenever I need one. Furthermore, from this point forward, anyone needing a ride to the dialysis clinic only needs to call you, and you must provide a ride.” Realistically, how do you respond? Welcome to the world of the pharmaceutical company.

    • mel

      That’s so well put! and you could add ‘and bear in mind that the vehicle you are driving contains the thousands of dying people you are currently rushing to hospital, so that stopping for this hitchhiker will severely decrease their chances of survival’

  • maggimia56

    And if given, the drug fails to help, or the boy dies rapidly after, that huge black mark could prevent this drug ever making it to being approved and saving many lives. A huge risk for the drug company, no one is asking me to gamble away my home, savings, job, future, but this is what is bing pushed upon a very small company.

  • Deb Robinson

    That could be readily rectified if they signed legal papers that they are not allowed to sue the company at all!!!! Also put in a clause that they would have to take a loan to pay the $50,000.00.

    • L Pam

      The issue is with the FDA process and filing. You can find this out by reading an article about this situation, like the one you can see if you scroll up.

  • Griffin

    There is also a matter of finite resources. The small company would also have to produce and follow up with each of these compassion cases, which would restrict the speed to market – there is a lot that goes into getting a drug through the FDA to market, they don’t have people just thumbing around w/ nothing to do. So as good as the “driving along” analogy is, it’s incomplete. Each day that the drug isn’t on the market there are how many “precious children/people” that die? So expand the analogy and while you’re taking the single person to dialysis in your minivan, there are five more needing the same trip to dialysis just down the block waiting for someone to come by with a car that no one knows about because everyone was so focused on the first guy with his sign.
    Bleeding hearts are important, just make sure it’s consistent and aware of the big picture.

  • Cathy Calia

    I understand that this is a small company and the compassionate requests would break them if they gave it to everyone. Might I suggest that the government, or St. Judes help them to cover some of the costs involved for this particular boy? This would make more sense to me. Maybe their insurance company? SOMEONE!!!! I would happily donate some money. We could do some kind of fund raising event via the internet. There has to be some way……….. My heart goes out to the family of this little boy. Hospitals, illnesses, this is no way to have to spend your youth……. Much love and all the angels being sent your way.

  • lisa womble

    This is horrible, I cannot believe they would let a child die… The world we live in is run by people like this…lord.. what have we come to ?…

  • Joseph Manser

    I wouldn’t put all the blame on the drug company. If you pay any attention to all the ambulance chasing, sue happy lawyers, you begin to see the real picture in this country and why many are hesitant to go out on a limb for other people. Also, FDA is really slow due to the possible outrageously high lawsuit awards. Check if the drug is available in another country, such is the case in many instances.

  • Angel Brown

    But if it was one of their children they would do it in a heartbeat. People need to start thinking about each other and not themselves that’s why this country is going downhill. Nothing but money grabbers run it. I’m so sorry about the boy that is very sad I hope a miracle happens God be with you and him. Dear Lord please don’t let this precious little boy die because the society is gready and don’t care for other people. Amen

  • Kelly J. Richardson

    Some please give me a number for this company..not so i can call and threaten then but so i can ask for a list of all the drugs approved and not approved yet by the f.d.a. that they make. i want to post them because maybe if millions of people boycott them and get there drugs from a competitive company someone will listen.

  • rocko

    so basically it comes down to not wanting to upset investors? well if that’s the case why not have a stockholders meeting and vote on it my guess would be most people would vote yes

  • Shirley Brinker

    Companies are just heartless and really only think of fame, money, and more money. I am very upset with their decision. Only prayer will help them change their mind.

  • stlmomof3

    If it were to save a single life or a thousand it is available and could be used to save this little boys life today. God bless this family and this precious little boy.

Comments are closed.

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