Company denies potentially life-saving drug to dying child

Company denies potentially life-saving drug to dying child

Posted: Updated:
Family photo of 7-year-old Josh Hardy Family photo of 7-year-old Josh Hardy

(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."

  • Top StoriesMore>>

  • Criminal profiler says Weleetka murders may not be fully solved

    Criminal profiler says Weleetka murders may not be fully solved

    Tuesday, September 16 2014 7:24 PM EDT2014-09-16 23:24:36 GMT
    Three guilty pleas, but a defendant who still says he's not responsible for murdering anyone. While Kevin Sweat awaits sentencing many may think the case is closed, but one criminal profiler says the case should be far from over.“In a real case run by serious professionals, you put the gun in the defendant's hand and you put the projectiles fired from that gun into the victim,” said Dr. Brent Turvey, an internationally renowned criminologist.
    Three guilty pleas, but a defendant who still says he's not responsible for murdering anyone. While Kevin Sweat awaits sentencing many may think the case is closed, but one criminal profiler says the case should be far from over.“In a real case run by serious professionals, you put the gun in the defendant's hand and you put the projectiles fired from that gun into the victim,” said Dr. Brent Turvey, an internationally renowned criminologist.
  • Serial burglar plagues West OKC neighborhood; suspect caught on tape

    Serial burglar plagues West OKC neighborhood; suspect caught on tape

    Tuesday, September 16 2014 6:47 PM EDT2014-09-16 22:47:38 GMT
    A serial burglar is plaguing one west Oklahoma City neighborhood. FOX 25 spoke to neighbors near Apache Drive in west Oklahoma City who said the number of incidents have spiked in the last few months."From the neighborhood, from the outside looking in, it looks like a good quiet neighborhood,” said neighbor Terry Wilson. “I never expected it to happen like that."The neighbor tells FOX 25 he's only lived in the neighborhood for three months. Within three weeks someone broke into his car so he ...
    A serial burglar is plaguing one west Oklahoma City neighborhood. FOX 25 spoke to neighbors near Apache Drive in west Oklahoma City who said the number of incidents have spiked in the last few months."From the neighborhood, from the outside looking in, it looks like a good quiet neighborhood,” said neighbor Terry Wilson. “I never expected it to happen like that."The neighbor tells FOX 25 he's only lived in the neighborhood for three months. Within three weeks someone broke into his car so he ...
  • Doctors: new enterovirus cases should not be cause for increased concern to parents

    Doctors: new enterovirus cases should not be cause for increased concern to parents

    Tuesday, September 16 2014 6:45 PM EDT2014-09-16 22:45:07 GMT
    A rarely seen strain of virus is sweeping across the United States. Tuesday CDC tests came back positive for the enterovirus D68 (EV-D68) in Oklahoma. Though, the virus has sent some children in the state to the hospital, doctors say parents need not be alarmed.
    A rarely seen strain of virus is sweeping across the United States. Tuesday CDC tests came back positive for the enterovirus D68 (EV-D68) in Oklahoma. Though, the virus has sent some children in the state to the hospital, doctors say parents need not be alarmed.
  • More HeadlinesMore>>

  • Man Accused of Starting Girlfriend's House on Fire While Kids Inside

    Man Accused of Starting Girlfriend's House on Fire While Kids Inside

    A Tulsa man is behind bars after police say he purposely set his girlfriend's house on fire while her children were asleep inside.
    A Tulsa man is behind bars after police say he purposely set his girlfriend's house on fire while her children were asleep inside.
  • Former State Department diplomat claims cover-up post Benghazi attack

    Former State Department diplomat claims cover-up post Benghazi attack

    Tuesday, September 16 2014 12:49 PM EDT2014-09-16 16:49:31 GMT
    As Congress' select committee on Benghazi prepares for its first hearing this week, a startling allegation from a former state department diplomat: Hillary Clinton confidants separated out potentially damaging documents from those turned over to the accountability review board. That board is investigating security lapses surrounding the September 11, 2012 terrorist attack on the U.S. mission in Benghazi, Libya.
    As Congress' select committee on Benghazi prepares for its first hearing this week, a startling allegation from a former state department diplomat: Hillary Clinton confidants separated out potentially damaging documents from those turned over to the accountability review board. That board is investigating security lapses surrounding the September 11, 2012 terrorist attack on the U.S. mission in Benghazi, Libya.
  • Millionaire business woman accused of poisoning autistic son

    Millionaire business woman accused of poisoning autistic son

    Tuesday, September 16 2014 6:31 AM EDT2014-09-16 10:31:38 GMT
    New York (CNN) -- Gigi Jordan showed no emotion as a New York prosecutor described to a jury a "chilling and horrifying scenario" in which the businesswoman who made a fortune in pharmaceuticals allegedly concocted a lethal cocktail of painkillers and anti-inflammatories and forced her 8-year-old autistic son to swallow it."Two fresh bruises on his nose, fresh bruises on his chin and chest suggest she got on top of him and, hopefully while he was asleep, filled a syringe with the poisonous co...
    New York (CNN) -- Gigi Jordan showed no emotion as a New York prosecutor described to a jury a "chilling and horrifying scenario" in which the businesswoman who made a fortune in pharmaceuticals allegedly concocted a lethal cocktail of painkillers and anti-inflammatories and forced her 8-year-old autistic son to swallow it."Two fresh bruises on his nose, fresh bruises on his chin and chest suggest she got on top of him and, hopefully while he was asleep, filled a syringe with the poisonous co...
ADVERTISEMENT
Bookmark and Share
  • FOX25 Slideshows

Most Popular

Stories
Videos
Compiling list...
  • FOX 25 FeaturesMore>>

  • Tell Me Something Good

    Tell Me Something Good

    Tired of all the bad news? Looking for some good news? Tell Me Something Good, does just that! FOX 25's Mike Brooks finds the good in Oklahoma and tells you all about it.
    Tired of all the bad news? Looking for some good news? Tell Me Something Good, does just that! FOX 25's Mike Brooks finds the good in Oklahoma and tells you all about it.
  • Waste Watch

    Waste Watch

    How are your tax dollars being spent? FOX 25 Waste Watch tracks whether local, state and federal governments, or any groups, are using your money wisely... or wasting it.
    How are your tax dollars being spent? FOX 25 Waste Watch tracks whether local, state and federal governments, or any groups, are using your money wisely... or wasting it.
Powered by WorldNow
Powered by 

WorldNow
All content © Copyright 2000 - 2014 WorldNow and KOKH. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.