Boy who was on the deathbed makes an amazing recovery
19 replies, posted
[QUOTE](CNN) -- After just three doses of an experimental drug, Josh Hardy -- whose parents had to launch a media campaign to get him the medicine -- is sitting up, doing homework and playing board games with his brothers, his mother said.
Just last week, Josh was so sick he could barely get out even a few words. He was in heart and kidney failure, and vomited blood several times an hour as his family held a vigil in the intensive care unit of a Memphis hospital.
Josh received doses of the drug brincidofovir Wednesday, Saturday, and Tuesday, and tests showed the level of adenovirus in his blood went down from 250,000 copies per milliliter to 367 copies per milliter.
"We expect it will be out of his system by Tuesday," his mother, Aimee Hardy, said Friday. "I'm beside myself with how effective this drug was so quickly."[/QUOTE]
[url]http://www.cnn.com/2014/03/21/health/cohen-josh-hardy/index.html?hpt=hp_c2[/url]
[QUOTE]Traditionally, drug companies have not been allowed to use so-called "compassionate use" patients like Josh as study subjects, so helping them out has been pure charity work on behalf of the drug company.
But the FDA allowed Chimerix to use data from Josh and others as part of its application to the FDA, helping to get the drug on the market faster.[/QUOTE]
The FDA's the been the villain alot recently. Glad to see them doing some good.
My expression is OP's avatar.
This kid is indeed badass, he whooped cancers ass four times
Shame that he might be on a dialysis machine for the rest of his life; still amazing that the medicine worked so well.
Hope this kid lives to live a fulfilling life, where he can experience; Happiness, Sadness, and Love.
Experimental? Means insurance is more than likely not going to cover it. Poor kid's medical bills are going to put his family and him in debt for the rest of their lives
What a shitty system
I think if the person's on their death bed, then you shouldn't have to do anything but ask for an experimental drug and get it. It's a What do I have to lose situation, and an everything to gain for the medication itself
[QUOTE=Rangergxi;44314110]The FDA's the been the villain alot recently. Glad to see them doing some good.[/QUOTE]
There is a reason for that rule though - people can, against all the odds, make miraculous recoveries through sheer luck. A single data point, which may also be anomalous, isn't much help for accurately proving the effectiveness of a drug.
And they laughed at me for buying stock in Chimerix.
[QUOTE=Camundongo;44314431]There is a reason for that rule though - people can, against all the odds, make miraculous recoveries through sheer luck. A single data point, which may also be anomalous, isn't much help for accurately proving the effectiveness of a drug.[/QUOTE]
There was a good comment about this on another article on this.
[QUOTE]I am in biotech developing new drugs, and this reporter should be ashamed of the oversimplifications in this story. It is not about profits, people. Really. It is about liability. I have worked in companies where we have had to deny compassionate use requests, sometimes from our own investors. The reason is because giving the drug to someone who is near death means that the person is highly likely to suffer all kinds of awful medical events while on the drug. Whether these events are related to the drug or not, the company developing the therapy must report those safety events to the FDA and they can jeopardize the ability of the drug to get approved eventually.
If this little boy takes the new drug but then has sudden organ failure due to his disease, it doesn't matter if it would have happened anyway-- Chimerix would have to report that a patient developed organ failure while on their drug. That might trip up the regulatory agencies and make them decide not to allow the drug to ever reach the market. If that happened, then all of the patients who would have had access to the drug will never get it.[/QUOTE]
[QUOTE=Camundongo;44314431]There is a reason for that rule though - people can, against all the odds, make miraculous recoveries through sheer luck. A single data point, which may also be anomalous, isn't much help for accurately proving the effectiveness of a drug.[/QUOTE]
wouldn't this make all testing completely pointless though? how do you human test at all since everybody has an extremely small chance to miraculously recover? is it different because they are charity cases?
[editline]21st March 2014[/editline]
i mean, i get how it would negatively throw it off, because most people were going to die anyways. but how would miraculous recovery really ever knock it up, especially since it is so rare...
[QUOTE=TheTalon;44314267]It's a What do I have to lose situation, and an everything to gain for the medication itself[/QUOTE]
Imagine it going wrong and being an FDA official.
[QUOTE=Ninja Gnome;44314595]wouldn't this make all testing completely pointless though? how do you human test at all since everybody has an extremely small chance to miraculously recover? is it different because they are charity cases?
[editline]21st March 2014[/editline]
i mean, i get how it would negatively throw it off, because most people were going to die anyways. but how would miraculous recovery really ever knock it up, especially since it is so rare...[/QUOTE]
If it's tested on a large enough group of people (preferably against a control group of people on the clinically recommended drug) then you can start to get a reasonable model of how the drug works - a small sample size makes it difficult to eliminate statistical anomalies.
On top of that, as AzzyMaster pointed out complications can occur in single or small groups of patients which (even if the patient's condition would be prone to that anyway) can skew an effective drug's perceived safety or effectiveness badly.
[url]http://wtvr.com/2014/03/19/josh-hardy-brincidofovir-is-working/[/url]
[url]http://www.caringbridge.org/visit/joshuahardy[/url]
Of course, an experimental drug made by who knows how many people saves their kid's life and the only person they thank for it is God.
[QUOTE]his family held a vigil in the intensive care unit of a Memphis hospital.[/QUOTE]
Everyone saying it's science's new drugs, but no one sees Jesus's hand in this. God bless.
Suddenly, Kalocin.
Lucky kid!
[sp]Read the title as "amazing discovery" and thought he had cured cancer or made some gut wrenching philosophical comment before passing along the lines of Aristotle. This is a better story however because it doesn't involve him being DEAD.[/sp]
I'm not impressed honestly
Everybody deserves a chance to live, and if it involves experimental drugs, they should be given that chance nevertheless.
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