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(CNN)   Boy in Tennessee is dying from a virus that is destroying his heart and liver. A company in North Carolina has an experimental drug that could help him, but refuses to give it to him. Why? Profits   (cnn.com ) divider line
    More: Sick, bone marrow transplant, St. Jude, NYU Langone Medical Center, intravenous, experimental drug, Art Caplan  
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2014-03-10 09:28:23 PM  
The company is acting responsibly in this case. If the kid gets it and dies, that death gets logged against the drug with the FDA; there isn't a special category for giving the drug as a last resort therapy to terminal cases when the drug hasn't been approved yet. This ding on the record might prevent or substantially delay the approval and marketing of the drug for public use. It is a horrible case and no one, not even drug compnay execs, ever want to have to make the choice between one child's life and the lives of many more patients in the future. What needs to happen is a wide ranging restructuring of the FDA especially regarding procedures governing drug testing and approval. The bureaucracy is astoundingly corrupt and inefficient and it often takes two or three times longer to bring a therapy to market in the US than in the EU.

I feel for the family and the boy. His entire life has been filled with suffering.
 
2014-03-10 10:12:45 PM  
This virus isn't going to disappear anytime soon.  Saving this kid would likely result others dying in the future.  I understand the perspective of the kid's parents.  But what about the parents of kids who will be going through this in the years ahead?  Are they less important, simply because we don't know their stories yet?

In a sense, this is a version of the classic trolley problem.  Sometimes you have to flip the switch and kill one person rather than not flip it and kill five.
 
2014-03-11 12:13:54 AM  
Yeah subby, profits.

Nothing to do with the fact that it could prevent the drug from being marketed in the future after further development, and thus saving others.
 
2014-03-11 12:15:19 AM  
Isn't this a repeat from last week?
 
2014-03-11 12:15:47 AM  
I think this comment on TFA explains it really well
"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.

Compassionate use patients need to be carefully chosen, and sadly the patients who are closest to dying are those who are usually denied. It is very sad and I feel for this little boy like everyone else but I totally understand the decision. They can't risk derailing their entire program for one patient."


The article is incredibly biased and the author is clearly appealing to emotion, rather than reason -- yeah, the CEO could indeed be playing for profit, but he's not entirely wrong -- or rather, at worst, the CEO is right for the wrong reasons.
 
2014-03-11 12:16:13 AM  
We have an FDA for a reason, you cant just go around tossing untested drugs to people.
 
BHK
2014-03-11 12:16:16 AM  
More like "Why? FDA."
 
2014-03-11 12:16:17 AM  
Subby's trolling or stupid, no other options. Sad case though.
 
2014-03-11 12:16:24 AM  
I can't go into this much. All I can say is this entire situation is horrific.
 
2014-03-11 12:16:52 AM  
Weeners from the article shot down the profit motive; the possibility of the kid's death while using the drug could mean ultimately that no one else will ever get the drug.

Save a kid, everyone else dies. Let the kid die, everyone else lives. An oversimplification, but that's what I got from it.
 
2014-03-11 12:17:39 AM  
The almighty dollar is the god in which we trust in the United States of Avarice.
 
2014-03-11 12:17:47 AM  
argh, foiled by the fark filter.
 
2014-03-11 12:18:10 AM  
Sad, and I wish it on no other parents.

Hopefully this drug does make it to market eventually and does all that it promises.
 
2014-03-11 12:18:13 AM  

muck1969: argh, foiled by the fark filter.


Four year olds, dude.
 
2014-03-11 12:18:26 AM  
This story breaks my heart but based on both sides arguments, I have to side with the drug company on this one.
 
2014-03-11 12:19:09 AM  
Yeah, because every company should be forced to GIVE AWAY their product. You know, for the good of society.
 
2014-03-11 12:19:13 AM  
Sadly, sometimes, life is a luxury that can't be had.
 
2014-03-11 12:19:23 AM  
Subby is a moran.
 
2014-03-11 12:19:42 AM  

Dinobot: The article is incredibly biased and the author is clearly appealing to emotion, rather than reason


This is an accurate summation of modern journalism.
 
2014-03-11 12:19:53 AM  
Fark off, subby. You know jack shiat about the issue and it's pretty clear you have no interest in learning about it since it may complicate your 'corporations are evil' narrative.
 
2014-03-11 12:19:58 AM  
The child has lived a lifetime of health issues that very nearly killed him on several occasions. Even if he were to receive this experimental drug, he is at incredibly high risk of dying from some other complication in the foreseeable future.

It's a terrible situation all around, and it's not easy for anyone involved. But as horrible as it is to say so, it sounds like it's time for the family to let go and let the child pass, if only so his own suffering ceases.

And I say that fully knowing the decision may not seem so easy were it someone I cared about.
 
2014-03-11 12:19:59 AM  
the issue is complex and unsuitable for a 144-long character debate.

#YouGotServed
 
2014-03-11 12:20:11 AM  
Regardless of everyone's opinion on the business rationale, we should all be able to agree on one thing... if the CEO's kids were sick they'd have access to the drug.
 
2014-03-11 12:20:18 AM  
Wait, so we know the drug works, but they can't get it to market until 2016?  While the FDA provides an important role in protecting us from snake oil, is it possible that maybe, just maybe, we could streamline the process a little, or at least come up with a way for third parties to pay for the expense of compassionate use cases?
 
2014-03-11 12:20:23 AM  
Rename the drug after this kid.
 
2014-03-11 12:20:46 AM  

pedrop357: Yeah subby, profits.

Nothing to do with the fact that it could prevent the drug from being marketed in the future after further development, and thus saving others.


Yeah, profits, like the profits of the insurance company who won't approve of a treatment because it's considered "experimental" or the profits of the drug company that doesn't want to hire a few more bodies to handle minor paperwork issues. Because who really does want to follow up with their customer to find out if the damn thing worked or not?

FTA: 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.
 
2014-03-11 12:21:37 AM  

Anastacya: Isn't this a repeat from last week?


Last month

/and no; it's a different kid
//same sh*tty situation, though
 
2014-03-11 12:21:42 AM  
Save the cheerleader, save the world.
 
2014-03-11 12:21:53 AM  

SevenizGud: Yeah, because every company should be forced to GIVE AWAY their product. You know, for the good of society.


This describes both you, and submitter. Stick to global warming threads with your DERP.

i3.kym-cdn.com

Also, St. Jude has bottomless pockets. If it was simply about money in this case, they could pay a hundred thousand times over.
 
2014-03-11 12:22:41 AM  

Cyno01: We have an FDA for a reason, you cant just go around tossing untested drugs to people.


except for the 245+ times the company did that exact thing in the last 4-5 years.  Oh, that's right, the company compiled that information and is using it to get the FDA to approve their drug for sale.  (They can't be bothered now, because this kid's case may end up not being consistent with others and they might have to explain it, costing them money.)

I think I remember this movie - is it the one where the dad takes the CEO hostage until they deliver the medicine to the hospital, or is the one where the dad hunts down the CEO and executes him after his child dies?
 
2014-03-11 12:24:18 AM  
Subbys an idiot, reporter is selling ad space, the drug company is right, the mom is being a mom, and as much as I would like to say there are no winners here there very likely will be many many winners in the future if the drug gets approved. Facts get to win over emotion sometimes.
 
2014-03-11 12:24:54 AM  

DarkSoulNoHope: pedrop357: Yeah subby, profits.

Nothing to do with the fact that it could prevent the drug from being marketed in the future after further development, and thus saving others.

Yeah, profits, like the profits of the insurance company who won't approve of a treatment because it's considered "experimental" or the profits of the drug company that doesn't want to hire a few more bodies to handle minor paperwork issues. Because who really does want to follow up with their customer to find out if the damn thing worked or not?

FTA: 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.


*clicks

"Gothic DJ, music productionist and promoter."

Clearly we should refer to your expertise in pharmacology, clinical trials, and byzantine FDA regulatory schema.
 
2014-03-11 12:25:48 AM  

Company denies drug to dying child



Screw you, company.
 
2014-03-11 12:26:01 AM  
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.


Damn. That poor kid and his family.
 
2014-03-11 12:26:06 AM  
Obama death panels
 
2014-03-11 12:26:45 AM  
This was brought up last month. Yes, it is tragic, horrific, and stupid this kid is dying of a terminal illness. That's not due to the drug company, and they have to follow the guidelines, or they're out of business.

It also is a crappy reality, but the grieving family would sue the everloving shiat out on the company when the drug failed to save Junior, thanks to the army of lawyers that love shiat like this.

It's a loser deal for them either way. Don't risk and threaten the chance for future patients if the drug tests are successful.
 
2014-03-11 12:26:46 AM  
Again!? Or is this the same story from a few weeks ago?
 
2014-03-11 12:30:01 AM  
Yep. I worked in the pharma industry. It is sad and horrible that the kid will die, but giving not giving him the drug is the right move. Any sort of serious adverse event while the patient is on the drug must be reported to the FDA. When the FDA evaluates the drug, it may choose to delay or deny the drug from going to market. Any patients that may have been saved by this drug going to market will be out of luck.
 
2014-03-11 12:30:41 AM  
For those who are NOT familiar with St. Jude:

St. Jude and ALSAC, their charity, cover costs of patient 100% for ALL Expenses incurred during their treatment. This includes travel and lodging. If this was just about money, St. Jude would have been able to pay it a thousandfold, as they literally have bottomless pockets. There are other issues going on in this case.

And it is in the Jude's best interests to do so if they could. Keeping this kid alive keeps the experiment he's a part of going. Every patient accepted to Jude is done so because they fit into an experimental cancer treatment model, or their protocol is heads and tails above what is being done at another facility in the United States, and sometimes in the World.
 
2014-03-11 12:30:48 AM  
What will be the first action the family takes after they browbeat this company into giving their son an untested drug and he does while on it?

c)lawyer up and sue
 
2014-03-11 12:33:42 AM  

sleeps in trees: I'm not disagreeing with you but you realise the FDA is a joke right!


Far better than what we had before it.
 
2014-03-11 12:35:15 AM  

Dow Jones and the Temple of Doom: Again!? Or is this the same story from a few weeks ago?


Same sh*t, different day.
 
2014-03-11 12:35:56 AM  
I understand both sides of this argument... and I'm really farking glad I'm not party to it.
 
2014-03-11 12:36:28 AM  
And if 5000 come out of the woodworks? We have a population of 300million, 5,000 isn't a lot..

Then what?  Maybe if our society wasnt such a sue happy leeching pile of puss, we could have nice things.
 
2014-03-11 12:36:47 AM  
This isn't the first time this case has been in the news.

Sorry, but the real problem here is the compassionate use rules--it's not just a matter of providing the patients with the drugs.

Even if nothing goes wrong it costs the drug company considerable time and money dealing with it--and it's a small outfit.  Do you want the drug company spending it's time on compassionate use or on getting the drug to market?
 
2014-03-11 12:38:20 AM  
Is anyone else stuck on the part of the story where a pharmaceutical company has actually created a cure for something?

I didn't think they did that anymore.
 
2014-03-11 12:38:34 AM  

Fark It: DarkSoulNoHope: pedrop357: Yeah subby, profits.

Nothing to do with the fact that it could prevent the drug from being marketed in the future after further development, and thus saving others.

Yeah, profits, like the profits of the insurance company who won't approve of a treatment because it's considered "experimental" or the profits of the drug company that doesn't want to hire a few more bodies to handle minor paperwork issues. Because who really does want to follow up with their customer to find out if the damn thing worked or not?

FTA: 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.

*clicks

"Gothic DJ, music productionist and promoter."

Clearly we should refer to your expertise in pharmacology, clinical trials, and byzantine FDA regulatory schema.


And what are you're credentials, may I ask? As I assume yours are similar to mine.
 
2014-03-11 12:38:39 AM  
It's weird to read reasonable, if grim, posts in a FARK thread these days. It's brutal algebra, but, the company's acting reasonably in this case. It's hard to say that, though, when your choice is either one kid dying or hundreds, even thousands, of others dying.
 
2014-03-11 12:38:41 AM  

Cyno01: We have an FDA for a reason, you cant just go around tossing untested drugs to people.


Exactly!  Especially if those drugs have been used successfully in other countries for decades.  It's just a coincidence that big pharma makes more money on less effective medicines.  Yup, just a coincidence
 
2014-03-11 12:39:15 AM  

Loren: Do you want the drug company spending it's time on compassionate use or on getting the drug to market?


It shouldn't be an either or thing.
 
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