7 year old child Josh Hardy needs help to save his life

[StarWight]

ARTICLE HERE

Facebook Link (To show the article is indeed real)

Saw this, it's been on the news, on facebook, and in other media. Basically, this 7 year old child needs a specific medication that has not yet been approved by the FDA. The pharmaceutical company who manufactures it, Chimerix, has been known to grant emergency access to the medicine Brincidofovir. However, they claim they have stopped allowing this because "they cannot afford it." This from a company who just received 72 MILLION dollars in federal funding. You can learn more in the article above.

I've since emailed Chimerix (their email address is [e-mail]

If enough people email them, or call them, or post this on facebook, they will probably *have* to grant this child access to the only medication that can save his life. So email away, let's get EVERY active member of this forum who gives a damn about other people to open the floodgates of the RPguild, telling this company to do wtf is right, and save this kids life. Without that drug, he *will* die. But enough people getting together, writing, calling, and sharing this story can make a difference!

[Gwazi Magnum]

I'm not sure if you also did this or not, but this may of been better posted in spam as they tend to have a bigger community.

Also, this article is from Fox News... :/
They're well known for pushing bias and false new articles.
I recall one where they claimed Obama was planning on killing all the elderly by cutting off any kind of health care to them, except for one shot meant to put them to sleep.

[Jannah]

Yea, I'm also inclined to take this with a grain of salt since it's coming from Fox "News". If there's other sources about it though I'll certainly take a look and try to do what I can.

[mdk]

Just to be a devil's advocate.... if you're a multimillion dollar company that relies on federal money (stupid but that's the medicine business for ya, hooray FDA), going around the government is a fantastic way to lose everything you've got.

If you're gonna be mad, be mad about overregulation. But anger isn't really constructive regardless.

[StarWight]

Complaining about the source isn't.....I mean the points not where it came from, it's the fact that this kid needs people to step up, and send emails to this company. And if u want another source, the family of that kid has facebook page I can link to. least, i think it's from the family, might just be by others who've heard about his plight and want to help.

You can not like fox news and still do something to help, you know. It's not about the source of the article, it's about a dying child--and a greedy pharmaceutical company who previously gave people this drug on an emergency basis but stopped because of money....as if they don't stand to gain anything by his success story when their drug helps.

[Jannah]

I'm just skeptical is all since Fox tends to sensationalize things from a very biased viewpoint(just like MSNBC too). Besides, I feel like since I'm not American my word won't mean shit anyway :/.

[StarWight]

Meh, I don't care whether you are American or not Jannah!! *hugs* You're my friend, and your word would mean a great deal! I know Fox News is one sided, hell all news are. I like Fox News and I can admit that not everything they say is spun gold.

BUT, when I posted this, I wasn't meaning to draw politics into the situation, I really just wanted to get word out there about this kid who needs help. And it IS real, they link right into the blog for the family, in the article. If I saw this on an MSNBC article, I'd still learn more, even though I don't trust them.

Nice Avatar, by the way I didn't even recognize you!! If I'd known you said that and not just someone else, I probably wouldn't have been *quite* so blunt about things, LOL. Seriously though, do a bit of digging, or I'll link you to the facebook page on skype if you want. This is genuine, for sure--and each letter helps. Nationality means nothing in this sort of thing, it's people coming together for another human being :)

[Jannah]

Sure. I'm willing to take a look at the page. Just get on Skype :D.

[Gwazi Magnum]

It might help to just link the facebook page on here.

Also we're not going "It's fox news that shared it, therefore we don't care about the child".
We're going "It's fox news reporting it, we're not even sure if this is a true story or not"/

[Jannah]

Magic Magnum said
It might help to just link the facebook page on here.Also we're not going "It's fox news that shared it, therefore we don't care about the child".We're going "It's fox news reporting it, we're not even sure if this is a true story or not"/

Yea pretty much.

[StarWight]

Facebook Link

There's also the family's blog listed in the article. But I'll update the first post to include that Facebook page I just listed here.

[Gwazi Magnum]

You would of been better off posting this news article here.

I found it through the facebook page and a source like usatoday would convince a lot more people than Fox News would of.
I might as well send an email at some point though for this.
Though is there anything like a petition for people to sign alternatively?

[StarWight]

Well, you *can* call them, and there IS a petition SOMEWHERE to get Obama to intervene...it has a lot of signatures too--but THAT, I have no idea where it's at :(

[Rare]

This drug hasn't been approved by the FDA and they want him to have it.. Seems like a great idea! They have a good reason for not giving the boy the drugs (It's because they need the FDA to approve it then they'll give the drug for a fee to the parents).

[Jannah]

Rare said
This drug hasn't been approved by the FDA and they want him to have it.. Seems like a ! They have a good reason for not giving the boy the drugs (It's because they need the FDA to approve it then they'll give the drug for a fee to the parents).

Good point, but I think he's getting them now anyway.

[mdk]

Magic Magnum said You would of been better off posting this news article here.

This is tempting me to do another 'How to read the news' posting, like I did in Turt's spam thread, but this really doesn't seem the place. I am curious though, so I'm gonna look at some more data on compassionate use and come back with what I find (anticipate, because it's bureaucracy, that the actual answer is sort of cold and disinterested and devoid of actual compassion).

[Brovo]

Rare said
This drug hasn't been approved by the FDA and they want him to have it.. Seems like a ! They have a good reason for not giving the boy the drugs (It's because they need the FDA to approve it then they'll give the drug for a fee to the parents).

This.

The government has not approved these drugs. It could help him, or it could totally fuck him up in unexpected ways.

There's a reason we have government approval programs for drugs which are specifically designed to alter a person's biological systems.

Also, MDK is right, working around the government (especially big pieces of it like the FDA) is a great way to get your company's federal funding program's throat slit. In the medical industry that's the equivalent to blowing open your own knee caps.

One child may die without the drug, but dozens, hundreds, or thousands more may die in the future if they lose their funding and are unable to get it FDA approved/research future iterations of the drug.

EDIT

Also, imagine the absolute nightmare horror publicity for the company if there was an unexpected side effect and the child died. Have fun wrestling that bit of grey world morality.

[mdk]

'Emergency use' clause -- you're looking at point (c), though the rest should give you an idea of the context of these sorts of exceptions and what they mean.

'Compassionate use' is not governed by a specific code (that I've found anyway). This UCSF page breaks down some of the different categories and respective criteria for 'compassionate use,' and here's the one that (I think) applies here:

UCSF said Treatment INDs or Individual Patient Access to Investigational Drugs/Devices for Serious Diseases: These mechanisms are primarily intended to give seriously ill patients access to experimental drugs or devices where no comparable or satisfactory alternative treatment is available. Although the test article sponsor is expected to continue conventional clinical trials and pursue marketing approvals with due diligence, expanded access studies involve systematic use of experimental treatments, and , with very rare exceptions, require the same review and approval as research, including both CHR approval and FDA approval in the form of an IDE (medical device) or an IND (drug/biologic).

It's still an approval process, much like getting a drug cleared by the FDA in the first place, only now you're putting your product up before it's actually ready to go, which becomes a huge consideration when the FDA is making its judgments on final approvals and shit. In other words, you've got a really hungry guy who's going to starve to death unless you feed him right this second, so you give him your undercooked noodles and he throws up. Now when you want to open your restaurant and sell noodles, that incident becomes.... bad. All you were trying to do was the right thing, and you screwed *everybody* out of getting delicious noodles.

Terrible analogy. Let's get back to data.

Consequences of Noncompliance with Federal Regulations

As mentioned in the “Brief Overview” of these guidelines, the University and the FDA wish to support a physician's obligation to treat a seriously ill patient with all available modalities. If, however, the strict emergency use requirements are not met, both the physician and the institution may suffer strong sanctions.

• Physician noncompliance may result in termination or suspension from treating patients in any and all FDA-regulated studies.
• If the institution fails to provide guidance to physicians and to establish clear procedures, the institution's ability to conduct FDA-regulated research may be restricted.

TLDR: In the interest of public health and safety, we maintain a boogeyman on a leash called the FDA, which gobbles up all the harmful things and keeps us safe. But it is a monster we've got here. Those who don't want to get eaten, aren't greedy -- they're smart. Unfortunately our zeal for safety has created a barrier by which the smart course of action is not the one that helps people in the short term. I don't know if there is any legal approach that gets this kid the help he needs, and I can identify with that a little, with my struggles lately.... I mean you could steal the drug, and then Chimerix is off the hook and you can feed the kid his pills and maybe he gets better. That's a way to go. Weeee're not talking about data anymore, which means it's time for MDK to shut up and find a coloring book. Carry on. If I get a chance I'll send them a pizza.... There's only so much I can do.

[Gwazi Magnum]

Brovo and MDK bring up good points I forgot to consider.

I understand the rationale of the drug may not be fully tested, but it's take the drug or the child dies.
But because of how drug testing and sale laws work, if it did go wrong that could cause far more people to not get the help they needed.

mdk said
This is tempting me to do another 'How to read the news' posting, like I did in Turt's spam thread, but this really doesn't seem the place. I am curious though, so I'm gonna look at some more data on compassionate use and come back with what I find (anticipate, because it's bureaucracy, that the actual answer is sort of cold and disinterested and devoid of actual compassion).

I agree it's still the news and up to debate and bias.
I'm simply saying "At least this one isn't Fox News".

[StarWight]

Rare said
This drug hasn't been approved by the FDA and they want him to have it.. Seems like a ! They have a good reason for not giving the boy the drugs (It's because they need the FDA to approve it then they'll give the drug for a fee to the parents).

So if it was your child, and the drug was his ONLY chance to live, and it has successfully treated those in his exact situation, you'd let him die just because it hasn't *yet* been approved by the FDA?