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#SaveJosh: Virginia boy's family pleads for drug to save his life
Fox Memphis ^ | 3/9/14 | Ch, 13

Posted on 03/10/2014 9:57:43 PM PDT by GailA

imee Hardy says her son is in agony. He has battled cancer on and off, and now he's in jeopardy again due to complications from a bone marrow transplant. Doctors believe Brincidofovir could save his life, but the maker of the drug won't provide it.

Chimerix is the company that makes Brincidofovir. They're facing a major ethical dilemma because they say there are hundreds if not thousands of people who need it, but if they give it to patients like Josh, it will slow down their efforts to make it widely available. They hope that will happen in 2016 if it passes all its clinical trials.

"If we were to make it available for this young boy, and I would very much like to as a human being, how would we say no to the dozens, hundreds—potentially thousands of other requests that we get for this drug?" said Kenneth Moch, president and CEO of Chimerix.

Read more: http://www.myfoxmemphis.com/story/24937836/savejosh-virginia-boys-family-pleads-for-drug-to-save-his-life#ixzz2vcvWSSyT Follow us: @myfoxmemphis on Twitter | fox13news.myfoxmemphis on Facebook

(Excerpt) Read more at myfoxmemphis.com ...


TOPICS: Culture/Society; Extended News; News/Current Events; US: Virginia
KEYWORDS: bioethics; brincidofovir; cancer; chimerix; drugmanufacture; dying; g42; healthcare; pharmaceuticals; sigatechnologies
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BULL FEATHERS. they have no heart or soul.

Their only issue is PROFIT!

1 posted on 03/10/2014 9:57:43 PM PDT by GailA
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To: GailA

Should read 7 year old, typo.

Contact Info
http://www.chimerix.com/contact-us


2 posted on 03/10/2014 10:01:52 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: GailA

Tough dilemma. Small company. They need the drug for clinical trials so many more thousands can get the drug by 2016. Do they give it to this cute boy and then deny it to the next 100 cute boys we hear about next week, and jeopardize the trials process? This is heartbreaking, and in no small part thanks to the FDA red tape.


3 posted on 03/10/2014 10:02:02 PM PDT by montag813
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To: GailA
They hope that will happen in 2016 if it passes all its clinical trials.

So the drug has not been approved by the FDA.

Yet the company is being blamed?

4 posted on 03/10/2014 10:02:04 PM PDT by Michael.SF. (I never thought anyone could make Jimmy Carter look good in comparison.)
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To: GailA

MEMPHIS, Tenn. (myFOXDC WTTG) -

A northern Virginia boy’s family is desperately pleading with the maker of a new antiviral drug to save his life. The drug, Brincidofovir, is still in the trial phase, and the company that makes it says if they help little Josh Hardy now, it will hamper their efforts to get it approved.

Josh, who is just 7, is currently being cared for at St. Jude’s Children’s Hospital in Memphis. His family is by his bedside, and his mom, Aimee Hardy, has been using social media to share their story with the world in hopes it will help save his life.

Read more: http://www.myfoxmemphis.com/story/24937836/savejosh-virginia-boys-family-pleads-for-drug-to-save-his-life#ixzz2vcxmqQby
Follow us: @myfoxmemphis on Twitter | fox13news.myfoxmemphis on Facebook


5 posted on 03/10/2014 10:02:58 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: GailA

Appeal to Chimerix Inc to release a compassionate use dose of Brincidofovir to Josh Hardy to save his life.

When Josh Hardy was 9 months old, he was diagnosed with a malignant rhabdoid tumor of the kidneys. It’s a highly aggressive, rare form of cancer that only 15 children are diagnosed with each year. After receiving a bone marrow transplant he developed an adenovirus, an acute infection that has left Josh in the intensive care unit at St. Jude. The virus can be deadly for people, like Josh, who have a weak immune system. Chimerix Inc holds the medicine but is in phase three of clinical development. With the help of the FDA hopefully he can get the dose that may very well save his life.


6 posted on 03/10/2014 10:04:15 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: Michael.SF.

I am wondering why the doctors would be recommending a drug that hasn’t been approved yet? They should know better than that.


7 posted on 03/10/2014 10:04:18 PM PDT by TigersEye (Stupid is a Progressive disease.)
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To: Michael.SF.
There is a federal law for COMPASSIONATE usage that will not effect future use in place. So why deny this 7 year old a chance at life?
8 posted on 03/10/2014 10:06:57 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: TigersEye

Because it is a Hail Mary issue. It may or may not work. But why deny a dying child a chance. Put yourselves in his parents position.

I lost a child to Cytomagalic Inclusion Disease virus because there where nor cures for it. He lived 33 days. I’ve walked the mile in these parents shoes. And parents who love their children will go to any length to save them. Who know the drug manufacture may be throwing a chance of a trial on 1 child away.

There are now Federals laws allowing for a compassionate use in cases like this. I know as a parent I’d risk it. The worse thing in the world is to sit helplessly by and watch your child die before your eyes. Except to have one Murdered.


9 posted on 03/10/2014 10:14:40 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: GailA

So you are agreeing to pay for the drug yourself? Will you buy it for everyone who wants it?


10 posted on 03/10/2014 10:14:55 PM PDT by Kirkwood (Zombie Hunter)
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To: GailA

What about all the other people who could benefit from this drug if they had it right now?


11 posted on 03/10/2014 10:15:41 PM PDT by TigersEye (Stupid is a Progressive disease.)
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To: TigersEye; Nachum

And because St Jude’s is a cancer research hospital and they know all about the trials.


12 posted on 03/10/2014 10:16:17 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: TigersEye
I am wondering why the doctors would be recommending a drug that hasn’t been approved yet? They should know better than that.

Could it be that they are smarter than the Regime?

13 posted on 03/10/2014 10:18:16 PM PDT by cynwoody
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To: GailA

I’m with the drug company on this.

Profit isn’t their only motive but, is their sole reason for existence.

Risk is also a factor and while they might have an easier time getting approved in other countries, they cannot legitimately deliver a drug outside our regulatory process.

For instance, there is a drug that been in use for years in Europe to combat Hep-C.

My friend had exhausted all remedies available in the U.S. With no relief.

We waited and prayed for approval here in the U.S.

Praise the Lord we think she may finally be rid of a disease that could have taken her from us far too young.

Simeprevir was approved for use in November 2013 and God willing her condition will be undetectable in two more months.

To be sure, it’s super expensive. Her insurance and the company she works for are taking excellent care of her.

They accommodate her if she is not well. They make sure she is well cared for when she takes treatment on Fridays.

If she is not well enough to make it work, someone goes out of their way and will pick her up. They then let her work best she can and bring her water all day long and accompany her to the restroom so she is always with someone.

We are grateful to God for such a generous people.

She never gives up and never gives in.

I think her company has accommodated her so much and her colleagues as well.

But, the company providing the drug wouldn’t be able to do so if there were no profit.

Of course, profit enables them to help many thousands more in the US and Europe, as well all they give away to African nations.

They’re evil yuh know.


14 posted on 03/10/2014 10:19:02 PM PDT by Vendome (Don't take life so seriously-you won't live through it anyway-Enjoy Yourself ala Louis Prima)
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To: cynwoody

The “Regime?” OK, Alex Jones. lol


15 posted on 03/10/2014 10:20:25 PM PDT by TigersEye (Stupid is a Progressive disease.)
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To: GailA

I see where your pain comes from.

So sorry you lost your baby.


16 posted on 03/10/2014 10:21:15 PM PDT by Vendome (Don't take life so seriously-you won't live through it anyway-Enjoy Yourself ala Louis Prima)
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To: montag813

Why not put the boy in the trial process?


17 posted on 03/10/2014 10:23:09 PM PDT by Kit cat (OBummer must go)
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To: montag813

FDA red tape be damn, a child life is a risk, and the parents are willing to take it.

If you look at how many BAD drugs are on the market you’d wonder why the FDA even existed. I have extreme drug INDUCED OP thanks to a drug I’ve been on since 1985 and never told it caused OP, or the need to take large dosages Calcium and D when I was put on Synthroid. And it it is a must have hormone drug.

Death Panels in the HMOS: Damaged Care http://www.washingtonpost.com/.../02/health/health052102.htm

Ketogenic Diet: First Do No Harm, the Movie First do No HARM
http://www.naturalhealthstrategies.com

Sick CT Teen Placed in Foster Care As Parents Continue to Fight For Custody
http://foxnewsinsider.com/2014/02/25/sick-ct-teen-justina-pelletier-placed-foster-care


18 posted on 03/10/2014 10:25:02 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: GailA

“Their only issue is PROFIT!”

There is no other reason to be in business!

Charity is for fools and those that want to go bankrupt!


19 posted on 03/10/2014 10:25:31 PM PDT by dalereed
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To: montag813

We are not looking at thousands, hundreds maybe.

You forgot the paid for congress both parties are at fault.


20 posted on 03/10/2014 10:27:08 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: Vendome
For instance, there is a drug that been in use for years in Europe to combat Hep-C.

My friend had exhausted all remedies available in the U.S. With no relief.

Sounds like she needs an airline before she needs a doctor.

My God damn the Regime!

21 posted on 03/10/2014 10:27:53 PM PDT by cynwoody
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To: TigersEye
The “Regime?” OK, Alex Jones. lol

Alex Jones? A hero of yours?

WTF is Alex Jones? And WTF should I care?

I refer to the government to which you obviously remain slavishly loyal.

You need a new lexicographer. (For those of you in Rio Linda, a lexicographer is an authority on the meaning of words.) I recommend the GOOG.

22 posted on 03/10/2014 10:43:34 PM PDT by cynwoody
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To: TigersEye

Because they think it is the only drug that will work.


23 posted on 03/10/2014 10:48:00 PM PDT by airedale
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To: Vendome

I’ve lost 2, one to illness one to murder. Been the victim of malpractice I can’t prove. I generally LOATH doctors. But if this drug can help this child, let them try it. There is no harm to the manufacture in a compassionate use case and may actually help them to prove the case for the drug. See your Private mail.


24 posted on 03/10/2014 10:50:45 PM PDT by GailA (IF you fail to keep your promises to the Military, you won't keep them to Citizens!)
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To: airedale

Since it hasn’t even passed the clinical trials yet they are making a big assumption. They should also know that the company isn’t going to want to jump the process.


25 posted on 03/10/2014 10:55:56 PM PDT by TigersEye (Stupid is a Progressive disease.)
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To: GailA; dalereed

““Their only issue is PROFIT!”

There is no other reason to be in business!

Charity is for fools and those that want to go bankrupt!”

Which is exactly whats wrong with this world when it comes to life-saving medicines.. Money is valued more than life.


26 posted on 03/10/2014 10:56:00 PM PDT by coldphoenix
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To: cynwoody

LOL!

No, she is currently on simeprevir

That’s the drug that is the last line of hope and we think she may very well succeed.


27 posted on 03/10/2014 10:56:19 PM PDT by Vendome (Don't take life so seriously-you won't live through it anyway-Enjoy Yourself ala Louis Prima)
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To: Vendome
No, she is currently on simeprevir

My point was, she had to wait for federal dispensation to get the drug.

That's where intercontinental jet transport comes in, either of patient to drug or drug to patient (much cheaper, but illegal, LOL).

That’s the drug that is the last line of hope and we think she may very well succeed.

That's excellent!

28 posted on 03/10/2014 11:04:36 PM PDT by cynwoody
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To: GailA

They must have tried the nearly 100 other approved antiviral drugs already.


29 posted on 03/10/2014 11:13:30 PM PDT by <1/1,000,000th%
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To: Michael.SF.

There are a lot of potential life saving drugs still in the FDA hoop jumping stage.
Maybe if the company and parents greased enough palms in the FDA, it will happen faster. Its the Chicago way.


30 posted on 03/11/2014 3:37:51 AM PDT by Yorlik803 ( Church/Caboose in 2016)
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To: Michael.SF.
Brincidofovir

Random thought - this looks like the name of an ancient Celtic hero.

31 posted on 03/11/2014 3:44:07 AM PDT by Hardastarboard (The question of our age is whether a majority of Americans can and will vote us all into slavery.)
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To: GailA
There is a federal law for COMPASSIONATE usage

And who makes that determination; the Fed or the company?

32 posted on 03/11/2014 6:46:37 AM PDT by Michael.SF. (I never thought anyone could make Jimmy Carter look good in comparison.)
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To: Hardastarboard

Or one of the characters in Vikings.


33 posted on 03/11/2014 6:47:42 AM PDT by Michael.SF. (I never thought anyone could make Jimmy Carter look good in comparison.)
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To: GailA
BULL FEATHERS. they have no heart or soul.
Their only issue is PROFIT!
??? The FDA doesn’t make a profit. All they do is exercise POWER by putting the company in that bind.
“It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their own interest.” - Adam Smith
I can’t find it in my heart to criticize anyone who is developing a wonderful drug.

The FDA, on the other hand . . .


34 posted on 03/11/2014 7:01:50 AM PDT by conservatism_IS_compassion ("Liberalism” is a conspiracy against the public by wire-service journalism.)
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To: Michael.SF.

The government can never be to blame....under a Democrat president.


35 posted on 03/11/2014 7:03:41 AM PDT by AppyPappy
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To: GailA

The FDA says “No way”.


36 posted on 03/11/2014 7:05:24 AM PDT by AppyPappy
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To: GailA

This is DIRECTLY the fault of YOUR GOVERNMENTS lows and regulations concerning drugs.

The company is at risk of bankruptcy from lawsuits if this UNLICENCED drug kills, or maims.

The CEO, as much as he might want to, cannot put his EMPLYEES and company at risk, because of YOUR GOVERNMENT

So look in the mirror if you’d like to see who’s to blame.


37 posted on 03/11/2014 7:15:54 AM PDT by Freeport (The proper application of high explosives will remove all obstacles.)
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To: GailA; AllAmericanGirl44; Armen Hareyan; B4Ranch; Ban Draoi Marbh Draoi; bayareablues; BykrBayb; ..
CANCER WARRIORS PING

This is a ping list for cancer survivors and caregivers to share information. If you would like your name added to or removed from this ping list, please tell us in the comments section at this link (click here). (For the most updated list of names, click on the same link and scroll to the end of the comments.)

38 posted on 03/11/2014 10:42:26 AM PDT by Tired of Taxes
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To: GailA

I’m very sorry for your losses. I hope this young boy can be helped somehow.


39 posted on 03/11/2014 10:51:28 AM PDT by Tired of Taxes
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To: GailA
BULL FEATHERS. they have no heart or soul.

Thalidomide babies, these were a few of the lucky ones......


40 posted on 03/11/2014 10:53:16 AM PDT by Hot Tabasco (Was Occam's razor made by Gillette?)
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To: GailA

This is a tough call. There are always “just over the horizon” drugs or treatments available as our R&D in medical research is second to none. If there was a way to secretly treat this young boy, then I would do it, but no such thing happens today and the drug companies know that.


41 posted on 03/11/2014 11:01:02 AM PDT by redleghunter
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To: GailA
From the linked article: "... but if they give it to patients like Josh, it will slow down their efforts to make it widely available. "

Manufacturing any medical product, including drugs, is a painstaking, highly regulated, and risky business. The company claims that so-called "compassionate" distribution of this as yet untested drug would slow down the program for getting it into full manufacturing.

Are people so dense that they cannot see that drug companies have practical limitations to what they can accomplish? You can't afford to go into full manufacturing for every drug that appears to have usefulness. You make enough, at high expense, to conduct the trials. If you divert that initial supply of the drug for "compassionate" use, then there is no supply to conduct the clinical trials.

What nefarious object would make more sense than what the company is claiming? Do we delay the testing on behalf of one patient and thus deny thousands later the timely delivery of this drug?

Other nations suffered the consequences of thalidomide. Imagine if we made such consequences the rule rather than the exception.

42 posted on 03/11/2014 11:01:21 AM PDT by William Tell
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To: Tired of Taxes
Josh, who is just 7, is currently being cared for at St. Jude's Children's Hospital in Memphis. His family is by his bedside, and his mom, Aimee Hardy, has been using social media to share their story with the world in hopes it will help save his life.

Josh is in the best hands a child can be in for his condition being with St Jude's children's hospital. When my son was diagnosed with leukemia back in 2010 (he is now 14 and doing great) family and friends wanted to know what they could do. Since I had very good health care coverage being military, I asked them to help out those who did not have the financial means for their children with leukemia. I asked them to donate generously to St Jude's.

43 posted on 03/11/2014 11:05:40 AM PDT by redleghunter
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To: GailA; All

All -

As per the news story, the company was giving the drug for “compassionate reasons” to many people. The company made a quote-unquote “ethical decision” to stop giving it to anyone two years ago and focus only on FDA approval. The company spokesman claims there are hundreds or thousands of people who could use it.

It seems the FDA should make some exceptions in this case so that patients can receive this drug.


44 posted on 03/11/2014 11:05:59 AM PDT by Tired of Taxes
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To: William Tell
do we delay the testing on behalf of one patient and thus deny thousands the timely delivery of the drug?

Put that way, the answer is no. But cynic that I've become, I would want to know that NO ONE has gotten to use the drug. Or if the child could be put on the trial.

45 posted on 03/11/2014 11:09:46 AM PDT by grania
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To: dalereed
Charity is for fools and those that want to go bankrupt!

I am going to have to strongly disagree with you FRiend. It depends on where are heart is.

Matthew 6:

22 The light of the body is the eye: if therefore thine eye be single, thy whole body shall be full of light.

23 But if thine eye be evil, thy whole body shall be full of darkness. If therefore the light that is in thee be darkness, how great is that darkness!

24 No man can serve two masters: for either he will hate the one, and love the other; or else he will hold to the one, and despise the other. Ye cannot serve God and mammon.

Matthew 10:

40 “He who receives you receives Me, and he who receives Me receives Him who sent Me. 41 He who receives a prophet in the name of a prophet shall receive a prophet’s reward. And he who receives a righteous man in the name of a righteous man shall receive a righteous man’s reward. 42 And whoever gives one of these little ones only a cup of cold water in the name of a disciple, assuredly, I say to you, he shall by no means lose his reward.”

Matthew 25:

34 “Then the King will say to those on His right, ‘Come, you who are blessed of My Father, inherit the kingdom prepared for you from the foundation of the world. 35 For I was hungry, and you gave Me something to eat; I was thirsty, and you gave Me something to drink; I was a stranger, and you invited Me in; 36 naked, and you clothed Me; I was sick, and you visited Me; I was in prison, and you came to Me.’ 37 Then the righteous will answer Him, ‘Lord, when did we see You hungry, and feed You, or thirsty, and give You something to drink? 38 And when did we see You a stranger, and invite You in, or naked, and clothe You? 39 When did we see You sick, or in prison, and come to You?’ 40 The King will answer and say to them, ‘Truly I say to you, to the extent that you did it to one of these brothers of Mine, even the least of them, you did it to Me.’

46 posted on 03/11/2014 11:15:13 AM PDT by redleghunter
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To: GailA

My deepest sympathy for the loss of your children.


47 posted on 03/11/2014 11:17:35 AM PDT by redleghunter
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To: redleghunter

St. Jude’s really is a godsend for children. So glad they helped your son!

Once, a nurse who used to work with pediatric oncology patients told me the children are tougher than most adults.

I can understand the company’s dilemma here, but I hope there’s some way to help this little boy and all of the other patients who need this drug.


48 posted on 03/11/2014 11:20:30 AM PDT by Tired of Taxes
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To: William Tell

An issue of marketing a product and a lengthy approval process. Best practice, morally, would be to keep secret the details of experimental or developmental drugs until they are ready for all. However the reality is companies must market the product before it is available to gain funding, move the stock of the company up and pave the way for FDA approval.


49 posted on 03/11/2014 11:24:30 AM PDT by redleghunter
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To: Tired of Taxes

My son actually was initally treated at Brooke Army Medical Center in San Antonio, then we moved him closer to our home to Scott and White childrens hospital in Temple Texas. I asked my family for generous donations to St Jude’s since my insurance fully covered my son and family members wanted “to do something for my son.” Best we could come up with is to donate to a facility which provides care to children who do not have the insurance coverage for cancer treatments.

Yes, the kids are tough and so are the oncology nurses and nurses aids. They have to be very special people to see and treat sick kids on a daily basis. And yes, see some kids pass away and they go to funerals as well.

3-1/2 years of chemo treatments, hospital stays of 2-3 weeks in the beginning; going to the ER and then another week of hospital stay for every fever above a certain point. My son endured that along with trying to be a normal kid and get school work done, maintain friendships and much more. He is truly a warrior. Compared to my colon cancer of surgery and 6 months of chemo, my ‘trial’ was a lot less trying.


50 posted on 03/11/2014 11:35:51 AM PDT by redleghunter
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