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 ...
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.
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.
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.
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.
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.
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.’
My deepest sympathy for the loss of your children.
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.
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.
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.
Try calling the FDA all you get is a computer or a phone answer person with no power to a damn thing! The Bad Drug Hot line is just a worthless computer just as hard as 0’care is to use. NO HUMANS!
St Jude picks up the cost. Which is why it is one of our chosen places to donate. Their cancer research alone has saved hundreds of thousands of children from various cancers. And that research carries over to adults.
I don’t begrudge any drug manufacture a profit if their drugs will help people either to cure or control a disease. It cost millions to develop them, and they have to recoup the cost. They have share holders to please too. FDA has a big role in this too, it needs revamped badly. There are British drugs that have been on the market for years, and work, but they have to go through the FDA process to be used here.
I do object to these slick ad campaigns they use to make their crappy product #1 when there are already proven drugs with less side effects on the market already for the same thing. It is how Crestor and Lipitor became 1 & 2. hubby takes Provacal, cheaper, works just as well, less side effects. These 2 drugs are dumped the most for their side effects. But maybe they will scare the Heck out of people instead with the long list of terrible side effects.
Prolia will be the next one OP drug 6 month shot, already has lawsuits against it, Jaw degeneration. Same as Fosamax.
Now they are doing it with Lyrica a Epilepsy drug, for Fibromyalgia and Peripheral Neuopathy. I belong to the FMS blog and nearly every one hates the side effects. They are already in enough pain, and you give them this crap and it increases the pain, kills your libido, and your hair can fall out along with uncontrolled weight gain among the few side effects of the drug. Per Pain Management Dr 50% drop off Lyrica because of the side effects.
I do object to doctors running test to pad their bills though. My internist knows I have a ENDO, he is not supposed to be running the same test. Nor do I need a Chest X ray or EKG every 3 months, in fact I don’t need to see the Internist on that level. Twice a year is all I need him unless something new crops up or a surgeon wants a EKG for a surgery.
I have relatives in the medical device field. Every part of any such device is tracked and accounted for. If you don't know where any part has been or where it came from, it CANNOT BE USED. There's no exception.
I would imagine that drugs are the same way. A numbered lot is manufactured and the items in that lot are accounted for. They're just not going to create a surplus beyond what is needed to do the testing. This may even include amounts needed to restart the testing if something is found to be wrong with the drug at the start.
One would also have to wonder what the drug company would be expected to do with any information that is generated due to compassionate distribution. If the boy gets the drug and then dies mysteriously, what obligation does the drug company have to find out why the boy died? None? Unlimited? Can such an occurrence disqualify the results of the controlled clinical trials?
Imagine going into a McDonalds and asking for an uncooked hamburger because you need the food right away and can't wait for it to be cooked. If a person doesn't eat, they die. But McDonalds can't address that problem by selling uncooked products.
That was nice of you to ask for donations to St. Jude’s.
Yes, indeed, your son is a true warrior! I’m amazed by the strength of children - and other young people, like teens.
Also, I’m glad to hear that your insurance through the military covered the cost adequately. Sometimes it looks to an outsider like myself as if the men and women in the service and their families are not receiving what they should be receiving. So, it’s heartening to hear that’s not the case all the time.
I see the analogy you're drawing. But, in the case of food, there are plenty of other restaurants and grocery stores that can sell you food. Also there are food banks that give away food for free.
But, with medicine, such as in this case, often there is only one company that can provide it. And this company was providing it for "compassionate" reasons until two years ago, when the company made a decision to stop. Now there's nowhere else to go.
As for the analogy to thalidomide: That was used to help pregnant women control nausea. It wasn't a life-saving drug.
Whereas, in this story, the drug has already proven to be life-saving. It seems the FDA policies might be what's holding back this medicine.
Good work all who fought for Josh. Company reverses their decision as Fox news reports:
Heard that this morning on the news. It takes people with hearts to reach out and right a wrong. Now just PRAY it works and does not make him sicker.
I know to well about drug side effects, I am the side effect queen, and some of them have created Drug Induced new diseases
Great news! :-)
Praying now that it will work for this young boy.
FYI - Update on this story: Great news!
The medicine is working:
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