Posted on 03/11/2014 5:22:52 PM PDT by workerbee
I don’t know why the FDA and the Drug companies in these situations cannot execute a secure hold harmless agreement, to protect the drug companies when all everyone is doing is trying to provide some POSSIBLE help, that may or may not work, in these rare illness cases. As long as patients and/or their legal reps sign, the FDA should support it and it should not interfere in ongoing trials.
Exactly. I spent 14 years in the industry first on generics and then on contract work. This would invalidate any clinical trial they are attempting to execute under current FDA guidelines. It costs billions of dollars to bring a single drug to market (successful or not. Any positive or negative response to the prescribing could have devastating consequences for this small, start up. They would in fact have to spend millions more to prove/dis-prove the drug worked or if the child unfortunately didn’t make it that the drug did in fact not kill him or contribute to it. Not to mention the potential civil suit. I feel for this family but it not simply a matter of giving the child the drug.
Read and re-read Post 12 until you understand this no-win situation. We can feel sad for the little Boy, but feelings will not help here.
A humane FDA would rule a waiver. Too bad that elections have many and hard consequences.
The ultimate answer is medical tort reform, like Texas passed, which works.
Not, the pharma should not do it. If done, where do you draw the line? The “victims” will create a line miles long.Correct. If you make an exception for one, you have to make an exception for everyone - or face the venom of people you don't make an exception for. Better to follow the rules and make no exceptions.
According to Fox News’ Peter Johnson Jr., Chimerix has given hundreds of patients emergency access to Brincidofovir in the past, but Moch said the company has since stopped this practice because “they cannot afford it.”
Evidently they gave the drug away before in spite of the dire possibilities.
According to Fox News’ Peter Johnson Jr., Chimerix has given hundreds of patients emergency access to Brincidofovir in the past, but Moch said the company has since stopped this practice because “they cannot afford it.”
The drug is currently in Phase 3 trials and has been tested on 150 pediatric patients. I can’t speak to their “giving away” product that has not yet been approved unless they did something in Phase 2. The drug looks promising but the data that will go to the FDA for submission isn’t expected until 2015. If the FDA accelerates the application it may take 12 to 18 months for approval after that submission. So, the drug is not approved and their attorney best have one hell of a legal agreement absolving the company of any liability if this child should not make it.
The same old senseless response. No change.
You may be correct! But they have less grounds for suing a company who is not one iota involved.
Agreed. Give them pure, unadulterated, immunity from prosecution in these situations.
Where did you come from? Big Pharma is totally evil. Why are you supporting them? They use their underlings at FDA to effectively block natural alternatives that work...and that work better than anything they have in their quiver. There cancer drugs are mostly deadly. They kill thousands every year with their patent drugs. I hope you are hooked though on all the stuff they put out for doctors to prescribe.
Young cancer survivor will get experimental treatment
A 7-year-old boy who has beaten cancer four times but whose weakened immune system is being threatened by a rare virus will start receiving an experimental treatment within 48 hours after the drug’s manufacturer reached an agreement with federal officials for a pilot trial to begin immediately.
The boy, Josh Hardy, will be the first patient to be enrolled Wednesday in the new study of the drug, brincidofovir, the Durham, N.C.-based company, Chimerix, announced late Tuesday.
Earlier the company had said it could not release the drug to Josh outside of clinical trials. The boy’s family had been pleading with the company to change its mind.
Nice news. Thanks.
There is still good, even with our self absorbed Africanized gubmit. The FDA approver will probably get terminated.
I suppose you believe that every large corporation is “totally evil” so there probably is no point in debating with you what I wrote.
Your statement that you hope I am hooked on all the stuff they put out paints a true picture of you as a person who is incapable of engaging in reasonable debate. Instead you lower yourself to name calling and wishes of harm to others - just like most liberals do!
You have mischaractized my comments to you. I know that the corporations that make up the patent medicine industry are evil. The FDA supports them. The FDA is in the business of protecting Big Pharma, not in protecting you or me.
These corporations that make prescription drugs are allowed to go on making and selling them even after they start killing people. And yes, many patent medicines kill people and the FDA does nothing. I would hope you do not support this, and the obscene profits on these ‘medications’.
And no, big corporations are not generally evil. Drug companies are evil. And that opinion is shared by many who have worked for them, and many doctors.
If you are on any prescription medications, read the side effects on each one. Do thorough searchs on each one. Look at info other than what the drug manufacturer has to say. You might not want to take their wares.
Chemo & radiation kill patients. Lipitor and other statins kill people. Tylenol, Acetaminophen damages livers to the point of the patient needing a transplant, and this happens many times. The acetaminophen’s are still allowed to be sold. The FDA recently issued a ‘warning’ but it has no teeth.
Thank you...informative!
I thought businesses couldn’t deny service ?
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