RIGHT TO TRY - Signed Into Law. Will Help Terminally ill Americans Bypass FDA Restrictions.

originally posted by: 727Sky

originally posted by: Phage
a reply to: carewemust

IMO, this RIGHT TO TRY legislation will open the door to easier FDA approval of some medications, save lives, and other benefits that we haven't thought of yet.

Just one example of how your source contradicts your opinion. Did you read it?

Providing the drug to patients outside of clinical trials can also be disruptive to the approval process because it can lead to data on negative clinical outcomes outside the highly controlled trial setting. While new legislation prevents this data from being used unless it is deemed "critical to determining safety," bad outcomes might give the FDA pause and delay the approval of drugs that might otherwise be available sooner.

Beyond these issues, federal right to try legislation will have minimal impact on the availability of experimental drugs for patients. Not only have 38 states already passed similar legislation, but the FDA already has a program in place designed to provide patients with experimental medications.

The right to try legislation will score the president and members on both sides of the aisle in Congress points, but ultimately it will change little for terminally ill patients and their families.

I would think the FDA and the AMA would do everything they can to block this !! Curing someone is a very bad business model.

The FDA and AMA are subject to the same laws that we are, 727Sky. RIGHT TO TRY is the Trump Administration removing yet another government regulation from our personal lives.

a reply to: Kandinsky

For a drug to meet the requirements of the law it must have passed Phase I trials. Safety trials. But there is an interesting clause in the law:

(2) No use of outcomes.--Notwithstanding any other
provision of law, the outcome of any production, manufacture,
distribution, prescribing, dispensing, possession, or use of an
experimental drug, biological product, or device that was done
in compliance with subsection (a) shall not be used by a
Federal agency reviewing the experimental drug, biological
product, or device to delay or otherwise adversely impact
review or approval of such experimental drug, biological
product, or device.

Seems odd, adverse (or no) results cannot be considered in ongoing trials but good results can be?

www.congress.gov...

originally posted by: Phage
a reply to: Kandinsky

Now I think about it, it's looking more obvious that the field of medicine would be open to trialling experimental, novel treatments with the consent of terminally ill patients.

But the science part of medicine recognizes that, lacking controls, any results gained (or lost) will not add to the knowledge base. Each case (whatever the outcome) will be anecdotal. If the patient survives, for ever how long, there is no statistical basis to support the treatment. If the patient suffers terrible side effects, there is nothing to hinder the next patient from suffering the same.

The biggest difference I can see both pro and con is the sick and dying will not have to go into bankruptcy with America's for profit medical care.

Many alternate meds, what the main stream medical establishment calls quackery, can be used at home away from all the bells and whistles of modern medicine..

Being old and having my fair share of friends and family die of medical complications or diseases... The hospitals seem to be the only ones to come out on top unless you count the the poison they call drugs that are supposedly beneficial that destroy one's immune system ...

If I ever am diagnosed with cancer the last drug I would take would be Chemo even at 1/10th the price they get for a bag of that poison crap. My decision my life/my death.. I think I would do that just is spite ! hahaha

a reply to: 727Sky

Many alternate meds, what the main stream medical establishment calls quackery, can be used at home away from all the bells and whistles of modern medicine..

You seem to be confused about what this law actually is. It is not about "alternative meds", it is about experimental treatments. It will have no effect on quackery, one way or the other.

If I ever am diagnosed with cancer the last drug I would take would be Chemo even at 1/10th the price they get for a bag of that poison crap. My decision my life/my death.. I think I would do that just is spite ! hahaha

I decided, 31 years ago, to undergo chemotherapy. I'm glad I did. So is my daughter, who was born 15 years later. It didn't cost me much and it gave me the rest of my life (and my daughter). Quite a bargain, actually.

a reply to: Phage

I decided, 31 years ago, to undergo chemotherapy. I'm glad I did. So is my daughter, who was born 15 years later. It didn't cost me much and it gave me the rest of my life. Quite a bargain, actually.

I like stories like that Phage and you and I are both glad it worked out that way for you. It did not work that way for my wife or several friends but every case is different.

Here is a HEART WARMING clip of President Trump signing the RIGHT TO TRY bill into law on 5/30/2018.

a reply to: 727Sky

Yes, it is. The outcomes of several of my friends have been good. Others, it's doubtful anything would have helped at the stage they were diagnosed. None of those who were in my boat and did not undergo chemotherapy survived.

But you might want to read the actual law.

(B) for which the patient has received a certification from a physician, who is in good standing with the physician’s certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options.

www.congress.gov...

I think this is great........good for Trump......perhaps this is one of the first steps to legalizing other methods of treatment......

As a libertarian I think you have the right to do what you will to improve your life.....

but again.......Trump will get no credit for this or congrats from the general public who have been trying for this for YEARS.......

And im not even a supporter.......you guys know how much I loathed this dude, but at least I can give him credit where its due........

More often than not now im being forced to SUPPORT and stick up for him because of the ridiculous and almost fanatical opposition to him......

Vote Rand Paul 2020

originally posted by: Phage
a reply to: 727Sky

Yes, it is. The outcomes of several of my friends have been good. Others, it's doubtful anything would have helped at the stage they were diagnosed. None of those who were in my boat and did not undergo chemotherapy survived.

But you might want to read the actual law.

(B) for which the patient has received a certification from a physician, who is in good standing with the physician’s certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options.

www.congress.gov...

Can confirm this with my family too........prayers and great thoughts for you and yours buddy to remain healthy and rockin

originally posted by: VictorVonDoom
If this law does nothing else, it will insure that we don't have armed police standing outside of a hospital keeping parents from taking their child elsewhere for treatment.

Any law that says people have the right to do something that doesn't hurt anyone, I'm all for it.

If you're talking about Alfie Evans, the police weren't armed and they weren't stopping the parents taking their child from the hospital.
They were protecting the staff from the hoards of Evans' "supporters" storming the hospital.

And lastly, Evans wasn't offered any therapeutic treatment from anywhere else, he was only offered the same palliative care as he'd been receiving for the previous 2 years.
Which he'd been receiving free of charge but the Italian hospital where happily asking for €65,000.

a reply to: Pardon?

I'll have to go back and check the story, but I thought the Italians were offering an experimental treatment and the British government wasn't allowing it.

So, if the parents had tried to take the child out of the hospital, the police would not have tried to stop them?

originally posted by: ManBehindTheMask
I think this is great........good for Trump......perhaps this is one of the first steps to legalizing other methods of treatment......

As a libertarian I think you have the right to do what you will to improve your life.....

but again.......Trump will get no credit for this or congrats from the general public who have been trying for this for YEARS.......

And im not even a supporter.......you guys know how much I loathed this dude, but at least I can give him credit where its due........

More often than not now im being forced to SUPPORT and stick up for him because of the ridiculous and almost fanatical opposition to him......

Vote Rand Paul 2020

It's nice to see you understand what some of us were saying all along. Sure he's a pinhead, but all the lying about him is only making the left look foolish. Let him do what he's going to do and either pass or fail on his own. But to actively hope for his failure, while being a US citizen just seems a bit disingenuous. (and stupid)

originally posted by: VictorVonDoom
a reply to: Pardon?

I'll have to go back and check the story, but I thought the Italians were offering an experimental treatment and the British government wasn't allowing it.

So, if the parents had tried to take the child out of the hospital, the police would not have tried to stop them?

Feel free to check the facts but no, there was no experimental treatment offered, just the same palliative care and for two weeks only.
The government had nothing to do with the situation, it was the Law Court as there was an order issued as the hospital felt it was futile keeping him on sustained ventilation as there was no way he would ever improve. Therefore, had the parents taken Alfie out of the hospital they would have been breaking the law and arrested.
As I said before though, the police were there to protect the staff as they were receiving serious threats of harm, not to stop the parents from entering the hospital.
Having worked in a children's hospital in the past, it's pretty obvious that there are a lot of parents who don't know what's best for their child, Alfie's parents being in that category.

a reply to: Pardon?

OK. So the police were there because of online threats against hospital staff. I guess we can assume that if there were online threats against the royal family the police would just post people outside Buckingham Palace and not try to track down the people making the threats. And since there was no police protection for the hospital staff after they left the hospital, any royals who left the Palace would be on their own.

It seems to me that placing police at the hospital was only half effective if the goal was protecting hospital staff since there was no protection away from the hospital. But it was 100% effective in making sure the boy wasn't taken from the hospital, even though that's not why they were there.

Funny how that works.

originally posted by: VictorVonDoom
a reply to: Pardon?

OK. So the police were there because of online threats against hospital staff. I guess we can assume that if there were online threats against the royal family the police would just post people outside Buckingham Palace and not try to track down the people making the threats. And since there was no police protection for the hospital staff after they left the hospital, any royals who left the Palace would be on their own.

It seems to me that placing police at the hospital was only half effective if the goal was protecting hospital staff since there was no protection away from the hospital. But it was 100% effective in making sure the boy wasn't taken from the hospital, even though that's not why they were there.

Funny how that works.

Living a mile away from the hospital and knowing quite a few people who work there, they were subjected to threats to their faces not just online.
Given the fact that in the days leading up to Alfie's death there were upward of 200 "supporters" camped on the central reservation just outside the hospital, outside the main entrance and car park intimidating both staff and patients (and road users, if you didn't sound your horn as you drove past, something was usually thrown at your car; again I live nearby and had to drive past on a daily basis) and given the fact that the mob had openly called to storm the hospital there was a good reason for police to be there.
Alfie's parents would not have been able to remove him without full cooperation from the hospital staff and leave with a proper handover to subsequent medical staff to take him wherever and his parents ALWAYS had full access to him 24/7 so the police must have been there to stop them taking him, mustn't they (sarcasm)?

Feel free to carry on thinking they were there for your reasons if it makes you happy though.
The facts say otherwise.

originally posted by: Pardon?

Feel free to carry on thinking they were there for your reasons if it makes you happy though.
The facts say otherwise.

I will. Thanks

And you feel free to continue believing what your government says are facts. It may not be required by UK law yet, but it's probably a good habit to have over there.

originally posted by: VictorVonDoom

originally posted by: Pardon?

Feel free to carry on thinking they were there for your reasons if it makes you happy though.
The facts say otherwise.

I will. Thanks

And you feel free to continue believing what your government says are facts. It may not be required by UK law yet, but it's probably a good habit to have over there.

I don't believe you have one clue about what you're talking about, in fact I think you're confusing what I said with something completely different.

The government aren't telling me any facts.
I'm getting the facts from the people who work in the hospital and from what I have personally experienced.
The government doesn't come into it at all.

But don't let the facts cloud your beliefs...