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Posted 4/12/2018 10:19 PM (GMT 0)
President Trump has stated he will sign this Bill into law if / when it reaches his desk. It would allow terminally ill patients to have access to experimental drugs before the FDA gives them formal approval, a process that can take years...It has passed the Senate by a unanimous vote...



time.com/5132892/right-to-try-bill-terminal-illness/
Posted 4/13/2018 12:48 AM (GMT 0)
I would like this law better if it at least required Phase 1 clinical trials be completed for safety before a patient could try it.
Posted 4/13/2018 2:05 AM (GMT 0)
I believe that is the case Prato...There are several hoops the person wanting the drug or treatment must jump through..Not the least of which the manufacturer or supplier must be willing to supply the drug in question..
Posted 4/13/2018 2:13 AM (GMT 0)
I am sure there are a TON of legal issues. They would be scared to death of being sued. Let the patient sign a waiver. As long as the patient is made aware of every issue that could arise from the drugs, even death, I say they should have access. If they are already terminally ill, what have they got to lose? It could even benefit those who aren't terminally ill as well, being sort of a trial process on its own.
Posted 4/13/2018 2:24 AM (GMT 0)

LisaInIndiana said...
I am sure there are a TON of legal issues. They would be scared to death of being sued. Let the patient sign a waiver. As long as the patient is made aware of every issue that could arise from the drugs, even death, I say they should have access. If they are already terminally ill, what have they got to lose? It could even benefit those who aren't terminally ill as well, being sort of a trial process on its own.

yeah kinda my take. I don't wanna be the guy that tells a dying person they can't have an un-FDA appoved drug because it may not help them. And I'd like the same curtesy extended to me as well.....please don't tell me I can't take a drug because it may not help....when I'm dying. shocked
Posted 4/13/2018 2:42 PM (GMT 0)
Basically, what the Bill does is protect everyone in the supply chain from lawsuits. I you use this new law to obtain an experimental drug, you are on your own, period. Many States have similar laws in place already...
Posted 5/31/2018 11:59 AM (GMT 0)
I'm bumping this thread because "right to try" was signed into law by the President this week. For those of us faced with running the course of all approved treatments, this makes good sense to me. Let me at least have a chance at a new drug once all the " standard of care" treatments have failed. I am hoping that this law will speed up the clinical trial process too.
Posted 5/31/2018 9:10 PM (GMT 0)
The bill does have conditions, must have at least passed Phase 1 trials and it does protect a few in the line of treatment.

“The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.”

/www.congress.gov/bill/115th-congress/senate-bill/204?q=%7B%22search%22%3A%5B%22right+to+try%22%5D%7D&r=2


Click on Text for the full text of the bill.
Posted 5/31/2018 9:30 PM (GMT 0)
No politics here.

Post Edited By Moderator (142) : 6/1/2018 4:24:23 PM (GMT-6)

Posted 5/31/2018 9:53 PM (GMT 0)
No politics here.

Post Edited By Moderator (142) : 6/1/2018 4:24:57 PM (GMT-6)

Posted 5/31/2018 10:06 PM (GMT 0)
Never underestimate the legal community's ability to find a way to bring a lawsuit - even in the face of new laws.

Remember that new laws have flaws.
Posted 5/31/2018 10:39 PM (GMT 0)
I wonder where the pharmaceutical companies are going to get the supplies of these experimental drugs for desperate patients. My understanding is that in the early throws of development, supplies are very limited. And those supplies are committed to clinical trials.

...Jerry
Posted 5/31/2018 11:20 PM (GMT 0)
If Big Pharma sees $$$$$$$$$$$$$$$$$ in manufacturing and distributing these experimental drugs I think you will be amazed how quickly they will be able to fill the demand, especially if success stories start to leak out....
Posted 5/31/2018 11:38 PM (GMT 0)
I'm a chemical engineer (although I never worked in the pharma industry). I would be amazed if the pharma companies would build plants capable of producing large supplies of experimental drugs based on the crap shoot that desperate patients may want them. And, if they did, I would question the ethics of that decision.

...Jerry
Posted 6/1/2018 1:04 AM (GMT 0)
Some may disagree, but this seemed to me to be a pretty cogent article on the past, present, and potential future of legislation of this type.

/sciencebasedmedicine.org/the-very-worst-version-of-the-sham-known-as-right-to-try-is-poised-to-become-law/

Charles
Posted 6/1/2018 5:26 PM (GMT 0)
I could see Big Pharma pushing for a new class of approval for special circumstances so they would be paid for by insurance.

I mean if they are allowed to treat, they will want compensation. Best way is through insurance.

So maybe a fight between insurance companies and the pharmacy industry
Posted 6/1/2018 7:42 PM (GMT 0)
There is already an expanded access law for compassionate use. The FDA approves most requests, but the drug company usually doesn't agree to supply it.

This "right to try" law, if it benefits anyone, will benefit only the very rich. Drug companies will charge an arm and a leg for the new drugs, if they are able to supply them at all. Insurance companies certainly won't cover the cost.

Doctors who have taken an oath to do no harm will be reluctant to prescribe drugs of unconfirmed safety even if they are free of legal liability. Desperate patients may be willing to try anything, even if it kills them more quickly. Because a Phase 1 trial only shows a dose safety relationship, it is unclear whether a drug has "passed" or not. What if a drug has 50% of patients experiencing Grade 3 symptoms, how can anyone assess whether it is worth the risk if the efficacy has not yet been discovered?

Also, I am unclear what is meant by "terminally ill patient." Is a man with newly diagnosed metastatic PC considered "terminally ill" even if he can be expected to survive 20 years with existing therapies?
Posted 6/1/2018 10:16 PM (GMT 0)
It's going to be disgustingly sad if we start seeing the families of patients who are already too sick to be eligible for clinical trials start reaching for straws by "demanding" drugs with inadequate safety information, and little known about risks and benefits.

Far too often, bad decisions about "Hail Mary" efforts lead to nothing more than a prolonged misery while living and a terrible death...yet the family—who longs for the olden days before sickness (days that are not returning)—feels that they were "doing something." Who benefited?
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