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Message
Colorado Passes "Right to Try " Bill
Posted on 5/17/14 at 9:13 pm
Posted on 5/17/14 at 9:13 pm
LINK
quote:
Colorado has become the first US state to allow terminally ill people to take experimental drugs - even those which are years away from getting federal approval.
State's Governor John Hickenlooper signed the so-called 'Right To Try' bill into law in Fort Collins.
It was passed unanimously after emotional testimony from relatives who told harrowing stories about trying to get federal permission to access experimental medicine.
"When you're terminal and there's a drug out there that might help you, it can seem that the obstacles to get that drug are insurmountable," said Senator Irene Aguilar, who co-sponsored the controversial bill.
She dubbed it the 'Dallas Buyers Club' bill, after the Hollywood film about an AIDS patient who smuggled medicine from Mexico because it was not cleared for use in the US.
Similar 'Right To Try' bills are to be signed in Louisiana and Missouri.
In November, voters in Arizona will decide whether to pass the legislation, which allows drug companies to provide experimental medications outside of clinical trials.
Colorado's bill has received a careful 'no comment' from doctors' groups, hospitals and health insurers.
It was amended to clarify that healthcare providers and insurers are not liable for any adverse effects if a patient chooses to take experimental drugs.
Patients and relatives who support the new law say they are willing to accept any amount of risk if there is a chance of prolonging life.
Among them is Keith Knapp, from Sacramento, California, whose wife Mikaela died last month from kidney cancer.
The Knapps tried in vain to access new drugs through existing "compassionate use" guidelines, which require permission from the US Food and Drug Administration.
But there are many critics of the bill.
Dr David Gorski, a surgical oncologist, says "Right To Try" proposals are simply feel-good measures that won't help many patients.
"These proposals are built on this fantasy that there are all these patients out there that are going to be saved if they could just get access to the medicine," he said.
"In reality, the patients that might be helped are very few, while the number of patients who could be hurt by something like this are many."
7
Posted on 5/17/14 at 9:19 pm to RollTide4Ever
People don't understand how this research and these trials work. All this will do is frick up the results of clinical trials. You can't just disregard how these experimental medications affect these patients.
quote:This.
"These proposals are built on this fantasy that there are all these patients out there that are going to be saved if they could just get access to the medicine," he said.
"In reality, the patients that might be helped are very few, while the number of patients who could be hurt by something like this are many."
Posted on 5/17/14 at 9:21 pm to RollTide4Ever
Dr. David Gorski has a very valid point.
Posted on 5/17/14 at 9:24 pm to RollTide4Ever
There is a reason new drugs have to go through clinical trials.
There is a reason why we should practice evidence based medicine.
Stupid laws like this make politicians feel good because they can take pictures with sick people and claim they helped them. But in reality, this will make identifying new cancer drugs that actually work even more difficult.
There is a reason why we should practice evidence based medicine.
Stupid laws like this make politicians feel good because they can take pictures with sick people and claim they helped them. But in reality, this will make identifying new cancer drugs that actually work even more difficult.
Posted on 5/17/14 at 9:29 pm to RollTide4Ever
I don't have a problem with it if the people choose to do so and understand the risks. If you're gonna die anyways and there's no current treatment, why not try?
I also think there should be a clause that if the patient isn't healed that it not affect the drugs approval if further clinicals show it to be effective. Nothing is 100% effective
I also think there should be a clause that if the patient isn't healed that it not affect the drugs approval if further clinicals show it to be effective. Nothing is 100% effective
Posted on 5/17/14 at 9:31 pm to deltaland
quote:The problem is, it is completely unethical to disregard how it affected someone. You can't do that.
I also think there should be a clause that if the patient isn't healed that it not affect the drugs approval if further clinicals show it to be effective.
How do you know it wasn't actually a side effect of the drug? Maybe it was an interaction with another drug. Maybe the person didn't take the medication correctly. Maybe it was something in their diet.
etc
etc
fricking etc
This post was edited on 5/17/14 at 9:34 pm
Posted on 5/17/14 at 9:49 pm to Scruffy
The bill states however that they are not liable for adverse effects. So if they aren't liable, then just throw some extra med on the side outside of the trial.
Posted on 5/17/14 at 9:50 pm to ASTL
quote:
So if they aren't liable, then just throw some extra med on the side outside of the trial.
Which, of course will render said trial essentially worthless.
Posted on 5/17/14 at 9:51 pm to ASTL
quote:It isn't a liability issue. It is an issue with the clinical trial results.
The bill states however that they are not liable for adverse effects. So if they aren't liable, then just throw some extra med on the side outside of the trial.
Clinical trials are controlled. There are screening processes for applicants. These aren't just random individuals. It is a very rigorous process.
By throwing random individuals into the pool, it alters the results with unknown factors. That is the issue, not liability.
Posted on 5/17/14 at 9:51 pm to Scruffy
quote:
How do you know it wasn't actually a side effect of the drug? Maybe it was an interaction with another drug. Maybe the person didn't take the medication correctly. Maybe it was something in their diet.
What if it were the drug and it really helped the person? It seems those resorting to these drugs don't have many options left. Good for them if it helps
Posted on 5/17/14 at 9:53 pm to ASTL
quote:
The bill states however that they are not liable for adverse effects.
All it will take is one tearful witness, one soft hearted judge, one slick lawyer and the myth of no liability evaporates.
Posted on 5/17/14 at 9:54 pm to RogerTheShrubber
quote:
What if it were the drug and it really helped the person? It seems those resorting to these drugs don't have many options left. Good for them if it helps
And what if ti kills them sooner, or makes what little time they left all the more miserable?
Besides, how will anyone know if it was the drug that helped them?
Outside of a formal trial, we will just be guessing.
Why don't we just give all these patients sugar pills? Statistically, some of them WILL get better.
This post was edited on 5/17/14 at 9:56 pm
Posted on 5/17/14 at 9:55 pm to RogerTheShrubber
quote:And what if some unknown factor causes a serious side effect thus resulting in the cancellation of the drug study and disposal of the drug?
What if it were the drug and it really helped the person? It seems those resorting to these drugs don't have many options left. Good for them if it helps
What if the factor that caused that side effect would've been discovered during the controlled trial and thus the results weren't tainted?
What if that drug could've saved many more lives had it not been discontinued because that individual tainted the clinical trial?
Or as memphis says, how do we even know it was the drug that had the positive effect?
Yes, these people are dying. It sucks. I get it. They have a right to be selfish, and I hate to use that word because it gives the idea that I don't care, but it compromises the drug trial for everyone else.
This post was edited on 5/17/14 at 9:59 pm
Posted on 5/17/14 at 9:59 pm to Scruffy
quote:
What if it were the drug and it really helped the person? It seems those resorting to these drugs don't have many options left. Good for them if it helps
And what if some unknown factor causes a serious side effect thus resulting in the cancellation of the drug study and disposal of the drug?
These people aren't included in the drug trials, correct? Not sure how they could deem the drug harmful under those circumstances.
If they believe in their clinical trials, why would they include these folks in their data?
Posted on 5/17/14 at 10:00 pm to RogerTheShrubber
quote:Because you can't disregard the effect the drug has on anyone.
If they believe in their clinical trials, why would they include these folks in their data?
If there is a major side effect in one of these individuals, how can the people running the trial just ignore that event? It doesn't work that way. It is still a negative effect.
At that point, the people running the trial have to ask themselves, "did the drug cause that event or was it something else?"
If one of these people has a terrible side effect or issue when taking this drug, they can't ignore that.
This post was edited on 5/17/14 at 10:02 pm
Posted on 5/17/14 at 10:08 pm to deltaland
quote:
I don't have a problem with it if the people choose to do so and understand the risks.
If they don't have a medical degree and their judgment is affected by dealing with a terminal illness, what are the odds that they'll fully understand and/or appreciate the risks?
Posted on 5/17/14 at 10:11 pm to Scruffy
quote:
If there is a major side effect in one of these individuals, how can the people running the trial just ignore that event? It doesn't work that way. It is still a negative effect.
At that point, the people running the trial have to ask themselves
I thought trials were separate from this type of use?
Maybe I'm not being clear. If the affect don't occur in clinical trials with controlled factors, It could very easily be assumed the bad affects weren't directly caused by the drug alone?
Posted on 5/17/14 at 10:12 pm to RogerTheShrubber
quote:
I thought trials were separate from this type of use?
Maybe I'm not being clear. If the affect don't occur in clinical trials with controlled factors, It could very easily be assumed the bad affects weren't directly caused by the drug alone?
quote:Not a good idea.
assumed
quote:So then what caused the effect with the drug?
weren't directly caused by the drug alone
All this does is complicate things. Like I said, it sucks that these medications are ready yet, and yes, our drug approval process is probably much more strenuous than it needs to be, but until that changes, why potentially throw a wrench into the gears?
This post was edited on 5/17/14 at 10:15 pm
Posted on 5/17/14 at 10:15 pm to Scruffy
If the affects weren't observed in trials under controlled conditions I don't see the problem.
Posted on 5/17/14 at 10:19 pm to RogerTheShrubber
quote:And here we have the junction of controlled and uncontrolled. There is still something causing the event, and the drug could be linked.
If the affects weren't observed in trials under controlled conditions I don't see the problem.
Like I said, I don't like the idea of complicating a system even more than it already is, nor do I like the addition of multiple unknown variables to a clinical trial.
This post was edited on 5/17/14 at 10:21 pm
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