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Right to Try bill passes House

Threegoofs

Threegoofs

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Well, the GOP are moving a bill thru Congress that *sounds* like a good idea, but as most of their ideas are these days, is ultimately a bad thing.

On the surface, it sounds great. Let patients try any potential lifesaving drug that might be out there. What could go wrong?

But realistically, it basically takes a program that already exists- the FDA’s compassionate use program, and removes any oversight of it.

This could really charge up some fly by night companies, who get an ineffective and potentially dangerous compound thru initial safety testing, and then try to offer the untested compound up for ‘right to try’ without bothering to go thru efficacy and further safety studies. But that’s exactly what some of the supporters want....there’s a lotta money in desperately ill patients!


Two good overviews:

'Right-to-Try' Drug Law Offers No Miracle Cure - Bloomberg

Right-to-try laws are hazardous to your health--and now they're backed by the Koch brothers
 
So many great bills pass the house and die in the senate.
Shame.

I can see the good and bad in this bill.
..but if you are going to die anyway....
 
PleasantValley said:
So many great bills pass the house and die in the senate.
Shame.

I can see the good and bad in this bill.
..but if you are going to die anyway....
Click to expand...

This one is reportedly likely to clear the Senate.

But you have fallen into the trap I just described. It SOUNDS like a great idea to give hope for terminally ill patients...but it fixes no problem and creates others.
 
Threegoofs said:
This one is reportedly likely to clear the Senate.

But you have fallen into the trap I just described. It SOUNDS like a great idea to give hope for terminally ill patients...but it fixes no problem and creates others.
Click to expand...

Not sure how you can say it doesn't fix a problem. when a terminally ill patient has no other means than to either use one of these "not approved by FDA" drugs or die, I would think that choice should be up to them.
 
So this basically passes the cost of R and D from companies to terminal patients.
 
Praxas said:
Not sure how you can say it doesn't fix a problem. when a terminally ill patient has no other means than to either use one of these "not approved by FDA" drugs or die, I would think that choice should be up to them.
Click to expand...

A compassionate program already exists. 99% of applicants get the experimental drugs already.
 
KevinKohler said:
So this basically passes the cost of R and D from companies to terminal patients.
Click to expand...

Yes, kinda.

But much worse. It actually may stifle development of some promising drugs from ethical pharma companies, because we don’t make significant quantities of many of these agents until marketing approval is secured. It’s not easy to do large scale cost effective protein synthesis. Now these compounds get diverted off to patients that contribute NO DATA on the drugs.

And some companies might just ditch the R&D completely, and be perfectly willing to sell snake oil to terminal patients and save the high costs of doing trials that more often than not, fail.
 
Threegoofs said:
Well, the GOP are moving a bill thru Congress that *sounds* like a good idea, but as most of their ideas are these days, is ultimately a bad thing.

On the surface, it sounds great. Let patients try any potential lifesaving drug that might be out there. What could go wrong?

But realistically, it basically takes a program that already exists- the FDA’s compassionate use program, and removes any oversight of it.

This could really charge up some fly by night companies, who get an ineffective and potentially dangerous compound thru initial safety testing, and then try to offer the untested compound up for ‘right to try’ without bothering to go thru efficacy and further safety studies. But that’s exactly what some of the supporters want....there’s a lotta money in desperately ill patients!


Two good overviews:

'Right-to-Try' Drug Law Offers No Miracle Cure - Bloomberg

Right-to-try laws are hazardous to your health--and now they're backed by the Koch brothers
Click to expand...

You omitted the salient factor, this is only for terminally ill patients.
 
I’ll note that Trump has now signed this into law.

Chances are, it won’t have any appreciable impact, although I have a feeling non-ethical companies can use it to rip off desperate, trusting people.

I’m sure it will be touted as a great accomplishment by all involved in its passage....even though it changes virtually nothing.

Good analysis here:

Federal Right to Try | In the Pipeline
 
Last edited:
Threegoofs said:
A compassionate program already exists. 99% of applicants get the experimental drugs already.
Click to expand...

I tell you from personal experience, very personal experience, this is not true. My wife was denied an experimental cure for Leukemia. She died. Four weeks later, the drug was approved as a therapy for her type of Leukemia. It has enjoyed a 63% cure rate for the patients who have received it.

I was approved for an experimental anti arrhythmia medication to prevent sudden death syndrome. It still keeps me alive. 98% of the US patients who needed this therapy were denied access at that time. All but two are dead. That was 34 months ago. A year later the medication received approval here, but not in Europe. And because of the co-payment expense, many patients are taking less expensive alternatives which have significantly higher death ratios.

Until this bill, nothing had changed. I hope you never suffer what so many have not enjoyed.
 
Praxas said:
Not sure how you can say it doesn't fix a problem. when a terminally ill patient has no other means than to either use one of these "not approved by FDA" drugs or die, I would think that choice should be up to them.
Click to expand...

I see your point, but I also see Threegoofs point, too. I can imagine some scammers taking advantage of/profiting off the dying. Then again, we already have that to a large extent in this country.

I admit, I need to look into this more, but my initial feelings are conflicted.
 
OldFatGuy said:
I tell you from personal experience, very personal experience, this is not true. My wife was denied an experimental cure for Leukemia. She died. Four weeks later, the drug was approved as a therapy for her type of Leukemia. It has enjoyed a 63% cure rate for the patients who have received it.

I was approved for an experimental anti arrhythmia medication to prevent sudden death syndrome. It still keeps me alive. 98% of the US patients who needed this therapy were denied access at that time. All but two are dead. That was 34 months ago. A year later the medication received approval here, but not in Europe. And because of the co-payment expense, many patients are taking less expensive alternatives which have significantly higher death ratios.

Until this bill, nothing had changed. I hope you never suffer what so many have not enjoyed.
Click to expand...

I guess you must be the 2%.

But the reasons these things get denied are not changing.

Most drugs in Phase 2 aren’t made in quantity. There’s barely enough to get to clinical trials. The company will deny the request anyway in these situations.

Also... I know of no new groundbreaking anti—arrhythmic drug approved in the last couple years.
 
Threegoofs said:
This one is reportedly likely to clear the Senate.

But you have fallen into the trap I just described. It SOUNDS like a great idea to give hope for terminally ill patients...but it fixes no problem and creates others.
Click to expand...

It creates a problem, the liberal democrats in the regulatory panels won’t be able to regulate people’s ability to seek treatment.

That’s solely what the opposition is about, protecting a political philosophy where you can’t take a risk if a socialist hasn’t determined it “safe” for you to do so.
 
EMNofSeattle said:
It creates a problem, the liberal democrats in the regulatory panels won’t be able to regulate people’s ability to seek treatment.

That’s solely what the opposition is about, protecting a political philosophy where you can’t take a risk if a socialist hasn’t determined it “safe” for you to do so.
Click to expand...

Yes. It’s all about the socialist libruls.

Great insight
 
Threegoofs said:
Yes. It’s all about the socialist libruls.

Great insight
Click to expand...

It sure is. The central philosophy of US liberals is the government through unelected panels and agencies must decide what is safe for you before you can make a decision. Which is on full display since they opposed this bill.
 
EMNofSeattle said:
It sure is. The central philosophy of US liberals is the government through unelected panels and agencies must decide what is safe for you before you can make a decision. Which is on full display since they opposed this bill.
Click to expand...

Yeah. Totally communist.

You nailed it. :roll:
 
Threegoofs said:
Yeah. Totally communist.

You nailed it. :roll:
Click to expand...

You have no refutation because you know it's true. You would rather someone die of natural causes then ask to take a risk on a drug that might kill them. your position is perfectly clear.
 
EMNofSeattle said:
You have no refutation because you know it's true. You would rather someone die of natural causes then ask to take a risk on a drug that might kill them. your position is perfectly clear.
Click to expand...

Absolutely.

You really hit the nail on the head.

Totally communist.
 
Threegoofs said:
Well, the GOP are moving a bill thru Congress that *sounds* like a good idea, but as most of their ideas are these days, is ultimately a bad thing.

On the surface, it sounds great. Let patients try any potential lifesaving drug that might be out there. What could go wrong?

But realistically, it basically takes a program that already exists- the FDA’s compassionate use program, and removes any oversight of it.

This could really charge up some fly by night companies, who get an ineffective and potentially dangerous compound thru initial safety testing, and then try to offer the untested compound up for ‘right to try’ without bothering to go thru efficacy and further safety studies. But that’s exactly what some of the supporters want....there’s a lotta money in desperately ill patients!


Two good overviews:

'Right-to-Try' Drug Law Offers No Miracle Cure - Bloomberg

Right-to-try laws are hazardous to your health--and now they're backed by the Koch brothers
Click to expand...

Here is a problem I have with it. Clinical trials have to be very controlled. Every thing a patient experiences during clinical trials goes in the report, it has to. Whether it was caused byt he drug or not. That's why you often see all those long list of side effects,, like say diarhea. All it means is patients in the clinical trials reported that. So taking a patients who doesn't fit the criteria and who is too far gone to help could taint the results of the clinical trial. That's why there are strict criteria during clinical trials, the wrong patient groups can sink the trial.

My guess is this bill doesn't take that into account. I would think the drug companies wouldn't want to give their experimental drug for someone who likely will die and that will harm their studies. I wonder how the FDA will handle this. Maybe I need to read more specifics and this will be answered.
 
Sampson Simpson said:
Here is a problem I have with it. Clinical trials have to be very controlled. Every thing a patient experiences during clinical trials goes in the report, it has to. Whether it was caused byt he drug or not. That's why you often see all those long list of side effects,, like say diarhea. All it means is patients in the clinical trials reported that. So taking a patients who doesn't fit the criteria and who is too far gone to help could taint the results of the clinical trial. That's why there are strict criteria during clinical trials, the wrong patient groups can sink the trial.

My guess is this bill doesn't take that into account. I would think the drug companies wouldn't want to give their experimental drug for someone who likely will die and that will harm their studies. I wonder how the FDA will handle this. Maybe I need to read more specifics and this will be answered.
Click to expand...

Actually, it’s now all up to the FDAto implement it.

It’s very telling that the FDA is directing all inquiries into the mechanics of this law to....drug companies.
 
Praxas said:
Not sure how you can say it doesn't fix a problem. when a terminally ill patient has no other means than to either use one of these "not approved by FDA" drugs or die, I would think that choice should be up to them.
Click to expand...

As long as there is no charge for the experimental treatments otherwise it leaves desperate patients open to quacks looking to make a buck. They should not be able to charge for non-approved treatments. After all they usually pay testers to take these drugs.
 
Threegoofs said:
I guess you must be the 2%.

But the reasons these things get denied are not changing.

Most drugs in Phase 2 aren’t made in quantity. There’s barely enough to get to clinical trials. The company will deny the request anyway in these situations.

Also... I know of no new groundbreaking anti—arrhythmic drug approved in the last couple years.
Click to expand...

Not even close. You don't have a clue. Hundreds of patients benefited from the same anti-arhythmetic I take, far more than 2%, and thousands needed it.

17 new anti-arrhythmic medications have been approved within the past 18 months. Each is therapeutic for different causations.

Quantities are never the issue. Phase 2 is not the question. Small companies that specialize in research for singular diseases and maladies often cannot afford FDA trials. As a simple example, one company ran a trial on a therapy made from honey with cinnamon, for both arthritic relief and a preventative prophylactic for bladder diseases. The FDA denied approval, stating these are common herbs not worthy of FDA examination. The company released the recipe online, the FDA threatened to sue and file fines. The company dissolved. The really sad part of the story, the company had isolated a cure for arthritic psoriasis, trying to raise funds for trials, which disappeared when they dissolved. Bayer bought their research, is now running the therapy through trials, expecting to sell doses for $50 each. A patient will need three doses daily. That dissolved company planned on selling doses for 75¢ each. The medication is made from freeze dried red tea, ginger and mint leaves.

I have the same access as you to the FDA public databases. They are skewed and tell a minor part of the story.

And don't get me wrong. We need the FDA, but we also need an FDA with a conscience.
 
OldFatGuy said:
Not even close. You don't have a clue. Hundreds of patients benefited from the same anti-arhythmetic I take, far more than 2%, and thousands needed it.

17 new anti-arrhythmic medications have been approved within the past 18 months. Each is therapeutic for different causations.

Quantities are never the issue. Phase 2 is not the question. Small companies that specialize in research for singular diseases and maladies often cannot afford FDA trials. As a simple example, one company ran a trial on a therapy made from honey with cinnamon, for both arthritic relief and a preventative prophylactic for bladder diseases. The FDA denied approval, stating these are common herbs not worthy of FDA examination. The company released the recipe online, the FDA threatened to sue and file fines. The company dissolved. The really sad part of the story, the company had isolated a cure for arthritic psoriasis, trying to raise funds for trials, which disappeared when they dissolved. Bayer bought their research, is now running the therapy through trials, expecting to sell doses for $50 each. A patient will need three doses daily. That dissolved company planned on selling doses for 75¢ each. The medication is made from freeze dried red tea, ginger and mint leaves.

I have the same access as you to the FDA public databases. They are skewed and tell a minor part of the story.

And don't get me wrong. We need the FDA, but we also need an FDA with a conscience.
Click to expand...

Oh good lord.

This is like an advertisement for snake oil! We can’t afford to study it, but try it! It works!
Who needs that complicated sciencey stuff anyhow- it just knocks 90% of drugs out of the running because they don’t work or aren’t safe!


And....

17 antiarrthmics in 18 months, huh?

Geez. Wait till all the Electrophysiologists I work with find out.

Which one are you on? Cinnamon and honey, or freeze dried red tea?
 
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