Author Topic: Right To Try  (Read 585 times)

Re: Right To Try
« Reply #15 on: June 04, 2018, 05:51:08 PM »
I was a terminally ill lab rat (working title for my autobiography). :-)

In 1993, shortly after I started graduate school I contracted HIV. I was uninsured and unable to afford medication on my part-time work-study salary, so to access treatment I volunteered for clinical trials for new HIV medications. Each trial typically lasted 3-6 months and while participating I got free doctors visits, lab work and some kind of HIV treatment, typically AZT plus something experimental. Over two years I participated in several different trials and was placed on a variety of medications, most of which were ineffective, some had bad side effects. Eventually my immune system was too compromised to qualify for any clinical trials. When I graduated and obtained full-time employment my infectious disease specialist said that I needed to quit the job, go on disability and get my affairs in order. I was 28 at the time and thought I could make it to 30 but my doctor told me I was "being unrealistic." CD4 count, generally speaking, measures impairment of the immune system, 500-1300 is normal, under 200 is AIDS and I was at 68 and dropping. I really wanted to work and didn't want to just give up and wait to die so I didn't go on disability. After a three month waiting period at my job I was eligible for insurance and got back on medications. Months later protease inhibitors were released and my HIV was suppressed for the first time. It took years for my immune system to recover. Clinical trials enabled me to make it through graduate school and live long enough for effective treatment to be invented. I feel like by participating I and other Poz lab rats were contributing to fighting the disease. Even if I hadn't lived, even if people who participate in experimental treatments don't survive, clinical trials contribute to scientific knowledge.

“You are the sky. Everything else – it’s just the weather.”

― Pema Chödrön

Online trdsf

Re: Right To Try
« Reply #16 on: June 04, 2018, 05:55:21 PM »
I want to know two things: what controls are there on pharma liability, and are they going to be charging patients for being their human trials?  Broadly speaking, I'm on board with patients having the option of experimental treatments when the tested ones aren't working, but not if it's really just a giveaway to the drug companies.
Sir Terry Pratchett, on being told about the theory that the universe is a computer simulation: "If we all get out and in again, would it start to work properly this time?"

Offline Mermaid

Re: Right To Try
« Reply #17 on: June 04, 2018, 08:23:03 PM »
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I was a terminally ill lab rat (working title for my autobiography). :-)

In 1993, shortly after I started graduate school I contracted HIV. I was uninsured and unable to afford medication on my part-time work-study salary, so to access treatment I volunteered for clinical trials for new HIV medications. Each trial typically lasted 3-6 months and while participating I got free doctors visits, lab work and some kind of HIV treatment, typically AZT plus something experimental. Over two years I participated in several different trials and was placed on a variety of medications, most of which were ineffective, some had bad side effects. Eventually my immune system was too compromised to qualify for any clinical trials. When I graduated and obtained full-time employment my infectious disease specialist said that I needed to quit the job, go on disability and get my affairs in order. I was 28 at the time and thought I could make it to 30 but my doctor told me I was "being unrealistic." CD4 count, generally speaking, measures impairment of the immune system, 500-1300 is normal, under 200 is AIDS and I was at 68 and dropping. I really wanted to work and didn't want to just give up and wait to die so I didn't go on disability. After a three month waiting period at my job I was eligible for insurance and got back on medications. Months later protease inhibitors were released and my HIV was suppressed for the first time. It took years for my immune system to recover. Clinical trials enabled me to make it through graduate school and live long enough for effective treatment to be invented. I feel like by participating I and other Poz lab rats were contributing to fighting the disease. Even if I hadn't lived, even if people who participate in experimental treatments don't survive, clinical trials contribute to scientific knowledge.


This is AWESOME!!! I love your story so much, what a happy ending.
We are tied to the ocean. And when we go back to the sea, whether it is to sail or to watch - we are going back from whence we came.

John F. Kennedy

Offline Mermaid

Re: Right To Try
« Reply #18 on: June 04, 2018, 08:24:06 PM »
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I want to know two things: what controls are there on pharma liability, and are they going to be charging patients for being their human trials?  Broadly speaking, I'm on board with patients having the option of experimental treatments when the tested ones aren't working, but not if it's really just a giveaway to the drug companies.
Patients are usually paid a small amount for their participation because it can take considerable time, but they aren't always paid. They are not charged.
We are tied to the ocean. And when we go back to the sea, whether it is to sail or to watch - we are going back from whence we came.

John F. Kennedy

Offline aitm

Re: Right To Try
« Reply #19 on: June 04, 2018, 09:09:57 PM »
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I was a terminally ill lab rat (working title for my autobiography). :-)

In 1993, shortly after I started graduate school I contracted HIV. I was uninsured and unable to afford medication on my part-time work-study salary, so to access treatment I volunteered for clinical trials for new HIV medications. Each trial typically lasted 3-6 months and while participating I got free doctors visits, lab work and some kind of HIV treatment, typically AZT plus something experimental. Over two years I participated in several different trials and was placed on a variety of medications, most of which were ineffective, some had bad side effects. Eventually my immune system was too compromised to qualify for any clinical trials. When I graduated and obtained full-time employment my infectious disease specialist said that I needed to quit the job, go on disability and get my affairs in order. I was 28 at the time and thought I could make it to 30 but my doctor told me I was "being unrealistic." CD4 count, generally speaking, measures impairment of the immune system, 500-1300 is normal, under 200 is AIDS and I was at 68 and dropping. I really wanted to work and didn't want to just give up and wait to die so I didn't go on disability. After a three month waiting period at my job I was eligible for insurance and got back on medications. Months later protease inhibitors were released and my HIV was suppressed for the first time. It took years for my immune system to recover. Clinical trials enabled me to make it through graduate school and live long enough for effective treatment to be invented. I feel like by participating I and other Poz lab rats were contributing to fighting the disease. Even if I hadn't lived, even if people who participate in experimental treatments don't survive, clinical trials contribute to scientific knowledge.



I am glad you are still with us. I do not know how I would have handled the same. We all think we have the great response but until someone looks you in the eye and says "your dead".....no one can ever know how they will react. Fighting back seems the obvious answer but then so many are willing to end it when their "problems" are quite tame in comparison. Good for you.
A humans desire to live is exceeded only by their willingness to die for another. Even god cannot equal this magnificent sacrifice. No god has the right to judge them.-first tenant of the Panotheust

Re: Right To Try
« Reply #20 on: June 04, 2018, 10:37:15 PM »
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We all think we have the great response but until someone looks you in the eye and says "your dead".....no one can ever know how they will react. Fighting back seems the obvious answer but then so many are willing to end it when their "problems" are quite tame in comparison.

I've known several people with HIV who killed themselves, either directly or by choosing not to take medication. I remember an HIV+ guy through an online forum and his YouTube videos who couldn't cope. He was in his early twenties and was convinced that HIV did not cause AIDS, that it was a result of "lifestyle choices" such as using drugs, bad diet, engaging in homosexual sex and taking HIV medications, which he considered poison. He insisted that because he was now a born-again Christian and renounced his sinful ways that he was going to be fine. The members of the forum tried to persuade him he was wrong, to please take medication, but his "faith" was unshakable. Regrettably, his faith killed him.
“You are the sky. Everything else – it’s just the weather.”

― Pema Chödrön

Offline Cavebear

Re: Right To Try
« Reply #21 on: June 05, 2018, 03:42:15 AM »
I personally support "the right to try".  If I am really dying of something, I think I have the right to try anything. 

It's MY LIFE and that some government thinks it has the right to tell me I have to die slowly or in an approved manner is completely offensive.
Atheist born, atheist bred.  And when I die, atheist dead!

Offline Johan

Re: Right To Try
« Reply #22 on: June 05, 2018, 07:03:38 AM »
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This is the second thing Trump has done which I actually like; the first being canceling the TPP. I hope this is a sign of things to come, and that maybe our president is shaping up to be more, er, presidential.
Except that in typical Trump fashion, he didn't actually do much of anything. He'll tell you he did, but he didn't. Giving terminal patients access to experimental drugs is something that already existed.


The FDA already had a long standing mechanism by which terminal patients could apply to receive experimental drugs. That process included submitting an application to a board who would have to approve it. About the only thing right to try does is eliminate that board approval process. That still seems like a good thing that Trump can brag about doing until you realize that FDA board approved about 98% of all applications.

So yeah, Trump signed a bill that opens up access to experimental drugs for a 2% of terminally ill patients who didn't already have it. That's a MAGA if ever there was one I guess.

Also this bill does nothing as far as requiring drug manufacturers to actually provide their not yet approved products for these patients. And often, they won't want to do that. This is because in their clinical trials, things are tightly controlled, in field trials with approved terminal patients, not so much. So if they provide a drug to a patient who decides to double up on the dose and then has an adverse reaction, that data must be included in their application to get the drug approved.

IOW, letting just any yahoo try their new but not yet approved drug could adversely impact their ability to bring that drug to market. Most drug companies are going to tend to shy away from that.


So yeah, Trump finally did a great thing. Except he didn't.
Religion is regarded by the common people as true, by the wise as false and by the rulers as useful

Offline Baruch

Re: Right To Try
« Reply #23 on: June 05, 2018, 07:07:31 AM »
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I personally support "the right to try".  If I am really dying of something, I think I have the right to try anything. 

It's MY LIFE and that some government thinks it has the right to tell me I have to die slowly or in an approved manner is completely offensive.

Except for actual suicide, ala Kavorkian.  Liability laws block that.  If your friends and family help you by commission or omission with the attempted suicide, they are liable.  The drug companies are not looking to get into that, and of course they want a controlled trial, for science and liability protection.
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Offline Cavebear

Re: Right To Try
« Reply #24 on: June 08, 2018, 02:58:36 AM »
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Except that in typical Trump fashion, he didn't actually do much of anything. He'll tell you he did, but he didn't. Giving terminal patients access to experimental drugs is something that already existed.


The FDA already had a long standing mechanism by which terminal patients could apply to receive experimental drugs. That process included submitting an application to a board who would have to approve it. About the only thing right to try does is eliminate that board approval process. That still seems like a good thing that Trump can brag about doing until you realize that FDA board approved about 98% of all applications.

So yeah, Trump signed a bill that opens up access to experimental drugs for a 2% of terminally ill patients who didn't already have it. That's a MAGA if ever there was one I guess.

Also this bill does nothing as far as requiring drug manufacturers to actually provide their not yet approved products for these patients. And often, they won't want to do that. This is because in their clinical trials, things are tightly controlled, in field trials with approved terminal patients, not so much. So if they provide a drug to a patient who decides to double up on the dose and then has an adverse reaction, that data must be included in their application to get the drug approved.

IOW, letting just any yahoo try their new but not yet approved drug could adversely impact their ability to bring that drug to market. Most drug companies are going to tend to shy away from that.


So yeah, Trump finally did a great thing. Except he didn't.

I'm a bit confused here.  You make sense at first, but then also seem to be supporting Big Pharma which sometimes drives up costs of drugs for be special reason other than profit.  What would you say I am misunderstanding?
Atheist born, atheist bred.  And when I die, atheist dead!

Offline Johan

Re: Right To Try
« Reply #25 on: June 08, 2018, 02:06:20 PM »
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I'm a bit confused here.  You make sense at first, but then also seem to be supporting Big Pharma which sometimes drives up costs of drugs for be special reason other than profit.  What would you say I am misunderstanding?
I have no idea what you're misunderstanding. I don't have any kind of innate hatred toward pharmaceutical companies nor do I believe they're all evil and just out to keep people sick so maybe that's it? When I'm sick, I'm kind of glad that medicine exists which can help me get better. I know, crazy right?
Religion is regarded by the common people as true, by the wise as false and by the rulers as useful

Offline Cavebear

Re: Right To Try
« Reply #26 on: June 08, 2018, 08:46:49 PM »
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I have no idea what you're misunderstanding. I don't have any kind of innate hatred toward pharmaceutical companies nor do I believe they're all evil and just out to keep people sick so maybe that's it? When I'm sick, I'm kind of glad that medicine exists which can help me get better. I know, crazy right?

And I wasn't suggesting you did.  Oh gosh no, not to keep people sick (though I'm sure someone out there is considering that as a marketing strategy).  I meant just taking advantage of trade protections to raise prices of limited drugs outrageously.
Atheist born, atheist bred.  And when I die, atheist dead!

Offline Johan

Re: Right To Try
« Reply #27 on: June 09, 2018, 09:09:37 AM »
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And I wasn't suggesting you did.  Oh gosh no, not to keep people sick (though I'm sure someone out there is considering that as a marketing strategy).  I meant just taking advantage of trade protections to raise prices of limited drugs outrageously.
Ok that makes it a clearer. What I think you're misunderstanding then is exactly how the process of getting a drug approved for market works, what it costs and how expensive bone headed mistakes can be.

It costs many many millions to get a drug from the lab to the store shelves. This is common knowledge. The manufacturer has to boatloads of testing. This is also common knowledge. What you might not understand is that once they're in the clinical trial and field trial stage, all that data must be submitted. The manufacturers don't have the option of leaving any data out.

So lets say a manufacturer is developing a cancer drug for a certain type of cancer. And lets say their initial lab testing suggested it to be 90% effective on individuals meeting a certain profile but only 50% on individuals who did not meet that profile. You would want to conduct all your efficacy study field trials on individuals who met the 90% profile and maximize your chances of getting good data. So now right to try comes along and suddenly every Tom Dick and Harry wants to try your new formula. If you give it all of them, you're bound to get lots of individuals who don't fall into your 90% profile and that's going to lower your overall efficacy results. Which could mean your drug doesn't get approved for anyone or it could mean the FDA decides it wants a shit ton more testing first which could add years and millions of dollars to the development process.

Much cheaper for them to do all their testing on the group meets the 90% efficacy profile and get the drug approved and labelled for individuals meeting that profile. Get it out on the shelves and get revenue coming in from it. Then you take that revenue and go back and work on figuring out why its only 40% effective for people outside the profile and figuring out how to modify it so it can approved and labelled for everyone. Obviously I'm watering the process down quite a bit and bastardizing it more than a little here, but it hopefully it gives a sense of what I was eluding to.
Religion is regarded by the common people as true, by the wise as false and by the rulers as useful

Offline Baruch

Re: Right To Try
« Reply #28 on: June 09, 2018, 09:41:45 AM »
That testing thing ... that is what tripped up Martha Stewart.  The drug of the company she invested in, didn't work out.

Or Elizabeth Holmes, CEO of Theranos.  Temptation to cheat the tests, or to over promote the marketing, is great.
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Offline Cavebear

Re: Right To Try
« Reply #29 on: June 11, 2018, 02:41:50 AM »
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Ok that makes it a clearer. What I think you're misunderstanding then is exactly how the process of getting a drug approved for market works, what it costs and how expensive bone headed mistakes can be.

It costs many many millions to get a drug from the lab to the store shelves. This is common knowledge. The manufacturer has to boatloads of testing. This is also common knowledge. What you might not understand is that once they're in the clinical trial and field trial stage, all that data must be submitted. The manufacturers don't have the option of leaving any data out.

So lets say a manufacturer is developing a cancer drug for a certain type of cancer. And lets say their initial lab testing suggested it to be 90% effective on individuals meeting a certain profile but only 50% on individuals who did not meet that profile. You would want to conduct all your efficacy study field trials on individuals who met the 90% profile and maximize your chances of getting good data. So now right to try comes along and suddenly every Tom Dick and Harry wants to try your new formula. If you give it all of them, you're bound to get lots of individuals who don't fall into your 90% profile and that's going to lower your overall efficacy results. Which could mean your drug doesn't get approved for anyone or it could mean the FDA decides it wants a shit ton more testing first which could add years and millions of dollars to the development process.

Much cheaper for them to do all their testing on the group meets the 90% efficacy profile and get the drug approved and labelled for individuals meeting that profile. Get it out on the shelves and get revenue coming in from it. Then you take that revenue and go back and work on figuring out why its only 40% effective for people outside the profile and figuring out how to modify it so it can approved and labelled for everyone. Obviously I'm watering the process down quite a bit and bastardizing it more than a little here, but it hopefully it gives a sense of what I was eluding to.

But what you are also supporting is a situation where a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection (a drug called Daraprim), was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars.

Please explain how the development costs of that drug justified the price increase...



Atheist born, atheist bred.  And when I die, atheist dead!

 

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