5 ms·

First, this is incredibly sad and I feel for Jake. However, I suspect his plea and guarantee of anonymity will go unanswered. I don’t know Jake from a hole in t

by redeux 3y ago

First, this is incredibly sad and I feel for Jake. However, I suspect his plea and guarantee of anonymity will go unanswered. I don’t know Jake from a hole in the wall, and I suspect that’s the case for anyone in his target audience. So, there’s nothing to back a reasonable expectation that he would hold up his end of the bargain. In fact, if he’s about to die there’s little incentive for him to keep his guarantee. I’m not saying he would break his promise, but it’s a risk. I think he would be much more likely to get someone to speak up if he worked with a reputable, professional journalist that has a history of protecting their sources.

nocoiner 3y ago
I grieve for this man and his family and loved ones, and I don’t know that I’d have the fortitude to fight for anything in the circumstances he’s facing. But I’m not sure what the goal is here. If there are experimental drugs that may be helpful, then I think any patient in his situation should have the ability to receive them if they want. But I don’t think that FDA should move faster on approving treatments for velocity’s sake alone. In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world.
- BurningFrog 3y ago
  Just having some kind of "decriminalized" state instead of only "approved" and "illegal" could make things a lot saner. And kill fewer people.
- noduerme 3y ago
  Just asking: If you had some chimerical target molecule in mind that you thought was worth trying to treat yourself with, how much would it cost to have it synthesized somewhere?
  - nocoiner 3y ago
    I am possibly not following your comment - I have no idea how much it would cost to have it synthesized. I would guess a pretty binary distribution between “surprisingly cheap” and “staggeringly expensive.” Are you saying the point of the post is that he is soliciting evidence of unapproved compounds that the FDA is sitting on that might be useful to treat his condition, and if he can find out about them, he’ll have them synthesized? That’s pretty brilliant if so. If that was the message though, it completely eluded me.
    - noduerme 3y ago
      I mean, I'm not saying he's doing that. But that's certainly what I would do. I made some inquiries at one point when I was living in eastern europe, through an American acquaintance who worked for a US drug company that sourced materials from labs there, about what exactly would be involved in taking a patent paper and having one of their subcontractors turn it into a drug. I got some interesting information that made it seem plausibly within reach for someone with a high 7-figure net worth (my plan was to get a price and crowd-source the cost from a network of people suffering from the same thing), but I didn't end up pursuing it. The molecule in question was fairly large and difficult to synthesize and purify, though.
      - nocoiner 3y ago
        Yeah, that’s a pretty genius idea. I’d be totally supportive of anyone who wanted to pursue something like that. I just don’t think that seeking treatment like that overlaps very much with the FDA’s role and mandate. Not to say FDA doesn’t need to be reformed; it probably does. But I don’t think mindless sclerosis is what’s taking time to evaluate new drugs.
        noduerme 3y ago
        Okay, this is me thinking with my "I'm going to die, therefore money and propriety are no object" cap: Who gives a fuck what one agency chooses to bless or not bless, if you're going to die? Go where you can get treatment, even if you have to go into debt to do it. This is just one country, one agency. The information itself is available. If you're staying in American and railing against the FDA, while dying, you're not making the best use of your time. We should proceed from the basic assumption that - with enough money - you can get any drug you want synthesized and professionally administered. Then, maybe, we should question why the FDA is slow to release them. It's a big world, and nothing is stopping anyone from experimenting on themselves, if they have the wherewithal to print what they want to inject. I'm not saying this guy has the wherewithal. But it's not the FDA that's the problem as much as the 101 fake miracle cures cooked up by seductive pseudo-scientists that the FDA is constantly doing yeoman's service to dispel. Rather than rail against regulation, go somewhere unregulated. That's the beauty of living in a big, messed up world.
- haldujai 3y ago
  There is a system by which to do so called the Right to Try act, you need to have tried all approved alternatives first and be deemed ineligible to participate in the clinical trial for the investigational treatment. From the first post of this story it was stated chemotherapy had not been tried yet or been rejected by the clinical trials at that time. When no comparable or satisfactory approved alternative exists, patients may receive access to investigational treatments under the Expanded Access/compassionate use program. Determination of whether chemotherapy is a satisfactory alternative is beyond my medical scope so I won’t comment, this is sub-subspecialist expert level knowledge. To my understanding though the Moderna trials are still in phase I (I.e. no data) whereas there is data on chemo and while is not great is something, so I suspect it might be but I have no experience in making this determination. It’s unfortunate he’s in this position. It is important to keep in mind no system is perfect and some patients will always slip through the cracks (not making a professional judgement on this case) but significantly loosening regulations with investigational therapies may also harm more patients than are slipping through. > In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world Even when you have hundred of millions of $ patient recruitment is the rate limiting step.

by redeux 3y ago

nocoiner 3y ago

I grieve for this man and his family and loved ones, and I don’t know that I’d have the fortitude to fight for anything in the circumstances he’s facing. But I’m not sure what the goal is here. If there are experimental drugs that may be helpful, then I think any patient in his situation should have the ability to receive them if they want. But I don’t think that FDA should move faster on approving treatments for velocity’s sake alone. In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world.

BurningFrog 3y ago
Just having some kind of "decriminalized" state instead of only "approved" and "illegal" could make things a lot saner. And kill fewer people.
noduerme 3y ago
Just asking: If you had some chimerical target molecule in mind that you thought was worth trying to treat yourself with, how much would it cost to have it synthesized somewhere?
- nocoiner 3y ago
  I am possibly not following your comment - I have no idea how much it would cost to have it synthesized. I would guess a pretty binary distribution between “surprisingly cheap” and “staggeringly expensive.” Are you saying the point of the post is that he is soliciting evidence of unapproved compounds that the FDA is sitting on that might be useful to treat his condition, and if he can find out about them, he’ll have them synthesized? That’s pretty brilliant if so. If that was the message though, it completely eluded me.
  - noduerme 3y ago
    I mean, I'm not saying he's doing that. But that's certainly what I would do. I made some inquiries at one point when I was living in eastern europe, through an American acquaintance who worked for a US drug company that sourced materials from labs there, about what exactly would be involved in taking a patent paper and having one of their subcontractors turn it into a drug. I got some interesting information that made it seem plausibly within reach for someone with a high 7-figure net worth (my plan was to get a price and crowd-source the cost from a network of people suffering from the same thing), but I didn't end up pursuing it. The molecule in question was fairly large and difficult to synthesize and purify, though.
    - nocoiner 3y ago
      Yeah, that’s a pretty genius idea. I’d be totally supportive of anyone who wanted to pursue something like that. I just don’t think that seeking treatment like that overlaps very much with the FDA’s role and mandate. Not to say FDA doesn’t need to be reformed; it probably does. But I don’t think mindless sclerosis is what’s taking time to evaluate new drugs.
      - noduerme 3y ago
        Okay, this is me thinking with my "I'm going to die, therefore money and propriety are no object" cap: Who gives a fuck what one agency chooses to bless or not bless, if you're going to die? Go where you can get treatment, even if you have to go into debt to do it. This is just one country, one agency. The information itself is available. If you're staying in American and railing against the FDA, while dying, you're not making the best use of your time. We should proceed from the basic assumption that - with enough money - you can get any drug you want synthesized and professionally administered. Then, maybe, we should question why the FDA is slow to release them. It's a big world, and nothing is stopping anyone from experimenting on themselves, if they have the wherewithal to print what they want to inject. I'm not saying this guy has the wherewithal. But it's not the FDA that's the problem as much as the 101 fake miracle cures cooked up by seductive pseudo-scientists that the FDA is constantly doing yeoman's service to dispel. Rather than rail against regulation, go somewhere unregulated. That's the beauty of living in a big, messed up world.
haldujai 3y ago
There is a system by which to do so called the Right to Try act, you need to have tried all approved alternatives first and be deemed ineligible to participate in the clinical trial for the investigational treatment. From the first post of this story it was stated chemotherapy had not been tried yet or been rejected by the clinical trials at that time. When no comparable or satisfactory approved alternative exists, patients may receive access to investigational treatments under the Expanded Access/compassionate use program. Determination of whether chemotherapy is a satisfactory alternative is beyond my medical scope so I won’t comment, this is sub-subspecialist expert level knowledge. To my understanding though the Moderna trials are still in phase I (I.e. no data) whereas there is data on chemo and while is not great is something, so I suspect it might be but I have no experience in making this determination. It’s unfortunate he’s in this position. It is important to keep in mind no system is perfect and some patients will always slip through the cracks (not making a professional judgement on this case) but significantly loosening regulations with investigational therapies may also harm more patients than are slipping through. > In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world Even when you have hundred of millions of $ patient recruitment is the rate limiting step.