7 ms·

Jake's wife on FDA deregulation https://bessstillman.substack.com/p/the-drugs-killing-dying-patients https://bessstillman.substack.com/p/the-drugs-killing-dyin

Jake's wife on FDA deregulation https://bessstillman.substack.com/p/the-drugs-killing-dying-patients https://bessstillman.substack.com/p/the-drugs-killing-dying-...

blackeyeblitzar 2y ago
Thanks - it’s so helpful for them to have documented this for us to understand a very complex and opaque process. All while they were under extreme stress.
fatnoah 2y ago
I've experienced this from both sides. First with my father who was dying of cancer and was informed that while some promising treatments were in trials, he was not eligible. Balancing potential harm from unapproved drugs vs. certain death within 12 months feels like an easy task. On the other side, my wife worked for a mid-sized pharma in the past. After several rounds of trials that each cost tens of millions of dollars, the FDA couldn't be convinced to approve the drug, despite hearings full of people who were either alive because the drug saved their lives or were hoping to have it approved for future use. After a couple more trials, the company ended up cutting losses and moving on to something else. Again, it feels like there should be some pathway here. Such a drug shouldn't be the first option if others are available, but if there's nothing else or other treatments haven't worked, what's the real harm in letting someone who's going to die anyway give it a shot.
- newzisforsukas 2y ago
  What was the drug?
  - fatnoah 2y ago
    TBH, I don't remember the name as it was one of those crazy generic beezelebubatab type of generic names.
- llamaimperative 2y ago
  Part of the harm is in people no longer trusting drugs. We're very fortunate to be able to get prescribed a drug and have certainty the risk-reward tradeoffs have been evaluated to extreme depth by experts far more equipped than we are.
  - barry-cotter 2y ago
    You are past of the reason the world is a worse place than it could be. Without people like you defending excessive caution as good for the PR of drug regulatory agencies millions of people who are dead would be alive, possibly tens of millions.
    - llamaimperative 2y ago
      Okay buddy. How many drug development programs have you worked on?
    - vinnyvichy 2y ago
      [flagged]
  - fatnoah 2y ago
    > Part of the harm is in people no longer trusting drugs. I'm not sure how trust would be eroded by the failure of an experimental drug to treat a terminal case where no other drugs are working.
- deleted 2y ago
  [deleted]
bena 2y ago
This is a complicated subject. Because those rules are in place for reasons. And some of those reasons are to prevent drug companies from turning the poor into lab rats with no regard to their safety. And I guarantee you, you let "terminal" patients skirt rules, there will be a hell of a lot more "terminal" patients. And I'm sure there are some non-regulation reasons to limit various therapies. They are trying to see if thing X can help. And if thing X only helps when combined with thing Y, you don't exactly get that information when focusing on thing X. Or the worse scenarios of thing Y making thing X ineffective or harmful. This was written from a very emotional place, and understandably so. But that state means they are not exactly in a position to consider all the reasons. And it must be frustrating as hell to have tried 40 things that didn't work to only be denied the 41st because you tried too many other things. Especially if that 41st thing turns out to be something that works. But I don't think the answer is let terminal patients take whatever they feel like.
- Zak 2y ago
  > But I don't think the answer is let terminal patients take whatever they feel like. I don't think anyone has the moral authority to tell anyone else what they can take, especially terminal patients. I do, however think governments have a responsibility to regulate how drug companies conduct trials so as to minimize harm to patients. This probably has the same outcome in practice, but I find the moral distinction important.
  - somerandomqaguy 2y ago
    I don't think it's just that. Imagine the kind of money the more unscrupulous could make selling sugar pills for $100 each saying that it's the cure for whatever is killing you. Desperation can cloud even the most rational of minds.
    - Zak 2y ago
      People selling stuff are in the same category as the drug companies; I have no objection to regulating them, and imprisoning them for fraud, with an enhanced penalty for preying on particularly vulnerable people in the case you described.
throwaway5752 2y ago
May Jake rest in peace and may his memory be a blessing to his wife and daughter. Their views on clinical trials were understandable given the circumstances. Those regulations were written in blood, miscarriage/birth defects, autoimmune conditions, genetic damage, and other horrors. This is a complicated ethical topic because clinical trials can harm patients and families of patients as much as they can help, and sometimes many years after the fact of the trial. It's not an appropriate discussion in a memorial post.
- blackeyeblitzar 2y ago
  > It's not an appropriate discussion in a memorial post. When else do we discuss it? This is bound to just disappear into history and the government will carry on with business as usual. I feel now’s the time to get people educated and discussing it at depth, when they care about it.
  - vinnyvichy 2y ago
    [flagged]
- barry-cotter 2y ago
  May you be treated as a free man and not the slave you wish others to be treated as.

Jake's wife on FDA deregulation https://bessstillman.substack.com/p/the-drugs-killing-dying-patients https://bessstillman.substack.com/p/the-drugs-killing-dying-...

blackeyeblitzar 2y ago

Thanks - it’s so helpful for them to have documented this for us to understand a very complex and opaque process. All while they were under extreme stress.

fatnoah 2y ago

I've experienced this from both sides. First with my father who was dying of cancer and was informed that while some promising treatments were in trials, he was not eligible. Balancing potential harm from unapproved drugs vs. certain death within 12 months feels like an easy task. On the other side, my wife worked for a mid-sized pharma in the past. After several rounds of trials that each cost tens of millions of dollars, the FDA couldn't be convinced to approve the drug, despite hearings full of people who were either alive because the drug saved their lives or were hoping to have it approved for future use. After a couple more trials, the company ended up cutting losses and moving on to something else. Again, it feels like there should be some pathway here. Such a drug shouldn't be the first option if others are available, but if there's nothing else or other treatments haven't worked, what's the real harm in letting someone who's going to die anyway give it a shot.

newzisforsukas 2y ago
What was the drug?
- fatnoah 2y ago
  TBH, I don't remember the name as it was one of those crazy generic beezelebubatab type of generic names.
llamaimperative 2y ago
Part of the harm is in people no longer trusting drugs. We're very fortunate to be able to get prescribed a drug and have certainty the risk-reward tradeoffs have been evaluated to extreme depth by experts far more equipped than we are.
- barry-cotter 2y ago
  You are past of the reason the world is a worse place than it could be. Without people like you defending excessive caution as good for the PR of drug regulatory agencies millions of people who are dead would be alive, possibly tens of millions.
  - llamaimperative 2y ago
    Okay buddy. How many drug development programs have you worked on?
  - vinnyvichy 2y ago
    [flagged]
- fatnoah 2y ago
  > Part of the harm is in people no longer trusting drugs. I'm not sure how trust would be eroded by the failure of an experimental drug to treat a terminal case where no other drugs are working.
deleted 2y ago
[deleted]

bena 2y ago

This is a complicated subject. Because those rules are in place for reasons. And some of those reasons are to prevent drug companies from turning the poor into lab rats with no regard to their safety. And I guarantee you, you let "terminal" patients skirt rules, there will be a hell of a lot more "terminal" patients. And I'm sure there are some non-regulation reasons to limit various therapies. They are trying to see if thing X can help. And if thing X only helps when combined with thing Y, you don't exactly get that information when focusing on thing X. Or the worse scenarios of thing Y making thing X ineffective or harmful. This was written from a very emotional place, and understandably so. But that state means they are not exactly in a position to consider all the reasons. And it must be frustrating as hell to have tried 40 things that didn't work to only be denied the 41st because you tried too many other things. Especially if that 41st thing turns out to be something that works. But I don't think the answer is let terminal patients take whatever they feel like.

Zak 2y ago
> But I don't think the answer is let terminal patients take whatever they feel like. I don't think anyone has the moral authority to tell anyone else what they can take, especially terminal patients. I do, however think governments have a responsibility to regulate how drug companies conduct trials so as to minimize harm to patients. This probably has the same outcome in practice, but I find the moral distinction important.
- somerandomqaguy 2y ago
  I don't think it's just that. Imagine the kind of money the more unscrupulous could make selling sugar pills for $100 each saying that it's the cure for whatever is killing you. Desperation can cloud even the most rational of minds.
  - Zak 2y ago
    People selling stuff are in the same category as the drug companies; I have no objection to regulating them, and imprisoning them for fraud, with an enhanced penalty for preying on particularly vulnerable people in the case you described.

throwaway5752 2y ago

May Jake rest in peace and may his memory be a blessing to his wife and daughter. Their views on clinical trials were understandable given the circumstances. Those regulations were written in blood, miscarriage/birth defects, autoimmune conditions, genetic damage, and other horrors. This is a complicated ethical topic because clinical trials can harm patients and families of patients as much as they can help, and sometimes many years after the fact of the trial. It's not an appropriate discussion in a memorial post.

blackeyeblitzar 2y ago
> It's not an appropriate discussion in a memorial post. When else do we discuss it? This is bound to just disappear into history and the government will carry on with business as usual. I feel now’s the time to get people educated and discussing it at depth, when they care about it.
- vinnyvichy 2y ago
  [flagged]
barry-cotter 2y ago
May you be treated as a free man and not the slave you wish others to be treated as.