15 ms·

Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.

by peytn 5y ago

eddynol 5y ago
Cuz it's a hard job. Try telling someone in a position of serious power who is going to loose his kid next year to back off. Who wants that job? Put your hand up.
- WarOnPrivacy 5y ago
  Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. I'll put my hand up to perform ethically at my job and not allow regulatory capture.
  - throwawaygh 5y ago
    > Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances. Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top). When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended. > I'll put my hand up to perform ethically at my job and not allow regulatory capture. But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
    - WarOnPrivacy 5y ago
      > But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off. It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
      - throwawaygh 5y ago
        Yes, he was giving yet another reason no one wants to do that particular job. I was given another. So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason). > It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment. But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say. And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say. Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
    - forcry 5y ago
      >Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear.. The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule. IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
- mperham 5y ago
  What's the alternative? Allow snakeoil? Now insurance has to cover it, incentivizing the creation of more ineffective drugs? Trust in efficacy is critical.
  - jcims 5y ago
    With cancer drugs at least, efficacy trials are regularly scoped to a fairly narrow portion of the patient population along things like the presence of specific mutations, whether those mutations are germline or somatic, previous treatment types administered and staging. Efficacy found for one combination of the above generally isn’t seen as transitive to the rest. The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.
pfisherman 5y ago
What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA. That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications. My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.
rgrieselhuber 5y ago
What does that mean for the Covid vaccines?
- WarOnPrivacy 5y ago
  Nothing, I believe. Every drug approval isn't suspect. Just the ones where pharma lobbyists get to spend the power they bought thru beefy campaign contributions. Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development. Good government and transparency tend to go together.
- seriousquestion 5y ago
  Maybe nothing, maybe a lot. Big pharma has huge influence in the government. The vaccines are authorized under emergency use, which is predicated on not having alternatives. That there is a campaign to discredit cheap off patent alternatives (Ivermectin) is at least concerning.
  - khuey 5y ago
    There's a "campaign to discredit cheap off patent alternatives" because they don't actually work and people are going out and poisoning themselves with pills made for horses.
    - seriousquestion 5y ago
      Taking a horse quantity of any drug is unwise, even one that won the 2015 Nobel Prize (Ivermectin). It still needs large scale RCTs for Covid-19 use, but there are some small trials that at least indicate it should be taken seriously and not outright discredited and smeared. "Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization." https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab358/6316214 https://academic.oup.com/ofid/advance-article/doi/10.1093/of... "Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low." https://www.sciencedirect.com/science/article/pii/S187140212100206X?via%3Dihub https://www.sciencedirect.com/science/article/pii/S187140212...
dang 5y ago
If you're going to make a comment like that it would be better to share some of the experiences—it would add substance, and be much more interesting.

Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.

by peytn 5y ago

Great. Speaking from first- and second-hand experience, the FDA is way more loosey-goosey than people think as long as you’re paying the right people.

eddynol 5y ago

Cuz it's a hard job. Try telling someone in a position of serious power who is going to loose his kid next year to back off. Who wants that job? Put your hand up.

WarOnPrivacy 5y ago
Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. I'll put my hand up to perform ethically at my job and not allow regulatory capture.
- throwawaygh 5y ago
  > Pharma lobbyists gained enough control over FDA oversight to get a failed Alzheimer's drug approved. We'll see. What's playing out now is exactly how robust institutions work. Individual components can be corrupted, but the institution has a whole holds because of checks and balances. Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear (namely, inclusion of Scientific Advisors in the review process, public records, and political accountability at the top). When an unconstitutional law is passed, it's law. Until a court strikes it down. If an unconstitutional law is passed and then struck down by a court, that's not the system failing. That's individuals within the institution failing but the institution as a whole working exactly as intended. > I'll put my hand up to perform ethically at my job and not allow regulatory capture. But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. Which, speaking as someone who has turned down similar types of government jobs because I could make 5x in the private sector, is quite a bit more of a sacrifice than I think you realize. (This isn't meant to excuse unethical behavior, btw, it's just that your comment is literally not responsive to GP's and GP is exactly right -- those jobs suck and if we want fewer failures like this one maybe we, the people, as the employer, should be at least paying market rate.)
  - WarOnPrivacy 5y ago
    > But that's not what he asked you to volunteer for. He didn't ask you to perform ethically at a job. He asked you to actually go get a PhD, do a post-doc or two, and then turn down well-paying industry jobs to work at the FDA and get demonized all day. That doesn't seem to be what he asked. He asked us to Try telling someone in a position of serious power who is going to loose his kid next year to back off. It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug, ostensibly in blatant and clear violation of their own protocols. Presented with that non-sequitur, I chose to restate the event in play.
    - throwawaygh 5y ago
      Yes, he was giving yet another reason no one wants to do that particular job. I was given another. So, it's a shitty job because people yell at you for <=$100K (his reason) and also you could be making $500+k elsewhere (my reason). > It isn't clear what losing a kid has to do with qualified officials approving a failed Alzheimer drug Your basic complaint is that those particular government workers were either corrupt or incompetent. I don't disagree with that assessment. But if you can't understand why people take industry jobs for $500K instead of government jobs for $100K, especially when the government job additionally requires "telling someone in a position of serious power who is going to loose his kid next year to back off", then I'm not really sure what to say. And if you can't understand how "the job is shit and doesn't pay well" has downstream effects like incompetence and corruption, then, well, I'm not really sure what to say. Most problems with failed governance in the USA basically boil down to "Want competence and ethics? Pay market rates & don't fucking outsource." See also: the Obamacare website debacle.
  - forcry 5y ago
    >Here, one individual component of the FDA was compromised, but other checks-and-balances are coming to bear.. The damning thing is the point it got up to, before the "checks and balances" came into play that we have to consider this as an exception rather than the rule. IMHO The scientific advisory resigning is itself the point where the failure of the process became apparent. Because, I am pretty sure "if you disagree then you should resign", is NOT part of the approval process. I mean, it is not within the framework that you are trying to portray as being robust.
mperham 5y ago
What's the alternative? Allow snakeoil? Now insurance has to cover it, incentivizing the creation of more ineffective drugs? Trust in efficacy is critical.
- jcims 5y ago
  With cancer drugs at least, efficacy trials are regularly scoped to a fairly narrow portion of the patient population along things like the presence of specific mutations, whether those mutations are germline or somatic, previous treatment types administered and staging. Efficacy found for one combination of the above generally isn’t seen as transitive to the rest. The solution now seems to be to simply not allow that medication to be used if the patient doesn’t match the parameters of the trial. Some portion of those people then die because the current ‘standard of care’ is the same toxic shit they have been pumping i to veins for the past 30 years to little or no effect.

pfisherman 5y ago

What experience have you had? How many INDs, 510ks, etc have you worked on? Because this does not line up with my experience at all. IME FDA is very anal about even the appearance of the conflict of interest, and loosey-goosey is the last descriptor you would ever want to use for any interaction with FDA. That being said, informal interactions where FDA talks you through regulatory options do happen for high priority / unmet need diseases, but there the “friendlies” are compartmentalized away from the those who review the applications. My guess is that the review will show that someone from FDA met with the company to facilitate the application because Alzheimer’s is a priority disease, but strict compartmentalization from the review process was maintained. If not, then someone is getting fired.

rgrieselhuber 5y ago

What does that mean for the Covid vaccines?

WarOnPrivacy 5y ago
Nothing, I believe. Every drug approval isn't suspect. Just the ones where pharma lobbyists get to spend the power they bought thru beefy campaign contributions. Also - Covid vaccines were under intense public and medical scrutiny, during every bit of their development. Good government and transparency tend to go together.
seriousquestion 5y ago
Maybe nothing, maybe a lot. Big pharma has huge influence in the government. The vaccines are authorized under emergency use, which is predicated on not having alternatives. That there is a campaign to discredit cheap off patent alternatives (Ivermectin) is at least concerning.
- khuey 5y ago
  There's a "campaign to discredit cheap off patent alternatives" because they don't actually work and people are going out and poisoning themselves with pills made for horses.
  - seriousquestion 5y ago
    Taking a horse quantity of any drug is unwise, even one that won the 2015 Nobel Prize (Ivermectin). It still needs large scale RCTs for Covid-19 use, but there are some small trials that at least indicate it should be taken seriously and not outright discredited and smeared. "Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection" - "there was a 56% reduction in mortality; p=0.004 .. with favorable clinical recovery and reduced hospitalization." https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab358/6316214 https://academic.oup.com/ofid/advance-article/doi/10.1093/of... "Ivermectin was associated with decreased mortality in patients with COVID-19... The certainty of evidence for mortality reduction was low." https://www.sciencedirect.com/science/article/pii/S187140212100206X?via%3Dihub https://www.sciencedirect.com/science/article/pii/S187140212...

dang 5y ago

If you're going to make a comment like that it would be better to share some of the experiences—it would add substance, and be much more interesting.