3 ms·

On the other hand, if you test the same hypothesis again and again and again, and don't finish up a trial and use interim data readouts to inform decisions, the

On the other hand, if you test the same hypothesis again and again and again, and don't finish up a trial and use interim data readouts to inform decisions, then after enough time, by pure chance, you'll apparently be able to pull an effect size out of the air and convince wall street and apparently even maybe regulators that your drug now works! I really hope the FDA tells biogen to take a hike. The last thing people need is false hope, and the last thing we need as a society is to be spending billions of dollars on an alzheimers drug that doesn't work. For something that important (and that profitable), the least biogen could have done is run that trial through the end.

hprotagonist 7y ago
From a previous post by the blogger on a separate drug washing out: And I think I’ll add this every time we have a big drug trial wipe out: keep in mind, that under a safety-only regulatory regime, that people would have been taking this drug (and paying for it, one way or another) for the last few years now, and it would have done them no good at all. When they could have been actually taking something that might help them. We do not know enough about investigational drugs to approve them without efficacy data.
- vikramkr 7y ago
  And the great thing about safety-and-efficacy regimes is that until you get a drug to work, the market can't be filled. If the FDA makes exceptions for biogen, then the alzheimers market for new drugs shrinks, disincentivizing research into drugs that will actually work. Why invest billions to make drugs that work if you can make that same money by pumping trash into the market?
  - hprotagonist 7y ago
    There's a post for that one, too :) https://blogs.sciencemag.org/pipeline/archives/2018/05/25/federal-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/05/25/fe... and https://blogs.sciencemag.org/pipeline/archives/2018/06/21/welcome-to-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we..., which concludes: the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
    - vikramkr 7y ago
      It's unfortunate that in this legal situation the most it seems regulators can do is avoid giving snake oil regulatory legitimacy and hope that people are dissuaded by "these statements have not been evaluated by the fda, and XYS is not approved to diagnose or treat any disease." At the very least though, it would be nice if the FDA didn't then turn around and give legitimacy to fancier snake oil - hopefully they do the right thing with biogen haha.
      - hprotagonist 7y ago
        You can thank orrin hatch for the total unregulation of the suppliments racket. Or curse him, which is probably the better course of action. https://blogs.sciencemag.org/pipeline/archives/2019/02/12/the-fda-and-the-dietary-supplements https://blogs.sciencemag.org/pipeline/archives/2019/02/12/th... for actual drugs, the FDA can and does show up at your plant unannounced with guns for two weeks for an unannounced audit more or less whenever they want. I await the day they can drop the hammer on the woo-aisle at whole foods with very poorly concealed anticipatory shadenfraude. Right now the best they can do is to sue POM Wonderful and the like : https://www.forbes.com/sites/chloesorvino/2016/05/02/the-verdict-pom-wonderful-misled-its-customers-a-blow-to-its-billionaire-owners/ https://www.forbes.com/sites/chloesorvino/2016/05/02/the-ver...
        vikramkr 7y ago
        I wonder if going after Purell is a way to start testing the extent of their power? https://www.nytimes.com/2020/01/28/health/purell-fda-ebola-virus.html https://www.nytimes.com/2020/01/28/health/purell-fda-ebola-v...

hprotagonist 7y ago

From a previous post by the blogger on a separate drug washing out: And I think I’ll add this every time we have a big drug trial wipe out: keep in mind, that under a safety-only regulatory regime, that people would have been taking this drug (and paying for it, one way or another) for the last few years now, and it would have done them no good at all. When they could have been actually taking something that might help them. We do not know enough about investigational drugs to approve them without efficacy data.

vikramkr 7y ago
And the great thing about safety-and-efficacy regimes is that until you get a drug to work, the market can't be filled. If the FDA makes exceptions for biogen, then the alzheimers market for new drugs shrinks, disincentivizing research into drugs that will actually work. Why invest billions to make drugs that work if you can make that same money by pumping trash into the market?
- hprotagonist 7y ago
  There's a post for that one, too :) https://blogs.sciencemag.org/pipeline/archives/2018/05/25/federal-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/05/25/fe... and https://blogs.sciencemag.org/pipeline/archives/2018/06/21/welcome-to-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we..., which concludes: the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
  - vikramkr 7y ago
    It's unfortunate that in this legal situation the most it seems regulators can do is avoid giving snake oil regulatory legitimacy and hope that people are dissuaded by "these statements have not been evaluated by the fda, and XYS is not approved to diagnose or treat any disease." At the very least though, it would be nice if the FDA didn't then turn around and give legitimacy to fancier snake oil - hopefully they do the right thing with biogen haha.
    - hprotagonist 7y ago
      You can thank orrin hatch for the total unregulation of the suppliments racket. Or curse him, which is probably the better course of action. https://blogs.sciencemag.org/pipeline/archives/2019/02/12/the-fda-and-the-dietary-supplements https://blogs.sciencemag.org/pipeline/archives/2019/02/12/th... for actual drugs, the FDA can and does show up at your plant unannounced with guns for two weeks for an unannounced audit more or less whenever they want. I await the day they can drop the hammer on the woo-aisle at whole foods with very poorly concealed anticipatory shadenfraude. Right now the best they can do is to sue POM Wonderful and the like : https://www.forbes.com/sites/chloesorvino/2016/05/02/the-verdict-pom-wonderful-misled-its-customers-a-blow-to-its-billionaire-owners/ https://www.forbes.com/sites/chloesorvino/2016/05/02/the-ver...
      - vikramkr 7y ago
        I wonder if going after Purell is a way to start testing the extent of their power? https://www.nytimes.com/2020/01/28/health/purell-fda-ebola-virus.html https://www.nytimes.com/2020/01/28/health/purell-fda-ebola-v...