21–30 of 55 posts
Based on the record of the pharmaceutical industry and their entirely captured regulatory agency, the FDA, it's not entirely unwise to wait about ten years after the introduction of a 'breakthrough drug' to see if it actually has negative side effects that were not discovered in the clinical trials. See Vioxx, etc. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534432/ > "Dr Graham, associate director in the FDA's Offi…
Based on the record of the pharmaceutical industry and their entirely captured regulatory agency, the FDA, it's not entirely unwise to wait about ten years after the introduction of a 'breakthrough drug' to see if it actually has negative side effects that were not discovered in the clinical trials. See Vioxx, etc. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534432/ > "Dr Graham, associate director in the FDA's Offi…
You may not have 10 years to wait if you're dying of some disease.
And probably for good reason? I really don't want to live in a society that gives people the ability to sign their life away so corporations can run scientific experiments on them that have a real chance of death.
I think there are some exceptions to this, but generally it makes sense to not let people go from "dying of a disease" to, "dying of a drug".
Earlier quoted context omitted.
As someone who has both designed and run clinical trials as my job, this assertion is likely* nonsense. First, the division you submit to will reject your recruitment criteria if they feel it does not accurately reflect the treatment population within the United States. They also reflect the specialty of the particular division (e.g. Oncology is allegedly far less worried about most side effects than, say, the Dermat…
Why on Earth did you not bother to look it up before asserting your opinion...? https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76... Body Weight Based on population pharmacokinetic analysis, higher body weight was associated with lower exposure. However, the effect of body weight on exposure had no meaningful impact on efficacy or safety and does not require dose adjustment. Assuming that grandparent comme…
You have linked to the the package insert, not the label, and it clearly states at the very top
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TEZSPIRE safely and effectively. See full prescribing information for
TEZSPIRE.
> ... this kind of info is on the label (prescribing information) even if it doesn’t make it into the short summary (package insert, typically only a dozen pages or so) given to patients. Doctors do read those, you know, and within their specialities know what kinds of things to look for.
You are simply quoting the short summary and drawing a conclusion based on the limited information that appears on it. Perhaps the author of the blog post made the same error. The doctor reads the actual prescribing information and the evaluation population must be specified there.
Earlier quoted context omitted.
As someone who has both designed and run clinical trials as my job, this assertion is likely* nonsense. First, the division you submit to will reject your recruitment criteria if they feel it does not accurately reflect the treatment population within the United States. They also reflect the specialty of the particular division (e.g. Oncology is allegedly far less worried about most side effects than, say, the Dermat…
Oh the irony that you’ve excluded an investigation of the relevant example here, but made broad claims nonetheless.
Earlier quoted context omitted.
As someone who has both designed and run clinical trials as my job, this assertion is likely* nonsense. First, the division you submit to will reject your recruitment criteria if they feel it does not accurately reflect the treatment population within the United States. They also reflect the specialty of the particular division (e.g. Oncology is allegedly far less worried about most side effects than, say, the Dermat…
While you may not have financial incentives, the psychological incentives are often very strong to maintain a positive idea of an industry one was a part of.
However by and large my concerns aren't around science (though there are exceptions, cough alzheimers), they are mostly around the marketing, pricing manipulation with regards to medicare (ever wonder why drug companies give everyone coupons?) etc. The FDA has very little to do with some of these issues and none with others (e.g. scamming the taxpayer)
In general I don't think pharma execs are necessarily nice people (though some are!) but most are not evil like the Sacklers.
Earlier quoted context omitted.
Why on Earth did you not bother to look it up before asserting your opinion...? https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76... Body Weight Based on population pharmacokinetic analysis, higher body weight was associated with lower exposure. However, the effect of body weight on exposure had no meaningful impact on efficacy or safety and does not require dose adjustment. Assuming that grandparent comme…
Both my note and the download you discuss are clear about this. You have linked to the the package insert, not the label, and it clearly states at the very top HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEZSPIRE safely and effectively. See full prescribing information for TEZSPIRE. As I wrote in my comment: > ... this kind of info is on the label (prescribi…
Earlier quoted context omitted.
I believe the FDA relies on the "maximum expected utility principle" - a cornerstone of free-market economic theory. > "By combining the concept of utility with the notion of rational decision making, economists in the mid-twentieth century established a basis for the maximum expected utility principle. This principle is a key concept behind the creation of autonomous decision-making agents." https://algorithmsbook.c…
> I believe the FDA relies on the "maximum expected utility principle" - a cornerstone of free-market economic theory. This has nothing to do with 'free-market economic theory'. It's about decision under uncertainty. The concept was expressed for the first time by Von Neumann and Morgenstern in a book that was supposed to explain how to play poker. > "Each portion of wealth has a corresponding portion of happiness, a…
Nor have I. It's such a remarkably stupid statement that it strikes me as stupid in itself to think anyone should be so stupid as to believe it.
It's also nothing whatsoever to do with expected utility theory (I don't know where they did get it from). 'Utility monsters' - per Rawls - are a valid objection; 'money monsters' are not, for the very reason that marginal economic gain is not equivalent to marginal gain in happiness/utility, nor would anyone think it is.
Other questionable exclusion criteria: removing patients from trials of a prophylactic drug if they are seen by medical staff outside the trial for any reason, especially for the condition being studied.
Earlier quoted context omitted.
Why on Earth did you not bother to look it up before asserting your opinion...? https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76... Body Weight Based on population pharmacokinetic analysis, higher body weight was associated with lower exposure. However, the effect of body weight on exposure had no meaningful impact on efficacy or safety and does not require dose adjustment. Assuming that grandparent comme…
Both my note and the download you discuss are clear about this. You have linked to the the package insert, not the label, and it clearly states at the very top HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEZSPIRE safely and effectively. See full prescribing information for TEZSPIRE. As I wrote in my comment: > ... this kind of info is on the label (prescribi…