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 comment is correct about morbid obesity exclusion, then you were the one spouting nonsense right? Doctors will definitely give this to patients regardless of weight with a note like that.
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.
Inside the document there are 3 things the 'HIGHLIGHTS OF PRESCRIBING INFORMATION', AND the 'FULL PRESCRIBING INFORMATION' AND finally 'PATIENT INFORMATION'
I cite the relevant information about weight from them 'FULL PRESCRIBING INFORMATION: CONTENTS: PART 12 CLINICAL PHARMACOLOGY and you act like I not you have performed some sort of bait and switch...
You are the one claiming expertise here, so enlighten me, where is the the carve out for "we didn't test this at all on the morbidly obese" in place a doctor will find it if not in 'FULL PRESCRIBING INFORMATION'?
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.
I doubt I'd have been able to build a career for myself in software engineering without Cygwin being available and lively back in the days when I was required to use Windows fulltime, and along with that I learned a lot from working with it that's been of great help to me ever since. And I'm to this day running Cygwin on the one Windows box I still maintain!
So, thanks for whatever hand you had in that. If you ever find yourself in Baltimore and thirsty, hit me up and I'll buy you that beer or other suitable beverage I owe you. :D
Second of all 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.
There have been some notorious cases, but by and large I’ve found the people I worked with at the agency to be professional and solid. I’m no longer in that business and have no reason to say anything I don’t believe.
* I didn’t bother to look up the label for this drug but they are all public info on the FDA web site and In the USP.