[gumby]

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 Dermatology division, due to the kinds of indications they deal with).

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.

[lkey]

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 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.

[gumby]

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 (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.

[jmgrosen]

The second page starts the "FULL PRESCRIBING INFORMATION"; the body weight quote above comes from section 12.3 of it and there is no mention of a weight exclusion in the discussion of the clinical studies in section 14. AFAIK, "label" typically refers to this sort of ~20 page prescribing information, but is there a different label you have in mind? I believe the one-page package insert is the last page, page 17.

[lkey]

Am I losing my gdmn mind here? You say look at the label not the insert, the FDA will have it. I link you to the FDA's label. The link literally had the word 'label' in it drugsatfda_docs >>> label <<<

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'?

[ada1981]

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.

[gumby]

That's a reasonable concern. All I can say is that I left that field for a reason (well reasons) and have some serious concern about some ethical issues and attempts at gaming the system.

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.

[jahewson]

Oh the irony that you’ve excluded an investigation of the relevant example here, but made broad claims nonetheless.

[gumby]

My note was clear that the package insert is insufficient for prescribing. It is explicitly marked so -- see a comment I wrote to another reply to my GP comment.

[throwanem]

Totally unrelated, but just briefly to say, thanks for your work with Cygnus.

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