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To improve medical trials, justify exclusion criteria

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Re: To improve medical trials, justify exclusion criteria

#31

Post by throwanem »

gumby wrote: post #24
jahewson wrote: post #15

Earlier quoted context omitted.

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

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.

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

Re: To improve medical trials, justify exclusion criteria

#32

Post by puffoflogic »

EEBio wrote: post #29
puffoflogic wrote: post #26

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.

How is that questionable? Isolating to one relevant treatment per group is a standard procedure.

It gives study staff the ability to exclude arbitrary sick patients from the trial. Combine this with a little harmless unblinding and the whole study outcome can be fabricated with plausible deniability.

Notice that I'm referring exclusively to studies of prophylactics. The patient getting sick is the data point.

Re: To improve medical trials, justify exclusion criteria

#33

Post by chmod775 »

meowface wrote: post #2

>These unjustified exclusions can have real clinical implications, too. For example, most asthma studies exclude morbidly obese people, as morbidly obese asthma is notoriously resistant to treatment and there aren’t good explanations as to why. However, once asthma drugs are approved, they’re approved for all asthmatics equally. As a result, morbidly obese people get prescribed asthma drugs that were never tested on…

I feel like I have to play devil's advocate here a bit.

Obesity is an easily treatable condition. One might try to treat them in order: Obesity first, then the asthma. That would justify excluding that particular complication from the study.

Re: To improve medical trials, justify exclusion criteria

#34

Post by AlchemistCamp »

chmod775 wrote: post #33
meowface wrote: post #2

>These unjustified exclusions can have real clinical implications, too. For example, most asthma studies exclude morbidly obese people, as morbidly obese asthma is notoriously resistant to treatment and there aren’t good explanations as to why. However, once asthma drugs are approved, they’re approved for all asthmatics equally. As a result, morbidly obese people get prescribed asthma drugs that were never tested on…

I feel like I have to play devil's advocate here a bit. Obesity is an easily treatable condition. One might try to treat them in order: Obesity first, then the asthma. That would justify excluding that particular complication from the study.

> Obesity is an easily treatable condition.

Is it? I thought long-term success rates were very low and that prevalence was increasing all over the globe.

Re: To improve medical trials, justify exclusion criteria

#35

Post by bryan_w »

AlchemistCamp wrote: post #34
chmod775 wrote: post #33

Earlier quoted context omitted.

I feel like I have to play devil's advocate here a bit. Obesity is an easily treatable condition. One might try to treat them in order: Obesity first, then the asthma. That would justify excluding that particular complication from the study.

> Obesity is an easily treatable condition. Is it? I thought long-term success rates were very low and that prevalence was increasing all over the globe.

Also a person who has trouble breathing tends to not do significant exercise because they run out of breath too quickly.

Re: To improve medical trials, justify exclusion criteria

#36

Post by chmod775 »

AlchemistCamp wrote: post #34
chmod775 wrote: post #33

Earlier quoted context omitted.

I feel like I have to play devil's advocate here a bit. Obesity is an easily treatable condition. One might try to treat them in order: Obesity first, then the asthma. That would justify excluding that particular complication from the study.

> Obesity is an easily treatable condition. Is it? I thought long-term success rates were very low and that prevalence was increasing all over the globe.

prevalence != difficulty of treatment

people's unwillingness to cooperate != difficulty of treatment

Asthma also isn't the only condition that is hard to treat in morbidly obese people. For many conditions it will be too late to start paying attention to one's calorie intake, but asthma is one that is survivable in the meantime. Severe discomfort and possible death tends to be a good motivator.

Re: To improve medical trials, justify exclusion criteria

#37

Post by avgDev »

photochemsyn wrote: post #4

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…

I just want to add some anecdotal evidence and what my experience has been like with a popular antibiotic. Cipro has wrecked my connective tissue and nervous system. This family of drugs has been around for a long time. The side effects have been discussed in medical studies for years. The drug has a black box warning label. Yet it gets prescribed very often against the current FDA recommendation to only be used for life threating infections. I have talked to top physicians in the US and they literally just ignore the problem like it doesn't exist. I have connected with physicians, chemists and other people with PhDs from all over the world who suffered the same. A pharmacists I know was called crazy by her colleagues when she said what happened to her.

My primary physician has stopped prescribing the medication, I send pages of research to him, which he probably didn't have time to read but it validated what is going on with me. He was surprised I actually took the covid vaccine, as not only did cipro screw me up but the whole medical community also completely ignored me and kept asking about anxiety. When I clearly had mechanical issues with tendons. They ran a bunch of tests and told me I was healthy.

Recently, Dr. Stefan Piper released a book on FQAD (flouroquinolone associated disability) and discussed pathogenesis, possible causes and therapies he has been using on hundreds of patients by now. He is an actual MD. From his experience a subset of people who are diagnosed with fibro, cfs developed it after taking the an fq antibiotic. Currently, there is no way to test for it. However, Mayo clinic is doing a study right now, to see if flouroquinolones are causing damage to mitochondria.

Re: To improve medical trials, justify exclusion criteria

#38

Post by TYPE_FASTER »

> Why no smoking?

Smoking can be an appetite suppressant: https://www.npr.org/2011/06/09/137085989/the-skinny-on-smoki...

> Why no diabetes, given that this is an overweight subject group?

Given the goal of intermittent fasting is to get insulin levels low enough that your body burns fat instead of sugar, and based on this article at least IF requires closer monitoring of your diet, maybe they wanted to eliminate a variable/variables.

https://www.verywellhealth.com/diabetes-and-intermittent-fas...

Re: To improve medical trials, justify exclusion criteria

#40

Post by throwthere »

chmod775 wrote: post #36
AlchemistCamp wrote: post #34

Earlier quoted context omitted.

> Obesity is an easily treatable condition. Is it? I thought long-term success rates were very low and that prevalence was increasing all over the globe.

prevalence != difficulty of treatment people's unwillingness to cooperate != difficulty of treatment Asthma also isn't the only condition that is hard to treat in morbidly obese people. For many conditions it will be too late to start paying attention to one's calorie intake, but asthma is one that is survivable in the meantime. Severe discomfort and possible death tends to be a good motivator.

Researchers generally analyze intervention success by intention to treat.

If a treatment is telling people to "start paying attention to one's calorie intake," and that doesn't have the desired effect, whatever the reason, I think it's fair to say that intervention isn't useful.

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