Re:Nobody knows why ultra-processed foods are bad for you
by dekhn on Tuesday November 26, 2024 @07:23PM
(#42251605)
You should try reading the FDA approval for the drug; it was already approved before these publications (which aren't so much clinical trials as just medical research). The FDA approval has a whole paragraph about how the effect size was too small to demonstrate statistical significance, and the trials had n=300.
It's also indicated for use in a disease we don't understand, for people who didn't respond to all the previously approved drugs. Not a good example at all.
Re:Nobody knows why ultra-processed foods are bad for you
by atombender on Tuesday November 26, 2024 @07:29PM
(#42251648)
I'm not comparing these to the FDA approvals process, but to your claim that trials use thousands of patients. These three studies are ascertaining the pregnancy safety of a drug, irrespective of whether we understand the disease or what the response rate is.
Cimzia has been well-studied, and we understand why it works on autoimmune diseases like inflammatory arthritis. It has 6 FDA approvals for different indications, so your description of the drug itself is incorrect.
https://pubmed.ncbi.nlm.nih.gov/29030361/ (N=16)
https://pubmed.ncbi.nlm.nih.gov/28814432/ (N=17)
https://ard.bmj.com/content/83/Suppl_1/1145.2 (N=21)
Of course, these are not nutritional studies.