Nobody knows why ultra-processed foods are bad for you

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.

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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.

[ Parent | on HN ]