MSB to dispute FDA finding in Type A meeting, page-481

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601706/#:~:text=The%20guidelines%20state%2C%20%E2%80%9CPlacebos%20may,the%20subjects%20must%20be%20fully

"SUMMARY

There are valid scientific and ethical considerations for using a control group in a clinical trial. Placebo-controlled trials are justifiable when they are supported by sound methodologic consideration and when their use does not expose research participants to excessive risk of harm. Consideration should be given to the ‘best-available therapy’ control groups in the evaluation of a new therapy or intervention over an existing therapy. Investigators should bear in mind that one should not sacrifice the scientific merit of a trial to include the best-available therapy control group as long as the placebo control group poses little harm to the participants and, importantly, the trial offers potential benefit to the subjects."

This sort of throws shade on the FDA's position. Hoisted by their own petard?



Also, withstanding the 'Placebo effect' (?), am I the only one here thinking this whole placebo thing is hogwash?

Placebos are inert - they are nothing in the form of 'maybe something'?

So giving placebos is the same as giving nothing, therefore how doesn't the deaths of all the kids prior to the trial act as the placebo? The placebo before the trial was a 'placebo' treatment in the form of steroids'. Technically, the kids would of gained the phycological 'effect' from the ineffectual treatment and 80% of them died.

Science gone mad! In generations to come they will look back at this time and consider placebo another flat earth moment. Or flat earth will be called a placebo moment.