Irving Kirsch, PhD from Harvard Medical School tells how antidepressants get approved by the FDA and why it is a flawed system.
Only Two Positive Drugs Studies Needed for Approval, While Negative Trials Ignored
He notes that drug companies only have to provide two studies showing positive results to get a drug approved regardless of how many trials failed to show any benefit.
“The FDA requires two adequately conducted clinical trials showing a significant difference between drug and placebo,” Kirsch writes.
“But there is a loophole: There is no limit to the number of trials that can be conducted in search of these two significant trials.
“Trials showing negative results simply do not count.
“Furthermore, the clinical significance of the findings is not considered.
“All that matters is that the results are statistically significant.”
© Copyright 2003-2021 - Larry Hobbs - All Rights Reserved.