madinamerica
Till Bruckner, PhD
March 29, 2018
[excerpt]
https://www.madinamerica.com/2018/03/nimh-violates-law-clinical-trial-results/The National Institute of Mental Health (NIMH) has violated a key U.S. transparency law aimed at curbing research waste and evidence distortion in medicine on numerous occasions, data compiled by STAT News shows. In total, NIMH failed to post the results of 11 of 24 trials covered by the law onto the publicly managed trial registry Clinicaltrials.gov within the twelve month deadline stipulated by the law. Three of those clinical trials remain without results on the registry to this day.
Congress passed the FDA Amendment Act in 2007 to ensure that the results of clinical trials are made public irrespective of whether their outcomes are positive or negative. It was hoped at the time that the new law would counter widespread reporting bias and evidence distortion in medical research, and restore some balance to a medical literature that has repeatedly been shown to systematically overstate the efficacy of drugs and underreport their harms. However, over ten years on, the law remains unenforced; not a single fine has been imposed.
Among those routinely violating the law are U.S. government institutions, among them the NIMH. Not a single major institution has a track record of full compliance. In total, out of 1,286 taxpayer-funded clinical trials, 923 violated the transparency law by posting results late or not at all. Out of those, 163 are still missing results on the registry.
