02-10-2015, 11:22 PM
http://retractionwatch.com/2015/02/09/fd...new-study/
Quote:For decades, the U.S. FDA has uncovered misconduct in clinical trials but hidden it from the public, according to a new paper in JAMA Internal Medicine.
The study, by New York University journalism professor Charles Seife, looked at 78 publications resulting from trials where the FDA found serious misconduct, including “failure to protect the safety of patients” and data fakery. Only three of those publications mentioned the problems uncovered by the FDA. No retractions or errata were ever issued for any of them.
For example, in one of the three cases:Quote:…data from several patients were excluded from the efficacy analysis because “site monitoring raised questions in regard to certain data at 1 study site.”65(p431) The FDA documents64 allege that none of the individuals enrolled at 1 study site had met the inclusion criteria and that the responsible researcher had fabricated chest radiographs of participants and committed other forms of misconduct.

