The US Food and Drug Administration frequently uncovers evidence of corruption and improper conduct in drug trials, but those improprieties are almost never mentioned in the medical journals that subsequently publish the findings of those same studies, according to research in JAMA Internal Medicine.
The study was conducted by Charles Seife of the Arthur L. Carter Institute of Journalism at New York University, who has also written an article for Slate about his study of documents between 1998 and 2013 “describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found.”
“Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems,” wrote Seife. “Falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%).”
Nevertheless, Seife found, “Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.”
Seife blamed the FDA. “When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted,” wrote Seife in Slate. “On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.”
JAMA Internal Medicine also has an audio interview with Seife.
Seife, Charles. “Research Misconduct Identified by the US Food and Drug AdministrationOut of Sight, Out of Mind, Out of the Peer-Reviewed Literature.” JAMA Intern Med. Published online February 09, 2015. doi:10.1001/jamainternmed.2014.7774. (Abstract and full text)
Are Your Medications Safe? (Slate, February 9, 2015)