One of the most important responsibilities of the Food and Drug Administration (FDA) in protecting public health is to conduct regular inspections of clinical trial sites to ensure that good clinical practices are being followed. But a recent study published in the peer-reviewed journal JAMA Internal Medicine has found that nearly half of all clinical trials are based on false information, and the FDA typically does nothing to address this widespread problem.
Charles Seife, M.S., from the Institute of Journalism at New York University conducted a cross-sectional analysis of publicly available documents that describe FDA inspections of clinical trial sites where significant evidence of objectionable conditions or practices was found. Narrowing down the pool to only those documents that contained enough information to fully identify the violations described, Seife came up with 57 trials for which evidence of “significant departures” was abundant.
These significant departures included underreporting of adverse events, violations of protocol, violations of recruitment guidelines and various other forms of scientific misconduct. And based on these criteria, a shocking 22 trials, or nearly 40% of those sampled, were verified to contain data that the FDA had determined to be falsified.
Among all the 57 trials for which FDA inspections had uncovered evidence of foul play: 14 (25%) were cited for problems with adverse events reporting; 42 (74%) for failure to follow the investigational plan or other violations in protocol; 35 (61%) for inadequate or inaccurate record keeping; 30 (53%) for failure to protect the safety, rights and welfare of patients, or issues with informed consent or institutional review board oversight; and 20 (35%) for violations not otherwise categorized.
“Examples of uncategorized violations include cases in which the investigators used experimental compounds in patients not enrolled in trials, delegated tasks to unauthorized personnel, or otherwise failed to supervise clinical investigations properly,” explains the study, the full text of which is available here:
FDA deliberately redacts clinical trial fraud to protect drug, vaccine industries from scrutiny
Among the dozens upon dozens of studies identified by Seife as having been tagged as fraudulent in some way by the FDA, only three of them actually indicated this in their final publication. The rest published their findings, which may or may not be accurate, as is, suggesting that a sizably large cohort of published “science” may actually be science-in-presentation-only.