According to a study, the U.S. Food and Drug Administration is able to identify problems in clinical trials during its investigations but seldom report on these findings, allowing fraudulent research to make their way into peer-reviewed literature.
Published in the journal JAMA Internal Medicine, the study was carried out by an investigative reporting class in the Arthur L. Carter Journalism Institute in the New York University taught by Professor Charles Seife, the author of the study. Students in the Science, Health and Environmental Reporting program participated by matching inspections done by the FDA with peer-reviewed articles.
"Since the FDA's evidence of misconduct -- even of fraud -- seldom makes its way into the peer-reviewed literature, researchers and doctors are unaware that they're making life-and-death decisions based upon experiments whose reliability has been called into question," explained Seife.
FDA inspections are classified depending on the severity of violations discovered. The most severe is known as "official action indicated," referring to objectionable practices or conditions that merit regulatory action. For the 2013 fiscal year, the FDA carried out 644 inspections and around 2 percent of these were classified to be OAI.
Seife and the rest of his class identified clinical trials that have been published despite significant problems found during an FDA inspection, determining if there was mention of the problems or not in the literature.
According to their findings, 57 clinical trials were published despite problems arising during an inspection by the FDA. Some of the problems about the published clinical trials include: falsified information; faulty reporting of adverse events; protocol violations; and inaccurate recordkeeping; oversight involving patient safety.
Only 4 percent of publications mentioned the violations recorded in FDA inspections mainly because the agency does not make the effort to tell journals that a clinical trial has been given an OAI during inspection nor is there a general announcement informing the public of the misconduct revealed in a certain study.
"The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA's allegations of research misconduct," concluded Seife.
To better serve the interests of the public, the FDA should make information about its inspections more freely available, ensuring readers and editors of scientific literature have substantial access to evidence of misconduct. Seife suggests that any OAI classification should be immediately tagged in the national clinical trials database.
