Only 3 of nearly 80 published studies mentioned issues of concern uncovered by FDA
WebMD News from HealthDay
By Dennis Thompson
HealthDay Reporter
MONDAY, Feb. 9, 2015 (HealthDay News) -- Medical journals and the U.S. Food and Drug Administration rarely report violations of scientific conduct that federal regulators unearth during spot inspections of clinical trials, a new analysis shows.
In a study published in the Feb. 10 issue of JAMA Internal Medicine, a review of FDA inspection reports between 1998 and 2013 revealed nearly 60 clinical trials in which regulators had uncovered violations serious enough to earn the agency's most severe classification -- "official action indicated," or OAI, said study author Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University.
Seventy-eight articles were published based on data from these trials. But only three of them mentioned the violations that regulators found, Seife and a team of graduate students determined. The violations included fraud, incompetence or misconduct.
"Your physician makes decisions based upon what he knows from the peer-reviewed literature," Seife said. "If that literature is tainted in some way without the physician knowing, then the physician is making treatment decisions based upon bad data."
The good news is that such violations are rare, according to Seife. During the 2013 fiscal year, about 2 percent of the nearly 650 inspections the FDA carried out at clinical trial sites were classified as OAI, according to background information in the study.
But when these violations are uncovered, they can be serious enough to undermine the findings reported from the clinical trial:
- A patient in a trial had a foot amputated two weeks after receiving stem cells to treat poor blood flow in a leg. Despite this, the article from the stem cell trial claimed that all of the patients reported improvement in their limbs.
- The FDA deemed an entire trial devoted to the blood-thinning drug rivaroxaban unreliable, due to systematic and widespread scientific fraud. Despite this, the findings from the trial were published in a journal with no mention of the FDA's condemnation.
- A patient died in a chemotherapy trial due to a researcher's falsification of documents, and the researcher ended up in prison after pleading guilty to fraud and criminally negligent homicide. None of the articles published from this clinical trial mention either the fraud or the subsequent homicide case.
source : Problems Spotted in Clinical Trials Can Go Unreported, Study Says
