A new study suggests that published FDA reports of scientific findings often don’t note instances of research misconduct and violations.
New York University professor Charles Seife and his students went through a significant number of documents and data from 1998 to 2013 and identified 57 clinical trials that received an “official action indicated” violation from the administration. This violation, according to Reuters, is the most serious type for trials. Reasons for the violations included false information, poor record-keeping and poor patient safety. Only three of the 78 reports analyzed noted the violations.
One report that was analyzed by Seife stated that all patients from a trial reported improvement, when in fact one participant had to undergo a foot amputation two weeks after receiving the treatment. Another case saw the FDA deeming an entire clinical trial unreliable, though the published report made no mention of that.
“These are major things,” Seife said. “No one really knows unless you go through these documents that anyone is questioning the integrity of the trials.”
Seife said that leaving such important details out of reports is dangerous for many reasons – one being that doctors would want to know if the FDA discovered problems with data collected considering they’d be using that data to decide on medication for patients. It also affects medical journals whose credibility could be undermined if they publish false information.
“This study highlights some disturbing examples where articles were published and information was lacking and this would be a concern to readers,” Dr. Robert Steinbrook, an editor at large at JAMA Internal Medicine, said. “What this does is call attention to a communication issue.”
The FDA responded to the study, maintaining its commitment to transparency despite the evidence against them.
The administration said it is “committed to increasing the transparency of compliance and enforcement activities with the goal of enhancing the public’s understanding of the FDA’s decisions, promoting the accountability of the FDA, and fostering an understanding among regulated industry about the need for consistently safe and high-quality products.”
Seife said that while the FDA has seemingly made more of an effort to become transparent with its reports, there is much more to be done.
“I’m not sure you’ll ever get traction until there’s some incentive behind it,” he said.
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