February 09, 2015
When U.S. health regulators find serious problems with how medical researchers collect their data, the researchers’ final reports often don’t mention it, a new analysis suggests.
Out of 78 published papers reporting on clinical trials in which the U.S. Food and Drug Administration found very serious issues, only three mentioned any violations, the new report says.
“These are major things,” said Charles Seife, a journalism professor and the study’s author.
Using documents and data from 1998 to 2013, Seife and his students at New York University in New York City identified 57 clinical trials that received an “official action indicated” violation - the most serious type of violation for trials - for reasons including poor recordkeeping, false information and poor patient safety.
Among the 78 published analyses of data from these sanctioned trials, only three noted the violations, which included researchers falsifying the data and patients being included in the trial even though they weren't eligible for it.
The problems that weren't reported were sometimes egregious. One paper, for example, said all patients reported improvement, but in fact, the FDA found that one patient had a foot amputated two weeks after receiving the treatment.
In another case, the entire clinical trial was considered unreliable by the FDA - but the published paper didn't mention that.
In another, researchers falsified data, which led to one patient’s death.
Data on these violations are not readily available. So it's impossible to say how often tainted data are published and how often the violations are noted, Seife said.
“No one really knows unless you go through these documents that anyone is questioning the integrity of the trials,” he said.
Doctors, he added, would want to know if the FDA found serious problems with data collection, since they'll be using that data to decide which medication is best for their patients.
Similarly, he said, editors of medical journals should be concerned because the violations may undermine the credibility of the information they publish.
“This study highlights some disturbing examples where articles were published and information was lacking and this would be a concern to readers,” said Dr. Robert Steinbrook, an editor at large at JAMA Internal Medicine who co-authored an editorial published with Seife's report.
“What this does is call attention to a communication issue,” said Steinbrook, who is also affiliated with the Yale School of Medicine in New Haven, Connecticut.
While he said communication with the FDA improved on such issues, “our suggestion is to go further.”
For example, both his editorial and the study suggest that clinical trial inspection reports be attached to the U.S. government’s database at ClinicalTrials.gov.
In a statement to Reuters Health, the FDA 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 agrees that there's been movement toward more transparency, but he says there is still a lot to be done.
“I’m not sure you’ll ever get traction until there’s some incentive behind it,” he said.