(Reuters Health)—A new study shows how fake news—specifically, information about scientific research that may be tainted by fraud—keeps getting spread through the medical literature, misleading doctors about the safety and effectiveness of the drugs they prescribe.
At issue is the failure of medical journals to flag research that’s been identified by the U.S. Food and Drug Administration (FDA) as potentially fraudulent, a task made difficult by the FDA itself.
The error is compounded when such studies are combined into so-called meta-analyses that perpetuate the error or fraud, according to a new analysis released March 4 online in JAMA Internal Medicine.1
It found that if studies with falsified data had been excluded, some of those meta-analyses would have painted a very different picture for one drug — the $1.6 billion-a-year clot-preventing medicine apixaban, which is sold by Pfizer and Bristol-Myers Squibb Co under the brand name Eliquis.
In nearly half the cases, if the flawed studies had been ignored, the conclusions of the meta-analyses would have changed and one third of them would have concluded that the drug didn’t work better than an older drug or a placebo.
“For the changes we saw, you would either see that the (benefit of the) product was no longer statistically significant or the odds went from showing a protective effect to a harmful effect,” chief author Craig Garmendia, PhD, of Florida International University tells Reuters Health in a telephone interview.
The analysis expands on a 2015 analysis by Charles Seife of New York University, also published in JAMA Internal Medicine, which concluded that FDA information about suspected fraud seldom makes its way into the medical journals that publish the results.
The new report “shows how a tainted study can affect the literature downstream, and that’s significant because these are things physicians base their guidelines on,” Mr. Seife says in a phone interview with Reuters Health. He was not involved in the new study.
“It demonstrates another consequence of the failure to alert the medical community and the public to research misconduct,” Robert Steinbrook, MD, an editor at large at JAMA Internal Medicine, tells Reuters Health by email.
Dr. Garmendia and colleagues focused on a series of clinical trials of Eliquis known as ARISTOTLE, which produced the largest number of studies with falsified data identified by Mr. Seife. The FDA found evidence that patient records at one treatment site in China were altered.
Nonetheless, the falsified data were included in seven apixaban studies, according to the 2015 report. The researchers doing those studies “published the same stuff over and over again without acknowledging there was a problem,” says Mr. Seife.