Dr. Evan Mayo-Wilson, an associate professor at the IU School of Public Health-Bloomington, has been awarded $146,087 by the Restoring Invisible and Abandoned Trials (RIAT) Initiative. Supported by the Laura and John Arnold Foundation, the RIAT Initiative focuses on the reanalysis and publication of clinical trial results that have not been reported completely or correctly.
RIAT is an international effort to tackle bias in the way research is reported with the goal of providing more accurate information to patients and other healthcare decision makers. Randomized controlled trials are known as medicine’s “gold standard” for reliable evidence. However, randomized controlled trials are falling short of that standard, in large part due to two fundamental problems: misreporting (many trials that are published are inaccurately or incompletely reported) and invisibility (not all trials conducted are published.)
In this study, Mayo-Wilson and colleagues will reexamine 6 trials of gabapentin. Gabapentin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of epilepsy; it was later approved for the pain condition “post herpetic neuralgia.” Today, doctors prescribe gabapentin widely for nerve pain, including problems for which it has not been approved by the FDA (called “off label” prescribing).
To promote the use of gabapentin for unapproved problems, the manufacturer published articles in medical journals. In those articles, the manufacturer cherry-picked the best results and did not report complete information about harms. Following multiple lawsuits, the manufacturer was fined by the U.S. Department of Justice and had to pay patients and providers who claimed that gabapentin was marketed illegally.
Mayo-Wilson and his team will reanalyze data from 6 trials and publish a full account of harms that were not reported previously in the medical literature.