On January 8, 2021, the Department of Justice announced that a Miami, Florida pediatrician pleaded guilty to one count of wire fraud in connection with a clinical research study of an asthma medication for children. Dr. Yvelice Villaman Bencosme admitted that between approximately 2013 and 2016, she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating data and participation of clinical trial subjects in connection with a study to investigate the safety and efficacy of an asthma medicine for children, between the ages of 4 and 11. Dr. Bencosme admitted that she falsified medical records to make it appear that the pediatric subjects came for scheduled visits, took study drugs as required by the trial and received payments for the visits. Dr. Bencosme was the principal investigator for the clinical trial at issue.
In addition to Dr. Bencosme’s guilty plea, a former study coordinator at the same medical clinic where Dr. Bencosme worked also pleaded guilty to a conspiracy charge in late 2020, and two other individuals have also been charged in connection with the fraud scheme and are awaiting trial.
This case is troubling not only because of the monetary fraud aspect but also because of the potential harm that could have come from reliance on the fraudulent study data.