A Florida doctor has pleaded guilty to falsifying clinical trial data for an asthma medication that was being studied in young children, the U.S. Department of Justice announced.
Yvelice Villaman-Bencosme, MD, admitted that, from 2013 to 2016, she participated in a scheme to defraud the pharmaceutical company behind the drug by fabricating data and participation in the clinical trial. The trial, conducted at Unlimited Medical Research in Miami, was meant to study the safety and efficacy of an asthma medication in children ages 4 to 11.
Villaman-Bencosme, who served as the primary investigator for clinical trials at Unlimited Medical Research, admitted that she falsified medical records to make it appear pediatric patients had arrived for scheduled visits, taken the study drugs as required, and received checks as payment for visits.
Last November, another employee of the clinic also pleaded guilty to falsifying data for the same trial. Lisett Raventos was the site director, director of clinical operations, and a study coordinator at Unlimited Medical Research. Two other defendants were also charged in the scheme.
Villaman-Bencosme and Raventos each face a maximum sentence of 20 years in prison. Villaman-Bencosme will also pay a forfeiture judgment of $174,000, according to her plea agreement with the Justice Department, the Miami Herald reported.
Fabricating clinical trial data endangers consumers, acting assistant attorney general Jeffrey Bossert Clark of the Justice Department’s civil division, said in a statement. It also erodes the public’s trust in the drug-approval process, said U.S. attorney Ariana Fajardo Orshan for the southern district of Florida.
Special-agent-in-charge Justin Fielder, of the FDA’s office of criminal investigations, added that compromised data can have a deleterious impact on the agency’s decisions about the safety and efficacy of medications.
It’s certainly not the first conviction for faking clinical trial data. Last October, Sami Anwar, a business owner in Richland, Washington, was sentenced to 28 years in prison, and was ordered to pay $1.9 million in restitution and forfeit $5.6 million as proceeds of clinical trial fraud, the DOJ previously announced.
Anwar pocketed millions of dollars from pharmaceutical companies while dumping medications he claimed to be testing, and for fabricating data for a number of studies, the Tri-City Herald reported. Hundreds of trial participants were affected, including several who suffered serious medical complications and another who died.