Medical Doctor and Study Coordinator Sentenced to Prison in Scheme to Falsify Clinical Trial Data
A Florida medical doctor was sentenced to 63 months in prison after pleading guilty to her role in a scheme to falsify clinical trial data regarding an asthma medication.
Dr. Yvelice Villaman Bencosme, 64, of Miami, previously pleaded guilty in U.S. District Court for the Southern District of Florida to one count of conspiracy to commit wire fraud related to her work at Unlimited Medical Research in Miami. Bencosme is the second defendant to be sentenced in connection with the scheme. On March 5, 2021, Lisett Raventos, 46, of Miami, was sentenced to 30 months in prison after also pleading guilty to conspiracy to commit wire fraud.
Bencosme was a licensed medical doctor who served as the primary investigator for clinical trials purportedly conducted at Unlimited Medical Research. Raventos was the site director, the director of clinical operations, and a study coordinator at the clinic. In pleading guilty, Bencosme and Raventos admitted that they participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at Unlimited Medical Research.
The clinical trial was designed to investigate the safety and efficacy of an asthma medication in children between the ages of four and 11. Bencosme and Raventos admitted that they falsified medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, took study drugs as required, and received checks as payment. In sentencing Raventos, U.S. District Judge Beth Bloom said that if the defendants’ actions had been left unchecked, the scheme “could have negatively impacted the treatment and well-being of children with asthma throughout the country.”
“Falsifying clinical trial data risks the health of those who might later rely on the drugs being tested,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Department of Justice will continue working with its partners at the Food and Drug Administration to investigate and prosecute anyone who endangers the public for personal gain.”
“Clinical trials are an essential part of the medical research process, as they ensure the effectiveness and safety to patients of new drugs,” said U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida. “Those who manipulate clinical data risk the public’s health and such criminal behavior will be prosecuted.”
“FDA’s evaluation of a new drug begins with an analysis of reliable and accurate data from clinical trials. Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review,” said Special Agent in Charge Justin C. Fielder of the Food and Drug Administration (FDA) Office of Criminal Investigations, Miami Field Office. “We will continue to investigate and bring to justice those whose actions may subvert the FDA drug approval process and put the public health at risk.”
Another defendant in the case, Maytee Lledo, pleaded guilty in February 2021 to conspiracy to commit wire fraud. She is scheduled to be sentenced on April 16, 2021, in Miami.
Trial Attorneys Joshua Rothman and Kara M. Traster of the Civil Division’s Consumer Protection Branch are prosecuting the case. The FDA’s Office of Criminal Investigations, Miami Field Office investigated the case and the U.S. Attorney’s Office of the Southern District of Florida has provided critical assistance.