A Florida medical doctor pleaded guilty to conspiring to falsify clinical trial data regarding an asthma medication, the Department of Justice announced today.
Dr. Yvelice Villaman Bencosme, 64, of Miami, Florida, pleaded guilty in U.S. District Court for the Southern District of Florida today to one count of conspiracy to commit wire fraud. Bencosme was a licensed medical doctor who served as the primary investigator for clinical trials purportedly conducted at a medical clinic called Unlimited Medical Research (Unlimited Medical) in Miami. In pleading guilty, Bencosme admitted that from approximately 2013 to 2016, she 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. 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 admitted that she falsified medical records to make it appear that pediatric subjects arrived for scheduled visits at Unlimited Medical, took study drugs as required, and received checks as payment for site visits.
“Clinical trials are critical to ensuring the safety and effectiveness of new drugs. Falsifying that data can endanger consumers,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “The Department of Justice will continue to work hand-in-hand with the FDA to investigate and prosecute fraudsters who put personal profit before public health.”
“When those charged with investigating the efficacy of new drugs manipulate the data for personal profit, they violate the public’s trust and pose serious threats to our collective health and safety,” said U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida. “Such selfish and irresponsible behavior is criminal and 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 who deny the public their right to safe and effective medicines.”
Bencosme pleaded guilty before U.S. District Court Judge Beth Bloom. When sentenced, Bencosme faces a maximum penalty of 20 years in prison. Bencosme is the second defendant to plead guilty in this matter. Lisett Raventos, a former study coordinator at Unlimited Medical, pleaded guilty to a conspiracy charge in November 2020. Two other defendants were charged in connection with the scheme, and they are presumed innocent until proven guilty beyond a reasonable doubt.
Trial Attorneys Joshua Rothman and Kara M. Traster of the Department of Justice 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 provided critical assistance.
Official news published at https://www.justice.gov/opa/pr/florida-medical-doctor-pleads-guilty-conspiring-falsify-clinical-trial-data