Yvelice Villaman Bencosme of Miami, Florida, has entered a guilty plea in US District Court for the Southern District of Florida, in response to one count of conspiracy to commit wire fraud.
Bencosme (who served as primary investigator for clinical purportedly conducted at the medical clinic Unlimited Medical Research in Miami) 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 UM Research.
The clinical trial at the center of the scheme was designed to investigate the safety and efficacy of an asthma medication indicated for pediatric patients between the ages of four and 11. Bencosme admitted to falsifying medical records to make it look as if patient participants arrived for scheduled visits at UM Research, took study drugs as required, and received checks as payment for site visits.
Acting assistant attorney general Jeffrey Bossert Clark of the Justice Department’s Civil Division, said clinical research fraud poses a risk to patients.
“Clinical trials are critical to ensuring the safety and effectivness of new drugs; falsifying that data can endanger consumers,” he said. “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.”
Ariana Fajardo Orshan, US attorney for the Southern District of Florida, said, “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. “Such selfish and irresponsible behavior is criminal and will be prosecuted.”
Justin Fielder, special agent in charge for the US Food and Drug Administration (FDA) Office of Criminal Investigation;s Miami field office, said, “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.”
Bencosme pleaded guilty before US District Court judge Beth Bloom. Upon her sentencing, , 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 UM Research, pleaded guilty to a conspiracy charge in November.
Trial attorneys Joshua Rothman and Kara 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 US Attorney’s Office of the Southern District of Florida provided critical assistance.