The U.S. Department of Justice reports a Florida physician just pleaded guilty to conspiring to falsify clinical trial data in relation to an asthma medication. Apparently, during clinical trials at a trial site called Unlimited Medical Research (UM Research) in Miami, Dr. Yvelice Villaman Bencosme pleaded guilty in U.S. District Court for the Southern District of Florida to one count of conspiracy to commit wire fraud. A licensed medical doctor, Bencosme served as a principal investigator at UM Research. In pleading guilt, she admits that from 2013 to 2016 she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating data and participation of subjects in a clinical trial at UM Research. The clinical trial was designed to investigate the safety and efficacy of an asthma medication in children between the ages of 4 and 11. The PI admitted that she falsified medical records to make it appear that pediatric subjects arrived for scheduled visits at UM Research, took study drugs as required per the protocol, and received checks as payment for site visits.
The Second Defendant from this Trial Site
Already, TrialSite reported on the case of trial site coordinator Lisett Raventos, who pleaded guilty to conspiracy change 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, reports the DOJ.
Crooked Principal investigators will be Prosecuted
U.S. Southern District of Florida Attorney Ariana Fajardo Orshan commented on the case, “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.” The federal prosecutor continued, “Such selfish and irresponsible behavior is criminal and will be prosecuted.”
Meanwhile, Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department Civil Division reminded all: “Clinical trials are critical to ensuring the safety and effectiveness of new drugs. Falsifying that data can endanger consumers.” Clark continued, “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.”
Special Agent in Charge Justin C. Fielder of the Food and Drug Administration (FDA) Office of Criminal Investigations, Miami Field Office, commented, ”We will continue to investigate and bring to justice those who deny the public their right to safe and effective medicines.”
Potential Jail Time—Up to 20 Years
Now Bencosme, since pleading guilty before U.S. District Court Judge Beth Bloom, can face a maximum penalty of 20 years in prison.
Site Watch: Who is Unlimited Medical Research?
A Florida LLC, this group seemed to be formed in 2013. They were selected by some prominent pharmaceutical companies for asthma and cardiovascular studies. According to one site, they claim a number of large sponsors as clients.
Call to Action: Trial sites and staff should be scrutinized carefully by site qualification teams.