Dr. Yvelice Villaman Bencosme, 64, of Miami, Florida, previously pleaded guilty in U.S. District Court for the Southern District of Florida to “one count of conspiracy to commit wire fraud” connected with her work at Unlimited Medical Research.  Bencosme is the second defendant to be sentenced in this scheme to falsify clinical trial data regarding an asthma medication.  The clinical trial was designed to investigate the safety and efficacy of an asthma medication in children between the ages of four and 11.  On March 5, 2021, co-defendant Lisett Raventos, 46, of Miami, was also sentenced to 30 months in prison.  Another defendant, Maytee Lledo, pleaded guilty in February 2021 to conspiracy to commit wire fraud and is scheduled to be sentenced on April 16, 2021.Bencosme was a licensed medical doctor and primary investigator at Unlimited Medical Research.  Raventos was the site director, the director of clinical operations, and a study coordinator.  In pleading guilty, Bencosme and Raventos both admitted 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,” according to the Department of Justice (DOJ).

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Former clinic staff testified that the drugs were usually simply thrown away and fake data was entered to make it appear as that asthma research was actually taking place.  When subjects were given the drugs, the record keeping was useless.Bencosme and Raventos admitted 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,” according to court records.  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.”  Misguided information may have been disseminated to the public.“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.”

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Medical Doctor and Study Coordinator Sentenced to Prison in Scheme to Falsify Clinical Trial DataInvestigations uncover fake clinical trials to defraud pharmaceutical companies