Miami Doctor Falsified Clinical Trial Data For Asthma Meds: DOJ

MIAMI, FL — A Miami doctor pleaded guilty to falsifying clinical trial data for a children’s asthma medication and committing wire fraud Friday, the Department of Justice said in a news release.

Dr. Yvelice Villaman Bencosme, 64, served as the primary investigator for clinical trials purportedly conducted at a medical clinic called Unlimited Medical Research in Miami.

In pleading guilty, she admitted that between 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 DOJ said.

The clinical trial was designed to investigate the safety and efficacy of an asthma medication in children between the ages of four and 11, the DOJ said.

Bencosme said 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.

“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.”

Special Agent in Charge Justin C. Fielder of the Food and Drug Administration Office of Criminal Investigations in Miami, 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 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. Two other defendants were also charged in connection with the scheme, and they are presumed innocent until proven guilty beyond a reasonable doubt, the DOJ said.

DOJ trial attorneys Joshua Rothman and Kara M. Traster prosecuted the case, which was investigated by the FDA.