Two Florida medical study coordinators sentenced for falsifying clinical trial data

Oct. 19 (UPI) -- Two Florida medical study coordinators are facing federal prison time after they were sentenced Wednesday for falsifying clinical trial data for monetary gain.

Senior U.S. District Judge Donald Graham, for the Southern District of Florida, sentenced Analay Rico to 40 months in prison and Daylen Diaz to 24 months, while also ordering both women to pay $2.1 million in restitution for defrauding clients at Tellus Clinical Research.

Rico, 37, worked as a lead study coordinator for clinical research at the Miami-based firm, while Diaz, 44, was a research assistant. Both women pleaded guilty in July after admitting they conspired with others at Tellus to defraud clients paying for clinical trials.

While clients were led to believe actual subjects were enrolled in trials for opioid dependency, irritable bowel syndrome and diabetic nephropathy, Rico and Diaz admitted there were no subjects and that all of the medical data was based on false case histories.

"Clinical trials are essential in determining the safety and effectiveness of drug treatments," said Principal Deputy Assistant Attorney General Brian Boynton of the Justice Department's Civil Division. "The Justice Department will continue to work with its law enforcement partners to prosecute anyone who intentionally falsifies this critical data for personal profit."

The Food and Drug Administration's Office of Criminal Investigations investigated the case.

"Reliable and accurate data from clinical trials is the cornerstone of the FDA's evaluation of a new drug," said FDA Assistant Commissioner for Criminal Investigations Catherine Hermsen. "Compromised clinical trial data could impact the agency's decisions about the safety and effectiveness of the drug under review."

Three co-conspirators, who also pleaded guilty in the scheme, have already been sentenced to prison times ranging from 30 months to 46 months. Three other defendants, charged by indictment, are awaiting trial in January.

"It's disgraceful when a criminal preys upon patients in a health care setting," said U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. "We will prosecute perpetrators who do to the fullest extent of the law."