Two women in Florida have been sentenced to prison for their roles in a conspiracy to falsify clinical trial data.
Senior U.S. District Judge Donald L. Graham of the Southern District of Florida sentenced Analay Rico, 37, of Fort Lauderdale, to 40 months in prison, and Daylen Diaz, 44, of Miami, to 24 months in prison. Rico and Diaz must also pay approximately $2.1 million in restitution. The pair were part of a scheme to defraud clients paying for clinical trial work intended to evaluate treatments for medical conditions, including opioid dependency, irritable bowel syndrome and diabetic nephropathy.
Rico worked as a lead study coordinator for a clinical research firm in Miami, Tellus Clinical Research, while Diaz was a research assistant and assistant study coordinator at the same firm. As part of their plea agreement, both Rico and Diaz admitted to agreeing to defraud clients. They also admitted to falsifying data that made it appear clients were participating in the trials, when in fact they were not.
“Clinical trials are essential in determining the safety and effectiveness of drug treatments,” Principal Deputy Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said in a statement. “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 fraud news comes as various U.S. federal agencies are cracking down hard on illegal healthcare schemes. Recently, the U.S. Department of Justice announced it had arrested three dozen people in a $1.2 billion telemedicine fraud scheme. The huge amount of fraud in that case came after new flexibilities were afforded to healthcare companies and providers to offer telehealth services during the COVID-19 pandemic. Clinical trials have also become critical during the pandemic as healthcare experts have sought out vaccines and treatments for COVID-19.
“Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug,” FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen said in a statement. “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
In addition to Rico and Diaz, three co-conspirators previously pleaded guilty and were sentenced for their roles in the scheme. Eduardo Navarro, 53, of Miami, was sentenced to 46 months imprisonment; Duniel Tejeda, 36, of Clewiston, Florida, was sentenced to 30 months imprisonment; and Nayade Varona, 51, was sentenced to 30 months imprisonment. Three additional defendants are awaiting trial in January for their connection to the scheme.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."