Investigations uncover fake clinical trials to defraud pharmaceutical companies.
The Department of Justice (DOJ) has announced Lisett Raventos, 46, of Miami, Florida, pleaded guilty in the U.S. District Court for the Southern District of Florida to one count of conspiracy to commit wire fraud. Raventos was the site director, the director of clinical operations, and a study coordinator at the Unlimited Medical Research (UM Research) clinic in Miami. She admitted that, in the three-year span from 2013 to 2016, she participated in a fraudulent scheme aimed at an unnamed pharmaceutical company, conducting fake clinical trials, falsifying data and fabricating the participation of subjects.
The supposed trial was established under the guise of investigating the safety of an asthma medication in children between the ages of four and eleven. Former clinic staff members testified that the drugs were usually simply thrown away and fake data was entered. When subjects were given the drugs, the record keeping was useless.
Raventos pleaded guilty before U.S. District Judge Beth Bloom, nominated to her position by former U.S. president Barack Obama, and faces a potential sentence of up to twenty years in prison.
“Clinical trials help ensure that new drugs are safe and effective for the public, and this defendant undermined that process,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “The Department of Justice will continue to work hand-in-hand with the Food and Drug Administration (FDA) to investigate and prosecute fraudsters who put personal profit before public health.”
“Fraud in the conduct of clinical trials is simply unacceptable, especially where the drug under investigation was meant to serve children and other vulnerable populations,” said U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida. “I thank our partners at the FDA’s Office of Criminal Investigations, Miami Field Office, for their work in investigating this scheme.”
“Reliable clinical trial data is a foundation for FDA drug approval. Falsifying that data leaves consumers at risk of taking drugs that are neither safe nor effective,” said Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations Miami Field Office. “We will continue to investigate and bring to justice those who endanger the public health when they engage in conduct that might subvert the FDA approval process.”
In a similar story, former physician Sami Anwar of Richland, Washington, the head of two U.S. contract research companies, was sentenced to 28 years in prison for faking the results of clinical trials, and in many cases, failing to administer the drugs being tested. Anwar’s companies conducted fake trials supposedly testing the treatment of cholesterol, diabetes, heart disease, liver fibrosis and cirrhosis, opioid addiction, rheumatoid arthritis, asthma, and bipolar disorder, among other conditions. For six years, he collected millions of dollars from pharmaceutical companies and sponsors who believed he was performing potentially life-changing research. Like Raventos, behind closed doors, Anwar simply dumped the medications and told his employees to create fake records. And when study participants were actually given the experimental drugs, he kept incomplete and useless records of the drugs’ efficacy.