Post by icemandios on Aug 12, 2021 15:01:21 GMT
Two data falsifiers sentenced to prison as FDA pledges to crack down on those undermining clinical trials
Zachary Brennan
Senior Editor
A federal judge on Wednesday sentenced two Florida-based clinical research site workers to more than two years of prison time each after they fabricated medical records to make it appear as though subjects were participating in clinical trials. And more prosecutions may be on the way as the FDA’s criminal investigations arm promises to haul in anyone else they find faking trial data.
The two sentenced — Eduardo Navarro, a nurse practitioner from Miami, to 46 months in prison, and Nayade Varona, an assistant study coordinator from Port St. Lucie, FL, to 30 months in prison — pled guilty in June and admitted to falsifying data in medical records from two clinical trials run by their company, called Tellus Clinical Research. The trials were intended to evaluate a drug for irritable bowel syndrome, although the US government database of clinical trials did not list either one.
Tellus has worked with big-name pharma sponsors in the past though, including Pfizer, Gilead, Takeda, Boehringer Ingelheim and Eli Lilly, among others. The site’s work on some of those trials also came into question, including ones related to opioid dependency (sponsored by Braeburn Pharmaceuticals) and diabetes (run by Gilead).
Four other Tellus workers, including the clinic owner, were charged in March with conspiracy to commit mail and wire fraud and at least one substantive count of mail fraud. In addition, two of them were charged with money laundering and one was further charged with making a false statement to FDA inspectors.
The FDA’s Office of Criminal Investigations, which investigated Tellus, made clear that the jail sentences should serve as a warning shot to the rest of industry about fabricating data.
“The FDA will continue to thoroughly investigate and bring to justice those who try to undermine clinical trials, an important part of the agency’s regulatory review of new drugs,” said FDA’s assistant commissioner for criminal investigations Catherine Hermsen. “The agency will aggressively pursue violations that threaten the integrity of clinical trial data in order to protect the public’s access to safe and effective products.”
Zachary Brennan
Senior Editor
A federal judge on Wednesday sentenced two Florida-based clinical research site workers to more than two years of prison time each after they fabricated medical records to make it appear as though subjects were participating in clinical trials. And more prosecutions may be on the way as the FDA’s criminal investigations arm promises to haul in anyone else they find faking trial data.
The two sentenced — Eduardo Navarro, a nurse practitioner from Miami, to 46 months in prison, and Nayade Varona, an assistant study coordinator from Port St. Lucie, FL, to 30 months in prison — pled guilty in June and admitted to falsifying data in medical records from two clinical trials run by their company, called Tellus Clinical Research. The trials were intended to evaluate a drug for irritable bowel syndrome, although the US government database of clinical trials did not list either one.
Tellus has worked with big-name pharma sponsors in the past though, including Pfizer, Gilead, Takeda, Boehringer Ingelheim and Eli Lilly, among others. The site’s work on some of those trials also came into question, including ones related to opioid dependency (sponsored by Braeburn Pharmaceuticals) and diabetes (run by Gilead).
Four other Tellus workers, including the clinic owner, were charged in March with conspiracy to commit mail and wire fraud and at least one substantive count of mail fraud. In addition, two of them were charged with money laundering and one was further charged with making a false statement to FDA inspectors.
The FDA’s Office of Criminal Investigations, which investigated Tellus, made clear that the jail sentences should serve as a warning shot to the rest of industry about fabricating data.
“The FDA will continue to thoroughly investigate and bring to justice those who try to undermine clinical trials, an important part of the agency’s regulatory review of new drugs,” said FDA’s assistant commissioner for criminal investigations Catherine Hermsen. “The agency will aggressively pursue violations that threaten the integrity of clinical trial data in order to protect the public’s access to safe and effective products.”