CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial data
The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.
Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.
“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 assistant commissioner Catherine Hermsen for FDA’s Office of Criminal Investigations.
The purported mastermind of the scheme, Villaman Bencosme, pleaded guilty to conspiracy to commit wire fraud in January and was sentenced to 63 months in prison and forfeited $174,000.
Villaman Bencosme previously admitted that she attempted to defraud GSK by using patients’ personal information from her private medical practice to create false information to be entered into case histories.
The plea deal listed one example of a patient known only as D.H., who Villaman Bencosme had said was “doing well” and recommended the continued use of medication after a visit in April 2015. None of the physician’s recorded statements in the checkup were true, however, as D.H. was not participating in the study.
Villaman Bencosme falsified case histories for at least 11 individuals and admitted to participating in the scheme between around September 2013 and June 2016.
The clinical trial in question was the GSK-sponsored study dubbed VESTRI, according to court documents from last August. Researchers had aimed to measure the long-term safety of Advair Diskus, an inhaled asthma medication, in patients aged 4 to 11 years old. Results from the study were reported in March 2016 and published in the New England Journal of Medicine that September.
“As soon as we became aware of possible clinical trial fraud we conducted an internal investigation; excluded the data from the studies and reports; and reported the potential fraud to the FDA and the Institutional Review Boards,” GSK previously said in a statement.