UPDATED: Feds charge another CRO staffer with faking data in a GlaxoSmithKline pediatric asthma study
A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.
Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.
The FDA Office of Criminal Investigations is continuing to investigate the case, which was launched last August.
“Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug,” said Justin Fielder, special agent at the Miami branch of the FDA’s Office of Criminal Investigations, in a statement. “We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
Palacio and three others working for the CRO known as Unlimited Medical Research fabricated participation of patients in the study between 2013 and 2016, the DOJ said. The purported mastermind of the scheme, a woman named Yvelice Villaman-Bencosme, pleaded guilty to conspiracy to commit wire fraud in January and was sentenced to 63 months in prison. As part of her plea agreement, Villaman-Bencosme was ordered to forfeit $174,000.
In that agreement, Villaman-Bencosme 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 four made it appear as though patients satisfied eligibility criteria, received physical exams, took the study drug and received payment for clinical trial visits.
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 Villaman-Bencosme’s recorded statements in the checkup were true, 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.
Asked for comment, GSK said it commissioned Unlimited Medical Research as one of the sites to conduct the VESTRI study and fully cooperated with the DoJ probe, a spokesperson confirmed to Endpoints News.
“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,” the spokesperson told Endpoints in an email.
Phone calls to Unlimited Medical Research went unanswered. The CRO giant Parexel was also listed as a study collaborator on the government’s clinical trials website, and Parexel told Endpoints early Thursday that the company has “no affiliation” with Unlimited Medical Research.
Two other individuals in the case have pleaded guilty to conspiracy to commit wire fraud. Lisett Raventos was sentenced to 30 months in prison in March, and Maytee Lledo was scheduled to be sentenced in April. Palacio was the only member of the group to also be charged with making false statements on a signed affidavit.
This story has been updated with comment from GlaxoSmithKline and Parexel.