Fourth defendant indicted in asthma trial scheme.
Former study coordinator, Jessica Palacio, 34, was hired to supervise a clinical trial GlaxoSmithKline’s (GSK) Advair Diskus, but she has now become the fourth person to be indicted for falsifying clinical data. Palacio was employed at Unlimited Medical Research in Miami and was supposed to be examining the effectiveness of the medication for children between four and 11 years old, according to court records.
Advair Diskus is currently approved to treat asthma in patients four years and older, and Advair HFA is a used to treat asthma in patients 12 years and older. However, there is no recommended for the ages in between, and essentially, the clinical trials were testing whether GSK could market the Diskus to a wider range of patients.
Instead, Palacio falsified medical records to make it look like children “visited Unlimited Medical Research, took study drugs as required, and were given physical exams by a clinical investigator,” according to the indictment. Palacio lied to a Food and Drug Administration (FDA) investigator when asked about the progress of her trial and was subsequently charged with conspiracy to commit wire fraud.
“When the efficacy of a new pharmaceutical drug is tested, public health and safety must always take precedence over profit,” Acting U.S. Attorney Juan Antonio Gonzalez said. “Medical researchers who manipulate clinical data and falsify records needlessly endanger the public and will be prosecuted.”
A Glaxo spokesperson added, “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. We fully cooperated with the Department of Justice (DOJ) investigation and are pleased with the outcome of the trials.”
“FDA’s evaluation of a new drug begins with an analysis of reliable and accurate data from clinical trials. Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review,” said Special Agent in Charge Justin C. Fielder of the Food and Drug Administration (FDA) Office of Criminal Investigations, Miami Field Office. “We will continue to investigate and bring to justice those who deny the public their right to safe and effective medicines.”
Three others have been previously connected to the conspiracy to commit wire fraud. Dr. Yvelice Villaman Bencosme, a physician who was a site investigator, 64, of Miami, pleaded guilty in U.S. District Court for the Southern District of Florida. She was sentenced to 63 months. Lisett Raventos, a former site director, director of clinical operations and a study coordinator, was sentenced to 30 months. Maytee Lledo, who worked as a receptionist for Bencosme at her private practice, was sentenced to 14 months.
“Clinical trials are an essential part of the medical research process, as they ensure the effectiveness and safety to patients of new drugs,” said U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida. “Those who manipulate clinical data risk the public’s health, and such criminal behavior will be prosecuted.”