MIAMI, Fla. — Two Florida women face up to 20 years in federal prison after they admitted to falsifying data in clinical trial work that would evaluate treatments for conditions such as opioid dependency.

The U.S. Department of Justice said Analay Rico and Daylen Diaz pleaded guilty to conspiracy to commit mail and wire fraud. The pleas come after an investigation into work they performed for Miami-based Tellus Clinical Research.

During the trials, court documents state the research company falsified data, pocketing money intended to pay for people’s participation.

The clinical trials

Between at least February 2014 and at least May 2016, court documents show Tellus Clinical Research, Inc. performed various clinical trials. The trials were on behalf of contract research organizations throughout the United States.

Among the clinical trials they were contracted for were two trials for a new drug intended to treat patients for opioid dependency, two trials concerning a new drug intended to treat patients with irritable bowel syndrome (IBS) and a trial for a new drug intended to treat a kidney disease caused by diabetes.

For the trials, the company needed to find participants with certain eligibility criteria. This includes:

  • for the opioid trials, subjects needed to meet certain criteria for opioid dependence
  • for the IBS trials, subjects needed to be diagnosed with IBS
  • for the kidney disease trial, subjects needed to have documented diabetic nephropathy and have certain levels of a specific protein in their urine.

The contracts stated sponsors would pay Tellus per study subject for each procedure, test, office visit, or other event required under the study protocol. In return, Tellus would pay each subject for their participation.

The fraud

Court documents allege Rico and Diaz, along with other co-defendants, sought to inflate the payments from sponsors or other research organizations. To do this, they falsified the participation of study subjects.

To do this, the documents state they recruited and enrolled subjects that they knew did not meet the eligibility requirements. They would falsify case histories to make it appear that they met the requirements.

They also used friends’ and family members’ information, in some cases without their consent. Court documents state they portrayed them as participants, even though they didn’t partake in the clinical trials.

During the trial, the document states they said the subjects took or were administered the study drug. Instead, they discarded it unused.

In the IBS trials, Tellus was required to provide blood samples from study subjects. The document states they drew blood from employees at the research firm and had it sent in for analysis. They then falsely represented the case histories to say the results were from the participants.

The IBS trials also required daily phone calls into an e-diary system. The document states the conspirators placed calls and answered questions in place of, and without the knowledge of, the study subjects enrolled in the trials.

When the checks came in for the trials, the document states the conspirators created false records that the subjects received checks. Instead, they would deposit the checks into a bank account owned and controlled by the co-conspirators.

The fallout

Rico and Diaz are not the first to have gone through the legal process in the conspiracy. The FDA says Duniel Tejeda, Eduardo Navarro, and Nayade Varona previously pleaded guilty and were sentenced to 30 months in prison, 46 months in prison, and 30 months in prison, respectively, for their roles in the scheme.

The Special Agent in charge of Miami’s field office for the FDA Office of Criminal Investigations says falsifying clinical trial data harms the cornerstone of FDA’s evaluation of a new drug.

“Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”

The U.S. Attorney for the southern district of Florida said cases like this endanger public safety.

“The public relies on the accuracy of clinical trial data,” said U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “Falsifying clinical data endangers the safety of consumers and violates the public’s trust. It is a serious crime that we will continue to vigorously prosecute.”

A trial is set for Sept. 27, in the case of three other defendants, Dr. Martin Valdes, Fidalgis Font, and Julio Lopez, 55, of Hialeah, all charged by indictment in connection with Tellus.

If convicted of money laundering, Valdes faces a maximum penalty of 20 years’ imprisonment, and Font faces a maximum of 10 years’ imprisonment. If convicted of making a false statement to the FDA, Valdes faces a maximum of five years’ imprisonment.