A federal judge sentenced a medical clinic owner and a pharmacy technician for their involvement in a clinical trial fraud scheme that included the falsification and fabrication of clinical trial data, the Justice Department announced. Miguel Angel Montalvo Villa, 53, of Miami, and Ivette Maria Portela Martinez, 53, also of Miami, were convicted by a jury on Sept. 5 of one count of conspiracy to commit wire fraud and one count of wire fraud. Montalvo Villa also was convicted of making a false statement to a regulatory investigator with the U.S. Food and Drug Administration (FDA). On Nov. 30, U.S. District Judge K. Michael Moore sentenced Montalvo Villa to 71 months in prison and Portela Martinez to 46 months in prison.
According to court documents and evidence presented at trial, Montalvo Villa was a co-owner, president and CEO of AMB Research Center Inc. (AMB), a medical clinic located in Miami that conducted clinical trials of new drugs for pharmaceutical companies and sponsors. Portela Martinez was an employee who served as recruiter, site manager, data entry specialist and pharmacist. The evidence showed that Montalvo Villa and Portela Martinez used the names and personal information of individuals without their knowledge or consent and listed them as enrolled subjects in a clinical trial for a drug that was being developed to treat Clostridium difficile-associated diarrhea (CDAD), a moderate to severe form of diarrhea. The trial evidence further showed that the defendants enlisted and used the names of family members and friends who purportedly participated as eligible subjects in the CDAD clinical trial — but no subject fully participated in that clinical trial, as required by the protocol.
