A federal judge in the US state of Florida sentenced Eduardo Navarro and Nayade Varona, both former employees of Tellus Clinical Research in Miami, to prison for falsifying clinical trial data for a drug being tested against irritable bowel syndrome. Navarro will serve 46 months in prison and Varona 30 months. Both pleaded guilty to the crimes. Judge José Martinez also ordered the defendants to pay a fine of US$2 million. The case was investigated by the office of criminal investigations at the Food and Drug Administration (FDA). Another four people have been charged, including Martin Valdes, the doctor who owns Tellus.
Between February 2014 and July 2016, the pair enrolled ineligible patients in clinical trials, falsified laboratory results and medical records, and stated that some individuals were taking the drug when this was not true. “Falsifying clinical trial data puts the public’s health at risk,” said Acting U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida, according to the U.S. Department of Justice’s website. “Compromised clinical data jeopardizes the researchers’ ability to evaluate the safety and efficacy of new drugs. Prosecuting these cases will continue to be a top priority for our office.”Republish