Kendall clinical trials for addiction and diabetes drugs were fraudulent, feds say

A Hialeah doctor helped a Kendall clinic’s owners fake clinical trials, testing that the FDA uses in approving drugs for public use, according to a federal court indictment unsealed last week.

Facing the most charges is Dr. Martin Valdes, a Coral Gables resident and medical director of Hialeah’s Healing Touch C&C, according to the company’s website and Valdes’ Florida Department of Health license. Valdes is charged with mail fraud, conspiracy to commit mail and wire fraud, money laundering and making a false statement to FDA inspectors.

The same charges, minus the false statement charge, hang over the head of Fidalgis Font, who registered Tellus Clinical Research with the state in 2012 and was its CEO. The indictment says Font laundered her loot with a $35,000 check on Tellus’ account to the Land Rover South Dade dealership.

Tellus’ study coordinator Julio Lopez, 54, and project manager/ study coordinator Duniel Tejada, 35, are looking at just the mail fraud and conspiracy to commit mail and wire fraud charges.

From February 2014 through July 2016, Tellus Clinical Research at 9425 Sunset Dr. supposedly ran two trials for an opioid dependency drug, two trials for an investigative drug dealing with irritable bowel syndrome and one trial testing a drug treating diabetic nephropathy, a kidney disease.

“The public must be able to rely on the accuracy and honesty of clinical trial data, which is essential to ensuring the safety of drugs approved for patient use,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The defendants undermined that process and put patients at risk. The Department of Justice will pursue and prosecute those who put personal profit before public health.”

FIT CRITERIA?

Drug manufacturers and contract research organizations pay various clinics to run clinical trials for each drug. Of course, the clinics sign agreements that the people used in the clinical trials fit the criteria for that drug’s testing.

The indictment says Valdes, the principal investigator for the trials, Font, Lopez and Tejada tried to get bigger payments from drug makers and the contract research organizations by lying about everything concerning the people used in the testing: whether or not the people had the medical condition the drug should address; if they’d been examined by the principal investigator and sub-investigator; if they’d been given the study drug; and if they’d been paid by Tellus.

Font and Lopez, the indictment says, used personal information from friends and family to create fake profiles of clinical trial participants.

The indictment says the foursome and some cronies tossed the drugs out.

David J. Neal: 305-376-3559, @DavidJNeal