Owner Of Medical Research Company Pleads Guilty To Lying About Drug Trial Data

The co-owner of a clinical trial company pleaded guilty on Wednesday to obstructing an inspection by the Food and Drug Administration (FDA). She allegedly schemed to falsify drug trial data, according to a report from the Department of Justice (DOJ).

Olga Torres of Miami was the co-owner of Unlimited Medical Research, a company dedicated to clinical drug research. In 2017, the FDA conducted a regulatory inspection of the company when Torres allegedly lied to an investigator. According to the DOJ, Torres admitted to falsely stating that clinical research on an asthma medication for children had been done honestly when she knew data in the trial had been falsified.

Torres was the fourth person at Unlimited Medical Research to plead guilty to falsifying data. Yvelice Villaman Bencosme M.D., Lisett Raventos, and Maytee Lledo have all been sentenced for the same crime.

Last year, the DOJ released a statement on Bencosme’s guilty plea. “In pleading guilty, Bencosme admitted that from approximately 2013 to 2016, she participated in a scheme to defraud a pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at Unlimited Medical,” the report stated. Bencosme admitted to falsifying medical records to make them show that the subjects of the research had come for scheduled visits at the research center, taken the drugs, and were compensated. The research Bencosme was supposed to be doing investigated the safety of an asthma medication for children four to 11 years old.

At the time, U.S. Attorney Ariana Fajardo Orshan accused Bencosme, a licensed medical doctor, of lying about the data for profit. “When those charged with investigating the efficacy of new drugs manipulate the data for personal profit, they violate the public’s trust and pose serious threats to our collective health and safety,” the attorney said. “Such selfish and irresponsible behavior is criminal and will be prosecuted.”

After Torres pleaded guilty, a DOJ official echoed Fajardo’s concern for the public when doctors and researchers falsify data. “Clinical trials help ensure the safety of new drugs, and falsifying clinical trial data can put the public at risk,” said Deputy Assistant Attorney General Michael D. Granston of the Justice Department’s Civil Division. “We will continue to work with our partners at the FDA to investigate and prosecute those who undermine the integrity of the clinical trial process.”

An FDA official also commented on the severity of these crimes. “Reliable clinical trial data is a foundation for FDA drug approval. Falsifying that data leaves consumers at risk of taking drugs that are neither safe nor effective,” said Assistant Commissioner Catherine A. Hermsen for the FDA Office of Criminal Investigations (OCI). “We will continue to investigate and bring to justice those who endanger the public health when they engage in conduct that might subvert the FDA approval process.”

The U.S. Attorney’s Office for the Southern District of Florida assisted with the case, and the FDA is still performing investigations.

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