Dr. Daniel Berger, who has been the subject of a Food and Drug Administration ( FDA ) investigation following alleged improprieties at his Northstar Medical Center, has reached an agreement with the FDA that will allow him to continue coordinating HIV/AIDS drug trials. Berger told Windy City Times about the agreement last week, two days after a Chicago Tribune article said the FDA was "seeking to disqualify" Berger from future studies.
Berger was informed of the investigation last November in a letter from FDA investigator Leslie K. Ball. Ball wrote that a spring 2009 audit of Northstar had found that the clinic "repeatedly or deliberately submitted false information to the sponsor in a required report," and that Berger "failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects."
The "sponsors" of Berger's trials were pharmaceutical companies developing drugs to treat HIV/AIDS. Berger and Northstar Medical Center, have been heralded for HIV/AIDS treatment and clinical drug research. Berger is the director of Northstar, which he founded in 1991.
Although the letter acknowledged that the fraudulent activity had been undertaken by Berger's study coordinatoran employee who, Berger alleges, also embezzled money from the clinicBall said that, as the principle investigator in the drug trials, Berger was "ultimately responsible" for the errors.
Berger fired the study coordinator, whom he identified as Wesley McQuerry, when the extent of the fraud became clear.
Berger told Windy City Times that, under the terms of the agreement reached with the FDA, his clinic will submit to regular monitoring by an independent agency, the details of which were yet to be worked out.
"My only fault," Berger said, "is that I hired a guy who lied about his background.
"I had every expectation that he was going to do his job. He went rogue and started finding a way to embezzle money with the research protocol."
The Tribune reported last week that McQuerry had previously served prison time for embezzling money from DePaul University, and had prior convictionson similar chargesin Minnesota. Berger said that he had been unaware of his employee's background when he hired him, although the Tribune article pointed out that "a basic Google search" yielded pertinent details about McQuerry's history.
"I fired him on the day that the auditor came out and showed me … the scope of his fraud," Berger said. "I had no idea of the scope."
Asked if he required new employees to submit to criminal background checks, Berger said wryly, "Now I do."