Daniel Berger is a happy man. The FDA has ruled that the Chicago internist and thought leader in the area of HIV can continue conducting clinical trials without any restrictions, despite evidence that his clinic submitted bogus data along with failing to perform basic tests including physical exams and electrocardiograms during one particular trial. Additionally, 200 tablets of the investigational drug went missing at his clinic during that trial.

Berger has maintained it was all the doing of one particular coordinator—a convicted felon who pled guilty to stealing $364,000 from the DePaul University alumni relations department in the 1990s and had served just one year of a seven-year prison sentence prior to working for Berger. Berger said he didn’t check the man’s background before hiring him and had no idea he was a “career criminal.”

Berger, clinical associate professor at the College of Medicine, University of Illinois at Chicago and founder of Northstar Medical Center, told CenterWatch that the employee, who worked for him for a few years, was using this particular trial to embezzle money, calling in pretending to be various patients and faking status reports in order to collect patient stipends.

“He would come in very early and stay very late at night,” said Berger. “He was doing things on his own and hiding charts. It’s very easy for someone to come in and point a finger at me and say, ‘You should have known,’ but really, here at the clinic, everything looked very normal and proper.”

Then a monitor noticed that patient signatures didn’t match, said Berger, who would not disclose how much the coordinator stole in patient stipends. To defend himself to the FDA, Berger, who has conducted human immunodeficiency virus drug research since the early days of the AIDS crisis, hired consultants with FDA backgrounds to sift through data from the 170 trials in which he’d been involved during his career. This, he said, was pivotal in showing that data were amiss only in the trial in question—and only data on which that coordinator had worked.

The FDA responded this month, telling Berger he would not be restricted in any way from conducting future research. Usually fraud cases like these result in a requirement that the investigator—if he or she is allowed to stay in research—only work on a limited number of studies or with a small number of patients, or call the FDA for permission each time a study becomes available to him. Berger said he offered to have an outside auditor come in to scrutinize study data every six months for three years going forward and report findings to the FDA. The FDA accepted that.

“I feel vindicated,” he said. “Everyone has been aware that I’ve been a person of integrity and would never have a motive to submit anything false, let alone in one particular study.”

Art Caplan, director of bioethics at the University of Pennsylvania, said principal investigators walk a tough road, as they are held responsible for each of their employees’ conduct on a study. “You can have the FDA making rules all day, but if someone just isn’t vigilant or doesn’t train or watch their subordinates properly, you can get into a lot of trouble,” he said.

Berger understands this all too well now. In the wake of the controversy, he has hired a company to conduct a seminar for him and his staff on how to prevent and detect fraud. “As a physician, you’re not taught how to be a criminal investigator, but I can do that now,” he said, adding that he will now conduct background checks on prospective employees.

Northstar Medical Center claims to be the largest private HIV treatment and research center in the Chicago area.

—Suz Redfearn