FDA Won't Disqualify HIV Doctor From Drug Studies
FDA Won't Disqualify HIV Doctor From Drug Studies [Chicago Tribune]
From Chicago Tribune (IL) (September 10, 2010)
Sept. 10--Federal regulators decided not to disqualify a prominent North Side HIV doctor whose clinic submitted fictitious data in a drug trial.
Instead, the Food and Drug Administration agreed to allow Dr. Daniel Berger to continue working on drug trials as long as an outside medical monitor periodically reviews his work for three years.
"I feel as if I’ve been vindicated," Berger said. "A big weight has been lifted off my shoulders, and I’m able to do my life’s work."
The FDA had threatened to disqualify Berger from conducting clinical trials -- one of the most serious and rarest actions the agency takes -- saying he "failed to protect the rights, safety and welfare" of patients under his care.
Berger’s agreement with the FDA is unusual. In other instances where the FDA halted disqualification proceedings, the agency often has placed limits on the number of trials doctors can conduct or the number of patients they can enroll. Berger faces no such restrictions. Under the agreement, which the agency made public this month, Berger must submit to the FDA annual reports on his monitored research for three years.
Berger has acknowledged that his Northstar Medical Center in Lincoln Park submitted phony data in a drug trial in 2008 but blamed a former study coordinator, whom he fired. Berger did not conduct a background check and did not realize that the coordinator was a convicted felon who served time in prison for embezzling more than $300,000.
Berger last year told the FDA that the former coordinator "fictitiously created" records of lab tests, physical exams and electrocardiograms, and forged the signatures of doctors and patients on key trial documents.
Some of the most essential tests that ensured the safety of patients were not performed, and more than 200 tablets of the investigational drug -- intended to treat chronic diarrhea in patients with HIV -- were missing, FDA records show.
Under federal law, the study’s principal investigator is ultimately responsible. The FDA, which began its investigation in March 2009, faulted Berger for lax oversight of the trial and for failing to investigate thoroughly when false trial records came to his attention. Had Berger reviewed the patient roster, a top FDA wrote last year, he "would have noticed irregularities and been able to stop the study coordinator’s violations."
Berger later hired a former FDA official to review all studies that involved the former coordinator. That review, Berger said, found the problems did not extend beyond the study the FDA cited. He and his staff also attended training on how to spot fraud.
Since the earliest days of the AIDS crisis, Berger has conducted more than 100 trials of investigational HIV drugs for pharmaceutical companies. These trials put Berger on a national stage. His work has been published in prestigious journals, including The New England Journal of Medicine and The Lancet, and he has served as a consultant and spokesman for drug giants.
When the FDA said it was seeking to disqualify Berger, one drug company forbade Berger from seeing patients for study visits and another replaced Berger as primary investigator with another Northstar doctor. That is changing, Berger said.
"We’re in the process of resuming my role as principal investigator in many studies and getting new studies," he said.
Berger said he is accustomed to routine monitoring by drug companies and described these periodic reviews by a professional monitor as "easy." He recently completed his first round of monitoring, and he said, "There were no signs of anything awry."
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Posted: September 2010