CHICAGO, June 15 (UPI) — The U.S. Food and Drug Administration said it seeks to disqualify a Chicago HIV doctor from further research after he allegedly gave false data in a drug trial.
The FDA said Dr. Daniel Berger “failed to protect the rights, safety and welfare” of his patients, the Chicago Tribune reported Monday.
The FDA said physicians’ and patients’ signatures were forged, including on forms where patients said they comprehended the risks of the trial and those where the patients weren’t too sick to sign up for a drug study, the Tribune reported.
The most basic tests for the safety of patients who undergo such studies, such as physicals and electrocardiograms, sometimes were not performed, the FDA said it discovered.
More than 200 tablets of the drugs being tested were missing, the FDA said records show.
In addition to being illegal, submitting false data may endanger lives because the FDA relies on clinical trial results in approving drugs, the Tribune said.
Berger said he blames a study coordinator formerly in his employ. The coordinator had a prison record for embezzlement, but Berger said he had not run a background check before hiring him.
“I feel disqualifying me is too harsh considering all the work that I’ve done and everything I’ve devoted myself to,” Berger said.
Berger has done human immunodeficiency virus drug research since the early days of the AIDS crisis and has served as a principal investigator on more than 100 clinical trials involving HIV pharmaceuticals.
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