FDA Seeks to Ban Chicago HIV Doc from Research

June 14, 2010

Jun 14 – In a rare move, federal regulators are seeking to disqualify a prominent Chicago HIV doctor from future drug studies after they discovered his clinic committed one of the most grievous sins of medical research: submitting fictitious data in a drug trial.

by Nancy Stone
Chicago Tribune

The Food and Drug Administration said Dr. Daniel Berger “failed to protect the rights, safety and welfare” of patients under his care.

Doctors’ and patients’ signatures were forged, even on forms where patients said they understood the risks of the trial and those where doctors said the patients weren’t too sick to enroll, the FDA found.

Some falsifications were obvious. One patient’s name was spelled differently in the trial records than it was in other medical records, the FDA said.

The most basic tests to protect the safety of patients who enroll in a study — physical exams and electrocardiograms, or EKGs, which measure the electrical activity of the heart — at times were not performed, the FDA found. More than 200 tablets of the investigational drug were missing, records show.

Berger acknowledges his clinic provided phony data to a drug company but blames a former study coordinator.  That coordinator was a convicted felon who served time in prison for embezzling hundreds of thousands of dollars, but Berger said he did not check into his background before hiring him.

Patients who took part in the trial likely don’t know about these problems. Berger told the Tribune that he never informed them.

In addition to being illegal, submitting false data can put lives at risk because the FDA relies on clinical trial results when it decides which drugs to approve, and the guidelines for using these drugs are based on trial results.

For the last six months, Berger and his attorney have tried to reach an agreement with the FDA that would allow him to keep participating in drug trials without major restrictions. Berger hopes for a final determination in the coming weeks. In the meantime, his drug trial work continues.

“I still feel disqualifying me is too harsh considering all the work that I’ve done and everything I’ve devoted myself to,” Berger said in an interview with the Tribune.

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