Federal regulators are looking to disqualify a prominent Chicago HIV doctor from future drug studies, said Chicago Breaking News. The regulators discovered that Dr. Daniel Berger’s clinic submitted bogus data in a <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug trial.
The U.S. Food and Drug Administration (FDA) said that Dr. Berger, “failed to protect the rights, safety and welfare” of patients in his care, quoted Chicago Breaking News.
Among other falsifications, there were forgeries of doctors’ and patients’ signatures. In one case, said Chicago Breaking News, one patient’s name was spelled differently from trial records and other medical records. Also, basic tests conducted to ensure patient safety were not performed, such as EKGs, and would have been immediately noticed if appropriately reviewed, according to Chicago Breaking News.
In excess of 200 tablets of the drug being tested were also found to be missing said the FDA, wrote Chicago Breaking News, citing records.
While Berger did not deny his clinic’s submission of the fake data, he blames the prior study coordinator, who was a convicted felon who served prison time embezzlement of hundreds of thousands of dollars, wrote Chicago Breaking News. Berger said he did not check into the man’s background prior to hiring him.
Regardless, Berger signed papers when he took over the trial indicating that he is solely responsible for clinical trial activities, explained Chicago Breaking News.
Submitting false data is illegal and can put untold lives in jeopardy because the FDA relies on clinical trial results when looking to approve or deny medications, said Chicago Breaking News. Guidelines used for trial drugs are also based on trial results, which adds to the risks accumulated when trials are inappropriately conducted.
Berger and his attorney have been working on a deal over the past six months, said Chicago Breaking News. Berger is hoping to be able to continue to be involved in drug trials without significant restrictions and is hoping for a decision in the next few weeks. As Berger waits for a decision, though, he is able to continue with drug trials, wrote Chicago Breaking News.
“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.
Berger has been involved in drug research since the AIDS crisis made headlines, has served as a principal investigator on over 100 clinical trials involving HIV medications; heads—with a population of about 3,000 patients—the Northstar Medical Center, described at the largest, private HIV treatment and research center in the Chicago area; has been hired as a spokesman and consultant by pharmaceutical companies; was named a clinical associate professor at the University of Illinois College of Medicine; travels nationwide to lecture on HIV treatments; and has had his work published in the New England Journal of Medicine, the Lancet, and other prestigious publications, said Chicago Breaking News.
The FDA action is not only rare, but considered one of its most serious.
