Windy City Times has learned that Northstar Healthcare, a Lakeview clinic that treats people with HIV, is being investigated by the Food and Drug Administration ( FDA ) for improprieties regarding how it documents drug trials.
According to Northstar founder/medical director Daniel S. Berger, last November he received a letter from the FDA's Leslie K. Ball notifying him of the initiation of proceedings that would disqualify him from conducting further drug trials. Ball is the director of the Division of Scientific Investigations within the FDA's Office of Compliance.
Under the sponsorship of pharmaceutical companies, Northstar conducts drug trials following FDA-approved protocols.
In the letter, Ball said that a spring 2009 investigation of Northstar had revealed numerous inconsistencies, for instance, that the clinic "repeatedly or deliberately submitted false information to the sponsor in a required report," and that Berger "failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects." The letter listed a number of documents that it said contained "fraudulent signatures."
Sections of the letter that indicate the name of the drug, or the company that produces it, were redacted.
Berger told Windy City Times that the investigation is an "ongoing matter" related to the "falsification of paperwork" on the part of a former employee of his.
"There's been no accusation that I've been involved in any way," said Berger. "I've cooperated fully with the agency. I've made, already, many corrective actions."
He said that problems arose after an employee, who no longer works for Northstar, falsified paperwork in order to embezzle money from the clinic. Berger declined to name the employee, and did not know whether that person was the subject of any investigation.
Karen Riley, who works for the FDA's Office of Public Affairs, said that because the investigation into Northstar is "open," she couldn't comment on the details of it.
Berger, who said that he continues to run drug trials at Northstar, indicated that he was hopeful that the matter would be successfully resolved. "I have a very long history of doing very quality research," Berger said. "I'm very optimistic that I will be cleared."
The FDA letter to Daniel Berger is available at www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM193324.pdf.