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FDA is reviewing
researchers' work

Reviews are routine: Dr. Richard Borison expected agency to check his studies

  MCG looking at changes admid reseach investigation - 10/05/96

Web-posted Oct. 18

By Paul Garber
Staff Writer

The Food and Drug Administration is investigating two former Medical College of Georgia researchers accused of research misconduct, an FDA spokeswoman said Thursday.

The FDA investigation was prompted by allegations of research misconduct against Richard Borison and Bruce Diamond, said Susan Cruzan, FDA spokeswoman.

``If results of studies are called into question the FDA would look into that to see if it had any effect on the approval of the drug,'' she said.

The two researchers have been expecting the FDA to review their studies, said their attorney, Jay Sawilowsky.

``Dr. Borison and Dr. Diamond look at this as only an audit they've been expecting,'' he said. ``(Dr. Borison) has been through FDA audits before and he has always passed them all.''

The researchers have already passed 13 audits performed by pharmaceutical companies since Dr. Borison's resignation from MCG in June, Mr. Sawilowsky said.

He refused to say which drugs or drug companies were involved in those audits.

``It's a routine thing for the FDA to audit a researcher,'' said Dr. George Schuster, chairman of MCG's Institutional Review Board. ``They come down here on a regular basis to review investigators. It's a system of checks and balances.''

MCG officials have yet to hear from the FDA about the federal investigation, said Clay Steadman, senior legal adviser for the college.

``We had notified the FDA and shared with them information from our internal investigation,'' he said. ``But they have not contacted us in any official capacity or asked us for any cooperation otherwise.''

The Georgia attorney general's office also is investigating the researchers amid allegations of possible criminal violations.

Because Dr. Borison and Dr. Diamond were affiliated with MCG and the Department of Veterans Affairs Hospital, part of the research money paid to them by drug companies should have gone to those institutions to help run the labs and pay the salaries of the staff.

Investigators are looking into allegations that some of the money was instead diverted to private companies affiliated with Dr. Borison and Dr. Diamond, say sources close to the probe.

Ms. Cruzan would not say what studies would be examined by the FDA.

Before resigning, Dr. Borison was studying such drugs as olanzapine, which was recently approved by the FDA for management of psychotic disorders, as well as Haloperidol and Respiderone, previously approved for schizophrenia, according to records from MCG's Institutional Review Board.

Dr. Borison was chairman of the Department of Psychiatry and Health Behavior before resigning in June.

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