NIH to Look Again at UCI Study

The National Institutes of Health have reopened an inquiry into the activities of two UC Irvine psychiatrists in the wake of a report in The Times that they skirted the school’s patient safety review board to test a drug without permission from the university.

The NIH, the primary government agency for funding of medical research, previously had looked into the drug company test by Steven G. Potkin and William E. “Biff” Bunney in 2005 after it received an anonymous complaint. The NIH did not conduct its own investigation but asked UCI officials to look into the matter and report back. The NIH closed the case after UCI told the agency it “found no evidence” that NIH funds had been misused.

Last March, the agency awarded UCI and Potkin control of a $24-million national brain-imaging study. Bunney is co-chairman of the psychiatry department at the School of Medicine.

The Times reported last week that UCI had investigated Potkin three times for alleged ethical and financial breaches, according to documents the paper obtained. Potkin said he was never disciplined. Each incident, however, raised questions about the doctor’s practices and how the university dealt with the issues. One incident involved more than $2 million in research funds Potkin directed drug companies to pay to a firm his family owned. In another case, UCI doctors accused him of wrongfully billing Medi-Cal for his research. The state and UCI concluded that Medi-Cal had not been defrauded.

In the third incident, school administrators became alarmed when they learned of the activities that led to the original NIH investigation. They ordered Potkin and Bunney immediately to halt their research, partly because it potentially put the university in violation of its contract with the federal government to monitor all research conducted by its faculty involving human patients. Such violations can be punished with withdrawal of funding or even suspension of a school’s research program.

After The Times story appeared, NIH officials contacted UCI for more information about the case, university spokesman Tom Vasich said. Spokespersons for UCI and the NIH confirmed the inquiry but would not provide details.

“UCI is in the process of responding to those requests,” Vasich said in an e-mail.

Neither Potkin nor Bunney could be reached for comment. In a previous interview, Potkin said he believed he had the university’s permission to conduct studies outside the school because of a shortage of research facilities on campus.

Potkin and Bunney applied to the university’s patient safety board in 2004 for permission to test an Alzheimer’s drug for Praecis Pharmaceuticals, a small company in Waltham, Mass., but the request was not immediately approved.

The professors went ahead anyway, conducting the trial through a company they formed, using Alzheimer’s patients at a private facility in San Juan Capistrano.

When medical school Dean Thomas Cesario learned of the study, he ordered it halted immediately and chastised the two researchers for circumventing the school’s oversight, saying it could have put UCI “at some risk” for not following the rules.

The doctors said they were only providing consulting services on the study but acknowledged they were listed as the principal researchers. Cesario rejected their answer.

“When you first conceived of the company with Biff, my clear understanding was that this was a consulting business,” Cesario wrote to the psychiatrists. “It was not a business to run clinical trials outside of the university.”

When the NIH inquired about the matter four months later, in April 2005, Cesario drafted a letter acknowledging that the doctors had conducted a clinical trial off campus through their company and that they had used UCI’s brain imaging facilities.

The letter was never sent. Instead, UCI performed a financial audit that “found no evidence” NIH funds were misused. A university spokesman said the audit had been performed at NIH’s request. The NIH accepted the university’s findings and did not conduct its own investigation.

Adil Shamoo, a bioethics professor at the University of Maryland and editor of the medical journal Accountability in Research, said the NIH can close a case if it is satisfied with the answers it receives but that the facts suggested the matter should have been investigated further.

“To deal with this issue solely as if it’s an accounting issue, it’s not appropriate,” he said. “These things had bearings on human subject protections, rather than a purely financial issue.”