Wednesday, August 16, 2006

Yet More Trouble in the OC - A Psychiatrist Gets Into the Act

I went away for a few days of vacation and all heck broke loose again. I will try to keep up with this and subsequent posts.

The Los Angeles Times reported a new story about complex relationships between a faculty member at the University of California - Irvine medical school and a variety of commercial firms. We had posted a few months ago about various management problems at the same institution, involving its liver transplant service, cardiology division, and bone marrow transplant service, (see posts here and here) which lead the new chancellor of the campus to "acknowledge a failure of leadership and accountability." (See post here.)

The Times focused on the actions over almost 20 years of Dr Steven G Potkin, Professor of Psychiatry and Human Behavior.

“UCI investigated Potkin for the first time in 1989. Doctors there told administrators that Potkin was inappropriately billing Medi-Cal for patients in research trials. Bills submitted for patients in Potkin’s studies had been turned down three times by Medi-Cal....” One psychiatrist alleged that Potkin planned “to fool Medi-Cal into reimbursing the department for unauthorized expenditures.” Other affadavits alleged that Potkin “directed staff to keep two sets of records, disguising the names of the drugs that patients were receiving on the version made available to Medi-Cal.”

However, “UCI eventually launched an audit.” It found “ no improprieties. Interviewed by the Times, Potkin “denied the billings were inappropriate.”


The Times reported that “in 20 of Potkin’s [research] studies, he arranged for drug companies to channel some funding directly to the firm Pacific Clinical Sutdies.... Pacific Clinical Studies was owned jointly, by Potkins brother Ralph, a pulmonary care doctor, and a trust in their parents’ names.” Then, “one Potkin client, Janssen, a drug firm in Titusville, N.J., became ‘increasingly uncomfortable with the payments it was making to PCS and stopped making them.... Janssen... was worried because of the arrangement’s similarity to a case in which the chairman of the psychiatry department at the Medical College of Georgia pleaded guilty to diverting research funds....” But again, “the UCI audit, completed in September, 1998, concluded that Potkin’s actions did not technically violate the university’s nepotism policy, since PCS got the money from the drug companies rather than from UCI. However, the audit suggested that PCS ‘may have been established’ to avoid paying university overhead....” Later, [UCI medical school Dean] Cesario and Fredric Wan, then vice chancellor for research, told Potkin that PCS could no longer work on clinical trials for the university. Potkin said in an interview that UCI knew about PCS’ involvement....” But a university spokesperson said that Potkin “did not reveal its [PCS’] ties to his family.”

“In 2004, Potkin and psychiatry department co-chairman William E. ‘Biff’ Bunney applied to the university board that monitors human research to test an Alzheimer’s drug for Precis Pharmaceuticals, a small company in Waltham, Mass. The request was not immediately approved. The professors went ahead anyway, using a private company they had previously formed to conduct research at an assisted living facility.... The professors had a previously signed agreement with the university allowing them to consult on clinical trials through their company but no to work as principal investigators on a study through the firm.” Then, “Thomas Cesario, the dean of UC Irvien’s medical school, took swift action. In a Dec. 8, 2004, memo, Cesario told the psychiatrists that he had learned of their outside trial and that they were violating UCI policies. ‘We require this study be halted immediately until further notice,’ he wrote.’ In the interview, Potkin said he “moved the study out from under UCI’s auspices because of a shortage of psychiatry beds available for research.”

Even though Potkin’s research efforts were investigated three times in the last three decades, no one apparently discerned any pattern until the Times article. In fact, the Times article characterized Potkin as “one of UCI’s biggest stars. The 60-year old psychiatrist is among the university’s most prolific researchers. He brings in lucrative contracts from some of the world’s biggest drug companies and has presided over as many as a dozen clinical trials at a time. "

The Times reporter interviewed Dr Mike Samoszuk, a former pathology professor at UCI who now works for “the medical device industry of a drug company.” He opined that the “university’s thirst for research funding may have caused it to look the other way when ethical lapses were discovered. ‘Even though clinical research is a noble and worthy activity, it’s very easy to lose your moral compass if your primary goal is the dollar amount of grant funding that you generate.’....”

It seems the more one looks, the more management problems one finds at the UCI medical school.

This saga is another example of the complex financial relationships that pervade medical schools and academic medical centers. Such relationships raise concern about the degree that research going on at these institutions is unduly influenced by the financial interests of those who run it. It also increases skepticism about the extent that faculty and administration have become distracted from their academic mission and their professional values by the lure of easy money from industry, coupled with ongoing pressure from the university to bring in more "external funding."

If you are an academic physician getting such money, it is time to think about how much your reputation and your values are really worth. If you are an academic administrator who has been pushing your faculty to better “support their salaries,” no matter what the source, it is time to think about how much your institution’s reputation and values are worth. And it is time for all of us to wonder why academic medicine has become so focussed on making money, and figure out how it can become otherwise.

1 comment:

Martin said...


I thought it was interesting that you were highly concerned about the failure of management at UCI. I, however, am far more concerned about the willingness of Dr. Potkin to circumvent the IRB in order to conduct a clinical trial. This is especially disturbing in light of the IOM's recommendation that prison-based research should be allowed to resume. Without strong IRB oversight it seems that the prison-based research system will become a hellish mockery of the system we have in place now.