Alleged ethical / financial breaches by UCI Psychiatrist drew scrutiny but no sanctions_LAT

"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." That conclusion by a former pathology
professor at the University of California, Irvine (UCI) who moved to
industry, sums up the prevailing culture in academic medicine.

The Los Angeles Times reports (below): "UCI’s medical programs have been
racked by problems in the last decade, including the theft of eggs and
embryos from patients, cancer research violations, illicit sales of body
parts and shortcomings in its liver, kidney and bone marrow transplant
programs. In each case, critics say, warnings were ignored and serious
problems downplayed. "

Psychiatry appears to be "leading" in the magnitude of ethical research
misconduct and financial disclosure violations: from Harvard, Pittsburgh,
Emory, California, and the National Institute of Mental Health-leading
psychiatrist have been shown to engage in activities that flaunt conflicts
of interest rules and regulations with impunity. Whereas others are likely
to do jail time for such activities-academics have powerful institutions to
shield their lawless actions.

The LAT investigative report features the career of UCI "star" psychiatrist,
Steven Potkin, who, LAT reports, is a brother-in-law of Jane Pauley who
wrapped up her career as TV news anchor to become a paid drug pusher. Dr.
Potkin is shown to be a master at getting grants: he garnered a $24 million
project from the National Institute of Mental Health: "at the same time
Potkin has attracted funding and recognition for UCI, he has also been
investigated three times by the university for alleged ethical or financial
breaches. although Potkin says he was not disciplined as a result the
investigations, each raised serious questions about his practices and how
UCI dealt with the issues."

"Most recently, administrators found in 2004 that the professor had skirted
the school’s patient safety review board to test a drug for a pharmaceutical
company without the required university approval. When UCI learned of the
research, it ordered Potkin to immediately halt the study.  Seven years
earlier, administrators looked into why Potkin had directed drug companies
to pay more than $2 million in research funds to a firm his family owned."
 
The LAT reports that according to a Janssen Pharmaceutica memo, officials
were nervous about how Dr. Potkin was diverting funds from UCI to Pacific
Clinical Studies, which "was owned jointly, by Potkin’s brother Ralph, a
pulmonary care doctor, and a trust in their parents’ names." Janssen
officials noted "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 funding from the school to a company he
controlled." That psychiatrist, Richard Borison, was sentenced to 15 years
in jail in 1998. See: http://www.va.gov/oig/51/press99/borison-pr.htm
 
The LAT reports that a UCI audit suggested that PCS "may have been
established" to avoid paying university overhead that is attached to
research projects."

"In 2004, Potkin and psychiatry department co-chairman William E. "Biff"
Bunney applied to the university board that monitors human research for
permission to test an Alzheimer’s drug for Praecis 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 the research at an assisted-living facility for
Alzheimer’s patients."

"In the affidavits [two psychiatrists] said 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."

The case documents the many facets of greed and corruption in academic
medicine. It provides ample evidence for much needed mandatory independent
checks and balances to salvage the good before the entire output is
infected. Academia can no more be trusted to police itself than any other
profession or institution. Congress has a duty to pull the purse strings and
bring the house to order.

Contact: Vera Hassner Sharav

veracare@ahrp.org <mailto:veracare@ahrp.org>  
 
 
http://www.latimes.com/news/local/la-me-potkin13aug13,1,7814898.story
The Los Angeles Times
Probes Targeted UCI Researcher
Alleged ethical and financial breaches by Dr. Steven G. Potkin drew scrutiny
but no sanctions. The professor defends his activities.
By Christian Berthelsen
August 13, 2006

TV news personality Jane Pauley had a message to deliver in April when she
spoke at a fundraiser for UC Irvine’s Brain Imaging Center. She told the 140
guests at the Island Hotel in Newport Beach about her battle with mental
illness and spoke in support of the research being done by the center’s
director – and Pauley’s brother-in-law – UCI psychiatry professor Steven G.
Potkin.

Potkin is 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.

Recently, his investigation into nicotine’s effects on the brain received
national attention. And in March, the university proudly trumpeted his role
in heading a $24-million National Institutes of Health project that will be
headquartered at UCI.

But at the same time Potkin has attracted funding and recognition for UCI,
he has also been investigated three times by the university for alleged
ethical or financial breaches, according to more than 300 pages of documents
obtained by The Times. And although Potkin says he was not disciplined as a
result the investigations, each raised serious questions about his practices
and how UCI dealt with the issues.

Most recently, administrators found in 2004 that the professor had skirted
the school’s patient safety review board to test a drug for a pharmaceutical
company without the required university approval. When UCI learned of the
research, it ordered Potkin to immediately halt the study.

Seven years earlier, administrators looked into why Potkin had directed drug
companies to pay more than $2 million in research funds to a firm his family
owned. The payments were related to studies he was performing at UCI. The
university concluded that the company may have been set up to avoid UCI
overhead fees, and it prohibited Potkin from using the company in future
research projects.

UCI launched its first investigation of Potkin’s work in 1989, four years
after the psychiatrist arrived at the university from the National
Institutes of Mental Health, where he specialized in schizophrenia research.
Fellow UCI doctors accused Potkin of wrongfully billing Medi-Cal for his
research. Although Medi-Cal rejected some billings for the clinical trial,
the state and UCI concluded that Medi-Cal was not defrauded.

Despite the repeated investigations, Potkin’s star has continued to rise,
and this summer he was given a raise and a promotion.

The grants that researchers such as Potkin bring are an important source of
funds for universities. The publicity brings prestige that attracts
students, professors and donors, which is especially important for a school
such as UCI, which is still trying to build its reputation.

UCI’s medical programs have been racked by problems in the last decade,
including the theft of eggs and embryos from patients, cancer research
violations, illicit sales of body parts and shortcomings in its liver,
kidney and bone marrow transplant programs. In each case, critics say,
warnings were ignored and serious problems downplayed.

Dr. Mike Samoszuk, a former pathology professor who left UCI late last year
to work as the chief medical officer for a medical device division of a drug
company, said that although he had no knowledge of the Potkin case, 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,"Samoszuk said.

UCI said it couldn’t discuss specifics of personnel matters. Potkin, in an
hourlong interview, defended his activities, saying that UCI administrators
approved his business dealings and that his work helped patients and the
university.

But documents provided by the university suggest that some of Potkin’s
activities had not been approved by UCI.

In 2004, Potkin and psychiatry department co-chairman William E. "Biff"
Bunney applied to the university board that monitors human research for
permission to test an Alzheimer’s drug for Praecis 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 the research at an assisted-living facility for
Alzheimer’s patients in San Juan Capistrano.

The professors had previously signed an agreement with the university
allowing them to consult on clinical trials through their company but not to
work as principal investigators on a study through the firm. The agreement
was later modified to allow the professors to supervise principal
investigators through their company.

On learning that the men had gone ahead without university approval of a
study that listed them as principal researchers, Thomas Cesario, the dean of
UC Irvine’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 a letter to Cesario the next day, the doctors acknowledged that they were
listed as the principal researchers but said they were only providing
"management and consulting" services for another company. The company the
doctors said was running the trial, Pharmacologic Development Physicians
Inc., had been established two months earlier by Steven Mee, a former
medical school student under Potkin and Bunney who had completed his
residency the year before. Mee did not return a telephone call seeking
comment.

Potkin said he was not trying to avoid university scrutiny but, rather, had
moved the study out from under UCI’s auspices because of a shortage of
psychiatry beds available for research. "What this issue has all been about
is the loss of research facility beds in a place that was supposed to do
research," Potkin said. "That was really the point. When we don’t have beds
and don’t have resources to do that, we have to come up with other solutions
to do that."

He also maintained that the amended permission form gave him approval to
conduct the trial and that UCI’s policy for monitoring research did not
apply to "outside activities."
"I would agree that things could have been written more precisely," he said.
"There’s no question in my mind that when we did this we had full approval
to do this."

Cesario thought differently.
"When you first conceived of the company with Biff, my clear understanding
was that this was a consulting business," Cesario wrote Potkin and Bunney on
Dec. 18, 2004. "It was not a business to run clinical trials outside of the
university."

In April 2005 someone complained anonymously about the Praecis trial to the
National Institutes of Health. The agency asked UCI whether a Potkin-owned
company had used NIH-funded school staff and resources for the research and
whether the doctors had performed a clinical trial without review board
approval. As a condition of receiving federal funding, research institutions
such as UCI must guarantee that its review boards will safeguard human
experiments.

"I’m surprised they didn’t suffer a direct, immediate and tough penalty,"
said Dr. Arthur Caplan, chairman of the medical ethics department at the
University of Pennsylvania.

Cesario acknowledged in a letter to the NIH that the doctors had conducted
their research through a private company and that they had used UCI’s
brain-imaging facilities. The letter also said the company paid for the
service, which was allowable under the NIH grant.

The letter, obtained as part of a public records request, was never sent.
UCI spokesman Tom Vasich said that before it was to be mailed, NIH said it
only wanted a financial audit. The three-page audit contained none of the
admissions in Cesario’s unsent letter. The report said the auditors "found
no evidence" that NIH funds were used for Potkin’s and Bunney’s private
company.  NIH accepted the university’s findings and did not conduct its own
investigation. A spokesman for the agency would not comment on the case.

Potkin’s research had earlier come under scrutiny in 1997, when
administrators asked questions about another outside company involved in his
work.

Research funds typically are paid to the university. But in 20 of Potkin’s
studies, he arranged for drug companies to channel some funding directly to
the firm Pacific Clinical Studies, according to university documents.
Pacific Clinical Studies was owned jointly, by Potkin’s brother Ralph, a
pulmonary care doctor, and a trust in their parents’ names. Potkin told
university auditors that the money was used to pay staff used in recruiting
patients for studies and for patient costs such as pet boarding.

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, according to a June 1998 internal UCI memo. Janssen,
according to the memo, 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 funding from the
school to a company he controlled. A spokesman for Janssen parent Johnson &
Johnson declined to comment.

The UCI audit, completed in September 1998, concluded that Potkin’s actions
did not technically violate the university’s nepotism policy, since PCS got
its money from the drug companies rather than from UCI. However, the audit
suggested that PCS "may have been established" to avoid paying university
overhead that is attached to research projects. The report said all of the
company’s money came from Potkin’s clinical trials, with the exception of
one his brother ran. The drug companies paid PCS $2.4 million.

Seven months after the audit was completed, Cesario and Frederic Wan, then
the vice chancellor for research, told Potkin that PCS could no longer work
on clinical trials at the university.

Potkin said in the interview that UCI knew about PCS’ involvement, since it
was mentioned in the school’s contracts with the drug companies. He said the
money PCS received was in addition to any research grant to UCI.

"Patients benefited," he said, "and more research was completed at the
university."

Vasich, the university spokesman, said that although UCI knew of the
company’s involvement, Potkin did not reveal its ties to his family.

UCI investigated Potkin for the first time in 1989. Doctors there told
administrators that Potkin was inappropriately billing Medi-Cal for patients
in his research trials. Bills submitted for patients in Potkin’s studies had
been turned down three times by Medi-Cal, documents show.

In response, Potkin called a meeting to present what UCI psychiatrist Dan
Bates described in an affidavit as a plan to "fool Medi-Cal into reimbursing
the department for unauthorized expenditures."

The sworn statement was one of four that UCI doctors and a psychologist
submitted in support of another physician who filed a complaint with UCI
alleging that he was retaliated against for making the Medi-Cal allegations.

In the affidavits, Bates and psychiatrist Chris Heh said 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.

According to the affidavits, although patients were receiving the
experimental drugs Raclopride and Zacopride, one set of charts indicated
that patients had been given drugs labeled Haldol-R and Haldol-Z. Haldol is
an FDA-approved drug that is eligible for Medi-Cal reimbursement, while the
other drugs are not.

Several doctors and nurses complained to administrators, and documents show
the whistle-blowers thought that their warnings were ignored.

Larry Drake, a business manager for the psychiatry department, wrote to
department chairman Bunney, "If you recall several months ago, after hearing
of these issues, I suggested that you form a committee to review the ethics
of the research unit. This was not done!"

UCI eventually launched an audit. The results, issued in September 1990,
said there were no improprieties. It said Medi-Cal had approved payments for
the hospital stays of some patients in the research trials and that the
state had not been billed for experimental drugs.

The state attorney general’s office did not file charges after conducting
its own inquiry.

In his interview with The Times, Potkin denied that billings were
inappropriate. He said Medi-Cal was billed only for the hospital stays of
patients before they were enrolled in the study.

He also said it was standard practice to keep two sets of charts in research
trials and that the notations were "absolutely not" done to justify Medi-Cal
billings. The drug labelings, he said, were a shorthand way of showing the
drugs were being tested againstHaldol.

In their affidavits, Drs. Heh and Nora Johnson said the drugs were being
tested against a placebo.

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