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Garfinkel Case at the University of Minnesota

Garfinkel Case at the University of Minnesota

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12/04/2012

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Page 2 of 3 2010 Factiva, Inc. All rights reserved.
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SE
NEWS
HD University kept silent for 4 years on research misconduct by Garfinkel
 
BY
Joe Rigert; Maura Lerner; Staff Writers
WC
1,068 words
PD
12 August 1993
SN
Star-Tribune Newspaper of the Twin Cities Mpls.-St. Paul
SC
MSP
ED
METRO
PG
01A
LA
English
CY
(Copyright 1993) 
LP
For almost four years, the
University of Minnesota
covered up its findings that Dr. Barry Garfinkelknew about and participated in scientific misconduct, including fraud, in a drug study, according to areport obtained Wednesday.
 
 As recently as last August the university said it had found no evidence of intentional wrongdoing bythe psychiatrist. The university had claimed repeatedly that Garfinkel was merely negligent insupervising the research.
 
TD
But a November 1989 report by the university's official investigating committee flatly stated thatGarfinkel, a nationally recognized expert in teen suicide, had taken part in fabricating records aboutone patient, either knew or should have known about other falsification of data and failed to correctwidespread misconduct in the study.
 
The 65-page report, which was kept secret, was released to the Star Tribune yesterday by court order after the newspaper sued the university for access to the Garfinkel file.
 
Garfinkel was found guilty last week in U.S. District Court in Minneapolis of five counts of mail fraudand filing false statements in connection with his research on Anafranil, an anti-depressant drug thatwas used on patients with obsessive-compulsive disorder. He was acquitted on 18 other charges. Hewas accused of faking reports on patient exams that either never took place or were conducted by aresearch assistant,
Michelle Rennie
, who had no medical training.
 
Rennie, the chief witness against Garfinkel at his trial, told the university that she faked data at hisdirection. Garfinkel vehemently denied telling her to falsify documents and said she misled him byfilling out inaccurate reports that he later signed.
 
The university committee ultimately couldn't decide which side was telling the truth. It concluded thatGarfinkel had "specific and personal" knowledge of the misconduct and never tried to stop it, whichthe committee said was tantamount to sanctioning the misconduct. In fact, the committee said he wasprimarily responsible for the misconduct.
 
The report, by four university professors who investigated the case for nine months, said Garfinkelknew some patients weren't getting the required exams. And it said that he took part in falsifying datain one case - when he reported conducting an exam on one teenage girl when he merely rode in a car with her mother.
 
The report harshly criticized Garfinkel for assigning Rennie to evaluate and treat some of his patients,saying that "could constitute a violation of medical ethics." Three committee members were hiscolleagues in the psychiatry department.
 
The committee also said the company that sponsored the drug study, Ciba-Geigy, had to share theblame for the problems.
 
The report said Rennie was incompetent and should have been fired "early in the study," and that thecompany "was clearly aware of most of the scientific deficiencies" in the research. It also concludedthat there was no evidence that anyone was trying to distort the study results "or that any malice wasintended."
 
Rennie lost her job after reporting the fraud in early 1989. Garfinkel remained head of child and
 
Page 3 of 3 2010 Factiva, Inc. All rights reserved.
adolescent psychiatry until he was indicted in February. He is still an associate professor in themedical school.
 
From the start, the university has been less than candid in its public statements about the case. In1990, it issued a joint statement with Garfinkel saying only that the study was flawed: "During thestudy, some problems occurred, including difficulties in the recording and preservation of data.Professor Garfinkel deeply regrets the errors which occurred."
 
That same year, the dean of the medical school, Dr. David Brown, signed a confidential agreementwith Garfinkel to keep the whole matter quiet except for the joint statement.
 
The university also said in 1990 that no formal disciplinary action was taken against Garfinkel as aresult of its investigation.
 
In August 1992, the university went a bit further, saying it had found "very substantial irregularities"and "research misconduct" in the study, but no evidence of intentional wrongdoing by Garfinkel. Thistime, however, the university said the dean had disciplined Garfinkel in 1990, docking him a month'spay of $5,250 and limiting his research.
 
The university made that announcement after being told by the Star Tribune that it planned to reportthat the U.S. attorney was considering criminal charges against Garfinkel.
 
University officials said that because Garfinkel had agreed to the penalties, they were not formaldisciplinary actions, which would have to be public under state law. In June, however, HennepinCounty District Judge Franklin Knoll ordered the university to give up the file. He wrote that theuniversity apparently made the agreement with Garfinkel "to keep the enormity of the misconductunder wraps."
 
University general counsel Mark Rotenberg said yesterday that "the university categorically rejectsany insinuation that we covered up any of the serious problems with the Anafranil study. Theuniversity was the first organization to look into this thoroughly, and we produced a lengthy reportwhich was thorough, independent and came to some very grave conclusions."
 
Rotenberg also said that standards of accountability at the medical school have evolved since then,and that Dean Brown might act differently on the case today. Brown, who stepped down as dean inJune, was not available for comment. President Nils Hasselmo was out of the country and could notbe reached.
 
Doug Kelley, Garfinkel's attorney, said that his client disagreed with some of the findings in the report,but "concluded that he had made mistakes and that he needed to take responsibility for them."Garfinkel accepted responsibility, Kelley said, as part of the voluntary settlement with the universitythat resulted in disciplinary action against him.
 
 At the time, Garfinkel disputed the findings as unfair and inaccurate. The committee "never adequately investigated the allegations" against him, he wrote in a 1989 rebuttal, which also wasreleased yesterday.
 
Throughout his 40-page response, Garfinkel lashed out at Rennie, accusing her of dishonesty and"gross dereliction of duty." He wrote that she was a "repeated prevaricator" who no longer could betrusted.
 
The committee rejected his argument that he wasn't to blame:
 
"He has characterized himself as the victim of an untrustworthy subordinate. However, the evidenceindicates that, from very early in the study, he had sufficient knowledge . . . of the extent and nature of most of the problems."
 
NS
GCAT : Political/General News | GHEA : Health | GHOME : Law Enforcement | GSCI :Science/Technology 
IPD
report investigation u of m research medicine fraud 
AN
Document msp0000020020328dp8c02rwm 
 
24 of 54 DOCUMENTSStar Tribune (Minneapolis, MN)August 19, 1993, Metro Edition
Hasselmo says he didn't know of fraud
BYLINE:
Sally Apgar; Joe Rigert; Staff Writers
SECTION:
News; Pg. 1A
LENGTH:
1522 wordsAn internal investigation that uncovered an unprecedented case of research fraud at the University of Minnesota waskept secret from President Nils Hasselmo for more than two years.Hasselmo said in an interview this week that he did not know until last summer that a faculty committee found in 1989that Dr. Barry
Garfinkel,
a prominent university psychiatrist, had participated in scientific misconduct in a drug study.He learned about it only when federal investigators subpoenaed records in the case.Hasselmo, who spoke for the first time Tuesday about the
Garfinkel
verdict and how the case was handled, also saidhe did not know until this week that university attorneys had reneged on a promise to give the investigative report to theU.S. Food and Drug Administration for its inquiry. FDA officials said the university's refusal delayed theirinvestigation, but they declined to call it an obstruction of justice."I don't think we are well-served by secrecy," Hasselmo said. "And I think, painful as it is, openness is the only waythat we can conduct the business of this university."Earlier this month,
Garfinkel
was found guilty in U.S. District Court in Minneapolis of five counts of mail fraud andfiling false statements in connection with his research on Anafranil, an antidepressant drug used in treatingobsessive-compulsive disorder. He was acquitted on 18 other charges.
Garfinkel
was accused of faking reports onpatient exams that never took place or were conducted by a research assistant with no training.After the verdict, Hasselmo declined to comment on the case except to express sympathy for
Garfinkel
and his family.This week he said his failure to comment was a "dumb" thing to do. He called the fraud "intolerable" and an"unfortunate development that strikes at the very heart of the institution."But the
Garfinkel
scandal goes beyond a conviction for research fraud. The university's handling of the case illustratesa management style that has damaged its credibility and has led to a major shakeup of top officials.In July, Deloitte & Touche, a national management consulting firm hired by the university, released a harsh reportcriticizing the Medical School's lack of control over more than $ 111 million in annual revenues. On the basis of itsfindings, Deloitte recommended a major management overhaul of the school. But while its study focused on thedamaging effects of mismanaging money, the
Garfinkel
scandal underscores the consequences of mishandling andwithholding information, an equally powerful currency.In this lax culture, Medical School Dean David Brown, who resigned in June, was able to strike a secret agreementwith
Garfinkel
that would make it possible for the university to cover up the internal investigation for almost fouryears. After an eight-month legal battle, the Star Tribune obtained copies of the agreement and investigative reportPage 1

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