University kept silent for 4 years on research misconduct by Garfinkel

SE HD BY WC PD SN SC ED PG LA CY LP

NEWS University kept silent for 4 years on research misconduct by Garfinkel Joe Rigert; Maura Lerner; Staff Writers 1,068 words 12 August 1993 Star-Tribune Newspaper of the Twin Cities Mpls.-St. Paul MSP METRO 01A English (Copyright 1993) For almost four years, the University of Minnesota covered up its findings that Dr. Barry Garfinkel knew about and participated in scientific misconduct, including fraud, in a drug study, according to a report obtained Wednesday. As recently as last August the university said it had found no evidence of intentional wrongdoing by the psychiatrist. The university had claimed repeatedly that Garfinkel was merely negligent in supervising the research.

TD

But a November 1989 report by the university's official investigating committee flatly stated that Garfinkel, a nationally recognized expert in teen suicide, had taken part in fabricating records about one patient, either knew or should have known about other falsification of data and failed to correct widespread 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 fraud and filing false statements in connection with his research on Anafranil, an anti-depressant drug that was used on patients with obsessive-compulsive disorder. He was acquitted on 18 other charges. He was accused of faking reports on patient exams that either never took place or were conducted by a research 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 his direction. Garfinkel vehemently denied telling her to falsify documents and said she misled him by filling out inaccurate reports that he later signed. The university committee ultimately couldn't decide which side was telling the truth. It concluded that Garfinkel had "specific and personal" knowledge of the misconduct and never tried to stop it, which the committee said was tantamount to sanctioning the misconduct. In fact, the committee said he was primarily responsible for the misconduct. The report, by four university professors who investigated the case for nine months, said Garfinkel knew some patients weren't getting the required exams. And it said that he took part in falsifying data in 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 his colleagues in the psychiatry department. The committee also said the company that sponsored the drug study, Ciba-Geigy, had to share the blame for the problems. The report said Rennie was incompetent and should have been fired "early in the study," and that the company "was clearly aware of most of the scientific deficiencies" in the research. It also concluded that there was no evidence that anyone was trying to distort the study results "or that any malice was intended."

Rennie lost her job after reporting the fraud in early 1989. Garfinkel remained head of child and Page 2 of 3 2010 Factiva, Inc. All rights reserved.

adolescent psychiatry until he was indicted in February. He is still an associate professor in the medical school. From the start, the university has been less than candid in its public statements about the case. In 1990, it issued a joint statement with Garfinkel saying only that the study was flawed: "During the study, 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 agreement with 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 a result 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. This time, however, the university said the dean had disciplined Garfinkel in 1990, docking him a month's pay of $5,250 and limiting his research. The university made that announcement after being told by the Star Tribune that it planned to report that the U.S. attorney was considering criminal charges against Garfinkel. University officials said that because Garfinkel had agreed to the penalties, they were not formal disciplinary actions, which would have to be public under state law. In June, however, Hennepin County District Judge Franklin Knoll ordered the university to give up the file. He wrote that the university apparently made the agreement with Garfinkel "to keep the enormity of the misconduct under wraps." University general counsel Mark Rotenberg said yesterday that "the university categorically rejects any insinuation that we covered up any of the serious problems with the Anafranil study. The university was the first organization to look into this thoroughly, and we produced a lengthy report which 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 in June, was not available for comment. President Nils Hasselmo was out of the country and could not be 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 university that 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 was released 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 be trusted. The committee rejected his argument that he wasn't to blame: "He has characterized himself as the victim of an untrustworthy subordinate. However, the evidence indicates that, from very early in the study, he had sufficient knowledge . . . of the extent and nature of most of the problems." NS IPD AN GCAT : Political/General News | GHEA : Health | GHOME : Law Enforcement | GSCI : Science/Technology report investigation u of m research medicine fraud Document msp0000020020328dp8c02rwm

Page 3 of 3

2010 Factiva, Inc. All rights reserved.

Page 1

24 of 54 DOCUMENTS Star 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 words

An internal investigation that uncovered an unprecedented case of research fraud at the University of Minnesota was kept 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 1989 that 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 said he did not know until this week that university attorneys had reneged on a promise to give the investigative report to the U.S. Food and Drug Administration for its inquiry. FDA officials said the university's refusal delayed their investigation, 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 way that 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 and filing false statements in connection with his research on Anafranil, an antidepressant drug used in treating obsessive-compulsive disorder. He was acquitted on 18 other charges. Garfinkel was accused of faking reports on patient 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 illustrates a 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 report criticizing the Medical School's lack of control over more than $ 111 million in annual revenues. On the basis of its findings, Deloitte recommended a major management overhaul of the school. But while its study focused on the damaging effects of mismanaging money, the Garfinkel scandal underscores the consequences of mishandling and withholding information, an equally powerful currency. In this lax culture, Medical School Dean David Brown, who resigned in June, was able to strike a secret agreement with Garfinkel that would make it possible for the university to cover up the internal investigation for almost four years. After an eight-month legal battle, the Star Tribune obtained copies of the agreement and investigative report

Page 2 Hasselmo says he didn't know of fraud Star Tribune (Minneapolis, MN) August 19, 1993, Metro Edition

under a court order last week. The university spent $ 180,000 in legal fees to defend Garfinkel and to keep the committee's report secret. The agreement, signed by Brown, shows that the university would destroy all copies of the investigative report except for one to be retained by the office of general counsel. The agreement also prohibited university officials and faculty members from speaking publicly about the faculty's findings. Hasselmo said this week, "I felt it was terribly awkward that the university could not state what action had been taken." When he learned about the case last summer, Hasselmo said, he encouraged attorneys to renegotiate the agreement to release information on the disciplinary action. The botched handling of the Garfinkel case is another embarrassment for the university, which is trying to recover from a series of research and management scandals that have battered the Medical School. In addition, the Garfinkel case raises questions about the assertion of universities around the country that they can and should police themselves on research fraud, rather than suffer interference from the federal government. Not only did Brown keep the case secret, he also imposed a relatively mild punishment on Garfinkel, docking him $ 5,250 in pay and restricting his research. Now, because of the felony conviction, Garfinkel could be barred from doing any more FDA-sanctioned drug research. He also will be replaced as chief of child and adolescent psychiatry at the university. University officials say they will wait until he is sentenced before deciding whether to take any further action against him. The Garfinkel case isn't the first time that Hasselmo has been caught in a difficult situation in the growing Medical School scandal. In an interview a year ago, he echoed the view of surgery chief John Najarian that irregularities in the ALG drug program were mostly paperwork problems of reporting and communicating with the FDA. Later, after the Star Tribune reported decades of violations of drug laws in the program, he admitted that the problems were "very serious" and ordered a major investigation. Since then, the three top administrators in the Medical School and Health Sciences have resigned, and the FBI is investigating. Looking at the Garfinkel case now, Hasselmo says he wished "he had been informed and could have had a hand in this from the beginning . . . but that is simply not the way the system works." Instead, a nine-month investigation by four faculty members, including three from Garfinkel's Psychiatry Department, stopped at Brown's desk in December 1989. The agreement to keep the faculty report secret went as far as the office of the academic vice president, No. 2 in the university administration. But even that did not get to Hasselmo, he said. Hasselmo holds Brown responsible for failing to get the investigative report to the president's office or involving him in the disciplinary action. But he did not criticize the former dean. Hasselmo said the university system does not necessarily involve the president in such cases. As he sees it, Brown and the lawyers made an "honest attempt to deal with a difficult situation" in a way that seemed appropriate at the time. Hasselmo added, "I think it would have been much better [if it had] been an open process, and that they had laid the facts out." He said he is now urging officials to avoid making any side deals in such cases.

Page 3 Hasselmo says he didn't know of fraud Star Tribune (Minneapolis, MN) August 19, 1993, Metro Edition

Brown declined to comment on his handling of the case. "It has caused enough pain and sorrow already," he said. Mark Rotenberg, the university's general counsel, said that once Brown agreed with Garfinkel to impose discipline informally, the university had no choice but to keep everything secret under a ruling that the Minnesota Supreme Court had made a short time before. If the university had taken formal disciplinary action against Garfinkel, he said, the case would have been made public. Rotenberg, who was not the general counsel at the time, said Brown's "good faith" decision probably was unwise. As for the FDA, Rotenberg said he would have tried to find a legal way to turn the university's investigative report over to the agency. Dr. Robert Young, who coordinated the FDA investigation of Garfinkel, said a university attorney asked the agency in early 1989 to defer its inquiry until the internal investigation was completed. Then, he was told, the faculty-committee report would be given to the agency. Nine months later, after the committee concluded that Garfinkel had taken part in research misconduct, university attorney Ann Russell told the FDA that it would have to sue the university to get the report, Young said. The agency got neither the report nor the data supporting it. What the university did, Young said, was violate an understanding among research institutions that they will cooperate with the agency to protect patients from fraud in drug studies. "For the government to sue the university for the report didn't seem like something that the FDA was going to do," Young said. "We would just do it ourselves. But it would take a lot more time and a lot more work. We would have to go over the same ground. We do not have the same degree of expertise." The university said that if it had released the report to the FDA it would have had to give it to everyone, Young said. "They didn't want it out." But he said the FDA would have kept the report confidential as part of its own investigation. Only when an investigation is closed can documents be made public under the Freedom of Information Act. Young found it "offensive" that the university would claim in a press release in August 1992 that it had cooperated with the FDA in the case. "This is not what I would characterize as cooperation," he said. Rotenberg said, "At the present time, it is the administration's clear policy that we should firmly discipline wrongdoers and explain to the public the basis for our discipline."

LOAD-DATE: August 21, 1993 LANGUAGE: ENGLISH GRAPHIC: Photograph Copyright 1993 Star Tribune

Psychiatrist sentenced for research fraud. (University of Minnesota child psychiatrist Barry Garfinkel)

HD BY WC PD SN SC PG VOL LA CY LP

Psychiatrist sentenced for research fraud. (University of Minnesota child psychiatrist Barry Garfinkel) John Henkel 718 words 1 April 1994 FDA Consumer FDAC 29 Vol. 28, No. 3, ISSN: 0362-1332 English COPYRIGHT 1994 U.S. Department of Health and Human Services A prominent University of Minnesota child psychiatrist was sentenced to six months in a federal correctional facility and six months of home detention with work release for engaging in mail fraud and making false statements in documents about clinical studies of the psychiatric drag Anafranil (clomipramine hydrochloride). Barry Garfinkel, M.D., former director of the university' s child and adolescent psychiatry department and a leading teen suicide expert, was free at press time pending appeal. His sentencing last Nov. 19 in the U.S. District Court for the District of Minnesota followed conviction on five felony counts.

TD

The court also sentenced Garfinkel to pay $214,000 in fines and perform 400 hours of community service. The jury acquitted him of 18 other charges. Garfinkel also could lose his medical license if his convictions are upheld. Garfinkel, 46, was chief researcher in a $250,000 study begun in 1986 to determine whether Anafranil, an antidepressant, was safe and effective in treating children and adolescents with obsessive-compulsive disorder (OCD). OCD has several forms, one of which is an obsession with cleanliness that manifests itself with repetitive hand washing or showering. FDA approved Anafranil for commercial marketing in late 1989, but the agency did not use Garfinkel's data. The Swiss-based drag company Ciba-Geigy, which sponsored the drug, chose the University of Minnesota in 1986 as one of five U.S. sites for the Anafranil studies. The approved research protocols for the study required that patients undergo weekly psychiatric evaluations and be monitored for benefits and adverse side effects of the medication. Patients were not to take other medications that affect the central nervous system. Rather than follow these procedures strictly, Garfinkel "established and executed his own research protocols but didn't tell anybody--not the university, Ciba-Geigy, or FDA--about it," says Mark Brown, associate FDA chief counsel who co-prosecuted the case. Garfinkel's wrongdoings came to light in March 1989, when his study coordinator, Michelle Rennie, complained of research misconduct to university and Ciba-Geigy officials. Both launched inquiries right away. The university's investigation found irregularities but no intentional misdeeds. But in June 1989, Ciba-Geigy notified FDA that it would not include Garfinkel's data in its new drug application for Anafranil approval due to problems it found with the university study. FDA conducted its own investigation from January 1990 through May 1991. The probe was delayed because the university refused to share its findings with FDA. The government subsequently obtained these findings through a subpoena. Ultimately, FDA collected an investigalive file of more than 10,000 pages. Evidence confirmed widespread misconduct in Garfinkel's study. In mid-1992, the U.S. attorney's office in Minnesota further investigated the case and led Garfinkel's prosecution. In court, the government's case centered on the evidence FDA had gathered, such as patient record forms Garfinkel submitted to Ciba-Geigy falsely representing that he had followed research protocols. At trial, the prosecution presented evidence that in as many as 140 instances, required office visits and psychiatric evaluations either did not occur or were conducted by employees with little or no medical training. For example, Rennie testified that Garfinkel told her to make up data for the official forms and to provide therapy to some study participants despite her lack of training. Other evidence showed that Garfinkel sometimes "examined" patients by having Rennie talk to them over the phone

Page 2 of 5

2010 Factiva, Inc. All rights reserved.

and that he administered medication prohibited in the study protocols. Yet Garfinkel signed documents throughout the study falsely representing that he complied with required protocols. The Garfinkel case "underscores the importance of the federal drug approval system," says FDA's Brown. "The system is supposed to ensure that any new drug is safe anti effective before being made available. By falsifying data, Garfinkel undermined the integrity of this system." In addition to Garfinkel's appeal, FDA also is appealing the sentence on the grounds that the court should have applied sentencing guidelines more strictly, resulting in a stiffer sentence. Garfinkel could have received up to 125 years in prison had he been convicted on all 25 counts originally named in his indictment. John Henkel is a staff writer for FDA Consumer. IPD AN Psychiatrists Medical research Fraud investigation Barry Garfinkel Document fdac000020011029dq410000w

Page 3 of 5

2010 Factiva, Inc. All rights reserved.

Page 1

13 of 54 DOCUMENTS Star Tribune (Minneapolis, MN) January 5, 1995, Metro Edition

Garfinkel wants to 'get on with things'; Psychiatrist convicted of fraud quits 'U,' opens private practice
BYLINE: Gordon Slovut; Staff Writer SECTION: News; Pg. 1B LENGTH: 780 words

Dr. Barry Garfinkel, the University of Minnesota psychiatrist who was convicted in 1993 of research fraud, has resigned from the university and opened a private practice in a strip mall near Lake Calhoun. His resignation ends the university's efforts to fire him, said William Donohoe, a university attorney. Garfinkel, 47, a Canadian citizen and former chief of child psychiatry at the university, said he decided to quit and go into private practice "because I wanted to get on with things." He is an authority on teen suicide, learning difficulties and attention-deficit disorder. Many of his patients are following him from the university to his private practice. He was a rising star at the university until it began to investigate a report in 1989 that something was amiss in his research on an experimental drug, Anafranil, used on university patients with obsessive-compulsive disorder. A federal investigation followed, and he was found guilty in U.S. District Court of two counts of mail fraud and three counts of making false statements for furnishing falsified data to the Ciba Geigy drug company. Garfinkel argued that he did not knowingly supply false data in the 1986-89 study, and he appealed the conviction. But the U.S. Court of Appeals upheld the conviction in the summer. Garfinkel was ordered to serve six months in a halfway house and six months under house arrest. He is about halfway through his stay at a Volunteers of American halfway house in south Minneapolis. On Wednesday, Garfinkel opened his office on the second floor of the Calhoun Village shopping center on W. Lake St. He appeared to be busy Wednesday and was booked to capacity for today. "I'm totally booked from 8 [a.m.] to 7 [p.m.], for tomorrow [Thursday] including lunch hour," he said. "One patient each hour, except for two patients with 30-minute appointments." He said he has always had a busy clinical practice: "I had the heaviest patient load in the psychiatry department." He said many of his colleagues, including Dr. Paula Clayton, the chairwoman of the psychiatry department, have supported him. Clayton, who has been under fire by some staff psychiatrists for some of her actions, could not be reached on Wednesday.

Page 2 Garfinkel wants to 'get on with things'; Psychiatrist convicted of fraud quits 'U,' opens private practice Star Tribune (Minneapolis, MN) January 5, 1995, Metro Edition When he completes his one year of restricted living, Garfinkel must begin paying off more than $ 210,000 in restitution and fines levied by the federal court, according to Andrew Luger, one of the U.S. attorneys who prosecuted the case. Luger said that about $ 170,000 of it will go to Ciba Geigy as restitution. He said Garfinkel will have to work out a payment schedule. The Minnesota Board of Medical Practice had placed a restriction on Garfinkel that would have made it difficult for him to continue in a research institution. It prohibited him from ever again participating in any drug research studies under threat of losing his license to practice medicine. It also ordered him to provide 1,000 hours of psychiatric service over the following 40 months at a site to be designated, which turned out to be the White Earth Indian Reservation. "The community service was no problem," Garfinkel said. "I was already doing more than what they required." Garfinkel said he spends three days a month on the reservation, seeing patients in a clinic, and in the Mahnomen hospital and high school. "They [the American Indian children] have a lot of learning disabilities and attention-deficit disorders and a high rate of suicide," he said. "Native American youth have a rate of suicide 10 times that of Caucasian youth." He said that no one knows why so many of the youths kill themselves, but he has been looking into the question since he worked in Toronto in the early 1970s. "Some feel it is related to pressures, stress and the lack of organization in their communities," Garfinkel said. "Some feel it is tied to alcohol and substance abuse." Leaving teaching - he had been at the university for 11 1/2 years - has made Garfinkel's life "dramatically different." He said, "I spent a lot of time on national committees. So it [private practice] is very different than my professional work. But I always enjoyed clinical work." He said that although he feels he was wrongfully accused and convicted, he feels grateful to people in the community. "It is amazing how much support I have received and in the many ways people have gone out of their way to support me," he said.

LOAD-DATE: January 9, 1995 LANGUAGE: ENGLISH GRAPHIC: Photograph Copyright 1995 Star Tribune