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23 of 54 DOCUMENTS Star Tribune (Minneapolis, MN) October 10, 1993, Metro Edition

Professor accused of coercing Hmong into 'U' drug study

Copyright 1993 Star Tribune

A psychiatry professor at the University of Minnesota has been accused of coercing Hmong refugees into taking an experimental drug in a research project. Colleagues have complained that Dr. James Halikas, director of the university's chemical-dependency treatment program, conducted an unethical experiment by failing to get informed consent from the patients and refusing to allow them to choose a more effective treatment. Halikas gave the drug, gamma-hydroxybutyrate, known as GHB, to eight Hmong opium addicts who were considered a vulnerable group because of their many medical problems and inability to speak English. Some of the patients repeatedly asked to switch to an alternative treatment, methadone, to help them stop using opium. But most were refused. "This is coercion and is unethical," wrote Dr. Sheila Specker, another doctor in the chemical-dependency program, in a memo to a department official on Aug. 4. Halikas, 52, concedes that he made some mistakes but says that he quickly corrected them and that no one suffered any harm. He vigorously denies coercing any patients into the study and notes that he was the first one to report the problems to the university's Human Subjects Committee. But Steven Yang, a chemical-dependency counselor for the Hmong, said they were "very angry" about what happened to them. He said the Hmong patients had been using opium to deal with chronic depression and pain, a legacy of their experiences during the Vietnam War. The substitute methadone also stopped the pain, but GHB left them suffering. Any attempt to coerce patients, or begin an experiment without informed consent, could be a serious violation of federal and university rules on experimenting with human beings. In fact, the rules are especially strict about protecting patient rights in cases such as this, where most of the subjects don't speak English. The university said Friday that such "serious breaches" could lead to disciplinary action. Two professors in the psychiatry department were so concerned about the study that they called for an investigation by the Human Subjects Committee, accusing Halikas of "a significant breach" of medical ethics. However, the chairwoman

Page 2 Professor accused of coercing Hmong into 'U' drug study Star Tribune (Minneapolis, MN) October 10, 1993, Metro Edition of the department, Dr. Paula Clayton, did not join in that request. Nor did Clayton or any other university officials report the allegations of misconduct to state licensing officials who have jurisdiction over the university drug program. When a state official heard about the allegations, she immediately reported them to the licensing officials and three other state and federal agencies for possible investigation. The licensing unit started an investigation last week. Halikas halted the study Aug. 5, the day after Specker, a junior colleague, wrote her memo citing "serious ethical concerns" about the research. Halikas says he sent a letter to the Human Subjects Committee on Aug. 10, eight days after he was first confronted about the problems by staff members of the department. The committee is now investigating. "I took prompt action as soon as the questions were raised," he said in an interview last week. "I owned up to the error . . . and I stopped the study." But now, he says, some colleagues at the university are overreacting to the situation because of a series of recent public scandals that have embarrassed the medical school. At first, Halikas decided to take an unpaid leave of absence. "I am completely demoralized by the current attitude and behavior of my colleagues," he wrote to Medical School Dean Shelley Chou. But last week, he changed his mind and now says he will fight any attempt to oust him. In a letter to his department head Thursday, he wrote, "I feel that I must postpone my leave until after this cloud hanging over my research project has been cleared up." University officials issued a one-page news release in September announcing that they were investigating allegations that patients "did not fully understand the nature of their participation" in the study. They also said Halikas had taken a voluntary leave. Since then they have refused to answer any questions about the case. Clayton, who is now on a leave of absence, also refused to answer questions about the case. Halikas is now the second professor in his department to face allegations of research misconduct in recent years. The head of child psychiatry, Dr. Barry Garfinkel, was convicted in August of five criminal charges for falsifying data in another drug study and is now awaiting sentencing. By coincidence, the Halikas case began unfolding just as a federal jury was deciding Garfinkel's fate. It began this summer when Halikas started a new study to test the effectiveness of GHB on narcotics addicts. Halikas, a widely published researcher on drug addiction, drew national attention in the late 1980s for his research on a pill to cure the craving for cocaine. He became interested in GHB, a chemical compound found in the human brain, when he learned that it had shown some promise suppressing withdrawal symptoms of heroin and methadone users in Italy. The drug was also widely used in Europe and Asia and was once sold in health food stores in the United States. Last year, Halikas won permission from the Food and Drug Administration to try it in a controlled study. Halikas said the drug is so mild that it has been used in Europe as a children's sedative. However, GHB has been linked to some severe side effects, including vomiting, seizures and coma. Three years ago, the FDA warned consumers to stop using GHB when it was being promoted as a "legal psychedelic" and bodybuilding supplement. More than 70 cases of GHB poisoning had been reported to the FDA by June 1991. Halikas said the side

Page 3 Professor accused of coercing Hmong into 'U' drug study Star Tribune (Minneapolis, MN) October 10, 1993, Metro Edition effects resulted only from larger doses than were given in his study. In July, to get his study going, he turned to a group of Hmong people who had been referred to the university for treatment of opium addiction. Many had started smoking opium in Laos, where it was widely used as a painkiller. The university has built a nationally recognized program around treating such difficult addictions. Most of the Hmong patients came to the university expecting to get methadone, not GHB. But about the same time, Halikas decided to close off the methadone maintenance program to any more Southeast Asians. They could still get it for rapid detoxification in the hospital but could no longer take it on a continuing basis. It was this decision that prompted some of his colleagues to accuse him of coercion, by effectively giving patients the choice of "GHB or nothing," Specker wrote. Halikas, though, says the timing was entirely coincidental. He said he suddenly realized that Southeast Asians had taken up 40 of the 65 slots in the methadone program and had no waiting list, while others had to wait almost 18 months to get in. "Two-thirds of the patients in our program are indeed Southeast Asian, and yet they don't account for probably more than 10 percent of the opiate addicts of the state," he said. From a public health standpoint, he said, that didn't make sense. "If it was based on medical need, the Hmong wouldn't be in the program at all," he said. "Their opium use isn't putting them at risk for HIV, for AIDS, for being shot, for being involved in robberies . . . for having addicted infants. So they're at much less medical risk than are other patients." He said he had to limit the number of Hmong people in the methadone program to make way for rural patients, pregnant women and other addicts. However, that's not what his staff told state and federal officials last year in an application for funds to expand the methadone program. Records show that they emphasized their "special concern" about the need to serve more Hmong and that Hmong were on the waiting list at that time. Halikas was awarded a three-year $ 591,000 federal grant to serve more Hmong as well as other drug addicts. There was no mention then of imposing any limit on their participation. Halikas conceded that his timing was bad. But he said his decision to set a new limit was never meant to coerce anyone into the GHB study. In any case, eight Hmong patients wound up in the GHB study, and they soon started complaining about it. Some went to Yang, the chemical-dependency counselor for the Lao Family Community in St. Paul, who had referred them to Halikas in the first place. He said they told him that methadone stopped the pain but that "the new drug is not as helpful." And they said, "Hey, Steve, you are the Hmong community, and we need your help. You should talk to them." Some patients also complained to Hmong community leaders, or elders, who asked Yang to intervene. But when Yang tried to reach Halikas, the doctor didn't return his calls. By early August, according to Specker's account, "nearly all" of the patients had asked "to be taken off GHB and placed on traditional methadone." But, she wrote, "Dr. Halikas stated to me that objectively they were doing 'fine' in their withdrawal, and that meant that the drug should be continued despite their vocalization of wishing to discontinue the drug. He also stated to me that the

Page 4 Professor accused of coercing Hmong into 'U' drug study Star Tribune (Minneapolis, MN) October 10, 1993, Metro Edition patients were happy with the drug." For his part, Halikas said he knew that some of the patients were unhappy in the study. But he said this was mainly because they didn't like going through withdrawal pains, which the GHB wasn't able to eliminate as well as methadone. In a written report, he said the patients didn't know the difference between withdrawal symptoms and side effects, so he and his medical team made "clinical distinction" and kept them on the GHB. When discomfort was truly a side effect of the drug, he said, the GHB was stopped or reduced. Almost immediately, Specker and the clinical director, Gregory Carlson, started raising concerns about the project. First, on Aug. 2, Carlson complained to Halikas that he had some serious ethical concerns about the study. Then Specker confronted him, asking why none of the patients had consent forms in their files. Specker wrote that Halikas "stated that the drug had been tried in Europe and was equivalent to using a vitamin. Therefore, he did not think that a consent form was necessary." Specker "strongly disagreed" and took her concern to Clayton, the department chairwoman. In meeting with Clayton, Halikas agreed to start getting consent forms. Later that day, he told Specker that he had obtained the signed consents from the four who were still in the hospital. He concedes, however, that he never obtained consent forms from the other four, who had already left the study. "I don't believe that I was abrogating any rules that involved patient safety," he said. "I do admit in retrospect that they should have signed the informed consent. But they were consenting every time they got the medication. They had to come up and ask for it." He also said two patients did stop taking the drug. "The medication was never forced on anyone." But Specker clearly wasn't satisfied. On Aug. 4, she sent her four-page memo to the chief of adult psychiatry, Dr. James Mitchell, spelling out her concerns. Among other things, she said Halikas had deprived them of a known effective treatment, methadone, in favor of an untried substance, GHB. And that, she wrote, was unethical. Halikas disagreed. Even methadone is still considered experimental for opium addicts, he wrote, so it can't be considered standard. And its effectiveness is still an open question, he said, because it merely replaces one form of addiction for another. "It's effective in the sense that they're not smoking opium. But when you look at it you say, gee, what have you done? We've changed them from something they do at home to something they have to come to the clinic for every day." However, his program touted the benefits of methadone for Hmong patients in last year's grant application. It stated that methadone has been "very helpful to these [Hmong] patients and is a pharmacotherapy of choice." Halikas and Specker agree on one point: This group of Hmong patients was a poor choice for an experimental study, because of language and cultural barriers. Doctors had to use interpreters to talk with patients. "That's why we had to stop," Halikas said. "That's why I was willing to stop. I'm not sure we can get informed consent from this population. . . . I did not think about it in advance, but when it was brought to my attention, I reacted promptly." In spite of the criticism, Halikas said the study was worth the try. "What I was trying to do was just see if this drug was any damn good," he said last week.

Page 5 Professor accused of coercing Hmong into 'U' drug study Star Tribune (Minneapolis, MN) October 10, 1993, Metro Edition "It really is a risk-benefit ratio that is the basis of all of human research," he said. "And the risk of this nutrient that has been available without a prescription for so many years, was really that there were no risks. And the potential benefit of having them not be addicted to a narcotic that we've not been able to get them off of [methadone] would have been a tremendous benefit." On Aug. 5, Halikas called off the study after a meeting with Clayton, Specker and other staff members. The next week, he wrote the Human Subjects Committee that he had stopped the study "because of irregularities . . . which raised reasonable questions about the possibility of coercion in a vulnerable population with very poor levels of communication in English." And he promised not to resume the testing without the help of a Hmong community advisory board. If he thought that would settle the matter, he was wrong. On Aug. 23, two of his colleagues, Mitchell and Dr. Thomas MacKenzie, wrote the same committee calling for an investigation. Three days later, Halikas told the Medical School dean that he was going to take a leave of absence in November. Shortly after, Specker was named to replace him as director of the chemical-dependency program. Clayton, the department chairwoman, appealed for calm in a Sept. 9 letter to a university attorney who is working with the Human Subjects Committee's investigation. She said that Halikas had already taken the proper steps in the wake of the problems and that he deserved due process from the university. But Halikas suspects that he can't get a fair hearing because of widespread rumors about the case. "My rights are all twisted up," he said Thursday. "I can't get due process when everybody's buzzing. So today I rescinded my leave." Yet the case has already gone beyond the university. The licensing division of the state Human Services Department is investigating possible abuse and neglect of patients. The three other government agencies that were asked to look into the case - the FDA, the Board of Medical Practice and the state Health Department - have not disclosed whether they will do so. Said Patricia Harrison, planning director of the state alcohol and drug authority, which oversees Halikas' grant: "It definitely should be investigated any time anybody raises questions about the care a chemical-dependency client is getting."

LOAD-DATE: October 14, 1993 LANGUAGE: ENGLISH GRAPHIC: Photograph Copyright 1993 Star Tribune

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2 of 2 DOCUMENTS Saint Paul Pioneer Press (Minnesota) July 10, 1996 Wednesday METRO FINAL EDITION

JUDGE DISMISSES DOCTOR'S SUIT AGAINST U; INVESTIGATION OF STUDY DID NOT VIOLATE RIGHTS
BYLINE: BYLINE: Patrick Sweeney, Staff Writer SECTION: METRO; Pg. 3B LENGTH: 589 words

After two years of litigation, a federal judge Tuesday dismissed a lawsuit filed against the University of Minnesota by a prominent member of the university's psychiatry faculty. U.S. District Judge James Rosenbaum ruled that Dr. James Halikas was not improperly denied due-process rights during an internal university investigation. The civil lawsuit grew out of allegations that Halikas failed to inform Hmong patients about the risks of a drug they received in a university-sponsored study of opium addiction. In an affidavit filed in the fall, the lawyer then representing Halikas said federal authorities had begun a criminal investigation of Halikas. On Tuesday, Assistant U.S. Attorney Hank Shea refused to comment on the criminal investigation. In 1993, Halikas, a tenured professor and director of the university's Chemical Dependency Treatment Program, was testing the efficacy of a drug known as gamma-hydroxybutyrate to help addicts trying to break their opium habits. In September of that year, the university issued a press release announcing that the university's Institutional Review Board - a watchdog group established to protect patients and to oversee compliance with research rules - was beginning an investigation of the allegations against Halikas. A junior faculty member had raised questions with her superiors about whether Halikas properly warned the Hmong addicts and informed them about their right to choose methadone instead of gamma-hydroxybutyrate. Halikas suspended the drug trial before the investigation ever formally began. The Institutional Review Board eventually concluded that Halikas had "exploited vulnerabilities" of his research subjects. The board suspended Halikas' right to use human subjects in research projects, but it invited him to re-apply for such permission. He also was removed as director of the Chemical Dependency Treatment Program. But the university never instituted disciplinary proceedings seeking to revoke Halikas' status as a tenured professor. In 1994, Halikas filed his lawsuit against the university, alleging the Institutional Review Board denied him an opportunity to cross-examine witnesses who testified during its investigation. Halikas also argued that the university

Page 2 JUDGE DISMISSES DOCTOR'S SUIT AGAINST U;INVESTIGATION OF STUDY DID NOT VIOLATE RIGHTS Saint Paul Pioneer Press (Minnesota) July 10, 1996 Wednesday METRO FINAL EDITION should not have issued the press release about the case. Rosenbaum granted the university's motion for a summary judgment in the case, ruling that Halikas was notified of the accusations against him and took advantage of an opportunity to appear before the board. Rosenbaum said neither university policies nor federal research regulations gave Halikas further due-process rights, similar to those he would have in a criminal prosecution. University Attorney Mark Rotenberg called the ruling a significant victory. "A federal judge has ruled," Rotenberg said, "that the university was fair, and is fair, and is protecting humans who are the subject of experiments in our medical school." Halikas, who said he had spent $100,000 of his own money on legal fees before his lawyers dropped his case, said Tuesday that he planned to continue seeking vindication through the University Senate. Halikas said university administrators took a get-tough approach to his case because of scrutiny the university was under after the federal criminal conviction of another psychiatry professor, Dr. Barry Garfinkel, and the criminal investigation that eventually ended in the acquittal of Dr. John Najarian. "It got caught up in the hysteria," Halikas said. LOAD-DATE: October 21, 2002 LANGUAGE: ENGLISH Copyright 1996 St. Paul Pioneer Press All Rights Reserved

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1 of 5 DOCUMENTS Star Tribune (Minneapolis, MN) May 26, 1998, Metro Edition

'U' psychiatrist is fined for improperly conducting drug trials

A University of Minnesota psychiatrist has been reprimanded and fined $ 3,500 by the state Board of Medical Practice for giving an experimental drug to opium addicts without their consent in 1993. Dr. James Halikas, 56, was one of four physicians disciplined this month for unprofessional or unethical conduct, the board announced today. Halikas, a professor of psychiatry, admitted that he failed to get signed consent forms before enrolling a group of Southeast Asian immigrants in the experimental treatment program, according to a signed agreement with the board. Halikas was the lead scientist on a study to test a drug called GHB, or gamma-hydroxybutyrate, as a possible treatment for opium addiction. He admitted that eight patients were started on the drug without signing consent forms, as required by federal law and university policy for human trials. Three patients signed the forms after they started taking the medication. The study was cut short in August 1993 after colleagues complained about how he was handling it. At the time, Halikas was a member of the university's human subjects committee, which polices all such research. The university expelled him from the committee, reprimanded him and suspended his right to work on research using human subjects. Although he's free to apply to resume such research, he has not been involved in any since then, the university says. In the agreement released today, Halikas also admitted to other violations in the study. Although patients were told they could drop out at any time, several were turned down when they complained about GHB and asked for more methadone, the traditional treatment given in combination with GHB. And two patients were given higher than approved doses. In addition to the reprimand and fine, the agreement states that Halikas must be supervised by another physician for two years and must notify the medical practices board of any involvement in human research. "The consent order is the last piece of the chapter that was done five years ago," Halikas said. "Now we can all put the episode behind us." In other disciplinary actions: - Dr. William Hosfield, 56, a psychiatrist from Golden Valley, was disciplined for unprofessional conduct in connection with his treatment of a suicidal patient who was hospitalized under his care. He admitted that he disclosed information about the patient's sexual behavior to her father without her consent; and that he contacted the patient after her mother fired him. He was fined $ 10,000 and barred from providing individual psychotherapy for at least three

Page 2 'U' psychiatrist is fined for improperly conducting drug trials Star Tribune (Minneapolis, MN) May 26, 1998, Metro Edition years. He also was required to undergo drug testing and complete a course in professional boundaries. - Dr. Donald Krabill, 66, of Wabasha, was disciplined for the third time by the board for chemical dependency and for improperly prescribing drugs. His license was restricted in 1990 because of his own chemical dependency, and in 1993 for prescribing narcotics to his wife, who also was chemically dependent. In the current case, he admitted that he improperly prescribed drugs to a family member in 1996 and that he gave prescriptions to three people with a history of chemical dependency, two of whom shared the drugs with his wife. Krabill was ordered to undergo therapy and drug testing and to attend a course in professional boundaries. His practice will be limited to pre-approved group settings under another doctor's supervision for at least four years. His attorney, Theodore Collins, said the conduct has not affected Krabill's practice because he travels around the state filling in for other physicians. "I think he's a good doctor, and I'm happy that they've allowed him to continue with appropriate restrictions," Collins said. - Dr. Mark Stevens, 43, a neurosurgeon in La Crosse, Wis., was reprimanded and fined $ 500 for engaging in a sexual relationship with a patient from 1992 to 1994 when he was a Navy physician in San Diego. Stevens was court-martialed for the offenses in 1996. Now practicing in La Crosse, he agreed to refrain from sexual conduct with patients, to undergo therapy and professional boundaries training, and to limit his practice to group settings under a supervising physician for two years. His lawyer, David Bunde, said Stevens has "really turned his life and his practice around" since the incident.

LOAD-DATE: May 27, 1998 LANGUAGE: ENGLISH Copyright 1998 Star Tribune