University of Minnesota suspends psychiatric drug studies enrollment due to reaction to student death

A report in Science Magazine based on a press release form the University of Minnesota

The University of Minnesota has halted patient enrollment in all psychiatric drug studies after a state report criticized the school’s handling of a suicide during a clinical trial in 2004. The report, released last Thursday by Minnesota’s Office of the Legislative Auditor, says the university’s reaction to both the death of 27-year-old Dan Markingson and subsequent calls for investigation have “seriously harmed” its credibility and reputation. The report also argues that the Markingson case “raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge.” Markingson had been enrolled in a trial for antipsychotic drugs while committed involuntarily to a university hospital. One of the trial leaders was his treating psychiatrist.

The university’s president, Eric Kaler, announced that his school would suspend enrollment in current and upcoming drug studies in the Department of Psychiatry until they could be reviewed by an outside institutional review board (IRB). The school’s IRB came under fire last month after a separate review suggested the panel was not examining trials as closely as it should be.

Although the two reports are very different, their authors express at least one overlapping worry: that the school has not responded well to criticism. In the words of the auditor’s report: “A primary problem uncovered by our review is past and current University leadership that is defensive, insular, and unwilling to accept criticism about the Markingson case either from within or outside the University. However, we do not have a recommendation that would change attitudes. … We can only suggest that the Legislature make the issue—and need for change—a more important consideration in selecting people to serve on the University Board of Regents.” The report recommends that the state legislature enact new laws that would allow the legislature to more closely monitor participation in psychiatric drug studies at the university.

The Board of Regents will meet this Friday to discuss the report.

Numerous news reports on the Scandal of the Death of Dan Markingson

A list of resources related to the death of Dan Markingson who was a psychiatric research subject who died during an experiment.

1. "Student dies at Rochester in MIT-based study,” Massachusetts Institute of Technology News Release, April 10, 1994.
2. In the Matter of the Civil Commitment of Daniel Markingson, State of Minnesota, County of Dakota, Court File PX-03-10465, November 17, 2003.
3. House Research Bill Summary, File Number H.F. 3553, Authors: Pugh, Whelan, and Bernardy; Subject: Clinical drug trials; oversight, Analyst: Lynn Aves, April 4, 2016.
4. Aftercare agreement for Dan Markingson, December 8, 2003.
5. "The Academic Health Center Responds to Carl Elliott’s Media Outreach," September 1, 2010.
6. “Once-Secret Drug-Company Records put U on the Spot,” Star Tribune (Minneapolis), March 19, 2009.
7. In the Matter of the Civil Commitment of Dan Markingson, Respondent, State of Minnesota, County of Dakota, File No. PX-O3-10465, November 20, 2003.
8. Aaron Friedman, “University of Minnesota research case is not a scandal,” Star Tribune (Minneapolis), May 16, 2013.
9. Alex Friedrich, “U's handling of drug study suicide earns an 'F' among peers,” Minnesota Public Radio News, April 23, 2015.
10. Alexandros Stamatoglou, “The Physician Payment Sunshine Act: An Important First Step in Mitigating Financial Conflicts of Interest in Medical and Clinical Practice,” 45 John Marshall Law Review 2012, pp. 963-990.
11. Alicia Mundy, “Sting Operation Exposes Gaps in Oversight of Human Experiments,” Wall Street Journal, March 26, 2009.
12. Andy Mannix, “Charles Schulz under Scrutiny for Seroquel Study Suicide,” City Pages, February 2, 2011.
13. Andy Mannix, “Dan Markingson's 2004 suicide: 'Corrective Action' issued to former U of M employee,” City Pages, November 13, 2012.
14. Arne Carlson,“Markingson case: University of Minnesota can't regain trust under current leadership,” Star Tribune (Minneapolis), April 13, 2015.
15. Association for the Accreditation of Human Research Protection Programs. An External Review of the Protection of Human Research Participants at the University of Minnesota with Special Attention to Research with Adults Who May Lack Decision-making Capacity, February 23, 2015.
16. Board of Regents of the University of Minnesota and Institutional Review Board, Notice of Taxation of Costs and Bill of Costs and Disbursements, State of Minnesota, County of Hennepin, Court File 27 CV-07-1679, April 29, 2008.
17. C. Fred Alford, Whistleblowers: Broken Lives and Organizational Power (Cornell University Press, 2002).
18. C.M Michael, S.J, Nass, G.S. Omenn (eds), Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Board on Health Care Services; Board on Health Sciences Policy; Institute of Medicine; Evolution of Translational Omics: Lessons Learned and the Path Forward, Washington (DC): National Academies Press (US); 2012.
19. Carl Elliott, "The Deadly Corruption of Clinical Trials." Mother Jones, September/October 2010, 54-63.
20. Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.
21. Carl Elliott, "Getting by with a Little Help from Your Friends." Hastings Center Bioethics Forum, October 18, 2013.
22. Carl Elliott, “The Best-Selling, Billion-Dollar Pills Tested on Homeless People,” Matter, July 27, 2014.
23. Carl Elliott, Matt Lamkin, “Restrict the Recruitment of Involuntarily Committed Patients for Psychiatric Research, JAMA Psychiatry 2016; April 1; 73(4):317-8.
24. Charlotte Haug, “What Happened to Dan Markingson?” Journal of the Norwegian Medical Association, 133, pp. 2443-2444.
25. Chris Hansen, “The Hansen Files: Drug Trials,” Dateline NBC, March 4, 2012.
26. Clinical Research and Compliance Consulting, "University of Minnesota Department of Psychiatry Assessment Report," December 31, 2015.
27. David Evans, Michael Smith, and Liz Willen, “Big Pharma's Shameful Secret,” Bloomberg Markets 14 (2005): 36–62.
28. Debra Dykhuis, Human Research Protection Program, letter to Robert Huber, May 6, 2015.
29. Debra Dykhuis, Human Research Protection Program, letter to Carl Elliott, June 5, 2015.
30. Duff Wilson, “For $520 Million, AstraZeneca Settles Case Over Marketing of a Drug,” New York Times, April 27, 2010.
31. Eden Almasude, “A Medical Student’s Call for Action Against Research Misconduct,” Bioethics Forum, June 3, 2014.
32. Emily Kaiser and Tom Webber, “Arne Carlson: U needs leadership overhaul after Markingson case,” Minnesota Public Radio News, April 13, 2015.
33. Ezekiel J Emanuel, Trudo Lemmens, Carl Elliott, “Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?” PLoS Medicine, July 25, 2006.
34. Gardiner Harris, “Report Assails F.D.A. Oversight of Clinical Trials,” New York Times, September 28, 2007.
35. Gina Kolata, “Johns Hopkins Admits Fault in Fatal Experiment,” New York Times, July 17, 2001.
36. J. Jacobson, Report of Examiner. Dakota County Court File No. PX-03-10. November 19, 2003.
37. J.P. McEvoy, J.A. Lieberman, et al. "Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison, American Journal of Psychiatry. 2007 July; 164(7):1050-60.
38. Jeanne Lenzer, “Drug Secrets: What the FDA Isn’t Telling,” Slate.com, September 27, 2005.
39. Jeff Baillon, “Nurse questions integrity of U of M drug researchers,” Fox 9 News (KMSP), May 19, 2014.
40. Jeff Baillon, “Nurse questions integrity of U of M drug researchers," Fox 9 News, KMSP, November 25, 2014.
41. Jeff Baillon, "U of M Drug Study Criticism Grows." Fox 9 News. KMSP. May 19, 2014.
42. Jeff Baillon, “Another Ethics scandal for the University of Minnesota Department of Psychiatry,” Fox 9 News, KMSP, July 15, 2014.
43. Jennifer Couzin-Frankel, “A Lonely Crusade,” Science, May 23, 2014;344(6186):793-7
44. Jennifer Couzin-Frankel, “Human subjects protections under fire at the University of Minnesota,” ScienceInsider, March 2, 2015.
45. Jeremy Olson, “Review finds lapses at University of Minnesota psychiatry department,” Star Tribune (Minneapolis), February 11, 2016.
46. Jeremy Olson, “Auditor to review U's drug trial suicide,” Star Tribune (Minneapolis), June 19, 2014.
47. Jeremy Olson, “U psychiatry chief steps down in wake of research criticism,” Star Tribune (Minneapolis), April 13, 2015.
48. Jeremy Olson, “Minnesota House, Senate Unanimously Pass Limits on Researchers’ Use of Mentally Ill Patients,” Pioneer Press (St. Paul), May 8, 2009.
49. Jo Zillhardt, Office of the Ombudsman for Mental Health and Mental Retardation, Medical Review Subcommittee, letter on death of Dan Markingson, June 17, 2005.
50. Jo Zillhardt, Office of the Ombudsman for Mental Health and Mental Retardation, Medical Review Subcommittee, letter on death of Dan Markingson, June 17, 2005.
51. Judy Stone, “A Clinical Trial and Suicide Leave Many Questions: Part 6: The Run-Around, or Why I Now Call for an Independent Investigation of University of Minnesota,” Scientific American Molecules to Medicine blog, March 26, 2013.
52. K. Geister, Report of Pre-petition Screening Team Re: Daniel Markingson, Respondent. November 17, 2003.
53. Katie Thomas, “A Drug Trial’s Frayed Promise,” New York Times, April 17, 2015.
54. Kia Farhang and Marion Renault, “Faculty push for independent research review," Minnesota Daily, December 09, 2013.
55. Laura Stark, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2011.)
56. Laws of Minnesota 2009, chapter 58; codified as Minnesota Statutes, 253B.095, subdivision 1(d)(4) and (e).
57. Leigh Turner, “The U of M should thoroughly investigate issues in the Markingson case,” MinnPost, March 11, 2014.
58. Mark Yarborough, Kelly Fryer-Edwards, Gail Geller, Richard R. Sharp, “Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors,” Academic Medicine 2009 April; 84(4):472-7.
59. Mark Yarborough, Kelly Fryer-Edwards, Gail Geller, Richard R. Sharp, “Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors,” Academic Medicine 2009 April; 84(4):472-7.
60. Matt Lamkin, “Will the U review or whitewash a research subject’s death?” Star Tribune (Minneapolis), December 18, 2013.
61. Matt Lamkin, Carl Elliott, “University of Minnesota research lapses show self-reform is failing,” Star Tribune (Minneapolis), February 11, 2016.
62. Meghan Holden, “Kaler talks Markingson case, bowl game,” Minnesota Daily, December 11, 2013.
63. Minnesota House of Representatives, Higher Education Finance and Policy Committee, April 13, 2016 (testimony on audio recording at 20 minutes.)
64. NMS Labs, Toxicology Report, Patient name: Dan Markingson, Minnesota Regional Medical Examiner’s Office, February 14, 2008.
65. Office of the Inspector General, U.S. Department of Health and Human Services, Institutional Review Boards: A Time for Reform, June, 1998.
66. Office of the Legislative Auditor, State of Minnesota, A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case, March 19, 2015.
67. Paul Tosto and Jeremy Olson, "The death of subject 13." Pioneer Press (St. Paul), May 18, 2008.
68. Peter Aldous, “Why Are Dope-Addicted, Disgraced Doctors Running Our Drug Trials?” Matter, July 28, 2014.
69. Public Citizen, Health Research Group, Public letter to President Eric Kaler, June 16, 2014.
70. Richard Smith, “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies,” PloS Medicine, May 17, 2005.
71. Robert Klitzman, The Ethics Police: The Struggle to Make Human Research Safe (Oxford University Press, 2015), p. 79-80.
72. Roberto Abadie, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Duke University Press, 2010.)
73. Sabriya Rice, “Policing the ethics police: Research review boards face scrutiny as feds propose new rules,” Modern Healthcare, December 12, 2015.
74. Sharon Matson. FDA Establishment Inspection Report, Stephen Olson MD. Report no. FEI 3004927371. July 22, 2005.
75. Shirley Wang and Avery Johnson, “AstraZeneca Papers Raise Seroquel Issues,” Wall Street Journal, February 27, 2009.
76. State of Minnesota Board of Social Work, Agreement for Corrective Action in the Matter of Jean M. Kenney, November 8, 2012.
77. Susan Perry, “U of M Suspends Enrollment in Psychiatric Drug Trials in the Wake of Scathing Report on Markingson Case,” MinnPost, March 20, 2015.
78. Susan Perry, “U of M Suspends Enrollment in Psychiatric Drug Trials in the Wake of Scathing Report on Markingson Case,” MinnPost, March 20, 2015.
79. Trudo Lemmens and Paul Miller, “The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives,” Journal of Law, Medicine and Ethics Fall 2003; 31: 3, pp. 398-418.
80. U.S. Department of Health and Human Services, Office for Human Research Protections, Institutional Review Board Guidebook, Cognitively Impaired Persons, Chapter 6(D), 1993.
81. William Heisel, “The Markingson Files: Conflicts of interest in clinical trials should be transparent,” Reporting on Health, June 06, 2011.
82. Zachary Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Johns Hopkins University Press, 2010).

Why the University of Minnesota psychiatric research scandal must be investigated

As writen by Carl Elliot, and Published on the MinnPost Website

Carl Elliott is a professor in the Center for Bioethics at the University of Minnesota.

Three former editors of the New England Journal of Medicine have called for an investigation. So has the scholar who uncovered the Guatemala syphilis studies. The former Health and Disability Commissioner of New Zealand has called the conduct of the researchers “unethical,” pointing out the need to “put in safeguards in place to prevent a similar tragedy from happening again.” A recent Medical Journal of Australia editorial compared it to the exploitation of poor black men with syphilis in Tuskegee, Ala. Yet the University of Minnesota, where the research scandal occurred, simply keeps repeating, “Nothing to see here, folks. Just move along.”

The research abuse in this case is so stunning that when I first learned about it I could scarcely imagine it happening anywhere, much less at the university where I work. In late 2003, psychiatric researchers at the University of Minnesota recruited a mentally ill young man named Dan Markingson into a profitable, industry-funded research study of antipsychotic drugs. The researchers signed him up over the objections of his mother, Mary Weiss, who did not want him in the study, and despite the fact that he could not give proper informed consent. Dan was acutely psychotic, plagued by delusions about demons, and he had repeatedly been judged incapable of making his own medical decisions. Even worse, he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.

For months, Mary tried desperately to get Dan out of the study, warning that he was getting worse and that he was in danger of committing suicide. But her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, “Do we have to wait for him to kill himself or someone else before anyone does anything?” Three weeks later, Dan committed suicide in the most violent way imaginable. His body was discovered in the shower of a halfway house, his throat slit so severely that he was nearly decapitated, along with a note that said, “I went through this experience smiling.”

Conflicts of interest, other issues

As outrageous as that sounds, there is more. The psychiatrists had financial conflicts of interest from their work with the pharmaceutical industry. The study sponsor also provided financial incentives for the researchers to keep subjects in the study as long as possible. Last fall, the state Board of Social Work found that the study coordinator had falsified the initials of doctors on study records, failed to warn Dan of new dangers of the study drugs, had been given medical responsibilities far beyond her training as a social worker, and had failed to respond to Mary’s warnings that Dan was in danger of killing himself.

After Dan’s suicide, it got even worse. When Mary’s lawsuit against the university was dismissed on technical grounds of “sovereign immunity,” the university lawyers filed a legal action against her called a “notice to assess costs,” demanding that she pay them $57,000 in legal fees. Yes, you read that correctly: The U tried to force the mother of a suicide victim to pay it $57,000.

None of this is a secret. The case has generated international outrage. Yet for three years the University of Minnesota has managed to bluster and stonewall its way through all the criticism, insisting that it has already been exonerated. Even when the state Legislature passed “Dan’s Law” in 2009, banning psychiatrists from recruiting mentally ill patients under an involuntary commitment order into drug studies, the university continued to insist it had done nothing wrong.

A petition to Gov. Dayton

Two weeks ago, as a last resort, Mary Weiss, the mother of Dan Markingson, and her friend Mike Howard started a petition to Gov. Mark Dayton. Their request is simple: Please appoint an external, impartial panel to investigate the scandal. More than 1,200 people have signed, including well over 150 academic experts. Many University of Minnesota alumni have joined as well. A typical but telling comment: “I am ashamed of my alma mater right now.”

This is not an issue from the distant past. We do not know if other research subjects have died, or if they have been injured or mistreated. We do not even know if mistreatment is still continuing today. That may well be the most compelling reason for Minnesotans to sign the petition. If a case of research abuse this brazen can be sanctioned and defended by the university, there is no way to feel confident that other research subjects are being protected. In 2004 it was Dan Markingson. But it could have been any of us.

Minnesotta Psychiatrist admits having sex with patient and calling it therapy

From a report in the Star Tribune

A New Brighton psychiatrist charged with sexually assaulting one of his patients pleaded guilty to one count of criminal sexual conduct Monday in Hennepin County District Court.

Thomas Folsom, 53, admitted to having sex with the patient and calling it therapy. He had been charged with four counts of criminal sexual conduct in the third degree; three of the charges were dropped.

According to the charges, the patient said Folsom told her that he was doing her a favor by engaging in sex with her and that she gradually became emotionally dependent on him. She also said she was led to believe it would be difficult for her to find someone to marry if she did not engage in sex acts with Folsom.

The patient began seeing Folsom two to three times a week in 1999 for depression and eating disorders. By May 2002, she was seeing him daily. When the patient's father became concerned after she had been charged about $77,000, Folsom said he would continue working with her for free.

Prosecuting attorney Theresa Galatowitsch said she will ask for the maximum sentence of 48 months. Sentencing is scheduled for Sept. 11.

The Decline of Psychiatry, Part 5

As seen in a comment by a reader made earlier on this blog:

Psychiatry residency programs now are happy if they get 55% U.S. medical school graduates, that's an increase over what it has been.

What do you call the U.S. medical school graduate who places last in his class? A psychiatry resident.

We have this news report on shortages of psychiatrists in Minnesota. Seems people are not signing up for the field. of course, we have to supply some snippets from the report as seen in The Daily News (of the Wahpeton, ND - Breckenridge, MN area).

A shortage of psychiatrists in Minnesota has caused a strain on current workers and left cities struggling to replace them. Some reasons behind the shortage include low pay in comparison to other jobs in the field and public stigma of the position. In 2004, a Minnesota Public Radio report revealed the state had one psychiatrist for every 10,000 people.

There is little evidence the problem will cease, especially in rural areas. Stefan Gildemeister, assistant director of the health economics bureau at the Minnesota Department of Health, said present calculations for the state are the same.

"A recent study we did, which looked at surveys in greater Minnesota, showed the vacancy rate for psychiatrists was higher than for any other specialty," he said. Breckenridge faces its own significant ratio. A maximum of 136 psychiatric patients walk through the doors of the Hope Unit at St. Francis Healthcare Campus per week, but there is only one psychiatrist to help them. "Many people who attend medical school do not plan on going into psychiatry," said Nancy Torson, MD, at the Hope Unit. "Historically, it has been difficult for programs to fill residency slots, and often they can't fill them."

[...] As psychiatry is one of the lower paying jobs in the field, Torson said "the patient population doesn't appeal to many med students."

[...]

Let's see, could there be lower esteem in the eyes of the public? Would all those news stories about shaky and suspect practitioners have anything to do with this? It sounds like you really have to want to be a psychiatrist to become a psychiatrist.

Psychologist charged with filing false rape report to cover up a marital affair.

From the Pioneer Press

A psychologist who claimed she was raped by a patient in her Selby Avenue office lied about the incident to cover up her extramarital affair with the man, according to a court document.

Jill Marie Ajao, 41, was charged Friday in Ramsey County District Court with falsely reporting a crime, a misdemeanor.

A call left at her home in St. Paul was not immediately returned.

On Oct. 26, 2006, police responded to a call from Ajao at her office, where she appeared "crying and visibly upset," the complaint said.

The complaint goes on:

Ajao told police that two days earlier, a new patient named "Jeff" had come in for a scheduled appointment at 2 p.m. During the session, "Jeff" raped her, she said, providing specifics of the rape.

The next day, police contacted a Minnesota Bureau of Criminal Apprehension sketch artist, who worked with Ajao to design a likeness of the suspect.

The day after that, Ajao changed her statement, saying she'd met the man at a bar down the hall from her office. She also said she had been at a sexual aids store called the Love Doctor on University Avenue and speculated that the man had seen her there and somehow found out who she was.

On Oct. 30, police interviewed a witness from the bar, who said she recalled Ajao being there with a man, and that they seemed familiar to each other. Police released to the media a surveillance photo of the man leaving the bar and received "hundreds" of calls in response from the public.

In January, Ajao met with St. Paul police Sgt. Paul Schnell at her request - changing her story again.

This time, she said she met a man online, and they got together Oct. 24 when she called him. She told police "there was an expectation that there would be no sex" but that her real intention was to "surprise and pleasure her husband" by putting an encounter together.

It was not immediately clear what she intended regarding her husband.

Still later, in February, Ajao sent an e-mail to the man, which was obtained by police. In it, the man asked if she "finally admitted that the encounter was consensual and that she claimed rape to cover up an affair." She replied that she had.

Police said the case is highly unusual and emphasized that real victims would be believed, as Ajao initially was

Three Minnesota state drug panel advisers declare potential conflicts of interest

As seen in the Pioneer Press

A Minnesota panel that chooses drugs for low-income Medicaid patients started operating under a new, tougher conflict of interest policy on Tuesday.

Members of the Medicaid Drug Formulary Committee now must declare potential conflicts of interest in writing, after an Associated Press review of drug company disclosure records found financial relationships between two members and the drug industry.

Three committee members - including psychiatrist John Simon, who got more than $350,000 from drug companies while serving on the panel - disclosed potential conflicts. The new policy requires them to reveal employment, compensation, honoraria, paid testimony, free travel and other perks in the past five years.

Pharmacist Margaret Artz disclosed that her daughter works as a sales representative for Novartis in Wisconsin and abstained from voting on three drugs made by the Swiss pharmaceutical company.

"While I do not consider her job as an influence on my judgments either on the DFC or in my own areas of employment, there may be the appearance of a conflict of interest," Artz wrote in her disclosure statement. "Therefore, I will abstain from voting on any matter relating to any Novartis product. If there are other or additional actions the MN Department of Human Services wishes me to do, I will comply."

Panelist Mary Graves disclosed that she worked for 3M Pharmaceuticals for three years ending in 2005. No drugs made by 3M came up at Tuesday's meeting.

Simon's form listed "Speaker's bureau for Eli Lilly, AstraZeneca, Forest, Wyeth" and "meals at talks; $55.00/year." He abstained from a vote on asthma drugs, one of them made by AstraZeneca.

Simon will leave the panel because of discomfort about his pharmaceutical ties at the Minnesota Psychiatric Society, which originally asked him to serve.

Dr. William Korchik, the panel's chairman, noted the "increasing interest about conflict of interest."

He asked that future public meeting agendas include the manufacturers of drugs scheduled for discussion. That information hasn't appeared in the past, although many of the pharmaceutical representatives who attend the meetings are keenly aware of whose products are being discussed.

"It's gotten so complicated, with some drugs where there might be agreements between more than one company," Korchik said. "It would be useful to have that on our agenda."

The Drug Formulary Committee helps shape state policy on prescription drugs for about 200,000 Medicaid patients, many of them disabled or mentally ill people whose medical bills are paid directly by the state. Last year, the panel's recommendations guided spending on $240 million worth of medications.

Psychiatrist quits drug panel over $350,000 in speaking and consulting fees from pharmaceutical companies

From the AP News report

A Minnesota psychiatrist who received more than $350,000 in speaking and consulting fees from pharmaceutical companies will quit a panel that advises the state on drugs for low-income Medicaid patients.

Dr. John E. Simon said on Wednesday that he will resign because the organization that originally asked him to serve, the Minnesota Psychiatric Society, was "a little uncomfortable with the appearance of conflict of interest" posed by his panel membership.

Financial relationships between the drug industry and two panel members, including Simon, came to light when The Associated Press reviewed disclosure records filed by drug companies under a pioneering state law. Eli Lilly & Co. and other drug makers paid Simon more than $350,000 in honoraria and fees while he was serving on the Minnesota Medicaid Drug Formulary Committee. Another adviser who resigned last year got $78,000.

The Minnesota Department of Human Services is asking the panel members to sign off on a new policy requiring them to reveal "real or perceived" conflicts of interest, including honoraria, compensation, free travel or other perks from drug companies within the past five years.

They must abstain from voting on "any related matters that may come before the committee."

Department spokeswoman Karen Smigielski said committee members are expected to approve the new policy before their next meeting on Tuesday.

The panel advises the human services agency on roughly $240 million worth of drugs for more than 200,000 patients, most of them mentally ill or disabled.

Simon said his work as a paid speaker didn't influence his decisions on the committee. He joined the panel in mid-2004, and said he will resign when the Psychiatric Society picks another psychiatrist to replace him.

"I thought I did a good job of representing the patients of the Society and for the interest of psychiatric patients," he said. "I have not heard otherwise."

Linda Vukelich, the Minnesota Psychiatric Society's executive director, praised Simon's service but said there were concerns that he would have to sit out key votes under the new policy. She said the organization is grappling more broadly with the influence of business, including the drug industry, on medicine.

"It's bigger than just one appointee or one situation," she said.

Ethics experts have said the links between Minnesota's drug advisers and the industry raise the possibility of similar arrangements in other states. But tracing the influence is difficult: Outside of Minnesota, only Vermont and Maine require drug companies to report payments to doctors for speeches, consulting and other services.

Minnesota psychiatrist reprimanded by Medical Board

From the Star Tribune

Dr. Larry Berger, an Eden Prairie psychiatrist, has been reprimanded by the Minnesota Board of Medical Practice for having an improper sexual relationship with a former patient.

Berger, 56, was cited for inappropriate conduct in a settlement agreement he reached with the board.

According to the agreement released Wednesday, Berger and a former patient he had treated irregularly for six years started chatting anonymously on the Internet in January 2005. He had treated the patient for the last time about eight months earlier, according to the board document.

After the patient and Berger decided that their physician-patient relationship had ended, they commenced a sexual relationship.

In January 2006, the board received a complaint about Berger.

Board officials said there are no specific rules regarding personal relationships between doctors and patients. If a complaint is made, the disciplinary board determines whether such relationships are inappropriate on a case-by-case basis, officials said.

The board takes into consideration the vulnerability of the patient and the speciality of the physician. Some specialities, like psychiatry, may be held to a different standard than others, officials said.

As part of the settlement, Berger agreed to take an education course on personal boundaries, meet quarterly with a board member and pay a fine of $1,620.

Drug makers step up giving to Minnesota psychiatrists

More on the money big drug companies are giving to psychiatrists. From this report

One in three Minnesota psychiatrists has received funding from drug manufacturers in the past five years, including seven past presidents of the Minnesota Psychiatric Society, two state drug policy advisers and 17 faculty psychiatrists at the University of Minnesota.

While drug company funding is hardly limited to mental health providers, a review of the latest Minnesota public data shows a much higher proportion of psychiatrists receiving money for research, lectures and consulting than other medical specialties.

Drug companies reported $2.1 million in contributions to Minnesota psychiatrists in 2006, up from $1.4 million in 2005.

It's arguable whether the money influences how doctors prescribe drugs or how doctors on influential advisory boards recommend how and when drugs should be used. The psychiatrists who take the money see it as a necessity in a system that needs more education about mental illness and shortchanges mental health research.

Health policy advocates believe the drug companies are getting a return on their investment regardless of whether the doctors know the money is influencing them.

"They wouldn't keep doing it - piling on more and more dollars - if they didn't think it was successful," said Joel Albers, a St. Paul pharmacist and health economist.

From 2002 through 2006, the nation's drug manufacturers reported $73 million in gifts, grants and reimbursements under Minnesota's one-of-a-kind reporting law. Payment records for 2006 were released earlier this summer and have been added to a Pioneer Press database at twincities.com that allows readers to search by name for doctors, nurses or institutions that have received money.

The state's reporting system is imperfect, as drug companies apply different criteria for the types of payments they must disclose. Some include scientific grants that are in doctors' names but actually go to their research institutions. Others include only the meals, gifts and perks Minnesota lawmakers were targeting when they passed the reporting law a decade ago.

The tally nonetheless is a crude indicator of the involvement and influence of the drug industry in medical care nationwide, especially in areas like psychiatry that rely heavily on some of the nation's most expensive drugs.

Such lawmakers as Sen. Chuck Grassley, R-Iowa, have been scrutinizing the Minnesota data and proposing federal laws to either disclose or restrict the money drug companies give doctors. Locally, the Minnesota Department of Human Services is considering tighter restrictions on members of its drug formulary committee, who advise the state on which drugs are most effective and offer the best value.

One committee member, Dr. John Simon, has received more than $570,000 since 2002 from six drug companies, according to state reports. Most of that was from Eli Lilly, whose antipsychotic drug Zyprexa is the most costly each year for Minnesota's fee-for-service health program for the poor and disabled.

While the committee offers guidance on numerous medications, its advice on mental health drugs is crucial. More than 200,000 Minnesotans are enrolled in the fee-for-service program, and 80 percent of them take at least one psychiatric medication.

Simon said pharmaceutical companies pay him to speak at conferences and clinics about their drugs or about the conditions treated by their drugs. While the situation hasn't occurred, he said, he would abstain from any committee votes involving drugs he has been paid to discuss.

He did vote in December 2004 for an unrestricted state policy with respect to Strattera, a nonstimulant drug Lilly makes for attention deficit disorder. Upon reflection, he said, he should have abstained or acknowledged his funding from Lilly before voting. However, he said, he also cast votes advising restrictive policies on Lilly drugs that regulate insulin and cholesterol.

"I certainly don't need to take care of the pharmaceutical companies," said Simon, who was appointed to the formulary committee by the Minnesota Psychiatric Society. "They're big boys and can take care of themselves by other means."

"Most of the psychiatrists who are really good," he added, "have ties to industry."

State records show 187 psychiatrists received $7.4 million from drug companies from 2002 through 2006. Twenty-eight received at least $50,000 during that period, while others received smaller amounts for gifts or speaking engagements. The median amount received was $2,700, which is three times the median amount of $900 for other types of doctors who received payments.

The state psychiatric society is reviewing literature and research on drug company influence and plans to offer members training on how to avoid conflicts, said Dr. Jeff Hardwig, society president.

"Does drug company marketing affect our practice? I think the answer must be yes," said Hardwig, a northern Minnesota psychiatrist with no drug company ties. "Practicing psychiatrists must be aware of how that might influence them and be on guard against undue influence."

Simon said psychiatrists are getting a greater share of drug company money because primary care doctors need more education about mental illness and how to treat it: "Go into your family practice clinic and complain about chest pain and see what they say, and then go in and complain about bipolar disorder and see what they say."

Former pharmaceutical executives said drug companies are interested in teaching doctors about treatment standards, because that will increase the number of doctors who act on that information and prescribe their pills. However, they said, pharmaceutical companies usually start by hiring doctors who are frequent prescribers of their drugs.

Psychiatric drugs are unique. If patients have success with certain medications, their doctors aren't likely to switch them, even when cheaper alternatives are available. That increases the stakes for drug companies to make sure their drugs are tried first.

It also makes decisions by formulary committees and other advisory boards particularly important. If Minnesota's formulary committee votes to restrict how a certain drug is prescribed, the state usually follows that recommendation.

A spokesman for industry trade group PhRMA said earlier this year that the money reflects valuable research and education that is advancing medicine. The group has questioned the relevance of the state database, because it mixes research grants with gifts and other types of unrelated payments.

Dr. David Adson, of the University of Minnesota, reportedly has received more than $560,000 since 2002 from drug companies. However, Adson said, most of that money is for research grants that pass directly to the university.

Like Simon, Adson has a state advisory role: He is the clinical leader of a program that notifies doctors whenever their prescriptions for antipsychotics and other psychiatric drugs are out of step with clinical standards.

Top psychiatrists are in demand, so it isn't surprising to find them giving paid lectures or conducting drug-company research while also serving on advisory committees, said Al Heaton, pharmacy director for Blue Cross and Blue Shield of Minnesota. But Heaton, who also serves on the state formulary committee, said those connections need to be disclosed upfront.

"It's better to have it kind of come out from under the rock, and people can create their own opinions and judgments, versus if it's not disclosed, and then you find out after the fact," Heaton said. "Then you just assume it was bad."

The psychiatric society nominated Simon to the state formulary committee because of his expertise and credentials, Hardwig said, but is considering whether it should ask him to step down.

Simon told the society this week he would do so if asked, to avoid even the appearance of a conflict.

MaryJo Webster contributed to this report. Jeremy Olson can be reached at 651-228-5583 or jolson@pioneerpress.com.

Search the database at twincities.com to see if your doctor received payments from pharmaceutical companies.

New Minnesotta Law Tracks Drug Companies’ Payouts

As seen here and also reported elsewhere

A groundbreaking Minnesota law is shining a rare light into the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled.

Those panels, made up mostly of physicians, hold great sway over the $28 billion spent on drugs each year for Medicaid patients nationwide. But aside from Minnesota, only Vermont and Maine require drug companies to report payments to doctors for lectures, consulting, research and other services.

A review of records in Minnesota found that a doctor and a pharmacist on the eight-member state panel simultaneously got big checks – more than $350,000 to one – from pharmaceutical companies for speaking about their products.

The two members said the money did not influence their work on the panel, and the lack of recorded votes in meeting minutes makes it difficult to track any link between the payments and policy.

But ethics experts said the Minnesota data raise questions about the possibility of similar financial ties between the pharmaceutical industry and advisers in other states.

“In the absence of disclosure laws, there’s certainly no way to know,” said Jack Hoadley, a research professor specializing in Medicaid at Georgetown University in Washington. “There are a lot of physicians in general who have at least some contract or grant funding out of pharmaceutical companies, and additional (who) do speaking engagements.”

The AP began looking at the records in mid-June. Soon after, the Minnesota Medicaid Drug Formulary Committee began considering a conflict-of-interest policy that would require members to disclose such financial relationships and recuse themselves from voting in some cases. The committee is expected to act on the policy next month.

John E. Simon, a psychiatrist appointed to the panel in 2004, earned more than $350,000 from drug companies between 2004 and 2006. Pharmacist Robert Straka served from 2000 to 2006 and collected $78,000 from various drug makers during that time.

Both men, and the committee chairman, said the payments did not influence their work with the committee.

But state officials said they would examine the panel’s past actions for any bias tied to the payments, and they will start screening appointees to more than two dozen advisory councils for similar links to the drug industry.

They will also require the Drug Formulary Committee to begin recording how each member votes at its meetings.

The Minnesota advisory panel’s recommendations to the state Human Services Department are almost always followed. The committee guided $240 million in spending on drugs for 202,000 patients last year. That’s slightly less than a third of all the state’s Medicaid patients – mostly disabled and mentally ill people whose medical bills are paid directly by the state.

The top drugs for Minnesota Medicaid patients covered by the panel’s advice in recent years have been schizophrenia treatments from Eli Lilly & Co. and AstraZeneca PLC – Lilly’s Zyprexa from 2000 to 2004, followed by AstraZeneca’s Seroquel in 2005 and 2006. About a third of the drugs on the state’s preferred drug list are made by companies that paid Simon, Straka or both.

A medical ethicist said state drug advisers should not take pharmaceutical companies’ money because of the power the panel exercises over the poorest, most vulnerable patients.

“This is a high-stakes committee,” said Dr. Arthur Caplan, chairman of medical ethics at the University of Pennsylvania School of Medicine. “If you’re going to have your hand on that tiller, you don’t want to think that anybody is trying to push it.”

Some other states have taken tough measures to guard against that. Nevada bars anyone from serving on its Pharmacy and Therapeutics Committee who is in any way paid by or affiliated with a corporation that makes prescription drugs.

“It’s as clean as we can get or we can dream up,” said Charles Duarte, the state’s Medicaid administrator.

In Idaho, committee members can be fired on the spot for failing to disclose a conflict of interest.

Here’s what the Minnesota records show:

Simon, a Minneapolis psychiatrist, earned $354,700 from companies including Eli Lilly and AstraZeneca from 2004 to 2006 in honoraria, speaker’s and consulting fees, and other payments ranging from $500 to $93,012. His stint on the formulary committee began in June 2004.

Simon said he continues to speak about new medicines for pay, giving talks an average of every week or two. He said the engagements let him share his expertise with primary care doctors and other health care workers who care for mentally ill patients.

Simon said his work for drug companies – primarily Eli Lilly, which has paid him nearly half a million dollars since 1998 – has not posed a conflict of interest because the antipsychotics, antidepressants and dementia drugs he promotes have never been discussed by the panel.

He declined to name the drugs, citing confidentiality agreements. If those drugs came up for discussion, he said, he would disclose his connections and abstain from voting.

Simon said he should be able to vote on drugs made by the companies that pay him, as long as they don’t come from the neuroscience or psychiatric divisions that pay him. But, he said, he would not oppose a stricter standard.

“There’s absolutely no record of my biasing in favor of one company or another or any of them,” Simon said. “I figure the preferred drug should be the one that cuts the best deal with the state.”

Spokesmen for Eli Lilly and AstraZeneca said their companies’ relationships with Simon had nothing to do with his role on the panel.

Lilly spokesman Phil Belt said Simon even voted against Lilly products, including a growth hormone and an insulin.

“It just wouldn’t be appropriate to assume or imply that our relationship with him is in any way a product of or influenced by his role on the Drug Formulary Committee,” Belt said.

Straka, a University of Minnesota pharmacy professor, earned $78,100 in honoraria and other fees from 2000 to 2006, including $36,745 from Schering-Plough Corp. and $24,623 from Merck & Co. He served on the panel from September 2000 to March 2006.

Straka said he was paid for educational talks usually arranged by medical groups who lined up the sponsors. He said he routinely discloses his ties with drug makers and did so as a formulary committee member, both verbally and in writing.

“I have no problem with the issue of fully disclosing things. I do that all the time,” Straka said.

But a public records request by the AP turned up no information about Straka making such disclosures. Nor do such statements appear in the committee’s minutes going back to February 2001. Other committee members and staff interviewed by AP could not recall him disclosing compensation from drug makers.

The information about Straka’s earnings might not have come out at all, because drug companies are not required to disclose payments to pharmacists under the Minnesota law. Many did so anyway in his case, with some listing him as an “M.D.” in their reports.

Some of the committee’s past discussions appear awkward in light of the payments.

The December 2004 minutes noted Simon speaking up for a staff proposal to put Strattera, an Eli Lilly drug for attention deficit disorder, into a category of its own with no prescribing restrictions. There’s no mention of his significant financial ties to Lilly.

“Dr. Simon affirmed the Department’s decision, stating that having a noncontrolled substance, nonstimulant drug available without PA restrictions was a valuable option,” the minutes said. PA refers to prior authorization, the procedure used to limit use of a drug.

Simon said Strattera was never the subject of his paid talks. He said he’s certified in addiction psychiatry and supported ease of access to the non-stimulant Lilly drug because he’s concerned about overuse of stimulant drugs.

Two months earlier, in October 2004, the committee took up cholesterol-lowering statin drugs, including Pfizer’s Lipitor and Merck’s Zocor. Straka’s motion to include both Lipitor and Zocor on the state’s preferred drug list passed on an unusually divided 3-2 vote, although no individual votes were recorded.

The January 2005 minutes say Straka questioned a staff request to revisit the issue after the agency discovered that giving both drugs preferred status would cost an extra $1 million a year. The panel voted 6-1 to let the state pick one statin to cover. Again, individual votes weren’t recorded.

The minutes say nothing about Straka being paid by Pfizer or Merck – although the companies’ disclosure reports show him getting $3,000 from Pfizer and more than $24,000 from Merck by that point.

When asked if the payments influenced his actions on the panel, Straka responded with an emphatic no.

“Absolutely not,” said Straka. “I vote based on facts, I vote based on evidence and that’s completely discussed at those meetings.”

Dr. William Korchik, the panel’s chairman, said he supports disclosure of committee members’ relationships with drug companies, “whether it’s stock, research or speaker’s fees.”

Korchik said he didn’t know the extent of the financial relationships until contacted by AP. But Korchik defended the panel’s work, saying the ties did not bias a group that works mainly by consensus.

“This whole thing may be an issue of appearance of conflict, but I really feel comfortable that the committee has not been hoodwinked,” he said.

Al Heaton, a pharmacist who has served on the committee since the early 1990s, is the only panel member mentioned in the last six years of minutes for disclosing a potential conflict of interest and abstaining from a vote – on bone drugs he had gotten funding to research years earlier.

“I think that’s important to know,” said Heaton, the director of pharmacy at Blue Cross and Blue Shield of Minnesota.

“An individual may be perfectly honest and totally objective, but finding it out afterward, then you always wonder were they or were they not?”

Psychiatrist admits to sex with patient

From this report out of Minnesota

A New Brighton psychiatrist charged with sexually assaulting a female patient as part of her "therapy" has a court hearing Aug. 17.

Thomas Lee Folsom, 52, had begun treating the patient in 1999 when she was hospitalized for depression and an eating disorder, according to the criminal complaint.

According to the complaint:

Folsom initially saw the woman two or three times a week, but the sessions eventually became almost daily. When the patient's father complained in 2002 about the expenses - by then, $77,000 - Folsom said he would continue the treatment "for free," the complaint said.

During the sessions, Folsom asked the woman to take off her clothes, which she did, and there was sexual contact on numerous occasions, most occurring in Golden Valley and Minneapolis.

In a tape-recorded conversation between Folsom and the patient, the psychiatrist admitted the sexual contact and later told police it had occurred "hundreds of times," the complaint said.

He was charged in April with four counts of third-degree criminal sexual conduct in Hennepin County District Court.

Folsom's attorney, Eric Olson, declined to comment.

Folsom is the former chief of psychiatry at Anoka-Metro Regional Treatment Center.

A Web page for his practice says he works out of a Nicollet Mall office in downtown Minneapolis. Under "Care Philosophy," Folsom states, "my emphasis is on nonmedication approaches to anxiety, depression and psychosomatic conditions."

AMA Debates Adding "Game Addiction" To List of Psychiatric Disorders

Needless to say, we thing this is remarkably unintelligent. See our quote from Wired Magazine at the end.

From the Star Tribune of Minneapolis - St. Paul

Blame it all on video games:

[...] The American Medical Association (AMA) is considering whether to formally classify video-game addiction as a legitimate psychiatric disorder, the Associated Press reported Thursday. The nation's leading doctors' group could vote on whether to add video-game addiction to a widely used mental-illness manual at a national meeting this weekend in Chicago, a move that would raise awareness about the issue and make it easier for patients to file insurance claims for treatment.

The debate among AMA members is expected to be heated. For starters, there's not even agreement that playing hours and hours of the latest game for Xbox 360 or Nintendo Wii or a multiplayer online role-playing game such as "World of Warcraft" is a true addiction, similar to dependence on alcohol or drugs.

"I think we always have to be cautious about overpathologizing behaviors that are trendy, age-specific or generational before we want to get everyone into therapy for it," said Dr. Jon Grant, a psychiatrist at the University of Minnesota Medical School. He specializes in studying and treating addictive behaviors in adults.

There's a lot to consider before heavy video-game use is called an addiction, he said. Players, including younger ones, may turn to games out of boredom, depression, loneliness and more.

"Is it a problem, or is it the symptom of a problem?" Grant said. "I don't know if we actually know that yet."

[...]

Addiction or disorder?

Andy McNamara, editor-in-chief of Minneapolis-based Game Informer magazine, said the AMA's actions are another sign of how video games are misunderstood.

"The simple fact that society calls too much gaming an 'addiction' and too much eating a 'disorder,' gives you an idea how the video-game industry is treated by the people who simply don't understand it," he said.

Walsh was careful to point out that what he calls video-game addiction affects only some people.

"I'm not suggesting that everybody who plays video games gets into trouble with them," he said.

Some players do see potential pitfalls in playing too much of games such as the immensely popular "World of Warcraft."I play this game actively and can attest to its addictive properties," said Sean Carter, 31, a Denver technology manager who commented through the Star Tribune's website. "The social interaction and forced cooperation with other live players combined with the open-ended story line can easily draw you in. It's a great example of the digital world replacing real life."

Although Walsh and the University of Minnesota's Grant differ on whether video games can generate addiction, they agreed that the AMA's proposal will help raise awareness for further exploration. "But it won't be an answer unto itself," Grant added.

The AMA could vote on the proposal by Monday, but even if approved, it will not appear in the mental-illness manual until the publication's next edition in 2012.

Wired Magazine has the right angle on this:

Honestly, does no one else see how ridiculous this is? Aren't there people who watch too much television? Ride their bicycles too much? Anything with an investment-payoff structure has the potential to be addictive, but it has much more to do with the person, not the thing itself. This isn't going to be much help to anyone -- all it does is further demonize gaming as a hobby and a medium.

If there really is a pathology at work here, the AMA should look harder to find the root cause -- something that's endemic to the human body, not a trendy label based on something that happens to be popular right now. If there's something about this addiction that's specific to electronic games played on a monitor, prove that. With science, and stuff.

Physicians Continue To Receive Pharmaceutical Company Payola Despite Sanctions

From the Daily Health Report of the Kaiser Network

The New York Times examined Minnesota state medical records showing that more than 100 physicians who had been cited for misconduct by the Minnesota Board of Medical Practice continued to receive drug company payments, and some continued to participate in clinical trials of experimental drugs. Although Minnesota is the only state to make its records public, many experts say the problem is national.

The Times' examination of Minnesota's records on drug company payments found that from 1997 to 2005, at least 103 physicians who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment during that period was $1,250, and the largest was $479,000. Sanctions issued by the board included reprimands, required retraining and suspension of licenses. Of the 103 doctors, 39 had been disciplined for inappropriate prescribing practices, 21 for substance abuse, 12 for substandard care and three for mismanagement of drug studies.

David Rothman, president of the Institute on Medicine as a Profession at Columbia University, said, "There's no reason to think Minnesota is unique" from other states in the nation. He added, "Clinical trial investigators must be culled from only the finest physicians in the country since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage." Karl Uhlendorf, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said the trade group would not comment on the Times' findings.

The Times profiled Faruk Abuzzahab, a Minnesota psychiatrist who received more than $55,000 in drug company payments from 1997 to 2005 despite being disciplined in December 1997. According to the board, Abuzzahab inappropriately discharged from the hospital a suicidal patient who declined to enroll in a clinical trial for which the doctor was recruiting. The patient later committed suicide (Harris/Roberts, New York Times, 6/3).

Ineffective Psychiatric Prison Rehab Programs

found this article on the probably ineffectiveness of psychiatirc rehab programs in prison

Prison probably hasn't changed the killer or child molester who just left a cell block and moved onto your block. There's a 40 to 50 percent chance the ex-convict down the street will cause trouble again, experts say. The ex-cons agree.

Of course, the argument is made that they need more shrinks and more money for shrinks in Minnesota.

But even as seen in this earlier story, even just changing the television shows available in prison will have a dramatic result.

But this wouldn't cost all that much. And conditions are the same or worse in many states around the USA

If they want to spend more money, they might want to look at this experimental program being tried in Mexico. here's an interesting statistic:

The 400 inmates who have been registered in the program were the base for the statistic for this study. The objective of the study was measure the rehabilitation success and the reduction of the recidivism was valid.

When the results were analyzed it was found that the recidivism rate in the inmates who did the drug-free withdrawal and any of the other courses is very low (10.24%).

Normally, according to the State data, recidivism due to robbery is 70%. From the 192, who were released, 124 had been arrested because of robbery. At the normal 70% rate of recidivism we would expect 87 persons from the 124 would have returned to prison. Instead only 10 have returned to prison.

With this rehabilitation treatment, the recidivism rate for robbery has reduced from 70% to 8.06%

But notably, this is not a psychiatric program. Which will surpise some people thoroughly.

Psycopath Program's Head Psych Resigns

Dr. Michael Farnsworth, the head of the Minnesota's treatment program for sexual psychopaths has resigned, but he has denied that he's leaving due to the political furor over a proposal to move some offenders from the program into less restrictive settings. The proposed changes, which ignited a dispute in June between Gov. Tim Pawlenty and Attorney General Mike Hatch, included the eventual move of some sexual psychopaths to halfway houses or other state programs or into the community under state supervision.

The matter has been a political hot potato. Since the dispute erupted, Gov. Pawlenty has issued an executive order making it virtually impossible for sexual psychopaths to be released unless required by a judge or the law.

At a legislative hearing, Anita Schlank, former clinical director of the program, testified that she resigned in June because she felt the proposed changes were partly driven by cost concerns, and, if enacted, would put the community at risk.