Friday, March 18, 2016

Fact-checking the testimony of the University of Minnesota administration to the Minnesota House of Representatives

During the hearing of the Higher Education Policy and Finance Committee on March 15, 2016, President Kaler, Vice-President Jackson and Vice-President Herman made a number of false or misleading statements to the committee.  We would like to correct the record.  Links to documents substantiating the facts are included in the text.

1) Dr. Charles Schulz

In response to questions about disciplinary actions taken against psychiatric researchers, President Kaler repeatedly stated that Dr. Schulz had retired, and he implied that Schulz been forced out of his position as Chair of the Department of Psychiatry. 

It is true that Dr. Schulz has retired. But the portrayal of his retirement as a disciplinary measure is not borne out by the facts.  When Schulz announced his retirement last spring, Dr. Jackson made a television appearance and praised Schulz as “excellent clinician” who has “saved hundreds if not thousands of lives.” Schulz was also allowed to keep his powerful position as executive medical director at Fairview Hospital, and only retired from that position after continued pressure from the public and Fairview staff. Even now, Schulz’s portrait hangs in the Department of Psychiatry. He still holds the titles of Adjunct Professor in the School of Public Health and “Professor Emeritus” – a title awarded in recognition of years of “valued service and contributions”  to the university. The title allows Dr. Schulz to represent the university and participate in academic processions “in a position of honor.”

2) Dr. Ken Winters

President Kaler first claimed that Professor Ken Winters, who forged a federal research document, had been fired. When challenged by Rep. Bernardy, who said she had a different understanding of Winters’ departure, Dean Jackson admitted that Winters had been given the option of retiring.  President Kaler then backtracked and admitted that Winters had not been fired. He said “I spoke too informally when I described the discipline he received.”

In fact, KMSP News reported that Winters received no discipline at all.  According to that report, Winters “hasn't been disciplined by the University for falsifying the document. Instead, he was given the option to retire at the end of the month.”  The university directory still lists Winters as an adjunct professor.

3) Dr. Stephen Olson

President Kaler and Dr. Herman told the committee that Stephen Olson, the researcher responsible for the study in which Dan Markingson died, had been suspended from conducting research. If this is true, that information has never been made public. It is also at odds with the communications we have received from research oversight offices at the university. We have requested investigations of five studies conducted by Dr. Olson, including the study in which Markingson died. In each case, the university has refused to investigate, delayed investigating, or concluded that Dr. Olson should not receive any disciplinary action. The last communication we received was on May 15, 2015. It stated, “The investigation has been completed with no referral for disciplinary action against Dr. Olson.”

Of course, it is possible that other actions have been taken against Dr. Olson that we are unaware of.  However, we would respectfully request that you ask the university to provide you with documentation of these actions.

4) Compass Point Research

Rep. Barrett asked Dr. Herman if he was aware that Compass Point Research, the company the university contracted with to audit 100 research protocols, had received warning letters from the FDA for failing to protect human subjects. Dr. Herman dismissed the issue, pointing out that many organizations are “reviewed by the FDA on a regular basis” and “given feedback on their activities,” and that this does not necessarily suggest a problem.

This is an extremely misleading response. The warning letters Compass Point Research received from the FDA were far from routine reviews.  Through its IRB, the Patient Advocacy Council, Compass Point Research allowed an Alabama physician to pay homeless people to test an experimental smallpox vaccine that carried serious medical risks. The physician was later disqualified by the FDA – an exceptionally rare event reserved for extraordinary incompetence or wrongdoing. Over the past fifty years, according to the FDA website, the FDA has disqualified only 225 researchers. The FDA found that not only had Compass Point failed to protect the subjects of the study, two of whom had to be hospitalized, it had refused to allow the FDA to inspect the full study records and meeting minutes.

5) Meeting with Dr. David Strauss

When asked whether whistleblowers and critics would be meeting with Dr. Strauss, an external consultant who will be visiting campus at the end of the month, Dr. Herman replied that Strauss would be meeting with faculty members and that arrangements were being made for a “direct communication” with Elliott and Turner.

In fact, Dr. Herman refused our request to meet with Dr. Strauss, saying that his schedule was full. He did say that Dr. Strauss had agreed to a phone call.

6) Research reform

Dr. Herman was asked whether Elliott, Turner and Gjere were being included in current research oversight. He replied that Elliott was working with the IRB.

This is untrue. Elliott has filed a number of requests for investigations to the IRB without any satisfactory resolution.  He has made many open records requests for information IRB activities, but those requests have been routinely delayed or refused. By no stretch of the imagination could this be construed as “working with the IRB.”

Niki Gjere is currently a member of the IRB, but she works with a panel that reviews psychosocial studies, not medical studies.

7) Pharmaceutical industry fraud

Rep. McDonald asked if the university would continue to do business with pharmaceutical companies that have not been honest with the University of Minnesota, such as AstraZeneca.  

Dr. Jackson replied that he was unaware of any issues of this sort with AstraZeneca. He also said, “If a pharmaceutical company were found to be fudging data, I would be disturbed by that, and I suspect our IRB would be disturbed by that, and I suspect would not want our researchers doing research with those companies.”

In fact, AstraZeneca paid $520 million in 2010 to settle federal litigation for fraudulent marketing of its antipsychotic drug, Seroquel. Unsealed documents showed that the company had buried or manipulated its research studies to make Seroquel look better than it actually was. Reports in the Star Tribune and City Pages linked Dr. Charles Schulz of the University of Minnesota to two questionable research studies.

In 2003 AstraZeneca pled guilty to felony charges of health care fraud and paid $355 million in penalties. Last year the company paid an additional $7 million to settle federal charges that it had paid kickbacks to physicians.

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Submitted by Carl Elliott, Leigh Turner and Niki Gjere to the Minnesota House Higher Education Policy and Finance Committee.

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