Monday, June 23, 2014

For the Record: A necessary audit of University of Minnesota drug research

"It is time to eradicate this stain on the reputation of 
a splendid university."

Arne Carlson, former governor of Minnesota 

The announcement by the legislative auditor that he will be reviewing the drug-testing program at the University of Minnesota is welcome news. Most of the concerns revolve around the suicide of an enrollee, Dan Markingson, in May 2004. However, the ongoing problems center on large amounts of money being afforded universities by drug companies in return for extensive testing of experimental drugs on human subjects. At best, it brings together a problematic mixture of conflicts of interest and human tragedy.

Over the span of the program, it has drawn considerable negative press, including headlines in the Star Tribune in August 1993 — “University kept silent for 4 years on research misconduct by Garfinkel” (Dr. Barry Garfinkel was convicted and sent to prison) — and continuing to May of this year, when Science magazine published a lead article analyzing the Markingson case and continuing issues.”

During this time, Dr. Carl Elliott, a professor in the Department of Bioethics, and his colleague, Dr. Leigh Turner, have been critical of the oversight of this program, including the various reports that cleared the university of wrongdoing. A large and distinguished cadre of doctors, researchers and scientists from the United States, as well as Canada and New Zealand, has joined in this criticism. As a result of the publicity, Elliott and Turner continue to receive calls from parents and families of enrollees declaring their concerns over mistreatment, failure to protect the harmed and misinformation given to potential subjects. This has been verified by a local TV investigation.

Unfortunately, instead of this compelling matter being resolved internally, the debate has continued to spill out to the public, drawing national media attention from the likes of the New York Times and the Boston Globe.

The legislative auditor now has the opportunity to conduct a thorough and professional audit of this operation covering the past 10 years. It is imperative for the well-being of all concerned that his report be exhaustive and credible in order that the necessary changes are instituted. This means that inherent conflicts of interest be closely monitored, that the integrity of the study be improved and that the subjects be fully protected.

This audit should involve:

1) A thorough review of the finances, including the number of studies, payments to doctors and clinicians, administrative costs, etc.

2) An examination of the conflicts of interest built into the process. This should include a background inspection of all program personnel as well as those who serve on an oversight board. Transparency should be the rule.

3) A disclosure of the number of tests, enrollees, injuries and deaths.

4) A full understanding of the oversight process, commencing with the Board of Regents. Are its members independent of management? How do they manage dissent involving management, faculty and/or the public? Why did they not intercede, particularly knowing the ills of the past involving criminal misconduct and continuing with public reports of ongoing concerns relative to the care of enrollees?

5) That the legal and human rights of the enrollee are fully protected and that the family is involved. This includes upfront disclosure of all needed information, professional monitoring and care, if harm is caused.

Logic would indicate that certain areas of management require more oversight than others, particularly when significant money comes from drug companies for testing on humans. Somehow, that special attention appears not to have been there, even when respected members of the faculty raised red flags.

I am most hopeful that the legislative auditor not only will deal with these concerns but also will come forth with standards that will significantly improve independent oversight and be fully protective of our enrollees, who all too often are our most vulnerable citizens. It is time to eradicate this stain on the reputation of a splendid university.