U bioethicists speak out for transparency

An open letter gains political support and raises questions about clinical drug trials.

by Jasper Johnson

In an attempt to spur reform, University of Minnesota bioethicists Carl Elliott and Leigh Turner have reached out to legislators with an open letter requesting, among other things, “annual committee reviews in the House and Senate of the performance of the Board of Regents.”

The push for reform stemmed from a perceived lack of oversight, accountability and transparency following the tragic deaths of Susan Endersbe, Dan Markingson and several others. Both Endersbe and Markingson were involved in experimental drug trials run through the University.

Former Minnesota Gov. Arne Carlson also supported the letter, which could have helped cause a delay in the selection of University regents, pending a state review of the school’s drug trial program. After she received the letter, Terri Bonoff, chair of the Senate Higher Education Committee, requested that Majority Leader Tom Bakk postpone the regent selection.

Bonoff described the letter as “damning,” and I would have to agree.

The letter alleges numerous counts of fraud and fabrications orchestrated by department members. Those responsible have been reprimanded for their actions, but further investigation is lacking, and the University’s involvement is shady at best.

The letter hammered home this point, citing conflicts of interest by those involved and an overall lack of thoroughness in the investigations.

The inconsistencies even involved the Institutional Review Board, a system designed to ensure medical ethics. According to the letter, Dr. David Adson, head of the University’s Institutional Review Board at the time of Markingson’s death, neglected to mention his “close financial ties to the company whose drug was involved in the Markingson case.”

Transparency is at the absolute core of public institutions.

These institutions need to be accountable for their actions. Because of the public’s consistent discontent, the manner in which the University conducts studies and investigations needs to be addressed.

The methods proposed by the authors of the letter should provide adequate framework for more meticulous supervision of future studies. The “committee reviews” and “special citizen’s commission” mentioned in the letter would hopefully improve the methods of supervision.

Medical ethics can be a very tricky subject to address, but no one should see the desire to have more thorough investigations and a more reliable administration as an extreme stance.

Rather, the opposing idea that an institution should exist with few checks and balances is sordid. There should be no reason why the University would wish to avoid investigation into the actions and policies of one of its departments.

Considering that the well-being of medical patients is at stake, the University needs to give serious thought to reforming the way it handles drug research trials and their oversight.