The original U draft was 13 pages. Now it's two, and some staff members are irked.
Last year, the people crafting new conflict-of-interest rules for the University of Minnesota Medical School touted them as some of the toughest in the nation.
The 13-page draft banned gifts to faculty, researchers and students from drug and medical device companies. It barred the companies from funding continuing education. It established strict guidelines for reporting industry relationships, including disclosure to patients and the public.
But six months later, a slimmed-down, two-page version bearing a few notable changes is winding its way through the university's considerable bureaucracy toward approval by the Board of Regents.
In its wake, the draft has left embattled supporters and passionate critics, and the controversial process has revealed how difficult it is for a modern university to disentangle industry from academia.
"I wish a lot of the controversy had not happened, because I think this process was really important for the school, its faculty and the students,'' Medical School Dean Dr. Deborah Powell said in an interview. "But I think we've arrived at a good place."
After the original draft was distributed, the Star Tribune reported that the co-chair of the drafting committee, Dr. Leo Furcht, had been disciplined by the U for his business dealings some years earlier, a fact not disclosed to other task force members.
Questions also lingered about Powell serving on the board of PepsiAmericas Inc., a Minneapolis bottling company, and whether it skews her perception of industry relationships. (She says it doesn't.) Last month, Powell's position as dean was eliminated in a department shakeup. The university called it a cost-saving move unrelated to ethics issues.
The policy was intended to manage the often-pervasive influence that drug and device companies have at the school without cutting off a vital source of research funding.
Powell said she received hundreds of e-mails and calls regarding the proposal. Working with department heads, she said, she tried to craft a policy that reached some consensus among the parties.
The consensus has proved elusive.
In recent weeks, the debate has raged in the student newspaper, the Minnesota Daily, and has bled into the blogosphere.
"The original document was excellent; I couldn't complain about it," said William Gleason, an associate professor in the U's Department of Laboratory Medicine and Pathology. But the new version? Gleason claims it has been watered down, much to its detriment.
A major change from the original document involves industry funding for continuing medical education, courses that keep doctors' and other professionals' licenses current. Critics say industry money influences doctors to prescribe expensive brand-name drugs and medical devices, sometimes in ways not approved by federal regulators.
The original draft called for an end to industry support of those courses within five years. The new version permits industry funding, but under the rules of a national accrediting organization. Powell called the guidelines "quite strict."
"We have no alternative source of funding for it,'' Powell said. "As the economy worsens, a lot of the people who take our courses can't afford to pay the tuition. Our courses are attended by nurses, pharmacists, physicians, and people felt we couldn't raise the tuition."
But Dr. Marcia Angell of the Harvard Medical School said: "Of all the financial deals between industry and physicians, [continuing medical education] is the worst. The medical profession should take full responsibility for educating its members, not abdicate it to companies with clear conflicts of interest.''
The revised policy also eliminates a provision calling for subjects in clinical trials to be enrolled by patient advocates, as opposed to the doctors involved in the study, who may be paid by drug and device companies.
"That was a huge issue,'' Powell said. "A lot of faculty argued in a very impassioned fashion that they're the person who knows their patients best.'' She noted that patient advocates will still be available for study subjects.
Another tweak: Faculty and staff at the Medical School must report external funding exceeding $500 from any single source. Previous drafts advocated dropping the reporting ceiling to zero. The current policy requires disclosure of funding of more than $10,000.
This grates at critics such as Gleason. "Why not make it zero?" he said. "Why don't they do it right -- right from the start?"
Yet several key recommendations remain intact, including a public website documenting all industry payments to Medical School faculty.
"There was no controversy about that," Powell said.
For Gary Schwitzer, an associate professor of journalism who served on the committee, the drafting process should have engaged the public from the very beginning.
"I urged the task force and the dean that editorial boards of local news organizations should be shown the draft recommendations and then asked for comment,'' he said. "Perhaps if that had happened, this slow, toxic dribble of news about the process would have been avoided.''
But Powell said the policy is a work in progress. "As more and more information comes out, the school will probably modify this in years to come. I think it's a good start."
Janet Moore • 612-673-7752