University of Michigan Medical School's conflict of interest policies will likely improve in 2010
Ray Hutchinson is the associate dean for regulatory affairs at the University of Michigan's Medical School
When a doctor prescribes a certain drug or suggests a certain medical device, how do patients know whether it has anything to do with a financial relationship the physician has with an outside company?
That conflict of interest question has growing interest from patients and those in the health care arena as the financial links between companies and medical institutions have been increasingly highlighted in recent years.
It hasn't escaped the attention of the University of Michigan and its medical school, which is planning to hold a series of symposia starting early this year to discuss better guidelines regarding clinical and educational conflict of interest, a U-M official said recently. New policies should be established by the end of 2010, said Ray Hutchinson, associate dean for regulatory affairs in U-M’s Medical School.
"I think most places have policies in place to deal with research and that’s in part driven by the fact that (National Institutes of Health) and others expect that," Hutchinson said. "I think the conflict of interest piece with respect to clinical care and educational activities (in the health care realm) is less well developed, but places are rolling out policies like Stanford and (Washington University) and St. Louis, and we’re coming up with ours."
Last month, a report from the U.S. Department of Health and Human ServicesÂ showed the policies at most of the nation’s universities relied on their researchers to self disclose any potential financial conflicts of interest from consulting jobs or relationships with drug and device companies.
The report also found about 50 percent of institutions don’t require faculty members to disclose how much money or stock they receive from these companies, The New York Times reported in an articleÂ that characterized U.S. researchers’ conflicts as “lightly supervised.”
Earlier this year, some pharmaceutical companies began disclosing financial relationships online. Other disclosures may be required in the future if the Physician Payments Sunshine Act, which would require any payment to doctors in excess of $100 in a year from industries to be posted online, is passed by Congress.
In a recent conversation, Hutchinson addressed the topic of conflicts of interest in medicine, U-M’s Medical School's conflict of interest policies and how they could change in the upcoming year.
Q: How does the conflict of interest policy work at the U-M medical school?
A: “We have a disclosure system that’s electronic for our faculty so they can disclose outside employment or outside relationships, and there’s an expectation they will do so We have a very high rate of compliance with that, like 98 percent, 99 percent of faculty do it, and we stay after them to try to get them to be fully compliant and do it. Of course, we don’t know for sure that everyone is disclosing everything they should, but we have guidance on what they should disclose, and we expect them to disclose any relationship where they get paid for outside work, particularly if it’s work that could be seen as being done on university time.Â
"Every faculty member is allocated a certain number of days per month, I think it's 4 per month, up to 48 per year, to do outside consulting-type work. So if it’s work of that nature, we expect it to be disclosed. If their relationship with company is related to the work, we expect that to be disclosed if they’re providing a medical legal opinion, we expect them to disclose that work.”
Q: Then what happens?
A: "There’s a kind of hierarchy for review. If there are issues that the chairs or we perceive could be viewed as potential conflicts of interest, we look into them. We also find out about (conflicts) through various other mechanisms. You know when there’s a grant request going, there’s a proposal approval form called the PAF and that asks whether there are any known conflicts of interest, so if somebody circles or responds in such as way to that, that’s a clue we ought to look further. The institutional review board for human research sometimes provides clues back to us there might by a conflict of interest with one piece of work."
Q: It does sound like the system is largely based around self disclosure, though.
A. "Yes, if you have a bad person, the disclosure system probably is not going to catch that individual, which is a pitfall, but we sort of base our work in general in the research arena that people are honest unless found out otherwise."
Q: Do you think that is a strong enough system being used by research institutions around the nation?
A: "Obviously there have been a number of flagrant examples of problems, so something does need to be tightened. I think there probably needs to be better education of what the lay of the land is, what the expectations are So some of it is education and yes, I suppose it probably wouldn’t be a bad idea to have an audit system, at least periodically and in some sort of probabilistic way, sample the faculty to make sure that people are doing what they are supposed to be doing.Â
"But even there, I mean, we would depend to some extent, even in a verbal interaction with them, on their honesty in telling us because it could be possible that they could be doing something we don’t know about for a variety of reasons.
"Now some of them will become more apparent as these companies start posting their own disclosures on whom they're paying They’re starting to do that with the expectation that if the Physician Sunshine Act passes that everybody will have to do it. We’ve started surveying the sites to see if we have faculty on the published sites to see who’s there and see if it jibes with our own disclosure system. So far, found a couple of discrepancies we’re going to need to follow up on where it looks like they underreported to us what the company reported they had received."
Q: What about continuing education courses? What sort of oversight is there regarding courses, which might be organized by certain interests or pharmaceutical companies?
A: "We’re trying to come up with some guidelines for what you might call clinical conflict of interest. It relates to things like (continuing medical education) CME activities, speakers’ bureaus where people take money for giving sometimes canned talks or talks that companies provide to them to deliver, not too cool, and consultancies or advisory board memberships for some of our faculty in pharmaceutical and other kinds of biomedical companies.
"We’re trying to develop a set of guidances with respect to those coming down the pike. And it’s been controversial - the CME activities have been controversial. The speakers' bureau has been controversial. The former because several of our faculty feel it’s a useful function that they deliver to the physicians of this area or to the physicians of this state where people come for CME activites they might not otherwise get, that they feel are of high educational value but happen at least in part because of pharmaceutical support."
Q: Why haven’t stronger clinical conflict of interest policies at U-M already been developed?
"It’s a new movement, if you will. I think that Stanford rolled their policy out, I think it was about a year and a half ago now. We’ve been thinking about it for that length of time or maybe even a speck more. I think there’s a fear if you rush into formulating things too quickly, you might actually throw the baby out with the bathwater, in a sense.
"The easy thing to do would be to be restrictive. To not allow certain things to happen because then it looks good and everyone thinks you're doing the right thing. But then what happens if you become so restrictive you actually impair health care delivery to patients by virtue of some unforeseen nuance or event that happens? I think that’s part of the reason for a little bit of caution for rushing into it The expectation is that we will finalize this; there will be a policy on clinical (conflict of interest) in terms of speaker’s bureaus, CME and memberships on advisory boards and consultancies, those sorts of paid activities within the industry done by the end of the year.”