Conflict-of-Interest.net

I’ve decided to open the blog for comments to see if this stimulates discussion (and ideas for me to blog about!). I’ll see how this works for a few weeks, and whether the comments are inundated by Spam…

Bryn

P.S. Apr 10: Comments closed because I was just getting spam. Was worth a try.

After a well needed two week break for the Xmas holidays (the Fall academic semester is always a killer!), I’m back into teaching prep (running 2 grad courses this term) and so am just now catching up on COI news. Here’re a few stories that caught my interest:

1) Journal editor gets royalties as articles favor devices (Dec. 24)

• This story continues with the ongoing debate about publishing and COI, but sheds light on a little examined area – that is COI encountered by journal editors. The gist of the issue that lots of focus has gone into building disclosure mechanisms for authors and reviewers, but very little to address issues associated with the editors, the ultimate arbiter of journal content and quality.
• See also this analysis by Nancy Walton at the Research Ethics Blog

2) Harvard Teaching Hospitals Cap Outside Pay (Jan 2)

• Two Harvard affiliated hospitals have implemented policies to limit the amount of pay for outside consulting on the part of senior administrators. “Senior officials…must limit their pay for serving as outside directors to what the policy calls “a level befitting an academic role” — no more than $5,000 a day for actual work for the board. Some had been receiving more than $200,000 a year. Also, they may no longer accept stock.”
• The issue here is ensuring that senior managers are 1) not being influenced by outside consulting (e.g., from pharma, medical device manufacturers) in their strategic planning, purchasing choices, etc., and 2) actually spending sufficient time in their primary job as administrators (which are already well paid): also called “conflict of commitment”. But one has to wonder if hospital officials should “ever” be on corporate boards? Even if they’re not doing much work or are only being moderately recompensed, isn’t the apparent COI sufficiently worrisome as to threaten the trust on the part of hospital staff and patients? (P.S. Feb 20: Partners’ Conflict of Interest Policy’s Reach Concerns Docs)

3) University of Michigan Medical School’s conflict of interest policies will likely improve in 2010 (Jan 4)

• There’s been a lot of coverage of Michigan’s COI policy development over the last year. Its good to see here that they’re moving the discussion outside the policy making environment of senior administrators, into the hallways and getting faculty, staff and students involved. Also good to note that, from the associate-dean, “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.” [Its worth reading the whole interview]

4) Faculty group urges UW provost to quit Nike board (Jan 5)

• Continuing with the thread of academic administrators and corporate involvement (see also my Dec blog post about Canadian funding agencies), this story about the Provost of the University of Washington joining the Nike corporate board raises issues about the responsibility and reputation of senior administrators.
• Beyond the issue of financial COI linked to personal remuneration (the Provost stands to add another $100-200K to her $500K university salary), the situation is further muddied by the fact that the “UW athletic department in 2008 signed an exclusive 10-year contract with Nike, worth at least $35 million to the university” and that Nike’s been the subject of a number of very public allegations about systemic poor labour standards (sweat-shops and such in early 2000; although maybe this situation has turned around). So there is a real concern on the part of faculty that the Provost’s appoint to the Nike corporate board could have “a “chilling effect” on future research about labor violations that implicates Nike, and that it isn’t in the best interests of the UW for top administrators to “offer up knowledge about the institution” to corporations — especially when the administrator stands to personally benefit.” — a serious institutional COI.

THE big COI story in the Canadian academic community these days is the appointment to the Governing Council (GC) of the Canadian Institutes of Health Research (Canada’s main funder of health research), of Dr. Bernard Prigent, the Vice-President of Medical Affairs for Pfizer Canada.

It has resulted in a nationwide petition (to date, almost 4000 signatories – including me), organised by Bioethics Professor Francoise Baylis and colleagues at Dalhousie university, on the grounds that the appointment of Prigent “represents a significant threat to the integrity of CIHR by entrenching an intractable structural conflict of interest.” This has lead to a flurry of news stories, initially reported by the CBC in late November, then in the Canadian Medical Association Journal (here and here), in opinion piece by Professor Baylis, and most recently on CBC Radio’s The Current.

There is a very real concern — which I share — that the appointment of a Pfizer VP to the CIHR GC further entrenches a particular commercial perspective in the upper direction of CIHR; that is, that the role of this funding agency should be more about actively promoting knowledge transfer and commercialization than supporting academic training and research in the basic and applied health sciences. Yet the appointment of a member of industry is in one sense not surprising: governing boards of universities and other public institutions very often have members from outside the local (academic) community to help provide a broader range of expertise and perspectives, networking and fund raising, etc. At CIHR, 5 of the 17 members of the GC do not have current university appointments, so the “commercial perspective” might not seem that dominant. Moreover, given that the mandate of the GC includes “developing strategic directions, goals and policies” and “evaluating the agency’s overall performance”, not to mention supporting innovation and knowledge transfer, the appointment of someone from the health industry, such as Prignent, might seem completely reasonable.

But concerns about COI remain, even at this high level of governance. The interests of a pharma are pretty apparent, and may well diverge from the interests of Canadian researchers who benefit from CIHR funding, that the Canadian public that pays for it. And Pfizer does not have a very good reputation at this moment. Yet as Chris MacDonald clearly explains in his Research Ethics Blog entry on this subject,

“Divergence of interests’ between a company’s shareholders and the public isn’t sufficient reason to exclude executives from that company. Nobody’s interests are perfectly aligned with the public’s. What matters is whether the divergence is sufficient to render an individual’s advice suspect in a way that cannot be remedied through standard mechanisms used to mitigate the effects of conflict of interest (mechanisms such as disclosure and recusal). So simply working for industry doesn’t strike me as an insurmountable flaw, particularly if (if!) the governing council’s role makes an intimate understanding of the drug industry useful. But the main point remains: it’s very hard to support the inclusion of an executive from this pharmaceutical company on the governing council of Canada’s most important health-research-funding organization.”

And, as Steven Lewis notes,

“There are excellent reasons to exclude people actively engaged in health care commerce from the GC table to save the institution, and themselves, from the appearance and reality of conflict-of-interest.  Canada would do well to take a lesson from the United States, which is moving in the opposite direction by removing registered lobbyists from advisory boards.”

P.S. (Feb 3, 2010): See this follow-on article by Steven Lewis in Open Medicine : Neoliberalism, conflict of interest, and the governance of health research in Canada

This morning’s post is a bit of a jumble of ideas, coming from reflections on a range of stories that I’ve been reading over the last few weeks, but which I haven’t yet had time to write about in more detail.

Payment for service
Health reform in the US has been the source of a lot of popular press about COI in recent weeks, in part turning on the story of the AARP lobby group (Conflict Of Interest For AARP In Health Bill Debate?). But see also this article in the NY Times (Maybe a New Day for Doctors’ Pay) about a more fundamental issue, and one that’s also common in countries — such as Canada — that have universal health insurance, but where MDs are paid on a fee-for-services basis.

Disclosure as remedy
Disclosure of COI to scientific journals, a voluntary act, is maybe too permissive (Physicians’ disclosures to UW, journals inconsistent). Journals do not have in hand any mechanisms to actually verify that contributing authors are being truthful in their declarations. But what are the alternatives, to not trust academics at all? See also: Medical Journal Conflict of Interest Disclosure and Other Issues

The use of disclosure requirements in institutional policies (e.g., at Universities, medical schools)  is a common mechanism for preventing or managing COI (U panel proposes conflict-of-interest policy). The problem is that, like with scientific journals, these are voluntary disclosures and thus subject to manipulation, being ignored, etc. More problematic, in my mind though, is the fact that most academics probably have little idea of what actually constitutes a COI, and many disclosure forms do not help matters, being vague, punctual (once a year?), and with little in the way of education or other resources to encourage ethical behaviour.

Drug development
With the global press coverage of the H1N1 “pandemic” and concerns about sufficient access to vaccines, there’s also been a fair amount of conspiracy theory-type critiques of Big Pharma for creating a market for its products. Now, while I think most conspiracy theories are based on misplaced fears (and an unrealistic belief in the power of large bureaucracies to actually keep secrets!), stories like the following should make us pause a moment: Conflicts of interest? Dr. Mehmet Oz owns 150,000 option shares in vaccine technology company.

Its the Thanksgiving long weekend in Canada, and I really should also be doing other work alongside getting out to enjoy some of the gorgeous Fall colours with my family. So here’s a quick list of interesting COI stories:

• Doctors’ disclosure list less complete than industry’s
• Conflict-of-Interest Disclosure Remains Thorny Issue
• Paranoid Perceptions of Peer Perfidy
• Opinion: Health care reform from a surgeon’s perspective
• Coke partners with doctors’ group