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I’m still not sure how it’s “easy enough” to remove financial COI when you’re writing guidelines that include services delivered by ancillary providers or medical subspecialists—e.g., you can’t very well include recommendations about chiropractic treatments without including chiropractors on the panel, but of course they have a huge financial COI since it’s how they make their living.

Teresa

From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Paul Elias
Sent: Friday, August 24, 2012 11:51 AM
To: [log in to unmask]
Subject: Re: Conflict of Interest Declarations

I think too that we need to consider the distinctions between what is actual COI, versus perceived vs potential...to me the last 2 are just as severe as the former. very interesting topic. and very difficult to study or prove at least the last 2...also hard to quantify intellectual compared to financial COI ...the issue is which one is more damaging to research? it seems easy enough to remove a financial COI but how do we for intellectual COI???





Best,

Paul E. Alexander




--- On Wed, 8/22/12, Ahmed Abou-Setta, M.D. <[log in to unmask]<mailto:[log in to unmask]>> wrote:

From: Ahmed Abou-Setta, M.D. <[log in to unmask]<mailto:[log in to unmask]>>
Subject: Re: Conflict of Interest Declarations
To: [log in to unmask]<mailto:[log in to unmask]>
Received: Wednesday, August 22, 2012, 7:07 PM

IMHO, we have two distinct but complementary issues:

1)      What to declare (and what not to declare)

2)      What did the group/ panel/ etc. do about it to neutralize the potential bias (short of kicking the person off the committee)



There is no black and white here. If you have a potential COI or bias, there may be a valid reason for it (e.g. you are truly the top expert in the field), but at the same time we everyone discussing the issue should know and understand both your level of expertise and potential bias/ COI.



There was a discussion about funding a while back on this list and it got pretty heated… with some people pretty much calling for a witch-hunt of anyone who has received a dime from industry. The answer is simple, if you don’t like (or believe) what they have to say then dispute it or reject it altogether. We can’t all work for gratitude and each has to make their own choices on where their loyalties lie.



Ahmed





From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Benson, Teresa
Sent: Wednesday, August 22, 2012 12:52 PM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: Re: Conflict of Interest Declarations



The kind of folks you describe who have “probably very strong biases” (speakers on specific drugs/devices, etc.) would indeed be excluded when we sort out “the worst COIs”—perhaps I misused the term “worst.”  But even if I excluded everyone who ever took a dime for research, speaking, consulting, or anything else, or who is explicitly identified with a particular school of thought through organization membership or self-funded publications, I’m still left with providers who have their own practice preferences, intellectual COIs based on where they got their training, and of course the fact that just being a surgeon/chiropractor/radiologist would make them more inclined to recommend those services.  I don’t see any way of getting around those potential COIs, except to try to balance them.



From: Poses, Roy [mailto:[log in to unmask]]</mc/compose?to=%5bmailto:[log in to unmask]>
Sent: Wednesday, August 22, 2012 1:22 PM
To: Benson, Teresa
Cc: [log in to unmask]<[log in to unmask]>
Subject: Re: Conflict of Interest Declarations



There is considerable evidence, albeit mostly anecdotal, that industry picks "key opinion leaders" (KOLs) who are most likely to cooperate with their marketing and public relations agendas, rather than the "best experts."

For a few examples:

The documents revealed in the recent 3 billion USD GSK settlement included evidence of how GSK used KOLs to disseminate marketing messages.  [The complaint is here:  http://www.justice.gov/opa/documents/gsk/us-complaint.pdf]  [The relevant Health Care Renewal post is here: http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html]

An anonymous BMJ article by a former industry insider discussed the use of KOLs to promote new products. [See Anonymous.  Post-marketing observational studies: my experience in the drug industry.  Brit Med J 2012; 344: 28.  Link here<http://www.bmj.com/content/344/bmj.e3990>.]

Another BMJ article noted that a former pharmaceutical representative stated that "key opinion leaders were sales persons for us."   [Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? Brit Med J 2008; 336: 1402-3. Link here<http://www.bmj.com/cgi/content/full/336/7658/1402>.]   [HCR post here: http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html]

A ProPublica report showed that pharmaceutical companies picked as paid speakers physicians who were most likely to promote their marketing messages, regardless of the doctors' competence, ethics, etc.  Their speakers' bureaus included US doctors who failed to get board certification, or who were sanctioned by state medical boards.  [HCR post here: http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html]

Thus, by allowing people with significant conflicts of interest on your panels you are allowing people likely to be compliant with the marketing goals of the companies who paid them.  I do not see how you could offset their probably very strong biases with panelists inclined in opposite directions.

You may want to read the whole US Institute of Medicine report for a rigorous discussion of COI:  http://www.iom.edu/Activities/Workforce/ConflictOfInterest.aspx

On Wed, Aug 22, 2012 at 12:22 PM, Benson, Teresa <[log in to unmask]<[log in to unmask]>> wrote:

I don’t think you can eliminate panelists with COI, then you’d also be eliminating a lot of the best experts, as well as all the ancillary professionals and specialists who make their living by providing a very specific service (e.g., chiropractors, vascular surgeons).  We just try to eliminate the worst COIs, and then to make sure the remaining conflicts are balanced (e.g., including equal numbers of potentially pro-medication and pro-surgery panelists).



From: Evidence based health (EBH) [mailto:[log in to unmask]<[log in to unmask]>] On Behalf Of Paul Elias
Sent: Wednesday, August 22, 2012 12:15 PM
To: [log in to unmask]<[log in to unmask]>

Subject: Re: Conflict of Interest Declarations



giving it more thought, you can ask for :



members names

interest declared

type of interest

decisions taken



the last can be "declare, and to withdraw from all discussions linked to the topic/intervention' etc....maybe one should state the actions taken.



also, the larger question is what strategy can one consider to help mitigate COI...? how can it be designed into the development PHASE of guideline???











Best,



Paul E. Alexander






--- On Wed, 8/22/12, Trish Groves <[log in to unmask]<[log in to unmask]>> wrote:

From: Trish Groves <[log in to unmask]<[log in to unmask]>>
Subject: Re: Conflict of Interest Declarations
To: [log in to unmask]<[log in to unmask]>
Received: Wednesday, August 22, 2012, 2:26 PM

You could start here:
http://www.icmje.org/coi_disclosure.pdf

It's probably more than you'll need, but will point you in the right direction.
Best wishes
Trish

Dr Trish Groves
Deputy editor, BMJ
and Editor-in-chief, BMJ Open

+44 207 383 6018
bmj.com<http://bmj.com> - the open access journal
bmjopen.bmj.com<http://bmjopen.bmj.com>
BMJ Group: http://group.bmj.com
twitter @trished



From:        "Benson, Teresa" <[log in to unmask]<[log in to unmask]>>
To:        [log in to unmask]<[log in to unmask]>
Date:        22/08/2012 14:24
Subject:        Conflict of Interest Declarations
Sent by:        "Evidence based health (EBH)" <[log in to unmask]<[log in to unmask]>>

________________________________



I’m looking for some good language for asking potential panelists about potential conflicts of interest—something more than “Please declare any potential conflicts of interest” followed by a blank line.  Does anyone have any good suggestions, or know of examples on the web they can point me to?  I’d especially love to see some verbiage for ferreting out intellectual COI.  Thanks!

Teresa Benson, MA, LP
Clinical Lead, Evidence-Based Medicine
McKesson Health Solutions
18211 Yorkshire Ave
Prior Lake, MN  55372
[log in to unmask]<http:[log in to unmask]>
Phone: 1-952-226-4033








--
Roy M. Poses MD FACP
President
Foundation for Integrity and Responsibility in Medicine (FIRM)
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Clinical Associate Professor of Medicine
Alpert Medical School, Brown University
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