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Research and Reporting Methods |

Conflicts of Interest Ethics: Silencing Expertise in the Development of International Clinical Practice Guidelines

Derek J. Jones, JD; Alan N. Barkun, MDCM, MSc (Clinical Epidemiology); Yidan Lu, MDCM; Robert Enns, MD; Paul Sinclair, MSc; Myriam Martel, BSc; Ian Gralnek, MD; Marc Bardou, MD, PhD; Ernst J. Kuipers, MD; and Joseph Sung, MD, PhD, for the International Consensus Upper Gastrointestinal Bleeding Conference Group
[+] Article, Author, and Disclosure Information

From McGill University, Montreal, Quebec, Canada; St, Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada; Canadian Association of Gastroenterology, Oakville, Ontario, Canada; Technion-Israel Institute of Technology, Rambam Health Care Campus, Haifa, Israel; INSERM CIC-P 803, CHU de Dijon and Bourgogne University, Dijon, France; Erasmus Medical Center, Rotterdam, the Netherlands; and The Chinese University of Hong Kong, Hong Kong, China.

Grant Support: The conference was underwritten by unrestricted, pooled funds from the Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Canadian Institutes of Health Research Institute of Diabetes, Metabolism, and Nutrition and arms-length contributions from AstraZeneca Mölndal (Sweden), Abbott Canada, and Olympus Canada. The Canadian Association of Gastroenterology also provided in-kind support and administered the meeting.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-1984.

Requests for Single Reprints: Alan N. Barkun, MDCM, MSc (Clinical Epidemiology), Division of Gastroenterology, Montreal General Hospital Site, McGill University Health Centre, 1650 Cedar Avenue, Room D7-346, Montreal, Quebec H3G 1A4, Canada; e-mail, alan.barkun@muhc.mcgill.ca.

Current Author Addresses: Mr. Jones: Research Group on Health and Law, McGill University Faculty of Law, 3664 Peel Street, Montreal, Quebec H3A 1W9, Canada.

Drs. Barkun and Lu: Division of Gastroenterology, Montreal General Hospital Site, McGill University Health Centre, 1650 Cedar Avenue, Room D7-346, Montreal, Quebec H3G 1A4, Canada.

Dr. Enns: St. Paul's Hospital, 770 1190 Hornby Street, Vancouver, British Columbia V6Z 2K5, Canada.

Mr. Sinclair: Canadian Association of Gastroenterology, #224, 1540 Cornwall Road, Oakville, Ontario L6J 7W5, Canada.

Ms. Martel: Montreal General Hospital Site, McGill University Health Centre, 1650 Cedar Avenue, Room T8-314, Montreal, Quebec H3G 1A4, Canada.

Dr. Gralnek: University of California, Los Angeles, Center for the Study of Digestive Health Care Quality and Outcomes, 11301 Wilshire Boulevard, Building 115, Room 318, Los Angeles, CA 90073.

Dr. Bardou: INSERM CIC-P 803, CHU de Dijon, Bâtiment du Pr Marion, 14 rue Gaffarel, BP 77908, 21079 Dijon Cedex, France.

Dr. Kuipers: Erasmus University Medical Centre, Room Ba-391, Box 2040, 3000 CA Rotterdam, the Netherlands.

Dr. Sung: Department of Medicine and Therapeutics, 9/F Clinical Science Building, Prince of Wales Hospital, Chinese University of Hong Kong, Sha Tin NT, Hong Kong. China.

Author Contributions: Conception and design: D.J. Jones, A.N. Barkun, R. Enns, I. Gralnek.

Analysis and interpretation of the data: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, M. Martel, E.J. Kuipers.

Drafting of the article: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, I. Gralnek, E.J. Kuipers.

Critical revision of the article for important intellectual content: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, I. Gralnek, M. Bardou, E.J. Kuipers.

Final approval of the article: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, I. Gralnek, M. Bardou, E.J. Kuipers, J. Sung.

Statistical expertise: A.N. Barkun, M. Martel.

Obtaining of funding: A.N. Barkun, E.J. Kuipers, J. Sung.

Administrative, technical, or logistic support: Y. Lu, P. Sinclair.

Collection and assembly of data: D.J. Jones, A.N. Barkun, Y. Lu, R. Enns, P. Sinclair, M. Martel, J. Sung.

Ann Intern Med. 2012;156(11):809-816. doi:10.7326/0003-4819-156-11-201206050-00008
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Background: It is unclear whether global experts with financial conflicts of interest (FCOIs) should be included in, be excluded from, or have a limited role in developing international clinical practice guidelines (CPGs). Optimal management of FCOIs to ensure independent, expert CPGs remains ethically contested.

Objective: To manage FCOIs and examine whether an ethics framework with discussion recusal by experts with FCOIs affects deliberations and voting on a CPG.

Design: Development of an ethics framework grounded on transparency and proportional management of COIs, including self-recusal, evaluation of the effect on COIs and CPG process by quantification of voting on recommendations, and qualitative assessment of experts' ethics dialogue.

Setting: International consensus meeting to formulate a CPG in gastroenterology.

Participants: 34 experts from 15 countries.

Measurements: Counting the votes of experts with and without declared FCOIs and qualitative assessment of ethics discussions.

Results: 62% of experts reported at least 1 FCOI. Eight out of 21 recommendations presented potential FCOIs. Experts with conflicts recused themselves from discussing 6 of the 8 recommendations, leaving a majority of nonconflicted discussants (median, 22; range, 19 to 26) for the 6 recommendations. Recusals did not affect voting outcomes but may have diluted the richness of the discussions. Ethics dialogue revealed accord on transparency but underscored challenges to proportional management of COIs beyond basic disclosure. Concerns about bias, COI definitions, expertise, and integrity express important international ethics questions.

Limitation: Small participant numbers and application of the framework to only 1 meeting of 1 CPG.

Conclusion: An ethics framework may help to identify and manage COIs and catalyze both ethics dialogue and innovative COI standards that seek to balance impartiality and expertise for trusted CPGs. Optimal balancing remains contested. Recommendations include frameworks, interdisciplinary analysis, and international policy initiatives to better manage COIs in the CPG process.

Primary Funding Source: Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Institute of Diabetes, Metabolism, and Nutrition of the Canadian Institutes of Health Research.


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Selected voting results for “at-risk” recommend-ations.

Votes from all participants are compared with votes excluding recused participants.

* For each recommendation, voting results in the first 3 categories of agreement on the 6-point Likert scale were grouped under “agree”; the rest were grouped under “disagree.”

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Relevance of FCOI and the Opportunities for Expertise
Posted on June 19, 2012
Mark A. LaPorta
Conflict of Interest: see below

While the usual connotation of FCOI (financial conflict of interest) is important, there are other connotations that go unspoken. OK, the professor or author doesn't have an investment or stock in the product of company, but he has two other investments,a t least: Big Egos want big recognition. Last I heard, Publish or Perish still applies in acadaemia, and fame and fortune is sought in the community. I've been amazed over a 30+ year career how many ideas should have been left behind before Professor Important used his name and influence to put pressure to alter the course of a standard of care, then his persuasion is passed on to the greater community by his acolytes and sycophants. When those "new ideas" are rescinded or "revisited" within a few years, did we really help advance the science or the discipline? I am not an acknowledged Professor by the usual criteria. I work with the public, I've logged 10's of 10-to-the-third clinical hours, I have training at two well-respected academies, and, I have continued to develop my intellect and analytical skills enough to know that I sure don't believe everything I read -- regardless of "peer-review" -- and I've observed the mess we've made in the name of our sacred profession and self-preservation.  Yet I am a professor. I profess the best of what health care -- not "healthcare" -- has to offer and I see what works -- I've been an evidence-based, medical-home-for adults bearer of Truth and real treat-em-like family informed consent even before my rigorous training.

I believe -- and profess -- that only approximately 15% of what we do is actually "necessary", but who am I to argue with the unwritten and unwitting standards? Why aren't we asking people - not patients -- who have "cured" their own/been relieved of diseases "how did you do it?". The rational ones don't tell you if you don't ask. After all that, will my expertise ever be considered in the development of clincal guidelines? We think not. Entire dimensions continue to be missed, opportunities for healing lost, and "primum non nocere" ignored. 

I keep my ACP Fellowship for reasons that border on a sentimental legacy -- and I value the letters after my name that are supposed to mean something above and beyond. My father was an anesthesiologist, a teacher, and personally directed and managed an ICU during the 60's through the early 80's. In 1968, he observed, "Medicine is like the nuclear arms race: we have the technology but not the phiolosphy". He also frequently quipped, "God Bless America".















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