AHRQ 2009 Annual AHRQ 2009 Annual ConferenceConference

Do Ask, Do Tell: Best Practices in Conflict of Do Ask, Do Tell: Best Practices in Conflict of Interest Policies for Research, Publishing, and Interest Policies for Research, Publishing, and

Recommendation-MakingRecommendation-Making

Non-Financial Conflicts of Interest

Steve KnickrehmSteve Knickrehm

James Bell AssociatesJames Bell Associates

Project TeamProject Team

AHRQ Project: AHRQ Project: Best Practices in Conflict of Best Practices in Conflict of Interest for Comparative Effectiveness Reviews Interest for Comparative Effectiveness Reviews and for Recommendation-Making Panelsand for Recommendation-Making Panels

James Bell Associates:

James Bell

Steve Knickrehm

Eastern Research Group:

John Eyraud

Andreas Lord

Nyssa Ackerley

Definition of Conflict of Definition of Conflict of Interest Interest

““A conflict of interest is a set of conditions A conflict of interest is a set of conditions in which professional judgment in which professional judgment concerning a primary interest (such as a concerning a primary interest (such as a patient's welfare or the validity of patient's welfare or the validity of research) tends to be unduly influenced research) tends to be unduly influenced by a secondary interest (such as financial by a secondary interest (such as financial gain).”gain).”

- D. F. Thompson, D. F. Thompson, Understanding Financial Conflicts of InterestUnderstanding Financial Conflicts of Interest, 1993, 1993

Emphasis on Financial COI (FCOI)—Emphasis on Financial COI (FCOI)—1993 1993

COI rules focus on financial gain because money COI rules focus on financial gain because money is: is: more objective more objective more fungible more fungible easier to regulate by impartial rules easier to regulate by impartial rules generally useful for more purposes. generally useful for more purposes.

““Just because we cannot do much about the Just because we cannot do much about the other secondary interests, it does not follow other secondary interests, it does not follow that we should do little about financial gain.” that we should do little about financial gain.”

- Thompson, 1993- Thompson, 1993

The Two Horns of the Non-The Two Horns of the Non-Financial COI (NFCOI) DilemmaFinancial COI (NFCOI) Dilemma

1.1. Medical and health care literature is Medical and health care literature is clear that NFCOI can be as damaging to clear that NFCOI can be as damaging to scientific integrity as financial interests.scientific integrity as financial interests.

2.2. Much of the literature assumes nothing Much of the literature assumes nothing can be done to manage nonfinancial can be done to manage nonfinancial interests and ignores its potentially interests and ignores its potentially damaging consequences.damaging consequences.

Leading Organizations Leading Organizations Increase Emphasis on NFCOIIncrease Emphasis on NFCOI

World Association of Medical Editors World Association of Medical Editors (WAME) Policy Statement(WAME) Policy Statement

International Committee of Medical Journal International Committee of Medical Journal Editors (ICMJE) Uniform RequirementsEditors (ICMJE) Uniform Requirements

JAMAJAMA LancetLancet Implementation ScienceImplementation Science AHRQAHRQ U.K. National Institute for Health and U.K. National Institute for Health and

Clinical Excellence (NICE)Clinical Excellence (NICE)

Academic CommitmentsAcademic Commitments Intellectual PassionIntellectual Passion

Personal RelationshipsPersonal Relationships Political or Ideological BeliefsPolitical or Ideological Beliefs

Institutional AffiliationsInstitutional Affiliations Religious BeliefsReligious Beliefs

Professional ConflictsProfessional Conflicts Professional RelationshipsProfessional Relationships

Recognition for Professional Recognition for Professional AchievementAchievement

Favors to Students, Friends, or Favors to Students, Friends, or FamilyFamily

Professional AffiliationsProfessional Affiliations Published Opinions or AdvocacyPublished Opinions or Advocacy PositionsPositions

* Compiled from WAME, ICMJE, JAMA, etc…

Types of NFCOITypes of NFCOI**

NFCOI Example 1—Religious NFCOI Example 1—Religious Beliefs Beliefs

Imagine you’re a peer reviewer who’s Imagine you’re a peer reviewer who’s received a request to referee a paper. The received a request to referee a paper. The paper reports the results of a study using paper reports the results of a study using cell lines derived from an aborted fetus as a cell lines derived from an aborted fetus as a diagnostic tool in identifying certain viral diagnostic tool in identifying certain viral infections. You are also a member of a infections. You are also a member of a religious organization morally opposed to religious organization morally opposed to fetal cell research. In your review, you raise fetal cell research. In your review, you raise questions about the study’s validity and questions about the study’s validity and methodology that might undermine the methodology that might undermine the paper’s chance of publication.paper’s chance of publication.

- PLOS Medicine Editors, - PLOS Medicine Editors, Making Sense of Non-Making Sense of Non-Financial Competing InterestsFinancial Competing Interests, 2008, 2008

NFCOI Example 2—NFCOI Example 2—Personal/Professional Personal/Professional

AssociationsAssociations

Imagine you’re an editor and you receive a Imagine you’re an editor and you receive a paper from the scientist who supervised paper from the scientist who supervised your postdoctoral fellowship. It’s been a your postdoctoral fellowship. It’s been a couple of years since you left his lab, but couple of years since you left his lab, but he has supported your career and you he has supported your career and you have warm feelings toward him; plus you have warm feelings toward him; plus you still join your former lab mates still join your former lab mates occasionally at their monthly pub night. occasionally at their monthly pub night. You select sympathetic reviewers and you You select sympathetic reviewers and you fight hard for the paper at the editorial fight hard for the paper at the editorial meeting. meeting.

- PLOS Medicine Editors, 2008- PLOS Medicine Editors, 2008

NFCOI Example 3—Published NFCOI Example 3—Published Opinions or Advocacy PositionsOpinions or Advocacy Positions

Dietary Approaches to Stop Hypertension (DASH)-Sodium Trial Dietary Approaches to Stop Hypertension (DASH)-Sodium Trial funded by the National Heart, Lung, and Blood Institute (NHLBI)funded by the National Heart, Lung, and Blood Institute (NHLBI)

Questions were raised about the lack of primary end points for all Questions were raised about the lack of primary end points for all subgroups in the published results, despite repeated requests.subgroups in the published results, despite repeated requests.

““It is plausible to assume that the reluctance of NHLBI may be It is plausible to assume that the reluctance of NHLBI may be based in its own conflict of interest in this matter. Dr. Lenfant and based in its own conflict of interest in this matter. Dr. Lenfant and his colleagues at NHLBI have spent the better part of the past two his colleagues at NHLBI have spent the better part of the past two decades championing sodium restriction as the most important decades championing sodium restriction as the most important dietary adjustment for the prevention and treatment of dietary adjustment for the prevention and treatment of hypertension. Without the data to justify this, we must ask hypertension. Without the data to justify this, we must ask whether the vested interests of the NHLBI might not have a role in whether the vested interests of the NHLBI might not have a role in apparent efforts to protect this policy.”apparent efforts to protect this policy.”

- David A. McCarron, “NHLBI’s Conflict of Interest: Why We Need the Data David A. McCarron, “NHLBI’s Conflict of Interest: Why We Need the Data

Quality Act”, Editorial, American Journal of Hypertension, 2003Quality Act”, Editorial, American Journal of Hypertension, 2003

Addressing the NFCOI Addressing the NFCOI DilemmaDilemma

““As with all competing interests, what’s in dispute is As with all competing interests, what’s in dispute is not that they exist, but how to manage them. The not that they exist, but how to manage them. The responsibility of journals and the wider research responsibility of journals and the wider research communities is to safeguard the credibility of the communities is to safeguard the credibility of the scientific and editorial processes. Three things scientific and editorial processes. Three things are needed to start making sense of non-financial are needed to start making sense of non-financial competing interests:competing interests:

1. Disclose

2. More Policy Development

3. More Research”

- PLOS Medicine Editors, 2008