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The evaluation of conflict for the 2008 Guideline Update comprised a two-stage procedure designed to obtain increasingly detailed and informative data on potential conflicts over the course of the Guideline development process.
In July 2006 and prior to the initial meeting in October 2006, Panel members completed a general screen, reporting any potential conflicts over the previous 5 years. Where potential conflicts existed, Panel members provided a narrative listing of the relevant organizations and types of conflict. Panel members were asked to update this screen as new information or potential conflicts became known.
Prior to the second in-person Panel meeting in June 2007, and before any decisions regarding Panel recommendations were made, Panel members were required to complete a more exhaustive disclosure process for calendar years 2005, 2006, and 2007, based on the United States Department of Health and Human Services, PHS Title 42, Chapter 1, Part 50 guidelines for the conduct of research (ori.hhs.gov/policies/fedreg42cfr50.shtml). Moreover, Panel members were asked to update this report as new information or potential conflicts became known. In keeping with the PHS-based guidelines, a potential conflict was designated as “significant” if one or more of three criteria were met:
Net reportable compensation in excess of $10,000 in any reporting year to the Panel member, spouse, or dependent child for outside activities from any entity whose interests may be affected by the recommendations in the Guideline (excluding public or nonprofit entities).
Leadership as an officer, director, or trustee in any reporting year by the Panel member, spouse, or dependent child in any entity whose interests may be affected by the recommendations in the Guideline (excluding public or nonprofit entities).
Ownership interests either in excess of $10,000 or 5 percent of the business in any reporting year by the Panel member, spouse, or dependent child in any entity whose interests may be affected by the recommendations in the Guideline (excluding public or nonprofit entities).
Panel members were asked to complete this PHS-based report for 3 calendar years (2005, 2006, 2007), that comprised both the 18-month period before the Guideline Panel was constituted, as well as the full period of Guideline development. For any significant conflict that was disclosed, Panel members provided a detailed description of the relevant organizational tie, including categorizing the amount of compensation or financial interests involved. Of the Panel members listed in this document, 21 of 24 had no significant financial interests as defined by the PHS-based criteria. In addition to these mandatory disclosures regarding compensation, leadership, and ownership, members were asked to disclose any other information that might be disclosed in a professional publication.
Three Panel members whose disclosures exceeded the PHS criteria for significant financial interest were recused from Panel deliberations relating to their areas of conflict; one additional Panel member voluntarily recused himself.
The following is a summary listing for any of the years 2005, 2006, and 2007 of all significant financial interests as defined above, as well as any additional disclosures Panel members chose to make.
William C. Bailey reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements.
Timothy B. Baker reported no significant financial interests. Under additional disclosures, he reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies.
Neal L. Benowitz reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company. Under additional disclosures, he reported providing expert testimony in lawsuits against tobacco companies.
Susan J. Curry reported no significant financial interests and no additional disclosures.
Sally Faith Dorfman reported no significant financial interests. Under additional disclosures, she reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence.
Michael C. Fiore reported no significant financial interests. Under additional disclosures, he reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome.
Erika S. Froehlicher reported no significant financial interests and no additional disclosures.
Michael G. Goldstein reported no significant financial interests. Under additional disclosures, he reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007.
Cheryl Healton reported no significant financial interests and no additional disclosures.
Patricia Nez Henderson reported no significant financial interests and no additional disclosures.
Richard B. Heyman reported no significant financial interests and no additional disclosures.
Carlos Roberto Jaén reported no significant financial interests and no additional disclosures.
Howard K. Koh reported no significant financial interests and no additional disclosures.
Thomas E. Kottke reported no significant financial interests and no additional disclosures.
Harry A. Lando reported no significant financial interests. Under additional disclosures, he reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel.
Robert E. Mecklenburg reported no significant financial interests. Under additional disclosures, he reported assisting Clinical Tools, Inc., through a governmental contract to develop a PHS 2000 Guideline-based Internet continuing education course.
Robin Mermelstein reported no significant financial interests and no additional disclosures.
Patricia Dolan Mullen reported no significant financial interests and no additional disclosures.
C. Tracy Orleans reported significant financial interests in the form of a dependent child who owns pharmaceutical stock, and no additional disclosures.
Lawrence Robinson reported no significant financial interests and no additional disclosures.
Maxine L. Stitzer reported no significant financial interests. Under additional disclosures, she reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication.
Anthony C. Tommasello reported no significant financial interests and no additional disclosures.
Louise Villejo reported no significant financial interests and no additional disclosures.
Mary Ellen Wewers reported no significant financial interests and no additional disclosures.
Liaisons followed the same process as Panel members in reporting significant financial interests. Their disclosures are summarized below:
Glen Bennett reported no significant financial interests and no additional disclosures.
Stephen Heishman reported no significant financial interests and no additional disclosures.
Corinne Husten reported no significant financial interests and no additional disclosures.
Glen Morgan reported no significant financial interests and no additional disclosures.
Ernestine W. Murray reported no significant financial interests and no additional disclosures.
Christine Williams reported no significant financial interests and no additional disclosures.
Peer reviewers were required to report significant financial interests at the time they submitted their peer reviews. The interests were reviewed prior to the adjudication of each reviewer's comments. Any significant financial interests are noted below their listing in the Contributors Section of this Guideline.
The availability of the draft Guideline report for review was announced in the Federal Register on September 28, 2007 (Volume 72, Number 188). Individuals who had informed Panel members or staff that they wished the opportunity to review the document were provided with an opportunity to do so. All those submitting comments were asked to disclose significant financial interests at the time their comments were submitted. Prior to each set of comments being considered and adjudicated, the disclosure information (or lack of disclosure) was noted and taken into consideration.
