Authorship and Algorithms: Assessing Authorship at Lilly. Jeffrey W. Clemens, Ph.D. Eli Lilly and Company

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1 Authorship and Algorithms: Assessing Authorship at Lilly Jeffrey W. Clemens, Ph.D. Eli Lilly and Company 1

2 Disclosure I am an employee and stockholder of Eli Lilly and Company. Eli Lilly and Company has reviewed this presentation for intellectual property and proprietary information considerations. I am the sole author of this presentation. ISMPP has provided me with partial registration and lodging for this meeting. Acknowledgements 2

3 Presentation Problem? What problem? What does industry say about authorship? Lilly s Approach to Authorship Principles Procedures and Tools 3

4 Office of Inspector General 2003 report pharmaceutical manufacturers are responsible for ensuring the integrity of data used for government reimbursement purposes. use of HCPs for marketing purposes including, for example, ghost-written papers or speeches implicates the anti-kickback statute. While full disclosure by physicians of any potential conflicts of interest and of industry sponsorship or affiliation may reduce the risk of abuse, disclosure does not eliminate the risk. 4

5 Medical Publishing World Not in a State of Denial ICMJE Uniform Requirements for Manuscripts Submitted to BiomedicalJournals FDAAA- Clinical Trial Registry and Results include Journal Citations Developing Good Scientific Publishing Practices: One Pharmaceutical Company s Perspective. CMRO Good Publication Practices for Pharmaceutical Companies (GPP) CMRO Best Practice Guidelines on Publication Ethics: a Publisher s Perspective. IJCP Good Publication Practices for Communicating Company Sponsored Medical Research: the GPP2 Guidelines. BMJ Author s Submission Toolkit: A Practical Guide to Getting Your Research Published. CMRO 5

6 Problem, What Problem? It s Ancient History For publications of clinical trials sponsored by the biotechnology/pharmaceutical/medical device industry, the issues related to ghost and guest authorship 1. Are largely addressed and need only to be monitored and enforced by the industry, its partners, and collaborators 2. Still a large problem and will continue to generate scandals and negative headlines 3. Are largely addressed but perceived to still be an issue by uninformed parties 4. Not described by any of the above 6

7 1. For publications of clinical trials sponsored by the biotechnology/pharmaceutical/medical device industry, the issues related to ghost and guest authorship: and just need to be monitored but still perceived to be an issue of the above 7

8 Not Ancient History- Still Stormy Senate Minority ( Grassley ) report- 24 June 2010 Despite acknowledgment of medical writers for editorial assistance, the role of pharmaceutical companies remains veiled or undisclosed Strengthening journal authorship policies appears to have limited effect on ghostwriting and disclosure of industry financing of medical articles PLoS Medicine Policy Forum 7 Sept "Industry-funded marketing messages may infest articles in every medical journal." and "Perhaps physician-investigators should create and uphold a standard where relationships with industry are regarded as unsavory rather than sought after. British Medical Journal Survey of corresponding authors for 896 articles published in 2008 in 6 top-tier medical journals Honorary or guest authorship estimated at 17.6% (n=545) Ghost authorship estimated at 7.9% (n=622) 1. Fugh-Berman AJ (2010) PLoS Med 7(9): e Wislar JS et al BMJ (2011) 343:d6128 Honorary and ghost authorship cross-sectional survey 8

9 Stormier Seas Ahead? PLoS Medicine Policy Forum August and January Propose use of False Claims Act and Racketeering and Corrupt Organizations Act as legal remedies for Medical Ghostwriting and to be sought by patients harmed by drugs publicized in ghostwritten papers If sponsor names physician as guest author in consideration of prescribing a medication, then the federal Anti-Kickback statute violated The legal scenario proposed 2 1. Paying physicians to become honorary or guest authors may influence their critical judgment 2. May increase product sales (and payer costs) 3. Patients put at risk because of misrepresented risk-benefit 4. Both physicians and sponsor companies may be legally liable Situation is so dire forced to seek judicial intervention to curb dangerous, unethical medical ghostwriting We believe the courts restoring the integrity of the medical literature. 1. Stern S. Lemmens T PLoS Med (8)e Bosch X et al PLoS Med (1):e

10 International Committee of Medical Journal Editor s Authorship Criteria 1 Authorship credit should be based on 1) Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) Drafting the article or revising it critically for important intellectual content; and 3) Final approval of the version to be published. Authors should meet conditions 1, 2, and 3. Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship. All persons designated as authors should qualify for authorship, and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. 1. Uniform Requirements for Manuscripts Submitted to Biomedical Journals accessed 23 March

11 Public Statement of Authorship Policies For employees of pharmaceutical, biotech, and device companies Does your company publicly (e.g., company website) state that their authorship policy aligns with ICMJE s Uniform Requirements for Manuscripts Submitted to Biomedical Journals? 1. Yes 2. No 3. Don t know 11

12 2. For employees of pharmaceutical, biotech, and device companies, does your company publicly (e.g., company website) state that their authorship policy aligns with ICMJE s Uniform Requirements for Manuscripts Submitted to Biomedical Journals? 12

13 Communication of Authorship Policies For employees of medical writing agencies, medical communication companies, and freelancers Do your pharmaceutical, biotechnology, and medical device industry partners inform you and your company of their authorship policies? Choose A, B, C, or D 1. Yes 2. No 3. Some do, some don t 4. Don t know 13

14 3. For employees of medical writing agencies, medical communication companies, and freelancers, do your pharmaceutical, biotechnology, and medical device industry partners inform you and your company of their authorship policies? 14

15 Lilly s Public Statements- Principles of Medical Research 1 Medical is accountable for the design, approval, conduct, and scientific disclosure of medical research sponsored by Lilly. Discloses publicly all medical research results that are significant to patients, health care providers or payers whether favorable or unfavorable in an accurate, objective, and balanced manner for customers to make more informed decisions about its products. Lilly complies with the International Committee of Medical Journal Editors' "Uniform Requirements for Manuscripts Submitted to Medical Journals. 1. accessed 23 March

16 How to Implement with Policies, Procedures, and Tools? Early 2000s- Global policies and procedures Selected components addressing authorship Formal invitation in writing before project starts to external authors that includes statements that Lilly s Authorship Criteria = ICMJE criteria No payment for fulfilling authorship responsibilities Commitment to provide the recipient full access to all data relevant Internal tools Authorship tool Contributor Assessment Job Aid 16

17 Evolution of Authorship Assessment Applied when Lilly or its agents are managing a publication 2000s One page appendix to global authorship procedure Intended to facilitate adherence to the Lilly Authorship Policy. Internal documentation of authorship decisions Information reflects the opinion of Lilly personnel assigned to the Scientific Disclosure and/or of the contributor. Check boxes related to items 1, 2, and 3 of ICMJE criteria Since 2010 for clinical manuscripts Authorship responsibility and approval tool External authors asked to state that they meet the ICMJE criteria before submission to the journal Retain evidence of substantive author feedback on all drafts sent for review 17

18 An Algorithm to Assess Authorship Contributorship Assessment Job Aid (SF Brown, Lilly) Parker RA, Berman NG. Statist Med 1998;17: Ahmed SM et al. Fam Med 1997;29: intended to help identify contributions that may satisfy the ICMJE Uniform Requirements for authorship Authorship decisions.. not be based solely on the derived numeric values, but must consider fulfillment of all three authorship criteria. Authorship and acknowledgements should be determined by discussion and consensus agreement among the Writing Team. Helpful for resolution of authorship disputes, should they arise. 18

19 Contributorship Assessment Job Aid Excel spreadsheet Sections for each of the three authorship criteria AND general requirement that author can take public responsibility for all or part of work Applied to ALL individuals that contribute to the manuscript Assigns weighted values to types of activities and multiplies by relative effort Subjective scale biased towards intellectual/scholarly and clinical/scientific expertise activities Sets a recommended threshold value (Minimum Activity Score) to be considered for byline authorship if all 3 ICMJE criteria also met Relative contribution by Activity Score can be used to discuss authorship order, corresponding, etc. 19

20 Uniform Requirements Criteria 1 Contribution to Design Contributions to Design: Conception: For an Original Study, provided substantive input into the overall design of the study and protocol development. May be thought of as 'thinking through a study' Activity Score (B) Contribution Multiplier (C) 4 Significant = 5; Moderate = 3; Minimal = 1; None = 0 B C Score Conception: For a Meta-Analysis or Post-Hoc Analysis of Existing Data, clarification of the research question, confirmation that the data are available to answer the question, and participation in design of the analysis May be thought of as 'thinking through a study' Wrote one or more sections of the research protocol and/or statistical analysis plan Provided critical review to sharpen a protocol before submission, without major substantive changes 4 Significant = 5; Moderate = 3; Minimal = 1; None = 0 2 Significant = 5; Moderate = 3; Minimal = 1; None = 0 1 Significant = 5; Moderate = 3; Minimal = 1; None =

21 Uniform Requirements Criteria 1 Contribution to Implementation Contributions to Implementation Participated regularly in study meetings with the investigators Activity Score (B) Contribution Multiplier (C) 2 Significant = 5; Moderate = 3; Minimal = 1; None = 0 B C Score Established timelines, selected sites and/or personnel, allocated resources, completed assignments, solved problems with study implementation 2 Significant = 5; Moderate = 3; Minimal = 1; None = Enrolled and treated patients; Implemented data collection and data management activities 4 Significant = 5; Moderate = 3; Minimal = 1; None = Advised only on specific issues when requested by the principal or other investigators 1 Significant = 5; Moderate = 3; Minimal = 1; None =

22 Uniform Requirements Criteria 1 Contribution to Data Analysis Contributions to Data Analysis Planned and directed the analysis, based on the statistical analysis plan Activity Score (B) Contribution Multiplier (C) B C 4 Significant = 5; Moderate = 3; Minimal = 1; None = Prepared written material that summarized the results of the analyses for the other investigators and/or prepared formal reports 2 Significant = 5; Moderate = 3; Minimal = 1; None = Conducted the analyses 1 Significant = 5; Moderate = 3; Minimal = 1; None = Criterion 1 Subtotal Minimum Activity Score (Column B) necessary to qualify for authorship =

23 Uniform Requirements Criteria 2 and 3 Contributions to Drafting and Approval Uniform Requirements Criteria 2: B C Score Contributions to Drafting: Drafted the article or revised it critically for important intellectual content. 4 Significant = 5; Moderate = 3; Minimal = 1; None = AND Uniform Requirements Criteria 3: B C Score Approval: Gave final approval of the version to be published AND 4 Yes = 1; No = General Requirement: B C Score Public Responsibility: Participated sufficiently in the work to take public responsibility for appropriate portions of the content 4 Significant = 5; Moderate = 3; Minimal = 1; None = Total: 79 23

24 A Call to Action? As a result of this presentation or others at this meeting, I will work to review, change, update, or otherwise modify my company s policies, procedures, or practices concerning authorship. 1. True 2. False 24

25 4. As a result of this presentation or others at this meeting, I will work to review, change, update, or otherwise modify my company s policies, procedures, or practices concerning authorship. 25

26 Conclusion When industry sponsors are involved, medical publishing for drugs and devices will continue to be closely scrutinized for honorary and ghost authorship by many parties Regaining credibility and trust will require transparency and disclosure of industry s role and setting clear expectations for all authors Procedures and tools are necessary as aids to facilitate compliance with stated principles and standards 26