1 Authorship Bernard Lo, M.D. August 27, 2009

2 Questions  Looked self up in Pub Med?  Omitted as author?  Co-author didn’t deserve it?  Asked to add author who didn’t deserve it?

3 Survey of UCSF fellows Omitted as author20% Co-author didn’t deserve it38% Asked to make someone author who didn’t deserve it37%

4 Case 1: Prior agreements fail  You are second author  First author not analyzing data or writing paper  You want to take lead, get paper out  What would you do?

5 Case 1: Prior agreements fail  Participants enrolled, data collected and entered into statistical program  First author not analyzing data or writing paper  You want to take lead, get paper out  What would you do?

6 Case 1: Prior agreements fail  What would you do?  Send an ultimatum to your colleague  Get your mentor to pressure him  Forget about the project and move on  Not sure

7 Case 2: Added author  Division chief asks to be author  Comments in seminars and on abstract  Not participate in design or analysis  What would you do?

8 Case 2: Added author  What would you do?  Hold your nose and do it  Refuse and stand up for your principles  Ask your department chair to intervene  Forget about the project and move on  Not sure

9 Question  How did you feel about this authorship experience?

10 Outline of session  Criteria for authorship  Problems with authorship  Practical dilemmas

11 Why have authorship?  Recognition  Job, grants, promotions  Accountability  Prevent fabrication, fraud, plagiarism

12 Criteria for authorship  Conception and design or data analysis and interpretation, AND  Drafting or substantially revising article, AND  Approving final manuscript

13 Criteria for authorship Not merely  Funding or equipment  Collection of data  Supervision of research group

15 Questions?

16 Problems with authorship 1. Publish articles that shouldn’t be published  False, fabricated data  Duplicate publications

17 Problems with authorship 2. Fail to publish articles that should be  Negative results 3. Too many authors = honorary authors  People listed who shouldn’t be 4. Too few authors = ghost authors  People omitted who should be authors

18 Advantage study (2003)  Randomized trial of 5557 patients  Refecoxib vs. naproxen  Discontinue Rx for GI reasons: 5.9% vs. 8.1%

19 Advantage study  MIs: 5 on rofecoxib vs. 1 on naproxen  3 additional rofecoxib deaths not reported

20 Statement by lead author “Merck designed the trial, paid for the trial, ran the trial... Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then was sent to me for editing”

21 Ghostwriting  Asked by medical education company to write a review paper on interactions between warfarin and dietary supplements sponsored by drug company JGIM 2005; 20: 546

22 Ghostwriting  Received draft article, with name on title page  Company developing oral anticoagulant  No mention of product  Biased against warfarin

23 Ghostwriting  Later asked to review same paper  No mention of ghost author  No mention of drug company sponsorship

Are these isolated cases? 24

25 Problematic authorship Honorary authors21% Ghost authors13% Ghosts acknowledged 0% JAMA 1998; 280:222

26 Problematic authorship No substantial contributions26% Provided subjects, materials, lab, technical assistance58% Collected data25% JAMA 1994; 271: 438

27 Preventing ghost authorship  All persons who had input into writing must be author or acknowledged  All persons named as authors or acknowledged must complete financial disclosure

28 Journal requirements for industry- sponsored research  Full responsibility for trial  Access to data  Data analysis  Control over publication  Including data detrimental to product  Disclose financial relationships  Including payment for writing

Questions? 29

30 Duplicate publication Articles in systematic reviews1234 Duplicate 103 (8%) No cross reference63% Translations12% JAMA 2004; 291: 974

31 Types of duplication  Identical sample and outcomes  Combine several articles  Report different outcomes on sample  New data added to preliminary article  Part of larger trial, same outcomes

32 What is wrong with multiple publications?  Inefficient transfer of information  Bias in evidence base

33 Problems with authorship 5. Authors in wrong positions

34 Who’s on second?  Less prestige than first  Middle authors contribute even less  Last author often senior  Not cited after 6th

35 Who understands order?  Not journal editors  Not deans

36 Survey of department chairs  Fictitious article and authors  Infer author’s contributions Epidemiology 2004; 15; 125

37 Contributions of authors  “Little idea of roles of any author”  If corresponding author, more credit

38 Documentation of authorship  Describe specific contributions  In manuscript  In promotion packet

39 Concussions in NFL players  Retrospective review of data from team physicians  Return to play not associated with increased risk of second concussion

40 Conclusion  “Might be safe for college/high school football players to be cleared to return to play on the same day as the injury”  “Keep an open mind to possibility that present analysis of professional football players may have relevance to college and high school players.”

41 Dispute among 5 authors  Two disagreed  One said passage added without her knowledge

42 Lead author  Proofs were sent to each author  No need to point out new passage  “If people who are not scientists or physicians are misinterpreting it, that is not the responsibility of those who wrote it.”

43 Reactions?

44 Case 1: Prior agreements fail  What would you do?  Send an ultimatum to your colleague  Get your mentor to pressure him  Forget about the project and move on  Not sure

45 Excuses  It’s in the pipeline  It’s next in the pipeline BMJ 1994; 309: 1739

46 Excuses  I’m reanalyzing the data  The data are on a Windows computer  I can’t find the right statistical test to prove it worked

47 Pragmatic concerns  Power differences  Future repercussions  Is it worth the hassle?  Can you live with yourself?

48 Just do it, diplomatically  “I know you’re very busy. I’m willing to take over as 1st author and write a draft.”  “If I haven’t heard in 3 weeks, I’ll assume you’re too busy to be first author.”

Questions? 49

50 Case 2: Added author  What would you do?  Hold your nose and do it  Refuse and stand up for your principles  Ask your department chair to intervene

51 Just say no, diplomatically  “The journal insists that all authors sign that they have met a list of requirements. I would feel very awkward signing this. I’d like your permission to give you a big thank you in the acknowledgments.”

Questions? 52

Emotional impact of authorship disputes After disputes commonly feel:  Angry  Hurt  Taken advantage of 53

54 Take home points  Be explicit about authorship positions and responsibilities  Spell out arrangements in advance