Ghostwriting is scientific misconduct

2. Ghostwriting is scientific misconduct Peter C Gøtzsche Director, Nordic Cochrane Centre Professor, University of Copenhagen Chief Physician, Rigshospitalet I have no conflicts of interest

3. El al

4. Et al Hecht F. Et al. gets Nobel Prize. N Engl J Med 1977;296:234.

5. What if a doctor had borrowed them a pencil?

6. Ghost authorship Types of scientific misconduct (Denmark): - distorted interpretation of results, distorted conclusions - plagiarism of the results or entire articles of other researchers - wrongful or inappropriate attribution of authorship - misleading grant or job applications - exclusions of persons from the group of authors despite their contributions to the paper in question (Scientific dishonesty, Danish Medical Research Council 1992)

7. Study material - Protocols for all randomised industry-initiated trials - approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-95 - that were subsequently published (N=44) - and corresponding trial reports. Gøtzsche et al. PLoS Med 2007;4(1):e19.

8. Ghost authorship Present if individuals - who wrote the trial protocol - performed the statistical analyses, or - wrote the manuscript were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment.

9. Ghost authorship No trial protocol, and no publication, stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators. No protocol stated that clinical investigators were to be involved with data analysis.

10. Ghost authorship The failure to name, as an author, an individual who has made substantial contributions to an article. 44 industry-initiated trials in Copenhagen: 75% had ghost authorship (minimum estimate) 91% if those acknowledged were considered ghost authors. (Gøtzsche et al. PLoS Med 2007) Almost 200 companies in USA provide writing services. Doctors contribute widely to illegal marketing, and to spreading doubt about lethal harms of drugs.

11. Ghost authorship In 33 of 44 trials (75%). In 31 trials, they were were statisticians. We likely overlooked other ghosts, as we had very limited information, in particular: who wrote the paper?

14. Sponsor control of trial in progress44 protocols from 1994-95 Sponsor: has access to accumulating data 16 can stop the trial for any reason 18 Total 32 JAMA 2006;295:1645

15. Sponsor owns data or needs to approve manuscript Mentioned in: 0 of 44 the trial reports 22 of 44 protocols from 1994-95 27 of 44 protocols from 2004 JAMA 2006;295:1645

16. Documents from rofecoxib litigation:Guest authorship and ghostwriting - Trial reports written by Merck scientists - Academic authors added up front who were not even listed as participating investigators - Merck support for review articles often hidden (as part of introductory editorial or on a separate ”disclosure” page) (Ross, JAMA 2008;299:1800)

17. What should we do about it? - Zero tolerance; ghost and guest authorship are scientific misconduct - Sanctions that hurt: - life-long quarantine from that journal for ghost/guest authors and company - information of superiors - searchable register on perpetrators

18. Suggestions for editors - Editors’ associations should develop policies saying that ghostwriting is scientific misconduct - “Instructions to Authors” should say that ghost and guest writing is scientific misconduct that will be exposed - All journal articles should list the contributions of the authors - Ask authors to specify who wrote the first draft of the paper - Ask authors of papers on drugs and devices whether people contributed who aren’t listed - Be careful when papers concern drugs or medical devices.

19. Suggestions for editors - Ask who wrote the protocol and did the statistical analyses - Contact these people if they are not authors - Don’t accept meaningless statements in Acknowledgments “We thank XX” (for what? making coffee?) “XX provided editorial assistance” (means: “XX from Company YY wrote the paper”) - Ensure guidelines on good publication practices for drug companies and medical journals are followed - Alerting the authors’ academic institutions and identifying the commercial companies if misconduct detected

20. Suggestions for editors - Editors should insist that medical writers be authors - European Medical Writers Association: writers usually do not qualify for authorship, although their role should be acknowledged - ICMJE criteria: each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content - It is not possible to write a paper without judgment and interpretation of data - Writers fulfill the authorship criteria

21. Further suggestions - Authors should retain copies of drafts to facilitate investigations of possible misconduct - To ensure accountability, ethical review committees and drug agencies should not accept protocols that have no named authors, although this is very common - To properly document misconduct, journals and PubMed should use the term “misappropriated authorship.” Currently, this type of misconduct is listed under “erratum,” but it is rarely an error

22. Conclusion If a cook isn’t cooking, what is a cook then doing? (Gøtzsche, PLoS Med 2009)

23. Sponsorship should be easily detectable Ghosts belong in fairy tales

25. Is Pssssst....Is anybody there?