1. Who stands behind the word? A journal editor’s view of ghostwriting Gavin Yamey MD Deputy editor, wjm Assistant editor, BMJ

2. What I want to talk about Why ghostwriting occurs How it deceives readers and editors How it distorts the scientific record and medical practice Disclosure as a partial solution

3. The background conditions for ghostwriting Industry is responsible to its shareholders Pharmaceutical companies must be profitable "The company—and therefore its statisticians and writers—is sworn to do whatever is legally possible to increase the value of its stockholders' stock" (Goodman)

4. Industry must publish favorable material Industry designs studies likely to favor its products Companies analyze the data Ghostwriters are paid by industry to add favorable spin If the data are not favorable, industry suppresses or delays publication "It could even be considered illegal to publish a study showing that one of their products doesn't work" (Goodman)

5. A case of industry influence BMJ 1998;316:1935-1938 Single author RCT of flutamide in pancreatic cancer Unexpectedly favorable result Randomization, statistical assistance, and data analysis: by industry Study was heavily criticized

6. How readers are editors are being deceived We are being deceived if the declared authors did not participate in the study design, had no access to the raw data, did not interpret it, or did not write it

7. The ghost-guest syndrome 2 features: A professional medical writer ("the ghost"): employed by industry, paid to write, not named as author A prestigious author ("the guest"): does not analyze data, does not write the manuscript, may or may not review the manuscript

8. Is the syndrome just a rarity? No! In one study, 19% of articles surveyed had named authors who would not meet ICMJE criteria for authorship (JAMA 1998;280:222-224) 11% had ghostwriters, who were not named as authors Reviews, editorials, clinical guidelines: higher prevalence?

9. Does the syndrome have any benefits? Many researchers are not good writers, or are too busy Ghostwriters can speed up the publication process, and will write a "better" piece than most doctors

10. The harms of ghostwriting Lots of evidence that industry distorts physician behavior and prescribing (www.nofreelunch.org/evidence.html) Publishing articles that are over-zealous about a product could have a similar effect Ghostwriting distorts the scientific record

11. Ghostwriters speak out "I agreed to do two reviews for a supplement to appear under the names of respected ‘authors.’ I was given an outline, references, and a list of drug- company approved phrases. I was asked to sign an agreement stating that I would not disclose anything about the project. I was pressured to rework my drafts to position the product more favorably."

12. Ghostwriters speak out (2) "I was told exactly what the drug company expected and given explicit instructions about what to play up and what to play down"

13. My feelings about ghostwriting Deceptive authorship Shadowy practice that has little to do with improving health care, and everything to do with profit I am deeply worried when industry is involved in study design, analysis, writing

14. What is the solution? In an ideal world, investigators would write up their own study No place for ghostwriters: investigators would write their study, the actual authors would write their editorial/review/guideline

15. Disclosure: better than hiding in the shadows "Everything must be held up to the light" If we really must have medical writers paid by industry, they ought to reveal themselves and their conflicts of interest: *named as contributors *funding source must be made explicit *exact contribution should be transparent

16. Disclosure is not a panacea Editors and readers are rightly cautious when they see industry influence If a study, editorial, review, or guideline has been sponsored by a company, what do we as clinicians do with the information? Do we just ignore it, or take it with a pinch of salt?

17. Conclusions Ghostwriting is a deception It distorts the scientific record, and may distort clinical practice Better to bring ghostwriters out of the shadows, but this is not a panacea

18. A matter of life and death "The integrity of a body of literature is itself our society's ultimate temporal forum for negotiating life and death, suffering and wellness.....the medical well-being of the society it serves is dependent on the question of who stands behind the word." (Mark Gruber, anthropologist)