Dear Dr Fugh-Berman

Many thanks to your prompt response to our comment. You raise many points in your response, which I shall take one at a time.

<em>“medical writers who work for industry do not control the final product…”</em>

That is indeed correct. Medical writers in general can only advise, and cannot dictate. Medical writers, by themselves, will never be able to ensure that all problems with publication ethics are eliminated. Control of the final product must rest with the named authors of the paper. Medical writers can help to facilitate this, but ultimately is it up to named authors to ensure that they do not sign their names to papers if they do not feel that they have control of what is in it. Medical writers do, however, have a responsibility to write scientifically justified articles, and to challenge both companies and independent authors if they have any concerns in that area.

<em>“…and rarely see their names on their work…”</em>

That statement, however, is demonstrably false. Medical writers frequently see their names in the acknowledgement sections of papers (the appropriate place for them, as few medical writers would fulfil ICMJE criteria for authorship), and this is becoming more common. Our own research found that 58% of contributions were acknowledged in 2008, a substantial increase since 2005 [1]. Admittedly, that figure of 58% is based on a survey with a low response rate, and may be inflated by response bias. However, even if it is an overestimate, it is clearly not true to say that medical writers “rarely see their names on their work”. It is worth noting that practices in this area have been changing rapidly in recent years, probably as a result of the various guidelines that have been published on the subject, such as those published by EMWA [2]. Before 2003, when the original GPP guidelines were published [3], there were no published guidelines stating that the contributions of medical writers should be acknowledged.

I do agree, however, that even a figure of 58% is far too low. It should be 100%. EMWA is working to educate its members about the importance of transparency in an attempt to increase that figure. Also, I and some colleagues published a checklist in this journal last year which is designed to allow journal editors to improve transparency of the role of medical writers [4]. Puzzlingly, PLoS Medicine have not started requiring authors to complete the checklist. As stated previously, medical writers cannot do everything by themselves. They need allies from the ranks of both clinical researchers and journal editors if they are to be successful in eliminating ghostwriting completely. My impression is that journal editors are quick to criticise ghostwriting (and rightly so), but much slower to take practical action to discourage it.

<em>“…so let’s call a ghost a ghost.”</em>

I don’t understand what you mean by that. Do you think that professional medical writers who are acknowledged for their contributions should be described as “ghosts”? If so, perhaps you could explain why?

<em>“The fact is that most of EMWA’s members are paid by industry…”</em>

Yes, that is true. However…

<em>“… and the manuscripts and other publications they write reflect the marketing goals of industry.”</em>

That is not an inevitable consequence of being paid by industry. In fact, some companies, such as Pfizer, now have policies which explicitly forbid personnel from their marketing departments being involved in the development of publications [5]. Although I am sure some papers have occasionally been published in which marketing messages have over-ridden scientific considerations, with the collusion of ghostwriters, I have never been asked to do this in my own experience of working with many pharmaceutical companies, so I suspect it is rare. If you have evidence that it is common, perhaps you could share it.

<em>“Readers interested in learning more about the role of medical writers…”</em>

Thank you for providing that reference, which I have read. That article contains many opinions and assertions, but few hard data. For example, the statement that medical writers write the paper “incorporating the appropriate marketing message” is not backed up by any data whatsoever. As stated above, no doubt this has happened on occasions, but there is no evidence that it is common practice.

<em>“Dr Dodgson called the practice of academic authors signing papers written by medical writers ‘pharmaceutical company sponsored plagiarism’”</em>

Dr Dodgson describes a specific unethical behaviour, in which academic authors sign their names to papers without having contributed to them. I totally agree that that is plagiarism, and many other things besides. To be clear, I absolutely do not support such behaviours, and would welcome sanctions against anyone involved. However, again you seem to assume that that is the way in which most medical writers work, but you present no evidence for that assumption.

<em>“EMWA’s statement that professional medical writers ‘produce their work in an ethical and transparent manner’ is more wishful thinking than actual practice”</em>

Do you have any evidence to support that statement? I refer you to reference 3 of my previous comment, which shows that misconduct may be less likely when professional medical writers are involved.

Clearly, some medical writers work in a way which is perfectly ethical, and some do not. It is very difficult to do good quality research into the proportion of medical writers in each category, but my own experience from 14 years of working in the medical writing industry tells me that the former category overwhelmingly predominates.

The challenge for all of us who are involved in biomedical publishing is to continue efforts to make it harder to get away with ghostwriting, writing papers in which the science is compromised by marketing messages, or other unethical behaviours. EMWA is actively involved in those efforts. Claiming that medical writers are part of the problem, when there are many medical writers working towards a solution and in need of allies if they are going to have any realistic prospect of achieving that goal, is not helpful.

References

1. Jacobs A, Hamilton CW. Decreased evidence of ghostwriting in a 2008 vs 2005 survey of medical writers. The Write Stuff 2009;18(2):118–123

2. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21(2):317–321

3. Wager E, Field EA, Grossman L. Good Publication Practice for Pharmaceutical Companies. Curr Med Res Opin 2003;19(3):149–154

4. Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A, Hamilton C. What Should Be Done To Tackle Ghostwriting in the Medical Literature? http://www.plosmedicine.o...

5. Pfizer policy on public disclosure and authorship. http://pfizer.com/researc...