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The Haunting of Medical Journals: How Ghostwriting Sold “HRT”

  • Adriane J. Fugh-Berman mail

    ajf29@georgetown.edu

    Affiliation: Department of Physiology and Biophysics, Georgetown University Medical Center, Washington, D.C., United States of America

    X
  • Published: September 07, 2010
  • DOI: 10.1371/journal.pmed.1000335
  • Featured in PLOS Collections

Reader Comments (8)

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Professional Medical Writers and Publication Ethics

Posted by AdamJacobs on 18 Sep 2010 at 17:30 GMT

Fugh-Berman’s article regarding the ghostwriting of publications about Prempro [1] raises some important points, but unfortunately misses others.

Most importantly, we in the European Medical Writers Association (EMWA) are concerned that she does not mention the significant distinction between ghostwriters and professional medical writers. Ghostwriters are shady individuals who hide from sight, while professional medical writers produce their work in an ethical and transparent manner.

Medical writing is a flourishing profession. Writing assistance in biomedical publications has many advantages but needs to be transparent and ethical.

We have published guidelines explaining what is expected of professional medical writers [2]. Professional medical writers who follow those guidelines would not allow marketing messages to trump scientific accuracy in published papers. In fact, some empirical evidence suggests that professional medical writers can help avoid misconduct. Woolley et al found that retractions of papers from the published literature were significantly less likely to be a result of misconduct when professional medical writers were acknowledged [3]. Further, research recently published by EMWA suggests that professional medical writers may also improve the reporting quality of randomised controlled trials [4].

We in EMWA actively endeavour to raise the profile of the medical writing profession and standards. We therefore believe that there is a clear distinction between ghostwriters who engage in unethical practices and professional medical writers who do not. Fugh Berman’s article describes only the bad side of medical writing, without mentioning its positive side, which creates a misleading impression.

We also wish to point out that, although using ghostwriters to insert unwarranted marketing messages into papers is unacceptable, and something we would unhesitatingly condemn, there is no evidence to suggest it is common. Statements such as “Industry-funded marketing messages may infest articles in every medical journal” are therefore entirely speculative and in no way supported by evidence. Although it is clearly very difficult to do high quality research into the prevalence of papers with inappropriate marketing messages, our own experience of writing many papers for many pharmaceutical companies suggests that it is probably extremely rare.

Adam Jacobs, Press Officer, EMWA
Andrea Palluch, Public Relations Officer, EMWA.

References

1. Fugh-Berman AJ. The haunting of medical journals: how ghostwriting sold “HRT”. PLoS Medicine 7(9):e1000335. doi:10.1371/journal.pmed.1000335

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. Woolley KL, Woolley MJ, Lew RA et al. Round Up the Usual Suspects? Involvement of Medical Writers and the Pharmaceutical Industry in Retracted Publications. Abstract presented at the Sixth International Congress on Peer Review and Biomedical Publication, Vancouver, September 2009.

4. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. The Write Stuff (Journal of the European Medical Writers Association) 2010;19(3):196–200

Competing interests declared: AJ runs Dianthus Medical Limited, which provides professional medical writing services to pharmaceutical companies and other clinical researchers.

AP is a freelance professional medical writer who provides services to pharmaceutical companies, clinical trial investigators, clinical investigative sites, and research sites.

RE: Professional Medical Writers and Publication Ethics

Fugh-Berman replied to AdamJacobs on 21 Sep 2010 at 04:59 GMT

Naturally EMWA seeks to distinguish its members from “shady individuals who hide from sight,” but medical writers who work for industry do not control the final product and rarely see their names on their work, so let’s call a ghost a ghost. The fact is that most of EMWA’s members are paid by industry (including pharmaceutical companies, medical education companies and clinical research organizations) [1], and the manuscripts and other publications they write reflect the marketing goals of industry.

Readers interested in learning more about the role of medical writers in publication planning -- “the finely calibrated process by which clinical trials, commentaries and other articles supporting the efficacy of particular products are written and released into the biomedical literature” -- should read the article I co-authored with Susanna Dodgson PhD, who taught medical writing at the University of Sciences of Philadelphia [2].Dr. Dodgson called the practice of academic authors signing papers written by medical writers “pharmaceutical company-sponsored plagiarism” in EMWA’s own newsletter. [3]

EMWA’s statement that professional medical writers “produce their work in an ethical and transparent manner” is more wishful thinking than actual practice when a corporate master determines the subject, point of view, final product, and when, where, and in what form the work is published, not to mention the name that decorates the paper as “author.”

1. See the membership breakdown under promotional slides at http://www.emwa.org/about...)

2. Fugh-Berman A, Dodgson S. The ethics of publication planning in the pharmaceutical industry. Open Medicine 2008;4(5): e40-43. http://www.openmedicine.c...

3. Dodgson S. From over the pond: Plagiarism in the pharmaceutical industry. The Write Stuff 2005; 14(3). Available at http://thewritestuff.emwa...)

Competing interests declared: Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in the paper to which this correspondence pertains. Dr. Fugh-Berman directs PharmedOut, a Georgetown University-based project founded with public money from the Attorney General Consumer and Prescriber Grant program and currently supported by individual donations.

RE: RE: Professional Medical Writers and Publication Ethics

AdamJacobs replied to Fugh-Berman on 21 Sep 2010 at 15:42 GMT

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...

Competing interests declared: As stated previously

RE: RE: RE: Professional Medical Writers and Publication Ethics

AdamJacobs replied to AdamJacobs on 21 Sep 2010 at 15:43 GMT

Ah, the HTML parsing didn't work as expected, but no doubt you can figure out what I meant. All the stuff between the <em> tags was supposed to be direct quotes.

Competing interests declared: As stated previously

RE: RE: RE: Professional Medical Writers and Publication Ethics

jonleo replied to AdamJacobs on 03 Oct 2010 at 19:20 GMT


Dear. Mr. Jacobs, You mention that the appropriate place to cite a medical writer is in the acknowledgement section. However, if the writer in question made a significant contribution to the project why should they not be listed as an author? Isn’t this the way it works in the rest of the academic world? For example, take study 329, which examined the use of Paroxetine in childhood depression, and which was published in the Journal of American Academy of Child and Academic Psychiatry . The majority of the work was done by Sally Laden, a medical writer employed by a medical writing company, but rather than being listed as an author she was just mentioned in the acknowledgement section. Do you think this was an appropriate categorization of her contribution? At the very least, she did significantly more work on the paper than many of the listed authors – all the drafts of the paper are available on the internet. And it is hard not to wonder if hiding her true role had something to do with the way the study was reported. As McHenry and Jureidini point out, while the published paper concluded that “Paroxetine was safe and effective for major depression in children” , there are internal company documents stating “Essentially the study did not really show that Paxil was effective in treating adolescent depression, which is not something we want to publicize.” Wouldn’t the readers of the article have been better served if Sally Laden had been listed as an author? As Jeffrey Lacasse and I proposed in the Chronicle of Higher Education: Why not call an author an author?

References

1 Keller et al. (2001) Efficacy of paroxetine in the treatment of adolescent major depression: A randomized controlled clinical trial. J Am Acad Child and Adolesc Psychiatry, 40:7.

2 McHenry, L. and Jureidini, J. (2008). Industry sponsored ghostwriting in clinical trial reporting: A case study. Accountability in Research 15:152-167.

3 Spielmans, G. and Parry, P. (2009) From evidence-based medicine to marketing-based medicine: Evidence from internal industry documents. Bioethical Inquiry. Published on line January 21, 2010

4 Leo, J, and Lacasse, J. (2010) Ghostwriting and Academic Medicine, Chronicle of Higher Education, July 19, 2010

No competing interests declared.

RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

AdamJacobs replied to jonleo on 04 Oct 2010 at 14:32 GMT

You raise an interesting question. The reason why I (and many others) say that medical writers should be listed in acknowledgements, rather than granted authorship, is that I am going by the ICMJE criteria. These state:

"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"

Note the last part of that: that authors should meet all 3 conditions. It is rare that medical writers would meet the first condition, although they will probably meet condition 2, and may sometimes meet condition 3.

The paper you describe is of an RCT. Unless the medical writer had been involved in the design or conduct of the study (which is possible, but unlikely), then authorship would not be appropriate in that case according to the ICMJE criteria.

In fact in the vast majority of papers written with the help of professional medical writers, not all 3 conditions are met.

Now, you could argue about whether the ICMJE criteria are appropriate, and that is certainly a legitimate argument. However, it's not one I particularly wish to get into. I regard that as something that journal editors need to figure out among themselves, and I will be happy to go along with whatever they decide. At the moment, most journals go by the ICMJE criteria, so I am going to take them as my guide.

I am aware that some journals do require that medical writers be listed as authors. They are perfectly entitled to do that (as long as they make it clear to readers that they are not following the ICMJE criteria), and if I were involved in submitting a paper to such a journal, I would have no problem with the medical writer being listed as an author.

If you feel strongly that the ICMJE criteria are misguided and the medical writers should be named as authors, then you really need to take that up with the journal editor community. They are the ones who make the rules.

Competing interests declared: As stated previously

RE: RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

jonleo replied to AdamJacobs on 05 Oct 2010 at 19:07 GMT

You make a great point and I think you point out a loophole in the ICJME requirements. However, I also think Sally Laden met all three requirements to be called an author. For requirement 1 which includes "analysis and interpretation of data" I think she meets this. I think that her stituation is typical of many of the more famous ghostwritten documents where a simple acknowledgement of editorial assistance did not do the real author justice.

No competing interests declared.

RE: RE: RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

AdamJacobs replied to jonleo on 06 Oct 2010 at 10:03 GMT

Well, I'm not familiar with that paper or what Sally did, so you may be right. But normally, analysis and interpretation of the data would be the job of the statistician, not the medical writer.

Perhaps it depends on what you understand by "interpretation". You could regard that as a broad definition which encompasses simply writing about it, but I don't think that was the intent: I think it was intended to cover the kind of things that statisticians do.

In case of doubt, the correct course of action is simply to explain to the journal editor who did what and let them decide who should be an author,

Competing interests declared: As declared previously

RE: RE: RE: RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

jonleo replied to AdamJacobs on 07 Oct 2010 at 13:34 GMT

Again, you make a great point. Here is a link to the first draft along with her memo stating that she wrote it. In the end of the paper (draft) she says: "In conclusion, the findings of this study provide the first validation of prelimary evidence of the effectivness and safety of the SSRI, paroxetine, in the treatment of adolescent depression." It appears from some of the comments in the draft that the statisticians were from the company. You mention that it is up to the editors to make a decision based on what the authors/writers report. It would interesting to hear from the editors in this case about what they were told. If medical editors allow this practice of giving acknowledgment to authors then clearly academic medicine stands apart from the rest of academia. It would be a tough sell to anyone outside academic medicine that she should not have listed as author. However, the bigger question is how many other ghostwritten articles were similar to 329's scenario?
http://www.healthyskeptic...

No competing interests declared.

RE: RE: RE: RE: RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

AdamJacobs replied to jonleo on 07 Oct 2010 at 17:12 GMT

I'm not sure that this paper tells us anything particularly interesting, as it was published over 9 years ago. Things have changed greatly since then. For a start, there were no guidelines in existence at that time, to the best of my knowledge, about how the role of medical writers should be disclosed.

But in any case, the question of whether Sally was an author is not straightforward, as it depends very much on your definition of authorship. By the standards generally accepted by medical journals, it doesn't look like she was, especially as she seemed to be seeking guidance from the named authors rather than taking decisions herself.

It's also not accurate to describe this as a ghostwritten article, as I see that Sally Laden was acknowledged in the published version.

Competing interests declared: As stated previously

RE: RE: RE: RE: RE: RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

jonleo replied to AdamJacobs on 07 Oct 2010 at 19:18 GMT

Again, you are going to lose the majority of the academic community when you claim that the person who wrote the first draft of an article, which was changed very little, should not be listed as an author. Mentioning her in the acknowledgment section was simply not doing her justice. You can only say this is not a ghostwritten article by using a very odd defintion of authorship.

No competing interests declared.

RE: RE: RE: RE: RE: RE: RE: RE: RE: RE: Professional Medical Writers and Publication Ethics

AdamJacobs replied to jonleo on 08 Oct 2010 at 08:58 GMT

Your concerns about definitions of authorship are entirely legitimate, but they are not my definitions, they are the ICMJE definitions.

I'd be interested to know if you are right about the majority of the academic community disagreeing with them. If you are, then they should probably be changed. However, for now at least, the ICMJE criteria are the authorship criteria used by the majority of journal editors.

If there are others who feel the same way you do, you could try lobbying the ICMJE about it. They do update their guidelines from time to time, and perhaps they would listen.

Competing interests declared: As stated previously