Ghostwriting: myths and realities – part 1

Adam Jacobs

Dianthus Medical Limited

There’s been a lot of guff written about medical ghostwriting lately, in blogs, in the mainstream media, and in peer-reviewed journals. Some of it is no doubt a result of genuine misunderstandings, but some of it may be deliberate misinformation, by people pursuing an anti-pharma-industry agenda.

There are many reasons why people may have an anti-industry agenda. Some may do it as a marketing tool to sow mistrust in legitimate pharmaceutical products and promote quack remedies. Journalists may profit from whipping up sexy tales of conspiracy theories, which we all know are always good for selling papers and even books. Some are involved in lucrative litigation against pharma companies, and others find employment and career development opportunities in organisations set up specifically to attack the pharmaceutical industry.

So when you hear accusations about conflicts of interest from such people, it’s probably a good thing if your irony meter is well fortified against overheating. This is not to pretend that pharmaceutical companies are populated entirely by saints, of course, but it is worth remembering that some people have their own reasons for making the pharma industry look bad.

"...it is worth remembering that some people have their own reasons for making the pharma industry look bad."

But I digress. Back to ghostwriting. I don’t want to get into responding to specific articles, as there have been very many of them and it would make this blogpost monstrously unwieldy if I responded to them all, but instead I would like to tackle some common myths and misunderstandings.

First of all, it is important to say what we mean by ghostwriting. Some articles launch into long tirades against ghostwriting without defining it, which makes it hard to know exactly what they are objecting to, and others use idiosyncratic definitions, which can cause great confusion. The mainstream definition of ghostwriting is that someone has made substantial contributions to writing a paper, and those contributions are not disclosed to the reader.

It’s important to realise that disclosure to the reader can take more than one form, and not all forms are always appropriate. Someone who wrote a paper may be named as an author, but only if that person fulfils the definition of authorship used by the journal that’s publishing the paper. Most journals use the ICMJE criteria, which are quite strict, and would normally exclude someone whose only contribution was writing assistance, such as a professional medical writer. In this case, the correct procedure is for the medical writer’s contribution to be described in the acknowledgements section of the paper. If that is done, then the paper has not been ghostwritten. Assistance from a professional medical writer is not at all the same thing as ghostwriting. That last point is not always appreciated by some commentators, but it is an important one.

There is certainly nothing wrong with assistance from professional medical writers, provided it is ethical and transparent. Indeed, it is widely believed that medical writers improve the quality of papers, and although this is difficult to measure, there is some evidence that professional medical writers shorten times to acceptance of papers, improve compliance with the CONSORT standard for reporting randomised controlled trials, and reduce the risk of fraud.

"Assistance from a professional medical writer is not at all the same thing as ghostwriting."

Although some have criticised the ICMJE criteria for authorship, and have argued that writing assistance alone should be sufficient qualification for appearing on an author byline, most notably the journal Neurology, that view has not gained mainstream acceptance, and the vast majority of journals use the ICMJE criteria. Medical writers must therefore comply with those criteria (unless they are submitting a paper to Neurology), and must not be listed as authors if they do not fulfil the criteria for doing so.

A distinction is sometimes made between ghostwriting and ghost authorship. A ghostwriter is one who contributed to the writing of the paper without fulfilling the criteria for authorship and is not mentioned. A ghost author is one who does fulfil the criteria for true authorship, and yet is still not mentioned anywhere in the paper. But that’s quite a fine distinction which I won’t go into further.

So, a ghostwritten paper is one written by someone who is invisible to the reader, in other words neither listed as an author nor mentioned in an acknowledgements section. Everyone agrees that this is a bad thing. The badness of ghostwriting really isn’t at all controversial. When you hear people talking about "the ghostwriting controversy", they are not talking about this. I’m never entirely sure what they are talking about, but it certainly isn’t any controversy over whether ghostwriting is a good thing or not.

Ghostwriting is a bad thing because it results in a lack of transparency, which is never good in science. There is also a commonly held belief that ghostwriters also contribute to spin, inaccurate presentation of results, and inappropriate insertion of company marketing messages that are not justified by the science. That may well be true, although I’m not aware of any empirical evidence that it is.

"...a ghostwritten paper is one written by someone who is invisible to the reader, in other words neither listed as an author nor mentioned in an acknowledgements section."

Actually, the question of spin and inappropriate reporting is completely separate from the issue of ghostwriting, although they are often conflated in many people’s minds. Spin and inappropriate reporting is also a bad thing of course, and that statement is even less controversial than saying that ghostwriting is bad. What might be a surprise to some people, however, is that although poor reporting of clinical trials results is all too common, there is no evidence that reporting from pharmaceutical companies is worse than reporting from independent academics. In fact a recent paper found that one particular way in which authors can cheat when reporting results, namely changing your mind about what the primary outcome measure of the study was after you see the results, is less common in industry sponsored papers than in papers from other sources.

Join me for part 2 of this article for some common ghostwriting myths.

Conflict of interest declaration: I own and run Dianthus Medical Limited, which provides professional medical writing services to pharmaceutical companies and other researchers. I am a former president of the European Medical Writers Association.

Part 2 of this article can be found here.

About the author:

Adam is an experienced medical writer and statistician. Before setting up Dianthus Medical in 1999, he worked as a medical writer for both a small contract research organisation and a large medical communication agency. Adam has a PhD in organic chemistry from the University of Cambridge and an MSc in medical statistics from the London School of Hygiene and Tropical Medicine.

He takes an active role in the European Medical Writers Association (EMWA), and was president of the association in 2004-2005. In 2003, he set up EMWA’s ghostwriting task force, as a result of which he was co-author of EMWA’s guidelines on the role of medical writers in peer-reviewed publications. He is a regular workshop leader for EMWA’s training workshops and a columnist in their journal, The Write Stuff, and was among the first few people to be awarded EMWA’s advanced professional development certificate. He is also a fellow of the Institute of Clinical Research and a Chartered Scientist.

In his spare time, he enjoys cooking, gardening, karate, long-distance running, travel, and hill walking (but not usually all at the same time).

He can be contacted via Twitter at @dianthusmed

What inaccuracies have you seen around ghostwriting?