Ghostwriting: myths and realities – part 2

Adam Jacobs

Dianthus Medical Limited

Continued from “Ghostwriting: myths and realities – part 1”

One common myth about ghostwriting is that it’s very common. You have probably seen the widely quoted statistic is that at least 50% of articles in the medical literature are ghostwritten. This figure is attributed to David Healy, who gave the figure in response to a parliamentary enquiry. Healy himself has pointed out that the figure has been misquoted, as he meant 50% of articles on drugs, not 50% of all articles. Apparently his estimate of 50% comes from a paper he published in 2003. There are some huge problems with estimating a prevalence of ghostwriting from that paper. First, it was based on papers published mostly in the 1990s, and as I shall explain shortly, much has changed since then. Second, it used data on publications relating to only a single drug (sertraline), and there is no way of knowing whether that drug is representative of publications on all other drugs. Third, it used different methods for identifying those papers deemed to be ghostwritten and those that weren’t. And finally, it lacked a robust method of determining whether the allegedly ghostwritten papers really were ghostwritten, and had to make some assumptions.

So that statistic that 50% of papers on drugs are ghostwritten is pretty much meaningless.

The fact is that we simply don’t know how many papers are ghostwritten. When you think about it, it’s actually pretty difficult to determine. My own data suggest that, as of 2008, slightly less than half of contributions by medical writers were ghostwritten. I freely admit that there are some serious limitations with that statistic as well, but given that it’s implausible that all papers on drugs are written by medical writers, it does seem very unlikely that anywhere near as many as 50% of papers on drugs could be ghostwritten. One study published in 2009 estimated that 12% of medical research papers (not exclusively drug trials) had ghost authors, which seems like a more realistic figure.

"So that statistic that 50% of papers on drugs are ghostwritten is pretty much meaningless."

Another common myth is that the problem is getting worse. There simply isn’t any evidence to support this, and I’m aware of 2 pieces of evidence that directly refute it. The same 2009 study I mentioned above also concluded that the prevalence of ghost authorship had decreased significantly since 1996. My own research found that there was a substantial decrease in the prevalence of ghostwriting between 2005 and 2008. Although my figures for the absolute prevalence of ghostwriting are probably not very reliable because of various limitations of the study design, we did at least use identical methods in both years, so any biases in the figures should be similar, and I believe that my conclusion of a decreasing prevalence is robust. The decreasing prevalence of ghostwriting is also pretty much what we would expect, given the proliferation of anti-ghostwriting guidelines and other initiatives that have occurred in the last decade.

This leads neatly into the final myth I want to tackle, namely the idea that ghostwriting is tolerated and that no-one is doing anything about it. Plenty of people are doing things about it. EMWA published guidelines on the role of professional medical writers in 2005, which make it very clear that ghostwriting is unacceptable. EMWA has been reinforcing that message to its members by various means since. But EMWA is certainly not the only organisation putting out those messages. ISMPP has also been very active in this area, and has not only contributed to the GPP2 guidelines, which, among other things, seek to banish ghostwriting, but has also published a position paper which clearly condemns ghostwriting. Many of the large pharmaceutical companies now have policies which expressly forbid ghostwriting, such as AstraZeneca and Pfizer.

"...there was a substantial decrease in the prevalence of ghostwriting between 2005 and 2008."

Now, don’t get me wrong: I’m not claiming that ghostwriting is no longer a problem. The prevalence may be decreasing, but I doubt that it has yet decreased to zero, which is where we’d all like it to be. There is clearly more work still to do.

So what more can be done? The professional medical writing community has already done plenty to set standards and educate its members, and I honestly don’t know what more we could do. That’s not to say that there isn’t anything more we could do, of course, so if you have any suggestions I’d love to hear them.

Many of the big pharmaceutical companies already have clear anti-ghostwriting policies, but there are many other companies that lack such policies. They need to develop them.

The academic community also has its part to play here. There would be few ghostwritten papers if academic authors refused to sign their names to papers written by a ghostwriter. Some academic institutions, such as Yale University, have made it clear that involvement in a ghostwritten paper is unacceptable, but plenty more could do likewise. Universities could also treat participation in ghostwritten papers as a serious case of academic misconduct, leading to disciplinary procedures. I think there is a long way to go here: on the whole, universities are very reluctant to take action against their own staff except in the most serious of cases.

Journal editors are the final, and perhaps the most important, players here. They are the ones who get to decide whether papers get published. Of course, they cannot be expected to detect all cases of ghostwriting if someone is determined to deceive them, but on the whole most people are honest. I strongly suspect that most cases of ghostwriting come from people who are simply unaware of ethical standards, rather than people who deliberately set out to be unethical. In fact there is even some (albeit weak) evidence of this, as my research on ghostwriting showed that people who were unaware of recent guidelines were more likely to be ghostwriters.

"Universities could also treat participation in ghostwritten papers as a serious case of academic misconduct..."

So, while authors of ghostwritten papers may not always volunteer the information about who wrote a paper, I suspect very few would deliberately lie if the journal asked clear questions about who wrote the paper as part of the manuscript submission process. To this end, I and some colleagues published a checklist that journals could use to detect ghostwritten papers before publication, although, to my knowledge, no journals are yet using it. Some journals do mention medical writers in their instructions for authors, such as The Lancet, although I don’t know to what extent they ask questions about this if authors do not volunteer the information. I really believe that the journal editor community could do so much more to help eradicate ghostwriting if they had the will to do so. Sadly, however, the energy that some journal editors put into writing indignant editorials about what a terrible thing ghostwriting is is seldom matched by practical action.

I do hope this post has cleared up some of the confusion surrounding ghostwriting, in particular clarifying the important distinction between ghostwriters and transparently acknowledged professional medical writers. I hope you’ll join with me in fighting ghostwriting wherever you see it, but not fall into the trap of fighting other things which are not ghostwriting.

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.

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 do think could be done to further reduce ghostwriting?