In which I defend my chosen profession from wily ghosts

Ah, ghostwriting. Yes, I believe I will step into the fray, thanks very much. Here goes nothing…

At AMWA’s annual meeting last month, the Keynote Address was given by William L. Lanier, MD, editor-in-chief of Mayo Clinic Proceedings, on the topic of preserving the integrity of medical literature. His talk focused on the role of the pharmaceutical and medical device industries (referred to broadly as “industry”) and their influence on the publication of clinical research. Thankfully, Dr. Lanier did not veer to one extreme opinion or the other on this controversial topic, neither defending the need for pharmaceutical companies to profit from their investment in R&D nor advocating a need to purify the medical literature of the taint of industry bias. Rather, he acknowledged the incredible impact that industry has had on medical science, the practice of medicine, and patient care, while also admitting that there are some who would try to hijack the peer-reviewed literature for their own gain, as evidenced by the HRT publication planning “scandal” that was revealed a few months back, and many others that have come to light since.

Once the floodlight was trained on the practice of publication planning and the use of ghostwriters by industry, there have been more than a few articles that have “exposed” these sinister practices and provided profiles of people involved. One particular story in The Atlantic profiled a medical ghostwriter, “David,” who has a background in life sciences research and ended up leaving academia to work at a communications company (sorta like me–maybe that’s why the article irked me so much). David described the type of industry-dictated spin that he was asked to put on his ghostwritten abstracts and journal articles as a source of personal humiliation and a true moral dilemma. He described the profession of medical writing and his fellow medical writers as sad, and the author of The Atlantic piece summed up this way:

Medical writing has little glamour, and whatever moral purpose it might once have carried has been rubbed away by the constant friction with commerce. If you are a true believer in the glory of the market, the work might be invigorating, and the long hours a mark of pride. But if you are a lapsed biologist, raised in the church of science but compelled to leave, it is apparently a source of nagging resentment. Says David, who for all his protests has yet to give up his job, “What a wretched epitaph to a life this would be.”

So…I had a pretty visceral reaction to this article. It really boiled down to the fact that not all medical writing is ghostwriting. To characterize the profession of medical writing as having no moral purpose, with the only source of pride being in furthering the profits of industry, is simply incorrect. Medical ghostwriting? Yes, absolutely. Medical writing? No. There are many, many kinds of medical writers, working for many, many clients who are not even connected to industry. Once I calmed down, I actually found it rather sad that “David,” who is portrayed as resentful and plagued by moral and ethical crises, has not learned that what he does–which is truly medical ghostwriting, with no acknowledgement that he is the actual author of the work AND with named authors who did not contribute–is not the only type of writing that is done by professional medical writers. I hope for his conscience’s sake that he is able to extract himself from his situation and find other ways to use his skills – it really would be a wretched epitaph if he never does.

The article also made me realize how little people understand that there are established ethics for medical writing. AMWA brought together a task force in 2002 to develop a code of ethics for medical writers and to delineate requirements for acknowledging the contributions of medical writers. As a result of their work, the task force published the AMWA Position Statement on the Contributions of Medical Writers to Scientific Publications, which can be found here. There is a fantastic FAQ on ethics in medical writing here, which includes these definitions:

“Ghost authoring” refers to making substantial contributions without being identified as an author. “Guest authoring” refers to being named as an author without having made substantial contributions. “Ghostwriting” refers to assisting in presenting the author’s work without being acknowledged. The term “ghostwriting” is often used to encompass all three of these practices.

What is “substantial contribution?” AMWA quotes the AMA Manual of Style on that one:

“A substantial contribution is an important intellectual contribution, without which the work, or an important part of the work, could not have been completed or the manuscript could not have been written and submitted for publication.”

So, back to our David. David is absolutely right in feeling that his work as a medical ghostwriter is morally perilous. In his current position, he is engaging in ghostwriting and ghost authoring, and the physicians being paid to put their name on his work are guest authoring (at best).

Medical journal editors are in agreement with AMWA and the general public in the recognition that ghostwriting needs to be rooted out and medical writers acknowledged for their contributions. Many, if not most, journals have accepted the International Committee of Medical Journal Editors (ICJME) Uniform Requirements, found here, which echo the same requirements for substantial contributions from named authors. But the journal editors can only do so much – in his AMWA Keynote Address, Dr. Lanier stated that medical writers need to remind their employers and industry clients about the ethical policies of the medical  journals to which they are submitting their manuscripts, and the consequences of being identified as a sponsor of ghostwritten articles. David should be listed as an author. Period. Easier said than done, I know. But that’s the issue.

What about acknowledging medical writers (and editors) who have not made substantial contributions to qualify as a named author? For example, I often help prepare manuscripts based on clinical study reports (CSRs), which involves formatting and rearranging information from the CSR into a journal article format and making sure it meets CONSORT requirements.

The discussion section might be the one place where I do a little more writing, and the place where a client might want some spin introduced. But even then, the CONSORT statement gives medical writers an ethical leg to stand on, by recommending a structured approach to the discussion section, as outlined by the Annals of Internal Medicine:

…Annals of Internal Medicine recommends that authors structure the discussion section by presenting (1) a brief synopsis of the key findings, (2) consideration of possible mechanisms and explanations, (3) comparison with relevant findings from other published studies (whenever possible including a systematic review combining the results of the current study with the results of all previous relevant studies), (4) limitations of the present study (and methods used to minimise and compensate for those limitations), and (5) a brief section that summarises the clinical and research implications of the work, as appropriate.

Preparing a manuscript from a CSR is not ghostwriting, in my opinion, but it does warrant some kind of acknowledgement. This is what the ICJME says:

All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chairperson who provided only general support.

So the demarcation for authorship vs. acknowledgement is substantial contribution vs. writing assistance.

I will sum up this lengthy post by saying that I was heartened by Dr. Lanier’s keynote address at AMWA in that it did not vilify industry or industry-sponsored research, but still acknowledged the need for transparency regarding industry involvement in publications of the research in the peer-reviewed medical literature. There must be a concerted effort among journal editors and professional medical writers to increase awareness of the ethical standards established by both groups regarding authorship and acknowledgement. Otherwise all medical writers run the risk of being mis-labeled as ghostwriters, like our sad friend David.

P.S. As a professional medical writer, I stipulate up front, in the service agreement, how my contribution will be acknowledged in the final article. Many times, the client is completely unaware of ICJME requirements or the policies of specific journals on authorship and they appreciate that I have brought the issue to their attention.