Monday, November 30, 2009

The Controversy Over Medical Ghostwriting

A form of ghostwriting has been in the news lately, shining a less-than-flattering light on the practice. So-called medical ghostwriting--where pharmaceutical or medical device companies pay ghosts to independently write journal articles and papers, then seek out researchers, professors and other experts who are compensated for allowing themselves to be named the authors of these papers and articles--is being challenged as unethical. The New York Times recently reported that Senator Charles E. Grassley (R-Ohio), ranking Republican on the Senate Finance Committee wrote to the top 10 medical schools and asked what they were doing about their professors who put their names on these papers and comparing the practice to plagiarism.

Ghostwriting, however, is a longtime practice and most ghosting arrangements bear no likeness to the shenanigans that are currently under Congressional fire. There are two important distinctions that make such "medical ghostwriting" different than most traditional (and ethical) ghostwriting arrangements.

Intellectual Collaboration: First and foremost, any intellectual collaboration that went on--the crafting of ideas and making a case for a specific point of view--was not done between the named author and the ghostwriter. In my collaborations, I spend hours speaking with the author, making sure I understand his or her ideas, insights, experiences, and the information he or she wishes to convey through the work. And while the author may have a point of view that he or she wishes to use to influence a way of thinking, the difference is that it's obvious. The author's name is on the cover of the book or the by-line of the article. First, a commercial or special interest creates a body of work that will be published or presented in a medium that is supposed to be "objective" and then pays an expert to lend his or her name and credibility to the piece without any input from that expert. Invariably, that means the collaboration is biased in favor of the sponsoring organization and the persuasion does not come via the expert's own intellectual property, experiences and viewpoints. Since medical journals, papers, and reports often shape current medical thinking, this type of veiled promotional activity may have serious implications for the public at large.

Conflict of Interest. Whether it's true or not, it is often assumed that a writer's allegiance is to the entity writing his or her check. So, if a writer is crafting a paper to be presented at a medical conference and being paid by a pharmaceutical company, it's a safe bet that the paper will not contain negative information about the pharma co, even if it's valid. At the same time, the so-called "expert" is being compensated for lending his or her name to the piece. It's safe to assume that the organization footing the bill is not going to enthusiastically fund anyone who doesn't toe the company communications line. In traditional ghosting arrangements, the writer is paid by the named author. They're on the same team, working toward a common outcome in the work. And once a writer is compensated by the author for such a collaboration, that expert goes into the do-not-use file because of similar conflict-of-interest issues when the writer reports for other media. After having been compensated by a source, there is an inherent conflict of interest in using that source for objective reporting.

Alisa Bowman rightly pointed out to me that this is similar to advertorial creation, where a writer may very well work directly with the funder to craft the message and then someone else's name is put in the piece. The difference there is that those sections are clearly labeled "Advertisement," "Advertorial," or "Special Advertising Section" to distinguish them from objective editorial. That was not the case in these instances of medical ghostwriting.

When an author and ghost work together to create a piece of work based on the author's ideas and knowledge, the ghost is a facilitator, helping the author get the right words written. When the ghost collaborates with a special interest in secret and then uses the credibility of another to influence public health decisions without any kind of disclosure, a serious breach of ethics has occurred.

What are your thoughts on latest medical ghostwriting findings? Join the conversation in the comments section.


  1. Hi, Gwen. I have to weigh in here. . . I am often hired by medical communication companies to work with physicians on articles for medical journals. We start with a conference call to discuss what should be in the article; I draft a detailed outline including sources that the doctor then reviews; then I draft the article, which the doctor then reviews and comments; I revise the article and it is submitted. I am acknowledged for my role on the paper; a couple of times I've even been listed as an author. This is what is required by national and international guidelines from the American Medical Writers Association and other publication-related bodies. In addition, if the pharma company is funding the cost of the paper's production, then that is also acknowledged as part of the submission, as are any other conflicts the physician may have. The "ghostwriting" that everyone is focused on right now is, by and large, from years ago;

    My loyalty is to the credibility of the information and to the audience for the article, the physicians who will be reading it; these papers also aren't about pharmaceutical companies, they are about clinical trials or other such medical information. And yes, many such articles are presented and published that are "negative;" I just attended a major medical conference in which numerous negative-result abstracts were presented.

    The media and Grassley have totally blown this whole ghostwriting issue out of perspective; they really need to get their facts straight.

  2. Nice to hear from someone experienced in the field.
    Deb, do you find this kind of debate crops up routinely in the medical writing community, or is this level of critique out of the ordinary?

  3. Deb, thanks so much for weighing in. I know what an honorable person you are and that you would adhere to ethical guidelines. I think the issue lies less with the writers, who do their research and submit material for approval by experts, and more with the funding bodies, editors, named authors, and overall lack of disclosure. While ghostwriting happens from time to time in many publications, it is, in most cases, unacceptable to publish work under the byline of an author who had been compensated in some way by his or her source. So, let's say a consultant hires a ghost to pen a piece about how to integrate customer relationship management to increase sales. In the piece (which was researched and written by the ghost and approved by the consultant), Microsoft's product is named as the best option on the market. That means one thing if the source is truly objective. But it's something else entirely if the consultant has been paid by Microsoft to lend his or her name to the piece, which was crafted by the ghostwriter.

  4. I can respond to Ellen's comment. Medical writing and the pharmaceutical industry has been undergoing an major ethical overhaul since 2004. Most medical writers with 5 years or more experience are honestly sick of the ghost writing topic and have stopped reading the WSJ and NYT stories because we've lost count. Our flaw has been a lot preaching to choir instead of using good PR to explain there is nothing wrong with a medical professional collaborating with a medical writer on a publication or explain the tremendous overhaul. All of Senator Grassley's digging involves skeletons that are at least 10 years old and people who aren't around; so while it fuels another ghost writing expose story and get his name in the news again, but has little real impact. As was eloquently put by a physician targeted by Senator Grassley, aren't there more important topics to tackle in the public agenda? A recent study shows the involvement of medical writer actually reduces the amount of misconduct in medical publishing, i.e. making up false results, etc; which a big expert in the pain field was fond guilty of in last year. In medical writing circles, there are questions about whether the climate is changing such that we will no longer have a role in publications. We'll all find plenty of other areas to work in. The downside is that progress in medicine won't be as fast because publishing is vital but never urgent and these doctors have pretty full days between treating patients and running research trials, so papers will get written much more slowly. Given the current requirements around posting clinical trial results on registries within 1 year of last patient visit (which is almost physically impossible given the time it takes to analyze the data), medical writers are needed now more than ever to communicate research results.

    Heather Haley