Ghostwriting and the Medical Writer
By Cynthia Haggard

Nearly every experienced writer has a story to tell about ghostwriting, often a tale that involves a questionable, or outright unethical, request by a client. Even the term, ghostwriting, makes many writers uncomfortable. AMWA discourages its use, but for lack of a better description, the term ghostwriting is used in this article.

You are an academic, an MD at Georgetown University and a recognized authority on herb supplements. As an academic, you need publications. One day a medical communications company that we will call XYZ Communications invites you to put your name on an article to be submitted to a peer-reviewed journal. The article is about negative interactions between herbal supplements and Warfarin. In their invitation, XYZ Communications encloses a draft of the article written by one or many ghostwriters who are paid for their time. They tell you this article is sponsored by a pharmaceutical company we will call ABC Drugs. You are told to go through this article to make changes and then return it to XYZ.

You know that ABC drugs does not manufacture Warfarin or herbal supplements, so you ask XYZ what its interest is. XYZ replies that “While there is no promotion of any drug within this paper, ABC Drugs is keen to set the scene for new anticoagulants that are not subject to the numerous limitations of Warfarin.” After more research, you realize that ABC Drugs has a competitor to Warfarin in the pipeline. What do you do?

This scenario is Adriane Fugh-Berman’s story, reported in the Journal of General Internal Medicine (JGIM) . When Fugh-Berman realized that ABC drugs had a competitor to Warfarin in the pipeline, she informed XYZ communications that she would not agree to be the named author on the piece.

But Fugh-Berman’s story does not end there. XYZ communications went ahead and recruited someone else to be the sham author, and the herb-Warfarin article was submitted to the JGIM. By a stroke of fate, Fugh-Berman was asked to review the article. When she told the journal editors about its odd origins, the piece was rejected. The editors of JGIM have since spearheaded an international discussion of ghostwriting by medical education companies (MECs) like XYZ communications. They have alerted members of the World Association of Medical Editors (WAME) that submitted papers may not properly acknowledge corporate funding or co-authorship and encouraged making “clear in their journal’s information for authors that medical writers can be legitimate contributors and that their roles and affiliations should be described in the manuscript.” WAME’s statement on ghostwriting can be found here.

As a medical writer, you may find yourself in similar difficult situations.

Cindy Hamilton, a freelance medical writer, helps with the development of manuscripts for peer-reviewed journals. She told me that her advice to people is to engage in a “stepwise interactive approach.” When Hamilton is given some work to do, her first step is to schedule a teleconference among all the involved parties (the sponsor; the named authors; and any other people, like statisticians, who may make a substantial contribution to the manuscript). The object of this teleconference is to agree on the basics, such as the target journal, authors and the order of authorship, people to be acknowledged for making substantial contributions that do not meet the criteria for authorship, the main message and the delineation of responsibilities.

Cindy says that the reason for doing this is to air the issues early on, and to make sure that everyone is on the same page about the approach to this manuscript. Having a teleconference with the involved parties holds everyone accountable. As the medical writer, getting in on the manuscript preparation at an early stage is crucial to preventing slanted or dishonest messages coming out on your watch. Once everything is nailed down, then it is your responsibility to check back regularly with your client to make sure that everyone is staying on message and that there are no nasty surprises. Another benefit of the stepwise approach is that it places you in a position to educate all involved parties about available guidelines and to encourage adherence to these guidelines.

Barbara Jones, who ghostwrites for continuing medical education (CME) companies, said there are regulations that prohibit the involvement of pharmaceutical companies in the creative development of CME programs. Still, these companies can suggest the faculty advisors who may be listed “authors” of the programs and they often review and revise copy. These individuals, often key opinion leaders, may also be members of a remunerated speaker’s bureau for the sponsoring pharmaceutical company. In addition, they may have been involved in clinical trials for a product’s FDA submission, and are likely to support the use of the products for the treatment of the disease-state addressed in a CME program. Against this background with inherent conflicts of interest, the writer and the reviewers need to be vigilant to preserve fair balance and objectivity in the choice of topics as well as in the use of descriptive language and qualitative terminology.

Michael Altus, who ghostwrites for MECs, told me that he was once asked to write a review article based on the outline of a manuscript. Before he took the job, he asked the company if the named author had prepared the outline. When he was told the named author had indeed approved the outline, Altus took the job. Fortunately, he found that the outline clearly reflected the named author’s perspective, because it involved summarizing the author’s research. However, he says that before taking any new jobs, he now asks for more details about how the named author participated in developing the outline.

AMWA’s involvement in the controversy over ghostwriting dates back to the 1990s and initially had to do with preparing CME documents. In that situation, a ghostwriter prepared the documents for a medical education company, with no disclosure about the identity of the ghostwriter, which pharmaceutical company they may have been working for or any other possible conflicts of interest. This controversy then evolved to include “ghostwriters” who wrote manuscripts that were submitted to peer-reviewed biomedical journals, again involving lack of transparency about the ghostwriters. At one point, the FDA threatened to ban all types of medical writing and was stopped by strenuous attempts by AMWA to educate the FDA about the many different types of medical writing and editing.

AMWA now has a position statement on manuscripts submitted to biomedical journals, including a letter to the editor which can be found on its website. However, AMWA does not have a position on CMEs. There are some guidelines regarding conflicts of interest, but none about author transparency. People who do regulatory writing for pharmaceutical companies, such as preparing CSRs for the FDA, also do not have a position statement to guide them, but in this case, the pharmaceutical company is held liable by the FDA for any falsification of the data. Most pharmaceutical companies have a cover page in their CSRs to acknowledge all parties who made substantial contributions. But even if the medical writers are not acknowledged, the FDA knows that the document is from that pharmaceutical company, and so there is no lack of transparency.

“The American Medical Writers Association (AMWA) recognizes the valuable contributions of biomedical communicators to the publication team. Biomedical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships. In all aspects of the publication process, biomedical communicators should adhere to the AMWA Code of Ethics.”

These consist of eight principles with a preamble. The most pertinent to the discussion of “ghostwriters” are: Principle 2, “Biomedical communicators should apply objectivity, scientific accuracy and rigor, and fair balance while conveying pertinent information in all media” and Principle 4, “Biomedical communicators should work only under conditions or terms that allow proper application of their judgment and skills. They should refuse to participate in assignments that require unethical or questionable practices.” The full code of ethics can be found here.

The International Committee of Medical Journal Editors (ICMJE) has guidelines that are used by more thanr 500 medical journals as a standard for researchers submitting papers for publication. These guidelines can be found here.

All AMWA members should be aware of the position statement and the code of ethics. The position statement can be used to support a request for acknowledgement from journals and employers. A letter is available for AMWA members to send to journal editors who do not acknowledge the contributions of medical writers and editors. The text of the letter can be found here.

Most people are not happy about ghostwriting. Michael Altus would like to see AMWA inform all of its sponsors and advertisers about its position statement and ask them to adhere to it. Altus agrees with Tom Lang’s distinction between ghostwriting and ghost authoring, posted on the lively exchange on the World Association of Medical Editors discussion list, Ethical Guidelines, Plagiarism and Ghost Writing.

“Ghost writing, in my definition,” says Tom, “is assistance with preparing early drafts of an article to save the author of record the time and effort of choosing words to express the author’s intellectual content. That is, the ghost writer packages information provided by the author. Ghost authoring, in my definition, is the act of preparing an almost final draft of an article before an author is identified. The implication is that the author cannot take responsibility for the article because he or she had little or no input into its ideas.”

Tom continues, “However, I can imagine an author agreeing with, say, a review article, and allowing his or her name to be listed as an author. I couldn’t do this, but I’m willing to consider that authors who DO do it are quasi-ethical, as opposed to being outright frauds.”

Altus recommends that all of us stay away from ghost authoring, because it debases the value of the scientific literature.

Barbara Jones agrees, saying that “a ghostwriter should make sure that he/she does not become a pawn (sometimes along with the author) in a game meant to advance promotional objectives under the guise of medical education or expert opinion.”

Cindy Hamilton, who is currently helping AMWA do a survey, believes that we should be conducting research to find out about current practices and then encourage everyone to adhere to the guidelines from the International Committee of Medical Journal Editors (ICMJE) and target journals.

As a new medical writer, I would like to see AMWA provide more hands-on help to writers who may find themselves in difficult situations. Perhaps AMWA should encourage new members to have a mentor they can call on for advice. And I think there should be more educational programs about ethical issues, especially for new members. That way, AMWA would better encourage writers to pursue ethical solutions to difficult situations.