Science, Medicine and Ghostwriting
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People who become scientists spend many years learning how to design, conduct, collect and analyze data from the experiments that they conduct. The ultimate goal of this seemingly endless exercise is to craft peer-reviewed publications that either support or refute the underlying hypotheses used to initiate the experiments in the first place. As part of our training, we are repeatedly reminded that it is our obligation to fastidiously and accurately report the results of our experiments and to assume “full ownership of the manuscripts and publications" that we author. The idea of allowing a person who didn’t participate in the design or execution of the research, to craft a manuscript for peer review is something that is virtually unheard of in the scientific community and, in the minds of some scientists, tantamount to scientific misconduct or fraud.
Physicians, on the other hand, who don’t learn how to conduct research or write scientific papers during their medical training, are frequently poor writers and have a little or no time to spend on writing scientific or medical manuscripts. Because of this, it is not uncommon for physicians who conduct medical research on behalf of pharmaceutical, biotechnology and medical devices companies to hire medical writers to write manuscripts for them. In fact, many physicians who work with pharmaceutical and biotechnology companies prefer and expect this arrangement. So, why the recent commotion over medical “ghostwriting”?
Drug companies typically hire medical communication agencies to develop and craft manuscripts that showcase the results of clinical or research studies that they have conducted. These companies will usually provide an agency with background information about a study, a research summary, clinical study reports, ideas or titles for proposed manuscript and a list of prospective authors (usually physicians who performed the studies on behalf of the company). Medical writers, who are either employed by the agency or work as freelancers use these materials to craft a detailed outline for the proposed manuscript. After the outline is completed, the agency usually shares the outline with physicians who were named on the list to determine who may be interested in authoring the publication. After an author is identified, the medical writer works closely with the author to develop a first draft of the manuscript. After the draft is reviewed by the author, changes are made to the draft, a revised version is circulated and the process is repeated until all stakeholders are satisfied with the manuscript. Once the publication has been copyedited and undergone legal and regulatory review it is submitted for peer review.
For the record, in my five years as a medical writer, I have never encountered a situation where the primary author doesn’t have final say over what will and won’t appear in a manuscript. When scientific, medical or business disagreements do arise, the author(s), medical writer and company representatives usually negotiate mutually-agreed upon solutions. Rarely, have I seen a company remove an author from a publication because his/her views or interpretations of the data were not consistent with those of the company that sponsored the research. The reason why drug companies and medical communication agencies have recently come under fire for their “ghostwriting” practices is because they have repeatedly failed to disclose that many of their publications were written by medical writers —whose names didn’t appear anywhere on the publications. Although this practice still exists, it is no longer as widespread or commonplace as it once was. These days, the names of medical writers who author manuscripts routinely appear in the acknowledgement sections of many scientific and medical publications. Moreover, in some instances, a medical writer may be able to garner co-author status on a publication —depending upon his/her level of involvement in the project.
In my opinion, there is little difference between graduate students, postdoctoral fellows and medical writers when it comes to preparing manuscripts for publication. It is not uncommon for the names of PIs, supervisors and others to appear as authors on publications even though their contribution to a project (or preparation of a manuscript) has been limited or nominal at best. Consequently, I fail to see any credible legal or ethical arguments against hiring a medical writer to write manuscript on behalf of an “author” as long as the “author” can demonstrate that he/she actively participated or was intimately associated with study design, conduct or analysis. Finally, to maintain the integrity and transparency of the medical writing process, it is imperative that medical writers who prepare manuscripts on behalf of study authors should be acknowledged or credited with “authorship” somewhere in a publication.
Until next time….
Good Luck and Good Job Hunting!!!!!!
If a person has not actually drafted a manuscript, he is not an author. To list someone as "author" who has not drafted the manuscript is obviously fraudulent. If the "medical writer" wants to consult a scientist and quote him, let him do so, as any journalist will do. Obviously the pharmaceuticals, etc., don't think that a journalistic article like that, if presented for what it is -- journalism -- carries the prestige they crave. So they misrepresent things by suppressing the true relationship between "medical writer" and prestigious scientist.
Although I too am a medical writer and am glad that I have the opportunity to look at the research and other scientific articles, etc., I do need to respond to this point:
"In my 5 years as a medical writer, I have never encountered a situation where the primary author doesn’t have final say over what will and won’t appear in a manuscript."
In my 2 years at med ed companies -- uhh, there is a part that the rest of the world is not seeing.
1. CME pieces -- the pharma company will send an email stating, "Our scientific accuracy department wants you to change and incorporate these points." Then the med ed company does so (sometimes after the so called experts have signed off on it). What do they ask to change? Increase the prevalence of the disorder, etc (=supposedly more people appear to have the disorder). Sometimes the only way to match those stats is to cite something 20 years old -- if the piece was actually peer-reviewed, they would not get away with this.
2. Peer-reviewed articles for medical journals - The pharma company calls or sends an email and says (5 minutes before the article is submitted) --"I just talked to the author - the author wants you to change sentence X to say ABCDEFG" Sometimes the info the pharma person wants you to put in does not match the literature.
If I were an investigator, I would never let another company submit the article on my behalf --ever-- they really will not see what is going on.