Medical Writers
As you can probably imagine, I have a few comments about this article.
1) The article highlights rare ethical breaches; in the context of the thousands of papers that are written with the assistance of medical writers they should not reflect on the profession as a whole.
2) I do not know what happened in the Vioxx case, but the fact is that the authors are always the last to see the article before it is submitted. If something important was removed, it was removed with their full knowledge and consent.
3) Medical writers are necessary. Asking a physician to spend hundreds of hours as the center point for all of the writing, discussion, and revisions that occur during the development of a manuscript is a recipe for the data never coming out. When I was a medical writer, I frequently waited weeks or months for the authors to just to find a few hours to review the manuscript.
4) Medical writers should not need to be acknowledged. They are technicians and should no more be listed as an author than the nurses and techs who contributed to the conduct to the study. Unless I contributed intellectual content (as opposed to organizing the data and presenting it in a readable fashion) I had no problem ghostwriting a study.
5) There are editorial guidelines that must be followed when writing a study. Only a professional should be expected to take the time to understand and follow these guidelines.
6) Physicians, in general, are awful writers. I hold up YMI's recent nimotizumab paper as an example of a paper written without professional help. It is poorly organized and barely readable (although the data were good!)
Finally, I'd just like to go through the process used to develop a primary publication:
1) After the data have been analyzed, the writer meets with all of the lead authors. In person, if it is a major study, or via teleconference if it is a minor study. The writer listens while the authors discuss what data will be presented in the paper and what should be included in the introduction and conclusion.
2) The writer generates an outline, which is circulated to all authors for comments and changes
3) Once the outline is approved by all lead authors, the medical writer uses the study report to write up the data. Frequently, the writer works directly with the statistician to clear up any inconsistencies and may recommend additional analyses. At this stage, the figures are created by a graphics professional and inserted in the outline.
4) The draft manuscript is circulated to all authors, who review, rewrite (usually there is extensive rewriting of the conclusions). The medical writer serves as the center point for the review, and resolves any disagreements among the authors.
5) The article is returned to the lead author after all authors have approved the draft. The lead author submits to the journal.
There are various modifications to this process that can occur--for example, the writer may write up just the data and leave the introduction and conclusion to the authors.
Five years ago, when I was primarily a writer, the pharmaceutical company that sponsored the study was permitted to comment like any other author. More recently, the pharma that sponsored the study usually gets a courtesy copy of the draft manuscript following submission--other than that they have little input beyond the writer's contact with the statistician.
This is the way the process works for me, I cannot speak for others. Like anything else, there is always the possibility of an ethical breach. It is the responsibility of the writer to ensure that commercial interests do not influence the content and that the content is fair and balanced.
AI
