Filed under: Uncategorized | Tags: AMWA, clinical study, communications, content, data, drugs, EMWA, FDA, ghost writing, guidelines, healthcare, ICMJE, medical journals, pharma, pharmaceutical, physicians, WAME
The debate over who should write medical journal articles has been raging for years. Although heated and passionate at times, these debates are often imprecise about what constitutes ghostwriting or what possible benefit there is in employing a professional medical writer. Let’s clear up some half-truths and misconceptions.
He’s not a ghost if you can see him.
There are definitely ghostwriters among us. At its most extreme, ghostwriting is the use of an invisible writer hired by the marketing department of a pharmaceutical company to produce a selectively favorable report of their product, with authorship attributed to a high-profile investigator whose sole participation is cashing their honorarium check. This extreme example is shunned by most who are responsible for producing medical communications. More often than not, journal articles are written by medical writers who adhere to rigorous ethical guidelines (EMWA, ICMJE, WAME, AMWA). Central to appropriate medical writing is close collaboration of the professional writer with faculty authors who direct and control content.
Who are you going to call?
Another crucial aspect of professional medical writing is transparency. Successful medical publications are a team effort. Just as physicians investigate, statisticians calculate, and peer reviewers authenticate, the job of the medical writer is to communicate. Skilled medical writers perform the time-intensive tasks involved in clarifying and translating data into a submission-ready manuscript. Full disclosure of the contributions of all members of the team is essential to restore trust in medical literature.
Is it time to give up the ghost?
Investigators cite limited time as the most common reason why they do not convert clinical trial data into publishable manuscripts. A 2005 study of publication rates of oncology clinical trial data found that up to one third of clinical research in oncology remains unpublished. A recent survey for the Food and Drug Administration found that encouraging the participation of medical writers would help reduce the non-publication rate associated with industry-sponsored clinical trials.
And now a word from our sponsor…
Much of our medical literature is funded directly or indirectly by the pharmaceutical industry. We need them and they need us. At our best, the collaboration results in significant advances in healthcare. A final step toward eliminating hidden biases and restoring trust in medical literature is full disclosure of industry support and open access to clinical study data.