The recent revelation that Eli Lilly used ghostwriters to write favorable articles on the use of Zyprexa and sought out physicians to put their names on the respective papers brings up the issue of the common practice of medical writers preparing manuscripts for submission to medical journals. This same topic came to the forefront last year when an article on ghostwriting in the pharmaceutical industry appeared in JAMA. It reported that Merck wrote articles on Vioxx and then paid doctors to add their bylines.
There are concerns that ghostwritten articles in peer-reviewed journals discussing unapproved indications encourage off-label use of a product. But don’t physicians read and draw their own conclusions from the literature? Of course, increased off-label use would increase sales of the product which may be another concern; however, if clinicians don’t see a response, would they continue prescribing the product?
So who should be held accountable for the publication of these articles? What about the journals’ responsibility? They have an editorial board and a peer review process. Isn’t it their responsibility to challenge the interpretation of the data, statistical tests, statements made in the discussion, and conclusions drawn?
Medical writers are essential in our industry. Nearly 50% of abstracts presented at medical meetings are never published as full manuscripts. Can you image what the percentage would be without medical writers? Few journals could survive without the manuscripts medical writers provide to healthcare publications.
It has been my experience with medical writers that their scrutiny of the data is far more thorough than that of the “authors.” Yes, it may be true that the authors, if they wrote the manuscript, would be as critical of the information, but relying solely on clinicians to publish would mean that fewer articles would make it into the medical literature — and certainly not in a timely fashion.
There is no doubt there is a need for transparency and disclosure of the role of a medical writer in the preparation of the manuscript. Significant efforts have been initiated by journals and associations of medical writers to make this happen. Medical publication practice guidelines were proposed in 1998 because of ghostwriting concerns. Revised guidelines, which encourage further transparency and recommend that all contributors be listed with the details of their contributions, will be published later this year. Then it becomes the responsibility of the pharmaceutical industry and healthcare publishing to abide by them so “ghostwriting” disappears from our vocabulary.
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Ken is a great deal more than just the president of a medical communications company. He is something of a hybrid. He’s part marketing manager, part creative director, and part copywriter. To the chagrin of his peers—but to the delight of his clients—Ken is a consummate perfectionist. As a former creative director for a high-end consumer agency, he challenged his creative teams to go beyond the mundane to produce work with real creative impact, something he’s just as fervent about today. From producing and directing TV commercials, to launching DTC and Rx-to-OTC switches, Ken brings his clients a world of experience in OTC pharmaceuticals as well as business, lifestyle, and high-end consumer products and services. Whether huddled with clients behind a mirror in a market research center in Houston, facilitating a strategic workshop in Madrid, or developing a global campaign either in the New Jersey or California office, Ken is always fully engaged, bringing “bestness” to all areas of his hectic but full life.
