Abstract
Dear Editor:
I am writing to request a fuller discussion of potential conflicts of interest in the paper by Narayanan and colleagues “Safety and Efficacy of the PleurX Catheter for the Treatment of Malignant Ascites.” 1 My concern relates to several points. First, the article focuses on a commercial product, the PleurX catheter made by CareFusion Corporation. In the acknowledgments appears the statement, “Writing and editorial support provided by Mark P. Bowes, PhD, and CareFusion Corporation” followed by the statement “No competing financial interests exist.” I believe that a device manufacturer by definition has a financial conflict of interest in a paper about that device. That the corporation also participated in writing and editorial support for the manuscript raises a question about whether this is original research or marketing clothed in the garb of legitimate science, or something in between.
Second, most of the article is favorable to the PleurX system. For example the authors mention a cost savings compared to inpatient large-volume paracentesis. They do not mention that there is not a low-cost alternative to their vacuum bottles, which cost $628.00 for 10 and which must be used once the device is placed. I question whether the methods employed by this study, namely retrospective chart review of hospital records, are strong enough to justify the authors' conclusions of safety and low incidence of complications, infections, and adverse events. Most of the patients (hopefully) died in hospice care and there is no mention that the authors had access to patient experiences in hospice.
As I look at the overall tone of the the discussion which cites a large number of favorable studies and facts, I wonder whether these are presented in this way because the authors accepted writing and editorial input from the device manufacturer. For these reasons I would like to know the following:
1. How was this study conceived? Did the authors approach CareFusion or did CareFusion approach the authors? 2. How was it funded? 3. What roles did the authors play? Did CareFusion or one of its employees lead the writing of this manuscript? Who wrote the discussion? 4. Have the authors ever received funding or other perks from CareFusion? 5. What was Mark P. Bowes's role specifically in preparation of this article, and what is his relationship, if any, with CareFusion? What exactly does “writing and editorial support” mean? Was he paid for writing this article, and if so, where did that money ultimately came from? 6. What exactly does “writing and editorial support” mean?