This is a comment, based on personal experience in this area, on the latest news about Vioxx – that Merck hired “ghostwriters” to write the scientific papers about Vioxx and thus were perpetrating “fraud.”
A new report (Ross, J.S., MD, MHS; K.P. Hill, MD, MHS; D.S. Egilman, MD, MPH; H.M. Krumholz, MD, SM. 2008. Guest authorship and ghostwriting in publications related to Rofecoxib: A case study of industry documents From rofecoxib litigation. Journal of the American Medical Association 299(15):1800-1812) suggests that methods employed by Merck to use scientific journals to promote its products show just how scummy this company is, in case you didn’t already believe it.
This is an issue that interests me because I was once a paid ghostwriter of a paper for a biotech company (which shortly after went belly up, and apparently the paper was never published). Based on the report’s definition, (“Ghostwriting has been defined as the failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript”) it is my impression from my own experience that biotech companies (including pharmaceutical) routinely pay “ghostwriters” to write papers intended for publication in medical journals. In my own case, the doctor whose name was to go on the paper did supposedly collect the data, and I was provided with a brief summary of the findings which I expanded into a full paper, which was then edited further by staff at the company.
Is such a process unethical? The way I saw it at the time, it was more an instance of the doctors collecting the data being too busy and/or subpar writers who could not be depended on to get the research written up and submitted to a journal for review in a timely manner, which is in the interest of the company promoting the product. On the one hand, this didn’t seem to be a big deal given that the doctor who “authored” the paper did actually collect the data, and even contributed discussion points in the summary, which made him a valid author on the paper. On the other hand, the experience did make me cynical about papers in medical journals, which from then on I viewed as rather poorly conducted and reviewed advertisements for industry products (a common theme on this blog). In my mind, the question of who actually wrote the words of the paper to present the data is insignificant compared to the fact that papers published in medical journals are held to an incredibly low standard of scientific rigor compared to, say, those published in ecology journals. Part of the reason for this is obvious – scientific rigor is much more difficult in human studies, in which researchers are ethically more limited than ecologists in the types of manipulations available. Somewhat of a lower standard is probably necessary for progress in the field.
But another reason never discussed for poor medical studies is that journals and the medical industry seem to have a reciprocal back-scratching arrangement: the journal gets a lot of press coverage when it publishes yet another “significant” paper, and the biotech industry gets the promotion of their products. The authors and reviewers, by the way, are tied up in the same knot as well; they are scientists who need to publish to progress in their career, and are also often funded by the biotech industry. “Conflict of interest” probably doesn’t begin to describe the complex web of interactions among all these parties.
A big problem with this system is that it creates a slippery slope. There certainly may have been instances when Merck’s methods were less defensible, for example:
Documents were found describing Merck compensating investigators with honoraria for agreeing to serve as authors on review manuscripts ghostwritten on their behalf by medical publishing companies. Honoraria varied, ranging from $750 to $2500. One author refused his honorarium from Scientific Therapeutics Information stating, “I really do not feel it is appropriate to be paid for this type of effort.”
Unfortunately, when you are so close to the line to begin with, crossing it becomes almost unavoidable. Paying the printed authors to put their name on any publication would certainly be crossing it.
Still, one wonders what planet Dr. Ross and the other authors have been on, given that they seem to imply that Merck should be singled out for using these methods to promote its products – they are shocked, shocked! to find what they did. Perhaps their disclosure statement sheds some light:
Although every effort was made to present this information objectively and fairly, it is important to note that all of the authors of this article have been compensated for their work as consultants/expert witnesses at the request of plaintiffs in litigation against Merck related to rofecoxib [Vioxx].
OK, they finally then admit that they may have heard of something like this before:
…it is reasonable to expect that the authorship practices observed in this case study may be used by other pharmaceutical companies as well. A recent press account seems to confirm as much, as does the presence of an industry specializing in medical writing.
They end with the extremely ironic statement, “We are hopeful that our findings encourage discussion of ways in which to improve the integrity of research.” Simply, the “integrity” of medical research is a joke, and has been for a long time. Companies and journals will continue this charade as long as it stays profitable.