Earlier this month one of my blogs was devoted to the seeming suppression of data from a study which showed that two cholesterol-reducing drugs were no better than one. It appears that the drug companies who make the drugs sat on these results for two years, before it was forced out of them by a US congressional committee. During this time, of course, the sales of a product containing a combination of these two drugs ramped up very nicely.
Profiting by keeping individuals ignorant of the facts is one thing, but risking their lives is another. Some of you may remember that back in September 2004, the drug company Merck pulled its painkiller Vioxx (rofecoxib) from the market after research revealed it more than doubled risk of heart attack. However, what at first appeared to be a big pharma acting with a degree of corporate responsibility turned sour when evidence came to light which suggests that Merck was aware of the life-threatening effects of Vioxx some four years before they withdrew it.
More revelations regarding this sorry tail surfaced this week in a review published in the Journal of the American Medical Association . The review is of industry documents relevant to litigation regarding Vioxx. It turns out that clinical trials and review articles about this drug were often written by Merck employees (!) or other unacknowledged authors. These would then generally have a ‘name’ – usually a recognised academic ” as the lead author. Not only would this person often have had little to do with the study, but may also not have disclosed that they were being ‘sponsored’ by Merck to boot.
The authors of this review, quite rightly I think, take a dim attitude to such practices and the ethics (lack of ethics, actually) displayed by them. Of course, one could argue that the Merck/Vioxx incident was a bit of a ‘one-off’. Except that it clearly is nothing of the sort. Here’s how the authors of the review put it:
�this case-study review is based on documents from a single company related to a single medication. We cannot determine if the authorship pattern we observed for clinical trial and review articles related to rofecoxib also would be observed in articles describing other Merck products or the products of other pharmaceutical companies. However, given the reported prevalence of guest authorship and ghostwriting among the most prestigious medical journals and that similar authorship patterns were identified using documents produced during litigation surrounding both gabapentin and sertraline, 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. Because Merck has traditionally characterized itself and its conduct as among the most ethically appropriate of pharmaceutical companies, perhaps the practices we observed are conservative in comparison with other companies within the industry.
This review highlights just some of the issues with the reliability of ‘evidence’. What I find interesting though, is how despite such revelations, many doctors and scientists will state with utter conviction the ‘facts’ about what science appears to show. Rarely, do I find, that they question the reliability of the evidence. I’m hoping this review will help doctors and scientists take a somewhat more circumspect view of the outpourings of pharmaceutical companies. One reason for this is that some ‘experts’ are paid by the drug companies to ‘promote’ their products. Sometimes in science it’s not enough to ‘consider the facts’: you may also need to ‘follow the money’.
Ross JS, et al. Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation JAMA 2008; 299(15):1800-1812