What is the purpose of publications? (…) The purpose of data is to support, directly or indirectly, the marketing of our product.” [1, 2]
BY JAQUELINE (Laika’s MediLibLog)
It is well known that studies with significant positive results are easier to find than those with ‘negative’ results. This so called publication bias can arise from the tendency to submit or accept manuscripts that have a positive rather than a negative or neutral result. It can also be the consequence of deliberately overemphasizing positive results or even worse: the results can be “embellished”, (partly) faked or negative results can be “hidden.”
In fact, pharma-sponsored trials rarely produce results that are unfavorable to the companies’ products [3, 4, 5]. For instance, none of the published 56 trials of NSAIDs in arthritis identified by Rochon et al in 1994 [3] had outcomes that were unfavorable to the company that sponsored the trials. Another study showed that studies funded by a company were four times more likely to have results favorable to the company than studies funded from other sources [1, 4]
Ghostwriters, who write articles that are officially credited to another person, are part of the tactics. Ghostwriters may be hired by companies to write articles for medical journals that appear under the names of scientists who didn’t substantially contribute to the paper. In extreme cases pharmaceutical companies and their agents control or shape multiple steps in the research, analysis, writing, and publication of articles. This so called ghost management can be outsourced to MECC’s, medical education and communication companies.
All the above approaches, -and more- are said to have been used by Merck to sell their Vioxx (rofecoxib) pills, the blockbusting painkiller, that could cause heart attacks and strokes [6]. Merck knew, but didn’t disclose (all) these adverse effects*. Later it appeared that many Vioxx- manuscripts were prepared by sponsor employees (ghost writers), but attributed to academic investigators who did not always disclose industry financial support. Distancing himself from one such article, first author Jeffrey Lisse said in an interview that:
“Merck designed the trial, paid for the trial, ran the trial…Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then it was sent to me for editing” [NY-times -[2005].
And although Merck has “voluntarily” withdrawn Vioxx from the market in 2004 and has agreed to pay billions to settle lawsuits in the US, the Vioxx-ghost keeps hunting Merck (and us).
In a few weeks 3 news-items have crossed my eyes.
A. The Guardian ( May 4) http://www.guardian.co.uk/business/2009/may/04/merck-vioxx-campaign-parliament mentioned that Merck refused to compensate hundreds of Britons who have suffered serious cardiovascular problems while on Vioxx. Ministers apparently backed down from supporting these people after lobbying by the company.
B. May 1st NewsInferno
C. The above news story was covered by Australian Newspapers including “the Australian”
“The drug company also allegedly produced an entire journal — called The Australasian Journal of Bone and Joint Medicine — and passed it off as an independent peer review publication.”
It is this sentence that has caused a tsunami, starting with the Scientist, via blog.bioethics.net to many other blogs of researchers, publishers, librarians and to newspapers. “Everybody” was alarmed.
What were the allegations? Are they all true? Who is to blame? Merck or Elsevier? Most importantly: is it an isolated incidence, something completely new and what is its impact?
Laika’s MediLibLog for more