Merck defends Vioxx in court, as publisher apologises for fake journal
Merck has begun the defence of its anti-arthritis drug rofecoxib (Vioxx) in the Federal Court of Australia, amid revelations that it lobbied to quash similar legal action in Britain, and as a publisher apologised for a journal sponsored by the company.
The United States based company is fighting a class action from more than 1000 Australians, led by Graeme Peterson, who had a heart attack in 2003 after taking rofecoxib for several years.
Over the past month Mr Peterson’s lawyers have released many internal company documents showing, they claim, how Merck’s marketing tried to minimise safety concerns about the drug and to “neutralise” and “discredit” potential critics. They also say that the company created an entire medical journal that appeared to be a legitimate peer reviewed journal but that in reality was simply a “marketing publication” (BMJ 2009;338:b1714, 28 Apr, doi:10.1136/bmj.b1714).
Opening the defence case last week, Merck’s legal representative Peter Garling said that the marketing was “consistent with the scientific data” from careful studies involving large numbers of patients. He said that the company would present evidence showing that Mr Peterson’s heart attack “was the result of pre-existing risk factors and not the medicine,” adding that “each person’s medical history and other surrounding facts and circumstances are different.”
Merck has previously settled class actions in the United States, paying out close to $5bn (£3.3bn; 
3.7bn) but without admitting fault or causation.
On the eve of the company launching its defence in the Australian class action, in the United Kingdom the Guardian reported that Merck had run a campaign to “head off government support” for similar legal action there (www.guardian.co.uk/business/2009/may/04/merck-vioxx-campaign-parliament). It said that documents released under freedom of information legislation show that government ministers retreated from supporting people affected by rofecoxib, after a Merck campaign that involved a lobbying firm.
Asked about the alleged lobbying, Merck told the BMJ that the company had simply responded “properly” to comments made by a member of parliament.
Meanwhile one of the world’s leading publishers of medical journals, Elsevier, released a statement last week from a senior executive apologising for the “improper” publication of Merck sponsored marketing material “that was made to look like journals,” published between 2000 and 2005. “This was an unacceptable practice, and we regret that it took place.”
Elsevier had published the Australasian Journal of Bone and Joint Medicine, the Merck sponsored journal that was described in the Australian federal court last month as a “marketing publication” by George Jelinek, a journal editor called by lawyers for the plaintiffs. Merck has not denied the claims but told the BMJ that “according to published reports, Elsevier published a series of similar journals.”
Dr Jelinek also testified that the role of the lead author of an influential 2001 study on rofecoxib published in Circulation involved little more than minor editing of a paper originally written in house by Merck scientists (http://circ.ahajournals.org/cgi/content/full/104/19/2280). The author in question, Marvin Konstam, has been reported as saying he acted properly and took responsibility for everything he published (www.theheart.org/article/965721.do), and Merck maintains that he was “very much involved with the design and authorship of the study.”
The federal court also heard that an internal email exchange discussing the Konstam paper before its publication showed concerns within Merck about the way the data on cardiovascular events associated with rofecoxib were being presented in the paper (http://dida.library.ucsf.edu/pdf/oxx03v10).
The paper’s discussion section stated that there was “no evidence that rofecoxib was associated with excess CV [cardiovascular] events compared with either placebo or non-naproxen NSAIDs [non-steroidal anti-inflammatory drugs].” However, a senior Merck employee, Briggs Morrison, described the claim in an email as “wishful thinking, not a critical interpretation of the data,” and wrote that “the data appears to have been interpreted to support a preconceived hypothesis.”
Despite these concerns a Merck employee signed off the manuscript, and exactly the same wording remained in the published version of the Circulation paper. In response to questions from BMJ, Merck said that the emails reflected the company’s process of “careful scientific review.”
After assessing many internal Merck documents, including these emails, Dr Jelinek testified to the federal court that in his view there was a “systematic attempt to flood the medical literature” with publications “with a well thought out set of objectives and key messages.”
The trial before Justice Jessup continues.
BMJ 2009;338:b1914