Merck Accused of 'Ghost Writing' Medical Article
DRUG company Merck had a cardiologist sign his name to a medical journal article it wrote claiming there was no evidence of any heart risk attached to its drug Vioxx, court documents allegedly show.
In an internal email in August 2001 to discuss a draft of the manuscript, Merck senior researcher Briggs Morrison expressed concern about the claim that Vioxx was not associated with an increased risk of cardiovascular events.
"That seems wishful thinking, not a critical interpretation of the data," Dr Morrison said in the email to colleagues.
"The data appears to have been interpreted to support a preconceived hypothesis."
The claim was nonetheless included in the final version of the article, which Merck employees sent to US cardiologist Dr Marv Konstam for approval.
Dr Konstam was named as the article's lead author when it was published in the medical journal Circulation in October 2001. Five of the article's authors were Merck employees and the remaining two, including Dr Konstam, were paid consultants.
The email was tendered to the Federal Court yesterday as part of a class action on behalf of every Australian who had cardiovascular conditions after completing at least one prescription of Vioxx between June 30, 1999, and its worldwide recall in 2004. The class action, which includes more than 1000 people, alleges Merck covered up a higher risk of cardiovascular conditions.
Professor George Jelinek, a medical journal editor with an interest in publication processes, reviewed various Merck documents provided by law firm Slater and Gordon, which is running the case against the drug company.
He said authors of the Konstam article should not have published "such a dogmatic conclusion" that there was no evidence Vioxx increased cardiovascular risk "in light of the scale of the potential health consequences" other data has suggested.
Professor Jelinek, in a statement tendered to the court, said Dr Morrison was not listed as an author "in spite of the fact that it seems he played a more influential role" in its creation than the named authors.
He said ghost authorship of a medical journal article by a drug company obscured any potential biases, rendering the medical community unable to make an informed decision on its findings.
Professor Jelinek said Merck produced two other journal articles, published in 2002 and 2003, that also dismissed any heart risk attached to Vioxx and "shared a number of common features" with the Konstam article which were "strongly suggestive of a common authorship or purpose".
In relation to a draft of one of those articles, which was later published giving Professor Matthew Weir as its lead author, Merck senior researcher Larry Hirsch emailed a colleague to say it was "… in good shape, although it does come across a bit too much as a 'Merck' paper".
Professor Jelinek said other Merck documents, including spreadsheets detailing proposed journal articles and authors, indicated "a systematic attempt to flood the medical literature … with a well-thought-out set of objectives and key messages."
He said Merck wrote some papers in-house and added academics as their authors, while others were "in effect subcontracted to commercial medical communications companies".
The drug company even produced its own "medical journal", the Australasian Journal of Bone and Joint Medicine, which, he said, was designed to resemble a peer-reviewed publication and reprinted previously published articles.
The trial before Justice Christopher Jessup continues.