Drug firm criticised by journal for clinical studies 'manipulation'

ONE OF the world's leading medical journals has criticised the drug company Merck & Co for its alleged "manipulation of clinical…

ONE OF the world's leading medical journals has criticised the drug company Merck & Co for its alleged "manipulation of clinical research articles and clinical reviews".

Using data obtained from court documents in the United States following litigation related to the arthritis drug Vioxx (rofecoxib), the Journal of the American Medical Association (JAMA) last night said it was concerned that "manipulation of studies and publications by the pharmaceutical and medical device industries is either increasing or there has been more exposure of these practices".

Vioxx, first marketed in the Republic in early 2000, was withdrawn following safety concerns in 2004. Research had found that taking the drug for longer than 18 months could increase the risk of heart attack and stroke by up to threefold compared with patients taking a dummy pill.

An investigator from the Food and Drugs Administration estimated the drug may have caused up to 140,000 cases of serious coronary disease in the US.

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Initial research had suggested rofecoxib and other drugs in the Cox 2 class of non-steroidal anti-inflammatory drugs were effective in reducing joint inflammation and pain and were less likely than previous products to cause gastro-intestinal bleeding as a side effect.

Dr Joseph Ross and colleagues from the Mount Sinai School of Medicine in New York reviewed court documents and the medical literature to examine the practice of guest authorship and ghost-writing related to rofecoxib.

"Only 50 per cent [ 36 of 72] review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company," the authors said. "This . . . review of industry documents related to rofecoxib demonstrates that Merck used a systematic strategy to facilitate the publication of guest-authored and ghost-written medical literature."

However, this conclusion was firmly rejected by Merck and Co, which said in a statement: "Merck believes that many of the comments in the Journal of the Medical Association are false, misleading or lack context.

"We believe that a full unbiased evaluation of the Merck papers show that many of the conclusions put forward by the author of the JAMA papers are incorrect."

The company said it had implemented a policy in 2006 to convene an advisory group of external scientists who are involved in the conduct and analysis of its research studies.

Merck however confirmed it would continue to use outside medical writers, "under the direction of the named authors".

In an editorial, the editor in chief of the Journal of the American Medical Association, Dr Catherine D De Angelis said: "Public trust for clinical research is in great jeopardy, especially when the extent of how widespread such practices have become is unknown."

The editorial calls for medical journals to disclose links between authors and for-profit companies and says that journal editors must consider authors' financial conflicts of interest when deciding whether to publish research. In a reference to the sponsorship of medical education by the pharmaceutical industry, the journal states: "Professional organisations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials."