Vioxx reports: Merck hired ghostwriters, concealed data

Apr 15, 2008, 21:58 GMT

Washington - Two studies being published Wednesday in the prestigious Journal of the American Medical Association (JAMA) claims that the Merck pharmaceutical company hid negative data about the now-banned Vioxx painkiller and paid ghostwriters for glowing articles about the drugs.

In a statement, Merck rejected the studies as 'incorrect.'

In excerpts from one of the JAMA articles released Tuesday, a team of scientists charged that Merck systematically enlisted ghostwriters to lend their names to positive reviews of Vioxx and other drugs which appeared in respected medical journals.

The authors of the charges, led by Dr Joseph Ross of Mount Sinai School of Medicine in New York, also included a disclaimer admitting they had been paid as consultants by complainants in a major legal suit against Merck.

Merck noted the conflict of interest in its statement.

Vioxx was pulled from market shelves over health risks in 2004 after a study showed the drug increased the risk of heart attacks.

Some 27,000 patients filed lawsuits, and last year, Merck agreed to pay a 4.85-billion-dollar settlement to patients.

The second study appearing in JAMA, by a team of scientists at the University of Washington in Seattle, analysed 250 internal and public documents about Vioxx.

They found that an internal Merck study in 2001 showed a near tripling of cases of death among Alzheimer patients who took Vioxx. A group of 1,069 patients had 34 deaths, while 1,078 placebo patients had only 12 deaths.

The statistics were withheld from US health authorities and the public, the authors Bruce Psaty and Richard Kronmal wrote. Instead, another set of statistics was released to the Food and Drug Administration (FDA), they wrote.

'This ... approach to reporting minimized the appearance of any mortality risk,' the team wrote.

Merck dismissed the findings as 'incorrect' and pointed out the possible bias of the team that wrote the report about ghostwriting. It said it has shared all of its studies with the FDA.

In an editorial accompanying the studies, JAMA editors said the ghostwriting charges put the 'public trust for clinical research ... in great jeopardy.'

They proposed a code of conduct that would keep for-profit companies from being the sole or primary collector of data about new drugs.

It would urge physicians to stay free of 'financial influences of pharmaceutical and medical device companies' - a well known problem in the health care industry.

'When integrity in medical science or practice is impugned or threatened - such as by the influence of industry - patients, clinicians and researchers are all at risk for harm, and public trust in research is jeopardized,' the editors wrote.