Posted in on April 15, 2008

Merck Used Ghostwriters for Vioxx Clinical Studies

Talk about foxes guarding the hen house! A recently published article in the Journal American Medical Association (JAMA) claims the drug maker Merck drafted many of the research studies for their best selling drug Vioxx, then had prestigious doctors put their names on the reports prior to publication.

In 16 of 20 papers that reported on clinical trials, a Merck employee was assigned as the author of the first draft of the manuscript. An outside academic scientist was then listed as the lead author when the study was published.

Researcher based their allegations on documents they discovered from Vioxx lawsuits detailing the industry wide practice of ghostwriting medical research studies that are published in academic journals. Vioxx, sold as a pain reliever, was pulled from the market by Merck in 2004, over evidence linking it to heart attacks and strokes. Late last year Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread. “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” continues Dr. Ross.

Merck has even acknowledged they hire medical writers or use in-house employees to draft research reports that a doctor will later assign his name as lead author. Merck defends this practice by claiming although they may have provided the draft, the doctor was a major contributor and the reports reflects his opinion. So we aren’t necessarily getting an unbiased opinion – essentially the doctor was told what the expected outcome should be.

Dr. Ross is concerned the issues go beyond the authorship of drug research studies, raising questions about the validity of the clinical trials on which the research is based. “Who designed the trial? Who did the trial? Who did the analysis? Who interpreted the analysis?” Dr. Ross asks.

Previous studies have shown drug makes spend almost twice as much marketing a drug as they do on research and development. Now it seems they aren’t really doing the unbiased, untainted research that they should be. The question we should be asking is…if Merck did it with Vioxx, what other research studies are the other drug companies fudging? Let’s get these foxes out of the hen house!

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