Merck wrote its own articles on Vioxx research and then paid prestigious doctors to append their bylines, according to a new story in the Journal of the American Medical Association. Of course, Merck isn't alone: the JAMA article notes that ghostwriting appears to be widespread in the pharma industry. "It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician," said the study's lead author, Dr. Joseph S. Ross of the Mount Sinai School of Medicine.
But the ghostwritten Vioxx research is noteworthy because the drug went on to become a best-seller--and then a fiasco, as Merck withdrew it because of links to heart attacks and, most recently, agreed to pay $4.85 billion to settle related lawsuits. It's also interesting because those very lawsuits unearthed documents that shine a bright light on the way Merck promoted Vioxx data. Usually, those documents are kept in drug company filing cabinets and never meet the public eye. Also, the JAMA reports allege that Merck dragged its feet when reporting data on safety risks that arose during two studies of Vioxx in dementia patients.
Now, these JAMA articles relied only on the legal documents and published studies; none of the authors were contacted. Since the reports were published, some expert authors have defended their roles in the Vioxx articles, saying that they didn't simply come in after the fact and add their names, but participated in the research itself. "It's simply false that we didn't contribute to the final publication," one said. But that same professor told USA Today that he never had all the statistical analyses for that study; his role in it was to judge the accuracy of participants' Alzheimer's diagnosis, not the effect of the drug, he said.
We may get some more public documents to pore over soon, however: Sen. Chuck Grassley has put one of the ghostwriting companies--Scientific Therapeutics Information--on the hot seat, asking the company about its dealings with Merck.
Plus, expect to see debate over JAMA's proposals for reform. They include a half-dozen bids for increased transparency in clinical trials and study publication.
- check out Merck's response to the JAMA articles
- find the JAMA abstract
- see Grassley's letters
- read the Boston Globe story
- see one researcher's conflicting accounts of a Vioxx study at Pharmalot
- check out JAMA's recommendations
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