Today’s issue of the Journal of the American Medical Association includes two articles and a commentary (
all freely available to the public*) that renew the debate surrounding pharmaceutical company Merck’s behavior with regards to the arthritis drug Vioxx (rofecoxib). The drug was voluntarily pulled from the market after safety concerns were raised (and 20 million prescriptions had already been written). Considerable controversy has surrounded the drug with regards to whether Merck understood and downplayed the increased risk of cardiovascular effects prior to the drug’s withdrawal from the market.
Although it was last updated in November of last year, NPR has an excellent timeline that provides a good introduction to the events surrounding Vioxx, from its 1999 approval through its 2004 withdrawal from the market following concerns that it increased risk of heart attack and stroke.
Today’s additions in JAMA make two essential allegations. Both allegations arise following the review of Merck documents discovered via Vioxx-related lawsuits:
1) Data that might have suggested the increased risk of heart attack and stroke earlier was withheld from the FDA, with Merck changing its method of analysis to reduce the appearance of deaths associated with the drug. It also indicates that the study in question had no Data Safety Monitoring Board, which would typically keep an eye on issues such as unexpected serious side effects and make decisions about whether to halt a trial.
2) Merck used ghostwriters or company employees to draft scientific reports for publication, later soliciting academic researchers to be listed as main authors while failing to acknowledge those who actually framed and drafted the study findings. The purpose of this is assumed to be that the academics would bring more prestige to the findings, making them more likely to be trusted (while readers generally assume a first author was heavily involved with the trial itself). The article also raises questions about whether these authors appropriately disclosed any financial ties with the drug company. The New York Times has a story on this with responses from some of the involved authors.
Merck has denied any wrongdoing.
To read the articles for yourself, see:
- Impugning the Integrity of Medical Science (editorial)
- Guest Authorship and Ghostwriting in Publications Related to Rofecoxib
- Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment
*Note: These articles were freely available to the public for a week or so, but are not at last check. Thanks to reader Michele for the tip.