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APHA Scientific Session and Event Listing

David Egilman, MD, MPH¹, Amos Presler², Lea Anne Hegg², Marion Billings, MSc², and Nfn Scout, PhD³. (1) Department of Community Health, Brown University, 8 N. Main St. #404, Attleboro, MA 02703, 508-226-5091, degilman@egilman.com, (2) Never Again Consulting, 8 N. Main St. #404, Attleboro, MA 02703, (3) Scout, 110 Grove St., Lincoln, RI 02865

In 2003, Annals of Internal Medicine published an article reporting the results from a clinical trial known as ADVANTAGE – a study that Merck marketing division funded and ran to ostensibly measure the gastrointestinal safety of Vioxx. The resultant 2003 article by Lisse and colleagues reported no statistically significant differences for any cardiovascular endpoints in comparisons of Vioxx (rofecoxib) and naproxen in ADVANTAGE, a 12-week clinical trial. In early 2005, the New York Times published an article noting the omission of a case from the published findings, skewing the results in favor of the drug's safety. In late 2005, the New England Journal of Medicine published an editorial expressing concern about the submission of a related Merck paper for the Vioxx Vigor study, showing the authors knowingly suppressed adverse data. Our research has found that underlying this already egregious omission of cardiovascular safety data from the published literature is more deeply disturbing evidence of medicine run amok.

Previously confidential internal Merck documents produced in tort litigation demonstrate a profile of deception related to the ADVANTAGE trial. This profile of deception includes the following array of tactics: misleading participants on the intent of the trial; conveniently ignoring the relationship of findings to adverse events from other trials; changing standard operating procedures midcourse to mask unfavorable data; choosing analysis methods that aggregate unfavorable and favorable findings, thereby reducing significance of negative information; systematically violating the standard operating procedures; reclassifying individual adverse events to reduce negative implications; misleading the lead author of the resultant article; and repeatedly delaying provision of full trial information to the FDA, to avoid a potential mandated product label warning. These newly uncovered documents and the disturbing pattern of deception they present open a window into the conduct of the company and through it, open a window on pharmaceutical industry research practices. With the Federal Drug Administration estimating that this drug hurt or killed between 88,000 and 139,000 Americans (the equivalent of 500-900 jet crashes) the research practices of pharmaceutical companies become a significant public health issue. We present suggestions to prevent future data manipulation in for-profit research, and discuss the powerful nexus between drug policy, litigation, human rights, and access to information.

Learning Objectives:

• Describe the tactics used by a major pharmaceutical company to gain approval for an unsafe drug.
• Assess the public health impact of these actions.
• Analyze how human rights intersect with drug policy, information access, and litigation activities.
• Articulate strategies to prevent similar scenarios in the future.

Keywords: Drugs, People-Caused Deaths

Presenting author's disclosure statement:

Not Answered

Handout (.ppt format, 753.0 kb)