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More questions raised about Vioxx

Pharma Compliance Alert, August 27, 2008

For the second time this year, Merck is facing criticism from a prominent medical journal about its research for withdrawn pain reliever Vioxx.

Merck framed marketing as science and endangered patients in 1999 when it disguised a marketing program as a scientific trial, according to an article in the Annals of Internal Medicine.

According to the article, Merck’s marketing division created the ADVANTAGE clinical trial in January 1999, before Vioxx was approved. Instead of collecting useful scientific data, ADVANTAGE was a seeding trial, designed to create positive experiences with Vioxx prior to its approval.

Merck said the study was to determine whether Vioxx users had fewer stomach complaints than patients on other pain medications. The company did not reveal the key role of its marketing division and the marketing objectives of the study to investigators, participants, or to the FDA. The company referred to the study as a seeding trial in internal documents.

Seeding trials have some positive benefits, but, the authors added, “The undisclosed use of research by corporate marketing divisions threatens the integrity of the relationship of industry, academia, patients, and society.”

In April, the Journal of the American Medical Association (JAMA) criticized Merck of writing its own articles about Vioxx, then paying physicians to put their names on the articles. Another JAMA article claimed Merck failed to disclose an internal analysis that found Alzheimer’s patients taking Vioxx had a three times greater risk of death than patients taking a placebo.

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