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Attorney General Gansler Enters into Consent Decree
with Merck Resolving an Investigation into the Marketing of Vioxx
Judgment Requires Merck to Improve its Disclosure of Potentially
Dangerous Side Effects
BALTIMORE, MD (May
20, 2008) - Attorney General Gansler’s
Consumer Protection Division today filed a Complaint in the Circuit
Court for Baltimore City, as well as a Final Judgment and Consent
Decree with Merck & Company, Inc. that resolves an investigation
by 30 states concerning Merck’s deceptive promotion of the
drug Vioxx. The Complaint filed by Attorney General Gansler alleged
that Merck violated the Consumer Protection Act by failing to inform
consumers that the use of Vioxx could cause serious cardiovascular
side effects. Merck denied that allegation.
Attorney General Gansler
alleged that Merck engaged in deceptive “direct-to-consumer” (“DTC”)
advertising that misrepresented Vioxx’s cardiovascular risks.
Today’s Consent Decree requires Merck to seek Food and Drug
Administration (FDA) approval of all of its DTC television drug
advertisements and to wait for approval and comply with FDA comments
before running the advertisements. Merck also must comply with
any request by the FDA to delay DTC advertising for any new, Merck
pain-relieving drugs.
The Consent Decree
also addresses:
- Merck’s use
of scientific data when marketing drugs to doctors;
- Merck’s “ghost
writing” of articles and studies
that purportedly were written by independent researchers;
- Merck’s
disclosure of conflicts of interest when its paid promotional
speakers present information in supposedly “independent” Continuing
Medical Education; and,
- Conflicts of interest
in Merck sponsored Data Safety Monitoring Boards.
“Consumers have a right to know about the side effects that
their medications can cause,” said Attorney General Gansler. “This
judgment will help ensure that Merck provides that information
to consumers in the future.”
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