Today we publish results from a cumulative meta-analysis which show that
the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as
early as 2000-a full 4 years before the drug was finally withdrawn from the
market by its manufacturer, Merck.
http://www.thelancet.com/journal/vol364/iss9447/full/llan.364.9447.early_onl
ine_publication.31245.1
Published online November 5, 2004.
The Lancet comment today, by Editor, Richard Horton
Vioxx, the implosion of Merck, and aftershocks at the FDA
Richard Horton
See Articles
Summary
Today we publish results from a cumulative meta-analysis which show that
the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as
early as 2000-a full 4 years before the drug was finally withdrawn from the
market by its manufacturer, Merck. This discovery points to astonishing
failures in Merck's internal systems of post-marketing surveillance, as
well as to lethal weaknesses in the US Food and Drug Administration's
regulatory oversight. In a recent Editorial, we commended Merck for acting
promptly in the face of new findings about the safety of Vioxx. Our praise
was premature. The evidence showing that Vioxx caused significant adverse
events was apparent well before data from the APPROVe trial triggered
Merck's overdue intervention. This week's report by Peter Jüni and
colleagues will add significant weight to ongoing litigation against Merck
by patients who believe they were harmed by this drug.
These findings also come in the wake of new disclosures that suggest Merck
was indeed fully aware of Vioxx's potential risks by 2000. Investigations
by the Wall Street Journal have revealed e-mails that confirm Merck
executives' knowledge of their drug's adverse cardiovascular profile-the
risk was "clearly there", according to one senior researcher. Merck's
marketing literature included a document intended for its sales
representatives which discussed how to respond to questions about Vioxx-it
was labelled "Dodge Ball Vioxx". Given this disturbing contradiction-
Merck's own understanding of Vioxx's true risk profile and its attempt to
gloss over these risks in their public statements at the time-it is hard to
see how Merck's chief executive officer, Raymond Gilmartin, can retain the
confidence of the public, his company's most important constituency.
The FDA's position is no less comfortable. The public expects national drug
regulators to complete research, such as that published by Jüni and
colleagues, in their ongoing efforts to protect patients from undue harm.
But, too often, the FDA saw and continues to see the pharmaceutical
industry as its customer-a vital source of funding for its activities-and
not as a sector of society in need of strong regulation.
Published online November 5, 2004.
http://image.thelancet.com/extras/04cmt396web.pdf (36kb)
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