Fwd: Vioxx, the implosion of Merck, and aftershocks at the FDA

[Guest guest]

http://www.thelancet.com/journal/vol364/iss9447/full/llan.364.9447.ear

ly_online_publication.31245.1

Published online November 5, 2004.

The Lancet comment today, by Editor, Horton

Vioxx, the implosion of Merck, and aftershocks at the FDA

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withdrawn from the market by its manufacturer, Merck.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 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, 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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Sheri Nakken, R.N., MA, Classical Homeopath

http://www.nccn.net/~wwithin/vaccine.htm

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