FDA Study Faults Merck's Vioxx - 27,000 deaths

[Guest guest]

The true number is probably much greater.

 

 

 

SSRI-Research@

Wed, 6 Oct 2004 10:45:43 -0400

[sSRI-Research] Report: FDA Study Faults Merck's Vioxx -

27,000 deaths

 

 

Biotech/Pharmaceuticals

 

Report: FDA Study Faults Merck's Vioxx

 

By TSC Staff

10/6/2004 8:33 AM EDT

URL: http://www.thestreet.com/stocks/biotech/10186419.html

 

 

An unreleased Food and Drug Administration study reportedly concludes

that Merck's (MRK:NYSE) recently recalled arthritis drug Vioxx may

have been responsible for more than 27,000 heart attacks and sudden

cardiac deaths in recent years.

 

An FDA study covering the time of Vioxx's approval in 1999 through

2003 concluded that the health episodes could have been avoided if

patients had instead used rival Pfizer's (PFE:NYSE) Celebrex drug,

according to a report in The Wall Street Journal.

 

Word of the study, which covered some 66,000 patients who had used one

or the other drug, comes a week after Merck's stunning decision to

voluntarily withdraw its No. 2 drug over heart safety concerns, a move

that knocked 27% off the drugmaker's share price in one day.

 

Merck's decision, although unwelcome to investors, was seen as a

highly responsible and ethical move, whose execution also received

high marks by crisis management experts.

 

The market withdrawal came less than a month after a published

FDA-sponsored study concluded that Vioxx put users at a greater risk

of heart attacks than those using Celebrex. The study said people

using Merck's arthritis drug had a 50% greater chance of heart attacks

and sudden cardiac death.

 

In the past week, Pfizer has repeatedly vouched for the safety and, by

implication, the superiority of Celebrex.

 

In issuing the withdrawal, Merck said its decision to pull Vioxx was

based on new, three-year data from a clinical trial that had just

become available to the company.

 

In a statement that day, the FDA said that the " risk that an

individual patient taking Vioxx will suffer a heart attack or stroke

related to the drug is very small, " but said users should still

contact their physicians.

 

Merck shares fell 48 cents, or 1.4%, to $32.95 in premarket trading.