[The FDA's Vioxx shennanigans are parallel to the CDC's hiding of
thimerosal's adverse effects by means of deliberate data-dilution and
by willing collusion by the IOM, FDA, and AAP. -Teresa]

FDA report links Vioxx to 27,785 heart attacks, deaths Agency releases study, had been warned of risk before




Bloomberg News
November 3, 2004
http://www.baltimoresun.com/news/health/bal-
bz.merck03nov03,1,948633.story
<http://www.baltimoresun.com/news/health/bal-
bz.merck03nov03,1,948633.story?coll=bal-health-headlines>

WA$$$HINGTON - Merck & Co. Inc.'s recalled Vioxx painkiller may have
contributed to 27,785 heart attacks and deaths from 1999 through 2003
because of the drug's effects on the cardiovascular system, U.S.
regulators said in a report published online yesterday.

Vioxx caused more heart attacks and deaths from sudden cardiac arrest
than would have occurred if patients taking Vioxx were on Pfizer
Inc.'s
Celebrex, Food and Drug Administration researcher David J. Graham
concluded after analyzing 1.4 million patient records.

Merck's announcement of the Vioxx withdrawal, the biggest drug recall
ever, wiped out almost $27 billion of the stock's market value Sept.
30.

The Wall Street Journal reported Graham's estimate of deaths and
heart
attacks Oct. 6. The agency posted the findings online yesterday.

Merck withdrew Vioxx because of a three-year company study showing
that
patients taking it for more than 18 months faced twice the risk of a
heart attack as those taking a placebo.

The FDA and researchers for Kaiser, the largest U.S. nonprofit
insurer
with 8 million members, had presented the report's preliminary
findings
in August at a conference in France.

The study was based on an analysis of the records of 1.4 million
Kaiser
members in California. Graham compared the incidence of heart attacks
and sudden cardiac death for patients taking Vioxx with those on
Celebrex.

Based on 92.8 million U.S. prescriptions for Vioxx, also known as
rofecoxib, from 1999 to 2003, Graham estimated that 27,785 more
patients
taking the Merck product may have had heart attacks or sudden cardiac
death than among those on Celebrex, made by Pfizer Inc. of New York,
the
world's biggest drugmaker.

'Widespread exposure'

"The population impact of rofecoxib's increased risk is great because
of
the widespread exposure to the drug," said Graham, the FDA's
associate
director for science in the office of drug safety, in a report dated
Sept. 30.

"This illustrates the effect that even a relatively small increase in
risk can have if you're dealing with a serious outcome that is not
rare
in the general population" such as heart attacks and sudden cardiac
death.

About 20 million people in the United States tried the drug since its
1999 introduction, according to Merck, the No. 2 U.S. drugmaker.

"In general, there is no reliable way to measure the actual use of
Vioxx
in the population, and therefore no reliable way to estimate the
actual
events," said Chris Loder, a Merck spokesman. "Because heart attacks
and
strokes occur in the general population, one cannot say that if
someone
had an event while taking Vioxx, that Vioxx caused it."

Sought halt

Graham also had said in the report that Vioxx use should be halted.

"Prior to today, my conclusions regarding rofecoxib were that high-
dose
use of the drug should be ended and that lower- dose rofecoxib should
not be used by physicians or patients," Graham said.

"If lower-dose rofecoxib remained on the market, physicians and
patients
needed to understand that risk [of heart attacks and sudden cardiac
death] was substantially increased and that there were safer
alternatives."

Two congressional committees are questioning the FDA's actions to
ensure
the safety of Vioxx.

The New England Journal of Medicine released a letter Oct. 6 from the
Cleveland Clinic's chairman of cardiovascular medicine, Dr. Eric J.
Topol, saying Merck and the FDA ignored earlier studies showing that
Vioxx was linked to elevated risk of heart disease.

The FDA, which had told Merck in 2002 to include warnings about the
heart risks on the Vioxx label, never required the company to conduct
additional safety studies or curtail its marketing, Topol wrote.

"We are in a situation where there seems to be no end to negative
reaction for Merck, even if the news has been previously reported,"
said
analyst Ira Loss of Washington Analysis in Washington, which advises
institutional investors.

Merck's shares fell $1.48, or 5.2 percent, to close at $26.80
yesterday
on the New York Stock Exchange. The stock has plunged 42 percent this
year.

On Monday, Merck's shares fell 9.7 percent after The Wall Street
Journal
reported that the drugmaker tried for years to stop safety concerns
from
hurting Vioxx sales. The report was based on internal Merck documents
and marketing materials.

Alabama attorney Andrew Birchfield said yesterday that he turned over
company documents and statements obtained in litigation to U.S.
Senate
investigators probing the recall.

Liability exposure

Investors were trying to estimate the hit Merck may take from
lawsuits
over Vioxx. The company said Oct. 21 that it had about $630 million
in
product liability insurance and hadn't established reserves for Vioxx
litigation. Merck reported that more than 300 lawsuits had been filed
by
Oct. 15.

Standard & Poor's said Monday that it may downgrade Merck's triple-A
rating on corporate credit and senior unsecured debt because of
"increasing concern about the magnitude of possible litigation."

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