Lancet publishes study results

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And to think the FDA was concerned about the deadly herb ma huang

and tryptophan .............

 

The Lancet publishes study results linking Vioxx to heart disease

Candace Hoffmann

 

01/25/2005

 

An FDA-sponsored study appearing in The Lancet suggests that Merck's

Vioxx (rofecoxib) may be linked to more cases of serious heart

disease and deaths in the US than previously estimated, the

Financial Times and other news sources report. Earlier this month,

the agency cleared the study's publication, parts of which have

already been made public.

 

Dr. David Graham, the FDA's associate director of science in the

agency's Office of Drug Safety, and his colleagues, analysed data

from 1.4 million patient records in California who had used Vioxx,

Pfizer's Celebrex (celecoxib), and other NSAIDs between 1999 and

September 2002. Of this patient population, 8143 people had serious

heart disease, 1508 of which had sudden cardiac death, BBC News and

other news sources report.

 

Vioxx was associated with a 34 percent higher risk of coronary heart

disease compared with those people taking other NSAIDs. Compared

with Celebrex, Vioxx users who took a standard dose of the COX-2

drug had 1.6 times the risk of coronary heart disease, and at higher

doses, 3.6 times the risk over Celebrex.

 

Extrapolating the data out to a larger population, Graham and his

colleagues concluded: " An estimated 88,000 to 140,000 excess cases

of serious coronary heart disease probably occurred in the USA over

the market life of rofecoxib. The US national estimate of the case-

fatality rate was 44 percent, which suggests that many of the excess

cases attributable to rofecoxib use were fatal, " as reported in The

Independent and other news sources.

 

But Merck spokesman Christopher Loder disagreed with the

findings. " An estimate of harm from Vioxx is speculation.

Determination of whether Vioxx was responsible for any patients'

[heart attack] or stroke can only be made on a case-by-case basis, "

he said, The Chicago Tribune reports.

 

Asked if the US extrapolation of the data might also apply to the

Canadian population where IMS Health says over 15 million

prescriptions for Vioxx have been written since 1999, Graham said

that it could. He estimates that in Canada, Vioxx might be

associated with as many as 4000 to 7000 deaths, The Globe and Mail

reports. In the UK, where the drug was prescribed to 400,000

patients, experts estimate nearly 1000 people may have developed

heart failure as a result of taking Vioxx, The Scotsman

reports.

 

But Muhammad Mamdani, a senior scientist with the Institute for

Clinical Evaluative sciences, notes that Graham's estimates " seem a

bit more like back-of-the envelope calculations. " " Do I believe

those numbers? Not really, " he said, The Globe and Mail

reports. " They could be higher or they could be lower. It's

dangerous to extrapolate a number from the

data. "