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7th January 2005
Medical experts now believe up to 160,000 people
suffer Vioxx damage. With thousands of cases expected & multiple
government probes underway, one analyst estimates Merck could face
legal damages totaling over $50 billion.
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LONDON, ENGLAND
Vioxx, the painkiller withdrawn
from the market in late September because of potentially fatal side
effects, should have been pulled years ago, a new study suggests.
The
U.S. pharmaceutical giant Merck withdrew Vioxx – a popular arthritis
drug that was one of its top-selling products – from the market on
Sept. 30 after evidence linked it to heart problems.
Now Swiss researchers say Vioxx "should have
been withdrawn several years earlier," in a new analysis
published online Thursday by the British journal The Lancet.
The University of Bern researchers pooled results
from 29 studies of Vioxx and found that people who took it had more
than double the risk of heart attack than those given dummy pills or
other painkillers.
Dr. Richard Horton, Lancet editor, accused both the
U.S. drug regulator and Merck of "ruthless, short-sighted and
irresponsible self-interest," according to the BBC.
It was the second report within days alleging
Vioxx's manufacturer knew about the drug's problems much earlier than
it admitted.
Merck's stock plunged nearly 27 per cent and its
stock market valuation dropped by $28 billion US after the
announcement.
Now analysts say Merck could face liabilities in the
tens of billions of dollars
because of Vioxx, in part because the
company stands accused – as in the Swiss study – of having known
about the drug's failings years earlier.
Richard Evans, an analyst at Sanford C. Bernstein
Research estimates Merck's legal costs could reach $12 billion.
Investment bank Merrill Lynch says Merck's liability
could be as high as $17.6 billion, based on an estimated 51,000
potentially successful lawsuits by patients claiming heart attacks or
strokes.
Plaintiffs' lawyers said there have been at least
700 Vioxx-related lawsuits filed against Merck so far, and one analyst
estimated the number at over 1,000. Merck said 300 suits had been
filed.
Merck insisted it had acted responsibly and
appropriately in the way it developed and marketed Vioxx.
"Merck was vigilant in monitoring and
disclosing the cardiovascular safety of Vioxx and we absolutely
disagree with any implication to the contrary," the company said.
The
company added it disagreed "that the data from the meta-analysis
published in The Lancet indicate that Vioxx should have been withdrawn
from the market several years earlier."
Written
by CBC News Online
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Scientific evidence of increased
heart attack risk associated with popular arthritis drug Vioxx was
available as early as 2000, say Swiss scientists, although the drug
was only withdrawn in September 2004.
Merck & Co, Inc, pulled its product from the
market on 30 September after participants in a clinical trial of
Vioxx’s effects on colon cancer started to show increased risk of
heart attack.
But after analysing the results from 18 random
clinical trials and 11 observational studies - many completed before
2001 - Peter Juni at the University of Berne, Switzerland, and his
colleagues believe that the decision could have been made much
earlier.
“If we can do this kind of analysis, it’s
difficult to see why it wasn’t done by the drug company or the
licensing authorities years ago,” says co-author Matthias Egger.
By the time it was withdrawn, an estimated 80
million people worldwide had taken Vioxx (rofecoxib). A memo posted by
the US Food and Drug Administration (FDA) on its website on 2 November
2004 suggests that Vioxx may have contributed to almost 28,000 heart
attacks in the US between 1999 and 2003.
But Merck dismissed the validity of the new study,
published on Friday, saying Merck had been “vigilant in monitoring
and disclosing the cardiovascular safety of Vioxx and that the company
absolutely disagrees with any implication to the contrary”. A
scientific critique, published by Merck in response, questions the
methodology of the new study.
Questions of interpretation
Indications of Vioxx’s potential risks surfaced in
2000 from Merck’s study of the drug’s gastrointestinal side
effects, dubbed VIGOR, say the Swiss team. The study compared Vioxx
with naproxen, another type of non-steroidal anti-inflammatory drug (NSAID)
used to treat arthritis.
VIGOR found that participants on Vioxx were five
times more likely to have a heart attack than those on naproxen.
However, the result was interpreted as a reflection of naproxen’s
protective effect on heart health because, like aspirin, it reduces
blood clotting.
“Naproxen would have had to reduce the risk of
myocardial infarction by 80% to have explained their results. If that
were true, I think we would know about that by now,” says Egger.
Juni and his colleagues pulled studies from
published and unpublished trials from the FDA’s database. All
together they represented more than 20,000 patients. They found a
two-fold increase in heart attack risk. And this was not dependent on
dose.
They also found no evidence to suggest that short
exposures to Vioxx were without risk - contrary to the previous
suggestion that heart attack risk increased only with long-term use.
“Health catastrophes”
Furthermore, Egger suggests that many participants
in Vioxx trials were at much lower risk of cardiovascular disease than
the elderly population who generally uses arthritis medication. Given
a representative population’s profile, Vioxx could raise the risk of
heart attacks by up to eight times, they suggest.
But Merck says the study’s conclusions are
“based on an analysis that violates the basic principle of
meta-analyses to combine ‘like with like’”. It asserts that the
“inappropriate combining” of data by the team “invalidates the
results and conclusions” of their analysis.
In a commentary accompanying The Lancet
article, editor Richard Horton calls the licensing and use of Vioxx
“public health catastrophes”, and called for further
investigations.
“Why clinical investigators studying Vioxx did not
do more to raise concerns is a fair question that needs to be
answered,” he writes. “But in doing so, we must not diminish the
importance of the covenant of trust that society has established with
powerful commercial and governmental institutions. For with Vioxx,
Merck and the FDA acted out of ruthless, short-sighted, and
irresponsible self-interest.”
Journal
reference: The Lancet (early online publication)
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