E-DRUG: Vioxx withdrawal (2)
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[The Vioxx withdrawal has taken the stock market by surprise (27 billion USD off Merck's value!) but potential problems with Vioxx had been raised several times before.
Remember the court case of Merck in Spain against Prof. Laporte? E-drug reported this on 23 January 2004. Laporte eon the case against Merck.
Below another message on an early warning. WB]
Dear E-druggers,
Below is our media release from yesterday and a report published in the
Sydney Morning Herald this morning.
regards,
Peter
Dr Peter R Mansfield
Director, Healthy Skepticism Inc
Countering misleading drug promotion.
peter@healthyskepticism.org
www.healthyskepticism.org
34 Methodist St, Willunga SA 5172 Australia
Media release: Immediate
Friday 1 October 2004
Vioxx withdrawal: Healthy Skepticism warned doctors 4 years ago!
Late yesterday Merck & Co. announced the worldwide withdrawal of VioxxR
(rofecoxib) because it causes heart attacks and strokes. Vioxx is one of
three new anti-inflammatory drugs called COX-2 inhibitors introduced during
the past 5 years that have become dramatically overused for arthritis
because of misleading promotion.
Dr Peter R Mansfield is Director of Healthy Skepticism, a GP and Research
Fellow at the University of Adelaide. Dr Mansfield said 'Healthy Skepticism
warned back in 2000 that the promotion of these drugs was misleading'.
(See: www.healthyskepticism.org/editions/2000/IN0004.htm )
'In July 2003 we recommended that these drugs be removed from the Australian
Pharmaceutical Benefits Scheme because they do more harm than good. By
contrast, drug companies have been promoting these COX-2 drugs as safer than
older anti-inflammatory drugs. Most doctors have been fooled. Had our
warnings been heeded, heart attacks and strokes would have been avoided as
well as saving the taxpayer hundreds of millions of dollars.'
He said 'Other drugs in the same class, Celebrex (celecoxib) and Mobic
(meloxicam), should also be regarded as too dangerous to use unless they can
be proven to be no worse than cheaper older anti-inflammatory drugs such as
ibuprofen.'
During the 4 financial years July 2000 to June 2004, Vioxx cost the taxpayer
$274,508,021. During the same period Celebrex cost the taxpayer $470,836,299
(source: Health Insurance Commission website www.hic.gov.au )
Dr Mansfield recommends that 'Everyone taking any of these drugs should stop
them immediately and consult their doctor. Paracetamol often provides
adequate relief of arthritis pain if used in adequate doses: at least two
500mg tablets twice a day. When paracetamol is not enough, older
anti-inflammatory drugs such as ibuprofen can be used to boost the effect of
paracetamol. Glucosamine has been less well studied but may be more
beneficial for long term use.'
Healthy Skepticism is an international research, education and advocacy
organisation that aims to improve health by reducing harm from misleading
drug promotion. Healthy Skepticism is based in South Australia.
(see: www.healthyskepticism.org ).
Healthy Skepticism Director Dr Peter R Mansfield is available for interview
today Friday 1 October 2004 on: 08 8556 4481, international +61 8 8556 4481.
Healthy Skepticism Inc
ABN 43 390 138 359
Arthritis drug link to heart ailments
By Ruth Pollard, Health Reporter
Sydney Morning Herald
October 2, 2004
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The sudden withdrawal of the arthritis drug Vioxx because of evidence it
increases the risk of heart attacks and strokes has forced the makers of a
rival treatment to defend its safety.
At least 300,000 arthritis sufferers around Australia are affected by the
withdrawal, which followed the release of results from a three-year clinical
trial that linked Vioxx to an increased risk of cardiovascular incidents.
The US pharmaceutical giant Merck, Sharp and Dohme announced the immediate
voluntary worldwide withdrawal of the drug on Thursday night, saying it was
"in the best interests of the patient".
The chief medical officer at the Therapeutic Goods Administration, John
McEwan, said the medicines regulator had been monitoring Vioxx and had
alerted doctors in October 2003 to some evidence of increased risk of
cardiovascular and cerebrovascular disease.
"The TGA recommends that patients stop taking Vioxx," Dr McEwan said. "We
have had a small number of reports in Australia of heart attacks and strokes
associated with it."
The rival drug company Pfizer was quick to reassure patients about the
safety of its drug. It makes Celebrex, another COX-2 inhibitor with a
similar chemical makeup to Vioxx.
"Pfizer Australia is confident in the long-term cardiovascular safety of
Celebrex, based on a large body of clinical evidence," senior medical
director Bill Ketelbey said in a statement.
Both drugs have been widely used to treat rheumatoid arthritis and
osteoarthritis. Vioxx was first approved for use in June 1999. A Merck
spokeswoman said it had made $84 million in Australian sales in 2003.
As thousands of worried patients contacted their doctors yesterday and the
scramble for alternative treatments began, concerns emerged over whether the
risk associated with Vioxx might also be present in other drugs in the same
class.
"There is a question mark over the class of drugs. We don't really know if
it is the molecule in Vioxx or a class effect," said Ric Day, a professor of
clinical pharmacology at St Vincent's Hospital, who has been an advisory
board member for Merck and Pfizer.
"There is not an equivalent study with Celebrex looking at as many people
for as long," Professor Day said.
He recommends the reassessment of the need for this class of drug, and
suggests patients look to non-drug options and simpler drugs such as
paracetamol.
The COX-2 inhibitors are often viewed as no better than ibuprofen or
paracetamol for pain relief, but are far more expensive than the older
drugs.
The medical director at the Arthritis Foundation of Australia, Graeme Jones,
said the longest Celebrex trial had been 12 months. Although the available
evidence shows it is "reasonably safe ... we can't be confident" about its
long-term safety, he said.
A South Australian GP, Peter Mansfield, who runs the Healthy Skepticism
website exposing pharmaceutical marketing techniques, said he suggested
Vioxx be removed from the benefits scheme in mid-2003.