The message is ready to be sent with the following file or link
attachments:
Shortcut to:
http://www.canada.com/montreal/montrealgazette/news/editorial/story.html
?id=db9094bf-7df5-434a-82d6-a47d731d9f22
EDITORIAL
Editorial | Send a letter to the editor
Vioxx shows why we can't trust drug companies
JANET BAGNALL
The Gazette
Friday, October 15, 2004
With sales of $2.5 billion last year, Vioxx is the biggest-selling drug
any company has ever recalled. Some questions about Vioxx:
Would its manufacturer Merck & Co. have gone ahead with a clinical trial
of Vioxx if it had not thought it could sell the drug on two fronts, one
as a pain reliever and a newer, second one as a cancer-prevention agent?
Would Vioxx have known such huge commercial success without the benefit
of one of the biggest direct-to-consumer marketing campaigns ever
mounted for a prescription drug? (Between January and June this year
alone, Merck spent about $45 million advertising the drug.)
Did Vioxx control pain better than older, cheaper drugs?
The answer to all the questions is no.
A final question: Was it known that patients taking Vioxx faced an
increased risk of heart attacks and strokes? Yes. Evidence pointing to
problems was publicly available from the time Vioxx was approved, in
1999.
Why then did Vioxx become one of the biggest selling drugs ever?
Chalk it up to the terrifying power of marketing - power exerted in this
case over the consumer, the medical community and, worst of all, over
regulatory agencies such as the highly respected U.S. Food and Drug
Administration. (Prescription-drug advertising has grown into a
$3.8-billion-a-year business in the U.S. in the seven years since it has
been allowed. In Canada, it remains illegal for drug companies to
directly target the public.)
Vioxx seems to be an almost perfect example of systemic failure. It was
a case of drug development, approval and marketing gone horribly awry.
For starters, there has never been any evidence Vioxx is a more
effective pain reliever, or better anti-inflammatory agent, than
Aspirin, Motrin, Aleve or any other older drug.
What was purportedly different about Vioxx, one of a new class of
anti-inflammatory drugs called COX-2 inhibitors, was it was safer: A
2000 study showed Vioxx did better than a generic painkiller Naproxen in
not causing ulcers or stomach bleeding. But the same study showed more
heart attacks in Vioxx patients than in those taking Naproxen.
Merck, however, advanced - on no evidence - an alternative theory. It
said these results did not show Vioxx posed a risk, but rather Naproxen
provided a protective effect against heart problems. It didn't do any
such thing. In studies published in 2002, Naproxen was found not to have
a significant protective cardiovascular effect. The same studies showed
Vioxx posed an increased risk of heart-related problems.
Unfortunately for people taking Vioxx, official reaction to these
findings was, to put it charitably, muted. Health Canada, for example,
requested a small change to Vioxx labels to tell users of the risks.
Merck officials had disputed Vioxx studies, including its own, based on
patient records, saying the only definitive test is a clinical trial in
which a drug's effectiveness is measured against a placebo. Eager to
position Vioxx as a cancer protection, Merck conducted such a test. The
trial was designed to show whether Vioxx was more effective than a
placebo in preventing the recurrence of colon polyps.
Unfortunately for Merck, what the trial showed was Vioxx doubled the
risk of heart attack and strokes. As news of the study's finding broke
last month, Merck finally ordered the drug's removal from the
marketplace.
The moral of the Vioxx story is, regrettably, that consumers might not
want to put wholehearted trust in a drug manufacturer.
Vioxx is not the only case in point. Neurontin is another example: This
drug was approved by the FDA as an epilepsy drug. After it was
prescribed for a number of nonapproved uses such as migraine and
attention deficit disorder, it ballooned into a $2.5-billion-a-year
drug.
It was even prescribed for bipolar disorder, despite the fact the
manufacturer's clinical trials showed in some cases the drug might have
worsened the disorder's symptoms. In May, the manufacturer, the
Parke-Davis division of Warner-Lambert (now owned by Pfizer), pleaded
guilty to criminal fraud and was fined $430 million.
In the United States, a group of elected officials have proposed
legislation requiring the results of clinical trials be posted on the
National Institutes of Health Web site, with penalties of $10,000 a day
for failure to comply.
On the research end of things, editors of several of the world's most
prestigious medical journals are working toward requiring drug companies
register all trials before anything can be published on their products.
Canada, which continues to demonstrate a not-so-touching faith in the
power of advisories, should reconsider its stance. We, too, need a
legislated answer to the problem of insufficient or wrong information
about prescription drugs.
[log in to unmask]
C The Gazette (Montreal) 2004
Note: To protect against computer viruses, e-mail programs may prevent
sending or receiving certain types of file attachments. Check your
e-mail security settings to determine how attachments are handled.
|
