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Good Riddance to Bad Drug: VIOXX
Good Riddance to Bad Drug: VIOXX -- Posted by fresh~horses on 10-02-04 09:38
NY Times
October 2, 2004
OP-ED CONTRIBUTOR
Good Riddance to a Bad Drug
By ERIC J. TOPOL
Cleveland - After three years of denying that the
arthritis drug Vioxx
could induce heart attacks and strokes, this week
Merck bowed to
reality: it withdrew Vioxx from the market.
The impact of this decision is far-reaching, and not
only because tens
of millions of people have tried Vioxx. It also
highlights the absence
of Food and Drug Administration oversight of the
pharmaceutical industry
as well as the lack of comprehensive long-term studies
of not only Vioxx
but its entire class of arthritis drugs.
In 2001, I was part of a team from the Cleveland
Clinic that published a
paper demonstrating the significant heart attack risk
of Vioxx. Our
research, published in The Journal of the American
Medical Association,
found that compared to naproxen, a commonly used
over-the-counter
anti-inflammatory drug with similar benefits, Vioxx
has a five times
greater heart attack risk. In response, Merck claimed
that early
conclusions about the risk were flawed, and attributed
the comparatively
high heart attack rates to an unproven protective
effect of naproxen.
Our study was followed by several others demonstrating
Vioxx's dangers.
Each time Merck had a similar reply: the study was
"flawed."
Merck finally had to acknowledge the truth, but only
by accident. The
company undertook a large, randomized trial of 2,600
patients with colon
polyps in hopes of proving that Vioxx could help their
condition. In the
process, though, Merck discovered that 3.5 percent of
patients taking
Vioxx suffered heart attacks or strokes as against 1.9
percent taking a
placebo. Merck at last did the right thing by
voluntarily and abruptly
taking Vioxx off the market.
There are two important issues to consider here.
First, the risk of
heart attack or stroke found in the Merck study, at 15
cases per 1,000
patients, may be greatly underestimated. Merck's trial
did not include
anyone with known heart disease - patients who might
be expected to have
the highest risk.
And the problem may extend beyond Vioxx and its users.
While it's true
that when compared to the other Cox-2 inhibitors,
Vioxx has repeatedly
carried a far greater risk of heart attack and stroke,
none of the
manufacturers of Vioxx's class of drugs, called Cox-2
inhibitor agents,
have studied patients who already have heart disease.
The number of
patients who may have sustained heart attack or stroke
as a result of
using these drugs could be tens of thousands. It would
be premature to
conclude that the other drugs still on the market,
like Celebrex and
Bextra, do or do not carry some risk of heart attack
until sufficient
testing is done.
While we remain in this zone of uncertainty, people
with arthritis
should remember that conventional over-the-counter
agents like naproxen
(as in Aleve) or ibuprofen (as in Advil) work
extremely well, are much
cheaper than the Cox-2 agents, and are not known to
have any risk of
heart attacks. In addition, one of the most-cited
benefits of the Cox-2
agents - that they are less likely to cause stomach
ulcers than
over-the-counter drugs - may been grossly exaggerated.
Second, and what may be more alarming, is that despite
studies showing
the magnitude of the public health problem, for
several years Merck did
nothing to investigate. This surely represents a
conflict between the
interests of the public and the interests of a company
with a
blockbuster drug that had sales of $2.5 billion in
2003.
Instead of doing the requisite research in patients
with heart disease -
who frequently have arthritis as well and are thus
prime users of
anti-inflammatory medicines - the company undertook
studies that avoided
them. At the same time, Merck spent at least $100
million a year for
direct-to-consumer Vioxx advertising, while the
company's employees and
their consultants published several papers in medical
journals rebutting
studies reporting Vioxx's heart attack risk. The Food
and Drug
Administration could have forced Merck to do the
appropriate research
studies, but instead it was a bystander.
As the Vioxx debacle shows, we have a long way to go
in this country to
get on track with prescription medications. Most
important, we need a
stronger regulatory agency to compel pharmaceutical
companies to do the
proper studies and force these companies to stop
direct-to-consumer
advertising unless a drug has major benefits for
patients and negligible
increased risk of heart attacks and strokes.
Our two most common deadly diseases should not be
caused by a drug.
Eric J. Topol is chairman of the department of
cardiovascular medicine
at the Cleveland Clinic.
Re: Good Riddance to Bad Drug: VIOXX -- Posted by bewellkel on 10-02-04 17:47
fresh~horses@despammed.com (fresh~horses) wrote in message news:...
> NY Times
>
> October 2, 2004
> OP-ED CONTRIBUTOR
> Good Riddance to a Bad Drug
> By ERIC J. TOPOL
>> Second, and what may be more alarming, is that despite
> studies showing
> the magnitude of the public health problem, for
> several years Merck did
> nothing to investigate. This surely represents a
> conflict between the
> interests of the public and the interests of a company
> with a
> blockbuster drug that had sales of $2.5 billion in
> 2003.
> The Food
> and Drug
> Administration could have forced Merck to do the
> appropriate research
> studies, but instead it was a bystander.
> Eric J. Topol is chairman of the department of
> cardiovascular medicine
> at the Cleveland Clinic.
Amen! Amen to most of the rest of what you reprinted as well. Topol
has the credentials, too, if you are into that sort of thing.
Our reliance on FDA-approved drugs has brought us to where those drugs
are the 4th leading cause of death in the US. They also result in at
least 1.6 million hospitalizations each year.
So it cracks me up when the FDA, and its supporters worry so much
about the safety of herbs and other supplements. Yeah, the FDA drugs
have been tested. They passed the tests. But the tests end up being
about as worthless as Kerry's global tests.
Kelley
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