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VIOXX CASE MAY HELP ALTERNATIVE MEDICINE

Re: VIOXX CASE MAY HELP ALTERNATIVE MEDICINE -- Posted by Ilena Rose on 10-15-04 11:43

On Fri, 15 Oct 2004 10:03:22 -0700, "Katherine Wolfe"
wrote:

>> Those creeps who are deriving a perverse glee from this incident should
>> experience her pain for a few days.

You must be discussing your own Corporate "Merck Probert" Apologist
behavior and total lack of concern for the thousands of unnecessary
deaths that could have been avoided had Merck been honest about the
dangers of Vioxx years ago ... instead of making their billions and
paying flacks like you to help cover up their lies.

~~~ Thanks Kathi ~~~

PERSPECTIVE - Failing the Public Health - Rofecoxib, Merck, and the
FDA

Oct 07, 2004 12:20 PDT

PERSPECTIVE

Failing the Public Health - Rofecoxib, Merck, and the FDA

On May 21, 1999, Merck was granted approval by
the Food and Drug Administration (FDA) to market
rofecoxib (Vioxx). On September 30, 2004, after
more than 80 million patients had taken this medicine
and annual sales had topped $2.5 billion, the
company withdrew the drug because of an excess
risk of myocardial infarctions and strokes. This represents
the largest prescription-drug withdrawal in
history, but had the many warning signs along the
way been heeded, such a debacle could have been
prevented.
Neither of the two major forces in this fiveand-
a-half-year affair — neither Merck nor the FDA
— fulfilled its responsibilities to the public. The
pivotal trial for rofecoxib involved 8076 patients
with rheumatoid arthritis and demonstrated that
this coxib had lower gastrointestinal toxicity than
naproxen.
1
Even though the drug was approved in
1999 on the basis of data submitted to the FDA, the
data were not submitted to a peer-reviewed journal
until the following year and did not appear in
print until November 23, 2000, one and a half years
after commercial approval had been granted. The
cardiovascular data reported in that article were
incomplete, in part because of incomplete ascertainment:
the design and execution of the trial had
not anticipated that untoward cardiovascular events
might occur.
1
It was not until February 8, 2001, that the FDA
Arthritis Advisory Committee met to discuss concern
about the potential cardiovascular risks associated
with rofecoxib. It remains unclear why the
FDA waited two years after its review and approval
of rofecoxib to conduct this meeting. My colleagues
and I reviewed the data from the meeting that were
made publicly accessible and published an analysis
of all the available data on rofecoxib and celecoxib
on August 22, 2001.
2
Our primary conclusion,
based on the clear-cut excess number of myocardial
infarctions associated with rofecoxib and the
numerical, albeit not statistically significant, excess
associated with celecoxib, was that “it is mandatory
to conduct a trial specifically assessing cardiovascular
risk and benefit of these agents.”
2
Such
a trial needed to be conducted in patients with established
coronary artery disease, who frequently
have coexisting osteoarthritis requiring medication
and have the highest risk of further cardiovascular
events. Given the very high coincidence of coronary
disease and arthritis, this group may represent
the largest segment of the population for whom
rofecoxib was prescribed. In light of the insight
that arterial inflammation is the basis for myocardial
infarction and stroke and the knowledge that
coxibs reduce the production of biomarkers of inflammation
such as C-reactive protein and improve
endothelial function, such a trial would also have
been quite attractive from the standpoint of potential
benefit. The trial would have prospectively
determined the incidence of cardiovascular events,
whose possible association with coxib treatment
had not been anticipated in the early and pivotal
trials of these drugs.

Unfortunately, such a trial was never done. The
FDA has the authority to mandate that a trial be
conducted, but it never took the initiative. Instead
of conducting such a trial at any point — and especially
after the FDA advisory committee meeting in
2001 — Merck issued a relentless series of publications,
beginning with a press release on May 22,
2001, entitled “Merck Reconfirms Favorable Cardiovascular
Safety of Vioxx” and complemented by
numerous papers in peer-reviewed medical literature
by Merck employees and their consultants. The
company sponsored countless continuing medical
“education” symposiums at national meetings in
an effort to debunk the concern about adverse cardiovascular
effects. The message that was duly re-inforced was
that rofecoxib had no cardiovascular
toxicity: rather, naproxen was cardioprotective.
Only by happenstance, in a trial involving 2600 patients
with colon polyps who could not have been
enrolled if they had had any cardiovascular disease,
was it discovered that 3.5 percent of the patients
assigned to rofecoxib had myocardial infarction or
stroke, as compared with 1.9 percent of the patients
assigned to placebo (P<0.001), necessitating premature
cessation of the trial and the decision to
discontinue treatment with rofecoxib.
Over the course of the five-and-a-half-year saga,
many epidemiologic studies confirmed and amplified
the concern about the risk of myocardial infarction
and serious cardiovascular events associated
with rofecoxib.3

These studies considered
large populations, up to 1.4 million patients, tracking
the use of various nonsteroidal antiinflammatory
medications or coxibs to determine the risk of
adverse events. Each time a study was presented or
published, there was a predictable and repetitive response
from Merck, which claimed that the study
was flawed and that only randomized, controlled trials
were suitable for determining whether there
was any risk. But if Merck would not initiate an appropriate
trial and the FDA did not ask them to do
so, how would the truth ever be known?
Meanwhile, Merck was spending more than
$100 million per year in direct-to-consumer advertising
— another activity regulated by the FDA
and a critical mechanism in building the “blockbuster”
status of a drug with annual sales of more
than $1 billion. For the past few years, every month
has seen more than 10 million prescriptions for rofecoxib
written in the United States alone. At any
point, the FDA could have stopped Merck from using
direct-to-consumer advertising, especially given
the background concern that the cardiovascular
toxicity was real and was receiving considerable
confirmation in multiple studies conducted by investigators
who were independent of Merck. The
only significant action taken by the FDA occurred
on April 11, 2002, when the agency instructed Merck
to include certain precautions about cardiovascular
risks in its package insert. The FDA also sponsored
one of the large epidemiologic studies performed
in a cohort of Kaiser Permanente patients.
Considering the tens of millions of patients
who were taking rofecoxib, we are dealing with an
enormous public health issue. Even a fraction of
a percent excess in the rate of serious cardiovascular
events would translate into thousands of affected
people. Given the finding in the colon-polyp
trial in low-risk patients without known cardiovascular
disease — an excess of 16 myocardial infarctions
or strokes per 1000 patients — there
may be tens of thousands of patients who have had
major adverse events attributable to rofecoxib (see
Figure).

I believe that there should be a full Congressional
review of this case. The senior executives at
Merck and the leadership at the FDA share responsibility
for not having taken appropriate action and
not recognizing that they are accountable for the
public health. Sadly, it is clear to me that Merck’s
commercial interest in rofecoxib sales exceeded its
concern about the drug’s potential cardiovascular
toxicity. Had the company not valued sales over
safety, a suitable trial could have been initiated rapidly
at a fraction of the cost of Merck’s direct-toconsumer
advertising campaign. Despite the best
efforts of many investigators to conduct and publish
meaningful independent research concerning
the cardiovascular toxicity of rofecoxib, only the
FDA is given the authority to act. In my view, the
FDA’s passive position of waiting for data to accrue
is not acceptable, given the strong signals that there
was a problem and the vast number of patients who
were being exposed. Furthermore, the tradeoff here
involved a drug for symptoms of arthritis, for which
many alternative medications are available, in the
context of serious, life-threatening cardiovascular
complications. Certainly there are many facts that
we are not privy to, such as the direct communication
between the FDA and Merck, but all the facts
can and should be scrutinized closely in a Congressional
review in order to avert such a catastrophe in
the future.
From the Cleveland Clinic Foundation, Cleveland.
1.
Bombardier C, Laine L, Reicin A, et al. Comparison of upper
gastrointestinal
toxicity of rofecoxib and naproxen in patients with
rheumatoid arthritis. N Engl J Med 2000;343:1520-8.
2.
Mukherjee DM, Nissen SE, Topol EJ. Risk of cardiovascular
events associated with selective COX-2 inhibitors. JAMA 2001;
286:954-9.
3.
Topol EJ, Falk GW. A coxib a day won’t keep the doctor away.
Lancet 2004;364:639-40.

Re: VIOXX CASE MAY HELP ALTERNATIVE MEDICINE -- Posted by Mark Probert on 10-15-04 13:17

"Ilena Rose" wrote in message
news:ni60n05qinp3tecp9j3hon1vembgt9fpia@4ax.com...
> On Fri, 15 Oct 2004 10:03:22 -0700, "Katherine Wolfe"
> wrote:
>
> >> Those creeps who are deriving a perverse glee from this incident should
> >> experience her pain for a few days.
>
>
> You must be discussing your own Corporate "Merck Probert" Apologist
> behavior and total lack of concern for the thousands of unnecessary
> deaths that could have been avoided had Merck been honest about the
> dangers of Vioxx years ago ... instead of making their billions and
> paying flacks like you to help cover up their lies.

Wrong, Suzerain of Selective Snipping. I was discussing this, which you
snipped:

"I was in the pharmacy a few days after it was pulled. This elderly woman,
leaning on her quad cane, was pleading with the pharmacist to renew her
Vioxx prescription. She said she would rather risk a heart attack than be in
the pain she had been in before she started on Vioxx. Nothing else worked as
well."

Yes, once again you prove that you are an intellectually bankrupt coward
whose reality check is vulcanized.

Re: VIOXX CASE MAY HELP ALTERNATIVE MEDICINE -- Posted by Ilena Rose on 10-15-04 14:05

On Fri, 15 Oct 2004 20:17:03 GMT, "Mark Probert" Probert@lumbercartel.com> wrote:

>She said she would rather risk a heart attack than be in
>the pain she had been in before she started on Vioxx.

That doesn't take away from the fact of the thousands who did NOT have
the choice to choose because of the hidden results, Merck Probert.

Re: VIOXX CASE MAY HELP ALTERNATIVE MEDICINE -- Posted by Mark Probert on 10-15-04 14:38

"Ilena Rose" wrote in message
news:bse0n0hgaj054hr9ku7p2ada3vg0dess0e@4ax.com...
> On Fri, 15 Oct 2004 20:17:03 GMT, "Mark Probert"
> Probert@lumbercartel.com> wrote:
>
> >She said she would rather risk a heart attack than be in
> >the pain she had been in before she started on Vioxx.
>
> That doesn't take away from the fact of the thousands who did NOT have
> the choice to choose because of the hidden results, Merck Probert.

> >> Those creeps who are deriving a perverse glee from this incident should
> >> experience her pain for a few days.

Re: VIOXX CASE MAY HELP ALTERNATIVE MEDICINE -- Posted by Ilena Rose on 10-15-04 12:10

Re: VIOXX CASE MAY HELP ALTERNATIVE MEDICINE -- Posted by David Wright on 10-15-04 18:18

In article ,
Katherine Wolfe wrote:
>
>"Mark Probert" wrote in message
>news:98Sbd.12336$Fe6.5271238@news4.srv.hcvlny.cv.net...
>
>> I was in the pharmacy a few days after it was pulled. This elderly
>> woman, leaning on her quad cane, was pleading with the pharmacist
>> to renew her Vioxx prescription. She said she would rather risk a
>> heart attack than be in the pain she had been in before she started
>> on Vioxx. Nothing else worked as well.
>>
>> Those creeps who are deriving a perverse glee from this incident
>> should experience her pain for a few days.
>
>Vioxx worked fabulously for me. I had some wierd side effects from
>it, and had to switch, but I can definitely see how someone might get
>better relief from that than from another AI. Too bad this lady has
>to go the rounds of recently released medications *again* to see if
>she can find something that will work for her.

I tried it for a week last year for some pains I was having in my feet
(a 1-week sample from my podiatrist). Man, that stuff *works*. I was
really impressed.

Fortunately, my feet have long since stopped hurting, but it was a
very nice one-week break back then.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)

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