Ayurveda - VIOXX CASE MAY HELP ALTERNATIVE MEDICINE

Author

VIOXX CASE MAY HELP ALTERNATIVE MEDICINE

Dr. Jai Maharaj

2004-10-12, 7:11 pm

Vioxx case may help alternative medicine

By Jim Warren
Herald-Leader Staff Writer
The Lexington Herald-Leader
Tuesday, October 12, 2004

The recent, unexpected demise of the popular anti-
inflammatory drug Vioxx -- and subsequent concerns that
were raised about similar drugs last week -- could boost
the already growing nationwide interest in complementary
and alternative medicines, two area physicians say.

"I think that, hopefully, this will be a wake-up call for
the general public," said Dr. James Roach of Midway. "I
don't think the public fully recognizes how dangerous
some of these drugs can be."

Dr. Edwards Smith, president of the Maharishi college of
Vedic Medicine in Lexington, agrees.

"When you ask patients out there, they've sort of had it
up to here with harmful drug side effects," Smith said.
"The appeal of natural medicines is that they don't have
the harmful side effects, and in many cases they may be
just as effective as prescription drugs."

Vioxx, a hugely popular treatment for arthritis since its
introduction five years ago, was pulled abruptly from the
market by its manufacturer, Merck and Co., late last
month after post-marketing studies suggested it increased
the risk for heart attack and stroke.

The Food and Drug Administration has deemed similar drugs
safe, but the European Medicines Agency in London said
last week it would review all similar drugs. And
researchers writing in the New England Journal of
Medicine voiced concerns with other drugs, including
Pfizer's popular Celebrex and its newer drug, Bextra.

Doctors, who said there had been rumblings in the medical
literature for some months about possible problems with
Vioxx, still were surprised by the sudden withdrawal of
the drug. Patients who had relied on Vioxx have been left
scrambling to find alternatives.

More at:
http://www.kentucky.com/mld/heraldl...lth/9875640.htm

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Steve Harris sbharris@ROMAN9.netcom.com

2004-10-13, 10:08 pm

usenet@mantra.com (Dr. Jai Maharaj) wrote in message news:<ZmM6H46gSym7@Ls428d4DhUiXQQ>...
> Vioxx case may help alternative medicine
>
> By Jim Warren
> Herald-Leader Staff Writer
> The Lexington Herald-Leader
> Tuesday, October 12, 2004
>
> The recent, unexpected demise of the popular anti-
> inflammatory drug Vioxx -- and subsequent concerns that
> were raised about similar drugs last week -- could boost
> the already growing nationwide interest in complementary
> and alternative medicines, two area physicians say.
>
> "I think that, hopefully, this will be a wake-up call for
> the general public," said Dr. James Roach of Midway. "I
> don't think the public fully recognizes how dangerous
> some of these drugs can be."
>
> Dr. Edwards Smith, president of the Maharishi college of
> Vedic Medicine in Lexington, agrees.
>
> "When you ask patients out there, they've sort of had it
> up to here with harmful drug side effects," Smith said.
> "The appeal of natural medicines is that they don't have
> the harmful side effects, and in many cases they may be
> just as effective as prescription drugs."

COMMENT:

We're led to the interesting question of how the *&^% Dr. Smith would
know whether or not any "natural medicines" were more safe or less
safe than Vioxx? Or how the @*^% Dr. Roach proposes to "fully
appreciate" how dangerous some of these "drugs can be" but has
knowledge that the alternatives are not?

Vioxx was pulled from the market after a study of longer than 1.5
years with more than 1300 people enrolled in tests of the drug vs.
placebo. No difference in stroke or heart attack risk was noted at
1.5 years of use, but only after that did the excess risk become
apparent. The trial was halted when the Vioxx group finally had a
total of 10 strokes or heart attacks vs. 5 for placebo (statistically
likely less than 3% of the time).

What we'd like is for Drs Roach or Smith to tell us of ANY tests of
ANY "natural remedies" which have been tested in double blind placebo
controlled tests using more than 1300 people for more than 18 months,
with a sensitivity which would have detected 5 extra heart attacks,
had their been any. Please tell me of any Ayurvedic herb which has
been that carefully tested for safety. Please cite references.

And please, don't bother to tell me that these things have been given
to millions of people for many years with nobody noticing any
problems. So was Vioxx. These problems don't show up out of the noise
unless you're doing a double blind controlled study with very careful
monitoring. Practitioners treating patients would miss such slight
deviations every time.

SBH

Orac

2004-10-14, 10:09 pm

In article <79cf0a8.0410131727.2fc43a45@posting.google.com>,
sbharris@ix.netcom.com (Steve Harris sbharris@ROMAN9.netcom.com)
wrote:

> We're led to the interesting question of how the *&^% Dr. Smith would
> know whether or not any "natural medicines" were more safe or less
> safe than Vioxx? Or how the @*^% Dr. Roach proposes to "fully
> appreciate" how dangerous some of these "drugs can be" but has
> knowledge that the alternatives are not?
>
> Vioxx was pulled from the market after a study of longer than 1.5
> years with more than 1300 people enrolled in tests of the drug vs.
> placebo. No difference in stroke or heart attack risk was noted at
> 1.5 years of use, but only after that did the excess risk become
> apparent. The trial was halted when the Vioxx group finally had a
> total of 10 strokes or heart attacks vs. 5 for placebo (statistically
> likely less than 3% of the time).
>
> What we'd like is for Drs Roach or Smith to tell us of ANY tests of
> ANY "natural remedies" which have been tested in double blind placebo
> controlled tests using more than 1300 people for more than 18 months,
> with a sensitivity which would have detected 5 extra heart attacks,
> had their been any. Please tell me of any Ayurvedic herb which has
> been that carefully tested for safety. Please cite references.
>
> And please, don't bother to tell me that these things have been given
> to millions of people for many years with nobody noticing any
> problems. So was Vioxx. These problems don't show up out of the noise
> unless you're doing a double blind controlled study with very careful
> monitoring. Practitioners treating patients would miss such slight
> deviations every time.

Well said!

--
Orac |"I am not interested in trying to compensate
| for your amazing lack of observation."
|
| Orac

Goody-Two-Shoes

2004-10-15, 2:08 am

sbharris@ix.netcom.com (Steve Harris sbharris@ROMAN9.netcom.com)
wrote:

>Vioxx was pulled from the market after a study of longer than 1.5
>years with more than 1300 people enrolled in tests of the drug vs.
>placebo. No difference in stroke or heart attack risk was noted at
>1.5 years of use, but only after that did the excess risk become
>apparent. The trial was halted when the Vioxx group finally had a
>total of 10 strokes or heart attacks vs. 5 for placebo (statistically
>likely less than 3% of the time).

Clearly there must be some sort of co-factor for those unlucky
additional five. Is there any effort made to find out what it is? Do
we understand the mechanism of action of this particular drug in
causing the extra strokes or heart attacks or do we simply rely on the
statistics and that's that?

It seems to me that this blanket withdrawal type of solution
--something similar happened with fen-fen (however it's spelled) and
with HRT--denies us a drug that may be perfectly safe for 97% of the
population if we can only identify what the co-factor is. Or if we're
willing to take the risk.

Mark Probert

2004-10-15, 11:08 am

"Goody-Two-Shoes" <Goody-Two-Shoes@Boring-Company.edu> wrote in message
news:21num09gctsjotglpogqtamjbnsk1rljqj@4ax.com...
> sbharris@ix.netcom.com (Steve Harris sbharris@ROMAN9.netcom.com)
> wrote:
>
>
> Clearly there must be some sort of co-factor for those unlucky
> additional five. Is there any effort made to find out what it is? Do
> we understand the mechanism of action of this particular drug in
> causing the extra strokes or heart attacks or do we simply rely on the
> statistics and that's that?
>
> It seems to me that this blanket withdrawal type of solution
> --something similar happened with fen-fen (however it's spelled) and
> with HRT--denies us a drug that may be perfectly safe for 97% of the
> population if we can only identify what the co-factor is. Or if we're
> willing to take the risk.

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.

Katherine Wolfe

2004-10-15, 7:24 pm

"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.

Katherine

Harvey R. Stone

2004-10-15, 7:24 pm

"Mark Probert" wrote in message
news:98Sbd.12336$Fe6.5271238@news4.srv.hcvlny.cv.net...
>
> "Goody-Two-Shoes" <Goody-Two-Shoes@Boring-Company.edu> wrote in message
> news:21num09gctsjotglpogqtamjbnsk1rljqj@4ax.com...
>
> 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.
>

Ooooh, you make a very good point. It is a point that includes the choice
people make when they take a DMARD...... The choice of Vioxx as a NSAID
has been taken away for good reasons and it is about Tomorrow not
about today's pain. Its about tomorrows death. We have people who are
not in pain making choices for the people who are...... I am sorry to say
that I am not smart enough to give an answer to that.

Harv

Ilena Rose

2004-10-15, 7:24 pm

On Fri, 15 Oct 2004 10:03:22 -0700, "Katherine Wolfe"
<wolfmoon@aracnet.com> wrote:
[vbcol=seagreen]

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.

Ilena Rose

2004-10-15, 7:24 pm

Mark Probert

2004-10-15, 7:24 pm

"Ilena Rose" <ilena@san.rr.com> wrote in message
news:ni60n05qinp3tecp9j3hon1vembgt9fpia@4ax.com...
> On Fri, 15 Oct 2004 10:03:22 -0700, "Katherine Wolfe"
> <wolfmoon@aracnet.com> wrote:
>
>
>
> 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.

Mark Probert

2004-10-15, 7:24 pm

"Harvey R. Stone" <hrstone@swbell..net> wrote in message
news:t6Ubd.5266$Lk3.755@newssvr12.news.prodigy.com...
>
> "Mark Probert" wrote in message
> news:98Sbd.12336$Fe6.5271238@news4.srv.hcvlny.cv.net...
woman,[vbcol=seagreen]
be[vbcol=seagreen]
worked[vbcol=seagreen]
>
> Ooooh, you make a very good point. It is a point that includes the
choice
> people make when they take a DMARD...... The choice of Vioxx as a NSAID
> has been taken away for good reasons and it is about Tomorrow
not
> about today's pain. Its about tomorrows death. We have people who
are
> not in pain making choices for the people who are...... I am sorry to
say
> that I am not smart enough to give an answer to that.

Nor am I. The pharmacist was very kind to her and gave her a list of
possible substitues which he told her that she should bring to her doctor.

Severe constant pain is a nightmare for people.

I have two close friends who are in constant pain. One suffers from Reflex
Sympathetic Dystrophy and his pain has only been relieved by methadone. His
wife left him.

The other one had a garage door with a newly installed opener fall onto her
neck and she wound up have three neck surgeries, the last one being a failed
fusion. She netted over $1.5M from Sears, and would gladly give the money
back for a day without pain. She is on morhpine and baely functions.
Fortunately, her husband is a great guy and is totally supportive of her aft
15 years.

Ilena Rose

2004-10-15, 7:24 pm

On Fri, 15 Oct 2004 20:17:03 GMT, "Mark Probert" 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.

Mark Probert

2004-10-15, 7:24 pm

"Ilena Rose" <ilena@san.rr.com> wrote in message
news:bse0n0hgaj054hr9ku7p2ada3vg0dess0e@4ax.com...
> On Fri, 15 Oct 2004 20:17:03 GMT, "Mark Probert" Probert@lumbercartel.com> wrote:
>
>
> 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.
[vbcol=seagreen]

Steve Harris sbharris@ROMAN9.netcom.com

2004-10-15, 7:24 pm

"Harvey R. Stone" <hrstone@swbell..net> wrote in message news:<t6Ubd.5266$Lk3.755@newssvr12.news.prodigy.com>...

> Ooooh, you make a very good point. It is a point that includes the choice
> people make when they take a DMARD...... The choice of Vioxx as a NSAID
> has been taken away for good reasons and it is about Tomorrow not
> about today's pain. Its about tomorrows death. We have people who are
> not in pain making choices for the people who are...... I am sorry to say
> that I am not smart enough to give an answer to that.
>
> Harv

COMMENT:

Your government thinks it is. Though to be fair, Vioxx was pulled off
the market by the maker, not the FDA. Those who claim some kind of
deception by the maker should keep this in mind.

Indeed, Vioxx increases the risk for heart attack and stroke by about
50%. You can do that easily by smoking a couple of cigarettes a day,
or by gaining 30 lbs. Or by being a couch potato.

The question of how much pain relief is worth a very small chance on
your life, is a good one. People risk their lives to have plastic
surgery to correct the size of their noses or whatever. People risk
their lives to fly to Paris for vacation, or drive on the freeway to
grandma's for Thanksgiving dinner. Why shouldn't they be allowed to
take a risk to relieve constant pain?

The answer of course is: no particular reason. The Vioxx risk is just
something that hadn't been noted before. If it had, it's possible the
drug would have been approved anyway. After we get used to it, perhaps
it will be on the market again.

Anybody seen the recent TV ads for Enbrel? You risk death from
infection, maybe an increased risk of developing lymphoma, and god
knows what else, all just to fix the heartbreak of psoriasis. Go
figure.

SBH

David Wright

2004-10-15, 10:08 pm

In article <ckovkc0a1o@enews1.newsguy.com>,
Katherine Wolfe <wolfmoon@aracnet.com> wrote:
>
>"Mark Probert" wrote in message
>news:98Sbd.12336$Fe6.5271238@news4.srv.hcvlny.cv.net...
>
>
>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)

David Wright

2004-10-15, 10:08 pm

In article <79cf0a8.0410151445.37321314@posting.google.com>,
Steve Harris sbharris@ROMAN9.netcom.com <sbharris@ix.netcom.com> wrote:
>"Harvey R. Stone" <hrstone@swbell..net> wrote in message
>news:<t6Ubd.5266$Lk3.755@newssvr12.news.prodigy.com>...
>
>
>
>COMMENT:
>
>Your government thinks it is. Though to be fair, Vioxx was pulled off
>the market by the maker, not the FDA. Those who claim some kind of
>deception by the maker should keep this in mind.
>
>Indeed, Vioxx increases the risk for heart attack and stroke by about
>50%. You can do that easily by smoking a couple of cigarettes a day,
>or by gaining 30 lbs. Or by being a couch potato.
>
>The question of how much pain relief is worth a very small chance on
>your life, is a good one. People risk their lives to have plastic
>surgery to correct the size of their noses or whatever. People risk
>their lives to fly to Paris for vacation, or drive on the freeway to
>grandma's for Thanksgiving dinner. Why shouldn't they be allowed to
>take a risk to relieve constant pain?
>
>The answer of course is: no particular reason. The Vioxx risk is just
>something that hadn't been noted before. If it had, it's possible the
>drug would have been approved anyway. After we get used to it, perhaps
>it will be on the market again.

I'd bet against that. Merck will have its hands full defending
lawsuits by zillions of people who once stood next to someone who was
taking Vioxx.

I believe Merck has a second generation COX-2 inhibitor in the
pipeline (I think I recall reading it was already available in
Europe). So that'll probably be the next product, though I'm sure now
we'll need another 1.5-year study to see if it causes cardiovascular
problems, or maybe the heartbreak of psoriasis.

-- 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)

Goody-Two-Shoes

2004-10-16, 2:08 am

wright@clam.prodigy.net (David Wright) wrote:

>In article <79cf0a8.0410151445.37321314@posting.google.com>,
>Steve Harris sbharris@ROMAN9.netcom.com <sbharris@ix.netcom.com> wrote:
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
>I'd bet against that. Merck will have its hands full defending
>lawsuits by zillions of people who once stood next to someone who was
>taking Vioxx.

Hmmm, you can still obtain Fen-Fen (or is it Phen-Phen?) from Mexico
so maybe a non-US supplier will be happy to jump in an fill the gap
for Vioxx. Maybe even a non-US manufacturer. Both via that
no-prescription-needed cheap pharmacy, the internet.

But no one answered my question: Is there a follow-up going on in the
medical research world or maybe Merck to find the co-factor and how
exactly Vioxx causes these excess deaths? The objective is to be able
to identify in advance persons who because of the co-factor would have
certain heart attack or stroke. Those people obviously shouldn't take
the drug: the rest of us can eat it like candy.

BTW, I'm also not entirely convinced of the validity of this study
despite the press falling over themselves to accept anything that's
based on "statistics" -- you know about damn lies... I suppose. Like
the used car salesman there's an aura of "Just trust us." On the face
of it it's almost impossible to randomize a trial of this nature: you
don't know the entire population and you can't compel any randomized
subject to participate.

Ilena Rose

2004-10-16, 11:08 am

On Sat, 16 Oct 2004 02:12:49 GMT, wright@clam.prodigy.net (David
Wright) wrote:

>Merck will have its hands full defending
>lawsuits by zillions of people who once stood next to someone who was
>taking Vioxx.

Perhaps you mean the thousands of widows, widowers and orphans of
their customers who died because they kept their product on the market
to make billions ... and "forgot" to warn them of the heart attack
risks.

Mark Probert

2004-10-16, 11:08 am

"David Wright" <wright@clam.prodigy.net> wrote in message
news:Bs%bd.17852$Qv5.5194@newssvr33.news.prodigy.com...
> In article <79cf0a8.0410151445.37321314@posting.google.com>,
> Steve Harris sbharris@ROMAN9.netcom.com <sbharris@ix.netcom.com> wrote:
choice[vbcol=seagreen]
NSAID[vbcol=seagreen]
not[vbcol=seagreen]
who are[vbcol=seagreen]
to say[vbcol=seagreen]
>
> I'd bet against that. Merck will have its hands full defending
> lawsuits by zillions of people who once stood next to someone who was
> taking Vioxx.
>
> I believe Merck has a second generation COX-2 inhibitor in the
> pipeline (I think I recall reading it was already available in
> Europe). So that'll probably be the next product, though I'm sure now
> we'll need another 1.5-year study to see if it causes cardiovascular
> problems, or maybe the heartbreak of psoriasis.

David, do no be so flip with the so-called heartbreak of psoriasis. Many
years ago I shared an office with a young woman who had intractable
psoriasis which, when there was an acute flare-up, was seriously
incapacitated for days at a time. He had the arthritic changes on x-rays of
her knees and ankles that a 80 year old would have..and she was only 30.
Psoriatic arthritis is a serious complication of this diease.

Kurt Ullman

2004-10-16, 11:08 am

In article <79cf0a8.0410151445.37321314@posting.google.com>,
sbharris@ix.netcom.com (Steve Harris sbharris@ROMAN9.netcom.com)
wrote:

>The question of how much pain relief is worth a very small chance on
>your life, is a good one. People risk their lives to have plastic
>surgery to correct the size of their noses or whatever. People risk
>their lives to fly to Paris for vacation, or drive on the freeway to
>grandma's for Thanksgiving dinner. Why shouldn't they be allowed to
>take a risk to relieve constant pain?
>
>The answer of course is: no particular reason. The Vioxx risk is just
>something that hadn't been noted before. If it had, it's possible the
>drug would have been approved anyway. After we get used to it, perhaps
>it will be on the market again.
>
IN hte final analysis the particular reason is two fold. One is
that the FDA gets nailed to the cross whenever any medication has
any nasty side effect that they SHOULD HAVE CAUGHT (no matter
whether or not it is catchable in real life). So, we have a
bureaucracy where it easier for them to pull something at the first
hint of any problems than it is try to give things like cost benefit
analysis in 10 second sound bites or to a Senator or Congresscritter
who doesn't want to hear it anyway.
On the part of the pharm company, again, it is easier to pull
something than it is to have someone take the risk and then decide
if that risk occurs, that it was REALLY the pharm company's fault
and they should PAY.
Viewed in these terms, taking away the risk to the patient by
not allowing the patient access to something is preferable.

--

"Jesus was provided for by his Father.
I suspect the same is the case with many of those writing on the web."
-- Michael Mendelsohn on alt.journalism.freelance

David Wright

2004-10-16, 7:10 pm

In article <NN9cd.22564$Fe6.8517868@news4.srv.hcvlny.cv.net>,
Mark Probert wrote:
>
>"David Wright" <wright@clam.prodigy.net> wrote in message
>news:Bs%bd.17852$Qv5.5194@newssvr33.news.prodigy.com...
>choice
>NSAID
>not
>who are
>to say
>
>David, do no be so flip with the so-called heartbreak of psoriasis.

I was only quoting Steve Harris, who had used the term in the post to
which I was replying (though I snipped that paragraph).

>Psoriatic arthritis is a serious complication of this diease.

A friend of mine has psoriasis. Interestingly, it cleared up when he
stopped drinking beer. (Maybe it was the gluten.)

-- 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)

Mark Probert

2004-10-16, 7:10 pm

"David Wright" <wright@clam.prodigy.net> wrote in message
news:0hgcd.18037$Qv5.5257@newssvr33.news.prodigy.com...
> In article <NN9cd.22564$Fe6.8517868@news4.srv.hcvlny.cv.net>,
> Mark Probert wrote:
Tomorrow[vbcol=seagreen]
sorry[vbcol=seagreen]
>
> I was only quoting Steve Harris, who had used the term in the post to
> which I was replying (though I snipped that paragraph).

I missed that. Sorry.

>
> A friend of mine has psoriasis. Interestingly, it cleared up when he
> stopped drinking beer. (Maybe it was the gluten.)

If only all the cases were so easy.