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NEJM "Correction" Vioxx not safe
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Sharon Hope
medicine forum Guru


Joined: 30 Apr 2005
Posts: 752

PostPosted: Tue Jun 27, 2006 3:25 am    Post subject: NEJM "Correction" Vioxx not safe Reply with quote

http://content.nejm.org/

The New England Journal of Medicine today published a 'Correction" to the
Merck-funded study that falsely claimed Vioxx didn't present heart risk
until after 18 months of treatment.

http://content.nejm.org/cgi/content/short/NEJMx060029

Per the conclusion of the Perspective

http://content.nejm.org/cgi/content/short/NEJMp068137

http://content.nejm.org/cgi/reprint/NEJMp068137v1.pdf

However, since the band

would necessarily include the estimated

excess risk associated

with the 36-month course reflected

in Figure 2 of the original

APPROVe trial, one could not conclude

from the data that a shorter

course of rofecoxib is safe.
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David Rind
medicine forum Guru Wannabe


Joined: 02 May 2005
Posts: 205

PostPosted: Tue Jun 27, 2006 11:34 am    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

Sharon Hope wrote:
Quote:
http://content.nejm.org/

The New England Journal of Medicine today published a 'Correction" to the
Merck-funded study that falsely claimed Vioxx didn't present heart risk
until after 18 months of treatment.

My sense from having read all of the new stuff in the NEJM yesterday,
and the original paper today, is that the above is probably unfair to
the authors of the study.

I do not think the paper claimed that Vioxx did not present a heart risk
until after 18 months of treatment (a claim Merck has supposedly made at
trials), but rather that they did not detect such excess risk until
after 18 months. They also said there was a hint from looking at the
data that the risk above placebo really started to separate past 18 months.

It turns out they messed up a statistical test to try to look at whether
there was an important change in the rate of events over the time of the
study, and this is what the correction was about. Someone looking at the
actual data, though, would still wonder whether the risks really started
to become apparent after 18 months.

So saying that the authors "falsely" made such a claim and that they
issued a " 'Correction' " (OP's sarcastic quotes) is probably unfairly
attacking the motives of the authors. Merck, on the other hand, does
appear to have unreasonably presented these data to suggest that Vioxx
is safe when used short term (at least as I have heard from news reports
about litigation).

--
David Rind
drind@caregroup.harvard.edu
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Joe Doe
medicine forum beginner


Joined: 24 Jan 2006
Posts: 35

PostPosted: Wed Jun 28, 2006 1:59 am    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

In article <e7r557$r5m$1@reader2.panix.com>,
David Rind <drind@caregroup.harvard.edu> wrote:

Quote:
Sharon Hope wrote:
http://content.nejm.org/

The New England Journal of Medicine today published a 'Correction" to the
Merck-funded study that falsely claimed Vioxx didn't present heart risk
until after 18 months of treatment.

My sense from having read all of the new stuff in the NEJM yesterday,
and the original paper today, is that the above is probably unfair to
the authors of the study.


A few months back the Wall Street Journal had an interesting article on
how the NEJM was actively involved in an attempt to salvage its
reputation by smearing Merck. The article is too long to summarize but
covers the sordid side of medical publication quite well - NEJM for
example sold 900,000 reprints of this article to Merck at a likely cost
of 700K to 800K!!

The article details of the article are:
Wall Street Jounal. May 15, 2006;PageA1
How the New England Journal Missed Warning Signs on VioxxMedical Weekly
Waited YearsTo Report Flaws in Article That Praised Pain Drug
Merck Seen as 'Punching Bag'
By DAVID ARMSTRONG


Roland
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Sharon Hope
medicine forum Guru


Joined: 30 Apr 2005
Posts: 752

PostPosted: Wed Jun 28, 2006 3:44 am    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

Since both my MIL and SIL each had a heart attack on Vioxx, with no
preexisting risk conditions, my view of who is the punching bag, Merck or
the patients, differs.

Interesting how far Pharmco spin has come - blame the journal for correcting
a misrepresentation of data in a study funded by the pharmco. (Sounds like
the corporate equivalent of classic domestic abuse, where the abuser blames
the victim)

Press coverage of the first Vioxx trial indicated that Merck was aware of
the increase in heart attacks, but chose to spin the drug as easier on the
stomach than aspirin. A cardiology expert for the plaintiff testified that
a single dose of Vioxx increased heart attack risk for 85 hours, by negating
the body's natural defenses against inappropriate clotting.

Different perspectives. Definitely.




"Joe Doe" <None@mail.utexas.edu> wrote in message
news:None-CE1033.20590927062006@geraldo.cc.utexas.edu...
Quote:
In article <e7r557$r5m$1@reader2.panix.com>,
David Rind <drind@caregroup.harvard.edu> wrote:

Sharon Hope wrote:
http://content.nejm.org/

The New England Journal of Medicine today published a 'Correction" to
the
Merck-funded study that falsely claimed Vioxx didn't present heart risk
until after 18 months of treatment.

My sense from having read all of the new stuff in the NEJM yesterday,
and the original paper today, is that the above is probably unfair to
the authors of the study.


A few months back the Wall Street Journal had an interesting article on
how the NEJM was actively involved in an attempt to salvage its
reputation by smearing Merck. The article is too long to summarize but
covers the sordid side of medical publication quite well - NEJM for
example sold 900,000 reprints of this article to Merck at a likely cost
of 700K to 800K!!

The article details of the article are:
Wall Street Jounal. May 15, 2006;PageA1
How the New England Journal Missed Warning Signs on VioxxMedical Weekly
Waited YearsTo Report Flaws in Article That Praised Pain Drug
Merck Seen as 'Punching Bag'
By DAVID ARMSTRONG


Roland
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David Rind
medicine forum Guru Wannabe


Joined: 02 May 2005
Posts: 205

PostPosted: Wed Jun 28, 2006 11:45 am    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

Sharon Hope wrote:
Quote:
Interesting how far Pharmco spin has come - blame the journal for correcting
a misrepresentation of data in a study funded by the pharmco. (Sounds like
the corporate equivalent of classic domestic abuse, where the abuser blames
the victim)

It's possible for more than one entity to behave badly.

The original editorial by the NEJM criticizing the VIGOR trial was just
odd -- it suggested the authors should have done something in the
analysis that really made no sense (reanalyze the data based on events
after the completion of the trial period). Then, it turned out that
those running the trial really had done something completely
inappropriate in the analysis (had different periods of time for
counting cardiac and GI adverse events), but it wasn't what the NEJM
editorial first mentioned. According to the Wall Street Journal piece
mentioned by another poster, the editors had not even spotted what the
VIGOR authors had done with the analysis until after the editorial, so,
if true, it's not just that the editorial was somewhat unclear.

In this pass, the NEJM did something I've never heard of before. They
published a correction to an article without the authors' agreement.
Normally, you only publish a correction under the authors' names. The
NEJM could conceivably have retracted the article about APPROVE, or they
could have written an editorial saying that the original article was
interpreted incorrectly and, had they known, they would have been
unwilling to publish it without changes, but it seems really strange to
issue a correction to an article written by someone else, even if
published in your own journal. Has anyone ever seen a major journal do
this? Perhaps it's more common than I realize.

--
David Rind
drind@caregroup.harvard.edu
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Jim Chinnis
medicine forum Guru


Joined: 30 Apr 2005
Posts: 1030

PostPosted: Wed Jun 28, 2006 8:16 pm    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

David Rind <drind@caregroup.harvard.edu> wrote in part:

Quote:
Sharon Hope wrote:
Interesting how far Pharmco spin has come - blame the journal for correcting
a misrepresentation of data in a study funded by the pharmco. (Sounds like
the corporate equivalent of classic domestic abuse, where the abuser blames
the victim)

It's possible for more than one entity to behave badly.

The original editorial by the NEJM criticizing the VIGOR trial was just
odd -- it suggested the authors should have done something in the
analysis that really made no sense (reanalyze the data based on events
after the completion of the trial period). Then, it turned out that
those running the trial really had done something completely
inappropriate in the analysis (had different periods of time for
counting cardiac and GI adverse events), but it wasn't what the NEJM
editorial first mentioned. According to the Wall Street Journal piece
mentioned by another poster, the editors had not even spotted what the
VIGOR authors had done with the analysis until after the editorial, so,
if true, it's not just that the editorial was somewhat unclear.

In this pass, the NEJM did something I've never heard of before. They
published a correction to an article without the authors' agreement.
Normally, you only publish a correction under the authors' names. The
NEJM could conceivably have retracted the article about APPROVE, or they
could have written an editorial saying that the original article was
interpreted incorrectly and, had they known, they would have been
unwilling to publish it without changes, but it seems really strange to
issue a correction to an article written by someone else, even if
published in your own journal. Has anyone ever seen a major journal do
this? Perhaps it's more common than I realize.

I've never, ever seen this happen. The behavior of the NEJM editors must be
close to unique. Their work throughout this is sloppy.
--
Jim Chinnis Warrenton, Virginia, USA
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William Wagner
medicine forum Guru


Joined: 29 Apr 2005
Posts: 809

PostPosted: Wed Jun 28, 2006 8:44 pm    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

In article <7oo5a2hgn7edhlhbick1h7agfi685k5fo6@4ax.com>,
Jim Chinnis <jchinnis@SPAMalum.mit.edu> wrote:

Quote:
David Rind <drind@caregroup.harvard.edu> wrote in part:

Sharon Hope wrote:
Interesting how far Pharmco spin has come - blame the journal for
correcting
a misrepresentation of data in a study funded by the pharmco. (Sounds
like
the corporate equivalent of classic domestic abuse, where the abuser
blames
the victim)

It's possible for more than one entity to behave badly.

The original editorial by the NEJM criticizing the VIGOR trial was just
odd -- it suggested the authors should have done something in the
analysis that really made no sense (reanalyze the data based on events
after the completion of the trial period). Then, it turned out that
those running the trial really had done something completely
inappropriate in the analysis (had different periods of time for
counting cardiac and GI adverse events), but it wasn't what the NEJM
editorial first mentioned. According to the Wall Street Journal piece
mentioned by another poster, the editors had not even spotted what the
VIGOR authors had done with the analysis until after the editorial, so,
if true, it's not just that the editorial was somewhat unclear.

In this pass, the NEJM did something I've never heard of before. They
published a correction to an article without the authors' agreement.
Normally, you only publish a correction under the authors' names. The
NEJM could conceivably have retracted the article about APPROVE, or they
could have written an editorial saying that the original article was
interpreted incorrectly and, had they known, they would have been
unwilling to publish it without changes, but it seems really strange to
issue a correction to an article written by someone else, even if
published in your own journal. Has anyone ever seen a major journal do
this? Perhaps it's more common than I realize.

I've never, ever seen this happen. The behavior of the NEJM editors must be
close to unique. Their work throughout this is sloppy.
--
Jim Chinnis Warrenton, Virginia, USA

Turning and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world,
The blood-dimmed tide is loosed, and everywhere
The ceremony of innocence is drowned;
The best lack all conviction, while the worst
Are full of passionate intensity.
Surely some revelation is at hand;
Surely the Second Coming is at hand.
The Second Coming! Hardly are those words out
When a vast image out of "Spiritus Mundi"
Troubles my sight: somewhere in sands of the desert
A shape with lion body and the head of a man,
A gaze blank and pitiless as the sun,
Is moving its slow thighs, while all about it
Reel shadows of the indignant desert birds.
The darkness drops again; but now I know
That twenty centuries of stony sleep
Were vexed to nightmare by a rocking cradle,
And what rough beast, its hour come round at last,
Slouches towards Bethlehem to be born?

-- William Butler Yeats, "The Second Coming"

.............


I really hope just an observed outlier.


Bill

--
S Jersey USA Zone 5 Shade
This article is posted under fair use rules in accordance with
Title 17 U.S.C. Section 107, and is strictly for the educational
and informative purposes. This material is distributed without profit.
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Andrew B. Chung, MD/PhD
medicine forum Guru


Joined: 25 Mar 2005
Posts: 8540

PostPosted: Wed Jun 28, 2006 11:47 pm    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

William Wagner wrote:
Quote:
In article <7oo5a2hgn7edhlhbick1h7agfi685k5fo6@4ax.com>,
Jim Chinnis <jchinnis@SPAMalum.mit.edu> wrote:
David Rind <drind@caregroup.harvard.edu> wrote in part:
Sharon Hope wrote:
Interesting how far Pharmco spin has come - blame the journal for
correcting
a misrepresentation of data in a study funded by the pharmco. (Sounds
like
the corporate equivalent of classic domestic abuse, where the abuser
blames
the victim)

It's possible for more than one entity to behave badly.

The original editorial by the NEJM criticizing the VIGOR trial was just
odd -- it suggested the authors should have done something in the
analysis that really made no sense (reanalyze the data based on events
after the completion of the trial period). Then, it turned out that
those running the trial really had done something completely
inappropriate in the analysis (had different periods of time for
counting cardiac and GI adverse events), but it wasn't what the NEJM
editorial first mentioned. According to the Wall Street Journal piece
mentioned by another poster, the editors had not even spotted what the
VIGOR authors had done with the analysis until after the editorial, so,
if true, it's not just that the editorial was somewhat unclear.

In this pass, the NEJM did something I've never heard of before. They
published a correction to an article without the authors' agreement.
Normally, you only publish a correction under the authors' names. The
NEJM could conceivably have retracted the article about APPROVE, or they
could have written an editorial saying that the original article was
interpreted incorrectly and, had they known, they would have been
unwilling to publish it without changes, but it seems really strange to
issue a correction to an article written by someone else, even if
published in your own journal. Has anyone ever seen a major journal do
this? Perhaps it's more common than I realize.

I've never, ever seen this happen. The behavior of the NEJM editors must be
close to unique. Their work throughout this is sloppy.
--
Jim Chinnis Warrenton, Virginia, USA

Turning and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world,
The blood-dimmed tide is loosed, and everywhere
The ceremony of innocence is drowned;
The best lack all conviction, while the worst
Are full of passionate intensity.
Surely some revelation is at hand;
Surely the Second Coming is at hand.
The Second Coming! Hardly are those words out
When a vast image out of "Spiritus Mundi"
Troubles my sight: somewhere in sands of the desert
A shape with lion body and the head of a man,
A gaze blank and pitiless as the sun,
Is moving its slow thighs, while all about it
Reel shadows of the indignant desert birds.
The darkness drops again; but now I know
That twenty centuries of stony sleep
Were vexed to nightmare by a rocking cradle,
And what rough beast, its hour come round at last,
Slouches towards Bethlehem to be born?

-- William Butler Yeats, "The Second Coming"

............


I really hope just an observed outlier.

The Yeats poem is appropriate on many levels. Many thanks to GOD for
your being inspired to post it, dear Bill.

Prayerfully in Christ's amazing love,

Andrew B. Chung
Cardiologist, Atlanta, Georgia, USA
http://HeartMDPhD.com/TheLife
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William Wagner
medicine forum Guru


Joined: 29 Apr 2005
Posts: 809

PostPosted: Thu Jun 29, 2006 3:54 pm    Post subject: Re: NEJM "Correction" Vioxx not safe Reply with quote

In article
<not-to-here-williamwag-477B65.16445428062006@sn-indi.vsrv-sjc.supernews
..net>,
William Wagner <not-to-here-williamwag@gmail.com> wrote:

Quote:
In article <7oo5a2hgn7edhlhbick1h7agfi685k5fo6@4ax.com>,
Jim Chinnis <jchinnis@SPAMalum.mit.edu> wrote:

David Rind <drind@caregroup.harvard.edu> wrote in part:

Sharon Hope wrote:
Interesting how far Pharmco spin has come - blame the journal for
correcting
a misrepresentation of data in a study funded by the pharmco. (Sounds
like
the corporate equivalent of classic domestic abuse, where the abuser
blames
the victim)

It's possible for more than one entity to behave badly.

The original editorial by the NEJM criticizing the VIGOR trial was just
odd -- it suggested the authors should have done something in the
analysis that really made no sense (reanalyze the data based on events
after the completion of the trial period). Then, it turned out that
those running the trial really had done something completely
inappropriate in the analysis (had different periods of time for
counting cardiac and GI adverse events), but it wasn't what the NEJM
editorial first mentioned. According to the Wall Street Journal piece
mentioned by another poster, the editors had not even spotted what the
VIGOR authors had done with the analysis until after the editorial, so,
if true, it's not just that the editorial was somewhat unclear.

In this pass, the NEJM did something I've never heard of before. They
published a correction to an article without the authors' agreement.
Normally, you only publish a correction under the authors' names. The
NEJM could conceivably have retracted the article about APPROVE, or they
could have written an editorial saying that the original article was
interpreted incorrectly and, had they known, they would have been
unwilling to publish it without changes, but it seems really strange to
issue a correction to an article written by someone else, even if
published in your own journal. Has anyone ever seen a major journal do
this? Perhaps it's more common than I realize.

I've never, ever seen this happen. The behavior of the NEJM editors must be
close to unique. Their work throughout this is sloppy.
--
Jim Chinnis Warrenton, Virginia, USA

Turning and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world,
The blood-dimmed tide is loosed, and everywhere
The ceremony of innocence is drowned;
The best lack all conviction, while the worst
Are full of passionate intensity.
Surely some revelation is at hand;
Surely the Second Coming is at hand.
The Second Coming! Hardly are those words out
When a vast image out of "Spiritus Mundi"
Troubles my sight: somewhere in sands of the desert
A shape with lion body and the head of a man,
A gaze blank and pitiless as the sun,
Is moving its slow thighs, while all about it
Reel shadows of the indignant desert birds.
The darkness drops again; but now I know
That twenty centuries of stony sleep
Were vexed to nightmare by a rocking cradle,
And what rough beast, its hour come round at last,
Slouches towards Bethlehem to be born?

-- William Butler Yeats, "The Second Coming"

............


I really hope just an observed outlier.


Bill

Andrew ... Yeats passed in 1926. His world was in turmoil much
like the Italian elite who decided not to have children in 1500. Our
world has it troubles but we also have much beauty and love about. If
those Jews/Muslims/ Christians look for commonality perhaps less pain
in the future. Meanwhile drive less and help the other if possible.

The second coming to me infers what we hold and trust will change.
Difficult or challenging much like dealing with CABG it is up to our
perceptions. Usually wrong but heck it provides an opportunity to
learn and fight the good fight.

Mystery comes to mind.


Bill

--
S Jersey USA Zone 5 Shade
This article is posted under fair use rules in accordance with
Title 17 U.S.C. Section 107, and is strictly for the educational
and informative purposes. This material is distributed without profit.
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