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Merck Should Have Pulled Vioxx in 2000 -Study Merck Should Have Pulled Vioxx in 2000 -Study -- Posted by Roman Bystrianyk on 11-04-04 17:28
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=374
Tom Armitage, "Merck Should Have Pulled Vioxx in 2000 -Study", Reuters
UK, November 5, 2004,
Link: http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=6721666§ion=news
U.S. drugs giant Merck & Co Inc. should have pulled its Vioxx
painkiller from the market four years ago, because data showing it
raised the risk of heart attacks has existed since 2000, Swiss
scientists said on Friday.
In a report for British medical journal The Lancet, researchers at the
University of Berne said there was substantial evidence of the
dangerous side effects of the drug by the end of 2000, but the
mounting data was not analyzed properly.
"Our findings indicate that rofecoxib (Vioxx) should have been
withdrawn several years earlier," the scientists said.
Merck did not recall Vioxx, a COX-2 inhibitor taken by about 20
million Americans, from the worldwide market until five weeks ago.
"The company could and should have made the statement several years
back, when the data we analyzed were readily available," Matthias
Egger, a professor at the university's department for Social and
Preventative Medicine, told a news conference.
The Swiss research follows newspaper reports earlier this week that
Merck had tried to fight mounting concerns about the drug's safety in
order to protect sales.
No one was immediately available at Merck to comment on the findings.
The U.S. Food and Drug Administration (FDA) recently published a study
estimating that Vioxx could have caused about 28,000 heart attacks or
deaths since it was approved in 1999.
Merck's shares have slumped around 40 percent since the recall, and
analysts estimate that it could face a bill of between $10 billion and
$15 billion in litigation.
INDEPENDENT EVALUATION
The Swiss scientists performed a meta-analysis on the data, taking in
results from past studies, some of which were available on the FDA Web
Site. They found that patients who took Vioxx were at greater risk
even after a few months, regardless of how much of the drug was taken.
Using 18 randomized controlled trials and 11 observational studies,
researchers saw that heart-attack risk more than doubled when Vioxx
was taken.
By the end of 2000, 52 heart attacks had occurred in 20,742 patients,
the researchers said. Of these, 41 were patients using Vioxx. The
increased heart-attack risks became apparent in studies which were
evaluated by external watchdogs.
"It could be that without independent evaluation of the data, the
assessment of adverse effects is biased so that the risks of a drug
appear smaller," Egger said.
"We therefore recommend that all studies be carried out with
independent external data evaluation."
Drug licensing authorities should review their procedures, the study
concluded, to ensure that data released after the drug launch is
analyzed for signs of side effects.
The authors also said an independent panel of experts should
investigate why manufacturers and licensing authorities did not
evaluate the data available on Vioxx sooner.
In an editorial in the journal, editor Richard Horton criticized both
Merck and the FDA, saying they acted out of "ruthless, short-sighted,
and irresponsible self interest."
"The licensing of Vioxx and its continued use in the face of
unambiguous evidence of harm have been public-health catastrophes,"
said Horton.
"This controversy will not end with the drug's withdrawal."
The study was part of a wider investigation into anti-inflammatory
drugs and their side effects conducted by the University of Berne on
behalf of the Swiss National Science Foundation. Full results are due
mid-2006.
Re: Merck Should Have Pulled Vioxx in 2000 -Study -- Posted by Anth on 11-05-04 09:12
It's ok they can get a little 'slap on the wrist', and still make some money
back from their research.
Anth
"Roman Bystrianyk" wrote in message
news:4f28e591.0411041728.7eb73bbc@posting.google.com... > http://www.healthsentinel.com/news.php?event=news_print_list_item&id=374
>
> Tom Armitage, "Merck Should Have Pulled Vioxx in 2000 -Study", Reuters
> UK, November 5, 2004,
> Link:
> http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=6721666§ion=news
>
> U.S. drugs giant Merck & Co Inc. should have pulled its Vioxx
> painkiller from the market four years ago, because data showing it
> raised the risk of heart attacks has existed since 2000, Swiss
> scientists said on Friday.
>
> In a report for British medical journal The Lancet, researchers at the
> University of Berne said there was substantial evidence of the
> dangerous side effects of the drug by the end of 2000, but the
> mounting data was not analyzed properly.
>
> "Our findings indicate that rofecoxib (Vioxx) should have been
> withdrawn several years earlier," the scientists said.
>
> Merck did not recall Vioxx, a COX-2 inhibitor taken by about 20
> million Americans, from the worldwide market until five weeks ago.
>
> "The company could and should have made the statement several years
> back, when the data we analyzed were readily available," Matthias
> Egger, a professor at the university's department for Social and
> Preventative Medicine, told a news conference.
>
> The Swiss research follows newspaper reports earlier this week that
> Merck had tried to fight mounting concerns about the drug's safety in
> order to protect sales.
>
> No one was immediately available at Merck to comment on the findings.
>
> The U.S. Food and Drug Administration (FDA) recently published a study
> estimating that Vioxx could have caused about 28,000 heart attacks or
> deaths since it was approved in 1999.
>
> Merck's shares have slumped around 40 percent since the recall, and
> analysts estimate that it could face a bill of between $10 billion and
> $15 billion in litigation.
>
> INDEPENDENT EVALUATION
>
> The Swiss scientists performed a meta-analysis on the data, taking in
> results from past studies, some of which were available on the FDA Web
> Site. They found that patients who took Vioxx were at greater risk
> even after a few months, regardless of how much of the drug was taken.
>
> Using 18 randomized controlled trials and 11 observational studies,
> researchers saw that heart-attack risk more than doubled when Vioxx
> was taken.
>
> By the end of 2000, 52 heart attacks had occurred in 20,742 patients,
> the researchers said. Of these, 41 were patients using Vioxx. The
> increased heart-attack risks became apparent in studies which were
> evaluated by external watchdogs.
>
> "It could be that without independent evaluation of the data, the
> assessment of adverse effects is biased so that the risks of a drug
> appear smaller," Egger said.
>
> "We therefore recommend that all studies be carried out with
> independent external data evaluation."
>
> Drug licensing authorities should review their procedures, the study
> concluded, to ensure that data released after the drug launch is
> analyzed for signs of side effects.
>
> The authors also said an independent panel of experts should
> investigate why manufacturers and licensing authorities did not
> evaluate the data available on Vioxx sooner.
>
> In an editorial in the journal, editor Richard Horton criticized both
> Merck and the FDA, saying they acted out of "ruthless, short-sighted,
> and irresponsible self interest."
>
> "The licensing of Vioxx and its continued use in the face of
> unambiguous evidence of harm have been public-health catastrophes,"
> said Horton.
>
> "This controversy will not end with the drug's withdrawal."
>
> The study was part of a wider investigation into anti-inflammatory
> drugs and their side effects conducted by the University of Berne on
> behalf of the Swiss National Science Foundation. Full results are due
> mid-2006.
Re: Merck Should Have Pulled Vioxx in 2000 -Study -- Posted by Mark Probert on 11-05-04 09:17
Actually, it is not OK for that. There should be a thorough investigastion
and, if sufficient evidence is found, a criminal action should be commenced.
In NY, the homicide statue contains a part where depraved indifference to
human life is condisdered to be the equivalent of intentional murder.
That works for me, with the right evidence.
"Anth" wrote in message
news:418bb48e$0$116$65c69314@mercury.nildram.net... > It's ok they can get a little 'slap on the wrist', and still make some
money > back from their research.
> Anth
>
> "Roman Bystrianyk" wrote in message
> news:4f28e591.0411041728.7eb73bbc@posting.google.com...
> > http://www.healthsentinel.com/news.php?event=news_print_list_item&id=374
> >
> > Tom Armitage, "Merck Should Have Pulled Vioxx in 2000 -Study", Reuters
> > UK, November 5, 2004,
> > Link:
> >
http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=6721666§ion=news > >
> > U.S. drugs giant Merck & Co Inc. should have pulled its Vioxx
> > painkiller from the market four years ago, because data showing it
> > raised the risk of heart attacks has existed since 2000, Swiss
> > scientists said on Friday.
> >
> > In a report for British medical journal The Lancet, researchers at the
> > University of Berne said there was substantial evidence of the
> > dangerous side effects of the drug by the end of 2000, but the
> > mounting data was not analyzed properly.
> >
> > "Our findings indicate that rofecoxib (Vioxx) should have been
> > withdrawn several years earlier," the scientists said.
> >
> > Merck did not recall Vioxx, a COX-2 inhibitor taken by about 20
> > million Americans, from the worldwide market until five weeks ago.
> >
> > "The company could and should have made the statement several years
> > back, when the data we analyzed were readily available," Matthias
> > Egger, a professor at the university's department for Social and
> > Preventative Medicine, told a news conference.
> >
> > The Swiss research follows newspaper reports earlier this week that
> > Merck had tried to fight mounting concerns about the drug's safety in
> > order to protect sales.
> >
> > No one was immediately available at Merck to comment on the findings.
> >
> > The U.S. Food and Drug Administration (FDA) recently published a study
> > estimating that Vioxx could have caused about 28,000 heart attacks or
> > deaths since it was approved in 1999.
> >
> > Merck's shares have slumped around 40 percent since the recall, and
> > analysts estimate that it could face a bill of between $10 billion and
> > $15 billion in litigation.
> >
> > INDEPENDENT EVALUATION
> >
> > The Swiss scientists performed a meta-analysis on the data, taking in
> > results from past studies, some of which were available on the FDA Web
> > Site. They found that patients who took Vioxx were at greater risk
> > even after a few months, regardless of how much of the drug was taken.
> >
> > Using 18 randomized controlled trials and 11 observational studies,
> > researchers saw that heart-attack risk more than doubled when Vioxx
> > was taken.
> >
> > By the end of 2000, 52 heart attacks had occurred in 20,742 patients,
> > the researchers said. Of these, 41 were patients using Vioxx. The
> > increased heart-attack risks became apparent in studies which were
> > evaluated by external watchdogs.
> >
> > "It could be that without independent evaluation of the data, the
> > assessment of adverse effects is biased so that the risks of a drug
> > appear smaller," Egger said.
> >
> > "We therefore recommend that all studies be carried out with
> > independent external data evaluation."
> >
> > Drug licensing authorities should review their procedures, the study
> > concluded, to ensure that data released after the drug launch is
> > analyzed for signs of side effects.
> >
> > The authors also said an independent panel of experts should
> > investigate why manufacturers and licensing authorities did not
> > evaluate the data available on Vioxx sooner.
> >
> > In an editorial in the journal, editor Richard Horton criticized both
> > Merck and the FDA, saying they acted out of "ruthless, short-sighted,
> > and irresponsible self interest."
> >
> > "The licensing of Vioxx and its continued use in the face of
> > unambiguous evidence of harm have been public-health catastrophes,"
> > said Horton.
> >
> > "This controversy will not end with the drug's withdrawal."
> >
> > The study was part of a wider investigation into anti-inflammatory
> > drugs and their side effects conducted by the University of Berne on
> > behalf of the Swiss National Science Foundation. Full results are due
> > mid-2006.
>
>
Re: Merck Should Have Pulled Vioxx in 2000 -Study -- Posted by firechief on 11-05-04 10:13
Mark Probert wrote:
> In NY, the homicide statue contains a part where depraved
> indifference to human life is condisdered to be the equivalent
> of intentional murder.
In California, while describing the elements of a crime, neglect
to perform a requred duty is the same as intent, as when running
a stop sign/red light or speeding without realizing it.
Re: Merck Should Have Pulled Vioxx in 2000 -Study -- Posted by Anth on 11-06-04 06:53
The thing is though this kind of behavious is happening all the time, it is
how they work.
The play down risks, exclude evidence from reports etc and they have too
much control.
They are not worth trusting imo, their game plan says money is their no#1
motive people's health ranks later.
Anth
"Mark Probert" wrote in message
news:9BOid.30673$fF6.8645113@news4.srv.hcvlny.cv.net... > Actually, it is not OK for that. There should be a thorough investigastion
> and, if sufficient evidence is found, a criminal action should be
> commenced.
>
> In NY, the homicide statue contains a part where depraved indifference to
> human life is condisdered to be the equivalent of intentional murder.
>
> That works for me, with the right evidence.
>
> "Anth" wrote in message
> news:418bb48e$0$116$65c69314@mercury.nildram.net...
>> It's ok they can get a little 'slap on the wrist', and still make some
> money
>> back from their research.
>> Anth
>>
>> "Roman Bystrianyk" wrote in message
>> news:4f28e591.0411041728.7eb73bbc@posting.google.com...
>> > http://www.healthsentinel.com/news.php?event=news_print_list_item&id=374
>> >
>> > Tom Armitage, "Merck Should Have Pulled Vioxx in 2000 -Study", Reuters
>> > UK, November 5, 2004,
>> > Link:
>> >
> http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=6721666§ion=news
>> >
>> > U.S. drugs giant Merck & Co Inc. should have pulled its Vioxx
>> > painkiller from the market four years ago, because data showing it
>> > raised the risk of heart attacks has existed since 2000, Swiss
>> > scientists said on Friday.
>> >
>> > In a report for British medical journal The Lancet, researchers at the
>> > University of Berne said there was substantial evidence of the
>> > dangerous side effects of the drug by the end of 2000, but the
>> > mounting data was not analyzed properly.
>> >
>> > "Our findings indicate that rofecoxib (Vioxx) should have been
>> > withdrawn several years earlier," the scientists said.
>> >
>> > Merck did not recall Vioxx, a COX-2 inhibitor taken by about 20
>> > million Americans, from the worldwide market until five weeks ago.
>> >
>> > "The company could and should have made the statement several years
>> > back, when the data we analyzed were readily available," Matthias
>> > Egger, a professor at the university's department for Social and
>> > Preventative Medicine, told a news conference.
>> >
>> > The Swiss research follows newspaper reports earlier this week that
>> > Merck had tried to fight mounting concerns about the drug's safety in
>> > order to protect sales.
>> >
>> > No one was immediately available at Merck to comment on the findings.
>> >
>> > The U.S. Food and Drug Administration (FDA) recently published a study
>> > estimating that Vioxx could have caused about 28,000 heart attacks or
>> > deaths since it was approved in 1999.
>> >
>> > Merck's shares have slumped around 40 percent since the recall, and
>> > analysts estimate that it could face a bill of between $10 billion and
>> > $15 billion in litigation.
>> >
>> > INDEPENDENT EVALUATION
>> >
>> > The Swiss scientists performed a meta-analysis on the data, taking in
>> > results from past studies, some of which were available on the FDA Web
>> > Site. They found that patients who took Vioxx were at greater risk
>> > even after a few months, regardless of how much of the drug was taken.
>> >
>> > Using 18 randomized controlled trials and 11 observational studies,
>> > researchers saw that heart-attack risk more than doubled when Vioxx
>> > was taken.
>> >
>> > By the end of 2000, 52 heart attacks had occurred in 20,742 patients,
>> > the researchers said. Of these, 41 were patients using Vioxx. The
>> > increased heart-attack risks became apparent in studies which were
>> > evaluated by external watchdogs.
>> >
>> > "It could be that without independent evaluation of the data, the
>> > assessment of adverse effects is biased so that the risks of a drug
>> > appear smaller," Egger said.
>> >
>> > "We therefore recommend that all studies be carried out with
>> > independent external data evaluation."
>> >
>> > Drug licensing authorities should review their procedures, the study
>> > concluded, to ensure that data released after the drug launch is
>> > analyzed for signs of side effects.
>> >
>> > The authors also said an independent panel of experts should
>> > investigate why manufacturers and licensing authorities did not
>> > evaluate the data available on Vioxx sooner.
>> >
>> > In an editorial in the journal, editor Richard Horton criticized both
>> > Merck and the FDA, saying they acted out of "ruthless, short-sighted,
>> > and irresponsible self interest."
>> >
>> > "The licensing of Vioxx and its continued use in the face of
>> > unambiguous evidence of harm have been public-health catastrophes,"
>> > said Horton.
>> >
>> > "This controversy will not end with the drug's withdrawal."
>> >
>> > The study was part of a wider investigation into anti-inflammatory
>> > drugs and their side effects conducted by the University of Berne on
>> > behalf of the Swiss National Science Foundation. Full results are due
>> > mid-2006.
>>
>>
>
>
Re: Merck Should Have Pulled Vioxx in 2000 -Study -- Posted by Mark on 11-06-04 05:05
"Anth" wrote in message news:<418bb48e$0$116$65c69314@mercury.nildram.net>... > It's ok they can get a little 'slap on the wrist', and still make some money
> back from their research.
> Anth
No it's not. Don't be a twit.
More evidence seems to be coming to light that there were known
problems with Vioxx at least four years ago. If these concerns bear
out, if it comes to light that Merck knew of risks they weren't
publicly declaring, then the higher-ups at Merck ought to face
criminal charges.
Mark, MD
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