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Prominent cardiologist criticizes drug ads
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| MrPepper11 2004-12-29, 11:06 am |
| Los Angeles Times
December 29, 2004
Cardiologist Criticizes Drug Ads Aimed at the Public
By Ricardo Alonso-Zaldivar, Times Staff Writer
WASHINGTON - The government should reassess its policy of allowing
prescription drugs to be advertised directly to consumers, a prominent
cardiologist urged Tuesday in the Journal of the American Medical
Association.
The heart attack risks of arthritis painkillers Vioxx, Bextra and
Celebrex have exposed a regulatory "house of cards" at the Food and
Drug Administration, wrote Dr. Eric J. Topol, chairman of
cardiovascular medicine at the Cleveland Clinic.
"Unbridled promotion exacerbated the public health problem," Topol
concluded. "The combination of mass promotion of a medicine with an
unknown and suspect safety profile cannot be tolerated in the future."
FDA officials have not publicly addressed the issue of whether
high-powered advertising campaigns for newly approved drugs are in the
best interest of public health.
Other leading academic researchers have suggested that new drugs should
be subject to a trial period before they can be touted directly to
patients.
Topol's sharply worded opinion article, to be published next month, was
posted on the medical journal's website as part of the growing debate.
Critics have accused the FDA of being too cozy with the drug industry
and unwilling to pursue evidence of problems with medications that it
has already approved.
Manufacturer Merck & Co. withdrew Vioxx from the market in late
September after a company-sponsored study confirmed research by Topol
and others that it increased chances of heart attacks and strokes.
Topol was among the chief critics of the drug.
New warnings have been added to the Bextra label, and concerns have
been raised about possible problems with Celebrex, both produced by
Pfizer Inc. The company recently agreed to suspend Celebrex advertising
while experts sorted out preliminary study findings that indicated a
heart risk for patients taking a high dose over many months.
All three drugs are of the same family of chemical compounds.
Celebrex and Vioxx, taken by millions of patients worldwide, were
heavily advertised on television and in magazines and were considered
blockbuster successes for their manufacturers. But though Vioxx had
fewer side effects on the stomach than earlier generations of arthritis
medicines, none of the three drugs was proved to be markedly better at
reducing pain.
"These drugs were mass-marketed from the moment they were commercially
available in the new world of direct-to-consumer advertising, with
unrealistic expectations about pain relief, marked gastrointestinal
protection and safety," wrote Topol. "One has to question the wisdom of
allowing direct-to-consumer advertising for lifestyle medications that
have no capability of preserving life or preventing major events such
as [heart attack] or stroke."
Proposals for FDA reform include creating an independent office to
monitor the safety of drugs already on the market and granting the
agency new legal authority to require drug companies to conduct
follow-up studies that would identify potentially dangerous side
effects.
New drugs are usually tested on several thousand people before being
approved, but problems may not emerge until hundreds of thousands of
patients have used a medicine.
--------
Full text available at
http://jama.ama-assn.org/cgi/content/full/293.3.366v1
Arthritis Medicines and Cardiovascular Events-"House of Coxibs"
Eric J. Topol, MD
JAMA. 2005;293 DOI 10.1001/jama.293.3.366).
| |
| listener 2004-12-29, 11:06 am |
| Personally, I find the mass-market advertising (print, tv and radio) of
potent medications unfortunate and, as in the case of alcohol, wouldn't
miss seeing it. I do find some of these slick commercials very 1984-ish.
Perhaps it would change the focus of pharma and force patients to rely on
and talk more to their doctors.
I disagree with Topol's opinion in that there will always be safety
issues with drugs and curtailing "unbridled promotion" will not lessen
that reality. But at least we won't be bombarded with actors pretending
to be real people pretending to find relief from real (powerful) drugs.
L.
"MrPepper11" <MrPepper11@go.com> wrote in news:1104329982.419333.95410
@f14g2000cwb.googlegroups.com:
> Los Angeles Times
> December 29, 2004
>
> Cardiologist Criticizes Drug Ads Aimed at the Public
> By Ricardo Alonso-Zaldivar, Times Staff Writer
>
> WASHINGTON - The government should reassess its policy of allowing
> prescription drugs to be advertised directly to consumers, a prominent
> cardiologist urged Tuesday in the Journal of the American Medical
> Association.
>
> The heart attack risks of arthritis painkillers Vioxx, Bextra and
> Celebrex have exposed a regulatory "house of cards" at the Food and
> Drug Administration, wrote Dr. Eric J. Topol, chairman of
> cardiovascular medicine at the Cleveland Clinic.
>
> "Unbridled promotion exacerbated the public health problem," Topol
> concluded. "The combination of mass promotion of a medicine with an
> unknown and suspect safety profile cannot be tolerated in the future."
>
> FDA officials have not publicly addressed the issue of whether
> high-powered advertising campaigns for newly approved drugs are in the
> best interest of public health.
>
> Other leading academic researchers have suggested that new drugs should
> be subject to a trial period before they can be touted directly to
> patients.
>
> Topol's sharply worded opinion article, to be published next month, was
> posted on the medical journal's website as part of the growing debate.
>
> Critics have accused the FDA of being too cozy with the drug industry
> and unwilling to pursue evidence of problems with medications that it
> has already approved.
>
> Manufacturer Merck & Co. withdrew Vioxx from the market in late
> September after a company-sponsored study confirmed research by Topol
> and others that it increased chances of heart attacks and strokes.
> Topol was among the chief critics of the drug.
>
> New warnings have been added to the Bextra label, and concerns have
> been raised about possible problems with Celebrex, both produced by
> Pfizer Inc. The company recently agreed to suspend Celebrex advertising
> while experts sorted out preliminary study findings that indicated a
> heart risk for patients taking a high dose over many months.
>
> All three drugs are of the same family of chemical compounds.
>
> Celebrex and Vioxx, taken by millions of patients worldwide, were
> heavily advertised on television and in magazines and were considered
> blockbuster successes for their manufacturers. But though Vioxx had
> fewer side effects on the stomach than earlier generations of arthritis
> medicines, none of the three drugs was proved to be markedly better at
> reducing pain.
>
> "These drugs were mass-marketed from the moment they were commercially
> available in the new world of direct-to-consumer advertising, with
> unrealistic expectations about pain relief, marked gastrointestinal
> protection and safety," wrote Topol. "One has to question the wisdom of
> allowing direct-to-consumer advertising for lifestyle medications that
> have no capability of preserving life or preventing major events such
> as [heart attack] or stroke."
>
> Proposals for FDA reform include creating an independent office to
> monitor the safety of drugs already on the market and granting the
> agency new legal authority to require drug companies to conduct
> follow-up studies that would identify potentially dangerous side
> effects.
>
> New drugs are usually tested on several thousand people before being
> approved, but problems may not emerge until hundreds of thousands of
> patients have used a medicine.
>
> --------
>
> Full text available at
> http://jama.ama-assn.org/cgi/content/full/293.3.366v1
>
> Arthritis Medicines and Cardiovascular Events-"House of Coxibs"
> Eric J. Topol, MD
>
> JAMA. 2005;293DOI 10.1001/jama.293.3.366).
>
| |
| Herman Rubin 2004-12-29, 7:06 pm |
| In article <1104329982.419333.95410@f14g2000cwb.googlegroups.com>,
MrPepper11 <MrPepper11@go.com> wrote:
>Los Angeles Times
>December 29, 2004
>Cardiologist Criticizes Drug Ads Aimed at the Public
>By Ricardo Alonso-Zaldivar, Times Staff Writer
>WASHINGTON - The government should reassess its policy of allowing
>prescription drugs to be advertised directly to consumers, a prominent
>cardiologist urged Tuesday in the Journal of the American Medical
>Association.
That the AMA would state this does not surprise me at all;
they have been consistently unwilling to let patients make
their own decisions, and maintain that physicians should
make all medical decisions.
This is exactly what I oppose. Physicians should give
medical information and advice, but in all cases where
possible, the patient should make the decision.
>The heart attack risks of arthritis painkillers Vioxx, Bextra and
>Celebrex have exposed a regulatory "house of cards" at the Food and
>Drug Administration, wrote Dr. Eric J. Topol, chairman of
>cardiovascular medicine at the Cleveland Clinic.
>"Unbridled promotion exacerbated the public health problem," Topol
>concluded. "The combination of mass promotion of a medicine with an
>unknown and suspect safety profile cannot be tolerated in the future."
This is totally unclear. ALL medications have risks and
benefits; what is needed is to provide the known information,
and let people make up their own minds. The information
provided in the advertising is more complete and more honest
than what is typically given by physicians.
Even without direct advertising, we have always had "mass
promotion". This is not surprising; if a pharmaceutical
company is putting a half billion dollars in the development
of a drug through FDA approval, it must make lots of sales
to recoup the investment, and also the investment in drugs
which do not make it.
>FDA officials have not publicly addressed the issue of whether
>high-powered advertising campaigns for newly approved drugs are in the
>best interest of public health.
>Other leading academic researchers have suggested that new drugs should
>be subject to a trial period before they can be touted directly to
>patients.
They are. There is a long testing period.
Also, there are other ways of learning about new drugs,
besides direct advertising. I do not believe that Humalog,
the Lilly quickly absorbed insulin, was so advertised when
I asked my endocrinologist whether it might be good for me.
He agreed with the trial, and I am still using it.
What I object to is any attempt by the AMA or FDA or anyone
else to restrict information. However, I believe that the
full information be given, and if it is, that the manufacturer
be exempt from liability from all unknown and most unexpected
side effects, and the consumer must know the risks and accept
them for the stated side effects.
I would suggest instead that if their cabal keeps someone from
getting a drug because of the restriction of knowledge, they
as individuals, not as agents of the government or officers
of the MDA, be fully responsible for the denial of treatment.
The one who makes the decisions is the one who should bear the
responsibility, and recourse should require showing fraud or
irresponsible concealment of information, or direct failure to
adequately provide the care offered.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
|
| hrubin@odds.stat.purdue.edu (Herman Rubin) wrote:
>
>This is totally unclear. ALL medications have risks and
>benefits; what is needed is to provide the known information,
>and let people make up their own minds.
True. People forget that every drug is essentially a poison,
attempting to interfere with the body's normal functioning in some
way. We hope the side effects are more than offset by the benefits,
but that may not always be the case, either individually or globally.
| |
|
|
Herman Rubin wrote:
> In article <1104329982.419333.95410@f14g2000cwb.googlegroups.com>,
> MrPepper11 <MrPepper11@go.com> wrote:
>
>
prominent[vbcol=seagreen]
>
> That the AMA would state this does not surprise me at all;
> they have been consistently unwilling to let patients make
> their own decisions, and maintain that physicians should
> make all medical decisions.
>
> This is exactly what I oppose. Physicians should give
> medical information and advice, but in all cases where
> possible, the patient should make the decision.
There are many places a patient can get medical information and advice.
Advertising is not one of them.
The point being made is that DTCA is more harmful than helpful.
DTCA is not education but rather promotion which exaggerates benefits
and downplays risks. It does not mention none drug options, how
prevalent the illness is, or how successful the advertised drug is
compared to a test group that took a placebo.
>
>
future."[vbcol=seagreen]
>
> This is totally unclear. ALL medications have risks and
> benefits; what is needed is to provide the known information,
> and let people make up their own minds.
The known information, in the past and now, does not include trials
which found negative information.
The information
> provided in the advertising is more complete and more honest
> than what is typically given by physicians.
It is de facto the same, coming primarily as it does from the same
source.
Physicians on the front line get their drugs and continuing medical
information from pharma, either delivered by pharmaceutical reps
bearing glossy advertising brochures, by pharma sponsored seminars,
workshops, conferences and "educational" junkets, from medical schools
also receiving monies from pharma; pharma sponsored research, books,
tuition, office equipment etc, and specialists acting as "consultants"
to pharma (conflict of interest and biased information--NIH's Dr.
Sonderland LA Times most recent example).
> Even without direct advertising, we have always had "mass
> promotion". This is not surprising; if a pharmaceutical
> company is putting a half billion dollars in the development
> of a drug through FDA approval, it must make lots of sales
> to recoup the investment, and also the investment in drugs
> which do not make it.
Pharma spends a lot more on marketing than they do on research. See
relevant comment in Marcia Angell's book and in the following study:
http://www.nybooks.com/articles/17244
http://www.familiesusa.org/site/Doc...t.pdf?docID=249
>
the[vbcol=seagreen]
>
should[vbcol=seagreen]
>
> They are. There is a long testing period.
Not long enough apparently. HRT, Baycol, Vioxx, Celebrex, Rezulin...
And no post-marketing surveillance that pharma can wiggle out of.
>
> Also, there are other ways of learning about new drugs,
> besides direct advertising. I do not believe that Humalog,
> the Lilly quickly absorbed insulin, was so advertised when
> I asked my endocrinologist whether it might be good for me.
> He agreed with the trial, and I am still using it.
>
> What I object to is any attempt by the AMA or FDA or anyone
> else to restrict information.
The are attempting to restrict advertising, not information.
However, I believe that the
> full information be given, and if it is, that the manufacturer
> be exempt from liability from all unknown and most unexpected
> side effects, and the consumer must know the risks and accept
> them for the stated side effects.
Will we get them to sign a release for every pill they take? Will
translators be used? How will we ensure all with varying levels of
education and comprehension are being served? Will we use the models
courts use for non-English speakers, or those with established
cognitive 'challenges'? How can we be sure the patient wasn't
emotionally overcome and willing to sign do and accept anything (as
they often are even in the abscence of this scenario?)
>
> I would suggest instead that if their cabal keeps someone from
> getting a drug because of the restriction of knowledge,
Again you *assume* that advertising is analagous to education. It is
not. education is never, nor should it be, so one-sided and so focussed
to a goal determined in a marketing department.
they
> as individuals, not as agents of the government or officers
> of the MDA, be fully responsible for the denial of treatment.
> The one who makes the decisions is the one who should bear the
> responsibility,
Patients can only make decisions based on the best available evidence.
And if the best available evidence is not all the available evidence,
and the patient is compromised in understanding, then the patient needs
an unbiased and uncompromised physican *as well as* his or her own best
efforts, to comprehend what his or her options are.
and recourse should require showing fraud or
> irresponsible concealment of information, or direct failure to
> adequately provide the care offered.
Your perspective here would entangle healthcare and all its players
even further into the litigious system you decry.
Zee
> --
> This address is for information only. I do not claim that these
views
> are those of the Statistics Department or of Purdue University.
> Herman Rubin, Department of Statistics, Purdue University
> hrubin@stat.purdue.edu Phone: (765)494-6054 FAX:
(765)494-0558
| |
| listener 2004-12-29, 7:06 pm |
| Steve <fjqi@hdsx.inv> wrote in news:0cq5t09gj6h6ie5b3tgo5it6m229kbrs77@
4ax.com:
> hrubin@odds.stat.purdue.edu (Herman Rubin) wrote:
>
> True. People forget that every drug is essentially a poison,
> attempting to interfere with the body's normal functioning in some
> way. We hope the side effects are more than offset by the benefits,
> but that may not always be the case, either individually or globally.
>
>
I think you're putting words into Mr. Rubin's mouth. He never used the word
"poison".
And what of drugs that attempt to interfere with the body's abnormal
functioning? Are they "poison" too?
L.
| |
| Williams 2004-12-29, 7:06 pm |
| The FDA has proved itself to be utterly worthless. If you see an ad on
TV, it's a good indication they're looking for "VOLUNTEERS"!!!!
| |
| MrPepper11 2004-12-30, 11:06 am |
| "A new analysis of four-year-old data shows a 'significant' increase in
heart attack and stroke in patients taking Vioxx after as little as six
weeks."
http://www.forbes.com/technology/20..._1230vioxx.html
Vioxx: More Debate, More Data
Matthew Herper, 12.30.04
As doctors struggle to come to grips with what the withdrawal of Vioxx
means for drug safety, the letters pages of the normally sedate New
England Journal of Medicine have turned into a battleground.
Today's issue contains a letter from Merck, defending itself against
charges from Dr. Eric Topol, the Cleveland Clinic's top cardiologist,
who has said repeatedly that the company should have known far earlier
that Vioxx increased the risk of heart attack.
It also contains Topol's response, in which he publishes a new analysis
of four-year-old data that he says shows a "significant" increase in
heart attack and stroke in patients taking Vioxx after as little as six
weeks. The data was previously available only in briefing documents
prepared by staff at the Food and Drug Administration.
The fight is more than just academic. The dueling letters are one of
the few times that Merck's scientists have publicly defended their
approach to the drug since the company pulled it off the market. And
Topol's analysis seems to show that even if Merck wasn't aware of the
possible risks to the heart posed by Vioxx, perhaps it should have
been.
In their letter, Peter Kim, Merck's research chief, and Alise Reicin,
who headed up much of the development of Vioxx, defend their company's
handling of the matter. "Merck has been proactive and conscientious in
evaluating the cardiovascular profile of rofecoxib (Vioxx)," they
write. "Dr. Topol's remarks to the contrary in his Perspective article
(Oct. 21 issue) are false."
Before 2000, they say, there was little clinical evidence of a heart
risk for Vioxx. Based on a theoretical risk alone, the executives
argue, Merck took care to watch for heart attacks and strokes in its
big clinical trial. The data from both less-reliable observational
studies and clinical trials was conflicting, and Merck began three big
cancer prevention studies that could also assess any risk Vioxx caused
to the heart. One of these studies was the one that resulted in Vioxx
being pulled from the market.
"The record, in short, is one of careful analysis at every stage, a
continued commitment to research and prompt and decisive action in
response to clinical-study results," the scientists say.
Merck's defense all along has been that Vioxx looked bad because
naproxen, another pain killer that it was compared to, actually
protected the heart. Naproxen is an older drug sold by Bayer as Aleve.
But in his response, Topol looks at data from a previous study that
compared 390 patients taking Vioxx to 588 patients taking a placebo.
The study, called 090, showed that five, or 1.3%, of patients taking
Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
placebo group. Although those numbers are small, they were
statistically significant, according to Topol. The data he based his
analysis on has previously been buried in FDA briefing documents.
Merck's Peter Kim has said in interviews that '090' was too small to be
considered a strong result.
For those that have been following the underlying scientific fight over
the testing of Vioxx, the letters are an interesting new twist. But
unfortunately for Merck, at this point the important forum for these
questions is not in The New England Journal of Medicine, but in the
courts, where the first Vioxx liability case could go to trial in 2005.
================================================================
| |
| Outrider 2004-12-30, 7:06 pm |
|
MrPepper11 wrote:
> "A new analysis of four-year-old data shows a 'significant' increase
in
> heart attack and stroke in patients taking Vioxx after as little as
six
> weeks."
>
> http://www.forbes.com/technology/20..._1230vioxx.html
>
> Vioxx: More Debate, More Data
> Matthew Herper, 12.30.04
>
> As doctors struggle to come to grips with what the withdrawal of
Vioxx
> means for drug safety, the letters pages of the normally sedate New
> England Journal of Medicine have turned into a battleground.
>
> Today's issue contains a letter from Merck, defending itself against
> charges from Dr. Eric Topol, the Cleveland Clinic's top cardiologist,
> who has said repeatedly that the company should have known far
earlier
> that Vioxx increased the risk of heart attack.
>
> It also contains Topol's response, in which he publishes a new
analysis
> of four-year-old data that he says shows a "significant" increase in
> heart attack and stroke in patients taking Vioxx after as little as
six
> weeks. The data was previously available only in briefing documents
> prepared by staff at the Food and Drug Administration.
>
> The fight is more than just academic. The dueling letters are one of
> the few times that Merck's scientists have publicly defended their
> approach to the drug since the company pulled it off the market. And
> Topol's analysis seems to show that even if Merck wasn't aware of the
> possible risks to the heart posed by Vioxx, perhaps it should have
> been.
>
> In their letter, Peter Kim, Merck's research chief, and Alise Reicin,
> who headed up much of the development of Vioxx, defend their
company's
> handling of the matter. "Merck has been proactive and conscientious
in
> evaluating the cardiovascular profile of rofecoxib (Vioxx)," they
> write. "Dr. Topol's remarks to the contrary in his Perspective
article
> (Oct. 21 issue) are false."
>
> Before 2000, they say, there was little clinical evidence of a heart
> risk for Vioxx. Based on a theoretical risk alone, the executives
> argue, Merck took care to watch for heart attacks and strokes in its
> big clinical trial. The data from both less-reliable observational
> studies and clinical trials was conflicting, and Merck began three
big
> cancer prevention studies that could also assess any risk Vioxx
caused
> to the heart. One of these studies was the one that resulted in Vioxx
> being pulled from the market.
>
> "The record, in short, is one of careful analysis at every stage, a
> continued commitment to research and prompt and decisive action in
> response to clinical-study results," the scientists say.
>
> Merck's defense all along has been that Vioxx looked bad because
> naproxen, another pain killer that it was compared to, actually
> protected the heart. Naproxen is an older drug sold by Bayer as
Aleve.
>
> But in his response, Topol looks at data from a previous study that
> compared 390 patients taking Vioxx to 588 patients taking a placebo.
> The study, called 090, showed that five, or 1.3%, of patients taking
> Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
> placebo group. Although those numbers are small, they were
> statistically significant, according to Topol. The data he based his
> analysis on has previously been buried in FDA briefing documents.
> Merck's Peter Kim has said in interviews that '090' was too small to
be
> considered a strong result.
>
> For those that have been following the underlying scientific fight
over
> the testing of Vioxx, the letters are an interesting new twist. But
> unfortunately for Merck, at this point the important forum for these
> questions is not in The New England Journal of Medicine, but in the
> courts, where the first Vioxx liability case could go to trial in
2005.
> ================================================================
Every one of the Merck exec should be brought up on charges. People
died because of the way they marketed this drug, knowingly spinning
clinical trial evidence. It did not have to be that way. They chose
that it would.
http://content.nejm.org/cgi/content/full/351/27/2875
"We indeed acknowledged that naproxen may have a cardioprotective
effect,5 but the magnitude of the effect would be unlikely to exceed
that of aspirin, at a 25 percent reduction of heart attacks. Instead,
in the VIGOR trial, there was a 500 percent increase in heart attacks.
This makes any "naproxen hypothesis" of cardioprotection mathematically
indefensible."
Eric J. Topol, M.D.
Cleveland Clinic Foundation
Cleveland, OH 44195
| |
| Herman Rubin 2004-12-30, 7:06 pm |
| In article <1104344919.067860.289990@c13g2000cwb.googlegroups.com>,
Zee <zwalanga@yahoo.com> wrote:
>Herman Rubin wrote:
[vbcol=seagreen]
[vbcol=seagreen]
>prominent
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
>There are many places a patient can get medical information and advice.
>Advertising is not one of them.
>The point being made is that DTCA is more harmful than helpful.
>DTCA is not education but rather promotion which exaggerates benefits
>and downplays risks. It does not mention none drug options, how
>prevalent the illness is, or how successful the advertised drug is
>compared to a test group that took a placebo.
Usually, the latter can be found in the PDR material, and
occasionally comparison with placebo. If the drug is not
enough better than placebo, the FDA is unlikely to approve
it as it stands. The information about the tests and their
results should be readily available, and the advertising
should say where it is. The manufacturers will supply this
if required.
As to comparing different drug options, finding this
information is quite difficult now, and the physicians
normally do not have any comparison; they may know the
options. With advertising, the public is likely to know
the options. When it comes to comparing the options,
individual variations come in quite strongly; for a
doctor to ignore these is bad medicine.
[vbcol=seagreen]
>future."
[vbcol=seagreen]
>The known information, in the past and now, does not include trials
>which found negative information.
This will not change if advertising is prohibited.
I doubt if the usage of Vioxx and Celebrex would be any
less if there had been no advertising. These are Cox-2
inhibitors, and for those with stomach or other sensitivity
to the usual NSAIDS, they were the drugs of choice before
there was advertising. Advertising may have increased the
number taking them, but those who changed to them would
not have been considered doing anything worse than possibly
spending more than necessary.
>The information
[vbcol=seagreen]
>It is de facto the same, coming primarily as it does from the same
>source.
The advertising is required to provide a fair amount of
information about side effects; the physicians do so
much less often. In fact, most physicians do not know
as much as is included in the advertising.
>Physicians on the front line get their drugs and continuing medical
>information from pharma, either delivered by pharmaceutical reps
>bearing glossy advertising brochures, by pharma sponsored seminars,
>workshops, conferences and "educational" junkets, from medical schools
>also receiving monies from pharma; pharma sponsored research, books,
>tuition, office equipment etc, and specialists acting as "consultants"
>to pharma (conflict of interest and biased information--NIH's Dr.
>Sonderland LA Times most recent example).
[vbcol=seagreen]
>Pharma spends a lot more on marketing than they do on research. See
>relevant comment in Marcia Angell's book and in the following study:
>http://www.nybooks.com/articles/17244
>http://www.familiesusa.org/site/Doc...t.pdf?docID=249
It is not so much research, as development. From the time
research, theirs or others, has produced a promising chemical,
until it is approved for the company to make available, is
likely to cost a half billion or more. Also, the ones which
do not end up being marketed, but which are tested, are likely
to run to 100 million on the average. And if the FDA does not
think they have done enough testing, back it goes.
The cost of testing is not the drug, per se. It is the medical
care of those being tested, whether given the drug or a placebo
or an alternative. There is the question of dosage, and it may
be necessary to test different dosages on thousands of people.
The "worst case" scenario is not often, but all of this enters.
It is for this reason that patents on drugs last at least until
10 years after the drug is approved for marketing; it may take
more than 10 years from the discovery of the chemical and its
possible usefulness for the approval to occur.
>the
[vbcol=seagreen]
>should
[vbcol=seagreen]
[vbcol=seagreen]
>Not long enough apparently. HRT, Baycol, Vioxx, Celebrex, Rezulin...
>And no post-marketing surveillance that pharma can wiggle out of.
Do you ever want to get a useful drug? If a drug is
suspected of increasing the cancer rate ten years down
the line, it would be at least 10 years of substantial
use before the drug can be used for any but experimental
patients.
The Rezulin problems were about one in 50,000, even
without liver testing. For HRT, many studies of
several years produced no indication of an increase
in cardiovascular problems, until there was a long
study with carefully randomized patients. This is
very difficult to do, as for any long study, many will
drop out.
[vbcol=seagreen]
[vbcol=seagreen]
>The are attempting to restrict advertising, not information.
At this time, it seems the AMA at least wants to restrict
information. In fact, our miseducational system has done
its best to see that laypeople have difficulty in finding
and getting the information, as does the medical establishment
until recently. Instead of advertising, we will have people
looking in the literature and finding a posting of some kind,
and there are many of those now, and disseminating it. These
disseminations are not as subject to regulations as advertising.
I have followed up on several of those, and find them to be
lacking, including some on which medical decisions have been
based by those whose knowledge of statistics is pure religion.
>However, I believe that the
[vbcol=seagreen]
>Will we get them to sign a release for every pill they take? Will
>translators be used? How will we ensure all with varying levels of
>education and comprehension are being served? Will we use the models
>courts use for non-English speakers, or those with established
>cognitive 'challenges'? How can we be sure the patient wasn't
>emotionally overcome and willing to sign do and accept anything (as
>they often are even in the abscence of this scenario?)
If you do not allow this, you will not be able to get any
drugs. Have you seen the suit about children's Aleve?
Considering that millions take it, do you not think that
someone will react badly?
We certainly can see that the medical information is
translated. For those with cognitive "challenges", we
have problems in any case. If a manufacturer states
that one in 10,000 may get such a side effect from the
drug, should there be any liability if that side effect
occurs to that one? Take a look at any drug in the PDR,
and see the information on side effects and indications
of serious adverse reactions. Much of that is required
to be in the advertising.
[vbcol=seagreen]
>Again you *assume* that advertising is analagous to education. It is
>not. education is never, nor should it be, so one-sided and so focussed
>to a goal determined in a marketing department.
As I stated, the drug advertising I have seen in magazines
and on television is quite fair. For prescription drugs,
one would have to see a doctor in any case.
>they
[vbcol=seagreen]
>Patients can only make decisions based on the best available evidence.
>And if the best available evidence is not all the available evidence,
>and the patient is compromised in understanding, then the patient needs
>an unbiased and uncompromised physican *as well as* his or her own best
>efforts, to comprehend what his or her options are.
It is often the case that a patient has more available
evidence than most physicians. There was even one case
when I asked a faculty member at a medical school about
certain properties of a drug. He considered the question
reasonable, but did not find the information in the
medical sources in his office. It took some "googling"
by me to find it.
>and recourse should require showing fraud or
[vbcol=seagreen]
>Your perspective here would entangle healthcare and all its players
>even further into the litigious system you decry.
No, it would not. If someone sues a manufacturer for
events warned by the manufacturer, the one suing
would have to pay all costs, including the costs of
the manufacturer defending it. The same would be the
case for suits against doctors for not achieving the
best possible results.
The present litigous system is due to expecting that
all drugs are "safe and effective", and that if there
are bad results in an operation, the doctor must have
done something drastically wrong. We need to educate
people to the fact that everything has risks and
benefits, and as long as they, including the best
estimate of the odds, are clearly stated, that there
is no liability for poor results.
Not only would we have to educate the public, but the
physicians. They do not know how to think that way.
We also are likely to need to provide computer programs
for the evaluation; I am quite adept at both theory and
computation, and I am likely to need that.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| Herman Rubin 2004-12-30, 7:06 pm |
| In article <1104426922.180905.180070@z14g2000cwz.googlegroups.com>,
Outrider <fresh~horses@despammed.com> wrote:
>MrPepper11 wrote:
>in
>six
Yes, but it took four years for them to get the increased
number of heart attacks and strokes.
It also has to be compared to the benefits which they got.
..................
[vbcol=seagreen]
>analysis
>six
In that case, the FDA bears some of the responsibility.
...................
[vbcol=seagreen]
>big
>caused
[vbcol=seagreen]
[vbcol=seagreen]
>Aleve.
Do you have any idea what statistical significance means?
I doubt that Topol does. In this case, a one-sided result
this strong or stronger would occur by chance one time in 25
if there was ABSOLUTELY NO difference, which is less than the
usual significance level, one in 20. This is all it means.
But in any case, the question has to be asked whether the
additional 1%, or even 5%, chance of cardiovascular
problems is worth the benefits of being able to take the
drug without gastrointestinal problems. Naproxen has
fewer such problems than aspirin, but it has them.
The data he based his[vbcol=seagreen]
>be
[vbcol=seagreen]
>over
>2005.
>Every one of the Merck exec should be brought up on charges. People
>died because of the way they marketed this drug, knowingly spinning
>clinical trial evidence. It did not have to be that way. They chose
>that it would.
If they had not marketed the drug, how many would be
severely suffering from arthritis, unable to move
about, or even in pain? ALL drugs have benefits and
risks, and these should be spelled out to the extent
known, and the individual make the decision, including
what is known about individual behavior.
>http://content.nejm.org/cgi/content/full/351/27/2875
>"We indeed acknowledged that naproxen may have a cardioprotective
>effect,5 but the magnitude of the effect would be unlikely to exceed
>that of aspirin, at a 25 percent reduction of heart attacks. Instead,
>in the VIGOR trial, there was a 500 percent increase in heart attacks.
>This makes any "naproxen hypothesis" of cardioprotection mathematically
>indefensible."
>Eric J. Topol, M.D.
>Cleveland Clinic Foundation
>Cleveland, OH 44195
As the blood-thinning properties of aspirin make it the
drug of choice in preventing cardiovascular problems, this
is almost a ridiculous statement. But we still have the
problem of providing pain relief without doing too much
other damage, and one reason why acetomenaphen (sp?) is
used so much is that it does not have the stomach acidity
reaction of aspirin; naproxen is in between, and the
Cox-2 inhibitors work in a different manner.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
|
| hrubin@odds.stat.purdue.edu (Herman Rubin) wrote:
>Do you have any idea what statistical significance means?
>I doubt that Topol does. In this case, a one-sided result
>this strong or stronger would occur by chance one time in 25
>if there was ABSOLUTELY NO difference, which is less than the
>usual significance level, one in 20. This is all it means.
>But in any case, the question has to be asked whether the
>additional 1%, or even 5%, chance of cardiovascular
>problems is worth the benefits of being able to take the
>drug without gastrointestinal problems.
I suspect very few folks have any understanding of the statistics
involved. It'll be interesting to see if Merck's attorneys are able
to explain this stuff to juries. The case against Merck is not nearly
as clear cut as people think, and the results of a trial could be a
big surprise (which would doubtless have everyone talking about those
"dumb jurors")
| |
| outrider 2004-12-30, 7:06 pm |
|
Herman Rubin wrote:
> In article <1104426922.180905.180070@z14g2000cwz.googlegroups.com>,
> Outrider <fresh~horses@despammed.com> wrote:
>
increase[vbcol=seagreen]
as[vbcol=seagreen]
>
> Yes, but it took four years for them to get the increased
> number of heart attacks and strokes.
>
They knew and suppressed the data which showed a significant problem
"within six weeks". (the origininating post).
> It also has to be compared to the benefits which they got.
If all this is washed away by a flood of mistrust, pharma and FDA have
no one to blame but themselves. Consumers simply do not trust them
anymore to act in the best interests of healthcare, over stockholders
share.
>
> ..................
>
>
in[vbcol=seagreen]
as[vbcol=seagreen]
documents[vbcol=seagreen]
>
> In that case, the FDA bears some of the responsibility.
Yes they most certainly do. Some might say, more responsibility.
Pat Oliphant Dec 20
http://www.ucomics.com/patoliphant/2004/12/20/
heart[vbcol=seagreen]
its[vbcol=seagreen]
Vioxx[vbcol=seagreen]
>
a[vbcol=seagreen]
>
>
that[vbcol=seagreen]
placebo.[vbcol=seagreen]
taking[vbcol=seagreen]
the[vbcol=seagreen]
>
> Do you have any idea what statistical significance means?
> I doubt that Topol does.
No. Like Topol most surely did in this situation, I would hire someone
who does.
In this case, a one-sided result
> this strong or stronger would occur by chance one time in 25
> if there was ABSOLUTELY NO difference, which is less than the
> usual significance level, one in 20. This is all it means.
>
> But in any case, the question has to be asked whether the
> additional 1%, or even 5%, chance of cardiovascular
> problems is worth the benefits of being able to take the
> drug without gastrointestinal problems.
They did not cause less gastrointestinal problems. (Are you reading the
newest literature on this?)
Naproxen has
> fewer such problems than aspirin, but it has them.
Naproxen raised heart attack risk. I'll take buffered aspirin. And if
it still bothers my stomach I'll take it with a meal. And if I still
have problems, I'll use prilosec or something as little problematic as
I can. I may try glucosamine and chondwhatever; I may also investigate
two nutraceuticals which have recently been mentioned on these
newsgroups. I will use ice, heat, postural modification and physical
therapy. Consistently. Not "try" but will.
>
> The data he based his
to[vbcol=seagreen]
>
But[vbcol=seagreen]
these[vbcol=seagreen]
the[vbcol=seagreen]
>
>
> If they had not marketed the drug, how many would be
> severely suffering from arthritis, unable to move
> about, or even in pain?
vida supra
ALL drugs have benefits and
> risks, and these should be spelled out to the extent
> known, and the individual make the decision, including
> what is known about individual behavior.
They should be spelled out. Period. The extent known, must be all
discovered. To date it has not. So this *must* change. Too bad it took
a Vioxx to bring this about.
>
>
Instead,[vbcol=seagreen]
attacks.[vbcol=seagreen]
mathematically[vbcol=seagreen]
>
> As the blood-thinning properties of aspirin make it the
> drug of choice in preventing cardiovascular problems, this
> is almost a ridiculous statement.
Really? If statins act not by lowering cholesterol but by temporing
inflammation in the way aspirin does, why then do people not just take
the less problematic and cheaper aspirin? Because, I would say, a
couple billion has not been spent telling us we are beautiful people
leaping around in the surf and aspirin got us there.
But we still have the
> problem of providing pain relief
I contend many do not do what they could and should before they take
painkillers. In rheumatoiod arthritis, this is different. But that is
not the majority of those using these drugs for what I think is often
frivolous reasons.
without doing too much
> other damage, and one reason why acetomenaphen (sp?) is
> used so much is that it does not have the stomach acidity
> reaction of aspirin; naproxen is in between, and the
> Cox-2 inhibitors work in a different manner.
>
>
> --
> This address is for information only. I do not claim that these
views
> are those of the Statistics Department or of Purdue University.
> Herman Rubin, Department of Statistics, Purdue University
> hrubin@stat.purdue.edu Phone: (765)494-6054 FAX:
(765)494-0558
| |
|
|
Herman Rubin wrote:
> In article <1104344919.067860.289990@c13g2000cwb.googlegroups.com>,
> Zee <zwalanga@yahoo.com> wrote:
>
>
>
allowing[vbcol=seagreen]
>
>
>
>
advice.[vbcol=seagreen]
>
>
benefits[vbcol=seagreen]
>
> Usually, the latter can be found in the PDR material,
C'mon. I am not going to buy this and update it and lug it around.
Most physicians (and pharmacists) do not read the PDR. Many physicans
are surprised to learn, for example, that there are tear-out ADR forms
in the back of this tome. A couple weeks ago I did a telephone
interview with a local pharmacist, the owner of a couple pharmacies one
located across from our university medical school. He was stunned to
find, following my directions, particular information about a statin
which every statin user who has suffered adverse effects knows. His
volume was 2 years out-of-date. The situation is worse with large
franchised (Costco) pharmacies. Do not startle them by asking for any
actual medical info.
and
> occasionally comparison with placebo. If the drug is not
> enough better than placebo, the FDA is unlikely to approve
> it as it stands.
I *have* seen something like that on the back of those glossy ads
showing preturnaturally taut-skinned septugenarian surfers. Prob is,
the people to whom these meds are being pitched cannot read print that
is font size 4.
And if they could, most of them would not understand it.
The information about the tests and their
> results should be readily available,
Yes it should. Isn't.
and the advertising
> should say where it is. The manufacturers will supply this
> if required.
Really! Dr. Rubin. Really? Have you got shares in Conde Nast or
something?
>
> As to comparing different drug options, finding this
> information is quite difficult now, and the physicians
> normally do not have any comparison; they may know the
> options.
With advertising, the public is likely to know
> the options.
Show me an one of those Viagra ads where it says something like: oh and
check out our competition's drugs that do the same thing, possibly
cheaper. Or, if you really are having probs, maybe better to talk to
your wife about what's going on in your marriage, and/or, your doctor
about what's going on with your health that could be causing this. Or:
do not use this drug for a weekend frat party.
And even if they did, this text is completely subverted by the sub-text
of the pictures and the leaping grinning satisfied customers.
When it comes to comparing the options,
> individual variations come in quite strongly; for a
> doctor to ignore these is bad medicine.
Dr. Rubin no-one knew the options on say, Nexium (prilosec does job
more cheaply and safely) or any number of drugs pushed this way. And by
the way, you are not going to see a Conde Nast publication with a
double-truck ad on...toenail fungus.
>
and[vbcol=seagreen]
>
Topol[vbcol=seagreen]
an[vbcol=seagreen]
>
>
>
>
> This will not change if advertising is prohibited.
>
> I doubt if the usage of Vioxx and Celebrex would be any
> less if there had been no advertising. These are Cox-2
> inhibitors, and for those with stomach or other sensitivity
> to the usual NSAIDS, they were the drugs of choice before
> there was advertising. Advertising may have increased the
> number taking them, but those who changed to them would
> not have been considered doing anything worse than possibly
> spending more than necessary.
>
>
>
> The advertising is required to provide a fair amount of
> information about side effects; the physicians do so
> much less often. In fact, most physicians do not know
> as much as is included in the advertising.
>
schools[vbcol=seagreen]
"consultants"[vbcol=seagreen]
>
>
>
> It is not so much research, as development. From the time
> research, theirs or others, has produced a promising chemical,
> until it is approved for the company to make available, is
> likely to cost a half billion or more. Also, the ones which
> do not end up being marketed, but which are tested, are likely
> to run to 100 million on the average. And if the FDA does not
> think they have done enough testing, back it goes.
>
> The cost of testing is not the drug, per se. It is the medical
> care of those being tested, whether given the drug or a placebo
> or an alternative. There is the question of dosage, and it may
> be necessary to test different dosages on thousands of people.
> The "worst case" scenario is not often, but all of this enters.
> It is for this reason that patents on drugs last at least until
> 10 years after the drug is approved for marketing; it may take
> more than 10 years from the discovery of the chemical and its
> possible usefulness for the approval to occur.
>
in[vbcol=seagreen]
>
to[vbcol=seagreen]
>
>
>
> Do you ever want to get a useful drug? If a drug is
> suspected of increasing the cancer rate ten years down
> the line, it would be at least 10 years of substantial
> use before the drug can be used for any but experimental
> patients.
>
> The Rezulin problems were about one in 50,000, even
> without liver testing. For HRT, many studies of
> several years produced no indication of an increase
> in cardiovascular problems, until there was a long
> study with carefully randomized patients. This is
> very difficult to do, as for any long study, many will
> drop out.
>
>
>
>
> At this time, it seems the AMA at least wants to restrict
> information. In fact, our miseducational system has done
> its best to see that laypeople have difficulty in finding
> and getting the information, as does the medical establishment
> until recently. Instead of advertising, we will have people
> looking in the literature and finding a posting of some kind,
> and there are many of those now, and disseminating it. These
> disseminations are not as subject to regulations as advertising.
> I have followed up on several of those, and find them to be
> lacking, including some on which medical decisions have been
> based by those whose knowledge of statistics is pure religion.
>
>
>
> If you do not allow this, you will not be able to get any
> drugs. Have you seen the suit about children's Aleve?
> Considering that millions take it, do you not think that
> someone will react badly?
>
> We certainly can see that the medical information is
> translated. For those with cognitive "challenges", we
> have problems in any case. If a manufacturer states
> that one in 10,000 may get such a side effect from the
> drug, should there be any liability if that side effect
> occurs to that one? Take a look at any drug in the PDR,
> and see the information on side effects and indications
> of serious adverse reactions. Much of that is required
> to be in the advertising.
>
>
focussed[vbcol=seagreen]
>
> As I stated, the drug advertising I have seen in magazines
> and on television is quite fair. For prescription drugs,
> one would have to see a doctor in any case.
>
>
evidence.[vbcol=seagreen]
evidence,[vbcol=seagreen]
needs[vbcol=seagreen]
best[vbcol=seagreen]
>
> It is often the case that a patient has more available
> evidence than most physicians. There was even one case
> when I asked a faculty member at a medical school about
> certain properties of a drug. He considered the question
> reasonable, but did not find the information in the
> medical sources in his office. It took some "googling"
> by me to find it.
>
>
>
> No, it would not. If someone sues a manufacturer for
> events warned by the manufacturer, the one suing
> would have to pay all costs, including the costs of
> the manufacturer defending it. The same would be the
> case for suits against doctors for not achieving the
> best possible results.
We in Canada by and large are not a litigious society. I do not even
consider this sort of thing and think, basically, this is reason why
things have gone so wrong in America. It is get away with what you can,
until you are stopped. Sue someone, they pay, and procedd with business
as usual. Wrong wrong wrong.
> The present litigous system is due to expecting that
> all drugs are "safe and effective", and that if there
> are bad results in an operation, the doctor must have
> done something drastically wrong. We need to educate
> people to the fact that everything has risks and
> benefits, and as long as they, including the best
> estimate of the odds, are clearly stated, that there
> is no liability for poor results.
Well good luck because I think as I have said above. And the major
thing that is going to change this in this situation is more and better
controls, and regulatory bodies which implement this and perform their
mandate.
>
> Not only would we have to educate the public, but the
> physicians. They do not know how to think that way.
> We also are likely to need to provide computer programs
> for the evaluation; I am quite adept at both theory and
> computation, and I am likely to need that.
Yes. Medical education has to be freed from pharma, industry, business,
control. Physicians need to become physicians again, not pill
dispensers. For example, I cannot even see my endocrinologist because I
refuse to take a cholesterol lowering med. He does not see that his
function is to help me achieve a certain goal, but only to achieve it
with the medications made by the pharma which funds his clinic, his
research, and pays him a fee per patient enrolled.
Zee
>
> --
> This address is for information only. I do not claim that these
views
> are those of the Statistics Department or of Purdue University.
> Herman Rubin, Department of Statistics, Purdue University
> hrubin@stat.purdue.edu Phone: (765)494-6054 FAX:
(765)494-0558
| |
| reeder 2004-12-31, 7:06 pm |
| On 30 Dec 2004 16:28:34 -0800, "outrider" <outrider@despammed.com>
wrote:
>
>Herman Rubin wrote:
>increase
>as
>
>They knew and suppressed the data which showed a significant problem
>"within six weeks". (the origininating post).
From the web site "VIOXX - the painful story of politics, business and
statistics errors"
http://www.interconus.com/products_dynatrack.htm
A theory that attributes the increased risk to abnormal changes in the
structure or shape of lipids caused uniquely by Vioxx, may explain why
LDLs are more susceptible to oxidative damage, and therefore,
contribute to cardiovascular damage. Such potential damage should be
monitored and reversed...
Question: How do you "reverse" the Vioxx damage?
| |
| reeder 2004-12-31, 7:06 pm |
| On 30 Dec 2004 16:00:24 -0500, hrubin@odds.stat.purdue.edu (Herman
Rubin) wrote:
>
>Do you have any idea what statistical significance means?
>
>I doubt that Topol does.
I'm sure Dr. Topol must have taken Statistics 101 in college:
Dr. Eric J. Topol is Chief Academic Officer of The Cleveland Clinic
Foundation and Provost of the Cleveland Clinic Lerner college of
Medicine of Case Western Reserve University. He is also Chairman of
the Department of Cardiovascular Medicine and Professor of Medicine
and Genetics. He is Program Director for the NIH supported Specialized
Center of Clinically Oriented Research (SCCOR) on the molecular basis
of coronary artery disease. He is certified as a Diplomate by the
National Board of Medical Examiners, and as a Diplomate by the
American Board of Internal Medicine in cardiovascular disease and
internal medicine.
Dr. Topol has been elected to the American Association of Physicians,
the American Society of Clinical Investigation, and the Johns Hopkins
Society of Scholars. He is a Fellow of the American college of
Cardiology, the American college of Physicians, and the European
Society of Cardiology. He has been recognized by the Institute of
Scientific Information (ISI) to be in the top 10 (#8) of cited
biomedical researchers in medicine (1993-2003), and he is ranked 1st
by Science Watch among authors of high impact papers in cardiovascular
research (1993-2003). His work on the genomics of coronary disease led
to the discovery of the first mutation (MEF2A deletion) inducing
coronary disease and heart attack (Science, 2003), and received
recognition as a top 10 research advance by the American Heart
Association, garnering Dr. Topol the Clinical Research Innovator Award
of the Doris Duke Charitable Foundation in 2001. The cardiology
program he directs in Cleveland has been ranked Number 1 in the United
States by U.S. News & World Report for the past 10 years.
Dr. Topol has served as chairman and principal investigator for more
than 15 international multi-center randomized clinical trials,
including the 5 GUSTO trials, the largest heart attack studies ever
conducted, and many others, with cumulatively more than 200,000
patients enrolled. He was the first physician ever to administer
recombinant t-PA, 2 different platelet glycoprotein IIb/IIIa
inhibitors (abciximab and eptifibatide), and a novel anticoagulant
(bivalirudin) to patients with coronary artery disease. The results of
these large-scale trials, involving 40 countries around the world,
have substantially changed our approach to patients with acute MI,
percutaneous coronary interventions, and unstable angina.
Currently he serves on the editorial board for over 20 peer-reviewed
medical publications including Circulation, Circulation Research,
Journal of the American college of Cardiology, American Journal of
Cardiology, Heart and the European Heart Journal. He has over 900
original publications and has edited 18 books, including the Textbook
of Interventional Cardiology (1s through 4th editions) and the
Textbook of Cardiovascular Medicine, the third edition now in
preparation.
http://www.clevelandclinic.org/
| |
|
| reeder <N0.NE@aol.com> wrote:
>
>I'm sure Dr. Topol must have taken Statistics 101 in college:
Not necessarily. Doctors are notoriously bad at statistics. As a
result, they consistently misinterpret and mis-communicate the results
of tests.
| |
| Williams 2005-01-01, 2:06 am |
| The FDA has proved itself to be utterly worthless. If you see an ad on
TV, it's a good indication they're looking for "VOLUNTEERS"!!!!
| |
| Williams 2005-01-01, 2:06 am |
| The FDA has proved itself to be utterly worthless. If you see an ad on
TV, it's a good indication they're looking for "VOLUNTEERS"!!!!
| |
| Andrew B. Chung, MD/PhD 2005-01-01, 4:06 am |
| MrPepper11 wrote:
>
> Los Angeles Times
> December 29, 2004
>
> Cardiologist Criticizes Drug Ads Aimed at the Public
> By Ricardo Alonso-Zaldivar, Times Staff Writer
>
> WASHINGTON - The government should reassess its policy of allowing
> prescription drugs to be advertised directly to consumers, a prominent
> cardiologist urged Tuesday in the Journal of the American Medical
> Association.
>
> The heart attack risks of arthritis painkillers Vioxx, Bextra and
> Celebrex have exposed a regulatory "house of cards" at the Food and
> Drug Administration, wrote Dr. Eric J. Topol, chairman of
> cardiovascular medicine at the Cleveland Clinic.
>
> "Unbridled promotion exacerbated the public health problem," Topol
> concluded. "The combination of mass promotion of a medicine with an
> unknown and suspect safety profile cannot be tolerated in the future."
>
> FDA officials have not publicly addressed the issue of whether
> high-powered advertising campaigns for newly approved drugs are in the
> best interest of public health.
>
> Other leading academic researchers have suggested that new drugs should
> be subject to a trial period before they can be touted directly to
> patients.
>
> Topol's sharply worded opinion article, to be published next month, was
> posted on the medical journal's website as part of the growing debate.
>
> Critics have accused the FDA of being too cozy with the drug industry
> and unwilling to pursue evidence of problems with medications that it
> has already approved.
>
> Manufacturer Merck & Co. withdrew Vioxx from the market in late
> September after a company-sponsored study confirmed research by Topol
> and others that it increased chances of heart attacks and strokes.
> Topol was among the chief critics of the drug.
>
> New warnings have been added to the Bextra label, and concerns have
> been raised
Yes, folks are going to be crippled by their osteoarthritis in the
middle of these concerns.
> about possible problems with Celebrex, both produced by
> Pfizer Inc. The company recently agreed to suspend Celebrex advertising
> while experts sorted out preliminary study findings that indicated a
> heart risk for patients taking a high dose over many months.
>
> All three drugs are of the same family of chemical compounds.
>
> Celebrex and Vioxx, taken by millions of patients worldwide, were
> heavily advertised on television and in magazines and were considered
> blockbuster successes for their manufacturers. But though Vioxx had
> fewer side effects on the stomach than earlier generations of arthritis
> medicines, none of the three drugs was proved to be markedly better at
> reducing pain.
>
> "These drugs were mass-marketed from the moment they were commercially
> available in the new world of direct-to-consumer advertising, with
> unrealistic expectations about pain relief, marked gastrointestinal
> protection and safety," wrote Topol. "One has to question the wisdom of
> allowing direct-to-consumer advertising for lifestyle medications that
> have no capability of preserving life or preventing major events such
> as [heart attack] or stroke."
Without God there can be no wisdom.
Thanks for the article, Zee.
May God bless you this New Year's day, in Christ's name.
At His service,
Andrew
--
Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
**
Suggested Reading:
(1) http://makeashorterlink.com/?L26062048
(2) http://makeashorterlink.com/?O2F325D1A
(3) http://makeashorterlink.com/?X1C62661A
(4) http://makeashorterlink.com/?U1E13130A
(5) http://makeashorterlink.com/?K6F72510A
(6) http://makeashorterlink.com/?I24E5151A
(7) http://makeashorterlink.com/?I22222129
| |
| Herman Rubin 2005-01-01, 7:06 pm |
| In article <1104452914.381959.29500@c13g2000cwb.googlegroups.com>,
outrider <outrider@despammed.com> wrote:
>Herman Rubin wrote:
[vbcol=seagreen]
>increase
>as
[vbcol=seagreen]
[vbcol=seagreen]
>They knew and suppressed the data which showed a significant problem
>"within six weeks". (the origininating post).
[vbcol=seagreen]
>If all this is washed away by a flood of mistrust, pharma and FDA have
>no one to blame but themselves. Consumers simply do not trust them
>anymore to act in the best interests of healthcare, over stockholders
>share.
..................
>in
>as
>documents
[vbcol=seagreen]
[vbcol=seagreen]
>Yes they most certainly do. Some might say, more responsibility.
>Pat Oliphant Dec 20
>http://www.ucomics.com/patoliphant/2004/12/20/
>heart
>its
>Vioxx
[vbcol=seagreen]
>a
[vbcol=seagreen]
[vbcol=seagreen]
>that
>placebo.
>taking
>the
[vbcol=seagreen]
[vbcol=seagreen]
>No. Like Topol most surely did in this situation, I would hire someone
>who does.
On this, you are almost certainly wrong. Statistical
significance is the mantra of the religious (meaning
ritualistic) use of statistics by people in the
medical field.
>In this case, a one-sided result
[vbcol=seagreen]
[vbcol=seagreen]
>They did not cause less gastrointestinal problems. (Are you reading the
>newest literature on this?)
If they did not, they never would have made it. At any
rate, they do work in a different manner than NSAIDs.
>Naproxen has
[vbcol=seagreen]
>Naproxen raised heart attack risk. I'll take buffered aspirin. And if
>it still bothers my stomach I'll take it with a meal. And if I still
>have problems, I'll use prilosec or something as little problematic as
>I can. I may try glucosamine and chondwhatever; I may also investigate
>two nutraceuticals which have recently been mentioned on these
>newsgroups. I will use ice, heat, postural modification and physical
>therapy. Consistently. Not "try" but will.
As we say in the diabetic newsgroup, your mileage may vary.
BTW, using Naproxen has been shown to reduce the
cardiovascular benefits of aspirin if taken together, but
it does have benefits. With the present attitude toward
side effects, I am surprised that aspirin has not been
withdrawn. However, I have never had any stomach problems
from aspirin, and what I take is not buffered.
I am taking a proton pump inhibitor, and it is doing its
job. But it seems that proton pump inhibitors increase the
occurrence of bacterial and viral infections; this is
because the first line of defense against them is stomach
acid.
People in a clinical trial, or other double-blind test, are
less likely to have non-major problems that unmonitored
people have because of the medical care from the trial.
>to
Definitely. One problem in using "statistical significance",
which I, as a statistician understanding the problem, which
is decision making under uncertainty, would never use as such,
is that it requires that there be a "balanced random" sample.
This is never the case. One can never prove something by
statistics, and can only revise the odds.
[vbcol=seagreen]
>But
>these
>the
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
>vida supra
>ALL drugs have benefits and
[vbcol=seagreen]
>They should be spelled out. Period. The extent known, must be all
>discovered. To date it has not. So this *must* change. Too bad it took
>a Vioxx to bring this about.
But at this time it is not, and I doubt this will get the
FDA to change their policy of concealment, which is a
necessary part of their withholding drugs from the market.
The policy should be to make the information available,
and let the user decide. The information available is
far less than that, in both directions.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| Herman Rubin 2005-01-01, 7:06 pm |
| In article <p22bt013g0fv1j3fbe9trk6nf00vt8l5p6@4ax.com>,
reeder <N0.NE@aol.com> wrote:
>On 30 Dec 2004 16:28:34 -0800, "outrider" <outrider@despammed.com>
>wrote:
.................
[vbcol=seagreen]
>From the web site "VIOXX - the painful story of politics, business and
>statistics errors"
>http://www.interconus.com/products_dynatrack.htm
>A theory that attributes the increased risk to abnormal changes in the
>structure or shape of lipids caused uniquely by Vioxx, may explain why
>LDLs are more susceptible to oxidative damage, and therefore,
>contribute to cardiovascular damage. Such potential damage should be
>monitored and reversed...
>Question: How do you "reverse" the Vioxx damage?
First of all, there is a question whether this theory
is correct. It would not surprise me that any drug
might have this side effect, but as stated this is
not verified.
If you are aware of the mass of literature on oxidative
damage, you could come up with quite a few possibilities.
What is known about the complicated biochemistry involved
is almost zilch, and this research is not the type which
gets the big funding.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| Herman Rubin 2005-01-01, 7:06 pm |
| In article <fv2bt0h1uj4sbdi315ba60cucn0vc64oua@4ax.com>,
reeder <N0.NE@aol.com> wrote:
>On 30 Dec 2004 16:00:24 -0500, hrubin@odds.stat.purdue.edu (Herman
>Rubin) wrote:
[vbcol=seagreen]
[vbcol=seagreen]
>I'm sure Dr. Topol must have taken Statistics 101 in college:
Statistics is not a normal part of the pre-med program.
Also, methods courses make it difficult to understand
concepts, and Statistics 101 is almost always a methods
course. Any attempt to teach it otherwise would cause
students who do not have a fairly strong mathematics
backgroumd to get the material in another department,
often under the name "research methods".
I have heard of someone submitting results to a medical
journal being told to collect more data until the
results were significant at the 5% level and then the
paper would be published. This invalidates much of
the religious use of statistics in medicine.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| George Conklin 2005-01-01, 7:06 pm |
|
"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
news:cr72k2$2fu4@odds.stat.purdue.edu...
> In article <p22bt013g0fv1j3fbe9trk6nf00vt8l5p6@4ax.com>,
> reeder <N0.NE@aol.com> wrote:
>
>
>
> .................
>
>
>
> First of all, there is a question whether this theory
> is correct. It would not surprise me that any drug
> might have this side effect, but as stated this is
> not verified.
>
> If you are aware of the mass of literature on oxidative
> damage, you could come up with quite a few possibilities.
> What is known about the complicated biochemistry involved
> is almost zilch, and this research is not the type which
> gets the big funding.
>
The whole problem with medicine is that the biochemistry of the human
animal is still mostly unknown, as in, "What causes cancer" and similar
questions.
| |
| George Conklin 2005-01-01, 7:06 pm |
|
"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
news:cr71ig$5240@odds.stat.purdue.edu...
>
> Definitely. One problem in using "statistical significance",
> which I, as a statistician understanding the problem, which
> is decision making under uncertainty, would never use as such,
> is that it requires that there be a "balanced random" sample.
> This is never the case. One can never prove something by
> statistics, and can only revise the odds.
>
My my Herman. At it again. Knowing the odds is what we need. The
biology of the human animal is far, far from known so the odds is what we go
on. You know that. Why rant and rave?
> But at this time it is not, and I doubt this will get the
> FDA to change their policy of concealment,
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
Herman, I did not know you were paranoid too. I thought you were just
thinking that the rabbit and the ant would solve social probems!!!
| |
| George Conklin 2005-01-01, 7:06 pm |
|
"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
news:cr736m$jcs@odds.stat.purdue.edu...
> In article <fv2bt0h1uj4sbdi315ba60cucn0vc64oua@4ax.com>,
> reeder <N0.NE@aol.com> wrote:
>
>
>
>
> Statistics is not a normal part of the pre-med program.
>
> Also, methods courses make it difficult to understand
> concepts, and Statistics 101 is almost always a methods
> course. Any attempt to teach it otherwise would cause
> students who do not have a fairly strong mathematics
> backgroumd to get the material in another department,
> often under the name "research methods".
>
> I have heard of someone submitting results to a medical
> journal being told to collect more data until the
> results were significant at the 5% level and then the
> paper would be published. This invalidates much of
> the religious use of statistics in medicine.
Which comment invalidates the use of the .05 level Herman?
| |
| reeder 2005-01-02, 4:06 am |
| On 1 Jan 2005 16:03:18 -0500, hrubin@odds.stat.purdue.edu (Herman
Rubin) wrote:
>In article <fv2bt0h1uj4sbdi315ba60cucn0vc64oua@4ax.com>,
>reeder <N0.NE@aol.com> wrote:
>
>
>
>
>Statistics is not a normal part of the pre-med program.
>
>Also, methods courses make it difficult to understand
>concepts, and Statistics 101 is almost always a methods
>course. Any attempt to teach it otherwise would cause
>students who do not have a fairly strong mathematics
>backgroumd to get the material in another department,
>often under the name "research methods".
->>But in his response, Topol looks at data from a previous study that
compared 390 patients taking Vioxx to 588 patients taking a placebo.
The study, called 090, showed that five, or 1.3%, of patients taking
Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
placebo group. Although those numbers are small, they were
statistically significant, according to Topol. The data he based his
analysis on has previously been buried in FDA briefing documents. <<-
I would submit that to most educated people, a product or process
which produces a 0.2% defect rate is a helluvalot preferable to one
which produces a 1.3% defect rate.
| |
| Herman Rubin 2005-01-03, 11:06 am |
| In article <6ZFBd.14627$RH4.7093@newsread1.news.pas.earthlink.net>,
George Conklin <georgeconklin1@earthlink.net> wrote:
>"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
>news:cr736m$jcs@odds.stat.purdue.edu...
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
> Which comment invalidates the use of the .05 level Herman?
The use of the .05 level, or the p-value which is a little
more detailed, tells me nothing about the effectiveness of
the new treatment. I do not need any information to tell
me that there is a difference, so why should I consider a
test that there is no difference to be of any import?
Also, there is a lot of use of meta-analysis recently in
medicine. For this to be as stated, it must include all
previous studies, not just those published. While some
studies in which some "non-significant" effects for a
particular criterion get published because something else
is significant, it will still be the case that the sample
can be highly biased. Large numbers are no protection.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| Herman Rubin 2005-01-03, 11:06 am |
| In article <57gft05gqormdfei6l9i73qrh80iavb27r@4ax.com>,
reeder <N0.NE@aol.com> wrote:
>On 1 Jan 2005 16:03:18 -0500, hrubin@odds.stat.purdue.edu (Herman
>Rubin) wrote:
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
>->>But in his response, Topol looks at data from a previous study that
>compared 390 patients taking Vioxx to 588 patients taking a placebo.
>The study, called 090, showed that five, or 1.3%, of patients taking
>Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
>placebo group. Although those numbers are small, they were
>statistically significant, according to Topol. The data he based his
>analysis on has previously been buried in FDA briefing documents. <<-
>I would submit that to most educated people, a product or process
>which produces a 0.2% defect rate is a helluvalot preferable to one
>which produces a 1.3% defect rate.
From this standpoint, all products have "defects". The
question is, are the good points better than the bad ones?
The "statistical testing" is whether the decay rates are
equal. We do not know that the defect rate is 1.3% for
Vioxx and 0.2% for the other painkiller; it could not have
been a placebo, or the difference in the rates of reducing
pain would have been obvious. The relative accuracy of the
estimate of a low rate depends on the number defective,
regardless of sample size.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| William Wagner 2005-01-03, 11:06 am |
| In article <crbqor$4tmg@odds.stat.purdue.edu>,
hrubin@odds.stat.purdue.edu (Herman Rubin) wrote:
> Also, there is a lot of use of meta-analysis recently in
> medicine. For this to be as stated, it must include all
> previous studies, not just those published. While some
> studies in which some "non-significant" effects for a
> particular criterion get published because something else
> is significant, it will still be the case that the sample
> can be highly biased. Large numbers are no protection.
If this were to determine a gold or any other mine it would be funny.
Can you imagine this bore hole says 150 meters of a rich deposit. Just
forget the other borehole data.
Thanks Herman!
Bill who wonders what the distribution of common sense is these days.
--
Zone 5 S Jersey USA Shade
Serious Vision Problems like Starghartıs ?
--> http://www.ocutech.com/
| |
|
| hrubin@odds.stat.purdue.edu (Herman Rubin) wrote:
>
>This is totally unclear. ALL medications have risks and
>benefits; what is needed is to provide the known information,
>and let people make up their own minds.
True. People forget that every drug is essentially a poison,
attempting to interfere with the body's normal functioning in some
way. We hope the side effects are more than offset by the benefits,
but that may not always be the case, either individually or globally.
| |
| George Conklin 2005-01-03, 7:06 pm |
|
"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
news:crbqor$4tmg@odds.stat.purdue.edu...
> In article <6ZFBd.14627$RH4.7093@newsread1.news.pas.earthlink.net>,
> George Conklin <georgeconklin1@earthlink.net> wrote:
>
>
>
>
>
>
>
>
>
> The use of the .05 level, or the p-value which is a little
> more detailed, tells me nothing about the effectiveness of
> the new treatment. I do not need any information to tell
> me that there is a difference, so why should I consider a
> test that there is no difference to be of any import?
>
The test tells you whether a drug is any better than nothing. Drug
companies seldom test a drug to see if it is better than an existing one, or
a cheaper one.
> Also, there is a lot of use of meta-analysis recently in
> medicine. For this to be as stated, it must include all
> previous studies, not just those published. While some
> studies in which some "non-significant" effects for a
> particular criterion get published because something else
> is significant, it will still be the case that the sample
> can be highly biased. Large numbers are no protection.
Well, yes, drug tests which show no significant result are not published.
The same is true in social science research too. The result is that there
is a bias and a whole lot of wasted research. No significance is just as
important as significance, and you are right in pointing out a bias here.
> --
> This address is for information only. I do not claim that these views
> are those of the Statistics Department or of Purdue University.
> Herman Rubin, Department of Statistics, Purdue University
> hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| Herman Rubin 2005-01-03, 7:06 pm |
| In article <p22bt013g0fv1j3fbe9trk6nf00vt8l5p6@4ax.com>,
reeder <N0.NE@aol.com> wrote:
>On 30 Dec 2004 16:28:34 -0800, "outrider" <outrider@despammed.com>
>wrote:
.................
[vbcol=seagreen]
>From the web site "VIOXX - the painful story of politics, business and
>statistics errors"
>http://www.interconus.com/products_dynatrack.htm
>A theory that attributes the increased risk to abnormal changes in the
>structure or shape of lipids caused uniquely by Vioxx, may explain why
>LDLs are more susceptible to oxidative damage, and therefore,
>contribute to cardiovascular damage. Such potential damage should be
>monitored and reversed...
>Question: How do you "reverse" the Vioxx damage?
First of all, there is a question whether this theory
is correct. It would not surprise me that any drug
might have this side effect, but as stated this is
not verified.
If you are aware of the mass of literature on oxidative
damage, you could come up with quite a few possibilities.
What is known about the complicated biochemistry involved
is almost zilch, and this research is not the type which
gets the big funding.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| Herman Rubin 2005-01-03, 10:06 pm |
| In article <p_gCd.16310$RH4.12787@newsread1.news.pas.earthlink.net>,
George Conklin <georgeconklin1@earthlink.net> wrote:
>"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
>news:crbqor$4tmg@odds.stat.purdue.edu...
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
> The test tells you whether a drug is any better than nothing. Drug
>companies seldom test a drug to see if it is better than an existing one, or
>a cheaper one.
I have seen them with comparisons with other drugs.
It definitely does NOT do this. Anyhow, that is not the
proper question to ask; the question to ask is whether
it is worth taking by some people, who might be able to
make the decision given the information. It is not for
the FDA to make such decisions, but rather to see that
the information is provided.
[vbcol=seagreen]
> Well, yes, drug tests which show no significant result are not published.
>The same is true in social science research too. The result is that there
>is a bias and a whole lot of wasted research. No significance is just as
>important as significance, and you are right in pointing out a bias here.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
|
|
(Borowitz Report)---The Food and Drug Administration announced today
that anyone who has taken any kind of pill in the last five years will
die by the end of this week.
| |
| reeder 2005-01-04, 7:06 am |
| On 1 Jan 2005 16:03:18 -0500, hrubin@odds.stat.purdue.edu (Herman
Rubin) wrote:
>In article <fv2bt0h1uj4sbdi315ba60cucn0vc64oua@4ax.com>,
>reeder <N0.NE@aol.com> wrote:
>
>
>
>
>Statistics is not a normal part of the pre-med program.
>
>Also, methods courses make it difficult to understand
>concepts, and Statistics 101 is almost always a methods
>course. Any attempt to teach it otherwise would cause
>students who do not have a fairly strong mathematics
>backgroumd to get the material in another department,
>often under the name "research methods".
->>But in his response, Topol looks at data from a previous study that
compared 390 patients taking Vioxx to 588 patients taking a placebo.
The study, called 090, showed that five, or 1.3%, of patients taking
Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
placebo group. Although those numbers are small, they were
statistically significant, according to Topol. The data he based his
analysis on has previously been buried in FDA briefing documents. <<-
I would submit that to most educated people, a product or process
which produces a 0.2% defect rate is a helluvalot preferable to one
which produces a 1.3% defect rate.
| |
| reeder 2005-01-06, 4:06 am |
| On 30 Dec 2004 16:00:24 -0500, hrubin@odds.stat.purdue.edu (Herman
Rubin) wrote:
>
>Do you have any idea what statistical significance means?
>
>I doubt that Topol does.
I'm sure Dr. Topol must have taken Statistics 101 in college:
Dr. Eric J. Topol is Chief Academic Officer of The Cleveland Clinic
Foundation and Provost of the Cleveland Clinic Lerner college of
Medicine of Case Western Reserve University. He is also Chairman of
the Department of Cardiovascular Medicine and Professor of Medicine
and Genetics. He is Program Director for the NIH supported Specialized
Center of Clinically Oriented Research (SCCOR) on the molecular basis
of coronary artery disease. He is certified as a Diplomate by the
National Board of Medical Examiners, and as a Diplomate by the
American Board of Internal Medicine in cardiovascular disease and
internal medicine.
Dr. Topol has been elected to the American Association of Physicians,
the American Society of Clinical Investigation, and the Johns Hopkins
Society of Scholars. He is a Fellow of the American college of
Cardiology, the American college of Physicians, and the European
Society of Cardiology. He has been recognized by the Institute of
Scientific Information (ISI) to be in the top 10 (#8) of cited
biomedical researchers in medicine (1993-2003), and he is ranked 1st
by Science Watch among authors of high impact papers in cardiovascular
research (1993-2003). His work on the genomics of coronary disease led
to the discovery of the first mutation (MEF2A deletion) inducing
coronary disease and heart attack (Science, 2003), and received
recognition as a top 10 research advance by the American Heart
Association, garnering Dr. Topol the Clinical Research Innovator Award
of the Doris Duke Charitable Foundation in 2001. The cardiology
program he directs in Cleveland has been ranked Number 1 in the United
States by U.S. News & World Report for the past 10 years.
Dr. Topol has served as chairman and principal investigator for more
than 15 international multi-center randomized clinical trials,
including the 5 GUSTO trials, the largest heart attack studies ever
conducted, and many others, with cumulatively more than 200,000
patients enrolled. He was the first physician ever to administer
recombinant t-PA, 2 different platelet glycoprotein IIb/IIIa
inhibitors (abciximab and eptifibatide), and a novel anticoagulant
(bivalirudin) to patients with coronary artery disease. The results of
these large-scale trials, involving 40 countries around the world,
have substantially changed our approach to patients with acute MI,
percutaneous coronary interventions, and unstable angina.
Currently he serves on the editorial board for over 20 peer-reviewed
medical publications including Circulation, Circulation Research,
Journal of the American college of Cardiology, American Journal of
Cardiology, Heart and the European Heart Journal. He has over 900
original publications and has edited 18 books, including the Textbook
of Interventional Cardiology (1s through 4th editions) and the
Textbook of Cardiovascular Medicine, the third edition now in
preparation.
http://www.clevelandclinic.org/
| |
|
| hrubin@odds.stat.purdue.edu (Herman Rubin) wrote:
>Do you have any idea what statistical significance means?
>I doubt that Topol does. In this case, a one-sided result
>this strong or stronger would occur by chance one time in 25
>if there was ABSOLUTELY NO difference, which is less than the
>usual significance level, one in 20. This is all it means.
>But in any case, the question has to be asked whether the
>additional 1%, or even 5%, chance of cardiovascular
>problems is worth the benefits of being able to take the
>drug without gastrointestinal problems.
I suspect very few folks have any understanding of the statistics
involved. It'll be interesting to see if Merck's attorneys are able
to explain this stuff to juries. The case against Merck is not nearly
as clear cut as people think, and the results of a trial could be a
big surprise (which would doubtless have everyone talking about those
"dumb jurors")
| |
| reeder 2005-01-06, 11:06 am |
| On 30 Dec 2004 16:28:34 -0800, "outrider" <outrider@despammed.com>
wrote:
>
>Herman Rubin wrote:
>increase
>as
>
>They knew and suppressed the data which showed a significant problem
>"within six weeks". (the origininating post).
From the web site "VIOXX - the painful story of politics, business and
statistics errors"
http://www.interconus.com/products_dynatrack.htm
A theory that attributes the increased risk to abnormal changes in the
structure or shape of lipids caused uniquely by Vioxx, may explain why
LDLs are more susceptible to oxidative damage, and therefore,
contribute to cardiovascular damage. Such potential damage should be
monitored and reversed...
Question: How do you "reverse" the Vioxx damage?
| |
| Herman Rubin 2005-01-06, 7:06 pm |
| In article <57gft05gqormdfei6l9i73qrh80iavb27r@4ax.com>,
reeder <N0.NE@aol.com> wrote:
>On 1 Jan 2005 16:03:18 -0500, hrubin@odds.stat.purdue.edu (Herman
>Rubin) wrote:
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
>->>But in his response, Topol looks at data from a previous study that
>compared 390 patients taking Vioxx to 588 patients taking a placebo.
>The study, called 090, showed that five, or 1.3%, of patients taking
>Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
>placebo group. Although those numbers are small, they were
>statistically significant, according to Topol. The data he based his
>analysis on has previously been buried in FDA briefing documents. <<-
>I would submit that to most educated people, a product or process
>which produces a 0.2% defect rate is a helluvalot preferable to one
>which produces a 1.3% defect rate.
From this standpoint, all products have "defects". The
question is, are the good points better than the bad ones?
The "statistical testing" is whether the decay rates are
equal. We do not know that the defect rate is 1.3% for
Vioxx and 0.2% for the other painkiller; it could not have
been a placebo, or the difference in the rates of reducing
pain would have been obvious. The relative accuracy of the
estimate of a low rate depends on the number defective,
regardless of sample size.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
| |
| George Conklin 2005-01-06, 7:06 pm |
|
"Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote in message
news:crbqor$4tmg@odds.stat.purdue.edu...
> In article <6ZFBd.14627$RH4.7093@newsread1.news.pas.earthlink.net>,
> George Conklin <georgeconklin1@earthlink.net> wrote:
>
>
>
>
>
>
>
>
>
> The use of the .05 level, or the p-value which is a little
> more detailed, tells me nothing about the effectiveness of
> the new treatment. I do not need any information to tell
> me that there is a difference, so why should I consider a
> test that there is no difference to be of any import?
>
The test tells you whether a drug is any better than nothing. Drug
companies seldom test a drug to see if it is better than an existing one, or
a cheaper one.
> Also, there is | | |