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Medical Forum / General / General / April 2007

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More Evidence that Drug Makers Should Not be Allowed to Design and Perform Their Own Studies

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PeterB - 26 Feb 2007 14:42 GMT
Drug firms may sway cancer trials
Email Print Normal font Large font Carol Nader
February 27, 2007

DRUG industry-funded trials of breast cancer therapies are more likely
to report positive results than those independent of drug companies,
according to a report.

Authors of the US study, who claim it is the first such analysis
specifically focusing on breast cancer trials, say pharmaceutical
industry involvement in published breast cancer research may affect
the way the trial is designed, its focus and its results.

The analysis has again raised concerns about the potential for
conflicts of interest in research that is funded by drug companies.

Three of the four authors of the analysis are consultants to drug
companies. They reviewed 140 studies reporting breast cancer therapy
results in 1993, 1998 and 2003. Almost half the studies reported some
form of drug company involvement, whether it be co-authorship,
supplying the drug or financial support.

Of the 56 studies examined from 2003, 84 per cent of the industry-
funded studies were "positive", compared with 54 per cent of the non-
industry sponsored studies.

The analysis was published in Cancer, the journal of the American
Cancer Society. It was led by Jeffrey Peppercorn, assistant professor
of medicine at the University of North Carolina school of medicine's
division of hematology and oncology. He is also a member of the
Speakers Bureau for Genentech and consultant to drug company Merck.

"The impact of the growing pharmaceutical industry involvement in
breast cancer clinical research appears similar to the impact of
industry sponsorship documented in other fields of medical research,"
the report concluded.

"The majority of clinical research currently is associated with the
pharmaceutical industry, and this association appears to have an
impact on research outcomes and may shape study design."

David Henry, professor of clinical pharmacology at the University of
Newcastle, said the findings echoed similar studies. He said there was
also "publication bias", in that journals were more likely to publish
studies that were positive.

"What you get in the end is industry-funded studies that find in
favour of the commercial products are the ones most likely to be
published and read by people," he said.

Cancer Council Australia chief executive Ian Olver said companies "may
be picking drugs that they're pretty sure are going to be winners".

"It's certainly a problem that the biggest pool of money for clinical
research is provided by drug companies that have at least a potential
vested interest in the outcome," he said.

A Medicines Australia spokeswoman said the industry made a significant
investment in clinical trials involving cancer research.

She said all clinical studies must be approved by an ethics committee,
and most were now registered on a clinical trial register.

Copyright © 2007. The Age Company Ltd.

http://www.theage.com.au/news/national/drug-firms-may-sway-cancer-trials/2007/02
/26/1172338547348.html

TC - 26 Feb 2007 14:58 GMT
> Drug firms may sway cancer trials
> Email Print Normal font Large font Carol Nader
[quoted text clipped - 52 lines]
> research is provided by drug companies that have at least a potential
> vested interest in the outcome," he said.

"potential vested interest" Hah! "vested interest" is vested interest.
There is nothing "potential" about it.

> A Medicines Australia spokeswoman said the industry made a significant
> investment in clinical trials involving cancer research.

Ooooohhhhhh...... that makes it all better then. They spent a
significant amount of money to subvert science from an independent
process to vested interest brand marketting. The amount spent makes it
all better then, and that is just so much more acceptable.

I say all of industries "significant investment" is a waste of money
insofar as science is concerned, because it is not science, it is
marketting. For anyone to call it science, one would have to wear
pretty opaque rose-coloured glasses.

> She said all clinical studies must be approved by an ethics committee,
> and most were now registered on a clinical trial register.

Time to re-vamp the "ethics" committee structure. And re-vamp the
requirements to register these marketting efforts as clinical trials.
Too many people with vested interests at the highest levels of the
research industry. Heads must begin to roll.

TC

> Copyright © 2007. The Age Company Ltd.
>
> http://www.theage.com.au/news/national/drug-firms-may-sway-cancer-tri...
PeterB - 26 Feb 2007 18:03 GMT
> > "It's certainly a problem that the biggest pool of money for clinical
> > research is provided by drug companies that have at least a potential
[quoted text clipped - 25 lines]
>
> TC

I noticed easy stepping by the article writer, as well.   The tone of
the piece is almost divorced from the facts presented.  Look at the
article as a microcosm of socio-economic consensus undergoing a large,
systemic change.  We are seeing two things happen at once.  1) The
facts about industry corruption are coming to light, regardless.  And
2) Social consensus still affords some measure of protection to the
players in big business.  What's important to see is that item #2 is
on the decline, while item #1 is gaining momentum.
monty1945@lycos.com - 26 Feb 2007 22:45 GMT
Though outright fraud is possible, what is much more common is
misinterpretation.  That is, the actual experimental findings are
discussed in a manner divoreced from reality.  An example is an
"essential fatty acid" study that featured a small number of pregnant
cats.  One of the cats had healthy kittens, despite a diet totally
devoid of "essential fatty acids," yet the conclusion was that the
"EFA" claim was supported.  If "EFAs" are absolutely essential, then
none of the cats could have given birth to healthy kittens.  Thus,
it's not a matter of outright fraud much of the time, but rather a
cult-like allegience to textbook notions.

Another example of the shenanigans being played can be found at:

http://raypeat.com/articles/articles/ru486.shtml

And there are examples of my site as well:

http://groups.msn.com/TheScientificDebateForum-/
PeterB - 27 Feb 2007 13:54 GMT
On Feb 26, 5:45 pm, monty1...@lycos.com wrote:

> Though outright fraud is possible, what is much more common is
> misinterpretation.  

I think misinterpretation is not the problem with drug studies.  Drugs
have a fairly broad range of effect in which approval can be achieved,
so that poor analysis is not the issue.   There are three main
problems with drug research and development to be addressed.  1) The
premise for most drug research is flawed because the objective of
achieving modification of a disease marker is meaningless.  Unless the
marker is proven to be a disease trigger, bending the marker will not
prevent, treat, or cure illness.  Such drugs also introduce new
disease, such as cancer and stroke risk, in an unknown percentage of
patients.  The overwhelming majority of all prescription drugs are a
threat to public safety and have not been shown to effectively treat
disease or extend life.  2) The drug maker is permitted to design the
study on which approval will be based.  This violates any principle of
"regulatory oversight" the public has a right to expect, and
underscores the complicity of FDA on behalf of its primary funding
source, the drug makers.  3) The absence of regulatory control
preventing the media from sponsoring phoney "news" regarding drug
development.  Typically, a press kit is provided to media by the drug
industry, therefore dissemination of such material constitutes
promotion, not "news."  Both that and direct to consumer advertising
should be illegal.

> That is, the actual experimental findings are
> discussed in a manner divoreced from reality.  An example is an
[quoted text clipped - 13 lines]
>
> http://groups.msn.com/TheScientificDebateForum-/
TC - 27 Feb 2007 15:17 GMT
> On Feb 26, 5:45 pm, monty1...@lycos.com wrote:
>
[quoted text clipped - 22 lines]
> promotion, not "news."  Both that and direct to consumer advertising
> should be illegal.

The popular media bows to the advertisers. And pharma spend literally
billions every year on guess what.... advertising in the popular
media.

TC

> > That is, the actual experimental findings are
> > discussed in a manner divoreced from reality.  An example is an
[quoted text clipped - 15 lines]
>
> - Show quoted text -
Herman Rubin - 28 Feb 2007 21:32 GMT
>On Feb 26, 5:45 pm, monty1...@lycos.com wrote:

>> Though outright fraud is possible, what is much more common is
>> misinterpretation.  

>I think misinterpretation is not the problem with drug studies.  Drugs
>have a fairly broad range of effect in which approval can be achieved,
[quoted text clipped - 17 lines]
>promotion, not "news."  Both that and direct to consumer advertising
>should be illegal.

Much worse than misrepresentation is statistical incompetence,
because the "medical statisticians" are essentially at the
level of someone who cannot use statistics at a BA level;
introductory methods courses without understanding cannot
do better, and it would be difficult to get medical faculty
to approve a "concepts" course which would require the use
of people with real statistical knowledge.

This is the case with government studies as well.  The
PROSPER study of statins in senior citizens is almost
as flawed as any I have seen, and I cannot get the
relevant information from the published "analysis";
I question how well the medical people could understand
such a study.  This applies to most of the medical
studies I have seen.

The FDA is not any more capable than those; however, it
has set up protocols for the drug companies to use, and
they are followed to the letter.  The conditions on the
design are rather stringent, but not necessarily sound,
and the analyses are utterly simplistic.  Well known
factors are not included in the study, except as
criteria for randomization, which is not the way to do
it; effects are not independent of the initial response.
Translation for the uninitiated:  good for the average
person does not mean good for YOU.

As for complications in the future, this is not at all
ascertainable in studying the effects of a drug for
approval.  Only approving the drug, and seeing what
happens, can find this out, unless we learn enough
biochemistry to get at this without clinical trials.

If a drug increases the danger of cancer and stroke
over 5 years from 1% to 2%, one would have to observe
4000 people for those 5 years to reliably find this
out, although one could catch worse situations faster.
Signature

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

TC - 01 Mar 2007 19:25 GMT
> In article <1172584448.394513.58...@z35g2000cwz.googlegroups.com>,
>
[quoted text clipped - 67 lines]
>
> - Show quoted text -

What was that saying about the three knids of statistics - statistics,
statistics and ????

TC
mainframetech - 01 Mar 2007 21:12 GMT
> > In article <1172584448.394513.58...@z35g2000cwz.googlegroups.com>,
>
[quoted text clipped - 74 lines]
>
> - Show quoted text -

 In the area of statistics and trials by drug companies, you might
try reading "The Cholesterol Myth" by Uffe Ravnskov M.D.  He looked
into many of the major heart disease studies and found that many were
flawed, but they helped the drug companies sell statin drugs.

Chris
Herman Rubin - 02 Mar 2007 02:02 GMT
>> > In article <1172584448.394513.58...@z35g2000cwz.googlegroups.com>,

>> > >On Feb 26, 5:45 pm, monty1...@lycos.com wrote:
>> > >> Though outright fraud is possible, what is much more common is
>> > >> misinterpretation.  

            .....................

>> > Much worse than misrepresentation is statistical incompetence,
>> > because the "medical statisticians" are essentially at the
[quoted text clipped - 3 lines]
>> > to approve a "concepts" course which would require the use
>> > of people with real statistical knowledge.

>> > This is the case with government studies as well.  The
>> > PROSPER study of statins in senior citizens is almost
[quoted text clipped - 3 lines]
>> > such a study.  This applies to most of the medical
>> > studies I have seen.

>> > The FDA is not any more capable than those; however, it
>> > has set up protocols for the drug companies to use, and
[quoted text clipped - 6 lines]
>> > Translation for the uninitiated:  good for the average
>> > person does not mean good for YOU.

>> > As for complications in the future, this is not at all
>> > ascertainable in studying the effects of a drug for
>> > approval.  Only approving the drug, and seeing what
>> > happens, can find this out, unless we learn enough
>> > biochemistry to get at this without clinical trials.

>> > If a drug increases the danger of cancer and stroke
>> > over 5 years from 1% to 2%, one would have to observe
[quoted text clipped - 5 lines]
>> > Herman Rubin, Department of Statistics, Purdue University
>> > hru...@stat.purdue.edu         Phone: (765)494-6054   FAX: (765)494-0558- Hide quoted text -

>> > - Show quoted text -

>> What was that saying about the three knids of statistics - statistics,
>> statistics and ????

>> TC- Hide quoted text -

>> - Show quoted text -

>  In the area of statistics and trials by drug companies, you might
>try reading "The Cholesterol Myth" by Uffe Ravnskov M.D.  He looked
>into many of the major heart disease studies and found that many were
>flawed, but they helped the drug companies sell statin drugs.

>Chris

The statin studies are among the worst, and they will not
get better until much more complicated statistical methods
than those I have seen in medical reports are used.  I have
had numerous doctors try to get me on statins, and I have
managed to convince some that it was at least reasonable
in my case not to do this.

In one British study on diabetes, sponsored by the British
government, it was stated that something was not important
because its p-value was 0.052.  If the p-value was 0.049,
it would have been quite important.

Signature

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

PeterB - 02 Mar 2007 15:56 GMT
> In article <1172783573.264397.30...@h3g2000cwc.googlegroups.com>,
>
[quoted text clipped - 65 lines]
> because its p-value was 0.052.  If the p-value was 0.049,
> it would have been quite important.

That's why drug approval should be based on endpoint data confined to
clinical outcomes in real patients, not the bending of markers "sold"
to the public as equivalent to the disease itself.
Ron Peterson - 02 Mar 2007 17:52 GMT
> > The statin studies are among the worst, and they will not
> > get better until much more complicated statistical methods
> > than those I have seen in medical reports are used.  I have
> > had numerous doctors try to get me on statins, and I have
> > managed to convince some that it was at least reasonable
> > in my case not to do this.

> > In one British study on diabetes, sponsored by the British
> > government, it was stated that something was not important
> > because its p-value was 0.052.  If the p-value was 0.049,
> > it would have been quite important.

> That's why drug approval should be based on endpoint data confined to
> clinical outcomes in real patients, not the bending of markers "sold"
> to the public as equivalent to the disease itself.

How can one distinguish between a "marker" and a disease? Hypertension
is a marker because it can be measured, but hypertension by itself can
cause damage to a body. The statins do lower cholesterol and reduce
the incidence of CVD, but statins also reduce inflammation which makes
it difficult to distinguish in which way the statins function to lower
CVD.

--
  Ron
TC - 02 Mar 2007 18:55 GMT
> > > The statin studies are among the worst, and they will not
> > > get better until much more complicated statistical methods
[quoted text clipped - 11 lines]
>
> How can one distinguish between a "marker" and a disease?

A marker or markers are part of what characterises the disease. The
disease shows itself as a collection of symptoms and markers.
Controlling one marker or one symptom of a disease without regard to
treating the cause of the disease is the most idiotic approach to
disease treatment ever concocted. And for advanced degree pinheads to
buy into it shows just how useless an advanced degree is.

Hypertension
> is a marker because it can be measured, but hypertension by itself can
> cause damage to a body.

Then determine the cause of the hypertension and and treat the cause.
Seeking to reduce hypertension while completely excluding any
consideration to the cause of the hypertension will sell drugs but
will not result in anything else other than a slight lowering of the
hyper tension at the expense of possibly very dangerous side effects
while allowing the cause of the problem to continue and cause other
symptoms and problems. But them thay can sell more drugs to control
those markers and symptoms while still not address the underlying
cause.

If your tires go flat constantly from nails in the driveway, the
mechanic will gladly sell you new tires every week while you break
your back with a carjack to get the flat tires to the mechanic every
week. You will be better served by buying a cheap magnet and clearing
the driveway of nails in the first place. Cheaper and easier on your
poor muscles.

>The statins do lower cholesterol and reduce
> the incidence of CVD, but statins also reduce inflammation which makes
> it difficult to distinguish in which way the statins function to lower
> CVD.

Bullshit. Statins barely lower cholesterol, and cholesterol does not
*cause* CVDs. It is an intermittent marker in CVDs, which means that
in those that have CVDs sometimes there is elevated cholesterol. And
there are many with CVDs that never showed any cholesterol problems.

Lowering cholesterol slightly/barely with statins does nothing except
cost you your money and your health while ignoring the real cause of
CVDs which is a diet chronically high in nutrient-deficient highly-
processed manufactured crap foods like sugar, hfcs, margarine, RTE
cereals, white flour, most vegetable oils, htp and utp milk, etc. and
deficient of real nutrients.

TC

> --
>    Ron
Herman Rubin - 02 Mar 2007 19:18 GMT
>> > > The statin studies are among the worst, and they will not
>> > > get better until much more complicated statistical methods
[quoted text clipped - 9 lines]
>> > clinical outcomes in real patients, not the bending of markers "sold"
>> > to the public as equivalent to the disease itself.

>> How can one distinguish between a "marker" and a disease?

>A marker or markers are part of what characterises the disease. The
>disease shows itself as a collection of symptoms and markers.
>Controlling one marker or one symptom of a disease without regard to
>treating the cause of the disease is the most idiotic approach to
>disease treatment ever concocted. And for advanced degree pinheads to
>buy into it shows just how useless an advanced degree is.

>Hypertension
>> is a marker because it can be measured, but hypertension by itself can
>> cause damage to a body.

>Then determine the cause of the hypertension and and treat the cause.

There are times that symptoms need to be treated, and this
is even when the cause cannot be treated.  If someone has
a high fever, get the fever down while investigating.

And too often the causes are not known.  There may be
some moderately easy changes, like losing 50 pounds, which
can have an effect on hypertension, but these are not
really causes.  Also, these do not always work.  This
does not mean that causes and their treatment are not
looked for.  Hypertension is a symptom, but can be
dangerous by itself.

>Seeking to reduce hypertension while completely excluding any
>consideration to the cause of the hypertension will sell drugs but
[quoted text clipped - 4 lines]
>those markers and symptoms while still not address the underlying
>cause.

This is definitely considered.  Also, if someone is going
to lose 50 pounds, which itself has undesirable effects,
it is still necessary to treat the hypertension.  My late
wife had hypertension which was treated, but with no
recognizable cause, including weight.

>If your tires go flat constantly from nails in the driveway, the
>mechanic will gladly sell you new tires every week while you break
>your back with a carjack to get the flat tires to the mechanic every
>week. You will be better served by buying a cheap magnet and clearing
>the driveway of nails in the first place. Cheaper and easier on your
>poor muscles.

Few medical conditions are as simply treated as such.  
There are more than 500 KNOWN internal medicine diseases,
and for most people, only half of which they have are
recognized, and a dozen at a time is not unusual.

>>The statins do lower cholesterol and reduce
>> the incidence of CVD, but statins also reduce inflammation which makes
>> it difficult to distinguish in which way the statins function to lower
>> CVD.

>Bullshit. Statins barely lower cholesterol, and cholesterol does not
>*cause* CVDs. It is an intermittent marker in CVDs, which means that
>in those that have CVDs sometimes there is elevated cholesterol. And
>there are many with CVDs that never showed any cholesterol problems.

It depends on the person; the effect can be considerable.
High LDL is known to cause deposits in blood vessels.  On
the other hand, high HDL tends to reduce the effect.  
The effect can also be minimal.  We need research in pure
biochemistry, not just to treat conditions.

>Lowering cholesterol slightly/barely with statins does nothing except
>cost you your money and your health while ignoring the real cause of
>CVDs which is a diet chronically high in nutrient-deficient highly-
>processed manufactured crap foods like sugar, hfcs, margarine, RTE
>cereals, white flour, most vegetable oils, htp and utp milk, etc. and
>deficient of real nutrients.

What we know about nutrition is negligeable, and what
physicians know about it is on the low side of what
is known.  I believe I know more than most people, and
what you have said in your last statement is only
partially true.  It is also the case that "natural"
diets are not optimal; evolution had to use what could
be done, not what should be done.

And when advising or prescribing for individuals, remember

    Your Mileage May Vary.
Signature

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 - 02 Mar 2007 19:30 GMT
>>> > > The statin studies are among the worst, and they will not
>>> > > get better until much more complicated statistical methods
[quoted text clipped - 98 lines]
>
> Your Mileage May Vary.

  Of course, then there are those studies which "show" that a majority of
elderly put on statins end up with a cancer diagnosis shortly thereafter.
Reason?  Probably because cholesterol is also an anti-oxidant.  In important
studies those with the absolutely lowest cholesterol levels (naturally) had
the highest mortality rates.
Kurt Ullman - 02 Mar 2007 19:53 GMT
>    Of course, then there are those studies which "show" that a majority of
> elderly put on statins end up with a cancer diagnosis shortly thereafter.
> Reason?  Probably because cholesterol is also an anti-oxidant.  In important
> studies those with the absolutely lowest cholesterol levels (naturally) had
> the highest mortality rates.
   
    More likely because cancer is a disease of the elderly.  Longer you
live, more likely you will get cancer. The shortly thereafter part
argues against stain being the cause.
george conklin - 02 Mar 2007 20:10 GMT
>>    Of course, then there are those studies which "show" that a majority
>> of
[quoted text clipped - 8 lines]
> live, more likely you will get cancer. The shortly thereafter part
> argues against stain being the cause.

 Or, more likely, the statins accelerated the disease.  It may have been
the Framingham study.  But in any case, those who had the lowest natural
levels of cholesterol had the shortest lives.
Herman Rubin - 03 Mar 2007 19:48 GMT
>>    Of course, then there are those studies which "show" that a majority of
>> elderly put on statins end up with a cancer diagnosis shortly thereafter.
>> Reason?  Probably because cholesterol is also an anti-oxidant.  In important
>> studies those with the absolutely lowest cholesterol levels (naturally) had
>> the highest mortality rates.

>     More likely because cancer is a disease of the elderly.  Longer you
>live, more likely you will get cancer. The shortly thereafter part
>argues against stain being the cause.

This is not a valid argument; the treatment and control
groups were both elderly, and age distribution was
matched.  The elderly tend to have a higher level of
HDL, which is a survival factor, and LDL is in known
to be involved in front-line activity against bacteria
and viruses.  Higher levels of HDL help against the
bad effects of LDL, so the right balance is helpful.

Signature

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

Kurt Ullman - 03 Mar 2007 19:55 GMT
> In article
> <kurtullman-DF39ED.14533402032007@customer-201-125-217-207.uninet.net.mx>,
[quoted text clipped - 18 lines]
> and viruses.  Higher levels of HDL help against the
> bad effects of LDL, so the right balance is helpful.

     Interesting. Are you saying that with the cancer diagnosis, too in
addition bacteria and virii? I would still think that the shorthly
thereafter part would argue against introduction of the statins as
cause. Most environmental cancers that I am familiar with, lung and skin
for instance, require long period of times before they show up.  
      I would also think that the matching would probably argue against
a bias because one side or the other is being generally followed closer
and thus finding things that might not have been without the added
poking found in trials..
PeterB - 09 Mar 2007 15:25 GMT
> In article <YW_Fh.5685$PL....@newsread4.news.pas.earthlink.net>,
>
[quoted text clipped - 7 lines]
> live, more likely you will get cancer. The shortly thereafter part
> argues against stain being the cause.

Non sequitur.  Your premise does not support your conclusion.  Our
knowledge of the etiology of cancer, especially in relation to
medication, is not sufficient to say anything about how quickly errant
DNA could manifest clinically as a drug side effect.  The fact that
cancer becomes more likely as we age is not an argument against the
potential for a statin to accelerate the incidence of cancer in those
predisposed to it.  Think about HRT, an "intervention" that elevated
the risk (and therefore incidence) of both stroke and breast cancer in
millions of women, yet we cannot say how much more quickly those who
were already predisposed to those conditions experienced those
diseases because of their "treatment."  All we can say is that their
risk was elevated.  And that's all we *need* to know.

PeterB
TC - 02 Mar 2007 19:40 GMT
> In article <1172861758.693608.287...@s48g2000cws.googlegroups.com>,
>
[quoted text clipped - 91 lines]
> diets are not optimal; evolution had to use what could
> be done, not what should be done.

You obviously only know a little more than a typical md, which is not
very much. Like you said "negligible".

We evolved with certain specific nutrient requirements. Meet those
nutritional requirements and we will be healthy and free of these
chronic diseases. Those nutritional requirements are not that much of
a mystery. All the necessary vitamins, minerals and essential macro-
nutrients are well known and easily available to us. We need to eat
the most nutritionally sound foods available, and freshness is of
great importance for nutrition soundness.

Recognising that refined and overly processed foods are not useful
nutrional sources is important. As well as recognising that some
"foods" aren't foods at all. And some "foods" are detrimental to our
health and, as such, can be classified as poisons. Soy was never a
food and never will be. At best, when fermented, it is a condiment.
Margarine is not food. Ultra high temp pasteurized milk is now a dead
substance with little nutritional value. White flour is a starch and
nothing more except for the cheap vitamins they throw into it so they
can call it "enriched". Sugar is not a food and contains no nutrition.
In fact it is a slow poison doing us great harm.

Cyanide is a natural substance. I would not recommend it as a food.
Eating natural stuff is a concept that needs to be refined.

I suggest eating foods, real foods, in their as-near-to-natural states
as possible. Real produce, grown in real healthy soils, eaten fresh.
Real meats from real animals having been reaered on their natural
foods. Minimal processing.

And of course, avoid all the fake manufactured overly processed crap
out there.

No pill can make you healthy. Without real nourishment, optimum health
is un-attainable.

TC

> And when advising or prescribing for individuals, remember
>
[quoted text clipped - 6 lines]
>
> - Show quoted text -
george conklin - 02 Mar 2007 20:12 GMT
> We evolved with certain specific nutrient requirements. Meet those
> nutritional requirements and we will be healthy and free of these
> chronic diseases.

 What bullshit.  The chronic diseases of today were present in the past,
when life expectancy was 35 years and food was in its natural unhealthy
state.
TC - 02 Mar 2007 21:35 GMT
> > We evolved with certain specific nutrient requirements. Meet those
> > nutritional requirements and we will be healthy and free of these
[quoted text clipped - 3 lines]
> when life expectancy was 35 years and food was in its natural unhealthy
> state.

That is bullshit. Diabetes T2 has tripled in 30 years. Obesity the
same. CVDs as well. The only major lifestyle difference between now
and the 1970's is the availability of refined and processed foods like
sugars, hfcs, white flours, manufactured crap food in general, high
temperature pasteurised milk, soybean proteins,  etc.

The impact of hfcs and sodas on health cannot be over emphasized. In
the 70's, I was a teenager and if I drank two sodas a month, that was
quite the treat. Today, almost every fridge has a couple of 2 litre
jugs of soda. Every fast food meal includes a litre or two of soda.
Every day millions of people now consume litres and litres of that
crap that conatins no nutrition, tons of calories, and hfcs that
buggers up your blood glucose levels to obscenely high levels,
chronically. RTE cereals are consumed by the ton by children. RTE
Cereals contain nothing but denatured grain starch, chemical
flavourings, and copious amounts of sweetners like hfcs.  Kraft Mac
and Cheese is crap food. No nutrition whatsoever. One of the biggest
selling orange drinks is Sunny Dee, it is a thick sugary syrup
coloured orange and flavoured with chemicals. Kids are drinking it by
the gallon. White bread contains no nutrition, except for the cheap
vitamins they throw in so they can call it "enriched". Powdered soup
bases are not real food. They are piles of chemical flavourings and
colouring.

And you wonder where these chronic diseases are coming from. It is
plain and simple malnourishment.

These chronic diseases have been plaguing us, to some degree, since
about 12,000 years ago, with the advent of grain agriculture in
Europe, and have only recently, the last 30 year, exploded in
incidence.

And it was not unusual for people to live into their 80's and 90's
several centuries ago. The causes of early death often included
infectious diseases, accidents leading to infections, dental abcesses,
warfare, etc. Remember, they did not have good concepts of hygiene and
they had no access to anti-biotics. Infections were typically
uncontrollable. Chronic diseases like diabetes T2, heart disease,
cancers occurred but not at nearly the levels seen today.

Your sweeping generalisations are crap. And dead wrong.

TC
Vernon - 02 Mar 2007 21:54 GMT
>> > We evolved with certain specific nutrient requirements. Meet those
>> > nutritional requirements and we will be healthy and free of these
[quoted text clipped - 47 lines]
>
> TC

Going on and on and on about all the various foods that are not the best and
actually somewhat negative ONLY CLOUDS the base, excess sugar, real and
substitute.
Overstatement and generalities ONLY CLOUD the basic issue, excess sugar.

It's like yelling and screaming in a crowd about the man who has a rope and
knife in his hand and is naked and extremely dirty.  Forget the idea that he
has a gun pointed at you and has already shot ten people.
george conklin - 02 Mar 2007 22:02 GMT
>> > We evolved with certain specific nutrient requirements. Meet those
>> > nutritional requirements and we will be healthy and free of these
[quoted text clipped - 47 lines]
>
> TC
george conklin - 02 Mar 2007 22:03 GMT
>> > We evolved with certain specific nutrient requirements. Meet those
>> > nutritional requirements and we will be healthy and free of these
[quoted text clipped - 47 lines]
>
> TC

  Your post therefore "proves" that life expectancy is declining.  In FAct,
it is increasing.  Thus modern diets are doing something right, despite your
fear of soda and everything else.
TC - 03 Mar 2007 17:48 GMT
> >> "TC" <tunder...@hotmail.com> wrote in message
>
[quoted text clipped - 57 lines]
>
> - Show quoted text -

I never said anything about life expectancy declining. I refuse to
debate with a.sholes who twist my words around to fit their bullshit.

TC
Vernon - 03 Mar 2007 20:18 GMT
>> >> "TC" <tunder...@hotmail.com> wrote in message
>>
[quoted text clipped - 66 lines]
>
> TC

Also, life expectancy has change very little.
When taking into account infant mortality drop and sub teen death rate drop,
life expectancy is LESS.
The base should be how long a seventeen year old is expected to live.
Herman Rubin - 03 Mar 2007 21:11 GMT
>>> "TC" <tunder...@hotmail.com> wrote in message

>>> news:1172871306.001969.13310@h3g2000cwc.googlegroups.com...

>>> >> "TC" <tunder...@hotmail.com> wrote in message

>>> >>news:1172864442.488404.302060@64g2000cwx.googlegroups.com...

>>> >> > We evolved with certain specific nutrient requirements. Meet those
>>> >> > nutritional requirements and we will be healthy and free of these
>>> >> > chronic diseases.

>>> >>   What bullshit.  The chronic diseases of today were present in the
>>> >> past,
>>> >> when life expectancy was 35 years and food was in its natural
>>> >> unhealthy
>>> >> state.

>>> > That is bullshit. Diabetes T2 has tripled in 30 years. Obesity the
>>> > same. CVDs as well. The only major lifestyle difference between now
>>> > and the 1970's is the availability of refined and processed foods like
>>> > sugars, hfcs, white flours, manufactured crap food in general, high
>>> > temperature pasteurised milk, soybean proteins,  etc.

All of these crap foods were available in the 1930's,
with the exception of soybean proteins, which research
seems to justify as beneficial.

As for Type 2 diabetes, which I have, part of the increase
is due to longevity, part to the control of the disease,
and part to the change in the definition.  I would have
been diagnosed at least 15 years earlier under the current
standards.  There are also treatments not available 30
years ago, and it was about 30 years ago that the disease
was recognized as insulin resistance, not deficiency of
normal insulin.  Insulin resistance can start years
before even moderate recognition can occur.  Never being
overweight, even as a child, may prevent the genetic
condition.

The prevalence of this disease is due to its genetic
advantages under primitive conditions; it rarely is
a debilitating condition until reproduction is over.

        .................L
Signature

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

Skeptic - 03 Mar 2007 22:44 GMT
> As for Type 2 diabetes, which I have, part of the increase
> is due to longevity, part to the control of the disease,
> and part to the change in the definition.  I would have
> been diagnosed at least 15 years earlier under the current
> standards.

Hmmm... interesting view.  While things like an altered definition of
diabetes can increase the prevalence, that alone won't come near accounting
for the tremendous increase.  There is undeniably an increase of diabetes,
meaning per 1000 people, more of it truly have the illness than in past
eras.  The collective laziness and fatness of our society probably does play
a signficant role in that.
Vernon - 03 Mar 2007 23:59 GMT
>>>> "TC" <tunder...@hotmail.com> wrote in message
>
[quoted text clipped - 26 lines]
>
> As for Type 2 diabetes, which I have,

Out of about 30 patients with type 2, I do not know of a single one who
didn't have a ridiculous diet including much sugar when a teen.
THEY don't think so and STILL are completely stupid in their diet.

>part of the increase
> is due to longevity, part to the control of the disease,
[quoted text clipped - 7 lines]
> overweight, even as a child, may prevent the genetic
> condition.

And having a decent diet, low in sugar and high in several B systems and
Cumin and Cinamin.
But, like you say flat out obesity is deadly.
There are those with a high metabolism who get it (succomb to it).  These
are the ones who die relativelyyoung with a meriad of other diseases.

> The prevalence of this disease is due to its genetic
> advantages under primitive conditions; it rarely is
> a debilitating condition until reproduction is over.
>
> .................L
Herman Rubin - 06 Mar 2007 16:47 GMT
>>>>> "TC" <tunder...@hotmail.com> wrote in message

>>>>> news:1172871306.001969.13310@h3g2000cwc.googlegroups.com...

>>>>> >> "TC" <tunder...@hotmail.com> wrote in message

>>>>> >>news:1172864442.488404.302060@64g2000cwx.googlegroups.com...

>>>>> >> > We evolved with certain specific nutrient requirements. Meet those
>>>>> >> > nutritional requirements and we will be healthy and free of these
>>>>> >> > chronic diseases.

>>>>> >>   What bullshit.  The chronic diseases of today were present in the
>>>>> >> past,
>>>>> >> when life expectancy was 35 years and food was in its natural
>>>>> >> unhealthy
>>>>> >> state.

>>>>> > That is bullshit. Diabetes T2 has tripled in 30 years. Obesity the
>>>>> > same. CVDs as well. The only major lifestyle difference between now
>>>>> > and the 1970's is the availability of refined and processed foods
>>>>> > like
>>>>> > sugars, hfcs, white flours, manufactured crap food in general, high
>>>>> > temperature pasteurised milk, soybean proteins,  etc.

>> All of these crap foods were available in the 1930's,
>> with the exception of soybean proteins, which research
>> seems to justify as beneficial.

>> As for Type 2 diabetes, which I have,

>Out of about 30 patients with type 2, I do not know of a single one who
>didn't have a ridiculous diet including much sugar when a teen.
>THEY don't think so and STILL are completely stupid in their diet.

When I was between 13 and 17, I was so skinny that doctors
tried hard, and unsuccessfully, to put weight on me.  By
age 19, the situation had completely reversed.  Go figure!

>>part of the increase
>> is due to longevity, part to the control of the disease,
[quoted text clipped - 7 lines]
>> overweight, even as a child, may prevent the genetic
>> condition.

>And having a decent diet, low in sugar and high in several B systems and
>Cumin and Cinamin.

I like cumin, but I have never seen it labeled as
promoting health.  Cinnamon is of advantage for
diabetics.  I have seen ginger and turmeric touted,
as well as green tea and very dark chocolate.

The advantages of antioxidants and polyphenols is
relatively recent; the FDA has not, to my knowledge,'
approved any claims about them, or about omega 3
fatty acids.

>But, like you say flat out obesity is deadly.
>There are those with a high metabolism who get it (succomb to it).  These
>are the ones who die relativelyyoung with a meriad of other diseases.

Now come up with a good method for losing weight
and keeping it off; changing a person's set point
is not that easy.  Experiments on rats jibe with
this, as well.

>> The prevalence of this disease is due to its genetic
>> advantages under primitive conditions; it rarely is
>> a debilitating condition until reproduction is over.
Signature

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

Vernon - 06 Mar 2007 17:28 GMT
>>>>>> "TC" <tunder...@hotmail.com> wrote in message
>
[quoted text clipped - 37 lines]
> tried hard, and unsuccessfully, to put weight on me.  By
> age 19, the situation had completely reversed.  Go figure!

Not at all uncommon even without any malady.
You are not "mature" until around 25.
Don't tell that to a 15, 18 or 21 year old.

>>>part of the increase
>>> is due to longevity, part to the control of the disease,
[quoted text clipped - 20 lines]
> approved any claims about them, or about omega 3
> fatty acids.

Don't bet your health on FDA.
As a diabetic you are probably aware that they REFUSE to let STEVIA be
labeled as a sweetener.  It's about the only safe one out there.

>>But, like you say flat out obesity is deadly.
>>There are those with a high metabolism who get it (succomb to it).  These
[quoted text clipped - 4 lines]
> is not that easy.  Experiments on rats jibe with
> this, as well.

Lower (not dumb lower) carb intake.
Weight (resistance) training.
Aerobics are absolutely great but do practically nothing for weight control
unless one does enough to ruin every joint in their body.
It's almost a sure bet (your sig) that you have a desk job.

You didn't say.  Were you mechanically active as a teen?  (No I don't mean
car mechanic)
There is some evidence that highly active (weight bearing etc) teens produce
a body metabolism model that requires higher than normal "forever"
lifestyle.

>>> The prevalence of this disease is due to its genetic
>>> advantages under primitive conditions; it rarely is
>>> a debilitating condition until reproduction is over.

As an ex attendee of the U of Minn, I was told that Purdue U was mediocre
:>)  :>)  Can't just let it go.
Herman Rubin - 07 Mar 2007 02:08 GMT
            .....................

>>>> As for Type 2 diabetes, which I have,

>>>Out of about 30 patients with type 2, I do not know of a single one who
>>>didn't have a ridiculous diet including much sugar when a teen.
>>>THEY don't think so and STILL are completely stupid in their diet.

>> When I was between 13 and 17, I was so skinny that doctors
>> tried hard, and unsuccessfully, to put weight on me.  By
>> age 19, the situation had completely reversed.  Go figure!

>Not at all uncommon even without any malady.
>You are not "mature" until around 25.
>Don't tell that to a 15, 18 or 21 year old.

            ..................

>> The advantages of antioxidants and polyphenols is
>> relatively recent; the FDA has not, to my knowledge,'
>> approved any claims about them, or about omega 3
>> fatty acids.

>Don't bet your health on FDA.
>As a diabetic you are probably aware that they REFUSE to let STEVIA be
>labeled as a sweetener.  It's about the only safe one out there.

>>>But, like you say flat out obesity is deadly.
>>>There are those with a high metabolism who get it (succomb to it).  These
>>>are the ones who die relativelyyoung with a meriad of other diseases.

>> Now come up with a good method for losing weight
>> and keeping it off; changing a person's set point
>> is not that easy.  Experiments on rats jibe with
>> this, as well.

>Lower (not dumb lower) carb intake.
>Weight (resistance) training.
>Aerobics are absolutely great but do practically nothing for weight control
>unless one does enough to ruin every joint in their body.
>It's almost a sure bet (your sig) that you have a desk job.

Not only that, but I never had any other kind.  During
those teen years, I was a student and at the end a
mathematics research assistant.  Except for one year in
the Army, much of that at desk work, I never had any
other kind.

Actually, aerobics did a great job for me, except it
ruined my knee (soft tissue damage) and made it difficult
to do much exercise since.  Right now I have multiple
problems.'

I agree with you about carb intake; I do not do Atkins,
but go more in that direction, and it seems not to have
made anything worse.

>You didn't say.  Were you mechanically active as a teen?  (No I don't mean
>car mechanic)
>There is some evidence that highly active (weight bearing etc) teens produce
>a body metabolism model that requires higher than normal "forever"
>lifestyle.

No, never.  I never had that much weight to bear at the time.

>As an ex attendee of the U of Minn, I was told that Purdue U was mediocre
>:>)  :>)  Can't just let it go.

For many things, it is.  Frankly, at this time, I do not
trust an undergraduate degree in mathematics from any
university in the country.

Signature

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

Vernon - 07 Mar 2007 14:25 GMT
> .....................
>
[quoted text clipped - 70 lines]
> trust an undergraduate degree in mathematics from any
> university in the country.

Boy, have you got that right.
Try being an Engineering or project manager and hire someone who can
ACTUALLY APPLY math.
David Wright - 05 Mar 2007 04:07 GMT
>Also, life expectancy has change very little.
>When taking into account infant mortality drop and sub teen death
>rate drop, life expectancy is LESS.
>The base should be how long a seventeen year old is expected to live.

That value is also continuing to rise, vernon.  Figures you wouldn't
know that.

 -- David Wright :: alphabeta at prodigy.net
    These are my opinions only, but they're almost always correct.
    "HPV shots don't cause promiscuity.  Tequila shots do." -- Bill Maher
Skeptic - 05 Mar 2007 04:51 GMT
>>Also, life expectancy has change very little.
>>When taking into account infant mortality drop and sub teen death
[quoted text clipped - 3 lines]
> That value is also continuing to rise, vernon.  Figures you wouldn't
> know that.

Correct.  The life expectancy of a 17 year old today is greater than it was
for a 17 year old 30 years ago.
N-H-P - 04 Mar 2007 21:21 GMT
> I never said anything about life expectancy declining. I refuse to
> debate with a.sholes who twist my words around to fit their bullshit.
>
> TC

http://blog.naturalhealthperspective.com/2007/03/04/tc-sure-does-like-to-complai
n-a-lot/


Agreeable as always, ... eh TC?
---
http://blog.naturalhealthperspective.com/
Keep on Blogging on Dude!
PeterB - 03 Mar 2007 19:29 GMT
> >> "TC" <tunder...@hotmail.com> wrote in message
>
[quoted text clipped - 55 lines]
> it is increasing.  Thus modern diets are doing something right, despite your
> fear of soda and everything else.

Bad logic.  The rise in aggregate lifespan at the population level
does not disprove the detriment of poor diet at the level of
individual health.  Maximum lifespan is genetic based, therefore diet
may not be as reliably correlated to lifespan as it is to disease
rates (and the evidence supports that.)  A variety of factors other
than diet are known to impact human health and lifespan, so while one
variable is predisposing, another is mitigating.  Health researchers
are well aware that lifespan is not the primary measure of population
health and fitness.  I agree totally with TC's premise that dietary
habits are well correlated to rates of disease and that lifestyle
choices are the best tool we have for improving personal health,
regardless whether we can extend our lifespans appreciably or not.

PeterB
George Conklin - 03 Mar 2007 23:59 GMT
> > >> "TC" <tunder...@hotmail.com> wrote in message
> >
[quoted text clipped - 59 lines]
> does not disprove the detriment of poor diet at the level of
> individual health.

  You have miserable logic.  You are saying that one at a time we call all
have poor diets but at the group level then live longer.  Ha Ha Ha.
PeterB - 05 Mar 2007 18:25 GMT
On Mar 3, 6:59 pm, "George Conklin" <georgeconkl...@earthlink.net>
wrote:

> > > "TC" <tunder...@hotmail.com> wrote in message
>
[quoted text clipped - 70 lines]
>    You have miserable logic.  You are saying that one at a time we call all
> have poor diets but at the group level then live longer.  Ha Ha Ha.

I did not say everyone has a poor diet, I said longer life does not
disprove the negative impact of a poor diet.  Even a child of eight
years old would understand that.  Question: Can most people have less
money than they need and still have enough money to live better than
their grandparents?   Of course they can.  Don't allow your ignorance
of the fundamentals of statistical science to fool you into thinking
you know something you don't.

PeterB
Skeptic - 03 Mar 2007 22:47 GMT
>   Your post therefore "proves" that life expectancy is declining.  In
> FAct, it is increasing.  Thus modern diets are doing something right,
> despite your fear of soda and everything else.

How does one conclude that increased life expectancy is as a result of diet?
Could it not be that other things are increasing life expectancy RELATIVELY
more than bad diets are decreasing it?  Of course.  I'm not saying that's
the case, but it is absolutely possible.
George Conklin - 04 Mar 2007 00:01 GMT
> >   Your post therefore "proves" that life expectancy is declining.  In
> > FAct, it is increasing.  Thus modern diets are doing something right,
[quoted text clipped - 4 lines]
> more than bad diets are decreasing it?  Of course.  I'm not saying that's
> the case, but it is absolutely possible.

  You don't get your name in the newspaper unless you declare we have a
"crisis" of "-----fill in the blank...."
Simply living longer does not count.
bigvince - 22 Mar 2007 04:57 GMT
> >> "TC" <tunder...@hotmail.com> wrote in message
>
[quoted text clipped - 57 lines]
>
> - Show quoted text -

Life expectancy has leveled of.  The generation that is now
approaching 55 is in worst physical condition then the previous one.
We are about to see an explosion of type to diabeates. This because of
our overconsumption of sugars. The insulin resistant syndrome or near
diabetes is a growing concern. Most life expectancy gains have been
accomplished by reducing early childhood deaths. While many would
attribute that to antibiotics and other medical procedures I agree
with a recent article in the British Medical Journal that said better
sanitation was the most inportant factor  Some of the discussion above
about statins which are the most widely prescibed drug in the world
and which have not really been shown to decrease mortality when used
in primary care. Medicine today is more about marketing drugs that
treat markers. Every one Knows that hypertention is the silent killer
but in a anylysis on bete Blocker published in the Lancet they were
shown to be no better that placebo against heart diesease and only
reduced stroke  by about 15% and increased  the incidence of
diabetes .In the UK they have been removed as primary care for
hypertention. Just Google [atenolol in hypertention a wise choice.].
Most MD don't understand that fact much easier to market The silent
killer; Bad lipids and many other things. Easier sell then educating
people on the inportance of diet ,excercise and a healthy lifestyle.
Herman Rubin - 03 Mar 2007 20:04 GMT
>> We evolved with certain specific nutrient requirements. Meet those
>> nutritional requirements and we will be healthy and free of these
>> chronic diseases.

>  What bullshit.  The chronic diseases of today were present in the past,
>when life expectancy was 35 years and food was in its natural unhealthy
>state.

Right on!  We evolved to survive the "natural" availability,
which was in no way optimal.  Also, from the standpoint of
survival, what life expectancy was best before civilization?

Under hunter-gatherer conditions, a "senior citizen" may be
useful as a store of knowledge, but is otherwise a drain on
the resources of the tribe.  The genetics for insulin
resistance, which can lead to the full-blown disease, Type
2 diabetes, has survival advantages in conditions of famine,
which our ancestors were likely to face.  Now, it is likely
to be only bad.  

Genes which have only bad consequences now had survival
advantages under "natural" conditions.  Sickly cell
anemia is now at least somewhat treatable; it used to
be almost certainly fatal.  Sickle cell trait, the
heterozygous form, has a small reduction in the ability
of the blood to transport oxygen, but confers substantial
ability to resist malaria.  What is better when?

Signature

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 - 04 Mar 2007 00:03 GMT
> >> We evolved with certain specific nutrient requirements. Meet those
> >> nutritional requirements and we will be healthy and free of these
[quoted text clipped - 7 lines]
> which was in no way optimal.  Also, from the standpoint of
> survival, what life expectancy was best before civilization?

  I don't know about "best," Herman, but from archeological digs and so
forth we know it was under 40 up until modern times.  Most of the time it
was about 30.

> Under hunter-gatherer conditions, a "senior citizen" may be
> useful as a store of knowledge, but is otherwise a drain on
[quoted text clipped - 3 lines]
> which our ancestors were likely to face.  Now, it is likely
> to be only bad.

 Correct.

> Genes which have only bad consequences now had survival
> advantages under "natural" conditions.  Sickly cell
[quoted text clipped - 3 lines]
> of the blood to transport oxygen, but confers substantial
> ability to resist malaria.  What is better when?

 Then there is the natural ability to resist the plague, which also gives
immunity to AIDS.
Herman Rubin - 02 Mar 2007 18:59 GMT
>> In article <1172783573.264397.30...@h3g2000cwc.googlegroups.com>,

>> >> > In article <1172584448.394513.58...@z35g2000cwz.googlegroups.com>,
>> >> > >On Feb 26, 5:45 pm, monty1...@lycos.com wrote:
>> >> > >> Though outright fraud is possible, what is much more common is
>> >> > >> misinterpretation.  

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

>> The statin studies are among the worst, and they will not
>> get better until much more complicated statistical methods
>> than those I have seen in medical reports are used.  I have
>> had numerous doctors try to get me on statins, and I have
>> managed to convince some that it was at least reasonable
>> in my case not to do this.

>> In one British study on diabetes, sponsored by the British
>> government, it was stated that something was not important
>> because its p-value was 0.052.  If the p-value was 0.049,
>> it would have been quite important.

>That's why drug approval should be based on endpoint data confined to
>clinical outcomes in real patients, not the bending of markers "sold"
>to the public as equivalent to the disease itself.

Drug approval is based on such data; in the US, the FDA has
essentially a rigid set of requirements.  That it can be done
better is not the fault of the drug companies.  Few medical
researchers understand the statistics they regularly use.

The studies I have attacked include those done by the British
government, not pharmaceutical companies.  There are lots of
similar studies, some of which may be sponsored by the
companies themselves.  They do show that statins have benefits,
and nobody disagrees that they have risks, for some.  It is
quite possible that if everyone took statins there would be
fewer cardiovascular problems, but even if this is the case,
should everyone take them?  

Signature

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 - 04 Mar 2007 00:04 GMT
> >> In article <1172783573.264397.30...@h3g2000cwc.googlegroups.com>,
>
[quoted text clipped - 34 lines]
> fewer cardiovascular problems, but even if this is the case,
> should everyone take them?

 Herman, have you shown in a refereed journal that applying the data
analysis you prefer has or will have resulted in large-scale changes in
outcomes?  If not, why not?
george conklin - 02 Mar 2007 19:26 GMT
>>> > In article <1172584448.394513.58...@z35g2000cwz.googlegroups.com>,
>
[quoted text clipped - 75 lines]
> because its p-value was 0.052.  If the p-value was 0.049,
> it would have been quite important.

That is a matter of tradition, not FAct Herman.  The .05 level is quite
arbitrary as you well know.
GMCarter - 03 Mar 2007 12:37 GMT
snip
>> In one British study on diabetes, sponsored by the British
>> government, it was stated that something was not important
[quoted text clipped - 3 lines]
>That is a matter of tradition, not FAct Herman.  The .05 level is quite
>arbitrary as you well know.

It also depends on what the comparator arm is. If a placebo when other
standards of care drugs exist, the clinical relevance may be nil.

Another approach that could augment the p<0.05 (which, though
arbitrary, is adhered to with some might), would be to apply Bayesian
statistics. These may give a better idea of whether the findings may
have clnical significance masked by a high p value.

        George M. Carter
Herman Rubin - 03 Mar 2007 20:54 GMT
snip
>>> In one British study on diabetes, sponsored by the British
>>> government, it was stated that something was not important
>>> because its p-value was 0.052.  If the p-value was 0.049,
>>> it would have been quite important.

>>That is a matter of tradition, not FAct Herman.  The .05 level is quite
>>arbitrary as you well know.

>It also depends on what the comparator arm is. If a placebo when other
>standards of care drugs exist, the clinical relevance may be nil.

If it is one drug or another, the double-blind tests can
still be used.  If the type of care is involved, this
does not work.  

>Another approach that could augment the p<0.05 (which, though
>arbitrary, is adhered to with some might), would be to apply Bayesian
>statistics. These may give a better idea of whether the findings may
>have clnical significance masked by a high p value.

>        George M. Carter

It has been shown that the level of significance is not
directly related to the evidence in favor of the new
treatment, nor does it at all indicate the quantitative
difference.  The use of the likelihood function, which
is the experimental evidence, is needed, and it is not
at all difficult to show this.

Also, multivariate statistical procedures, not at all
new but apparently understood by few medical people,
are needed and available.  

Signature

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 - 04 Mar 2007 00:06 GMT
> snip
> >>> In one British study on diabetes, sponsored by the British
[quoted text clipped - 29 lines]
> new but apparently understood by few medical people,
> are needed and available.

 I will strong agree with the last statement.  Multivariate analysis
especially for SES does show large social class differences which can easily
mess up a so-called clinical study.
GMCarter - 04 Mar 2007 13:32 GMT
>snip
>>>> In one British study on diabetes, sponsored by the British
[quoted text clipped - 11 lines]
>still be used.  If the type of care is involved, this
>does not work.  

Double-blind wasn't the aspect I was referring to but rather the use
of a placebo or, if one exists, a pre-existing standard of care.
Often, drug companies prefer placebo especially if their new drug,
very costly, isn't likely to be any better than older drugs.

>>Another approach that could augment the p<0.05 (which, though
>>arbitrary, is adhered to with some might), would be to apply Bayesian
[quoted text clipped - 7 lines]
>is the experimental evidence, is needed, and it is not
>at all difficult to show this.

Please tell me more about the likelihood function.

>Also, multivariate statistical procedures, not at all
>new but apparently understood by few medical people,
>are needed and available.  

There's a number of ways to undertake multivariate analyses that I
think are rather routinely done.

        George M. Carter
George Conklin - 04 Mar 2007 00:05 GMT
> snip
> >> In one British study on diabetes, sponsored by the British
[quoted text clipped - 14 lines]
>
> George M. Carter

Ok, but have you or Herman applied the Bayesian techniques to a clinical
outcome to show the difference?
GMCarter - 04 Mar 2007 13:35 GMT
>> snip
>> >> In one British study on diabetes, sponsored by the British
[quoted text clipped - 17 lines]
>Ok, but have you or Herman applied the Bayesian techniques to a clinical
>outcome to show the difference?

I cannot speak for Herman but I have not. Yet! I'm not a statistician
but have worked on clinical trial development. An interesting paper in
PLoS recently discussed the technique and how it can be used. Not as a
replacement but rather as an adjunct analysis.

But then, I think we need to FIRST clean up clinical science and
eliminate the pernicious influence of privatized R&D which has turned
it into a mockery where profit matters, lives and health are secondary
and irrelevant.

        George M. Carter
George Conklin - 04 Mar 2007 14:31 GMT
> >> snip
> >> >> In one British study on diabetes, sponsored by the British
[quoted text clipped - 29 lines]
>
> George M. Carter

  Medicince may be the only business where research is supposed to be
supported by government.  At least the drug companies do their own research.
How much more can government do anyway?
GMCarter - 05 Mar 2007 13:30 GMT
snip

>   Medicince may be the only business where research is supposed to be
>supported by government.  At least the drug companies do their own research.
>How much more can government do anyway?

Medicine should not be a business. That's the first, false premise.
"Business" implies commodities. Is your life and health nothing more
than a commodity? That view is genocidal when it goes to people being
denied treatment due to overinflated and arbitrary costs.

Government does a GREAT deal of R&D already--pharma thus benefits from
tax dollars and then turns around, hides behind a distortion of patent
law, and screws the crap out of everyone.

Discovery pipelines narrow as blockbusters are exclusively sought.
Crap like ezetimibe is vomited onto the scene, pointlessly--except for
profit.

Your question is excellent. The government can and does do clinical
trials through phase 2 and even 3. I think that we can have public
funding for all the way through post-marketing studies.

(As an aside, this will work even better and with greater economy if
we have a single payer health care system and thus fewer forms for
physicians to waste time and lives with.)

Kucinich I believe has a bill to sponsor just this kind of thing.
Discovery then could be FAR more collaborative. Licensing fees up and
downstream of the discovery process would be eliminated. Some stinking
pharma lawyers might have to find other work as would the armies of
brain dead, greed-fueled lobbyists and salesmen.

A sacrifice that pales in comparison to the millions that could be
helped when SCIENCE rules the roost, not profit. (And with a return to
the use of patent to inspire innovation, not stockholder profit.)

        George M. Carter
Herman Rubin - 07 Mar 2007 01:47 GMT
snip

>>   Medicince may be the only business where research is supposed to be
>>supported by government.  At least the drug companies do their own research.
>>How much more can government do anyway?

>Medicine should not be a business. That's the first, false premise.
>"Business" implies commodities. Is your life and health nothing more
>than a commodity? That view is genocidal when it goes to people being
>denied treatment due to overinflated and arbitrary costs.

Medical care is a commodity, which is, and will be, in short
supply.  That costs are overinflated and somewhat arbitrary
is due to the existence of anti-insurance (no real insurance
operates the way "medical insurance" does, and insurance
company and federal regulations greatly add to the costs.
My podiatrist told me he has as many clerks as nurses.  At
least 20% of the cost is due to this.

>Government does a GREAT deal of R&D already--pharma thus benefits from
>tax dollars and then turns around, hides behind a distortion of patent
>law, and screws the crap out of everyone.

I doubt that 10% of the testing costs of drugs is matched
by government R&D.  It should be all R, but this would go
against the government mandates.  

>Discovery pipelines narrow as blockbusters are exclusively sought.
>Crap like ezetimibe is vomited onto the scene, pointlessly--except for
>profit.

With the emphasis on cures, rather than on understanding,
and this comes from the government funders, what do you expect?

>Your question is excellent. The government can and does do clinical
>trials through phase 2 and even 3. I think that we can have public
>funding for all the way through post-marketing studies.

Rarely.  Doing this for ONE drug would use up a big part
of the entire federal health R&D annual budget.

>(As an aside, this will work even better and with greater economy if
>we have a single payer health care system and thus fewer forms for
>physicians to waste time and lives with.)

If we have a single payer system, innovation will greatly
decrease.  I would like to get rid of the "reduced rates"
allowed by the insurance companies.  This CANNOT produce
good medical care.  Right now, many physicians are refusing
to take Medicare patients because the government allowed
rates are less than their marginal net revenues.

>Kucinich I believe has a bill to sponsor just this kind of thing.
>Discovery then could be FAR more collaborative. Licensing fees up and
>downstream of the discovery process would be eliminated. Some stinking
>pharma lawyers might have to find other work as would the armies of
>brain dead, greed-fueled lobbyists and salesmen.

It costs most of a gigabuck to carry out the phase 3
testing.  Getting this back through temporary monopoly
is the basis of the idea of patents; the patenter must
provide the information for anyone "skilled in the art"
to make the drug in return for the temporary exclusive
rights.  The government cannot pay for all of this.

>A sacrifice that pales in comparison to the millions that could be
>helped when SCIENCE rules the roost, not profit. (And with a return to
>the use of patent to inspire innovation, not stockholder profit.)

What typically happens is that the idea comes up, and
then there is a sale of the patent rights (of unknown
value at the time) to a company which can carry out
development.  I once came up with an idea for something
to be used on an electronic computer, and a university
patent committee decided that it was patentable, but
not worth patenting.

With medical patents, there is a special rule that the
patent does not expire until 10 years after approval
to market the drug, while for ordinary patents, there
is a fixed time from submitting the patent.  This is
because it too often takes more than 10 years to get
through the approval stages.  Also, many drugs fail,
and the costs of testing these need to be recovered.

Science is what scientists do, not science administrators.
At this time, the government is directing most science.
Medicine seems to have the largest independent activity,
instead of most science being in this category.  I would
rather get rid of almost all government involvement.

Signature

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

GMCarter - 07 Mar 2007 12:33 GMT
>snip
>
[quoted text clipped - 9 lines]
>Medical care is a commodity, which is, and will be, in short
>supply.  

That's one view--one that has failed dismally. The United States as a
result of embracing this view spends 15% or more of its GDP on
healthcare, has outcomes in terms of infant mortality, longevity, etc.
on a par with the Czech Republic (where they spend a LOT less on
healthcare) and with 47 million of us uninsured.

That's a model called "disaster" in any book but the kind of brain
dead, head-up-the-a.s ostrich-style approach of people like George W.
Bush and Dick Cheney.

A lot of those costs are related to the tons of paperwork, forms in
quintuplicate  and efforts to deny claims that characterize the lethal
and destructive "insurance" industry.

snip...
>>Government does a GREAT deal of R&D already--pharma thus benefits from
>>tax dollars and then turns around, hides behind a distortion of patent
[quoted text clipped - 3 lines]
>by government R&D.  It should be all R, but this would go
>against the government mandates.  

LOL...you're psychotic. The "D" part is a HUGE chunk of pharma's
inflated lie that it costs $800 million to bring a drug to market (let
alone that half the cost is capitalization). R&D costs would be MUCH
lower without the thorny thicket of patents that charge outrageous
licensing fees for every step in discovery. Let alone all the costs of
sending millions of minions of brain dead reps to hawk drugs to
physicians.

>>Discovery pipelines narrow as blockbusters are exclusively sought.
>>Crap like ezetimibe is vomited onto the scene, pointlessly--except for
>>profit.
>
>With the emphasis on cures, rather than on understanding,
>and this comes from the government funders, what do you expect?

What in the world are you babbling about now? Oh my god. You really
believe this bullshit? Provide some evidence then, please.

        George M. Carter
George Conklin - 07 Mar 2007 13:03 GMT
> >snip
> >
[quoted text clipped - 23 lines]
> quintuplicate  and efforts to deny claims that characterize the lethal
> and destructive "insurance" industry.

You know, of course, that all the uninsured could be covered if we stopped
paying clerks to deny claims and simply paid for needed care instead.  I
notice the so-called "insurace" discount at work personally this month.  A
leg immobilizer (for a torn tendon), which is a velcro gizmo, was billed at
$100.  Approved charge?  $17.95, which is ample.  The poor slob without
insurance gets the $100 bill.
GMCarter - 07 Mar 2007 18:15 GMT
>> >snip
>> >
[quoted text clipped - 31 lines]
>$100.  Approved charge?  $17.95, which is ample.  The poor slob without
>insurance gets the $100 bill.

Yep--that's right. I'm one of those poor slobs.

And they are going to murder me, just like they are murdering lots of
people in the US and around the world to charge these unreasonable
prices.

I'm weary of living in