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 A Pauling Therapy Study Design Exercise 
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Ascorbate Wizard
Ascorbate Wizard

Joined: Tue Nov 22, 2005 3:16 pm
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Post Cost
We'll we are almost at the point where we need to list the cost per measurement of the various techniques that can be used to measure atherosclerosis.

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Owen R. Fonorow, Orthomolecular Naturopath


Sun Jul 08, 2007 8:33 am
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Post proposal
Owen,

I'm not certain if serial arteriography is still a common diagnostic tool. I wasn't able to determine that it is widely available and, if it is, how much it would cost.

As an alternative, perhaps an Ultra-fast CT scan would work?

If so, the cost per scan would be about $400. I believe, based on your prior proposal, that we'd want to perform at least two scans per participant.

Cost per patient: $800 (total)

http://www.labiomed.org/cardiology/ebt/ ... wsweek.htm

Then, we should have a CBC performed two times.

Cost per patient: $100 (total)

http://www.lef.org/newshop/items/itemLC381822.html

Add to that, the L(p)a test, performed two times.

Cost per patient: $80 (total)

http://www.lef.org/newshop/items/itemLC016873.html

We could also give each participant a home blood pressure monitoring devise. They could monitor and note their readings on a regular basis.

Cost per patient: under $100

http://www.amazon.com/dp/B000FK1V2Q

It's possible that the LEF may give us a "member discount" (I'm a member). That would drop the blood test costs by 25%.

Ultimately, the cost per participant, would be approximately $1000 - not including the supplements.


Tue Jul 10, 2007 10:47 am
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Ascorbate Wizard
Ascorbate Wizard

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Post Yes
Given you numbers, a small study of 20 participants would cost a minimum of $20,000, not counting the cost of the doctors visits.

The problem with the current "Fast CT Scans" is that they measure calcium. In my experience, calcium deposits more on the "outside" of the artery, away from blood flow, and these scores are not resolved by vitamin C and lysine. In other words, the opening can enlarge, the blood flow generally increase, without the calcium score going down. (On the other hand, vitamin K probably affects the calcium score.)

I think I can get the VAP Lp(a) tests for around $30/test.

One reason I like the Cardio-Vision (blood pressure/computer) is that after the initial investment (was $5000, probably less now) the cost per test is nil.

But this is where the rubber meets the road

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Owen R. Fonorow, Orthomolecular Naturopath


Tue Jul 10, 2007 10:56 am
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Post follow-up
Owen,

If not the Ultra-fast CT scan, then what other (commercially-available) procedure would you suggest?

Do you think a Duplex Ultrasound would be a better option? It appears to run about $500 per test.

http://ves.sagepub.com/cgi/content/abstract/37/3/165

http://www.vascularweb.org/_CONTRIBUTIO ... sound.html


Tue Jul 10, 2007 11:11 am
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Ascorbate Wizard
Ascorbate Wizard

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Post Lets look at this differently
Lets say we have $5000 for the study.

If we have 10 people in the study, then we have $500 per person.

If we can get them to purchase their own vitamin C and lysine, and the doctors/scientists to donate their time, then we have $500 for all the measurements.

But 10 people is really small - 5 on placebo?

You can see why we tried (twice) to interest the U. S. Government NIH in funding such a study.

I was hoping that we (in this topic) would be able to come up with an efficient way to measure the effectiveness that wouldn't break the bank. (I know that digg.com is attempting to do what the NIH won't - raise money to fund tests of a non-patentable cancer cure, and perhaps we could go that route with an economical study design)

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Owen R. Fonorow, Orthomolecular Naturopath


Wed Jul 11, 2007 10:15 am
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Post Re: Lets look at this differently
ofonorow wrote:
Lets say we have $5000 for the study.

If we have 10 people in the study, then we have $500 per person.

If we can get them to purchase their own vitamin C and lysine, and the doctors/scientists to donate their time, then we have $500 for all the measurements.

But 10 people is really small - 5 on placebo?

You can see why we tried (twice) to interest the U. S. Government NIH in funding such a study.

I was hoping that we (in this topic) would be able to come up with an efficient way to measure the effectiveness that wouldn't break the bank. (I know that digg.com is attempting to do what the NIH won't - raise money to fund tests of a non-patentable cancer cure, and perhaps we could go that route with an economical study design)


Owen,

I've enjoyed this exercise. I participated even though I strongly suspected that we'd come (back) to this point. Ultimately, we're going to have to include some objective means of determining any changes in plaque progression or regression and that's going to cost money - unless some sympathetic professional offers these services for free or a reduced fee.

In my opinion, we'll need this (at a minimum).

A baseline test consisting of:

a) an CBC blood test
b) an Lp(a) blood test
c) a Duplex Ultrasound or similar procedure

These same tests would need to be performed at the end of the study as well.

Since this would be considered a "pilot study", I think a total of five participants would be sufficient. There would be no need for a control. I don't think anybody is suggesting that the placebo effect can affect plaque content in one's arteries.

Now to the funding. If we wait for the government to fund such a study ... we'll accomplish nothing at all. Perhaps they'll consider funding such a study if the results of our pilot study are positive but otherwise, it's probably more of a pipe-dream.

So, how shall we go about practicing the good ol' American way and making this study happen without the support of the government? This is not an impossible situation. I'm offering my support and assistance and I'm hopeful that others would be willing to provide the same.


Thu Jul 12, 2007 9:51 am
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Ascorbate Wizard
Ascorbate Wizard

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Post peeve
I generally agree. However, if we are going to attempt this, it should include more subjects, and more inexpensive measurements. It just peeves me that Willis in 1953 was able to take such remarkable picturees.

I think Willis had more subjects in 1954, 6 controls and 10 on ascorbic acid (If I can count)
See vitamincfoundation.org/pdfs
SERIAL ARTERIOGRAPHY IN ATHEROSCLEROSIS, G. C. Willis, A. W. Light, W.S. Cow, Canad. M. A. J. Dec 1954, Vol 71, 1954, p. 562-568

I also notice that you can not see the pictures on the pdsfs from the scans of the old documents I received as reprints from the Canadian Medical Journal. (What I have isn't great, but they are much clearer on paper.) He called the technique "serial arteriography", and I notice he said it was based on a "lindborn" method (1950).

You can google S. A. and find papers on cancer that use a technique with the same name, but I doubt it is the same.

On page 562 and 563, Willis describes his serial arteriography technique that includes inserting needles under the skin into the artery with a die before filming. The pictures are outstanding, but this is apparently a painful testing technique.

As an aside, we have had a doctor give us an idea. There are patients with various conditions, and he said that we can get most of the testing paid for by Medicare. We'd probably only have to pay for the Lp(a) tests, etc.

But I still don't have a clear alternative in my mind to the Willis Serial Arteriography - an Ironclad method for measuring changes in large arteries near the heart.

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Owen R. Fonorow, Orthomolecular Naturopath


Thu Jul 12, 2007 6:05 pm
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Post Medicare and more
Owen,

In all honesty, I thought of the insurance/Medicare possibility but I wasn't sure if it might get the participating physicians in trouble. Maybe this was a misplaced concern but it lingered in my mind none-the-less. I want to make sure that we do this in a way that won't harm anyone - and maybe utilizing the support of Medicare would not. I'm just not sure.

Do you have any relationship or connection with any good cardiologists? If so, perhaps they'd be willing to offer their opinion about what sort of testing would be most appropriate. I suspect they may tell you that the "gold-standard" is an angiogram - which is expensive, invasive and potentially dangerous. I'd like to find another way - even if it sacrifices (to some extent) the clarity of the data. That's why I mentioned the Duplex Ultrasound.

BTW, I did Google Serial Ateriography prior to mentioning the Ultra-fast CT and the Duplex Ultrasound. I abandoned that option when I essentially found very little recent information regarding it's use in coronary-health matters. Also, I didn't find any evidence that it is commercially available and if so, how expensive it would be.


Thu Jul 12, 2007 9:26 pm
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Ascorbate Wizard
Ascorbate Wizard

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Post aortic duplex ultrasound
http://ves.sagepub.com/cgi/content/abstract/37/3/165

Quote:
The charges for CT angiography in their institution average $2,779 per study, for a 3-year total of $22,232 per patient. The charges for aortic duplex ultrasound average $525 per study, with a 3-year total of $4,200 per patient. Adding the cost of routine abdominal radiographs to confirm stent graft position ($147 per study) would bring this 3-year total to $5,376, a savings of $16,856 per patient.



Good work. There is probably no less expensive way to "see" inside the arteries. Even if we only preformed 2 studies per patient, that is still one thousand dollars per study subject for this one type of measurement.

As far as using medicare/medicaid, the idea was to cover routine blood analysis and doctor examinations that the patients would undergo anyway. Not to try to cover something like a Duplex Ultrasound. The doctor was a kidney specialist and his patients were on dialysis.

I suppose if we found heart patients, who routinely undergo cardivascular examinations, we might be able to defray some of these expenses.

I have a distant relative, who is a research cardiologist at UCLA (Gregg Fonarow), and who has had some of his research showing the "benefits" of statins published, which made news.

I tried to contact him to interest him in researching vitamin C, to no avail. He didn't say this, but I sense he doesn't want to risk his reputation.

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Owen R. Fonorow, Orthomolecular Naturopath


Sat Jul 14, 2007 7:24 am
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Ascorbate Wizard
Ascorbate Wizard

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Post CardioVision
http://www.newlinemedical.com/CardioVision.html

Quote:
Cardiovision is a test that is safe, quick and painless and very affordable so that you can monitor your cardiovascular health.

In addition to blood pressure and pulse information, the Cardiovision also generates information on the elasticity or flexibility of the brachial artery. Called the Arterial Elasticity Index (AEI), the AE-I is a number that correlates with arteriosclerosis. Because arteriosclerosis reduces flexibility in arteries, the higher the AE-I, the more likely someone is to have hardening of the arteries, the lower the number, the less likely. Why is it important to know how flexible your arteries are? Arteries are responsible for moving the majority of the blood through the vascular tree. Consequently non-flexible arteries cause the heart to work harder. This extra strain on the heart can lead to cardiovascular disease.

It is estimated that 60-70 million Americans walk around with this "silent killer," not realizing that some lifestyle changes could decrease their risk of this potentially fatal disease. The Cardiovision screening test is a non-invasive painless, 3-minute test to monitor your cardiovascular health. The test will measure: arterial elasticity (indicating clear or obstructed arteries), blood pressure and potential arrhythmia.

The Cardiovision instrument utilizes the oscillometric method of blood pressure measurement and the software of the Cardiovision drives the oscillometry to monitor specific data points of the brachial artery elasticity. It compares those data points against previously diagnosed patients with cardiovascular disease and arrhythmia, and interprets this data to categorize an individual's pulse pattern and condition into one of five identified, distinct graphical patterns which show close correlation to known cardiovascular conditions. In this way Cardiovision is able to screen for the presence of coronary artery disease and cardiac arrhythmia. The association between cardiovascular risk factors and an increased incidence of coronary heart disease is well established. The systolic and diastolic values displayed on your Cardiovision report represent your blood pressure reading. The Mean of the systolic and diastolic measurements is also displayed as well as your pulse rate. Each are labeled accordingly on your Cardiovision report. A Cardiovision Pulse Wave Pattern is also given and a narrative discussing the significance of your pattern is also provided.


Apparently CardioVision units are still for sale. If any one can find the manufacturer, perhaps we can obtain one for less than $6000.

These links may be useful

http://www.newlinemedical.com/cardiovision_links.html

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Owen R. Fonorow, Orthomolecular Naturopath


Sat Jul 14, 2007 7:31 am
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Owen,

Cardiovision may very well be the tool that can make this experiment both cost-effective while retaining a high-degree of legitimacy (because the test is FDA approved).

It seems to me (and I could be wrong, of course) that instead of purchasing one of these monitoring devices ... we should instead find practitioners that offer this form of testing in their own offices/clinics. For instance, I found one place that offers such a test for $25 a pop.

http://healthintentionally.com/cardiovision.htm (based in San Diego ... southern California)

Now, the trick would be to find enough similar testing facilities in close proximity to where the participants live. I've done a preliminary search and found that this test is (fairly) widely available throughout the USA and Canada.

To me, this seems like a more practical way to apply the testing. How do you feel about this?


Sat Jul 14, 2007 12:02 pm
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Ascorbate Wizard
Ascorbate Wizard

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Post CardioVision
I like CardioVision very much, it is non-invasive and quick, but there is one significant caveat.

It is really a test for calcium, not blood flow.

Consider the case of one gentleman I know who was in his 70s.
He was on 2 or 3 jars of Tower Heart Technology for years,
and his Lp(a) was 3 mg/dl.

A friend started a company that provided the so-called "fast CT" scans.
He offered to test the gentleman for free.
THe reports came back "massive disease" which actually means, massive calcium deposits.

The man checked himself into the hospital for an angiogram.
The results showed very little blockage, LAD wide open, etc.

So we have a case of high calcium, but good blood flow and no blockage.

Later, the same gentleman was with me when we first saw Cardio-Vision and we both had CV measurements taken.
My reading was completely within the normal range,
but this gentleman's arterial stiffness index was off the charts.

In other words, CardioVision is sensitive to calcium. T
he test can produce a false positive (if bad is positive) when the arteries are calcified.
This experience also taught me that taking high vitamin C and lysine is not going to change calcium readings.

p.s. I advised the gentleman to begin supplementing vitamin K. He did, and the next year (now several years ago) at the next conference, we both had our CardioVision measurments taken, and his ASI and mine were normal and almost identical.


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Owen R. Fonorow, Orthomolecular Naturopath


Sun Jul 15, 2007 8:28 am
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Post a few questions
Owen,

Given that Cardiovision is influenced by calcium deposits (and the C/Lysine combo doesn't really address this) ... what do you suggest we do? Is there a test that would be suitable for detecting non-calcium deposits (that fits our needs - cost, convenience, safety, etc.)?

Obviously we wouldn't want to use a testing procedure that would leave us with results that would require qualifications. Unless, we could somehow screen for patients that have arterial plaque that is not calcium-based. I just don't know how difficult this would be.

As an aside, what type and how much vitamin K did your friend use (to reverse the calcium deposits)?


Sun Jul 15, 2007 1:05 pm
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Ascorbate Wizard
Ascorbate Wizard

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Post Vitamin K
Well, he told me he only changed 2 things over the course of that year. So there is a confusion factor.

I recommended that he take perhaps 2 mg of vitamin K. He went to a health store, and the "vitamin K" product he picked up was about the RDA, or 150 micrograms.

And he shared with me that during the year he had also obtained a prescription for Viagra. 8)

As far as the proper measurements, to me, this has been the point of this exercise. Can we, or others, invent a convincing, yet low-cost method of studying vitamin C/lysine.

Any study we do ought to have Lp(a) and CardioVision measurements, in addition to general blood tests, (depending on costs). I like the AtheroTech VAP blood test. For the record, these are the measurements that we proposted to the NIH. (For the first NIH grant request, we also proposed Thalium Stress Tests because Dr. Warren Levin considered these to be the "gold standard" of whether or not the coronary arteries were blocked, but those tests are very expensive.)

Back to brainstorming, we are

A) interested in blood flow, which means we are interested in the diameter of the opening in the major coronary arteries (which of course changes as the arteries dilate).

B) interested to a certain extent, in the thickness of the arteries, when the thickness is abnormal.

C) very interested in whether these arteries have plaque, and how thick the plaques are.


The Willis serial arteriography measured A, CardioVision may indicate B, and USC and others have a means to measure B (IMT), and Bush Cardioretinaometry provides an indirect measurement of C.

Can we think of indirect measurements of A and C? For example, Angina Pain in many cases is an indicator of A, or perhaps all 3. But how do we objectively measure pain, and account for the fact that some people experience no pain.

This is where the idea of walking up stairs, or some measure of exertion, comes from. We need a measurement that can be used to objectively measure improvement, as long as we can eliminate the factor of muscle tone.

So this is the challenge. Can we think of an indirect measure of blood flow, plaque build-up and heart function that can be objectively used to measure progress or regression in CVD patients?

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Owen R. Fonorow, Orthomolecular Naturopath


Mon Jul 16, 2007 7:45 am
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Post possibility
Owen,

Please review the content on these links:

http://www.lifelinescreening.com/About/Pages/Index.aspx

http://www.lifelinescreening.com/Servic ... troke.aspx

I wonder if this might be a piece to our puzzle?


Mon Jul 16, 2007 1:36 pm
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