Niacin scams

In the Track Your Plaque program, we often resort to niacin (vitamin B3 or nicotinic acid) to:

--Raise HDL cholesterol
--Reduce the proportion of small LDL particles
--Shift HDL towards the healthy larger fraction (HDL2b or "large")
--Reduce lipoprotein(a), the most aggressive risk factor known


But niacin comes with a crazy "hot flush," a warm, prickly feeling that usually envelops the upper chest, neck and face that is, without a doubt, annoying. Around 1 in 20 people simply cannot tolerate any amount of niacin >100 mg, while others have no problem even into the 3000 mg per day or more range. (Tolerance to niacin is genetically determined, governed by the rapidity of metabolism to the niacin metabolite, nicotinuric acid.)

The niacin flush has spawned an entire panel of niacin-like scams, agents that sound like niacin or may even contain niacin, but exert no beneficial effect whatsoever:

Flush-free niacin--I have previously posted on this useless but ubiquitous preparation that often costs several times more than conventional niacin. Flush-free niacin, or inositol hexaniacinate, does indeed contain niacin, but it is not released in the human body. You simply pass it out down the toilet, where this preparation belongs in the first place.

Nicotinamide--Also called niacinamide. While the nicotinamide/niacinamide forms of vitamin B3 can be used to treat B3 deficiency ("pellagra"), they do not reproduce the lipid and lipoprotein effects of niacin. For our purposes, they are useless.

Niacin-containing heart-healthy supplements--These are the multi-supplements that contain a little of everything that might be beneficial for the heart, but none at a dose that provides genuine benefit. Don't throw your money away.


There's also a prescription niacin, Niaspan, that costs 20-fold more than the best over-the-counter preparation, Sloniacin. Niaspan has yielded hundreds of millions of dollars for the pharmaceutical industry. Your money, in my view, is far better spent on Sloniacin (around $12-14 per bottle of 100 tablets of 500 mg).

For more on niacin, here's an article I wrote for the Life Extension Magazine people a while back: Using Niacin to Improve Cardiovascular Health.

Deja vu all over again?

HeartHawk brought a report and debate on The Heart.Org website to my attention:

Screening for risk factors or detecting disease? Debate divides the CV community. After landing on theheart.org, paste this onto your URL address:article/883239.do. (Full address: http://www.theheart.org/article/883239.do. I don't know why, but I couldn't go there directly.)

Some interesting comments:

Dr. Jay Cohn (University of Minnesota):

"They're saying that we can't identify disease very effectively so let's just stick with risk factors, which we know are very poorly predictive and nonspecific. It boggles my mind as to why they won't open up their minds to the importance of moving forward in finding better strategies to identify the disease that we are treating. It's very strange. They criticize these disease markers because they are not predictive of events, but they are looking at very short-term outcomes. We're interested in lifetime risk. We're screening people in their 40s who are concerned about morbid events in their 60s and 70s, and no trials are going to track them that long."

"You have to accept the pathophysiologic reality that heart attacks don't occur in the absence of coronary disease, and coronary disease doesn't occur in the absence of endothelial dysfunction and vascular disease, all of which now can be identified."

". . . Can we as a society and as a profession accept the idea that there is a link between the vascular abnormalities and the events? "And that that linkage is tight enough that it should allow us to accept slowing of progression of the vascular abnormalities as an adequate marker for slowing disease progression, without waiting for events to occur? As soon as you use the word surrogate, people jump up and say we have all these markers that we know don't work well—things like premature ventricular contractions [PVCs] on the electrocardiogram, LDL, HDL—but those are not the markers we're talking about. We're talking about structural and functional changes in the blood vessel and in the heart."



Wow. The idea may be starting to catch on.

As an interesting aside, Cohn et al use a 10-test panel to screen for vascular disease:

"Named for the center's benefactor, the Rasmussen score includes tests for large and small artery elasticity (compliance), resting blood pressure, blood-pressure response to moderate treadmill exercise, optic fundus photography, carotid intimal-media thickness (IMT), microalbuminuria, electrocardiography, left ventricular (LV) ultrasonography for LV volume and mass, and brain natriuretic peptide (BNP). Each test result is scored out of 10 for low, intermediate, or high risk, and the combined results yields a score that Cohn et al believe is more predictive than any of the existing standalone tests."


The counterarguments in this debate were provided by Dr. Philip Greenland (Northwestern University), who repeated his oft-used argument that, while he accepts that vascular disease can be identified, no one has proven that measuring it improves outcomes:

"We do have that evidence for risk-factor screening. Even though people criticize risk-factor assessment because it is not sensitive enough or not accurate enough, the interesting and curious thing is that we actually have evidence that if you go to the trouble of screening for risk factors and treating them, patients have better outcomes. We do not have that evidence for any of these other tests."


An interesting debate ensues that includes Track Your Plaque friend, Dr. William Blanchet, who characteristically argues persuasively in favor of broad screening for coronary disease with coronary calcium scoring:

"If we were doing our jobs in primary prevention, we would not need to look at improved intervention and secondary prevention to reduce coronary death."


Here's a shock: Dr. Melissa Shirley-Walton, the cardiologist who previously preached the "cath lab on every corner" argument seems to have undergone a change of heart:

"What if I walked up to a gentleman and said, "you are at risk for CAD, take a statin", to which he replies, "I'm afraid of those meds". BUT if he sees his calcium score........he is then convinced to be pro-active. What is so wrong with that? What is so wrong with allowing him to spend 250.00 US out of pocket in order to save the US 150,000.00 US later on?

No hard endpoints you say with intensive therapy for primary prevention? What about extrapolating from trials for secondary prevention like HATS? ARBITER2? And what exactly is the true definition of secondary prevention? Is it truly primary prevention if we already have intima thickness abnormalities, or fatty streaks? That would more likely fall under secondary prevention by today's new standards.

So, I'm all for any visual aid that will encourage compliance with life style change, necessary medical therapy and followup. If the patient is willing to spend 250.00$ to get a calcium score, so be it. Better yet, why not lower the price so everyone can have the option if they are motivated enough to seize an opportunity?"



I have to admit that I thought that Dr. Blanchet was wasting his time trying to persuade Shirley-Walton et al, but perhaps he is having an impact, though having hammered away at them for the last year or so.

These arguments, for me, eerily echo many previous debates I've heard. But I am encouraged by the more favorable treatment the notion of atherosclerosis screening is receiving. Just 5 years ago, all coronary calcium scoring would have received from the conventionalists is "more clinical studies are needed."

So perhaps the cardiology and medical worlds are inching slowly towards broad acceptance of screening for coronary and vascular disease.

BUT, screening is not sufficient. What do you do with the information?

Here is where the conventional-thinkers stop. The question that seems to occupy them: Perhaps we should screen people for hidden coronary and vascular atherosclerosis so we can better decide who needs a statin drug or a procedure.

I would pose a different challenge: We should screen people for hidden coronary and vascular atherosclerosis so we can better decide who needs to engage in an intensive program of disease reversal using natural means and as little medication and procedures as possible.

Well, perhaps in time.

Lead to Gold: The alchemy of transforming nutritional-supplement-to-medication

Here's a recipe to make hundreds of millions of dollars. Others have done it and you can do it, too!

1) Identify a nutritional supplement that works.

Find some agent deemed to fall within the broad allowances of the 1994 Dietary Supplement Health and Education Act . However, because this agent is already in the public domain and is essential non-patent-protectable, you may need to develop some patent protectable aspect of its production, application, or encapsulation. This patent-protected aspect may or may not provide genuine advantage, but that's not your concern. Your concern is protecting your investment and providing the appearance of exclusivity.


2) Identify a medical indication for your product.

Choose a disease or condition that is likely to yield unquestioned efficacy, e.g., omega-3 fatty acids to reduce high triglycerides in people with familial hypertriglyceridemia (triglycerides >500 mg/dl). While this will restrict your ability to make market claims, it will not restrain your ability to sell or allow use of your agent for "off-label" applications. In fact, there are methods to surreptitiously promote the use of your product for off-label use, such as hiring experts to discuss the science behind your product with doctors who can prescribe your product. Ideally, your product's primary indication will provide a substantial market on its own to justify your investment. However, the eventual off-label sales can be substantial, even outstripping the sales generated through your primary indication.


3) Obtain at least $230 million to pay for the clinical trials required to obtain FDA approval.

You will also have to raise the capital to build the business to manufacture, distribute, and sell your product.


4) After FDA approval is obtained, your business is up and running, and distribution begins, start bashing the non-FDA-approved nutritional products that stand to compete in your market.

You could point out that only your product has actually passed through the rigorous FDA process. You could make claims regarding purity, potency, "approved by your doctor," etc., whether or not there is any truth behind the claim.


5) Buy that second vacation home in Aspen and the corporate jet you've been dreaming about! After all the risks you've taken, you deserve it!


That's it, plain and simple. It is a tried-and-true formula that has been applied many times.

It is a formula like this that brought Lovaza-brand omega-3 fatty acids to market, Niaspan brand of niacin, ergocalciferol form of vitamin D, Folbee (prescription combination B vitamins), with a slightly different spin for Synthroid (since the Armour Thyroid it is meant to replace is not a nutritional supplement, but a low-cost, generic thyroid replacement).

Whatever you do, don't EVER run a head-to-head comparative trial of your agent versus the nutritional supplement competition. For instance, NEVER compare Lovaza to supplemental fish oil capsules, matched milligram-for-milligram for EPA and DHA content. NEVER compare Niaspan to over-the-counter Sloniacin. NEVER compare Armour Thyroid to Synthroid. You never know what you might find. (Psssssttt! They might be equivalent!)

The formula is not a foolproof road paved with riches, however. There have been market failures, as well. Folbee, for instance, is hardly a household name. So there's risk involved, no question about it. But, should it all work out, the payoff can be big, VERY big, as it has been for Niaspan and Lovaza.

So, start thinking about how you might follow this formula for:

1) Cholecalciferol (vitamin D3)--e.g., for osteopenia, low HDL, or high c-reactive protein
2) Vitamin K2--also for osteopenia
3) Magnesium--for suppression of ventricular arrhythmias (especially Torsade de Pointes)
4) Iodine--for goiter and iodine deficiency
5) Vitamin C--for uric acid reduction

Who said you can't turn lead into gold?

Another interview with Livin' La Vida Low Carb's Jimmy Moore

I recently provided another interview for Livin' La Vida Low Carb's Jimmy Moore.

You may remember Jimmy as the irrepressible host of the Livin' La Vida Low Carb Show who lost around 200 lbs, dropping from 410 to 230 lbs on a low-carbohydrate diet.

In this hour-long interview, we discussed some of the dietary strategies that we use in the Track Your Plaque program.

Jimmy's website is definitely worth exploring. It's loaded with great interviews, including with Good Calories, Bad Calories author, Gary Taubes.

"Millions of needless deaths"

"Millions of needless deaths" is the title of an editorial by Life Extension Magazine's Bill Faloon.

". . . If vitamin D’s only benefit was to reduce coronary heart attack rates by 142%, the net savings (after deducting the cost of the vitamin D) if every American supplemented properly would be around $84 billion each year. That’s enough to put a major dent in the health care cost crisis that is forecast to bankrupt Medicare and many private insurance plans."

Although I don't agree with all the over-the-top commentary that issues from Mr. Faloon or Life Extension (although I sit on their Medical Advisory Board), I agree with virtually all of the issues he raises with vitamin D.

Despite the enormously compelling observations of vitamin D potential effects in populations, the medical community's reluctance comes from the lack of treatment data. In other words, what we lack are long-term data on vitamin D supplementation vs. placebo on rate of heart attack, vitamin D vs. placebo on risk of colon cancer, etc.

The data that exists connecting vitamin D levels with cardiovascular risk originate from three population observations:

1) The NHANES data in 16,000 participants showed 20% increased risk of cardiovascular events in those with vitamin D levels <20>20 ng/ml after factoring in all standard risk factors.

Another NHANES analysis showed the high prevalence of vitamin D deficiency in those with cardiovascular disease.

2) A German study of 2500 participants that showed showed the lowest quartile of vitamin D levels (<13.3>28.4 ng/ml.

3) The Health Professionals' Follow-Up Study of 18,000 males showed a 2.4-fold increase in cardiovascular events in those with vitamin D levels <15>30 ng/ml.

While we lack treatment data (vitamin D vs. placebo) in a large population, we do have data that Suzie Rockway, Mary Kwasny (both from Rush University, Chicago) and I generated on the effect of vitamin D as a part of a broader treatment program on coronary calcium scores:

Effect of a Combined Therapeutic Approach of Intensive Lipid Management, Omega-3 Fatty Acid Supplementation, and Increased Serum 25 (OH) Vitamin D on Coronary Calcium Scores in Asymptomatic Adults.
Davis W, Rockway S, Kwasny M. Amer J Ther 2008 (Dec 15).

The impact of intensive lipid management, omega-3 fatty acid, and vitamin D3 supplementation on atherosclerotic plaque was assessed through serial computed tomography coronary calcium scoring (CCS). Low-density lipoprotein cholesterol reduction with statin therapy has not been shown to reduce or slow progression of serial CCS in several recent studies, casting doubt on the usefulness of this approach for tracking atherosclerotic progression. In an open-label study, 45 male and female subjects with CCS of >/= 50 without symptoms of heart disease were treated with statin therapy, niacin, and omega-3 fatty acid supplementation to achieve low-density lipoprotein cholesterol and triglycerides /=60 mg/dL; and vitamin D3 supplementation to achieve serum levels of >/=50 ng/mL 25(OH) vitamin D, in addition to diet advice. Lipid profiles of subjects were significantly changed as follows: total cholesterol -24%, low-density lipoprotein -41%; triglycerides -42%, high-density lipoprotein +19%, and mean serum 25(OH) vitamin D levels +83%. After a mean of 18 months, 20 subjects experienced decrease in CCS with mean change of -14.5% (range 0% to -64%); 22 subjects experienced no change or slow annual rate of CCS increase of +12% (range 1%-29%). Only 3 subjects experienced annual CCS progression exceeding 29% (44%-71%). Despite wide variation in response, substantial reduction of CCS was achieved in 44% of subjects and slowed plaque growth in 49% of the subjects applying a broad treatment program.


I also summed up the data as of early 2008 in a Life Extension article:

Vitamin D's Crucial Role in Cardiovascular Protection


I do agree with Mr. Faloon: It's time to take the vitamin D issue very seriously. Personally, I think it is foolhardy to not correct vitamin D deficiency, even in the absence of long-term treatment data.

Should we subject people living in tropical climates with vitamin D blood levels of 90 ng/ml to long-term observation? Though that has not yet been done, it has been done--in effect--through observations on the prevalence of diabetes, heart disease, and various cancers by latitude: the farther away from the equator, the greater the prevalence of these diseases.

That's more than good enough for me.

Thiazide diuretics: Treatment of choice for high blood pressure?

Thiazide diuretics are a popular first-line treatment for hypertension among the primary care set.

This practice became especially well-established with the 2002 publication of the ALLHAT Study (Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic:The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)).

ALLHAT showed that an inexpensive diuretic like chlorthalidone (a weak diuretic in the thiazide class, similar to hydrochlorothiazide) as first-line treatment for hypertension achieved equivalent reductions in cardiovascular events (cardiovasular death and heart attack) as non-thiazide antihypertensives, lisinopril (an ACE inhibitor) and amlodipine (a calcium channel blocker, better known as Norvasc).

After 7 years of treatment, there was 14% death or heart attack among all three groups--no difference.

This was interpreted to mean that inexpensive thiazide diuretics like chlorthalidone offer as much benefit as other blood pressure medications at reduced cost.

On the surface, that's great. Anything that detracts from the ubiquitous pharmaceutical industry propaganda of bigger, better, more expensive drugs to replace old, inexpensive, generic drugs is fine by me.

But you knew there'd be more to this issue! If we accept that thiazides are equivalent to other single-drug treatments for high blood pressure, what do we do with the following issues:

--Thiazides deplete body potassium-This effect can be profound. In fact, built into the ALLHAT mortality rate is an expected death rate from potassium depletion. When potassium in the body and blood go low, the heart becomes electrically unstable and dangerous rhythms develop.

--Thiazides deplete magnesium--Similar in implication to the potassium loss, magnesium loss also creates electrical instability in the heart, not to mention exaggeration of insulin resistance, rise in triglycerides, reduction in HDL.

--Thiazides reduce HDL cholesterol

--Thiazides increase triglycerides

--Thiazides increase small LDL particles--You know, the number one cause for heart disease in the U.S.

--Thiazides increase uric acid--Uric acid is increasingly looking like a coronary risk factor: The higher the uric acid blood level, the greater the risk for heart attack. Thiazides have long been known to increase uric acid, occasionally sufficient to trigger attacks of gout (uric acid crystals that precipitate in joints, like rock candy). (Fully detailed Special Report on uric acid coming this week on the Track Your Plaque website.)

What about the advice we commonly give people to hydrate themselves generously? Yet we give them diuretics? Which is it: More hydration or less hydration? You can't have both.

Do thiazides exert an apparent cardiovascular risk reduction in a society due to its flagrant sodium obsession?

Thus, there are a number of inconsistencies in the thinking surrounding thiazides. In my experience, I have seen more harm done than good using these agents. While I cannot fully reconcile the reported benefit seen in ALLHAT with what I see in real life, all too often I see people having to take another drug to make up for a side-effect of a thiazide diuretic (e.g., high-dose prescription potassium to replace lost potassium, allopurinol to reduce uric acid, etc.). I have seen many people get hospitalized, even suffer near-fatal or fatal events from extremely low potassium or magnesium levels.

My personal view: ALLHAT or no, avoid thiazide diuretics like the plague. Sure, it might save money on a population basis, but I suspect that the ALLHAT data are deeply misleading.

What's better than a thiazide, calcium blocker, or ACE inhibitor? How about vitamin D restoration, thyroid normalization, wheat elimination?

"High-dose" Vitamin D

I stumbled on one of the growing number of local media stories on the power of vitamin D.

In one story, a purported "expert" was talking about the benefits of "high-dose" vitamin D, meaning up to 1000, even 2000 units per day.

I regard this as high-dose---for an infant.

Judging by my experiences, now numbering well over 1000 patients over three years time, I'd regard this dose range not as "high dose," nor moderate dose, perhaps not even low dose. I'd regard it as barely adequate.

Though needs vary widely, the majority of men require 6000 units per day, women 5000 units per day. Only then do most men and women achieve what I'd define as desirable: 60-70 ng/ml 25-hydroxy vitamin D blood level.

I base this target level by extrapolating from several simple observations:

--In epidemiologic studies, a blood level of 52 ng/ml seems to be an eerily consistent value: >52 ng/ml and cancer of the colon, breast, and prostate become far less common; <52 ng/ml and cancers are far more likely. I don't know about you, but I'd like to have a little larger margin of safety than just achieving 52.1 ng/ml.

--Young people (not older people >40 years old, who have lost most of the capacity to activate vitamin D in the skin) who obtain several days to weeks of tropical sun typically have 25-hydroxy vitamin D blood levels of 80-100 ng/ml without adverse effect.

More recently, having achieved this target blood level in many people, I can tell you confidently that achieving this blood level of vitamin D achieves:

--Virtual elimination of "winter blues" and seasonal affective disorder in the great majority
--Dramatic increases in HDL cholesterol (though full effect can require a year to develop)
--Reduction in triglycerides
--Modest reduction in blood pressure
--Dramatic reduction in c-reactive protein (far greater than achieved with Crestor, JUPITER trial or no)
--Increased bone density (improved osteoporosis/osteopenia)
--Halting or reversal of aortic valve disease

(I don't see enough cancer in my cardiology practice to gauge whether or not there has been an impact on cancer incidence.)

My colleagues who have bothered to participate in the vitamin D conversation have issued warnings about not going "overboard" with vitamin D, generally meaning a level of >30 ng/ml.

I know of no rational basis for these cautions. If hypercalcemia (increased blood calcium) is the concern, then calcium levels can be monitored. I can reassure them that calcium levels virtually never go up in people (without rare diseases like sarcoid or hyperparathyroidism). Then why any hesitation in recreating blood levels that are enjoyed by tropical inhabitants exposed to plentiful sun that achieve these extraordinary health effects?

For the present, I have applied the target level of 60-70 ng/ml without apparent ill-effect. In fact, I have witnessed nothing but hugely positive effects.

Vitamin D Home Test

The ever-resourceful Dr. John Cannell of the Vitamin D Council has announced the availability of an at-home, self-ordered vitamin D test kit for $65. The Vitamin D Council newsletter is reprinted below.

(However, please note that, as wonderful as the advice Dr. Cannell provides, I don't agree on several small points, such as the lack of need for vitamin D if you use a tanning bed or obtain "sufficient" sun; I have seen many people with dark tans, virtually all over 40 years old, who are still severely deficient. I attribute this to the lost capacity for vitamin D activation as we age.)

I have not used this service. Should anyone choose to try it, please let us know how it goes.



The Vitamin D Newsletter
December 28, 2008

The Vitamin D Council is happy to announce that we have partnered with ZRT Laboratory to provide an inexpensive, $65.00, in-home, accurate, vitamin D [25(OH)D] test. The usual cost for this test is between $100.00 and $200.00.

If you read this newsletter, you know about our interest in accurate vitamin D testing. In the next few weeks, you may read about the Vitamin D Council's quest for accurate vitamin D blood tests in the national media. Before we partnered with ZRT, we verified, repeatedly, that ZRT provides accurate and reliable vitamin D tests and that their method corresponds very well to the gold standard of vitamin D blood tests, the DiaSorin RIA.

Our ZRT service is not just inexpensive, it means no more worrying about your doctor ordering the right test or interpreting it correctly. You buy the test kit on the internet or by phone, a few days later the kit comes in the mail, you or a nurse friend do a finger stick, collect a few drops of blood, and send the blotter paper back to ZRT in the postage paid envelope provided with the kit. A week later you get results back in the mail and know accurate 25-hydroxy-vitamin D levels of you and your family.

For every test you order, ZRT will donate $10.00 to the Vitamin D Council. Please read the new page hyperlinked below on our website as it both explains the procedure and how to order the test.

http://www.vitamindcouncil.org/health/deficiency/am-i-vitamin-d-deficient.shtml

Executive summary: keep your family's 25-hydroxy-vitamin D blood test above 50 ng/ml, year around. Most adults need at least 5,000 IU per day, especially this time of year. Most children need at least 1,000 IU per day per every 25 pounds of body weight. Bio Tech Pharmacal provides high quality and inexpensive vitamin D. Currently Bio Tech Pharmacal is providing vitamin D for numerous scientific studies. To see their prices and for ordering, click the hyperlink below.

http://www.bio-tech-pharm.com/catalog.aspx?cat_id=2

As a gift to our readers for the New Year, Thorne publications have provided a free download to a basic paper about vitamin D. I wrote it earlier this year for educated lay people as well as health care practitioners. Please read this paper carefully, your family's well-being, even lives, may depend on you understanding it.

http://www.thorne.com/altmedrev/.fulltext/13/1/6.pdf

Seasons Greetings
John Cannell, MD
vitamindcouncil.org

Where do Track Your Plaque membership revenues go?

People pay about $90 per year to become Members on the Track Your Plaque website. This provide access to our in-depth Special Reports, guides, webinars, and our proprietary software data tracking tools. Members can also participate in online discussions, such as those in the Track Your Plaque Forum and chats.

Why is there a charge for membership in the program and where does the money go?

Money raised from membership fees goes towards:

1) The costs of doing business, e.g., server fees, software purchases, legal fees. Hosting webinars, for instance, costs us about $99 per month for the GoToWebinar software service.

2) Software development--Our most recent round of software data tracking tools, for instance, cost us nearly $30,000. That may not be a lot from big business standards, but it is onerous enough that obtaining membership dues really helps.

3) Graphics development--A website without graphics would be awfully dull, regardless of the quality of the textual content. Some of the newest tools on the Track Your Plaque website require photography and graphics work, which can add up very quickly.


Where membership fees do NOT go:

1) In our pockets--In fact, except for the various contractors who are paid for their services (e.g., software developers), NOBODY on the Track Your Plaque staff are paid: not me, nor any of the behind-the-scenes staff. Some of the staff overlap with my office staff, but they are paid purely out of the office revenues, not out of Track Your Plaque membership dues.

2) Towards overhead costs beyond those listed above--For example, membership fees do not pay for office lease, utilities, phones, etc.


We rely on membership fees because we have chosen to remain as free of commercial bias as possible. We host no advertising, we have no behind-the-scenes corporate or institutional agendas, we show no favoritism to any business or commercial operation. We believe this permits editorial freedom that few other health websites can enjoy. (In fact, I know of no other that is so free of commercial bias, outside of small blogs or narrow-interest websites.)

If you want to see what damage commercial bias can create, just go to a health website like WebMD. I challenge you to find information that is not flagrantly biased by commercial influence, namely that of the drug industry. (According to the WebMD SEC filings, in fact, the great majority--approximately 80%--of their $331 million revenues (2007) were derived directly or indirectly from the drug industry.) This commercial bias reaches into all of WebMD's related businesses, including MedicineNet.com, RxList.com, Medscape.com, and several others.

Preventing heart disease is not a money maker, sad to say. It is, from the perspective of conventional heart care, a big money loser. Undergo a heart catheterization, hospitalization, stent or bypass for anywhere from $14,000 to well over $100,000---or pay $90 for in-depth health information that dramatically reduces the potential need for the hospital and its procedures, minimizes need for prescription medication (statins alone, of course, are a $27 billion annual revenue phenomenon), and achieves all this by maximizing nutrition, self-purchased nutritional supplements, and inexpensive heart scans. Nobody is going to make a bundle off of this approach.

So that is why we charge a membership fee. I often get a laugh from some of the comments of people on this blog or even in my office who believe that we are rolling in money from the website from membership dues. The opposite is true: We don't pay ourselves. Virtually every penny is reinvested back into the website to better serve the Members.
"Heart scans are experimental"

"Heart scans are experimental"

Let me warn you: This is a rant.

It is prompted by a 44-year old woman. She has a very serious lipoprotein disorder. Her family experiences heart attacks in their 40s and 50s. I asked for a heart scan. Her insurance companied denied it.

This is nothing new: heart scans, like mammograms, have not enjoyed reimbursement from most insurers despite the wealth of data and growing acceptance of this "mammogram" of the heart.

However, 10 minutes on the phone, and the "physician" (what well-meaning physician can do this kind of work for an insurance company is beyond me) advised me that, while CT heart scans for coronary calcium scoring are not covered, CT coronary angiograms are.

Now, I've been witnessing this trend ever since the big players in CT got involved in the game, namely Philips, Siemens, Toshiba, and GE. These are enormous companies with hundreds of billions of dollars in combined annual revenues. They, along with the lobbying power of cardiology organizations like the American College of Cardiology, have gotten behind CT coronary angiograms. This is most likely the explanation of why CT coronary angiograms have rather handily obtaining insurance reimbursement. Interestingly, the insurance company I was speaking to is known (notorious?) for very poor reimbursement practices.

A CT heart scan, when properly used, generates little revenue, a few hundred dollars to a scan center, barely enough to pay for a device that costs up to $2 million. However, CT coronary angiograms, in contrast, yield around $2000 per test. More importantly, they yield downstream revenues, since CT angiograms are performed as preludes to conventional heart catheterizations, angioplasty, stents, bypass surgery, etc. Now we're talking tens or hundreds of thousands of dollars revenue per test.

What puzzles me is that much of that increased cost comes out of the insurance company. Why would they support such tests if it exposes them to more costs? I'm not certain. It could be the greater pressures exerted by the big CT companies and powerful physician organizations. I seriously doubt that the insurance companies truly believe that heart scans for coronary calcium scoring are "experimental" while CT coronary angiograms are "proven." If all we did was compare the number of clinical studies that validate both tests, we'd find that the number of studies validating heart scans eclipses that of coronary angiograms several fold. Experimental? Hardly.

The smell of money by physicians eager to jump on the bandwagon of a new revenue-producing procedure is probably enough to have them lobby insurers successfully. In contrast, plain old heart scans just never garnered the kind of vigorous and vocal support, since nobody gets rich off of them.

If CT coronary angiograms are sufficiently revenue producing that my colleagues and the CT scanner manufacturers have managed to successfully lobby the health insurers, even one as financially "tight" as the one I spoke to today, well then I take that as testimony that money drives testing, as it does the behavior of hospitals, many of my colleagues, and can even force the hand of insurers.

Comments (25) -

  • Cindy Moore

    12/19/2007 12:51:00 AM |

    It seems like everything medical is profit driven!!  One of my biggest irritants with insurance companies is the unwillingness to act pro-actively and approve preventative procedures, treatments, etc.

    They spend a fortune each year on statins, but won't cover heart scans. They spend millions on coronary bypass, PTCA, etc but they won't pay for inpatient smoking cessation programs, and many still have no coverage for lifestyle change programs!!

  • Peter

    12/19/2007 6:14:00 AM |

    Nice post this one. Just keep telling yourself; there is no conspiracy. The depth of complexity generated by billions of often quite small acts of personal greed, when combined together, does behave like a coherent plan. Eventually there may be studies looking at this as a phenomenon in its own right. The further out of the mainstream that you live, the more interesting it becomes to consider the hows and whys. No conspiracy, just human greed. Some small quanta of greed, some enormous. You even get personal greed combined with the will to do general good. Very complex.

    Peter

  • Anonymous

    12/19/2007 9:35:00 AM |

    Years ago, my baby was in NICU with a condition that seriously affected his immune system; the drs wanted him on breast milk to help boost the immune system, and since I wasn't always at the hospital anymore (I had returned to work by then), the drs wrote an order for a breast pump.

    Since I worked in that field, I asked the lactation specialist for a catalog of pumps from the same company the insurance company used, and found out the pump I *wanted* cost $300, but the pump the insurance comp wanted me to have cost $1000. I asked the lacto nurse about the pumps, and the cheaper one (shaped like a large purse with a shoulder strap) worked just as good as the more expensive pump (a boxy machine attached to a wheeled pole, like a short IV pole) was better if there were going to be many women pumping.

    Since it was just going to be me pumping, and the cheaper pump was so much easier to transport to work, I asked the insurance company if I could have the $300 version. They denied it, and I had to contest it with my lacto-specialist coworker's written letter that the cheaper one would work just as well.

    The insurance company's nurse told me she was glad I contested it with a letter from a lacto-specialist, because now the company would save money on pumps.

    WOW! It took somebody that had experience in that field with access to a specialist just to get an insurance company to change to a much cheaper, but just-as-effective, medical device. So your story doesn't surprise me at all. Insurance companies are either getting kickbacks, have too many layers of bureaucracy to approve anything different, or might just be dumb sometimes.

    S

  • Anonymous

    12/19/2007 12:43:00 PM |

    How did we get to this point that revenue generation overrides the care of patients?  Can we blame Hollywood for creating a myth of the health care provider that knows it all and worries endlessly over the health of patients, government and insurance companies not giving enough oversight over hospital practices, and/or patients not questioning enough the motives of health care providers?  What ever the answer, I imagine future generations will read about these times and cringe over the health care practices of today.

  • keith

    12/19/2007 1:21:00 PM |

    I asked my cardiologist to order a scan for me in a big boston hospital. My insurance wouldn't cover it until enough "risk factors" were documented on the claim form. The test was $270, money very well spent.

    What is sad is that most people believe patients' health is the medical community's primary concern. Also, interestingly, those with marginal insurance are forced to advocate for themselves and as such can, perversely, end up with better care.

    keith

  • Dr. Davis

    12/19/2007 1:24:00 PM |

    I truly get the sense that there are factors present that we are not privy to: behind-the-scenes maneuvering, closed-door politics, etc. It's surely not always in a health insurer's best interests to follow the policies often in place. So we can only conclude that something fishy is going on.

  • Dr. Davis

    12/19/2007 1:25:00 PM |

    You could be right.

    An inadvertent, collective evil?

  • Dr. Davis

    12/19/2007 1:37:00 PM |

    Yes, Keith. You make a crucial point.

    Caveat emptor, whether it's in the doctor's office, hospital, or used car lot. Watch your wallet and recognize that they all share one thing: they are profit-seeking operations with your welfare second.

  • Thomas

    12/19/2007 3:05:00 PM |

    This is NOT a defense of insurance cos, just an attempt to explain their possible thinking. One reason for an objection to CT heart scans is because there could be potentially very many ordered, relative to CT/angiograms. It is like a pyramid, with a much greater number of lower cost procedures resulting in a higher amount of claims submitted, and higher overall cost experience. So, they say no.

    I don't think insurance cos. engage in collusion with equipment makers or doctors. They just use a logic that isn't necessarily in my or your best interests.

  • Mike

    12/19/2007 3:36:00 PM |

    That is one reason that I am against mandatory medical insurance. The patient and doctor should decide what medical care is appropriate, not an insurance company.

  • Dr. Davis

    12/19/2007 4:55:00 PM |

    It may indeed be as simple as that. And, in fact, that is what I told many people who were frustrated by their insurer's failure to reimburse heart scans. However, more recently, I have begun to wonder if there is more to this question. I've just witnessed this phenomenon too often: When big money is involved, things happen. Heart scans do not make big money for anybody. CT angiograms provide potential for lots of big money.

  • Michael

    12/19/2007 7:54:00 PM |

    Out of curiosity, do insurance companies ever pay for heart scans, if they are considered high risk? That is, have had a heart attack, extremely high lipids, or some other heart disorder?

    The only rationale I can imagine for declining calcium scans, while paying for full CT scans, is what Thomas suggested -- it's a numbers game. Since generally speaking, only high risk people get CT scans, the numbers are relatively low. If everyone got calcium tests (although in the long run it'd pay off for them), insurance companies would have to pay a lot out of pocket now.

    But... if insurance companies paid for calcium scans for high risk people, it'd make sense both in the short and long term for them, I'd think. Then again, in my own experience, I find the behavior of my health insurance company bizarre. They'll gladly pay for physician visits/testing even when I tell them the doctor never actually did those things... yet decline certain tests I need just because less reliable (and cheaper) alternatives exist.

  • Thomas

    12/19/2007 11:52:00 PM |

    The evolution of the marketing and ins. coverage will be interesting to watch. For example, a hospital in the Chicago suburbs markets a 64 slice CT scan direct to the public for $99. No doctor referral needed. You can bet they figure stress tests and angios will follow. Nonetheless, you can get the scan about as cheap as possible.

    In my town far away, cardiologists won a turf war with radiologists to be the exclusive readers of these tests, and they aren't being marketed. And, the tests aren't on sale either. Local politics, and the ability to control patient flow, is probably the most important driver, but if you live in a large metro area, you may find what you're looking for at a decent cost.

  • Dr. Davis

    12/20/2007 4:54:00 AM |

    Some insurers do try and distinguish who is "high risk" or not, depending on conventional risk factors.

    Of course, the difficulty is that conventional risk factors fail to identify many people truly at high risk for heart disease and heart attack. In effect, health insurers have legislated who can or cannot obtain reimbursement for a heart scan.

  • MAC

    12/20/2007 8:11:00 AM |

    I have heard it expressed that insurance companies have no interest in preventative medicine. The benefits are too long term for them to see the results. People change jobs, change insurance carriers, etc.

  • Dr. Davis

    12/20/2007 12:37:00 PM |

    Yes, I believe that is true. From their perspective, better to pay lots for the occasional catastrophe rather than pay for the many more who would use preventive services. Insurance is not in our best interests, but of the collective financial good.

  • Anonymous

    12/20/2007 5:36:00 PM |

    Three years ago I had a stress test done due to chest pains and triglycerides as a risk factor.  I ended having an area of concern and my doctor wanted to do a CTA.  The insurance company approved it and I was all set up to go when I mentioned the test to my allergist.  She was concerned that I may have a reaction to the contrast dye, so the CTA was canceled and they sent me for a calcium score test.  The insurance company wouldn't pay the $195 for the test even though they were ready to pay a few thousand for the CTA!  Anyhow I came back with a big fat 0 for the test so the money was worth the piece of mind.

  • Dr. Davis

    12/21/2007 2:40:00 AM |

    What a great example of how useful cheap, simple heart scans can be. You also spared yourself over 90 chest x-rays of radiation.

  • g

    12/21/2007 4:26:00 AM |

    The latest Oprah mag Jan 2008 has this article about the first sign of heart disease/obstruction is 'fatigue' and reports that the MD may order a heart 'CT scan'... (this health writer is on TOP OF HER GAME -- unlike DR. Oz!!)

    Don't read the proposed 'treatment' -- the writer is not apparently informed on TYP yet!

    http://www.oprah.com/health/omag/health_omag_200801_fatigue_102.jhtml
    Most Often Overlooked Causes of Fatigue (2 or 4)

    Heart Trouble

    Fatigue is a distinct characteristic of cardiovascular disease in women, according to recent research. In one study of 515 female heart attack survivors, 70 percent reported unusual fatigue in the weeks before; just 57 percent had acute chest pain. In another study, fatigue was a symptom for women with dangerously clogged arteries that escaped notice on heart scans.

    Why it's overlooked: Only one in ten women realizes that heart disease is her biggest health threat. And emergency room doctors are six times more likely to give women with serious heart problems (as opposed to men) a clean bill of health.

    Other Symptoms: Shortness of breath. Indigestion. Pain in your shoulder, arm, or jaw. But for many women, nothing at all.

    Tests: Your doctor will order an exercise stress test or angiogram if she suspects clogged arteries in your heart. Because that test isn't always accurate in women, she may order a CT scan or echocardiogram as well. She'll also test your cholesterol, blood pressure, and blood sugar—diabetes can quadruple a woman's heart risk.

    Treatment: You may get a cholesterol-lowering statin and medicines to treat blood pressure, such as diuretics. You'll also be advised to follow a heart-healthy diet and get regular exercise.

    From Why Am I So Tired? in the January 2008 issue of O, The Oprah Magazine.

    THANK YOU! g

  • g

    12/22/2007 4:30:00 PM |

    FYI... Recent pubs -- 12/1/2007 and 12/15/2007 respectively

    Merry Xmas Dr. Davis! You have many buddies in more progressive countries! Regards, g

    (1) Non-invasive screening for coronary artery disease: calcium scoring
    Raimund Erbel1, Stefan Möhlenkamp1, Gert Kerkhoff2, Thomas Budde2, Axel Schmermund3
    http://heart.bmj.com/cgi/content/
    extract/93/12/1620

    Despite the decrease in overall mortality from coronary artery disease, the number of out-of-hospital deaths from myocardial infarction is in the range of 60% of all infarct related case fatalities.1 In patients with known risk of sudden cardiac death (SCD), such as survived resuscitation, left ventricular aneurysm or low left ventricular ejection fraction, the incidence of SCD is in the region of 30% per year. In the general population, it is only 0.5% per year.2 However, the absolute number in this group is 10 times higher than in the patient population with known SCD risk, reaching more than 300 000 case fatalities per year in the USA.2 Even renowned cardiologists such as Ronald W Campbellw1 and Jeffry M Isnerw2, who were experts on the topic of arrhythmias and myocardial infarction, suffered SCD. The MONICA (Monitoring trends and determinants in Cardiovascular disease) study reported that of all coronary . . . [Full text of this article]

    (2) Cardiac computed tomography: indications, applications, limitations, and training requirements

    Report of a Writing Group deployed by the Working Group Nuclear Cardiology and Cardiac CT of the European Society of Cardiology and the European Council of Nuclear Cardiology
    http://eurheartj.oxfordjournals.org
    /cgi/content/abstract/ehm544v1

    As a consequence of improved technology, there is growing clinical interest in the use of multi-detector row computed tomography (MDCT) for non-invasive coronary angiography. Indeed, the accuracy of MDCT to detect or exclude coronary artery stenoses has been high in many published studies. This report of a Writing Group deployed by the Working Group Nuclear Cardiology and Cardiac CT (WG 5) of the European Society of Cardiology and the European Council of Nuclear Cardiology summarizes the present state of cardiac CT technology, as well as the currently available data concerning its accuracy and applicability in certain clinical situations. Besides coronary CT angiography, the use of CT for the assessment of cardiac morphology and function, evaluation of perfusion and viability, and analysis of heart valves is discussed. In addition, recommendations for clinical applications of cardiac CT imaging are given and limitations of the technique are described.

  • g

    12/22/2007 4:42:00 PM |

    Another FYI...  HOLY MOLY This is why the lame Framingham misses the entire picture --- failure to take into acct that 70-80% of the population are on the Metabolic spectrum is like trying to see thru gauze blindfolds. very holey... (I guess it's good I can't access TYP right now... I'm spending my time otherwise well spent *ha*).  I LOVE the first line...'Coronary artery calcification is pathognomonic of coronary atherosclerosis.'  Hope you and your familia have a great holiday season -- full of wishes fulfilled and hope re-ignited!  Thanks for letting me loose *ha ha* Take care, g

    http://content.onlinejacc.org/cgi/
    content/abstract/50/23/2218

    J Am Coll Cardiol, 2007; 50:2218-2225(Published online 14 November 2007).

    CLINICAL RESEARCH: CORONARY ARTERY DISEASE
    Determinants of Progression of Coronary Artery Calcification in Type 2 Diabetes
    Role of Glycemic Control and Inflammatory/Vascular Calcification Markers
    Dhakshinamurthy Vijay Anand, MBBS, MRCP*,,*, Eric Lim, MBChB, MA, MRCP*, Daniel Darko, MD, MRCP, Paul Bassett, MSc, David Hopkins, BSc, MBChB, FRCP||, David Lipkin, BSc, MD, FRCP*,¶, Roger Corder, PhD, MRPharmS and Avijit Lahiri, MBBS, MSc, MRCP, FACC, FESC*
    * Cardiac Imaging and Research Centre, Wellington Hospital, London, United Kingdom

    Objectives: This study prospectively evaluated the relationship between cardiovascular risk factors, selected biomarkers (high-sensitivity C-reactive protein [hs-CRP], interleukin [IL]-6, and osteoprotegerin [OPG]), and the progression of coronary artery calcification (CAC) in type 2 diabetic subjects.

    Background: Coronary artery calcification is pathognomonic of coronary atherosclerosis. Osteoprotegerin is a signaling molecule involved in bone remodeling that has been implicated in the regulation of vascular calcification and atherogenesis.

    Methods: Three hundred ninety-eight type 2 diabetic subjects without prior coronary disease or symptoms (age 52 ± 8 years, 61% male, glycated hemoglobin [HbA1c] 8 ± 1.5) were evaluated serially by CAC imaging (mean follow-up 2.5 ± 0.4 years). Progression/regression of CAC was defined as a change 2.5 between the square root transformed values of baseline and follow-up volumetric CAC scores. Demographic data, risk factors, glycemic control, medication use, serum hs-CRP, IL-6, and plasma OPG levels were measured at baseline and follow-up.

    Results: Two hundred eleven patients (53%) had CAC at baseline. One hundred eighteen patients (29.6%) had CAC progression, whereas 3 patients (0.8%) had regression. Age, male gender, hypertension, baseline CAC, HbA1c >7, waist-hip ratio, IL-6, OPG, use of beta-blockers, calcium channel antagonists, angiotensin-converting enzyme (ACE) inhibitors, statins, and Framingham/UKPDS (United Kingdom Prospective Diabetes Study) risk scores were univariable predictors of CAC progression. In the multivariate model, baseline CAC (odds ratio [OR] for CAC >400 = 6.38, 95% confidence interval [CI] 2.63 to 15.5, p < 0.001), HbA1c >7 (OR 1.95, CI 1.08 to 3.52, p = 0.03), and statin use (OR 2.27, CI 1.38 to 3.73, p = 0.001) were independent predictors of CAC progression.

    Conclusions: Baseline CAC severity and suboptimal glycemic control are strong risk factors for CAC progression in type 2 diabetic subjects.

    Why did they NOT look at 25(OH)D when they were looking at the osteo- whatever thingy. *uurrgghh*

  • g

    12/22/2007 5:03:00 PM |

    I like this guy... he proposes heart CTs for all T2DM to screen for silent MIs. just like colon CA screening... and breast CA screening... wow ya think?

    CAD in most people esp T2DM is diffuse and systemic (maybe someday we can CAC someone's wrist like we do for Bone Mineral Density testing for osteopenia/porosis screening at the local drugstore?)... and very accelerated when glucose and insulin are elevated (without a good mod/high healthy MUFA PUFA diet and systemic TYP strategies).
    http://content.onlinejacc.org/cgi/
    content/abstract/49/19/1918

    Noninvasive Screening for Coronary Atherosclerosis and Silent Ischemia in Asymptomatic Type 2 Diabetic Patients
    Is it Appropriate and Cost-Effective?
    George A. Beller, MD, MACC*
    Cardiovascular Division, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.

    Coronary artery disease (CAD) accounts for 65% to 80% of deaths in diabetic patients. The merits of screening asymptomatic type 2 diabetic patients for either Innocent the presence of coronary atherosclerosis by imaging of coronary calcification using cardiac computed tomography or (B) silent ischemia by stress myocardial perfusion imaging (MPI) remain controversial. Some observers have advocated for such noninvasive screening in at least the subset of the diabetic population who have significant clinical CAD risk factors, so that the highest risk patients for future cardiac events can be identified and offered more aggressive intensive medical therapy or coronary revascularization and optimum medical therapy. Computed tomography coronary calcium scanning could be the first noninvasive screening test in these clinically high-risk diabetic patients, followed by stress MPI to detect silent ischemia in those who exhibit high coronary calcium scores.

  • Dr. Davis

    12/23/2007 12:36:00 AM |

    Hi, G-

    As you see, some people in the medical community are waking up to the great usefulness of heart scans to detect hidden coronary plaque.

    However, it's going to be another five or more years before they also wake up to the idea of using it to TRACK the disease.

  • g

    12/23/2007 4:56:00 AM |

    Not unless you win global recognition for your achievements and TYP ...  Smile

    Can u imagine a world where the failure to offer TYP would be malpractice...for someone with diabetes? pre-diabetic? with Lp(a) or Homocysteinemia?  I do... and  who knows sooner than u might think.

    I think behind every genius-man, there stands a genius-woman. Once when I couldn't log on, couldn't access 'chat' and couldn't find reports when they were right in front of my *darn* NOSE... a wise woman told me 'you can't know everything.'  *ha ha* give her a hug for me Smile
    g

  • Anonymous

    1/2/2008 1:55:00 AM |

    Just a note to g regarding screening for osteoporosis at the wrist.  These are very ineffectual tests.  It is best to use the spine +/or hip as osteoporosis starts at the center of the body.  By the time it is detected in the distal extremities, you would already have significant bone loss. At least this is my understanding as a technologist. Could this also apply to artery disease?

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