The battle for natural hormones

The battle for preservation of availability of compounded natural hormones goes on.

It started with pharmaceutical manufacturer, Wyeth, who petitioned the FDA to disallow the mixing of pharmaceuticals, especially natural human hormones, by specially trained pharmacists at what are called "compounding pharmacies." These are pharmacies that have special equipment and where trained pharmacists can mix up specific preparations for dispensing. These are available by prescription.

For instance, I have been prescribing natural human testosterone and progesterone for nearly 10 years. I have found service to be excellent, with lots of learning materials provided to patients by the pharmacy. The pharmacists I've spoken to have been courteous and knowledgeable. Compounded hormones are also shockingly less expensive. While a testosterone patch from a pharmaceutical company costs around $4.00 per day, the same quantity of testosterone cream formulated by a compouding pharmacy costs around $0.50 per day--87.5% less.

Wyeth hides behind a smoke screen of concern over quality. But the price differences tells the entire story: they want to eliminate the inexpensive competition and hold us all hostage to the far more expensive, often inferior products that they produce. They'd sooner force a woman to use horse-derived Premarin than to allow her access to human estrogens and progesterone.

To me, this is an outrageous affront to our freedom of choice, both as consumers as well as a physician. If you feel as strongly as I do about opposing the unfair and bullying ways of Wyeth Pharmaceuticals and the FDA, the P2C2 association of compounding pharmacists makes writing a letter to your Senator easy by going to

http://iacprx.convio.net/site/PageServer?pagename=P2C2

Just enter your info and personalize the comments, and the e-mails will be generated for you.

Lipitor and memory

At first, I was skeptical. A book from a nutty author and physician named Duane Graveline kept on coming up in conversations with patients. His book, Lipitor: Thief of Memory , details his personal experience with dramatic changes in memory and thought while taking Lipitor.



Now this is a drug that I've seen used thousands of times. But I've now seen about a dozen people who have had distinct struggles with memory and clarity of thinking while taking Lipitor. Most took doses of 40 mg per day or more, though an occasional person takes as little as 10 mg. The association seems to be undeniable, since it improves after two weeks off the drug, recurs when resumed. Just today, I saw two people where this effect may be an issue.

Curiously, I've not seen it with any other statin agent. Unfortunately, uncovering any scientific data on the issue is a hopeless quest. Either it's very uncommon or, worse, the data has been suppressed.

Any way, I believe that Dr. Graveline was right: Lipitor, in a small number of people, does indeed seem to exert real detrimental effects on the mind.

If you take Lipitor, should you stop it in fear of long-term effects on your mental capacity? I think it's premature to toss the drug out based on this relatively uncommon relationship. This particular effect is likely to be idiosyncratic, i.e., peculiar to an occasional person but does not seem to apply to the majority, probably by some quirk of metabolism or penetrability of the barrier between the blood and nervous system tissue.

If, however, you feel that your thinking and memory have deteriorated on the drug, please speak to your doctor.

EKG's and heart disease


How helpful are EKG's for detecting hidden heart disease?

I pose this question because several patients asked this question just this week. It's also a frequent point of confusion and misperception.

Your EKG is nothing more than an expression of the surface electrical activity emitted by heart muscle activity. Multiple (12) leads are attached to the body simply to provide various "views" of this electical activity. EKG, or sometimes "ECG", is short for "electrocardiogram".

What modifies this surface electrical activity? Anything that modifies the electrical activity within the heart itself, or interferes with the detection of the activity. An old heart attack modifies the patterns of electrical conduction in the heart and that can change your EKG. An ongoing heart heart attack likewise. High blood pressure commonly creates changes in the EKG, as does lung disease. A bellyache can change your EKG, as can a stroke. (These non-heart-related phenomena probably are often due to changes in autonomic, or "automatic," nervous system activity.) The heart generates electrical activity in a predictable sequence that generates the heart beat, or "rhythm". EKG's are useful for monitoring heart rhythm, also.

Does having plaque in your coronary arteries have any effect on the EKG? None whatsoever, unless plaque rupture caused heart attack or is about to cause heart attack. So, you can have a horrendous CT heart scan score of, say, 3000, yet maintain a perfectly normal EKG, as long as the heart muscle is normal.

Then why bother with these iffy tests? They are indeed useful to diagnose the cause of active symptoms. For instance, go to the ER with chest pain and an EKG could show changes suggesting that the chest pain is a heart attack. EKG's are also useful for future comparison. Any change in EKG can suggest certain things, like new heart rhythm disturbances unrelated to coronary plaque.

Think of your EKG as just like buying a used car. Say I'm trying to sell you my 1999 Buick Century. It looks pretty good from the outside and I tell you that it has 70,000 miles and runs well. You ask to open the hood, look in the interior and take it out for a drive. I tell you no, you can't do that.

Would you buy the car? Of course you wouldn't. You were permitted only a very superficial examination of the car. You have no idea what's going on inside. Just because the paint job looks brand new doesn't mean the engine and transmission are good.

The same with your EKG: It's a superficial look at one aspect of this used car called your heart. If the EKG is normal, that's good, just like a good exterior on the Buick. But you cannot assume that the heart is otherwise normal.

View the EKG as a simple, superficial test that can only provide minimal reassurance, no matter how often you have it done.

A new Track Your Plaque record

Neal, a 40-year old school principal, and his young wife were terrified on learning of his CT heart scan score of 339, a concerningly high score for any age, particularly age 40.

To make matters worse, all of Neal's plaque was located in the critical left mainstem coronary artery, the shared stem of two of the three coronary arteries. A heart attack in this location is instantly fatal.

So, it was especially gratifying that Neal has set the Track Your Plaque record for largest magnitude of plaque reversal: 51% in his first year.

Studies that show a reduction in heart attack make the news. They talk about 1, 2, up to 6% regression, all achieved with high doses of statin drugs. Yet we are seeing huge, extraordinary quantities of heart disease reversal that haven't yet made headlines, amounts that far exceed those featured in the news. We should be encouraged by experiences like Neal's.

Watch for the upcoming Track Your Plaque newsletter for more details on Neal's story--how he came to the program, how he accomplished this huge effect, and why his experience was such a success. If you haven't yet subscribed, go to the www.cureality.com homepage and click on the upper right hand corner.

The Plavix Scam

Periodically, I'll see a flurry of TV ads for Plavix. It comes with a polished computer-animated cartoon that shows how platelets clump and form a blood clot, causing heart attack.

Imagine there's a pile of oil-soaked rags in a corner of your garage. I come by and tell you to get a good fire extinguisher to keep next to the rag pile in case they spontaneously ignite.

Does that make sense to you?

Wouldn't it be better to get rid of the oily rags and forget about the fire extinguisher?

Plavix is the fire extinguisher. The oil rags are your coronary plaque. The solution is to gain control over plaque behavior. Unfortunately, the TV ads (intentionally, I suspect) give the impression that blood clots just form out of the blue for no reason. Of course that's not true. It requires active, growing, inflamed atheroslcerotic plaque that ruptures, uncovering the "angry" and platelet-adhering material underneath the thin covering or endothelial lining.

Urging everybody to take Plavix is absurd. The TV ads urge many people who have no business taking the drug to take it. There are, without a doubt, groups of people who are better off taking Plavix and aspirin: people who are in the midst of heart attack, people who have unstable plaque, people with recent stents or bypass. Perhaps people at high risk for plaque rupture, e.g., extensive coronary plaque that has continued to grow.

These tactics are consistent with the experiences I've had with the sales representatives from the company (when I used to actually talk to sales reps; my office is now barred from them). The reps very aggressively would urge me to consider having everyone take Plavix. No kidding.


For us, i.e., for people who just have a heart scan score but interested in engaging in a powerful program of prevention and reversal, Plavix rarely provides any advantage. The answer is, just like our oily rag analogy, control the plaque, not put out the fire.

Lipoprotein(a) and small LDL

You won't find a lot of scientific validation for this, but it is my firm impression that small LDL, by some crazy means, has the capacity to "turn on" or "turn off" lipoprotein(a), Lp(a).

Recall that Lp(a) is a specific genetic trait, passed to us (if you have it) by mother or father. It falsely elevates LDL cholesterol and escalates heart disease risk more than just about any other known abnormality.

A frequent hint that Lp(a) might be present is a comment I hear often from patients: "My doctor said statin cholesterol drugs don't work for me. I tried them all and my cholesterol won't go down." Or, the result was substantially less than expected. That's because, when Lp(a) is lurking in your cholesterol value, it is unaffected by the statins.

It's been my in-the-trenches observation that, the more fully expressed the small LDL pattern becomes, the worse the Lp(a) behaves. In other words, if small LDL is suppressed effectively, Lp(a) doesn't seem to carry the same dangers as in someone who has plenty of small LDL. I don't know why this is. (I expect that the answer will come from someone like Dr. Marcovina at Stanford, who is at the forefront of Lp(a) structural research. Lp(a) is a complex molecule with several components. How and why it interacts with other particles remains a mystery.)

There are a little bit of data to confirm this. The Quebec Cardiovascular Study has presented some data to this effect, that the combination of small LDL particles and Lp(a) are a particularly lethal combination. We are trying to correlate our data from a CT heart score perspective to discern any statistical relationships.

This raises a very important therapeutic issue if you have Lp(a): the worst thing you can do if you have Lp(a) is become overweight. Excess abdominal fat is a huge trigger to create small LDL particles. Even though being overweight itself has no effect on the measured level of Lp(a), it activates small LDL which, in turn, throws gasoline on the Lp(a) fire.

If you have Lp(a), stay skinny.

Optimal medical therapy

I was re-reading some of the details behind the recently announced COURAGE Trial comparing angioplasty/stent in 1100 people compared to "optimal" medical therapy in another 1100. You'll recall that no difference was found.

In particular, over approximately 5 years, 20% of participants in each group died, experienced heart attacks, or strokes. Of those treated with "timal" medical therapy, 32% ended up getting a procedure like stents or bypass anyway due to deteriorating symptoms.

What is "optimal" medical therapy? I bring this up again because the study investigators in COURAGE, as well as in similar trials, say this with a straight face. Optimal medical therapy means aspirin and/or Plavix (the anti-platelet, aspirin-like blood thinner); "aggressive" statin drug therapy to reduce LDL cholesterol to 60-85 mg/dl; and "anti-ischemic" therapy (that reduces angina and the phenomena of poor coronary blood flow) using nitroglycerin preparations, beta blockers, and other drugs.

I do give credit to the investigators for having the courage to perform this trial in a world hell bent on doing procedures and still reporting the neutral outcome. But the notion of "optimal" medical therapy begs for comment.

Indeed, this is regarded as optimal by most practitioners. Some would even argue excessive, based on the low LDL target achieved. Would you be satisfied with a 20% likelihood of heart attack, stroke, or death or 5 years, a 1 in 5 roll of the dice? I would not. Recall that we aim for near-total elimination of risk.

What could have been further "optimized"? Plenty. For instance:

--What is the real LDL, not the fabricated, calculated LDL? The two can be commonly 100 mg/dl different.

--How about raising HDL to 60 mgd/?

--What about reducing the proportion of small LDL particles? After all, small LDL is the number one cause of heart disease in the U.S., not high LDL.

--What is Lp(a)? If you treat LDL with a statin drug, Lp(a) is unaffected and continues to trigger huge plaque growth. You will fail if this is not identified and corrected.

--What is vitamin D3? One of the most powerful facilitators of plaque reversal I know of.

--What are triglycerides? Triglycerides create hidden particles in the blood like intermediate-density lipoprotein, potent triggers for coronary plaque growth. Speaking of intermediate-density lipoprotein, that's another very important pattern to identify, the after-eating persistence of dietary fats.

--Why aren't they taking fish oil? With a 28% reduction in heart attack and 45% reduction in sudden death from heart attack, this alone would have halved the number of "events" in the "optimal" medical treatment group.

Of course, there's more. But the idea that aspirin, statins, and anti-ischemic therapy is somehow optimal is silly and sad at the same time. But that's the bias. The COURAGE Trial does represent a step forward, a step away from the "stent everyone and everything" mentality that motivates my colleagues, aided and abetted by their co-conspirators, the hospitals. But you and I know better. "Optimal" medical therapy, in truth, can mean a far better approach that can dramatically reduce, perhaps eliminate, risks for events like heart attack. The conventional "optimal" medical therapy will suffice only if you're content with a 20% likelihood of heart attack, death or stroke, or a 32% likelihood of an urgent procedure in your future.

Niacin, postprandial patterns

For a detailed report on the very important postprandial (after eating) patterns that contribute hugely to heart disease risk, read my recent article in Life Extension Magazine, available (no cost) at:

Uncovering a Hidden Source of Cardiovascular Disease Risk
at http://www.lef.org/magazine/mag2007/mar2007_report_heart_01.htm


For a report on using niacin to reduce risk of heart disease, see another report in the same issue of Life Extension:

Ask the Doctor: Using Niacin to Improve Cardiovascular Health
at
http://www.lef.org/magazine/mag2007/mar2007_atd_01.htm.

Also, keep your eyes open for a lengthy report focused exclusively on the Track Your Plaque program in an upcoming issue of Life Extension. I'll provide links in this Blog when it comes out.

What's better than fish oil?

One of the recent questions on our Track Your Plaque Forum related to what to do about a triglyceride level of 101 mg/dl while on fish oil.

Recall that, contary to conventional thinking like that articulated in the ATP-III cholesterol treatment guidelines, we aim to reduce triglycerides to 60 mg/dl or less. This is important to suppress the formation of abnormal triglyceride-containing lipoprotein particles, especially small LDL, reduced HDL, lack of healthy large HDL, VLDL. ATP-III advises a level of 150 mg/dl or less. Unfortunately, triglyceride levels this high guarantee appearance of all these undesirable particles and an increasing heart scan score.

What's better than 4000 mg of fish oil for its 1200 mg of EPA and DHA (omega-3 fatty acids)? More fish oil. In other words, the 4000 mg fish oil providing 1200 mg EPA + DHA is our minimum. A simple increase to 6000 mg to provide 1800 mg EPA + DHA is usually all that is necessary to reduce triglycerides and put a halt to the cascade of abnormal lipoprotein particles that trigger plaque growth. Occasionally, a somewhat higher dose may be required. Doses are best divided into two, with meals (e.g., three capsules twice a day).

Another important issue: An over-reliance on wheat products can also increase triglycerides. This includes any flour product like breads (regardless of whether it's white, whole wheat, or whole grain--they all raise triglycerides), pretzels, bagels, breakfast cereals, and pasta. A dramatic reduction in wheat-containing products will reduce triglycerides substantially, help you reduce your abdominal fat, reduce blood pressure, raise HDL and reduce small LDL, clear your mind, provide more energy, avoid afternoon "fogginess" . . . Huge benefits.

Valve disease and vitamin D

There are two common forms of heart valve disease: aortic valve stenosis (stiffness) and insufficiency (leakiness), and mitral anular calcification.

Both valve issues are regarded as evidence of senescence, or aging--the older you are, the more likely you will have one or both. Both conditions involve progressive calcium deposition and, to some degree, cholesterol deposition. They might be regarded as phenomena of "wear and tear" just like hip arthritis.

There are no known therapies to stall or stop the development of mitral anular calcification. However, several attempts have been made over the years to identify treatments that can slow or stop the progression of aortic valve disease, which is becoming increasingly common and is addressed by surgical valve replacement when severe. The most recent trials have examined whether high-dose Lipitor (80 mg) has any effect (it did not) and high dose Crestor (40 mg), which slowed but did not stop the deterioration of stiff valves.

It's been my suspicion that vitamins D and K2 may play a crucial factor in valve health. After all, vitamin D is the master controller of calcium deposition. Preliminary data also suggest that people who are intentionally made vitamin K deficient with the drug, Coumadin, develop twice the calcium deposition on aortic valves that non-Coumadin takers develop.

I saw a patient Friday, Marianne. In addition to a moderate heart scan score of 379 at age 71, Marianne had a leaky (insufficient) aortic valve. By an echocardiogram 18 months ago, the valve was moderately leaky. I put Marianne on vitamin D, 4000 units, to raise her blood level to 50 ng/ml.

Last week, I asked Marianne to have another echocardiogram. This time, no leakiness whatsoever--none. I have never seen this happen before. Although Marianne is only one example and we don't want to extrapolate too far from the experience of one person, it's hard not to attribute this phenomenal response to vitamin D supplementation.

I wonder what would have happened if we had added vitamin K2, as well?

Anyway, just another potential wonderful effect of vitamin D restoration.
All posts by william-davis

Why not just get "perfect" lipids and call it a day?

What if you achieved the Track Your Plaque lipid targets: LDL cholesterol 60 mg/dl, HDL 60 mg/dl, and triglycerides 60 mg/dl?

After all, these are pretty stringent standards. Compared to national guidelines (the ATP-III Guidelines of the National Cholesterol Educational Panel), the Track Your Plaque 60-60-60 goals are laughably ambitious. There's a lot of wisdom hidden in those numbers. The triglyceride level of 60, for instance, is a level at which triglycerides become essentially unavailable for formation of triglyceride-containing lipoprotein particles such as small LDL and VLDL.

If you get to the 60-60-60 target, isn't that good enough? What if you just held your values there and went about your business? Will coronary plaque stop growing and will your CT heart scan score stop increasing?

Sometimes it will. But, unfortunately, many times it will not. The experience generated through clinical trials bear this out. Studies like the St. Francis Heart Study and the BELLES Trial both showed that just reducing LDL cholesterol is insufficient to stop plaque growth. Beyond the Track Your Plaque experience, there's no clinical trial experience that shows whether the 60-60-60 approach does any better.

In our experience, achieving 60-60-60 is indeed better than just reducing LDL. That makes sense. Just raising HDL from the average of 42 mg/dl for a male, 52 mg/dl for a woman adds advantage. Compound this with triglyceride reduction from the plaque-creating equation, and you've doubled success.

But there's even more. What if you had hidden patterns not revealed by conventional lipids? How about lipoprotein(a)? Small LDL? Postprandial (after-eating) abnormalities? Hypertensive effects (more common than you think)!

In 2006, stopping the increase in your heart scan score is, for most of us, not just a matter of taking Lipitor or its equivalent and sitting back. For nearly all of us, stopping the progression of your score is a multi-faceted effort.

Hospitals: Then and Now

It's 1920. The hospital in your city is a facility run by nuns or the church. It's a place for the very ill, often without hope of meaningful treatment, but nonetheless a place where surgeries take place, babies are born, the injured and chronically ill can find care. No one has health insurance and there's no Medicare. Everyone pays what they can. The hospital is accustomed to doling out plenty of care without compensation. For that reason, they welcome donations and sometimes will build new additions or other facilities in honor of a major donor.

Volunteeers are common, since the wards are understaffed and generally suffering from a shortage of trained nurses and personnel associated with the church. Drugs, such as they are, are often prepared from basic ingredients in the hospital pharmacy. Product representatives hawking medicines and devices are virtually unheard of.

Though their therapeutic tools are limited, the physicians are a proud group, dedicating their careers to healing. The majority of the medical staff volunteer large portions of their time to care for the poor who come to the hospital with very advanced stages of disease: metastatic tumors, advanced heart failure, debilitating strokes, overwhelming septicemia, etc.

Hospitals are usually governed by a board of clergy and physicians who make decisions on how to apply their limited resources and continually seek charitable donations.


Fast forward to present day: Hospitals are high-tech, professional facilities with lots of skilled people, complicated equipment,and capable of complex procedures. While they still house people with advanced illnesses, the floors are also filled with people with much earlier phases of disease. In general, they do a good job, with quality issues scrutinized by a number of official agencies to police practices, incidence of hospital-related infections, medication errors, care protocols, etc.

The hospital of 2006 is a more more effective place than the hospital of 1920. But its aims and operations are different, also. Though some churches are still involved in hospitals, more and more are owned by publicly-traded companies that answer to shareholders--shareholders who want share value to increase. Though donations are still sought, much of the revenues are obtained by concentrating on profitable, large-ticket procedures. More procedures are often generated by advertising.

Because they operate to generate profits, several hospitals in a single city or region compete with one another. The 21st century has therefore witnessed the phenomenon of hospital-owned physicians: more and more practicing physicians are employees of their hospital. That way, the physician brings all his patients and procedures to his hospital, not to a competitor. The top of the funnel is the primary care physician, who tends to see all disease when it first occurs. The primary care physician then sends the patient to the specialist, who is obliged (by contract) to perform his/her procedure in the hsopital paying their salary.




Representatives from companies manufacturing and selling expensive hospital equipment and drugs are everywhere, falling over themselves to gain attention of the physicians using their equipment and the hospital buyers who make purchasing decisions. Millions of dollars can be transacted with just one sale.

The number of volunteers has dwindled. The poor and uninsured are commonly diverted elsewhere, often to a government-funded, and often second-rate, institution. Hospitals measure success by comparing annual revenues and numbers of major procedures.

The hospital of 2006 is a vastly different place than 1920. If you're expecting charitable treatment, compassion, and selfless care, you're in the wrong century. In 2006, the hospital is a business. You don't expect charitable treatment at Wal-Mart or from your car dealer. Don't expect it from your hospital. They are businesses and you are a customer. Recognize this fact, lose the nostalgia for the hospitals of yesterday, and a lot more will become clear to you.

The dreaded small LDL particle

Brian is a 59-year old landscape architect whose starting CT heart scan score was 276.

Brian's food choices at the start were deplorable: a pound of sausage per week, sometimes more; butter on anything and everything; up to two pounds of cheese per week; hot dogs; etc. His lipoproteins were accordingly just as miserable: low HDL, high triglycerides, excessive (postprandial, or after-eating) IDL. Small LDL was a particularly stand-out pattern, with 95% of all LDL particles in the small category.

Brian made a dramatic turnaround in lifestyle and corrected all of his patterns--except for small LDL. After one year, small LDL still occupied 95% of all LDL particles, even though the quantity of LDL had been reduced. In order to help convince Brian that correction of his small LDL was going to be necessary to achieve control oover coronary plaque, I suggested that he undergo another heart scan. His score: 435, or a 57% increase.

Each day that passes, I gain more and more respect for small LDL as a cause for coronary plaque growth. Conventional thought among lipid experts is that small LDL should no longer be a factor if total LDL (e.g., LDL particle number) is reduced. But our experience suggests otherwise: when small LDL persists, we tend to see continued, sometimes frightening, plaque growth.

I therefore asked Brian to intensify his efforts: additional weight loss off his somewhat prominent abdomen (since visceral fat increases small LDL), further reduce wheat products and processed carbohydrates, increase niacin (to 1500 mg per day), and use more raw almonds and oat bran.

Don't let small LDL get the best of you. It is a nasty, sometimes persistent abnormality that has impressive effects on plaque growth.

Winning Through Intimidation

Do you remember the book, Winning Through Intimidation by author Robert J. Ringer?



In his 1984 bestseller, author Ringer details how to succeed in business by overwhelming clients and competition by appearing hugely successful and powerful. Rather than a business card, he'd hand out an elegant book to represent himself. He'd show up in a limousine to a meeting, even when he could barely afford it. He used these tactics, even when he was a small-fry, in commercial real estate and built a successful business following such techniques.

This reminds me a lot of what happens in conventional medical practice: The large and successful hospitals, filled with trained staff and technology, exude legitimacy and success. How can they possibly be wrong? Such overwhelming know-how and multiple levels of expertise mustbe right!

Let's be grateful that we do have access to such high-tech, capable care. Unfortunately, just as Mr. Ringer used deceptive practices to appear something he wasn't, this is also true in hospitals. Not all physicians have your best interests in mind. Their principal concern is how profitable your care can be for them--can you be persuaded to have your stent, bypass, etc.. After all, look around you: Aren't all this equipment and personnel impressive? Aren't you intimidated?

The patient that most recently drove home this issue for me recently was a smart and capable executive who came in for consultation. He had been told by his internist that a surgery (to replace his aorta, a HUGE procedure) was probably necessary. In my view, it was not--his process was simply not that far progressed. The risks for danger over the next several years was virtually nil. Unfortunately, this man, now confused and worried, sought an opinion from the chief of thoracic surgery (in the usual white coat and with professorial demeanor, I'm sure) in a major metropolitan hospital (in Chicago), who promptly rushed him off to the operating room.

The pathology report, cleverly not mentioned in any other of the hospital documentation, showed what I had suspected: this man had mild disease that wasn't even close to requiring surgery. But, with all that technology, $100,000 or so of costs, chief of surgery who looked the part, etc.--they must be right!

Robert Ringer's concepts only ring too true for hospitals and some of the unscrupulous physicians in practice. Don't allow yourself to be intimidated.

Can natural treatments "cure" or "treat" any disease?

According to current FDA policy, the answer is a flat "NO!"

No natural treatment, whether it be fish oil (as a nutritional supplement), l-arginine, vitamin D, magnesium, various flavonoids like theaflavin or resveratrol, can be declared to treat or cure any disease. That's why you see the evasive and vague wording on nutritional supplements, nutraceuticals, and various foods, like "Supports heart health" or "Supports healthy cholesterol". Claiming, for instance, that taking 6000 mg per day of a standard OTC fish will reduce triglycerides and stating so on the label of a supplement is unlawful and prosecutable.

Think what you will of Mr. Kevin Trudeau (author of Natural Cures They Don't Want You to Know About"): visionary, consumer advocate, David vs. the Goliath of the FDA and "Big Pharma", or huckster, scam artist, and one-time felon. But Trudeau got it right on one important issue: The FDA dictates what claims can be made to treat disease. On one of his ubiquitous informercials, Trudeau states:


"...the way the system works today, you have the Food and Drug Administration—the FDA, and you have the drug industry. They really work in tandem. Unfortunately, there’s an unholy alliance there. People don’t know that the majority of commissioners of the FDA, which allegedly regulates the drug industry, and the food industry—Food and Drug Administration, the commissioners of the FDA—the majority of them—go to work directly for the drug companies upon leaving the FDA and are paid millions and millions and millions of dollars. Now in any other format, that would be called bribery; that would be called a conflict of interest; that would be called payoffs. That’s exactly what’s happening right now. So what has occurred is the Food and Drug Administration is really working in tandem with the drug industry to protect their profits. Example: The Food and Drug Administration says that only a drug can diagnose, prevent, or cure any disease."


He goes on to say that

"...the Food and Drug Administration says only a drug--nothing else--can cure, prevent, or diagnose a disease. Therefore the Food and Drug Administration continues to call more and more and more things diseases. Therefore they eliminate all-natural remedies. No one can say what a natural remedy can do if it’s been classified as a disease. So Attention Deficit Disorder is now a disease. Therefore only a drug can cure, prevent, or diagnose it. Cancer is a disease. Acid reflux is now a disease. Obesity is now a disease."

(PLEASE do not construe this as an endorsement of Mr. Trudeau's overall opinions. But I do think he's right on this one point.)

The stated purpose of this restrictive policy is to protect the public. Indeed, in years past before protective legislation, ineffective and even poisonous products were commonly sold as therapeutic treatments. (Remember cocaine and morphine in cold remedies? Lead and other toxic agents were also common.) Unfortunately, a huge gap has emerged as clinical data accumulates that support the efficacy of nutritional treatments and other non-traditional methods to treat or alleviate diseases. Any disease, or anything construed as disease as Trudeau points out, can onlybe treated by a drug.

In the FDA's defense, they have made slow progress in allowing "claims" of benefits for several supplements and food substances, such as the beta-glucan of oat products, soy protein, and most recently barley (for cholesterol reduction). The scrutiny is quite thorough and the wording of the policy is quite specific. Regarding oat products, for instance, the policy states:

"FDA concluded that the beta-glucan soluble fiber of whole oats is the primary component responsible for the total and LDL blood cholesterol-lowering effects of diets that contain these whole oat-containing foods at appropriate levels. This conclusion is based on review of scientific evidence indicating a relationship between the soluble fiber in these whole oat-containing foods and a reduction in the
risk of coronary heart disease.

Food products eligible to bear the health claim include oat bran and rolled oats, such as oatmeal, and whole oat flour...To qualify for the health claim, the whole oat-containing food must provide at least 0.75 grams of soluble fiber per
serving. The amount of soluble fiber needed for an effect on cholesterol levels is about 3 grams per day."


(Source: FDA Talk Paper which can be viewed in its entirety at http://www.fda.gov/bbs/topics/ANSWERS/ANS00782.html.)

In light of the boom in nutritional and non-traditional research that validate or refute efficacy, is such a policy still necessary? Or does it inhibit the open dissemination of information and result in a extraordinary monopolization of health treatment for the drug companies?

This debate will likely rage for the next two or more decades, particularly as drug companies are increasingly viewed as profit-seeking enterprises and more validation is gained by non-drug treatments.

For the moment, don't dismiss a "treatment" because it doesn't come by prescription. But don't reject a drugjust because it is a prescription. We need to strike a healthy, rational balance somewhere in between.

Can procedures alone keep you alive?

My days in the hospital remind me of what heart disease can be like when no preventive efforts are taken--what it used to be like even with my patients before taking a vigorous approach to prevention (though over 12 years ago).

Several cardiologists in my hospital, for instance, express skepticism that heart disease prevention works at all. Yes, they know about the statin cholesterol drug trials. But they claim that, given their experience with the power of coronary disease to overpower an individual's control, statin drugs are just "fluff". Coronary disease is a powerful process that can only begin to be harnessed with major procedures, i.e., a mechanical approach.

So these cardiologists routinely have their patients in the hospital, often once a year, sometimes more, for heart catheterization and "fixing" whatever requires fixing: balloon angioplasty, stents, various forms of atherectomy. Year in, year out, these patients return for their "maintenance" procedures. Their cardiologists maintain that this approach works. The patients go on eating what they like, taking little or no nutritional supplements, and medications prescribed by their primary care physicians for blood pressure, etc. But no real effort towards heart disease prevention beyond these minimal steps.

Can this work? Very little at-home, preventive efforts, but periodic "maintenance" procedures?

It can, perhaps, for a relatively short time of a few years, maybe up to 10 years. But it crumbles after this. The disease eventaully overwhelms the cardiologist's ability to stent or balloon this or that, since it has progressed and plaque has growth diffusely the entire period that maintenance procedures have been performed. In addition, acute illness still occurs with some frequency--in other words, plaque rupture is not affected just because there's a stent in the artery upstream or downstream.

Not to mention this can be misery on you and your life, with risk incurred during each procedure. It's also terribly expensive, with hospitalization easily costing $25,000-$50,000 or more each time. (Compare that to a $250 or so CT heart scan.)


As people become more aware of the potential tools for prevention of heart disease, fewer are willing to submit to the archaic and barbaric practice of "maintenance" heart procedures in lieu of prevention. But it still goes on. If you, or anybody you know, are on this pointless and doomed path, find a new doctor.




Bloodletting, another antiquated health practice

Support your local hospital: HAVE A HEART ATTACK!

I'm kidding, of course. But, in your hospital's secret agenda, that's not too far from the truth. Catastrophes lead to hospital procedures, which then yields major revenues.

Prevention, on the other hand, yields nothing for your hospital. No $8,000 to $12,000 for heart catheterization, several thousand more for a stent, $60,000-plus for a bypass, $25,000 or more for a defibrillator. In other words, prevention of heart attack and all its consequences deprive your hospital of a goldmine of revenue.

The doctors are all too often conspirators. I heard of yet another graphic example today. A man I didn't know called me out of the blue with a question. "I had a heart scan and I had a 'score' that I was told meant a moderate quantity of plaque in my arteries, a score of 157. My doctor said to ignore it. But I got another scan a year later and my score was 178. So I told this to my doctor and he said, 'Let's get you into the hospital. We'll set up a catheterization and then you'll get bypassed.' Of course, I was completely thrown off balance by this. Here I was thinking that the heart scan was showing that my prevention program needed improvement. But my doctor was talking about bypass surgery. Can you help? Does this sound right?"

No, this is absolutely not right. It's another tragedy like the many I hear about every day. Heart scans are, in fact, wonderfully helpful tools for prevention. This man was right: he felt great and the heart scan simply uncovered hidden plaque that should have triggered a conversation on how to prevent it from getting worse. But the doctor took it as a license to hustle the patient into the hospital. Ka-ching!

This sort of blatant money-generating behavior is far from rare. Don't become another victim of the cardiovascular money-making machine. Be alert, be skeptical, and question why. Of course, there are plenty of times when major heart procedures are necessary. But always insist on knowing the rationale behind such decisions, whether it's you or a loved one.

Hospitals contain experts in ILLNESS

Hospitals contain many experts in sickness. This seems obvious. But walk down the hallways of any hospital, and you'll quickly be convinced that hospitals contain almost no experts in health.

People (hospital staff, that is, not the patients) in hospitals are especially good at identifying and treating disease. They lack knowledge of health.

If your nurse is 100 lbs overweight and struggles to walk down the hall because of arthritis in both knees, would you entrust her with health advice?

If your doctor sits down in the cafeteria and eats his lunch of a ham sandwich with cheese on a bun, fried onion rings, and a milkshake and pastry, can you believe that he/she possesses any insight into health and nutrition?

If your physical therapist or cardiac rehabilitation counselor struggles nearly as much as you while climbing a single flight of stairs, can you accept their advice on how to regain your stamina and use exerise to full health advantage?

The answer to all these questions is, of course, no. Hospital staff are generally expert at dressing surgical wounds, stopping bleeding, identifying infections, and providing the support services for surgical and diagnostic procedures. In contrast, they are generally miserable at conveying genuine health advice. They certainly fall short in being examples of health themselves.

To hospitals and their staff, health is a temporary situation that persists only until you become ill. Illness is an inevitability in the hospital staff mindset. Health is a temporary state in between illnesses.

We need to shake off this perverse mentality. Health is the state of life that should dominate our practices and philosophies. Illness via the occasional catastrophe, e.g., broken leg from skiing, car accident, etc., is the province of hospitals. We should gravitate towards this philosphy and away from the over-reliance on hospitals that has come to dominate our present perceptions of health. Hospitals are not glamorous. They are, for the most part, profit-seeking businesses intent on portraying themselves as champions of health.

When I walk down the halls of hospitals, I am shocked and ashamed at the extraordinary examples of ill-health presented by hospital staff. Yet they falsely paint themselves as experts in both illness and health. Don't believe it for a second.

Are there still unexplored causes of heart disease?

I met a woman today. She had her first heart attack at age 37. She just had her 2nd heart attack this morning, at age 40.

Several issues are surprising about her story. First, she's pre-menopausal. Heart attacks before menopause are unusual. We'll occasionally see women have a heart attack before or during menopausal years only if they're heavy smokers and/or they have had diabetes (either type I or type II) for many years. But this young woman had neither. She is slender and has never smoked.

Even more surprising are her basic lipid values: LDL cholesterol 35 mg/dl, HDL 150 mg/dl, triglycerides 317 mg/dl. This is a very unusual pattern.

Unfortunately, this is all developing acutely in the hospital. (I've just met her today--she's not a Track Your Plaquer!) Lipoprotein analysis would be extremely interesting. In particular, I'd like to see whether she has any other markers besides elevated triglycerides of a "post-prandial" abnormality, i.e., persistence of abnormal particles after eating. The high triglycerides make this quite likely.

If this proves true, the omega-3 fatty acids from fish oil will be a lifesaving treatment for her, since they dramatically reduce both triglycerides as well as persistent postprandial particles like intermediate-density lipoprotein (IDL). (Track Your Plaque Members: See the Special Report on Postprandial Abnormalities on the present home page at www.cureality.com for a more in-depth discussion of this fascinating collection of patterns that is just started to be explored.)

In the real world, especially acute care medicine, there's always a kicker: she speaks no English. Unfortunately, communicating the intricacies of a powerful program like ours that aims to identify all causes of heart disease, then corrects then and aims for coronary plaque regression, is difficult if not impossible.

I also do occasionally worry that, given this woman's extraordinary risk at a young age, and overall very unusual lipid patterns (HDL 150?!), if there are causes presently beyond our reach. We have to make use of the tools available to us for now.

Everything causes heart attack!

The media are presently gushing about a recent study that associates caffeine intake with heart attack.

CBS News: That cup of coffee you're craving might not be such a good idea. Research in the September issue of Epidemiology suggests coffee can trigger a heart attack within an hour in some people.


Some reporters and their quoted sources are musing about whether it's the caffeine, cream vs. other whiteners, time of day, interaction with other risk factors, etc.

My advice: Get a grip! How many relatively benign, every day factors in life can be blamed for dire health risks?

The problem with many of these studies is that they are cross-sectional. They do not enroll participants, then "treat" with coffee (or other substance in question) vs. placebo. In other words, it is not a randomized trial, the sort of trial necessary to prove a hypothesis. That's all that can be generated by a study like this one: a hypothesis.

Perhaps there's a bit of warning for the person with uncorrected lipids and lipoproteins, has no idea that they have extensive coronary plaque because they've never had a heart scan, and have a slovenly lifestyle. Maybe that person might have exaggerated risk from a cup of coffee.

But for us, involved and intensively addressing all causes of coronary plaque to the point of stabilizing or reducing it, coffee is likely a non-issue.

For more conversation on coffee and this report, go to the www.cureality.com home page.