Lipoprotein(a) Research Foundation

There is no longer any doubt that lipoprotein(a) is a major causal factor in heart disease:

Meta-analysis (combined re-analysis) of 27 prospective studies:
Danesh J et al. Lipoprotein(a) and Coronary Heart Disease: Meta-Analysis of Prospective Studies


Lp(a) and "subclinical" atherosclerosis
Brown SA et al. The relation of lipoprotein[a] concentrations and apolipoprotein[a] phenotypes with asymptomatic atherosclerosis in subjects of the Atherosclerosis Risk in Communities (ARIC) Study.

Lp(a) and oxidized LDL
Tsimikas S et al. Oxidized phospholipids, Lp(a) lipoprotein, and coronary artery disease.

Lp(a) predicts peripheral vascular disease
Valentine RJ et al. Lp(a) lipoprotein is an independent, discriminating risk factor for premature peripheral atherosclerosis among white men.

Peltier M et al.Elevated serum lipoprotein(a) level is an independent marker of severity of thoracic aortic atherosclerosis.


Lp(a) across various populations
Gambhir JK et al. Association between lipoprotein(a) levels, apo(a) isoforms and family history of premature CAD in young Asian Indians.

Weber M et al. Metabolic factors clustering, lipoprotein cholesterol, apolipoprotein B, lipoprotein (a) and apolipoprotein E phenotypes in premature coronary artery disease in French Canadians.



Lp(a) and stroke risk
Jurgens G et al. Lipoprotein(a) serum concentration and apolipoprotein(a) phenotype correlate with severity and presence of ischemic cerebrovascular disease.

Willeit J et al. Lipoprotein(a) and asymptomatic carotid artery disease. Evidence of a prominent role in the evolution of advanced carotid plaques: the Bruneck Study.




From just about any direction, Lp(a) has been conclusively associated with atherosclerotic disease. We have more than enough data proving association.

But there are two areas of desperate need:

1) Data on effective treatments.

2) Raising awareness of this widely unknown (among the public) and ignored (among health professionals) genetic condition.

Treatment remains a real struggle. In a recent detailed Track Your Plaque Special Report, Unique Treatment Strategies for Lipoprotein(a) Reduction, we summarized the treatment approaches that have some power to reduce Lp(a) and/or its potential for causing heart disease. But, even armed with an appreciation for the world's scientific literature on this genetic condition, full control remains difficult for many people.

Track Your Plaque's HeartHawk has Lp(a) and he has struggled with this pattern for the last several years. He details some of his thoughts in a recent blog post.

More research and clinical studies are required and we need it soon if we hope to gain better control over this genetic pattern that affects up to 20% of people with coronary or vascular disease. Much of the needed research is sophisticated, background work similar to that being done by Dr. Santico Marcovina at University of Washington, Dr. Angelo Scanu at the University of Chicago, and Dr. Sally McCormick in New Zealand.

However, much of the needed research also consists of brief clinical experiences that detail whether or not there is an effect of various potential agents. Larger experiences, for instance, with potential treatment agents such as various phospholipid fractions, acetylcysteine, antibiotic regimens, some hormonal treatments, etc. could be performed quickly and simply. These studies would not require the $20 or $30 million typically spent by a drug company for a study, nor the several hundred million dollars to gain FDA approval of a new agent. They would simply be examinations of existing agents. These studies still cost money, require expertise, staff, and equipment. But the cost is a tiny fraction of the drug industry's investment in research. But it also means that investment return is nil from a drug manufacturer's perspective. Yet there are literally dozens, perhaps hundreds, of agents that hold some promise but have not been thoroughly studied.

For instance, if a specific modification of the phosphatidylcholine molecule were to generate a substantial Lp(a) reducing effect, Merck, Pfizer, and AstraZeneca would yawn--it is non-patent protectable, cannot be protected from competitors through the costly FDA approval process, and therefore is simply not worth their investment--regardless of whether it works or not.

(This is yet another example of how the drug industry, as well as hospitals and many health professionals, have lost sight of their real mission: to alleviate disease, not to profit from sickness.)

HeartHawk and I have discussed on a number of occasions whether a Lipoprotein(a) Research Foundation should be formed, an organization that seeks to fund the smaller research efforts that may accelerate productive research in Lp(a) and perhaps yield useful strategies faster than hoping for somebody to simply stumble on a treatment, or wait for the drug industry to create a unique, patentable entity that returns billions.

I'd like to propose that our Track Your Plaque program begin to fund such an effort. But a lot more help will be needed, particularly to generate the money to fund genuine, high-quality research from high-quality researchers.

If any readers of the Heart Scan Blog have any thoughts or insights into this process of creating a foundation, we'd appreciate your input.

More on ASTEROID

Since we are on the topic of the ASTEROID trial and rosuvastatin, I'd make one more point before I start to sound like I'm plugging this drug (which I definitely am not).

In an informative Roundtable Discussion (open to subscribers to the American Journal of Cardiology; sorry) amongst Dr. Steve Nissen, principal investigator behind ASTEROID; and Drs. Vincent Friedewald, Christie Ballantyne, P. Shah, and William Roberts, Dr. Nissen made some interesting comments:


Dr. Shah: In ASTEROID, was the magnitude of atheroma volume change seen across different levels of LDL-C and HDL-C?

Dr. Nissen: No. There was no plaque regression seen in the 17 persons with LDL-Cs >/= 100 mg/dl, and there was little change in persons with LDL-Cs of 70 to 100 mg/dl. Only in persons with LDLs less than or equal to 70 mg/dl was there significant regression. The study was not powered to look for an HDL-C(which increased by 14.7%)-raising effect.



Interesting. In other words, ASTEROID, in a fairly internally consistent way, suggests that the lower the LDL is reduced, the more likely plaque regression is obtained. This is consistent with the Track Your Plaque experience, in which we've advocated reducing (calculated) LDL cholesterol to 60 mg/dl for the past several years.

Unfortunately, the message that the ASTEROID Trial sponsors, AstraZeneca, as well as the roundtable discussion panel (later in the discussion) try to make is that there is something magical about Crestor, that it yields benefits superior to other statin agents or other means of reducing LDL.

I disagree with this message. In the Track Your Plaque experience, we do aim for a similar LDL target. But we also employ a number of other strategies. We have also succeeded in regressing plaque without use of any statin drugs (though, admittedly, many people do require statin drugs to obtain LDLs in this range). We also witness magnitudes of reversal that often far exceed that seen in ASTEROID.

The Rountable Discussion is unfortunately tainted, as is the ASTEROID Trial itself, with deep drug industry financial involvement of the Roundtable participants. In fact, the discussion begins with a listing of the financial disclosures of the participants, a listing that occupies a full column of a two-column page. The potential biases of the participants doesn't necessarily invalidate the arguments, but to me suggests that participants are more likely to argue in favor of the sponsor's drug, or that participants were chosen because of these biases.

Why bother to even mention the ASTEROID Trial in a venue (the Heart Scan Blog, that is) that purports to seek unvarnished, unbiased truth in coronary plaque reversal? Because useful information can sometimes be found in unlikely places. Just like the four-year old child who blurts out an unexpected pearl of wisdom, so it can happen with the gobbledy-gook that emerges from the drug industry.

Every once in a while, they are worth paying attention to.

LDL cholesterol, statins, and plaque regression

The ASTEROID Trial reported in 2006 examined the effects of LDL cholesterol reduction using the statin drug, rosuvastatin (Crestor), with coronary atherosclerosis quantified and tracked with intracoronary ultrasound. The Track Your Plaque report, New study confirms: LDL of 60 mg reverses plaque, on the ASTEROID Trial provides commentary on the results.


Though I remain skeptical that a statin-only treatment strategy can reverse coronary plaque in the majority of people, I do believe that the AstraZeneca-sponsored ASTEROID Trial does add to the wisdom on heart disease management. More importantly, it has served to raise awareness among both the public and my physician colleagues that atherosclerosis is indeed a potentially reversible condition.


Specifically, the ASTEROID results confirm that, either directly or indirectly, LDL cholesterol reduction achieved with statin agents does correspond to increasing degrees of plaque reversal. The mean (calculated) LDL cholesterol achieved in ASTEROID was 60 mg/dl, the same as the Track Your Plaque suggested LDL target.

Though the ASTEROID Trial is not news, I stumbled on a chart posted on the ASTEROID Trial website that clearly highlights how a number of other studies beyond ASTEROID have fallen into this pattern:





The graph reveals a linear relationship: The greater the reduction in LDL cholesterol with statin drugs, the greater the plaque regression ("change in percent atheroma volume"). (Several other studies not included in the graph also cluster into the same linear relationship.)

I am no supporter of drug companies, nor a defender of their policies and practices. But I do believe that their data can serve to teach us a few lessons. For instance, here is an (cherry-picked, to be sure) example of intracoronary ultrasound cross-sectional images before and after two years of rosuvastatin, 40 mg daily:





The color-coded/outlined atherosclerotic coronary plaque is shown shrinking, while the "lumen," or the path for blood to flow, enlarges. The reduction in coronary plaque is irrefutable. (The small circle within the lumen with the white halo surrounding it is the ultrasound catheter.)

If you and I were to choose a single treatment approach to coronary disease reversal, then 40 mg of rosuvastatin is probably at the top of the list. However, in the Track Your Plaque program, we do not advocate a single treatment strategy. While the Crestor-only approach is relatively straightforward--one pill a day--few people, in my experience, can tolerate this dose for any length of time. Patients invariably have to stop the drug or reduce the dose severely due to muscle aches when I've had patients try it. Contrary to the ASTEROID results, in my experience the majority of people, perhaps all, eventually give up with this improbable "one-size-fits-all" scheme.

The Track Your Plaque approach, while more complicated and involves several nutritional supplements and strategies, in my view addresses more causes of coronary plaque, is better tolerated, and provides health benefits outside of just LDL cholesterol reduction. It also minimizes or eliminates the need for prescription medication.



Studies cited in graph:

1.Nissen S et al. N Engl J Med 2006;354:1253-1263.
2 Tardif J et al. Circulation 2004;110:3372-3377.
3 Nissen S et al. JAMA 2006;295 (13):1556-1565
4 Nissen S et al. JAMA 2004;292: 2217–2225.
5 Nissen S et al. JAMA 2004; 291:1071–1080

Dr. Agatston to the rescue


Dr. Arthur Agatston, author of wildly successful South Beach Diet, has just released a new book titled The South Beach Heart Program. Dr. Agatston has started on a media speaking circuit to promote his book and concepts.


A reporter from Time, who interviewed Dr. Agatston, commented:

". . .not enough doctors prescribe niacin for their heart patients, even though the medicine is a proven treatment for raising 'good' cholesterol. Physicians are reluctant, Agatston suggests, because niacin requires diligent follow-up to watch for side effects, taking time that most primary-care practices cannot afford. On the other hand, he says, too many doctors are performing heart operations that represent a financial windfall for hospitals. Bottom line: there isn't as much money to be made in prevention as in treatment."

Amen.

Dr. Agatston echoes many of the concepts that the Track Your Plaque program advocates. His notoriety is going to help disseminate the idea that 1) CT heart scans are the #1 method to identify hidden atherosclerotic coronary plaque, 2) taking control of your heart scan score is the best way to seize hold of your future, and 3) the present-day popularity of heart procedures like stents and bypass is intolerable, inexcusable, and needs to be reined back.

Agatston also brings great credibility and fairness to the conversation and his comments will gain tremendous attention in the press and with the public.

When is a vitamin not a vitamin?

When it's a hormone.

That's the stand that several researchers in vitamin D have taken and I think they're right. Dr. John Cannell has made a fuss over this in his www.vitamindcouncil.com website.

Structurally, vitamin D is most closely related to testosterone, estrogen, and cortisol. You wouldn't call testosterone vitamin T, would you?

Vitamins are also meant to be obtained from food. Yes, vitamin D is in milk but only because humans are required to put it there to prevent childhood rickets. Otherwise, the only substantial food source of vitamin D is in oily fish like salmon and then only a modest quantity.

Vitamin D is cholecalciferol, a hormone. Deficiencies of hormones can have catastrophic consequences. Imagine that every winter your thyroid gland shuts down and produced no thyroid hormone. You'd get very ill, gain 30 lbs, lose your hair, feel awful.

That's what happens when you're sun deprived and thereby deficient in cholecalciferol--you're deficient in a hormone. And it happens to most of us every year for many months.

I continue to witness spectacular effects by bringing 25-OH-vitamin D3 blood levels to 50 ng/ml with supplementation, including an apparent surge in success dropping heart scan scores.

An epidemic of heart disease reversal

Heart disease reversal is nothing new in my office. However, I have to admit that it's not something that generally happens each and every day.

As our approach is refined, we are witnessing an unprecedented frequency of plaque reversal. Since Monday (today is Tuesday), I've seen four people who have regressed their coronary plaque and dropped their heart scan score.

Pat was the most recent addition to this list. At age 53, I was honestly surprised at the ease of dropping her heart scan score from 128 to 42 in the space of a year. I was surprised because among her lipoprotein patterns was the dreaded combination of lipoprotein(a) and small LDL, probably the most aggressive risk for heart disease I know of and also among the most difficult to gain control over. She also suffered a deep personal tragedy in her family, an emotional convulsion that can sometimes wipe out any hope of plaque reversal.

I'm hopeful that this virtual epidemic of heart disease reversal continues. And I hope that you participate in it.

Second heart scan and heart attack risk

At first, Joe felt disappointed, defeated, and frightened. After his heart scan, a radiologist at the center told him that his score of 264 was moderately high. He told Joe that he was at moderate risk for heart attack and that a nuclear stress test was going to be required.

This left Joe feeling confused. After all he'd had a heart scan 18 months earlier and his score was 278, 5% higher.

I reassured Joe that the radiologist had not been aware that Joe had a prior heart scan. The radiologist didn't know that Joe's heart scan score had actually been reduced.

In fact, Joe's risk for heart attack was not moderate--it is now very low, since his score was 5% lower. While growing plaque is active plaque, shrinking plaque is inactive plaque and thereby at far less risk for heart attack.

I wrote about this phemonenon in a previous Blog: When is a heart scan score of 400 better than 200? at http://heartscanblog.blogspot.com/2006_09_01_archive.html. When you've had more than one scan, the risk for heart attack suggested by the score takes a back seat to the rate of change of your score. In other words, even though Joe's score of 264 represented a moderate risk (of approximately 3% per year, roughly 30% over 10 years), this no longer held true, since it actually represented a 5% decrease over a previous score.

Joe's risk for heart attack is probably close to zero. ALWAYS view your second (or any subsequent) heart scan score in the context of your previous score, not in isolation.

Track Your Plaque newsletter subscribers: We will detail more of Joe's story in the coming January 2007 newsletter. If you'd like to read or subscribe to the newsletter, go to http://www.cureality.com/f_scanshow.asp.

Heart scan curiosities #5

Despite the controversy over drug-coated stents, I maintain that the best stent is no stent at all.

Yes, there are indeed times when such things are necessary, but not with the frequency that they are implanted nowadays.

Another reason why stents are an undesirable phenemenon is that they muck up your heart scan. Take a look:





The long white object in the center is a stent in the left anterior descending artery of this 60 year old man. Just beyond the stent (at about 1 o'clock from the stent) is a plaque that could be scored. However, you can see that, with the presence of the stent, the bulk of this artery is no longer "scorable". If this man wishes to "track his plaque", he will have to be content with tracking only the circumflex and right coronary arteries, the other two arteries without stents.

The stainless steel or similar metallic materials of current stents simply prevent us from seeing through them for plaque scoring purposes. It's best if you can simply avoid getting one for this and other reasons.

Track Your Plaque Members: Watch for the upcoming editorial by our Heart Hawk on drug-eluting stents.

One bite or many mouthfuls

A reader brought this beautiful series of food photos to my attention:

http://www.wisegeek.com/what-does-200-calories-look-like.htm

It's simply a graphic display of what 200 calories of various foods look like. You'll note that vegetables and fruits permit large servings to yield 200 calories. Processed foods, on the other hand, require very little to tally up the same calorie load. In particularly, look how little in the way of wheat products are required to match that amount.

Heart scan curiosities #4

Here's an interesting example of a 63-year old man with a heart scan score of 112. However, his aortic valve was also severely calcified (loaded with calcium). In other words, the normally flexible and mobile "leaflets" of the aortic valve were coated with calcium and other tissues that interfere with its free motion. The aortic valve is the starburst white in the center of the heart.








This is what the aortic valve should look like on a CT heart scan--you shouldn't see it at all.

The first man with the calcified valve will unfortunately require a new prosthetic aortic valve sometime in his future. This is usually determined with the help of an ultrasound, or echocardiogram, a better test for assessment of the aortic valve (though useless for detection of coronary plaque).

It's my suspicion that chronic and longstanding deficiency of vitamin D is among the factors that contribute to the abnormal deposition of calcium on the aortic valve. We desperately need more data on this. Nonetheless, perhaps this adds yet another reason to 1)get a CT heart scan, and 2) bring your vitamin D blood level to normal. (We aim for 50 ng/ml year round.)

Fish oil and the perverse logic of hospitals

Hospitals are now starting to carry prescription fish oil, known as Omacor, on their formularies. It's used by some thoracic surgeons after bypass surgery, since fish oil has been shown to reduce the likelihood of atrial fibrillation (a common rhythm after heart surgery).

Why now? The data confirming the benefits of fish oil on atrial fibrillation has been available for several years.

It's now available in hospitals because it's FDA-approved. In other words, when fish oil was just a supplement, it was not available in most hospitals. Whenever I've tried to get fish oil for my patients while in hospital, you'd think I was trying to smuggle Osama Bin Laden into the place. The resistance was incredible.

Now that FDA-approved Omacor is available, costing $130 dollars per month for two capsules, $195 for the three capsule per day dose for after surgery, all of a sudden it becomes available. Why would this irrational state of affairs occur in hospitals?

Several reasons, most of which revolve around the great suspicion my colleagues have towards nutritional supplements. In addition, there's the litigation risk: If something has been approved by the FDA, their stamp of endorsement provides some layer of legal protection.

However, I regard those as pretty weak reasons. I am, indeed, grateful that fish oil is gaining a wider audience. But I think it's absurd that it requires a prescription to get it in many hospitals. Imagine, as the drug companies would love, vitamin C became a prescription agent. Instead of $3, it would cost far more. Does that make it better, safer, more effective?

Of course, no drug sales representative is promoting the nutritional supplement fish oil to physicians nor to hospitals. I now see people adding the extraordinary expense of prescription fish oil to their presription bills.

In my view, it's unnecessary, irrational, and driven more by politics and greed than actual need. Take a look at the website for Omacor (www.omacorrx.com). Among the claims:

"OMACOR is the only omega-3 that, along with diet, has been proven and approved to dramatically reduce very high triglycerides..."

This is a bald lie. Dozens of studies have used nutritional supplement fish oil and shown spectacular triglyceride-reducing effects.

Their argument against fish oil supplements:

"Dietary supplements are not FDA-approved for the treatment of any specific disease or medical condition. Get the Facts: nonprescription, dietary supplement omega-3 is not a substitute for prescription OMACOR."

Does that make any sense to you? Should you buy a GM car because only GM makes genuine GM cars? This is the silly logic being offered by these people to justify their ridiculous pricing.

How about: "The unique manufacturing process for OMACOR helps to eliminate worries about mercury and other pollution from the environment."

Funny...mercury in fish tends to be sequestered in the meat, not the oil. Independent reports by both Consumer Reports and Consumer Lab found no mercury, nor PCB's, in nutritional supplement fish oil. But just suggesting a difference without proving it may be enough to scare some people.

Just because something is used by a hospital does not make it better. The adoption of fish oil is hospitals is a good thing. Too bad it has to add to already bloated health care costs to enrich some drug manufacturer.

Repent for past sins

If the food temptations of the holidays got the best of you, and you're now 5, 10, 15 lbs or more over your pre-holiday weight (our record is 18lbs!), then it's time for serious action.

One easy method to regain the control you may have lost is to pick some period, say, 3 days. During those three days, eat nothing but vegetables--no breads, meats, dairy products, certainly no cookies, cakes, pasta, etc., not even fruit. Follow this routine and weight drops rapidly. Vegetables are wonderful but sometimes boring, so use healthy condiments to spice them up: mustards (hot, brown, yellow, horseradish); healthy salad dressings, which are olive or canola oil-based; salsas, a fabulous garnish with no nutritional downside whatsoever; pesto; tapenades; horseradish added to other condiments or even by itself (wasabi).

Of course, fasting in one of its several variations is another rapid method to regain control. My favorite is to use soy milk in a modified fast, usually 4-6 glasses of a low-fat, low-sugar soy milk per day, along with plenty of water. (Please refer to the precautions detailed in the recent Track Your Plaque Special Report, Fasting: Fast Track to Control Plaque , particularly if you fast 5 days or longer or take blood pressure or diabetic medication.)

Of course, yo-yoing your weight--up during the holidays, down after their conclusion--is not good for you. It does raise the likelihood of diabetes, not to mention cultivate the patterns that contribute to coronary plaque growth, especially small LDL. But if temptation got out of control and you need to regain lost ground, these two strategies work fabulously well for most people.

If you've gained, say, 10 lbs during the holidays, but simply resume your usual habits, chances are you won't lose the weight. Year after year, this can add up to an enormous weight gain. The time to act is now. It's easier to lose the 10 lbs of weight you gained recently, rather than the 50 lbs you've stacked up over the past 5 years.

Interview with an outspoken advocate of truth in diabetes

I stumbled onto Jenny Ruhl's Diabetes Update blog after I received several very insightful comments to this blog whenever I posted a discussion on diabetes or pre-diabetes/metabolic syndrome.

Who the heck was this commenter who clearly had deep insight into diabetic issues?

It turned out to be Jenny Ruhl, a woman who learned her lessons the hard way: by receiving a belated diagnosis of (an unusual form of) diabetes, then receiving plenty of mis-guided advice from physicians on diet and treatment. Reading her many blog posts and websites, you get the clear sense of how hard this individual worked to gain the depth of knowledge she's acquired, on a par or superior to most diabetes specialists.

And she minces no words in expressing her heartfelt and carefully considered opinions. But that's what I look for: people who are unafraid to voice opinions that may not be consistent with the flow of conventional thought, but ring true and prove effective.


Dr. Davis: From your blog and websites on diabetes, it is clear that you exceptionally knowledgeable in the world of diabetes, metabolic syndrome, and related disorders. Can you give us a little background on how you came to this quest?

Jenny: Though I was told I was a "classic type 2" [diabetic] by my doctors, nothing I read about diabetes corresponded to my own experience. I knew my diabetes had not been caused by obesity because I'd been a normal weight all my life until my blood sugars went out of control at which point I developed ravenous hunger and gained a lot of weight very quickly.

I also wondered at the huge gap between what Dr. Bernstein said was a normal blood sugar and what my doctors told me was a safe blood sugar for a person with diabetes. The people I met who followed Bernstein's very low carb diet had much better blood sugars and far fewer complications, but my doctors dismissed this as irrelevant. So I decided to do some research to find out who to believe. I plunged into the medical journal articles that had recently been made available on the web to see if I could answer two questions: What causes diabetes? and "What does science actually know about what blood sugar levels damage organs?"

The result was the information that became the basis for the Blood Sugar 101 site. Initially, I attempted to sell it as a book, but editors told me that though what I'd learned was "fascinating" it would be "over the head" of the typical health book buyer who wanted simple explanations and if possible, a simplistic slant towards "cure." Fortunately, the very strong response and high traffic volume to the web site proved that, as I had thought, there are a lot of people who do want more than an oversimplified overview and who, given the information they needed, were able to make huge positive changes in their health.


Dr. Davis: What do you think your life would be like if you hadn't pursued this unique course?

Jenny: Possibly a lot shorter.

People in my family die of heart attacks in their 50s, probably from undiagnosed high blood sugars. The pattern of the type of diabetes I have is to have a normal fasting blood sugar and an extremely high post-meal blood sugar after consuming very few grams of carbohydrate. When doctors diagnose using only the fasting blood test, they miss those highs, which research is now finding to be a primary cause of heart disease.

I also would have been a lot fatter. My doctors told me that I was packing on 20 lbs a year due to "normal menopausal changes" and that there was nothing I could do about it. Lowering my carbs significantly dropped all the weight I had gained and I still weigh a lot less now than I did in 1998.


Dr. Davis: You've been a keen observer of the diabetes scene for some years. Have you discerned any important trends in both the public's perception of diabetes as well as how diabetes is managed in the conventional world?

Jenny: The huge difference I see is that, over the last decade, the online diabetes community has learned the value of cutting back on carbohydrates and shooting for truly normal blood sugar levels. So people who put some time into researching diabetes online and talking with those of us who have succeeded in avoiding complications will learn that they do not have to settle for very high blood sugars and deterioration their doctors think inevitable.

Unfortunately, the media have put most of their energy into promoting the discredited idea that diabetes is caused by gluttony and sloth and to promoting the equally discredited idea that people with diabetes should eat a high carbohydrate diet and avoid fat.

So for now there is a huge divide in the quality of life of those people with diabetes who educated enough to go out on the web and educate themselves and those who get their diabetes information from doctors. Sadly most doctors still encourage patients to eat low fat/ high carb diets, and counter the very high blood sugars this diet produces with oral drugs of questionable efficacy, while assuring patients they will be safe if they maintain blood sugar levels that meet the American Diabetes Association's recommendations, though a mass of research shows these are high enough to produce every single diabetic complication possible.


Dr. Davis: I understand that you've released a new book, Blood Sugar 101. How is your book unique in the world of diabetes books? Who should read Blood Sugar 101?

Jenny: Blood Sugar 101: What They Don't Tell You About Diabetes differs from other books in that it gives the reader a much deeper understanding of what is really going on in their bodies as their blood sugar control breaks down and what sciences knows about how abnormal blood sugars cause complications. Then it gives the reader the tools they need to find what diet and/or drug regimen will brings their own, unique, blood sugars down to a truly safe level.

Unlike some books, this one does not present a one-size-fits-all solution, but recognizes that Type 2 diabetes is really a catch-all diagnosis that covers a lot of disorders that behave quite differently. That is why what works for one person with diabetes may not work for another.

Because this book provides details available nowhere else about the physiology of diabetes and the drugs available to treat it, readers will find the information they need to work with their doctors to craft a regimen that brings their blood sugar into the range that preserves and improves their health.


Dr. Davis: Before we close, tell us a little about yourself outside of your diabetes advocate role.

Jenny: I live in rural New England and am a passionate gardener. I've been online since 1980 when I was part of the team at IBM that developed the first commercial email program, PROFS. I got involved in online discussion groups in 1987 and have been messaging on bulletin boards ever since.

I was a professional singer/songwriter in Nashville in my youth and spent my middle years as a bestselling author of books about consulting. Right now a lot of my energy goes into managing the financial and software side of a family business that makes hand made pocket tools for collectors.


Dr. Davis: Thank you for your great insights, Jenny!

The Marshall Protocol and other fairy tales

True to form, Dr. John Cannell has published yet another wonderfully insightful Vitamin D Newsletter.

One item caught my eye, a response to a question about the Marshall Protocol. I, like Dr. Cannell, was inundated with questions about this so-called protocol, which amounts to little more than the unfounded speculations of a non-physician, actually someone not even involved in health care.

In all honesty, I blew the whole issue off after I read Dr. Marshall's rants. They smack of pure quackery, though from somebody who clearly has a command of scientific lingo. To Dr. Cannell's credit, he took the time and effort to construct a rational response in the latest issue of the newsletter. I reproduce his response here:



Dear Dr. Cannell:

I understand Dr. Marshall conducted a study and found vitamin D is bad for you. What kind of study did he do?

Mary, Minneapolis, Minnesota


Dear Mary:

I have been inundated with letters asking about Professor Marshall's recent "discovery." Some have written that to say they have stopped their vitamin D and are going to avoid the sun in order to begin the "Marshall protocol." The immediate cause of this angst is two publications, a press article in Science Daily about Professor Marshall's "study" (which is no study but simply an opinion) in BioEssays. Dr. Trevor Marshall has two degrees, both in electrical engineering. Before I begin, I want to again remind you that I am a psychiatrist who works at a state mental hospital. In my duty to full disclosure, I must say that I have known a lot of psychiatrists in my life and a few electrical engineers. If I knew nothing else of a disagreement between two people but their professions, I would believe the electrical engineer, not the psychiatrist.

In reading his two articles, Dr. Marshall's main hypotheses are simple. (1) Vitamin D from sunlight is different than vitamin D from supplements. (2) Vitamin D is immunosuppressive and the low blood levels of vitamin D found in many chronic diseases are the result of the disease and not the cause. (3) Taking vitamin D will harm you, that is, vitamin D will make many diseases worse, not better. If you read his blog, you discover that the essence of the Marshall protocol is: "An angiotensin II receptor blocker medication, Benicar, is taken, and sunlight, bright lights and foods and supplements with vitamin D are diligently avoided. This enables the body's immune system, with the help of small doses of antibiotics, to destroy the intracellular bacteria. It can take approximately one to three years to destroy all the bacteria." That is, Dr. Marshall has his "patients" become very vitamin D deficient.

Again, Dr. Marshall conducted no experiment and published no study. He wrote an essay. He presented no evidence for his first hypothesis (sunlight's vitamin D is different than supplements). From all that we know, cholecalciferol is cholecalciferol, regardless if it is made in the skin or put in the mouth. His second hypothesis is certainly possible and that is why all scientists who do association studies warn readers that they don't know what is causing what. Certainly, when low levels of vitamin D are found in certain disease states, it is possible that the low levels are the result, and not the cause, of the disease. Take patients with severe dementia bedridden in a nursing home. At least some of their low 25(OH)D levels are likely the result of confinement and lack of outdoor activity. However, did dementia cause the low vitamin D levels or did low 25 (OH)D contribute to the dementia? One way to look at that question is to look at early dementia, before the patient is placed in a nursing home. On the first day an older patient walks into a neurology clinic, before being confined to a nursing home, what is the relationship between vitamin D levels and dementia? The answer is clear, the lower your 25(OH)D levels the worse your cognition.

Wilkins CH, Sheline YI, Roe CM, Birge SJ, Morris JC. Vitamin D deficiency is associated with low mood and worse cognitive performance in older adults. Am J Geriatr Psychiatry. 2006 Dec;14(12):1032-40.

Przybelski RJ, Binkley NC. Is vitamin D important for preserving cognition? A positive correlation of serum 25-hydroxyvitamin D concentration with cognitive function. Arch Biochem Biophys. 2007 Apr 15;460(2):202-5. Epub 2007 Jan 8.


These studies suggest that the low 25(OH)D levels are contributing to the dementia but do not prove it. Only a randomized controlled trial will definitively answer the question, a trial that has not been done. So you will have to decide if vitamin D is good for your brain or not. Dr. Marshall seems to be saying demented patients should lower their 25(OH)D levels. Keep in mind, an entire chapter in Feldman's textbook is devoted to the ill effects low vitamin D levels have on brain function.

Brachet P, et al. Vitamin D, a neuroactive hormone: from brain development to pathological disorders. In Feldman D., Pike JW, Glorieux FH, eds. Vitamin D. San Diego : Elsevier, 2005.

It is true that in some diseases, high doses of vitamin D may be harmful. For example, in the early part of last century, the AMA specifically excluded pulmonary TB from the list of TB infections that ultraviolet light helps. They did so because many of the early pioneers of solariums reported that acutely high doses of sunlight caused some patients with severe pulmonary TB to bleed to death. Thus, these pioneers developed very conservative sun exposure regimes for pulmonary TB patients in which small areas of the skin were progressively exposed to longer and longer periods of sunlight. Using this method, sunlight helped pulmonary TB, often to the point of a cure. Furthermore, it is well known that sunlight can cause high blood calcium in patients with sarcoidosis. In fact, sarcoidosis is one of several granulomatous diseases with vitamin D hypersensitivity where the body loses its ability to regulate activated vitamin D production, causing hypercalcemia.

Cronin CC, et al. Precipitation of hypercalcaemia in sarcoidosis by foreign sun holidays: report of four cases. Postgrad Med J. 1990 Apr;66(774):307-9.

Furthermore, although medical science is not yet convinced, some common autoimmune diseases may have an infectious etiology. I recently spoke at length with a rheumatologist who suffers from swollen and painful joints whenever he sunbathes or takes high doses of vitamin D. As long as he limits his vitamin D input his joints are better. To the extent vitamin D upregulates naturally occurring antibiotics of innate immunity, sunlight or vitamin D supplements may cause the battlefield (the joints) to become hot spots. I know of no evidence this is the case but it is certainly possible.

However, If Dr. Marshall's principal hypothesis is correct, that low vitamin D levels are the result of disease, then he is saying that cancer causes low vitamin D levels, not the other way around. The problem is that Professor Joanne Lappe directly disproved that theory in a randomized controlled trial when she found that baseline vitamin D levels were strong and independent predictors of who would get cancer in the future. The lower your levels, the higher the risk. Furthermore, increasing baseline levels from 31 to 38 ng/ml reduced incident cancers by more than 60% over a four year period. Therefore, advising patients to become vitamin D deficient, as the Marshall protocol clearly does, will cause some patients to die from cancer.

Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91.

I will not write again about Dr. Marshall's theories. No one in the vitamin D field takes him seriously. Personally, I admire anyone willing to swim against the tide and raise alternative theories. I have done the same with influenza and autism. However, I agree with the New York Times, An Oldie Vies for Nutrient of the Decade and Jane Brody's conclusion, "In the end, you will have to decide for yourself how much of this vital nutrient to consume each and every day and how to obtain it." I agree. You will have to decide for yourself.

John Cannell, MD
The Vitamin D Council

Breaking news from the American College of Cardiology meetings

The American Heart Association (AHA) was kind enough to send me an e-mail headlining the breaking news from the American College of Cardiology (ACC) meetings underway in Chicago:


ISAR-REACT 3
A Randomized, Double-Blind, Active-Controlled, Multi-Center Trial (ISAR-REACT 3) of Bivalirudin Versus Unfractionated Heparin in Troponin-Negative Patients Undergoing Percutaneous Coronary Interventions After Pre-Treatment With 600 mg of Clopidogrel

TRITON - TIMI 38 Stent Analysis
Prasugrel Compared to Clopidogrel in Patients With Acute Coronary Syndromes Undergoing PCI With Stenting: The TRITON - TIMI 38 Stent Analysis

Percutaneous Coronary Interventions in Facilities without On-Site Cardiac Surgery (NCDR)

(And four other similar reports)


Let's meld the ACC headlines with the financial headlines:

July 2, 2007
The Medicines Company announces reacquisition of all marketing rights to bivalirudin, anticoagulant growing in use for coronary angioplasty and related procedures. 2008 sales anticipated to be in the $15-20 million range, to grow to $90-110 million, a growth rate of 50% per year.


November 20, 2007
Drug manufacturing giant, Eli Lilly, vies for a portion of the $5 billion (annual revenues) oral anti-platelet market, now occupied by Plavix, with its newer, but questionably better, agent, prasugrel.


Growth of the coronary angioplasty (percutaneous coronary intervention, or PCI) doesn't ordinarily make headlines, but the performance of specific companies within the industry does. Angioplasty and cardiac device maker (inc. the drug-coated stent, Taxus), Boston Scientific, for instance, announced record sales of $8.537 billion for 2007, an increase of $536 million. How to grow this market? We could always hope for more people with heart attacks or other unstable symptoms. Or, we could . . . increase the number of hospitals capable of PCI! Brilliant.


The money behind this push for procedures is staggering. It drives enormous marketing efforts, pays Washington lobbyists, pays for many nice dinners and trips for doctors who engage in the system, and pays for very costly research.

And the AHA and ACC are kind enough to let us know about these great pieces of news.