by mjorrin | February 22, 2016 3:45 pm
[ed. note: Michael Jorrin, who I like to call Doc Gumshoe, is a longtime medical writer (not a doctor) who writes about non-financial health and medical issues for us a couple times a month — this time, he’s covering one of the many over-hyped health ads for “secret” supplements[1] and treatments that we all see every day, much like we cover the over-hyped “secret” investment ads most other days. Enjoy!]
I take these on partly because they’re entertaining – for me, certainly, and for you, I certainly hope. I have to remind myself to disaggregate the manner and style and method of the promotion from the actual substance of whatever it is that is being promoted. The promotion might be ludicrously over the top, grotesquely exaggerated and pitifully lacking in sense and reason. But there might, just might, be at least some merit in the purportedly miraculous cure.
On the other hand, if the cure/treatment really does reliably work, and if there is bona fide data to substantiate that, then why does the promotional material so frequently slip over the dividing line between reason and lunacy? My personal prejudice – and I freely admit that it’s a prejudice and not a studied conclusion based on lengthy analysis of data – is that there’s an inverse relationship between the frequency and intensity of the advertising and promotion of a product or service and the quality of the product itself. Hershey’s chocolates, for example, never saw any need to advertise, but the lousiest beers always seemed to advertise the most. So the mere fact that I cannot access the internet without being instructed to go to websites that promise to give me secret information that will save my life, raises my suspicion index by several orders of magnitude.
The templates for these promotions are strikingly similar.
So let’s move on to the specific miracle cure that prompted me to do this piece.
Fighting off the Cardiac Killer
The lengthy presentation starts out by taking dead aim at the Framingham Heart Study, which is an act of brazen iconoclasm, guaranteed to capture your attention. If you’re going to score points by making a frontal assault on the medical establishment, the Framingham study is an ideal target. The specific charges leveled against the study were that it ignored HDL cholesterol[4], and that it recommended a diet based on excluding cholesterol-rich foods, such as butter, eggs[5], cheese, and red meat. All I can say in response to that is, “not so fast!” Strictly speaking, the second item in that docket is false, since Framingham did not get into the business of formulating and recommending a specific diet. The first part, ignoring HDL cholesterol, might have been true up until about thirty years ago. But to evaluate that bill of attainder, we have to take a closer look at what the Framingham study did, and also at the historical evolution of our understanding of cardiovascular risk.
When the Framingham Study started, in 1948, the concept of specific cardiovascular risk factors had not yet come into being. It was thought that as people got older, they were more likely to die of heart attacks, and that was about it. Blood pressure was known to increase with age, and that was considered normal. In fact, the “normal” diastolic blood pressure[6] marker was “100 plus your age,” and there were no drugs available for the chronic management of what we would today consider hypertension[7]. As for cholesterol, it had been identified as the main constituent of the plaques that clog our arteries as long ago as 1913, when a couple of Russians found that feeding egg yolks to rabbits resulted in the rabbit version of human atherosclerotic plaque. However, it had also been learned that cholesterol in the diet of these rabbits did not by itself inevitably produce the villainous plaque; some rabbits, like some humans, could consume cholesterol and avoid atherosclerosis. And other animals, particularly rats, can consume cholesterol and not form arterial plaque. The issue remained in doubt, and to some degree, still remains in doubt.
The Framingham Heart Study recruited 5,209 adults from the town of Framingham, Massachusetts, and followed them annually. The original Framingham cohort was enlarged at several points, and the children and grandchildren of the original cohort are now being studied. After about ten years, some of the risk factors specifically identified by the study were that cigarette smoking, hypertension, elevated serum cholesterol, and obesity[8] were strongly linked to higher cardiovascular risk, while exercise was linked to lower cardiovascular risk. That may seem rather obvious at this point, but back in the 1960s, it was new information, and the strong statistical correlations between those risk factors and heart disease emphatically confirmed what some observers had suspected for a long time, but had been unable to substantiate.
And that, believe it or not, is where the “Cardiac Killer” promotion takes aim at the Framingham study, referring to it as “the infamous Framingham Study,” and accusing it of spreading “the most deadly dietary advice in history.”
Before we go on with the details of the promotion, let’s peel back the curtain and see who is behind it.
Dr Arash Bereliani and Princeton Nutrients
If you Google the spokesman for this promotion, the website for Princeton Nutrients pops up before any other, and here’s what it says about Dr Bereliani:
Dr. Bereliani
Board Certified Cardiologist,
Director at Beverly Hills Institute of Cardiology & Preventative Medicine
Dr. Bereliani is a fellow of the American College of Cardiology and an active member of the American Heart Association, the American Medical Association, ASNC the American Society of Nuclear Cardiology (ASNC), the Society of Nuclear Medicine (SNM), the American Academy of Anti-Aging Medicine (A4M) and the American College for Advancement in Medicine (ACAM).
I could find no indication that Dr Bereliani is anything other than a reputable practicing physician. Various websites quote patients who think highly of him, and he has admitting privileges at top hospitals in the Los Angeles area, including Cedars-Sinai. Does he really believe what he says, including the statement about the “infamous” Framingham Study? Well, we have been hearing about a couple of prominent physicians who claim to believe the unbelievable, including the one in the news lately who’s not too sure about evolution. However, one thing is evident: Dr Bereliani is by no means a noted researcher, including on the specific nutrients and supplements that he is touting. For example, a search of PubMed turns up three papers by A. Bereliani, all dating from the 1990s, and none in the cardiovascular area; two have to do with temporal bone trauma and one with a complication arising from a miniature disk battery[9] lodged in the nose. Not likely to be the same person.
And, by the way, Princeton Nutrients has absolutely nothing to do with Princeton University. They’re in California. So let’s go back to the Dire Warnings section of the spiel.
What is the “most deadly dietary advice in history?”
That’s easy: avoid those high cholesterol foods – butter, eggs, red meat, cheese. And why is that dietary advice “deadly”? Because, according to Dr Bereliani’s doctrine, that diet lowers your HDL cholesterol, which is the form of cholesterol that helps keep your arteries free from plaque. Is there anything to that accusation? Here’s where it gets a bit complicated.
For a start, Dr Bereliani emphatically and somewhat superciliously claims that the Framingham Study utterly missed the boat on cholesterol, because there are, in his words, “two kinds of cholesterol.” Well, that’s two kinds of hooey. First, there are certainly not two kinds of cholesterol. Cholesterol is cholesterol, pure and simple, but because cholesterol is not water[10] soluble, it is conveyed in the bloodstream in little bundles of lipoproteins, which are composed of protein, lipids, triglycerides, and cholesterol. The proteins are on the surface of these little bundles, and that’s how the lipoprotein bundles are carried in the circulatory system. The lipoprotein bundles vary in size, from very large, low-density bundles, to much smaller high-density bundles. The low-density bundles, or LDL-cholesterol, mostly transport cholesterol to its numerous destinations in our bodies, whereas the high-density bundles, or HDL-cholesterol, transport cholesterol on its outward-bound passage, through the bile duct for excretion in feces.
And the Framingham study certainly did not miss the boat on HDL-cholesterol. For more than 30 years, the Framingham Risk Calculator has included HDL-C levels as one of the parameters in calculating the likelihood of a cardiovascular event. Framingham factored in HDL-cholesterol as soon as its role was understood.
It’s common for people, even those who know better, to refer to “good cholesterol” and “bad cholesterol,” those being HDL-cholesterol and LDL-cholesterol, or HDL and LDL for short. But that quick and easy distinction obscures key facts. One is that our food contains no LDL or HDL cholesterol – those little packets are assembled in our own bodies.
The charge that a diet that minimized cholesterol-rich foods like butter, eggs, etc., is deadly because it lowers HDL-cholesterol is hard to figure. In the first place, many decades of disappointing experience with diets that are low in cholesterol has made it clear that lowering dietary cholesterol has very little effect on a person’s cholesterol levels. That’s because most of the cholesterol in our bodies is home-made. We synthesize it ourselves, mostly in our livers. The usual calculation is that only about 15% to 20% of the cholesterol in our bodies enters in the form of dietary cholesterol, i.e., from butter and eggs and the former usual suspects.
Granted that some of the food we eat makes a better feedstock for cholesterol synthesis, but no matter what we eat, we will manufacture cholesterol. That’s because we need it. Cholesterol is a basic component of most of the tissue in our bodies, and also of most hormones. For example, our skin is extremely high in cholesterol. If there were no cholesterol in our skin, we would become totally permeable – we would turn into puddles.
Now, it is certainly true that a number of factors, including diet, affect the balance between the low and the high density bundles. One is exercise. There are those who say moderate alcohol[11] consumption favors the HDL-cholesterol level. Some foods – salmon, nuts, olives, avocados – may boost HDL-cholesterol, although the omega-3 hypothesis has been contested. And our individual metabolisms play a large role. Robust levels of HDL-cholesterol in relation to total cholesterol are an indication that our overall cholesterol-processing machinery is working efficiently and that we’re not accumulating excess cholesterol and dumping it in our arteries.
But as for evidence that the low cholesterol diet – whether advocated by the Framingham Study or not – is harmful, let alone “the most deadly diet in history,” there is none whatever.
In fact, about 25 years ago, Dr William Castelli, then directing the Framingham study, made the astonishing admission that limiting cholesterol-rich food from the diet didn’t seem to do a thing to most people’s serum cholesterol levels. This is entirely contrary to Dr Bereliani’s heated charges that Dr Castelli was “poisoning the well” and “spreading cholesterol lies.” The reason that nixing butter and eggs did nothing – and in some cases, actually resulted in increased serum cholesterol – is that, as we know now, most of the cholesterol in our serum is of our own manufacture. And those people who were cutting out dietary cholesterol had to eat something, didn’t they? So, instead of the previous “usual suspects,” a lot of them ate what we now know to be considerably more harmful foods, like margarines that were rich in transfats.
By the way, Dr Castelli’s admission came a couple of years before publication of the Scandinavian Simvastatin Survival Study in 1994, usually abbreviated as “4S,” which demonstrated that treating individuals who had established risk factors for cardiac events such as heart attacks with a statin significantly improved survival. The results of the 4S study have been replicated in numerous other cohorts, with other statins[13], many, many times. The pros and cons of statins can and will be endlessly debated, but it is a fact that statin treatment has saved countless lives.
What, then, is Dr Bereliani’s answer?
Having established his credentials as a rock-solid critic of mainstream medicine – that being a prerequisite for the promotion of miracle cures – Dr Bereliani quits lambasting Framingham and, instead, restates one of the conclusions of mainstream cardiac medicine, which is that the real cardiac killer is not cholesterol in itself, but unstable or vulnerable plaque. The vulnerable plaque hypothesis is complex, and I won’t state it in detail, but the basics are as follows.
The starting point is the absorption of LDL-cholesterol into the artery wall – a process that happens throughout life and affects just about everybody to some degree. It used to be thought that that process was the whole deal – that cholesterol in the artery wall would progressively narrow the artery, choke off the flow of blood to the heart, and cause heart attacks. That does happen is some cases, perhaps as many as one third, but in the majority of heart attacks it’s another process that goes on.
It has now been learned that the presence of the LDL particles can induce an inflammatory process, involving cytokines and certain white blood cells, which essentially consume some of the LDL particles that have become oxidized. These macrophages swell up, becoming what are called foam cells. They then release enzymes that erode the artery wall. But when the artery wall is eroded, it can crack. At this point, several harmful things can happen: bits of the plaque from the artery wall can be released into the bloodstream. And blood platelets, whose mission it is to form wound-healing clots, are recruited to the site of the injury. But those clots also can be released into the bloodstream. Thus, either clumps of the plaque or blood clots are carried in the bloodstream. If these clots or clumps obstruct an artery that is supplying blood to the heart muscle, the result is a shortage of oxygen to that muscle – a myocardial infarction, or a heart attack.
This much Dr Bereliani explains, after a fashion, although he makes it seem as though what he’s presenting is his own brilliant discovery and not the result of enormous amounts of research by the villainous medical establishment. What he then fastens on as the culprit in this process is oxygen, never mind that the principal job of the bloodstream is to transport oxygen to all our organs and tissues. It’s the oxidation of the LDL particles that’s at the root of the problem, and the way to defeat the “Plaque of Death” is to prevent oxidation.
This can be accomplished by the action of “key anti-inflammatory nutrients,” also referred to as “heart-healing nutrients” and other terms meant to increase our confidence in what’s coming. Doc Gumshoe cannot conceivably survey the entire universe of anti-inflammatory diets and supplements, but let me just stake out a simple position: inflammation[14] is a necessary part of our physiologic response to a huge number of events in our bodies, and an essential part of the immune response. But it can also cause serious problems, as in its role in the formation of vulnerable plaque. And diet certainly does have an effect on our inflammatory response. One of the most reliable authorities on the whole subject is Christopher Cannon, of the Harvard Medical School, who wrote the book The Complete Idiot’s Guide to the Anti-Inflammation Diet. His bottom line is that the basic anti-inflammatory diet is very close to the Mediterranean diet – fish, olive oil[15], plenty of vegetables and whole grains, and a modicum of wine to wash it down.
Dr Bereliani doesn’t think that’s anywhere near enough. He refers to those as “Stage One Antioxidants.” Those may have been adequate in ancient times, i.e., the 20th century, but now that we live in the more dangerous 21st century, those old antioxidants[16] have been eroded and contaminated, in his words, by POPs – “persistent organic pollutants.” Similarly, vitamins[17] C, E, and A, are “solutions of the past.” And as for healthy food, it is simply impossible to eat enough of it to get the “heart-healthy nutrients” we need to combat the “Cardiac Killer.”
But now, the good news!
According to Dr Bereliani, there are three indispensable allies that we can enlist in our defense. He beats around the bush a good deal before naming these, but we’ll go right to the payoff. The first of these is pyrroloquinolone quinone, or PQQ. This substance is found in all plants, particularly in parsley, green peppers, kiwis, papayas, and tofu. Dr Bereliani does not bother to repeat the obvious point that we can’t live off those foods, or get nearly enough of them to supply us with the needed amounts of PQQ. What does PQQ do? The clearest statement that I have been able to find is that it may protect brain cells against oxidative damage under special circumstances, such as when blood flow is restored to the brain after a stroke. In bacteria, it has been observed to promote the generation of mitochondria. PQQ has been the subject of considerable research – PubMed lists more than 800 published papers about PQQ, but the overwhelming majority are animal studies, and not directly involved in prevention or treatment of any disease or condition in humans. Only six papers connecting PQQ with cardiac disease are listed in PubMed, and only one of those is about the potential use of PQQ in humans, referring to PQQ as “a novel biofactor for which a proposition can be made for physiological importance.” The paper goes on to mention that PQQ has been tentatively identified as a component of interstellar dust. So at least we know it’s been around a while.
The second Cardiac Killer antagonist is n-acetyl cysteine, or NAC, which is a very slight modification of the amino acid cysteine. It has been used as a drug for a long, long time. PubMed lists nearly 17,000 published papers about NAC, and they go back a long way – the earliest listed paper dates to 1933. NAC is a standard treatment for acetaminophen toxicity leading to liver failure, although it produces fairly significant adverse effects when taken after alcohol consumption. This is a serious complication, since it’s frequently the combination of chronic acetaminophen and regular alcohol consumption that causes liver damage. NAC is also used in the treatment of influenza[18], chronic obstructive pulmonary disease, and helicobacter pylori, which is the micro-organism implicated in gastric ulcers. There is a certain amount of controversy regarding NAC and pulmonary arterial hypertension – it may be useful in treating this condition, but at very high doses (in animals) it appeared to contribute to it.
In terms of the activity of NAC in cardiac health, it does appear to affect genes involved in oxidative stress[19], which is a factor in the creation of vulnerable plaque, i.e., the Cardiac Killer. The chief benefit of NAC, however, is that it replenishes glutathione, which is a naturally-occurring antioxidant in the body. Dr Bereliani and Princeton Nutrients do not promote glutathione as a supplement, although plenty of other supplement manufacturers do. That’s because it’s much more effective, and much cheaper, to boost glutathione levels by means of NAC supplementation. And, according to Dr Bereliani, another benefit of glutathione is that it recycles PQQ, so NAC and PQQ are a good Cardiac-Killer-fighting team.
And the third hero in this epic struggle is a familiar one – coenzyme Q-10, usually stated as CoQ10. This substance is found in every cell in our bodies, and is indeed a powerful antioxidant. There are indications that CoQ10 confers benefits in a number of cardiac conditions. Persons with higher levels of CoQ10 who have heart attacks appear to be less likely to have subsequent heart attacks. CoQ10 levels seem to be – at least in some individuals – inversely related with serum cholesterol levels, and may mitigate some of the adverse effects of statins such as the muscle aches that many statin users experience. That substance may also reduce blood sugar in persons with diabetes[20].
There has been considerable clinical research into CoQ10, although not nearly as much as with NAC. There are more than 3,000 papers listed in PubMed that mention CoQ10 as an antioxidant, but very few are actually clinical trials in humans. A Cochrane review identified six trials in 218 participants as well as five ongoing trials. In two trials evaluating the effects of CoQ10 on blood pressure, one (in 20 subjects) found a significant lowering of systolic blood pressure with CoQ10 supplementation; the other found no difference. One trial evaluating the effect of CoQ10 alone on serum cholesterol found no effect whatever. Of four trials evaluating the effect of CoQ10 with statins on serum cholesterol, three found no effect, and the fourth found a small effect. None of the studies investigated mortality, acute coronary syndromes (e.g., heart attacks, severe angina), or adverse events. (Flowers N et al, Cochrane Database Syst Rev. 2014)
CoQ10 is present in a number of the usual foods, but Dr Bereliani, predictably, scorns the notion that we should try to get enough CoQ10 through diet. A supplement is the only way. However – and here’s where we come to the final clincher in Dr B’s argument – those supplements, whether of PQQ, NAC, or CoQ10, that we can find on the shelves of our drug store or health food store, are not going to do the job. They are past their useful life, or they will be destroyed by the hydrochloric acid in our stomachs, or they are the wrong concentration, or they are spoiled, contaminated, corrupted, and of no value.
But do not give up hope! There is an answer! And by now, we all know what it is. Princeton Nutrients packages a supplement, called VitaPulse, which combines PQQ, NAC, and CoQ10 in the exact proportions that Dr Bereliani claims are the right combination to combat the Cardiac Killer. It gets past the HCl in the gut, and costs $67 per month. But if you put in your order in the next 24 hours, the price drops to $49 for a month’s supply – that’s only $1.50 per day! Dr B. doesn’t specify when that 24 hour period expires, and the offer seems to be perpetually in effect, so let’s not complain about that.
Whether VitaPulse actually does what Dr Bereliani claims is open to question. The Princeton Nutrients website includes the following disclaimer:
Supplement Facts:
Serving Size: 1 Capsule
Servings per Container: 30
Amount Per Serving % Daily Value
CoQ10 100 mg **
N-Acetylcysteine (NAC) 250 mg **
PQQ Na2 10 mg **
(Pyrroloquinoline Quinine Sodium Salt)
** % Daily Value Not Established
Other Ingredients: Silica, Vegetable Cellulose
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
(By the way, for what it’s worth, PQQ is pyrroloquinoline quinone, not quinine. Their typo, not mine. )
The larger question is whether the VitaPulse supplement, or indeed, any of the individual components, confers any genuine benefits with regard to blocking the formation of vulnerable plaque, which is what we’re really talking about. It’s possible, but reliable data is nonexistent. There are tons of testimonials from no doubt sincere and grateful individuals who say that they have benefited from these supplements and from the Princeton formulation. On the other hand, some nutritionists question supplementation with CoQ10 in particular, on the basis that we have no need for this substance beyond what we already have in our bodies.
However, I am not content with leaving Dr Bereliani and Princeton Nutrients with the verdict of “it won’t do any harm and may possibly do some good.”
My view, speaking now as a concerned observer of the entire healthcare[21] scene, is that whether the particular supplement is of any benefit or not, the promotion, and Dr Bereliani’s part in it, does considerable harm. It discredits the immensely valuable research done by the Framingham Heart Study, and, by extension, standard medical research. I will do no more than remind you of the declines in cardiovascular mortality since the appearance of statins – from about 370 per 100,000 population in 1990 to about 250 per 100,000 in 2011. But more important, it minimizes the possibility that important health benefits can be attained through life-style modifications. “Forget about getting enough antioxidants through diet – it’s hopeless!” says Dr Bereliani by implication. It’s like the diet promotions that tell us that we can eat anything we want and as much as we want, so long as we swallow their little pill.
Doc Gumshoe will not swallow their little pill, nor yet, their big scam.
* * * * * * *
A few days ago, the Brookings Institute released startling data. The disparity in life expectancy between rich and poor in the US is growing. Men born in 1950 who are in the top 10% economically can expect to live 14 years longer than men born in the bottom 10%, and for women, that disparity is 13 years. Some of the possible reasons for that huge difference might be that the poor are much more likely to smoke, while the rich certainly do get more and better preventive medical care. But Doc Gumshoe ventures to say that the kind of quick-and-easy miracle remedies touted by Dr Bereliani and his ilk also contribute that disparity. Forget about the advice of the medical establishment and keep right on eating that junk food (and feeding it to your kids)! As long as you take our magic pill, you’ll be okay!
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