Omega-3s during Pregnancy and Lactation

Maintaining optimal levels of omega-3’s is important for all of us, but one population that deserves special attention is women who are pregnant and nursing. The omega-3 fatty acids are critical for optimal brain health and function at all ages of life, but these essential fatty acids play a vital role during fetal development and infancy. Pregnant women have a higher requirement of omega-3s, in particular DHA, because of the rapid cell growth and development of new tissues and organ systems. Optimal development of the brain and central nervous system, the eyes, and the immune system – have all been associated with adequate intake of DHA. In fact, DHA is a major structural fat in the human brain and eyes, representing about 97% of all omega-3 fats in the brain and 93% of all omega-3 fats in the retina. During the last trimester, the fetus accumulates 50-70 mg DHA each day, nearly the same amount that most American’s consume from diet alone. Both the mother’s DHA intake and circulating DHA concentrations are important in determining fetal blood concentrations of DHA. Without supplementation, maternal levels of omega-3s will decrease during pregnancy and will be further decreased when breast-feeding, as the essential fatty acids are also components of breast milk. These nutrients continue to be vitally important for development of the brain during infancy and this is the reason DHA is now added to infant formulas. Babies continue to accrue DHA into the central nervous system until about 18 months of age.

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Fish Oil: It Conveys Much More Than Cardiovascular Health

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Numerous studies have evaluated the effects of the omega-3 fatty acids, DHA and EPA, on cardiovascular health. Overwhelmingly, scientists and clinicians involved in such research believe that omega-3 fatty acids play various beneficial roles in preserving optimal vascular and cardiac health: Anti-Inflammatory, Anti-Thrombotic, Anti-Arrhythmic, and TG-Lowering effects are considered to be the most relevant. Recently, Smith et al. published a fascinating and novel clinical trial looking at a non-cardiovascular yet widespread adverse aspect of aging: muscle mass decline. They published their findings in the American Journal of Clinical Nutrition: Fish oil–derived n–3 PUFA therapy increases muscle mass and function in healthy older adults. All parameters evaluated improved with the administration of 3,200 mg of daily DHA+EPA. Thigh muscle volume, handgrip strength, one-repetition maximum (1-RM) lower- and upper-body strength, and average power during isokinetic leg exercises all demonstrated statistically significant improvement. Improving muscle strength as we age can have far-reaching beneficial consequences that could reduce both morbidity and mortality. Thus, these findings need to be further studied in larger and even more consequential trials. But what additional meaning can we garner from their trial?

I believe that beyond their fascinating and clinically pertinent findings there actually lies a far more evocative message. It is simply that we should be extraordinarily cautious about abandoning the evaluation of therapies (even dietary) when they make biological and physiological sense. Fish oil consumption is woefully low in the US when compared to the far more healthy Japanese population. Our life expectancies are far shorter and various cancers occur more frequently in the US. It is scientifically quite plausible that our deficiency in omega-3 fatty acids plays a significant role in our relatively diminished health. But, after the publication of a few clinical trials failed to demonstrate the cardiovascular benefit of fish and fish oil in select patient populations, some physicians truly abandoned their prior admonitions for patients to augment fish consumption. They were derailed by the controversial results of just a few trials (that many exceptional researchers consider to be flawed in the first place). This type of knee jerk reaction has no place in medicine. It is dangerous and counterproductive. To protect our patients and maintain our scientific integrity, we must always practice with open and attentive minds. Once again I implore my scientific colleagues as well as the oftentimes superficially inquisitive media to follow the science, not the hype.

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Homocysteine and Folic Acid Supplementation: Another Medical “About Face”

On March 15, 2015 JAMA published on line the results of a superbly designed and potentially practice changing trial. The China Stroke Primary Prevention Trial (CSPPT), tested whether or not the addition of folic acid to anti-hypertension medication could reduce the occurrence of a first stroke. As three quarters of all strokes are “first strokes” and as strokes are a leading cause of death and disability worldwide, the question posed by this trial had far reaching implications. The trial met its endpoint so quickly and incontrovertibly that for ethical reasons it was prematurely terminated. Folic acid can reduce the risk of stroke. Those of us who have open-mindedly interpreted prior studies expected this finding; many others found the results to be shocking.

Important homocysteine related trials like HOPE 2 and others had already demonstrated either statistically significant reductions in stroke with folic acid supplementation or at least signals toward such an outcome. Yet many of the most “vocal” researchers, physicians, and reporters proclaimed that since heart attacks were not reduced with folic acid, “the homocysteine hypothesis was dead.” This perspective always bothered me. We had observational and even interventional trial data supporting the use of folic acid in certain settings. And stroke, the disorder we could impact with a simple vitamin, is horrific. Strokes are terrifying, disabling, and deadly. They are also extraordinarily common. So why would these doctors, scientists, and media members snub data supporting a simple and safe vitamin treatment to potentially reduce such events? It would be helpful to know the reason, as the same phenomenon is currently occurring in relation to omega-3 fish oils.

Plenty of data support fish oil supplementation yet a few trials do not. And as with homocysteine, it seems that the media and many scientists/doctors have chosen to focus their attention on the limited neutral – and oftentimes overtly flawed – data rather than supportive experimental, biologic, physiologic, clinical trial, and common sense evidence. Interestingly, one of the vital lessons gleaned from CSPPT is that those individuals with either specific genetic mutations or very low levels of folic acid received the greatest benefit (reduction of stroke) from taking folic acid. In parallel fashion, one of the key trial limitations of fish oil studies has been the persistent failure to measure blood levels of the omega-3 fatty acids DHA and EPA. It certainly stands to reason that those with lower levels of these critical fats will also gain the greatest advantage from their supplementation. So why not simply measure them? Well, in clinical practice, some of us do. And some of us even advise correcting abnormally low levels with simple and safe fish and fish oil pill consumption.

I am at once elated and disturbed by the CSPPT findings. They prove the efficacy of a simple therapy; yet, they broadcast the hubris of many in my field. Time and again we have had to make an about face in our opinions and recommendations. I see nothing inherently wrong in changing our position as more data emerge. What I struggle with is the egg on our face, the about face that occurs far too late, long after adequate data have told us what to do. Perhaps we will learn though. Maybe as more trials like CSPPT emerge, as more scientists and doctors with the conviction and devotion to finding a greater truth push tirelessly along their paths we will finally learn to be more open minded and accepting of ideas and findings even when they go against our grain.

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Hot Off the Press

In medical school we learned about a life threatening form of polydipsia. A subset of patients with schizophrenia consume so much water their sodium can fall to levels unable to sustain life. Twenty liters per day often leads to not just severe illness, but death. How could this be? Water is life’s elixir, and therefore more must be better; correct? Well, simply put, the answer is no. Our kidneys can only handle a water intake of less than one liter per hour. When people exceed this limit, blood becomes diluted; sodium levels fall; and cells swell. As our brain is encased in bone, it has nowhere to go when it swells. Consequently swollen brain cells can lead to permanent damage and even death. It’s not just the unfortunate schizophrenic patients who succumb to such a fate; others do as well. One woman died after drinking six liters in just three hours during a “water drinking competition.” Others have died similarly during college hazing. The point is that a rapid, excessive and unnatural intake of our most vital ingredient for life can kill us in a matter of hours. More is definitely not always better. Aristotle was correct in his dictum of moderation. So where am I going with this you might ask. Let’s consider the most recent “negative” fish oil study by Dr. Voest that was published in a most reputable journal. (For my take on other similar articles please see prior blog posts).

Based upon the fact that some cancer cells can produce long chain fatty acids, Dr. Voest hypothesized that the omega-3 fatty acids in fish could blunt the effect of chemotherapy (such a thought process itself lacks strong scientific validity). Testing his hypothesis he administered 100 microliters of fish oil to 20 gm mice. He was right; fish oil did blunt the effects of chemotherapy. And so his findings were published in the prestigious JAMA Oncology. But let’s look at his study in proper perspective. Ignore the fact that mice are not the optimal animals to study here. Also, ignore the fact that tumor cells produce many substances that have nothing to do with their “desire” to counteract chemotherapy.  Simply examine the administered dose. One hundred microliters of fish oil for a 20 gm mouse is equivalent to 400 ml of fish oil for an 80 kg (175 pound) man. Can you imagine guzzling nearly a half-liter of fish oil? The very thought is life threatening! That’s also tantamount to swallowing around 400 fish oil capsules. Who in his right mind would do that? I’d guess no one. The study therefore has no clinical relevance. The author’s conclusion that patients should avoid fish the day prior to receiving chemotherapy has no basis in science. Yet, the study is on the news; patients are concerned that fish causes cancer; doctors who don’t fully understand this area of medicine will become as alarmed as the patients; doctors’ offices will once again be flooded with unnecessary and distracting queries born of inappropriate trial conclusions; and some people who desperately need to consume fish will place themselves in harm’s way by eschewing vital nutrients. The fallout is, and will continue to be, monumental.

Why such studies are done, and why they are published in top-notch journals eludes me. I understand why the media exploits them; they are fodder for ratings. Still, I will continue to proclaim that such studies must be quelled, and the media must become more cautious. It is fine to conjecture, study, and test hypotheses no matter how outlandish they may seem. What is not acceptable however is perpetuating false conclusions as though they are hardened facts. Such a practice – which is prevalent today – leads both doctors and patients astray and pulls us from important issues, those that can truly save lives and help humanity. Let’s get back on track and re-emphasize honesty in medicine as our prime agenda. Honesty should always trump a good story.

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Beware the Pervasive Reach of Bias – Fish Oil Study Questioned

“Striking a Nerve: Bad Odor to This Fish Oil Study” was the catchy and misleading title for a MedPage headline last week. The “fishy study” to which the cynic refers was published in The American Academy of Neurology. Not exactly a shabby journal. The authors – William Harris, PhD and James Pottala, PhD – erudite and prolific contributors to omega-3 fatty acid research examined the brains of aging women from the Women’s Health Initiative Memory Study and noted a statistically significant association between hippocampal size and omega-3 RBC (Red Blood Cell) levels. In other words, women with low levels of the omega-3s DHA and EPA had more hippocampal atrophy than those with high levels. The importance here is that dementia is frighteningly prevalent (affecting 20% of women) and the hippocampus is likely playing a causal role in its development. Therefore, if we can identify factors – whatever they may be – that prevent hippocampal atrophy, we must pay close attention and examine them further. This is precisely what the authors stated; their findings were encouraging and hypothesis generating. In fact, their final statement, “This study thus adds to the growing literature suggesting that higher omega-3 FA tissue levels, which can be achieved by dietary changes, may hold promise for delaying cognitive aging and/or dementia” does not declare certainty, simply solid hope.

Why then would this study be unfairly condemned? This is a somewhat rhetorical question as I don’t have a clear answer. What I can say with certainty though is that no one should read or listen to an opinion and accept it as fact without first going to the primary source. Everyone would agree this to be true in politics. We must now sadly acknowledge its validity in the world of science as well.

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Omega-3 Fatty Acids and Risk for Prostate Cancer

This article by William S. Harris, PHD was originally published by the Foundation for Health Improvement and Technology’s on the website.

William S. Harris, PhD
Senior Research Scientist, Health Diagnostic Laboratory, Inc. (Richmond, VA)
Professor, Department of Internal Medicine, Sanford School of Medicine, University of South Dakota
President, OmegaQuant Analytics, LLC (Sioux Falls, SD)

On July 11, 2013 a paper was published online by Brasky et al. in the Journal of the National Cancer Institute entitled, “Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial.” The authors found that higher plasma omega-3 fatty acid levels were associated with increased risk for developing prostate cancer. In this study, plasma phospholipid omega-3 levels were measured in 834 men who eventually developed prostate cancer (the time between plasma sampling and diagnosis is not available from the abstract), and 1393 men who did not. Using standard statistical methods, they found that men in the highest quartile of omega-3 had a 43% to 71% increased risk for prostate cancer (depending on severity). This is the same conclusion that the same group reached in 2011 in a study in another cohort entitled, “Serum Phospholipid Fatty Acids and Prostate Cancer Risk: Results from the Prostate Cancer Prevention Trial.”(1) So with two studies reaching the same conclusion, it is important to seriously consider its findings.

I will be the first to admit that had this study turned out the “right” way, I would have embraced its findings and had no criticism of its design or methods. It is disingenuous, therefore, for me to find fault with the way the study was conducted just because I don’t agree with the findings. Nevertheless, we should examine the methods to be clear on the context of the conclusions.

First, the reported EPA+DHA level in the plasma phospholipids in this study was 3.62% in the no-cancer control group, 3.66% in the total cancer group, 3.67% in the low grade cancer group, and 3.74% in the high-grade group. These differences between cases and controls are very small and would have no meaning clinically as they are within the normal variation. Based on experiments in our lab, the lowest quartile would correspond to an HS-Omega-3 Index of <3.16% and the highest to an Index of >4.77%). These values are obviously low, and virtually none of the subjects were in “danger” of having an HS-Omega-3 Index of >8%. In Framingham, the mean Omega-3 Index of participants who were not taking fish oil supplements was 5.2% and for those taking supplements, it was 7.5%.(2) Both of these numbers are considerably higher than the values reported by Braskey et al., even in their highest quartile. Thus, it is extremely unlikely that these patients were taking fish oil supplements. Indeed, the SELECT study (in which all these patients were participants) was a randomized trial of vitamin E and selenium supplements for the prevention of prostate cancer. In the study protocol, it is stipulated that if the subjects wanted to take a multi-vitamin, the study would provide it; nothing is said about fish oil supplements, but it is hard to imagine their use was widespread in this trial.

So to conclude that regular consumption of 2 oily fish meals a week or taking fish oil supplements (both of which would result in an Index above the observed range) would increase risk for prostate cancer is extrapolating far beyond the data. This study did not test the question of whether giving fish oil supplements (or eating more oily fish) increased prostate cancer risk; it looked only a blood levels of omega-3 which are determined by intake, other dietary factors, metabolism, and genetics. The endless repetition of “supplements are dangerous” in the news media is not based on any data from this study.

But even granting that the associations they reported are real, the findings of this study do not mean that EPA and DHA play any role in the development of prostate cancer. Associations do not imply causation. For example, it is possible that some component of whatever fish these patients were consuming was carcinogenic, in which case the serum omega-3 levels were just a marker of fish (i.e., carcinogen) intake.

It is important to put these findings into perspective (which the authors failed to do). First consider the risk of dying from prostate cancer vs. ischemic heart disease (IHD). Based on the National Vital Statistics Report for deaths in the US in males in 2010, (, there were about 28,500 deaths from prostate cancer and 207,500 deaths from IHD: a 7.3x higher rate of death for heart disease. If one assumes (conservatively) that higher fish intake reduces risk for death from heart disease by only 10%, and (liberally) increases risk for death from prostate cancer by 50%, then the chances of dying from coronary heart disease (CHD) are still 4.4x higher than from prostate cancer. This very crude analysis suggests that even in the worst case scenario, the benefit of higher omega-3 intakes/levels still outweighs the risk.

The authors also failed to present the fuller story taught by the literature. The same team reported in 2010 that the use of fish oil supplements was not associated with any increased risk for prostate cancer.(3)A 2010 meta-analysis of fish consumption and prostate cancer reported a reduction in late stage or fatal cancer among cohort studies, but no overall relationship between prostate cancer and fish intake.(4) Terry et al. in 2001 reported higher fish intake was associated with lower risk for prostate cancer incidence and death,(5) and Leitzmann et al. in 2004 reported similar findings.(6) Higher intakes of canned, preserved fish were reported to be associated with reduced risk for prostate cancer.(7) Epstein et al. found that a higher omega-3 fatty acid intake predicted better survival for men who already had prostate cancer,(8) and increased fish intake was associated with a 63% reduction in risk for aggressive prostate cancer in a case-control study by Fradet et al..(9) So there is considerable evidence actually FAVORING an increase in fish intake for prostate cancer risk reduction.

Another piece of the picture is to compare prostate cancer rates in Japan vs. the US. Here is a quote from the World Foundation of Urology*:

“[Prostate cancer] incidence is really high in North America and Northern Europe (e.g.,  63 X 100,000 white men and 102 X 100,000 Afro-Americans in the United States), but very low in Asia (e.g., 10 X 100,000 men in Japan).” (

Since the Japanese typically eat about 8x more omega-3 fatty acids than Americans do and their blood levels are twice as high, you’d think their prostate cancer risk would be much higher… but the opposite is the case.

There is also a wealth of evidence from randomized clinical trials with fish oils in which the incidence of cancer (rarely subsetted) is always tracked as a possible adverse event. The table below shows the findings for the 8 major studies reported to date which included over 78,000 patients. In none of these studies was cancer incidence significantly increased by omega-3 fatty acid supplementation.

Reported incident cancer diagnosis (cancer deaths) Trial    

                                                                n         Dur. (yrs)  Placebo  N-3
Alpha-Omega(10) (prostate cancer)    4,837      3.4              0.8%         1.4%
Heart Failure(11) (cancer death)          6,975      3.9              3.2%         3.1%
GISSI-Prevenzione(12)                        11,320    3.5              2.25%       2.65%
JELIS(13)                                             18,645    4.6              2.4%         2.6%
SUFOLOM3(14) (cancer death)           2,501      4.2              6.5%          7%
Origin(15)                                            12,536     6.2   no difference in cancer rate
Risk and Prevention(16)                      12,513     5                 7.2%         7.9%
Omega(17)                                           3,851      1                 1.4%          1.7

In summary, the work of Brasky et al. does add to the evidence-base for omega-3 fatty acids and prostate cancer, which taken as a whole (not even getting into animal studies which are typically positive) support a neutral, if not beneficial, effect of fish oil in prostate cancer. The RCT data do not support an effect of omega-3 on cancer risk in general, and a 2012 review of omega-3 and prostate cancer concluded, “Thus, epidemiological studies provide inconsistent results, suggesting an inverse association of LC n-3 PUFA.”(18)

There will always be mixed findings in studies of “diet” and “disease” since both predictor and outcome entail so many variables, known and unknown. Higher omega-3 levels are associated with lower rates of death from any cause,19,20 from sudden cardiac arrest,21 and with slower rates of cellular aging.22 The risk benefit for fish oils remains very favorable. Read More…

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A Deeper Look at the Omega-3 Fish Oil Question

man jogging on beach
How many times have we borne witness to the medical recommendations and subsequent reversals and re-reversals of prominent medical societies? In the ‘70s the American Heart Association (AHA) advocated the use of margarine’s hydrogenated oils (trans fats) in place of butter. That, we all now know, was a critical error. The AHA also banned eggs – since reversed – and advocates the use of oils high in omega-6 fatty acids (a recommendation that is currently under significant scrutiny by the scientific community). The AHA has also advised people to eat fish and fish oils. That opinion, still widely held by world leaders in this scientific arena, is now in jeopardy. Last week, Rizos et al published a meta-analysis in the famed Journal of the American Medical Association (JAMA). Rizos findings in a nutshell, omega-3s and fish oil do not help stave off heart disease. There are a number of problems with their trial, but I will limit myself to the two that I consider to be most significant.

First, the statistics. There is a convention in medical science that outcomes are considered to be significant when the p value is < 0.05. In English this means that when the probability that a particular outcome is due to chance is less than 5%, we consider it to be true. A p value of 0.01 (which is less than 0.05) means there’s only a 1% likelihood that a finding is due to chance. This, we consider to be true. On the other hand, a p value of 0.5 means that there’s a 50% possibility that a particular finding is due to chance. We would not consider this finding to be true. You see though, it’s all about possibilities. In reality, we never know that something is true or false, just that it’s likely or not to be true or false. It’s important for you to recognize that our p value designation of 0.05 is considered gospel. Any first year medical student can tell you that. Now consider Rizos’ paper. He performed extraordinarily complex statistical maneuvers and ultimately decided to utilize a p value of 0.0063. That’s correct; he changed convention. By so doing he made the possibility of finding fish oil to be beneficial about 10 times as difficult as it would have been had he stuck to the rules. In fact, had he used a p value of 0.05, the trial would have shown that fish oil indeed does lower cardiovascular death. Instead of the media reporting that fish oil has no value, the headlines would have read, “Take your fish oil. It just might save your life!” That’s because the p value found for cardiovascular death reduction was 0.01, meaning that there is only a 1% possibility that this finding is due to chance, and there is a 99% likelihood it is a real finding! So please don’t stop eating fish or taking fish oil because of this trial’s findings.

Another point of contention is that Rizos described the three cardiovascular benefits of fish oil and omega-3s as: triglyceride-lowering, anti-hypertensive, and anti-arrhythmic. He omitted the two most salient cardiovascular benefits, anti-inflammation and anti-thrombosis (blocking blood clots). He ignored fundamental pathophysiology, an error that I feel can have dire and far-reaching consequences.

In sum, we must not abandon fish oil because of this meta-analysis. So many trials have shown the benefits of omega-3s in myriad medical conditions, such as rheumatologic disorders, cardiovascular disease, macular degeneration, and not least of all, the dementias like Alzheimer’s. Our scientific understanding of the advantages of increasing fish consumption is irrefutable. We cannot afford to repeat the 1970’s misguided AHA initiative for margarine to replace butter. Although doctors on the Today Show and many other popular stations took Rizos’ study at face value and unjustly condemned fish and fish oil, we cannot fall prey to this misinformation.

My advice is to continue your fish and fish oil unless your physician offers a solid reason for you to stop.

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Cholesterol and Vascular Disease Part 5: Non-Statin Cholesterol Medications

Last week, in part 4 of this blog series we spoke about the statins. This week we will look at other cholesterol medications. Another very effective method for decreasing LDL is by combining a statin with other drugs.


  • One of the most effective add-on medications is Ezetimibe. This medicine works by blocking cholesterol absorption in our small intestine. It’s not just the cholesterol we eat that is blocked; more importantly it’s the enormous amount of cholesterol that is recycled daily between our liver and intestine. At this point, clinical trials have failed to demonstrate a reduction in heart attack and stroke by using Ezetimibe. Still, many lipid specialists (me included) believe that future trials will demonstrate its importance in particular patient populations.
  • Another important class of cholesterol-lowering drug is called the bile acid sequestrants. Welchol is the most commonly utilized of these medications. By blocking the reabsorption of bile acids in our intestine our liver is forced to produce more bile acids from their precursor, cholesterol. Interestingly, WelChol also has the added benefit of lowering blood sugar and increasing HDL. Patients with very high triglycerides should be careful of this medication because it can increase triglycerides further. Like Ezetimibe, WelChol is best used in combination with a statin.
  • Niacin, vitamin B3, is also often used in cholesterol management. It’s best known for its impact on raising HDL and lowering triglycerides. Niacin also has an effect on LDL however. It increases LDL particle size, and by so doing, can actually decrease LDL particle number. Niaspan is the pharmaceutical version of niacin that is most commonly utilized by the physicians. It’s method of action is poorly understood and quite complex. Like WelChol and Ezetimibe, niacin is also best used in conjunction with a statin.
  • Fenofibrates represent yet another class of medications that is used for cholesterol management. Their dominant effect is to lower triglycerides and raising HDL. At this point clinical trials have not found them to be effective in decreasing cardiovascular events, but they are improving lipids and lipoproteins.
  • The active ingredients in fish oil, DHA and EPA, can also have an effect on lipids and lipoproteins. They can lower triglycerides, increase HDL, and sometimes increase particle size and by so doing decrease particle number. In patients with very high triglycerides, fish oils can at times increase LDL cholesterol. Their method of action is also quite complex and beyond the scope of this blog.

Diet and Exercise

In managing cholesterol abnormalities we should never neglect the value of diet and exercise.  A healthful diet will unquestionably improve your lipid and lipoprotein profile. Even when taking a statin, a healthful diet must be maintained.  In fact, there is a specific dietary program called the Portfolio Diet that is geared specifically to lower cholesterol. Exercise can also benefit your lipid and lipoprotein profile. Daily exercise for 30-60 min. can significantly decrease your LDL particle number, increase your HDL, and lower your triglycerides. The bottom line, if you’re physically capable, exercise every day.

A few other cholesterol management strategies are either in the pipeline, or utilized only in very high risk patients. They will be the subject of next week’s blog, part 6 in this series, Cholesterol and Vascular Disease.

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