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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The Glory of Gum – A Smoker’s Tale

Recently, on a medical sojourn, I was met at the airport by a garrulous woman driver. She was a young-appearing fifty year old who as it turns out had recently sustained a TIA, or “mini-stroke.” Although my first thought was atrial fibrillation, she actually had developed a near occlusion of her left carotid artery. Her right carotid artery, she informed me, had a mere 40% stenosis. Our discussion continued and I gleaned that she had a very strong family history of early onset vascular disease, several close relatives even dying quite young from their events. So my next thought was Familial Hypercholesterolemia. But no, her LDL was apparently normal. Then she fessed up. She had been – and continued to be – a smoker. Just like everyone else in her family! Shocking.

To smoke cigarettes nowadays is something I simply cannot wrap my head around. Cancer, stroke, heart disease, lung disease, wrinkles… Tobacco is devoid of any redeeming quality. It’s just plain bad. So why would anyone smoke in the first place? But, once an individual has experienced a near death event that is a direct consequence of tobacco, how in the world could she continue to smoke. My 40-minute drive took on a mission. I was going to get her to quit. I asked about her children and even grandchildren. We spoke about loss of limbs, dependence upon an oxygen tank, facial cancers and their attendant disfigurement, another stroke – the next one of course placing her in a wheel chair, unable to speak or care for herself. Then she dropped me at my destination. She was to pick me up several hours later. Before stepping out of the car I told her with stern authority that a cigarette should never again cross her lips. Chew gum I said. Gain weight if you must, but please don’t ever come near another cigarette. (I must confess; my tone was intentionally severe and perhaps even paternal. The impact I hoped would justify my behavior.)

I went through my day, completed my tasks, and eagerly awaited her return. Upon her arrival she stepped from the car and proudly and loudly through a mouthful of gum intoned that she had done it. She quit smoking. I am not certain whether her resolution will last an hour or a lifetime. For that moment though she was no longer a smoker. A gum chewer yes, but not a smoker.

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The National Lipid Association – A Glimmer of Hope

The field of Medicine is undeniably in turmoil. Patients are unhappy with long wait times in doctors offices coupled with ever shortening visits with their physicians. Doctors are dismayed by their unprecedented spike in “busy work,” instigated predominantly by insurance companies and governmental mandates. The fallout from more time spent on paperwork is of course less time spent with patients. There are after all only 24 hours in a day.  So it is eminently fair to say that neither doctors nor patients find themselves happy with the current course Medicine is following. Oftentimes outlooks are so bad that many of us in the field feel there is no hope. In essence we believe the battle has been lost; there is no chance of recovery.

Enter the National Lipid Association (NLA). Currently boasting over 3,000 active members, the NLA is a group of diverse doctors, nurses, dietitians, scientists, and exercise physiologists whose governing goal in participating in the organization is to improve healthcare. I just returned from the 2014 Annual NLA meetings in Orlando Florida and was once again struck by the authenticity of this sentiment. Meetings began as early as 6 AM and extended well into the evening hours. And the seats were not bare. They were filled by groups of highly focused and engaged individuals. Ranging from Cholesterol Guideline discussions, to basic science talks on drugs’ mechanisms of action, to lectures reinforcing the need to amplify our efforts to identify and treat patients with the not so rare but highly lethal disorder Familial Hypercholesterolemia, the topics were fascinating and irrefutably pragmatic. The attendees were riveted. Side conversations were plentiful, including promises of new clinical trials and better ways to help our patients. The pace was quick and the excitement, palpable. All this at a medical meeting!

Although uniformly doctors are troubled by Medicine’s fall from grace, rays of hope were clearly visible at the NLA meeting. Beneath our acrimony doctors, nurses, and others in medicine still have at their core the desire to help. We genuinely want to be the ones who people look to during their oftentimes-darkest moments. We also most definitively strive to keep people from experiencing such grim periods. The best way to achieve these goals is to continuously learn. Curiosity, inquiry, dialogue, knowledge, and caring are the cornerstones of the practice of Medicine. And these are the elements that beat at the heart of the National Lipid Association.

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The Great FH Debate: Reinforcing the fact that “Time is Plaque”

Currently a debate rages in the world of Familial Hypercholesterolemia (FH).  Old school thinking is that this lipid disorder – typically caused by a mutation in one of three genes – is exceedingly rare. The initial teaching stated that the homozygous form (two mutations – one from mother and one from father, HoFH) occurs at a rate of one in a million, while the heterozygous form (one mutation from just one parent, HeFH) occurs at a rate of one in 500. Recent explosions in not only genetics, but also the acquisition of large volumes of patient data have put this prior supposition in question. Now, a recent study published in the European Heart Journal by Sjouke et al truly proves that we have grossly underestimated the prevalence of FH. Examining over 100,000 patients who were referred for genetic analysis, the authors found 74 patients with clinically significant mutations consistent with the homozygous form of FH (HoFH). Being abundantly cautious in their interpretation of data, the authors pared the number down to just 45, from which they conducted a mathematical calculation of the prevalence of FH. (Their minimalist rationale is beyond the scope of this blog, but suffice it to say that had they included all patients, the disease prevalence would be far greater). Their restrained assessment revealed the prevalence of HoFH in an unselected population to be 1 in about 300,000 while the prevalence of HeFH, 1 in 244.

Perhaps more striking and even earthshattering is what the authors discovered about the wide range of HoFH LDL-C levels. Older belief systems had maintained that the LDL-C in untreated HoFH should always exceed about 450 mg/dL. In their comprehensive and novel analysis however, the authors discovered untreated HoFH patients with LDL-C levels as low as 170 mg/dL. 170 mg/dL overlaps not only the HeFH population, but the non-FH population as well. The bottom line here once again is that as in diagnosing all other diseases, clinicians must maintain open minds when diagnosing FH. When considering FH, we must always look for a family history of premature vascular disease, very high LDL-C levels, signs of the disorder on physical examination, and the presence of aggressive coronary artery or cerebro-vascular disease in the patient we are evaluating. Most important is for all clinicians to keep FH on the tips of our tongues. Without considering the diagnosis, we will never make it. And without making the diagnosis, we will never treat it. Early treatment can be life saving so early diagnosis is of course paramount. In no other lipid disorder is the concept that “Time is Plaque” more apparent. FH patients bathe in their own LDL-C in utero and beyond. The longer they remain untreated the worse they do. So let’s think of FH and treat it when we see it. By doing so we can hope to prolong the lives of more than a million people right here in the USA.

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Omega-3 Fish Oils – Misleading and Erroneous Interpretations of Scientific Studies Can Cause Harm

Recent statistics demonstrate a small but pervasive decline in national sales of fish oil supplements. Before I continue, let me make it clear that I have a bias here. In 2007 I formulated VitalOils1000, the first omega-3 fish oil carefully and uncompromisingly concentrated and purified so as to enable the American Heart Association’s recommended 1,000 mg of combined EPA and DHA to be placed in a single enteric coated soft gel.

Now, seven years later, VitalOils1000 still stands alone among a sea of fish oil choices (sorry; I couldn’t resist). Needless to say, I am very proud of that accomplishment. So my conflict is clear; I want people to take VitalOils1000. I believe it’s good for them. In fact – that’s why I designed it. So I am disturbed by the decline in people’s consumption of fish oils. Though the “business” ramification of this decline bothers me, I am far more disturbed by its root cause. Falsely frightened people have crumbled under the illusory conclusions of a few poorly constructed trials and the even-more-poorly constructed conclusions derived by “critics” of these trials.

Consider first the fact that four decades of research spanning bedside to bench and back again have demonstrated the sweeping benefits of the omega-3 fatty acids DHA and EPA – fish oil’s “active ingredients”. That’s forty years of thousands of brilliant minds examining the omega-3 issue from a multitude of vantage points. Forty years of overwhelmingly positive conclusions! Then come a few – and I mean a few – poorly designed studies with at times truly ridiculous conclusions. As with most other aspects of news reporting, the negative draws more readers and listeners than the positive. And so the media ran with the story. Some doctors even jumped on the bandwagon. “Fish oil is not what we thought it was,” they concluded. In response, omega-3 experts from around the world voiced their discontent. But their voices were muted as they failed to resonate with fear. The scientists and doctors spoke with authority and knowledge, devoid of histrionics. And so their side of the story didn’t sell newspapers or airtime. The outcome we now witness is that some people prematurely “drank the media cool aide”. They stopped their fish oils.

The problem is that I and many others in this field are left with the great concern that these individuals have left themselves less well protected against a host of disorders than they had been while taking fish oils. Unless they’ve dramatically increased their fatty fish consumption, they have certainly placed themselves in a relative omega-3 deficient state. Think of this: the average American consumes about 100 mg of combined EPA and DHA daily while the average Japanese consumes eight times this amount. And the Japanese have far lower rates of heart disease and prostate cancer than do Americans. Yet, the scant research behind the omega-3 fear mongering cited concerns about the ineffectiveness of omega-3s in cardiovascular disease as well as the possibility of omega-3s predisposing to prostate cancer.

There are many other plausible explanations for these inconclusive trials (see my blog Throwing the fish out with the fish water is however not called for. And so my conclusion here is once again to read the primary research. Do you own homework – though it may be hard – and decide for yourself what you think is best. If you need help evaluating the literature, look for the opinions of those who are true leaders in this field – William Harris, PhD, Bruce Holub, PhD, Tom Brenna, PhD, Susan Carlson, PhD (not the owner of the supplement company), and Kevin Maki, PhD for starters. There are plenty of others but be sure to listen to the experts.

Sadly we can no longer rely upon the media’s “Medical Experts” to be our source of scientific veracity. They are too busy, and often forced to weigh in on disciplines far removed from their particular areas of expertise. They cannot possibly be expected to know everything about every medical field. I am sorry to leave you with the task of “doing your own homework”, but nowadays it is something we must all become accustomed to do.

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Interventional Prevention – Taking Cardiovascular Disease Prevention to a New Level

In the November 27, 2013 JAMA issue, my letter, “The Pitfalls of Population-based Prevention was published with a very favorable response from Dr. Harvey Fineberg, the head of the Institute of Medicine (IOM). I was elated to see not only the letter’s publication and my introduction of the term, “Interventional Prevention” – a modern-era approach to risk reduction – but Dr. Fineberg’s forward-thinking reply as well. Interventional Prevention is after all a departure from “standard” prevention practices. We typically think of prevention in two facets, primary and secondary.

Primary prevention entails thwarting events before they have occurred while secondary prevention is the system wherein doctors utilize strategies to stop adverse events from occurring AFTER a first event has taken place. For example, hypertension and tobacco abuse are both well-established risks for heart attack and stroke. Our goal as health care practitioners is to lower blood pressure and help patients stop smoking in order to prevent heart attacks and strokes. In patients who have already had one of these events, this is termed secondary prevention; while it is primary prevention in those who have never suffered such an outcome. This describes the established approach to prevention.

Interventional Prevention is a much more proactive process. In this construct, doctors use cutting-edge predictors of risk such as biological markers in our blood and urine and imaging of different vascular beds (carotid and coronary arteries for example) to diagnose “hidden” disease or biologic perturbations and motivate patients to make significant lifestyle and medication changes in order to reduce their risk. Then we can evaluate these same markers and actually see improvements. We can do this in patients who have never had heart attacks and strokes, ostensibly decreasing their risk of ever experiencing such an adverse outcome. In Interventional Prevention, doctors identify and expose novel risks, make changes in patients’ regimens, and then facilitate improvement in what would otherwise have been “hidden” risk factors. Essentially we illuminate the invisible thereby affording patients and doctors the opportunity to heal aspects of our bodies before these perturbations cause irreparable harm. For example, with appropriate interventions we can demonstrate improvement in inflammatory blood enzymes such as LpPLA2. High levels of LpPLA2 predict both heart attacks and strokes while low levels predict the opposite. Through proper interventions we can witness the normalization of this and many other blood and urine biomarkers, clearly demonstrating on an individual basis the improvement in health and concomitant diminution of risk. This is truly patient-centric medicine. The medicine of the future has already arrived.

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New AHA / ACC Cholesterol Guidelines – Controversial but not to be Feared

Last week four guidelines were released by the AHA and ACC. A tremendous amount of controversy surrounded the Cholesterol Guidelines as they deviated in fundamental ways from prior standards. The writers of the guidelines took a strict Evidence Based Medicine (EBM) slant, limiting extrapolation and thereby altering the traditional approach to cholesterol management. For example the format of all prior clinical trials did not specifically address cholesterol goals. Thus they were excluded from the guidelines. That does not, however, mean that it is wrong to continue to try to “get our patients to goal”. It simply means that in the strictest view of EBM, there is insufficient evidence to do so. The American Society for Preventive Cardiology (ASPC, of which I am Treasurer) and several other organizations endorsed the document. The National Lipid Association (NLA) did not. It is critical for practitioners to understand two things when trying to utilize this document as effectively as possible. First, the guideline was meant to be a living work, one that will be updated at regular intervals. Second, and perhaps far more consequential, it is essential that practitioners ardently adhere to a single paragraph from the guidelines which follows:

“Guidelines attempt to define practices that meet the needs of patients in most circumstances and are not a replacement for clinical judgment. The ultimate decision about care of a particular patient must be made by the healthcare provider and patient in light of the circumstances presented by that patient. As a result, situations might arise in which deviations from these guidelines may be appropriate.”

In sum, we most always remember that guidelines are just tools to help practitioners understand the most recent evidence in medicine. They are not laws. Clinical judgment must always reign supreme.

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High Cholesterol Levels – Time is Plaque

In the initial days of thrombolytic therapy (potent blood thinners used to treat heart attack patients) we had a saying that, “Time is Muscle”. The intent was of course to get our patients treated as quickly as possible, understanding that the longer their arteries remained closed, the more heart muscle would be lost. More damage meant worse outcomes. And so we got faster and faster, ultimately treating our patients within minutes of their initial evaluation. This need for speed has been brought into the era of acute interventions, the stents. Now we speak of door to balloon times and all hospitals boasts of their superior swiftness. The faster we get our patients to the cardiac catheterization lab for definitive treatment to stop their heart attacks, the better they do.

Analogous to the situation with heart attack patients, individuals with extremely high LDL cholesterol are now known to develop plaques in their arteries in accord with the duration that they experience their high lipid levels. Some children have such high cholesterol levels starting even from when they’re in utero; they develop heart attacks before the age of five. This of course is quite rare, but it does illustrate the importance of both cholesterol levels and time in plaque formation. For proper prevention we need to adopt a greater sense of urgency, one that embodies our understanding that the longer one has high cholesterol levels, the more likely he or she is to develop vascular disease. In short, we ought to start declaring, “Time is plaque!”

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TCT, a Great Interventional Cardiology Meeting, but Just One More Thing…

Today’s blog post will be brief. The TCT meetings just ended but an essential fact was omitted and should be shared with doctors and laypeople alike. 25% of patients who experience heart attacks before the age of 45 have a common genetic disorder called Familial Hypercholesterolemia (FH). 25% is actually quite a substantial number so it’s important for us to identify and treat these patients appropriately. As the disorder is genetically transmitted, 50% of first degree relatives will also have this disease. That means there’s a 1 in 2 chance that each child, sibling, and parent of patients with FH will also harbor this disorder, a genetic mishap that increases the risk of premature heart attacks by up to 20 fold! The sooner such patients are identified and treated, the less likely they are to ever have a heart attack. So please know your risk!

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Related: more blog articles on the topic of Familial Hypercholesterolemia (FH)

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