Response to “A New Gender Issue: Statins” an Article by Roni Caryn Rabin

There appears to be an endless supply of medically related stories in the lay press that serve nothing more than to create mass misunderstanding of science and medicine. Surely their provocative messages sell papers and airtime. But they have an often-ignored downside as well. Tuesday we saw another such article. In the New York Times’ Rabin piece, a prevalent fear of medications is fueled, and the integrity of a prominent physician is impugned. (Full disclosure – I too unabashedly receive compensation from pharmaceutical companies for consulting and educational purposes.) Statistics are cited; the quintessential anti-statin doctor is quoted; and fabricated conclusions are rendered. The science of statin therapy is much too complex for a single cursory article to do it justice. In fact, entire conferences are devoted to the subject matter. And yet a sweeping conclusion – with potentially devastating ramifications – has again been made. Women reading this article will do what one would expect, either discontinue their statins on their own, or hopefully discuss such an action with their doctors prior to doing so. The article is meant to be terrifying, citing exceedingly rare muscle complications and referring to an unproved complication of statins, memory loss. So much is left unconsidered. For starters, the ACC/AHA risk scoring system cited by Ms. Rabin likely underestimates, not overestimates, CVD risk in women. And, as the leading cause of death in US women is cardiovascular disease, we do not want to make the mistake of under-evaluating and under-treating this segment of the population.

Today in the office I saw a young woman who suffers from premature heart disease that would not have been detected or appropriately treated had the guidelines been followed to a tee. Yet her coronaries have been non-invasively imaged; significant disease was detected; and yes, statins are being utilized. As a result, her life may very well have been saved. Doctors must be able to think and act with fluidity, moving both within and beyond the guidelines, in order to render the best care we can. Articles such as Ms. Rabin’s serve solely to diminish our ability to do so.

To demonstrate more clearly why we need to drastically broaden – not shrink – our efforts to identify and treat cardiovascular disease in women here are a few chilling and sobering statistics:

  • Women are 15 times more likely than men to die within the year following a heart attack.
  • Women with angina have twice the morbidity and mortality as men with angina, even in the absence of obstructive coronary artery disease.
  • 64% of women dying suddenly from heart disease had no prior symptoms.
  • Women under 50 are three times as likely as men under 50 to die after a bypass operation.
  • Marriage decreases cardiovascular risk in men, yet increases it in women (a frightening statistic, yet one that provides fodder for some excellent jokes).

Other similar statistics abound. The point is that we unambiguously understand that women are at great risk for heart disease. Sadly though, we currently have inadequate clinical trials assessing their risk. The appropriate answer is to fight even harder to identify and treat women at risk. It is not to dismiss our vast and growing understanding of the salient role cholesterol plays in the genesis of cardiovascular disease. It is not, as this article implies, to withhold a medication that has done more to thwart heart disease than any other therapy in the last century. I entreat all in the press to be more circumspect and responsible in your reporting. You have a great influence on your readers. Please wield it with caution.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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ConsumerLab Approval: A Brief Boast about VitalOils1000

couple bike riding

I make it my practice not to blog about VitalRemedyMD or any of its products, but this week demands a self-promoting shout-out. VitalRemedyMD is a company I started over ten years ago. It is now owned and operated by my wife (Laura Baum – also an MD). VitalOils1000 was created about six years back as the first and only enteric-coated fish oil pill to contain a full 1,000 mg of combined DHA and EPA. Thus, VitalOils1000 was the first omega-3 fish oil to meet the American Heart Association recommendation for individuals with cardiovascular disease in just one pill. This fact holds true even when considering prescription fish oil.

Yesterday we made the grade again. On April 6th ConsumerLab.com, the preeminent watchdog of the nutritional supplement world, released their every-other-year study of omega-3 fish oil products. Once again VitalOils1000 was “approved.” This year, in addition to “proving” our purification, concentration, and quality of enteric coating, we were also tested for PCBs and Dioxins. We were one of only two products tested in this comprehensive fashion, and we “passed” this important criterion as well. Our purification process of supercritical fluid technology enables us to achieve these exceptionally high standards for safety and purity.  There is so much confusion about omega-3 products that I felt compelled to write about our continued success with VitalOils1000. Needless to say, I am very proud. Thank you for permitting me a moment to boast.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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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.

Learn more about comprehensive preventive cardiology at preventivecardiologyinc.com

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A Walk on the Beach

Florida beach sunrise

Whenever feasible my wife and I enjoy a walk on the beach. This weekend was spectacular in southeast Florida, perfect for a peaceful, health-promoting amble upon a welcoming bed of sand. The ocean was obliging. The air carried a salt water scent and the breeze kept us comfortable as we strolled during the sun’s rise. Then it happened. The pungent odor of cigarette smoke invaded our space, instantly driving away our much-needed bliss. We looked at each other wondering who could possibly smoke at the beach. After all, the beach is meant for physical and mental salubrity. It is nature’s place; it is the embodiment of our reconnection to our roots, the birthplace of humanity in fact. How could someone mar this place and what would that someone look like?

Sitting by the shore, two young parents – accompanied by their three castle-building children – puffed continuously on their cigarettes. Walking thirty-plus feet from them, my wife and I could barely tolerate the smoke they emitted. Imagine then how much smoke their kids were inhaling! We know from countless studies that second hand smoke is deadly. In fact, every year approximately 40,000 Americans die as a consequence of second hand smoke. And, in view of our focus on healthcare dollars, we cannot ignore the extraordinary financial toll tobacco takes on our economy. Money is one thing. Offending my wife’s and my sensibilities and putting us at risk is another. Even more consequential though is the fact that these parents were unwittingly (I hope) putting their own children in harm’s way. Is this child abuse? I would argue it is. The data are irrefutable. Tobacco in any form – smoked, chewed, sniffed, or even involuntarily inhaled – can kill us. And, death aside, the immense cascade of hostile chemicals caused by tobacco and nicotine are terrifying. That being so, how is it not child abuse to subject one’s offspring to an ongoing and deadly threat? So while healthcare reform stares us unblinkingly in the eyes, let’s not neglect some of the most obvious and profound changes we can legislate. Let’s honestly and fervently take on the tobacco issue. Make smoking in public illegal. Make smoking in the presence of children illegal. In this situation let’s not get sidetracked by issues of civil liberties for the tobacco abusers. If they want to smoke in private, that’s okay. But, they are killing the rest of us. That is simply unacceptable.

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WomenHeart: a leader in our fight against heart disease in women

woman jogging at sunrise
Today I’m traveling to Washington DC in order to attend the 13th Annual Wenger Award Ceremony. The celebration is hosted by WomenHeart: the National Coalition for Women with Heart Disease. Honorees will include The Honorable Debbie A. Stabenow, U.S. Senator, State of Michigan; Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research and Quality (AHRQ); Abbott Vascular: and Rita Redberg, M.D., M.Sc, the Editor in Chief of the Archives of Internal Medicine.

For me, the event promises to be very exciting; after all, I will have the opportunity to communicate with some of the most important leaders in the national initiative to understand and thus prevent cardiovascular disease in women. But the event means much more than that.  It represents the great strides that are being taken to finally identify and distinguish important aspects of cardiovascular disease between the sexes.

Until about 10 years ago cardiovascular disease was felt to be a man’s problem. We have grown to understand that women too are plagued by this Leviathan of ailments. In fact, cardiovascular disease is the leading cause of death in women, outstripping even breast cancer by 11-fold. Women have differences in their cardiovascular risk factors, their symptoms, and their response to treatments, both invasive and non-invasive. Physicians must learn to evaluate and treat women differently from the way they do men.

The American Society for Preventive Cardiology (ASPC) is also doing its part to “spread the word”. On July 12 and 13 at the spectacular Boca Raton Resort, the ASPC will host its Second Annual Women’s CVD Prevention Conference. Last year was a great success and this year promises to be even better. Sponsored by Boca Raton Regional Hospital and endorsed by such organizations as WomenHeart and Go Red for Women, doctors and physician-extenders will be taught by the best of the best. Professors from Harvard, John’s Hopkins, Duke, the Mayo Clinic, UCSD, Emory, and other prestigious universities will come together in Boca Raton in order to teach clinicians practical aspects of managing their women patients.

The conference, which I will be chairing, is an unprecedented venue for clinicians to elevate their management of cardiovascular disease and its risk factors in women. I would highly encourage practitioners from around the country to attend. To learn more about the program, and sign up for attendance please visit aspconline.org. I promise you will not be disappointed.

Please read more about preventive cardiology at www.preventivecardiologyinc.com.

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National Go Red Day – February 1st


In celebration of the American Heart Association’s 10th year helping women fight heart disease through their Go Red movement, men and women across America are being asked to stand together and wear something red on February 1st. This may seem like a silly concept, but solidarity and awareness are often needed to eradicate a foe. And make no mistake about it; heart disease and stroke represent a terrible adversary for women, even more so than for men. A few frightening and light-shedding statistics are:

  • Women are 15x more likely than men to die in the year following a heart attack
  • 64% of women dying suddenly from heart disease had NO prior symptoms
  • Congestive Heart Failure in the setting of a normal pump function is much more common in women than men… and we don’t know how to effectively treat this
  • Women under 50 are 3x as likely as men to die after a heart attack or bypass surgery
  • Marriage decreases cardiovascular disease risk in men but increases it in women!
  • Risk factor scoring and “traditional” risk factors fail to adequately identify women with Cardiovascular Disease
  • And to make matters even worse, diagnostic testing for heart disease  is less accurate in women than in men

And so I believe it is only fitting for us all – men and women – to band together on February 1st and simply wear Red.

photo credit: Go Red for Women

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Preventive Health News

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The Cardiovascular Disease Taskforce Calls for Urgent Action

The CVD Taskforce, a group of eminent experts who represent five leading heart-health organizations, has published a paper calling for urgent action to reduce premature mortality by 25 percent by 2025. The Taskforce paper is released ahead of World Heart Day on September 29th, when supporters worldwide will rally in support of healthful homes and countries, with a particular focus on the lesser-known CVD risks for women and children.

The Paper recommends a set of ambitious global targets to curb the growing incidence of non-communicable diseases (NCDs), which includes cardiovascular disease (CVD – heart disease and stroke). The new targets and recommendations are critical components in the effort to prevent millions of premature deaths worldwide.

The Taskforce is calling on governments and the CVD community to accelerate progress on the commitments made at last year’s United Nations High-Level Meeting on NCDs, announcing support for 10 evidence-based targets. The first step in this program, agreed to at the 65th World Health Assembly in Geneva this past May, was to set a global target to reduce premature deaths from NCDs to 25 per cent by 2025.

Additional targets to achieve by 2025:

  • A 10% relative reduction in the prevalence of physical inactivity in adults aged 18+ years
  • A 30% relative reduction in prevalence of tobacco abuse
  • A 30% relative reduction in mean adult (aged 18+) salt intake, with the ultimate aim of achieving a recommended consumption level of less than 5 grams (5,000 mg) per day
  • A 25% relative reduction in the prevalence of high blood pressure

Other CDV-related issues and behaviors targeted include fat intake (saturated and trans-fatty acids), cholesterol, obesity, excessive alcohol intake, and the wider use of drug therapies and essential medicines to prevent and treat CVD.

“The number of people with CVD is growing and its impact is disproportionately felt by those in the developing world, where people die younger; we now have the opportunity of a lifetime to stem its rise with concerted international action that will help countries tackle the preventable causes of CVD,” said Dr Sidney C. Smith, Jr (World Heart Federation President and Chair of the writing group).

With cardiovascular disease currently costing governments nearly $863 billion globally, the Taskforce recommends a set of interventions designed by the World Health Organization and designated as “best buys” – cost-effective treatments that can be delivered regardless of the income level of a country. These include the widespread adoption of multi-drug therapies that could save nearly 18 million lives over a 10-year period, at a cost of just over a dollar a day.

“Cardiovascular disease risk can be lowered by public policies that help people to make healthier choices. This set of robust targets can focus governments’ efforts on this vital task and make progress measurable,” said Dr Ralph Sacco, Past President of the American Heart Association.

Sources: EurekAlert and the World Heart Federation

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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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