Our “Guardian Genes”: The Modern Doctor’s Holy Grail

Any doctor worth his salt recognizes that patients don’t always respond the way we anticipate they will. For example, utilizing the best of our scientific methodologies we know LDL is causally related to vascular disease. High LDL causes disease while low LDL mitigates it.  Yet, we occasionally see patients with extraordinarily high LDL and no disease, as well as those with very low LDL and severe disease. In some circumstances, patients with a vascular disease promoting mutation – as in Familial Hypercholesterolemia – will have severe and premature heart disease while their relatives with the same mutation somehow remain unscathed. How can this be? What we’ve all come to believe is that there must be protective genes that somehow offset the detrimental aspects of other genes. Let’s dub these desired genes “Guardian Genes”.

In the case of vascular disease promoting disorders, Guardian genes cause the exception, not the rule. They Teflon coat individuals who under normal circumstances should develop heart attacks and strokes. This wonderful rarity can unfortunately lead to a misunderstanding of disease processes as well as their cures. When someone speaks of grandma whose LDL was 300 and yet lived to the ripe old age of 100, sans MI or stroke, the take-home message often is, “Those doctors don’t know what they’re talking about. LDL is not the cause of heart disease. My LDL is only 200 and as grandma lived to 100 and with worse numbers, why should I take that statin medicine. Just look at the Internet and you can see how terrible those medicines are.” Unfortunately the Guardian genes are currently merely speculative. As such we cannot identify them. And, we know that intra-family variability in development of vascular disease supports the notion that theses guardian genes are inherited entirely separately from the disease promoting genes. What that means is just because grandma won the lottery, don’t bet your life (literally) that you did as well. In my own practice I’ve seen 70-year-old parents mourn the deaths of their 40-year-old sons and daughters who died of MIs. Though they shared the same bad genes, the parents did not suffer the unfortunate (and more predictable fate) of their children.

The bottom line here is that we doctors must base our treatment recommendations on the odds. We weigh and measure the pros and cons of therapeutic options (like the statins) against the likelihood that an individual patient will develop a serious event such as a heart attack, stroke, or even death. We use our best judgment based upon many facets of knowledge and understanding. We then make our recommendations hoping to stave off future adverse cardiovascular events. We never risk a patient’s life hoping he or she has inherited a guardian gene. Until we identify the elusive lifesaver guardian genes they will remain relegated to being the modern day Holy Grail of genetics. We all pray we will find them, but until that day we must continue to practice within the limits of our understanding. And while we do, we hope our patients understand that our suggestions and recommendations are born of both a deep understanding of the science of medicine and the burning desire to help our patients live the longest and best lives possible.

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More Evidence that the Hallowed RCT is Just a Demigod

I know I’ve written about this issue before – and I guarantee I will write about it again – but I assure you it is important enough to be discussed until even after it has been resolved. The Randomized Controlled Trial (RCT) has become something greater than life. It is the foundation of all Guidelines; it is the subject of Board test questions; it is the trump card in all roundmanship controversies. RCTs have taken on a power beyond all other aspects of medical knowledge. And I am sure this fact represents one of Medicine’s most perilous errors. Instilling RCTs with veto power across all lines of medical debate has relegated such things as clinical acumen, understanding of pathophysiology, and good old-fashioned common sense to second-rate skills. Endowing the RCT with omnipotence has all but eliminated the need for doctors and other health care practitioners to read extensively and understand the fundamental principals of medicine. Two recent examples plainly illuminate this problem.

In one case, a woman with a history of breast cancer as well as ASCVD finished her fifth year of Arimidex. Should she continue was the question, even though the medication might have been making it more difficult to effectively manage her lipids. No study had resolved this issue and so she decided to discontinue the medication. Troubled by her decision I contacted her oncologist and asked him what his gut suggested we do. He favored continuation of the medication. We listened to his well-honed instinct and simply fought a bit harder to control her cholesterol. Last week she was one of the first to have a test to predict the value of Arimidex continuation beyond year five. It turns out that she has a very high risk of breast cancer recurrence in the absence of drug. In other words, the oncologist’s gut was spot on. Perhaps the decision saved her life.

In another case, a friend recently told me that since our conversation regarding his atrial fibrillation four years ago – when I had suggested he stop drinking seltzer and also increase his magnesium intake – he completely stopped experiencing episodes of Afib. At the time he was having such frequent bouts of arrhythmias that radiofrequency ablation was strongly advised by all his physicians. Fortunately he tried an unproved treatment (which I, an electrophysiologist, had seen work in other patients) and it was entirely effective.  By trying something safe yet unproved, he was spared a potentially life-threatening procedure.

Reflecting on how we all practice medicine, I cannot but acknowledge the fact that most of our decisions are based upon data distinct from what can be found in the RCT. The bottom line: let’s respect and honor that which makes doctors more than just a commodity – our knowledge, instinct, clinical acumen, common sense, and sometimes our depth of caring.

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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The Approaching Medical Maelstrom

The AHA 2014 Scientific Sessions are over and I have already written twice about IMPROVE IT but I feel compelled to write again. Although the media has been oddly silent about the trial (why is that I wonder???), I predict its fallout will greatly impact the disciplines of Cardiovascular Disease Prevention, Clinical Lipidology, and even the essence of clinical practice. The reasons are manifold. First, the trial proved two critical theories: a lower LDL cholesterol level is better, and statins are not the only way to achieve a clinically relevant LDL reduction. Additional key considerations from IMPROVE IT include:

  •  Lower LDL in properly chosen patients (and probably almost everyone) yields lower rates of stroke and heart attack, the two most formidable foes of modern man. For example, in the trial, an LDL of 53 was significantly better than an LDL of 70. Should we doctors then aim for 40, or perhaps even 25?
  • In our high-risk patients should we consistently and continuously add medications to statins in order to drive cholesterol levels lower and lower? For example, in a patient with a prior heart attack is it now fair to accept 70 for an LDL when we know that 53 would decrease our patient’s chance of having a recurrent and potentially life-threatening event?
  • What do we do with the hotly debated 2013 ACC/AHA Cholesterol Guidelines? They eliminated LDL goals and allowed for the use of Zetia only with individualized – and typically time-prohibitive – clinician/patient discourse, but they did NOT encourage driving LDL lower than 70. The Guidelines advocated for an LDL response to therapy of > 50%. So where does that leave our heart patients who start with LDLs of 180, for example. If they achieve the intended LDL reduction of 50% and thereby remain with an LDL of 90 mg/dL the guidelines surely say all is well – job well done. They state there is no indication to go further. Well now there is an indication. Now we can say with certainty that an LDL of 53 is a far better goal than 90. Having an LDL of 90 leaves significant and now manageable residual risk. So then how can a health care provider in good conscience advocate keeping such a patient at an LDL that clearly conveys greater risk?
  • The Guidelines also strongly advocate our utilization of maximum statin doses prior to adding an agent like Zetia. Knowing that higher dose statins produce more side effects while yielding a diminishing return on cholesterol lowering, wouldn’t it now be more prudent for doctors to prescribe low dose statins in combination with Zetia? This would limit side effects while yielding lower LDL levels than would the Guideline recommended approach. More food for thought.
  • How will insurance providers respond to Improve-It’s results? After the ACC/AHA Guidelines’ release, with lightening speed they downgraded access to add-on therapies such as Zetia. Of course that saved them money. So what now? Will they respond in kind, follow the science, and quickly allow patients access to these medications? We shall see but I have my doubts. Profits it seems oftentimes take precedence over science and health.
  • One more crack at the Guidelines for now: It is true that we do not know what represents the optimal LDL cholesterol level in human beings. Based upon our ever-expanding understanding of lipids including our body’s limited need for extraneous cholesterol however, it is safe to say that that level is probably quite low, perhaps even as low as 25 or 30 mg/dL. And, given the fact that many of us are goal-oriented, wouldn’t it now make sense to join our friends across the pond as well as our very learned friends here at home in the National Lipid Association and simply reinstate LDL goals?
  • As I sit at my desk tapping these keys I am clearly frustrated by the politics and economics woven inextricably into the fabric of medical practice. But I am also comforted and encouraged by the knowledge that many of us have already spent the last decade and beyond practicing the way we felt the science dictated. And by so doing, in the matter of LDL-lowering with Zetia, for every 120 patients we’ve treated in an Improve-It style, we’ve saved 3 from enduring a stroke or heart attack. This fact renders all our struggles worthwhile.

On a final note let us not forget that doctors have NO financial incentive to prescribe these medications. Our only “dog in the fight” is protecting our patients from harm. Insurance providers often do have a financial incentive to preclude doctors from prescribing some medicines (typically those that cost them more money). So whom do you, the patients, want to be in control of your medication regimen – the more highly educated and clearly non-conflicted physicians, or the less knowledgeable and often-conflicted insurance carriers? The answer to me seems pretty clear.

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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IMPROVE-IT Proves that with LDL, Lower is Most Definitely Better

The IMPROVE-IT verdict is in and it will change the practice of cardiovascular disease prevention. For the first time, a non-statin medication has been shown to reduce cardiovascular events (including stroke and MI) when added to a statin. Achieving an LDL level of 53 vs 70 by the end of the trial’s first year translated into a significant ASCVD risk reduction. The risk reduction is so substantial that in this patient population the “number needed to teat” was only 50. That means that for every 50 patients treated with Zetia on top of a statin, a serious/life-threatening event was prevented. And, there were no safety issues associated with adding Zetia. Thus, a downside was not present. There are so many ramifications of this trial; I will highlight a few:

  • As believed by most lipid (cholesterol) specialists, lower LDL is definitely better.
  • Ezetimibe should be added to statins in appropriate patients.
  • The hotly debated 2013 ACC/AHA Cholesterol Guidelines now require an addendum adding Ezetimibe to front line therapy.
  • Many insurance companies will have to revisit their denials of Zetia – it has now been shown to be highly effective and must be a part of doctors’ armamentaria.
  • Other emerging medications that dramatically lower cholesterol – the PCSK9 inhibitors and possibly the CETP inhibitors – will likely lower ASCVD events in the right patients.
  • In patients with severe genetically caused high cholesterol – specifically those with Familial Hypercholesterolemia – doctors will try even harder to use varied tools to lower LDL as much as possible. This includes using LDL apheresis, a procedure that has frequently been denied coverage by many insurance carriers, even after experts have testified about its efficacy.
  • We have learned that an understanding of biology and pathophysiology, in the context of clinical experience and careful observation, should not be dismissed solely because of the absence of a large randomized controlled trial (RCT). Though it took an RCT to prove this point, those of us who have been using Zetia religiously for many years have borne witness to its efficacy. We did not need this trial to tell us how important the medication is in the management of ASCVD, but it surely makes us feel better (and a bit vindicated as well). Most consequentially, it is heartwarming to consider the vast numbers of patients we’ve helped avoid experiencing heart attacks and strokes as a result of our well-considered and steadfast convictions.

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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IMPROVE-IT Trial: the Day of Reckoning Approaches

Tomorrow morning a large crowd will gather here at the AHA meetings in frigid Chicago to learn the findings of the long-awaited IMPROVE-IT trial. The trial will demonstrate whether or not Ezetamibe (Zetia) added to a Simvastatin (Zocor) successfully decreased cardiovascular events in high-risk patients.

Many lipid specialists and cardiologists, myself included, have used Ezetamibe in combination with statins since the drug’s release. We believe wholeheartedly in the “lower LDL is better” hypothesis. Our clinical results, though anecdotal, have been uniformly exceptional. We fully anticipate that – barring confounding circumstances – the trial will be a winner.

Making this prospect even more impactful is the current NEJM publication by Dr. S. Kathiresan, (a brilliant Harvard Cardiologist/Geneticist) describing a novel genetic mutation that decreases LDL cholesterol, and concomitantly reduces ASCVD events. Where is this mutation you might ask: In the same receptor that is blocked by the drug Ezetamibe. Essentially individuals bearing such a mutation are born with the equivalent of continual Zetia use. This experiment of nature surely supports the speculation that Ezetimibe effectively lowers heart disease, even on top of statin therapy.

For now, we can only speculate about IMPROVE-IT’s findings. Tomorrow will bring some hard facts along with an assessment of how the findings will impact not only doctors’ use of Ezetamibe, but equally importantly, how health insurance companies will view the matter as well. Until tomorrow my admittedly unbiased fingers will be tightly crossed.

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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IT’S A MAD WORLD

Last week’s The Voice brought us a superb rendition of the timeless song Mad World which emotionally depicts collective adolescent angst. Mad World to me however conjures feelings about our modern world, besieged by increasing racial and ethnic strife, both of which are continually fueled by those who should instead be squelching the consuming conflagration. Writing a blog limits my ability to comprehensively analyze this issue so I will mention just two problems that clearly are being fueled by either the ignorant or the malevolent.

The first is racial division. No one can honestly deny the growth of this destructive force. Many examples could be cited and hypotheses rendered but watching the news last evening I was struck by a single worrisome observation. Apparently the upcoming senatorial elections are not only consequential, but also nail-bitingly close. So both sides are doing whatever they can to mobilize their troops to vote. It certainly makes sense to do so. What struck me though was listening to African American Democrats at all levels of power emphasize the need to mobilize the black voters. The black vote they say is nearly uniformly Democrat and therefore they must encourage them to vote. What strikes me is the notion that African Americans are being bundled into a singular stereotyped group by those Blacks currently holding elected office. Are ALL Blacks really the same? Shouldn’t Blacks be recognized to have disparate views independent of their skin color? I know Black doctors, lawyers, engineers, scientists etc. Are we to believe they all hold the same political stance? The answer of course is no; they do not. Imagine if you heard the white politicians calling Whites out to vote – the notion would not only offend Blacks and Whites alike; it would also be terribly misguided. So, how do the African American politicians calling for Blacks to vote not see they are marginalizing the Black Race? If I were Black, I would be appalled by their supplications. I would also recognize their actions to foster, not fix racial divisiveness.

The second issue concerns growing Anti-Semitism. Recently a relative called me to express her concern about a bumper sticker saying “Boycott Israel”. There are so many examples of Anti-Semitism here and abroad, some restricted to verbal abuse, others physical. Let’s just look at the Boycott Israel notion. I would suggest that anyone supporting such a stance should lead by example. That would mean you couldn’t have a colonoscopy as the Israeli’s invented the camera used in that procedure. You couldn’t have a capsule endoscopy – they invented that too. If you have Multiple Sclerosis you’d probably have to abandon your medication and if you were a paraplegic you’d have to abandon your device that helps you walk. Yes, the Israeli’s invented those medical marvels too. If you like your flash drive; oops, that’s got to go; and if you like text messaging, sorry you better stop – Israeli’s again. The list of Israeli inventions is nearly endless and if you add Jewish inventions you might as well stay home and raise your own food and build your own appliances. In fact, you won’t be able to go shopping at all because a Jew invented the barcode. The point is that before you spew racial or ethnic derision, get educated. Know what you’re talking about and if what you’re saying is based solely on bigotry; try staying silent.

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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The 2014 FH Global Summit – An International Meeting of Minds and Hearts

On October 13th the world’s “who’s who” in FH research and patient care convened in an oddly elongated New York City hotel meeting room. For two days the group shared novel information, spontaneous ideas, well-conceived proposals for future research, and even heart wrenching stories from a handful of brave and resilient FH patients.  Windowless room notwithstanding, leaders from the Netherlands, South Africa, Australia, Chile, Russia, France, Sweden, Oman and the US uniformly basked in the bliss of a mutual goal, raising awareness and improving treatment for this far too common and oft-unrecognized disease.

Some of the highlights included a one-year review of the FH Foundation’s CASCADE FH Registry. We were all pleased and proud to learn that the Registry had surpassed its forecast goal by over 30% (Actually by over 400% of a more modest prediction). We travelled the world identifying FH “Gaps Across the Globe.” During this session leaders from diverse nations compared and contrasted barriers to care, offering useful methods to hurdle such obstacles. We heard from a continuum of clinicians – internists, lipid specialists, endocrinologists, cardiologists, and gastroenterologists – as well as PhDs occupying a wide range of disciplines. To say the conference was comprehensive fails to express its exceptionality. It was a time apart from other times, a transcendent growth opportunity for all those fortunate enough to be in attendance. It will surely serve as a solid springboard for meaningful clinical collaborations throughout the next year.

In sum, the 2014 FH Global Summit was so spectacular it will be hard to surpass in 2015. However, considering the passion and energy shared by members of the FH Foundation and colleagues across the globe, I feel safe in predicting that 2015 will exceed even the extraordinariness of this year’s event.

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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September 24th is National FH Awareness Day

the FH Foundation

Join us for the FH Foundation Tweetathon @ #KnowFH 2PM EST September 24th

    • Familial Hypercholesterolemia (FH) is a genetic disorder
    • FH results in very high LDL cholesterol levels
    • FH results in a 20x increased risk of heart attack
    • FH causes premature heart disease
    • FH begins in utero (before birth)
    • FH is woefully underdiagnosed: < 10% of FH patients diagnosed in US
    • About 1 in 200 people have FH
    • FH can be diagnosed by your HCP
    • If you think you have FH, go to www.thefhfoundation.org to learn more
    • Find an FH expert at the FH Foundation
    • Diagnosis is the first step toward treatment
    • Treatment can stop heart attacks
    • Treatments are available
    • Learn more about FH: Join us on September 24 at 2PM EST

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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A Warning During National Cholesterol Education Month

The Internet teems with self-proclaimed experts in every discipline. They exercise free speech saying whatever they choose, ignoring all consequences. The freedom to speak one’s mind is a right that can never be eroded; yet it must be wielded with responsibility and intellectual honesty. And herein lies a pervasive problem. People who know very little are saying an awful lot. In the case of cholesterol, erroneous information can lead to unnecessarily dire consequences – heart attacks, strokes, and even death. Let’s look at LDL, what we know to be true and what we also know to be false.

LDL is a lipoprotein particle that carries cholesterol in our blood. Cholesterol requires such a transporter, as it would crystalize without it. (Knife-like crystals would then literally tear apart the linings of our blood vessels. Not a pretty image!) LDL’s main purpose is to deliver its cargo, leftover cholesterol, to our liver for disposal. It does not – I repeat, it does NOT – carry cholesterol to any other part of our body to be used for beneficial purposes. But many on the Internet say otherwise. They use our body’s undeniable need for cholesterol as evidence that LDL is necessary for brain health, hormone production, and optimal cellular function. And yet there is absolutely no evidence to support their claim. They state that lowering LDL with medications like the statins can lead to dementia and general cellular dysfunction (among countless other things). Their contention is that lowering LDL will leave our cells starving for cholesterol. Again, there is no evidence to support this. And, what they neglect to tell their readers is that every cell in our body has the capacity to make its own cholesterol. So if levels become too low, cells turn up their cholesterol-manufacturing system and create as much as they need. These charlatan fear-mongers also fail to let their information-craving audience know two essential facts. First, LDL undeniably causes vascular disease. And second, statins have unequivocally been shown to reduce heart attacks, strokes, and death.

Supporting the first fact are century-old trials that validate the causal relationship between LDL and cardiovascular disease. But the most compelling information has come on the scene only just recently. Proof positive (to the best of our current scientific capacity) comes in the form of Mendelian Randomization studies (MR studies). These studies use the random assortment of genes during the process of reproduction to eliminate what we call “confounders”, conditions that falsely produce findings while oftentimes going unrecognized. MR studies are actually nature’s superior form of Randomized Controlled Trials (RCT), the bedrock of modern science. And, to date, every LDL MR study has consistently shown that LDL is more than simply associated with cardiovascular disease; it is a major cause. Patients with genetically low LDL are protected from disease, while those with genetically high LDL, such as Familial Hypercholesterolemia (FH) patients, are besieged by disease.  In sum, high LDL is bad. Don’t let anyone tell you otherwise.

The second fact is also backed by innumerable studies and clinical trials. Statins – when given to the right patients – decrease heart attacks, strokes, and death. Statins save lives. Again, please don’t let anyone try to convince you otherwise. As to who are the “right” people to receive statins, we have guidelines to help us decide, but the ultimate decision is one that should be made between patient and physician.

The bottom line, whether it is with LDL or any other serious issue we strive to understand, we must all be very careful about our sources. My credo is to always find a primary resource. In the case of LDL, read and listen to the real experts, those who spend their lives understanding the issues with the sole goal of helping patients become healthier and live longer, better lives.

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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The Joyful Luxury of Bringing Home a Puppy

The world is under siege.  Muslim extremists in Iraq are “cleansing” the hijacked country of the world’s most ancient Christians. Men, women, and children are being slaughtered, after they’ve been tortured and raped. Jewish teenagers are being kidnapped and executed by similar extremists; people are being beheaded in city streets. These are the same missionaries of terror that pierced our false sense of security, destroying our towers and the thousands of innocents within. Our civilized world is unequivocally in peril. A return to the dark ages is at our doorstep.  Some say there is nothing to fear; it’s a minority who are at the source of this evil. Yet a minority can create catastrophic consequences. Witness the horror of Nazi Germany. And, a “minority” in the world of Muslims is likely well upwards of 200 million people. This is a minority in truth, but one demanding our unwavering attention and concern.  So how does a puppy fit in this story?

Yesterday my wife fell in love with a nine-week-old puppy. We had recently lost a dog to a sudden splenic rupture from cancer and in truth I believed it would be a long time coming before my wife would open herself up to another similar love. But I was mistaken. She informed me of her find and I immediately knew another dog would be coming home. I was sold on this notion with a simple question, “Isn’t this what life is supposed to be about?” Irrefutable. Life should be about love and puppies and the luxury and freedom to enjoy both. As a Preventive Cardiologist I couldn’t deny both the emotional and physical salutary impact of smiles and laughter engendered by the presence of a simple pup. Then I considered those in other parts of the world; Christians, Jews and non-radicalized Muslims fleeing and dying at the hands of terrorists. These individuals cannot enjoy the American luxuries of which I speak. We are a nation of fortune; but this fortune was built on the selfless sacrifices of our fathers and forefathers. Freedom is not an easy thing to gain but I fear it is quite easy to lose. Understanding this, we must be hyper-vigilant about safeguarding it. Yet its nemesis nips at our heels. Political correctness aside, when critically and honestly examining the world one must acknowledge there is but a single group that seeks to dominate all others. Yes, a minority threatens us, and most of the world abhors the actions of this minority. The minority, however, is fierce, brutal, enormous, powerful, determined, and patient. They will have their way if we do not face and stop them. If we fail, love and puppies, and other often-unappreciated freedoms will become our memories, and the dreams of future generations.

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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