Good-by Niaspan. Welcome back Immediate release niacin.

 

One of my clients who has been on Niaspan for 14 years informs me that he has experienced unsolicited advice from many would-be physicians as well as recently trained physicians about the inadvisability of the medication Niaspan. Now this patient had Familial Combined hyperlipidemia with total cholesterols in the 220 range and mildly elevated triglycerides. His ApoB was in the top 5%. For years his total LDL-P has been lowered in the 700 nmol per liter range (bottom 1%) and he has succeeded in reaching the age of 80 without an untoward cardiovascular event. Yet many unsolicited advisors have the chutzpah to make recommendations without benefit of a required medical degree and also physicians with an insufficient experience with this medication. It was noteworthy to hear that at least one of these would-be advisors did recommend particle numbers over the standard lipid panel.

Now the recent generation of physicians who read the flawed and fake AIM-HIGH or HPS Thrive II as if it were Gospel do not have the benefit of the experience nor can they recall the previous trials involving niacin prior to AIM-HIGH or HPS Thrive II, in which the use of niacin had beneficial effects. Now based on AIM-HIGH or HPS Thrive II, how many of you think I should have discontinued niacin in this patient. I know Lipidology lecturers who did exactly that to the point of discontinuing their own Niaspan even though there was not one untoward reaction. After all in reality niacin is nothing but a vitamin. 

It is amazing at National Lipid Association( NLA) meetings to hear the contrast between how old-timers who have had experience with niacin and today’s new generations describe this medication. It is amazing how the pharmaceutical companies with its arm twister, the so-called evidence based medicine trials which apply to very  few in the clinical world, can control the thinking process of the great majority of today’s recently trained physicians and even some old-timers.

Recently the price of Niaspan has shot out of sight reaching up to $700 or more for a 30 day supply of 1000 mg  which is directly an abuse perpetrated by our pharmaceutical corporations and their control of the medical delivery system. On the brighter side with regard to Nisapan, there is a much cheaper alternative i’e. Immediate release niacin costing a little over $8. for #100 500 mg tabs. Because of the gouging by the pharmaceutical industry allowed by our medical delivery system, I am in process of switching the majority of my clients from Niaspan to immediate release niacin and I have no intention to write any further Niaspan prescriptions, or to be a further unwitting or witting accomplice to the pharmaceutical industriy in the fleecing of America. 

I have been successful in minimizing the cost of many of the other anti-cholesterol medications to an affordable level for the vast majority of my clients. Looking into the future, I do not envision, except for the ASO for ApoCIII,  a meditation that should be a clear rival for niacin but if anything this meditation because of the profit motive, similar to PCSK9 inhibitors with its excessive cost, injudicious indications and really unknown future side effects will probably be financially unavailable to many of the US citizens who could benefit. 

For those who now still benefit and will continue to benefit from niacin in the future, I say, Thank God for immediate release niacin.

Does a Desert of Ignorance still Exist for Preventive Cardiovascular Disease?

Greater than 20’s years ago I became aware of a young obese physician who suffered a heart attack and proceeded to perish. Although he selected the group he felt was most experienced in interventional cardiology, the cardiac damage was too extensive to allow his survival even with the then putative most advanced interventional techniques. He left a wife and several teenage children to fend for themselves. Another neurology colleague from Broward county suffered a heart attack within the first 10 years of his practice and although he returned within a few years, his name slipped from the active practitioners in Broward county. Another colleague suffered a heart attack and never worked another day as a physician. Less than 10 years ago at a meeting in Broward county I became re-acquainted with a colleague that I knew well in the first 10 years of my practice, whom I was surprised to ascertain that he had suffered from a acute myocardial infarction and was also on disability. Upon questioning he became interested when I apprised him I was utilizing Advanced Lipid testing and was including the prevention and arrest of atherosclerosis as part of my cardiology practice. However, as with many patients who have undergone interventional cardiology procedures, he had an umbilical cord to his interventional cardiologist and was concerned that it would be severed if he sought the opinions of another cardiologist. All these incidents were well before the year 2000 when we physicians were blinded by the standard lipid panel. Certainly prior to this time there was a desert of ignorance of how to prevent and treat atherosclerosis. The big question is does this desert persist today.

Over the last 20 years, there are still even today, too numerous to count, heart attacks and strokes, which do not exclude physicians. Millions with this same fantasy, despite being sold on today’s highly superior technological advancement, have met their demise or become allocated to the secondary prevention machinery of our medical delivery system. From other similar experiences and my own disastrous start with a hidden metabolic syndrome, I decided that for myself I would prefer to avoid this path and at this time and my age it appears I did. A heart attack or stroke now would not be considered premature. Every year beyond my present age serves to bolster the course that I chose in my 60s. I might be presumptuous enough to claim I will never have a heart attack but gazing upon my history up to age 65, not a stroke.

Over the last 20 years, at times in my career I have intermittently wondered whether cardiovascular disease treatment in United States is a desert of ignorance, as opposed to enlightenment. The latter is claimed by the pharmaceutical industry, vendors and news media, all of whom who are paid or receive benefits for these advertisements,

Recently I was apprised there was a high 40s yo physician cardiologist who suffered a stroke. I wondered if he had any inkling or suspicion and had taken any steps to avert this event. It was said that he was on one of the most powerful LDL-C lowering medications available today. Although this drug for the time it has been released supposedly decreases CVA’s by 21%, do not be that impressed. Four out of five individuals destined to have a CVA off this medication  still suffer a stroke with this medication at a cost of 15-$20,000 per year/treated individual. The question is how many of the population and which physicians are next in line. From previous statistics the numbers will be overwhelming. 

This event made me reminisce about my previous experiences and how I would have and did handle this problem for myself and previous patients. From my experience strokes are caused by hypertension controlled or uncontrolled, various hyper and dyslipidemia’s including LPa insulin resistance, diabetes mellitus  cerebrovascular vascular anomalies, cerebral atherosclerosis, occult thrombotic or platelet  disorders, embolic cerebral vascular disease either vascular or valvular, atrial cardiac arrhythmias, hello hello Afib and the usually neglected latent patent foramen ovale. When I saw predominantly cardiology patients I was aware of each and every risk factor that would predispose my patient to a stroke as well as heart attack. Each of these parameters was addressed with the best treatment of the day; albeit the vast majority as a secondary prevention cardiology patient as they mostly joined my cardiology practice after they had their first event.

Today, in my opinion, cardiovascular medicine is still, despite the rave technological advances, a desert of ignorance possibly spotted with rare or occasional oases of enlightenment, spawned as a result of our profit oriented medical delivery system and the lack of complete well rounded and trained practitioners caught up primarily in the profit motive and the super subspecialties which exist today.

Today’s Flawed and Fake Medical Trials

 

Recently I was presented with unsolicited lab data ( above) on a patient whom I am not charged to divulge, who is the typical patient I have cared for in the last 18 years and unwittingly poorly throughout my earlier career. This case has what appears to be an unbelievable astounding but in reality not infrequent response, to a single anti-cholesterol medication & vitamins; despite lacking my usual work up which includes inflammatory, absorption and production markers as well as insulin resistance parameters. 

I was struck by the upstream effort against the tide of this individual to spread affordable and effective knowledge and experience what I and hopefully many others have been applying for years .

Recently because of the accelerated pricing of Niaspan consistent with gouging, similar to the recent EpiPen scandal, I was at a Walmart pharmacy inquiring about the immediate release form of crystalline niacin which was the vitamin involved in the above patient’s treatment . Thereupon, the pharmacist proceeded to denigrate niacin insinuating that I did not know the literature. Now I did not quite agree with this gentleman and walked out to another Walmart. However, this incident is not stand alone event. I have had many other providers and would be providers even ivory tower institutions disparage niacin, in fact attempting to interrupt successful treatment of the dyslipidemia of some of my patients and I am quite sure others.

In college I started of in the premed program but switched to Physics because I leaned more to analytical thinking. Premed and medical school was mostly about regurgitation of vast amounts of facts with little time devoted to analysis which does require some experience. Unfortunately the medical literature dictum of publish or perish leaves little time for peer-review with correlation & application to the real world. 

It is one thing to know what the literature states and another to be able to critically evaluate, usually referred to as peer review. Now peer-reviewers to me are the readers of the articles. Others think that the peer review involves the editors and those who chose the articles for publication. As a Board-Certified Cardiologist since 1973 along with 2005 inaugural year certification in Clinical Lipidology and my recently successful completion of Clinical Lipidology recertification exam in which I am now grandfathered and exempt from any future examination, I believe I have a bit more critical and analytical perspective than the lay public, the vast majority of physicians and pharmacists who lack peer review capability as well as proponents of big Pharma. 

The above pharmacist’s impression emanates from two flawed trials, which in my opinion much like our news media which in last 50 years has generated fake news, has generated data inconsistent , inconsequential or mal-applied in the real world and therefore have drawn false conclusions. Whenever I see data inconsistent with my near 45 year experience I always think of a phrase I learned in medical school about Willie Sutton’s robbing banks i.e. “ Sutton’s law”, ascertain or observe where the money is involved then evaluate who benefits.

Recently upon viewing the Agenda at a National Seminar Symposium, I noticed an interesting discussion about the Niaspan topic; unfortunately not well emphasized because it was on the last day near adjournment. I was unable to attend this session but I decided before the lecture to compose and send to the presenter my peer-reviewed assessment about the status of niacin including Niaspan, in addition to still contemplating about placing this discussion on social media. I never received a response because it may not have been successfully sent. I felt that the data from the relatively recent Mega trials would be emphasized and the older trials would be ignored. Later upon viewing the presenter’s synopsis from another source, my belief was buttressed.

There have been other flawed trials. An example is the Seven Countries Trial( which in my opinion started the obesity epidemic) which is still revered when the history of trials are reviewed at symposiums.

The recent PCSK9i inhibitor trials Odyssey and Fourier are examples of over exaggerated ballyhoo which in short is for a medication that in the future will be vastly underutilized because of its lack of affordability, much less than the statins when they were initially introduced. PCSK9i are set up to be an add-on and not a competitor of the statins. Its powerful LDL-C lowering into the teens results in outrageous cost inefficacy. We should not be concentrating on a transient sojourn of LDL-C into the teens but on the product of ApoB particles over years. Some of PCSK9i other beneficial effects are being glossed over, ignored or relegated to non-significant status. Further discussion an exploration of this topic will be better served in the future

The Complete Cardiologist and Why He or She is so Rare

 

What is the difference between most cardiologists and a complete cardiologist? Most Cardiology training programs involve extensive time within the coronary care and ICU units addressing cardiovascular symptoms and problems once they have surfaced. Usually symptoms of Cardiovascular Disease are manifested when 80% or greater of the body vasculature is already compromised. Eighteen years ago I wondered where I stood on this spectrum and turned myself to advanced lipid testing, which I was already utilizing with my patients. Lo and behold I discovered I was similar to them. I then wondered if my recently discovered secondary prevention concepts would work for me as primary prevention and applied them. I did not want for myself any part of what I was seeing with my patients. It was at that time that I became a complete cardiologist and I then proceeded to try to identify others at risk years before may would become symptomatic. 

Being a complete cardiologist means preventing arresting or stabilizing cardiovascular disease progression years before it is allowed to take a stronghold and manifest symptoms. Unfortunately despite statements to the contrary our statistics really expose the truth about our failure which in my opinion is secondary to the failure of our physician’s training institutions especially cardiologists. 

Equally obstructive are the variety of guidelines of great disparity, published by various National and International associations. which are at odds with the real world of medicine and only serve the financial needs of corporations involved in medicine. A complete cardiologist circumvents all these obstacles and prescribes an effective affordable plan for cardiovascular disease prevention in keeping with the whole families financial needs rather than allowing one compromised family member to siphon resources from other family members.

Unfortunately with the medical insurance industry, it is much more profitable to withhold any treatment before symptoms appear (i.e. how the greatest profit from the premiums is realized) The Insurance companies are well aware that many clients over the years will change to different competing medical insurance programs based upon the availability and rising costs and it is not profit-effective to prevent CVD disease in individuals, most of whom will end up leaving them. 

Once symptoms appear, the medical vendors have a picnic followed by a picnic for the pharmaceuticals companies with their multiple medications, a fraction of which should have been used to prevent cardiovascular disease prevention. It is simply not profitable for the Insurance companies to do primary prevention years before although it appears they espouse this concept, but in reality are only paying lip service. 

If a patient is to become involved in primary prevention of cardiovascular disease they must bear the costs, not the insurance company, and reap the benefits although they may have difficulty in determining to take the plunge or if they will or will not benefit. Either way even if no event is experienced, one’s longevity and quality of life will be extended as atherosclerosis is impeded.

Other factors that are limiting effective primary cardiovascular disease prevention is the disparity in training of physicians. Most physicians sell to their patients what they know or what the pharmaceutical companies medical vendors hospitals, Insurance companies  drug plans, all of whom have control of the medical literature. 

Today the overwhelming new therapeutic options i.e. vast number of new outrageously expensive medications with supposedly statistically significant beneficial effect and most only with a minimal 1-2% absolute risk reduction benefit in which 100% of patients are recommended for the treatment is being huckstered at an outrageous cost which gouges into each family’s budget leaving little available for future education etc.. All this is is a long way from the Capitalism of reasonable profit upon which I was raised.

My Peer-Review of AIM-HIGH & HPS-THRIVE II

 

 

 

 

Fake Medical trials: Do they exist?

Today we are reputed to have fake news. What is fake news? My understanding is that it is the substitution, distortion or withholding of true facts (reality) and the substitution of partial (semi-true) or completely untrue altered facts or opinions, or just flat out unwittingly or wittingly incorrectly or inaccurately drawing conclusions from facts to justify an ulterior objective. A medical trial that ignores, neglects or mistakes the effective mechanism of action of a tested drug could lead to a fake trial. Even Harold Bays recognizes that fact in his Annual Summary presentation delivered at the National Lipid Association meeting in New Orleans in 2016

Most providers know that penicillin or antibiotics are ineffective with viral infections. Most URIs are viral infections. If we were unaware or ignored this fact and conducted a trial in which penicillin was employed in URIs against a control (no antibiotics for a URI. it would be a negative trial. Subsequently, if some trial participants developed anaphylactic shock or other penicillin associated side effects, penicillin would have been deemed harmful and without benefit. Now we all know with regard to penicillin that is not true.

From my observations AIM-HIGH and HPS THRIVE-2 are such examples of fake trials in the sense that they tested HDL hypothesis (a red Herring) which from the AFCAPS-TEXCAPS should have been suspected as flawed and were an injudicious waste of money. Administration of any medication involves a risk/ benefit ratio and if one tests or utilizes medications inappropriately, one will have risk with little or no benefit.

In the case of AIM-HIGH and HPS II Thrive II, an already questionable or non beneficial mechanism of action was invoked as the hypothesis i.e. elevating HDL-C to decrease cardiovascular risk which in my opinion should have been suspect with the U-shaped HDL mortality curve of AFCAPS-TEXCAPS and since has been disproved by Mendelian Randomization Studies. Niaspan was unfortunately selected as the agent because of the large increase in HDL-C mostly contributed by the hepatic holo-particle receptor mechanism inhibition. Subsequently there have been major failures of the HDL hypothesis with the CETP trials and subsequent Mendelian randomization studies having all but put the HDL raising hypothesis to rest. Unfortunately Niaspan became the punching bag for a flawed hypothesis trial.

Laropiprant an unknown new medication not previously studied was added to Niaspan. What was the effect of this brand-new medication on Niaspan’s effectiveness? Niaspan’s true effective mechanism of action (DGAT2 & HSL hormone sensitive lipase inhibition did not appear to be a considered. Under present development is a DGAT inhibitor Pradigastat which when and if it gets to market will most probably be unaffordable as are many of today’s new medications. But Pradigastat lacks adipose tissue hormone sensitive lipase inhibition which is responsible for 60 to 70% contribution to VLDL and triglycerides produced in the bloodstream .

For the most part low HDL is product of latent or overt insulin resistance with or without obvious unfavorable triglyceride values. High HDL is a product of hyper-absorption of cholesterol or dysfunctional HDL both of which are atherogenic.The HDL hypothesis may have been put to rest but with its multiple putative beneficial actions one or more of which may resurface with more knowledge. However, it will not be the HDL level but rather it’s biochemistry.

I often refer to a Data Graph of the Framingham heart Study (FHS) study conducted over a 25 year time period, not 3-5. In analyzing this graph I observed that cardiovascular events below a total cholesterol of 150 is not discernible, at least statistically. Assuming a normal HDL of 45, normal triglycerides of 100-150, the average LDL calculation for this event free group is around 75 -80 mg/dL which is near the 5th percentile. The vast majority of those in AIM-HIGH and HPS II Thrive II were already at this LDL level and would had have little statistical discernible separation. Also from the Framingham Heart Study FHS for those individuals below a total cholesterol of 150 mg/dL, I would certainly have difficulty discerning a statistical mortality separation from those who had elevated LPa > 50 mg/dL or not.

Over the last nearly 20 years I was not in the habit of prescribing Niaspan to somebody with an LDL-C around 70 mg/dL unless they had substantial LDL-P, LDL-C discordance. In the past when I ran across undesirable medications and rapidly discovered their deficiencies, I removed them from my prescription list. That never happened with Niaspan. Niaspan’s benefit in appropriately indicated patients greatly and markedly outweighs the risk.

Although I achieved board certification in Clinical Lipidology in the inaugural class of 2005, I do not consider myself a Clinical Liidologist, rather with my board certification in Cardiology I consider myself a Preventive Cardiologist. Recently I have earned the title of Grandfathered Diplomate of the American Board of lipidology. Approaching 20 years now, I had used Niaspan on an estimated to 750 to 1000 patients, and possibly more, secondary prevention cardiovascular disease patients, but disappointedly much less with primary prevention. The vast majority had FCH or Familiar Combined Hyperlipidemia or by my recognition I prefer “the metabolic syndrome”. Niaspan with its mechanism of action as an inhibitor of DGAT2 & Hormone Sensitive Lipase HSL was easily the best medication for treating ApoB, LDL particle number, LDL-P, VLDL-C, VLDL-P & which today has a newly coined name, “Remnant Cholesterol”. Surprisingly except for Zetia, in my hands Niaspan had the best tolerability even with its flushing symptoms. Niaspan’s occasionally increased insulin resistance was manageable. I found the Fibrates and Bile Acid Sequestrates to be more problematic By far the worst side effect profile were and still are the statins and that was before we learned about the association with diabetes. Prior to this recognition, I many times could have mistakenly completely and inappropriately attributed a decrease in insulin sensitivity to Niaspan as statins means were for the most part on board.

From my experience Niaspan was not in general a potent total cholesterol and LDL-C lowering drug but it was and is a potent LDL particle number, non-HDL ApoB and if you prefer remnant cholesterol lowering drug, something the AIM-HIGH & Thrive HPS II investigators appeared to have ignored or overlooked. The statins have limited effectiveness for remnant cholesterol and herein lies the residual risk so commonly seen in FCH patients on only statins e.g. Tim Russert. Tim Russert’s LDL on a Statln was 63 mg/dL but his low HDL-C of 32 and high triglycerides 300mg/dl belied his substantial residual risk, i. e. an elevated remnant cholesterol, non-HDL with an extrapolated astronomical LDL-P estimated to be 2000 nm/L, which was never addressed and today is still not addressed by the vast majority the practitioners.

What I am most disappointed is that since, AIM-HIGH and HPS THRIVE II, there has been and is an ongoing denial to the vast number of non-atherosclerotic and atherosclerotic disease patients with FCH, the one medication that most effectively addresses their biochemical abnormality through an attempt to remove what I consider the most effective medication for FCH Niacin without a better contemporary or adequate replacement, which I consider reprehensible.

On the horizon I see unaffordable medications touted to treat the triglyceride disorder associated with FCH as a probable hollow promise for the future. Pradistat will probably be insufficient compared to Niaspan & the ASO ApoCIII when it arrives will probably be unaffordable for the vast majority as well as the recalcitrant insurance companies.

Thus in my opinion AIM-HIGH & Thrive HPS II were fake trials and I have my opinions as to the reasons. Since AIM-HIGH and HPS THRIVE II, I have become more critical and circumspect of the conclusions of a plethora of medical trials, even outside of Clinical Lipidology; always raising the suspicion or possibility that ulterior motives are involved, specifically money. Today I often wonder if our fake news concepts have seeped into our medical trials and indeed, to some extent I even have lost some confidence in so called “evidence based medicine”.

Today’s Flawed and Fake Medical Trials

Recently I was presented with unsolicited lab data ( above) on a patient whom I am not charged to divulge, who is the typical patient I have cared for in the last 18 years and unwittingly poorly throughout my earlier career. This case has what appears to be an unbelievable astounding but in reality not infrequent response, to a single anti-cholesterol medication & vitamins; despite lacking my usual work up which includes inflammatory, absorption and production markers as well as insulin resistance parameters.

I was struck by the upstream effort against the tide of this individual to spread affordable and effective knowledge and experience what I and hopefully many others have been applying for years .
Recently because of the accelerated pricing of Niaspan consistent with gouging, similar to the recent EpiPen scandal, I was at a Walmart pharmacy inquiring about the immediate release form of crystalline niacin which was the vitamin involved in the above patient’s treatment . Thereupon, the pharmacist proceeded to denigrate niacin insinuating that I did not know the literature. Now I did not quite agree with this gentleman and walked out to another Walmart. However, this incident is not stand alone event. I have had many other providers and would be providers even ivory tower institutions disparage niacin, in fact attempting to interrupt successful treatment of the dyslipidemia of some of my patients and I am quite sure others.

In college I started of in the premed program but switched to Physics because I leaned more to analytical thinking. Premed and medical school was mostly about regurgitation of vast amounts of facts with little time devoted to analysis which does require some experience. Unfortunately the medical literature dictum of publish or perish leaves little time for peer- review with correlation & application to the real world.

It is one thing to know what the literature states and another to be able to critically evaluate, usually referred to as peer review. Now peer-reviewers to me are the readers of the articles. Others think that the peer review involves the editors and those who chose the articles for publication. As a Board-Certified Cardiologist since 1973 along with 2005 inaugural year certification in Clinical Lipidology and my recently successful completion of Clinical Lipidology recertification exam in which I am now grandfathered and exempt from any future examination, I believe I have a bit more critical and analytical perspective than the lay public, the vast majority of

physicians and pharmacists who lack peer review capability as well as proponents of big Pharma.

The above pharmacist’s impression emanates from two flawed trials, which in my opinion much like our news media which in last 50 years has generated fake news, has generated data inconsistent , inconsequential or mal-applied in the real world and therefore have drawn false conclusions. Whenever I see data inconsistent with my near 45 year experience I always think of a phrase I learned in medical school about Willie Sutton’s robbing banks i.e. “ Sutton’s law”, ascertain or observe where the money is involved then evaluate who benefits.

Recently upon viewing the Agenda at a National Seminar Symposium, I noticed an interesting discussion about the Niaspan topic; unfortunately not well emphasized because it was on the last day near adjournment. I was unable to attend this session but I decided before the lecture to compose and send to the presenter my peer-reviewed assessment about the status of niacin including Niaspan, in addition to still contemplating about placing this discussion on social media. I never received a response because it may not have been successfully sent. I felt that the data from the relatively recent Mega trials would be emphasized and the older trials would be ignored. Later upon viewing the presenter’s synopsis from another source, my belief was buttressed.

There have been other flawed trials. An example is the Seven Countries Trial( which in my opinion started the obesity epidemic) which is still revered when the history of trials are reviewed at symposiums.

The recent PCSK9i inhibitor trials Odyssey and Fourier are examples of over exaggerated ballyhoo which in short is for a medication that in the future will be vastly underutilized because of its lack of affordability, much less than the statins when they were initially introduced. PCSK9i are set up to be an add-on and not a competitor of the statins. Its powerful LDL-C lowering into the teens results in outrageous cost inefficacy. We should not be concentrating on a transient sojourn of LDL-C into the teens but on the product of ApoB particles over years. Some of PCSK9i other beneficial effects are being glossed over, ignored or relegated to non-significant status. Further discussion an exploration of this topic will be better served in the future

page3image5790256

 

Joining the ISCVP International Society for Cardiovascular Disease Prevention

Joining The ISCVP (International Society for Cardiovascular Disease Prevention)

Recently I gave a presentation about metabolic syndrome emphasizing my successful last twenty-year approach and at the end of the lecture I divulged that I did not heavily rely upon therapeutic lifestyle changes. I came under severe rebuke by one attendee despite the fact in my lifetime I had obtained a medical degree, accumulated more than 45 years of medical practice, quadruple board certification especially in Cardiovascular Disease and Clinical Lipidology, the latter in which I recently became a grandfathered diplomate, one of the only 200-250 in the country, I proceeded to cite a more recent New England Journal  of Medicine article, the LOOK AHEAD trial, discussed by Jay Cohn MD at a recent ISCVP sponsored course in Sarasota. But that was to no avail. Old untrue concepts die hard and can persist for centuries.

However, confusing as it is, even at this course there were some speakers still espousing the benefit of TLC with regard to event reduction and longevity. I personally detect in my life time the ceding of treatment standards away from physicians to other financially controlling groups and probably computers in the future.

For the last 20 years I have not pushed therapeutic lifestyle changes upon my patients as I did in the first 27 years. This was simply because, whatever the reason, it did not work.  I noticed years ago that the vast majority of  patients had difficulty adhering to any diet regimen outside of their race, ethnic or religious background and forget about any substantial sustained weight loss. My previous instructions about TLC learned from my early medical training caused me to lose more patients then I ever helped. Patients did not return either because they were disappointed with their results from my instructions that they could not personally attain or sustain. Secondly they could not face the disappointment in themselves or envisioned in me during their office visit. Thirdly they may have felt I did not know what I was talking about. As time progressed the latter became the truth but I was smart enough to stop TLC emphasis 20 years ago.

This group in the International Society for Cardiovascular disease prevention is the first time I have heard any individual from any medical society move toward the conclusions I drew 20 years ago and consequently because of his more realistic approach, I enrolled as a member.

When I finished my training we had little to offer the public e.g. the care rendered to Dwight Eisenhower for recurrent myocardial infarctions and frequent flyer status to the hospital for his cholesterol problem. Although today we have the statins and other anti-cholesterol medications as well as other enormously expensive medicines approaching the market, we still have had a steady unabated stream to the hospital for interventional or bypass procedures.

 

CVRRUSA’s scientific and economical pathway to durable affordable real heart attack prevention with value

The vast majority of physicians when treating cardiovascular risk obtain the standard lipid panel and then treat according to the ACC/AHA guidelines with a Statin attempting to lower the LDL cholesterol by greater than 50% but not necessarily to a specific goal. They may or may not add a cholesterol absorption inhibitor, which is not endorsed by the FDA. The problem is that most cardiac patients happen to be have FCH Familial Combined Hyperlipidemia and despite a Statin almost all retain significant residual risk.

Most if not all patients are under the impression that with their medical insurance they are all paying and receiving heart attack prevention. Not true! Even with a Statin (only 1 in 4 events are  prevented). With advancing years, if one is lucky and survive an initial cardiac event, one is passed on to the US hospitals with its interventional cardiovascular disease or surgical re-vascularization procedures. It appears in the U.S, preventive cardiology forces exist along with interventional cardiology working hand-in-hand to extract as much money as the public and insurance companies can bear. Physicians like to have their patients affection, but they prefer the hospital to like them even more

With one’s first cardiovascular event, all is downhill. One’s body changes permanently both physically and psychologically and most never return to work and thereafter develop subsequent significant social problems. Loosing one’s employment or medical insurance is a formula for bankruptcy. In my opinion our present system has potential financial catastrophe for any US citizen.

Most people’s response would be a hopeless “what can you do?”. With regard to atherosclerosis and heart attacks, the answer is the approach of clients of CVRRUSA. As an illustration, a well-to-do 50-year-old with a family of 4 and without a history of symptomatic ASHD pays $2700/month for a high deductible medical insurance plan $5000/individual. He was under the care of a cardiologist because of hypercholesterolemia. Initially he had a LDL-C > 190 mg/dL with a vascular age by CAC score of a 78-year-old when he was in his 40s. He at least once, possessing doubts, had discontinued  the statin for about a year. He was inquisitive and became aware of LDL particle numbers. His physician and others physicians acquaintances were not very informative.

He expresses his vexation to a retired cardiologist, a classmate of mine at P&S, who states “I know a guy who can help you”. This individual contacted me and agreed to an evaluation and treatment, outside of his insurance coverage for which he would have been totally responsible anyway because of his high deductible. After receiving his previous records and his Advanced Lipid Blood tests, this individual despite being on high intensity statin Lipitor 40 mg/day still had significant residual risk. His LDL-C was 92 mg/dL around the 15th percentile and particle number of 1231 nmole /L, the 30th percentile, demonstrating a mild discordance. His HDL was 71 mg/dL From my observations for a primary prevention candidate most physicians really would not add or alter this drug regimen. They might point to his high HDL as being cardio protective. Do not buy that? HDL-C in this range is in reality is a risk factor either secondary to dysfunctional HDL or cholesterol hyper-absorption, possibly the results of Statin induced compensatory mechanisms or a genetic abnormality involving the NPC1L1 receptor. In fact individuals with hyper-absorption have a higher incidence of cardiovascular events.

Since cholesterol absorption parameters were included in his studies, it was determined that he was hyper absorbing cholesterol. Appropriate therapy was applied and his LDL-C dropped 37 mg/dL to 55 mg/dL, at least below the 2nd percentile and probably the 1st. His LDL-P  had decreased to 882 nmol/L, the 6th percentile. What percentage of physicians would have discovered his hyper absorption problem or instituted therapy?

Now these results are pretty decent and for 80% of similar patients would suffice. However, he also has one of my lipoprotein nemesis. 20%, 1 in 5 of similar individuals would have significantly elevated LPa (mine is elevated also) which is one of the reasons I still continue to be intensely interested in preventive cardiology. His significantly elevated LPa which in addition to his hyper-absorption is associated with significant residual risk.

What does one do for elevated LPa? Niaspan has been trashed or as one of my colleagues states “has been defamed”. This individual was offered an alternative (a PCSK9 inhibitor)  for which I was slightly tentative because of the cost $1000-$1500/Month(to be borne by him) and also the present cloudy PCSK9 indications picture. However, his Cleveland Clinic cardiologist was more authoritative stating that the expense of this additional medication was far less than the total cost of a heart attack. Fortunately this gentleman could afford it.

With the addition of PCSK9 inhibitor his total cholesterol decreased to 92 mg/dl, LDL-C to 19 mg/dl, LDL-P to 442 and his LPa decreased greater than 55% 209 nmol/L to 99 nmol/Lr

Let us analyze the economics, costs and value of this individual’s work up, treatment and medically indicated medications, which was more costly than usual because of his high deductible. He was self purchasing, generic Lipitor and costing $100 somewhere/Month. CVRRUSA could have and eventually did place him on brand Lipitor for $0.40 per day or $12 per month or an alternate high intensity brand Statin for about $0.25 day or $7.50/mo, easily saving over $100 per month. His local pharmacist was charging him $10 per pill for the medically necessary hyper-absorption inhibitor (CAI) which with CVRRUSA’s input is now costing $3 per pill, a $210 savings per month. This approximate $300 per month savings on medically necessary medicines for the first year was more than double the fee he paid for CVRRUSA’s services. He considered these prices a medical bargain but most importantly is assured maximum treatment with regard to his cardiovascular risk factors. CVRRUSA has identified all treatable cardiovascular risk factors and minimized his cardiovascular risk as much as possible considering what was available with today’s drug armamentarium. thus enabling the greatest benefit he could obtain. Hopefully, in the future the new and improved indications will be developed for PCSK9 inhibitors.

He has also been apprised of possible future medications targeting LPa. An ASO for LPa is in the offing with a probable huge price tag. Now remember elevated LPa is present in 20% 1 in 5 of the population and as opposed to FH which is most recently reputed to be 1 in 250. If  the ASO LPa had the same price tag or more than the PCSK9 inhibitor, it could only be maximum distributed as is the PCSK9 inhibitor through insurance coverage and at those prices the potential to bankrupt our present medical system exists.

His therapeutic goals were achieved within months which could have been sooner except that medications have to be added sequentially to obviate confusion. Compare months with CVRRUSA to attain superior goals as opposed years of incomplete treatment with a statin only and significant undetected residual risk.

A major disappointment was that it would have been advantageous for him to have contacted CVRRUSA 10 years earlier with earlier treatment probably greatly delaying progression of his ASHD for that time lapse. Unfortunately, delay in treating cardiovascular risk factors as well as other areas is inherent in our medical delivery system.

Most importantly with regard to the the overall lifetime economics (i.e.value), except for the( PCSK9 inhibitors), this medical regimen is for the vast majority of Americans affordable even without depending upon insurance drug plans and can be adhered to for years without financially draining or infringing upon other essential life necessities, provided other omni-present negative self-serving societal advertisements or input are resisted.

Surely with this approach for a compliant group, interventional procedures and their cost can be avoided with decreased lifetime medical costs. Hopefully his PCSK9 inhibitor and soon to appear Blockbuster priced ASO for LPa could become more reasonable and be brought into the medication Insurance fold. Do not hold your breath.

The take-home message: most of us can be optimally treated with years of affordable proven medications without reliance on insurance but we do not know where to look because we are bombarded with advertisements from multiple self-interest groups. CVRRUSA is an alternative that should be on everyone’s lips.

Real Combination Lipid Rx

During my medical training rather than consider a third year as a chief medical resident I elected to do a year of hematology-oncology. I thought hematology- oncology would expand my experience and better prepare me for a career in medicine and in retrospect I was correct. Those were the years chemotherapy for cancer and hematological disorders switched from single drug to combination therapy (MOPP COPP etc) with amazingly improved mortality. Thus I did not develop a mental set against expansion of combination therapy.

In the year 2000 with the availability of Advanced Lipid Testing and before the appearance of multiple medical organizational guidelines, which I find confusing and less then definitive, I treated the most common cause for heart attacks in my and any similar cardiology practice Familial Combined Hyperlipidemia (FCH) very aggressively with multiple medications directed at correction of undesirable biochemical abnormalities and lipoproteins by favorably altering gene expression

In February 2016 I attended a continuing medical education course. During the CME course, a case was presented which was an extreme incompletely treated case of FCH (Familial Combined Hyperlipidemia)or in my opinion the Metabolic Syndrome. My initial response was the treatment of this problem would be a piece of cake. This male patient on a statin had an LDL-C of 63 mg/dL(best 1-2 %) with an HDL of 32 mg/dL and a TG of 300 mg/dL. No other lipid parameters were obtained. Well, this case happened to be the prominent TV commentator Tim Russet and as you may know he met his demise shortly thereafter.

HIs untimely death caused an uproar which with time has been repressed and forgotten and little really learned, as are most untoward events. My FCH experience as documented by my websites includes innumerable successful treatments of severe metabolic syndromes e.g. My Metabolic Syndrome Journey.(A 50 minute presentation) because I have and continue to Incorporate the principles of combination (three or greater medications) therapy initiated by that one year of hematology-oncology

The organizer of the above CMR course mentioned that the news media was calling into question the LDL hypothesis and in my opinion was well they should.The attending faculty was then polled as well as the participants. Most of the faculty emphasized therapeutic lifestyle changes which I am sure the patient had been attempting for years and which would not have come close to correcting his metabolic abnormalities. Most of the course participants would have added to this patient’s single statin regimen, a single medication, the flavor of the month treatment at the present time, Omega-3 fatty acids, not my first choice. One panelist, a retired prominent researcher, amazingly dismissed both the AIM-HIGH trial and HP2-Thrive by recommending Niaspan.

I was stunned by the vacillation, variation and lack of assertiveness of the panel, except for the retired researcher. I was tempted to initiate a more in depth discussion but had second thoughts about possibly disrupting the meeting about a topic that would most certainly have exceeded the time allowed, but should have been discussed more in detail with greater audience input.

pastedGraphic.pdf

Recently in preparation for a successful recertification examination in Clinical Lipidology I was required to become familiar with the many National and International Cardiovascular Guidelines and I must say if I did not rely upon my experience predating the large onslaught of consensus panel guidelines, I also would have similar thoughts like most individuals on that panel.

Contrary to the approach with Tim Russert i.e. a single Statin, we need to look at alternatives that WORK for each individual and not rely upon exceedingly variable guidelines from different National and International Consensus Groups who apply one- size-fits-all and now rely only upon Mega-Trials allowing a clear advantage to the big- money interests in medicine.

Just look around you, we are far from all biochemically and genetically similar. So, how can one-size-fits-all? Answer: it doesn’t

What has Medicare part D become?

Recenty with the health insurance Drive upon pricing my medications with my health insurance broker with various Medicare part D providers, the gravity of this problem was even more greatly amplified and was accompanied by a stunning “aghast” from my friend (the Health insurance broker).
In my opinion Medicare part D is the pharmaceutical companies, along with the blessing of US Congress, concocted adroit maneuvers to extract the maximum amount of money that any patient is willing or able to be separated from for second rate generic drugs, when brand names can be purchased in other developed countries for many times less. Together the US monthly premium and the deductible usually cover the cost of medicines in Europe & Canada, who are still making a profit. Then the U S additional markup on these medications ascends close to 10 times higher then what could be purchased in Europe or Canada 
The system is set up so that with the patient’s deductible and monthly premium Americans are already paying for their medications and anything above that is a donation to the pharmaceutical industry.
Somehow we providers stood by either unaware, acquiescing, or incapable of preventing this congressionally approved transfer of wealth to the pharmaceutical companies.
However, I can say that Cardiovascular Risk Reduction USA patients have avoided this scalping and at times because of judicious drug apportionment are paying less than the European and Canadian market.