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Pharma Against Statins, PCSK9 Their Replacement

Pharma against statins  --  what’s going on –6/9/15

Suzy Cohen, America’s most trusted pharmacist, Dear Pharmacist column in Coachella valley Beacon April 2015, p. 11.  www.suzychoen.com   Syndicated appears on Dr. Oz TV show.  Sign that pharma is in the process of switching to new improved cholesterol drugs.   Mercola.com, Dr. Mercola on her site, along with Prevention.  Big on natural cures



Statins safety is now questioned in the corporate media. In the article below syndicated pharmacist Suzy Cohen names three products of the mevalonate pathway that are partial blocked by statins and she mentions their negative health consequences.  She even provides a link to a journal article where it has just been discovered that statins “stimulate atherosclerosls and heart failure” and list the three partial block bio-important products blocked (the abstract of the research article used by Cohen is found after her article below) . Why hasn’t these issue raised by Suzy Cohen been brought before the public and physicians in the over 20 years the blockbuster statins has been on the market?  This is only the tip of a large and complex body of journal articles exposing pharma’s second biggest heist.  And why has the article by Suzy Cohen been widely distributed while the chorus of vocal critics has been essentially ignored by the corporate media?    


This sort of revelation by pharma is all about money and thus marketing; and Suzy probably merely signed her name to an article ghost-written by pharma.  This is a pattern used over and over again by pharma to switch prescribing of physicians from the older to newer drugs.  Pharma is now promoting their replacements for the cholesterol lowering statins because most of them are now off patent.  The attack starts with pointing out side effects.  The article below is of interest, but don’t lose sight of orchestrated music played by pharma.  It is the first chords of a symphony which we will be hearing over.


Suzy Cohen is an attractive pharmacist who has appeared repeatedly on the Dr. Oz Show, and other programs.  She writes a regular syndicated column, writes books, and has a website to promote her and her products at http://suzycohen.com/.   


For the new product watch Amgen’s video on how their new PCSK9 receptor drug works—and remember that is marketing dressed as science. http://www.cholesterolneversleeps.com/what-is-pcsk9.html?WT.z_co=A&WT.z_in=DYS&WT.z_ch=DSP&WT.z_ag=AG705&WT.tsrc=DSP&WT.mc_id=A_DYS_DSP_AG705

Of course the new drugs are to be far more expensive, much more than the statins that are still on patent, over $14,000/year.  For an article on it go to second one on this page.



http://suzycohen.com/articles/statins_cramps/    PDF        http://suzycohen.com/articles/statins_cramps/

Taking Statins?  Beware!

by Suzy Cohen pharmacist   on April 8, 2015 in FatigueHeart DiseaseHeart HealthMedications, MedicineMen's HealthMethylationThyroidWomen's Health · Comments { 151 }  ---  April 2015

If you’re one of the millions of people diagnosed with high cholesterol, you will more than likely be given a prescription “statin” pill. It’s easier to take a statin, truly I get it, it’s hard to control diet and to exercise and to live a life of limitations after all this time. For a satirical look at what you need to do before taking a statin, read my quick (and somewhat silly) scenario at the doctor’s office here. 
Now, let’s get back to the statins, these work well to reduce cholesterol:
-Lovastatin for Mevacor
-Atorvastatin for Lipitor
-Pravastatin for Pravachol
-Fluvastatin for Lescol
-Simvastatin for Zocor
-Pitavastatin for Livalo
-Rosuvastatin for Crestor
-Others in combination form

What do they do?

Statins affect many pathways in the body. They are strong anti-inflammatories [not so. weak], so strong that they are being tested for their use in cancer patients![1]   As for cholesterol reduction, they work by crushing a natural enzyme in your body that would otherwise allow you to make your own cholesterol.

Statins do not suck out gooey cholesterol from your arteries, nor does it negate cheese fries.

No, these drugs merely suppress new production of cholesterol. Here’s where blind faith (take this pill and you’ll feel better) collides with scientific research.

This year a study was published (in the Expert Review of Clinical Pharmacology), entitled,
Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms. Repeat: “Statins stimulate atherosclerosis and heart failure.” Whoa!

The researchers concluded, “The epidemic of heart failure and atherosclerosis that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs.” What an irony! The problem is that many other studies have found similar disastrous effects on the heart. It has to do with mitochondrial dysfunction, which means that the little generators in your heart cells get sick.

Your heart is a very high energy muscle. It requires thriving, mitochondria in order to churn out ATP, your energy molecule. Statins are toxic to mitochondria because they deplete coenzyme Q10 which is needed for healthy mitochondria. Statins also deplete a special protein called “Heme A” that totes oxygen and iron to your heart. The long-term depletion interrupts ATP production and leads to cellular fatigue among other major problems. You cannot survive long-term without adequate ATP production so it needs to be restored. Fatigue, cramps, muscle weakness, memory loss, depression, cancer … you must have ATP in your body or else! (Biting my lip)

Statins inhibit the biosynthesis of vitamin K2 which we manufacture if we have healthy intestinal gut flora.
Do you?
I don’t know anyone who has a perfect gut. K2 also comes from fermented veggies. It protects our arteries from calcium plaques or atherosclerosis. Without enough K2, statin-induced or not, we are compromised.[2] (Eyes rolling now).

Today, we know statins block very special, powerful selenium-containing proteins known as selenoproteins, the most famous of those is called glutathione peroxidase, which protects muscle tissue from free radical damage (oxidation).

What’s the busiest muscle in your body? It has to work 24/7. It’s your heart! (Smacks forehead).

Your heart muscle cells are ‘burned’ form all the oxidation (due to the impairment of selenoprotein biosynthesis) and this is a factor in congestive heart failure. This reminds me of Keshan’s disease which is heart failure due to low selenium.

If you have to take statins, please use the lowest dose possible. Be diligent about putting back the nutrients that statins interfere with such as the coenzyme Q10, selenium, and vitamin K2, along with other heart healthy nutrients. There are exceptions to taking these nutrients so ask your doctor (yes, the same one that gave you the statin.)

This is a classic case of drug mugging, and I hope you will consider replenishing some of the affected nutrients, especially if you have uncomfortable or new symptoms.  I wrote about this in my book, Drug Muggers.  Remember to talk to your physician about dosages of these vitamins, because it is highly individual; dosages vary from person to person based upon age, sex, weight, kidney or liver function, even genetic SNPs and much more.  Also, keep in mind how important nutrients are in your body. Your body runs on the essentials, it does not run because of medication. As an example, if you have low levels of a natural B vitamin (folate) then you cannot properly methylation. If your methylation pathways are hindered, your toxins build up and your cholesterol ratios are adversely affected.  There are over 200 drugs that reduce folate, all discussed and listed in my Drug Muggers book.   For that matter, there are many SNPs that cause illness, or personality quirks and traits, so read my article on “Genes, Methylation and Your Health” right now. Please be sure to leave me your comments below, on my forum where we can discuss things together and help one another. Everyone, chime in! 

Copyright © 2014 Suzy Cohen, RPh & Dear Pharmacist, Inc. All Rights Reserved. 

Photography by Melissa Shanley - Web Design by Stephanie Vinson

The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Dear Pharmacist, Inc. Suzy Cohen is a clinical consultant for Essential Formulas, Inc.

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The article below is from the link provided by Suzy Cohen.  This is an abstract of the 10-page journal article; however, the full article is not available to the public, scientists, or doctors without a payment of $89 for 24 hour access.   

http://www.ncbi.nlm.nih.gov/pubmed/25655639

Expert Rev Clin Pharmacol. 2015 Mar;8(2):189-99. doi: 10.1586/17512433.2015.1011125. Epub 2015 Feb 6.

Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms.

Abstract

In contrast to the current belief that cholesterol reduction with statins decreases atherosclerosis, we present a perspective that statins may be causative in coronary artery calcification and can function as mitochondrial toxins that impair muscle function in the heart and blood vessels through the depletion of coenzyme Q10 and 'heme A', and thereby ATP generation. Statins inhibit the synthesis of vitamin K2, the cofactor for matrix Gla-protein activation, which in turn protects arteries from calcification. Statins inhibit the biosynthesis of selenium containing proteins, one of which is glutathione peroxidase serving to suppress peroxidative stress. An impairment of selenoprotein biosynthesis may be a factor in congestive heart failure, reminiscent of the dilated cardiomyopathies seen with selenium deficiency. Thus, the epidemic of heart failure and atherosclerosis that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs. We propose that current statin treatment guidelines be critically reevaluated.



[1] Like with dementia, pharma funds studies to “prove”, and thus create confusion.  However, animal studies have shown that rather than prevent cancer, statins cause cancer.  Given the broken reporting system pharma hides side effect, thus animal studies must be relied upon.  For details See Ignored the Awkward! by Prof Uffe Ravnskov MD, p 84-88—one of the two best book on cholesterol myth.  Pharma has also funded studies to show that statins prevent dementia, while the truth is statins cause dementia.

[2]   The issues are complex, for example vitamin K mechanism should prevent atherosclerosis.  The potential benefit of vitamin K in reducing cardiovascular disease (CVD) risk is due to its function as a cofactor in the post-translational modification of matrix gla protein (MGP) in vascular smooth muscle cells (VSMC). Increased calcification of blood vessels is a risk factor for CVD as it lends to the hardening of arteries and/or to the development of hard atherosclerotic plaque. MGP may play a role in preventing ectopic calcification in the arteries, Wiki.  Other relevant functions is that of osteoporosis prevention because vitamin K is involved in bone remodeling. Where lies the truth about this and other roles has been muddled by pharma producing for financial reason studies to support their business goals—see for some examples.   .  

The Replacement for Statins

PCSK9 lowers LDL, drugs that mimic this enzyme are to replace statins

PCSK9 has medical significance because it acts in cholesterol homeostasis. Drugs that block PCSK9 can lower low-density lipoprotein cholesterol (LDL-C), and are beginning Phase III clinical trials to assess their safety and efficacy in humans, and to determine if they can improve outcomes in heart disease.[2][3]  Variants of PCSK9 can reduce or increase circulating cholesterol.

LDL-C is removed from the blood when it binds to an LDLR on the surface of liver cells, and is taken inside the cells. When PCSK9 binds to an LDLR, the receptor is destroyed along with the LDL particle. But if PCSK9 does not bind, the receptor can return to the surface of the cell and remove more cholesterol.[2]

Other variants are associated with a rare autosomal dominant familial hypercholesterolemia(HCHOLA3).[5][6][7] The mutations increase its protease activity, reducing LDLR levels and preventing the uptake of cholesterol into the cells.[6]  Drugs can inhibit PCSK9, leading to lowered circulating cholesterol. Since LDL is considered a risk factor forcardiovascular disease like heart attacks, it is plausible that these drugs may also reduce the risk of such diseases. Clinical studies, including phase III clinical trials, are now underway to describe the effect of PCSK9 inhibition on cardiovascular disease, and the safety and efficacy profile of the drugs.[8][9][10][11] Among those inhibitors under development in December 2013 were the antibodies alirocumab, evolocumab, 1D05-IgG2 (Merck), RG-7652 and LY3015014, as well as the RNAi therapeutic ALN-PCS02.[12]  Wiki        .

                                                 

^^^^^^^^^^^^^^^^^  Institute for Clinical and Economic Review   Sept 2015

http://www.icer-review.org/pcsk9-draft-report-release/

ICER Draft Report on Effectiveness, Value, and Pricing Benchmarks for PCSK9 Inhibitors for High Cholesterol Posted for Public Comment

Boston, Mass., September 8, 2015 – The Institute for Clinical and Economic Review (ICER) has released a new draft report, titled PCSK9 Inhibitor Therapies for High Cholesterol: Effectiveness, Value, and Value-Based Price Benchmarks. The report includes a comprehensive review of currently available evidence on the newly approved PCSK9 inhibitors alirocumab (Praluent®, Regeneron/Sanofi) and evolocumab (Repatha™, Amgen), and also provides analyses of cost-effectiveness and potential budget impact under different utilization assumptions. Based on these findings the report presents the draft ICER value-based price benchmark for these drugs; prices that reflect the magnitude of estimated improvements in long-term patient outcomes and a threshold for new drug costs that does not exceed growth in the overall national economy.

It has been estimated that as many as 3.5-15 million Americans with elevated cholesterol may be eligible and considered for treatment with PCSK9 inhibitors. But there is remaining uncertainty about interpretation of the existing evidence on the clinical effectiveness of these drugs for different types of patients. In addition, with a list price over $14,000 per year there are serious questions regarding the price at which these drugs would represent a sensible value to patients and to the health care system.

“Patients, clinicians, insurers – everyone needs good information in order to make the best decisions about the use and pricing of new drugs,” Steven D. Pearson, MD, MSc, the Founder and President of ICER noted. “Our goal is to meet that need and in doing so not shy away from analyzing cost-effectiveness and potential budget impact.”

ICER’s draft report summarizes evidence demonstrating that PCSK9 inhibitors reduce LDL-cholesterol by approximately 55-60% among patients who are already on statins or who cannot take them. ICER concludes that this evidence provides moderate certainty that PCSK9 inhibitor therapy improves patient outcomes given remaining uncertainty about whether markedly lower LDL-cholesterol levels will translate into lower rates of heart attack and stroke. ICER’s report also concludes that the two PCSK9 drugs appear to have equivalent overall effectiveness for most patient groups.

The results of ICER’s analyses indicate that the price that best represents the overall benefits these drugs may bring to patients would be between $3,615 and $4,811, representing a 67% discount off the list price. But, as Pearson noted, this price range excludes a critical consideration: potential budget impact.

“Even if these drugs were used in just over 25% of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue on into the future.”

The report concludes that it would take a further price reduction to an annual drug cost of $2,177 for the total costs of these new drugs to come down to a level at which doctors and insurers would not have to try to limit patient use in some way to keep overall health care cost growth within bounds. Pearson concluded, “Our draft report therefore suggests that $2,177 is the price that should serve as an alarm bell –if the cost is more than $2,177 a year, drug companies, doctors, insurers, and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the health care system, or adopt other measures to help make these drugs more affordable.”

The report, as well as accompanying draft voting questions, will be open to public comment until September 22nd at 5:00 PM EDT. Comments should be emailed to info@icer-review.org. ICER will review all comments received and incorporate changes to the report as necessary. A revised draft report and voting questions will be posted on October 6th. Guidelines for submitting public comments, including formatting specifications, are posted on the CEPAC website.

The revised draft report will be the subject of deliberation and vote at the next meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC) on October 27, 2015 in Boston, MA. During the meeting on October 27th, CEPAC members will publicly deliberate on the evidence on comparative effectiveness and value as presented in the report and discuss the findings with a policy roundtable of experts to determine strategies to implement evidence-based recommendations that support effective coverage and use of PCSK9 inhibitors. The meeting will be free and open to the public. There will be a limited number of slots available for anyone wishing to make an oral comment on the report during the in-person meeting. Requests to make an oral comment should be submitted to info@icer-review.org by Tuesday, October 20th.

 

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Relevant Links

The issues raised in the journal article and by Cohen are just the tip of the iceberg.  If you care to know more of the 2nd biggest heist by pharma, click on these links:  Part 7 Videos on YouTube on food, drugs, and health issues    Cholesterol Myth    Cholesterol Myth, source History   Infection in Artery Walls the Major Cause of Atherosclerosis     Statins    CVD Myths:  fats, sugars, cholesterol and statins    Junk treatments  

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