The other day I sat down and wrote PART I of a 25 year overview of EBM (Evidence-Based Medicine) showing you why, if you value your health, it must be taken with a grain of salt --- especially anything FUNDED BY INDUSTRY.  Nowhere is this easier to see than the arena of CHOLESTEROL STUDIES and STATIN DRUGS (I'll go ahead and throw in the newest entry as well, PCSK9 INHIBITORS), and no class of drug is the 'evidence' more hotly contested.  As we start dissecting what science actually says about cholesterol and statin drugs, my hope is that you come away with a better understanding of the fact that "best evidence" is rarely as it appears on the surface.

The very first thing everyone needs to understand when studying the risk-to-benefit ratio of any drug is the difference between RELATIVE RISK -VS- ABSOLUTE RISK.  Allow me to give you a good example.  In last year's flu season, the FLU SHOT had a terrible efficacy.  The medical community touted it as 20% effective, telling the public that twenty percent was better than not getting a shot at all (experts are already promising that this year's season will be equally as bad, with an equally ineffective vaccine --- HERE).  What they did not tell you, however, was that in real numbers, 20% means that the NV (number to vaccinate --- the number of people who must be vaccinated to prevent a single case of flu) is 100.  To further complicate things, we eventually learned that last year efficacy was closer to 10% than 20%, meaning that the NV was (gulp) 200 ---- HERE.  As you will see, the scenario with statin drugs is virtually identical.

Case in point, Dr. Chris Centeno's two online articles on cholesterol and statins (The Cholesterol Drug Problems Two Step: Or How the Tail Wags the Dog in Medicine and Blueberries or Statins to Reduce Heart Attack Risk? Your Call…).  Listen to this specialist in regenerative medicine tell it like it is as far as absolute risk -vs- relative risk.  Note that the absolute difference in risk for statin vs no statin is 1% --- 3% minus 2%.

"For years, I’ve been an ardent critic of the Madison avenue message that we all desperately need to lower our serum cholesterol by taking cholesterol drugs (statins). First, we have observed that these drugs tend to hurt adult stem cells. Second, I’ve had to research them for my own use. In that research, I was appalled at the paltry benefits of the drugs versus the hyped benefits out of the Madison avenue pharma machine. To add insult to injury, major Cardiology meetings these past few years have consistently revealed that the main cholesterol number that the commercials told you was critical is largely meaningless.....   You might be wondering why I didn’t quote the number thrown around by Pfizer for how much the cholesterol miracle cure Lipitor reduces heart attack risk (36%). This is because it’s not a 36% reduction in heart attack risk, but “relative risk”. You get to 36% only after a little creative math quoting that the difference between the percentage of heart attacks in the Lipitor versus the placebo group (2% versus 3%).  Risk reduction for heart attack; eating blueberries, 32% over 18 years; taking statins, 1% over 3.5 years."

Comical if it wasn't so deceptively perverted.  Truth is, when we look at the rare cholesterol study not tainted by industry (2002's Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial that was published in JAMA for example), we see that after following over 10,000 patients for an average of nearly five years, "Pravastatin did not reduce either all-cause mortality or CHD significantly when compared with usual care...."  And this, folks, is exactly what we see time and time again with statins, even though the pharma-funded biomedical community continues to tell us otherwise.  Writing in a 2008 edition of Bloomberg (Do Cholesterol Drugs Do Any Good?), author John Carey answered the rhetorical question he posed in his paper's title.

"Dr. Wright's team was analyzing evidence from years of trials with statins and not liking what it found. Yes, Wright saw, the drugs can be life-saving in patients who already have suffered heart attacks, somewhat reducing the chances of a recurrence that could lead to an early death. But Wright had a surprise when he looked at the data for the majority of patients, like Winn, who don't have heart disease. He found no benefit in people over the age of 65, no matter how much their cholesterol declines, and no benefit in women of any age.   He did see a small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials. But even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalization—despite big reductions in "bad" cholesterol."

This is exactly what a growing number of scientists and cardiologists have been pointing out for a very long time, and it has to do with surrogate markers / surrogate endpoints. In the same way that diabetes drugs lower blood sugar like crazy but don't much alter morbidity or mortality (HERE), statin drugs likewise do a fantastic job of addressing a similar surrogate endpoint.  They unarguably lower cholesterol levels, yet do little to change numbers of heart attacks, strokes, or death rates.  In fact, there are studies we will discuss momentarily showing that statins actually increase death rates.  Now allow me show you the statin family's example of the 1 in 200 statistic I mentioned earlier.

Writing for Medium, Dr. Jason Fung, a nephrologist (kidney specialist) and expert on various forms of FASTING, LOW CARB, and KETOGENIC DIETS, showed in a post the other day that when it comes to statin drugs, the number to treat is 200.  In other words, it takes 1,000 people being on statins to prevent five heart attacks (a great example of O&D that we'll discuss momentarily).  Renowned cardiologist, DR. ASEEM MALHOTRA (remember the name because we'll be meeting him again), agreed with this assessment, while actually upping the ante in June's issue of The Pharmaceutical Journal (Ignorance is Not Bliss: Why We Need More Empowered Patients).......

"Most healthcare professionals know that 80% of cardiovascular disease is in fact caused by lifestyle factors, including an unhealthy diet, smoking and a sedentary lifestyle. But most are not aware of results from high-quality observational studies and randomised controlled trials which reveal that dietary changes rapidly reduce cardiovascular risk in addition to reducing morbidity and mortality.  Even less understood is that overdiagnosis and overtreatment represent a major threat to the sustainability of healthcare, with medical researcher Peter C Gøtzsche estimating, based on the best available data, that prescribed medicine is the third most common cause of death after heart disease and cancer. In 2011, Don Berwick, president emeritus of the Institute for Healthcare Improvement, estimated that around a third of the United States’ $3 trillion expenditure on healthcare brings no benefit to the patient.  And there is an epidemic of misinformation, making it doubly hard for healthcare professionals and patients to know the actual benefits and risks of the treatment they are taking, with biased funding of research, biased reporting in medical journals, biased reporting in the media, commercial conflicts of interest and an doctors being unable to understand and communicate health statistics."

Statins are an integral part of the epidemic of OVERDIAGNOSIS & OVERTREATMENT that is KILLING PEOPLE at an almost unheard of rate --- something you already know if you've been following my site for any length of time.  And like Dr. Malhotra, suggested by his title, EMPOWERING PATIENTS should not simply be something to merely pay lip service.  The primary goal of my website has always been providing you with relevant science-based content that can be put immediately into action.  In other words, I want to empower you so that you can change your life (HERE)! The real question, however, is why, as we near the end of the second decade of the 21st century, is this still an issue?  Allow me to show you by providing a recent history of statins in light of EBM.

In 2014, EBM expert and epidemiologist, Dr. Ben Goldacre, wrote an editorial for the British Medical Journal titled What Statins Tell Us About the Mess in Evidence-Based Medicine (I pulled it from his blog, Bad Medicine), letting readers know that because statins are the world's number one prescribed drug, the evidence for statins should be easy and abundant since there is so much data on the subject.  Instead, he said that despite these mountains of data, there is still "uncertainty about the risks and benefits of statins."  And while he professes to believe that more trials and more data will ultimately solve this dilemma (I'm not holding my breath), listen to his telling conclusions.....

"While disputes over individual numbers are important, the leading protagonists in the statin wars seem, above all, to be suffering under a grand delusion that all patients think like they do. On the one hand, we have clinicians and researchers insisting that no sane patient would refuse a safe simple treatment that reduces their chances of a heart attack by one in 200; on the other, we have clinicians and researchers insisting that one in 200 is a laughable and trivial benefit, which no sensible patient could ever care about."

A couple years ago, in an article titled The End of Evidence-Based Medicine?, Thomas Hagar, a microbiologist / immunologist, took an opposite approach as far as the medical community ever being able to solve this problem, saying of statin drugs; "If there’s any place EBM should work, it’s in the arena of statins, the biggest-selling, most widely prescribed prescription medicines of our time. They are also the most studied, with hundreds of scientific papers assessing their risks and benefits."  The logical conclusion is that if we create enough "good" studies with mountains of "good" data, we could actually solve this problem.  Hagar showed that this is not the case.

"More studies — more EBM — won’t solve the problem. Because the problem is rooted in places that EBM can’t go. In human greed and fallibility, in our proclivity to adopt hard positions and defend them, in our personal ideas of what’s good for our society, and the ways in which these ideas conflict with others. EBM is misused by those who might profit, and when the stakes are high enough, will rarely lead to a consensus accepted by all."

As if this debate weren't confusing enough already, in 2011, COCHRANE, the worldwide organization of scientists and researchers known for their data-crunching meta-analysis of mass quantities of data and turning it into intelligible consensus statements, published a study titled Cochrane Review Questions Evidence for Statins for Primary Prevention in Low Risk Groups that challenged the way society currently uses statin drugs, "after finding selective reporting of outcomes, failure to report adverse events, and inclusion of people with cardiovascular disease in published studies."  In January of 2013 they reversed course with another meta-analysis (Statins for the Primary Prevention of Cardiovascular Disease), this time touting massive benefits of statins.  How massive?  A later study gives the answer.

In October of 2013, the BMJ published yet another study (Should People at Low Risk of Cardiovascular Disease Take a Statin?), this one concluding that "A review of statins for primary prevention of cardiovascular disease could alter guidance for those with a 10 year risk of less than 10%.  Statins have no overall health benefit in this population and that prescribing guidelines should not be broadened."  How broad is broad?  "Under the proposed 2013 standards, however, no level of risk would preclude statin therapy, raising the question whether all people over the age of 50 should be treated."  In other words, the new statin guidelines would have required anyone over age 50 to be on statin therapy (since moved to 40).  Not surprisingly, when we looked at who was writing the guidelines (HERE), we saw why ---- the authors were on big pharma's payroll, in many cases being paid by multiple companies.

This sort of "schizophrenia" is common in pharmaceutical medicine, and especially common in the field of statins and cholesterol guidelines.  Allow me to show you some more of this double-mindedness by showing you a few of the studies on statins published since Y2K.  Listen to these conclusions of a 2001 issue of QJM: An International Journal of Medicine (Age and Gender Bias in Statin Trials).  After looking at almost 15,000 subjects the authors stated, "Statin drug trials have suffered from age and gender bias, having been mainly conducted in middle‐aged male populations. The extrapolation of evidence from these trials to older people and women needs further evaluation."  Interesting in light of the number of studies since then showing that giving geriatric patients statins is all but a total waste of time and money.  Don't believe me?  Look at the material published for our own government's "Choosing Wisely" campaign.

"Many older adults have high cholesterol. Their doctors usually prescribe statins to prevent heart disease.  But for older people, there is no clear evidence that high cholesterol leads to heart disease or death. In fact, some studies show the opposite—that older people with the lowest cholesterol levels actually have the highest risk of death.  Statins have risks.  Compared to younger adults, older adults are more likely to suffer serious side effects from using statins.  Statins can cause muscle problems, such as aches, pains, or weakness. Rarely, there can be a severe form of muscle breakdown.  In older adults, statins can also cause falls, memory loss and confusion, nausea, constipation, or diarrhea.  Often, older adults take many drugs. These can interact with statins and lead to serious problems. Side effects, like muscle pain, may increase. Statins can also cause a fatal reaction when taken with heart-rhythm drugs.  Statins may increase the risk of type-2 diabetes and cataracts, as well as damage to the liver, kidneys, and nerves."

Considering last year's conclusions from JAMA Internal Medicine's famous ALLHAT trial (Anti-Hypertensive and Lipid-Lowering Treatment to Prevent Heart Attack), we can't be surprised.   In this study statins were found to carry "no benefit as primary prevention in the elderly".   Not only that, but the authors determined that, "statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit."  This, folks, is talking about what are known in the medical community as ADVERSE EVENTS.  The craziest thing about AE's is that hundreds of studies (yes, hundreds) have shown that AE's are only reported to the proper authorities slightly more than 1% of the time (not a misprint, click the link).  This means that side effects for almost every drug or class of drug out there are far more common than anyone outside the research community would believe possible --- a fact that phamra works hard at hiding from the general public.  How does this pertain to statin drugs?

The icing on the cake was a 2008 study from Beatrice Golomb's (MD / Ph.D) Statin Research Group at Cal State San Diego (Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism).  Rather than going into great detail here, you can read THE POST I did earlier this year on the 10 year anniversary of this astounding study.  Realize, however, that the bibliography was 900 studies long, going into detail on the many and sundry side effects of statin drugs.  For those of you wondering why a "mitochondrial mechanism" is such a big deal, HERE is the post to look at.  A couple years later, Martha Rosenberg did an interview with a renowned cardiologist and statin researcher whose CV reads like a Who's Who in the field of cardiology (Dr. Barbara Roberts is director of the Women's Cardiac Center at the Miriam Hospital in Providence and associate clinical professor of medicine at Brown University after spending two years at the National Heart, Lung and Blood Institute of the National Institutes of Health).  Here are a few cherry-picked random tidbits of this interview  (Do You Really Need That Statin? This Expert Says No).

"Most trials that prove statins' effectiveness in preventing cardiac events and death have been funded by companies and principle investigators who stand to benefit from their wide use.  Every week in my practice I see patients with serious side effects to statins, and many did not need to be treated with statins in the first place. These side effects range from debilitating muscle and joint pain to transient global amnesia, neuropathy, cognitive dysfunction, fatigue and muscle weakness.  Many doctors have swallowed the Kool-Aid. Big Pharma has consistently exaggerated the benefits of statins and some physicians used scare tactics so that patients are afraid that if they go off the statins, they will have a heart attack immediately. Yet high cholesterol, which the statins address, is a relatively weak risk factor for developing atherosclerosis. For example, diabetes and smoking are far more potent when it comes to increasing risk.  Of course patients will also be staying on the drugs for life unlike trial subjects. Then, the data from the studies are usually given in terms of relative rather than absolute risk. The absolute risk of a cardiac event is only reduced by a few percentage points by statins."

What's doubly interesting is how later in her interview she put much of the blame for this fiasco squarely at the feet of the American Heart Association (an organization that I have shown you time and time again functions at levels of corruption previously seen only in Washington DC and Chicago), referring to them as "big pharma's lap dog" and "hired hands" for industry.  Which brings us to an interesting piece by the always-relevant Gary Schwitzer of Health News Review.  In 2013 he wrote a piece on the AHA titled Statins and Cardiovascular Conflicts of Interest in which he described numerous ways in which the American people are being conned by Big Pharma.  "Both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies."  Schwitzer went on to quote a couple famous cardiologists from an Op Ed written for the New York Times.

"We believe that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy Americans. Instead of converting millions of people into statin customers, we should be focusing on the real factors that undeniably reduce the risk of heart disease: healthy diets, exercise and avoiding smoking. Patients should be skeptical about the guidelines, and have a meaningful dialogue with their doctors about statins, including what the evidence does and does not show, before deciding what is best for them."

In 2014, writing on her blog Heart Sisters (Women and Statins: Evidence-Based Medicine or Wishful Thinking?), Carolyn Thomas showed that even though organizations like the AHA and AMERICAN COLLEGE OF CARDIOLOGY strongly recommend statins for, well, almost everyone (at one time recommending they be put in our nation's water supply ---- HERE), she also revealed that numerous cardiologists and organizations are bucking the system by not recommending statins.  One of the cardiologists that Thomas quoted essentially said what I've stated numerous times on this site.  "If you don’t have heart disease, the best way to avoid getting it is so simple, so easy to understand, and so not up to your doctor.  Pills should never be the basis of preventing heart disease."

As 2015 rolled around we were presented with yet another freaky statin study, this one by a team of six Japanese cardiologists writing in the 'Statins & Lipid Hypothesis' section of Expert Reviews (Statins Stimulate Atherosclerosis and Heart  Failure: Pharmacological Mechanisms), which concluded exactly what the title suggested (you can read my assessment of this study HERE; below is the abstract word for word).

"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-proteinactivation, 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 congestiveheart failure, reminiscent of the dilated cardiomyopathies seen with selenium deficiency. Thus, the epidemic of heart failure and atherosclerosis that plagues the modern world mayparadoxically be aggravated by the pervasive use of statin drugs. We propose that current statin treatment guidelines be critically reevaluated."

And while cholesterol guidelines are constantly being "re-evaluated," the people ultimately making the decisions concerning the blood cholesterol level that statin therapy should be started are all too frequently being paid monster dollars by BIG PHARMA, either outright or as "CONSULTANTS".  Speaking of more studies, the cholesterol flood gates opened wide in 2016, yet again leaving us without a viable medical consensus on statin benefits -vs- statin dangers. 

The biggest of the lot was the cage fight between the United States Preventative Task Force and a group of high-ranking cardiologist / epidemiologists from around the world.  Publishing in JAMA (Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement), "The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 7.5% to 10%."  The 'evidence' was given a rating of Grade B.

Although not it's sole meaning, dyslipidemia includes high cholesterol.  What's critical to understand is that guideline authors, under the effects of pharmaceutical dollars and wielding fear instead of education as their most potent tool, have repeatedly lowered what's considered 'normal' cholesterol levels, accomplishing the desired effect of creating tens of millions of new statin customers.  In the November issue of the Journal of the American Medical Association, two of its editors (both MD's) had this to say of the 'Grade B Evidence' from the study above in an editorial titled Statins for Primary Prevention: The Debate Is Intense, But the Data Are Weak.  "The evidence for treating asymptomatic persons with statins does not appear to merit a grade B or even a grade C recommendation."

The debate got so fierce that the Washington Post published an article in October of that year titled Who Should Take Statins? A Vicious Debate Over Cholesterol Drugs.  Which begs the question; how can two groups look at the same set of data yet come to completely opposite conclusions?  When billions of dollars are on the line, it's not only common, but I showed you a great current example the other day concerning the HPV VACCINE DEBACLE that caused a split resulting in over 1/3 of the executive board of the Cochrane Collaboration resigning.

What did we learn about statins and EBM as 2016 rolled around?  For starters, Steve Mitchell of Consumer Reports wrote a story titled Cholesterol-Lowering Drugs May Be Linked to Diabetes, in which he revealed "Diabetes isn’t a new side effect of statins. The Food and Drug Administration added it to the [warning] label of all statins in 2012 based on a review." Based on advice from his panel of "experts" who were from the ACC / AHA, Mitchell suggested using a "calculator" to figure your own personal risk of developing cardiovascular disease.  Take a guess who invented the "Risk Calculator" (also known as the ACC / AHA Heart Calculator)? The name being a dead giveaway; it was invented two of the most corrupt organizations in all of medicine; the American Heart Association and the American College of Cardiology. 

What did a May 2016 study (Accuracy of the Atherosclerotic Cardiovascular Risk Equation in a Large Contemporary, Multiethnic Real-World Population) say about the accuracy of this calculator?  Only that it "substantially overestimated actual 5-year risk in adults without diabetes, overall and across sociodemographic subgroups."  Overestimation of risk means more statin prescriptions --- way more statin prescriptions.  In other words, this calculator was and continues to be used as a marketing tool instead of something to actually help patients.

Then, in December of 2016, a group of renowned cardiologists led by Dr. Aseem Malhotra (see earlier link) published a scientific paper in the journal Prescriber (More Clarity Needed on the True Benefits and Risks of Statins) revealing why the data for statins appeared, at least on the surface, much better than it really was.  "After closer scrutiny of the evidence, we believe the Lancet paper is misleading."  What "evidence" is Malhotra and crew talking about?   Easy.  They are talking about the number one way that industry fools not only the general public, but peer-review and watchdog agencies as well --- INVISIBLE & ABANDONED STUDIES.  This is the research --- a whopping half of all biomedical studies --- that never sees the light of day because it either goes unpublished or is not completed once the financiers realize it's not turning out the way they had hoped.  Laura Donnelly's article for The Telegraph (Lancet Study on Statins was 'Fundamentally Flawed', Critics Say) put it this way......

"A group of doctors has attacked the Lancet study. Writing in The Prescriber, a group of medics led by cardiologist Dr Aseem Malhotra criticized the way the Lancet research was carried out.  They said some of the data behind the trials had not been published, while some claims about the impact of the drugs on cholesterol were based on forecasts.  Lead author Dr Malhotra said 'Decades of misinformation on cholesterol and the gross exaggeration of statin benefits with downplaying of side effects has likely led to the overmedication of millions of people across the world. The lack of transparency in the prescription of statins is just one symptom of a broken system of healthcare where finance based medicine has trumped independent evidence and what is most important for patients.'  His views were backed by Harvard statin expert Dr John Abramson, Sir Richard Thompson, former president of the Royal College of Physicians, and Professor Sherif Sultan, president of the International Society for Vascular Surgery."

It's time to move into 2017, where I found an ultra-cool study in the aptly-named Journal of Controversies in Biomedical Research (Recent Flaws in Evidence-Based Medicine: Statin Effects in Primary Prevention and Consequences of Suspending the Treatment).  Although this study pummeled statins more ferociously than the beating Khabib Nurmagomedov delivered to Connor McGregor in LAST SATURDAY NIGHT'S CHAMPIONSHIP CAGE FIGHT, there was one particular aspect that was especially telling. 

The authors looked specifically at studies on statin discontinuation.  In other words, if statins are such an incredible life-saver, when people go off of them we should see a dramatic spike in deaths in those specific populations. Not only do we see nothing of the kind, the study's authors, a team of internationally renowned cardiologists, showed that just the opposite might be true.  Listen to these completely CHERRY-PICKED findings from the section of this study titled Statin Discontinuation: Is There Evidence of Increased Mortality?

"Statin discontinuation does not lead to increased heart disease and overall mortality..... On the contrary, one might even conclude that statin discontinuation could save lives.  If statin therapy actually saves lives, discontinuing this therapy obviously raises the question of thereby provoking an increased risk of fatal heart disease complications. So far, only extrapolations and calculations have supported this concern. For instance, a retrospective Danish study estimated the absolute increase in total mortality to be 1.1% in the 10.5 years following statin cessation.....  Regarding specifically heart disease deaths, those supposed to be mainly reduced by statins, one observes again a decrease in 2013 (33,400 deaths) compared with 2012 (34,600) or the 2009–2012 average (35,200). We note that the decreased rate of fatal IHD tended to flatten in the years preceding 2013 (−1200 between 2009 and 2010, −900 between 2010 and 2011, and +200 between 2011 and 2012), leading to expect no decrease or even an increase between 2012 and 2013. On the contrary, there was an unexpected new decrease (−1200) in 2013 indicating that if statin discontinuation had played a role in the rate of fatal heart disease in 2013, it was by preserving lives.  Taken altogether, and contrary to current beliefs, statin discontinuation may not only not result in mortality increase, but it could even have favorable clinical effects. Scientists should seriously examine the issue in the near future by investigating the real effects of statin discontinuation rather than making dubious extrapolations and calculations. In the meantime, patients and physicians ought to just as seriously consider whether statin therapy is useful in each particular case as statin discontinuation definitely does not seem to be associated with deleterious effects...."

As we enter the year of our Lord, 2018, don't forget to browse the study, Association of Statin Exposure With Histologically Confirmed Idiopathic Inflammatory Myositis in an Australian Population, which was published in last month's issue of JAMA Internal Medicine.  The authors concluded that, "there was a statistically significant 79% increased likelihood of statin exposure in patients with idiopathic inflammatory myositis compared with controls."  What is IIM?  Idiopathic inflammatory myositis refers to "itis" (INFLAMMATION) of the heart and surrounding blood supply that is "idos" (origin unknown). 

Not surprisingly, the longer a person had been on statins, the greater their chances of developing IIM.  Between the years 2000 and 2002, 6% of the IIM population was taking a statin.  By 2012, that number had climbed to half for those on statin drugs for a decade or more.  Dr Marc Micozzi (MD / Ph.D) said this of the phenomenon in last month's article, The Blockbuster Drugs Linked to Permanent Heart Damage.  "The severe and debilitating inflammatory myositis does not resolve when statins are stopped. And it can result in a permanent autoimmune disorder." So now we have statins causing, or at least contributing to AUTOIMMUNITY (which it also does with both DEMENTIA and NEUROPATHY)

Look folks, I could have gone on and on and on with this post.  Despite what your doctor is trying to convince you of, statins are not everything they have made out to be. In fact, the more I learn the more I wonder if they are anything they've been made out to be?  For those of you looking for more information, take a peek at the video put together by Dr. Sam Eggersten, a family physician who has been seeing patients since 1979.  And for those of you looking for a way to break free from the pain, inflammation, and chronic conditions you've been plagued with for way too long, be sure and check out THIS ULTRA-COOL POST.  Oh, and don't forget to like, share, or follow on FACEBOOK as it's arguably the best way to reach those you love and care about most with life-changing information.

Just a few short weeks ago I broke down and cried with a patient who had recently been diagnosed with ALS.  It was all I could do to pull myself together to see my next patient.  As a devoutly Christian woman, she is not at all afraid of dying, it's just that dying with ALS (Lou Gherig's Disease) can shake the confidence of even the most devout. Because she's been a patient for such a long time, I'm not really sure if she is on STATINS or not, but after reading Dr. Malcolm Kendrick's article from earlier this week (Statins and Amyotrophic Lateral Sclerosis), I'm certainly going to find out.

In his article, Dr. Kendrick, a Scottish GP, discussed a study from this month's issue of Drug Safety called Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA’s Adverse Event Reporting System.  The authors of this study reported that "These findings extend previous evidence showing that significantly elevated ALS reporting extends to individual statin agents, and add to concerns about potential elevated occurrence of ALS-like conditions in association with statin usage."  Not surprisingly, the study was done by the venerable statin researcher, DR. BEATRICE GOLOMB (MD / Ph.D) and her Statin Study Group from UCSD.  When you see the numbers they came up with, it's nothing less than a shock to the system.

Cholesterol is critical for the proper function of numerous bodily systems.  It makes up the LIPID BI-LAYER OF THE CELL MEMBRANE of all 100 trillion of your body's cells.  It is the precursor for all SEX HORMONES.  GLIAL CELLS make their own cholesterol in order to generate the myelin sheaths that surround nerves.  There are a plethora of others.

After mentioning a 2007 report by another governmental agency (WHO) warning of the same relationship (a relationship denied by our TRUST-US-FDA in 2008 -- HERE), Kendrick started breaking down the numbers for us.  For instance, if you take Rosuvastatin (Crestor), your chances of developing ALS go up over 800%.  If Pravastatin (Pravachol) is your statin of choice, you just increased your chances of developing ALS by 1,500%.  The two most common statin drugs on the market; Atorvastatin (Lipitor) and Simvastatin (Zocor / FloLipid) ratchet up those odds by 1,600% and 2,200% respectively.  And finally, for anyone who might be taking Lovastatin, your chances of developing Amytrophic Lateral Sclerosis just increased by an almost unfathomable 107 times or 10,600%.  Kendrick went on to explain the significance...

"It is often said that association does not mean causation. However, this is only true up to a point. Most statisticians agree that an odds ratio over 6 represents proof of causation. When you find that people taking atorvastatin have a seventeen-fold increase in risk of ALS, this is proof of causation. The effect is too massive to be due to anything else."

For the record, the odds ratios determined for these various statins varied from a low of 6.57 to a high of 167.  Not a misprint.  This means that a rare disease like ALS that would normally affect between nine and ten thousand people a year in the US, is now affecting far greater numbers ---- something we are seeing in Westernized nations around the globe.  Although the statistics Dr. Michael Roizen touts would likely be higher since as near as I can tell he wrote this approximately 15 years ago, pay attention to what the "Chief Wellness Officer" of the Cleveland Clinic said in this quote from ShareCare (How Many People Take Statin Drugs?)

"15 million Americans are now taking a statin drug, according to the large pharmaceutical survey organization (IMS, Instructional Management Systems), most don't take the drug as they should. Only 32 percent take statins as their doctor prescribed -- many skip taking over 50 percent of their pills or even any pills. Furthermore, even though the National Institutes of Health recommends that 35 million Americans take statins, considerably more than that actually do. If all the benefits we think statins provide actually prove to be true, perhaps statins should be taken regularly by almost all of us, as aspirin is, and started at about the same time, age thirty-five or forty. At the present time, we can't recommend that practice, for two reasons. First, as mentioned, statins are so new that we don't know if they have negative effects from long-term use. Second, you don't want too low a cholesterol value, as this may cause neurologic or immune dysfunction."

First off, realize that there are more doctors than you realize who think that in similar fashion to FLUORIDE or CHLORINE, statins ought to be included in our public water supply (HERE).  Secondly, the reason that most people don't take the drugs as they should is because of their zany side effect profile (muscle pain, DEPRESSION, and DEMENTIA are only a few of the known side effects).  Thirdly, why would someone who is a spokesman for medical "wellness" be pushing statins so ardently?  And lastly, the final sentence above reveals that doctors know good and well what statins can do to the nervous system.

Dr. Kendrick went on to show that because adverse events and the death rate of many diseases (ALS included) are not being accurately reported (HERE is a classic example of this phenomenon) the result is that this relationship is not being widely reported either.  Unfortunately, several meta-analysis have shown that adverse events are only reported to the proper authorities between 5 and 1% of the time (HERE).  "So, there are strong signals that ALS has sharply increased in several countries.... Cause and effect? Well, if the study in Drug Safety is correct, there must have been a rise in ALS caused by statins.  If statins are causing ALS in 10,000 people each year in the UK and the US, alone, should we not be demanding an immediate review? Because the number one requirement of medicine is First, do no harm."  When AE's are rarely reported, drugs wind up looking far safer than they actually are.

Be aware that if you are one of the hundreds of millions of Americans struggling with CHRONIC INFLAMMATORY DISEASES (diabetes, heart disease, cancer, high cholesterol, weight issues, etc) or AUTOIMMUNITY, there are some steps you can start taking to restore normal physiology and homeostasis to your system (HERE).  Oh; and if you thought this post was beneficial, be sure and share it with those you love and care about most on FACEBOOK.

It was 10 years ago in April that Dr. Beatrice Golomb, an an MD / Ph.D researcher and professor at Cal State San Diego where she runs the Golomb Research Group (I've mentioned many times on this site (HERE), published her landmark study in the American Journal of Cardiovascular Drugs (Statin Adverse Effects: A Review of the Literature and Evidence for A Mitochondrial Mechanism). What still amazes me about Dr. Golomb's paper is that the bibliography contains just shy of 900 studies (892 to be exact).  And after Golomb's team combed through all that research, she shocked the cardiac care world with these cherry-picked conclusions...

"Statins are a widely used class of drug, and like all medications have potential for adverse effects (AEs).  We hypothesize, and provide evidence, that the demonstrated mitochondrial mechanisms for muscle AEs have implications to other nonmuscle AEs in patients treated with statins. In meta-analyses of randomized controlled trials, muscle AEs are more frequent with statins than with placebo. A number of manifestations of muscle AEs have been reported, with rhabdomyolysis the most feared. AEs are dose dependent, and risk is amplified by drug interactions that functionally increase statin potency, often through inhibition of the cytochrome P450 system. An array of additional risk factors for statin AEs are those that amplify (or reflect) mitochondrial or metabolic vulnerability, such as metabolic syndrome factors, thyroid disease, and genetic mutations linked to mitochondrial dysfunction. Converging evidence and empirical considerations suggest that mitochondrial dysfunction may also underlie many non-muscle statin AEs... such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction. Physician awareness of statin AEs is reportedly low even for the AEs most widely reported by patients."

When it comes to cholesterol, our government, in cahoots with both the medical community and BIG PHARMA, uses a constant stream of PUBLIC FEAR CAMPAIGNS geared at scaring you into wanting to lower your CHOLESTEROL.  And not just to lower your cholesterol (there are plenty of natural ways for the average person to accomplish this), but to lower it via one of the most popular classes of drugs in America, STATINS.  And here's the rub...

You'll never hear me say that statins don't lower cholesterol.  The truth is, they frequently lower it like gangbusters.  The problem is that there is often a massive price to pay for lowering cholesterol with statins, in what Dr. Golomb refers to as "AE's" (adverse events).  Unfortunately, few people are aware of the hundreds of studies that have shown time and time again that AE's are reported to the proper authorities not much more than 1% of the time (HERE), making most medications appear much safer on paper than they are in the real world.  I am going to use today's post to revisit Dr. Golomb's amazing study, because unfortunately, the more things have changed, the more they've stayed the same.

Lest we fail to grasp how important this study was, Dr. Golomb began by telling us that, "Statins have been the best selling prescription drug class in the US and include atorvastatin, the best-selling prescription drug in the world – indeed in history."  While this is no longer completely accurate, it's largely so, with the #1 selling drug still from the statin family of drugs, Crestor (rosuvastatin) instead of Lipitor (atorvastatin).  And because so many people are unnerved by the mere mention of the word cholesterol, Golomb provides and extremely basic lesson in cholesterol physiology, helping make those without medical training aware of the various functions it serves as well as the substances for which it's a precursor. 

• SEX STEROIDS:  ESTROGEN, PROGESTERONE, and TESTOSTERONE, just to name the more common ones, are made from cholesterol.
• CORTICOSTEROIDS:  Corticosteroids, glucocorticoids, mineralocorticoids, and others (cortisone, cortisol, aldosterone, etc) are of critical importance for a wide variety of physiological functions. 
• BILE ACIDS:  Bile (gall) is an important digestive juice that's made by your liver and stored in your gallbladder.  PROPER DIGESTION is compromised without it.
• VITAMIN D:  How cool is it that sunshine turns cholesterol into one of the most important vitamins in your body --- Vitamin D!  Just understand that Vitamin D is not really a vitamin as much as it is a hormone / hormone precursor, with about a jillion important functions.
• LIPID BI-LAYER:  Every single cell in your body is contained within a LIPID BI-LAYER made up largely of cholesterol.

So, as you can see, cholesterol has a lot of important functions. Knowing what these are allows us to start figuring out what sort of AE's a person might have if they deplete their cholesterol or attack the metabolic pathways that either manufacture or utilize cholesterol.   We'll get to that, but first I want to talk about the why of this study --- why are statins such a problem for so many people?  Dr. Golomb sums it up in a single sentence.  "Statins lead to dose-dependent reductions in coenzyme Q10, a key mitochondrial antioxidant and electron transport carrier that serves to help bypass existing mitochondrial respiratory chain defects."  Allow me to explain.

MITOCHONDRIA are the organelles within each cell that manufacture cellular energy in the form of something called ATP.  Every single function of the body requires ATP, and all of the body's numerous chemical reactions (including those that make ATP) are catalyzed by enzymes --- substances that speed the reaction up, in many cases thousands of times faster than would occur without the enzyme.  Co-enzyme Q10 is one such critical enzyme.   What Dr. Golomb is saying is that if you don't have enough CoQ10 to act as a catalyst, not only will you not be able to keep up with your body's massive demands for cellular energy, but you won't be able to bypass any existing "MITOCHONDRIAL RESPIRATORY CHAIN DEFECTS" in a "dose-dependent" fashion. In other words, the higher the daily dose of statins or the longer you've been on them, the greater the chance you have of developing some really nasty health problems.  If you want to see what these look like, click the link and take a look at the pie graph.

As many people are aware, far and away the most common side effects of statins involve muscle.  "The best recognized and most commonly reported AEs of statins are muscle AEs, and include muscle pain, fatigue and weakness as well as rhabdomyolysis."  Most people understand the first group of AE's mentioned, but if you aren't quite sure about RHABDOMYOLYSIS and its relationship to the others, be sure and click the link because Rhabdo is freaky stuff!

Before I move on, I need to talk about a phenomenon seen with almost all drugs, but greatly exaggerated with statins; the ability to be on both the good and bad side of the equation as far as the effects of the medication are concerned.  Allow me to explain.  There are numerous studies that show varying amounts of benefit to certain physiological functions with statins. The example Dr. Golomb used was "improved walking distance".  However, in similar fashion to a bell curve (in this case the bell will be somewhat lopsided), some studies show as many people having problems (AE's) as people being helped.  This is because statins tend to have strong effects either way, positive or negative, and in some cases, both, simultaneously.  For instance, a person taking a statin might be able to walk further without pain, but with every dose is increasing their chances of developing statin-induced AE's.  So, although the gross effect of Dr. G's analysis was that statins don't cause muscle pain, she believes it was because the AE's were balanced out by significant numbers of people who improved on the drugs. 

"Evidence supports the proposition that antioxidant effects of statins underlie (or contribute to) many fundamental statin benefits – including benefits to flow and oxygen delivery and inflammation. These effects may participate in improved walking distance in patients on statins, including benefits to muscle/walking in persons with and without peripheral artery disease. Yet a subset of people reproducibly exhibit increases in markers of oxidation on statins, and the occurrence of this increase has been tied to muscle pain while on statins."

As noted by Golomb and her team, statin-induced muscle problems unfortunately do not always resolve once people stop taking them (be sure to read the comment from Chris Wunsch in my post on Rhabdo above). "Muscle effects arising on statins do not uniformly resolve fully with statin discontinuation."  In some cases, these effects are described as only "partially reversible."  And of these, she describes Rhabdo as "among the best-recognized and most feared complications of statins; it occurs when muscle damage is severe, leading to a marked elevation of CK (e.g. in excess of 10 times the upper limit of normal) often accompanied by evidence of renal dysfunction and occasionally renal failure and death."  The list of other problems directly associated with Rhabdo include severe malfunction of, "heart, pancreas, liver, bone marrow, respiratory function, and central nervous system toxicity" or, as this letter to the editors of the American Journal of Medicine (Multiorgan Failure Induced by Atorvastatin) by a group of three specialists indicated, "all of the above." 

It was the crazy side effects that kept MY FATHER IN LAW from taking statins.  Awesome guy who spent a chunk of a year in Jefferson Barracks polio hospital when he was seven --- iron lung and the whole bit.  Despite the fact that he simply could not take statins because of muscle AE's (something especially problematic is someone with post-polio syndrome), his doctors would hound him on every single doctor visit.  It seems that this is a common theme. 

Dr. Golomb wrote, "Although some investigators promote very low LDL cholesterol targets, proposing that lower is better and no LDL-C is too low, the US FDA has stated that 'all statins… should be prescribed at the lowest dose that achieves the goals of therapy (e.g. target LDL-C level).' Intensive statin treatment in RCTs does not improve mortality, even in patients with heart disease, relative to less intensive treatment. Moreover, intensive treatment comes at the cost of an increased risk of adverse outcomes."  I once had a very young, thin, and at least apparently healthy patient, whom I quizzed as to why he had written on his intake forms that he was on statins.  He replied that since his father had previously suffered a heart attack, his doctor suggested that he should go on statins in order to prophylactically prevent one of his own, especially since he had 'good insurance'.  No lie, his total cholesterol was under 100 --- the physician's target level.  Gulp!

We know that statins cause muscle side effects, but what about other side effects?  "Drug interactions arise when drugs inhibit metabolic pathways of statins, compete for metabolism with statins, or cause similar or interacting toxicity.  Several widely used statins – atorvastatin, simvastatin, and lovastatin are metabolized by the cytochrome P450 pathway."  I've written extensively about BIOTRANSFORMATION, and the body's need to be able to clear toxins (not to mention DRUGS) via the P-450 CYTOCHROME SYSTEM.  If you cannot clear drugs (statins included) from your system, they build up and cause problems.  What sorts of problems?  They affect the body's 'powerhouse,' the mitochondria.

"While a medley of potential mechanisms may cause or contribute to statin AEs, mitochondrial mechanisms have been repeatedly implicated in muscle AEs. Mitochondrial defects predispose to problems on statins. Additionally, statins predispose to mitochondrial defects in all users and, to a greater degree, in [EPIGENETICALLY] vulnerable individuals. Dose-dependent reductions in coenzyme Q10 can reduce cell energy, promote oxidation, promote apoptosis [cell death], and unmask silent mitochondrial defects."

Although the most common AE's are muscle-related, there are plenty of others.  Listen as Golomb explains.  "Muscle and brain are the organs most classically affected in mitochondrial disease (mitochondrial myopathy and encephalomyopathy are classical manifestations of respiratory chain diseases).  Muscle is highly aerobically dependent and selectively vulnerable to mitochondrial pathology.  But given the evidence for mitochondrial vulnerability and pathology related to statin AEs, it merits note that other organs – including brain, liver, heart and kidney – can be affected by mitochondrial pathology as well, and we suggest mitochondrial mechanisms may also be involved in a range of nonmuscle statin AEs."  Without spending inordinate amounts of time on each one, what are these AE's?  In no particular order they include,  "mitochondrial encephalomyopathy, fatigue, cognitive problems, gastrointestinal and neurological symptoms, psychiatric symptoms, sleep problems, and glucose elevations."  All of this begs the question, what can be done to reverse course and get better?

"Randomized trial evidence has little to offer in understanding recovery profiles for statin AEs.  Even for the most commonly reported AEs involving statins, patients state that physicians often dismiss the possibility that their AE may be statin related. Failure to recognize drug AEs can prevent needed reassessment of the risk-benefit profile for statin treatment – and where appropriate, modification of the treatment regimen, in the face of possible or probable statin AEs."

This is exactly what I saw with my father in law.  No matter how serious the side effects or how many times he told his doctors he could not take statins because they caused both pain and weakness, they constantly pushed him to take the drugs.  "Try them again, you might have gotten over your reaction to them.  It may have been a fluke.  Try a different dose.  Try a different drug.  Try that drug with this drug."  It was crazy.  And although the first step in solving AE's of all sorts should probably include supplementing with CoQ10 (as well as calling your doctor to be taken off the statin immediately), there are plenty of others that could make a difference as well.  Chief among those would be diet, which was not mentioned in this meta-analysis, although Dr. Golomb has lectured on EVIDENCE-BASED DIET. 

As you've seen, cholesterol is important.  It's good stuff.  Good stuff.  So, why does it sometimes stick to arteries?  When the body is in A STATE OF PERPETUAL INFLAMMATION, the arterial walls become damaged and in similar fashion to other epithelial tissue barriers, "LEAKY".  The body then uses the wax-like fat, cholesterol, to patch the damage.  This process is also dose-dependant, meaning that the more SYSTEMIC INFLAMMATION, the greater the damage that must be repaired, and the more cholesterol is ultimately deposited on the arterial walls.  And what does society continue doing (medical community included)?  The public is continually told, bad cholesterol, bad cholesterol, bad cholesterol, good statins, good statins, good statins.  And through all of this, there's another dirty little secret that I haven't even mentioned yet.

In similar fashion to our national war on BLOOD SUGAR (via gravy-sucking DIABETES DRUGS), we continue to viciously attack surrogate markers (in the case of statins, cholesterol), while the real markers of health (rates of morbidity and mortality) barely budge --- the whole relative risk -vs- absolute risk phenomenon (HERE).  In other words, even though statins frequently lower cholesterol like crazy, they have far less effect on improving your chances of having heart attacks, strokes, or an early death.  And let's be honest with each other for just a moment; who can trust our current cholesterol guidelines anyway (HERE)?

Just like the FLU VACCINE, which I have been spending a great deal of time on recently, statin drugs don't really do what's claimed of them.  Fortunately, however, if you have issues with cholesterol, there are ways to attack the inflammation that is at the very least, a significant contributing factor (HERE).  And as always, be sure and ask your doctor if it's safe to switch from a diet of TWINKIES and HYPER-PROCESSED GRAINS, to a diet of WHOLE FOODS, based on ANTI-INFLAMMATORY PROPERTIES (I've been a fan of those under the PALEO umbrella for a long time, although KETOGENIC is exciting for helping regulate cholesterol as well).  Dr. Golomb's ground-breaking study is one more proof that your doctor can't do it for you; that real health is largely on your shoulders.

Before I really begin today's post, I want to refresh your memory concerning an under-reported aspect of the practice of medicine --- underreporting.  Failing to report the adverse effects (aka side effects) of DANGEROUS DRUGS AND PROCEDURES is so widespread and common that two huge meta-analysis of the peer-reviewed scientific literature said that at the very best, 1 in 10 serious side effects is ever reported to the proper authorities, with most studies putting that number closer to 1 in 100 (HERE).  Furthermore, we know that the incidence of adverse events in laboratory trials is about 1/8 the number reported in real-world trials on the general population (HERE).  Unfortunately, none of this seems to be changing very much (HERE).

Now; allow me to introduce you to Dr. Beatrice Golomb.  Dr. Golomb (MD / Ph.D) is a professor, author, and researcher at the University of California's San Diego School of Medicine.  Her CURRICULUM VITAE reads like a venerable Who's Who of research medicine.  Among other things, Dr. Golomb heads up the The UCSD Statin Study Group.  If you recall, her team of scientists published 2008's shocking Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism in the April, 2008 issue of the American Journal of Cardiovascular Drugs (HERE).

The aspect of this study that left most readers so shell-shocked was not only the frequency and severity of the reactions to STATIN DRUGS, but the fact that her team reviewed 892 studies to come to their conclusions.  What conclusions? 

"Statins are a widely used class of drug, and like all medications have potential for adverse effects.  We hypothesize, and provide evidence, that the demonstrated mitochondrial mechanisms for muscle adverse effects have implications to other nonmuscle adverse effects in patients treated with statins.  Converging evidence supports a mitochondrial foundation for muscle adverse events associated with statins, and both theoretical and empirical considerations suggest that mitochondrial dysfunction may also underlie many non-muscle statin adverse events. Evidence from trials and studies indicate the existence of additional statin-associated adverse events, such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction. Physician awareness of statin adverse effects is reportedly low even for the adverse events most widely reported by patients."

This cherry-picked paragraph is not to difficult to decipher.  After digging through almost 1,000 studies on the subject, Golomb's team found that beyond their most common and well-known side effect --- STATIN-INDUCED MUSCLE PAIN --- there are a wide variety of others nasty side effects as well.  Because these side effects are believed to occur primarily in the mitochondria --- the part of your cells responsible for manufacturing energy, and because each and every cell in your body contains thousands of these organelles --- the side effects of Statin Drugs can affect virtually any and all parts of your body.  Furthermore, doctors continue to promote CHOLESTEROL as the problem, while touting Statins as the cure, yet always underplaying their ugly side effects.

A recent issue (July 1) of the oldest scientific journal in America, Scientific American, asked a question via the title of an article in their "Neurosciences" section --- Do Statins Produce Neurological Effects?  The article's author?  Dr. Beatrice Golomb.  Because the article is so short (literally a one minute read), I am giving you the link (HERE).   But this is not where I want to stop discussing Dr. Golomb's work.

Because I deal with so many people who have various forms of CHRONIC PAIN --- often times related to the FIBROSIS or SCAR TISSUE that develops in FASCIA (the mucousy cellophane-like membrane that surrounds muscles and other tissues) due to trauma, POSTURAL CONSIDERATIONS, or Inflammation (HERE) --- I have been fooled in the past by musculotendinous pain caused by Statin Drugs.  Unfortunately, Statins are not the only drug that cause these sorts of adverse events; not by a long shot.  Enter Fluoroquinolone Antibiotics.

If you've followed my site for very long, you already realize the importance I put on GUT HEALTH.  There is probably nothing greater you can do to foul your family's health (often times permanently) than to give them ANTIBIOTICS on any sort of regular basis.  What do I mean by "regular" basis?  HERE'S THE ANSWER.  And while all antibiotics are bad news, there is one kind of antibiotic that is particularly bad news because of its propensity to cause debilitating (and often permanent) muscle and tendon pain / degeneration --- FLUOROQUINOLONE ANTIBIOTICS.  There is little research going on in trying to figure out why. 

Just over a year ago, the author of the website My Quin Story: Life After Levaquin, A Challenging Journey published a post called Fluoroquinolone Academic Research Update – Dr. Beatrice Golomb UCSD.  THE AUTHOR, who was "Floxed" (debilitated by Flouroquinolone Antibiotics) in 2007 at age 47, wrote that.....

"Dr. Golomb has been tenaciously trying to get a paper of case studies published on a group of floxies for several years. Her attempts have been met with rejection. She acknowledges that the rejection comes from the nature of questioning pharmaceuticals in the current research environment, but she remains undaunted and will continue."

Dr. Golomb is actually trying to get enough people (10,000) for a study (HERE) that will help to explain why some people end up essentially crippled after taking this kind of antibiotic.  Considering what I know about this class of drug, whose side effects are grossly under-reported as well (they are usually blown off by the medical professionals who treat them as unrelated or arthritis), what she is doing is super extra cool.  But Dr. Golomb is studying an equally cool topic as well --- the fact that there are more problems with vaccines than meet the eye.

If you are interested in seeing some of Dr. Golomb's work in the area of vaccines (BTW, she is also one of the world's foremost experts on Gulf War Syndrome), take a look at the symposium she spoke at a few years ago in Jamaica (THE VACCINE SAFETY CONFERENCE). It seems that Dr. Golomb is raising the same issues I have been raising with my numerous VACCINE POSTS for over two and a half decades.  All I can say is bully for her!  Any brilliant physician who is willing to lay it all on the line in order to ask the hard questions is nothing short of a hero.  Remember that as much as questioning vaccine policies in modern America can get even the most credentialed professional blacklisted (HERE is a prime example).

Below are a couple of videos of Dr. Golomb's presentations, much of which center around the fact that WE CANNOT TRUST MEDICAL RESEARCH to have our best interest in mind.

Back in the Dark Ages, people believed that decaying flesh caused maggots.  After all, turn over any dead animal with you foot, and what did you see?   Despite our scientific advances, beliefs haven't changed much.  We still have a medical profession that ERRONEOUSLY BELIEVES germs are the sole cause of infectious disease --- while the VERY DRUGS they prescribe to kill said germs destroy our collective immune systems.  And while there are any number of other examples, the current example of STATIN DRUGS might just take the cake.

Although mainstream medicine has been increasingly squawking about HIGH CHOLESTEROL LEVELS for decades, there is opposition --- a steadily growing group of renegades within the profession that thinks the hype over High Cholesterol is mostly a bunch of poppycock CREATED TO MAKE MONEY.  This was brought to the forefront with Dr. Golomb's ground-breaking 2008 study (Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism).  According to the University of California in San Diego, "The UCSD Statin Study group, headed by Beatrice A. Golomb, MD, PhD, has actively been researching statin medications and their risk-benefit balance, including possible side effects".  After REVIEWING NEARLY 900 STUDIES on the topic, her group concluded that....

"Converging evidence supports a mitochondrial foundation for muscle adverse events associated with statins, and both theoretical and empirical considerations suggest that mitochondrial dysfunction may also underlie many non-muscle statin adverse events. Evidence from randomized controlled trials and studies of other designs indicates existence of additional statin-associated adverse events, such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction.  Physician awareness of statin adverse events is reportedly low even for the events most widely reported by patient.  Statins are a linchpin of current approaches to cardiovascular protection: however, adverse events of statins are neither vanishingly rare nor of trivial impact."

Golomb's researchers are not a lone voice in the wilderness.  If you have the academic credentials, you could join a group called THINCS (The International Network of Cholesterol Skeptics).  Led by UFFE RAVNSKOV MD / Ph.D, the members of this organization believe that animal fats and cholesterol are not the primary culprits in heart disease and high cholesterol ---- something I myself have written about any number of times (HERE is one of them).    Their website has a huge list of studies and articles to this effect.  But there's more.

We have been browbeat with the idea that Stain Drugs can be our savior --- if we can just get enough people on them.  For example, it's not science fiction that in similar fashion to CHLORINE & FLUORIDE, there is a movement within the medical community attempting to get Statins infused into our water supply (HERE).   Stop for a moment.  What if I told you something so shocking that you would probably dismiss it outright?  What if it were discovered that not only are Statin drugs not helping us in terms of heart disease and hardening of the arteries (arteriosclerosis / atherosclerosis), but are actually making the problem(s) worse?  Would you believe me or would you write it off as another rant?

It might be easy to write me off, but it's much tougher to write off a study published by a group of seven cardiology researchers in the February, 2015 issue of Expert Review of Clinical Pharmacology (Statins Stimulate Atherosclerosis and Heart Failure: Pharmacological Mechanisms).    Read the title of the study again, and pay attention to their conclusions.

"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."

Gulp!  Although I have been beating this same drum for over two decades (HERE is the main reason why), I did not expect to see the day when doctors actually admitted that the drugs they are prescribing for high cholesterol and heart disease are causing the very problems they are prescribing them for in the first place --- an almost identical scenario to what we've seen with OSTEOPOROSIS DRUGS.  And while a rapidly increasing number of researchers are coming to THE CONCLUSION that dietary cholesterol or saturated fat is not a health risk, our nation's treating physicians are slow to catch on.  For instance, despite the recent revelation by our government that the cholesterol in your food has almost no bearing on the amount of cholesterol in your blood, we get a steady stream of this sort of thing from mainstream medicine --- and unfortunately, our government. 

The government's new 'Dietary Guidelines' --- guidelines that still; despite the dietary debacle of the past three decades, continue to beat the drum for, "grains (at least half being whole grains), fat-free and low-fat dairy, soy...."  On average we...  are right on target for grains; and those under 13 years old consume only about 1/2 the amount of dairy recommended....  are very very low on fish-derived protein; and also high on solid fat consumption."  The only fish that has any health benefit is wild, cold-water fish (HERE).  And as to the solid fats (Saturated Fats), click on the previous link.

In the January 11th issue of the British Medical Journal's Evidence-Based Medicine Blog, Dr. Geoffrey Modest discussed these recommendations by saying, "Several very large observational studies have not found that eating foods high in cholesterol is much of a cardiovascular risk factor. Also, as a perspective, only a small minority of circulating cholesterol (about 20%) is from diet, most is from genes…."  But are these two sentences really true?

The first sentence is completely true.  However, the idea that we can blame our Cholesterol woes ON OUR GENES and not our diets is totally and ridiculously false.  Wait a minute.  How can this idea be false, when I agree with Dr. Modest's assertion that dietary cholesterol does not cause high blood levels of cholesterol?  The problem is not the cholesterol we are consuming; it's our NATIONAL ADDICTION TO SUGAR AND JUNK CARBS!  Although the government is telling us that our grain consumption is just about perfect, many of us know better (HERE is the ridiculous diet they continue to recommend).  Grain is what you fatten farm animals with.  And this doesn't even begin to touch on the issue of grains as they relate to FOOD SENSITIVITIES.  It's no wonder that America is in the throes of an epidemic of Cardiometabolic Syndrome.

Although you may have never heard the term, Cardiometabolic Syndrome (sometimes referred to simply as Metabolic Syndrome or its old name, Syndrome X), it is yet another of the 'epidemics' currently raging in America.   In order to be "officially" diagnosed with Cardiometabolic Syndrome, you must have three of the following.

• HYPERTENSION:  Hypertension is another name for HIGH BLOOD PRESSURE.  A study from the 2005 issue of Lancet (Global Burden of Hypertension....) said that over 26% of the world's adult population had Hypertension as of Y2K.  The CDC puts the percentage of American adults currently dealing with Hypertension at almost 30% (70 million).

• HIGH TRIGLYCERIDES:  This means you have too much fat in your blood.  According to CDC statistics, somewhere between one in four and one in three Americans has High Triglycerides.  What causes fat in the blood?  I've shown you already that it is junk carbs and not dietary fat.

• CENTRAL OBESITY:   In case you were not aware, BELLY FAT is a risk factor for every health problem you could name in the next five minutes.  And on top of that, an estimated 7 to 10% of our population is MEDICALLY OBESE, NORMAL WEIGHT (MONW aka "Skinny Fat").  Likewise, if your BMI is over 30, or your waist is over 35 inches for women and 40 inches for men, you are OBESE.  According to CDC statistics, nearly 7 out of 10 Americans are overweight or obese.

• HIGH FASTING BLOOD SUGAR OR ABNORMAL A1C TEST:  This is largely due to LIVING THE HIGH CARB LIFESTYLE.  Both are heavily associated with both early puberty and PCOS. However, it is critical to remember that DIABETES is not so much a blood sugar problem as it is a problem of unbridled Inflammation.  The CDC says that nearly 10% of the American population (over 29 million) have Diabetes.  The number with INSULIN RESISTANCE (pre-Diabetes) is thought to be nearly double this.  My guess is that this last statistic is grossly underestimated.   Interestingly enough, one of the main risk factors for developing Dysglycemia seems to taking medication --- virtually ANY OF THEM.

• CHOLESTEROL RATIO ISSUES:  Although today's doctors are certainly concerned with Total Cholesterol levels over 200, you will earn a diagnosis of Cardiometabloic Syndrome if your HDL ("good" cholesterol) is too low, and your LDL ("bad" cholesterol) is too high.  According to the CDC's 2015 article, High Cholesterol Facts, 73.5 million adults (31.7%) have this problem.

• PROTEIN (ALBUMIN) IN THE URINE:  Your kidneys should be filtering protein out of the urine.  Kidney damage is a hallmark of Diabetes.  If you are not filtering protein, it's a good indication you have some sort of blood sugar dysregulation going on.  In fact, WebMD's article on the subject states, "Albuminuria is most often caused by kidney damage from diabetes".

• INCREASED CRP (C-REACTIVE PROTEIN LEVELS:  Although this test is fairly generalized, it is indicative of SYSTEMIC INFLAMMATION.  Because Inflammation is the root of virtually every health problem under the sun, it would behoove you to click the link and spend three minutes to understand it.

When your doctor EXAMINES YOU and realizes that you have at least three of the above bullet points, you will be "officially" diagnosed with Metabolic Syndrome.  Rest assured that you will be put on Statin Drugs.  I won't lie to you; these drugs lower cholesterol like crazy.  But interestingly enough, they only lower your chances of heart attacks, strokes, and death, slightly --- MANY STUDIES say not at all.

Back to the dead-animals-causing-maggots example from the beginning of this post.  We all know the maggots came from flies, not from the decaying meat itself.  We need to think of cholesterol in similar fashion.  Unless you truly have a genetic cholesterol issue (relatively rare, although this is what EVERYONE IS TOLD), cholesterol is not your problem.  Cholesterol just happens to be the material that your body uses to patch the damage to your blood vessels caused by INFLAMMATION.   It's also why TOM BRADY is largely correct as to the diet eaten by he and his family.

First it was RED MEAT & SATURATED FAT that was killing us.  Then it was eggs.  After that came the campaign against SALT.  One of the biggest targets of medical malignment (and PHARMACEUTICAL RICHES) has been CHOLESTEROL --- mostly via STATIN DRUGS.  And on top of all this, most doctors are still urging people to eat a LOW FAT DIET (although thankfully, this last point is subsiding to a small degree).  Forget the Statin Drugs though.   When it comes to lowering Cholesterol there's a new sheriff in town; the PCSK9 Inhibitors.

PCSK9 is the common terminology used to describe the enzyme encoded by the Proprotein Convertase Subtilisin / Kexin type 9 gene.  PCSK9 helps create the enzyme that binds to the receptor for the so-called "bad" Cholesterol ---- LDL (Low Density Lipoprotein).  According to the government's National Institutes of Health (Genetics Home Reference' PCSK9)......

"The PCSK9 gene provides instructions for making a protein that helps regulate the amount of cholesterol in the bloodstream.   The PCSK9 protein appears to control the number of low-density lipoprotein receptors, which are proteins on the surface of cells. These receptors play a critical role in regulating blood cholesterol levels. The receptors bind to particles called low-density lipoproteins (LDLs), which are the primary carriers of cholesterol in the blood."

If you can somehow "block" the PCSK9 gene, there will be more receptors --- mostly in the liver --- that bind to LDL, and remove it from the bloodstream, thus lowering blood levels of 'bad' Cholesterol.   If you believe that Cholesterol is the root of all evil, this sounds fabulous.  For those few who have "genetic" high cholesterol (Familial Hypercholesterolaemia), it might be fabulous.  The problem is, advertisements for Statin Drugs have brainwashed the American people in two unique ways.  Allow me to explain.

The highlighted paragraph above was cherry-picked, meaning I removed a couple of sentences for the sake of space and clarity.  One of those sentences read thusly, "Cholesterol is a waxy, fat-like substance that is produced in the body and obtained from foods that come from animals."  This statement is patently untrue, as even the most current governmental guidelines on Cholesterol ("GUIDELINES" tend to run far behind current research) have abandoned this idea (HERE).   Believing dietary Cholesterol has much of anything to do with blood levels of Cholesterol is a huge part of what leads doctors to ignore THIS, while promoting something more akin to THIS.

Secondly, very few people with high blood levels of Cholesterol or Triglycerides are that way because of "genetics" --- even though this is what large numbers of patients are being told.  An acquaintance had a heart attack at age 30, discovering at that time he had a Triglyceride reading of 18,000 (under 150 is considered "normal," with anything over 500 being considered "high risk").  I once had a patient whose total cholesterol was something like 1,500 without meds, and 450 controlled.  These are people who actually have a 'genetic' issue.  The rest of you have an EPIGENETIC ISSUE. 

Unfortunately, none of this has stopped drug companies from preying on those who have bought into these two misnomers.  The company / drug that most readily comes to mind is Merck's VYTORIN, with their clever TV commercials a few years back.  Vytorin is a Statin Drug (it contains another Cholesterol-lowering medication as well), about which their website states....

"Let's start with a fact that may surprise you. Did you know your cholesterol comes from two sources? That's right, not only does cholesterol come from food, but it also has a lot to do with your family history.  This may explain why your LDL (bad) cholesterol could still be high, even though you're trying hard to lower it with diet and exercise.  When diet and exercise aren't enough, adding VYTORIN can help. Ask your doctor if VYTORIN is right for you."

This new wave of drugs is about to make Statins passé.  As the medical community moves forward in its never-ending war on Cholesterol (they are actually being 'pushed' forward by Big Pharma), it is PCSK9 Inhibitors that are proving themselves to be the gold mine du jour.  As I showed you earlier, PCSK9 Inhibitors reduce Cholesterol levels via blocking the PCSK9 gene.  For the most part, this is being done via introducing genetically modified "Monoclonal Antibodies" (most of these drugs end in the suffix "mab"), which are cultured in MICE, YEAST, or viruses.  However, in similar fashion to WHAT'S BEING DONE WITH BLOOD PRESSURE, it's vaccines that are proving to be the delivery method of choice as far as the new anti-cholesterol drugs are concerned.  How do these vaccines work?

Instead of introducing a "germ" so that one's Immune System can make antibodies against it, an AUTOIMMUNE REACTION is induced.  Viruses that have had their DNA removed are used as the carrier to get the vaccine against the PCSK9 gene where it is wanted.  According to that venerable wellspring of knowledge and truth, Wikipedia, the "vaccination was associated with significant reductions in total cholesterol, free cholesterol, phospholipids, and triglycerides."   Not surprisingly, I.A. (Induced Autoimmunity) is the direction that any number of the NEARLY THREE HUNDRED VACCINES CURRENTLY IN DEVELOPMENT are headed.  As a side note, the "mab" drugs (Monoclonal Antibodies) also happen to be used to treat various Autoimmune Diseases such as RA.

What are the side effects of these sorts of drugs?  Who knows and who really cares --- just as long as they lower Cholesterol.  According to the medical site Healthline.com (PCSK9: What You Need to Know; Side Effects and Risks), "Adverse events were reported in 69 percent of people taking evolocumab in the clinical trials. Injection-site swelling or rash, limb pain, and fatigue were some of the reported side effects.  In the alirocumab trials, adverse events were reported in 81 percent of participants taking the drug. These included injection-site reactions, muscle pain, and eye-related events.   Long-term side effects and risks are not yet known".  According to Wikipedia, these effects were severe enough during the studies that, "Before the infusions, participants received oral corticosteroids, histamine receptor blockers, and acetaminophen to reduce the risk of infusion-related reactions, which by themselves will cause several side effects."  The effects they are talking about can be seen HERE.

Thus far, the worst side effect of PCSK9 Inhibitors seems to be one of same side effects associated with Statin Drugs --- Neurocognitive Dysfunction (HERE).  However, you should not be surprised to see a massive spike in side effects as these drugs begin to hit the market.  Firstly, because we know that numerous meta-analysis show that only about 5% of any drug's side effects are actually reported to the proper authorities (HERE).  Secondly, these drugs are lowering cholesterol levels to previously unheard of levels.   What?  I was under the assumption that you could never be too rich, too thin, or have Cholesterol levels that were too low.

Writing for the July 11, 2013 issue of CNN's website (New Drugs Could Drop Cholesterol to Extreme Lows) author Matt Sloane wrote, "With a statin medication, you can often get somebody's cholesterol between 70 and 100 mg/dL," said Dr. Elliott Antman, president-elect of the American Heart Association and a dean at Harvard Medical School. "If you use these monoclonal antibodies, you could see a number way less than 50."  Once you understand why Cholesterol is necessary for good health (HERE is one reason) you'll begin to see the madness in this idea of pushing Cholesterol levels to, "way less than 50.".  And what about the financial cost? 

Suffice it to say that the cost of PCSK9 Inhibitors is through the roof.   In a recent article for Formulary Journal called Move Over Sovaldi: Could PCSK9 Inhibitors be a Bigger Cost Challenge?, Tracey Walker wrote, "The cost of these drugs will add nearly $50 per month to the premium costs for every insured person in the United States,” said Don Hall, a former health plan CEO of Delta Sigma LLC, in Littleton, Colo. “If this was the last of the high-cost, high-use pharmaceuticals, the system could adjust and move forward. Unfortunately it's only the beginning as new drugs for a range of neuromuscular diseases and cancer are poised to hit the market in the next few years. We are quickly getting to the point where healthcare costs crush our economy."

It seems as though Hall may be underestimating these costs by a wide margin.  I recently read a report saying that the 33% average cost increase for your Health Insurance for the upcoming year (2016) can be largely attributed to this new class of Cholesterol drug (along with the new Hep C drugs).   But unlike the over-priced Hepatitis drugs, which have a cure rate of 90% (at a three month cost of almost $100,000) these drugs cure nothing.  They only lower Cholesterol levels, and will need to be taken (according to most doctors) for the rest of your life.  Although I have seen a wide array of cost estimates online, the most common seems to be in the $1,000 per month range --- or about $12,000 per year.   This is on top of the cost for your Statins ($50 - $500 per month).

Here's the scoop folks, unless you have true "Familial Hypercholeterolemia" (genetic High Cholesterol), you don't need PCSK9 Inhibitors.  Which begs the question of how common this particular disease really is.  According to the July, 2014 issue of the European Heart Journal (Homozygous Familial Hypercholesterolaemia....), "Historically, the frequency of clinical HoFH has been estimated 1 in 500, although higher frequencies [can be seen] in specific populations."  This mimics what Clinical Biochemist Reviews (Familial Hypercholesterolaemia) stated back in 2004.  In other words, there are approximately 650,000 Americans who might benefit from these sorts of drugs.  Bottom line; most of you do not need to be begging your doctor for a prescription.

Just the other day I saw yet another article suggesting we need to put STATIN DRUGS in our drinking water.  Nope; I am not making this up.  There are lots of doctors who believe that virtually everyone could benefit from LOWER CHOLESTEROL LEVELS.  Amazing, considering their known side effects (click the links to see what I mean).  One of my favorite articles on Statin Drugs is called Dangers of Statin Drugs: What You Haven’t Been Told About Popular Cholesterol-Lowering Medicines by Sally Fallon and Mary G. Enig, PhD.  When you read this and other newer articles / studies, you quickly learn that not only are side effects of statins not rare, they are actually rather common (HERE).  It seem that for some reason, the British Medical Journal, one of the oldest and most respected medical journals on the planet, does not want you to know this.

Dr Fiona Goodlee, the editor-in-chief of the BMJ, recently withdrew two scientific papers from their
archives, denounced the results of the studies, and is in the process of forcing retractions from the study's authors.  Trust me when I tell you that these studies were not done by Bevis and Butt Head.  The first study, by Dr. John Abramson (MD) of Harvard Medical School was called Should People at Low Risk of Cardiovascular Disease Take a Statin?  The study concluded that, "The evidence does not show that the benefits of statins in low risk patients outweigh the harms and that the advice for treatment of this group should not be changed."  Later that same week, Aseem Malhotra, an interventional cardiology specialist registrar at Croydon University Hospital in London, England published an editorial in BMJ called Saturated Fat is not the Major Issue.  The jist of the paper was that TRANS FATS and SUGAR / CARBS seem to be the driving force in Cardiovascular Disease and METABOLIC SYNDROME / DIABETES, not SATURATED FATS --- a fact I have belabored on this site.

Although Goodlee herself has been the hatchet-person for these studies, the actual act of retraction has been left up to others.  She decided that, "the right thing to do is to pass this decision to an independent panel."  In the immortal words of Dana Carvey, "Isn't that special".  I'll not get into what "INDEPENDENT PANELS" tend to look like, but suffice it to say that they are rarely as "independent" as they claim to be.  Folks; this is EVIDENCE-BASED MEDICINE at its finest.  Sort of makes you wonder how much money / favor changed hands in this filthy little tryst.

Medical research is a funny thing.  And because of this fact, it's quite difficult to know how much faith to put in it.  Take for instance the most recent study on STATIN DRUGS (HMG-CoA-reductase inhibitors) --- the class of drugs used to to lower CHOLESTEROL.  A recent meta-analysis (11 studies) published in the Journal of Sexual Medicine was introduced in a tele-briefing from a physician working at Rutgers Medical School --- Dr. John Kostis.  Kostis suggested that according to this latest research, Statin Drugs can improve scores on the International Inventory of Erectile Function (IIEF) questionnaire by over 20% (3.5 points out of 17 questions).  The IIEF was developed by Pfizer --- the manufacturers of Sildenafil (Viagra) --- working with researchers also from Rutgers. 

We know that Statins have plenty of side effects (take a look at the links above).  Could one of their 'good' effects really be that they can help men who have PERFORMANCE ISSUES in the bedroom?  If so, this would be news to me.  I have been following the scientific literature pretaining to both SEXUAL DYSFUNCTION and Statins for many years, and have yet to see anything quite so optimistic as the spate of recent headlines promoting this latest study.  In fact, over the course of the past decade, I have seen numerous doctors and studies touting the exact opposite. 

Other than anecdotal reports from patients, the first time I became aware that there was a relationship between Statins and Impotence came from a June 2004 study published in the British Journal of Clinical Pharmacology (Is Decreased Libido Associated with the Use of HMG-CoA-Reductase Inhibitors?).  The author's conclusions?  "Decreased libido is a probable adverse drug reaction of HMG-CoA-reductase-inhibitors.....  The ADR [Adverse Drug Reaction] may be caused by low serum testosterone levels, mainly due to intracellular cholesterol depletion."

A few years later came 2008's bombshell.  Dr Beatrice Golomb (MD, PhD, Professor of Medicine and director of the Statin Study Group at UC San Diego School of Medicine) published a freaky study citing nearly 900 peer-reviewed papers showing just how harmful Statin Drugs could really be.  The meta-analysis (Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism) was published in the American Journal of Cardiovascular Drugs, and listed absurd numbers of side effect directly attributable to Statins.  Of course, plenty of air-time was given to the all-to-common MUSCULAR PAIN associated with these anti-cholesterol medications.  But numerous other studies were touting other less well-known side effects, including ALZHEIMER'S, NEUROPATHY, INSULIN RESISTANCE, DIABETES, TENDINOPATHIES / FASCIAL WEAKNESS.  Oh; and let's not forget "Sexual Dysfunction" made the list as well.  Unfortunately, Dr. Golomb's teams concluded that when it comes to Statins, "Physician awareness of such side effects is reportedly low".

This issue came up again (no pun intended) in 2009 when Dr. Golomb published research linking Statin use to decreased sexual pleasure and diminished orgasm intensity.  The study, which looked at over 1,000 adults, revealed a drop in male sexual pleasure by nearly 50% --- in only six months on certain Statin Drugs.  Women were also affected.  The drugs that decreased LDL the most, seemed to be the worst offenders.

The hits kept coming in 2010 when the Journal of Sexual Medicine (The Effect of Statin Therapy on Testosterone Levels in Subjects Consulting for Erectile Dysfunction) looked at 3,500 men and then came to some ugly conclusions.  Listen to these words taken straight from the study's abstract.  "Both total and calculated free testosterone levels were significantly lower in subjects taking statins. Our data demonstrated that statin therapy might induce an overt primary hypogonadism [shriveled testicles] and should be considered as a possible confounding factor for the evaluation of testosterone levels in patients with ED."   Gulp!  Web MD dot com actually carries this headline on their website, "Statins May Lower Testosterone & Libido. Men With Erectile Dysfunction on Statin Therapy Are Twice as Likely to Have Low Testosterone."  But in all honesty, none of this should come as a surprise. 

Cholesterol is the precursor for all the sex hormones, including Testosterone.  The thing is, never forget that Testosterone is the hormone that not only creates and maintains the male sex drive, but the female sex drive as well.  When you start tinkering with Cholesterol levels in an unnatural method (i.e. drugs), you are going to get some crazy side effects, including the potential inability to get an erection sufficient for sex.

By the time 2011 rolled around, sales of Statin Drugs were booming, and SEXUAL FREQUENCY in Americans was decreasing dramatically (HERE also).  Coincidence?  You decide.   The "Space Doc" (Duane Graveline, former USAF flight surgeon, former NASA astronaut, and retired family physician) published an article on his site called, "Sexual Side Effects of Statins: Impotence, Loss of Libido and Erectile Dysfunction - ED"  Listen to what Dr. Graveline says about Cholesterol.  "Cholesterol is perhaps the most important substance in our lives for we could not live without an abundant supply of it in our bodies. Researchers everywhere are learning how extraordinarily complex and often surprising are the pathways that produce and metabolize cholesterol. Cholesterol is the precursor for a whole class of hormones known as the steroid hormones that are absolutely critical for life, as we know it. These hormones determine our sexuality, control the reproductive process, and regulate blood sugar levels and mineral metabolism. This same substance that society has been taught to fear happens to be the sole source for our hormones, androgen, estrogen and progesterone."  He goes on to cite a number of Statin studies that I have not mentioned, as far as their tendency to cause impotence.  You can read his entire article HERE.

The March 10, 2012 issue of The Morning Call (newspaper) had an article on Statin Drugs written by a knee surgeon.   The article started out saying, "What does a knee surgeon know about statins' side effects? Plenty, after seeing scores of patients improve their memory, strength, vigor and sex drive after stopping these popular drugs."  The author, Dr. Thomas Meade of Allentown, Pennsylvania went on to say that, "A recent Cochrane Review of many studies confirmed 1,000 people without heart disease had to be treated with statins to prevent one death. Therefore 999 people, paying $5 per pill, are not going to live one day longer, but they will enrich the pharmaceutical industry's coffers and are at risk for the many real side effects of stopping production of cholesterol — a wonderful molecule responsible for healthy cell membranes, sex hormones, nerve conduction and brain function, all of which contribute to life as we know it today.  Statins are simply the most prescribed drug in the history of medicine and the most profitable, with annual revenues of $26 billion. Profits are so lucrative to "big pharma" that drug manufacturers have influenced most medical organizations and respected high-profile physicians to continue to look for every opportunity to exaggerate any new study that validates prescribing the highest dose of statins to an increasing patient population under the false assumption that it will improve their quality of life."  Hopefully you caught those parts about Cholesterol and sex hormones / sex drive.

Then in 2012, both Dr. Mercola's site and Britain's NetDoctor site (comparable to our "Web MD") told us that Statins tend to cause "impotence".  Think about it like this for a moment.  Impotence is different than simply a loss of libido.  Impotence is a total loss of sex drive ---- the inability to have, or even desire to have sex.  The thing is; there are any number of ways to lower your cholesterol naturally, and most of them start with LOW CARB DIETS and a simple EXERCISE PROGRAMS. 

But now --- all of a sudden --- we are supposed to believe numerous headlines from around the country touting this study and the benefits of Statin Drugs in the bedroom?  If you did not know better, you would almost think Statins were an aphrodisiac after reading some of these articles.  Commenting on the study, Dr. Jeffery Kuvin of Boston's Tufts Medical Center chimed in, "Over the years it's become apparent that erectile dysfunction is an indication of decreased vascular health in men, and it's considered by many to be a significant cardiovascular risk factor."  It's true.  There is an intimate relationship between cardiovascular health and the ability to get and maintain an erection.  My only question is whether or not taking a drug is the best way to solve the underlying reasons men have this problem.  For some potential solutions to this issue, you can look at the two previous links or go HERE or HERE.

It happens like clockwork.  Every few years, the powers-that-be in the world of Cardiovascular Health get together to determine how much to lower what is considered the "safe and healthy" level of BLOOD CHOLESTEROL.  Of course, the lower these standards are, the more people will be diagnosed with "high" cholesterol, and the more doctors will prescribe medication to them.  And that much more money will be made by the big Pharmaceutical Companies. 

A few months ago, I shared a post on this subject  (HERE), and revealed to you the phenomenal numbers of Financial Conflicts of Interest (COA's) among those creating these guidelines.  In fact, it was so bad that after the guideline authors revealed their financial conflicts, they simply wrote, "The other members of the writing groups reported numerous relationships with industry," and left it at that.  And although we knew that these new "EVIDENCE-BASED" guidelines would increase the number of Americans taking statins, we did not know how dramatic this increase would be until earlier this week.   A study by Dr. Michael Pencina of the Duke Clinical Research Institute and published in the most recent issue of the New England Journal of Medicine (Application of New Cholesterol Guidelines to a Population-Based Sample) revealed the answer.  And while shocking, the results were not surprising in the least.  The study's conclusions are as follows.

Wow!  When doctors started suggesting putting STATIN DRUGS in the drinking water several years back, they were not far off the mark of the goals that are currently being attained by organized medicine and big pharma.  Stop and look at these numbers for a moment.  This is an incredible financial windfall for big pharma. Thirteen million new Statin users, with increases in usage so massive in the "without cardiovascular disease" category, it almost defies the imagination (and certainly defies common sense).  The goal of 100% Statin usage is within striking distance.  And under the new guidelines, simply having HIGH BLOOD PRESSURE in the right age group can be enough to get you put on a Statin drug.   Unfortunately (and unbeknownst to the average person), the government's dietary recommendations are a significant part of the problem (HERE).

The American people need to be aware that the day is coming ---- probably well within my lifetime ---- that because we've turned over healthcare costs to the government, the government will be completely control every facet of your healthcare.  This means that they will determine what drugs you are prescribed.  How will this happen?  Many countries with government-controlled medical care mandate a certain number of doctor visits per person, per year.  If your cholesterol levels are above what government physicians determine is healthy; since tax dollars are paying for your healthcare, you will follow governmental recommendations or you will be booted completely out of the system (unless, of course, you are here illegally). 

For the record, the COA's revealed by Dr. Pencina and his chief co-author included

• McGill University Health Center:     McGill does a lot of research in the area of heart disease, cholesterol, and drugs to lower cholesterol (both statins and non-statins).

• AbbVie:  AbbVie, a division of Abbott Laboratories, manufactures the non-statin cholesterol drug "Niaspan", which is commonly prescribed along with statins.  Clinical trials have shown it provides no benefit in lowering cholesterol.  They are also heavily involved with stents, vessel closure devices, endovascular and coronary technologies.

• Janssen:   Janssen is the collective name of the Pharmaceutical Companies of Johnson & Johnson. They recently came up with a new class of Type II Diabetes drug, and are involved with several dyslipidemia drugs.

• Eli Lilly:   Eli Lilly makes the stain drug Livalo.  They have also been working on a class of drug to increase HDL --- something which has proved elusive to the pharmaceutical industry.  They have also been involved with the non-statin drug PCSK9 as well.  As a side note, Eli Lilly has claimed that their drug Livalo has fewer side effects than other statins.  Listen to what Dr. John Briffa has to say about the way that Eli Lilly is exploiting this fact on the July 13, 2012 issue of his blog.  "It’s well known that about 75 per cent of people who start statins stop again within a year.  Recently, the drug company Eli Lilly issued a press release regarding a survey called ‘Understanding Statin use in America and Gaps in Education’ (‘USAGE’). The USAGE survey was an attempt, on the face of it, to better understand the reasons for why so many individuals stop taking their statins. More than 10,000 people were polled, and the results are in.  It turns out that off all of the reasons individuals might stop their statin medication, ‘side effects’ was the most commonly cited reason. According to the survey, a full 62 per cent of respondents cited side effects as the reason for stopping their medication."  According to Eli Lilly, Livalo is the perfect solution for these folks.
  

• Boehringer Ingelheim:    Boehringer Ingleheim makes about 30 different drugs, including many for the cardiovascular system.

To read more about the COA's in this area of industry guidelines within the field of cholesterol, you can go to the blog of Dr. Barbara Roberts --- a professor at Brown University (HERE) and read a short article she wrote on the subject.  She says the conflicts in this area are over half a billion dollars.

Recently, the American College of Cardiology (the ACC) and the American Heart Association (AHA) got together for a big meeting in California for the purpose of creating new guidelines for treating Heart Disease.  Despite paying lip service to reducing the risk of Heart Disease by promoting "Heart Healthy Lifestyles" (their stated goal in this department was supposed to be managing lifestyles, weight, and cholesterol levels), we can see from the headline quote at the top of the page where this meeting was headed from the beginning.  Should we be surprised?  Absolutely not!  The same sort of incestuous relationships that characterize politics do a great job of depicting what's going on in much of the medical / pharmaceutical research profession as well.  Allow me to show you what I am talking about.

The new Cardiovascular Health Guidelines suggest that people should be given STATIN DRUGS, not simply based on HIGH CHOLESTEROL levels, but on the basis of their age, sex, lifestyle (sedentary, smoker, TYPE II DIABETES, blood pressure, etc) and weight.  In fact, the group's recommendations were so sweeping that if they had their way, (I am not making this up) 1 in 3 American adults would be on these drugs.  Re-read this last sentence and let it sink in a moment.  Also understand that with large scale Socialized Medicine, sooner or later these "recommendations" are going to become "regulations" --- something you will be forced to do --- quite possibly against your will.

TREATMENT GUIDELINES
The group chose a couple of doctors to actually physically write / type the guidelines (Donald Lloyd-Jones, MD, and Neil Stone M.D. both of Northwestern University in Chicago).  It should be noted what MedPage Today said about these two doctors; "Stone and Lloyd-Jones reported that they had no conflicts of interest."  This makes you feel all warm and fuzzy until you read a bit further (you know; the fine print at the bottom) and realize that, "Eckel [you will meet him momentarily] reported relationships with Amylin, Eli Lilly, Esperion, Foodsminds, Johnson & Johnson, Novo Nordisk, Vivus, GLAXOSMITHKLINE, and Sanofi-Aventis/Regeneron, and Ryan reported relationships with Alere Wellbegin, Amylin, Arena Pharmaceuticals, Eisai, Novo Nordisk, Nutrisystem, Orexigen, Takeda, Vivus, and Scientific Intake."  Of the dozens of other doctors and scientists who were part of the Guideline Committee, this is what the rest of the fine print at the bottom said.  "The other members of the writing groups reported numerous relationships with industry."  Do you have any idea what that really means?  It means that there were so many financial conflicts of interest, it would have taken pages (that would be plural) to list them all?  HERE is more on this topic. 

Can we trust these doctors.  Suuuuuuure we can.  And I have this wonderful piece of ocean front property in Arizona that I would just looooooove to sell you ---- cheap.  I bought it from George Strait himself!  Seriously people; we have seen over and over and over again that power and money tend to have a corrupting effect on people.  In the quote at the top of the page, Dr. Harold said that these guidelines were made in response to "evidence".  Evidence?  Don't kid yourself.  EVIDENCE-BASED MEDICINE is part of the wall of double-speak that the industry leaders hide behind in order to make you think that what they are doing is "scientific".  It's always embarrassing when the "evidence" shows that guidelines and treatment(s) are based solely on money.    I promise that DR. KUMMEROW was never invited to be on this committee!


LIFESTYLE RECOMMENDATIONS
Were the lifestyle recommendations any good?  Although the recommendations for people to get of their sedentary butts, quit smoking, and eat healthier foods, were exactly what we would expect, the dietary guidelines left something to be desired.  Dr Robert Eckel of the University of Colorado at Denver, wrote the diet recommendations.  It is exactly what I would expect.   He issued a, "strong recommendation to consume a diet rich in fruits, vegetables, whole grains, low-fat dairy, legumes, fish, poultry, and nuts and low in sweets, sugar-sweetened beverages, and red meats."  Some of this I would agree with wholeheartedly.  However, the idea that eating a diet high in grains is simply fueling the fire that is AMERICA'S NUMBER ONE HEALTH PROBLEM.  Not to mention, the issue of GLUTEN and GLUTEN CROSS-REACTORS.  If you happened to read THIS POST that I wrote a few months ago, you already know that the majority of practicing physicians pooh pooh the idea of non-Celiac Gluten Sensitivity as a "fad".

Furthermore, the recommendations say to severely limit red meat.  I have shown you TIME and TIME AGAIN that this is folly.  It is amazing to me how these doctors cannot get the recent past out of their heads when it comes to red meat.  In fact, if you will look at the PALEO DIET, you will see that about half of these "expert's" recommendations are going to actually cause INFLAMMATORY REACTIONS that lead to a host of disease processes.  I should also note that the way that the guidelines are written implies that while "sugar sweetened beverages" are bad, DIET BEVERAGES are fine. 

Then there are the non-dietary recommendations for dealing with OBESITY by Dr. Donna Ryan of Baton Rouge (Pennington Biomedical Research Center on the LSU campus).  She wants at least 6 months of weight loss counseling and intense in-home interventions done by trained healthcare providers.  Firstly, it sounds rather expensive to me.  Secondly; has it been shown to work in the past?  In a word; no.


WHERE ARE WE HEADED WITH ALL OF THIS?
What does all of this prove?  Only what most of my readers already knew.  You cannot trust the government, or the organizations which are funded by the government, to do what is right for your health.  If you are concerned for your family's health, you'll have to take the bull by the horns and do it yourself.  Do your own research, figure out what it takes to GET HEALTHY, and then take the steps to get it done.  Never, ever, ever blindly listen to anything that any doctor tells you (self included) without studying the matter out for yourself.  No; it's not easy.  But then nothing good in life ever is.

Although Jane Fonda is usually the one credited with starting the whole "no pain; no gain" mantra in her early 80's leg-warmer workout videos, I would guess it's been around much longer than that.   While I totally believe her statement to be true, everything hinges on one's definition of the word pain.   Another of Fonda's quotes from her videos (feel the burn), helps clarify this concept's original meaning.  Suffice it to say that her point was to work through the "burn" ---- not to train until you permanently damage your muscles.  Unfortunately, there are some who actually advocate this sort of thing.  And although there are many different kinds of "extreme athletes" today, some of the most extreme seem to come out of Crossfit movement.

Let me start by saying that I have never officially been part of a CrossFit program or gym.  However, because I have a gym in the basement of my clinic, I am able to incorporate many of their training methods into my workouts.  A few of the things my son and I do that could be considered "CrossFit-like" are KETTLEBELL SWINGS, all sorts of Burpees, several novel kinds of pushups and pullups, and pounding a tire with a sledge hammer as well as two five pound hammers (one for each hand).  I am also getting ready to put up some rings. 

I am sold on CrossFit's typically short duration, high intensity style of training, as well as the wide variety of atypical exercises.  But, with any sort of physical training (running, powerlifting, swimming, gymnastics, MMA, etc, etc, etc), people can push things beyond what their body can withstand and repair ---- sometimes far beyond.  It has taken me a lot of years to figure out that when it comes to getting in shape, sometimes less is more.  I can remember Joe Wieder writing about over-training back in early 1980's issues of Muscle & Fitness.  Although I did not "get it" then, I now understand just how easy is is to "over-train" and end up wearing your body down instead of building it up.  Speaking of over-training; a few days ago someone sent me a link to a recent article called, CrossFit's Dirty Little Secret.  The article, written by a Physical Therapist, was about the, "troubling trend among CrossFitters".  And just what is this troubling trend?  Have any of you heard of something called Rhabdomyolysis?

I'll get to exactly what Rhabdomyolysis is momentarily, but the thing to remember is that none of this is new information.  For years, newspapers and magazines have been carrying headlines touting the dangers of CrossFit such as, "Getting Fit, Even if it Kills you" (2005, New York Times), Inside the Cult of CrossFit (2011 Men's Health), and "Lawsuit Alleges CrossFit Workout Damaging" (2008, Navy Times).  There have even been a couple articles on the topic of Rhabdo by CrossFit's founder himself, Greg Glassman.  I am not going to get into depth here (read the articles if you want), but if you are a novice who is trying to do advanced workouts; or if you are pushing your body to the realm of stupidity, you are headed for a breakdown --- probably sooner than later.  It is only common sense to workout within your body's limits.  I'm not in terrible shape now, and I used to be in really good shape.   However, I would not even think of doing some of the workouts that I have seen others do.   Again, know your limitations, and exercise your brain before exercising your body.

We live in a culture of excess.  Americans take something like two thirds of the world's medications even though we are less than 5% of the world's population.  We act like every meal is going to be our last (just look at OBESITY RATES here in America --- nearly 40% of the adult population).   And when we do exercise, some of us really exercise.  The hottest video workouts today are things like P-90X, Insanity, and other super high intensity routines, with every new video being touted as more intense than the one before it.  Unfortunately, most of these could in no ways be considered to be "low duration".  Low Duration Exercise.  It is one of the things that drew me to the concept of CrossFit in the first place (many of their workouts last no more than 15 minutes). 

The last several years have seen my workouts get progressively shorter.  Why?   Virtually all the peer-reviewed literature says that this is the best way to train (here are several articles on CARDIO TRAINING -vs- STRENGTH TRAINING).   One of the first books I read on the subject (Bill Phillip's Body for Life), was talking about high intensity / low duration exercise a decade and a half ago.  I even remember reading Arthur Jones talking about the famous "Colorado Experiment" with the recently deceased CASEY VIATOR back when I was in college, but blew it off assuming that his gains were all steroid-related.  I guess the problem is that just like the disagreement we have over what "no pain, no gain," really means, we cannot seem to agree what either 'high intensity' or 'low duration' really mean either.  But let's get back to the real reason you are reading this post ---- Rhabdo.

Allow me to break down the word "Rhabdomyolysis" for you.  Rhabdo = "striped", Myo = "muscle", and lysis = "to break or separate".  Thus, Rhabdomyolysis is the breakdown of striped (skeletal) muscle.  , now let's talk about what causes it.  Although it is quite possible to induce Rhabdomyolysis via working out really really hard (such as in CrossFit), there is another far more common way to develop this problem.  Although Rhabdo can occur from injuries, overworking or over-training muscles, as well as a host of other reasons, the number one on the list is STATIN DRUGS --- by a landslide (HERE).  For example; I do not personally know anyone who has ever developed Rhabdo from working out too hard.  But I know scores of people who have had varying degrees of muscle pain and weakness as the direct result of taking Anti-Cholesterol Meds. 

Rhabdomyolysis can occur when overworked, abused, traumatized, or poisoned skeletal muscle rapidly undergoes lysis.  The muscles cells rupture their contents as the tissue is broken down into its components. This releases muscle cells and their constituent parts into the bloodstream.  Certain byproducts of this process such as the oxygen-carrying protein myoglobin, can damage the kidneys to the extent that dialysis is required for survival.   But short of complete kidney failure, Rhabdo can cause permanent muscle damage as well a host of other nasty problems.  So; how would you have any idea you might be dealing with Rhabdomyolysis?  Just watch for the signs.

But let's go one better.  Wouldn't it be nicer to altogether avoid Rhabdo in the first place?  With some common sense, it can be done.  Here are a few of the steps for avoiding Rhabdomyolysis.

• GET TO AN EMERGENCY ROOM IF YOU SUSPECT YOU ARE DEALING WITH RHABDOMYOLYSIS:  In case you have not figured it out, this stuff is serious.  The diagnosis is made via a simple blood test (CPK).  Don't gamble with this problem as it can be both permanent and deadly!

• DRINK LOTS OF WATER:  One of the risk factors for Rhabdo is dehydration.  Notice that I said to drink more "water".   Sorry, SODA, juice, and Gatorade don't count.
  

• START SLOW AND KNOW YOUR LIMITS:  Although many who develop workout-induced Rhabdo are untrained or under-trained, many are extremely fit individuals who simply pushed the envelope too far. As you get in better shape, push the envelope slowly --- a little bit at a time.  A "Murph" (Named after Navy Lt. Michael Murphy, who was killed while serving in Afghanistan; the Murph consists of a one mile run, followed by 100 pull ups, 200 pushups, and 300 air squats, and then another mile run ---- all for time), is probably not the best place to start.  

• REALIZE THERE IS NO DISHONOR IN BACKING OFF:  If you think a certain workout might be over your head, modify it. 

• LEARN MORE ABOUT STATIN DRUGS:  I realize that this bullet point seems out of place, but you have to understand that the most common side-effect of Statin Drugs is "muscle pain / soreness".  I recently asked two medical doctors what drugs they would never take.  Top of the list for both?  The ANTI-CHOLESTEROL drugs.   To begin to understand why they would say this, pay attention to the words of world-renowned cholesterol expert, professor Flemming Dela from the Center for Healthy Aging at the University of Copenhagen, Denmark (the study was reported in the January 2013 issue of the Journal of the American College of Cardiology). "A well-known side effect of statin therapy is muscle pain. Up to 75 per cent of the physically active patients undergoing treatment for high cholesterol experience pain. This may keep people away from either taking their medicine or from taking exercise.......  The effect of statins is marginal for these patients.  In a previously published Cochrane analysis only 0.5% reduction in all-cause mortality was detected, indicating that for every 200 patients taking statins daily for five years, one death would be prevented."  This research was done because 40% of the Dutch over the age of 65 are on Statin Drugs, with a whopping 75% of these complaining of muscle pain.
  

Should you stop taking Statin Drugs?  Only you and your doctor can answer that question.  However, once you learn that CONTROLLING YOUR BLOOD SUGAR is the best way to deal with all sorts of blood lipid issues, dropping the dangerous drug might just be an option for you (HERE is more information on the blood sugar / cholesterol link with Dr. Oz, and HERE are some diet tips).   Should you do nothing but wimpy workouts?  No way Jose!  Even the intense CrossFit workouts can fantastic when done correctly.  Never let your trainer or instructor push you into something you are not comfortable with.  Use some good old fashioned common sense when you are pushing things to the max.

Recently, a meta-analysis of a large number of studies on STATIN DRUGS (Cholesterol Medications) hit the media circuit.  The gist of the study was that these drugs are safe, and not to be afraid of them.  If you click on the link, you will see that I don't exactly agree with this study's assessment.  It seems that despite the study's findings, I'm not alone.

Interestingly enough, it seems that in a recent poll of mostly healthcare providers (Physicians and Nurses, as well as "lay persons") done by MedPage Today, a whopping 70% of those polled agreed with me.  In fact, reading the comments of many of those polled revealed that they felt they had been lied to by their doctors and the pharmaceutical industry about the risks of Statin Drugs.  THIS LINK will be up for a short amount of time (until they run another poll).  Make sure to take the few minutes it will take to read this article and see what people in the know really think about Statins.

In a Canadian study that was published just days ago in the Annals of Internal Medicine (Statin Toxicity From Macrolide Antibiotic Coprescription: A Population-Based Cohort Study), nearly 150,000 older individuals were observed for interactions between their ANTIBIOTICS and STATIN DRUGS.  As you can see from the links, both of these classes of drugs are extremely dangerous when taken by themselves (particularly the FLUOROQUINOLONE ANTIBIOTICS), however, when taken in tandem, the combination proved deadly for a significantly greater number of individuals than those not taking the drugs at all.  Once you understand the relationship between GUT HEALTH, CHOLESTEROL, and one's overall health, you can't be too surprised.

Although the number one side effect of statin drugs in this study was RHABDOMYOLYSIS (something I discussed concerning statin drugs just the other day -- HERE), the study showed that when combined with CERTAIN ANTIBIOTICS, the risk was increased for statin toxicity in the form of kidney damage, hospitalization, and yes, even death. 

Seriously people; if you want to nip both infections and high cholesterol in the bud, understanding THIS CONCEPT (strict control of sugar and carbs) is the best way to do it (HERE is a great example).  Oh; for the record, things were actually worse than the study actually concluded because the authors admitted that, "The absolute risk increase for rhabdomyolysis may be underestimated because the codes used to identify it were insensitive."  Just remember that statins are cruddy drugs not just because of their myriad of nasty side effects, but because they don't get to the root of the reason you have high cholesterol in the first place --- RUNAWAY INFLAMMATION.

For those of you struggling with your health, it's your lucky day.  Make sure and read THIS POST about what it will take to turn your life and health around.  Then find someone to partner with and hold you accountable and get started today!

It's not news that STATIN DRUGS cause muscle pain.  In fact muscle pain is their number one side effect.  However, it's critical for you understand that referring to what is going on simply as "muscle pain" is missing the bigger picture.  The 'trust us' side-effect warnings for Statin Drugs refers to this muscle pain as Rhabdomyolysis ----- a problem that most people have never heard of.  Let's take a minute and break it down into bite-sized chunks that are easy to understand.

Rhabdo means "with stripes", Myo means "muscle", and Lysis means "rupture".  So, in a nutshell, Rhabdomyolysis infers that striped muscle (skeletal muscles --- i.e. biceps, triceps, quadriceps, gluteus, etc, etc) are actually breaking apart at the cellular level and releasing their contents into the extracellular fluid, which eventually make their way to the blood stream.  The chief breakdown product of Rhabdomyolysis is something called 'myoglobin'.  Myoglobin is an oxygen-carrying protein in the muscle that is analogous to hemoglobin, an oxygen-carrying protein found in the blood. 

How do you know whether or not you have Rhabdomyolysis?  One of the classic findings is going to be dark or "Coke-colored" urine.  But it is usually found via blood test long before the urine ever gets to that point.  The main symptom is pain.  Because muscle tissue is actually being broken and destroyed at the cellular level, people suffering with this problem are going to have muscle / joint pain, weakness, point tenderness, and even swelling of the affected muscles.  This means that patients / doctors can easily be fooled as I have several times over the years. 

Rhabdomyolysis can look just like artrhritis, a Rotator Cuff Problem, FIBROMYALGIA, a knee problem, or any number of other painful conditions.  This is why I always find out whether or not someone is on Statin Drugs (or for that matter, other drugs) before I do anything else.  By the way, certain other things like HYPOTHYROIDISM, DIABETES, AUTOIMMUNE CONDITIONS, CERTAIN ANTIBIOTICS, ANTI-DEPRESSION DRUGS, HARDCORE WORKOUTS, and drug or alcohol abuse can all contribute to the development of this problem as well.

A study was published in this month's issue of JAMA Internal Medicine (Statins and Musculoskeletal Conditions, Arthropathies, and Injuries) showing some extremely disturbing evidence.  Dr. Ishak Mansi and his team of researchers, working out of the The North Texas Health Care System (Dallas' huge VA), showed that musculoskeletal adverse events and diseases are significantly higher in those taking Statins than in those not taking Statins (study size was over 46,000 individuals). 

The study concluded that, "Musculoskeletal conditions, arthropathies [Arthritis], injuries, and pain are more common among statin users than among similar nonusers."  They went even further and clarified the term "muscluloskeletal conditions".   They included, "all musculoskeletal diseases, arthropathies [Arthritis] and related diseases, injury-related diseases (dislocation, sprain, strain) and drug-associated musculoskeletal pain".   Stop and think about this for a moment.  Not only are injuries to the MUSCLES, FASCIA, TENDONS, and LIGAMENTS significantly greater in those taking Statins, but so are the diseases affecting these tissues (not to mention bones), as well as adverse side effects of a wide variety of drugs. 

Interestingly enough, the main reason that this study was done in the first place was to "prove" that Statin Drugs had anti-inflammatory powers that could actually help people with arthritis and musculoskeletal pain.  Probably why one of the authors disclosed associations with AstraZeneca, Bristol-Myers Squibb, Elan, Forest, Ortho-McNeil Janssen, and PFIZER.  It would be safe to say that these companies are now in full "Damage Control Mode".  Fortunately for us, it is getting harder for Big Pharma to BURY STUDIES LIKE THIS.  To learn more about CHOLESTEROL, just click on the link.

We all know that statins are wonderful --- aren't they?  They save millions of lives ---- don't they?   They prevent millions of heart attacks and strokes ---- can't they?   In this post, I will explore some of the myths and half-truths about statins --- some more of that EVIDENCE-BASED MEDICINE that we all love so much.  Be warned that statins are not all they have been cracked up to be, and certainly not worthy of the pedestal they have been placed on.  And despite the fact that they are arguably the single biggest money-making class of drug in the world, the foundation that has propped them up for so many years is crumbling.  As Dr. Seneff said in YESTERDAY'S POST, it is only a matter of time before these drugs go the way of Thalidomide and HRT.

Although the writing is on the wall for these drugs, Big Pharma will not go down without a fight, and are pushing back harder than ever.  It was not that long ago that a young man (early 20's) came to see me for back pain.  In the consult and examination, I found out he was taking a statin drug.  He was on the thin side, so I figured he must have one of those genetic 'Hypercholesterolemia' things going on.  Nope.  In fact, before his doctor (someone I know) put him on statins, his total cholesterol was a too-low 125 (anything under 150 puts you at risk for all sorts of health problems including certain kinds of CANCER, hemorrhagic strokes, and DEPRESSION).  His doctor was trying to get his total cholesterol under 100.  When I asked him why, he told me the two reasons given for this.   His dad had had a (non-fatal) heart attack a few years earlier ---- and he had good insurance.  No joke!  I was dumbfounded.   Although he was young, what about statin drugs and the geriatric population?

"We present the case that can be made for not treating octogenarians [people in their 80's] with statins [drugs that lower cholesterol] for the primary prevention of cardiovascular disease. This case is built on three points:

• Cholesterol levels are not associated with cardiovascular disease events [chiefly heart attacks and strokes] in octogenarians without overt coronary artery disease;
• No randomized, controlled trials have assessed the role of statins in reducing events in octogenarians without coronary artery disease; and
• Statins may increase risks of myositis [muscle inflammation / pain], rhabdomyolysis [muscle deterioration / degeneration], and cancer [cancer] in the elderly. "
  

Who in the world would say something this outlandish?  Some half-cocked idiot?  Another one of those crazed hillbilly chiropractors from southern Missouri?  Some psychopathically deranged hippie?   Mad Magazine?  Nope, nope, nope, and nope. The above quote  was taken directly from the November / December 2003 issue of the American Journal of Geriatric Cardiology --- not exactly an Alfred E. Neuman publication!  The study itself was done by a team of researchers at Yale University School of Medicine's Department of Internal Medicine.

To answer in one word, the question posed in the title........ YES!  You should not only be worried about cholesterol-lowering statin drugs (HERE), if you are taking these drugs you should be terrified!  In a 2009 paper co-authored by Beatrice Golomb, MD, PhD, associate professor of medicine at the University of California's San Diego School of Medicine, and director of U.C. San Diego's Statin Study Group (the study was published in the prestigious medical journal American Journal of Cardiovascular Drugs), her team showed why statin drugs are dangerous ---- very dangerous.

Doctor Golomb's review individually cited almost 900 peer-reviewed medical studies dealing with the wide array of health problems associated with taking cholesterol-lowering drugs.  What is the number one side effect of these drugs?  Something called RHABDOMYOLYSIS.  Let's look at this word for a moment.  Rhabdo (striped) Myo (muscle) lysis (to break down or tear apart).  Thus, Rhabdomyolysis is the break down of striped (skeletal) muscle.  What did Dr. Golomb have to say about statins and cholesterol?  "Muscle problems are the best known of statin drug's adverse side effects, but cognitive problems and peripheral neuropathy, or pain or numbness in the extremities like fingers and toes, are also widely reported."

Mitochondria are the part of the cell that create energy in the form of ATP (HERE).  However, this process of making energy also creates something else.  Free Radicals.  Oxygen Free Radicals are harmful compounds that are a known cause of cancer.  This is why we consume "antioxidants" in the form of foods (colorful vegetables, fruits, and berries).  These antioxidants protect us against this process we call "Oxidation".   When mitochondrial function is diminished for any reason, the body produces less energy and more "Free Radicals".  This is a double whammy that not only causes various disease processes, it leaves you with a diminished ability to fight against them because your body is not making enough energy to do so. 

Coenzyme Q10 ("Co-Q10") is a compound central to the energy-making process that occurs within mitochondria.  It also acts as a powerful antioxidant whose other job is to "quench" the internal fire known as free radical oxidative damage.  The problem with statin drugs, however, is that they lower Q10 levels.  They do this because they are designed to block the metabolic pathway involved in cholesterol production ---- the very same pathway which produces the body's supply of Co-Q10.  How big is the loss of anti-oxidative power in the body?   Just listen to the words of Dr. Golomb.

"The loss of Q10 leads to loss of cell energy and increased free radicals which, in turn, can further damage mitochondrial DNA." Because statins cause progressively more mitochondrial damage over time ---- and as these energy powerhouses tend to weaken with age ---- new and more severe adverse effects tend to develop the longer a patient takes statin drugs.  Golomb goes on to say, "The risk of adverse effects goes up as age goes up, and this helps explain why.  This also helps explain why statins' benefits have not been found to exceed their risks in those over 70 or 75 years old, even those with heart disease."  Furthermore, both high blood pressure and diabetes are linked to higher rates of mitochondrial dysfunction.  This is why say the study's co-authors, these conditions are consistent with a higher risk of statin side effects.

Golomb goes on to explain in a recent interview, "From the reports that come into us, people are experiencing severe muscle weakness, which is also linked to cognitive problems.  We're really interested in the balance of risks and benefits of these drugs. There are lots and lots of people looking at the benefit side. There are so few people evaluating the [risk] side. You can bet that the $20 billion a year in statin drug company revenue is going to make sure that any promising lead looking at potential benefits will be followed."  You know what?  She is right.  I will get to this topic soon enough, but suffice it to say that there a whole host of doctors screaming the same things at the top of their lungs.  Unfortunately, they are being drowned out by Big Pharma's never ending 'noise' about the need for every American to be on Statins.  Think I'm kidding?

Not very long ago, "Sir" Rory Collins, Professor of Medicine and Epidemiology at the Clinical Trial Service Unit of Oxford University stated, "Give statins to all over-50s: Even the healthy should take the heart drug".  Sir Rory happens to be the lead researcher on one of one of the biggest cholesterol studies in history.  His study's conclusions are that lowering LDL cholesterol with statins is safe, effective, and saves large numbers of lives.  And where did the money for his research come from?   Three places:

• The British Heart Foundation

• The National Health Service (NHS)

• UK Biobank

I know you'll all be shocked to hear this, but Sir Rory just happens to be the Principal Investor and Chief Executive of Biobank.  How much money are we talking about here? Try £62 million on for size!  That's 100 million dollars for those of you keeping score at home.  This does not even begin to take into account the fact that Sir Rory has received money from numerous Pharmaceutical Corporations.  Is this a conflict of interest?  Let's ask the companies involved.  Some of the bigger companies you have no doubt heard of before.

• AstraZeneca

• Bayer

• Bristol-Myers Squibb

• GlaxoSmithKline

• Merck

• Roche

• Sanofi

• Schering (not to be confused with Schierling)

• Solvay (a huge chemical manufacturing corporation)

DO STATINS LOWER CANCER RATES?
In recent years the news has headlined numerous stories saying things like, "Cholesterol Drugs May Lower Cancer Risk"  But is this really true?  I have always been under the impression that statin drugs increase the risk of cancer, not lower it.  So, where is this information coming from, and who can we trust to give us the straight dope on this issue?  It seems that a study done several years ago in Israel looked at the medical records of over 200,000 people and came to the conclusion that statin drugs decrease cancer rates.

The study, published in the medical journal Preventing Chronic Disease, said that patients who regularly took statin drugs for the longest time had the lowest rates of cancer over the 7 years of the study.  Their conclusions?  The authors stated that their study, "demonstrated that persistent use of statins is associated with a lower overall cancer risk.....  the association between statins and cancer incidence may be relevant for cancer prevention."  Bear in mind that this and other statin studies have been dissected to show that their lower cancer rates claim is at best, grossly exaggerated; and at worst, completely false.

In a recent study of the effects of statins on the elderly, nearly six thousand people aged 70-82 were given either a statin or placebo over a three year period.  Cancer rates were one quarter greater in the statin group.  Another study (a meta-analysis) looked at the results of several different studies, finding that the combination of statin drugs and the cholesterol-lowering drug Ezetimibe (Vytorin), was associated with a forty five percent increased risk of dying of cancer.  Read that last sentence a couple more times and let it sink in!



FDA CALLS FOR STILL LOWER CHOLESTEROL LEVELS
Although the Food and Drug Administration (FDA) has recently ruled that labels for statin drugs must include warnings about some of the side effects associated with statins (memory loss, confusion, Type II Diabetes, and myopathy / rhabdomyolysis / muscle & tendon problems), they keep lowering the levels of what is considered to be a "normal" cholesterol level.  For the past three decades, Big Pharma will parade their "homegrown" research by the FDA, showing them that cholesterol is the Great Satan --- the leading cause of our country's number one killer; heart disease.  The goal is always the same.  They want the FDA to step in yet again and change (lower) what constitutes a healthy cholesterol number.  This has been done over and over again, and means that more and more people will be told they have high cholesterol, and subsequently need to be on statin drugs.   I realize that statins dramatically lower cholesterol.  However, there are a whole host of Physicians, Researchers, and Scientists telling us that we are being bamboozled by the drug companies.  What's going on here?  

Dr. John Briffa, contributing editor on THE CHOLESTEROL TRUTH, has been exposing countless flawed statin trials on their blog, revealing one of the biggest medical cons of our time in the process. On their site, he also explains why cholesterol is not the villain it is made out to be and how the mainstream has got hold of the wrong end of the stick when it comes to heart disease prevention. What are the most common Statin Drugs in America?  Here's a short list

• Advicor  (lovastatin with niacin) – Abbott
• Altoprev (lovastatin) – Shionogi Pharma
• Caduet [atorvastatin with amlodipine (Norvasc)] – Pfizer
• Crestor (rosuvastatin) - AstraZeneca
• Lescol (fluvastatin) – Novartis 
• Lipitor (atorvastatin) - Pfizer
• Mevacor (lovastatin) – Merck
• Pravachol (pravastatin) -- Bristol-Myers Squibb
• Simcor (niacin/imvastatin) – Abbott
• Vytorin (ezetimibe/simvastatin) – Merck/Schering-Plough
• Zocor (simvastatin) – Merck

Sorry; these studies don't exist.  Oh, don't get me wrong.  There are about a jillion studies on statin drugs and their supposed benefits.  However, when these studies are carefully dissected and analyzed, you find that they are not only not helping people live longer by avoiding heart attacks and strokes, they can actually increase chances of heart attacks and strokes in some patients (can anyone say "decreased mitochondrial function"? --- HERE).  Who remembers my post from about 6 months ago on BETA BLOCKERS?

A few years ago, a study known as the JUPITER Trial suggested cholesterol-lowering statin drugs might even prevent heart-related deaths in many more people than just those with high cholesterol.  However, researchers now say that the JUPITER results were flawed -- seriously flawed!  Not only is there no "striking decrease in coronary heart disease complications", but a new report has also called into question drug company's involvement in this and similar drug studies.  What did an ABC News expose have to say about this study?

"... major discrepancies exists between the significant reductions in nonfatal stroke and heart attacks reported in the JUPITER trial and what has been found in other research ... 'The JUPITER data set appears biased."

But how can "research" be biased?  After all, isn't it all independent --- isn't it?  No it's not.  Let me give you one example out of thousands.  A few years ago, the sugar industry published a study saying that high amounts of sugar did not cause behavior problems in children.  If you are a parent, common sense will tell you otherwise.  So where was the sleight of hand?   The studies compared the behavior two groups of children.  Group I (the control) was given the sugar equivalent of about 18 cupcakes a day.  Group II (the experimental group) was given not quite double this amount of sugar.  When BEHAVIOR PROBLEMS were compared between the two groups of children, there was no statistical difference.  Duh!  I wonder why?  If you want to see a picture of what financial conflict-of-interest looks like in Big Pharma, HERE is one.

Pretty soon I am going to hit you a few of the actual studies on statin drugs.  I promise that you will not only be shocked, you will be ticked off about the way you have been duped.  In the mean time, here are some of the areas to watch with particular diligence.

• NEUROLOGICAL PROBLEMS:  These include amnesia, forgetfulness, confusion, the tendency to be disoriented, increased symptoms of senility, short-term memory loss.  I will never forget reading the story of Mike Hope in an issue of Smart Money a decade ago.  The neurological side effects of statin drugs are devastating, and frequently permanent.

• MUSCLE PAIN:  Although muscle pain is the most common side effect of statin drugs, calling it "Muscle Pain" is extremely (and purposefully) misleading.  Like I said earlier, this side effect is technically called Rhambomyosis or Rhabdomyolysis.  It is not simply pain or muscle soreness.  It is pain, muscle soreness, and weakness caused by the degeneration of your muscles.  Although many people on statins have mild to moderate increases in muscle and joint pain and / or fatigue, I have seen numerous cases that are totally debilitating.  The first thing I want to know when people come to me for SCAR TISSUE REMODELING is whether they are on a statin.
  

 

• LIVER DAMAGE:   People who start statin drugs should have their liver enzymes checked via a blood test about six weeks after starting the drug.  One of the side effects of statin use is increased production of liver enzymes, which has the potential to cause permanent liver damage.  
  

 

• COMPLICATIONS WITH DIGESTION:  These usually take the form of nausea, diarrhea, constipation, or abdominal pain.  As I said earlier, this is due to in part to the fact that statin drugs alter your body's ability to metabolize fats and sugars properly.

 

•  MIGRAINE HEADACHES & REGULAR HEADACHES:  I deal with lots of people with chronic headaches (HERE).  If you are prone to either you may find that statin use will trigger your headaches and migraines more often as well as allowing them to become more severe / intense.  Dizziness and flu-like symptoms are also side-effects along these lines.
  

There are a growing number of scientists and doctors who believe that in most cases, high cholesterol and fatty build up on the arterial walls is a function of INFLAMMATION.  For more information on this subject, I would suggest you go HERE.

DR. STEPHANIE SENEFF is an MIT professor whose areas of study are extremely diverse.  Her two year old essay entitled, "How Statins Really Work Explains Why They Don't Really Work" (HERE), is an excellent primer on the subject of cholesterol side-effects.  She has many other published works on statins as well as other drugs.  I would suggest you read her incredible article!