Statin Drugs – The Real Reason Official Guidelines Still Demonize Fats Despite the Evidence?

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Lardo di Colonnata – A lard specialty from Tuscany, real Mediterranean food!

Nina Teicholz, investigative journalist and author of the International bestseller The Big Fat Surprise, wrote an article for the BMJ (formerly the British Medical Journal) in September 2015, which makes the case for the inadequacy of the scientific advice that underpins the Dietary Guidelines (Teicholz, 2015). The title of the article was “The scientific report guiding the U.S. dietary guidelines: is it scientific?” Ian Leslie writing for The Guardian reports that the response of the nutrition establishment was ferocious: 173 scientists – some of whom were on the advisory panel, and many of whose work had been critiqued in Teicholz’s book – signed a letter to the BMJ, demanding it retract the piece (Leslie, 2016). Prominent cardiovascular and nutrition scientists from 19 countries called for the retraction. However, to this day, the article remains published. The BMJ has officially announced that it will not retract the peer-reviewed investigation after stating that two independent experts conducted formal post-publication reviews of the article and found no grounds for retraction (Sboros, 2016).

Yet, behind every mainstream medical practice, strict questionable guidelines are still followed faithfully every day. Doctors are still following cholesterol targets that are often unattainable without cholesterol lowering drugs, but many do try to achieve their targets with extremely low fat diets recommended irresponsibly in dietary guidelines.

Unfortunately the rest of the world has followed suit on these dietary changes. Traditional high fat foods have been given up for the low fat scam. Promoters of the highly touted Mediterranean diet, with its olive oil and ‘low animal fat’, fail to mention the fact that there are still fat loaded recipes that were passed from generation to generation among the Mediterranean people. Lardo di Colonnata with its cured strips of fatback and herbs and spices; Greek barbecue which often involves an entire lamb roasted on a spit; or the kokoretsi which is made from the internal organs of the lamb – liver, spleen, heart, glands – threaded onto skewers along with the fatty membrane from the lamb intestines, all of these are foods of the long-lived Mediterranean people. Yet the ‘American style Mediterranean Diet’ selectively picks foods from the diet of the Mediterranean people to give the picture they desire. Ironically, many of the Mediterranean people have adopted this Americanized version of the ‘Mediterranean Diet’.

The truth is that cholesterol is a substance our bodies make naturally, and it’s absolutely essential to our health. Cholesterol is so crucial that the body produces some 1000-1400 milligrams of it each day, mainly in the liver. Cholesterol is also synthesized to a smaller extent in the adrenal glands, intestines, reproductive organs, etc.

We are told by the “Official Thought-Control Institutions” to limit consumption to less than 300 milligrams of cholesterol per day, but our liver’s production of cholesterol is controlled by a feedback mechanism based on how much we eat. If we eat a lot of cholesterol, we produce less, leaving much needed liver energy for other important tasks. If we eat little cholesterol, replacing it with carbohydrates and vegetable oils, then the body will produce the cholesterol from these dietary raw materials. However, a high-carb and vegetable oil diet yields a very bad cholesterol profile even when the cholesterol is in normal range. If we hardly eat any cholesterol and we block its production with lowering cholesterol drugs, then we are limiting the supply of something the body desperately needs for its proper function. Yet statins, cholesterol-lowering drugs, are among the most profitable drugs in the history of the world.

Restricting or eliminating cholesterol in the diet overburdens the liver, which now has to overproduce it through its enzyme HMG-CoA reductase from food in our diet. This enzyme is the one that is blocked by statin drugs for the purpose of lowering the amount of cholesterol the body produces. But, as with all pharmaceuticals, it comes with a price. HMG-CoA reductase is also the enzyme needed for the creation of coenzyme Q10 (CoQ10), which is a key nutrient for energy production in our cells. CoQ10 is also a major antioxidant. People complain of muscle cramps or aches while on statins drugs. Keep in mind that your heart is a muscle as well. Coincidence or not, the incidence of congestive heart failure has spiked during the time statins have been a top selling drug. Even when statin drugs are not at fault for the increased prevalence of congestive heart failure during the last decades, we don’t necessarily want to decrease CoQ10 levels in a failing heart.

Coenzyme Q10 – also called ubiquinone, which means ‘occurring everywhere’ – plays an important role in the manufacture of ATP, the fuel of our cells. It is present in every cell of our bodies, especially in the very active cells of our hearts. Depriving the heart of CoQ10 is like removing the spark plug from an engine. It just won’t work. Low levels of CoQ10 are involved in practically all cardiovascular diseases including angina, hypertension, cardiomyopathy and congestive heart failure (Sarter, 2002). It is ironic that statins, for “heart health”, block coenzyme Q10.

Statins’ many potential side effects include depression, confusion, memory problems and inability to concentrate. It hinders our body’s ability to fight microbes, increases liver damage, increases risk of cancer, fatigue, impotence, kidney failure, rhabdomyolysis (destruction of muscle cells) and shortness of breath among other things (for a database on statin adverse effects, see here). Cholesterol levels that are below 150 mg/dL may increase the risk for cancer, hormonal imbalances, depression, sexual dysfunction, memory loss, Parkinson’s disease, type 2 diabetes, stroke, suicide, and violent behavior.

As scientists are beginning to understand the intricacies of cholesterol’s role in the function of our trillions of cell membranes, including the details of nutrient transport across membranes, they are starting to realize what a bad idea this whole statin business is. Well, some of them are, anyway. According to some researchers:

“Current guidelines encourage ambitious long term cholesterol lowering with statins, in order to decrease cardiovascular disease events. However, by regulating the biosynthesis of cholesterol we potentially change the form and function of every cell membrane from the head to the toe. As research into cell morphology and membrane function realises more dependencies upon cholesterol rich lipid membranes, our clinical understanding of long term inhibition of cholesterol biosynthesis is also changing.” (Wainwright, Mascitelli, & Goldstein, 2009, p. 289)

We make highly unstable and dysfunctional cell membranes when we restrict organic animal fats. This harmful effect has far reaching consequences. And doctors, unfortunately, don’t seem to be receiving this information.

The past decade of research has shown the importance of cholesterol-rich membranes and their fundamental implications for our brain and nervous tissue, immune system and all areas where lipoproteins are created, secreted, delivered and utilized. Cholesterol is so vital to the formation and correct operation of the brain that neurons require additional cholesterol to be secreted by brain cells. No wonder some people lose their memories with statin therapy!

Statin drugs also impair the secretion of new myelin, the fatty coating that covers the nerve cells and facilitates their firing. The connection between cholesterol and its fundamental role in the immune system and in the cell membrane should also be kept in mind when it comes to autoimmune diseases.

Modern guidelines say that it is desirable to have a level of total cholesterol of less than 200 mg/dL. When I was in medical school, which was not that long ago, the upper limit was 240 mg/dL. Once upon a time, it used to be 280 mg/dl. Apparently, in 1970, the rule-of-thumb for a healthy serum cholesterol was in the 200 plus range. Now most doctors try to keep cholesterol below 200, which most people find very difficult (if not impossible) to achieve through diet and lifestyle changes alone. Since then, statin drugs like Lipitor became one of the all-time top-selling drugs in history (Angell, 2005).

The European guidelines on cardiovascular disease prevention in clinical practice (Piepoli et al., 2016) recommends that very high-risk patients lower their LDL cholesterol to less than 70mg/dL (<1.8 mmol/L) or “a reduction of at least 50% if the baseline is between 70 and 135 mg/dL (1.8 and 3.5 mmol/L).” (Ibid., p. 2331) Conveniently, pharmaceutical companies have the drug just for such a drastic reduction. For example Orvatez by Merck which combines ezetimibe (blocks the absorption of cholesterol) and atorvastatin (a statin drug) can bring LDL cholesterol down to 50 mg/dL. Merck highlights in a chart made for doctors that if a patient has a baseline LDL cholesterol of 70 mg/dL, target LDL should be of 35 mg/dL! And I’m not the only one who sees a problem with this. As the Mayo Clinic shyly puts it:

“There is no consensus on how to define very low LDL cholesterol, but LDL would be considered very low if it is less than 40 milligrams per deciliter of blood… very low levels of LDL cholesterol may be associated with an increased risk of cancer, hemorrhagic stroke, depression, anxiety, preterm birth and low birth weight if your cholesterol is low while you’re pregnant.” (Lopez-Jimenez, 2015, para. 2-3)

The above-mentioned European guidelines include a disclaimer where we read the following:

“[the] Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient’s health condition and in consultation with that patient and, where appropriate and/or necessary, the patient’s caregiver. Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient’s case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations. It is also the health professional’s responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.” (Piepoli et al., 2016, p. 2315)

Since I have first hand experience of the way research is done in Europe, most specifically Italy, I decided to have a look at the disclosure forms of the experts involved in the development of these guidelines. As it happens, there is no direct hyperlink to the disclosure from the electronic version. I found it hyperlinked in a smaller font as the last section of the menu on a separate page at their escardio.org website. After a while you get good at digging for these details that very few are trained to look for and/or are interested in. The declaration of interest is a PDF file of 35 pages and it specifies that “the report below lists declarations of interest as reported to the ESC by the experts covering the period of the Guidelines production, from Task Force creation to publication.” (Available at https://www.escardio.org/static_file/Escardio/Guidelines/DOI_CVDPrevention.pdf)

That is, the declaration of interest only covers 2014 and 2015, and it is not given by a third party. Most of the authors have so many links to Big Pharma that their declaration of interest can take an entire page. The reader can have fun searching for Big Pharma sponsoring for the years not covered for both the sponsored and the few authors who had nothing to declare in 2014 and 2015. I challenge anyone to find at least one author who chose to attend only conferences that were not financed by Big Pharma as a general rule for his entire career.

As Marcia Angell, Senior Lecturer in Social Medicine at Harvard Medical School and former Editor of the New England Journal of Medicine states:

“If drug companies and medical educators were really providing education, doctors and academic institutions would pay them for their services. When you take piano lessons, you pay the teacher, not the other way around. But in this case, industry pays the academic institutions and faculty, and even the doctors who take the courses. The companies are simply buying access to medical school faculty and to doctors in training and practice.

This is marketing masquerading as education. It is self-evidently absurd to look to companies for critical, unbiased education about products they sell. It’s like asking a brewery to teach you about alcoholism, or a Honda dealer for a recommendation about what car to buy. Doctors recognize this in other parts of their lives, but they’ve convinced themselves that drug companies are different. That industry-sponsored education is a masquerade is underscored by the fact that some of the biggest Madison Avenue ad agencies, hired by drug companies to promote their products, also own their own medical-education companies. It’s one-stop shopping for the industry.[…]

It’s easy to fault drug companies for much of what I’ve described, and they certainly deserve a great deal of blame. Most of the big drug companies have paid huge fines to settle charges of illegal activities. Last year Pfizer pleaded guilty and agreed to pay $2.3 billion to settle criminal and civil charges of marketing drugs for off-label uses-the largest criminal fine in history. The fines, while enormous, are still dwarfed by the profits generated by these activities, and are therefore not much of a deterrent. Still, apologists might argue that, despite its legal transgressions, the pharmaceutical industry is merely trying to do its primary job-furthering the interests of its investors-and sometimes it simply goes a little too far.

Doctors, medical schools, and professional organizations have no such excuse; the medical profession’s only fiduciary responsibility is to patients and the public.” (emphasis added) (Angell, 2010, para. 35-36, 39-40)

If only health care professionals at large would take a stand against the massive conflict of interests from pharmaceutical and food industries and their role in the corruption of the medical science, it wouldn’t have come to the point where there are guidelines advising the reduction of cholesterol to levels never seen before in medical records. Another line of research would have been followed where dietary and environmental factors and their role in inflammation and our health would play a greater role. Hopefully we will wake up soon, otherwise we risk a guideline recommending zero levels of LDL cholesterol. It sounds absurd, but then, I thought that an LDL target 35 mg/dL would shock conventional practitioners to realize the absurdity of these recommendations, and that doesn’t seem to have happened.

Statin drugs are among the most profitable drugs in the history of the world. Those profits buy a lot of propaganda: lobbyists, advertising and marketing to doctors, and free continuing medical education. Think of what even a small percentage of their massive profits could do for prevention if it were invested in public education towards a truly health promoting diet. Think of all the diseases that would essentially disappear from the face of the planet. But expecting a corporation to willingly cut off its main source of profit is a pipe dream. Even if they knew the truth about diet, it would be kept as the most tightly guarded secret in history.

It’s really not in the drug-maker’s’ best interest to have people making healthy dietary choices. So instead of promoting prevention strategies, cholesterol drugs continue to post record-breaking profits and create poor health and side effects in the people taking them. Those people in poor health can then be treated with more drugs. How many people do you know on multiple medications for various ailments? Whether the cause if malfeasance or ignorance is largely irrelevant because the result is the same.

It is only your own awareness that can turn things around. The public is gradually awakening to the fact that statins are virtually useless for the vast majority of people who take them, and yet they carry significant risks.

A group of eminent doctors including the President of the Royal College of Physicians, Sir Richard Thompson, argue in a declaration letter that a doctor making a case for these drugs can quite easily look ill-informed, biased or just plain stupid in the eyes of their patients. According to one of the letter’s signatories, Dr David Newman, Assistant Professor of Emergency Medicine and Director of clinical research at Mount Sinai School of Medicine:

“I am always embarrassed when I have to tell patients that our treatment guidelines were written by a panel filled with people who stood to gain financially from their decisions. The UK certainly appears to be no different to that of the United States. The truth is, for most people at low risk of cardiovascular disease, a statin will give them diabetes as often as it will prevent a non fatal heart attack – and they won’t live any longer taking the pill. That’s not what patients are looking for.” (Briffa, 2014, para. 20)

The letter was addressed to the chair of NICE, the National Institute for Health and Care Excellence in the United Kingdom. In the letter, the proposition to reduce the threshold for prescribing statins to those with a 10% risk of cardiovascular disease is rejected by addressing six major concerns (letter available at www.nice.org.uk/Media/Default/News/NICE-statin-letter.pdf):

  1. The medicalization of millions of healthy individuals
  2. Conflicting levels of adverse events
  3. Hidden data
  4. Industry bias
  5. Loss of professional confidence
  6. Conflicts of interest

So again we see guidelines being written to favor the industry and the over-medicalization of millions of people.

Ironically, the very same experts for some of these guidelines disagree, calling for expert groups such as the Adult Treatment Panel (ATP) IV to “abandon the paradigm of treating patients to LDL targets” (Hayward & Krumholz, 2012).

Blinded by the numbers, doctors will see LDL levels at 70 and say their patients are doing well. They could fail to see what might actually be in front of their eyes – an ill-looking and nutritionally deficient person. Cracking skin, plunging libido, muscle wasting, memory problems, blood sugar imbalances, premature aging – but hey, cholesterol numbers are right on the money! It is astounding to see how we as doctors do so little critical thinking, focusing only on arbitrary guidelines dictated by the same companies selling the drugs that are the only things that make the numbers possible. Talk about a collective blind spot facilitated by decades of programmed schooling. Even when a patient points out, ‘but I eat no fats and no salt and I’m getting worse!’, we might fail to connect the dots.

As if this weren’t enough, here’s another bit of irony. In one study, the use of statin drugs was associated with microalbuminuria (Van Der Tol et al., 2012). Microalbuminuria is a marker of poor endothelial function and it’s endothelial function which determines cardiovascular disease risk. Microalbuminuria is also a marker of kidney problems.

Similarly, in a study of nearly 26,000 beneficiaries of Tricare – the military health system in the United States – those taking statin drugs to control their cholesterol were 87 percent more likely to develop diabetes. The research confirmed past findings on the link between statins and diabetes risk, but it is among the first to show the connection in a relatively healthy group of people. The study included only people who at baseline were free of heart disease, diabetes, and other severe chronic disease (Veterans Affairs Research Communications, 2015).

In this same study, statin use was also associated with a very high risk of diabetes complications. Among 3351 pairs of similar patients–part of the overall study group–those patients on statins were 250 percent more likely than their non-statin-using counterparts to develop diabetes with complications (Mansi, Frei, Wang, & Mortensen, 2015). Statin users were also 14 percent more likely to become overweight or obese after being on the drugs. The study also found that the higher the dose of any of the statins, the greater the risk of diabetes, diabetes complications, and obesity. Ironically, it is those who have had a cardiovascular disease event who are prescribed higher doses of statin drugs.

Moreover, more frequent statin drug use is associated with accelerated coronary artery and aortic artery calcification, both of which greatly contribute to cardiovascular and all-cause mortality (Saremi, Bahn, & Reaven, 2012). An evaluation of thousands of individuals with no known cardiovascular disease and undergoing a coronary CT angiography which visualizes atherosclerosis, concluded that statin use is associated with an increased prevalence and extent of coronary plaques possessing calcium (Nakazato et al., 2012). So doctors might be prescribing a medicine that contributes to onset of the very thing they are trying to prevent.

In the meantime, people are getting increasingly high levels of calcified hearts. During heart surgery, the surgical instrument known as the ‘bone eater’ ends up being used to replace valves that should have remained silky and smooth. I know what I speak after witnessing and conducting thousands of open heart surgeries in three different countries.

Two top vascular surgeons have summarized statins in a damning report called “The Ugly Side of Statins. Systemic Appraisal of the Contemporary Un-Known Unknowns“. In the report they state: “The statin industry is the utmost medical tragedy of all times,” and that “statins are associated with triple the risk of coronary artery and aortic calcification.” (Sultan & Hynes, 2013, p. 180, 183)

The picture isn’t pretty. The decades of massive anti-fat propaganda has brainwashed all of us without exception. Upon being questioned about their dietary habits, a patient might guiltily recall all the fats they ate and think that those are to blame for their health woes. Never mind that they eat mostly carbs, or that most of the fats they do eat are of the processed, plastic and vegetable oil variety. On doctors orders, they remove the animal fat from their diets, thereby increasing the carbs and vegetable oils, the very two steps that will deteriorate their health. When and if cholesterol targets are not reached by these measures, then the doctor has ‘no choice’ but to put them on a statin drug.

There is, however, a small percentage of people out there who genuinely have a true genetic predisposition to high blood cholesterol called familial hypercholesterolemia, which is a condition which is characterized by an impaired or even lack of ability to metabolize cholesterol. This condition can have serious health consequences and sufferers may need medical interventions to bring their cholesterol levels down. But that doesn’t mean this can be extrapolated to all people who don’t have this genetic problem.

Medical research has not proven that lowering (or low) cholesterol in and of itself reduces risk of death from heart disease across a population (Siri-Tarino, Sun, Hu, & Krauss, 2010; Chowdhury et al., 2014). Men with very low cholesterol levels seem prone to premature death. Below 160 milligrams per deciliter (mg/dl), the lower the cholesterol level, the shorter the lifespan. These men die of cancer, respiratory and digestive diseases, and trauma (Smith, 1997). As for women, if anything, the higher their cholesterol, the longer they seem to live (Teicholz, 2014).

Despite these facts, it is estimated that by 2020, revenues from statin drug sales will reach 1 trillion dollars. Never mind that most people taking these drugs are not at risk for heart disease.

References

Angell, M. (2005). The truth about the drug companies: How they deceive us and what to do about it. New York: Random House Trade Paperbacks.

Angell, M. (2010, May 1). Big Pharma, Bad Medicine. Retrieved from http://bostonreview.net/angell-big-pharma-bad-medicine

Briffa, J. (2014, June 18). Prominent doctors declare their opposition to the planned expansion of statin prescribing. Retrieved from http://www.drbriffa.com/2014/06/18/prominent-doctors-declare-their-opposition-to-the-planned-expansion-of-statin-prescribing/

Chowdhury, R., Warnakula, S., Kunutsor, S., Crowe, F., Ward, H. A., Johnson, L., . . . Angelantonio, E. D. (2014). Association of dietary, circulating, and supplement fatty acids with coronary risk. Annals of Internal Medicine, 160(6), 398-406. doi:10.7326/m13-1788

Hayward, R. A., & Krumholz, H. M. (2012). Three reasons to abandon low-density lipoprotein targets: An open letter to the adult treatment panel IV of the National Institutes of Health. Circulation: Cardiovascular Quality and Outcomes, 5(1), 2-5. doi:10.1161/circoutcomes.111.964676

Leslie, I. (2016, April 07). The sugar conspiracy | Ian Leslie. Retrieved from https://www.theguardian.com/society/2016/apr/07/the-sugar-conspiracy-robert-lustig-john-yudkin

Lopez-Jimenez, F. (2015, October 30). Cholesterol level: Can it be too low? Retrieved from http://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/expert-answers/cholesterol-level/faq-20057952

Mansi, I., Frei, C. R., Wang, C., & Mortensen, E. M. (2015). Statins and new-onset diabetes mellitus and diabetic complications: A retrospective cohort study of US healthy adults. Journal of General Internal Medicine, 30(11), 1599-1610. doi:10.1007/s11606-015-3335-1

Nakazato, R., Gransar, H., Berman, D. S., Cheng, V. Y., Lin, F. Y., Achenbach, S., . . . Min, J. K. (2012). Statins use and coronary artery plaque composition: Results from the International Multicenter CONFIRM Registry. Atherosclerosis, 225(1), 148-153. doi:10.1016/j.atherosclerosis.2012.08.002

Piepoli, M. F., Hoes, A. W., Agewall, S., Albus, C., Brotons, C., Catapano, A. L., . . . Verschuren, W. M. (2016). 2016 European Guidelines on cardiovascular disease prevention in clinical practice. European Heart Journal, 37(29), 2315-2381. doi:10.1093/eurheartj/ehw106

Saremi, A., Bahn, G., & Reaven, P. D. (2012). Progression of vascular calcification is increased with statin use in the Veterans Affairs Diabetes Trial (VADT). Diabetes Care, 35(11), 2390-2392. doi:10.2337/dc12-0464

Sarter, B. (2002). Coenzyme Q10 and cardiovascular disease: A review. The Journal of Cardiovascular Nursing, 16(4), 9-20. doi:10.1097/00005082-200207000-00003

Sboros, M. (2016, December 10). Victory for Teicholz in battle of butter. Retrieved from http://foodmed.net/2016/12/04/victory-teicholz-battle-of-butter-bmj/

Siri-Tarino, P. W., Sun, Q., Hu, F. B., & Krauss, R. M. (2010). Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. American Journal of Clinical Nutrition, 91(3), 535-546. doi:10.3945/ajcn.2009.27725

Sultan, S., & Hynes, N. (2013). The ugly side of statins. Systemic appraisal of the contemporary un-known unknowns. Open Journal of Endocrine and Metabolic Diseases, 03(03), 179-185. doi:10.4236/ojemd.2013.33025

Teicholz, N. (2014). The big fat surprise: Why butter, meat, and cheese belong in a healthy diet. New York: Simon and Schuster.

Van Der Tol, A., Van Biesen, W., Van Laecke, S., Bogaerts, K., De Lombaert, K., Warrinnier, H., & Vanholder, R. (2012). Statin use and the presence of microalbuminuria. Results from the ERICABEL trial: A non-interventional epidemiological cohort study. PLoS ONE, 7(2). doi:10.1371/journal.pone.0031639

Veterans Affairs Research Communications. (2015, May 07). Strong statin-diabetes link seen in large study. Retrieved from https://www.sciencedaily.com/releases/2015/05/150507145328.htm

Wainwright, G., Mascitelli, L., & Goldstein, M. R. (2009). Cholesterol lowering therapies and membrane cholesterol. Stable plaque at the expense of unstable membranes? Archives of Medical Science, (5), 289-295.

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