Are you the unwitting victim of the Statin drugs – Cholesterol – Heart Hypothesis (Theory) that has created a multi-billion-dollar industry?

Written by Diana Chan R.Ph, BCNSP (Pharmacist, Board Certified Nutrition Support Pharmacist)

Many people, especially those over 50,  are taking Statin drugs as prescribed by their doctors as preventive medicine in hope of preventing heart diseases and extend their lifespan by lowering their cholesterol levels based on the Cholesterol – Heart Hypothesis (theory). Is this theory true? Are you aware of the dangers of Statin drugs? Are you the unwitting victim of the “Statins – Cholesterol – Heart Hypothesis” that has created a multi-billion-dollar industry? If you are one of those people taking statins, you owe it to yourself to educate yourself. Keep reading to learn more.

Why did “experts” keep lowering the normal levels of common diseases including the normal cholesterol levels?

“In the hope of extending treatment benefits to patients with early disease, various professional societies have recommended changing several common disease definitions by lowering the threshold value (cutoffs) for diagnosis. Adopting the new definitions would dramatically inflate disease prevalence. In other words, healthy people with no symptoms can be turned into sick people based on the new definitions.

 Threshold value (cutoffs) are set by “expert panels” of physicians. They claim their main focus is not overlooking anyone who could possibly benefit from diagnosis and treatment.  But their decisions were often influenced by personal financial interests and not by purely scientific process. So they tend to set cutoffs that are expansive, leading many healthy individuals to be labeled abnormal and thus receiving treatments that bring them harm rather than benefit. [1] [2]

Doctors are expected to follow the new guidelines because they are handed down from the “experts” and they do not want to take the risk of potential litigations if they don’t. In addition, they are constantly reminded and persuaded by sales representatives from drug manufacturers about the new guidelines and also being offered material incentives such as free vacation packages set up as seminars for continued education. 

The Cholesterol hypothesis that creates a multi-billion dollar industry.

 Let’s look at the example of cholesterol levels. We are constantly reminded that we need to pay attention to our cholesterol level. When all of a sudden the threshold for abnormal total cholesterol fell from greater than 240 to greater than 200, an additional 42 million “new cases” of high cholesterol were created. [3] In 2011, US doctors wrote nearly 250 million prescriptions for cholesterol-lowering drugs, most of them are Stain drugs, creating a US$18.5-billion market.[4]

Nov. 12, 2013, New guidelines would double the number of Americans on cholesterol-lowering drugs.

Ever since the organization of heart professionals, along with the American College of Cardiology (ACC), issued new guidelines for measuring and treating cholesterol levels, it’s been on the defensive.

Also, the target cholesterol levels that doctors established – below 200 mg/dL for most adults, and below 100 mg/dL for LDL, (bad cholesterol), were not based on solid scientific studies. There was nothing magic about those numbers; they came from studies of people with heart attacks and were extrapolated to healthy populations to help them prevent first heart events. [5]

Cholesterol lowering drugs –especially Statin drugs, is a multibillion-dollar business. Pfizer’s atorvastatin (Lipitor), a Statin drug, went on sale in 1997 and became the best-selling drug in the history of prescription pharmaceuticals before its patent expired in 2011. Sales surpassed $125 billion. AstraZeneca’s rosuvastatin (Crestor), another Statin drug was the top-selling statin in 2013, generating $5.2 billion in revenue that year. So, a small decrease in number denoting normal cholesterol level brings in additional  multibillion dollars in revenues for statins manufacturers.

How did the Statin drugs manufacturers convince healthcare professional and general public about the benefits and effectiveness of Statin drugs?

Studies sponsored by pharmaceutical companies tend to  inflate claims of Statin drugs’ effectiveness and downplay the harmful effects using “relative risk” instead of “absolute risk”.  Pfizer, in an advertisement, proclaims: “Lipitor reduces risk of heart attack by 36%,” based on the findings of a large randomized trial in which 10,305 individuals were assigned to take Lipitor or a placebo.

The trial showed that 1.9 percent of people taking Lipitor suffered a heart attack while 3.0 percent of the placebo group had one. Going from 1.9 to 3.0 is a 36% increase-“relative risk”, but the “absolute risk” –the  difference between 1.9 and 3.0 is only 1.1%. This difference can be accounted for by the “margin of error”. On the other hand, they report deleterious effects in terms of absolute risk, minimizing their magnitude.[6]  The pharmaceutical companies are trying to mislead the consumers.

How Statin drugs evolve into “gold standard” of preventive medicine for cardiovascular diseases.

Since the approval of the first statin-lovastatin by FDA in 1987, after a little more than 15 years, Statin drugs quickly became the “gold standard“ for drugs affecting lipid metabolism, mainly through aggressive marketing strategy using an army of enthusiatic and aggressive pharmaceutical reps (aka drug rep or drug pushers). Read more about how drug pushers have on doctors. The enthusiasm for statins became  so great around 2000, that the suggestion of adding statins to the drinking water as their next logical application was a common joke among those in the field.[7]

Very likely, the “normal” cholesterol level will be changed (most likely lower) again in the future based on the recommendation of the future “expert panels”. Whatever the decision, the pharmaceutical industry will be watching closely, says Donny Wong, an analyst at Decision Resources, a market-research company based in Burlington, Massachusetts. Although most statins are off patent, the big pharmaceutical companies are racing to bring to market the next generation of LDL-lowering drug which has not yet been shown to reduce heart attacks or strokes. [8]

How aware are you of the Statin drugs dangers?

In August 2001, manufacturer-Bayer voluntarily withdrew cerivastatin (one of the many statins) from the market, due to disproportionate number of reports of rhabdomyolysis-associated death, especially when cerivastatin was combined with gemfibrocil. By Jan. 2002, about 100 deaths were attributed to cerivastatin related rhabdomylysis. [9]

“Jay Cohn, a cardiologist at the University of Minnesota Medical School in Minneapolis, also worries that the focus on LDL levels offers up the wrong patients for statin therapy. Most of those who have a heart attack do not have high LDL. Cohn advocates treating patients with statins based on the state of health of their arteries, as revealed by noninvasive tests such as ultrasound. “If your arteries and heart are healthy, I don’t care what your LDL or blood pressure is,” he says. “ [10] With this statement, Dr. Jay Cohn pretty much discredited the whole cholesterol-heart hypothesis. More on Statin drugs dangers / side effects later. Keep reading.

Understanding the “cholesterol-heart hypothesis”, aka “lipid hypothesis”, and “diet-heart hypothesis”.

 “Many scientists had been and more and more are challenging the  “cholesterol-heart hypothesis”, i.e., the “lipid hypothesis”, and the “diet-heart hypothesis”, which indicts saturated fat along with cholesterol for causing atherosclerosis.  Substantial evidence now proves beyond a reasonable doubt that these hypotheses are wrong. This evidence show that atherosclerosis is an inflammatory disease. Late Russell Ross, professor of pathology at the University of Washington, demonstrated that atherosclerosis is a chronic inflammatory disease as seen in cirrhosis, rheumatoid arthritis, and chronic pancreatitis.” [11] [12] [13] [14] [15]

I am pretty sure as new research and new studies continue to come out, perhaps we will find out what really cause atherosclerosis that lead to heart disease. Someday, statins might turn out to be like trans-fat (margarine) which was touted as the best creation to replace natural saturated fats decades ago, is now something being disowned by all quality processed food products because trans fats has been shown to increase the risk of coronary artery disease in part by raising levels of the lipoprotein LDL, lowering levels of the lipoprotein HDL, increasing triglycerides in the bloodstream and promoting systemic inflammation.  [16] [17] [18]

If you are subjecting yourself under the instruction by your doctor, to statins treatment for long term when you actually feel there is nothing wrong with you, don’t you think you owe it to yourself to learn more about statins instead of putting blind faith in your doctor?

 What are statins?
 How are they made?
 How they are supposed to work to lower cholesterol level?
 And more importantly do they really prevent heart disease?
 What are their side effects?

Let’s find some answers to these questions

What are statins?  Brief history of statins: [19]

First thing you need to know is that statins are mycotoxins- toxins which are antibiotics,  extracted from fungus just like Penicillium  which is antibacterial microbe extracted from Penicillium mold. Antibiotics can kill bacterial cells, but they can also kill good cells in our body. Many of the newer statins are synthetic derivatives of the earlier statins extracted from fungus.

During the development of statins, a link between cholesterol and cardiovascular disease, known as the Lipid Hypothesis, aka  Cholesterol – Heart Hypothesis (theory) was suggested by Cholesterol researcher Daniel Steinberg while the Coronary Primary Prevention Trial of 1984 demonstrated cholesterol lowering could significantly reduce the risk of heart attacks and angina, however physicians, including cardiologists, remained largely unconvinced.[21]

List of Statin drugs:

The first agent identified was mevastatin, a molecule produced by the fungus Penicillium citrinum in 1971, by  Akira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo.

A British group isolated the same compound from Penicillium brevicompactum, named it compactin.

 Mevastatin was never marketed, because of its adverse effects of tumors, muscle deterioration, and sometimes death in laboratory dogs.

Cerivastatin (trade name: Lipobay, Baycol)- Synthetic (withdrawn from the market in August, 2001 due to risk of serious rhabdomyolysis)

By 1978, Merck had isolated lovastatin (trade name: Mevacor, Altocor, Altoprev) from the fungus Aspergillus terreus, first marketed in 1987 as Mevacor.[20]

Pravastatin (trade name: Pravachol) Fermentation-derived (a fermentation product of bacterium Nocardia autotrophica)

Simvastatin (trade name: Zocor, Lipex) Fermentation-derived (simvastatin is a synthetic derivate of a fermentation product of Aspergillus terreus)

Others are synthetic:

Atorvastatin, (trade name: Lipitor, Ator)
Fluvastatin, (trade name: Lescol, Lescol XL)
Pitavastatin, (trade name: Livalo, Livazo, Pitava)
Rosuvastatin  (trade name: Crestor)

Combination products

Simvastatin + ezetimibe (trade name: Vytorin, Inegy)
Lovastatin + niacin extended-release (trade name: Advicor, Mevacor)
Atorvastatin + amlodipine (trade name: Caduet, Envacar)
Simvastatin + niacin extended-release (trade name: Simcor)

Not all the healthcare professionals are convinced that the benefits of Statin drugs outweigh the their side effects/dangers. Why?

Cholesterol confusion and statin controversy- Abstract[22] by DuBroff R, de Lorgeril M. World J Cardiol. 2015 Jul 26 indicated: “The role of blood cholesterol levels in coronary heart disease (CHD) and the true effect of cholesterol-lowering statin drugs are debatable. In particular, whether Statin drugs  actually decrease cardiac mortality and increase life expectancy is controversial. Concurrently, the Mediterranean diet model has been shown to prolong life and reduce the risk of diabetes, cancer, and coronary heart disease (CHD). We herein review current data related to both statins and the Mediterranean diet. We conclude that the expectation that CHD could be prevented or eliminated by simply reducing cholesterol appears unfounded. On the contrary, we should acknowledge the inconsistencies of the cholesterol theory and recognize the proven benefits of a healthy lifestyle incorporating a Mediterranean diet to prevent CHD.”

The French paradox: Why is it called “paradox”?

The French paradox is the observation of low coronary heart disease (CHD) death rates of French despite high intake of dietary cholesterol and saturated fat.

Why do we call it the paradox? Simply because it contradicts the well accepted “cholesterol-heart-hypothesis” by the pro “cholesterol-heart-hypothesis” scientists who have been trying to convince us that high intake of dietary cholesterol and saturated fat is the culprit for CHD. This “cholesterol-heart-hypothesis” is the basic premise for marketing Statins and other cholesterol-lowering drugs.  If we believe the French phenomenon is right, then there is no need to sell cholesterol-lowering drugs. Why should the drug manufacturers let the French Paradox kills the goose that lays the golden eggs?

Could it be that the phenomenon in France – high intake of dietary cholesterol and saturated fat is right and the effort of using Statin drugs or other cholesterol-lowering drugs to lower cholesterol and the low fat diet is wrong? If that is the case, drug manufacturers would not be happy, would they? So, the scientists decide to call French high cholesterol and high fat diet a PARADOX.

Why cientists/researchers, not financially tied to pharmaceuticals  companies, are not buying the cholesterol-heart hypothesis?

Many others scientists/researchers, not financially tied to pharmaceuticals  companies, are not buying the cholesterol-heart hypothesis. They believe this lipid hypothesis was shoved down the throat of the doctors in medical school and therefore down the throat of their unaware patients.

Let’s try to understand the two sides of the story about the cholesterol-heart hypothesis without using too much scientific jargon. My job is to help my readers to understand the key messages presented by multitude of clinical trials and studies and case reports in layman’s language by cutting through all the scientific and statistical mumbo jumbo. I also want to point out that I am not here to promote any particular diets or products (vitamins or supplements) with the aim to lower cholesterol level. That subject belongs to a separate book.

How Statin drugs work

Researchers who postulated the lipid hypothesis (aka  cholesterol-heart hypothesis), believe and label LDL as “bad” cholesterol. The LDL can clog up the artery and therefore cause atherosclerosis which in turn cause coronary heart disease (CHD). They are telling us Statin drugs  work by reducing the liver’s production of cholesterol by blocking an enzyme called HMG CoA Reductase, the rate-limiting enzyme of the mevalonate pathway[23] that the liver uses to make cholesterol.  So, statins are also known as HMG-CoA reductase inhibitors meaning they stop/interfere with the normal function of HMG-CoA reductase and therefore lower LDL. [24] [25]

I don’t mean to get too technical, but it is important to understand the functions of “mevalonate pathway” before we can understand the downside of statins- meaning why they carry such harmful side effects.  The mevalonate pathway, also known as the isoprenoid pathway or HMG-CoA reductase pathway is an essential metabolic pathway present in basically all living cells.[26] The pathway is responsible for producing isoprenoids (AKA Terpenoids),  which is a diverse class of over 30,000 biomolecules such as cholesterol, heme, vitamin K, coenzyme Q10, and all steroid hormones.[27] [28]

So, you see, when Statin drugs interfere with the HMG-CoA reductase within the mevalonate pathway to achieve the goal of lowering LDL cholesterol (assuming LDL is bad), they also at the same time interfere with the production of heme, vitamin K, coenzyme Q10, and all steroid hormones. Do you think that might present a health  problem? No wonder people taking Statin drugs are often advised to supplement with CoQ10, which is vital to energy production in all our cells, especially those organs with the highest energy requirements—such as the heart, liver, kidney [29] and skeletal muscle.

To understand the Statin drugs’ dangers, we  need to  understand the Mevalonate Pathway.

The cells in our body do not live forever. They need to replicate, meaning the old cells die and new cells need to be born. There are between 50 and 75 trillion cells in the body. Each type of cell has its own life span.[30] Red blood cells live for about four months, while white blood cells live on average more than a year. Skin cells live about two or three weeks. Colon cells die off after about four days. Sperm cells have a life span of only about three days.

So, the mevalonate pathway is vital to cell replication and therefore our continued existence. Statins (fungal toxins), by interfering with the normal functions of this pathway, stop normal cell cycles, blocked DNA replication and thus gradually kill cells. Each time you take a dose of  Statin drug on a daily basis, it is as if you are giving permission to a robber to come into your house to take away your valuable possession. Statins rob your cells’ ability to produce the vital enzymes and hormones your body needs and the cells gradually lose their ability to reproduce. People are unaware of the insidious way Statin drugs work, since it is happening very slowly over a long period of time, you do not associate your deteriorating health with the statin you are taking. You might be blaming your deteriorating health to aging, lack of exercise or other bad habits you might have. What is even worse is that when you start complaining about your new aches and pains, your doctor will prescribe more symptom-treating drugs for you. Since each drug has its own side effects, you start having more complaints each time you go to see your doctor, and as a result your medication list gets longer and longer.

Alas! You might start out as a healthy person taking statins as a preventive measure, sooner or later you become a sick person! You don’t even know what is going on with your body. You have become a perfect “willing victim”.

Why trials that disagreed with the “Cholesterol -Heart-Hypothesis” were getting less publicity than those that were supportive of it.

 “There was ongoing contention about the results and meaning of intervention studies undertaken before the introduction of statins.[31] [32] [33] [34] A meta-analysis (a statistical analysis that combines the results of multiple scientific studies) of cholesterol-lowering trials found that trials that were supportive of the lipid hypothesis were cited almost six times as often as those that were not, and although there was a similar number of trials unsupportive of the hypothesis, none of them were cited after 1970; some of the supportive reviews also exclude and ignore certain trials which were less favorable to the hypothesis. This meta-analysis, including the less-cited trials, found that mortality was not decreased by lowering cholesterol, and that the lowering of cholesterol was unlikely to prevent coronary heart disease.[35] [36] [37] Uffe Ravnskov, director of The International Network of Cholesterol Skeptics, maintains that “prominent scientists have turned white into black by ignoring all conflicting observations; by twisting and exaggerating trivial findings; by citing studies with opposing results in a way to make them look supportive; and by ignoring or scorning the work of critical scientists.”  [38] [39]

Scientists who disagree with the lipid hypothesis do not believe there is such thing as “bad” cholesterol. The pro lipid hypothesis scientists condemned LDL as “bad” cholesterol because it is found in artery of people with atherosclerosis. However, the LDL found in clogged artery is “oxidized”, which is the key word. The opposing scientist believe it is the oxidation of the LDL that is responsible for the clogged artery, not the LDL itself.  Since cholesterol including LDL  is essential for all animal life, each cell is capable of synthesizing it by way of a complex 37-step process, beginning with the mevalonate pathway. Furthermore, it can be absorbed directly from animal-based foods.[40]  

We live in environment that surround us with many different types of oxidants, such as chlorine in our tap water, insecticides and herbicides sprayed on our vegetables and fruits, contaminated air we breathe in and the list goes on and on. There is not enough space in my book to have a lengthy discussion on oxidants and antioxidants. The materials for that subject is enough to fill several books. So the important thing to know is to avoid oxidants as much as possible and take in enough antioxidants such as vitamin C, to keep the LDL from being oxidized. It sounds simple enough, but in reality it is not. But this idea does not generate business for drug manufacturers. If all people believe this theory can eliminate many different diseases, many medical facilities will be closed down and many doctors will have to go out of business. Many researchers who work for drug manufacturers will go hungry. It will practically collapse the whole medical establishment. You might say that is not good for our economy and our employment rate. However, if you are the suffering patient, do you honestly care about that?

Hippocrates: “Do no harm”

How our healthcare system is influenced by money.

Medical profession is supposed to be here to serve sick people, not the other way around. People should not be treated as “money trees” for the medical profession and the drug industry.

Well, unfortunately, for consumers, eventually the pro lipid hypothesis (cholesterol-heart hypothesis) scientists won and Statin drugs are here to stay. Why? Money,  bookoos of money, in the billions each year. The Statin drugs’ manufacturers can pretty much predict how much dough they can roll into their bank accounts each time the “expert panels” decide to lower the normal cholesterol levels and the doctors are convinced to comply to the new guidelines.  No wonder the healthcare cost is so high in this country-USA, the most powerful country in the world  which does not guarantee healthcare  for all its citizens and yet we waste so much money on unnecessary treatments. Besides the cost of the drugs, we must also add in the cost for future healthcare for those innocent victims who have been harmed by the Statin drug treatment. 

Some, if not all, prominent scientists who work for FDA are also consultants of pharmaceutical companies. The doctors who made up the “expert panels” responsible for setting up the national medical policy on the treatment of cholesterol via the NCEP (the National Cholesterol Education Program)  are paid advisors of statin manufacturers. In the book-How Statin Drugs Really Lower Cholesterol and Kill You One Cell At A Time, James B. Yoseph and Hannah Yoseph, MD painstakingly exposed the chronological events of statin development and the scientists (by names) responsible for the passage of statins onto the world market mostly by manipulating the drug study results, boasting the benefits and hiding or downplaying the harmful side effects of statins. They said and I quote:

“Follow the money. Cures are not profitable.

Lying and ignoring, on the other hand, can be hugely profitable

if the end result is a popular drug “treatment”.”

My personal assessment and opinion

You might ask me: Who are you? As an individual pharmacist, why do you think you are qualified to dispute the doctrine of the powerful expert panels made up of 14 different highly educated individuals with MD and/or PhD behind their names and some of them are nobel laureate?

My answer to you is very simple: Use some common sense.

1. First and foremost, you are a healthy person.

2. You are told to take a drug that is not a “cure” for anything.

3. You are told to take this drug for the rest of life just because your cholesterol levels do not conform to certain arbitrarily defined numbers.

4. Your doctor never take time to explain to you how Statin drugs work. All they probably tell you is that statins lower cholesterol and that decrease the chance of heart disease. Many physicians are probably ignorant about how statins Statin drugs really work-that is by interfering with mevalonate pathway which is essential for cell regeneration and that Statin drugs  interfere with the vital functions carried out by the mevalonate pathway, which in turn lead to many side effects and eventually cell death. Even if they do know how Statin drugs really work, they will not explain it to you as a patient because he is too busy and/or he feels you are just an ignorant patient and you would not understand anyway.

5. If you are aware of the side effects and the statistics of people who have been harmed by them, you will think twice about taking them even if they are free.

What are Statin drugs?

First of all, Statin drugs are mycotoxins, antibiotics that kill cells. Antibiotics not only kill bacterial cells, they can kill good cells too. That is why you don’t want  to take  antibiotics such as penicillin for the rest of your life, especially if you are a healthy person. If I tell you that you should take an antibiotic for the rest of your life because your cholesterol is high, you probably say to me: “I think you are crazy”. But that is exactly what you are doing when you are taking Statin drugs.

Let’s take a look at the Side effects of statin drugs:

Myopathy is the most common adverse effect of Statin drug treatment, manifested by muscle aches and pains, weakness, instability, and easy fatigue. [41] [42] The most severe manifestation of statin-induced muscle damage is rhabdomyolysis, (the destruction of striated muscle cells) which carries a 10 percent mortality rate. Fragments of ruptured muscle block renal tubules and cause kidney failure.  In one randomized trial of 1,016 healthy men and women given statins or a placebo, 40 percent of the women taking statins suffered exertional fatigue or decreased energy. [43] [44] [45] [46] Other adverse effects include an increased risk of diabetes mellitus, and increased liver enzymes in the blood due to liver damage [47] [48], birth defects, intestinal injury, kidney failure, lung injury, memory and cognition loss, mental illness, nerve injury, pancreatic injury, sexual dysfunction, skin injury, tendon injury, thyroid injury, drug-induced lupus erythematosus and other autoimmune disorders [49], and even cancer. [50]

The insights from a large randomized statin trials in July 2007 that explored the “Effect of the Magnitude of Lipid Lowering on Risk of Elevated Liver Enzymes, Rhabdomyolysis, and Cancer” concluded: “Risk of Statin drug-associated elevated liver enzymes or rhabdomyolysis is not related to the magnitude of LDL-C lowering. However, the risk of cancer is significantly associated with lower achieved LDL-C levels. These findings suggest that drug- and dose-specific effects are more important determinants of liver and muscle toxicity than magnitude of LDL-C lowering. Furthermore, the cardiovascular benefits of low achieved levels of LDL-C may in part be offset by an increased risk of cancer.” [51]

Statin drugs also cause CoQ10 deficiency because they interfere with mevalonate pathway, the processes responsible for CoQ₁₀ production. CoQ₁₀ is important for muscle cells and in blood sugar regulation.[52]

Smart inventors don’t take statins because they know they are poison. Next time you see your doctor, ask him he takes statin himself. On a second thought, if he is a doctor who prescribes statins indiscriminately, he will probably tell you that he does when in fact he does not.

If you are taking a Statin drug, you are a guinea pig of
a human Statin drugs experiment.

LDL is not bad and LDL is not our enemy. High cholesterol is not a disease. We have to critically examine why we need to lower the level of LDL.

6. Lame indication
   

Mevacor (lovastatin) by Merk, was approved on Dec. 19, 1991. Here is the information on the application:  

CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for: Application number: 19-643/S-017 [53]
Trade Name: Mevacor
Generic Name lovastatin
Sponsor: Merk Sharpe and Dome Research Laboratories
Approval Date: Decembe 19, 1991

Indications: An adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate.

This is the lamest indication I have ever read about an indication for a drug. The only medical claim is that stains lower cholesterol without any proof of real benefits or safety. On the contrary, there are serious side effects, which are listed on the package insert.

7. Too much money made from putting unaware healthy people on poison.

In 2010, Pfizer’s Atorvastatin (Lipitor) generated some 10.7 billion U.S. dollars of revenue. [54] Spending on cholesterol drugs in the United States alone reached nearly $19 billion in 2010. In the face of many statins being off-patent and the price has dropped significantly, in 2017 the global cholesterol-lowering industry is still worth $19.2 billion. According to New Visiongain Report in 2018, the Cholesterol-Lowering Drugs Market Will Reach $24.63 billion In 2019. [55] [56]

“The pharmaceutical industry spends hundreds of millions of dollars each year promoting the idea that high cholesterol causes heart disease. The other side of the story receives very little attention. As a result, even doctors may have been misled; since they have only been exposed to the pharmaceutical industry’s viewpoint.” Could it be possible that nearly everything your doctor and the media is telling you about high cholesterol and how it relates to saturated fats, heart disease and strokes is wrong? [57]

Expert panel continues to update NCEP’s (The National Cholesterol Education Program’s) cholesterol guidelines for prescribers so as to ever-increase the population of lifetime statin users, including children.

The lower the standard acceptable level, the more drugs they sell; the more diseases caused or exacerbated by the drugs, the more drugs they sell. It is virtually like having a license to print money. [58]

My own story

My own cholesterol level has always been hovering slightly above 240. Even though my HDL (good cholesterol) has been considered high, every year my primary doctor tried to convince me to take a statin drug. Being a pharmacist, I am always very concerned about the side effects of statin drugs-especially myopathy/rhabdomyolysis as explained above.

So every year I refused to take any statins. I have been living with that decision for over 30 years. My diet has changed over the years, but my cholesterol level pretty much stays the same. So 30 plus years later, I am still a very healthy woman, not taking any drugs for any chronic diseases, not only saving many thousands of my own money, but also many more thousands of the tax payers’ money.  I am certainly not in the high risk group for heart disease.

Obviously I do not expect to convince everyone not to take statins using my example alone. You can find plenty of examples of people taking statins and suffering from side effects after taking the drugs for a period of time without realizing the projected benefits. Besides, there are many other ways to lower your cholesterol. But I have yet to be convinced that lowering cholesterol level has anything to do with heart disease.

A real story shared by a close friend of mine

On Feb 2, 2018 a close friend of mine, knowing that I am writing about the issues of Statin drugs to put in my book concerning med issues, sent me an email to share her experience with her primary physician in Austin in relation to Statin drugs with me. She stated that she had not seen her doctor for many years. When she went for her routine checkup, her doctor hardly even looked at her, lest giving her a physical exam which is expected as part of a routine checkup. All he did was glancing over the new office paperwork, then told her she needs to start taking a Statin drug because she was over 50 years old and all people over 50 need to do that. He did not even order a cholesterol test to find out her current cholesterol levels. When she refused the Statin drug therapy, he still insisted prescribing it to her. He then told her to just submit the prescription to a pharmacy but not have it filled. He further explained- that way, he would fulfill his “duty” in order to avoid the drug company and insurance company from giving him “troubles”.

“Duty”?, what duty?- the duty of telling his patient to take a drug for the rest of her life because she is over 50 years old without sound reasons? The “duty” of prescribing a drug for patients without warning them the side effects/dangers of the drug?

“Troubles”?, what “troubles”? The “troubles” of not meeting the quota set by the pharmaceutical company in order to receive kickbacks in terms of money or gifts? The “troubles” of not complying with the current medical guidelines set by “experts” who have financial ties to pharmaceutical companies? The “troubles” of losing their license to practice medicine if they don’t practice exactly the way they were taught in school without independent thinking?

Alas! This case is a blatant indictment of the “cholesterol-heart hypothesis” hypocrisy and the corrupted physicians’ medical ethic. It leaves one to wonder how much kickback physicians are receiving in return for writing Statin drug prescriptions, in the name of money or gifts disguised in different glorified names, such as CME (continued medical education) held at fancy restaurants, hotels or cruise ships or frequent luncheons/dinners and other goodies brought over to doctors’ office by pharmaceutical reps. If you are a doctor, a pharmacist or a pharmaceutical rep, you know what I am talking about. READ MORE ABOUT “Drug Reps’ Influence on Doctors’ Prescribing Habit”

If you are in the higher risk of coronary heart disease, just know that there are many factors involved, at least not just because your cholesterol is above what the “expert panels” consider as normal.

The important questions are: Do you really need or want to lower your current cholesterol level with Statin drugs? How low do you want to go with it? Do you know the side effects of Statin drugs and low cholesterol?

Since many people have the erroneous idea that cholesterol is the bad guy, I would like to present a brief description of the important functions of Cholesterol.

Important functions of Cholesterol  [59][60] [61] [62]

Cholesterol is found in every cell of your body. It composes 30% of all animal cell membranes. The membrane surrounding each of our cells is a called the plasma membrane— a continuous double-layer of phospholipids, interweaved with cholesterol and proteins. Cholesterol maintains the integrity, fluidity of the cell membrane by securing important proteins in the membrane and help these proteins maintain their functions.
Cholesterol is needed for the synthesis of vitamin D and all steroid hormones, including the adrenal gland hormones cortisol and aldosterone, as well as the sex hormones progesterone, estrogens, and testosterone, and their derivatives.

Since cholesterol is a precursor for steroid hormones, such as estrogen and testosterone, which are very important for men and women. Hormones are involved with reproduction, maturation of eggs and sperm and preparation of the uterus to nurture the embryo. So, one other concern about low cholesterol involves women who may become pregnant. Pregnant women with low cholesterol may face a higher risk of delivering their babies prematurely or having babies who have low birth weight.[63] [64]

There are now more than 100 peer-reviewed studies showing that low cholesterol levels are associated with earlier death. [65]

Knowing the important functions of cholesterol, it is easy to understand if your cholesterol is inadequate, you will dry up like a prune–your skin will shrink with signs of pre-mature aging. You can have mental issues such as depression and anxiety, lack of mental concentration, loss of memory. It can also affect your bone health, ability to maintain a healthy sexual life and your overall energy level and vitality will diminish. [66]

If you maintain a healthy life style with exercise and nutritious diet, chances are you will not see very low cholesterol or very high cholesterol level. On the other hand, your cholesterol level can be brought too low if you are on the cholesterol lowering drugs including Statin drugs.

My comment on the current status of cholesterol-heart hypothesis and the use of Statin drugs for prevention:

In the glorified name of prevention of heart disease, doctors are educated to treat arbitrarily predetermined numbers without sound scientific proof. Unaware and uneducated patients, who totally trust their doctors to know better, have become “willing victims”. Meanwhile many healthy people have been harmed and many more will be harmed while the pharmaceutical companies that make statins continue to roll in a lot of dough!

I want to illustrate how you can be converted from a healthy person into a sick person in just a few months by your doctor “who knows better” by using a hypothetical case here. However, this case, although hypothetical, is put together using real information, real side effects of the drugs, professional education and experience.  It does reflect the reality of people’s experience.

Mr. Joe, 50 years old, went to see his primary physician-Dr. Lee, for a routine physical checkup. Mr. Joe at this point was a healthy individual with no bad habits–non-smoker and non-alcoholic. He also exercised on a regular basis, almost every day. He did not have any chronic diseases and therefore he was not taking any drug on a daily basis. His blood works were all within normal limits and his blood pressure was fine. In other words, he had a clean bill of health.

Dr. Lee: Mr. Joe, you look pretty healthy. That is good. But you are 50 years old now, we need to be more careful.

Mr. Joe: What do you mean? I am careful. I feel like I am in my thirties.

Dr. Lee: I see that your cholesterol levels are borderline high. Your total cholesterol is 205 and your LDL is 105. According to your family history, your father died of heart attack at age 89.

Mr. Joe: So?

Dr. Lee: I want you to start taking a cholesterol-lowering drug- a statin drug, which is most effective in lowering your cholesterol, especially your LDL. This is a preventative measure to keep you from getting heart disease. I will send a prescription for Lipitor electronically to the pharmacy of your choice. Remember, you need to take it every day.

Mr. Joe: OK, doc. You know better. Thank you for taking care of me. Goodbye.

Dr. Lee: If you have any problem, come back to see me. We will take good care of you.

A few months later, Mr. Joe went back to see Dr. Lee.

Dr. Lee: Good morning, Mr. Joe. What can I do for you today?

Have you been taking your cholesterol-lowering drug I prescribed for you?

Mr. Joe:  Yes, every day like you told me to. But, I hate to admit, I have a little problem right now.

Dr. Lee: What kind of problem?

Mr. Joe: It is a little embarrassing. My wife is complaining lately that I am not very romantic with her. She is kind of active woman, you know what I mean? I am losing interest in being intimate with her. Even if I did get into the mood, I had a hard time “getting it up”, you know what I mean?

Dr. Lee: Ah, you mean you are starting to have ED (Erectile dysfunction). That is simple to take care of. I can write you a prescription for Viagra or Cialis, which one do you prefer?

Mr. Joe: What is the difference between the two?

Dr. Lee: Viagra is usually taken only when needed, 30 minutes to 1 hour before sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day. Cialis lasts longer, up to 36 hours. You can also take Cialis 5 mg daily. That way, you don’t have to worry about when to take it.

Mr. Joe: That sounds great, I will take Cialis 5mg for daily use. My wife should be happy. Is there anything I should pay attention to?

Dr. Lee: If your erection lasts longer than 4 hours, call me. (Chuckles)

So Mr. Joe left his doctor’s office a happy man.

A few months later, Mr. Joe went back to see Dr. Lee.

Dr. Lee: Good afternoon, Mr. Joe. How are things going these days?

Mr. Joe: Well, I am doing better in the intimacy department,                   

Dr. Lee: That sounds excellent. (Smiling)

Mr. Joe: But, for some reasons, I just do not have the stamina like I used to have. My muscle is not as strong as it used to be. I thought it is because for the last few months I have not been exercising as much as I used to. I up my exercise routine the past couple of weeks, but the more I tried, the more my muscle didn’t seem to co-operate. I feel tired all the time. On top of that I am having stomach and digestive problems. I have this sour taste in my mouth and feel nauseated sometimes. I feel like I am having acid reflux and I have trouble falling asleep at night. Oh, by the ways, I also had frequent headache. What is happening with me Doc?

Dr. Lee: Well, you are not getting any younger. Perhaps you should cut down on your exercise. There is such thing as over-exercising. Take some multiple vitamins every day. I will write you 3 prescriptions to take care of your problems. Here are your new prescriptions: Nexium for acid reflux,  Ambien for insomnia and promethazine for nausea as needed. Just buy some Tylenol over the counter for your headache. Try not to get stressed out.  Schedule a follow up appointment in one month. I need to keep an eye on you.

Mr. Joe: OK, doc. I hope things will get better.

Unfortunately, things did not get better for Mr. Joe because of all the side effects from the medications prescribed by his doctor. He also realized that he was getting constipated all the time. He got tired of going to see his doctor, so he just bought MiraLax (polyethylene glycol) an over-the-counter laxative to take care of that. In less than a year his medication list had grown from 0 to 7. In addition, he had trouble waking up in the morning, and felt drowsy throughout the day. It was affecting his job performance. So, he decided to drink coffee to keep him awake and his coffee consumption gradually increased. The large amount of coffee he was consuming further aggravated his acid reflux condition.

Before he had a chance to go back to see Dr. Lee for a follow up appointment, he fell one night on the way to the bathroom and broke both of his ankles because he felt very dizzy most likely due to all the side effects of his prescription drugs. Now he was in severe pain and was unable to walk. So, he had to sit in the wheelchair to get around for many months worrying about whether he would lose his job.

Alas, now Mr. Joe needed 3 new prescriptions right away–one for pain, one for inflammation and one for depression. The most effective pain medications are very addictive. Chances are he would be taking either Vicodin (a combination of acetaminophen and hydrocodone) or OxyContin (long-acting oxycodone-some of the most addictive opioid drugs). Since he would be taking pain medication for many months to come, the chance of him getting addicted to it was very high. Now you might as well add one more person to the opioid epidemic. More prescriptions would be expected to counteract the side effects of the 3 new drugs added to the list as a result of his fall.

How much healthcare professionals know about drug-drug interactions?

The answer might surprise you. Most patients do not care or don’t know better to ask the question about drug-drug  interactions because they trust their doctors. They blindly believe if a drug needs to be prescribed by their doctors, it must be safe or at least safer than the drugs you can buy over the counter without prescription. Actually, the reverse is true. The reason a drug needs a prescription is because it is more dangerous than the over-the-counter counterpart.

If you are wise enough to ask: “What are the drug interactions of all these drugs, now up to 10 for Mr. Joe?”, my assumption is: his doctor would either say: “Ask your pharmacist” or “I am not sure” or “Don’t worry about it” because he does not know to be honest with you. If you ask your pharmacist, who is supposed to be the “expert” in this matter, he/she is under pressure to tell you something. “Drug-drug interactions” is a vast and complicated subject. Most references in drug literature only give you the drug-drug interactions between 2 or 3 drugs.  I am a pharmacist. So, I can tell you if your pharmacist pretends to know all the drug interactions for a regimen of multiple drugs, he/she is lying to you. I was put in that position by doctors often when I used to work as a hospital pharmacist when patients were discharged with 10 -20 different prescriptions. I was always overwhelmed by that duty and at a loss as to what to tell the patients, who expected that I should know it all. We might have references for drug-drug interactions between drug A and B,  drug C and D or drug E and F — and so on. But no one knows what all the drug-drug interactions are when a person is taking drug A+B+C+D+E+F+………..Z. You get the picture? Most harmful drug side effects are additive. If you are taking multiple drugs, you are just playing with Russian roulette!

When it rains, it pours. Mr. Joe was laid off by his employer because the company needed someone to fill in his position. As a result, he lost the health insurance provided to him by his employer. Since his doctor only accepts patients with private insurance, he could no longer be “taken care” of by Dr. Lee. Mr. Joe’s life started to spiral downhill….. Alas, he was a perfectly healthy 50 year old man less than a year ago!

 “The passage to hell can be paved with good intention”

Sources for injury reports

If you want to know more about injury reports caused by drugs and medical devices, you can find millions of them in the following websites:

FDA’s Adverse Event Reporting System (FAERS)
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.

MedWatch: The FDA Safety Information and Adverse Event Reporting Program
https://www.fda.gov/Safety/MedWatch/default.htm

Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.

FDA Adverse Event Reporting System (FAERS) Public Dashboard
https://fis.fda.gov/sense/app/777e9f4d-0cf8-448e-8068-f564c31baa25/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysis

The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

FDA’s Sentinel Initiative
https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm

Launched in May 2008, Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market and complements the Agency’s existing Adverse Event Reporting System.

PubMed
PubMed comprises more than 28 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.
https://www.ncbi.nlm.nih.gov/pubmed

Examples of medical hypotheses (theories) that proved to be false over time.

In modern/main stream medical history, there are many examples of hypotheses/theories and treatments once touted as great medical inventions/discovery eventually proved to be poison or fallacy over time after many people had been harmed. I am  presenting three significant examples for my readers who might not know about them or remember them.

1. The thalidomide disaster

The thalidomide disaster happened before my time as pharmacist. I only learned about it in Pharmacy school.  

Thalidomide, discovered by scientists at a German pharmaceutical company was first marketed in 1957 in West Germany. The drug was primarily prescribed as a sedative or hypnotic, and to cure “anxiety, insomnia, gastritis, and tension“. Afterwards, it was prescribed for pregnant women against nausea and to alleviate morning sickness. Later on, thalidomide became an over-the-counter drug in West Germany on October 1, 1957. It was proclaimed a “wonder drug” for insomnia, coughs, colds and headaches. Advertisement claimed that it can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.  Shortly after the drug was sold in West Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived. Throughout the world, about 10,000 cases were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness. [67] [68] [69] In November 1961, only 4 years later, thalidomide was taken off the market due to massive pressure from the press and public. Class action lawsuits in many countries continued for decades. After further research, thalidomide is currently being prescribed for leprosy and cancer treatment with emphasis on warning against its usage for pregnant women due to its teratogenic property.  The disaster from thalidomide prompted many countries to introduce tougher rules for the testing and licensing of drugs. [70]

2. Hormone replacement therapy (HRT)

For many years practicing as a pharmacist, I remember filling prescriptions on a daily basis for Hormone replacement therapy for post menopausal women usually for the symptom of hot flashes. It was considered as a safe standard treatment.

Then came along the  Women’s Health Initiative (WHI) [71]
The WHI, first awarded in 1992,  studied strategies to prevent heart disease, breast and colorectal cancer, and osteoporosis in more than 161,000 post-menopausal women aged 50–79 years.

From the WHI Hormone Therapy Findings, we now know that hormone therapy—estrogen plus progestin or estrogen alone, not only did not prevent heart disease in postmenopausal women as once thought, it actually increased the risk for heart disease, stroke, blood clots, breast cancer, and dementia. HRT also should not be used to lower cholesterol levels. Although hormone therapy with estrogen alone had some benefits for younger women who had a prior hysterectomy, estrogen increased the risk for stroke and blood clots in these and other women in the study.

Other not so surprising information coming out of WHI:

• The scientific knowledge gained from the WHI hormone trials has helped save an estimated $35.2 billion in direct medical costs in the United States.
• An in-depth analysis of final data from one of the Women’s Health Initiative (WHI) Postmenopausal Hormone Therapy Trials has found that the investment in WHI resulted in a return of $140 in net economic value for each dollar invested in the trial.

Recent research done by the Million Women Study, funded by Cancer Research UK has proven current HRT use is associated with an increased risk of ovarian cancer, endometrial (womb) cancer, brain tumor and Gallbladder disease. [72]

Findings from these studies have changed the face of women’s health and medical practice around the world by providing practical information to women and their physicians about hormone therapy, dietary patterns, calcium/vitamin D supplementation, and their effects on the prevention of heart disease, cancer and osteoporotic fractures.

I still remember the day when doctors were told to take all their female patients off their HRT immediately. Women around the country suffering from hot flashes were scrambling around to find alternative therapy. I received many phone calls from friends and relatives requesting recommendations for alternative therapy because their doctors did not give them any such recommendations. Again as a skeptical pharmacist, I never accept the HRT when I became menopausal and now I am glad that I didn’t.

3.      Propoxyphene taken off market after decades of use

FDA NEWS RELEASE [73] For Immediate Release: Nov. 19, 2010 Xanodyne agrees to withdraw propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.  

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 2009, 10 million people have been prescribed some form of the drug. There is no telling how many prescriptions had been dispensed since 1957.

Double jeopardy: propoxyphene in combination with acetaminophen (Darvocet-N 50 & Darvocet-N 100). Each tablet of Darvocet-N 50 contains 50 mg propoxyphene napsylate and 325 mg acetaminophen. Each tablet of Darvocet-N 100 contains 100 mg  propoxyphene napsylate and 650 mg acetaminophen. Darvocet-N 100 had been one of the most popular pain killers for several decades

Acetaminophen (brand name Tylenol) is an over-the counter medication for pain & fever and its main side effect is liver toxicity.

FDA (Posted 01/14/2014) Recommendation to Discontinue Prescribing and Dispensing Acetaminophen Prescription Combination Drug Products with more than 325 mg. [74]

FDA is recommending health care professionals to discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

My Comment:

I remember dispensing Propoxyphene (Darvon, Darvocet-N 50 or Darvon-N 100) for decades as a registered pharmacist in US since I graduated from pharmacy school in 1974 on a daily basis. I often wondered if that drug was effective at all because my personal experience told me that it was not. However, I was taught that it may not work the same way for everyone. So decades later, we, the professionals, were told that this drug not only is ineffective and it is downright dangerous. All of a sudden, one day in 2010, we were told to stop dispensing this popular pain killer prescribed by doctors every day for half a century. Can you imagine what it can do to the confidence the professionals have on the drugs they are dispensing on a daily basis? There is no telling how much money the pharmaceutical manufacturers have profited from these ineffective and dangerous drugs. It must be in the billions. I can’t help to feel I was part of it simply because I am a pharmacist. I am outraged!

CONCLUSION:

So you see, medical hypotheses or theories change over time as scientists continue to research and make new discoveries. When a new medical hypothesis is presented, a new  generation of doctors are educated based on that hypothesis even if it is faulty. So if you think your doctors always know better, think again. Of course, they definitely know better than you if you do not educate yourself and you do not think “outside of the box”. The three previous examples confirmed by history prove my point. What is the fate of the Cholesterol-Heart-Hypothesis/Theory and the “Gold Standard” preventive therapy for coronary heart diseases with Statin drugs? We have yet to find out.

So how do you protect yourself from being the victims/ guinea pigs of medical fallacies? I believe the minimum you can do is: Educate yourself. If you feel healthy, don’t go looking for something wrong! Skepticism is healthy.

READ MORE ARTICLES ABOUT MEDICAL ISSUES

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