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Drug Companies Upset Physicians are not Prescribing More Cholesterol-lowering Statin Drugs

Posted By AdminM On April 18, 2019 @ 8:13 pm In Medicine Watch | No Comments

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Cholesterol Managers Want to Double Statin Prescriptions

Cholesterol is found in nearly every cell in your body. This waxy substance is vital for optimal functioning of cell membranes, regulating protein pathways and supporting brain health, hormone levels and reducing your heart disease risk. Your body also uses cholesterol to manufacture vitamin D after being exposed to the sun.

As Zoe Harcombe, Ph.D., has noted,¹

“It is virtually impossible to explain how vital cholesterol is to the human body. If you had no cholesterol in your body you would be dead.”

The majority of the cholesterol in your body, approximately 80%, is manufactured in your liver,² suggesting your body cannot survive without it.

The remaining 20% is absorbed from the foods you eat but only at a rate of 20 to 60% of what’s in your food.

As Alice Lichtenstein, senior scientist and director of the cardiovascular nutrition laboratory at Tufts University, told Eating Well, the absorption rate depends on the individual,³ and if you consume less, your body compensates by making more.

In other words, there is a level at which your body attempts to maintain your cholesterol by manufacturing more or less in response to your dietary intake. Since animals use cholesterol in much the same way as humans, beef, pork and chicken have similar levels of cholesterol in the meat.

In the past decades cholesterol has been vilified as a primary culprit in heart disease. Merck brought the first statin drug, Lovastatin, aka Mevacor, to market in 1987.^4,⁵

Since then, statins have gone on to become the biggest selling class of pharmaceutical compounds of all time, with annual sales in excess of $19 billion in 2017 and projected to reach $24.4 by 2022.^6,⁷

Although the growth has been rapid, recent data demonstrate physicians are not prescribing statins ^[3] to all eligible patients.⁸

Physicians Not Offering Statins to Eligible Patients

According to research from the Centers for Disease Control and Prevention (CDC),⁹ 36.7% of U.S. adults over the age of 21 met the eligibility requirements in 2015 for cholesterol lowering treatment with statins as defined by the 2013 guidelines issued by the American College of Cardiology and the American Heart Association.

These guidelines define four groups said to benefit from statins,¹⁰ including those with atherosclerotic cardiovascular disease, diabetes and low-density lipoprotein (LDL) cholesterol levels between 70 and 189 milligrams per deciliter (mg/dL). According to the CDC, 55% (43 million American adults)¹¹ who fit the criteria are currently taking statin medication.

Despite these extraordinary numbers, a new study¹² from Duke University Medical Center finds 26.5% of U.S. adults who fit the current criteria to use cholesterol-lowering drugs are not taking them. The study is suggesting this occurs since doctors do not offer the drugs to their patients or the patients express concern over the side effects.¹³

The guidelines were expanded by the U.S. Preventive Services Task Force¹⁴ to include individuals who did not have a prior history of heart disease but who had concurrent health conditions that may place them at higher risk for heart attack in the future, such as obesity ^[4], high blood pressure ^[5], diabetes ^[6], high cholesterol and age.

According to the current survey, 59.2%¹⁵ who were not taking the drug said their physician had not offered them a prescription. This was most common among women, black people and uninsured patients.

In an email to Reuter’s, Dr. Ian Kronish, associate director of the Center for Behavioral Cardiovascular Health at Columbia University Irving Medical Center, commented on the findings, saying some physicians may not have been completely behind the changes to the guidelines published in 2013, particularly for patients who didn’t have extremely high cholesterol levels or a previous history of heart disease.¹⁶

How Do Statins Work?

Statins don’t stop your body from absorbing cholesterol from your food, but rather prevent your liver from making the cholesterol it was designed to produce by blocking an enzyme in the mevalonate pathway called HMG-CoA reductase, used to make cholesterol in the liver.

Essentially, this classification of drugs blocks the mevalonate pathway, which plays a key role in multiple cellular processes, not just the production of cholesterol. Although studied with regard to cholesterol synthesis, the extent of the impact of the mevalonate pathway is not fully understood.¹⁷

The drugs also deplete your body of coenzyme Q10 ^[7] (CoQ10), which may in part account for many of its devastating long-term results. A black box warning was proposed to warn patient and physicians about this reduction in CoQ10,¹⁸ but in 2014 the FDA decided against it.¹⁹

CoQ10 is used in energy production by every cell in your body and is vital for optimal health and longevity. In its reduced form, ubiquinol, it’s a crucial component of cellular respiration and the production of adenosine triphosphate (ATP), a coenzyme used as an energy carrier in every cell in your body. Since your heart is the most energy demanding organ, depleting this energy supply can have devastating consequences.

Former FDA Commissioner Had Strong Ties to Big Pharma

The featured study was performed at Duke University by scientists with a history of producing research supporting statin use and calling for a greater number of prescriptions in patients who may not have had a previous history of heart disease,^20,^21,^22,^23,²⁴ continuing a legacy of pharmaceutical support left by Dr. Robert Califf,²⁵ who served as U.S. Food and Drug Administration (FDA) commissioner from February 2016 until January 2017.²⁶

In May 2014, Califf, a Duke cardiologist and study chairman, gave a presentation²⁷ to a group of experts, describing ways to increase the pace of innovation through the transformation of the research process. Specifically, his last slide called for a plan to simplify the regulatory systems governing research, believing it may have slowed biomedical innovation.

This was near the end of his association with Duke University, as he was soon to be nominated by then President Barack Obama as the FDA commissioner.²⁸

During his confirmation hearings he defended his position in accepting drug industry funding and promised to not lower the agency’s safety standards.

When questioned by senators, Califf attempted to disarm his previous statement that regulations governing research were too complicated and slowed innovation by saying,²⁹

“I’ve never been a proponent of lowering standards. If anything, I’ve argued for raising them.”

According to The New York Times,³⁰ Califf had been associated with scientific papers produced by pharmaceutical company researchers, he’d been paid by seven drug companies and a device maker for consulting services, and his university salary was partially supported by drug companies, including Merck, Novartis and Eli Lilly.

In a conflict of interest section at the end of one paper, he declared financial support from more than 20 companies and research entitites.³¹ Daniel Carpenter, a Harvard political science professor with an expertise in the FDA calls him the “ultimate industry insider.”³²

Califf also resigned from the board of directors at Portola Pharmaceuticals on January 26, 2015, just prior to his nomination as FDA commissioner, having received compensation of $259,623.³³

Recently, Duke Clinical Research Institute paid $112.5 million to settle claims that bogus research data³⁴ were submitted to the National Institutes of Health to acquire grant money for research.³⁵ Seven years of data were determined to be unreliable.

Risks Associated With Statins Supported by Science

Among those who were offered but declined statins in the featured study,³⁶ the most common reason stated was fear of side effects ^[8] from the drugs.³⁷ Senior study author Dr. Ann Marie Navar from the Duke Clinical Research Institute³⁸ believes public perception of side effects is unrealistic. She commented:

“Although there are risks associated with statins, the public fear of side effects is out of proportion to the actual risks. Misconceptions about statins are everywhere and are fueled by false information on the internet.”

However, despite Navar’s attempt to downplay the side effects of statin medications, the risks are well-documented and supported by scientific evidence, so the fears are well-founded. According to the FDA:³⁹

There have been rare reports of serious liver problems. Patients should notify their health care professional right away if they have the following symptoms: feeling unusually tired or weak; loss of appetite; upper belly pain; dark colored urine; yellowing of the skin or the whites of the eyes.
Memory loss and confusion have been reported. The conditions are generally non-serious and reversible after stopping statin use.
Increases in blood sugar levels have been reported.
Before starting a statin, patients should inform their health care professional about all medicines that they are taking or plan to take. Some medicines may interact with statins, increasing the risk for side effects.

However, these are only the side effects acknowledged by the FDA and not the full scope of the effects supported by research. A reduction in CoQ10 triggered by this classification of drugs may increase your risk of acute heart failure⁴⁰ and atherosclerosis, as found in data published in Expert Review of Clinical Pharmacology.⁴¹

The study addressed several physiological mechanisms, including how the drug inhibits the synthesis of vitamin K2, which is responsible for protecting your arteries from calcification. One of its biological roles is to move calcium out of your blood and into the proper areas of your body, such as your bones and teeth.

Since statins inhibit the function of vitamin K2,⁴² it may place you at risk of deficiency, which may contribute to osteoporosis ^[9], heart disease, brain disease and inappropriate calcification. The same enzyme used by your liver to produce cholesterol that is inhibited by statins is also involved in the production of ketone bodies.

The depletion of CoQ10 and the inhibition of vitamin K2 also increases your risk of other serious diseases including cancer. Long-term statin use more than doubles a woman’s risk of two types of breast cancer,⁴³ and significantly increases a man’s risk for prostate cancer.⁴⁴ Research has also associated statin use with an increased risk of diabetes,^45,^46,⁴⁷ neurodegenerative diseases,⁴⁸cataracts^49,⁵⁰ and musculoskeletal disorders.⁵¹

How to Evaluate Your Risk of Heart Attack

As you consider whether taking statins make sense for your health, it’s important to understand what your cholesterol numbers ^[10] mean. Your total cholesterol is not a strong indicator of your risk of heart disease. Better indicators are:

The ratio of your high-density lipoprotein (HDL) to total cholesterol — To get this number, divide your HDL level by your total cholesterol and multiply by 100 to get the answer. Ideally, your HDL to cholesterol ratio would be 24% or above.
Your triglyceride to HDL ratio — Your triglyceride to HDL ratio should ideally be below 2.

Two tests that are even more important for assessing your cardiovascular disease risk are your serum ferritin and gamma glutamyl transpeptidase (GGT). The GGT is used as a screening marker for excess free iron and a great indicator of your risk of sudden cardiac death. The recommended and ideal levels of ferritin and GGT are as follows. For more information about these tests, read my previous article, “Cholesterol Does Not Cause Heart Disease ^[11].”

• Ferritin — Adult men and non-menstruating women: 30 to 40 nanograms per milliliter (ng/mL) or 75 to 100 nanomoles per liter (nmol/L).

The most commonly used threshold for iron deficiency in clinical studies is 12 to 15 ng/mL (30 to 37 nmol/L). You do not want to be below 20 ng/mL (50 nmol/L) or above 80 ng/mL (200 nmol/L). High iron during pregnancy is also problematic; having a level of 60 or 70 ng/mL (150 or 175 nmol/L) is associated with greater odds of poor pregnancy outcomes.

• GGT — Below 16 units per liter (U/L) for men and below 9 U/L for women. Above 25 U/L for men and 18 U/L for women, your risk of chronic disease increases significantly.

Protect Your Heart and Lower Your Risk of Heart Disease

Here are a number of suggestions to help protect yourself against heart disease. For further discussion of how lifestyle factors impact your risk, see my previous article, “Nearly Half of American Adults Have Cardiovascular Disease ^[12].”

Avoid environmental pollutants and toxins, including smoking ^[13], vaping ^[14], heavy metals, herbicides and pesticides, especially glyphosate.
Minimize your exposure to electromagnetic fields and wireless radiation from cellphones, Wi-Fi, routers, smart meters and more, as this kind of radiation has been shown to cause serious free radical damage and mitochondrial dysfunction.
Eat an unprocessed whole food-based diet low in net carbs and high in healthy fats. A ketogenic diet ^[15] — which is very low in net carbohydrates and high in healthy fats — is key for boosting mitochondrial function.
When your body is able to burn fat for fuel, your liver creates water-soluble fats called ketones that burn more efficiently than carbs, thereby creating fewer reactive oxygen species and secondary free radicals. Ketones also decrease inflammation and improve glucose metabolism.⁵²
Eat nitrate-rich foods to help normalize your blood pressure. Good sources include arugula, cilantro, rhubarb, butter leaf lettuce, mesclun mixed greens, beet greens, fresh beet juice, kvass (fermented beet juice) and fermented beet powder.
Get plenty of nonexercise movement each day; walk more and incorporate higher intensity exercise as your health allows.
Intermittently fast. After you’ve become accustomed to intermittently fasting for 16 to 18 hours, you may try a stricter fast once or twice a week, when you eat a 300- to 800-calorie meal loaded with detox supporting nutrients, followed by a 24-hour fast. So, in essence, you’re then only eating one 300- to 800-calorie meal in 42 hours.
If you have heart disease, consider enhanced external counterpulsation (EECP). To find a provider, see EECP.com.⁵³
If you have heart disease, you may also consider taking g-strophanthin, an adrenal hormone helping to create more parasympathetic nervous system neurotransmitters, thereby supporting your parasympathetic nervous system. It also helps flush out lactic acid. Strophanthus is the name of the plant, the active ingredient of which is called g-strophanthin in Europe, and ouabain in the U.S.
Get sensible sun exposure to optimize your vitamin D status and/or take an oral vitamin D3 supplement with magnesium and vitamin K2.
Implement heart-based wellness practices such as connecting with loved ones and practicing gratitude.