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

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Screen Shot 2019-04-18 at 4.48.28 PM [1]

Cholesterol Managers Want to Double Statin Prescriptions

by Dr. Joseph Mercola [2]

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

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,48cataracts49,50 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:

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].”

Read the full article at Mercola.com [2].

References

1 ZoeHarcombe.com, We Have Got Cholesterol Completely Wrong [16]

2 Harvard Health Publishing, How It’s Made: Cholesterol Production in Your Body, February 2017 [17]

3 Eating Well, How Much Does the Cholesterol I Get Through Food Really Affect My Blood Cholesterol Level? [18]

4 Chemical and Engineering News, 2009; 87(23) [19]

5 News Medical Life Sciences, Statin History [20]

6 Statin Nation, October 4, 2017 [21]

7 PRNewsWire, October 4, 2017 [22]

8, 12, 15 J Am Heart Assoc. 2019;8:e011765; Originally pub. March 27, 2019 [23]

9 Morbidity and Mortality Weekly, 2015;64(7) [24]

10 American Heart Association, Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, Slide 13 [25]

11 Centers for Disease Control and Prevention, Cholesterol [26]

13, 16 Reuters, March 28, 2019 [27]

14 U.S. Preventive Services Task Force, November 2016 [28]

17 Clinical Biochemistry, 2007;40(9) [29]

18 Holistic Primary Care, October 15, 2002 [30]

19 Lawyers and Settlements, January 16, 2015 [31]

20 New England Journal of Medicine, 2014;370(15):1422 [32]

21 JAMA, 2016;316(19):1981 [33]

22 Duke University, 2016;37 [34]

23 Circulation, 2018; doi.org/10.1161/CIRCOUTCOMES.117.004249 [35]

24 JAMA, 2017;318(10):964 [36]

25 Portside, September 27, 2015 [37]

26 FDA.gov Robert Califf MD [38]

27 Disrupting Clinical Research: Transforming a System; Robert M. Califf MD, May 1, 2014 [39]

28, 30, 32 New York Times, September 19, 2015 [40]

29 StatNews, November 17, 2015 [41]

31 European Heart Journal, 2014;36(7) [42]

33 U.S. Securities and Exchange Commission, Portola Pharmaceuticals, Inc. [43]

34 U.S. Department of Justice, March, 25, 2019 [44]

35 NPR, March 25, 2019 [45]

36 Journal of the American Heart Association March 27, 2019 [46]

37 CNN, March 27, 2019 [47]

38 Duke Clinical Research Institute, Ann Marie Navar [48]

39 U.S. Food and Drug Administration, Cholesterol Lowering Drugs Get Labeling Changes [49]

40 BMJ OpenHeart, 2015;2:e000326 doi: 10.1136/openhrt-2015-000326 [50]

41 Expert Review of Clinical Pharmacology, 2015 Mar;8(2):189 [51]

42 Integrative Medicine: A Clinician’s Journal, 2015;14(1):34 [52]

43 Cancer Epidemiology Biomarkers Prev. 2013;22(9):1529 [53]

44 Prostate. 2011;71(16):1818 [54]

45 JAMA, 2011;305(24):2556-64 [55]

46 The Lancet, 2010;275(9716) [56]

47 BMJ, 2009;57:495 [57]

48 Movement Disorders 2015; doi.org/10.1002/mds.26152 [58]

49 Open Journal of Endocrine and Metabolic Diseases 2013;3(3) [59]

50 JAMA Ophthalmology 2013;131(11):1427 [60]

51 JAMA Internal Medicine 2013;173(14):1318 [61]

52 IUMB Life April 3, 2017, DOI: 10.1002/iub.1627 [62]

53 EECP.com [63]