Statin Denialism Internet Cult with Deadly Consequences

steven nissen md cardiology cleveland clinic new york timesStatin Denialism: an Internet Cult with Deadly Consequences

An editorial by Cleveland Clinic cardiologist Steven Nissen (above image) appeared in the Annals of Internal Medicine this week lamenting the problem of  “Statin Denialism” on the Internet.(1-2)

steven nissen md cardiology clevelnd clinic 2Dr Steve Nissen’s editorial reveals the Mom and Pop bloggers operating out of their basements have convinced millions of American to stop taking their statin drugs.   I suggest this is not the “Real Problem”.  The real problem is “Statin Drug Denialists” lurking in the academic medical community, and publishing their “Statin Denialism” articles in the mainstream medical literature. Above two images of Steven E Nissen MD courtesy of New York Times and Cleveland Clinic.

Statin Denialists in the academic cardiology community such as  Dr Edward Gill Professor of Cardiology at University of Colorado actually have DENIED that statin drugs have any benefit for reducing calcium score.

I just can’t believe that!

Dr Gill states:

“five randomized controlled trials have demonstrated that not only does statin treatment not reduce coronary calcium, but in fact, the progression of coronary calcium by CT scanning is indistinguishable from placebo treatment.” (Curr Atheroscler Rep. 2010 Mar;12(2):83-7.).

Another denialist is William R Ware, PhD, Emeritus Professor University of Western Ontario Canada, who wrote in 2009 that modern imaging studies have falsified the cholesterol theory of atherosclerosis. Dr Ware says:

“Contrary to the conventional wisdom, total cholesterol (TC) and LDL cholesterol in asymptomatic individuals are not associated with either the extent or progression of coronary plaque, as quantified either by electron beam tomography (EBT) or coronary CT angiography” (Med Hypotheses. 2009 Oct;73(4):596-600.)

Dr Ware also says this data has been largely ignored by mainstream cardiology. He says,

“The evidence falsifying the hypothesis that LDL drives atherosclerosis has been largely ignored.”

These denialists are not mom and pop bloggers on the internet.  These Statin Denialists are in the mainstream medical literature!!!

More Statin Denialism articles in the mainstream medical literature:

Heart Attack Victims Have Low Cholesterol

If cholesterol was truly the cause of heart attacks, then one would expect heart attack victims to reveal the high cholesterol causing their heart attack.  They found the opposite.  Heart attack victims have low cholesterol.  A study  analyzed 137,000 heart attack patients from 541 US hospitals and found mean cholesterol was only 174.  This is low, not high. (10)

Henry Ford Hospital

In addition, if high cholesterol was truly the cause of heart attacks, one would expect heart attack victims with the highest cholesterol to have the worst prognosis, and lowest cholesterol to have the best prognosis.  They don’t.  A study from Henry Ford Hospital in Detroit showed that three years after a heart attack, the patients with lowest cholesterol had the highest mortality (14% vs. 7 %) (10).

Laughing All the Way to the Bank

Statin-Drugs-Steven-Nissen-Laughing-all-the-way-to-the-bank.jpgLeft image : Doctor Receiving Financial Stipends, Research awards, speaking fees etc from statin drug makers: Courtesy of the best you magazine
Laughing all the way to the bank

The Elderly

A dozen studies show low cholesterol in the elderly is a marker for increased mortality, not improved survival.(11)

Selected Medical Conditions – Lower Cholesterol Increases Mortality

Also, in selected medical conditions such as congestive heart failure, haemodialysis, chronic obstructive pulmonary disease (COPD), as in the elderly, higher cholesterol is associated with improved survival, and lower cholesterol with increased mortality.(10)

No Mortality Benefit in Primary Prevention Setting

Another statin denialist from Cambridge, Dr Kausik K. Ray, MD published his article in 2010 concluding that men with elevated cholesterol and no history of heart disease had no mortality benefit from taking a statin drug.(13)   Dr Ray says:

“Data were combined from 11 studies …on 65,229 participants followed for approximately 244,000 person-years, during which 2793 deaths occurred. The use of statins in this high-risk primary prevention setting was not associated with a statistically significant reduction in the risk of all-cause mortality.”

“Pleiotropic Effects”  – Anti-Inflammatory Effects of Statins –

Statin Drugs  Reduce Mortality after Cardiac Surgery.(12)

The two studies on this statin drug benefit for cardiac bypass by Curtis and Barakat refer to the anti-inflammatorypleiotropic effects” of statin drugs.  Cardiac bypass is associated with massive release of proinflammatory cytokines and intense systemic inflammatory response.(12)  Statin drugs can help with all this inflammation by down regulating Nuclear Factor Kappa Beta  (NF-κ B), the master controller of the inflammatory response.  So, yes, there is a potential benefit for Statins as anti-inflammatory agents.  Statin drugs block the inflammatory cytokine release in the post operative patient, thus reducing mortality from the procedure.  Surprising, the authors comment that there was no proven reduction in myocardial infarction post cardiac bypass with statin drug use. This was a disappointment. The reduction in mortality was thought to be due to reduction in systemic inflammatory response.  There was another benefit with reduction in episodes of atrial fibrillation.  It appears that the benefit of statin drugs in this population is not as cholesterol lowering agents.  The benefits are due to anti-inflammatory properties of statins. If so, then one might consider other anti-inflammatory interventions which down regulate NFkB.  (12)

U-Shaped Mortality Curve

Jap_LIT_Total-Cholesterol_LDL_U_shaped_curve_Mortality_Circ_2002Left Image: J-Lit Mortality Data Chart courtesy Eddie Vos Highest mortality (6%) on statins is seen at lowest cholesterol vales of 160 and below.  Lowest mortality seen  at total cholesterol of 250.  Above 250, mortality increases.  from Matsuzaki, Masunori, et al. “Large Scale Cohort Study of the Relationship Between Serum Cholesterol Concentration and Coronary Events With Low-Dose Simvastatin Therapy in Japanese Patients With Hypercholesterolemia. Primary Prevention Cohort Study of the Japan Lipid Intervention Trial (J-LIT).” Circulation journal 66.12 (2002): 1087-1095. J_Lit_Circ_2002_MABUCHI

Eddie Vos Chart Shows No Mortality Benefit in Primary Prevention

The reality isLipitorMortalityChart that there is no mortality benefit from lowering cholesterol with statin drugs: Both lines on the mortality chart (left) are superimposed meaning the number of deaths in the statin drug group was identical to the number of deaths in the placebo group.   Left chart image: Courtesy of Eddie Vos

Analyzing data from five statin drug studies (4S, WOSCOPS, CARE, TEXCAPS/AFCAPS and LIPID), Peter R Jackson found a 1% increase in mortality after 10 years on statin drugs in people with no pre-existing heart disease (primary prevention) (Br J Clin Pharmacol. 2001 Oct; 52(4): 439–446.).

RitaRedbergMD2HealthyMenShouldNotTakeStatinsWallStreetJournalRita Redberg MD (14)

Another statin denialist is Rita Redberg, MD who bluntly says in JAMA 2012 that healthy men should not take statins. (14) Left image courtesy of Rita redberg, M.D.

Who Benefits from Statin Drugs ?

Statin drugs were FDA approved based on a small benefit over placebo for middle aged men with known heart disease.  This is called secondary prevention.

Secondary Prevention of Heart Disease in Males

Considering the media and marketing hype over statin drugs, one would think there must be something to it, so let’s take a look at the statin drug studies in the best case scenario, middle aged men with known heart disease, also known as secondary prevention. This group has proven mortality benefit, and these are the studies submitted for FDA approval for this class of drugs. Let’s take a closer look at the data from two of the most representative secondary prevention studies with statin drugs, the 4S (15-16) and the LIPID Studies (17).

4S Trial with Simvastatin in Scandinavia (15,16) – 0.6% per year

Here is a quick recap of the 4S-Trial data.

The 4S trial was done on 4444 patients who had known heart disease, randomized to simvastatin or placebo, and followed for 5.5 years.  At the end of the follow up, they reported 182 deaths in the statin drug group (8.2 %) and 256 deaths in the placebo group (11.5% ).  This provided  an absolute mortality benefit of 3.3% over 5.5 years, or 0.6% per year.  The 6-year probabilities of survival for placebo was 88.5 % and for simvastatin was 91.8%, a difference of 3.3%.(15-16)

LIPID Pravastatin  Study (17) – 0.5% per year

Here is a quick recap of the LIPID Trial data.

9,000 patients with unstable angina and history of myocardial infarction were randomized to either placebo or Pravastatin and followed for 6.1 years.(17)

The statin group had 11% mortality and the placebo group had 14.1 % mortality over 6.1 years.  This is a 3.1% mortality benefit over 6.1 years or 0.5% per year.  After 6 years probability of survival in the placebo group is 85.9% and in the Statin drug group is 89%, a difference of 3.1 %.   (17)

Absolute Mortality Benefit of 0.5% per year in Secondary Prevention

So, as you can see from the above, the absolute mortality benefit in the best case scenario, in secondary prevention trials, is only 0.5% – 0.6% per year.  This benefit is underwhelming, and actually quite shocking that it is so minimal, especially since drug company marketing suggests much larger benefit.

Conclusion:  The benefits of statin drugs have been over hyped, and adverse effects underplayed.  A number of dissenting physicians  have earned the label of “statin denialists” by casting doubts on statin drugs.  These “statin denialists” have stated the benefits of statin drugs are minor, in the range of 0.5% per year reduction in absolute mortality for middle aged men with known heart disease.  For all other categories, such as women, the elderly and healthy males, there is no benefit.  Benefits of statin drugs, are related to the anti-inflammatorypleiotropic effects” of statins, rather than any reduction in serum cholesterol which can be quite dramatic.  Perpetuation of the statin drug myth is essential for maintaining drug industry profits. The financial stakes are high, so don’t expect change any time soon.  Above left image: Vending machine for statin drugs.

Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Florida 33314
954-792-4663

Articles with Related Interest:

Statin Drugs Revisited

Getting Off Statin Drug Stories

Cholesterol Lowering Drugs for the Elderly, Bad Idea 

Statin Drugs  Reduce Mortality after Cardiac Surgery.

Rita Redberg MD Says Healthy Men Should Not Take Statins

Links and References:

1) Nissen, Steven E. “Statin Denial: An Internet-Driven Cult With Deadly ConsequencesStatin Denial: An Internet-Driven Cult With Deadly Consequences.” Annals of Internal Medicine.

2) Steve Nissen says the battle for patients’ hearts and minds is being lost  by Larry Husten, CardioBrief July 24, 2017

3)  Gill, Edward A. “Does statin therapy affect the progression of atherosclerosis measured by a coronary calcium score?.” Current atherosclerosis reports 12.2 (2010): 83-87.

4) Ware, William R. “The mainstream hypothesis that LDL cholesterol drives atherosclerosis may have been falsified by non-invasive imaging of coronary artery plaque burden and progression.” Medical hypotheses 73.4 (2009): 596-600. cholesterol atherosclerosis falsified coronary artery plaque Ware Medical Hypotheses 2009

5) Steven Nissen conflicts of interest disclosure: Dr. Nissen reports grants from Esperion Therapeutics, during the conduct of the study; grants from Amgen, grants from Pfizer, grants from Astra Zeneca, outside the submitted work; .

6) Nissen reported receiving research support from Amgen, Abbvie, AstraZeneca, Cerenis, Eli Lilly, Esperion Therapeutics, Novo-Nordisk, The Medicines Company, Orexigen, Pfizer, and Takeda and consulting for a number of pharmaceutical companies without financial compensation (all honoraria, consulting fees, or any other payments from any for-profit entity are paid directly to charity, so neither income nor any tax deduction is received).

7) Cleveland Clinic Dr. Shamelessly Promotes Statin Drugs Calling Side Effects ‘Imagined’  Wednesday, July 26th 2017 at 11:00 am Sayer Ji, Founder GreenMEdINFO

8) I Admit It: I’m A Member Of The Cult Posted by Tom Naughton in Bad Science, Media Misinformation, Random Musings…special note: to Tom Naughton…I hate you because your post is actually a lot funnier than mine…

9) Will Stopping Statins Kill People? The statin skirmishes of recent years have turned into bitter conflict. Dr. Nissen says stopping statins will lead to many deaths. What about side effects? Joe Graedon July 27, 2017

10) Getting Off Statin Drug Stories

11) Cholesterol Lowering Drugs for the Elderly, Bad Idea by Jeffrey Dach MD

12) Statin Drugs Anti-inflammatory Effects

13) Ray KK, Seshasai SR, Erqou S,  et al.  Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants.  Arch Intern Med. 2010;170(12):1024-1031,

14) Redberg, Rita F., and Mitchell H. Katz. “Healthy men should not take statins.” JAMA 307.14 (2012): 1491-1492. Healthy men should not take statins Redberg Rita Mitchell Katz JAMA 2012

4S Study Seconday Prevention

15) http://www.ncbi.nlm.nih.gov/pubmed/7572690
Am J Cardiol. 1995 Sep 28;76(9):64C-68C.
Reducing the risk of coronary events: evidence from the Scandinavian Simvastatin Survival Study (4S). Kjekshus J, Pedersen TR. National Hospital, Department of Medicine, Oslo, Norway.

The Scandinavian Simvastatin Survival Study (4S) was designed to evaluate the effects of cholesterol reduction with simvastatin on mortality and morbidity in patients with coronary artery disease (CAD). A total of 4,444 patients with angina pectoris or previous myocardial infarction and serum cholesterol levels of 213-310 mg/dl (5.5-8.0 mmol/liter) while treated with a lipid-lowering diet were randomly assigned to double-blind treatment with simvastatin or placebo. Over the 5.4 years of median follow-up, simvastatin produced changes in total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol of -25%, -35%, and +8%, respectively, with minimal adverse effects.

A total of 256 patients (12%) in the placebo group died compared with 182 (8%) in the simvastatin group, a risk reduction of 30% (p = 0.0003) attributable to a 42% reduction in the risk of coronary death.

Noncardiovascular causes accounted for 49 and 46 deaths in the placebo and simvastatin groups, respectively. Major coronary events were experienced by 622 patients (28%) in the placebo group and 431 patients (19%) in the simvastatin group, corresponding to a risk reduction of 34% (p < 0.00001).

16) http://www.ncbi.nlm.nih.gov/pubmed/9576425
Circulation. 1998 Apr 21;97(15):1453-60.
Lipoprotein changes and reduction in the incidence of major coronary heart disease events in the Scandinavian Simvastatin Survival Study (4S)
Pedersen TR, Olsson AG, Faergeman O, Kjekshus J, Wedel H, Berg K, Wilhelmsen L, Haghfelt T, Thorgeirsson G, Pyörälä K, Miettinen T, Christophersen B, Tobert JA, Musliner TA, Cook TJ. Aker Hospital, Oslo, Norway.

17)  LIPID STUDY
http://www.nejm.org/doi/full/10.1056/NEJM199811053391902
Prevention of Cardiovascular Events and Death with Pravastatin in Patients with Coronary Heart Disease and a Broad Range of Initial Cholesterol Levels
The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group
N Engl J Med 1998; 339:1349-1357November 5, 1998

 

Jeffrey Dach MD
7450 Griffin Road
Suite 190
Davie, Fl 33314
954 792 4663

Summary
Statin Denialism Internet Cult with Deadly Consequences
Article Name
Statin Denialism Internet Cult with Deadly Consequences
Description
Statin Denialists We Know WHO You Are and We Are Coming For YOU !
Author
jeffrey dach md
  • Dan Golthing

    Dr Dach, thanks for all your articles. I’m surprised that you of all people have seemed to have missed the “Holy Grail” of health and wellness. Nothing better for clearing arterial plaque and reducing blood pressure. can cure arthritis, can cure cancer, and the list is endless.

    The non-domesticated animal kingdom know this, yet it is free. It will not help a doctor make a payment on his Mercedes. So guess who won’t mention it and promotes it as “dangerous”?

    http://soilandhealth.org/wp-content/uploads/02/0201hyglibcat/020127shelton.III/020127.toc.htm

    Start with chapter 2.

    Also…

    http://apache2.pum.edu.pl/~fasting/upton.pdf

    The world needs some intelligent doctors like yourself promoting the ultimate natural healing process.

  • Tom Naughton

    Well, I was a standup comic for several years …