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Statins: Overprescribed in Healthy People?

Friday, July 28, 2017


An article published in the July 25, 2017, ScienceDaily titled "Statin Denial: An Internet-driven Cult with Deadly Consequences" certainly got our attention.


It’s credited to an editorial written by Steven E. Nissen, MD, of the Cleveland Clinic, which appeared in the July 25, 2017, Annals of Internal Medicine, suggesting research has proven  that internet propaganda promoting bizarre and unscientific criticisms of statins has given these life-saving drugs a bad reputation. 


The article reports that people on the internet with little or no scientific expertise state that statins are harmful while peddling “natural” remedies for elevated cholesterol levels.


While some of Dr. Nissen's claims may be true, statin's life-saving reputation has been questioned in a large number of prestigious peer-reviewed medical journals, suggesting that the statin industry ​clearly earned their questionable reputation.


A 2015 article published in Expert Reviews of Clinical Pharmacology titled "How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease" suggests that although statins are effective at reducing cholesterol levels, they have failed to substantially improve cardiovascular outcomes and morbidity.


They described the deceptive approach statin advocates have deployed, creating the appearance that  impressive cholesterol reduction results in cardiovascular disease reduction outcomes through their use of a statistical tool called relative risk reduction (RRR), a method that amplifies the trivial beneficial effects of statins, while minimizing the significance of numerous adverse effects of statin treatment.


An understanding of general terminology used in clinical research will help readers understand how relative risk reduction can be used to play with study results. The authors of this Expert Review of Clinical Pharmacology review did a brilliant job of illustrating the absolute risk (AR), the relative and absolute risk reduction (ARR), and the number needed to treat (NNT).


They illustrated the use of these terms in clinical research this way: “Consider a five-year trial that includes 2,000 healthy, middle-aged men. The goal of the trial is to see if a statin can prevent heart disease. Half of the participants are administered the statin and the other half a placebo. In most clinical trials, during a period of five years, about 2% of all healthy, middle-aged men experience a nonfatal myocardial infarction (MI). In our hypothetical trial, 2% of the placebo-treated men and 1% of the statin-treated men suffered an MI. Statin treatment, therefore, has been of benefit to 1% of the treated participants. Thus, the absolute risk reduction (ARR), which quantifies how effective a treatment is on the population at risk was on 1 percentage point, and the number needed to treat (NNT) was 100, resulting in only 1 of 100 people benefiting from the treatment. 


"Put another way, the chance of not suffering from an MI during the five-year period without treatment was 98%, and by taking a statin drug every day, it increased by 1 percentage point to 99%.


“We know that health care workers and the public are not going to be impressed with a mere 1% point improvement, therefore, instead of using the ARR, they present the benefit in terms of relative risk reduction (RRR). The RRR is a derivative of the ARR in which the difference in disease outcomes in two groups is expressed as a ratio. Hence, using RRR, the investigating directors can state that statin treatment reduced the incidence of heart disease by 50%, because 1 is 50% of 2.”


Representative examples of statistical deception in statin trial data presentation included the JUPITER trial, the Anglo-Scandinavian Cardiac Outcomes Trial-Lipids Lowering Arm (ASCOT-LA), the British Heart Protection Study (HPS) trial, the CARE cancer trial, and the SEAS trial, just to mention a few.


The Clinical Pharmacology expert review also suggests that substantial adverse events of statins are more serious and far more common than is typically reported in the trial publications, including the initial run-in phase in which statin-intolerant individuals (study subjects who experience very early adverse events) are removed from the studies before formal initiation. So these subjects do not have to be included in the published study results, even though some reports suggest up to 20% adverse reaction during the run-in phase. 


Medical literature reported adverse effects of statins include an increased rate of cancer, cataracts, diabetes, cognitive impairment, and musculoskeletal disorders. Also interesting to note, the benefits of statins are routinely reported as relative risk, while adverse effects tend to be expressed in terms of absolute risk.  


The review authors include 83 published clinical studies to support their claim of probable statistical deception where statin medications are concerned.


  

Ellen Troyer, with Spencer Thornton, MD, David Amess and the Biosyntrx staff



PEARL

Statin drug use is a bit out of the Biosyntrx scientific advisory board wheelhouse, but the founders and many board members have been monitoring published long-term statin drug outcomes and adverse events for some time, particularly where statin-increased risk of cataract is concerned. ​


The mortality rate for cardiovascular disease during the past three decades of statin use, based on the numbers used in this week's Annals of Internal Medicine editorial, which you can see in the link, only moved from 0.357 percent down to 0.167 percent, which certainly doesn't seem that effective, given adverse side effects and the enormous amount of private and government health care dollars spent on ​these medications.

 

Interestingly, the June 2017 Annals of Internal Medicine also published a cross-sectional analysis of national health and nutrition examination surveys, concluding that in the absence of risk factors, the prevalence of increased atherosclerotic cardiovascular disease (ASCVD) risk is low among women younger than 50 and men younger than 40, even though the American College of Cardiology and American Heart Association now recommend lipid screening in all adults older than 20 years to identify those at increased risk for ASCVD and possible statin therapy, further pushing these drugs on patients well beyond the point of clinical usefulness.


​Our obvious next question: Given our health care crisis and life expectancy, shouldn't 'Lifestyle Medicine' counseling and extreme caution become ​the coin of the realm standard, before ​prescribing what could amount to 60+ years of ​daily statin meds for young people?


Follow the money: Statins alone are reported by many to already be more than a 25 billion dollar a year cash cow, in an industry sector now suggested to spend twice as much a year on advertising as it does on research and development. 











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