* Kent Holtorf, MD, founder of the non-profit National Academy of Hypothyroidism, directs the Holtorf Medical Group with locations across California, in Kansas City, and Minneapolis. Dr. Holtorf specializes in researching and employing "innovative evidence-based therapies for hard-to-treat and poorly understood illnesses." This expert opinion, originally published by AoL Health on August 26, 2010, is reproduced with kind permission of the author.
Statins: "The Good, the Bad, and the Ugly"
It appears that everyone has a simple indicator of health known as cholesterol. Those with “good” cholesterol levels feel comforted and those with “high” levels are stressed about their increased cardiovascular risk.
A patient is thankful when their doctor is able to lower their cholesterol level with a prescription. “What a great doctor,” many proclaim as they brag to their friends about the improvement.
Doctors love it, too. They can easily help the patient with a simple blood test and a five-minute visit. Some physicians even half-jokingly say that these medications should be added to the drinking water. What could be easier?
As it turns out, the prescription may not be so beneficial after all.
Statin drugs are used to lower cholesterol levels and are the most prescribed (and marketed) medications in the U.S. They have been touted as an effective means to prevent heart attacks and strokes.
A major trial [in late 2008] reported that patients with normal cholesterol levels but increased inflammation had a small but significant reduction in cardiovascular events when placed on the statin, Crestor. Based on the results of this trial, the Food and Drug Administration approved an expanded indication for Crestor in February 2010. This expanded indication includes individuals with normal cholesterol levels who have elevated inflammation in the body (defined by C-reactive protein level) and at least one risk factor like high blood pressure or smoking.
However, subsequent analysis has shown that this trial was significantly flawed.
There is evidence of manipulation by both the drug company sponsor and the study authors. Instead of objective endpoints that are usually used to determine effectiveness - heart attack, stroke or death, for example - the study used outcomes based on endpoints of human decisions like hospital admissions or procedures, which are prone to significant bias and manipulation.
The conflicts of interest were overwhelming.
• The lead investigator owned the patent on the test that the study concluded would be the basis for treatment.
• The drug company collected and controlled all the data;
• And the majority of authors had financial ties to the drug company.
An investigation published in the Archives of Internal Medicine found disturbing inconsistencies in the data and concluded that the trial was flawed.
The results of the trial do not support the use of statin treatment for the prevention of cardiovascular disease.
They also raise troubling questions concerning the role of commercial sponsors.
• Statins were initially approved by the FDA for the prevention of a repeated heart attack or stroke in patients with high cholesterol who had already suffered from a heart attack, which is called “secondary prevention.”
• Physicians and the public then came to believe that statins could prevent heart attacks in individuals without heart disease but with elevated cholesterol levels, which is known as “primary prevention.”
• This has resulted in the majority of people who use statins doing so for primary prevention of heart attacks and strokes.
• This has, of course, been continuously reinforced by massive drug company marketing to both doctors and the public to support the $25 billion in sales that these medications bring in each year.
It is becoming clear that the benefits of using a statin for primary prevention have been greatly exaggerated and have not been shown to be beneficial when compared to a placebo.
Evidence keeps mounting that using a statin to lower cholesterol in someone without known heart disease is of little, if any, benefit. In recent years, 14 major studies either found no cardiovascular protection with statin use in those without known heart disease or were halted because no benefit was shown.
A review study published in the Annals of Internal Medicine analyzed the evidence of statin use for primary prevention. Data were available for over 65,000 high risk patients who were treated with statins to lower cholesterol for primary prevention.[“Statins and All-Cause Mortality in High-Risk Primary Prevention - a Meta-analysis of 11 Randomized Controlled Trials Involving 65,229 Participants,” Jun 28, 2010.] The study found no benefit to treatment.
There is also rising concern about certain side effects that have not been discussed or are underreported…
• These include the well-known but often dismissed muscle pain and fatigue as well as increased risk of depression, memory loss, cataracts, and neuropathy (nerve degeneration).
• Statins are also shown to reduce the levels of thyroid-stimulating hormone, making thyroid tests unreliable when the patient is on a statin.
• Statins are also shown to reduce immunity, increasing the risk of infections (including MRSA), as well as reducing the body’s ability to repair tissue.
• New concerns also include evidence that statins increase the risk of developing type 2 diabetes by 9%.
Of greater concern is the emerging evidence for significantly increased cancer rates, especially breast cancer, in those taking statins.
In one five-year study, there was a 12-fold increase in the incidence of breast cancer in women taking a statin, and other trials are finding that any benefit in reduced cardiovascular mortality may be offset by an increased incidence of cancer.
A review study published in the Journal of Cardiology that included more than 300,000 patients found that:
• The more LDL cholesterol [popularly termed ‘bad’ cholesterol] was reduced, the greater the risk of cancer.
• Those who achieved an LDL level below 100 milligrams per deciliter had twice the cancer risk of those who achieved a level of 150 mg/dl.
A number of trials have not found any increased incidence of cancer, but these have severely underrepresented women and the elderly.
It appears clear that there has been an over-exuberance surrounding the benefits of statin drugs. This enthusiasm has largely been fueled by market forces rather than evidence.
While statins have been shown to be of benefit in those with prior cardiovascular events, the dramatic expansion and common use for primary prevention is being called into question as it may be associated with more risks than benefits.
- Kent Holtorf, MD, Aug 26, 2010
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Articles in the ProHealth library on this subject include, for example:
• “FDA Warning Re Popular Statin Drug Dose and Muscle Injury, Pain" – Jun 8, 2011
(“All [statin drugs]… carry some risk of an injury called ‘myopathy’ characterized by unexplained muscle weakness or pain.” - FDA)
• “Cholesterol Lowering Statin Drugs Cause Muscle Pain, Destroy Muscle in Many Patients” – Jul 25, 2009
(“A subgroup of patients appears to be more susceptible to statin-associated myotoxicity, suffering persistent structural injury. Statins inhibit formation of cholesterol – a key component of cellular membranes.”)
• “Cholesterol-Depleted Brain May Account for Statin Drug-Related Anxiety & Depression (Also Reported by Some Individuals on Low-Cholesterol Diets)” – Jun 30, 2010
(“The scientists showed that maintaining normal cholesterol levels in the brain is important for the function of cell receptors for serotonin, a brain hormone that influences mood and behavior.”)
• "Statin & Antidepressant Combo Can Put Blood Sugar Into Orbit" – Taken by Up to 1 Million in US – May 25, 2011
(“Patterns found in medical records analysis are identifying harmful effects of drug combinations that the FDA approval process can’t – and this combo was just the most common of four with the same effect.”)
• “Statin Drug Appears to Weaken Body’s Immune Defenses” – Mar 1, 2010
(“[This drug] might help lower cholesterol, but when it comes to infection it’s an entirely different story. First it impairs the ability of specialized immune cells, called macrophages, to kill pathogens. Then, it enhances production of molecules, called cytokines, which trigger and sustain inflammation.”)
• “One Gene Variant for Liver Function Determines How We Respond to at Least Half of All Drugs” – May 15, 2010
(“Study found that 1 in 10 people has a gene variant linked to slower liver metabolization of statin drugs (and in fact about half of all current Rx drugs) that could make 'normal' doses potentially toxic.")
• "Mayo Publication Reports Cardiovascular Risk Slashed with Higher Omega-3 Intake; Dosage guidelines Suggested – Mar 10, 2008
(“Controlled trials involving 32, 000 participants showed reductions in cardiovascular events of 19% to 45% in those randomized to receive omega-3 fatty acid supplements containing DHA & EPA, vs. controls.”)
• "'You’re My Wife?' Amnesia is Possible Side Effect of Statin Drug” – Dec 3, 2003
(A doctor at UC-San Diego studying the effects of statins on cognition and mood said she had documented at least 100 cases of memory problems that might be due to statins, including 30 cases of transient amnesia, and pointed out that with millions taking the drugs, thousands could be affected.)
• “Brain Fog & the Need for Good Energy Supply to the Brain” by Sarah Myhill, MD – Feb 10, 2010
(“My guess is that statin drugs, by reducing the cholesterol that the brain loves, are contributing to our current epidemic of Alzheimer’s disease. Certainly it is rare for my CFS patients to tolerate statins - nearly always they are made ill by them.”)
• "Red Yeast Rice – Natural Option for Supporting Healthy Cholesterol" – Jan 27, 2010
(“The collective research strongly suggests that supplemental red rice yeast may be considered part of an effective and safe approach to cholesterol management for those seeking an alternative to use of prescription statin drugs.”)
Note: This information has not been reviewed by the FDA. It is general information, should not be construed as medical advice, and is not meant to prevent, diagnose, treat or cure any illness, condition, or disease. It is very important that you make no change in your healthcare plan or health support regimen without researching and discussing it in careful collaboration with your professional healthcare team.