–“We are losing the battle for the hearts and minds of our patients.”
A leading cardiologist has unleashed a blistering attack on “statin denial,” which he calls “an internet-driven cult with deadly consequences.”
In an editorial in Annals of Internal Medicine, Steve Nissen (Cleveland Clinic) expresses grave concerns over statistics showing that only 61% of people given a prescription for a statin were adherent at 3 months. “For a treatment with such well-documented morbidity and mortality benefits, these adherence rates are shockingly low. Why?” he asks.
Nissen writes that “we are losing the battle for the hearts and minds of our patients to Web sites developed by people with little or no scientific expertise, who often pedal ‘natural’ or ‘drug-free’ remedies for elevated cholesterol levels.” The anti-statin forces employ two distinct strategies, “statin denial, the proposition that cholesterol is not related to heart disease, and statin fear, the notion that lowering serum cholesterol levels will cause serious adverse effects.” Nissen admits that some patients will have statin-related adverse effects but “intolerance in many patients undoubtedly represents the nocebo effect.”
Outcomes After Adverse Reactions
The editorial accompanies a study from Brigham and Women’s Hospital looking at what happened to 28,266 people who reported an adverse reaction to statin therapy. 70.7% continued to receive statin prescriptions after reporting the adverse reaction. After four years the rate of cardiovascular events was 12.2% in those who continued to receive statin prescriptions versus 13.9% in those who did not.
“Statins remain a first-line therapy for managing cardiovascular risk, but many patients do not reattempt statin therapy and remain without treatment for prolonged periods after an adverse reaction,” said Alexander Turchin, senior author of the paper, in a press release. “Alternative therapies such as ezetimibe are not as effective, and new classes of drugs are expensive. Improving our understanding of the benefits and risks of reattempting statin therapies before switching to a different class of drugs could help both patients and physicians make informed choices about care.”
The authors acknowledged that because it was a retrospective study they “could establish only associations rather than causal relationships.” In his editorial, Nissen acknowledged these limitations but said the study is “reasonably convincing: Discontinuing statin treatment has serious negative consequences.”
How Did We Get Here
Nissen places a substantial portion of the blame for statin denialism on the Dietary Supplement Health and Education Act of 1994 (DSHEA), which loosened regulation of dietary supplements, spurring what is now a $30 billion a year industry selling an “array of worthless or harmful dietary supplements.” According to Nissen, supplement makers “commonly imply benefits that have never been confirmed in formal clinical studies.” Nissen singled out Dr. Oz for an article, “Reverse Your Heart Disease in 28 Days,” that didn’t mention statins.
Responding to email questions, Nissen defended the use of statins in primary prevention, writing “we have abundant scientific evidence demonstrating that treatment of high risk primary prevention patients substantially reduces the risk of cardiovascular morbidity.” He acknowledged that statins, like other drugs, have adverse effects, “but the benefits are so well documented that every effort should be made to encourage use of these drugs in appropriate patients. The diversion of patients away from evidence-based therapy by advocates of unproven dietary supplements must be vigorously opposed by physician-scientists. Similarly, the claims that cult diets can reverse heart disease have no scientific basis and represent a danger to public health.”
James Stein (University of Wisconsin), expressed strong support for Nissen’s editorial. “I have scores of patients who stop their statins based on fears that mainly come from the internet, though I have to say, ‘friends’, pharmacists, and many primary care docs play into the fears. We spend a lot of time trying to sort out various aches and pains, non-specific symptoms, and anxieties that are not due to statins. Many lives have been lost or impaired because of statin non-compliance. There is a special place in hell for people who use fear tactics and misinformation to promote books and natural health aids, including crazy diets, at the expense of proven medical therapies, rather than as complimentary options under medical direction. I am not sure why Americans are so susceptible to these charlatans.”
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