Does the controversy over statin drugs herald a new era of doctoring?

In July, I wrote a short blog post expressing doubt about the value of statin drugs. Medscape republished it on their website and it went viral–in a medical sort of way. The post has 631 comments. It was Tweeted extensively, page views have been off the charts (for me), and I even received an invitation to discuss my views on a famous television show, which I declined.

This week, Medscape published Statins: The Good, the Bad, and the Unknown, a referenced review article of my blog post and its comments. In the well-written five pages, Dr. Gordon Sun (UCLA Medical Center) covered four major issues of present-day statin therapy. I’d recommend reading the entire article. Here are a few words about the issues he highlighted.

Statin benefit:

Everyone, including me, agrees that statin drugs confer benefit in patients with established blood vessel disease (atherosclerosis). The doubt I expressed about statins related to their value in three groups of patients–those without blood vessel disease, women and the elderly. In these patients, which number in the millions, the benefit of statin drugs are dubious.

Consider the what-if possibility of statin drugs being available over the counter. Would a consumer (say with an elevated cholesterol level and no other risk factors) part with her own money for a drug that has no mortality benefit and a NNT (Number Needed to Treat) of 140 to prevent a non-fatal heart attack in the future? Might this person spend hundreds of dollars thinking she was the 1 of 140, or, would she justify not buying the drug because she was far more likely to be one of the 139 of 140 who would get no benefit?

Statin myopathy:

In the second page of Dr. Sun’s review article, he delves into the debate on muscle-related complaints with statins. This controversy played out recently in the British Medical Journal. The consternation stems from the fact that observational trials report a much higher incidence (11-29%) of muscle complaints than do clinical trials (1-5%). The most likely explanation is that patients in clinical trials were screened for muscle issues before entering the study, whereas in real life, statin drugs are used in all-comers. In other words, clinical trials may not be representative of real world populations.

Any caregiver that has more than a token practice will tell you that statin drugs cause muscle symptoms in more than 1-5% of patients. What’s more, the biochemistry of statins lend plausibility to muscle complaints. Although cognitive bias can obscure truth, it strains credibility to ascribe statin-induced muscle complaints to the nocebo effect–IMHO.

Statin-lifestyle interaction:

Dr. Sun further expanded on the idea that a “healthy lifestyle is the foundation for cardiovascular health.” This idea is central to how we think about using cardiac drugs or procedures. When I prescribe a treatment to a patient, I explain the goals of the intervention. In the case of statin drugs, the goal is not to move a lab value (LDL or HDL); it is to extend life. With this long-term objective in mind, studies that suggest patients on statin drugs eat more, move less and put on weight should give us pause. We have recently learned, from a Swedish study, that simple lifestyle behaviors may render much of heart disease unnecessary–without drugs.

The interactions of drugs with other drugs and unintended biologic functions is greatly under-appreciated. Nary is the chemical that exerts its effects on only one system. And…as we learn more about personal (genomic) medicine, it will soon be clear how much our genes determine a drug’s effects.

Personal beliefs about statins–and the future of medical practice:

The final issue addressed in Dr. Sun’s review extends past the biology of statin drugs and heart disease. It gets to the notion of how medicine will be practiced in the future. Namely, in this information age, who is the expert?

Dr Sun noted that most of the commenters on Medscape (caregivers) shared my doubt about statin drugs. And it wasn’t just Medscape readers. He cited a survey of more than 1600 New England Journal of Medicine readers, in which more than half would have withheld statin drugs in a case of primary prevention. These are remarkable findings because recent expert guidelines have suggested an expanded role for statins.

At least for statin drugs, the disconnect between patients, doctors and experts is expanding. This, I believe, heralds a new era of medical decision-making. In the past decade, guideline-directed care equated to quality care. You have a disease and we have established treatments. Now, it seems the more we learn, the less we know.

Statin doubt is one example. The lack of benefit of aggressive blood pressure and blood sugar control in the elderly is another. How the drug dronedarone rose to first-line therapy in atrial fibrillation could be taught as a lesson in Conflict of Interest-101. Don’t get me started on the marketing of fear, eg, the LifeVest and the pink campaign. Then there was the idea of giving beta-blockers to patients before surgery–a guideline-directed measure now debunked because of fraudulent science.

I can feel it. Can you? Skepticism is making a comeback–due in large part to the spread of knowledge.

In a world where healthcare increasingly fails to deliver health, this is cause for celebration.

JMM

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