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

11 comments

  1. Thank you John for another great post. Hopefully the concept of providing full information to patients regarding “preventive measures” such as taking a statin will be increasingly presented in the form of NNT data. Far fewer patients would choose to be on a statin if they knew that their chance of improved outcome was only 1 in 140 (and that the other 139/140 patients pay the cost and are subject to side effects of statin therapy without chance for benefit). Would be great if the additional concept could be routinely conveyed (and received by the patient!) that at least comparable benefit could be attained regarding improved outcome by adopting healthy lifestyle choices (at zero cost with everyone benefiting regardless of whether they reduce the risk of future heart attack or not).

  2. John a great article I suggest that primary prevention be reviewed revisited as it’s no longer adequate to treat either a cholesterol level or a BP number but instead to measure pre-clinical markers of atherosclerosis using arterial PWA and neurohormonal scores of HRV then treat abnormalities with lifestyle as 80% will benefit then add statins and antihypertensive medication This I have done for 16 years it sure beats handing toxic compounds to improve meaningless numerical scores. I’ve had a patient who asked me how many kilos of cheese can he eat per week now that he’s on a statin No that’s not the intention!

  3. John, provocative and useful post as always.
    The crux of the issue for me is that people lose sight of the fact that high cholesterol the vast majority of the time is not a disease, it is only a marker for increased atherosclerosis risk. The disease we are treating is atherosclerosis.
    You write:
    “Everyone, including me, agrees that statin drugs confer benefit in patients with established blood vessel disease (atherosclerosis)”
    The new guidelines would have almost all men over the age of 60 take a statin but if such men have no atherosclerosis by vascular and/or coronary calcium testing the benefits are nonexistent (http://wp.me/p30zF0-cS).
    If there is a consensus that those with atherosclerosis benefit the most from statins, doesn’t it make sense to see which patients have silent atherosclerosis?

  4. Thanks Dr. John for this summary. You have hit so many heads of so many nails here, I scarcely know where to start!

    The statement “clinical trials may not be representative of real world populations” is not quite right. The phrase “may not be” should be replaced with “ARE NOT”, as by definition, trial participants are screened in a way that those of us who are patients out here in the real world are not. Researchers generally don’t like patients with co-morbidities (mucks up the data) or are too old or too hormonal or too female or too ill to be relied on to show up when and where they’re supposed to during the trial. For more reasons to be skeptical, one only needs to consider decades of cardiac research that ignored women entirely.

    I have noticed over the past six years that the audiences at my women’s heart health presentations generally do not believe that heart disease or any other bad diagnosis will ever happen to them. That’s why they accept statin prescriptions because they think they can now eat all the cheese and cheesecake they like with impunity. That’s also why even women who smoke two packs a day for 30 years (like Martha Lear, author of a new book all about her heart attack) are so inexplicably *surprised* when it happens. My advice to my audiences now is: “Why not just live your life as if you already know you’re at very high risk for heart disease one day?” There is simply no downside in eating a healthy Mediterranean-type diet, managing stress, getting a good night’s sleep and (as you like to say) exercising “on the days you plan to eat”.

    For those without heart disease who are interested in whether a statin is of any cardioprotective use to them, I really like the Number Needed To Treat site: http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-prior-heart-disease/

  5. Let me through this out there……When you prescribe a statin why do you choose a specific one? One that you think works best for you? One that you like the rep? One that is cheap?
    Personalized medicine specifically Pharmacogenetics can give you info so that you can avoid the myopathy and also provide you with the best Beta Blocker, Anti-platelet, Anti-Depressant….. Its here backed by double blinded randomized clinical trials…..

  6. This is my problem: Ten years ago my cholesterol and triglyceride levels were terrible. My doctor put me on a statin and fish oil supplements. It didn’t do very much until another doctor who was helping me with weight loss suggested that I take processed foods out of my diet. That one suggestion turned everything around and my lipid levels have been spot on since then. Because I have taken cardio toxic chemotherapy I get a nuclear stress test done every 3 years. The cardiologist wants to do it every year, but I draw a line. Every time it shows that my cardiac arteries are clear. Last year I had peripheral and renal artery ultrasounds. The results came back that they were clear. At my physical in September my doctor thought he heard a whoosh in one of my carotid arteries and I had an ultrasound of both arteries. The results came back and my doctor told me that I have the arteries of a 20 year old. Then he said “Just keep taking the statin and the fish oil and I’ll check it again in three months.” So how do I get my doctor to see that the statin and the fish oil are probably worthless?

    1. Unfortunate or not – the reality (as per Dr. John’s blogs as well as my 35 years of experience in the field as clinician and educator) – is that you may or may not be able to “get your doctor to see” your point – which is why patients are encouraged to take the active role that you have already done in your own health care. Realistically – you have a few choices: i) Continue with this physician if positive attributes outweigh his/her drawbacks – but continue to “draw a line” on what you (after much research and discussion with others) feel is reasonable and optimal for you; or ii) Look for another physician whose outlook, flexibility and acceptance are more in line with your preferences for treatment. The GOAL (in my opinion) is that clinician and patient WORK together to individualize treatment in optimal cost- and risk-effective manner in a way that the informed patient is comfortable with and desires. This does NOT mean that the clinician should not convey what he/she believes – but only that ultimate decision after the patient is fully informed on potential for benefit vs potential for harm from various interventions (or non-interventions) should rest with the patient and NOT with the physician …

      There ARE clinicians out there who abide by the above suggested approach – though depending on where you live, you may need to look a bit to find them. I know – because I have interacted with many such clinicians in my national travels and teaching activities.

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