Study: statin drugs overprescribed for healthy adults

by Carolyn Thomas  ♥  @HeartSisters

A study from Johns Hopkins Hospital may be very bad news for drug companies that make statin drugs for cholesterol management.(1)  Statins, of course, are considered the darlings of Big Pharma. I’ve heard cardiologists joke (at least, I think they were joking) that statins are so fabulous at lowering our LDL (bad) cholesterol that we should be putting the drugs into our drinking water.

Virtually all heart attack survivors are now routinely prescribed statins (whether they have high cholesterol or not) and there’s a major marketing push for docs to prescribe statins as cardiovascular preventive therapy for virtually all adults, particularly to reduce blood levels of the inflammatory byproducts called C-reactive protein. But the Johns Hopkins study lead investigator Dr. Michael Blaha has this important new warning:  

“Our results tell us that only those adults with some measurable buildup of calcium in their coronary arteries have a clear benefit from any statin therapy, but those who are otherwise healthy and have no significant calcification should focus on aggressive lifestyle improvements instead of early initiation of statin medications.”

But meanwhile, pharmaceutical industry-funded research continues to make fantastic claims about the benefits to all of popping those daily statins:

• They reduce blood-levels of C-reactive protein, a sign of inflammation in the body!
• They reduce the risk of heart attack, stroke and diabetes!
• They protect coronary arteries!
• They treat auto-immune diseases like psoriasis, rheumatoid arthritis and maybe even MS!
• They improve bone health!
• They fight dementia and Alzheimers Disease!

Gee, if you believe all those industry-funded studies, maybe we should be adding statins to our drinking water. . .

Until now, that is, when the Johns Hopkins study, reported at the last American Heart Association’s annual Scientific Sessions in Chicago, found that taking daily doses of a statin medication to protect coronary arteries and ward off heart attack or stroke may actually be a bad idea.

Dr. Roger Blumenthal, director of the Ciccarone Preventive Cardiology Center at Johns Hopkins, explained:

“Statin therapy should not be approached like diet and exercise as a broadly based solution for preventing coronary heart disease. These are lifelong medications with potential side effects.”

He also pointed out that as many as 5% of people on statins develop serious side effects such as severe muscle pain. One in 255 will develop diabetes. Dr. Beatrice Golomb, by the way, who has been studying the effects of statin drugs on women at the University of California, San Diego, estimates that serious side effects may actually be problematic for up to 15% of patients, not the lowball 1-7% as reported by the drug companies who manufacture statins.

Dr. Mark Ebell, a professor at the University of Georgia and deputy editor of the journal, American Family Physician was interviewed about this issue by the New York Times for a piece called “Great Drug, But Does It Prolong Life?”  He added:

“In studies of middle-aged men with cardiovascular disease, statin users were less likely to die than those who were given a placebo.

“But many statin users don’t have established heart disease; they simply have high cholesterol. For healthy men, and for women with or without heart disease, and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.

“High-risk groups have a lot to gain, but patients at low risk benefit very little if at all. We end up overtreating a lot of patients.”

The Johns Hopkins study also refuted C-reactive protein levels in the blood as predictors of blocked arteries, thus disputing the findings of the highly publicized JUPITER* study in 2008. This new study found that high levels of C-reactive protein in the blood, (a score at or above 2 milligrams per litre) offered no predictive value after accounting for established risk factors, including age, gender, ethnicity, hypertension, blood cholesterol levels, obesity, diabetes, smoking and a family history of heart disease. Study participants in the new analysis had varying blood levels of the inflammatory byproduct, until now believed by some to be a predictor of all kinds of coronary disease.

Read the full report from Johns Hopkins.

* The JUPITER trials: first released in 2008, involved 17,802 healthy men and women with normal LDL-cholesterol levels but elevated CRP levels assigned to take a drug called rosuvastatin 20 mg (Crestor, made by AstraZeneca) 20 mg or a placebo pill.  JUPITER was stopped after 1.9 years of follow-up. Research results reported that Rosuvastatin significantly reduced non-fatal heart attacks and strokes, hospitalization for unstable angina, revascularization procedures like bypass surgery or cardiac catheterization, and confirmed death from cardiovascular causes compared with placebo. There was a 55% reduction in non-fatal heart attack, a 48% reduction in the risk of non-fatal stroke, and a 47% reduction in the risk of heart attack/stroke/cardiovascular death.

Dr. Paul Ridker of Boston was the lead author of the JUPITER study. His research was funded by AstraZeneca, the very drug company that makes Crestor. He’s also received previous grants and consulting fees from the same company. In fact, nine of the 14 authors of the JUPITER study have financial ties to AstraZeneca. Ridker also happens to hold the legal patent on CRP blood-testing technology that stands to explode in sales if his JUPITER study’s recommendations are accepted by cardiologists worldwide, so he has much to gain with the publication and acceptance of his research.

But in June 2010, France’s Dr. Michel de Lorgeril, along with researchers from several countries, took a much closer look at Ridker’s JUPITER results. His team published their interpretations in the Annals of Internal Medicine, concluding that the JUPITER trial was “flawed on many levels, biased by commercial interests, and its findings have actually been exaggerated to favour the drug, not the facts”.

Read more about the JUPITER drug trials:  When Medical Research is Funded to Favour the Drug, Not the Facts on The Ethical Nag: Marketing Ethics For The Easily Swayed.  Read more about taking statins for heart disease prevention if you have no prior heart disease.

 

(1)  Michael J. Blaha et al. Association between hsCRP≥2, Coronary Artery Calcium, and Cardiovascular Events – Implications for the JUPITER Population: Multi-Ethnic Study of Atherosclerosis (MESA). Lancet. 2011 Aug 20; 378(9792): 684–692. doi:  10.1016/S0140-6736(11)60784-8

 

See also:

• Can Statins Prevent My Head From Exploding?
• Universal Cholesterol Screening for Little Kids?
• Yet Another Cardiac Risk Calculator? My Response in the British Medical Journal
• Women, Controversial Statin Guidelines, and Common Sense
• Women and Statins: Evidence-based Medicine or Wishful Thinking?
• How Merck Got Us to Spend $21 Billion On Drugs That Don’t Work
• Women at Greater Risk for Side Effects When Taking Statins

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