Interview with Barbara H. Roberts, M.D., author of The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs
Statins are medications which lower cholesterol by inhibiting an enzyme involved in its production by the liver and other organs. First approved by the FDA in 1987, statins are arguably the most widely prescribed medicine in the industrialized world today--and the most profitable, representing $26 billion a year in profits to the drug industry. In fact, Lipitor was the world's best selling drug until its patent expired recently. Yet, most trials that prove statins' effectiveness in preventing cardiac events and death have been funded by companies and principle investigators who stand to benefit from their wide use. In February, the FDA warned that statins can increase users' risk of type 2 diabetes and memory loss, confusion and other cognition problems.
Barbara H. Roberts, M.D., is Director of the Women's Cardiac Center at the Miriam Hospital in Providence, Rhode Island and Associate Clinical Professor of Medicine at the Alpert Medical School of Brown University. She spent two years at the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) where she was involved in the first clinical trial that demonstrated a beneficial effect of lowering cholesterol on the incidence of heart disease. In addition to The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs, she is also author of How to Keep from Breaking Your Heart: What Every Woman Needs to Know about Cardiovascular Disease.
Barbara Roberts, MD by author photo
Martha Rosenberg: Statins have become so popular with adults middle-aged and older in industrialized countries, they are almost a pharmaceutical rite of passage. Yet you write in your new book there is little evidence they are effective in many groups and no evidence they are effective in one group, women without heart disease.. Worse, you provide evidence, including stories from your own patients, that they are doing serious harm.
Barbara Roberts: Yes. Every week in my practice I see patients with serious side effects to statins and many did not need to be treated with statins in the first place. These side effects range from debilitating muscle and joint pain to transient global amnesia, neuropathy, cognitive dysfunction, fatigue and muscle weakness. Most of these symptoms subside or improve when they are taken off statins. There is even growing evidence of a statin link to Lou Gehrig's disease.
Martha Rosenberg: One patient you write about caused a fire in her home by forgetting that the stove was on. Another was a professor who experienced such memory loss on a statin he could no longer teach; others ended up in wheelchairs. The only thing more shocking than the side effects you write about is the apparent blindness of the medical establishment to them. Until half a year ago, there were practically no warnings at all.
Barbara Roberts: There is no question that many doctors have swallowed the Kool-Aid. Big Pharma has consistently exaggerated the benefits of statins and some physicians used scare tactics so that patients are afraid that if they go off the statins, they will have a heart attack immediately. Yet high cholesterol, which the statins address, is a relatively weak risk factor for developing atherosclerosis. For example, diabetes and smoking are far more potent when it comes to increasing risk.
Martha Rosenberg: One group you say should not be given statins at all because there is no benefit and significant risk is women who have no heart disease.
Barbara Roberts: In three major studies of women without diagnosed heart disease, but who were at high risk (in one of these studies, each participant had to have high blood pressure and three other risk factors), 40 women out of 4,904 on statins had either a heart attack or cardiac death, compared to 44 women out of 4,836 on placebo. That is not a statistically significant difference. Since the likelihood of experiencing a statin side effect is about 20 to 25 percent, the risk of putting a healthy woman on a statin far outweighs the benefit. Still, statins are routinely given to this group because the guidelines are shaped by Big Pharma. The guidelines are not supported by the evidence and in the case of healthy women I don't follow them.
Martha Rosenberg: You give a story in your book about your 92-year-old patient who had a total cholesterol of 266, triglycerides of 169, HDL cholesterol of 66, and LDL cholesterol of 165. Her primary care doctor wanted her to take a statin, but you did not feel she needed to because she had no evidence of heart disease, had never smoked, did not have high blood pressure and was not diabetic.
Barbara Roberts: Yes and today she is 103 and a half-- and doing fine, never having taken a statin.
Martha Rosenberg: In the Truth About Statins you explain pretty clearly how studies have made statins look more effective and safer than they are. How has this been done?
Barbara Roberts: First of all, the studies are of short duration and some of them even have a "run in" phase during which people are given the drug to see if they tolerate it. If not, they are not enrolled in the study. Secondly, study subjects are cherry-picked to exclude the very elderly, people with liver or kidney disease or those with any chronic illness that might "muddy" the results--
Martha Rosenberg: In other words, the very people who will be taking them?
Barbara Roberts: Yes and of course patients will also be staying on the drugs for life unlike trial subjects. Then, the data from the studies are usually given in terms of relative rather than absolute risk. The absolute risk of a cardiac event is only reduced by a few percentage points by statins and in some patients, like the women without heart disease we just talked about, the reduction is not even statistically significant . In some studies surrogate endpoints like inflammation or artery thickness are used but a favorable change in surrogate markers does not always translate into clinical benefit. In addition, many studies use composite end points which include not only "hard" end points like heart attack or death (which are pretty hard to misdiagnose) but also "softer" end points like the "need" for revascularization or the occurrence of acute coronary syndromes. For example, studies may be performed in many countries with very different rates of revascularization procedures, making use of this as an end point very problematic.
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