In my Apr. 23, 2016 blog I wrote about Statins & Muscle Pain and described how the drug industry tries to cover up the muscle pain side effects of statins. In June 2017 The Lancet published “Statin-associated muscle symptoms: beware of the nocebo effect.” This is a study that actually denies that statins have side effects and “scientifically proves” that it’s all in the patient’s head! They reference the Nocebo effect, which is the opposite of the Placebo affect. It’s the most condescending attitude toward patients that I’ve witnessed in recent years.
The article was funded by a manufacturer of atorvastatin and reanalyzed data from a previous study (Lancet 2003; 361:1149). The preamble to the article admits that “patient-reported statin intolerance, predominantly due to statin-associated muscle symptoms (SMS) is a common and difficult-to-manage condition affecting millions of patients worldwide.” It is reported in about one fifth of patients. We don’t know how many patients just put up with the side effects and don’t complain. The researchers hired by the makers of the statin drugs say that “the development of SMS does not necessarily signify statin intolerance since statin therapy might not always be pharmacologically involved.”
Drug trials are strange beasts in or of themselves. What about the Hawthorne Effect (AKA the observer effect) in which individuals modify an aspect of their behavior in response to their awareness of being observed. We take that effect and divide humans into two camps – those who like to complain and those who don’t. Couldn’t the Hawthorne Effect explain the results of this study? To me this effect, and the fact that studies are manipulated to get the results that drug companies want, make them almost useless.
Another Lancet study, Mar. 18, 2017 called Safety and Efficacy of Statins describes how the actual occurrence of muscle pain in patients on statins is derived. They subtract the number of patients who report pain on the placebo from patients who report pain on the statins! Does that make any sense at all?
Add to this murky soup a paper in Expert Rev Clin Pharmacol March 2015 called “How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease.”
Here is the abstract of this 2015 paper:
We have provided a critical assessment of research on the reduction of cholesterol levels by statin treatment to reduce cardiovascular disease. Our opinion is that although statins are effective at reducing cholesterol levels, they have failed to substantially improve cardiovascular outcomes. We have described the deceptive approach statin advocates have deployed to create the appearance that cholesterol reduction results in an impressive reduction in cardiovascular disease outcomes through their use of a statistical tool called relative risk reduction (RRR), a method which amplifies the trivial beneficial effects of statins. We have also described how the directors of the clinical trials have succeeded in minimizing the significance of the numerous adverse effects of statin treatment.
In spite of the facts in the above abstract, the pro-statin camp thinks statins are so wonderful that we should just put them in our drinking water and not tell anyone about the potential dangers because then people will just imagine they are having side effects! For the anti-statin view, I tell people to read an insightful and witty critique of the statin industry in Dr. Malcolm Kendrick’s book, The Great Cholesterol Con.
In my blog Cholesterol is Not Your Enemy I remind readers that doctors “want to blame heart disease on something and cholesterol does seem convenient.” To try and convince patients that cholesterol is bad, when it’s not, is one thing. But when they are forced to take a drug that has side effects and they are told that any side effects are all in their heads, that’s Draconian.
What do I recommend? Magnesium of course. For years I’ve talked about one of the functions of magnesium – its ability to lower cholesterol. Here is an edited abstract from the J.Am.Coll.Nutr. 2004 Oct;23(5):501S-505S, by Rosanoff and Seelig:
Mg(2+)-ATP is the controlling factor for the rate-limiting enzyme in cholesterol biosynthesis. Formation of cholesterol in blood, as well as of cholesterol required in hormone synthesis, and membrane maintenance, is achieved in a series of enzymatic reactions that convert HMG-CoA to cholesterol. The enzyme that deactivates HMG-CoA Reductase requires Mg, making Mg a Reductase controller rather than inhibitor. Mg is also necessary for the activity of lecithin cholesterol acyl transferase (LCAT), which lowers LDL-C and triglyceride levels and raises HDL-C levels. Desaturase is another Mg-dependent enzyme involved in lipid metabolism. Desaturase catalyzes the first step in conversion of essential fatty acids (omega-3 linoleic acid and omega-6 linolenic acid) into prostaglandins, important in cardiovascular and overall health.
Carolyn Dean MD ND
The Doctor of the Future®
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