Are negative news stories about statins hazardous to your health?
Some Danish researchers wanted to find an answer to that questions. In a study published online December 2 in the European Heart Journal, Doctors Sune Fallagaard Nielsen and Borge Gronne Nordestgaard examined the Danish Civil Registration System records for data on statin prescriptions, heart attacks, and death from cardiovascular disease, and compared them to the incidence of statin-related news stories in the Danish media, for the period 1995-2010. The researchers found 1,931 news stories, and graded them as either positive (731 stories) neutral (1090 stories) or negative (110 stories).
The researchers looked at all individuals who received their first statin prescription after reaching the age of 40. For each individual, the negative statin-related news exposure during the six months after the first statin prescription was estimated as the weighted sum of all negative statin-related news stories that the individual could have been exposed to; each negative statin-related news story was weighted by the official readership, number of viewers, or number of listeners, for the medium publishing that story, divided by the total number of individuals living in Denmark. The same method was used to estimate exposure to positive or neutral statin-related stories. After controlling for pre-existing cardiovascular disease or diabetes, age, sex, geographical residency, ethnicity, educational levels, and a host of other variables, the researchers concluded that for the period 1995-2010, statin discontinuation due to negative statin-related news stories increased the relative risk of heart attacks by 26% and the risk of cardiovascular death by 18%. In absolute terms, for every 100 Danish statin users, discontinuation due to negative statin-related news stories was judged to have led to two extra heart attacks and one extra cardiovascular death for the fifteen-year period. The authors concluded “These findings suggest a need for protocols aimed at increasing early adherence to statin therapy.” An article in the New York Times was less cautious in its assessment, stating “A Danish study has found that new stories that focus on the risks or adverse events of statin drugs may lead people to stop taking the medicines, and probably contribute to increases in heart attacks and deaths.”
Dr. Nordestgaard, one of the two authors of the paper, is a Clinical Professor of Medical Sciences at the University of Copenhagen. He has accepted consultancy fees and/or lecture honoraria from AstraZeneca, Pfizer, Merck, and Regeneron—all manufacturers of statins. In a telephone interview explained why he did the study. “Whenever there’s a negative story about statins, patients come in and complain. Suddenly they have the side effects they read about, and they want to stop the medication.”
The paper did not look at the rate of non-fatal serious events other than heart attacks, even though in the introduction the authors note that “Initiation of statin therapy may lead to side effects ranging from very rare rhabdomyolysis to less rare and milder symptoms of muscle aches and other forms of discomfort.”
In a telephone interview, Doctor Uffe Ravnskov stated “When you lower cholesterol, you increase the risk of other diseases. Muscle problems are the most common side effect of treatment, but they didn’t look at that.” Uffe Ravnskov is a medical doctor and the author of Ignore the Awkward: How the Cholesterol Myths Are Kept Alive. “I’m also certain that the number of diabetic patients would be lower among those who stopped the treatment, because diabetes is a side effect of statin treatment. That has been shown in many studies.”
The paper also did not look at all-cause mortality, even though two years ago Doctor John Abramson of Harvard University and his colleagues re-analyzed the data from a 2012 meta-analysis by the Cholesterol Treatment Triallists’ Collaboration, and found that statins produced no reduction in all-cause mortality for patients judged to be at low risk for cardiovascular disease. The paper, published November 2013 in BMJ, created a firestorm of controversy. Professor Sir Rory Collins of the CTT demanded a full retraction of the paper, an almost unheard-of sanction. Professor Collins has accepted money from Merck, AstraZeneca, and Pfizer.
And what was the point of contention that led Professor Collins to demand the retraction? The article by Abramson et al. claimed that another study had found that the rate of statin-related side effects was 18-20%, when in fact the reported rate was 17.4%.
BMJ hired two independent statisticians to review the paper by Abramson et al.—a much more thorough examination than the normal peer review process—and found no errors in Dr. Abramson’s analysis of the data. In the end BMJ refused to retract the paper, although they did publish a correction which stated, in part, “The primary finding of Abramson and his colleagues—that the Cholesterol Treatment Trialists’ data failed to show that statins reduced the overall risk of mortality among people with < 20% risk of cardiovascular disease over the next 10 years—was not challenged…”
In a telephone interview, Doctor Barbara Roberts stated “The benefits of statins have been vastly exaggerated and the dangers have been vastly downplayed.” Barbara Roberts is a Clinical Associate Professor of Medicine at Brown University and the author of The Truth About Statins. “All-cause mortality is what you’re really interested in. If you have a drug that lowers your chance of dying of heart disease but increases your risk of dying of something else—that’s not a good thing.”
“We probably could have looked at all-cause mortality,” Dr. Nordestgaard agreed. “What I thought would have meaning for people that are interested in this field was myocardial infarction and cardiovascular death. Those are the two major endpoints that you look for when trying to prevent cardiovascular disease.”
He denied the possibility that all-cause mortality could have been higher among those who adhered to statin treatment. “It’s not like they die from something else. You know, when you do scientific papers, you can look at many different things, but if you try to put it all in one paper then reviewers and readers don’t understand anything of it, so you have to be specific in what you look at. It’s not possible they die of something else, no.”
In conclusion, Dr. Nordestgaard advised “If a patient on statins thinks about stopping his statin, then he should go and see his doctor and discuss it and get a balanced view of what are the positive sides of this medication to prevent heart disease and death, a balance to what might be the potential side effects.”
List of Sources
Patrick D Hahn is an Affiliate Professor of Biology at Loyola University Maryland and a free-lance writer. His writing has also appeared in Biology-Online, Loyola Magazine,Popular Archaeology, Natural News,Canada Free Press, and the Baltimore Sun.
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