Earlier this week the United States’ Food & Drug Administration (FDA) updated the information it provides to doctors and patients about the safety of statins, the cholesterol-lowering drugs used by millions of people worldwide for the prevention of heart disease and stroke.
The main new additions concern some rare reports of entirely reversible memory loss and other reports of small increases in blood sugar levels among some people taking statins.
In The Sydney Morning Herald’s leading article on March 1, the first sentence states that as a consequence of these developments: “Thousands of Australians could be taken off cholesterol-lowering medications because of mounting evidence that they increase the risk of diabetes and dementia.”
However, the report from the FDA specifically emphasises that the reports of reversible memory loss “did not appear to be associated with fixed or progressive dementia, such as Alzheimer’s disease”. It also states that these reports “did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline”.
The SMH article has, as a consequence, misinformed its readership and, as a result, may well cause some readers to stop taking medication that would otherwise have prevented them having a heart attack, stroke or early death. This is no small mistake.
The other concern noted in the FDA update relates to reports of small increases in haemoglobin A1c, which is an indicator of blood sugar control among people with diabetes.
However, this has not been a universal finding with some very large randomised trials demonstrating no effect of statins whatsoever on blood sugar levels. Additionally, the same studies have shown that statins can improve kidney function, which is one of the principal goals of good blood sugar control.
Most importantly, however, there is now unequivocal evidence that treatment with statins among people with diabetes reduces their risk of heart attack, stroke and the need for coronary revascularisation (either bypass surgery of stenting). These benefits vastly outweigh any small increase in blood sugar levels, should such effects actually be proven to exist.
This episode draws into sharp focus the difficulties faced in providing consumers with balanced reliable information about the effects of drugs on health.
Most drugs have some side effects that will affect some patients. However, the risks of such side effects have to be considered in the context of the benefits that are likely to be gained.
Balancing potential benefits and risks is a challenge for doctors and patients: these can be literally life-and-death decisions, and exaggerated media reports about drug effects does not make this any easier.
While it might be a way to increase newspaper circulation and advertising, if the result is the inappropriate termination of life-saving treatment for even a few, there is a serious need to question the nature of these stories and their possible consequences.
*Stephen MacMahon is the James Martin professor of medicine, University of Oxford, professor of cardiovascular medicine, University of Sydney and principal director, The George Institute for Global Health. Declaration: The George is involved in NHMRC-funded research on a low-cost “polypill” for the prevention of cardiovascular disease in resource-constrained environments.