We are questioning the wisdom of recommending statin treatment for a large segment of the world’s population simply because they have elevated lipid levels or are assumed to be at increased risk for coronary events because of the presence of other risk markers. Even using the outcome in the Heart Protection Study (HPS)1 with the most optimistic figures (?Any major vascular event?), the number of individuals who benefited from treatment did not exceed 5.4%, a figure that included many events with minor or no future health consequences. Such small treatment rewards demand a careful analysis of the potential risks.

It is already known that statins may induce fatal rhabdomyolysis, cardiac insufficiency, peripheral polyneuropathy, hepatic toxicity, and mental disturbances. A much more momentous issue is that all statins have proven carcinogenic in laboratory animals using blood concentrations that approximated those achieved in clinical practice.2 While no significant increased incidence of cancer was reported in HPS, we believe that an important aspect of this potentially serious problem has been overlooked.

There is often a considerable lag between the time a cancer starts in an internal organ and its clinical diagnosis. Lung cancer for instance, is not commonly detected until after five years or more of smoking. In contrast, cancers of the skin are diagnosed early in their development and might therefore be the first type of malignancy observed as a result of exposure to a carcinogenic drug. It is therefore troubling that in HPS, non-melanoma skin cancer was seen in 243 patients treated with simvastatin compared with 202 cases in the control group.1 This difference was not statistically significant (p=0.06), but non-melanoma skin cancer was seen more often in the first simvastatin trial as well (13 cases in the treatmeRAlso disquieting was the significant increase in the CARE trial of breast cancer, another readily detectable malignancy.4 These cases occurred in women who had been treated previously for breast cancer. Although breast cancer was not seen more frequently in HPS, subjects with a history of malignancy were excluded from the study, omitting those who would have been at greatest risk for statin-related cancers.

1. Heart Protection Study Collaborative Group. MRC/BHF heart protection study of cholesterol lowering in 20 536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7-22.

2. Newman TB, Hulley SB. Carcinogenicity of lipid-lowering drugs. JAMA 1996; 275: 55-60

3. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344:1383-1389.

4. Sacks FM, Pfeffer MA, Moye LA, et al. for the Cholesterol and Recurrent Events Trial investigators. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med 1996; 335: 1001-1009.

OCTOBER 23, 2002

A “SECOND OPINION” EXTRA: Statins To Reduce Cholesterol – The Cancer Connection

Yesterday, the British Medical Journal (BMJ) published an important letter from scientists who have been keeping a close watch on the widespread – and growing – use of statin drugs. These are the cholesterol-fighting pills that are being recommended worldwide, often only because someone has elevated cholesterol or is thought to be at risk for heart disease. The letter in BMJ explores the possible cancer-statin link.

The media has played a huge role in promoting these drugs as though they offer huge benefits to millions of people. This is simply not true. The evidence speaks otherwise. Any careful analysis of the science surrounding statins will reveal that the rewards for taking these drugs are often slim and the risks appear to be on the increase as more research is conducted by scientists who have not glued themselves to the money machines of drug companies.

We have made it very clear at redflagsweekly.com that statins are also known to deplete a vital nutrient in the body called CoEnzyme Q10. You may want to read more about this in the RFW Report no. 3 which provides an up-to-date assessment of the science on CoEnzyme Q10 and how this nutrient may play an important role in the treatment of a wide range of illnesses.

-Nicholas Regush