Statins And Cancer: Cause For Concern

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http://bmj.com/cgi/eletters/323/7322/1145#26439

 

Statins And Cancer: Cause For Concern

 

Uffe Ravnskov

Magle Stora Kyrkogata 9, S-22350 Lund, Sweden,

Paul J. Rosch, Peter H.Langsjoen, Joel M. Kauffman, and Kilmer S. McCully

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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 treatment group vs. six in the

control group).3 If the results from both simvastatin trials are calculated

together, non-melanoma skin cancer occurred significantly more often after

simvastatin (p=0.028).

Also 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.

 

 

 

 

 

 

 

 

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