Cancer and statin treatment
Skeptics and others
The results from the recent HPS trial together with those from the 4S trial show without
any reasonably doubt that the statins, or at at least simvastatin, is carcinogenic, see
letter from members of our group on
http://bmj.com/cgi/eletters?lookup=by_date&days=1#26439 The letter is available here
the next 24 hours. After that, go to http://bmj.com/ and click on Rapid Response and
search for the correct date (22/10).
A month ago we sent a more elaborate version of the text to Lancet, where the HPS report
was published, but it was rejected by the editor. Unless someone else has sent a similar
paper this decision is most surprising considering the tremendous public health
implications. We think that our observation and calculation should be told to the public
as soon as possible, so do what you can to disseminate the message.
Uffe Ravnskov
Copy of item referred to above at: http://bmj.com/cgi/eletters?lookup=by_date&days=1#26439
Statins and Cancer: Cause for concern
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.