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The International Network of Cholesterol Skeptics
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Letter to the editor of Lancet submitted on November 25, 2007 by Paulm Rosch.
Read also the editor´s answer below and Paul Rosch´  comments.

Statin Safety
Sir - In her review of statin safety (Nov 24), Jane Armitage noted an increase in adverse effects with "use of higher doses and interacting drugs".  Duration of treatment also increases the frequency and severity of complications.  However, the goal of statin therapy to lower LDL below 100 mg/dl (and 70mg/dl for some patients) is difficult to achieve, which mandates taking higher and higher doses for longer periods, if not perpetually.   

This is irresponsible and dangerous since the success of statins shows no relationship to such LDL levels or how much LDL is lowered.¹  In the CARE and WOSCOPS trials, no clinical benefit was observed in patients with an LDL below 125 mg/dL² or a greater than 24% decrease in LDL.³  All statins are carcinogenic in laboratory animals at doses equivalent to those used clinically.¹  Cancer can take decades to surface but a significant increase in malignancies apt to be detected early has already been reported, such as skin cancer in the first two simvastatin studies and breast cancer in the CARE and PROSPER trials.   

Armitage makes no reference to these or other well-documented statin complications, including cognitive defects, amnesia, heart failure, and peripheral polyneuropathy.4 Since over 90 percent of significant drug side effects are not reported and statin complaints are usually ignored by physicians, the frequency and seriousness of adverse reactions to statins is undoubtedly much greater than appreciated.  Markers of inflammation like CRP might be preferable to monitor statin therapy, especially since their reduction does not correlate with LDL lowering.5

 References 
1. Alsheikh-Ali AA, Maddukuri PV, Han H, Karas RH.  Effect of the Magnitude of Lipid Lowering on Risk of Elevated Liver Enzymes, Rhabdomyolysis, and Cancer Insights From Large Randomized Statin Trials.  J Am Coll Cardiol 2007;50(5):409-418.
2. Sacks FM, Moyé LA, Davis BR, et al. Relationship between plasma LDL concentrations during treatment with pravastatin and recurrent coronary events in the Cholesterol and Recurrent Events trial. Circulation 1998;97:1446–1452.
3. West of Scotland Coronary Prevention Study Group. Influence of pravastatin and plasma lipids on clinical events in the West of Scotland Coronary Prevention Study (WOSCOPS). Circulation 1998; 97:1440–1445.
4. Ravnskov U, Rosch PJ, Sutter MC, Houston MC. Should we lower cholesterol as much as possible? BMJ 2006;332:1330-1332. 
5. Rosch PJ. Determining Optimal Statin Dosage. Mayo Clin Proc 2003;78:379-380.

 Here is the answer from the editor (Paul Rosch´  comments in bold)

Dear Dr Rosch,
Thank you for submitting your letter. After in-house review, I'm afraid we have decided not to accept it for publication. We regret that we are unable to write a personal note for every letter we turn down, but the following common reasons for rejection may help you with future submissions: lateness (ie, more than 2 weeks after publication of the article on which you are commenting) (the letter was sent within 2 weeks), inclusion of original research (the section is not peer reviewed, so we cannot publish such work here) (no original work was included in the letter), submission of case reports (we have a separate section for these)(it is not a case report), reiteration of points made by another correspondent (no other correspondent has responded, and inappropriate length (limits are 250 words and 5 references) (the letter has 250 words and 5 references). If none of these apply to your letter, please be assured that we have nevertheless considered it carefully and probably had to refuse it because we have simply received too much good material (No letters commenting Armitage´s review have been published).
Yours sincerely

Zoë Mullan
Senior Editor

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