In November of 2009 the Pharmacovigilance Working Party of the European Medicines Agency put out a recommendation that "product information for statins across the EU to include sleep disturbances, memory loss, sexual dysfunction, depression and interstitial lung disease as possible adverse reactions and to advise to stop treatment with statins, should a patient develop interstitial lung disease. The PhVWP informed the CMD(h) accordingly." Has anybody seen or heard of these warnings in the US? The only echo of this I've seen is the Yale University School of Medicine report on statins and interstitial lung disease in the OCT 2008 issue of Chest where it says "Statin-induced ILD is a possible newly recognized side effect of statin therapy. The mechanism of lung injury is not defined." And Merck in its patent applications #4933165, 5082650 and 5316765 of about a decade ago says it is very important to recognize the possibility of statin-induced damage such as cardiac and liver and that this damage could be averted by the pills they have invented -- but they are just sitting on the patents. They spent a lot of time and money developing these pills (which combine a lot of CoQ10 and a little statin) and then haven't ever produced them. Meanwhile, nobody else can produce them either and nobody seems to have heard of Merck's efforts in this direction. Anybody know why?
Patent application #4922165 has to do with cardiomyopathy due to statins; #5316765 belonged to the Karl Folkers Foundation, which apparently is no longer active as of the death of founder Karl Folker, who for a long time worked at Merck and this patent has been disclaimed as to any part of it after Jan 21 2009 (it explains cardiac and liver damage due to statins); and #5082650 belongs to Per Langsjoen (it was taken out by him plus Folker) and discusses treatment with Q10 of lovastatin-induced cardiomyopathy (lovastatin is Mevacor).
A Google search comes up with a long list of patent apps and patents granted having to do with formulations designed to avert, avoid, eliminate, or reverse statin damage - but who would produce them? And the original idea - Q10 treatment - is the only one that seems to have traction, but that of course means two different pills - statin plus Q10 - and not the combination pill Merck talks about having invented.
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