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Wednesday, December 20, 2006 9:29:09 PM
[0006] Accordingly, in one embodiment, the present invention relates to a method for inferring a muscle adverse effect statin response of a human subject from a nucleic acid sample of the subject. Such a method can be performed, for example, by identifying, in a nucleic acid sample from the subject, a nucleotide occurrence of at least one statin response-related SNP of a marker as set forth in any of Tables 1, 2, 4, 5, or a combination thereof, whereby the nucleotide occurrence is associated with a muscle adverse effect in response to administration of the statin, thereby inferring the muscle adverse effect statin response of the subject...
My impression is that the followup study they refer to in the PR was conducted to confirm their ability to infer response from a single key biomarker. It doesn't necessarily follow, however, that a classifier could not further refine the sensitivity of the test or that the single variant wouldn't be incorporated into a broader, more sensitive test. Indeed, according to the patent we have the following:
[0115] The SNPs identified above were used to make classifications of patients receiving Lipitor®. Genotypes were determined from a sample (e.g. blood) from patients suffering muscle adverse effects (case) and from patients not suffering muscle adverse effects (controls). Genotypes were selected for which the prevalence between cases and controls was more extreme than 63%:37%, or 37%:63% (giving a risk of non-response in terms of classification theory of about 3). As shown in Table 3, the results demonstrated that a Lipitor® patient could be classified into the non-adverse response (muscle reaction) group with 96% accuracy, and that 98% of the cases (individuals who exhibited muscle reactions) were properly classified...
For anyone interested, this would appear to be the patent in question:
(WO/2006/053322) COMPOSITIONS AND METHODS FOR INFERRING AN ADVERSE EFFECT IN RESPONSE TO A DRUG TREATMENT
http://www.wipo.int/pctdb/en/fetch.jsp?LANG=ENG&DBSELECT=PCT&SERVER_TYPE=19&SORT=1171397...
And BTW, while the incidence of myopathy has been reported as high as 5%, the number of patients that suffer at least mild ADR's may be significantly higher:
An "adverse statin response" is any negative response to statins, particularly a muscle adverse response such as a myopathy, rhabdomyolysis, and the like. Methods for identifying a muscle adverse effect are well known and include, for example, measuring creatine kinase, wherein increased levels above normal are indicative of adverse response to statins. About 20% of patients who take statins complain of muscle ache, and elevated creatine kinase levels are indicative of myalgia (muscle injury).
If I were you guys, I'd give all that math a rest until I really knew what I was talking about. I recognize that in your case Frog, that's never stopped you before and is not likely to now. But you ought to think about exercising a little better restraint in the future. Afterall, you only have two feet and I think you already swallowed one.
BTW, is it true? Do Frog legs really taste like chicken? LOL
Later,
W2P
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