Another ENHANCE Panel: Still No Discussion of "Missing" or "Implausible" Data
MedPage Today provides an online video recording of another panel discussion of the ENHANCE study that was held at the recent ACC meeting. The panel was convened "just hours" after the report of the Vytorin-trial results by primary investigator John Kastelein, MD, PhD, on March 30 and the alleged monopoly of a follow-up panel discussion by Yale cardiologist Harlan Krumholz.
In the video recording, Kastelein maligned the day's previous panel discussion, during which a "single individual" conferred a "verdict" on the drug, and no questions were taken from the audience. The day's second, counterpoint panel included not only Kastelein, but also Schering-Plough officers Bob Spiegel, MD, Enrico Veltri, MD, and Tom Musliner, MD, as well as University of Chicago cardiologist Michael Davidson, and the panel was opened for questions from the on-site audience and by phone.
Most of the questions were posed by the media (eg, DocGuide, MedPage Today, ABC News, CBS News) and were disappointingly fixated on previously covered issues, such as the validity of cholesterol lowering as a surrogate marker for atherosclerosis reduction.* Only one questioner, from CBS News, requested more information regarding the delayed release of the trial results (and therefore, alluded to the missing or implausible data). Kastelein fielded the question and gave a passing reference to "data cleaning" during his explanation; however, no other direct explanation of the reasons for or manner of data handling were discussed.
*The panel consensus is that, according to the overwhelming bulk of the data, the lowering of total and LDL cholesterol levels are associated with the significant reduction of atherosclerosis and atherosclerosis-related events.
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The irony of the ENHANCE trial results is that the answer from the experts is "high dose statins". Have physicians forgotten the biochemistry of cholesterol? Did anyone ever learn the mevalonate pathway, and the consequences of blocking this essential biological pathway? Blocking production of: 1. isoprenylated proteins, which have (a)primary roles in membrane attachment and protein functionality.(b)isoprenylated protein blocking leads to interference with production of small G protein superfamily . (c) interference with production of glutathione reductase (recall major antioxidant system for brain); (d) interference with production of selenoprotein and its functions. 2. Statins interfere with production of dolichol, necessary for(a) neuropeptide formation,(b) cellular immunity and glycoprotein production (recall Insulin-like growth factor and the myraid of functions performed by that substance?) (c) Dolichol production is necessary for glycohydrolases, necessary for DNA repair. 3. Statins interfere with production of coenzyme Q10--thus affecting (a)mt function and (b)the anti-oxidative stress aspects of this substance. Lest one forget, cholesterol is: 4. the precursor for all steroid hormones.
Just what was the NNT for statins for primary prevention??? and what is the NNT for secondary prevention in middle aged males? elderly males? females?