Sanctimony About Vytorin's "Secret" Panel

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  • 01/17/2008
The increasingly insufferable Roy Poses pontificates again and again and again about how everyone who is a consultant to drug companies cannot be trusted. To point out how zealotry should not be confused with objectivity let us go through the following exercise using the deflation of the self-impressed Dr. Poses as an example, with giving him the platform: " pretending a panel is independent, when potential or perceived conflicts may exist, is misleading. This only casts more doubt on the willingness of these two drugmakers to let the facts speak for themselves - and not spin or cloak info that should be fully vetted."

So by definition, any financial tie is a conflict or perceived conflict which transmutes into faulty or inaccurate data which cannot be trusted which in turn transforms into a drug that should not be taken. Which is why people should stop taking SSRIs, Avandia, Vytorin,

Now I guess that should also apply to Zocor, the forerunner of simvastatin, the generic version of Zocor, especially if we have a negative risk to benefit result of that drug right? This in keeping with the other Poses or Pharmalot principle that disclosure of all negative trial result are to the public good.

So here is a negative trial reported in JAMA in 2004 on Zocor

he myopathy rate of the 80-mg/d dose of simvastatin observed in the A to Z trial and the previously reported meta-analysis are not particularly surprising. For many years following its introduction, the maximum dose of simvastatin approved by the Food and Drug Administration (FDA) was 40 mg/d. However, in 1997 the manufacturer undertook a development program to study 2 higher doses of simvastatin (80 mg/d and 160 mg/d).8, 19-20 Although a favorable report appeared in the medical literature,20 development of the 160-mg/d dose was abandoned due to high muscle toxicity.8, 19 Although never reported in the scientific literature, the financial community was informed that the rate of muscle-related symptoms was 5.7% for the 160 mg/d dose.19 The dose of 80 mg/d of simvastatin was eventually approved, but in 2002, the FDA product label was modified to include warnings about concomitant medications than inhibit cytochrome P450 3A4, the major metabolic pathway for simvastatin elimination.21 This warning was provoked by cases of rhabdomyolysis when simvastatin was administered with 3A4 inhibitors.21"
It is important to reassure practicing physicians and patients that the unfavorable risk-benefit relationship observed in the A to Z trial does not in any way diminish the value of intensive statin treatment in secondary prevention, including ACS patients. There was a trend toward reduced events in the A to Z trial, a finding that supports the lower is better concept. The increased myopathy rate applies only to a specific dose of a single agent and should not tarnish this remarkable class of drugs.24 It must also be emphasized that simvastatin in doses of up to 40 mg/d has shown excellent safety and efficacy in a series of clinical trials. For now, though, the 80-mg/d dose of simvastatin should be used with caution, particularly because other effective agents are available. Finally, in an era when criticism of selective reporting of positive trial results is common,25 the A to Z investigators are to be commended for their prompt and thorough reporting of a critically important major trial that did not meet its original objectives."

Ok, so we know that high dose simvastatin, the same dose compared in the ENHANCE trial carries risks. But we are reassured that other agents are available and that the 80mg can be used with caution.

Now, the person who wrote that editorial on the A to Z study was a paid consultant to Merck.

Steve Nissen. Who was a consultant to Merck, Astra Zeneca, Pfizer, Sankyo, Sanofi, Eli Lilly, Takeda, Novo Nordisk, Atherogenics, Lipid Sciences, GlaxoSmithKline, Hoffman LaRoche, Kos, and Wyeth. Dr Nissen also has directed clinical trials in collaboration with Astra Zeneca, Pfizer, Sankyo, Eli Lilly, Takeda, Atherogenics, and Lipid Sciences.

The same person now trashing Vytorin.

Sorry to beat the same drug over and over again but the bloggers and MSM keep referring to the same sources as well. Their views are biased and dangerous. I trust the doctors and researchers drug companies pay as advisors ten times more than then the second guessers who would discourage patients from taking drugs because of a built in bias against perceived financial conflicts without even looking at street creds or expertise. That is prejudice, plain and simple. And at a fundamental level it suggests that anyone who consults for drug companies is a prostitute and endangers the public health.

That's not independence or objectivity. That's intellectual thuggery.

He claims the Vytorin results are doctored

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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