Comments on: Vytorin Is Unlikely To Cause Cancer: FDA http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/ News, Comment and Conversation Fri, 10 Feb 2012 16:20:41 +0000 http://wordpress.org/?v=2.6.2 By: patrons99 http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/#comment-454502 patrons99 Sun, 27 Dec 2009 23:28:20 +0000 http://www.pharmalot.com/?p=20592#comment-454502 Cholesterol is the precursor for all of the steroid (mineralocorticoids, glucocorticoids, sex hormones) hormones, vitamin D, and a number of metabolically important cofactors, e.g. Coenzyme Q10 (ubiquinone). Vitamin D3 is actually a hormone whose biologic effects are ubiquitous, not just a vitamin. Hence, the statins as potent inhibitors of not just cholesterol biosynthesis, have far reaching pleiotropic effects. So, given the length of time in the marketplace, and given the number of patients on statins, along with often a dozen or so additional pharmaceuticals, should it really come as any surprise that safety concerns are now appearing. Perhaps, in retrospect, we should have seen them coming. Cholesterol is the precursor for all of the steroid (mineralocorticoids, glucocorticoids, sex hormones) hormones, vitamin D, and a number of metabolically important cofactors, e.g. Coenzyme Q10 (ubiquinone). Vitamin D3 is actually a hormone whose biologic effects are ubiquitous, not just a vitamin. Hence, the statins as potent inhibitors of not just cholesterol biosynthesis, have far reaching pleiotropic effects.

So, given the length of time in the marketplace, and given the number of patients on statins, along with often a dozen or so additional pharmaceuticals, should it really come as any surprise that safety concerns are now appearing. Perhaps, in retrospect, we should have seen them coming.

]]> By: riv http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/#comment-453331 riv Wed, 23 Dec 2009 18:32:10 +0000 http://www.pharmalot.com/?p=20592#comment-453331 What do you mean Peto has been vindicated. He's still got the data buried under his wine cellar. Hehehe. "Currently available information". Right-o Bob. (Sorry Ed. I shouldn't post when streaming music.) It glitched and posted before I was done. What do you mean Peto has been vindicated. He’s still got the data buried under his wine cellar.

Hehehe. “Currently available information”. Right-o Bob.

(Sorry Ed. I shouldn’t post when streaming music.) It glitched and posted before I was done.

]]> By: pharmavet http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/#comment-453303 pharmavet Wed, 23 Dec 2009 17:04:48 +0000 http://www.pharmalot.com/?p=20592#comment-453303 Anon, that is why we have something called p-values. Anon, that is why we have something called p-values.

]]> By: Anon http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/#comment-453107 Anon Wed, 23 Dec 2009 03:00:40 +0000 http://www.pharmalot.com/?p=20592#comment-453107 To paraphrase Bob Temple, ex-FDA Director of Medical Policy, failure to prove something doesn't mean it doesn't occur. To paraphrase Bob Temple, ex-FDA Director of Medical Policy, failure to prove something doesn’t mean it doesn’t occur.

]]> By: pharmavet http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/#comment-453090 pharmavet Wed, 23 Dec 2009 01:29:37 +0000 http://www.pharmalot.com/?p=20592#comment-453090 Sir Richard Peto has been vindicated. No surprise. He's the best statistician in the world. Sir Richard Peto has been vindicated. No surprise. He’s the best statistician in the world.

]]> By: Condor http://www.pharmalot.com/2009/12/vytorin-is-unlikely-to-cause-cancer-fda/#comment-453039 Condor Tue, 22 Dec 2009 21:12:01 +0000 http://www.pharmalot.com/?p=20592#comment-453039 Good pick-up, here Ed. . . . The FDA pronouncement -- while nominally "<i>good news</i>" -- will <b>also</b> <a href="http://shearlingsplowed.blogspot.com/2009/12/fda-at-least-vytorin-doesnt-appear-to.html" rel="nofollow">remind many stock anaylsts (yet again!) of the link seen in SEAS</a> -- that is, the increased incidence of cancers, for people on Vytorin, vis-a-vis a placebo.Now, true-enough, FDA is saying that the SEAS cancer link does <strong><em>not</em></strong> appear, at <strong><em>this</em></strong> time, to be a <em>cause-effect </em>link. However, if the "<i>new</i>" talking point on Vytorin is something like "<em>Gee, at least we don't THINK it causes your cancer risk to rise, in pursuit of lower cholesterol levels</em>. . ." Well. . . . New Merck is going to have an even tougher time -- on reversing the scrip-writing trends away from Vytorin -- compared to Crestor, Niaspan or Lipitor. None of those ever showed a cancer signal. And each of those cholesterol control drugs sport outcomes data; Vytorin sports none. So, it seems like Vytorin <i>may</i> not hang around long enough to see the 2014 or so finish of IMPROVE-IT. [Study size juiced to 18,000 -- as an event-driven study, it may never reach enough events to define a properly powered study outcome.] Namaste Good pick-up, here Ed. . . .

The FDA pronouncement — while nominally “good news” — will also remind many stock anaylsts (yet again!) of the link seen in SEAS — that is, the increased incidence of cancers, for people on Vytorin, vis-a-vis a placebo.Now, true-enough, FDA is saying that the SEAS cancer link does not appear, at this time, to be a cause-effect link. However, if the “new” talking point on Vytorin is something like “Gee, at least we don’t THINK it causes your cancer risk to rise, in pursuit of lower cholesterol levels. . .”

Well. . . . New Merck is going to have an even tougher time — on reversing the scrip-writing trends away from Vytorin — compared to Crestor, Niaspan or Lipitor. None of those ever showed a cancer signal.

And each of those cholesterol control drugs sport outcomes data; Vytorin sports none.

So, it seems like Vytorin may not hang around long enough to see the 2014 or so finish of IMPROVE-IT. [Study size juiced to 18,000 -- as an event-driven study, it may never reach enough events to define a properly powered study outcome.]

Namaste

]]>