tag:blogger.com,1999:blog-4241416962008169508.post7902096769449614378..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: Dechert LLP Misconstrues Recent ENHANCE FDA "SAFETY" Update, Before Judge CavanaughUnknownnoreply@blogger.comBlogger6125tag:blogger.com,1999:blog-4241416962008169508.post-70815143044923190572009-01-19T15:00:00.000-05:002009-01-19T15:00:00.000-05:00As Bob Temple said ENHANCE is not an event trial c...As Bob Temple said ENHANCE is not an event trial come back later. CIMT means nothing from efficacy, yes LDL prevents CV events but ENHANCE is meaningless.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-38581588847404542922009-01-15T10:06:00.000-05:002009-01-15T10:06:00.000-05:00Again, Nathan (I presume) --This is now about what...Again, Nathan (I presume) --<BR/><BR/>This is now about what will be evidence in a federal court.<BR/><BR/>The latest FDA Announcement was, by its terms, about declaring Zetia/Vytorin "<I>not unsafe</I>".<BR/><BR/>Dechert's touting it as evidence of <B>efficacy</B>, in a court of law, has "<I>opened the door</I>" -- to allow the plaintiffs to counter that notion -- and prominently highlight the <A HREF="http://shearlingsplowed.blogspot.com/2008/04/fda-letter-re-vytorin-please-revise.html" REL="nofollow">FDA's earlier formal letter</A> characterizing Schering's Vytorin ads as "<I>misleading" and "deceptive</I>" -- given the ENHANCE results.<BR/><BR/>One of the central claims of the <I>Polk</I> putative class action suit alleges the ads were false, and thus "<I>deceptive</I>".<BR/><BR/>It seems that the FDA agrees.<BR/><BR/>Net result? Not good for Schering -- in a court of law.<BR/><BR/>NamasteAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-22978234280877747242009-01-14T18:18:00.000-05:002009-01-14T18:18:00.000-05:00Oh, but the FDA statement IS all about the efficac...Oh, but the FDA statement IS all about the efficacy. I saw precious little regarding actual safety.<BR/><BR/>The FDA says lowering LDL corresponds to lowering the relative risk of cardiovascular events. What did Vytorin (Zocor and Zetia in one pill) do in the ENHANCE study? Lower LDL 56% when Zocor alone lowered LDL only 39%. I believe this would amply satisfy that hankering for efficacy, or effectiveness, yes?<BR/><BR/>The (end)point of this study was not to count MIs, CVAs, CABGs, or corpses. It was about changes in plaques and lipid parameters in patients who had an LDL (not Total Cholesterol but LDL) above 300mg/dL. <BR/><BR/>When it comes to plaque in these patients, neither treatment seemed to work so well. But for lowering LDL, the numbers suggest that two drugs are better than one.<BR/><BR/>So, the FDA says lower cholesterol is better but they have yet to determine if how that mission is accomplished really matters. I guess we will see if they take a stand on that issue when they finish sifting through the epidemiological data from the SEAS trial.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-84624852001213893482009-01-14T10:14:00.000-05:002009-01-14T10:14:00.000-05:00Nathan -- Welocme back!I do think your observation...Nathan -- Welocme back!<BR/><BR/>I do think your observations are generally valid -- but in the context of presenting what will amount to evidence in federal court, it is my opinion that it was unwise for Dechert to cast an FDA SAFETY update as an endorsement of the drug's EFFICACY.<BR/><BR/>FDA plainly did NOT say that the mechanism of action -- the gut mechanism employed by Zetia/Vytorin -- improves CV risk outcomes.<BR/><BR/>But that is what the Schering ads CLAIMED, up until January of 2008. And that is one of the central claims of the <I>Polk</I> suit. The Ad was deceptive -- and Schering knew it.<BR/><BR/>I think this overly-aggressive style of legal grandstanding will not serve the Schering shareholders well, in the longer run.<BR/><BR/>The judge will see through it -- it seems a rather ham-handed, cheesey tactic.<BR/><BR/>Perhaps "Okay", on the very margin, for ad copy (pre-January 2008) -- not at all PROBATIVE, as a legal defense, in a court of law -- in January 2009.<BR/><BR/>NamasteAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-62945200280844596512009-01-14T09:30:00.000-05:002009-01-14T09:30:00.000-05:00The "efficacy" on which Vytorin is approved and re...The "efficacy" on which Vytorin is approved and reccommended is cholesterol reduction. In that sense, the "efficacy" of Vytorin was actually reaffirmed by the ENHANCE trial. The FDA has no reason to doubt the efficacy of Vytorin. What they *DO* have reason to doubt is whether or not cholesterol reduction (by itself) is really a valid "efficacy" that we should be aiming for. Thier safety statement re-affirms that (for now) the FDA believes that cholesterol reduction is benificial even without proof of "clinical benifit". (ie reduction of heart attacks, mortality, etc)Nathanhttps://www.blogger.com/profile/04127385507871380774noreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-63947484156508505172009-01-14T06:57:00.000-05:002009-01-14T06:57:00.000-05:00Condor, your logic is a bit flawed. Re-read the F...Condor, your logic is a bit flawed. Re-read the FDA statement. It urges patients to NOT STOP taking Vytorin without talking to thier doctor. The FDA isn't in the buisness of encouraging drug use just because the drug is safe. So what? If drug must be safe AND have reasonable evidence of efficacy. The fact that the FDA does not want to people to discontinue use is an implicit affirmation of its efficacy. (or at least an implicit affirmation of the biomarker being utilized for efficacy - cholesterol levels) <BR/><BR/>Here's the FDA statement: "Based on currently available data, patients should not stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health care professional if they have any questions about Vytorin, Zetia or the ENHANCE trial."Nathanhttps://www.blogger.com/profile/04127385507871380774noreply@blogger.com