In a letter-brief filed with the court just yesterday, Ezra D. Rosenberg, of Dechert LLP (Schering's law-firm in Polk, one of the most-important ENHANCE-related putative class actions -- the sales practices and marketing action, Case No. 08-cv-285) urges Judge Cavanaugh to mis-read the FDA's updated safety announcement on Vytorin/Zetia -- as an efficiacy announcement.
Dechert suggests, entirely-erroneously, in its brief before Judge Cavanaugh, that the FDA SAFETY Announcement affirms Vyorin's efficacy. It does no such thing, and I strongly suspect Judge Cavanaugh will sniff this out, immediately. Take a look at the title of the FDA document at issue: "FDA Issues Update to Safety Review on Cholesterol-Lowering Drugs". Safety -- safety -- safety, not efficacy. Sheesh; really.
Dechert goes on to quote this portion of the FDA Announcement (but simply omit the title of the document):
. . . .Preliminary results from ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) had indicated there was no significant difference between Vytorin and Zocor-treated patients in the thickness of the walls of the blood vessels of the neck (the carotid arteries) although there was greater lowering of the amount of LDL cholesterol in patients with Vytorin compared to Zocor.
Measuring the thickness of the carotid arteries via ultrasound imaging is considered a biomarker of risk for cardiovascular disease.
FDA has now completed its review of the final clinical trial report of ENHANCE. After two years of treatment, there was no significant difference in carotid artery thickness between Vytorin patients and Zocor patients. However, the levels of LDL cholesterol, decreased by 56% in the Vytorin group and decreased by 39% in the Zocor group. . . .
That is precisely the opposite of an efficacy finding. All FDA said was that Vytorin was not definitively unsafe. [Full Dechert letter-brief-filing here, as a PDF file.]
Mechanism of action will prove to be everything, here.
I guess Dechert only listened to the less-well-informed members of the fourth-estate (and the spin-meisters in Kenilworth).
Dechert goes on to make thinly-veiled preemption noises, using the FDA Announcement as fodder, but those seem unavailing, given the firm's misreading of the actual purpose of the FDA's statement last week.
This is, honestly, sort of surprising. Are there no ex-scientists among the lawyers at Dechert? Wild.