Vytorin Is Unlikely To Cause Cancer: FDA
6 CommentsBy Ed Silverman // December 22nd, 2009 // 1:54 pm
A link, however, can’t be ruled out. Although this leaves something of a question mark hovering over the controversial cholesterol drug, the agency says it reviewed data on Vytorin and Zetia from the SEAS trial, along with interim findings from two large, ongoing studies - SHARP and IMPROVE-IT.
“Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out,” the agency said. The ongoing studies will provide more data to assess cancer risk when they are completed, but results won’t be known for awhile: the SHARP trial is expected to conclude in 2010 and IMPROVE-IT in 2012.
You may recall that the results of the SEAS trial in September 2008 found a total of 105 cancer cases among Vytorin patients compared with 70 taking a placebo. That was an upward revision from the rates of 93 and 65 reported from preliminary findings reported two months earlier (see here and here). The findings, which followed a scandal over the release of a different clinical trial known as Enhance, contributed to plummeting sales last year.
However, Leerink Swann analyst Seamus Fernandez tells Reuters the FDA statement was positive though expected. The cancer issue “was an overhang for the stock, so getting it out of the way as a potential concern is a positive. It’s good from the perspective of eliminating an investor overhang,” he says. “You’re never going to really truly be able to state definitively that there isn’t a cancer risk. In fact, FDA wasn’t truly definitively able to say there wasn’t a cancer risk with the use of statins (cholesterol drugs) for about ten years.”
Merck spokesman Ron Rogers tells Reuters the drugmaker is “pleased by the conclusions reached by the FDA review” of the trial.
Condor
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
pharmavet
Sir Richard Peto has been vindicated. No surprise. He’s the best statistician in the world.
Anon
To paraphrase Bob Temple, ex-FDA Director of Medical Policy, failure to prove something doesn’t mean it doesn’t occur.
pharmavet
Anon, that is why we have something called p-values.
riv
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.
patrons99
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.