The Vytorin Limbo: Going Lower All The Time
9 CommentsBy Ed Silverman // October 20th, 2008 // 9:31 am
Last summer, it appeared prescriptions for the controversial cholesterol pill may have finally hit a plateau, but not at all. The latest monthly report from Schering-Plough shows yet another decline.
The latest monthly data shows prescriptions fell 3.7 percent in September, perhaps reflecting the ongoing confusion over the results of the SEAS clinical trial, which unexpectedly yielded a mysterious number of cases of cancer and cancer-related deaths, not to mention a failed primary endpoint.
Moreover, Vytorin’s share of the overall cholesterol market fell to 6 percent last month, from 6.4 percent during August, according to a Schering-Plough filing with the Securities and Exchange Commission. Back in January, before the controversy over the Enhance trial exploded, Vytorin’s share of the overall cholesterol market stood at 9 percent.
Meanwhile, scrips for Zetia - which is combined with Merck’s Zocor to form Vytorin - fell 1.5 percent last month. The drugmakers’ combined cholesterol ‘franchise,’ which amounted to 15.2 percent of the cholesterol market in January and 12.1 percent in June, slid to 10.8 percent last month.
Hat tip to ShearlingsGotPlowed for the reminder
Condor
Thanks for the kindness, Ed!
And, hey! — Call me crazy, but. . . these dreary US market share trends certainly invoke the skeptic in me — skeptical in this case, that Merck’s “Frankenstein Revival” of “Cordaptive” (though the FDA won’t let them call it that), or Laropiprant, with Niacin — is ENTIRELY UN-related to the Cholesterol Joint Venture’s year-long swoon:
http://shearlingsplowed.blogspot.com/2008/10/end-of-vytorinzetia-merck-decides-to.html
Cheers!
– Condor
BPW
Two huge reasons - ENHANCE and SEAS. It appears that ENHANCE was linked to the first hit, but SEAS definitely needs to be considered as the trigger for the second one. ENHANCE showed a lack of effect on atherosclerosis, but SEAS raised the CANCER concern. It’s one thing for a doc to precribe a drug that doesn’t have effects beyond LDL-C, but it’s another thing all together to prescribe a drug that may have a link to increased cancer. The latter is very scary!
JD
If you morons would inform yourselfs…cancer risk has been seen in many long term trials, about 8% of patient populations…and the cancer results in the SEAS trial were multi-varied…Colon, Skin, Lung, Etc…as one would normally see in patients in their 60s, 70s and 80s…in addition, Dr, Richard Peto, researcher and statistician from CTSU at Oxford University analyzed trial data from over 20,000 patients taking Vytorin long term and found no link to Vytorin and increase in cancer…this news is just additional propaganda drummed up by reporters…it is also sad to see that some physicians were suckered into the same irresponsible reporting…get the facts…my father and coworkers take this great product, and their cholesterol is completely under control!
Condor
JD, your high-handed assertion (while calling the rest of us “morons”) suggests a lack of understanding of the nuances, and the complexity, of the SEAS (and other trials’) results. Do take a moment to consider this in the NEJM — from some of the foremost lipid experts in the world (ezetimibe is one of two active ingredients in Vytorin, and the sole active ingredient in Zetia):
“. . . .Ezetimibe interferes with the gastrointestinal absorption not only of cholesterol, but also of other molecular entities that could conceivably affect the growth of cancer cells. The fact that the combined data from all three trials showed an increase in cancer mortality with ezetimibe should not be assumed to be a chance finding until further data are in. It is appropriate that SHARP and IMPROVE-IT continue. Careful follow-up of the patients in these trials will be essential, and other existing data sets on ezetimibe-treated patients should be analyzed for cancer end points. The Food and Drug Administration has already announced that during the next few months it will conduct its own analysis of the potential cancer hazard of ezetimibe.
We will continue to follow the matter, and we are prepared to promptly publish in the Journal new information that sheds further light on this unexpected finding. Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug. . . .”
Per the New England Journal of Medicine, September 25, 2008 — Full Link:
http://content.nejm.org/cgi/content/full/359/13/1398
JD
Yes…and the Editor of the NEJM was in his past job implicated for being too friendly with PFizer…and now it looks like he is trying to mend fences by making these extreme commments in his editorial, instead of waiting for the FDA’s final analysis…as I said, Dr. Richard Peto is a regarded world wide cancer expert and has weighed in with analysis and determined that the results were due to chance…8% incidences of cancer are the normal standard in many long term studies, and this is the same percentage as seen in all the large statin trials since 1994 till today…this is a similar percentage as seen in the SEAS trial…the additional assumption that Zetia’s blocking of plant sterols or other molecules would raise the incidences of cancer is a far stretch for the editor of the NEJM…he should wait till all the analysis is done before giving his “unbiased?” opinion…Vytorin and Zetia are just the latest drugs to bash in 2008…that sells papers and pays for lawyer settlements…and who wins?…Lipitor and Crestor and Lawyers!
BPW
JD - Is that as in lawyer? perhaps Schering-Plough, Merck, MSP, or highly-paid hired gun. If not a lawyer, then someone with a massively huge bias. Face it, docs aren’t prescribing these drugs because there is concern about their ultimate effects. This will not change until much more data is known. MSP has already enlarged IMPROVE-It once, so there must be concern about differential effects between the groups. It will take longer to do more patients, so maybe we’ll know something by 2014! In the meantime, the drugs will remain on the back burner. Look out if additional cancer concerns arise in the meantime, either from SHARP or IMPROVE-IT.
Andy
It seems like JD is a typical Big Pharma bully! If you don’t agree with him/her, then you’re a moron! perhaps not a lawyer as suggested above, but maybe a commercial type. They like to yell, scream and kick their feet! Poor MSP - everybody is picking on them. Sad that they brought it all upon themselves.
JD
No…no lawyer or pharma bully here…your right, I am wrong…silly of me…it’s OK to put out irresponsible reporting and editorials based on scientific “biased opinion”…all these doctors have an “opinion” and they use their “platforms” like the NEJM and New York Times to push their views, even though they are no where involve in the actual analysis to determine accurate results…I call that irresponsible, because it could cause a patient to read some article and stop taking their medications…that would be super for a patient taking a blood thinner or hypertension medication…many of these doctors have vested interests and do research for competitor products, like Dr. Steven Nissen…these are the doctors that should temper their scientific “opinions”…because as you see from this long debate thread, their “opinions” affect how you have formed your opinions, which I’m sure many of you have formed yours from reading their Yahoo and Google articles…instead from actual scientific research of the facts
David
JD has invited the negative responses because of his statement that attacked the intelligence of others. It is inappropriate in a blog environment. Opinions are fine, but lay off the personal attacks!