Congress Asks FDA For Vytorin Cancer Data
15 CommentsBy Ed Silverman // July 31st, 2008 // 9:29 pm
The House Energy and Commerce Committee wants the FDA to turn over the results of an analysis looking into the potential links between Vytorin and cancer. The move, which was first reported by The Wall Street Journal, comes after last week’s release of the SEAS study showing an unexpected increased risk of cancer and cancer-related deaths compared with patients on a placebo.
In explaining the findings, Merck and Schering-Plough pointed to a separate analysis they funded by Richard Peto, an Oxford University epidemiologist, who looked at data on 20,000 patients from two other ongoing Vytorin trials, one of which he runs, and declared the SEAS cancer findings were a “bizarre hypothesis.”
However, the Peto analysis of the SEAS study was given to the FDA, but not released to the House committee, which has been investigating the prescription drug safety and has also probed Vytorin marketing in light of questions about the drug’s efficacy in reducing “bad” cholesterol, the Journal notes.
In a letter to the FDA, John Dingell, the Michigan Democrat who chairs the committee, writes that based on the SEAS finding, “Vytorin may not be safe. Its potential for cancer and cancer deaths may be a significant cause for concern among physicians and patients.” And he wants the FDA to turn over Peto’s analysis and related documents. An FDA spokeswoman tells the paper that, “We are looking into this question for Congress.”
A spokesman for the drugmaker’s joint venture declined to comment on the committee’s request, but told the paper they objected to Dingell’s statement about Vytorin’s safety. Merck and Schering-Plough “believe that the finding in SEAS regarding cancer is likely to be an anomaly.” He added, “We don’t believe that changes in the clinical use of Vytorin are warranted.”
Condor
I don’t have anything remotely momentous to add to Ed’s story, above — save this — seeing the actual words on Dingell’s, and Stupak’s letterhead — is really something (I sorta dislike PDFs, for no particular reason).
So I just set it — as an easy-view image, right here — inside the blog-page:
http://shearlingsplowed.blogspot.com/2008/07/wall-st-j-on-seas-cancer-concerns-for.html
Great stuff, Ed!
Laurie
“believe that the finding in SEAS regarding cancer is likely to be an anomaly.”
Likely??? I think we’d all like a bit more confirmation than “likely”.
Salmon
I expect that FDA will come back with a reply that it’s not releasable as it’s under review, i.e. priviledged under deliberative process.
They can’t use the usual trade secret excuse as it’s based on a request from a committee head and the head of a subcommittee.
However, today’s ruling regarding Harriet Miers and executive priviledge may just nix this argument.
Personally I like the idea of Unitary Executive, especially when you look at in the context of original intent. Alexander Hamiliton in Federalist Paper No. 70 basically indicates that it’s purpose is in part so you know exactly who to hold ultimately responsible.
Condor
Salmon — I think Judge Bates’ decision today is exactly why FDA will turn the documents over without a fight.
Congress plainly has oversight responsibilites — constitutional duties, actually — to fufill, here. Where the safety of a drug is involved some “deliberative process” argument is going to cut very little ice.
What is the rationale for NOT turning it over?
I don’t see any. [Sorry to say, Salmon -- we'll have to agree to disagree about the unitary executive and federalist no. 70. But I do sincerely respect your views.]
Once again, Schering COULD have controlled the narrative on this issue — the SEAS cancer finding, by being MUCH MORE fully-forthcoming — and providing the analysis Dr. Peto prepared, as background data — to the public, on July 21, 2008.
Inexplicably, Schering chose “more of the same” — sorta a half-reformed ENHANCE disclosure approach. . . . Puzzling.
So it goes.
Condor
And now, this monring — despite EU approval earlier in the week (and a stock price bump) — Schering learns that the US FDA has declared suggamadex “non-approvable”.
When it rains — it pours,
Take a look:
http://shearlingsplowed.blogspot.com/2008/08/fda-suggamadex-is-non-approvable-ouch.html
Will Schering be able to turn this one around at FDA? I dunno.
Condor
One other observation, if I might:
The emerging theme — considering the overnight letter from Reps. Stupak and Dingell — is one of “deficient data provision” out of Kennilworth — to governmental regulatory bodies.
Not. A. Good. Thing.
Disgusted
Dear Rep. Dingell,
Please stay after Schering-Plough. Somebody needs to hold them accountable for their actions. IMO, they have been thumbing their nose at rules, regulations and the law for far too long. I believe that this has occurred regualrly since the present regime took over, even when they were under a Corporate Integrity Agreement. I think that the only way their behavior will chenge is if they are trult held accountable for their actions. Too many times, it’s a little slap on the wrist, a fine paid by the shareholders, no admission of guilt, and top executives laughing all the way to the bank! IMO, there need to be personal fines and prosecutions for their actions. Hit them where it hurts. I believe that this issue is only the tip of the iceberg for this cast of clowns!
Marilyn Mann
Nice post by Roy Poses on a recent editorial on ENHANCE:
http://hcrenewal.blogspot.com/2008/08/shut-up-they-explained-to-ezetimibe.html
Marilyn Mann
On Gooznews, a plausible explanation of why ezetimibe might increase cancer risk:
http://www.gooznews.com/archives/001140.html
Justice in Michigan
Thanks for link, Mariynn. Do you know if we know for certain that statins do not impact plant sterol absorption?
Marilyn Mann
Statins by themselves cause an INCREASE in cholesterol and plant sterol absorption. That is not the case, however, when a statin is combined with ezetimibe. In that case, the ezetimibe reduces plant sterol absorption.
Justice in Michigan
Fascinating. Thanks.
Piper
That’s interesting. Steve Nissen was just quoted as saying the opposite. I have no insight one way or the other.
Marilyn
Piper, You must be mistaken. What/where is the quote from Steve Nissen you are referring to?
Deb
Please clarify this in layman’s terms. I am just a simple person who would like to know what risks have been discovered?
I used Vytorin for at least one year., and am now on the Simvastatin, Mico-K and Maxide.
Alos what does plant sterol asorption mean??
Thanks from Simple.