Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy. Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.
Showing posts with label jupiter. Show all posts
Showing posts with label jupiter. Show all posts
Sunday, October 24, 2010
Tuesday, February 09, 2010
Friday, November 21, 2008
JUPITER study - meh!
The British Medical Journal has published an editorial discussing the results of the recently completed JUPITER Study.
This editorial aims to put the results of the study in context with the existing evidence based and understand what the results mean in terms of current practice.
The authors of this study conclude that no change is required.
In addition the Rapid Responses are heavily critical of the decision to stop the study early and make for interesting reading.
Hat tip: Matt
This editorial aims to put the results of the study in context with the existing evidence based and understand what the results mean in terms of current practice.
The authors of this study conclude that no change is required.
In addition the Rapid Responses are heavily critical of the decision to stop the study early and make for interesting reading.
Hat tip: Matt
Friday, November 14, 2008
Pharma Giles on JUPITER
“So me an’ Paul were ‘aving a couple of pints dahn the pub, as yer do, like, when ‘e sez t’me, “’Ere, Dave, ‘ow’s the ol’ Crestor sales doin’ then?”
“Leave it aht,” I sez. “We keep runnin’ trial after bleedin’ trial based on tryin’ to show some sort of worthwhile clinical benefit, an’ all we keep comin’ up wiv is bugger all, know wotta mean, like? Best fing we can do is t’ let it slide off patent in a coupla year’s time, like, an’ jus’ cut our losses.”
“Sounds t’ me like you ain’t designin’ the trials right,” sez Paul, neckin’ ‘is Stella. “Wot you need is a way of testing all the old geezers you sign up, such that when you put ‘em on your drug, some of ‘em give the answers you want rather than poppin’ their clogs or getting’ diabetes an’ stuff like they usually do.”
“Yeah, right,” I sez, “an’ where am I gonna find this magic test, then?
“Funny you should say that, Dave ol’ son,” he sez to me, wiv a big wink. “It jus’ so ‘appens that I happen to ‘ave a personal patent on a rahver nifty little test for CAP…”
“On yer bike,” I sez. “The only fing I reckon you can test for is CRAP, cos you’re spouting it right now.”
“Nah, straight up Dave,” he sez, all serious, like. “It’s kosher. CAP. C Active Protein. If you make sure all the fat old geezers and dears on your next big trial are chock full of CAP, chances are they’re gonna respond to your old Crestor. And wiv’ my test tellin’ you that, you can’t fail.”
“So ‘ow much are you charging fer this magic test o’ yours, then?” I arsks.
“A tenner,” he sez. “Thas nuffink compared to wot you’re chargin’ for Crestor over the course of a week or two. ‘Course, I only make a quid or two on each test, but if it all comes up roses, then you get to shift a load o’ Crestor, I get to flog my test kits, and it’s….”
“BUCKETSAMONEY!!!!” we both shout.
“Well, get ‘em in, then,” sez Paul. “Ere’s t’ doin’ business wiv yer.”
A coupla pint o’ Stella, later, Paul sez t’ me, “Ere, this clinical trial,” e’ sez. “Wot yer callin’ it, then?”
“Well,” I sez, “it’s a big, bloated ball of toxic gas that’s basically ‘ostile to ‘uman life, like, so we wuz thinkin’ of callin’ it “JUPITER”, know wot I mean?”, I sez.
“Like it,” sez Paul. “An’ where are yer gonna publicise the results?”
“Oh, it’ll be in all the reputable journals as usual,” I sez.
“Wot, like the BMJ and the NEJM, sorta fing?”
“Gordon Bennett!” I sez, “don’t be a plonker! Nah, we’ll get it the Wall Street Journal and the Daily Express, same as we always do when we wanna uncritically hype a load of average results, hide the duff ones and pretend we got a wonder drug on our ‘ands…”
“Blimey, it really could be bucketsamoney,” sez Paul.
“Course, we can’t do nuffin illegal, like, like pushin’ the stuff to doctors before we got approval for people wiv ‘igh CAP n’ that,” sez I, tryin’ to keep a straight face.
“That would’n be right, would it, like?” sez Paul, tryin’ not to piss ‘imself.
“Nah”, I sez….
“BUCKETSAMONEY” we both sez together. “Mine’s a Stella….”
And the rest is history.
Apologies to Harry Enfield and Merrill Goozner.
“Leave it aht,” I sez. “We keep runnin’ trial after bleedin’ trial based on tryin’ to show some sort of worthwhile clinical benefit, an’ all we keep comin’ up wiv is bugger all, know wotta mean, like? Best fing we can do is t’ let it slide off patent in a coupla year’s time, like, an’ jus’ cut our losses.”
“Sounds t’ me like you ain’t designin’ the trials right,” sez Paul, neckin’ ‘is Stella. “Wot you need is a way of testing all the old geezers you sign up, such that when you put ‘em on your drug, some of ‘em give the answers you want rather than poppin’ their clogs or getting’ diabetes an’ stuff like they usually do.”
“Yeah, right,” I sez, “an’ where am I gonna find this magic test, then?
“Funny you should say that, Dave ol’ son,” he sez to me, wiv a big wink. “It jus’ so ‘appens that I happen to ‘ave a personal patent on a rahver nifty little test for CAP…”
“On yer bike,” I sez. “The only fing I reckon you can test for is CRAP, cos you’re spouting it right now.”
“Nah, straight up Dave,” he sez, all serious, like. “It’s kosher. CAP. C Active Protein. If you make sure all the fat old geezers and dears on your next big trial are chock full of CAP, chances are they’re gonna respond to your old Crestor. And wiv’ my test tellin’ you that, you can’t fail.”
“So ‘ow much are you charging fer this magic test o’ yours, then?” I arsks.
“A tenner,” he sez. “Thas nuffink compared to wot you’re chargin’ for Crestor over the course of a week or two. ‘Course, I only make a quid or two on each test, but if it all comes up roses, then you get to shift a load o’ Crestor, I get to flog my test kits, and it’s….”
“BUCKETSAMONEY!!!!” we both shout.
“Well, get ‘em in, then,” sez Paul. “Ere’s t’ doin’ business wiv yer.”
A coupla pint o’ Stella, later, Paul sez t’ me, “Ere, this clinical trial,” e’ sez. “Wot yer callin’ it, then?”
“Well,” I sez, “it’s a big, bloated ball of toxic gas that’s basically ‘ostile to ‘uman life, like, so we wuz thinkin’ of callin’ it “JUPITER”, know wot I mean?”, I sez.
“Like it,” sez Paul. “An’ where are yer gonna publicise the results?”
“Oh, it’ll be in all the reputable journals as usual,” I sez.
“Wot, like the BMJ and the NEJM, sorta fing?”
“Gordon Bennett!” I sez, “don’t be a plonker! Nah, we’ll get it the Wall Street Journal and the Daily Express, same as we always do when we wanna uncritically hype a load of average results, hide the duff ones and pretend we got a wonder drug on our ‘ands…”
“Blimey, it really could be bucketsamoney,” sez Paul.
“Course, we can’t do nuffin illegal, like, like pushin’ the stuff to doctors before we got approval for people wiv ‘igh CAP n’ that,” sez I, tryin’ to keep a straight face.
“That would’n be right, would it, like?” sez Paul, tryin’ not to piss ‘imself.
“Nah”, I sez….
“BUCKETSAMONEY” we both sez together. “Mine’s a Stella….”
And the rest is history.
Apologies to Harry Enfield and Merrill Goozner.
Tuesday, November 11, 2008
AstraZeneca - Crestor: PharmaGossip starts "Jupiter Watch"
As the pharma world continues to digest data from the JUPITER study on AstraZeneca’s Crestor, the firm’s chief executive is taking a cautious line on what effect it will have on sales of the cholesterol blockbuster.
In a teleconference with reporters, David Brennan said it is too early to predict how the data from the landmark study, which demonstrated a dramatic risk reduction of cardiovascular death in people with low to normal cholesterol levels, will affect sales of Crestor (rosuvastatin). He noted that there has been “a flurry of estimates” from analysts about the commercial impact of JUPITER, “some of them pretty bullish” but “I would urge caution when forecasting the speed of such changes".
The initial response to the study has been that it will transform the way statins are prescribed, ie to people with normal levels of cholesterol. Mr Brennan did add that it is "reasonable to think" the data will be considered when the American College of Cardiology and other such bodies update their treatment guidelines for heart disease next year.
However he stressed that AstraZeneca will not promote Crestor for use as a preventative in healthy patients who are at risk of heart problems until it obtains approval. The company will submit the findings of JUPITER to regulators on both sides of the Atlantic in the first half of 2009.
Mr Brennan also noted that the benefits of Crestor shown in the study, which for example demonstrated that the combined risk of heart attack, stroke or CV death was reduced by 47%, does not necessarily extend to similar cholesterol drugs. "We know all statins are not created equal," he added.
Dresdner Kleinwort analyst Tim Franklin issued a research note saying that while some doctors may opt to prescribe generic statins as a preventative, many will now choose to use Crestor on the basis of JUPITER. He added that “the surprising level of risk reduction observed with Crestor compared to previous statin studies also tells us that it is not always possible to extrapolate from one product to another or from one set of data to another quite so easily".
Although Mr Brennan is being cautious about sales forecasts for Crestor, which had third-quarter revenues of $922 million (up 28%), analysts seem convinced about the positive effect of the study. Morgan Stanley says they could reach as much as $8 billion in 2014, while UBS is predicting sales of at least $7 billion in 2012.
By Kevin Grogan
PharmaTimes
Insider says: Dave has said it plain and simple - no promotion of JUPITER until approval.
Please feel free to let PharmaGossip know if you spot this happening!
In a teleconference with reporters, David Brennan said it is too early to predict how the data from the landmark study, which demonstrated a dramatic risk reduction of cardiovascular death in people with low to normal cholesterol levels, will affect sales of Crestor (rosuvastatin). He noted that there has been “a flurry of estimates” from analysts about the commercial impact of JUPITER, “some of them pretty bullish” but “I would urge caution when forecasting the speed of such changes".
The initial response to the study has been that it will transform the way statins are prescribed, ie to people with normal levels of cholesterol. Mr Brennan did add that it is "reasonable to think" the data will be considered when the American College of Cardiology and other such bodies update their treatment guidelines for heart disease next year.
However he stressed that AstraZeneca will not promote Crestor for use as a preventative in healthy patients who are at risk of heart problems until it obtains approval. The company will submit the findings of JUPITER to regulators on both sides of the Atlantic in the first half of 2009.
Mr Brennan also noted that the benefits of Crestor shown in the study, which for example demonstrated that the combined risk of heart attack, stroke or CV death was reduced by 47%, does not necessarily extend to similar cholesterol drugs. "We know all statins are not created equal," he added.
Dresdner Kleinwort analyst Tim Franklin issued a research note saying that while some doctors may opt to prescribe generic statins as a preventative, many will now choose to use Crestor on the basis of JUPITER. He added that “the surprising level of risk reduction observed with Crestor compared to previous statin studies also tells us that it is not always possible to extrapolate from one product to another or from one set of data to another quite so easily".
Although Mr Brennan is being cautious about sales forecasts for Crestor, which had third-quarter revenues of $922 million (up 28%), analysts seem convinced about the positive effect of the study. Morgan Stanley says they could reach as much as $8 billion in 2014, while UBS is predicting sales of at least $7 billion in 2012.
By Kevin Grogan
PharmaTimes
Insider says: Dave has said it plain and simple - no promotion of JUPITER until approval.
Please feel free to let PharmaGossip know if you spot this happening!
Monday, November 10, 2008
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