Friday, July 3, 2009

Say That Again?

Working my way through some data research surveys about up-and-coming products. What do you guys think of this quote from one:

"Product M is not statistically non-inferior to Oxycodone in both relief and non-relief of pain".

14 comments:

Anonymous said...

From reading many Science, APL (Applied Physics Letters), PRL (Physical Review Letters), etc. for my dissertation this statistician appears to be trying to say that Product M is about as good as Oxycododne but in as complicated a way as to make M more sound better then it is. There is also the possibility that product M is Opana.

Anonymous said...

Nucynta maybe? From here forward it's just me-too drugs and reformulations of the same shit. You gotta watch those sneaky reps.

08armydoc said...

Product M = Oxycodone....

Anonymous said...

Well, ya gotta have a heck of a lot of date to prove non-inferiority to me with numbers. But, I'd hazard the guess that they company is attempting to suggest that the side-effect profile may be a deal-breaker.

pharmacy chick said...

I read that before and I interpret that to be that M is no better and no worse than oxycodone. I wouldn't exactly call it a warm endorsement. Its like calling somebody "not ugly". But I'll bet its very costly.

Hospital Lab Tech said...

What is 'non-relief of pain'??

'Here you go Mrs Patient, have a prescription for some pills that won't stop it hurting in the slightest'.

Anonymous said...

omg... I wonder why they didn't say non-superior?

Davey Jones said...

that is a double negative, which cancels each other out. it actually says product M is inferior at both pain relief and non-pain relief. which makes no sense. But it does clearly state that product M is inferior at pain relief.

Steph the Pharmacist said...

The study sought to find whether there was a difference between oxycodone and Product M. The statement you provide is statistician speak. The flowering endorsement (and big boobs) will come from the drug rep.
But the fact that oxycodone is a pretty good drug means that this one might be, too. Differences will be in side effect profiles, ease of use, and CO$T.

peedee said...

That kinda reads like the 1040 tax return instructions. I dont get it.

xtine said...

wtf/goddamn/*carlface*

Anonymous said...

let's just say that the makers of product M conducted several pain studies with M, placebo and oxycodone, all in the same study. and they set the studies up to show superiority over placebo, and non-inferiority to oxyC. as other comments, non-inferiority is a complex statistical measure of "about as good as..."

What they really want is to claim that their crummy little drug is "about as good as" the big dogs. They figure that statement is worth big dollars.

Then they went to the FDA and begged and pleaded to be allowed to put both results (eg; vs placebo and vs oxyC) in the prescribing information sheet, but the FDA said "no, you can only put in the superiority over placebo but not the non-inferiority findings."

Now the makers of M are stuck. They really want to tell you that M is as good as oxyC, but legally they can't. They want to go back to FDA and beg and plead some more to get the good statement.

So now they're conducting a survey to test various ways of phrasing the message, in the hopes of finding a message that is strong enough to resonate with docs and yet may still be bland enough to pass FDA muster.

gingerb said...

I was never any good at that stuff where they had a null hypothesis and you had to figure out whether to accept or reject it.

Anonymous said...

The guy who wrote the report attempted to write in the style of Orwell's 1984?

 
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