A blockbuster diabetes drug called Invokana has pulled in hundreds of millions of dollars for Big Pharma, but the FDA recently announced that the treatment is causing even more problems in diabetics.
For big pharma, but the fda recently announced with diabetics, but the fda are the people who allowed that to happen. tim, a dysfunctional fda has allowed it to happen again. yeah, it is the caboose on the type 2 diabetes when you look at the history of what the fda you got avandia, that had heart attacks and strokes. now with invokana, the latest in the type failure and
A condition known as diabetic tim, you and i tried the rezulin case out the reason … when the jury came back and absolutely shocked that the company had not labs up, they had actually manipulated and changed the numbers on the lab tests. approval process and you’ve got your billion momentum, it takes a lot of public outcry, either make a change or label or take the drug
Off the market. after 2 years on the market, it’s already come and make us do something, well, we’ve how bad is it as far as shutting down people’s kidneys? percent more likelihood with invokana versus class of you going through acute or chronic kidney failure. like all of the other type 2 diabetes drugs it puts the body into an emergency excretion the urination process
Is actually a mechanistic process. this class is the only type 2 diabetes drug go into a very, very fragile organ, and that’s the kidney. first of all, the company doesn’t really care them, that they might be fined for this kind of conduct. marketing took the lead on everything, and isn’t that basically what we see on every one of these blockbuster drugs? finally caught
Onto, and that’s this condition this drug almost didn’t get out of committee, when the ad comm, when these experts on the clinical trial, they discovered in the very when you looked at the people who were on invokana group there were thirteen people there was a majority vote that the investigators profile, and the fda and janssen’s negotiated to study, all the way into 2017
On the back folks as guinea pigs, the cardiovascular risk profile of invokana. why is this just second rate, third world become just okay with the fda, that, “hey, this is what we are. we are a banana republic kind of review organization”? it is a two word answer, pap, a two word answer what the fda does now, it no longer looks a heart attack, really helping you not go
Instead it looks at a surrogate marker, so what is the benefit in terms of preventing heart attack? instead it looks at a test, one test, the are correct, the way the fda thinks they should be, then they rely upon that. therefore we’re going to assume that all of want to have happen to people won’t happen that surrogate markers are number one, misleading, do is prevent
Things of clinical consequence these clinical trials, the fda lets them go when you add to that the fact that it’s big they go out and they go to work for the very to, they go to work for the very people they’re the drug industry puts their plants inside the fda.
Transcribed from video
Diabetes Drug Invokana Linked to Ketoacidosis and Kidney and Heart Failure – The Ring Of Fire By The Ring of Fire