FDA OKs deadly diabetes drug based on mysterious, non-existent study

Did the FDA just approve a deadly new diabetes med — based on a study that doesn’t even exist?

It’s been two years since the agency refused to allow Novo Nordisk’s Tresiba shot on the market. We were told the drug could be a heart attack waiting to happen — and that it could even kill us.

But now Novo is free to unleash its deadly syringe on millions of Americans, thanks to a study that the FDA says puts all those old, frightening fears to rest.

The only problem? There is no study.

And it’s clearer than ever that the FDA and Novo are working hand-in-hand on a dangerous lie that could put diabetics everywhere right in the crosshairs.

A two-headed monsterNovo has been promising for years that Tresiba, a long-lasting insulin shot, was going to be a better and safer way for you to control your diabetes.

But even people investing millions in Novo stock weren’t buying that nonsense.

“We don’t think that’s true,” said Amit Roy, a financial analyst who watches Novo’s every move. “And if you look at the FDA documentation they don’t think it’s true either.”

You see, in 2013 the FDA actually rejected Tresiba — and with good reason. They found that the drug could increase your chances of a heart attack or stroke, and that you could even drop dead from taking it.

An FDA panel even voted 12-0 to demand more heart studies on Tresiba. And when was the last time you saw a dozen people doing government work agree on anything?

That’s when Novo launched the DEVOTE trial — the same research that the FDA says proved Tresiba is safe for your heart.

But they may as well have named this study PHANTOM or BIGFOOT. Because none of this is real.

What the FDA isn’t telling you is that there is absolutely no completed research proving that Tresiba is any safer today than it was two years ago.

The fact is, the DEVOTE trials won’t be finished for years — and the research is so incomplete and sketchy that even top Novo executives haven’t seen it yet.

But even still, researchers are admitting there’s plenty of “uncertainty” in the early results.

Uncertainty? When it comes to my heart? No thanks.

And if this all sounds fishy to you — that the FDA is approving drugs based on studies that practically don’t exist and that nobody has seen — well, join the club.

But get used to it. Because this is the new world we’re all going to be living in.

The FDA has already been approving new and dangerous meds at a faster pace than at any time in history. And, as I warned you last week, it’s about to get a whole lot worse.

That’s because President Obama just appointed a drug industry consultant, Dr. Robert Califf, to be the next FDA commissioner. The same Dr. Califf who has raked in a personal fortune helping shuttle dangerous drugs through the approval process.

If that wasn’t a clear signal that Obama now expects the FDA to approve every drug application that shows up on its doorstep, I don’t know what is.

And now with Tresiba approved, the FDA has all but guaranteed that Novo will be able to bring an even deadlier diabetes drug to market — one it thinks could be worth billions. It’s called Xultophy and it’s a two-headed monster that’s been sitting in the Novo pipeline for years.

It combines both Tresiba and Victoza — the same Victoza that carries a big black box warning saying it causes thyroid cancer. There hasn’t been a duo this deadly since Bonnie and Clyde!

Of course, there’s no way Novo could ever prove that a drug that causes heart attacks and cancer is safe for diabetics.

But, unfortunately, it looks like they don’t have to any more.

Sources:

“Novo score a game-changing diabetes approval, reversing an embarrassing rejection” Damian Garde, September 25, 2015, FierceBiotech, fiercebiotech.com

“Analysts bet Novo’s insulin drug will get U.S. green light” Teis Jensen, September 15, 2015, Reuters, reuters.com