Diabetes drug’s amputation risk buried while heart ‘benefits’ hyped

Invokana makeover shows how drug risks can be hidden by hype

A little over a month ago, I told you how the type 2 med Invokana can double your risk of suffering an amputation.

That’s something the FDA is now requiring the drug to carry a black-box warning over.

But now you might be seeing headlines about how the drug is somehow safer as it can prevent heart attacks and strokes.

If that sounds fishy to you, you’re absolutely right!

Because Invokana didn’t suddenly get any safer. What it got was that classic “lipstick on a pig” makeover straight from its drugmaker, Janssen Pharmaceuticals.

And for anyone with type 2, knowing the whole story is now more important than ever.

Painting a bleak CANVAS
It’s not often you hear top medical experts in diabetes playing a version of the game “Would You Rather?”

That, however, is exactly what Dr. John Buse, chief of endocrinology at UNC-Chapel Hill, has found himself doing when it comes to Invokana.

“I would much rather have a small heart attack than lose a toe,” he says, adding his preference for “a big heart attack” over losing a leg.

But to hear the way this drug is being hyped by a Janssen shill, professor Bruce Neal — senior director of The George Institute for Global Health in Australia — you would never suspect that you’d ever have to make a choice like that.

In fact, that little detail doesn’t even come up until the end of the Institute’s press release on the newly discovered heart “benefits” of the drug, saying how Invokana fills the bill in protecting “millions” from the “very real risks of stroke and heart attack.”

But in reality, another “very real risk” is turning you into an amputee.

Both the claim that Invokana is somehow a heart-saver and the amputation risk came from combining two trials on the med, dubbed CANVAS, all bought and paid for by Janssen.

Professor Neal, who headed up the CANVAS trial, is practically bubbling over with enthusiasm for Invokana. He says the results were exciting, and show that Invokana can “protect” millions from having a stroke or heart attack and has “many other benefits too.” (More on that in a minute.)

Yet when CANVAS finally finished up and was published a few weeks ago, it wasn’t exactly the slam-dunk the drugmaker had hoped for. For one, there were the not-so-little problems of UTIs and weakened bones.

Then, of course, there was the doubling of the amputation risk for both toes and legs!

Why would Invokana cause such a big spike in amputations? Dr. Neal admits they don’t really know.

In fact, one expert said that it “deepens the mystery” about all of the SGLT2 inhibitors.

And if you look at the actual numbers that came out of CANVAS, for every 1,000 patients who took the drug, there were close to 27 serious heart events — compared to a tad over 31 who got the placebo.

Is that worth risking a leg over?

But no matter. Because due to some press release magic, Invokana now has a “clear benefit” over these other drugs for type 2.

I don’t know how you’d gain anything by losing a digit or a limb!

This story tells us two very important things:

just how creative drugmakers can be in cherry-picking the data they broadcast, and
just how much we don’t know about Invokana and all these other SGLT2 inhibitors.

For anyone with type 2, it sure looks like there are a vast array of drugs out there to help you manage your diabetes. But in real life, the big names you see advertised on television all the time — Jardiance, Farxiga, and Invokana — all work basically the same way.

They all dump glucose into your urine. And as an eAlert reader, you know that’s a very risky way to lower your blood sugar.

Remember those “other benefits” Professor Neal was touting? Among them you can count dehydration, reduced kidney function, and a life-threatening condition called ketoacidosis (also the subject of an FDA warning).

Professor Neal’s George Institute is hyping how Invokana “heralds” in a “new era” for those with diabetes and that the CANVAS study has “major implications” about this treatment for type 2.

Well, I’ll say it does!

What this all boils down to is that Big Pharma researchers can be just as creative in spinning their results as an ad agency is when making a commercial.

And just like you can’t judge a book by its cover, you can’t judge a drug by its press release!

“J&J drug prevents heart attacks at cost of amputated toes” Matthew Herper, June 12, 2017, Forbes, forbes.com