Don’t be fooled by this risky med’s ‘longer life’ claim

For Big Pharma, the pot of gold isn’t at the end of a rainbow.

Instead, it can be found directly at the FDA’s doorstep!

But unfortunately, what will soon be bringing in the billions for drugmakers Eli Lilly and Boehringer Ingelheim looks like nothing more than a cruel trick being played on those with type 2 diabetes.

Because what this pair wants you to hear about its type 2 med Jardiance is far from the whole story.

A ‘cascade of adverse events’

When Jardiance was first approved over two years ago, I gave you the lowdown of why it’s a very dangerous drug to take if you have type 2.

First off, it’s part of an entirely new class of diabetes meds called SGLT2 inhibitors. They work by forcing your kidneys to excrete glucose in your urine. While that may sound easy, it’s not that simple.

Side effects include severe dehydration, which can lead to a drop in blood pressure. And that can cause dizziness and falls. Your blood pressure could even drop to a level that’s deadly.

Back when Jardiance was approved, even the FDA warned that if you’re taking diuretics (water pills) and happen to be over 75, you’re “more susceptible” to those risks.

Then, there’s the problem of the big increase in urinary tract infections this drug can cause, as well as yeast infections – and that’s both in women and men.

An expert called this method of blood-sugar control one that can trigger “a cascade of adverse events.”

But the drugmaking duo behind Jardiance are hoping all that’s history now. Because all they want you to hear is this: If you have type 2 diabetes and heart problems, Jardiance will help you live longer!

And that’s quite a claim – actually it’s the first time the FDA has ever allowed a drugmaker to say that about a diabetes med.

Stockbrokers and analysts immediately pulled out their calculators and figured that this absolutely amazingly wonderful money-making new claim will generate extra sales of close to two billion for Jardiance within the next ten years.

Think about it! Just a handful of words added to the hype for this med will put billions more into the pocket of these drugmakers. Of course, when it comes to sales pitches, being able to say your drug will help diabetics live longer is catching the brass ring if there ever was one.

Which brings me to the $64,000 question. How did the drugmakers come to that conclusion?

Well, at some point during the post-marketing safety trial Lilly and Boehringer were required to run, they decided to turn it into a trial that would allow them to make such a claim. Incredibly, the FDA went along with the plan and let them do basically whatever they wanted to.

And when the study was complete – ta-da! – they announced this amazing longevity find using a statistical magic stunt called “relative risk.”

Relative risk is a smoke-and-mirrors trick that experts have called a misleading way to exaggerate differences that “are either insignificant or do not even exist.”

But not everyone at the FDA bought it.

When this longer-life claim was analyzed by the FDA’s expert advisory committee, it just squeaked by with a vote of 12-11. And even those who voted for letting the drugmakers go with it had reservations. Many commented that they were not sure about using one single study to support such a claim.

Others were concerned that the way Jardiance supposedly prolongs life is still a big mystery.

And another said “Good luck on figuring out what to do.”

Well, I can help you figure out what to do without using any statistical mumbo jumbo.

If you have type 2 diabetes and your doctor wants you to try Jardiance, just tell him “no.” Instead, ask for other options that don’t put you in the crosshairs of serious side effects that aren’t relative, but very real.

“FDA approves empagliflozin for reducing CVD death” Miriam E. Tucker, December 2, 2016, Medscape, Medscape.com