Big Pharma studies show more bad news for this type 2 treatment

Drug Alert: Could this be the most dangerous diabetes drug ever approved?

Let’s be honest. It’s pretty much a given that any drug trial sponsored by industry will have positive results.

In fact, one paper looked at over 500 of these studies and found that 85 percent of those funded by the drug companies result in really happy news about their products.

So when not one, but two of these trials for a single drug come out badly, imagine how dangerous that one pill must be!

And that may be only the tip of the bad-news iceberg.

Of course, as the evidence mounts against this already-approved drug for type 2 diabetes, the FDA’s plan of action is…well, not much.

Approve first, question later

Last month I warned you about another diabetes drug, a brand new one the FDA had just approved in January.

It’s has “modest” benefits, but a big risk for your heart and liver. And that’s not to mention the bladder and breast cancer dangers that come along with this pill with the odd name, Farxiga.

And then there’s the even harder to say Onglyza.

Onglyza is supposed to “work” by making your body produce more insulin while telling your liver to stop making so much glucose.

And like that other high-risk drug Farxiga, this one really doesn’t work very well, either.

Also made by AstraZeneca, Onglyza got the green light back in 2009 — and then the FDA asked for more “post-marketing” studies.

It’s not like the drug didn’t come out of the gate with a long, scary list of side effects. Among them were damage to the pancreas (which can “lead to death”), interactions with many other diabetes drugs, and dangerously low blood sugar.

And those are the ones already on the label!

Add to that more bad news that came out last spring about how Onglyza can affect the pancreas, possibly leading to pancreatic cancer.

Sounds like it should have been reason enough to pull the plug right there!

But finally, last summer the results were released on the industry-sponsored trial that Big Pharma hoped would give Onglyza a somewhat cleaner bill of health.

Bristol-Myers and AstraZeneca were aiming to show how the drug helps keep those with type 2 from having heart attacks and strokes.

The only problem is…it doesn’t.

The results showed Onglyza was no better than a placebo.

Financial analysts said that it could have added a cool $1 billion to sales had a placebo not outshined it.

But, the experts said at least it was no worse!

How about that one in a commercial?! Voice-over scene showing couple in a rowboat eating lunch: “Ask your doctor about Onglyza for type 2 diabetes, shown in studies to be no worse than a placebo!”

Now, if it was only a case of “no worse” that would be bad enough. But here’s the third strike against Onglyza. And it comes from another industry-sponsored study.

Throwing the concept of “no worse” out the door, the diabetes drug now appears to actually put patients at risk for heart failure.

Started in 2010 and completed last year, the research looked at over 16,000 patients with type 2 diabetes. It found a “significant” increase in those taking the drug ending up in the hospital with heart failure.

Sauntering into action, the FDA issued a “safety announcement” last week saying it found the study to be “preliminary” and that patients should not stop taking the drug and to talk to their doctor if they have any questions.

Well, you bet we have questions! Like, how did this dangerous drug with no clear benefit over older diabetes drugs get approved in the first place?

But here’s the scariest part of this whole thing: The drug companies only released what’s called the “headline results” from this trial. What other bad news might be hiding in there, news we may never get to hear about?

The final chapter for Onglyza may be years in coming. But that may be years too late for the millions already taking this drug. And the millions more who will start on it while the FDA sits on its hands and waits for more study results.

Sources:
“FDA puts AstraZeneca’s diabetes med Onglyza on review for heart safety” Tracy Staton, FiercePharma, February 11, 2014, fiercepharma.com

“FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR” FDA Drug Safety Communication, February 11, 2014, fda.gov