Last year, I told you about how the newest, priciest diabetes drugs like Jardiance and Victoza are making claims that they prevent heart disease. I told you how the news outlets were trumpeting these stories loudly while completely ignoring the safety issues with these drugs—not to mention the price tag.
I’ve been waiting for the next development. These pricey pills are nearing the end of their patents, and Big Pharma is looking for ways to keep their hands in your wallet by keeping patented versions on the market. They’ve already managed this with Victoza, which I’ll talk about in a moment. Now they’re trying to do it with Jardiance. And considering the life-threatening side effects that were associated with Victoza, it’s a pretty sure bet that another incarnation of Jardiance—complete with shiny new patent protection—will be a shoo-in. Here’s what’s happening.
Once again we’re human guinea pigs
Diabetics, as you probably know, are at more risk for heart disease than non-diabetics. And diabetes medications have a history of making this problem even worse. So the FDA, in a rare show of wisdom, decreed that all new diabetes drugs have to go through a trial to prove that they don’t up the risk of heart disease…too much, anyway. Unfortunately, they don’t have to do that till they’re already FDA approved and being prescribed to patients by the thousands.
This is what’s called a “post-marketing trial.” And if you ever need proof that NOTHING Big Pharma or the FDA does is really about your health, this is it. Not only are drugs routinely approved without this important safety testing, they often have years to complete this so-called “post-marketing” testing. This is where we are with the new diabetes drugs.
Last year, drugmaker Boehringer Ingelheim ran such a “post-marketing trial” on its expensive diabetes drug Jardiance. And while the health media lackeys are declaring it the holy grail of diabetes drugs and claiming that it prevents deaths from heart disease, there are some very important things we’re not being told. In spite of the foot-kissing headlines, even the FDA responded to this study with a resounding “Meh.”
Here's what Big Pharma doesn’t want us to know
This was a big study. It included about 7,000 people scattered all over the world. It was originally intended just to show that the drug didn’t raise the risk of heart disease. Then the drugmaker changed the rules to try and show that it actually reduced the death rate. And this is exactly what the news outlets are reporting. This is what the study results show, as they stand. However, here’s what we’re not being told:
Jardiance might actually cut the risk of death from heart-related incidents (though this is open to question, as I’ll discuss in a minute). But it doesn’t—and this is very important—it doesn’t reduce the total number of heart attacks or strokes. So, even if the study result are valid, you’re not less likely to have a heart attack or stroke. You’re just (maybe) less likely to die from one. Which brings us to point number 2:
The study didn’t include “silent” heart attacks. There could have been a thousand “silent” heart attacks and they wouldn’t count. Call me a skeptic, but this seems like a glaring flaw in the study design. Silent heart attacks are common. They’re often deadly. And to begin with, the study did include them in the primary endpoint. Then a “protocol amendment”—a change to the study rules mid-stream—removed them.
This should make us worry. As an FDA panel member said, "Anytime the sea changes, there are red flags that go up." In other words, there’s no earthly reason to drop this as one of the “events” measured unless it’s happening a lot and making the drug look bad. The fact that the study runners dropped silent heart attacks should make us wonder exactly how often they happened and why the researchers decided to keep them secret.
On top of that, there’s a lot of missing data. Out of the 7,000 people in the study, 211 dropped out without completing it. Their information is not included. They could have each had a heart attack and a stroke and heart failure besides, and no one—including the FDA—would be the wiser.
And then there are the “undetermined” deaths.
124 of the people who died during the study have data that’s also inaccessible. That is, their information is not included in the study results, and it’s not being released to anyone. Including the FDA. Everyone is just supposed to take the researchers’ word for it that they didn’t die from a “cardiovascular event.”
And did I mention that the study was funded and run by the drug developer?
Of course that means the study results are bound to be complete and unbiased, right? Because drug developers never downplay “adverse events,” hide data, or spin the results.
Nevertheless, the FDA panel voted 12-11 to approve the drug for preventing heart “events” in type 2 diabetics. So we can expect to see a new advertising campaign promoting it for heart disease soon.
These are the priciest diabetes drugs in history—and Big Pharma wants to keep it that way
Jardiance and its sister drug Victoza are insanely expensive, costing hundreds of dollars per month. Older diabetes drugs such as metaformin are a fraction of the cost, have fewer side effects, and are comparable in effectiveness. The new drugs can also have life-threatening side effects such as ketoacidosis, kidney damage, and in the case of Victoza, even cancer.
Patients don’t want to pay for them. Insurers don’t want to pay for them. Big Pharma needs to find something to make these drugs more attractive to both groups. They did this with Victoza by renaming it “Saxenda” and marketing it as a weight loss drug for diabetics. They plan to do it for Jardiance by marketing it as a heart disease prevention drug. That was the sole purpose of this study.
So don’t fall for the hype. This study has more holes than a sieve, and the missing information makes the whole thing reek to high heaven. If you’re diabetic and you’re concerned about heart disease risk, look to lifestyle rather than a drug solution.