If this no-shot insulin sounds too good to be true, that’s because it is
Don’t buy the hype on this dangerous new diabetes treatment
There’s a new med hitting the market soon that’s exactly what Big Pharma always hopes for.
A drug that patients will not just ask their doctors about, but will demand.
That’s NOT because it works really well, or even because it’s safer than other treatments for people with type 2 diabetes. In fact, this new insulin drug is coming out of the gate with a black box warning.
So why will people be insisting to their docs that they want to try it?
Because it’s an inhalable insulin that can allow you to take fewer shots — possibly even none.
But the “cost” of ditching those insulin needles can be very high.
And I’m not talking about what it will cost you in money, but in terms of your health.
It could even cost you your life.
A billion-dollar deal
The drug is called Afrezza, and it’s a fast-acting, inhaled insulin powder that’s delivered through a small device that looks like an asthma inhaler.
It’s coming on the market already wearing a black box warning — one for acute bronchospasm. That’s a sudden restriction in your ability to breath, just like an asthma attack.
Because of that, the FDA says that people with asthma or lung disease shouldn’t go near the drug. And anyone who is planning on taking it needs to have a thorough examination first to make sure their lungs are healthy enough to use it.
But even those with lungs in tip-top shape can be harmed by Afrezza.
In the drug’s trials they found a “decline” in lung function in those taking the drug — and these were people who had no lung problems at all at the start.
And this damage to the lungs started in just the first 3 months of therapy. Since patients were only tested for two years, the FDA has no idea if they ever got their lung function back to normal even after they stopped using the drug.
But it gets even worse.
Because Afrezza may actually cause lung cancer.
That wasn’t unexpected, especially considering that the only other inhalable insulin on the market had the same terrible side effect.
The other drug was Pfizer’s Exubera, and it was only made for two years. Pfizer “said” it stopped selling the drug for financial reasons — it just didn’t catch on with patients.
But in 2008 — the year after the company stopped making it — it was forced to send a “Dear Doctor” letter out to warn physicians that the drug may cause lung cancer, as well as reduce lung function.
And it had to send that letter out even when there were very few patients who were still taking the drug. That’s just how dangerous it was.
And there’s no evidence that Afrezza will turn out to be any better.
But the FDA did what the FDA does. So now it’s on the market…coming soon to a pharmacy near you.
And that’s not because it’s so much better than injected insulin, either. The FDA’s own scientists had originally said that the drug is only “marginally effective” and may be “risky.”
But the FDA is right on top of that risk. It’s required that a “REMS” plan be put in place. That stands for “Risk Evaluation and Mitigation Strategy,” and it’s a way to see how bad a drug is after it’s approved by monitoring all the guinea pigs — also known as patients — who take it.
Now you may have never heard of the company who developed Afrezza, I know I didn’t.
It’s called MannKind, and it’s named after its founder and head, Alfred E. Mann, an 88-year-old billionaire aerospace and medical device tycoon. And Alfred E. Mann just cut a billion-dollar deal with drug giant Sanofi to market the drug and to handle further dealings with the FDA.
Mr. Mann was apparently totally obsessed with bringing this drug to market. So much so that he kept it financed for years with his own money. And that was after two initial FDA turndowns.
He said that diabetes is a big problem and his company is “committed” to get Afrezza in the hands, or lungs, of as many of these patients as possible.
Keep in mind, this may be a giant leap for MannKind. But it’s a giant risk for you.
Sources:
“Deal with Sanofi means inhaled insulin on US market in 2015” Lisa Nainggolan, August 11, 2014, Medscape, Medscape.com
“U.S. regulator approves Afrezza inhalable insulin” June 27, 2014, The Los Angeles Times, latimes.com
“FDA approves Afrezza to treat diabetes” June 27, 2014, FDA press release, fda.gov


