Last
week, the FDA approved a new kind of insulin that doesn't need to be
given by injection. It is inhaled, and it's for both types 1 and 2
diabetics.
Could this be what those with diabetes have been hoping for -- an
insulin treatment that can allow them to take fewer shots, or even none
at all? It sounds too good to be true.
And it is.
In researching this new insulin, I found some very important things that your doctor may not tell you, or even know himself.
It will be hitting the market very soon. So before you're told about
this "pain free" and easy way to take insulin, here's what you need to
know right now.
No free lunch
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!
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.
It looks like Afrezza may actually cause lung cancer.
That makes sense, 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. It went ahead and approved it anyway.
Now don't think that's 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 Mr. Mann apparently was 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
getting 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.
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