I sent a letter to our diabetes clinic, explaining that I felt they were endangering my son by not prescribing him Afrezza, since he has to use huge amounts of insulin on peaks that, more often than not, result in lows, when they could prescribe a very fast acting, no-tail insulin.
The convened a meeting of all movers and shakers: the treating endo, the diabetes director, clinic director, and two (great) nurse practitioners, and spent two hours with us discussing options. They offered us:
the 670G, which will worsen the A1c for us
amylin injections, which are not effective for random peaks
But no Afrezza. They told us we could try the clinical trials. I looked up the pediatric clinical trials online this afternoon, but my son is not eligible: they only take people with an A1c between 7.0 and 10.0.
Their reason for refusing to prescribe Afrezza is that, because insulin is a growth factor, it could be much more dangerous for a kid’s lung tissue, in particular in facilitating tumor growth.
Sorry, I know that is not the outcome you were looking for. Do you feel their reasoning for rejection has any basis? Or are they just being overly cautious in your opinion?
Are they suggesting that it causes tumors? That would be quite different from a concern that if he already has a lung tumor it would grow faster: Given his age, if he already has a lung tumor it will need to be dealt with in any case, so in this latter case I don’t understand their issue beyond general physician timidity.
I feel they are being quite inflexible in their approach: they don’t want the headache and the risk.
But I don’t deny there is some risk, until the research has been done. My point to them was: the risk we know is a bad low event, and the clear danger of diabetic complications if my son’s peaks continue; the risk we don’t know is Afrezza, but is it worse than the risk we know? Likely not. They didn’t budge though.
I feel it was a meeting that was driven by legal, because I essentially wrote that they are responsible for a bad low if one happens to my son.
I should look into this.
That is primarily what they mean; that and concerns of endangering the completion of lung tissue growth.
Insulin levels are correlated to cancer risk, so I understand the vague concern. On the other hand, your son’s baseline rate of getting lung cancer at his age (presuming he is a non-smoker) is pretty tiny. So even if affrezza increased the risk of cancer three-fold, that risk would still be tiny in comparison to the risk of retinopathy, kidney disease, neuropathy, and cardiovascular disease that are exacerbated by high blood sugar numbers.
From the doctors’ perspective, though, those two risk profiles can’t be weighed equally. On the one hand are complications they can, perhaps, better prevent with treatment but in no way directly cause, because it is an underlying risk associated with T1D. On the other hand is a treatment that could potentially induce a deadly disease that would never have otherwise occurred, even if the risk is very small overall and is totally unquantified. That drug is also not FDA-approved in children, so if prescribed off-label, they could be facing some censure. So from a liability perspective I understand the decision.
Many people are having excellent results with this… I would not dismiss it based on the very few accounts we’ve seen on this forum, the t1 Facebook groups are ecstatic about these
We use our pump in a very flexible manner through many different modes of operation and activities, sports or otherwise. Having great in great detail as much about the experience of new adopters, I feel that (a) nights would be better for us by a large margin, but (b) there is a lot we do today that we would not be able to do with the 670G, and (c) my control engineering background tells me that the 670G cannot deal with peaks.
Essentially, the strength of the 670G is to control small variations around a constant or slowly varying basal. That’s what its algorithm is good for. A night without a strong hormone peak is perfect ground for the 670G (although I am not sure that it will deal well with repeating phenoms such as dawn phenomenon)—the rest of the day won’t work well for us.
Unfortunately for this case, I suspect once a practice has made a decision to strictly stay on-label with any product I highly doubt any amount of protest by the patient or the family will accomplish much…
Honestly if I was a doctor I wouldn’t prescribe it to children until it’s approved either… I’d be strongly advocating its approval, but all they’re doing is exposing themself to liability by going off label… and for what, in their perspective?
There has been no response correlation between Afrrzza and lung cancer. 2 smokers in the clinical trial developed lung cancer, and later 2 non-smokers did. Even the FDA couldn’t see a correlation there.
I personally believe there is little or no risk unless someone is already predisposed to cancer.
There are a good number of kids using it off label - and doctors prescribe off label drugs all the time - but they need to be comfortable in the potential risk and liability.
I am finding a lot of doctors are only willing to prescribe Aftrzza, even to adults, after it has been proven thru use.
I’m just going based on the social media reports. I’m not sure. I can poke with a few people that may know. Very unlikely it is in the Midwest, from my experience.
Grrrr… that type of government/insurance/pbm micromanagement makes me so frustrated. I wish there were no such thing as a prescription so we could just experiment at will and Darwin would rule. I hope you find someone that will work with you somewhere. My primary care doc will pretty much do anything I want him to (labs/prescriptions) since he feels sorry for me but won’t appeal insurance or to pre-auths so I’m stuck out of pocket for weird things and I don’t like spending money that I’ve worked hard for and don’t have to spend.