I was curious about your thoughts on the article’s content. Zachary Bloomgarden must be a big pain for Mannkind because he’s really the only doctor I read about that seems to be outright against Afrezza. His article on Afrezza is old, and I’d really like to hear if his perspective has changed.
Also, I think Nasser missed some of the benefit of Afrezza’s fast-action. The article quotes him saying he would consider prescribing for the following groups only,
“First, patients with type 1 diabetes who are taking basal insulin once daily, but prefer to take their prandial insulin in the inhaled formulation; second, patients with type 2 diabetes uncontrolled on oral agents, and are reluctant to start subcutaneous insulin due to needle phobia or other reasons; third, patients already on subcutaneous prandial insulin who develop frequent late post-prandial hypoglycemia (4-5 h after meals); fourth, patients who develop skin reactions to insulin subcutaneous injections such as lipoatrophy or lipohypertrophy.”
I love physicians that are against something, they generally present really cogent arguments that often help the patient understand the mechanism and issues present with a treatment that would otherwise be hidden to most patients.
They also allow a patient to weigh the issues in their mind with a better understanding of both sides of the argument and then make an informed decision on what is best for themselves.
In Exubra’s case, it would feel horrible to be a physician that prescribed something and then exposed their patients to increased risk of lung cancer. ouch. Cases like this often lead physicians to get very conservative, especially physicians (like endo’s or GP’s) that have longstanding relationships with the patient.
I think there are also great arguments about why Afrezza might not have the same risk of lung cancer. But ultimately, the patient needs to understand the risks and make their decision.
Not a single mention of the many benefits of afrezza, but a detailed exploration of every concern and possible risk, even exploring the risk profiles of previous inhaled insulins and then linking them to afrezza, but then acknowledging that it’s completely different and likely not relevant.
Strikes me as a pretty biased write-up. With any medication, risks (real or not) can only possibly weighed against rewards.
I don’t know if this can be said for all physicians that are against something, but I do agree that a good physician would inform a patient of the risks and let them make their own decision.
I think what bothers me most about Dr. Bloomgarden is his 2014 article. I see this article quoted all over the place!
For example, he says this: “Seven-point glucose profiles in the type 1 studies (measuring the blood glucose before and after each meal and at bedtime), showed consistently higher glucose levels with Afrezza before and after lunch and dinner and at bedtime, so that less hypoglycemia and less weight gain might simply be a function of having taken what amounted to a less effective insulin.”
I think high preprandial and bedtime blood sugar levels might show that a higher basal rate is needed and high prostprandial blood sugar levels would indicate that not enough insulin was given. Instead, he concludes that Afrezza is less effective. He fails to acknowledge that no insulin works the same and adjustments are always needed any time a new insulin is started.
Well not to be a debby downer here, but honestly, physician communication and research will always be geared towards the risk and the benefits profile. Clearly in the Afrezza case the benefits have been shown in the initial study and research, and the risks are what is unknown and therefore the most interesting. Having had to notify physicians whose device choice in a patient was recalled, they are really upset when this happens, and likewise when they prescribe a drug and it proves to be detrimental to the health of their patients they are also very upset.
Now asking for unbiased opinion pieces like you have linked to, is like asking for water to not be wet.
Here is what at least one non-Afrezza user (me) is dealing with: My lung capacity is one of the things I like the best about my 61 year old self and keeping my BG levels and self worth where I want them demands that I work out hard not easy. How can I do that if I am coughing or short of breath? I’m NOT trying to rain on anybody’s powder parade but just giving the alternate view from my vantage point. I don’t want to take the risk unless clinical studies aimed at Type 1’s similar to me show the risk of me inadvertently screwing up my lifestyle is minimal. Do such studies exist?
If I can keep a reasonable A1C hovering around 6 using Humalog MDI, is there a good reason to switch to inhaled powder if it means risking my current lifestyle just to make it a little easier to control post-meal spikes? Right now my “time in target” reported by F Libre is 80% for past 7 days, target range 70-150. I’ve had those same bad spells as everybody where post-meal spikes are a problem and seem uncontrollable. I prefer to tinker with Humalog corrections when those bad spells hit.
Here’s the quote I tried to thread in above: “Even with careful screening, giving Afrezza only to volunteers who had normal lung function and who had never smoked or had quit smoking at least six months before starting the treatment, about one in twenty had a 15-20% reduction in the FEV1 and about one in forty had a reduction by more than 20%.” (Darn computer stuff, I am getting out of practice!)
I shouldn’t have linked the article. It’s full of misinformation that has been contradicted in later studies. I’m sorry for linking it. Here’s a study that assessed Afrezza’s impact on lung function:
“The difference in decline in FEV1 from baseline to 24 mo between the TI-treated group and usual care group was small but statistically significant: 0.037 liters (95%CI: 0.014 to 0.060)[14]. However, after 3 mo, the rate of change in respiratory parameters was not statistically different between patient groups. This suggests that worsening of pulmonary function in patients treated with TI occurred early in the first 3 month, and do not progress further up to 2 years of follow-up.”
and this study:
“Treatment group difference for mean change from baseline in forced expiratory volume in 1 s was small (40 mL) and disappeared upon TI discontinuation.”
I respect your decision to choose not to use Afrezza, but please don’t base it upon a reference to Bloomgarden’s horrid article in my post!
Everyone has to make their own choices, @John58. And I am not arguing with you here, just clarifying and musing.
My lung capacity has actually improved over the 2 years I have used Afrezza. I am in no way relating the improvement to Afrezza use - it is likely from my weight loss. Due to my physiology and weight, I do have a reduced (obstructed) 1s FEV already. I do work out hard and it never affects me.
To clarify, a cough from Afrezza is a reaction to your body not being used to inhaling the insulin, so that is a bit overstated. A cough usually goes away after a couple weeks of use.
On the subject of studies, the official FDA reports say:
In the registration trials 2 heavy smokers developed lung cancer—1 while in a controlled comparative clinical trial and 1 while in an extension. This incidence of lung cancer (0.8 cases per 1000 patient-years)2 was felt by the company to be within the range of lung cancer observed in the general population (approximately 0.23-1.22 cases per 1000 patient-years, according to the American Lung Association)
and
At the Afrezza panel hearing on April 1, 2014, the FDA reviewers raised the issue of whether inhaled insulin causes preexisting lung cancers to grow more quickly than they would otherwise grow
More recent studies have even caused the black box warning to be removed by the FDA.
However, I fully understand someone not knowing if they have pre-existing lung cancers and not wanting to risk it.
Thanks and also thanks Katers for the info. When I play ice hockey I usually have great stamina and feel like it’s the most valuable part of my game that has not declined with age like the rest of my body. For that reason I’m feeling super protective of it.
A more lucid description of my attitude is a general feeling that a lot of clinical studies don’t necessarily apply to me based on the cohort of A1C’s they include in the studies which are usually higher than mine. I realize that is an attitude that can not be addressed by more clinical studies so I guess that leaves me rooted in place with my Humalog MDI. At least for the time being. The march of time with Type 1 seems to inevitably lead to changes in BG control strategies and I try to keep an open mind.
Pretty awesome that you’re playing ice hockey at 61!
I’ve spoken to another very athletic person who was concerned about pulmonary function as well. He chose to use Afrezza occasionally rather than regularly.
I think @Sam has mentioned a few athletic people in this forum that use Afrezza, but I’ll have to look for those posts to see who they were.
I can’t read the entire reply because I have email access only. But I can tell you there are quite a few serious athletes using afrezza and it is an absolute non issue.
