Investors in Afrezza Don't Appreciate Questions

A person that says he is a researcher is calling me out for my recent blog on Afrezza. If he is indeed a researcher, why does he need to hide under a user name? Oh, probably because he may be afraid of exposing his true investing nature in Afrezza.

I do appreciate him for promoting my blog. I am not confused as he tries to portray me, but I will not use Afrezza. I think until many other issues are put to rest, many people will wait and make sure that Afrezza will not end up as Exubera did – being pulled from the market for lack of use. Many of the people posting are investors and are forcing issues like joining diabetes forum websites and in essence advertising Afrezza. Most of the good forums are deleting these posts and when they republish them, they are banned as a participant from the forum. All forums will accept paid advertising, but will delete advertising that is free in this manner.

Some people with diabetes that I have talked to are afraid of what it will do to their lungs and some are afraid of lung cancer. I just tell them that if they are afraid, then wait until Afrezza has been on the market for five to seven years and this will confirm or deny their fear. Others have said the acute bronchospasm that has been observed will cause them not to use it. One said this applies to him as he has been recently diagnosed with COPD and therefore he would not consider using it.

Others in our support group are now saying that the research into smart insulin may be worth waiting for, as rodent testing has been very positive. The researchers are now developing the smart insulin into a therapy for human use. The sad part of this is that it will not be ready for clinical trials for another 2 to 5 years. Presently, this is being targeted for people with type 1 diabetes, but maybe it will become available “off label” for type 2.

Either way, I have to wonder if inhaled insulin will be that popular. It may be among the younger people with diabetes, but without testing in the elderly, many may avoid using it.

Afrezza, Is It the Answer for People with Type 2 Diabetes?

I had not expected to write this, but after seeing this on another blog by Scott Strumello and a comment to it, I felt it was time to open a dialog about it and hopefully see other bloggers write about it.

Several of our support group members have been talking about Afrezza and how they want to see if they will be allowed to use it. Brenda, Allen, and I have decided against it because there is still a big question about determining the correct dose. Tim and Jason are still considering it. Barry has taken a wait and see and warns that it may not even be available to those of us receiving VA benefits. He also wonders if Medicare will allow it.

After reading Scott's blog, we have to wonder from the early hype, will Afrezza even become a product for use in the United States. As of February 3, it supposedly is available in the US, but will every pharmacy carry it.  Currently one local pharmacy has it, but doctors are only prescribing for type 1 diabetes, but not for type 2.  The other pharmacy currently is not carrying Afrezza and offered no reason.  When I first wrote about Afrezza, I had some concerns which are still valid. This has caused me to start listing the pros and cons:

Pros -

• May help many type 2's that have needle phobia
• May help type 2's that are afraid of other insulins
• May be prescribed earlier and not as a medication of last resort

Cons -

• Acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD)
• No testing has been done for the elderly and health illiterate
• No testing on people with diabetes that develop pneumonia
• No testing on people with other respiratory problems that often necessitate oxygen use.
• Hypoglycemia may become an even greater concern with Afrezza

Afrezza is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Even with the hype, there are too many unanswered questions about Afrezza that we have not been provided answers to, as of yet. Many of these questions may be answered after it has been on the market for a period of time.

If you are a person that is using Afrezza, please consider responding to this request at Diabetes Update, as this is one place to put the information to use and spread the word about your results.

FDA Approves Afrezza to Treat Diabetes

With everyone going ga-ga over FDA approving Afrezza, I have some serious doubts about how many people will be able to use it. I know that I will not be one of them. This is because of one thing – I would have difficulty getting the correct dose into my system because of sinus problems which can occur anytime and make breathing difficult. When this happens, I am forced to breath through my mouth.

This is not one of the problems even listed, but if you have this problem, getting the mist into your lungs may be difficult. Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.

With the above information, I would also be concerned about people with diabetes that develop pneumonia. In addition, nothing is mentioned about any testing for the elderly. People at all ages can have respiratory problems causing breathing problems and often the necessity for oxygen use. From the way drug reps promote drugs and doctors prescribe, I can see patients with respiratory problems being prescribe Afrezza. To me it seems that the FDA has missed some information and at a minimum left their brains at home when they approved Afrezza.

Afrezza is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Even then it was approved and it will work for some people and that is a good thing. At least the FDA is requiring some post-marketing studies for Afrezza. These studies include a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric (young people under the age of 19) patients. The second study is a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza. This trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function.

Two additional trials have been ordered. They are pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response, and one to characterize within-subject variability. Both are important and hopefully will help regulate the dosage on an individual basis.

I would hope that individuals with any of the problems mentioned above would hesitate before letting the doctor prescribe it for them. Let the people with diabetes without significant health problems be the ones to find out if Afrezza works for them.