Today the diabetes world is abuzz with talk of tomorrow’s FDA panel meeting for Afrezza, the inhaled insulin from MannKind (NASDAQ:MNKD). Looking over the various news and analysts notes it appears that Afrezza is in big trouble and may actually NOT be approved by the panel. These reports are based largely on the documents posted on the FDA’s web site ( which are related to the meeting. Based on these various reports and subsequent FDA documents shares of MannKind are in a free fall today already down some 14%.

Now Diabetic Investor hates to gloat but in this case we will as we’ve been saying that FDA approval of Afrezza was by no means a certainty and even if the drug did receive full FDA approval it would never be the multi-billion drug many thought it will be. Honestly the FDA panel would do everyone a huge favor by voting NOT to approve the drug. This would end all the nonsensical talk about how Afrezza will revolutionize diabetes treatment.

Just as a way of teasing everyone Diabetic Investor will have much more on the MannKind situation tomorrow. While we don’t want to let the cat out of the bag just yet let’s just say that MannKind executives and certain stakeholders aren’t overly upset seeing shares tank. Stay tuned.

Now getting back to this buzz that the panel will actually, heaven forbid vote no tomorrow, the real question is why everyone is so damn surprised. Honestly the data on Afrezza really isn’t all that compelling. About all the drug really had in its favor is the fact that it’s inhaled rather than injected. That’s why Diabetic Investor was always so amused when the so-called experts touted Afrezza as it was as if they didn’t actually read any of the study data which basically said this was an ok if unspectacular drug and had it not been for its delivery system would have never received the attention it has received.

The simple fact is these so-called experts do what they always do; they ignore the facts and make the data fit their preconceived notions of what diabetes treatment should be. This is same phenomenon was just covered last week when we wrote about the quest to develop an artificial pancreases, a quest which quite frankly stands a better chance of becoming a reality than Afrezza becoming a successful diabetes treatment, which given the circumstances that’s really saying something.

Now if anyone really wants to drive these folks crazy have the guts to tell them “While newer treatments and devices are always appreciated we can manage diabetes quite nicely with the current crop of drugs and devices already on the market.” In the real world, again a place that seems off limits to these so-called experts, one issue that never gets discussed is the lack of patient compliance, simply put if the patient actually took their meds as prescribed we wouldn’t have nearly two-thirds of patients not achieving control. Diabetic Investor has spoken with hundreds of primary care physicians, as they treat nearly 80% of all patients with diabetes, and a constant theme heard universally is that patients aren’t compliant with their therapy regimen.

Yes we know this would be akin to saying that the patient should take some ownership of their diabetes management, that there is such a concept as personal responsibility.  Just try and broach that subject with these so-called experts, now we should warn everyone as expect to see one great hissy fit. Diabetic Investor isn’t sure when this happened but many of these so-called experts seem to believe that patients should not be held responsible for their diabetes management, that we need new drugs, simpler to use devices because managing diabetes is just too damn hard. While Diabetic Investor does not disagree that new and hopefully better drugs will make a difference or that devices should be more patient friendly. However the simple fact is with every so-called innovation or improvement in drugs or devices we have not seen a corresponding reduction in the number of patients achieving control.

Alternate site testing, smaller blood samples, combination medications, smaller less painful needles, once-daily meds, once-weekly meds, smarter insulin pumps and continuous glucose monitoring systems all innovations over the past 5 years or so have not resulted in better overall patient outcomes. Patients still don’t test their glucose as frequently as they should, studies have shown that patients actually skip insulin injections even though they know they shouldn’t, other studies have shown that patients would actually sacrifice years off their lives than to do all things they supposed to do to properly manage their diabetes. Will someone please explain to Diabetic Investor how new drugs and/or new devices would change any of this.

Listening to these so-called experts one would believe that diabetes is not manageable with the tools we have available, that it’s not the patient’s the fault it’s the system that has failed. While diabetes is not easy to properly manage it is manageable. Yes better tools would be nice but they are NOT the answer. Better drugs would be great but they aren’t the answer either. The 800 pound, more like two ton pink elephant standing in the center of the diabetes room which these so-called experts ignore is that the most effective tool for getting patients to properly control their diabetes, proven by hundreds of studies, is patient education. But here too the so-called experts dismiss the notion that heaven forbid a patient get this education because diabetes isn’t their fault.

The bottom line here is too many folks in the diabetes world are looking for the silver bullet, some magic potion, and secret formula or way cool whiz bang device that will manage diabetes without interaction from the patient with diabetes. Yes that sure would be nice but in the real world that isn’t about to happen anytime in the foreseeable future. Isn’t it about time we acknowledge this fact and do whatever we can to help get these patients the education they desperately need? Or should we continue to pursue pie in the sky ideas which may never actually work? Diabetic Investor unfortunately already knows the answer and so does most everyone in the diabetes community – very sad but very true.