This past Wednesday an FDA panel voted not to approve Lilly’s Jardiance as an add-on therapy for patients with Type 1 diabetes. We weren’t surprised by this vote as quite frankly the data wasn’t overly compelling. What did check our eye was this from a company issued press release;
“With about 40,000 Americans diagnosed with type 1 diabetes every year, we see today’s meeting as an important means of elevating the discussion around the challenges of managing blood sugar levels for those with type 1 diabetes and the need for new treatment options,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We continue to believe the totality of data from the EASE program indicates a favorable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes and look forward to continuing to work with the FDA in this review process.”
Let us say from the start we are not against any attempt to help patients with Type 1 diabetes more effectively manage their diabetes. However the statement from Dr. Eid which noted that about 40,000 Americans are diagnosed with Type 1 each year does show how sometimes things are just a little off kilter in our wacky world. The fact is and we’re sure we’re going to get in trouble for saying this Type 1 diabetes gets far too much attention or perhaps we should say patients with Type 2 diabetes do not get enough attention.
The facts, yes, those pesky facts, are patients with Type 2 diabetes vastly outnumber patients with Type 1 diabetes. Yet for reasons we have never quite understood this minority of patients gets more attention than the majority of patients. Type 1 patients are catered to achieving royal like status. While patients with Type 2 diabetes are treated like the ugly sister no one wants to be seen with. The lone exception are the millions of insulin using Type 2 patients, but even these patients are considered inferior to their Type 1 brothers and sisters.
We have long maintained this bias towards Type 1 patients not only exists but is bad for business. Diabetes besides being a chronic disease is also a lifestyle and the facts are Type 1 and Type 2 patients live very different lifestyles. Yet for reasons we have never understood drug, device and now coaching companies design their platforms with Type 1 in mind, not Type 2. Falsely believing that patients with Type 2 diabetes will respond to the same stimuli as patients with Type 1 diabetes.
This bias also is prevalent in the analyst community and limits their understanding of the potential of various drugs and devices. CGM adoption is a perfect example of how this bias limits their thinking. To most analysts CGM is a tool for Type 1 patients when in fact it’s a tool for all patients with diabetes regardless of how they manage their diabetes. These analysts just can’t comprehend that non-insulin Type 2 patients will just use this valuable tool differently than Type 1’s.
The same goes for the recently approved oral GLP-1 from Novo Nordisk Rybelsus. Because the GLP-1 market is expanding and because Rybelsus is the first oral administered GLP-1, the analysts believe it will be a surefire blockbuster. The analysts dismiss the complex dosing regimen for Rybelsus falsely believing patients will follow the instructions to the letter. It sure would be nice if they did but this is not how things work in the real world, a world in which patients forgot 95% of what their doctor said the minute they walk out of the office.
We’re guessing that when the Intracia exenatide micropump is approved by the FDA and Intarcia goes public, these same analysts will fail to understand the elegant simplicity of this device. That will see that the micropump must be inserted into a patient’s body and that one fact alone will prevent them from seeing the true potential of this GLP-1 delivery system.
Yet drugs and devices aren’t the only area where analysts are missing the boat as they look at company like Livongo and believe that patients will embrace being coached. That this embrace will be long lasting. Our experience says that while some of these patients will embrace being coached most will not. They might for a short period of time but since there are no tangible, touchable rewards for following this coaching they will eventually go back to their old habits. This does not mean that the coaching is not valuable, it is. However as every head football coach knows coaching alone does not win the game, it’s the players who must execute.
It would be wise if the analysts and companies looked at diabetes not just from a clinical perspective but looked at diabetes from a lifestyle perspective. Just as people in general have vastly different lifestyles, patients with diabetes are no different. What works for a Type 1 does not necessarily work for a Type 2. Or as the old saying goes all German Sheppard’s are dogs but not all dogs are German Sheppard’s.