Waiting to Exhale
Will Exubera find new life as a Type 2 insulin?
NOTE: The inhalable insulin Exubera was discontinued in 2007. Read more here.
On January 26, 2006, diabetes was afforded a sort of celebrity status in the mainstream press when headlines across the country read, "FDA Approves Inhalable Insulin." Nearly one year after its market launch, however, many people with type 1 diabetes who take insulin are retreating away from Exubera. According to an April 10, 2007 New York Times article, despite Pfizer's marketing efforts, "Exubera receives only about one of every 500 prescriptions for insulin written in the United States."
Daniel Einhorn, MD, FACP, FACE, is a clinical professor of medicine at the University of California, San Diego. In discussions with diabetes patients and professionals, the sentiment he most often hears regarding Exubera is that it is a fine option. However, patients are telling him that shots were never really all that bad.
"The person with diabetes has experience with how painless, quick and easy injectable insulin is," states Einhorn, who is also the medical director of The Scripps Whittier Institute for Diabetes. "Needles and insulin pens have simply become so good that using them is no obstacle once you have taken that first injection."
One Exubera User's Experience
Meredith Cummings, a type 1 from Tuscaloosa, Alabama, says that her Exubera experience was a big disappointment.
"I was diagnosed 21 years ago, and when you wait 21 years for something like an inhalable insulin, your hopes can get really high," says Cummings, who didn't expect to go off shots entirely (she would still need her once-daily, 16-unit injection of Lantus); she was just looking to simplify.
For Cummings, however, simplification came with a price: control.
"The thing that got me was the lack of accuracy with the dosages," says Cummings. "I had been on the insulin pump for seven years and I got used to being accurate. Then I went back to shots and was not quite as accurate. With Exubera, however, it was such a guessing game. I started having severe highs and lows frequently. One day, I would be 25 mg/dl and the next 500 mg/dl; I couldn't find a middle ground."
Cummings, who is back to taking her morning shot of Lantus and her meal-time boluses with Humalog, says her control is back to normal.
Calling All Type 2s
Exubera still has the potential to be a blockbuster drug. That potential, however, may reside in the type 2 market.
More people with type 2 diabetes actually take insulin than do people with type 1, making this an untapped and potentially lucrative market for Pfizer, especially type 2s who require small amounts of insulin but are afraid of shots.
"The place I see Exubera being really useful is in getting type 2s onto insulin right away when their A1cs get above 6.5% or 7%," says Nancy Bohannon, MD, FACP, FACE, of Monteagle Medical Center in San Francisco. "Not waiting until they are at 8% or 9% or even higher, or have been in the 7s for five years. We want to get them under good control and keep them under good control in order to avoid complications. This means starting insulin, on average, five years earlier than it is currently being started. Hopefully Exubera will allow us to easily accomplish that, even in needle-fearful people."
Jane Jeffrie Seley, GNP, MPH, MSN, CDE, diabetes nurse practitioner, New York Presbyterian-Weill Cornell Medical Center in New York City, tells dLife that a study of the consequences of delaying insulin therapy (Diabetes Care, 2004 Jul;27(7):1535-40) found that if the A1C is over 7%, it usually takes ten years to convince the patient to go on insulin. If it's over 8%, it usually takes five years.
"I know how difficult it is to get some patients to take that step and go on insulin," says Seley. "For that percentage of patients who are extremely needle phobic and unwilling to go on insulin, if I can get them to take Exubera, I'll be able to help them achieve better glycemic control and they are going to be better able to avoid complications. And that's why it's a useful tool."
Seley says she would restrict prescribing Exubera only to a type 2 who needs a meal-time insulin but is unwilling to take injections.
"If you have asthma, other respiratory conditions or have smoked in the past six months, I would not recommend it."
A Type 2's Story
Tony Olivieri of Chicago, Illinois, is one such type 2 who requires insulin but has always been needle phobic. Diagnosed with type 2 in 1977, Olivieri was placed on oral medications. He describes the first ten years of having diabetes as being a "roller coaster ride."
"My glucose readings became progressively worse [and] my type 2 had gotten very much out of control," says Olivieri. "My glucose levels were at times in the 300+ range, and my A1C was over 7% and sometimes higher.
After numerous attempts to correct the problem, Olivieri's doctor told him he had no choice but to begin using insulin.
"This was in 1987," says Olivieri. "Although I was a beat cop working in the streets of Chicago, the thought of injecting a needle into my body was horrific. So, I would not always take the required shots."
Not taking his insulin shots only worsened Olivieri's control. He actually started taking Exubera in 2002 as a clinical trial participant. He now takes it as a meal-time insulin, the amount of which is determined by the amount of carbs he is about to consume.
"The more carbs I consume, the more insulin I take," says Olivieri, who is grateful to now be in control of his diabetes, instead of it being the other way around.
He also loves Exubera's simplicity.
"…Insert an Exubera ‘blister' containing the powdery insulin into the inhaler, cock the dispersal mechanism, push the button to puncture the blister, inhale the insulin, and presto! No pain, no needles to lug around or to dispose of, no liquid insulin to refrigerate..."
Olivieri has noted a difference in his A1Cs as well, which he says are now around 6.4%.
Where Does Exubera Go from Here?
When asked to comment on Exubera and goals for its future, Olivier Brandicourt, senior vice president and general manager of Pfizer's Metabolic and Cardiovascular Division told dLife, "We are focusing our efforts on working with physicians to highlight the benefits of earlier insulin use, educating the healthcare community on how to use Exubera and providing a support network to ensure a positive experience for patients.
When asked about Exubera as a treatment option for type 2s, Brandicourt says, "Type 2 diabetes is a progressive disease and many patients eventually get to a point where diet, exercise, and pills are no longer enough to control their blood sugar levels. Yet many delay moving to the next stage of their treatment."
Brandicourt says Exubera can significantly improve blood sugar levels when pills are no longer enough and can help patients control their disease.
"It provides another option, one that gives good blood sugar control and high patient satisfaction."
Jalapeno Broccoli Mojo-Lime Chicken Wilted Kale and Cannellini Beans with Garlic Cauliflower Salad Grilled Chops with Spicy Red Pepper Sauce Citrus Spice Snack Cake Cappuccino Ice Sausage and Bean Salad Turkey-Beef Kabobs Cauliflower with Cheddar Sauce
If you listen closely, you may hear the sound of 25 million Americans with diabetes rejoicing today. In a revolutionary movement, the FDA has given 510(k) approval on Abbott's HbA1C test which is expected to help millions of Americans with Type 1 or 2 diabetes or those at risk. Abbott's ARCHITECT Clinical Chemistry Hemoglobin A1C (HbA1C) test is a dramatic shift in diabetes diagnosis and monitoring. Instead of the HbA1C tests performed at a laboratory and constituted as blood work, the...