How much evidence do we need?

How much evidence do we need?

According to a new study scheduled for presentation this week at the Academy of Managed Care Pharmacy’s 23rd annual meeting and showcase in Minneapolis, patients with diabetes who adhere to their medication therapies have a significantly lower risk of hospitalization. The study, conducted by pharmacy benefit manager Prime Therapeutics using data from more than 15,000 patients, found that medication adherence among diabetes patients cut the risk of hospitalization by 31%, compared with patients who were not compliant.

While this particular study does not reveal anything that was not already known, the results are significant as they reinforce a growing trend in diabetes drug development where less is more. This trend actually began with the introduction of Lantus, the first long acting insulin. Physicians embraced Lantus as it was simple to dose and for the majority of users required just one injection per day. Looking at the earnings announced last week by Novo Nordisk (NYSE:NVO) and the gains being made by their once daily GLP-1 Victoza®, it’s becoming obvious that physicians and patients prefer therapy option which are not only safe and effective but require less frequent administration.

This is also very good news for Bydureon from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS), which is administered just once a week. Although Diabetic Investor has always known that Bydureon has the potential to be a game changing product there are many who continue to doubt the drug. First these doubters said Type 2 patients would not embrace any drug which is delivered via injection. The success of Lantus and now Victoza prove that patients are not adverse to injectable therapy options. Once the injection myth was disproved the doubters came up with a laundry list of reasons to reinforce their Bydureon doubts.

What these Bydureon doubters have never understood is that diabetes is not just a chronic disease but a lifestyle. They never understood what a patient with diabetes goes through each and every day of their lives. They never understood that the majority of patients with diabetes want to live their lives with diabetes and not for their diabetes. This is what makes Bydureon such a compelling option, as patients can administer the drug just once a week in complete privacy. No glucose monitoring, no complex calculations to determine the correct dose, little concern over hypoglycemia and the additional benefit of at minimum the drug is weight neutral and in many cases produces measurable weight loss.

Physicians, in particular primary care physicians, understand and what this and other studies have confirmed is that medication adherence or lack thereof is a key reason why more than two-thirds of all patients are not achieving proper control. They also understand that it really doesn’t make a difference how a drug is delivered. The central fact is the majority of patients with diabetes are not only taking multiple medications to control their diabetes but taking additional medications for their other medical conditions. According to data provided by Healthy Outcomes, 76% of patients take medications for conditions other than their diabetes. Additionally 42% of patients take 4 or more medications each day.

What makes the case for Bydureon even more compelling is that it reduces the patient’s diabetes medication regimen to one simple injection administered just once a week. The patient does not have to carry around any pills, syringes or a glucose monitor. They don’t have to worry about what they eat or when they eat. There is no need to find a private area so they can take their insulin. Although diabetes is not contagious there is tremendous vanity factor associated with diabetes. The simple fact is for many patients they don’t want their diabetes to be public knowledge.

Still with all this compelling evidence there are still those who continue to doubt that Bydureon can be a game changer. Just as we’re sure there were many who doubted that we would never hear the words; Osama Bin Laden is dead. Yet, thanks to the brave Navy Seals and persistence of our brave men and women in uniform, the worlds most wanted terrorist is now fish food. Although the fight on terror is not over the USA has dealt a serious blow to terrorists around the world.

Let’s just hope that the FDA does not make the millions of patients with diabetes wait 10 years for their day of reckoning. Bydureon won’t need the diabetes epidemic but it has the potential to help millions of patients take control of their diabetes. As Diabetic Investor has noted on far too many occasions we need more, not less, weapons to fight diabetes. The key question is; will the FDA join the fight?