Is anyone listening out there?

Is anyone listening out there?

Yesterday Diabetic Investor attended a session entitled “Updates and Advances in T2DM and Incretin Therapies” presented by David Kendall, MD Medical Director and Chief of Clinical and Professional Services at the International Diabetes Center in Minneapolis, MN, Ralph Defronozo, MD Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center and Richard Pratley, MD Professor of Medicine and Director of Diabetes and Metabolism Translational Medicine Unit at the University of Vermont College of Medicine. The panel was chaired by George Grunberger, MD, FACP, FACE founder and chairman of the Grunberger Diabetes Institute.

Listening to these four distinguished gentleman speak one can only hope that someone from the FDA was in audience. All four of the gentleman plus over 90% of the audience which consisted of more than 330 endocrinologists agreed that GLP-1 therapy is superior to DPP-4’s for the treatment of type 2 diabetes. The panel also noted the many benefits of GLP-1 therapy that go beyond glycemic control. Dr. Pratley noted that the weight loss effect we’ve seen with GLP-1’s is not likely due to nausea nor delayed gastric emptying and this effect appears to be durable. He went out to note that the many positive effects GLP-1’s have on cardiovascular risk factors. Dr. Pratley pointed out that the beneficial blood pressure effects were not due to weight loss although the weight loss does contribute to sustained reductions.

Diabetic Investor spoke with several members of the audience all of whom felt comfortable using GLP-1 therapy with their type 2 patients. Without prompting several noted they are anxious to see Byetta LAR receive FDA approval as they see once-weekly administration as a key to increasing patient compliance. While there was some talk regarding pancreatitis and thyroid cancer, the vast majority of attendees did not believe that GLP-1 therapy actually was the cause of these issues. As one physician noted it’s difficult to establish this link in a patient population that is at greater risk of pancreatitis to start with. He went on to note that he was actually quite surprised the incidence rate for Byetta users was actually lower than the general diabetes population.

Looking at Liraglutide, Diabetic Investor could not find one physician who believed that liraglutide usage would cause thyroid cancer in humans. The general consensus was the drug should be approved by the FDA with some post-marketing surveillance plans to monitor the thyroid issue. The majority of these physicians believed after looking at the risk/reward profile and the difficulty of getting their patients to adequately control their diabetes, the benefits of GLP-1 therapy outweigh any known risk factors.

Given that this people actually treat type 2 patients and have seen the difficulty of controlling type 2 diabetes firsthand one just might wonder what the FDA is thinking these days.   As Dr. Kendall pointed out during his presentation physicians need more tools not less to help their patients better control their diabetes.

The question here is anyone listening to these experts and the physicians who treat patients with diabetes on a daily basis.

On a separate note Diabetic Investor wonders if Carl Icahn was listening to what was being said here. As everyone knows Icahn and Amylin (NASDAQ:AMLN) are involved in nasty proxy fight. One of Mr. Icahn’s claims is that Amylin is wasting money trying to cultivate the primary care physician market. During the presentation the audience was asked several questions, with their responses tabulated automatically using a PDA like device. Based on the responses one thing is crystal clear endocrinologists are already sold on GLP-1 therapy and the long-acting versions of GLP-1 therapy.

Mr. Icahn may take a look at Januvia sales, which the majority of the attendees here consider a lackluster drug. By cultivating the primary care market Januvia is now a blockbuster drug and continues to gain share. This is not happening because endo’s are prescribing the drug this sales increase is directly tied to primary care providers prescribing the drug to more and more of their type 2 patients.

The bottom line here is LAR will only become a mega-blockbuster with primary care providers prescribing the drug. As we have noted before nearly 80% of all patients are treated by a primary care provider. Although Amylin should not simply assume that endo’s will prescribe the drug it’s evident that the majority are pre-sold on LAR and will prescribe it as soon as it become available. PCP’s are different and will need to be sold on the benefits of LAR over existing therapy options. It may seem obvious but it’s difficult to sell a PCP without a sales force that understands diabetes, the needs of the PCP and the unique benefits of LAR. The ultimate success of LAR will depend on how will PCP’s adopt the drug, selling to endo’s alone is a start bit won’t get the job done.