The Butler Did It

The Butler Did It

According to Webster’s New World dictionary a zealot is defined as “a person who is zealous, esp. to an extreme or excessive degree; fanatic.” Unfortunately the diabetes world has been invaded by zealots before and based on the way things are going it’s likely to happen again. The most recent example and almost picture perfect example of a diabetes zealot is that crusading cardiologist Dr. Steven Nissen, the creator the Avandia controversy. Just as Dr. Frankenstein could not invasion the havoc he created when his experiment ended up being a monster, the good doctor could have never imagined the havoc he has created for the FDA and any company trying to get a diabetes treatment approved.

Today we have another candidate for the diabetes zealot category, Dr. Peter Butler the director of the Larry Hillblom Islet Research Center David Geffen School of Medicine at UCLA. Just as Dr. Nissen went after Avandia, Dr. Butler seems intent on getting the blockbuster drug Januvia pulled from the market while at the same time stopping physicians from prescribing any GLP-1.  Dr. Butler, like the good doctor, has an impressive resume and a fondness for attention. Diabetic Investor isn’t quite sure but we’re beginning to believe that Dr. Nissen and now Dr. Butler, crave the spotlight likes a diabetic patient going through a severe hypoglycemic event craves sugar.

Where the two zealots separate is their specialties, as everyone knows the good doctor is not a diabetologiest or endocrinologist but a cardiologist, so his rather off the wall views on diabetes can be excused as being a cardiologist he hasn’t been trained in diabetes and therefore knows practically nothing about diabetes. Dr. Butler however is a different story, according to his bio which can found at http://www.lhirc.med.ucla.edu/PB_Pubs.htm, “Dr. Peter Butler underwent training in internal medicine in Edinburgh and Newcastle upon Tyne in the UK. He then underwent training in Endocrinology at the University of Newcastle upon Tyne and then at the Mayo Clinic in Rochester MN where he was also a research fellow. He was then appointed to a clinical faculty position at Mayo Clinic in Endocrinology, Diabetes and Metabolism.”

So unlike Dr. Nissen who actually has an excuse for being ignorant regarding diabetes, Dr. Butler based on his resume has none. One just might think that a well-educated person trained in diabetes would understand that diabetes is a complex disease state and that patients with diabetes are at greater risk for developing pancreatitis just because they have diabetes. One might also think that someone who’s been around diabetes for most of their adult life might also understand that we need more not less weapons to help fight diabetes. That what Dr. Nissen did actually did more harm than good and that if you’re going to go after a blockbuster drug and the most promising class of new drugs you better not base your accusations on fuzzy math.

It’s also not a good idea to submit a commentary on a flawed study which contains factual errors. According to the director of media relations for the JAMA Network, the commentary Dr. Butler wrote entitled “Glucagonlike Peptide 1- Based Drugs and Pancreatitis Clarity at last, But what about Pancreatic Cancer” was pulled from the JAMA Internal Medicine web site after the publication discovered the commentary may have contained factual errors. Now JAMA has yet to reveal who discovered this error or how the commentary made its way onto the web site before being properly vetted, but it should be noted that the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists  (AACE) issued a joint statement condemning the study which promoted the commentary.

The statement reads as follows;

“The American Association of Clinical Endocrinologists  (AACE) and the American Diabetes Association believe that the study by Singh et al, Glucagon-like Peptide 1-Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus, published online February 25th in JAMA Internal Medicine does not provide the basis for changing treatment in people with diabetes. Fortunately, there will be new data available relatively soon which will allow physicians to definitively assess risks and benefits of this class of medicines.

The analysis is a retrospective study using data from an administrative database. This type of analysis is not considered as robust as a prospective randomized controlled clinical trial, the gold standard for evaluating treatments. There are currently nine ongoing, prospective, controlled trials of GLP-1 based therapy with over 65,000 subjects, which should provide answers to these important safety questions.

While there are risks and benefits associated with any therapy, the retrospective analysis indicates GLP-1 based therapies are associated with a relatively small excess risk of hospitalization for acute pancreatitis, with only two additional cases per 100 patients over a three-year period. This same population of adults, between the ages of 18-64 with type 2 diabetes, had a greater risk of hospitalization for acute pancreatitis if they used tobacco, consumed alcohol or were obese.

As with any therapy, we encourage patients to speak with their doctors to assess which treatments are best for them and to not stop therapy on their own without consulting their doctors.”

Now Diabetic Investor does not want to be overly harsh on Dr. Butler and did reach out to him, via email and telephone, to get his side of the story. Given how much fun we had exchanging emails with Dr. Nissen, Diabetic Investor hoped Dr. Butler would take the high road and have an adult conversation, not act like a spoiled little child whose feelings have been hurt because someone dared to tell him that he’s really not as smart as he thinks he is. However, no such luck just yet as we have yet to hear from Dr. Butler. Let’s hope when we do, he does not copy Dr. Nissen in handling the media or at least any media outlet that knows more about diabetes than he does. Given that Dr. Butler actually knows something about diabetes we suspect it will be a much more intelligent and enjoyable conversation.

Still we have to wonder what he hopes to accomplish with his quest. Does he really believe that physicians will stop prescribing Januvia, Byetta, Bydureon or Victoza? Does he believe the FDA should take some sort of action regarding these drugs? Let’s hope he doesn’t want another circus in Washington D.C. like we had with Avandia.

As we noted yesterday there are numerous studies on this subject and contrary to the title of the withdrawn commentary there is no clarity on the issue. The reality is Januvia and Janumet are a $6 billion franchise and GLP-1’s are the fastest growing segment of the diabetes drug market. Physicians are well aware of the risk/reward profiles for both Januvia and GLP-1’s, they are also well aware of the risk of not having these drugs in their diabetes weapons arsenal. Like Diabetic Investor, these physicians must live in the real world and are not tilting at windmills. Each day they see the devastating impact of what happens when patients aren’t under good control.

So again we would love to hear what Dr. Butler has to say and let’s hope he does not cop out and say something like he’s just expressing his point of view to stir further debate. We have no problem with the doctor expressing his views, however we have a huge problem when those views are one sided lacking a full understanding of diabetes. We’ve been down that road already with the crusading cardiologist and don’t need another Avandia like controversy. Let’s hope this time that the butler didn’t commit the crime.