Does the Butler have a partner in crime?

Does the Butler have a partner in crime?

Just when it seemed this flap over pancreatitis and GLP-1 usage couldn’t get any stranger, the British Medical Journal (BMJ) has decided to add their two cents with the publication of an editorial entitled “GLP-1 based agents and acute pancreatitis Drug safety falls victim to the three monkey paradigm” written by Edwin A M Gale, emeritus professor of diabetic medicine Department of Diabetes and Metabolism, Southmead Hospital, Bristol UK.

Published this past Thursday Dr. Gale writes:

“Investment companies knew that the Food and Drug Administration safety database carried a signal for acute pancreatitis with the antidiabetic drug exenatide (a glucagon-like peptide 1 (GLP-1) agonist) in 2006, a year before the agency alerted doctors—a curious reflection on the way we mix business with medicine. The signal had reached astronomical dimensions (more than 10 times that in control drugs) by 2011 and has accelerated since.2 Furthermore, all GLP-1 based agents that have been on the market for more than two years have also generated a signal for acute pancreatitis, suggesting a class effect.”

Dr. Gale concludes by stating:

“Why have the companies been so slow to respond to this threat? Because of the “three monkey paradigm,” which operates as follows. Companies are legally responsible for monitoring the safety of their own products, but self evidently cannot be held responsible for tackling a safety concern that does not exist. A concern that can be plausibly doubted or denied carries no legal liability, whereas one that gives rise to serious consideration (even in internal emails, which are discoverable) leaves the door wide open to litigation. Inviting companies to monitor the safety of their own products thus provides them with the strongest possible incentive for failing to do so, an instance of the law of unintended   consequences. The three monkeys, who neither hear nor see nor speak, have been allowed to flourish at the heart of our system for protecting the public. The regulators should not follow this example.”

It should surprise no one that Dr. Gale uses the recently published study in JAMA Internal Medicine on this very subject, a study which has widely denounced, as supporting evidence to his belief. Equally unsurprising Dr. Gale references a study by Dr. Butler which was published in Diabetes Care back in 2010. Thankfully Dr. Gale does not reference Dr. Butler’s the commentary on the recent study published in JAMA which was pulled from the JAMA web site due to “factual errors”.  A commentary which will be republished next week without these errors, although no one at JAMA or Dr. Butler is publicly revealing what the error was or who discovered it.

It’s interesting in the commentary which was pulled from the JAMA web site and obtained by Diabetic Investor Dr. Butler writes;

“At present, the GLP-1 class of drugs is heavily promoted (and prescribed) as having purported advantages that outweigh its risks. Singh and colleagues provide a timely reminder that, despite large numbers of underpowered studies claiming the contrary from marketing companies, little is yet known about long-term adverse effects of the GLP-1 class of drugs on the exocrine pancreas. Unfortunate recent history documents unacceptable delays by regulatory authorities to act on serious adverse events detected in post marketing surveillance of drugs for T2DM, deemed 2 times a farce by Gale. We Hope history will not repeat itself with GLP-1 based drugs, because in this case, 3 times would not be a charm.”

Before we get into the inaccuracies in this one paragraph, it’s interesting that Dr. Butler uses a study by Dr. Gale to support his position. Again this is hardly shocking as the two partners in crime seem to believe there is vast conspiracy by the FDA and drug companies to hide the “truth” from the public.

It seems besides sharing a love of conspiracy theories these partners in crime also share a revisionist view of recent history. If the Avandia controversy showed anything it was the system, albeit flawed at times actually worked. The FDA looked at all the available evidence and ultimately decided Avandia should carry a black box warning. While this may have not gone far enough for some, it was ultimately the correct decision as many believed the evidence against Avandia was based on fuzzy math. Ultimately Avandia was withdrawn from the market by GlaxoSmithKline (NYSE:GSK) who then faced a multitude of class action lawsuits.  For Dr. Butler and Dr. Gale to imply that FDA didn’t do its job or that Glaxo did not pay a heavy price is just plain ludicrous.

The truth is these partners in crime cannot seem to grasp the fact that there is conflicting opinions on this subject and that all known evidence suggests there is no clear answer to the question they continue to raise. Worse though is that two physician who are supposed to know something about diabetes, seem so ignorant on the subject. That they will ignore real life facts just to prove they are right and everyone else is just plain wrong. This is like a child who kicks and screams because Mom and Dad have told him to go to bed without desert.

What’s unfortunate here is like true co-conspirators they use each other to promote one distorted point of view, hoping that people will not investigate and form their own opinion; rather these lemmings will just accept opinions as actual facts.  This is exactly what zealots like Dr. Butler, Dr. Gale and that crusading cardiologist Dr. Nissen do. They believe that they are the only ones who known the real truth and then when the facts don’t support their theories they blame it on everyone else claiming there is this broad based conspiracy that’s covering up what’s really going on.

Now Diabetic Investor is not a scientist, we don’t have a medical degree and we’re not schooled in advanced statistical analysis, we do however have the capacity to think for ourselves, investigate and draw our own conclusions based on all the available evidence.  As it stands today all the evidence shows that we really don’t know whether or not there is a causal relationship between GLP-1 usage and increased incidence of pancreatitis. We also believe this is a difficult, if not impossible point to prove when looking at patients with diabetes who have an increased risk of developing pancreatitis just because they have diabetes in the first place.

We also believe that there is no one-size fits all approach for treating diabetes and that no one drug or class of drugs is the right choice for every patient. That patients working with their healthcare team should review both the risks and rewards of any therapy regimen when deciding which is best for their particular situation. Reasonable people understand that there is no such thing as adverse event free drug. They also understand that if diabetes is not controlled it will lead to several very unpleasant and costly complications.

Yet for the three headed monster of Dr. Nissen, Dr. Butler and now Dr. Gale, they believe that individuals are incapable of independent thought and should blindly follow whatever they say no matter whether the facts support their theories. This isn’t good science designed to promote a healthy debate, this is propaganda designed to support just one and only one point of view. As Peter F Drucker wrote, “The danger of total propaganda is not that the propaganda will be believed. The danger is that nothing will be believed …. The end result of total propaganda are not fanatics, but cynics.” When it comes to treating diabetes this is the last thing we need and ultimately the most dangerous.