Sure hope the “Good Doctor” is happy.

Sure hope the “Good Doctor” is happy.

It looks like we can add dapagliflozin to the list of diabetes drugs killed by Dr. Steven Nissen, that crusading cardiologist who thinks he knows something about diabetes. According to  joint press release; “Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults.

The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials. Bristol-Myers Squibb and AstraZeneca will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.”

This announcement was followed by a Bloomberg story which noted; “The decision reflects the heightened regulatory scrutiny of diabetes pills since GlaxoSmithKline Plc’s Avandia was tied to heart attacks in 2007 and was later forced off the market in Europe and restricted in the U.S.”

For the sake of diabetic’s everywhere let’s hope that dapagliflozin is the last drug to suffer from the situation created by the “good doctor.” It is not an overstatement to state that the “good doctor” and his crusaders have done more harm to the diabetes population than anyone could have imagined. Instead of having more and better drugs and devices available, instead of having more and better weapons to fight this disease which is growing at epidemic rates, costing millions more like billions in additional healthcare costs and creating a healthcare crisis, the “good doctor” and his minions have forced physicians to fight this ragging forest fire with a garden hose.

Shortly we will learn if the “good doctor” has done irreparable harm as the PUDFA date for Bydureon is quickly approaching. Now Bydureon is no wonder drug and it’s not for every patient. It’s also true that even with the many benefits provided by the drug – once-weekly dosing- solid glucose control- weight loss- etc. – the drug does have some issues that must be watched by the physician.  Yet on balance when all the data is looked at it most physicians interviewed by Diabetic Investor believe they would prescribe Bydureon for their type 2 patients as it offers the most compelling risk/reward profile they have seen in some time. They realize, like most normal people do, that there is no such thing as a drug that does not carry the risk of adverse events. However they have also witnessed with their own eyes what happens when their patients aren’t properly controlling their diabetes. Given the devastating consequences of poorly controlled diabetes weighed against the possible adverse events that may come from using Bydureon, these physicians believe poorly controlled diabetes is the greater evil.

This is something the “good doctor” and his band of crusaders have never understood, the simple yet well-known concept of risk/reward analysis. Instead this band of crusaders and their leader have put their faith into the voodoo science, if you can call it that, of meta-analysis.  Frankly the more we learned about meta-analysis the more we believed it had more holes than a chunk of Swiss cheese. Unlike real science, a meta-analysis is subject to the whims of the people performing the study. This would be like the NFL saying that Chicago Bears really had a great season as they were 7-3 when Jay Cutler was their quarterback and we really shouldn’t include their remaining games because the team had an incompetent backup quarterback.  Yet in the real world, somewhere where the “good doctor” does not live, all the games count no matter who plays under center.

Looking back Diabetic Investor wonders if the “good doctor” is happy with the mess he has created at the FDA. A mess that actually came back to bite the crusading cardiologist right on the butt when studies showed a relationship between satin usage and diabetes. When this link was first reported the “good doctor” in a column that appeared in USA Today stated; “What I fear here is that people who need and will benefit from statins will be scared off of using the drugs because of reports like this” – as the old saying goes people in glass houses ……

The reality here as Diabetic Investor noted when the Avandia controversy first came to light is that the once opened the worms won’t get put back in the can and unfortunately this is exactly what has happened. Given the way the “good doctor” ambushed Glaxo and the public by “leaking” his now famous meta-analysis to the press and certain members of Congress, there was no way we could have an intelligent and true debate on this subject. Instead the circus came to town, there were lots of accusations thrown back and forth and when it was all said and done nothing of any real value came from the debate.

The FDA does what they always do when they are dragged in front of Congress and basically told that while they did the best they could with the data they had at the time they really screwed up and things better change and better change in a hurry. Not wanting to experience this event again the FDA retrenched and became even more conservative in their approach to approving new diabetes drugs and devices.  The situation has become so bad at the FDA that drug and devices companies are now heading overseas first and realizing that FDA approval is a long and winding road with many fits and starts. While new drug development has always been a risky and expensive business, the ultra-conservative nature of the FDA has increased the risk and expense level to new heights.

Lastly one has to ask is the American public better off today than they were when the “good doctor” began his crusade. Are drugs and devices safer? Are patients, the people who really matter here, better off today than they were before the Avandia controversy? Has the FDA learned from this experience?

Or has the exact opposite happened, is the American public actually worse off today?

Sure hope the “good doctor” is happy with the monster he has created.