How good is good enough?

How good is good enough?

While most of the country was eating turkey, watching football and getting together with their families an article that appeared on the CNN web site was creating somewhat of a firestorm over why the FDA has yet to approve an artificial pancreas. The article entitled “Artificial pancreas could be ‘holy grail’ for Type 1 diabetics” and can be found at isn’t groundbreaking nor does it really cover any new ground, what makes the article so compelling is where it appeared.

Given where the article appeared it’s understandable that other media outlets have picked up on the story adding their respective opinions. Looking over the history of what’s been written on the subject, including what we have written here at Diabetic Investor, most everyone agrees that an artificial pancreas is a major advancement in the treatment of Type 1 diabetes and that while the systems aren’t perfect they are good enough to get the job done. It has also become standard operating procedure to dump on the FDA as nearly everyone outside the agency who truly understands the system believes the FDA is being overly conservative in their approach and basically standing in the way of this ground-breaking technology.

Lost in all this rancor over the artificial pancreas is the bigger picture of where technology is and where the FDA stands. While Diabetic Investor believes the artificial pancreas would be a major advancement in the treatment of Type 1 diabetes, in the real world this system, if approved, would only be used by a handful of patients. However, the FDA’s backward thinking towards advanced technology is hurting a far larger group of patients and quite frankly costing this country millions of dollars.

As regular readers of Diabetic Investor know, we don’t believe that advanced technology alone can solve the many issues facing patients with diabetes. We have consistently stated that while we see many potential benefits of advanced technology, all this advanced technology becomes basically worthless IF it’s not used by the patient or is used incorrectly by the patient. However, the more maddening issue is that patients aren’t even getting the chance to even see some of this technology because of the FDA.

Besides holding up progress on the artificial pancreas, the FDA is also delaying the progress of mobile health apps and the coming integration of mobile devices with diabetes devices. These delays impact the majority of patients with diabetes who consistently wonder why they are forced to carry around so many of their devices when in their eyes these devices could be easily integrated into their mobile device. Take a simple thing like a glucose monitor, does anyone really understand why the FDA has yet to approve the iBGStar from Sanofi-Aventis (NYSE:SNY), a meter which attaches to an iPhone or why the agency has yet to approve the Pogo from Intuity Medical, an all-in-one device that would make the hassle of testing easier for the patient.

The reason is obvious; the FDA rather than live in the real world and understand what a patient with diabetes goes through each and every day of their lives, lives in some sort of fantasy land. Rather than concentrate on issues which are truly relevant the agency instead worries about issues that would impact less than 1% of the patient population. In the case of the iBGStar and the Pogo, the FDA seems to believe that patients with diabetes are like heroin addicts sharing their bloody meters and lancets just as heroin addicts share needles.  But they don’t stop there, the agency also believes that these patients with their bloody meters and lancets also have HIV or Hepatitis and are passing along these conditions to the unsuspecting person with whom they are sharing their bloody meter and lancet with, this unsuspecting person who also happens to have an open wound. And no we are not making this up which should tell everyone why the agency is in desperate need of reform.

The FDA is also poking their noses into the area of mobile health apps, an area of particular interest to patients with diabetes. While Diabetic Investor agrees there should be some set of universal standards for these apps, we are highly concerned the FDA will do what it always does; try and kill a house fly with a tactical nuclear weapon. Look for the FDA to develop a set of standards so onerous that the companies who are developing these systems will have no idea how or if they should proceed; standards which only will delay these apps from reaching the patient.

The harsh reality is for all the talk about reform at the agency; talk is cheap and actions speak louder than words. Based on their actions the FDA has consistently demonstrated they are ill-equipped to handle the task. The simple fact is advanced technology and diabetes management goes together like peanut butter and jelly. It is also true that the patients who use these systems as intended stand a better chance of achieving better overall outcomes. Technology alone may not be the answer; however, it is also true that we’ll never know the true potential of all this advanced technology if it never makes its way into the hands of patients.

The insulin pump market is a perfect of example of how technology can progress when given the chance. There is no disputing that insulin pumps today are far better than they were 10 or even 5 years ago. It is also true these systems still have imperfections and there is more room for improvement. However, whatever these imperfections are insulin pumps as the stand today, are good enough and do get the job done. Diabetic Investor shudders to think of where insulin pumps would be today had they come to market under the current regulatory environment. Perhaps a better question is; would they be here at all had the FDA taken such a narrow minded backward thinking view, as they do today, back when insulin pumps first arrived.

Diabetic Investor is not saying it’s easy for the FDA to keep up with the advancements in technology nor are we stating these devices or apps should not be regulated. While there are many faults with the FDA, the agency IF it worked as designed, does serve a valuable role. However, the agency is NOT working as designed and needs to be redesigned from top to bottom. The harsh reality is the FDA is not just standing in the way of innovation; they literally have blood on their hands as patients are needless suffering because of their ultra-conservative narrow minded backward thinking.

While it would be nice to believe that perfection is possible, when it comes to diabetes drugs and devices, perfection is not possible or realistic. Just as there is no such thing as a completely safe drug with absolutely no adverse events, neither is it possible to have a device that never malfunctions and works 100% of the time. Given that nearly two-thirds of all patients with diabetes are NOT properly controlling their diabetes which leads to numerous complications and is costing our government billions, one just might think the FDA would understand that when it comes to diabetes drugs and device sometimes good is good enough.