Wisconsin Libertarian congressional candidate Andy Craig released the following statement regarding FDA delay of life-saving medical technology:
How the FDA is killing me: a personal perspective on diabetes and government
Since I was diagnosed at age thirteen, I have struggled with type I (“juvenile”) diabetes and its complications. Like many, I don’t always do the best job managing this condition. But like many other diabetics, my life has also been damaged and possibly shortened by the Food and Drug Administration.
Diabetes management is largely a matter of balancing food consumed with insulin injected, to maintain blood sugar levels within an acceptable healthy range. Prior to the invention of insulin injections in 1920, a diagnosis of type I diabetes was universally fatal, usually within a matter of weeks. Today, I and many other diabetics use an insulin pump to keep us alive. This pager-sized device fits into my pocket, and I wear it at all times. It provides a steady drip of insulin, and larger doses at meal times, more closely mimicking an undamaged pancreas than traditional injections. It is, in my opinion, a miracle of modern medical technology.
However, even with the essential aid of glucometers to monitor blood sugar levels, it still boils down to an “eyeball it and guess” method of self-medication. It’s not ideal medical precision, and that shows in the large number of preventable hospitalizations and deaths each year from type I diabetes. The main obstacle to better diabetes management is not the availability of tools and medications for the job; it is the fallible human being who has to make these daily decisions.
There exists a device that could do this task better and easier. It is called an “artificial pancreas.” The artificial pancreas is not some kind of lab-grown human organ. It’s actually just a regular insulin pump, paired with another existing technology called continuous glucose monitoring, which checks blood sugar levels every few minutes instead of every few hours. Connect these two devices, and a simple computer program using a mathematical algorithm can manage a patient’s blood sugar levels all on its own, just like a natural pancreas does. It’s not quite fully automated, but it’s close.
Studies have shown up to an 80% reduction in out-of-range blood sugar levels using this type of computerized control, compared to current methods. The technology has also been around for years. The insulin pump I first started using ten years ago is capable of being wired to be an artificial pancreas.
Teenage diabetics who have been allowed to participate in trials with this technology, and their parents, have been reluctant to switch back at the end of the tests. Some patients have even resorted to unapproved “hacking” of their insulin pumps to implement similar features.
So why has this life-saving, and simple, combination of two already-approved devices not available on the market and in widespread use? Thank the federal government. The Food and Drug Administration has repeatedly held back the approval process on artificial pancreas research for years.
That delay has cost billions of dollars in preventable hospitalizations and complications such as organ failure and amputation. The delay can also be directly blamed for thousands of preventable deaths. But the FDA’s incentive isn’t to care if their delay cost lives: their only concern is they not approve something that might harm somebody. If artificial pancreases reach widespread use, somebody will misuse it or one will malfunction, and a patient will be killed or harmed by that. That is the unpleasant reality of how medicine works.
The balance of these concerns in this case is overwhelming in this case, but still the FDA continues to delay. If the current policy had been in place in 1921, we’d still be watching children die for another five to seven years, waiting for government approval of insulin injections.
Diabetics aren’t the only ones harmed by FDA bureaucracy. Medical innovations across the board are slowed, delayed, sometimes prevented altogether, all of which translates into lives lost. That’s why, if elected, not only would I vote for legislation to fast-track approval of artificial pancreas technology. I would also propose legislation changing how the FDA works, mandating the consideration of reliable, objective estimates of life-years lost and other quantifiable costs due to the length of the approval process. If the FDA seeks to maintain a balance between blocking dangerous drugs and approving life-saving drugs, it must first stop ignoring one side of the equation.
With some states already contradicting the FDA on the legality of drugs ranging from marijuana to experimental treatments for the terminally ill, the FDA’s decision might not be relevant in the long term. But until that occurs, this is a problem Congress needs to address, before the FDA literally costs me an arm and a leg, or worse.
