Interesting Timing

There are certain ironies in this wacky world of ours. As everyone knows in about two weeks the diabetes world will gather in that beautiful city by the bay for our annual confab. Given the conference is in San Francisco a stone’s throw away from Silicon Valley one area that’s sure to get attention is all the toys in the toy chest. San Francisco is also home to many in the West Coast Mafia a group that just loves to pontificate about these way cool whiz bang toys even the ones that don’t stand an ice cubes chance in hell of making to the market.

The Mafia besides knowing little about how this business really operates has become vocal proponents of the We Won’t Wait movement. A group that is making some tremendous strides plus getting lots of attention, disproportionally so given how few actually participate in the movement. It does not seem to matter that less than 10,000 people have become active in this movement.

Now let’s make something crystal clear before everyone starts having a kanipshin, we are not against making the toys we play with better. And this group/movement has made several notable and positive contributions to our wacky world. However one concern we have expressed consistently is that for all the good this movement can achieve everyone seems to forget should something go wrong the consequences can be dire. Unlike the conventional toys in the toy chest who must go through the rigors of the FDA approval process and then are monitored by the FDA these toys are unregulated and unmonitored.

Another issue we have had with these unregulated systems is their lack of support. Or perhaps we should rephrase that, their lack of coordinated support. Recently we had the pleasure of meeting some patients using these systems and were struck by a couple of things.

1. These are some of the most dedicated and passionate people we have ever encountered and good thing too as they have to be to make their systems work. They scour the internet looking for hackable pump, understand that there is little in the way of structured support and realize that this unregulated unmonitored system should it malfunction can kill them. Plus they fully appreciate they are off the grid a little and seem willing to put up with the extra work.

2. We were very surprised that so many of these people as dedicated and passionate as they are were unaware of regulated and monitored systems that are on the market right now. They seem resigned to the fact that companies like Medtronic, Tandem and Insulet will never give them what they want and in effect have tuned out of what these companies are doing.

3. Money not surprisingly paid a huge role in their decision to go off the grid. Several noted that they would prefer to be using the Basal IQ system from Tandem and then upgrade to the Control IQ when it comes out but because the system isn’t covered by their insurance, they couldn’t afford it.

4. This should shock no one as they universally loved the Dexcom system and hate, really hate the Medtronic sensor. Heck they hate, really hate Medtronic.

5. Again and this should not be shocking either IF insurance was taken out of the equation the majority would switch to Tandem or Insulet in a heartbeat.

We mention all of this because this past Friday the FDA issued the following warning;

“The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.”

A warning that prompted a social media feeding frenzy. Some tried to dismiss this warning as an isolated event, while others correctly noted that even regulated systems can and do malfunction.

Not to get off track but we as well have been very vocal about how Medtronic is playing very fast and very loose with the FDA’s adverse event reporting in an attempt to cover up the many issues with the 670G. The difference though is the FDA can and likely will take direct action against Medtronic while there are no consequences no governing body that can take direct action these unregulated systems.

Worse because these systems are unregulated the patient has no legal recourse. Unlike Medtronic who is facing several lawsuits over the 670G, these unregulated systems which are a collection of devices all from different companies are not easily sued.

Listen we are the last people on this planet who wants more regulations, more red tape or more hoops for companies to jump through. However a closed loop insulin delivery system is not just a life sustaining device but also a potential killer. As much as everyone hates the FDA approval process the rigors of this process are needed especially with any device that delivers insulin. The same can said for monitoring, the adverse event reporting system currently in place may have its drawbacks however it’s better than no monitoring.

The FDA’s ongoing investigation of Medtronic is a perfect example of how even this imperfect system is working. Yes, it is unfortunate, sad and shameful that patients had to die because the system they were using did not work as advertised. However the families of these patients have legal recourse. While nothing will replace their loved ones who have passed but at least they have recourse.

The fact is this dedicated, passionate group of people want the same thing we all want, systems that work, that are affordable and accountable. They want the toy makers to listen to their needs and not just give them lip service. These people are not motivated by greed they are motivated by the disease they live with every day of their lives and they want their lives to be better.

The FDA should be commended for being proactive and issuing this warning. It should serve as a cold reminder to everyone who is off the grid of the risk they are taking on. We doubt it will change what they are doing but if they become even more vigilant with what they are doing this is a good thing.

The message to the toy makers if they are willing to listen is put the needs of the patient first. Do not place your quest for a good quarter or a fatter bonus over the lives of patients. Keep in mind that making money and putting patients first are not opposite goals. They actually go hand in hand for if they do one the other will follow. This is what made MiniMed, before it was acquired by Medtronic, so great. It’s also another reason Dexcom is doing so well.

Medtronic is about to pay a heavy price for their greed. Even if the FDA does not come down hard on the company, patients are speaking with a very loud voice. They are sending a clear message to the company. Sadly it did not have to be this way this whole situation could have been prevented and avoided. Yet because the company placed profits before the welfare of its patients, they are getting what they deserve.