April 18, 2011

Tea and Crumpets News Network: Minimed Enlite

News and comments on diabetes products from Europe is getting to be a regular staple of YDMV. On one hand it is good that new products are coming to market.  On the other it is less than awesome that these things are not available here. It  speaks volumes about the state of regulatory affairs that innovations for better care are happening in Ye Olde Countries and not in the the Colonies of the New World.

Our good friends at Shoot Up have a post up on the new MM Enlite sensor. Sort version of the story; smaller, less harpoon like inserter, six day life. The folks at Shoot Up are doing there best to get'm to try'm. Stay tuned to the Tea and Crumpets News Network (TCNN) for a review. Click over to the other side of the Atlantic and read up:
http://www.shootuporputup.co.uk/2011/04/the-age-of-enlite-enment/
http://www.shootuporputup.co.uk/2011/04/let-there-be-enlite/ 


Editors Note: It may be wise to click out now. All that follows is a pointless and silly rant.


Somehow the brain trust in Regulatory Prohibitions on Communications Division (#NotIntendedToBeAFactualStatement) of the FDA doesn't quite appreciate that information is fungible.

I can hears some alert readers, who haven't had coffee yet, asking, "What the heck did he just say, fungus-able? Information has a fungus, is that like a computer virus? Honey! Do we have Norton Anti-Virus updated? "

Don't get you knickers in a knot. Fungible means easily replaced with an other identical item. Money is fungible. Any one dollar can be use just like the next. Information is easily replaced with... other information. Nothing is as exchangeable as words.

Information that is prohibited by the FDA here is easily replaced with information from other sources. So while MM can't say Jack Diddly to anyone in the U.S. of A. about a new sensor (and for the record it was actually funny to listen to the verbal gymnastics that they went through not to say anything about new products at #MdetronicDAF), we can read our friends across the pond who can say something about the new sensors. The information get fungible-ed... er... something like that.

There in lies a problem: Information isn't as fungible as money.

Now folks, far be it from me to suggest that Bloggers are possibly flawed. (Other ones. Not me, of course.) It seems that instead of having patients rely on some kind of 21st century whisper down the lane it would be better if the vendors could come out and offer comments and or corrections on the misstatement that may work there way into blog-o-sphere mishmashes.

So in an effort to sort out the mess I am making here (a mess that is kinda making my point along the way) there is not a Regulatory Prohibitions on Communications Division at the FDA as far as I know. There are new sensors and meters available in Europe that aren't through the FDA black ops process (Black Ops = #NotIntendedToBeAFactualStatement.)  More innovations including CGM enabled pumps are on the way into European markets and simultaneously US regulatory delay. I think we would all be better served if y'all didn't find out about these things solely from 'reputable' unofficial sources like say, me.

Seriously, I know better than to trust me.

All of this is not to say that I do not value the goals of the FDA or a regulatory process. I believe there is great value in safe devices (#IntendedToBeAFactualStatement). I like all parents of kids with T1 diabetes want the best for their kids. That starts with safe. I also believe that efficient markets crave information and that it is not detrimental to safety of patients or markets to have factual information responsibly shared by the people who know that information best. Best, in this case, would include the folks who make said devices.