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.

 

9 comments:

tmana said...

Two problems with the FDA: (1) not enough money has crossed the correct palms to approve the devices; (2) they have a "zero tolerance" policy for defects, adverse effects, and unintended consequences 20 years down the road. In short, one "bleeder" from one sensor in the next 20 years can shut down the whole project (because a whole bunch of ambulance-chasers will be screaming "bloody murder"... literally).

Bennet said...

I don't think money is even close to the issue if by crossing palms you mean corruption. I in now way think there is wide spread corruption or bribery in the FDA process. Mostly because corruption is directly contrary to the risk aversion you talk about. Corruption is used to move otherwise unacceptable products to the market. Once there those flawed products would create the expensive legal actions you speak of.

I think that risk aversion in a vacuum is an issue. That is, less than perfect devices may be a significant improvement over the way less than perfect management that is used in real practice. The relative risk isn't the issue considered. It is the absolute risk of any device is. It is pursuit of the perfect preventing the good that will lead to better health.

Alison said...

Thanks Bennet. I think we may have to rename ourselves the Tea & Crumpets News Network, I think that's a rather spiffing name old chap.

I won't even get into the whole FDA thing, but if I ever get NICE and the NHS fully sorted over here, I promise they'll be next on my list ;-)

Alison said...

Having said I'll keep out of this, I now can't help just poking my nose in slightly.

Here in the UK, drug companies aren't allowed to market direct to patients, only to medics. So it's impossible to get source info on things such as insulin or any other drug, other than getting it filtered through a Dr. While this does save us from those endless TV comercials advertising drugs and then reading out the list of side effects at break-neck speed, it does mean that if I ever want drug info I either have to pretend to be a Dr or use the interweb to access some US sites. Slightly different problem, same solution!

Bennet said...

TCNN does have a ring to it doesn't it. Blame all the episodes of Top Gear on NetFilx.

No side effects ad would make the telly much less ripe for sarcastic satire, but then I have Shoot Up et al to lampoon so all is well.

Anonymous said...

Thanks for this! I have been hunting around for ages for more info on the "comfort" sensors, now named Enlite. My curiosity has now been satisfied. Although our DD uses the Minimed pump, her insulin needs are starting to lower (teen). We have MM pump and Dexcom cgms. This MM model still looks bulkier than the Dexcom we have now and Dex is again reducing the size of the Dex, which means less of a footprint on the body. Both claim to be more accurate in the hypo range. Seeing new MM Enlite in the flesh so to speak, allows us to make our final decision on which pump to get when her warranty runs out. So we will be able to choose Animas which will integrate with Dex, having the appropriate knowledge to do so. Thanks for posting this! P.S. Will miss MM Revel; it's a great pump.

Sara said...

You are my favorite blogger #notintendedtobeafactualstatement

I also share the love of Stephen Colbert!

I think if you are going to write about news across the pond though you have to find words to include like 'colours' or 'realise'. The British are so funny with their u and s.

The MiniMed CGM that I tried was so uncomfortable (especially compared to the DexCom) that really anything would be an improvement.

Bennet said...

Sara I have a hard enough time spelling American, colourful English would completely befuddle me but thanks for the tip.

I think your use of the Colbert hash tag is brilliant and appropriate. #notintendedtobeafactualstatement

LY/MI

Tim said...

Tea & Crumpet News Network - rather, old chap! *twiddles moustache*