I heard your discussion at the Diabetes Technology Conference and I am enjoying your blog. I am a former FDAer and share many concerns that others have. However, I thought the FDA presence at the conference was impressive. I see them at a lot of conferences (different folks, same agency) and they have constraints on what they can and cannot say. This was definitely one of their better efforts.

I am also a type 1 for 25 years or so (who’s counting?). I was about the same age as you at my onset. I spoke at a session on clinical trials in a pre-conference workshop. I wrote a brief account of the conference, from a different perspective, on my blog: Carl’s Blog on FDA Stuff. Stop by sometime. The words below are very difficult for an old man with bad eyes. I’m on my second attempt.

Cheers,

carl-

Who knows one day the FDA might have to approve our cell phones too. The areas that used to be defined in different areas are running together now so there’s a lot of gray. I used to write code and developed an EMR years ago so this gives me some insight here as there were many times when what I thought was a good idea was actually not a good software design and had to go back and change when working with the family practice doctor. We call it “eating our own dogfood” in the software side of things. Actually eating one’s own dogfood though is how it should be, otherwise you do not know how designs, devices, etc. will work in the real world. There’s a huge difference between what is called proof of concept and the real world!

Also, with devices you need to know where your information is going too and with all the web based software applications that come with devices this gets a bit gray too. I feel it should all go to a personal health record where it keeps the patient in control. All of this is confusing the average patient by all means and this is not what is supposed to be going on.

Devices and drugs are also changing delivery methods, many to inhalants as there are devices that can track this. I have posted about these items with correspondence from the likes of Cambridge Consultants, one of the companies who designs such devices and sells the license and product to healthcare companies. Some of what I hear sets me on edge as well. Yesterday I posted about Best Buy joining in the device business as well as selling other fitness products.

http://ducknetweb.blogspot.com/2009/11/best-buy-announces-personal-health.html

UCLA has a study going on about participatory sensing with devices and i hope they have some results soon too!

http://ducknetweb.blogspot.com/2009/06/are-cell-phones-enabling-anyone-to-be.html

In summary, you can’t just through devices out to consumers and expect results if they do not have a model to implement without total disruption of life, I agree 100% on this. Some of what I see out there scare me too! Again, I think perhaps if some of the experts actually got involved themselves and used some devices to get some first hand experience as to what the patient can expect, we might have some different expectations, so I am back again to eating one’s own dogfood.

We are being driven crazy with compliance I agree and how to go about it with a human model and just simply meeting the parameters of the algorithms they design is not going to work. I stuck the word “algorithms” smack center on my blog so hopefully consumers can learn what this is all about and how to make sense of what is being designed without real world human experiences and rather relying on a “proof of concept” notion. I deal directly with physicians too and they are frustrated on their side of the coin too as they watch all of this evolve as well.

Bottom line is to not forget we are humans and all healthcare is the people business. We can’t stop technology but we can all certainly voice our opinions and remind everyone at all levels that we are in fact all still humans and need to be cared for as human beings. This entire area of devices that report data is becoming so fragmented and confusing to everyone all the way around and there are no real laws and regulations for so much of it as it is so new.

The FDA is still catching up with getting their technology act together, literally as of at the end of 2008 there were employees there who were still writing studies out in longhand and not using a computer! That is scary in itself but I believe now that is quickly being corrected throughout.

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