Dear Children with Diabetes and their Readers,
I have been beating the drum for the FDA to approve noninvasive blood glucose testing devices for over a year now. Last week, my son Benjamin (11 years old) and I were called to testify in front of the Commerce Committee's Oversight and Investigation (O & I) subcommittee. The O & I subcommittee is chaired by Rep. Joe Barton (R-TX) and the ranking minority member is Rep J. Klink (D-PA).
Rep. Barton asked Ben and I to testify as to our perceptions of the problems associated with the way in which devices for diabetics are now submitted to, and approved by, the FDA. Despite all of my previous involvement with the FDA, nothing prepared me for last week's hearing.
I must tell you that I have never seen such smugness as was displayed by the FDA physicians and their representative attorneys. I now believe that unless there is a dramatic mobilization of diabetics around the country, noninvasive technology, and other technology designed to aid diabetics, will never see the light of day.
The FDA doctors passed judgment on a device that they had no understanding of. The FDA admitted that they use outside consultants that have "conflicting interests" with the devices that they review. The chairman of the FDA panel reviewing the Diasensor 1000 admitted that he knew prior to seeing the data on the machine, that the device was not going to be approved. He further stated that the voting members of the committee (the chairman of the committee was not a voting member) had already made up their mind not to approve the device and the technology, prior to the start of the meeting. The Chairman of the O & I subcommittee was so shocked at hearing this that he took time from the hearing to congratulate the FDA panel chairman for being an honest man and admitting this to them.
There are now members of the House that are calling for the resignation of top FDA administrators and even Dr. Kessler, who heads up the FDA. I hope that diabetics and their families, especially the parents and relatives of children with diabetes, will take up the cause and write and/or call their representative in the House and Senate, to find out what is going on at the FDA.
The issue at hand is much larger than Biocontrol, the Diasensor 1000 or even noninvasive technology itself. The issue is this: Who is watching the FDA as they "protect" us? It might be said that FDA protection has proven that it is hurting us, if not killing us.
I have spent many hours on the internet emailing thoughts back and forth to/from many of you, and I thank you for all of your support up until now. However, this is an election year and means that we, the parents of diabetics, have special clout--but only if we choose to use it. It amazes me that with over 16 million diabetic people in this country, diabetics are, by and large, a very silent group. Perhaps this is because many of us are resigned to our disease, or perhaps because we believe that we are under "control" and therefore do not wish to rock the boat.
Let me assure you that the way things work in Washington and with your elected representatives is by rocking the boat, and rocking it hard. If you remain silent on this, you only have to look in the mirror to answer the question, "Why has technology moved so slowly with this disease?" The fact of the matter is that other than a very few improvements, the science of caring for and managing diabetes has NOT improved much in the last twenty years. Sure, we have smaller, lighter invasive blood glucose monitors, a new insulin delivery system and a few new brands of insulin, but that is very little to show for all the years and all the money that has gone into so-called diabetes research.
The time to act is now! The person to do this is you! Call your elected officials. Demand that more money be allocated from the NIH budget to diabetes research. Ask why the FDA is refusing to approve new noninvasive technology. These are our children who we are supposed to be protecting. They can't make the calls. We MUST do this for them--and for ourselves.
Thank you for taking the time to read this.
Questions, comments and replies may be sent to Ron Brenners at email@example.com.
- The US House of Representatives will investigate FDA handling of Biocontrol Technology's 510(k) submission. (September 20, 1996)
The opinions expressed in this letter are those of the author and not necessarily those of children with DIABETES
Last Updated: Thursday August 29, 2002 20:59:48
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