Another diabetes dad sent an email asking about the JDRF New York Times Ad. Specifically if anyone knew the source of the 1:20 number it cites. I replied that I had traded emails with Aaron Kowalski and Jeffery Brewer at JDRF about the ad.
The ad is not for the diabetes community. Period.
In the diabetes community we know that insulin has risk and that those risk involve the possibility of death from excessive insulin. I often hear those who live with diabetes and "Get It" wish that the general population understood type 1 better. The non-diabetes world doesn't have a frame of reference for diabetes management risks and this ad puts that into stark terms.
That and I hope that in my kids lives they each have 20 non-diabeteic people people in their 'get' fottaly tine.
To me that 20 to 1 is more important than 1 in 20.
I maybe wrong, I often am.
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Of the people I know in the diabetes community, and I know a lot of y'all there is nobody among us who is more passionate about with people with T1D living long, happy, well managed lives than Aaron and Jeffery, certainly including my craziness.
Hypoglycemia can kill. Should we be less motivated to address hypos if the life time mortality risk is 1:40, 1:60 1:100? Shouldn't be just be motivated to make less of a risk, until it is not a factor at all?
The data for the ad is the based on various articles by Philip E. Cryer, MD. Significant in that is a piece in the American Journal of Medicine, Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. http://www.amjmed.com/article/S0002-9343(11)00687-5/fulltext
The data for the ad is the based on various articles by Philip E. Cryer, MD. Significant in that is a piece in the American Journal of Medicine, Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. http://www.amjmed.com/article/S0002-9343(11)00687-5/fulltext
That article in turn references:
The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Long-term effect of diabetes and its treatment on cognitive function. N Engl J Med. 2007;356:1842–1852
http://www.nejm.org/doi/full/10.1056/NEJMoa066397
Feltbower RG, Bodansky HJ, Patterson CC, et al. Acute complications and drug misuse are important causes of death for children and young adults with type 1 diabetes. Diabetes Care. 2008;31:922–926 - http://care.diabetesjournals.org/content/31/5/922
Skrivarhaug T, Bangstad H-J, Stene LC, Sandvik L, Hanssen KF, Joner G. Long-term mortality in a nationwide cohort of childhood-onset type 1 diabetic patients in Norway. Diabetologia. 2006;49:298–305 -All of which I have printed and am in the process of re-re-reading and formulating thoughts on. Here is a readers digest of where I am so far.
http://www.springerlink.com/content/f932481234766352/
The ad is not for the diabetes community. Period.
In the diabetes community we know that insulin has risk and that those risk involve the possibility of death from excessive insulin. I often hear those who live with diabetes and "Get It" wish that the general population understood type 1 better. The non-diabetes world doesn't have a frame of reference for diabetes management risks and this ad puts that into stark terms. Mark Twain has a famous comments on numbers, "Figures often beguile me," he wrote, "particularly when I have the arranging of them myself; in which case the remark attributed to Disraeli would often apply with justice and force: 'There are three kinds of lies: lies, damned lies, and statistics.'" There is little reason to think Disraeli actually said that, but there is history, humor and Mark Twain. Think: The Daily Show.
The effect of the ad statistic on some people with, and more significantly maybe some parents of T1D kids, is an increase in fear. I am not sure that is productive. (Please see ad is not for the diabetes community above.) I know a young woman who was so scared by dead in bed she disconnected her pump every night. Her parents were at a total loss as to why her night time BGs were so bad. It may not be a surprise folks who "Get It" that her A1C were through the roof. This was before blue candles and 1:20 ads in the paper. Fear is real.
Hunter S Thompson wites of "The Fear" in Fear and Loathing in Las Vegas. "The Fear" in my mind is a character in the book. A book I found hysterical. I don't find diabetes fear so amusing. It can lead to actions, as was the case with the young woman who was disconnecting, that are dangerous.
Many in the Diabetes On-line Community write about the phycological aspects of diabetes care. Many say the mind game is as difficult as physiological management effort. In that context feeding the fear is a bad thing. Also turning those people (PWDs) to thinking about the statistics and motivating them into discussions about the numbers instead of discussions about doing stuff to move the ball forward on solutions is contrary to the goal of better living with T1D.
All that said I have issues with simplifying the underlying papers to 1 in 20. Dr. Cryer writes about T2D as much or more than about T1D in Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. He cites ACCORD, ADVANCE and VADT studies all of which appear to be T2D studies. In T2D there may be means of managing health other than insulin. In ACCORD the goal was A1C under 6% and the trial was stopped due to harm to T2D patients of that aggressive goal.
It also appears that the good Dr. Cryer's article was a response to another in the same journal issue that seemed to say that hypoglycemia was a comorbidity of other causes of death, seemingly downplaying hypos. So maybe he was saying, Hey you idiots hypos are dangerous in and of themselves... well he probably wouldn't say idiots, in fact I don't see that word used anyplace in his article. Maybe Mark Twain or Disraeli who used the "I" word.
It also appears that the good Dr. Cryer's article was a response to another in the same journal issue that seemed to say that hypoglycemia was a comorbidity of other causes of death, seemingly downplaying hypos. So maybe he was saying, Hey you idiots hypos are dangerous in and of themselves... well he probably wouldn't say idiots, in fact I don't see that word used anyplace in his article. Maybe Mark Twain or Disraeli who used the "I" word.
Cryer writes "Older estimates were that 2%-4% of patients with type 1 diabetes die from hypoglycemia. [16], [17] and [18] More recent estimates are that 6%,[19] 7%,[20] or 10%[21] of those with type 1 diabetes die from hypoglycemia."
Notes 19, 20 and 21 are the ones I shared above. 20 and 21 are studies form the UK and Norway, started in 1978 and 1973 respectively. Both are T1D studies. I have concerns that studies starting then will have significant data from pre DCCT, pre Lantus and pre Pump care regimes. Who is on NPH?
One can argue that pre DCCT was typically less aggressive care and that means less hypos so these may understate the risk. - Or - One can argue that the lack of stable basal insulin, pumps modern meters ect. made hypos more frequent due more peaky nature of the tools available. I don't know. I suggest there is grounds to wonder if the fruits of the studies is all apples. Maybe there are some oranges involved.
We hold these truths to be self evident: the risk of fatal hypos is a lot higher if one takes insulin than if one does not. Even so that is not the only source of stress in a T1D household.
1:20 is not an annual rate but a life time projection. Looking at the reciprocal, when they die, 19 of 20 people with T1D will not die of hypos related issues. That is a lot better than the 100% that died of DKA in pre insulin days.
Diabetes care is about balance.
Diabetes care is about balance.
That and I hope that in my kids lives they each have 20 non-diabeteic people people in their 'get' fottaly tine.
To me that 20 to 1 is more important than 1 in 20.
I maybe wrong, I often am.
.
Posts
great post, thanks for all the data. i agree, that ad was not for us. i'm tempted to share it with everyone in my life who doesn't 'get it', but maybe they saw it in the paper already anyway.
ReplyDeleteThanks for this post. I have a couple of concerns about this ad.
ReplyDeleteFirst, I would much prefer that FDA look at the science and make a decision. While already prone to making politically driven decisions, JDRF has made it much more likely that FDA will make a political decision in this case. When it comes to my safety, I am not interested in using products approved for political reasons, rather than for reasons based on valid, robust and unbiased scientific evidence.
Second, I use a Minimed CGMS. It is highly inaccurate. And by "highly inaccurate," I mean DANGEROUSLY inaccurate (I have hypoglycemia unawareness and the plan was to have this CGM keep me safe - turns out it was a bad plan). If Medtronic is planning to use their current technology in the way suggested in the ad, I would be EXTREMELY concerned about the safety of the users.
Third, I question how much JDRF was paid-off and/or pressured to run this ad. Its new leadership is very cozy with industry and industry increasingly is doing its lobbying through activist organizations these days. I question what benefits and perks it will receive for running it. I question how much donation money it will receive from Medtronic. I question its motives, overall.
Personally, I support getting new products to market quickly ONLY if they are safe. This ad says nothing about safety; it only panders to people's emotions and pushes for approval when approval my, in fact, be unwarranted, premature and dangerous. We just don't know.
Thanks for commenting. I share your hope that the FDA would be driven by science. Sadly I think the problem is that the FDA is NOT looking at the science. The regulatory agencies around the world have and have on the basis of compelling science approved LGS.
ReplyDeleteOne of the things the FDA is requiring or may be requiring since they don't have guidelines out yet is the impact on A1C of cutting off insulin when someone is low.
My suspicion is that the FDA is acting out of political caution rather than science.
I agree better senosors would be better. Medtronic want to use the next generation of sensor with LGS. It is not approved in the States yet. It is over seas. You want better sensors, you could have them if you lived in Europe now.
As for three. My bet is zero pay off and no pressure. In fact I think the pressure come from JDRF and goes to industry to get better tools in our hands.
JDRF is investing in AP and this ad is a very very small part of that investment. I can say with a fairly high degree of certainty that JDRF executive field a lot of calls from social media writes who have an particular interest in conflict. Mostly because I am one who does. So is a great guy named and Scott Strummello. Check out his blog http://blog.sstrumello.com/. We are big fans of transparency and we
As I said in the post I don't think ANYONE has the interest of people and parents more at heart than Aaron and Jeffery. I am also willing to bet they would say that I do in fact ask a LOT of questions. I don't question their motives one bit.
I hope you can come to that feeling too.
What would it take?
Bennet-
ReplyDeletei LOVE this, and am so glad you decided to post it on your blog.
also, thanks for being such an encourager on twitter! :)