Another diabetes media blitz you won’t believe. Check out “FDA study: Insulin pumps linked to injuries, deaths in teens,” an Associated Press headline that’s appearing all over God’s creation today.
And I quote:
“The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote.”
“Some teens didn’t know how to use the pumps correctly, dropped them or didn’t take good care of them. There were two possible suicide attempts by teens who gave themselves too much insulin, according to the analysis.”
The FDA study referred to is published in the May issue of the journal Pediatrics; it reports of “adverse events and deaths in adolescents using the pumps occurred from 1996-2005.”
I’ve been corresponding this morning with Steve Sabicer, the spokesman for Minneapolis-based Medtronic Inc. who’s quoted in the AP article, and we’re both wondering: What was the FDA thinking??
“This FDA retrospective analysis fails to include ANY data on how other patients manage their diabetes, or what a ‘safe’ level of adverse events might be when managing such a complicated disease as diabetes. In fact, most studies contradict this AP story and point to how insulin pump therapy reduces the incidence of adverse events and deaths in patients. A consensus statement on the topic was published in Diabetes Care not too long ago on this very issue.”
Here is a LINK to that consensus piece, which states — and I quote:
“Based on the available evidence and the experience of the expert panel, CSII (insulin pump) therapy may be appropriate for children and youth of all ages provided that appropriate support personnel are available. CSII use in children and adolescents may be associated with improved glycemic control and improved quality of life and poses no greater, and possibly less, risk than MDI (multiple daily injection) therapy.”
It’s just short-sighted and frankly silly to blame the insulin pump — again, one of the best D-tools we’ve ever had available — for volatility in some young people’s diabetes care. I cringe to think what kind of repercussions these headlines will have for insurance reimbursement, which is already so tough. Of course, again, I can only assume it’s all about the money. But talk about risks: the only way you’d get my pump away from me (as Charlton Heston might say) is to pry it out of my cold, dead hands.