More Damaging Headlines: the FDA Disses Insulin Pumps

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.”Fda_retreat_2

“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.

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15 Responses

  1. Wade C,
    Wade C, May 5, 2008 at 12:44 pm | | Reply

    I thought that was Charlton Heston’s line, not Eastwood.

  2. AmyT
    AmyT May 5, 2008 at 12:58 pm | | Reply

    You are so right, Wade. I just fixed. Funny how those two got mashed in my mind :)

  3. Keith
    Keith May 5, 2008 at 1:43 pm | | Reply

    This morning Fox news did a short segment on this. While I normally like their coverage, this had to be some of the poorest journalism I’ve ever seen. Just following in the FDA’s footsteps I guess.

  4. Allison Blass
    Allison Blass May 5, 2008 at 2:09 pm | | Reply

    You mean people can hurt/kill themselves using prescription drugs?? ::gasp:: *That’s* never happened before!

    Has anyone listened to the commercials these days about how teens are using prescription drugs to get high? Despite all the issues the drugs have had, most painkillers are still on the market.

    People can be stupid, but that doesn’t mean the drug/medical device doesn’t help the millions of people who are smart… Shame on the FDA for being so presumptuous.

  5. Scott
    Scott May 5, 2008 at 2:21 pm | | Reply

    I wrote about this earlier today. The FDA study which was by itself the most interesting element of the report, since the FDA has largely been criticized for its failure to examine Adverse Event data involving all of its approved products, we need look no further than last year’s scandal involving the type 2 diabetes treatment Avandia as an example of what I mean by that.

    This study found 13 deaths reported, and simple math applied here indicates the incidence of actual deaths was 0.81% (in other words, less than 1%), but when compared to Adverse Event reports involving insulin without a pump, the number cannot even be considered statistically significant! It would be even more interesting to see whether these same reports correlated with a similar Adverse Event filing for insulin – my suspicion is that they would not, but somehow those questions are never asked by our regulators!

    The top 3 issues associated with the non death-related Adverse Event reports were all linked to patient education, noncompliance, and perhaps most troubling, problems during sports or other activities. Adverse Event reporting is an area the FDA has done a poor job of gathering information in the past, although the Agency held a workshop on this very subject earlier this year and even sought public commentary on the matter — I know, because I submitted a lengthy document myself, co-authored with a number of other people.

    This is simply incendiary reporting, but the FDA has a long way to go before anyone believes they are monitoring Adverse Events the way they need to be.

  6. Hannah
    Hannah May 5, 2008 at 2:30 pm | | Reply

    Really? REALLY? Where’s the love? And how many folks intentionally OD’d on insulin by regular injection? And what do they mean by injured? If you haven’t snagged your tubing on a doorknob at least once, you’re not a real pumper! (Or in OmniPod’s case, if you haven’t whacked your pod against a door…)

    Are uninformed individuals now going to start harping on us about how we all need to go back to MDI because of how BAAAADD pumps are for us? *headdesk*

  7. Cara
    Cara May 5, 2008 at 3:02 pm | | Reply

    The FDA can be complete morons at times. I couldn’t believe this when I read it this morning on a news site.
    Sigh. Can’t they every look at both sides???

  8. Lauren
    Lauren May 5, 2008 at 8:01 pm | | Reply

    A significant number of people in this country are injured by their pillows each year. Should there be a nationwide pillow recall? How I hate these sensationalistic stories, just like the “glucose monitoring just stresses people out” story from a few weeks ago. I’m not a pumper, I inject; somehow I doubt I’m safer from insulin reactions and the various other pitfalls of standing in for your broken beta cells.

  9. Kendra
    Kendra May 6, 2008 at 6:27 am | | Reply

    This release is disheartening because it means I’ll spend time deflecting even more “concerned” comments from people whose knowledge of diabetes comes from whatever random soundbyte they happened to hear on the morning radio show on their way to work…”Oh, you use an INSULIN PUMP? I heard those were DANGEROUS.”

    It’s having diabetes that is inherently dangerous, not the tools we use to treat the disease. Yes, pumps have drawbacks and I know more than one T1 who has received an accidental overdose of insulin thanks to a pump malfunction, and many T1s who have had pump blockages not taking into account their level of diabetes education or their age — but did anyone ask the people with diabetes about their personal cost/benefit analyses? Most people on pumps are on Amy’s side, I think. You’d have to pry mine out of my cold, dead hands for sure. What this article doesn’t address is the huge drawbacks to MDI as well, and the glaring fact that you can just as easily overdose or underdose insulin on shots. This disease is a pain in the ass and it’s dangerous sometimes, bottom line.

    DON’T DIS MY PUMP. Dis diabetes all you want, though.

  10. AmyT
    AmyT May 6, 2008 at 7:09 am | | Reply

    Well said, Kendra!

  11. Beth
    Beth May 6, 2008 at 8:19 am | | Reply

    Most troubling is the inclusion of the suicide attempts, because deliberate misuse doesn’t really have anything to do with pump safety.

    I have an big iron skillet I often use for cooking — it’s one of the most useful items in my kitchen. But if I choose to whack someone on the head with it, it doesn’t mean there’s anything wrong with the skillet; it means I made a bad choice with a good tool.

  12. Kathleen Weaver
    Kathleen Weaver May 6, 2008 at 1:48 pm | | Reply

    The pump line from you, you were so resistant — though I think you are still “allergic” to the tubing…..

    But back to the story — where is the study on insuln pens and teenage using? Where is the story about teenagers mis using insulin vials.

    From personal experience (I’m a teacher, large urban high school, and I’m often asked to counsel students by the nurse), if you can abuse it, teenagers will.

    Of course, not YOUR teenager, the other parent’s teenager.

  13. pumpmavin
    pumpmavin May 12, 2008 at 10:48 am | | Reply

    It wouldn’t hurt for you to fire off a letter to the editor of the journal Pediatrics. I believe your points here are spot on and could help stop some future silliness in this area.

  14. Acai
    Acai December 26, 2008 at 5:22 pm | | Reply

    Kendra, wow, I have to agree with you on that. Well said!

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