FDA Committee Recommends Avandia Stay on Market
Yesterday, a U.S. Food and Drug Administration advisory panel recommended in a 22 to 1 vote that FDA keep the controversial type 2 diabetes drug Avandia on the market. The panel also voted 20 to 3 that the drug does raise heart disease risk, however, and backed the requirement of a "black-box" warning on Avandia labeling. An estimated one million Americans currently use Avandia to control their diabetes.
In May, the New England Journal of Medicine published a controversial metanalysis of research examining Avandia and heart disease risk, setting off a significant debate in the diabetes community and Congress, and prompting the FDA to accelerate the committee hearing process on the drug.
While the panel's decision is considered a 'recommendation' to the FDA, the agency historically has followed its advice. However, CNN reports that there is disagreement within the FDA itself over the fate of the drug, quoting Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs, as telling the panel: "It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn." GlaxoSmithKline, the manufacturer of Avandia, continues to stand by the safety record of the drug.
RELATED: More on Avandia
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Noting Errors - Sneak Peak from Blogabetes!
Welcome to the start of a new work week and another preview from the Blogabetes bloggers. This week, blogger Nicole Purcell makes her Blogabetes debut:
Errors: When Things Take An “Accidental” Turn for the WorstAh! It’s a new day and my fasting blood sugar comes in at a sweet 103 mg/dl. “Not too shabby,” I think, maybe feeling a bit arrogant.
I go about the business of the day - exercise, hop in the shower, dry the hair, feed the cat - get in the car for work. Drive 30 of the 45 minutes it takes to get there.
And then I think - caught in a wave of abject panic, “Where is my pump?”
I do the pat down, you know the one. I pat with flat, frantic hands at my bra, my hip, my waistband. And I know then exactly where my pump is. On the shelf in the bathroom, pumping insulin into oblivion instead of into me.
“Man.” I think. I also think. Alright, maybe I say aloud - a number of colorful words not suitable for a family website.
And I head back toward home, calling the office to let them know that I’ve been delayed.
It is, I know, one of those errors I have the potential to make everyday. Thankfully, on most mornings, I am far more cautious about the mental checklist of a type 1, insulin pumping diabetic. Meter - check. Enough strips for the day - check. Glucose tabs for car - check. Syringe and Insulin, just in case - check. Insulin Pump - double check!!
But the fact of the matter is - with so many potential missteps in a day - I make my share. I think we all do.
Have you ever, for example, gotten so into a work project that you test in the morning, have some breakfast, and then realize that suddenly - it’s 3:30 pm? And you wonder how that happened - and you pull our your meter and realize that not testing for 6 hours hasn’t had the effect on blood sugar that your normal, 3-4 tests in that period does.
Or - have you ever been at dinner with friends, enjoying the company, having some wine, grazing in a not-so-everyday kind of way, and at the end of the evening you dread testing your blood sugar because you just KNOW you’ve forgotten to bolus, or miscalculated the many, many carbs you’ve consumed?
How about those lows that make you unfathomably hungry - or that seem resistant to every morsel you put in your mouth? Have you ever just given into one of those - eating 9,000 grams of carbs? OK - so maybe 9,000 grams is a slight exaggeration - but you get the point.
And the highs that seem more stubborn than a two-year old who wants a candy bar at the grocery store - what about those? Have you ever treated one of those repeatedly, ignoring any suggestions your pump might be giving you - disregarding every rule you have about being exact?
These are only a few of the everyday negative possibilities we face. Sure - some of them are within our control - if we think about it logically. But there are times when our brains are so addled with out of range blood sugars that logical thought is beyond our grasp. And there are times that it seems perfectly logical to eat 9,000 grams of carbs or to give 9,000 units of insulin.
I find that for me, it is this potential for everyday errors that really gets the best of me. I feel smallest - most frustrated - most angry about having diabetes - when something negative happens that I know I could have cut off at the pass - if I’d thought more clearly, if I had a better memory, if I had been more conscientious about testing, if I wasn’t so damned hungry or so damned angry about being high.
The best I can do - I guess - the best all of us can do - is to stay as aware as we can about what it takes to control this disease. And to not be so hard on ourselves when one of the million potential errors gets in our way.
Someone please remind me of this post the next time I forget to reconnect pump before I leave for work.
Check back Friday for more from the bloggers! And be on the lookout for the Blogabetes official launch in August!
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My Year of Living Dangerously
Happy Friday, dLifers! Today we have another preview post from the soon-to-be launched Blogabetes, this time from Robert Rummel-Hudson:
My Year of Living DangerouslyI am going to begin this, my very first blog post here, with a confession.
I have fallen off the wagon.
Not the booze wagon; even before my type 2 diagnosis in February 2006, my drinky drink days were mostly behind me. (College was fun, from what I remember.) No, the wagon I have fallen off of is the healthy living, weight-losing, diabetic-under-control wagon.
When I was diagnosed with type 2 diabetes last year, my a1c was hovering above 10, and I was about 35 pounds overweight. I was also terrified. I was 38 years old, with that big number (let's call it "thirty-ten") looking in the near future. My own father died at the age of fifty-one after about twenty years of poorly managed diabetes. I was determined that this wouldn't be me.
After trying a variety of drugs, my doctor settled on metformin for my blood sugar, which made me sick, and phentermine for dieting, which made me skinny and jumpy. I said a tearful goodbye to the foods that I loved amd a tentative hello to a new way of eating that wasn't much fun but likewise wasn't as bad as I thought it would be.
By the end of the summer, I had lost all but about five of the pounds I was trying to lose. My a1c was down below 7, and I was feeling happy and healthy.
And then, in August, I got a book deal for a memoir that was only about thirty percent written. It was good news, of course, but it meant a lot of writing ahead of me, and lots of traveling and celebrating as well.
For the next five months, I hunkered down to finish the book, and the old bad habits that I had shaken during the summer slowly crept back into my life.
"You don't have time to exercise," said the bad habits. "You should sit at your computer and write, and perhaps have a snack while you do so. Isn't that better?"
Yeah. Cut to my last doctor's visit, about a week ago. My weight is back up almost twenty pounds, and my a1c is over 8. All of those new clothes I bought last fall for my first media event back in December? Trying to put them on made for a sad, sad sight. I felt like the girl in Willy Wonka and the Chocolate Factory when she turned into a blueberry. Or perhaps Jabba the Hutt.
So what went wrong?
I think that in addition to the writerly lifestyle of sloth I slipped into as I finished the book, I also began to trust my meds more and monitor my blood sugar less. I suppose I must have figured that at the highest permissible dosage of metformin (which does NOT make you feel extra swell, so don't let anyone tell you differently), I thought I could ease up on the diet and exercise. I figured that suffering through the fun effects of my meds was a sort of penance that I was paying, one that would allow for the occasional pasta bowl or ice cream sandwich. I figured wrong, as just about any other diabetic not suffering from some kind of head injury or clinical delusion could have told me.
So this is probably a good time for me to begin blogging about diabetes again, since I have gone from a success story to a cautionary tale. Some of the folks who'll be blogging here at dLife will no doubt be doing so from the professional and maybe even medical perspective of "Person Who Knows Stuff".
Look for me to cover the "Guy Who Learns Everything the Hard Way" beat. Now if you'll excuse me, there's a salad and a treadmill calling my name. And they don't sound especially friendly.
Look for more from the Blogabetes bloggers on Monday morning. And have a terrific weekend!
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Watermelon Gets a Low-Sugar Makeover
Sweet, juicy watermelon is a perennial summertime favorite, naturally rich in nutrients such as cancer-fighting lycopene, vitamin A, and potassium. Unfortunately, it also packs a big glycemic punch, making it a less favorable choice for people with diabetes. But good news may be coming to a supermarket near you. The United States Department of Food and Agriculture (USDA) reports that the agency's Agricultural Research Service (ARS) has developed a new breed of watermelon that contains the same nutrients in conventional varieties, but cuts the sugar content by over 50 percent. According to USDA, the ARS has shared the new lower carb melon with growers, and hopes to see the watermelons "showing up in produce aisles by summer's end."
RELATED: Nutritionally-Analyzed Watermelon Recipes
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Managing Your Child's Diabetes - from Blogabetes
Welcome to the start of another week, and another sneak-peek into dLife's Blogabetes. This morning's post is written by Julia Zegarra, Blogabetes writer and mother of a child with diabetes:
Mrs. Fix-itI’m more than a little OCD when it comes to Olivia’s diabetes care. Not in the “must log every number and every carb and every speck of exercise” (because, hello? She’s twelve and doesn’t ask for food any more, she just goes and gets it and exercise? Hah. But that’s another post.), but more in a “I need these numbers to be even,” way.
It’s maddening. Olivia could eat the same thing at the same time and do the same amount of exercise (hah) every day and still have wildly different bg readings each day. And I just want. To. Fix. It. I finagle insulin doses like pieces on a chess board. I obsess and worry over the timing of her insulin dose – should she have that before she eats? After? Dual wave? Square wave? Super bolus?
This is not a good disease to try and manage when you’re more than a little OCD. In fact, it’s the type of disease that has you up at 2 a.m., pleading with the internet for some help. Thankfully, there are plenty of sources to go to: here, of course. The Children With Diabetes Website and their parents email list and various diabetes-related bulletin boards.
But what I can never get is an answer to the question of “Why?” The doctors, the other parents, the posters on the bulletin boards all shrug and say “That’s just diabetes.”
It’s enough to make me lose my mind.
Check back on Friday for more from the Blogabetes writers!
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Blogabetes Sneak Peek - The Grape Conundrum
Here's another sneak peek into the soon-to-be launched Blogabetes! Today's post is from Blogabetes blogger Carey Potash:
The Grape ConundrumWe're constantly weighing things. Weighing grams. Weighing negatives. Weighing the lesser of two evils.
On the soccer field at halftime I weigh the effect grapes will have on Charlie when his blood sugar is 260. I weigh this against the sadness he'll have if he's the only kid unable to enjoy a halftime snack. This one's easy though. I'll never ever subject him to exclusion.
But, how many grapes? I don't like that he's 260, but he's running around like a wildebeest for two hours. He should come down. Right? Well, maybe. He may also go up higher with all that adrenaline pumping. He may just stay the same somehow and then plummet later. I can't bolus him and risk a low.
But there's that difficult decision again. The rest of his teammates are reclining on soccer ball pillows and popping grapes like Julius Caesar and I've allotted Charlie a measly three.
"There ya go, Bubba," I say, slowly dropping the grapes in his palm one at a time to create the illusion of several.
His sweaty pink face stares back at me with a "huh?" look on it. The three little grapes look pathetic in his cupped, grass-stained hands.
I'm a greedy pirate captain reluctant to share my gold with my first mate. A mob boss unfairly divvying up the loot to my top henchman.
"Fine! One more, but then scram!"
"OK, five more, but that's it!"
"No! Not the quivering chin! Dammit! Three more, but THAT IS IT!"
The thing that just stabs me in the heart is his sweet little voice that tails off with a lisp.
"Dad, can I please have more grapessssssshhh?"
Without knowing the situation, an onlooker might think my deep struggle and uncertainty over a single grape was peculiar at best. Appropriate perhaps if the question was "can I sleep over Eric's house?"
The kid who blows up fish.
Check back on Monday for another post from Blogabetes!
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Looking for a particular feature on dLife.com, or maybe you aren¹t sure about how to update your profile? Our Frequently Asked Questions may have the answer. We¹ve compiled a list of facts dLife members most often want to know about dLife and the dLife.com website. Take a spin through the dLife Support FAQ to see if your question has already been answered!
Remember, the Frequently Asked Questions link can always be found in the bottom navigation of the dLife.com website.
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Coming Soon ... Blogabetes!
dLife is introducing Blogabetes - a new diabetes blog featuring some of your favorite voices from the diabetes blogosphere and introducing some new voices as well! Blogabetes will highlight "real life" with diabetes. These are people making sense of a "diabetes diet." These are people wearing insulin pumps. These are the parents of children with diabetes. These are people with type 1 or type 2 diabetes telling the true stories of what it's really like to live with diabetes.
Over the next few weeks, as we prepare to launch Blogabetes, we'll be giving dLife Today readers a sneak preview from featured Blogabetes writers. Check out today's post from Michelle Kowalski:
Finding My DemonIt happened when I was giving the baby a bath on Sunday evening. It was the first time in a week. It wasn’t really a light bulb moment, just something that felt familiar. That "Oh yeah, I remember."
My four-year-old wanted to watch me, to “help” with the baby’s bath. Everything she did made me want to scream—moving the step stool closer to the sink, talking jibber jabber to the baby, touching the water to make sure it wasn’t too hot or cold. She wasn’t being annoying, she wasn’t doing anything out of the ordinary, she just wanted to be involved. And all I could do was tell her to Stop! Stop! Just Stop It! I was thinking Just Leave Me Alone…I Want To Do This Myself…Alone…Get Away From Me!
And then it hit me—literally like a ton of bricks. At the airport the day before, I bought a smallish bag of M&M’s. Just a handful in the airport and that was it for Saturday. But I had a heavy lunch of Wendy’s that day—and hadn’t taken any insulin to cover it—and then an equally heavy fast food dinner, again with no insulin. Why I didn’t cover with the insulin that I had in my bag I really don’t know. A post for another day, I guess.
So on Sunday, I was recovering from the carb-heavy Saturday and then topped it off with the rest of those M&M’s, which I ate mostly in secret. Not to mention an assortment of white flour carbs in the form of pre-made sandwiches and frozen pizza. (That’s what happens when you’ve been gone for a week. You eat what you can find until you go to the store.) All of which had been essentially cleansed from my system the previous week which I had spent with my family at my parents’ house out of town. I was a good person with diabetes that week. I checked my sugar often, I took insulin to cover too many carbs, I didn’t eat sweets. Well, I ate fewer sweets. Sunday evening, though, I was high. Plain and simple.
Looking back, I felt wonderful that entire week. I didn’t get unnecessarily annoyed. I didn’t snip. I always treated my children and my husband with respect. And it took me a bag of M&Ms and a couple trips to a fast food joint to remember that.
Check in on Mondays and Fridays through August for the latest from the Blogabetes writers!
RELATED: Daily Living at dLife.com
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Update from Minimed
Please find below the latest from Steven Cragle at Minimed:
"Recently, Medtronic became aware of cases where exposure to strong magnetic fields like Magnetic Resonance Imaging (MRI) resulted in damage to Medtronic Paradigm insulin infusion pumps. Medtronic has taken this situation very seriously, and we have voluntarily notified our patients, physicians and the FDA about these incidences, reinforcing the need for caution when using our insulin infusion pumps while in close proximity to strong magnetic fields like MRIs.
The FDA has agreed with our assessment of the situation, and categorized this announcement as a Class II Field Correction, requiring us only to notify patients of the potential risk MRIs pose to their insulin pumps. Patients should not be concerned or take any further action unless they believe their Paradigm insulin pump has been exposed to an MRI machine. Patients should not return their Paradigm insulin pump to Medtronic unless they believe this exposure has taken place.
Extensive testing with other magnetized devices such as airport metal detectors, electronic article surveillance equipment and cellular phones will not adversely affect pump operation."
If you have any questions or concerns, please visit www.minimed.com.
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Minimed Pump Field Correction
EDITED: The FDA's Enforcement Report for the week of July 11th has announced a Field Correction for some of the Minimed Paradigm Insulin Infusion Pumps. The report is as follows:
PRODUCT:
Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007
CODE:
All serial numbers for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
RECALLING FIRM/MANUFACTURER:
Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.
REASON:
Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE:
334,000 pumps
DISTRIBUTION:
Nationwide and Internationally
For questions, you can call 1-800-MINIMED or visit the Minimed website at www.minimed.com.
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In Need of Training
The blogosphere is a-buzz about Roosevelt Sims, the 65-year old man who was thrown off of an Amtrak train outside of Williams, AZ for appearing drunk and disorderly when in fact he was recently diagnosed with diabetes and experiencing a low blood sugar.
Thankfully, Mr. Sims was found safe and sound, but hypoglycemia being mistaken for drunkeness is in the news all-too often lately. Ask Doug Burns. Do you think that employers are providing enough training to their staff? Where is the line drawn between what is "part of the job" and simply "being a compassionate human being?"
What do you think?
RELATED: Diabetes Advocacy
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Food for Thought
Recent research reveals that "Compounds found in pumpkin could potentially replace or at least drastically reduce the daily insulin injections that so many diabetics currently have to endure." Is this a story to follow or are we just waiting for the clock to strike midnight?
Talk about it in the dLife Community Forum.
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dLife Season Premiere!
The season premiere of dLifeTV airs on Sunday, July 15th. It’s “Diabetes Hardball” when Nicole Johnson turns the tables on MSNBC’s Chris Matthews. Dr. Aaron Vinik talks about advances in treating diabetic neuropathy, and in Real People, Real Stories, a Connecticut woman who uses yoga to lower her blood sugar and stress.
RELATED: dLifeTV schedule
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Fourth of July Festivities
Get ready for fireworks, fun, sand, sun...and the challenges of summer holiday blood sugar control. Enjoy your Independence Day by arming yourself with warm-weather resources from dLife.
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