FDA warning on T2D meds

Editors Note

From the FDA

FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes 

Today FDA announced it is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.

Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
For additional information, go to: http://www.fda.gov/Drugs/DrugSafety/ucm343187.htm

Edited 3/18/13 to include: 

Some caveats and balance is provided here by the The Endocrine Society response here: 

http://www.endo-society.org/media/press/2013/Experts-Raise-Concerns-about-JAMA-Study-and-Pancreatitis-Risk-of-Diabetes-Medications.cfm 

- Posted using BlogPress from my iPhone

Good Diabetes Education and Crossing Language Lines

Diabetes doesn't care what language you or I speak. It doesn't wait around for people to chose it. It chooses people around the world.

Yesterday the President of Argentina suggested, that Diabetes is a disease of the rich, because of their sedentary lifestyle. See this post at Diabetes Advocates.

Diabetes is hard enough without silly, pointless and false preconceived opinions. Late night comedian are bad enough but it is their job is to stay dumb ass stuff. A presumably responsible head of state is completely different. Their job is to lead from the facts.

Diabetes is many things, many of which are bad. It doesn't need help to be awful. Diabetes doesn't care about income or language. It makes all walks of life harder. So do ignorant comments. Health is not grounds to separate, classify or stigmatize individuals.

One thing people with diabetes can do is to us honor other's struggles without offering trite solutions. I have learned about the diabetes in my home from friends from Venezuela, Korean and the United Arab Emigrates, Canada, the UK, South Africa, Australia, Germany and more nations. I am supported by African Americans, Asian American, Hispanic American, Caucasian Americans rich, poor, female, male and every race creed and mixture I have met. I choose to try to give that back in kind to everyone I can.

We can empathize with people around the world who have diabetes, not by their choice, but by their biology. Maybe we can realize we are closer to each other than our nationality, language and culture imply to those look for such superficial implications.

We are simply humans. A lot of us get 'the sugar.'

Each of us can choose and what we choose matters. We can choose stigma and lessen ourselves by thinking less of others.  Or we can choose to draw strength from supporting each other and in doing so be humane as well as human.

I choose stand with my friend good friend Manny and many others who choose to cares about people.

Help New York Decide to Invest in Diabetes Education

Edited to add the video can be seen here if the NYC site is down, sadly this project didn't get to the next round. Still the idea and video are fantastic: http://vimeo.com/57393712

New York City is challenging, designers, and engineers to develop new products with potential.  Part of the process is a "Popular Choice Finalist" aka social media voting. Here is why this contest matters to people living with diabetes.

HbA1C looks like this: 

See the Video 

Here all this time we thought it looked like a number with a one place decimal like 7.6, 6.4 or 9.7. Often the number is accompanied by a look of disappointment from the person reading the lab sheet. So of course we thought it was a number that is all anyone ever said about it.

But look at the picture. It is a model of a hemoglobin protein. The red bits are the protein's HEME Groups, the part of the protein that move oxygen around the body. They give blood its red color. The spiky blue parts are glucose molecules attached to the hemoglobin. The more of them the higher the A1C. If the little blue bastard are sticking to every hemoglobin cell in our bodies, they are sticking to everything else too.

This model is one of a kind. Wouldn't it be kick ass if every educator had one of these so that patients could see, touch and and feel to understand that A1C in more than a arbitrary number?

We can help get these to educators by voting in New York City's Next Top Makers contest. The winner moves on to a round of professional advice and possible funding. I think better diabetes education tools is a fantastic idea. If you do too, vote. Vote early and often if you can figure out how.

Then, please, spread the word on you blog, Twitter feed, Facebook... where ever. Together we can help NYC think beyond commercial potential to public health value.

Voting is open to March 27 at 5:00pm EDT.

ThePerfectD aka @ThePerfectDBlog

I wrote this a few years ago. I still feel the same way, maybe more so. 

I try to learn from my feelings around type 1 how to honor others without a response that minimizes their struggles.  

When I was at the low point of my deluge of diabetes related emotions I looked forward to a weekly podcast. It was my link to a world that shared similar lives. The news on science was a glimmer of hope for the future. The advice on care provided strength to do better day to day. Mostly the voice of the presenter was a connection to an individual who honored my struggles.  

I got to meet her. She is far more dynamic and caring than I could have guessed and I had ridiculously high expectations. I got to see her again the next year. She introduced her mom. I considered that to be a privilege. Her mom is a hero to me. I want my daughters as well raised this mom's.

The ODC has grown in amazing ways. Still there is room for more, particularly when it is making space for the return of woman I wrote that for. New blog, but all that and more. 

Welcome back Christel, ThePerfectD http://theperfectd.com 

Empathy. Honoring struggle without trite solutions.

I wrote this as a response to my good friend Scott Benner's post Our Community at Arden's Day. It is also a response to Sara, Jess, a classic by Bob, a new blog by Christel, a host of Facebook messages, Tweets, texts, phone calls and more.  I originally posted it at Arden's Day and have copied it here.  

In my view empathy is what hold the diabetes community together. By empathy. I mean to honor another’s struggle without offering them a trite formula. I have written about empathy a lot. I think the DOC does it well, most of the time. Lots of folks do that. Scott, you do. So so Sara, Jess, Bob and countless others. I hope I do, I hope Tom gets back to it. 

From my perspective both the lines of honoring and trite were crossed, and crossed with forethought, by DRI. That is unfortunate, to the point that I agree with your assessment of both cruel and unthinkable. 

Here is why I say DRI forthought. 

This came days before Tom's Facebook post. It is a DRI email teasing "The Next Quantum Leap: The Biological Cure" in the subject line. Clearly the "The Biological Cure" hype was DRI's communication plan. So in addition to Tom's rationalization laced, "I'm sorry," DRI need to be accountable for the hype they apparently hoped to manipulate. They need to return to honoring the struggle and apologize for trite formula hyping "The Biological Cure" to serve their immediate ends. That should happen without the ‘but we didn’t mean it they way we clearly said it’ we have seen. 

Let me be clear I am NOT saying encapsulation is a trite path to treatments. Hyping it as "The Biological Cure" is. "The Biological Cure" is not the same as saying it a very promising path to a possible cure that is soon to enter human trials. As they say on sesame Street, "One of these things is not like the other." One is cruel, the other is honest.

Living and breathing the science of type 1 isn't same as the emotions of living with or parenting a child with Type 1. DRI has shown the clear appreciation of the relationship the two. In an 2010 story, Rive Greenburg quotes DRI’s Dr. Ricordi saying, "I hate to over-promise because so many people have been disillusioned." So it is even more disheartening to see DRI choose hype and discredit Dr. Ricordi’s prior empathy for the community. 

Calling it "The Biological Cure" now completely discounts what that they have achieved buy putting it on the same footing as every other claim of a cure in 5 or 10 years. 

Hyping a cure in 5 years as is not honoring the struggle. A cure in five years is THE standing joke of false hope. We all know it and know why.  I suggest that by definition anything 5 years out is NOT a cure.  Five years is a lifetime with type 1. 

The idea becomes trite when put into the context of the tragic cases where 5 years is more than a person lifetime with type 1. Lets all hope those are few. Sadly we know none is not realistic. 

Am I encouraged by encapsulation? Sure. Have been for years and years. I expect encouraged by progress for years to come. I am encouraged by lots of stuff: better basal insulins, faster bolus insulin, better sets, glucose responsive insulins, innovation in CGM, better data management and mostly the peer to peer community. 

Am I very discouraged by the premeditated choice of hype over empathy by DRI? Absolutely. 

I suggest that tuning out their communications, specifically this campaign is not a trite response.  If this becomes a successful communication / funding campaign, who will be next to play the hyped cure card? When will we see copy cats? What will that serve? How does that honor the struggle for the next few years?

I decided to unsubscribe to DRI email as a step in turning down their choice of hype. I encourage other to do so too. I did so to send a small message that choosing hype over empathy is self selection out the community that honor other’s struggle without offering a trite formula.

I welcome an honest conversation about advancing encapsulation. This wasn’t it. Rewarding it as such only invites more hype. 

An AP by Any Other Name: Animas HHM

Artificial Pancreas is in the news again. This time the press release is from Animas. Yesterday the news was of an article in the New England Journal of Medicine.

Everyone's favorite bard said, "A Rose by any other name would smell as sweet." Sorry Bill,  I am beginning to think you were wrong.  I think the first steps of AP smell sweeter with different names.

My experience talking with other parents is that the term Artificial Pancreas is all wrapped up expectations of it doing what they really, really want. That is magically managing diabetes so well they don't need to worry about it. Being reasonably smart people, who are regularly frustrated by their child's diabetes varying in inexplicable ways, the discrepancies of life, liberty to eat and CGMs, they conclude that the present technology can't deliver that magic.

No kidding. It can't.

There is a whole bit on this in Forbes by David Kliff, Stretching The Truth About An Artificial Pancreas to which others and I replied.

Here is what matters to me as a dad of T1D kids - the NEJM article says the first steps of AP can lessen the number of hypos and keep kids in range longer. This is where the Animas release kicks in, remember the Animas press release? This is a story about the Animas press release.

In the Animas release they don't call it AP. Go ahead go read it. Search it for the word Artificial. It ain't there.

The story is about, "a first-generation closed loop insulin delivery system." I will give you that AFGCLIDS is no rose. They got that.  They call it HHM for Hypoglycemia-Hyperglycemia Minimizer. I would call it Hypblurglycimic Minimizing System. Then I would go for a whole Gilbert and Sullivan operetta - HMS Pancreas.  But I digress.

Like LGS (Low Glucose Suspend) the idea isn't to manage precisely to target. The goal is to help minimize bad sh*t from happening. Preventing bad sh*t, is a good thing.

Progress happens incrementally. Regulators are gonna be more comfortable regulating incrementally and payers will probably be more likely to pay if academia (see NEJM above) can show incrementally better outcomes and hopefully incremental savings in the reduction of expensive hospital visits.

Staying in range more means better long term outcomes. That may not be actually magic but it is a nice parlor trick.


Oh and my apologizes to centuries of British culture.

AP, aka LGS in NEJM

Artificial Pancreas with kids at camp is the topic of  New England Journal of Medicine article just out called, Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp. It looks like they used the Medtronic Veo.

It is a report testing AP outside of the hospital. Reader digest version: Kids had fewer lows and better control with AP.

http://www.nejm.org/doi/full/10.1056/NEJMoa1206881

PODD Earnings Call Info for Patients.

The PODD earrings call is  on Seeking Alpha. Here are a few points I thought patients may like to know.

New PODDs in weeks 

For our existing customers, we will begin the transition from the original product to the new OmniPod in the next few weeks. 

Verio PDM 

... we expect to file in the coming months a submission requesting 510(k) clearance for a PDM integrated with LifeScan Verio blood glucose meter. We are hopeful that this new PDM will be commercially available in 2013  

IOB 

... one of the blocking things that was out there was our whole insulin on-board calculation and not to bore everybody with the kind of arcane way we did it, but we thought we had kind of a better mouse trap. It wasn't the way the market leader did it. So this product basically put it in line with the way the market leader did it

CGM 

.... Finally, in January, we signed an agreement with a new continuous glucose monitoring partner. The agreement calls for both parties to continue development work already underway towards the ultimate goal of an OmniPod integrated with a CGM sensor. 

In Q& A re the name of the sensor partner, 

... we have with the company until we get to the point where we think we have a final version, a commercial version, we agreed not to give involved in disclosing that 

.... we tested on pigs, so far so good. Sometime next year we'd like to be doing it on people. And we'd like to be doing it on people not as a stand-alone sensor, but in our integrated format. So the big engineering hurdles/opportunities for us is how do we insert this within the framework of the product we have? And how close can it be to the insulin delivery? And the third one is -- and we've tested this a lot now, but we still have to go through in testing it in final is can the sensor withstand ETO sterilization. 

There is more on the CGM partnership in the Q&A part the call. Hop over to Seeking Alpha if you are interested.

PODD Earnings Released

Seeking alpha has a post up on PODD (aka Insulet) 2012 Earnings.

http://seekingalpha.com/news-article/5766041-insulet-reports-fourth-quarter-and-full-year-2012-results?source=email_rt_mc_press_0

Conference CallInsulet will host a conference call on Wednesday, February 27, 2013 at 5:00PM Eastern time to discuss the Company's fourth quarter and full year 2012 results and present information concerning its business, strategies and outlook. To listen to the conference call, please dial (877) 831-5664 for domestic callers and (832) 412-1780 for international callers. The passcode is 98386780. A replay of the conference call will be available two hours after the start of the call through March 27, 2013 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 98386780. An online archive of the conference call will also be available by accessing the Investor Information section of the company's website at http://investors.insulet.com.

Animas offers rebate on Dexcom G4

Got this email form Animas, haven't found a web version to link:

We've partnered with Dexcom to integrate glucose sensing with our insulin pumps. Find out how we can help you make a smooth transition to next generation technology as soon as it becomes available. Animas pumpers are eligible for a $200 rebate on Dexcom G4™ PLATINUM CGM today. Get the latest, greatest pump technology for just $99 when it becomes available with the ezAccess Upgrade Program.† Call 1-877-YES-PUMP to learn more, and to get all the perks that come with pump therapy from Animas and CGM from Dexcom.   *To receive the $200 rebate, Animas patients must be within their warranty period and must purchase the Dexcom G4™ PLATINUM CGM System by 04/30/2013. †The ezAccess Upgrade Program is effective 6/1/2011 to 4/30/2013. The ezAccess Upgrade Program excludes individuals with Medicare or Medicaid, or any other federal or state healthcare plans. It is not valid for patients who reside in MA. Offer not available to participants of the Animas Access Program or prior ezAccess Upgrade Program participants who have not purchased a full revenue pump since last upgrade. Other exclusions may apply.