Help a Dad asking for better education.

Tom Karlya, aka Diabetes Dad reached out and asked for help getting the word out on a North Carolina diabetes education ask.

I'm happy to help share.

The effort is to help provide education about the symptoms of diabetes so that kids are not sent home entering DKA with a suspected flu or other childhood bug. Tom outlines the issue better than I. Like so many advocacy issues this popped up at the last second. All the more reason we need a strong advocacy database.

http://diabetesdad.org/2015/04/27/today-the-world-changes-but-we-must-act-by-2pm-est-please-help/

Access is the point of Advocacy

The prompt for today:

Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you “formally” advocate for any cause, share the issues that are important to you.

Yes.
All of the above,
and then some.

Diabetes is Big. Policy is Big.

They touch at a lot of different points. Because both are big, often one touch point doesn't know what the other is trying to do.

It would be glorious, for example, if efforts at prevention were connected to the key idea of access via insurance reimbursement for quality education on how to successfully prevent or at least postpone type 2. Great if third party payers looked at education as the investment in saving lives and expenses down the road that it is, sadly it is not always seen that way.

The list of issues in the prompt seem quite different;

• 504 and schools
• Misconceptions
• CGM and CMS
• Special Diabetes Program
• Test Strips
• Connections with peers

I don't see it that way. To me they are all access to issues:

• Access to safe school environments.
• Access to accurate public messages about diabetes.
• Access to treatment and technology to continue to successfully manage diabetes.
• Access to research to better treat diabetes. 
• Access to reliable devices.
• Access to people who can help individuals stay positive and engaged. 

Advocacy is acting to ensure access. What people need access to may, like diabetes, vary. The need to act with and for each other doesn't vary. If we don't act for better diabetes access, who will?

Yay Team!

At the risk of sounding like one of the Borg collective from Star Trek Star Trek: The Next Generation, I was 6 of 17. One of a diverse group of people who spoke at the Afrezza ADCOM meeting.

It was an interesting day. It overstate things, possibly wildly, but I’ll describe the day as MannKind spoke about the wonders of their insulin and FDA showered upon it a lack of love. Pubic speakers talked of a need for options. The panel considered risk, patient needs and in what the called a difficult choice voted almost unanimously for the drug. 

I don’t know what FDA will do, approve it or not. They have to July 15.  

I do know that those who spoke with me were a fascinating group that spanned the cross section of the diabetes community.  There were a number of physicians who treat PWDs, CDEs who teach PWDs, ADA and JDRF that represent PWDs, and a mix of type 1, type 2 and type 3 (caregivers) people who live with diabetes.

I have not seen as wide a mix at any previous FDA meeting. Nor I had not seen anything like Manny Hernandez’s video presentation, bringing views into the room from a champion who could not be there physically. He spoke of reactions to the drug at tuDiabetes and estudiabetes. He spoke in Spanish, with subtitles when representing Spanish speaking American. That was an appropriate first in my experience. 

Through the diversity of speaker, the message could not have been clearer if we had sat down and scripted it out. In fact one public speaker commented about that, noting that we had not. 

There is not one best way to manage diabetes. People with diabetes need more options to consider with their health care professionals. 

Doctors and patients should consider care plans that reflect individual lifestyles, fears and aspirations. There is an emotional component to care, some folks are afraid or needles. Some shy away from the stigma of injecting in a restaurant, plane or other public place. Some fear hypoglycemia. Others reached unprecedented control with an ultra fast acting insulin.  

Following the public comments, it seemed that in addition to the critical safety issues, the panel also considered the psycho - social aspect of diabetes self care.  All too often, it seems to me, these are overlooked with words like adherence and compliant.

I hope the panel would have had those discussions without the hour of public comments. In the hand full of these meeting I have attend, that as not been the case, certainly to the extent we saw on April 1. 

I hope this was not some twist of April Fool’s Day fate. I hope that the broad community of physicians, CDEs, Big Advocacy and individual PWDs will continue speak in one voice because more options means better care. 

No doubt, the idea of options will need to be better appreciated by third party payers. We can help. Advocacy, just like good diabetes care, work best with a team, doctors, educators and advocates all working with and for patients. 

FDA EMDAC Public Comments

I had the privilege of offering public comments at the December 12 FDA Advisory Committee meeting for BMS/AZ's dapagliflozin (aka DAPA). My comments were roughly what follows. I say roughly because I know I get lost and stray from the notes. I have tried to bring what portions of my ad-libbing I remember into what follows.

My sincerest thanks to Kelly Close and the team at diaTribe for sharing detailed background material that made it possible to offer informed comments. DAPA has had a complex and carefully scrutinized regulatory path. There were concerning possible signals of risk. Without being able to read though its history it would have been impossible to appreciate the Sponsor's (FDA hearing speak for the pharma companies behind the drug application), FDA's and committee's conversation on those risks. 

My Comments:

Good afternoon. My name is Bennet Dunlap. I have no relationship with the sponsor. My travel here today is at my own expense, including the cost to a good nights sleep of getting up at 4:am to drive down from Philly for this meeting. 

I am a diabetes advocate, a blogger, been a PCORI reviewer and I recently created the StripSafely.com campaign for meter accuracy. I am a member of Diabetes Advocates, an association of diabetes patients and writers. Last time I was here I absolutely slaughtered the name of the drug in question, so this time I’m not even going to try.

Like 26 million other Americans, I live with diabetes. This morning somebody spoke of unintended wisdom. Those of us with diabetes will take wisdom any which way we can.

I often feel that, the conventional wisdom in medical literature projects that diabetes care is easy. Many of us have felt it is not.  We have found  it doesn’t help when – despite our best efforts – we are labeled non-compliant.  Maybe the problem has to do with unrealistic expectations, or maybe the problem has to do with imperfect treatments.

What I am certain about is while all of us with diabetes can benefit from similar diet and exercise, there is no one size fits all approach to good diabetes medications. We need choices to talk about with people like Bob Ratner, (Gesture to Bob who just spoke) our doctors…  and we need innovation.

Which brings me to the purpose of today’s meeting.

Has the sponsor met the safety and efficacy requirements to market their candidate drug and does it present potential heal value to some of us living with diabetes?             

Broadly speaking, the class of SGLT medication is an exciting new opportunity for glucose regulation. The class encompasses four benefits we haven’t seen together before in one diabetes therapy:

- improved glucose, 

- weight loss, 

- less hypoglycemia, 

- and ease of use that comes with a pill. 

Expanding the class with this DAPA increases choice: although there is already one approved for SGLT-2 therapy, a second one would provide obvious benefits from competition, broader education and outreach. 

We all know third party payers love to bid the pharma. companies against each other and a second SGLT-2 would give them a chance to do so in this exciting new class.

As you consider benefits of diabetes medication outcomes, I encourage you to look to endpoints that can create success in patients’ daily lives. In addition to endpoints of lowering A1C, and avoiding cancer and CV risk profiles -  look to endpoints that we can see and feel in our daily efforts to be “compliant.” Medicines that show less weight gain or even loss and less hypoglycemia can help with the phyco-social struggle to stay compliment. 

The safety issues raised at the DAPA first hearing we're quite concerning. Nobody wants to trade blood sugar control for cancer. I appreciate the scrutiny the the agency and sponsor have given to the issues. I was particularly interested in this mornings presentation on the bladder cancer risk and look forward to detailed professional exploration of it this afternoon. 

As Dr Wilding pointed out this morning, we need better treatments. As a patient I worry that regulation creep may inhibit those innovation. That the endpoints move after trials have begun. What constitutes an effective study need to be resolved before the trials start, not after the fact in discussion at an advisory meeting. 

In closing, please remember diabetes care… is self-care. As patients, we see our doctors just a few times a year, maybe for a combined total of an hour, or two if we are really lucky. That leaves us on our own, responsible for self-care the other eight thousand, seven hundred, fifty eight hours a year. 

We could use a hand seeing success in that.  

Thank you very much.

StripSafely & Tim Gunn's Sports Jacket.

Who doesn't love a sequel to a summer block buster?

OK it may be a stretch to call StripSafely a summer block buster but a guy can dream right?

DSMA's Blog Carnival is revisiting the Strip Issue with this prompt:

What would your comment be on meter accuracy at the Diabetes Technology Society meeting? 

I actually commented as a panelist at the meeting.

Here s a little video clip.
http://www.youtube.com/watch?v=SK0HWO7-JXk

So since there are already comments on record, I will share some of my hopes and make a confession. Let's start with that confession part. I had an ulterior motives creating the campaign.

I wanted to see if we as a community could come together and make a difference through action. 

We can.

We should do it a lot more often.

Here is how I know. The FDA called me, on a Friday evening well after business hours. Nobody work late on Friday unless the boss has bee in their bonnet. Also I got a letter back from my Congresswoman and it was very clear she reached out to FDA and got the official FDA response.

An official response and after hour calls on a Friday are an indication that we, the DOC, managed to get their attention. We need to keep it and use that attention for good. Good to means getting tighter accuracy standards AND requiring all meters systems sold to meet the new standard. No old stuff at or not quite at the old standard still sold. Yes - they could pass a new standard for new products but leave all the old stuff approved in the market. No we should not sit quietly if they do.

Keep int attention to me means moving to include positive feed back into the program. Show the regulatory process some lovin' when they take positive steps. Those of us outside the beltway (and the FDA campus is outside too) know the truth of what the great political commentator and sage Mick Jagger said, "you can't always get what you want, but if you try sometime, you just might find, You get what you need."

We are not going to get everything we want as fast as we want it from FDA. We are more likely to get it if we ask, often. It is a revolutionary concept in DC process, I know but saying thanks will help.

So, I think, we the DOC will need to keep writing about StripSafely. DC has it little temper tantrums and forgets everything outside their little ticky tack world. We don't have to play that game. We may have differences politically but we all speak BG and all will benefit form better meter systems.

There are other issues too. Ones maybe a little more complex than StripSafely, like approving new insulins or better devices. Our voices as patients can help policy makers serve us, their constituents. Let use some of the lesson learned form StripSafely like;

• serious and solemn are the same thing so we can have fun with our advocacy 
• policy makers listen if enough of us speak up
• it helps to have a central source of information and base request on peer reviewed papers
• it is a marathon not a sprint 

I'll close with an idea I heard from a leader of a community leader. We have more skin in the game than anyone. We need to learn to wear our emotion not as our heart on our sleeve but as sports jacket. Something that adds a professional appearance to the stature of the facts we present.

Yeah I know a fashion metaphor. I am a regular Tim Gunn (bet seriously, who knows better how to wear a jacket?)

“This post is my October entry in the DSMA Blog Carnival. If you’d like to participate too, you can get all of the information at http://diabetescaf.org/2013/09/october-dsma-blog-carnival-3/“

FDA, SLGT-2, EMDAC, T2D & DOC - Alphabet Soup

Last week I had the privilege of giving public comments at a FDA hearing of a proposed new type 2 drug in the class know as SLGT-2. These FDA meetings go by abbreviation EMDAC. So I was the DOC's, T2D, SLGT-2, FDA, ENDAC guy - Stick that in your soup bowl.

The drug in question is a new means of treating T2D. Instead of influencing insulin production or sensitivity, it prevents the kidneys from transporting glucose out of the urinary process, This recovery of glucose conserves energy in the body. DiaTribe has a nice little summary of the specific drug with links to more of their excellent and detailed reporting. If you prefer smaller bites of information here is a twitter search: https://twitter.com/search?q=Canagliflozin&src=typd.

Probably for most of the millenniums that humans have been around this conservation of energy was an important evolutionary advantage.  Not so much today.

By inhibiting this retention of glucose, patients on the medication excrete something like 100 to 300 calories of sugar a day. BG decreases. Significantly it only seems to happen at elevated BD levels.  When BG is in range the SLGT-2 isn't facilitating the excretion of BG or so I understood the presentation.

Readers digest version: SLGT-2s helps T2Ds pee out excessive sugar but doesn't make'm go low.

This may have a beneficial impact on weight. There are of course issues and the increase sugar in the urinary tract causes some increase in infections. YDMV.

There hearings follow a set agenda:

• The committee listens to at the drug sponsor's presentation (sponsor = company seeking approval.) 
• The FDA responds with a presentation of their review.  
• The committee then ask both a bunch of questions. 
• Most of the committee are physicians but there is one patient representative. 
• (The patient representative, at both the EMDAC sessions I attened, was fantastic. She did all patients proud. )
• The public chimes in after lunch. 
• The committee considers specific questions. 
• The committee votes a recommendation to the FDA.

This hearing had 5 people offering public comments, 2 were from the Diabetes Advocates, Kelly Close and myself. One was from the ADA, one was from the American Association of Clinical Endocrinologists. Finally one was with with a public interest group he helped start with Ralph Nader. (See my friend Scott Strumello's comment for more details, Thanks Scott for offering them.)With the exception of the public interest group affiliate, the public comments were about the need for drugs that get used, don't induce hypos and that while no drug is right for everyone, diabetes patients need options to consider with their health team.

I had the privilege of going last - batting clean up as it were. I tried to be slightly humorous with my inability to pronounce Canagliflozin to put an real world  face on the potential patient users of this drug who probably can't pronounce it either. I tried to be clear that I was there as a member of an e-patient and advocacy group. This to suggest that there are possibly a lot of us who may benefit from the drug, even if we cant pronounce it. I spoke about my family history with different Type 2 medications programs to also suggest that probably there is a bunch of us T2D for who it may not be the best choice. Either way that is a choice to make individually with one's physician,

My comments were influenced by listening to the sponsor and FDA presentation and my fellow public speakers. I mentioned Kelly Close by name and twice emphasized her points. 1) there are not enough diabetes specialist, as it took me 6 month to get an endo. appt. to confirm my T2D diagnosis and 2) we need drugs that people take, that work. I the speakers from the ADA and AACE about the fear of hypos that cause some patients to not take their all their meds. I mentioned that even those of us who know better may reduce our meds to avoid hypos, noting that a physician presenting in the morning said he himself did so and implied what do they expect form us civilians?

Both the patient representative on the committee and a member of the sponsor's team approached Kelly and I after the close of the meeting. They thanked us for our comments.  Which was very kind.

The room is a wee tad intimidating. I certainly don't yet feel totally comfortable speaking there. I will keep going and will become better at presenting there. I hope that other patients advocates continue to share views and I am happy to chat with anyone interested doing so at future sessions.

Alphabet soup helps.

Patient Voices

At a blogger event with a drug company one conversation turned to why they were engaging with diabetes people rather than patients from one of their other lines of business. The company folks replied it was because the diabetes online community (aka DOC) is significantly more active than the online patient communities of the conditions they serve.

Yay us! Right?

I had the chance to see another side of patient engagement this week. The FDA had an advisory committee considering a potential new basal insulin. There was a part of the meeting where 'we the people' could speak. Thanks to a little help with gas money from the Diabetes Advocates I drove down and spoke as a dad of T1d teens.

Comments about the DOC, like the one I started with, could make one think patients have more influence than maybe we do really do. Patients were not a significant voice in the FDA meeting room.

The majority of the committee discussion I heard was not about diabetes outcomes but about potential cardio vascular signals that may, or may not, be a potential risk. The talk around hypos and the possibility of reducing them seemed to me to be detached from the idea of hypos as a material health issue. In fairness I did not hear all the presentations.

A few physicians spoke in the public comment forum. God bless them. They were patient advocates. A doctor from the Endocrine society spoke very clearly to the fear of hypos as a barrier to good care. I found it particularly significant that he was talking about the role emotions play in the process of care, specifically the fear. Next time we complain that the care community doesn’t get the emotional side, I want to remember who spoke up to the FDA about the impact of the fear of hypos.

Hypos matter. The conversation about night time lows should be about the impact they have on how patients self manage, the fear of them and the complications of nocturnal hypos  - including dead in bed. Sadly a big part of the conversation was about what time frame counts as a nocturnal hypo; 10 p.m. to 6 a.m., 12 a.m. to 6 a.m., or 12 a.m. to 8 a.m..

While I found the time of a nocturnal hypos conversation inane for the most part this meeting was a serious science event. I freely admit it was a little intimidating to speak as a layperson, particularly following four very articulate physicians. However if we the DOC don’t show up to speak for patients who will?

We need better care options. Innovative insulins even incrementally innovative insulins are an area of better options. We would benefit form longer non-peaking basal insulin, faster bolus insulin and the holy grail of injectables glucose responsive insulins. So we need to be our own advocates making our case for benefits of better tools.

I felt there was a distinct under current in the conversation that there are perfectly serviceable insulins on the market now, so the process can hold possible innovations to a higher standard with more and longer trials without any adverse affect.

No.

Delaying or preventing access to better tools is an unfortunate outcome. These CV tests will cost more and so be barriers to new insulins making it into the butter compartments of people with diabetes. I am not sure Banting and Best could have had done CV studies. (Nor do I think there process is a model for modern safety and efficacy.)

Let me be clear. I am not advocating neglecting other safety issues such as CV risk. I am suggesting that we as patient community need to be part of the off line conversations that determine the medications and tools that are options for us to explore with our physicians. We need to be there to voice the value of better diabetes care. Maybe even introduce into the process a definition of better that not only looks at A1C but one that considers stability of glucose levels. That can include fewer or no night time hypos.

I am not saying there was no conversation about balancing better diabetes care with risks. I am saying from my perspective the value of better care appeared to be trivialized at times. In fairness I may be over stating my views.  (Raise you hand if you think I ever over state my views - ok, that is everyone who has ever read anything I ever have written.) The committee did recommend the insulin subject to ongoing CV consideration 8 to 4. Clearly the 8 felt there was benefits that were significant even with possible risks.

Still I think patient voices are needed to help balance the benefit side of consideration. We could even help the good doctor from the endo society make the case that the emotional parts of diabetes care are significant. I have been kicking myself the past two days for letting emotion breaks into my voice when I spoke about doing night time blood tests. In retrospect maybe that was a good thing. Maybe I helped him make his point. He did reach out and shake my hand as I retuned to my seat.

If we are not part of the process who will be our voice? How can we consistently do that?

#TwoBits from DiaTribe

I am a fan of DiaTribe. Kelly’s team writes detailed and thoughtful pieces. If you don’t subscribe to the newsletter, you should, just click here to sign up.

Kerri has a great piece about advocacy there.  She makes it clear that Your Advocacy May Vary (YAMV.) In fact, it should. Advocacy is a wide ranging continuum of things that boil down to taking a position and doing something because you care.

I love this part:

Every voice matters, and every person living with diabetes or caring for someone with diabetes has a unique way of sharing, connecting, and inspiring the diabetes community as a whole. Simply touch one life and you’ve made all the difference.  

To that I add don't just use you voice use your ears and share the great stuff you hear.


The NEW NOW NEXT article in this issue of DiaTribe is about new medications that can help folks with some diabetes complications. I freely admit I am no expert on meds for complications. With a master in health communications I do know a little about sharing industry information about them.

Lucentis (aka ranibizumab; manufactured by Roche’s Genentech) entered new ground with their communication practice. Roche were the pioneers in building relationships with diabetes social media with blogger summits. One of the outcomes of these relationships is Roche is starting to treat social media as a legitimate way to communication with patients. Roche reached out and asked if a bloggers, including Kelly Close, others and I, would like to attend an online media briefing for Lucentis by Genentech. A hand full of us accepted the invitation.

What is significant is that the DOC was treated like other forms of media. Writers were invited to a conversation, treated respectfully and given a chance to question Genentech researchers. I appreciate that they fielded question and responded in detail to social media. They followed up with information requested in the call.

Social media has a long way to go to build mutually respectful relationships with industry, regulators, researchers, care givers and the rest of the diabetes ecosystem. That system is complex, interrelated and necessary to keep people with diabetes well and chasing life’s dreams. The social media communication process is not perfect. What Roche and Genentech have started is significant, they didn't let perfect be the enemy of better

I hope other follow Roche / Genentech's example of treating social media as a legitimate communication method.

More Art Than Science

Support the diabetes arts: http://main.diabetes.org/goto/theBetesNow

More Art than....

... Science

New Video on theBetesNOW.com

More Art Than Science

A Grievance

I have a Grievance with the FDA

It take them too darn long to approve better stuff for diabetes care. Someone should do something about that...

... and there is an opportunity to do something right now. The FDA docket on Low Glucose Suspend (LGS) is open for just a few more weeks. Take advantage of this chance to share your views with the regulators and congress.

You can click here to comment.

You may feel that you are not qualified. You may fear that you do not know all the ins and outs of medical studies and that is what this seems to be about.

I think this is about more than ins and outs of studies. This is about timely approval of devices that can help manage diabetes. You may not use a CGM, you may not pump,  you may have doubts about artificial pancreas but if you live with diabetes regulatory delay puts you at risk. 

I think we should have an expectation that the FDA will preform their regulatory duties with alacrity.  That doesn’t seem to be the case with LGS. Here is a product that is in use in 40 different countries and the FDA still doesn’t have a process for considering applications to approve it here. That is more than a little late to the party.

If nothing else the FDA should hear from people with diabetes saying that devices should not come to the US market years after they are approve else where. The FDA needs to do its thing in a timely, citizen friendly and focused manner.

I think LGS can save lives. Particularly lives lost to sever overnight lows. I

That could mean fewer blue candles on Facebook. There are few things I hate seeing more than that symbol of grief and remembrance of a life lost to diabetes. Further delay moving forward on devices to that may keep kids alive is unacceptable. 

LGS is not a magic bullet. It is no cure. 

It does offer a means of lowering potentially tragic risks. What there is NOT is a means of the FDA will considering these and other pump / sensor advances as they are created.

Please comment on the Docket. I view it is one way of avoiding blue candles. I hope it is only ONE of MANY ways of avoiding blue candles. We need all the ways we can get to keep them out. The FDA should be our ally not an impediment in those efforts.

Comment to the FDA and share those thoughts with your member of Congress. Be someone who does something. As it says in the first amendment, “petition the government for a redress of grievances.” 

Aug 11, 11 #TwoBits

Here are two great bits from around the DOC today:

Bob on being an advocate life.
http://tminustwo.net/2011/08/10/making-room-for-advocacy/

Caroline Sweeney's letter to the editor is a great role model post for a comment to the FDA:
http://www.pressherald.com/opinion/council-should-extend-petition-limit_2011-08-11.html?pageType=mobile&id=4
(scroll down to "Keep on making progress toward artificial pancreas")