October 1, 2015

My Script for FDA

I wish I could tell you what I actually said at FDA's Labeling Workshop. Bellow is the script I worked up. I am at my best when I get up and channel the material and just go with it. It like speaking in tounges or something. The only conscious thought I am aware of when it is happening is to not say "um."

I was off this script by about word 3 but it does, I think, and hope, reflects what I said.

I can tell you that whatever I said, I was well received by individuals participating in the workshop from both FDA and industry. I felt respected and did my very best to contribute relevant patient comments to the proceedings and do so with good humor.

It was a privilege to be invited to represent patients and people with diabetes. As some point, the transcripts will surface and the truth will come out. 'Till then this is my story and I am sticking with it.

Hi, I am Bennet Dunlap. My wife and I have four kids, Let me brag here - Two are out of college, have jobs and insurance! Two live with type 1 diabetes and have done so since the were 7 and 9.  Like 28 or 9 million Americans, I live with type 2 diabetes.

After 3 decades as a banker, I apologize for what I did to the American Economy it was clearly all my fault, I earned master's degree in health communication to serve as an advocate for people with diabetes.
Since I am the first patient here, maybe I can back up and talk a little about what patients want from devices to inform what we want from labeling. It is relevant.

We want to be SAFE. We want the devices to help us be healthy. Ideally while keeping us both safe and healthy devices don’t add too much of an additional burden to our lives.
LABELS help keep us safe; They tell us how to use a device. What we should used it for. How to find help, and what to do if it doesn't work right.
People are going to look for help. Ideally the correct information is easy to find. If not, we will look in other places and, to be honest, some of us are dummies.

We are going to find help when we need it and look for the friendliest way to do that. That friendly place should be the official label. To do that maybe write like you would to a friend and not the plaintiff in a legal proceeding. And no 6 point font some of us have trifocals. (wave glasses to room)

Devices and their instructions are drivers of healthy actions.
Many, devices drive of self-care, including medication dosing.
Diabetes is a great example, PWD use devices to manage and treat daily. For millions of American, including my children, that management includes calculating insulin doses multiple times a day.

Look at that picture. See the meter. It says 110. What you don't see is that The tolerance is +/-20% 95% of the time. 95% of the time means 5% it may be off in the weeds. My kids test and take insulin about five times a day, 365 days a year so that 1800 doses of insulin 5% is 90 doses a year bases off reading outside +/- 20%.

The reality is not ONE meter, sold to patients for self-management use in the USA, is APPROVED to dose insulin. Not one. Yet millions of people like my kids do it EVERY DAY.

What a device is labeled to do matters. There has been one meter approved, that I know of, that was specifically labeled NOT to be used to dose insulin or calibrate a Continuous glucose meter,

We need to flip that around. Labels should explicitly say what a device is to be used for. What it is for is as important as what it is not for to be used for. And that "to be used for" needs to keep up with real world dynamics. So if it is for dosing insulin - say so.

Labels should reflect reality, we do dose insulin, and those devices that are accurate enough to do so should say so.

Technology advances, everywhere but the USA the standard is now +/- 15%. When FDA puts new guidelines out the old stuff should not be allowed to continue to be used to dose insulin and the new device labeling is a tool to do that.

The Patient's job is to use the devices to stay healthy, not figure out which is living up to its approved performance. We can't do that.  FDA should enforce labeling. Peer reviewed studies show there are meters that fail to live up to the +/- 20% 95% of the time

Failing to deliver promised accuracy is Device Regulations VW. The Scientific Journals make it clear there are devices failing to deliver +/- 20%. Even when FDA ups the guidance to something new, these VW TDI of the glucose meter world will be no the road - that is approved and for sale. Some insurance buyers who look the only price will continue to select them over more competent devices. I fear this will include Medicare.  My question here is intended use labeling if it doesn't get the VW TDI OFF THE MARKET?

Other things will go wrong.

Look things go wrong.
I saw a FACEBOOK Avatar picture of A PWD's that said ERR 5. A very common message that meant the meter didn't get enough blood. Things wrong enough that we can joke about it.

Patients need to know where to go to get help and where to go if the if the help doesn't.{pause}. help…. We need to know how to report errors - So error can be fixed.

If you listen to patients, you hear a lot of stories of calling a device company and being told a device error is the patient's fault. It may well be, some of the time, but the strong feeling is some device companies doesn't report errors because they choose to see the error as the customer's fault. Nobody is perfect if a company has no device error reports that is a bright red flag that they are far from perfect.

FDA has an app for that. I’m a smart enough guy. I struggle with the app. When we talk about better labels a constantly easy app would help - a lot.

We patients need consistent, easy to use, instructions on what to do to report so FDA can use the reports. By consistent I meant manufacturers can't double talk it, personally I am for dictated language by FDA on error reporting. Including what information makes the report useful and how to file it outside of the company's reporting structure. The ethical companies are reporting already; one has to wonder about the VW of the medical device world.
Failing to report is a safety issue.

Remember safety? I started this thing talking about safety.

Zero reports of errors are madness.

Speaking of madness.

JAMA estimates 97,000 Insulin-related ER visits for lows, aka overdosing insulin. NIH estimates 93k er visits for all stimulants including methamphetamines. That insulin beats Breaking Bad is nuts, and it cost us all.

I took the JAMA numbers and the Journal of Managed care’s cost estimates and it over a half billion. I was a banker $640 million is almost real money. - Mostly seniors so we are all paying for that via Medicare.

But enough of my silly rants, I felt it would be useful to survey people with diabetes, quick biased poll.
The top 8

Quotes from the survey:

Think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. 

Almost anyone should be able to pick up the instructions and "get it" with relative ease.

I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills”?

Please don't use this as an excuse to increase packaging or costs.

I get very frustrated when I have pump sets coming with HUGE manuals every time I buy them


September 28, 2015

FDA Public Workshop - Medical Device Patient Labeling - I may mention VW.

I am speaking as a "stakeholder" at FDA's Public Workshop - Medical Device Patient Labeling, September 29-30, 2015. I'm scheduled to go at 10:35, kicking of stakeholders on the 29 and a round table conversation on identifying label needs on the 30th.

Word is that it will be webcast. The site says registration is required and "All webcast registration requests should contact Susan Monahan at susan.monahan@fda.hhs.gov*"

Update: These appear to be the links and they look like they allow a Guest Login
Webcast Links for the September 29-30, 2015 Public Workshop: Below are the webcast links for the Public Workshop from an FDA email:
Medical Device Patient Labeling 

Directions for mobile access to the meeting
1. Download the Adobe Connect Mobile App
2. Enter Meeting
3. Log-in as a Guest: Enter Name
4. Accept disclaimer
A key part of what I have to say will be your views shared with YDMV .

While not exactly on the topic, I will add my 2¢ that meters are like cars. YDMV is a direct copy of the Your Milage May Vary disclaimer of window sticker milage claims. Your meter may vary and just like VWs the test done for the feds may not be close to real world performance.

It is not the driving public job to know the real emissions of cars, nor the PWD's job to know if meters preform to FDA standards. Our jobs are to drive safe and in the case of diabetes is to do the self management to be safe. We need to know the devices we use are safe and that the emissions and device safety police have our backs.

I'm open to the betting odds of my be being allowed back day 2 if I say that day 1. LOL


Here are some of the slides I will be using:

September 23, 2015

The DAA to Congress! Yo. LISTEN UP!

This from the Diabetes Advocacy Alliance:

It's Time for Congress to Listen to the Voices of People with Diabetes!

Over 29 million Americans are living with diabetes. With these numbers, you might expect that Congress would hold many open meetings, called hearings. Meetings where citizens like you can raise concerns about diabetes, and members of Congress can use that information to enact legislation.

But they haven't - it has been five years since the last congressional hearing on diabetes on Capitol Hill.

It's vital that we make diabetes top-of-mind for our members of Congress, and get them to focus on policies that would help people with diabetes and those at risk.

That's why Novo Nordisk and members of the Diabetes Advocacy Alliance are working together to ask Congress to hold a hearing on diabetes this fall. This one-day event would give the diabetes community the chance to make our voices heard. And we need your help!

CLICK HERE to make your voice heard and send your members of Congress a letter asking them to hold a hearing to bring attention to diabetes.

Diabetes impacts you every day. Let Congress know how it can help.
The Diabetes Advocacy Alliance consists of 20 member groups representing patient, professional and trade associations; other nonprofit organizations; and corporations. The DAA strives to influence change in health care policy and in the US health care system to improve diabetes prevention, detection and care. 

September 21, 2015

Fill in the blank: NPH. Not Particularly _______

There is a reason people call it Not Particularly Helpful. This from Diabetes Care:

Study: NPH insulin must be resuspended before injection 
There was as much as a 23% difference in insulin levels and as much as a 62% variation in blood glucose control among diabetes patients who shook and didn't shake their NPH insulin pens before injecting, according to a study in Diabetes Care. Researchers found patients who didn't shake the pens before injecting had lower insulin levels if they injected the needle flat or pointing up and higher insulin levels if the needle was facing down. Reuters 


September 17, 2015

T1D Exchange Abstracts at European Association for the Study of Diabetes (EASD)

From: https://t1dexchange.org/pages/t1d-exchange-to-present-several-abstracts-at-the-51st-european-association-for-the-study-of-diabetes-easd-annual-meeting/

Here are some introductory paragraphs from their release to tempt you to read more:
New Intranasal Glucagon Effective in Children and Adolescents. Preliminary clinical trial data have demonstrated that a new, user-friendly, needle-free delivery system is as effective in children and adolescents as the injected form of glucagon. Known as Glucagon Nasal Powder and developed by Locemia Solutions, this represents a major step in advancing a treatment that has been largely unchanged for roughly 25 years.
Autoimmune disease comorbidities in children and adults with type 1 diabetes Type 1 diabetes is often associated with other autoimmune diseases (AD), but currently well-characterized, evidence-based screening guidelines for diagnosing those diseases in type 1 patients does not exist. To better understand factors associated with and the prevalence of AD in type 1 diabetes patients, researchers analyzed data from the nearly 26,000 patients in the T1D Exchange Clinic Registry.
Do patients use their insulin pump’s built-in bolus calculator?A built-in bolus calculator in an insulin pumps uses personalized settings to make bolus doses (doses of fast-acting insulin) more accurate and curb insulin stacking (repeated insulin injection at close intervals) – but it remains unclear if the calculator is crucial to pump management, a reflection of user ability or simply a feature of the device.
Researchers analyzed data from the T1D Exchange Clinic Registry to assess the frequency of bolus calculator use and determine associated demographics, clinical characteristics and outcomes. Among the nearly 1,950 participants, they found:
  • 79% of participants using an insulin pump reported frequently using a bolus calculator;
  • 82% of participants who reported using a bolus calculator frequently checked their blood glucose levels compared with 66% of participants who infrequently check;

September 11, 2015

Glu Pregnancy Survey Event Sept 28th

Glu is hosting an event at the end of the month (28th) in Boston discussing the results of their pregnancy survey and chatting about all things that can help and/or hinder a successful baby outcome while living with type 1.  They will be broadcasting it live through a super cool feature called blab.im

Here is the link where you can submit questions up to a few hours before the event starts. https://blab.im/glu-t1d-exchange-type1-diabetes-and-pregnancy

September 10, 2015

I try to be for stuff.

I am not a scientist, a researcher or epidemiologist. I was a banker, and my undergrad degree is in finance, so I have a little bit of a feel for portfolio management.  From that, I have some appreciation for the idea of balancing risks.

Pharmaceutical development is spectacularly risky. Most drug candidates fail. The costs are HUGE. Estimates are the average new drug cost well over a billion dollars.  To a finance guy, high costs and high failure rates is the very definition of risk.

Risk is mitigated by diversifying. Hell, we all know don’t put all your eggs in one basket right? I doubt there will be “a” cure for type 1, as in one treatment that works for all. I suspect there will be a variety of cure-ish advancements. Each, hopefully, is relatively independent or the others so a lack of success in one area does not preclude success in another.

Vaccination against T1D would be great. I’m not sure how you figure out who needs it. Or how to get the anti-vacs community to accept it.  Those are way smaller issues than finding an effective vaccination for some portion of the possible population.

That would leave a lot of people with T1D. Mostly adults. Many of who are looking to destress their lives with insulin. I’m all for a variety of possible solutions to parts of the puzzle. Because - Your Diabetes May Vary.

I am for closing the gap between the lab bench and the practical world of high volume production of clinical treatments. Scaling up from one-offs studies to mass production is not trivial. That is at time difficult where the potential market is limited, like type 1 diabetes.

I am for people with diabetes working to the ends that they see as valuable and giving where they feel called to give. Part of you call to action is to be knowledgeable. No small task. In that regard, I find Joshua Levy blog an excellent read on the science. Even reading there and from other sources I am not confident that I would know what bets to place. What cure like opportunities will succeed in both the science and the market. Make no mistake both are required.

Living well till there are steps to a cure matters too. Accurate blood testing matters, access to strips and insulin matters. CGM’s matter. Psychosocial issues matter - a lot.  Type 2 medications may help some type 1 and type 1 devices may help some type 2s. Stigma does not help anyone, and that includes parents of type 1 kids (like me) realizing that type 2 is a disease not a character fault. Just like type 1 type 2 is rooted in physiological responses.

I am for a diversified approach to living better, finding steps to incrementally more cure-like treatments that diversify risk and in doing so fosters successful outcomes. I am wary of any one set of best things being the solution in five and particularly ten years. I'm for creating new things were you see a gap that need filling, without name calling those who prioritize differently. I'm for diversified investments in diabetes: basic research, better living while research happens, psychosocial support, successful life transitions, empowering patients and more.

I am for JDRF
I am for ADA
I am for CWD
I am for DSMA
I am for the DOC
I am for #WeAreNotWating and for and effective FDA and don't see that as a conflict.
I am for DCAF
I am for StripSafely
Through all of that I am for YDMV as I try to be for PWD.

September 1, 2015

CeQur announces financing to scale up T2D wearable three-day insulin-delivery device.

CeQur Type 2 Insulin Patch  


PR Newswire, LUCERNE, Switzerland and MARLBOROUGH, Mass., 1 September, 2015  
CeQur SA (“CeQur” or the “Company”), a leader in simple insulin infusion for people with diabetes, today announced a Series C financing of $100 million. The financing will support further clinical and regulatory activities, manufacturing scale-up and commercial operations for the 2016 first commercial launch of PaQ®, the Company’s fully optimized second-generation three-day insulin infusion device.
“We are very excited to work with such experienced investors who share our views about the significant opportunity PaQ brings to transform the lives of millions of people with type 2 diabetes,” said Doug Lawrence, CEO of CeQur. “Today when people with type 2 diabetes progress to insulin they need to inject, and current alternatives have cost and complexity limitations. CeQur’s second-generation PaQ will provide a superior alternative to injection therapy and allow us to build a high-growth business in the emerging category of simple and cost-effective insulin infusion to benefit patients, physicians and payors.” 

We Take Hits. - Thanks Emily Coles - #DOCBurnout2015

 If life with diabetes is comparable to battle then maybe the DOC is sitting around the bar swapping war stories. Ok, that is a bit of a stretch but it lets me bring in this picture

The picture Emily Coles from Master Lab. You can see her presentation on YouTube here. She talked about the planes that came back with hits.

The places where there were not red dots is where the holes brought down the plane. No stories at the bar.

Speaking up means taking hits. In the DOC what is really sad is some of these may have been friendly fire. Christel writes about that here.

My contribution to DOC burnout day is this: know you are going to take hits if you speak up. That is part of the process. Reinforces the places where the hits may keep you from succeeding in your mission.

There was a reason missions flew in formation back in the day. Strength in numbers.

The DOC is not combat. We can take a day off. It is OK to not trade stories at the bar. My 2¢ for the day is simply; we are stronger together.


August 31, 2015

Sanofi and Google Life Science Team Up

Sanofi and Google announced and agreement to work jointly on diabetes projects report Boolmberg and Wall Street Journal report and a press release. 

Sanofi's press release states the two companies will:

- Will work together on new digital technology and tools for diabetes -

- Aim to use data and miniaturized technology to provide patients with more tools to self-manage their disease, healthcare professionals with the ability to better support and treat patients -

- Strive to shift from episodic, event-driven diabetes care to continuous, value-based care

Bloomberg quote Google saying:
“Diabetes is the first disease we’re focusing on as we become an independent company,” Google said in the statement. “We’re announcing a new partnership with Sanofi to move technology out of the lab more quickly and work on better ways for patients and physicians to collect, analyze, and understand all the multiple sources of information that impact diabetes management.”