December 17, 2013

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 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.

December 10, 2013

of Dexcom, FDA and Pump Integration

Like a lot of folks I have been waiting to see the Dexcom CGM integrated with insulin pumps to provide a better system for people with diabetes. Like a lot of folks I am a tad (a word that here means "a whole lot") impatient. 

I heard an interesting explanation of some of the processes today in a Dexcom presentation at the Oppenheimer 24th Annual Healthcare Conference by Steve Pacelli EVP of Dexcom. 

19:55 into call if you want to listen along at home. 

The gist of the comment was that the pump companies have lived in the regulatory environment of 510(k) approval. The pump sensor combination is viewed as a system by the FDA (just like I do in the first sentence of this post.) Systems falls under a PMA approval process at FDA. About the PMA process Steve said for, “these pump partners, their world dramatically changes when they incorporate CGM into their solutions.”

What the hell is the difference between 510(k) and PMA you ask? Good question. 

Here goes. 510(k) is substantially equivalent to some already approved device. PMA is a more robust evaluation.  I'll make the grossly overly simplistic comparison that 510(k) is like sayin, "Yo! FDA. Our thingy here is like that other thingy over there. You approved it and so since we are like it, we should be approved too," and PMA is turning in a full term paper, with APA formatted footnotes, to a bear of a grader.

A FDA web site says this:
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 
“Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.”
Pacelli goes onto talk about some of the PMA documentation required including testing, validation and quality systems. 

Don’t care much about regulatory paths? Fair enough. Steve continues to think that Animas will complete FDA questions in January putting an approval in teh middle of 2014 and t:slim filing in Q1 and maybe getting an approval in late Q4 2014 or early 2015. 

Actual regulation times may vary. LOL.

Please, listen to the call for more accurate insights, this is a blog on the internet. Also in the full disclosure department, I own shares of Dexcom and Tandem.

December 9, 2013

In PA? Act TODAY! Safe at School

from the ADA:

Students in Pennsylvania Not Safe at School

As hard as it is to imagine, children with diabetes in Pennsylvania aren’t always able to get insulin and glucagon at school because school staff members are prevented from helping a child in need.
While some students have a full-time nurse in their school, others share their school nurse with multiple schools, and that nurse cannot always be available to provide both everyday and emergency care. Even in schools with a full-time nurse, the nurse often isn’t available during field trips and extracurricular activities. But diabetes can’t wait.
Diabetes must be managed 24 hours a day. At home, a child has parents, babysitters, and others to help, but at school, there may be no one who can care for them. Without this careful management, these vulnerable children face frightening short term complications and an ever increasing risk of blindness, heart disease, kidney failure, amputation - even death.
In the horrific situation where a child with diabetes has a severe low blood glucose level and the school nurse isn’t present, the current solution is to call 911 and hope an ambulance arrives in time, rather than having staff administer life-saving glucagon. That’s not a response we can allow to stand!
Right now, legislation is pending in Pennsylvania that would make a huge difference in children’s lives. It would allow school staff members to be trained to give insulin and glucagon so there is always someone there to help, even when a school nurse cannot be. It would also allow students who are mature enough to do so to independently self-manage their diabetes at school.
There’s no time to waste! Your legislators are expected to vote on this legislation very soon. That’s why they need to hear from you today.
Stephen Habbe
Pennsylvania State Advocacy Director
American Diabetes Association

December 6, 2013

What is Important

This is a repost from August 2, 2008. Still True. The business structure of CWD is changing. What is important stays the same. 

Congratulations Jeff, Laura and everyone associated with Friends for Life on keeping what is important, important. 

Love Ya/Mean It

I had a teacher in college who regularly asked in lectures "What's Important?" I wrote down what he said next 'cause it was gonna be the a test.

They say a picture is worth a thousand words here is a thousand words worth of what's important about Friends for Life. This is Joe, Paul and the teens from eastern Europe. It's getting late, folks are heading to bed, all the tables are clear but one. All the kids are clearly involved in the conversation.

The body language was interesting. At times, the kids were leaning in paying attention. At other times Joe and Paul were doing the leaning in hands on the table listening to what the kids were saying.

This is what Friends for Life is about. It is what Joe and Paul are all about. More than everything else Friends For Life is about personal contact. The give and take of understand what living with type 1 is like.

I have no clue what they were talking about. That's their business. What the picture says to me is that there are a lot of tables we can sit at. There are times when sitting at a table with type 1 peers and mentors is the only one that counts.

What is important? Friends For Life.

December 4, 2013

Abbott Recalls Certain FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips


November 27, 2013
ABBOTT PARK, Ill., Nov. 27, 2013 — Abbott today announced it is initiating a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both "FreeStyle® Blood Glucose Meter" and "FreeStyle® Flash Blood Glucose Meter” [neither of which have been in production since 2010], as well as the OmniPod® Insulin Management System1.
When the test strips are used with the newer FreeStyle brand meters including FreeStyle® Freedom Blood Glucose Meter, FreeStyle Lite® Blood Glucose Meter* and FreeStyle Freedom® Lite Blood Glucose Meter*, the blood glucose test results are not affected. Testing with the FreeStyle InsuLinx® Blood Glucose Meter is not affected by this action, as FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test strips.
The affected test strips are from lots that hold expiration dates from between May 2014 and March 2015, and can be identified as follows:
Lot Numbers
The company is notifying healthcare professionals, pharmacies, distributors and customers about the recall; customers affected by this action are instructed to call Abbott's diabetes care customer service at1-888-736-9869 for a replacement of the affected test strips at no charge.
For more information, please visit

November 19, 2013

HON Certified

I am happy to announce that Your Diabetes May Vary is now a HON Certified site.

I try to be trust worth and transparent, if at time a loony, patient / caregiver voice. HON creates a structure that respects and allow me to pledges to honor the following 8 principles of the HON Code of Conduct (HONcode).

YDMV's about section contains most of the details of how YDMV seeks to stay in compliance with these principles.

It has taken the better part of a year from application to certification. I am fine with that. I appreciated the detail of question they posed and the refinements in my about section that those questions inspired. I encourage other to seek certification too. I do respect those who choose to behave ethically and still choose not to seek HON Code certification. Certified or not, I think the principles provide a good outline of what those using the web can look for, in the online conversations about health, as a measure transference and trust.

The internet is a wild and crazy place to talk about health. Doing so to agreed upon standards helps sort out that wild and craziness a little.

October 17, 2013

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.

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“

October 15, 2013

Munchausen by Internet

Health Community Forensics and What to Do
Health issues can be isolating. For many the comfort of online connection with other patients in similar situations is critical to staying emotionally strong enough to engage with care. Communities of patients who “get it” are valued across a variety of health conditions. These communities breakdown isolation and help patients feel understood. Sadly these communities occasionally also deal with individuals who pretend to have the health issue the community cares about.

Munchausen by Internet
There are a few names for ‘faking it’  behavior, some call them Trolls and others use the term Catfish after a 2010 movie and MTV series.(1) There is also a more specific scientific term, Munchausen by Internet. Maia Szalavitz has written articles at Time on the the topic that are a good way to understand the phenomenon; Munchausen By Internet: Faking Illnesses Online, Nov. 30, 2012 (2)  and Phony Cancers and Self-Inflicted Acid Attacks: A National Outbreak of Munchausen’s? Sept. 22, 2010. (3) Faking it, it seems is it own form of illness.

Pulman and Taylor write that, “Munchausen by Internet occurs when medically well individuals fake recognized illnesses in virtual environments, such as online support groups.” (4) Their paper, Munchausen by Internet: Current Research and Future Direction, “focuses on the aspect of Munchausen by Internet in which individuals actively seek to disrupt groups for their own satisfaction.”

This behavior exists and online health communities need to be able to identify and appropriately deal with occasional cases of Munchausen by Internet. While anger, stemming from a deception that belittles communities members value is a natural response, it may not be the best recourse. But before talking about what to do maybe it is a good idea to chat about how to spot it.

Health Community Forensics
There are some signals be aware of in health communities. Maybe the first is simply to understand the condition and be aware of comments that seem to lack first hand experience.  Another clue may be participation strictly in the heath community and have no other social media presence and / or strictly participating on the topic of the disease in social media, no favorite song, movie, book or other sign of a real life outside the disease. Look at the time line to see if there is a digital footprint before the time a possible troll joined a health community. These are signs, not proof and there are legitimate community participants who may choose to limit other social media activity.

The highly publicized case of Notre Dame linebacker Manti Te’o inspired a number of news stories on how to identify a catfish. Forbes writer Kashmir Hill offers some good advice:

  • “Beware of tales of ‘devastating accidents or illness.’” Ok by definition some of these are in communities of devastating illness but keep an eye out for the accidents. Not that they don’t happen to people with devastating illness but it may be a clue.
  • “Do a reverse image search on the photos they send Use TinEye or Google Image Search.” That the empathetic patient may be someone else photo.  Savvy catfish might make this difficult though.
  • “Get your digital stalk on.... If the digital trail is sparse, be suspicious. Do those friends look real?”

Feldman (5) as cited by Pulman and Taylor suggest as means of detection:

  • Posts consistently duplicating material in other posts, books, or health-related websites.
  • Characteristics of the supposed illness emerging as caricatures.
  • Near-fatal bouts of illness alternating with miraculous recoveries.
  • Fantastical claims, contradicted by subsequent posts, or flatly disproved.
  • Continual dramatic events in the person's life, especially when other group members have become the focus of attention.
  • Feigned blitheness about crises that will predictably attract immediate attention.
  • Others apparently posting on behalf of the individual having identical patterns of writing.

These fake cases can damage the trust of online communities and so risk the credibility of peer to peer support. Pulman and Taylor state:

A troll can disrupt the discussion on a newsgroup, disseminate bad advice, and damage the feeling of trust in a Web community. Furthermore, in a group that has become sensitive to trolling—where the rate of deception is high—some honest but naïve question can be quickly rejected as trolling. This can be off-putting to a new user who is immediately bombarded with accusations when venturing a first post.

The last, a distrust of new members threatens the very reason why peer to peer communities exist. Communities should be as aware of to the risk to communities from over vigilance to potential cases of Munchausen by Internet as the trolls themselves.

What to Do:
Admit it, you have been thinking, is there something wrong with this person? Apparently there is. Focus on your community’s need to respond to protect the integrity of peer to peer support. Pulman and Taylor summarize suggestion by Sabino and Fordtran: (6)

1. Let the patient know what you suspect but without outright accusation.
2. Support the suspicion with facts.
3. Provide empathetic and face-saving comments.
4. Avoid probing to uncover the patient's underlying feelings and motivations so as to minimize disruption of emotional defences that are essential to her function.
5. Assure the patient that only those who need to know will be informed of the suspicion of factitious disease.
6. Make sure the staff demonstrate continued acceptance of the patient as a person worthy of their help.

I fear that public confrontation may create a challenge.  It may create an interest in the troll coming back and trying again. The point is not to confront, out , punish or harm the person faking it. The goal is to protect the integrity of patient communities, to help peers support peers. A flame festival with a troll risks burning down the home of real peer support. I suggest that focusing on nurturing what is real should be the goal when dealing with Munchausen by Internet.  

What matters is the real community.

Related Links:


4 Andy Pulman, MA and Jacqui Taylor,BSC, MSc, PhD,  Munchausen by Internet: Current Research and Future DirectionsJ Med Internet Res. 2012 Jul-Aug; 14(4): e115. Published online 2012 August 22. doi:  10.2196/jmir.2011
5 ‎Feldman MD. Munchausen by Internet: detecting factitious illness and crisis on the Internet. South Med J 2000 Jul;93(7):669-672. [Medline]
6 Savino AC, Fordtran JS. Factitious disease: clinical lessons from case studies at Baylor University Medical Center. Proc (Bayl Univ Med Cent) 2006 Jul;19(3):195-208. [Medline]

JDRF in Start Up with Venture Firm to Fund T1D Companies.


PureTech Ventures, JDRF Team Up to Form Type 1 Diabetes Startup Creator 

Disease foundations often give money to startups working on treatments that might help the people they advocate for. But it’s not too often you’ll see a nonprofit foundation join with a venture firm to create their own company, as JDRF andPureTech Ventures are doing today. 
Boston-based PureTech has secured a $5 million investment from New York-based JDRF (formerly known as the Juvenile Diabetes Research Foundation) to spawn T1D Innovations. The new entity is described as a company-creation vehicle that will help form, and provide seed funding, to startups that develop innovative therapies for type 1 diabetes. The plan is to funnel as much as $30 million from other non-profits, strategic and financial investors, into T1D, and use the cash to start eight to 10 projects. Many may go by the wayside, with a few surviving and becoming new independent companies. 
“The goal is not to make a quick buck, that’s not why we’re doing this,” says David Steinberg, a PureTech partner and TID’s initial CEO. “It’s really to lower the activation energy of getting these things out of academia and out of the realm of more basic research into that translational development pipeline.”

It will be interesting to learn more about this and the relationship to JDRF's IDDP program.

October 11, 2013

Ryan Read get a full 2014 Ride

Good news out today for T1D Racer Ryan Reed:

Roush Fenway Racing Announces Ryan Reed As The Driver Of The No. 16 American Diabetes Association Drive To Stop Diabetes SM Presented By Lilly Diabetes Ford Mustang For The 2014 NASCAR Nationwide Series Season

Concord, N.C. (Oct. 11, 2013) -- Roush Fenway Racing (RFR) announced today its partnership with Ryan Reed and the American Diabetes Association Drive to Stop Diabetes SM campaign, presented by Lilly Diabetes. Reed will drive the No. 16 RFR Ford full-time in the 2014 NASCAR Nationwide Series season, competing for a championship and rookie-of-the-year honors. Reed, a NASCAR driver making his dreams come true while living with type 1 diabetes, collaborated with the American Diabetes Association for the Drive to Stop Diabetes SM campaign in 2013, driving for RFR in a limited schedule.  
It also was announced today that Lilly Diabetes has joined the campaign. Lilly, a leader in diabetes care since 1923, will be part of three NASCAR Nationwide Series races in 2013, Charlotte, Phoenix and Homestead and the entire 2014 season.


October 8, 2013

Tom Hanks goes on Letterman and talks about type 2 diabetes and I was watching Colbert.

Tom's conversation with Dave is an opportunity to talk about type 2 without the association of the obesity blame game. Tom Hanks is not the picture of obesity in America. More he is literally the picture of how typical Americans views themselves. A star. An Oscar winning, motion picture everyman.

He (like a lot of us, including me) has faced elevated glucose for an extended period of time (aka pre-diabetes). For Tom, those blood sugars have progressed. That is what T2D does. It progresses. Let's not blame Tom (and by extension every T2D) for that progression.

He has been aware, has worked with his physician to slow the progression to a full type 2 diabetes diagnosis to years - decades. Still those blood sugars have progressed. Tom had the courage to stand up and say Doc, your weight loss suggestion isn't realistic so, "I'm gonna have Type 2 diabetes, because there is no way I can weigh as much as I did in high school."

This isn't Tom failing and being T2D. This is him keeping it as just elevated BG, as pre diabetes, for a long time. Then, and with some humor moving, to the next step in the progression.

Also nice to hear Dave say he has had issues with high blood sugars. Here in lies the point. Type 2 isn't just some stereotypical obese person that media can offer up, and we collectively can look down on for not going to the gym. Not some imaginary fatty (who isn't 'us') to blame.

Look at Dave and Tom as the new poster boys of pre-diabetes and T2D. Think decades of talking with a physician about type 2 and working to slow the progression. If and when it does progress to type 2 diabetes, blame the rat bastard diabetes and honor the success of the patient, like Tom, who for the efforts made to keep it as elevated BGs and slow his progression to type 2.

I hope Tom can be just successful in the next phase of his progression with diabetes. Be successful working with his care team to do what he can to be healthy. When and if he hits another step, another medication, with the same humor move to the next step confident in the success that slowed the progression to it.

Type 2. It is a disease not a character flaw.

You can judge me for choosing Colbert over Dave, that may be a reflection of character.

September 27, 2013

Medtronic LGS Approved!

Just saw a press release that Medtronic has FDA clearance for the 530G Low Glucose Suspend (LGS) system. This is good news. It is the first step on the path to AP.

LGS uses a sensor to stop delivering insulin when the system detects a low. That seem only logical.

Regular YDM readers may have seen these posts on LGS

Approval is good news. It shows FDA has figured out how to allow an innovative step to better diabetes management. Before people start quibbling about sensors sensitivity and perfection, let's remember that diabetes perfection is not possible. Better is.

This is a significant step to better.

Your Diabetes May Vary

September 24, 2013

The FDA and Smartphones.

NY Times reports that the FDA will regulate some apps.

The times says FDA will start looking at apps and "would regulate only a small portion of the rapidly expanding universe of mobile health applications." They quote Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health. “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly.”


More from mobihealthnews:

September 18, 2013

There's Hope

Hope Warshaw that is, diabetes educator and advocate for the Diabetes Online Community. Hope is an advocate for peer to peer support. See why I am proud to have her as a friend by reading her blog. This post with resources to help people with the online community is outstanding.

Share it with your friends and maybe even your diabetes educator.

September 17, 2013

I Love it When a Plan Comes Together (or at least starts to)

My first reply to a StripSafely letter from Congress was a long piece that included the history of the FDA and nothing about the subject to which the good Senator was replying, meter accuracy. I shared it with some friends who were a little disappointed. 

Not to worry, regardless of sequesters and partisanship, Congress sorts and counts. If we get enough letters to them, they will start sorting and counting diabetes accuracy messages. They don’t need to know or understand anything about diabetes care, at first, they need to start counting. Maybe they have. 

Yesterday I received a letter from my Congresswoman. (Yes, woman. Cool right?)  She (or her staffer more accurately) wrote specifically about FDA  post market oversight. Citing exactly the three points FDA wants me to hear; inspections, MDRs and recalls. That is glorious. That can only mean the Congresswoman’s office reached out to FDA. The FDA had some explaining to do to the Hill. 
Each episodes of the “A-Team” ended with Hannibal saying, “I love it when a plan comes together.” The joke being that things may not go as planned but the A – Team gets results, typically with a lot of action.
I know the FDA has action hero-ish special abilities. On September 5th the Agency published a story of how twenty one individual, potentially contaminated, candy bars from New Zealand were tracked down by FDA to keep American consumers safe.  FDA should just as actively use its powers for good to Americans safe from test strips that fail to deliver the accuracy on our fingers that those test systems had to demonstrate to be approved for sale.
If anything is clear from the Diabetes Technology Society meetings on May 21 and September 9, it is that we know there is a problem. We know firms fail to comply with MDRs and other parts of FDAs existing regulatory controls. Committees, commissions and post market studies to know more, without enforcing more, is unacceptable.
We need acton for plan to come together.
fdA team

People with Diabetes are starting to get the FDA’s attention. StripSafely is still in the opening of the third act. Regular viewers know what is needed, action, lots of it.
If you get a reply from you Congresswoman (or man) that mentions three parts of a  post market program, write back. Tell congress we need more action, independent inspection. We have a letter for that. Face and BA are in shed beating the Strip Safely Twitter page into shape too.
The third act is always the most fun.
(My lodging to attend the September 9 meeting was paid for by the Diabetes Hands Foundation.)

September 2, 2013

If it happens to Walmart, Does it Happen to FDA?

This piece in the New Your Times paints a troubling picture of gaming the system of Walmart overseas factory inspections. I would love to know who makes more of an effort to inspect overseas factories Walmart or FDA. 

Fast and Flawed Inspections of Factories Abroad

No question the processes of FDA and Walmart are different. Still this articles does raise questions about a culture of gaming the inspection system.

I am not saying this is what is happening with test strips. I am saying this is what PWD do not want for an inspection process.

September 1, 2013

One of Three

To Perpetuity.

Diabetes doesn't end. This fantastic piece from the Diabetes Art Day collection, by the Gulo family, makes that clear. 

Diabetes is a disease not a character flaw. A disease that 25 million american live with, significantly more than that if the undiagnosed are includes. Some estimates put that 'significantly more' as ONE in THREE Americans.

FDA is is holding patient meetings to provide "a more systematic approach to obtaining the patient perspective on certain disease areas." Diabetes isn't on of them. Let's Change that

1 in 3

 One in three of us have it and the other two loves someone who does. I have asked FDA for a patient meeting on diabetes. Join me, sign the petition, get two loved ones to sign too.

Be one of three

August 29, 2013

FDA / Sponsor a Patient Meeting on Diabetes

The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.

But not diabetes.

That is unacceptable.

Four “slots” remain open (view the current list), and we want the FDA to add diabetes to its meeting docket for 2013.

According to the American Diabetes Association, nearly 26 million Americans have either type 1 or type 2 diabetes, and an additional 79 million have prediabetes. Those numbers are also increasing each year – the CDC estimates that if current trends continue, one in three US adults will have diabetes by 2050.

No one disputes that diabetes is one of America’s – and the world’s – most serious health epidemics. In 2012, more than one in five total US healthcare dollars was spent on diabetes, totaling $245 billion, and the government covered 62% of those costs, meaning everyone is paying for this epidemic. Despite growing needs, research dollars have also leveled off.

New therapies need to be investigated, tested, and brought to market, and as part of that process, the FDA must understand the daily challenges that patients face.

We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.

Our voices need to be heard.

Please sign this petition to urge the FDA to sponsor a patient meeting focused on diabetes – and the sooner, the better.

Thank you very much.

You can sign the petition here:

August 21, 2013

Come Play!

My friend Scott Johnson won’s Athletic Achievement award and I think that says a lot. Scott is into athletics for all the right reasons; joy, sportsmanship, camaraderie, and health. Scott wants everyone he meets to join the basketball game and play for the simple fun of playing. I hadn’t played basketball since the 70s, Scott made me feel welcome on the court. Same with a young kid who was standing there watching the game, Scott handed him the ball and invited the kid onto the game. That is why, for me, he is a role model. Athletics isn’t about self aggrandizement, it isn’t about winning, to Scott it is about joining with others and playing.
play |plā| verb
1 engage in activity for enjoyment and recreation rather than a serious or practical purpose:
2 take part in (a sport):
I am proud of Scott. 
( I am proud of Kerri the Dancing Check too.)

This is not to say I have anything against serious sports. I was screaming like the lunatic I am, when Charlie Kimball’s team won the Indycar race at Mid Ohio. Team. Racing is a team sport with all kinds of different skills contributing to a common effort to make the team's car get there first.

Today, I would love you to join me in some play. I want you to be part of a team, one that needs a lot of players who are willing to do something a little outside their individual and collective “box.” Join the StripSafely Tweet In.
  1. Go to the StripSafely Twitter Page, 
  2. Find your Elected officials, Listed by State. (Maybe include the Congressional leadership too)
  3. Click the Tweet about Meeting Link.
That will send a Tweet asking the representative asking them to send a staffer to the September 9 Diabetes Technology Society meeting. That is easy and it isn’t asking a lot from Congress, just being aware of our need for accuracy.

Some feel that politics is a dirty partisan game, I know others have felt that way. They found that speaking up from principal was not only empowering but could be fun too. Maybe our voice can help reduce  partisanship by not playing that game. Just be real.

Let's make this fun! Tweet the 'stock' message then improvise some of your own tweets, share why accurate diabetes testing matters to you. Be nice, be a good sport, no trash talking, join with others and play. Maybe as a team we can all win the race to more accurate glucose testing.

Lets make this a team effort about joy, sportsmanship, camaraderie, and health.