Monday, August 29, 2011

To Those With Congressional Concerns

As predicted, the whole Pump Hacking issue in the news has led to some of those unintended consequences we in the diabetes community feared.

Word came recently that two influential and high-ranking Congress members have taken an interest in this "pump hacking" issue and requested that the Government Accountability Office conduct a review of the Federal Communications Commission's (FCC) actions in regard to wireless medical devices. Both Democratic Reps. Anna G. Eshoo from California and Edward Markey from Massachusetts pushed this after reading about this "pump hacking" issue in the media.

So unfortunately, now comes the necessary response to not only these particular elected individuals but also to others who have a Congressional-voice and may be brought into all of this. I am sending the below letter to my own House and Senate leaders from Indiana, those who are on this committee, and to the FDA that is concerned with these issues. I encourage others to do the same to get the word out.

Also, what do you think of my letter? What needs to be addressed that isn't currently included, or re-phrased? Do you think that this kind of advocacy can make a difference? Thanks in advance for any feedback.

Dear Reps. Eshoo and Markey:

I’m writing to you both in regard to your recent letter to the U.S. Government Accountability Office on Aug. 15, which relates to your concern about wireless health technology security in response to recent media coverage.

As someone who’s been living with Type 1 diabetes for most of my life and has been using an insulin pump for a decade, this is an issue I have a personal interest in and believe warrants my writing to you both about this. I’m a patient-advocate who writes a personal diabetes blog and uses social media to share my story, and with that I wanted to take a moment to write to you about this topic.
First, thank you both for what you do generally and for specifically taking an interest in this important issue. I share your concern that wireless security be protected and these medical devices be secure, and that device makers and those in regulatory roles should ensure this happens.

However, I believe that currently happens and this “hacking” issue should not take away from those real-world concerns that already present a true danger. As you move forward, I hope that you ensure the focus of this review does not take away from the regulatory process that's already burdened by delays at the FDA level and puts the United States behind others worldwide in offering these types of medical device innovations.

While these “hacking” possibilities do theoretically exist in this 21st Century, I’m personally not concerned and have faith in the process we have reviewing these issues. I continue to trust that the medical device manufacturers are aware of these possibilities and address them accordingly, and that the FDA already addresses them thoroughly with existing regulatory procedures in place. Although a threat may exist in theory, the practical risk is non-existent and shouldn't be blown out of proportion. Please don’t let these far-fetched, unlikely scenarios hold up these valuable life-saving tools for those of us Living with Diabetes and facing these concerns every day. It’s so important for the FDA to prioritize these risk and evaluate them objectively, based on what the real concerns are.

For example, hypoglycemia is currently costing the lives of American children and adults – those high stakes mean that this guidance is incredibly important and must be done adequately as soon as possible, in order to not remain behind the rest of the world in providing innovative technology to protect lives. The FDA is studying something called Low Glucose Suspend, which is offered outside the U.S. and is proven to save lives. But that innovation is not offered here and the FDA has only recently started seriously exploring this issue; we need this option in our country because people are dying as a result of low blood sugars too often and this could help prevent that.

Even as that serious issue exists, few Congress members use their voice and influence to discuss it. Instead, you are focused on a matter that’s essentially next-to-impossible chance these devices will be hacked. That comes as many of your constituents struggle to get your attention on an even-broader matter that is incredibly important and time-sensitive.

Not only can the U.S. move forward on that technology aspect, we can also be a part of a bigger conversation worldwide about improving health and lives. The first-ever United Nations (UN) High-Level Summit on Non-Communicable Diseases (NCDs) happens Sept. 19-20, 2011, and heads of state from across the globe will meet in New York City to discuss important health issues such as diabetes, cancer, cardiovascular disease, and chronic respiratory diseases. A similar event in 2001 raised the profile of AIDS/HIV internationally, and the same must be done now. More can be found online here: http://www.ncdalliance.org. Unfortunately, neither President Barack Obama nor our country’s top leaders have expressed an interest in attending – even to just have a seat at the table to listen and learn, symbolizing to the world that we care about these issues even if we can’t officially support or commit to anything specific. That is a travesty that politics can trump over some so universally significant.

As a voter who observes all of this from the patient perspective, I am disappointed that members of my Congress are focusing so much energy and resources to these less-significant issues – even as higher-priority matters demand attention in the U.S. and abroad. I’d hope that senior members of the House Energy and Commerce Committee such as yourselves could help spread more awareness about this necessary balance and where our country’s attention should be focused.

I appreciate your consideration, and again for what you do overall. I’m also forwarding this letter on to other members of your committee and my own representatives in the House and Senate. I look forward to observing your reflection and support on these matters.

Most gratefully,
Michael Hoskins
Greenwood, IN

Monday, August 22, 2011

Don't Keep Swimming


Somehow, there's a tell-tale sign that a suddenly-influential Low is creeping into my world while I'm at work:

“ I miss my dog.”

And that seemingly-innocent thought leads to all kinds of hypo-craziness, apparently.

That realization came earlier this week, actually on the EXACT SAME DAY that similar circumstances played out two years earlier. On a Thursday afternoon in mid-August, at 3:30 p.m.

Then: Aug. 18, 2009. Now: Aug. 20, 2011.

My parents happened to be visiting from out of town then, too.

Uncanny coincidences can’t even describe the eeriness of this latest example of Lows in the Workplace, that mirrored those that played out in 2009. These hypos can come out of nowhere and punch you in the gut. Or, as Kim from Texting My Pancreas says, it’s like you are being hit with a “huge Incredible Hulk fist made of concrete and carbonite.”

And so it was.

Just as before, I found myself at my desk thinking about my black lab, Riley. Missing her. Wanting to see her, jump around, wrestle and just have some fun. That led to suspiciously-unusual amounts of focus on this thought, and an eventual decision that maybe I should cut out early to make my way home to see her.

On that August afternoon in 2009, I tested and came out in the low 100s and all seemed OK. Even though I didn't feel totally cool, the test apparently proved otherwise and I was already pressed with work duties. I had something to take care of at 3:30p, and so I made my way out of the office - where the plummeting blood sugar soon caught up to me and presented itself. In the end, it was an experience I’d describe as one of the scariest in my life, and one that truly Changed My Life.

Not this time, though.

When this Low hit, I was ironically reading Kim’s latest post about Lows in the Workplace, when it all came together and clicked.

I’d had trouble focusing on my work, so tried a quick blog-read distraction despite my dropping BG. In mid-comment as the touchscreen buttons became more elusive and unclear, everything made sense in a moment: sweating merged with coldness, concentration evaporation, blurry vision. Rationale thought was nowhere to be found, even though I probably thought everything seemed completely normal at the time. I could keep working away and not be dissuaded, and just deal with the D-matter once my work was finished.

"I'm Fine," went through my mind (of course), followed closely by the thought of "Pay No Attention, All Is Well Here" and "Go About Your Regular Work-Tasks, Please."

Obviously, not. A blood test proved the point, and Skittles were my solution to the sudden 62 mg/dL.

Tried to stand up, and darn near fell over and caused a ruckus there in my office. Found some change and, despite seeing the multi-flavored glucose tab jar in my desk drawer there, decided that the break room vending machine would offer a better remedy. Stepping downstairs away from prying eyes, I inhaled the candy quickly – but not so fast as to sacrifice the chance to snap a quick Blackberry photo of my meter and Skittles posing together for Twitter distribution.

Not too long after that, things began to seem real again – that flurry of surrealness was passing and I made my way back to my desk to pick up where I’d left off earlier before plummeting. Back at my desk, I glanced at the calendar and it suddenly dawned on me: It was the SAME TIME as this type of thing happened before. Two years ago, in fact. That’s when a Low hit even more suddenly than it did this time, and despite trying to do everything right, too much went wrong.

I’m glad it didn’t get too bad this time.

Just an annoying happening, likely a causality of two specific events: 1. That being my 3rd day of a Pump Hiatus where I’ve returned temporarily to twice-a-day Lantus shots and Multiple Daily Injections of Humalog boluses; and 2.) Pressing work deadlines that day that kept me on my toes but led to skipping lunch. I’d been hurrying all day, telling myself to press on and that I could easily do. Maybe even subconsciously telling myself “You CAN do it” and diabetes wouldn’t “hold me back” this time. Hindsight is 20/20, obviously. But at the time it made perfect sense for my tunnel-vision type of workday.

Stories like this are scary and not cool, but they seem to happen to so many of us PWD. Why do we do this type of thing, thinking we're "fine" when we'r really not? Maybe someday someone will provide a clear answer to this psychological D-mystery. The best we can do is deal with it as needed rather than trying to “just keep swimming” until a later time… because soon enough, we may find ourselves drowning as a result. Better to find that live jacket while we still have the strength to swim.

Hopefully, in the future, I'll recognize my severe dog-missing and lack of focus as clear signs that it's time to test and do something, as happened this round.

Friday, August 19, 2011

Post Apocalypse D-Management

We were watching the disaster-themed movie marathon on Sci Fi recently, and a crazy D-scenario came to mind: What if THAT particular apocalyptic situation played out and those of us People With Diabetes had to maneuver our own survival? Hmm.

This particular flick was a 2009 TV-movie Polar Storm, with the plot basically being that a comet collides with Earth and knocks the planet of its axis, throwing off its magnetic field and causing some crazy EMP bursts that randomly appear and short any electronic device going at the time. So, any cars or cell phones - and anyone touching those at the time of the burst - would pretty much be out of luck.

(Disclaimer: the fact that I was actually watching this movie should in no way signal my endorsement for others to watch it, or hint that my thumbs are in any way pointing upwards when describing the quality of this screen-writing... It was just a way to pass some time without having to exercise the mind. Seriously.)

Anyhow. As some of this transpired on the screen, I glanced at Suzi and wondered aloud: "So, let's say hypothetically this really happened... would my insulin pump be affected? Would I have to disconnect it?" We speculated that would probably be the case. A few minutes later, a character with a pacemaker saw that very scenario play out and leave him dead on the street. Our suspicions were confirmed, indeed.

So, if a meteor ever crashes into Earth and throws off the magnetic field, guess I'll be unhooking the insulin pump and going the syringe-and-vial route.

Or, maybe I'm already in apocalypse-prep since I recently went on another Pump Hiatus and am a few days into that Multiple Daily Injection routine again. Nothing against my pump, just pretty much the same reasons as mentioned last year when I took a needed break - mentally and emotionally - from my trusty pump. Hoping I can lower my A1C again by a whole % point just like before!

Even if I can't, at least I'll be working toward better management more diligently.

And, you know, will be ready for D-Management Post Apocalypse Style. This is not to be confused with the Zombie Apocalypse, that I'm already prepared for with my arsenal of lancets. Now, D-Mom and I need to fashion some sort of lancet-shooting device to combat the zombies... that's a work in progress and options are being explored.

Hopefully, whatever the end-of-the-world disaster may be, it holds off until I can bring my BGs down... or something like that.

Wednesday, August 17, 2011

He Does The Beta Cell Bash

One of my fellow Diabetes Advocates Cara recently came up with a great idea to reach more people outside of the diabetes online universe and bring them into this community. Her "Your Voice" project is a wonderfully-clever spin on guest-blogging and a way we can all embrace to expand the DOC's reach and bring more people into this outstanding community of connections and support.

This guest post comes from Michael K. Schwab, a 51-year old Type 1 diagnosed almost four decades ago who I had the pleasure of meeting at an Adult D-Meetup in Indianapolis earlier this year. We got to talking about careers, music, and exercise and he agreed to guest-blog for me about his own adventures from career choices, exercise fun, and musical talent. Let's just say: You've all heard The Monster Mash... well, here's a guy who's going to make The Beta Cell Bash the newest thing for the D-World (something that very well may make him eligible for a future Blunt Lancet Tour or upcoming D-Prom-A-Palooza some day!)

You can find Mike over on Facebook, and as well as at The Indiana Cure Chasers since he's the coach of the JDRF Ride Team Indiana. So, with that - take it away, Mike!

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Death Valley ride in Oct. 2010
My sister asked me recently how often I checked my glucose when after first being diagnosed with Type in March 1973, and she seemed astounded when I replied that, I went to my endo every three months and he’d draw a tube of blood and let me know the results the next day. A lot has changed since then. I can’t remember the last time that I had to pee in a cup and do my in vitro urine test. While it’s been a gravel road at times during these 38 years, I count myself lucky to still be what I like to call an “original equipment” diabetic (meaning no complications or replacement parts).

Currently, I work in a business to business sales position for a musical import company and sell musical things to music stores to make my house payment. But it didn't start off that way.

When graduating from Purdue in 1983, there weren’t a lot of jobs available at the time. I managed to get hired for an Industrial Engineering position, but flunked the physical when the company doctor found out I was T1 and had a 7.1 A1C (a brand new test at the time). My general practitioner at the time told the company doctor I was basically a walking time bomb, so instead I became an Over the Road Trucker for 14 years, and spent a dozen of those years driving with the woman that I was married to for 24 years. Up until the last few years that we trucked, the DOT had not allowed insulin-dependent diabetics to operate tractor trailers, so it wasn’t something I made known.

A few years previous to our exodus from the trucking biz, we began doing music. I taught myself how to play guitar when I was 32. In short, getting out of the truck allowed us to pursue music on a more serious level. We started a gothic band, were able to garner some radio airplay, and toured regionally until 1998 when we jumped genres and did what a lot of people described as Celtic-Goth-Alt-Rock. Eventually, we evolved into a Celtic Acoustic Rock Band.

It was through the band that I started pumping in about 2002, after hiring a drummer who was on a pump and talked me into trying something new. I had a lot of trepidation and was worried about ripping out the infusion site (which I do), that I would be hard on the casing (which I am), but all in all it has turned out to be a stellar piece of T1 control equipment! That was about 10 years ago and while I still take the occasional short breaks from my R2D2 unit and go back to Lantus and Humalog, I’m very happy to be a pumper!

Playing at Victory Field in Indy in 2000
In 2004, we decided to use the band to found a fundraising event we dubbed, “The Beta Cell Bash” and raise money for the JDRF Ride Team. At the time, this cycling team was doing a single venue event in Death Valley where each member of the team would raise $5,000 or more for the privilege of riding 105 miles in the hottest, driest desert in North America. The event lasted for 3 years until the break up of the band in late 2006, with our final show in late November after a great run of more than 1,500 shows, coast to coast tours, getting an award from Billboard Magazine, multiple year finalists in the JP Folks International songwriting contest, and playing in front of audiences that most musicians only dream about! We were able to go out on top in front of a sold out crowd at Radio Radio in Broad Ripple (Indiana).

But when we went out at the end of that year, it led me to a new adventure that has turned into a passion for endurance exercise – all to help out the D-Cause!

I’ve always been active, which may have been my saving grace with my T1 and general avoidance of complications. During the trucking years, we lifted weights 5-6 times every week and competed in power-lifting. Later, I somehow fell in love with cycling and endurance sports in general. In fact, I’m now a triathlete (A.K.A. a triabetic) and am currently working towards a long term goal of qualifying for the world championship Ford Ironman event in Kona, Hawaii.

My cycling has gone from two 100+ mile events to a plan for at least eight events this year and another eight in training rides. My yearly mileage hovers around 7-8,000 miles and my longest single day ride to date was in July when I rode 165 miles between Indiana’s state lines. Also, I’m preparing right now for my 4th Death Valley century ride this October and I am coaching the JDRF Indiana Ride Team. What a turn for the good my life has taken since November 2006, when Beta Cell Bash ended!

Now, we’re exploring the possibility of bringing back The Beta Cell Bash for 2012 – we’ll see what the future holds!

Monday, August 15, 2011

A D-Camp Director's Insight

Badge created by Meredith from With a Side of Insulin
One of my fellow Diabetes Advocates Cara recently came up with a great idea to reach more people outside of the diabetes online universe and bring them into this community. Her "Your Voice Project" is a wonderfully-clever spin on guest-blogging and something we can all embrace to expand the DOC's reach and bring more people into this outstanding community of support. So, I asked Cara if I could point some of my upcoming guest-posters from my own D-Community offline and she agreed that'd be cool. 

So, here's the first: Jenna Holt, a 24-year old Type 1 diagnosed about seven years ago and the newest leader of the Diabetes Youth Foundation of Indiana that runs the Camp Until A Cure. You can find her on Facebook, and with that I'll let Jenna take it away:

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I was diagnosed late in the game, at age 17. People liked to comment on whether it was easier being older and able to understand what was going on, or if by knowing a different lifestyle my whole life was harder to change. Well, after contemplating it for a while, I decided that neither is worse than the other. It was simply a change to be dealt with. What was hard was being different. An example: going to volleyball practice and being told that I was lazy by teammates when my sugars would drop below 50 because I would have to sit out and treat from exercise. I was still rather new at “living with diabetes,” but lazy was not a characteristic used to describe me. I was the only one in my school with diabetes, which meant a lot of confusion and myths. This continued through college. I didn’t really go out of my way to find a support group or people who were like me. I knew who I was, had great friends (most knew I was diabetic but not enough to be a resource), and was enjoying life. I guess I was old enough to take care of myself and not worry about finding others who could understand, who could empathize versus sympathizing.

But the Diabetes Youth Foundation of Indiana changed my life three years ago, and it can be summed up in three words: passion, hope, and inspiration.

I found out about an organization that runs a camp for children with Type 1 (just like me.) I jumped at the opportunity to get involved. Year One I was a counselor, talk about an indescribable experience. I had worked with kids all my life, although I took a different path from teaching. I am convinced that kids are better teachers than most adults I know. That being said, Year Two with DYFI brought me back as the Diabetes Education Instructor. The previous statement about children being teachers still held true - Not only are these kids resilient, but they are intelligent. They have to be.

This past January, I became the DYFI’s executive director. In all my time working with the camp, I was greeted by several counselors and staff “just like me.” These people understood what was going on when I was cranky (one of my defaults of being low), and I finally fit in. Maybe this is where my goal of reaching out to more children and teens with Type 1 has become such a focus of my new position with DYFI. I know there are kids out there who are just like me. In fact, I have had the privilege of meeting some of them. I would like to believe that what you don’t know doesn’t hurt you; however, I always felt something was missing. I was right.

This past camp season proved to be nothing short of amazing. We had over 180 kids from all over Indiana and a few other states who came together to enjoy being kids while learning about how to properly take care of their disease; and yes, this includes diet. With over 30 new campers, our DYFI family grew! Watching them learn from each other and form lasting friendships is something that is hard to put into words. Imagine that one moment in your life that gave you goose bumps, where you realized that something was taking place, something bigger than cheap thrills or material items. That moment where you felt a renewed hope, a feeling of inspiration. This is the best way to describe those three weeks of camp.

Mike asked me if I’ve had any lows while at camp, and there have been for sure! Last year, we had our sugars posted in the Diabetes Ed room for all the kids to see and ask questions. I had some lows and some highs, as did all the staff. I never had an extreme low, but last year I do remember having to go to the infirmary to get some glucose-- there was one day I couldn't keep my sugars up. I would keep track of the (six D-member) staff's sugars before breakfast, lunch, dinner, and bedtime and this gave kids the opportunity to say "Hey, you had a high... how come?"

See, even PWDs CAN skydive!
Overall, DYFI is an amazing organization. Part of what makes this organization so great: it’s family members. The kids, the parents, the staff, the volunteers, the supporters, the board members, the family and friends of these people, those who take a stand against myths and negative perceptions in the community all make up this family. Growing up in a rather small family, I always dreamed of having a bigger one. Without even realizing it at the time, my dream came true. I now spend my time working to serve this family. Through fundraising, grant writing, frequenting support groups, and any other opportunity that comes my way, I hope to be able to raise more money and reach more kids – particularly kids who may be feeling what I was feeling. I don’t think I could ask for a better way to spend my time.

Passion is something that will take you farther than anything else. This is a passionate family with a passionate director. With this combination, DYFI will inevitably continue to serve children and their families. Like I mentioned previously, DYFI has changed my life. It is my hope to help change the lives of others in the community.

Friday, August 12, 2011

Focusing on Hope



We remember, and in your memory we focus on the future...


Those in the Diabetes Community who we've lost too early.


Most recently.


And over time.

Then, there are those shining beacons that we've lost from outside the D-World, whose lives and spirits touch us all. 


Eleanor Josaitis, co-founder of Focus: HOPE in Detroit, who was a beacon of hope for that community and died Aug. 9.


Even in loss, we go on.



"I pray for the wisdom to listen,
and the courage to act."
- Eleanor Josaitis, of Focus: HOPE in Detroit.


Wednesday, August 10, 2011

Dear FDA

Finally, the FDA is exploring a diabetes innovation that is long overdue: Low Glucose Suspend. Basically, the CGM-component allowing an insulin pump to detect what your blood sugar is at and shut off it reaches a certain threshold that's too Low for comfort. This allows someone who may very well be sleeping overnight to not drop any lower with continued insulin before being able to treat, wake up, or at least become aware that something isn't right.

Worldwide, this is already available and the U.S. is simply behind - mostly because of the FDA's reluctance to approve this and ask the important questions to assess why this option is so necessary.

But now, that's happening. The FDA has released some draft guidelines that are up for public comment, and want to hear what everyone thinks about the proposal. Bennet over at YDMV has a great write-up about this, and he is just one of the many Diabetes Advocates who's hoping the broader Diabetes Community will get word about this and make our collective-patient voice heard on this.

What they're looking at includes how they should allow Low Glucose Suspend, how that might stop delivery of insulin to people who've already had too much insulin or are already Low, and how a system that cuts off insulin might increase risk of raising one's Hemoglobin A1C over time with higher BGs.

To post to the FDR public docket go here: http://www.regulations.gov/#!submitComment;D=FDA-2011-D-0464-0001.

Everyone is also encouraged to copy their comment into an email or letter to the elected officials at both the state legislature and Congressional levels, so that more eyes are brought into all of this. Below is a copy of what I've sent to the FDA and am mailing to my elected representatives.

Dear FDA...
One of my greatest fears as someone who lives with Type 1 diabetes, is not waking up because of a Low blood sugar. Local paramedics have made multiple trips to my home because of overnight Lows that have resulted from an inbalance in my blood sugars, issues that have occurred without any warning despite all the management care that I take each day and night. Even with the multiple blood tests, meal management, and accurate insulin dosage, Low blood sugars happen and have dropped me so low that I am not able to wake up or function on my own. They have caused me to thrash and even become violent, hallucinating and trying to harm my wife as she tries to get more fast-acting sugar into my system to counter this hypoglycemia.

Both children and adults with Type 1 diabetes have died as a result of these overnight hypoglycemic events, and even those happening during the daytime hours, causing them to lose awareness suddenly without warning.


One way to prevent these tragedies and potential risk would be a Low Glucose Suspend, an option that is currently available on insulin pumps outside of the United States. These work effectively and save lives, however this is not available in the U.S. because of the FDA’s regulatory review process. If someone is going Low in the night but does not realize and have the ability to wake up to suspend his or her insulin delivery, then this Low Glucose Suspend system would allow that person to have a safety net preventing them from continuing to receive insulin – dropping them even lower and into a possible coma.

I am pleased that the FDA is finally considering this, and do hope the realistic concerns of people with diabetes are addressed – the hypos and the balance of juggling these Highs and Lows in our daily lives. Not the slight increases in Hemoglobin A1c numbers, which are just one indication of a person’s D-management and really mean nothing if that person dies from an overnight low.

Our A1c tests are not perfect, and are simply one resource in a very large and ever-expanding tool box that we use to manage our diabetes efficiently and practically. Living with diabetes is preferable to dying because of diabetes, something that is more likely now as a result of not having this Low Glucose Suspend capability.

As a country, our current regulatory system preventing this life-saving option means we are behind the eight ball on this technology and losing innovation and dollars to other places globally that have Low Glucose Suspend available. I’m hopeful that the FDA develops guidelines bringing us more in line with what’s available worldwide, and also aids in the development of future innovations such as the Artificial Pancreas.

Since the FDA started taking comments on this topic, some news reports have circulated about potential risks to those using wireless medical devices such as insulin pumps and continuous glucose monitors. While these “hacking” possibilities do theoretically exist in this 21st Century, I’m not concerned and have faith in the process you have reviewing these issues. I continue to trust that the medical device manufacturers are aware of these possibilities and address them accordingly. While a threat may exist in theory, the risk is non-existent and shouldn't be blown out of proportion. Please don’t let these far-fetched, unlikely scenarios hold up these valuable life-saving tools for those of us Living With Diabetes and facing these concerns every day. It’s so important for the FDA to prioritize these risk and evaluate them objectively, based on what the real concerns are for those using these devices. Hypoglycemia is currently costing the lives of American children and adults – those high stakes mean that this guidance is incredibly important and must be done adequately as soon as possible, in order to not remain behind the rest of the world in providing innovative technology to protect lives.

Thank you kindly,

Me.
(A Pancreatically-Challenged Taxpayer Who Loves Cupcakes and CAN Eat Ice Cream while preparing for the Zombie Apocalypse.)

Monday, August 8, 2011

Hacking Into Real Concerns

So, there was this hacker’s conference in Las Vegas recently.

That was where Jay Radcliffe, a security researcher and fellow Type 1 diabetic, gave a presentation about his findings that someone could remotely hack into insulin pumps and continuous glucose monitors to manipulate data and even control the devices.

Some specialty publications picked up the story, as did the Associated Press and then basically the same story ran in a number of newspapers nationwide, including U.S.A Today. Eventually TV media-players like Fox and CBS picked it up with their own variations, too. Headlines and stories reiterated the basic point of what Jay said at the conference: 'Hackers can do this to kill people using these devices, and we should all be concerned."

This issue came up earlier in the year with an MSNBC article on hackable medical devices, and this is the latest highlighting a topic that may very well be possible and a concern for those of us using these devices.

That's where we are now. This has all sparked discussion about how Jay presented his findings about this security flaw, the realistic concerns this may or may not present, the media portrayal of all this, and potential unintended consequences this could have on public perception, the regulatory review process, and our patient-community that needs and lives with this kind of technology every day.

Frankly, I’m a little split on this whole issue. First, I am not even sure how I feel about Jay's presenting this at the conference and giving the media a “pump-attack” story in the first place. Would it be different if he discovered this and just blogged about it online? Should he have kept it hush-hush and just contacted the device manufacturer(s) without letting the masses know? Is this reasonable proactive awareness on a potential security flaw, or a needless scare tactic being used to prove a point?

I've read that Jay used some sensational skull-and-crossbone images to promote this at the hacker's conference, and contacted the press ahead of time. And it does appear that this was self-promotional, rather than a "protect my fellow PWD" message... But I don't know. It's tough and I am torn. But really, that's not the point. The media response to all of this is.

From what I’ve read, pretty much all of the articles – whether it be the specialty hacker/techie publications or the mainstream newspaper stories – seem balanced and fair. They are essentially reporting on what Jay presented on. The AP story that ended up nationwide didn’t "sensationalize" the story, or do what that terms means when it comes to media sensationalism, and it doesn't strike me as an example of irresponsibly playing this up. It focused on Jay's research/presentation, offered responses from the FDA and medical device industry, and included objective perspective from another researcher on this type of thing. I don't see anything editorially or journalistically wrong with that.

They are reporting on a story, just as a local reporter would write about a local county government meeting where someone does a Power Point on how rezoning a property will lead to mass development years down the road - you are just reporting on what they tell you and getting the different sides. Even if the readers disagree with the rezoning and what one person says future development might look like, and the readers despise the fact that anyone would even discuss this in the first place, it's still information that is worth getting out to people so they can use their own minds to decide for themselves whether it's an issue or not.

Here, Jay said publicly that he hacked his pump and others could do the same, that it could be done to kill someone. The media isn’t overplaying anything; just reporting on what he said is possible. Two examples stand out, from what I’ve seen published online: CBS and a techie blog that do seem to use overly-sensational language to make the point. While I don’t like that on its face, even those writings overall balanced things out in their coverage based on what Jay put out there.

We can’t shoot the messenger; in this case that's the media and even Jay Radcliffe. Just because he talked about it and the media wrote a story, and people may react negatively to it and it could have unintended consequences, doesn't mean the story shouldn't have been told or written.

This comment from the MSNBC article sums up my feelings on this, i think:

"Pretending a problem doesn't exist is a great way to turn it into a crisis. Security through obfuscation is a joke and a policy that has been discarded by every decent security researcher in the field. Sticking your head in the sand doesn't solve anything and it is only (through) identifying problems openly that solutions can be developed and deployed."

However, I think the Diabetes Community does need to be concerned now with any potential unintended consequences from all of this. I do think we need to keep perspective on how minimal this really is as far as something to be concerned about when talking about D-devices. My response would go something like this:

1. Medical device makers - we trust you in recognizing these issues and addressing them as needed.

2. FDA: We hope you will hold companies responsible in addressing these issues, but not needlessly hold up technology when a company has addressed these potential concerns. This isn't a practical issue for anyone who uses these devices, and shouldn't overshadow the real world problems the diabetes community faces without these products and the developing innovations out there. Overnight lows, swinging blood sugars, and long-term complications resulting from these BG issues are what the focus should be when evaluating the devices.

3. Media: Please maintain the practice of fair and balanced coverage, both on the potential security risks as well as the practicality and FDA response to all of this. Let’s not sacrifice accuracy in order to sell more papers or get more viewers or page visits. That is our responsibility, as the Fourth Estate. We need to make sure this doesn't become a big deal, when it's really not.

4. Insulin pump users: Calm down. This really isn't a big deal. Avoiding Lows and DKA are much more important. Oh, and making sure the TSA isn’t needlessly hassling us and our fellow PWDs with over-the-line security procedures.

These are just my views. Others have and are writing about this from their perspectives, as well – I encourage you to read those posts. Some of those include:

- Manny Hernandez at TuDiabetes reached out to the medical manufacturers for a response, and so far he's posted this Q&A with Medtronic and then this one from Animas.
- Kerri at Six Until Me has a great interview recap with Jay Radcliffe himself.
- Scott Hanselman also has a more tech-specific analysis of this issue and the initial media coverage.
- Kelly Booth over at Trials & Tribulations has also written on this topic.
- Pearlsa shares some thoughts on this, since she blogs at A Girl and Her Reflections.
-D-Dad Matt at Type 1 Online talks about this from his view as the parent of a CWD, and as someone in the IT industry.
- Bennet also has this brilliant post going at how we should keep this all in perspective, and not get overly concerned about this when the reality doesn't dictate it as a big deal.
- Sara's post at Moments of Wonderful talks about the hackers that really don't care about us.
- Scott Strange has a simple message, that the threat is real but the risk is essentially non-existent.

You can also follow discussions on Twitter using #pumphack as a hashtag.

Overall, I agree that the D-Community should get our collective voice out there to the medical device makers that we trust them to handle this, and to the FDA that this isn't what they should be worrying about because it’s really not that big of an issue in the bigger picture. The focus shouldn't shift from the benefits, and true live and death dangers that exist by NOT having these resources available.

Saturday, August 6, 2011

Take That

Yes, I CAN eat ice cream.


Loved this hot fudge sundae, with a cherry on top...

(SWAG = 50g -> I'll leave your mind working on how that D-Math worked out...)

Take THAT, Wendell!

And THIS...


See that window to the right there? I believe that's the office of a certain publisher...

So, Take THAT Southside Times...

Even on your own FRONT STEPS, I have no problem eating ice cream.

And so can the rest of the Diabetes Community.

Not matter what you say or write, those of us Living With Diabetes are more than capable of eating ice cream even as we do what we do in managing our D-Lives and overall health effectively.

DON'T tell us otherwise, or pretend to know what's best for OUR worlds.

This is what I think of your writing...


Thanks for playing.

Thursday, August 4, 2011

Cutting Clinical Trial Red Tape

A news story came out recently in the Washington Post, discussing the federal government's proposed sweeping revisions to the rules governing scientific research on human subjects. Apparently, this is the first change in two decades to the "Common Rule" that governs nearly all human-clinical research financed by taxpayers and it protects those in the trenches doing this work while also streamlining the oversight and paperwork required of scientists.

Here's a news release on that from the HHS on this rule revision. That release says this:

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.

Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways.

Comment is sought on the following:
  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. Updating the forms and processes used for informed consent.
  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  7. Providing uniform guidance on federal regulations.
Honestly, most of that went over my head. I truly don't understand what it means, for those researching, conducting clinical trials, or participating on the other side of that research. Curious about the impact of this in the diabetes research arena, I took the question to a someone I know who has a better idea what this might mean to us.

That is Indiana University researcher Patrick T. Fueger in the Department of Pediatrics, whose diabetes research focuses on pancreatic beta cells and islet proliferation.

He says, "This could be a great thing. I’d have to read the proposal in its entirety to be certain of that. The whole process to get a study approved is filled with red tape. The proposal seems to minimize that while maintaining the protection of human subjects. The biggest benefit will be streamlining research that uses surveys and interviews. Right now, you have to get your survey approved and if you change one question (even just deleting it) you have to get a new approval. You have to talk about the risks of filling out a survey. I think I did one once and listed paper cuts as a potential risk to the study participants. Most researchers are pretty ethical and police each other in many ways. Streamlining the approval process and cutting out some red tape is a welcome update to this facet of research."

Nothing is final at this point. Published on July 25 in the Federal Register, public comments are being accepted for a 60-day period. It's listed as an Advance Notice of Proposed Rulemaking (ANPRM), entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Comments can be submitted here, using the ID number HHS-OPHS-2011-0005.

Monday, August 1, 2011

Ants Crawling All Over Me

Ever feel like something’s crawling on you?

That's how I have been feeling lately. And it drives me nuts.

My mind is trying to convince me that there are ants crawling on my feet, lower legs, and even upper legs and arms.

Late last week, the Diabetes Online Community got a glimpse of my craziness when I randomly tweeted:


GET OFF ME!!!! (Me at desk, yelling at imaginary ants crawling on my arm...)

Yes, that's what it felt like.

However, there haven't actually been ants crawling on me... Instead, this has been a mirage created in my mind by the return of mild neuropathy. An unwelcome acquaintance who's crashed my D-Life party in the past, and sadly appears to be back knocking at the door in the form of those annoying imaginary ants. You may recall the story of my Burning Toe and how I've handled the on-fire feeling in the past. Lately, it's not reached the level of shooting pain or burning. Rather, the neuropathy's been presenting itself through a tingling sensation. The kind where it feels as though something (read: ANTS) are crawling on me. On my toes. Feet. Legs.

Everywhere, whether I'm sitting on the couch, at the kitchen table, laying in bed, or at my desk in the office. It's a bit unnerving. And it freaks me the Eff out.

But that's what I want to tell you about, because that's why I got into this whole blogging about my diabetes thing in the 1st place. To tell those "real" stories about what these early signs of complications are really like and how people just like me are dealing. Not the horror stories focusing on fear and “amputation” and “death.” I wanted to hear the versions that doctors never told me about what D-Complications actually feel like before those extreme end-game stages.

Actually, back in 2005 as a newly-married guy, those early toe-tingling and foot burning experiences from early neuropathy is what took me online to search for those just like me. And that's how I found Kerri and so many more of those real stories my soul was searching for. And so much more.

So, maybe this all means it's a good time for me to share my own real story about this.

About what it's like when it physically feels like there are bugs crawling on you, but you know there's something more medically sinister at work. About how you then ponder the other D-Complications that could be crawling around unnoticed inside, lurking and waiting to show themselves. Is there more going on... What about the fact that I can barely wear contacts anymore as I once did, thanks to weakened eyes and the mild retinopathy that still lingers? Or how my teeth and gums are wounded soldiers in the war-zone that is my mouth, a battlefield plagued by strained nerves and root-canal welcoming forces? Or my drowning mental state that everyday tries to stay afloat, even while carrying the heavy bricks of depression and worry? Or all the other issues that may or may not be actually connected to diabetes but make me feel like I'm fighting a losing battle.

Good. Bad. Ugly. And Everything in Between.

Including this one, about the D-Complication we'll refer to as Bugs of the Mind.

Now, some relevant info that pertains to these metaphoric insects: I'm sure that the actual presence of ants in my house hasn't helped. They swarmed earlier in the year and times before that, and we went all Chuck Norris on them with an Ant Elimination Plan. They went away. But now they've returned with the recent heat-wave, and on several occasions in the past week or so I've seen them in the sinks, on counter tops, and even on the living room couch and floor. A couple times, a stray ant has accosted me and made the daring attempt to scatter across my skin. I've aimed to execute these loan scouts, and searched for hidden base camps in the usual or even unlikely spots in the house - but have found no widespread invasions like before. Of course, all of this has convinced me I'm surrounded by ants and am under constant attack - even though I know that's not actually the case.

That fuels the mind games that Ants Crawling All Over Me.

I've written before that this D-Complication has appeared as a warning sign that my D-Management is in need of improvement, and so that's what I'm going with here. No need at this point to turn to any medication, as I'd done years ago when the pain was impacting life. My BGs have been all over the place, making even regular glucoaster rides on D-Coaster Day look like a calm line. Bringing Larry The Loaner CGM back into my life briefly has been helping lately, and hopefully soon that leads to the symptoms calming down.

This CGM may very well be a Mental D-Ant killer. Or so I'm hoping... because honestly, this all bugs the crap out of me and makes my skin crawl.