Scott's Web Log

Immunologist Matthias von Herrath to Work for Novo Nordisk

2012-01-23T22:20:00.000-05:00

For those of you who missed the news, it was announced today that immunology researcher Matthias von Herrath will be sharing his duties with La Jolla Institute for Allergy and Immunology (the announcement actually says he'll stick around La Jolla part-time, probably to continue with his existing teaching obligations) to take a position leading Danish insulin giant Novo Nordisk's type 1 diabetes research and development center in Seattle which will focus on autoimmunity treatments (see the press release at http://prn.to/zQ3xJZ). For those of you in the Seattle area, the type 1 diabetes research and development center will be will actually be housed in South Lake Union neighborhood alongside Novo's team of autoimmune/inflammatory disease researchers. The Novo Nordisk Type 1 Diabetes R&D Center is expected to open this summer (2012), and will be staffed by approximately 20 researchers.

As I reported in August 2008, Novo Nordisk actually opened a research facility in Seattle back in 2008 (see my blog posts at http://bit.ly/w0I2Y1 AND http://bit.ly/wh50SH for details), but in my assessment, not much progress has been reported since that happened, with nothing even mentioned in the company's investor presentations or SEC filings.

Readers may recall that not one but TWO autoimmunity treatments designed for type 1 diabetes both failed to meet their efficacy endpoints in 2011: specifically, teplizumab which was being developed by a Maryland-based biotechnology company known as Macrogenics and big pharma partner Eli Lilly and Company, as well as otelixizumab which was being developed by Massachusetts-based biotech company Tolerx and big pharma partner GlaxoSmithKline. It should be noted that there is still additional research being done into these products to determine if these drugs might work on certain groups of patients, but it seems clear that neither is likely to become a product administered to all newly-diagnosed patients to arrest the autoimmune response that causes type 1 diabetes.

Perhaps Teva's [Andromeda's] recent progress in the field is prompting them putting some genuine resources into it now? (see http://buswk.co/viRH12 for more, also catch the post at DiabetesMine.com in which I was asked for input at http://goo.gl/DkI4u).

Aharon Schwartz, vice president of innovative ventures at Teva told Bloomberg BusinessWeek in an interview on the company's Diapep 277 in late 2011 (see my 2010 coverage on that treatment HERE):

"When we started we thought, even if the results are positive, we would have competition. Now we are the only game in town."

My guess is that statement didn't sit well with Novo Nordisk's top brass in Denmark. I can only hope that Novo Nordisk, especially after it's poorly chosen Paula Deen endorsement for Victoza (check out the Forbes story HERE) disaster (which rightfully deserves some of the criticisms it has received from others within the pharmaceutical industry) will make good on the type 1/autoimmunity research.

Novo Nordisk reportedly sought Dr. von Herrath to lead the Center due to his stellar record in type 1 diabetes research.

"Dr. von Herrath is generally regarded as one of the top researchers in the world in type 1 diabetes," said Dr. Jacob Sten Petersen, Novo Nordisk corporate vice president. "He has made several key advances and is the kind of dedicated, talented researcher that can fuel true innovation in type 1 diabetes treatment." Dr. von Herrath is the recipient of the Juvenile Diabetes Research Foundation's (JDRF's) prestigious Scholar Award in 2008 for Live Imaging of Islet Destruction (the announcement for that can be viewed HERE, and the stunning videos can be accessed HERE, be sure to look towards the end for "supplemental data" for the actual videos) and he also received the Outstanding Scientific Achievement Award from the American Diabetes Association.

The company (Novo Nordisk) has done very little with the Seattle autoimmunity and inflammation research facility it opened since it was announced back in 2008 (see HERE), so the recent news that the company had hired a world-class immunologist could be a positive sign. However, I would dare say that it will likely be a few years before this move is likely to yield much of anything, but it's nevertheless positive.

End-of-Year Reconciliations; New Year, New Insurance

2012-01-15T21:10:00.000-05:00

Happy New Year Everyone! What would a new year's post be withough including the awesome ABBA song "Happy New Year" (it's Flash audio, sorry for the Apple loyalists who really can't enjoy it the way the web was truly meant to be enjoyed) in honor of the occasion? See HERE (it's a Vietnamese site) to download the MP3 to the song (it was working when I wrote this post).

But beyond New Years tunes from 1970's-era Pop Stars from Sweden, the "Happy" New Year had a particular meaning for me in 2012, at least when it comes to managing diabetes. I ended 2011 much like I've ended prior years. I spent part of the last few weeks of 2011 (I began shortly before Thanksgiving) trying to make sure all the t's were crossed and the i's were dotted when it comes to the byzantine healthcare coverage system. I can be thankful for having coverage, but am less-than-thankful at how freakin' complicated all of it is.

Part of my year-end process also included making my last 90-day supply orders from Medco for the year, especially since I had a very high-deductible plan and because insurance was finally paying 100% of these orders at the end of the year I wanted to get what I was entitled to IMHO. Of course, that starts all over on January 1, so at least if I was able to stock-up, I should have sufficient supplies for a few months into the new year.

Personally, in spite of the big cost-savings for insurance companies, I find absolutely nothing convenient about mail-order pharmacies. Notably, I can't have them shipped to my apartment because stuff literally tends to disappear from my doorstep (I live in the city) or worse, dogs treat packages left at my front door like a fire hydrant. Either way, "home" delivery simply isn't a viable option. Of course, I am seeing both CVS and Walgreens are now promoting the ability to fill 90-days of scripts at the retail pharmacy, provided of course, your plan ALLOWS retail pharmacy fulfillment (my plan did not).

As a result, I am obliged to ship all this crap to my office. I have boxes of testing supplies, needles and the rest shipped to work. When those stupid pillow-like containers they put temperature-sensitive items like insulin in arrive, I have to figure out how lug all that crap home on public transit (the subway). I usually toss all the unnecessary packaging (including like my 300th ice-pack, I have more of those than anyone needs, and don't have room in my tiny freezer for any more, so they go directly into the trash -- my, what an efficient "system" mail-order is!). When all is said and done, they take up far less space and make it easier for me to carry home on the subway ride home.

As I already hinted, I pretty much had to order ALL of my scripts by mail-order with this plan (I had a limit of just $250/year in retail pharmacies, mainly for emergency prescriptions for things like antibiotics which patients simply can't wait a week to receive), I knew the drill very well. I also had many other accounts to manage as part of my year-end ritual: HRA, FSA, transit, and I needed to reconcile those. The reason for my doing this is that I've learned over the years that it saves much aggrivation and money. The last thing I need to be dealing with is an unexpected bill for services and NOT being able to expense it because the bill arrived too late to be submitted for reimbursement.
Beyond Medco stuff, I also looked at balances in all of my various healthcare (and transit) accounts. I also had an HRA (health reimbursement account paid for by my emplployer) since my employer subsidized part of my huge deductible (that was a great benefit, but it meant having yet another account that I had to keep track of). And, I had an FSA (again, great benefit, but yet another account for me to keep track of). To top things off, I also had a transit account (again, nice because it enables me to pay for these things using pre-tax dollars reducing my taxible income, but that too was yet another account for me to reconcile and keep track of. Fortunately, my administrator allowed online access to these accounts, so I could login and check out the details without much difficulty. Guess what -- I DID find a discrepancy!

U.S. Leads the World in healthcare (The Third-World, that is)

As it turns out, there was an issue related to services from June 15th, when I saw my endo this summer. I was back to see him in September, so this was a really old claim issue that no one bothered to ask about until I raised the issue with a question. Man, this kind of crap really pisses me off. Anyone who claims the U.S. has a "world-class" healthcare system is in my opinion, an absolute fucking idiot. The U.S. may lead the world in healthcare -- the third world, maybe! I doubt anyone in Europe (Western or Eastern) has to deal with all this payment "he-said, she-said" bullshit, and when interviewed, few would ever want the U.S. system. It just sucks.

In the process, I discovered that my FSA/HRA administrator believed that I owed them $204.40, but when I questioned them on their math, they actually acknowledged that the amount should really have been $172.90 (and they're the ones entrusted to "manage" tens of thousands of healthcare dollars from both my employer and me on MY behalf?! No wonder U.S. healthcare costs are so out-of-control!!). It appears that my insurance company had covered some services from my June 15 endo appointment that the FSA administrator wasn't paid for (since I pay upfront using my HRA/FSA account, and then wait for reimbursement since my endo was out-of-network, although I can expense my co-pays using my FSA), so I called them to figure out whether they were trying to charge it against the wrong account or something (stranger things have happened).

As it turned out, my insurance company supposedly paid for that particular claim, but neither my doctor nor I was the recipient of their payment! So I called my insurance company and after dealing with VRU-hell to finally reach a real, live person (and, they weren't in India, but New York of all places!), I learned that they actually did send 2 checks totalling $172.90, but neither of those checks were ever cashed. I said to the rep "Gee, that just might be a sign the check got lost." I mean, how many recipients, whether it was a doctor, a lab, or a patient would be holding onto a reimbursement check for nearly $200 for 6 months, uncashed? Hello?! Fortunately, this had (has?) a seemingly easy solution.

I told the insurance company "I need you to stop payment on those checks and reissue them both, and mail them to ME" (evidently, they were made payable to me). She did not give me any excuses about how she might not be able to do it for me (which I was expecting), but she cautioned me that it may take 6 weeks for those checks to arrive, which should be in February sometime. I can live with that. I guess my HRA/FSA is going to have to wait for 6 weeks before they get paid, but its no skin off my back, even though all of this is actually MY money, but I had it taken using pre-tax dollars long ago and if I don't use it, it disappears permanently. This is the kind of stuff that makes me wonder precisely what planet all those people who believe and actually claim the U.S. healthcare system is world-class actually live on? The way I see it, the U.S. healthcare system has far too many people with their hands collecting (and skimming something off the top) all this money, but not enough people auditing or actually ensuring that patients really receive quality healthcare. Don't blame patients or doctors, blame all the other layers of "covered entities" (as defined by HIPPA) for that.

Anyway, it looks like when all this billing B.S. is finally resolved, I still had a few extra dollars in my FSA to buy about 6 months of contact lenses and some Dex4 LiquidBlast shots, and because I already had my endo write me "prescription" for those items when I went in September, so I can indeed expense them, but I had to wait until my last two prescriptions of the year were filled via Medco, so the week before Christmas for me involved a lot of shopping, but not for holiday gifts, but FSA-expensible items!

Experience has proven that a few phone calls at the end of the year makes sure I'm not stuck the next year.

As I've lamented a number of times over the years, I work boutique consulting firm, and although I really love the work environment at this company, as a smaller-sized firm with offices in New York and London, the company has been challenged with skyrocketing healthcare costs in the U.S. (it's a non-issue in our U.K. office, which has national healthcare). U.S. insurance companies, as I've discovered, play games that ought to be illegal with low rates to lure new clients in, only to try and double the rates (or more) they charge the following year. As a result, I've literally had about 5 different healthcare (insurance) providers over the last 7 years. I've seen the ugly, the $#!tty and the reason why U.S. healthcare reform was a real necessity for U.S. business: because without it, the U.S. economy simply cannot create quality jobs -- we're likely to produce dozens of jobs that require a paper hat (McJobs, anyone?) or in places like Walmart, but decent jobs, not so much. We're not talking about trying to compete with China (who the hell would want the working conditions those poor workers, many of them children, tolerate?!), we're talking multinational companies choosing to do things like manufacture stuff in places like Canada, Europe or Japan rather than in the U.S. because the liability for healthcare in the U.S. is simply uncompetitive with these places.

Last year, I thought I was certain to join the growing ranks of Americans (Mercer Consulting estimated the percentage around 40%) who have very high-deductible plans without any subsidies from thier employers. In fact, I had been saving in anticipation of this unfortunate reality for much of 2011 knowing what my employer had said was going to be the case in 2012. However, a surprising thing occurred in 2011, namely that my healthcare insurer (one that overwhelmingly serves the City of New York's employees, people like the FDNY, NYPD, teachers in the public school system, City Hall employees, etc.) had decided to stop offering the plan my employer was offering in 2012. The company, which is preparing to de-mutualize itself to become yet another for-profit insurance company (I wasn't exactly in love with this company, but had learned to work within their confines over the past 2 years), stopped offering a plan with out-of-network coverage, so my employer decided to remarket it's healthcare business, extending our coverage with the existing carrier until the end of 2011.

As a result, although our plan year ended officially in August 2011, we remained with the same provider until the end of 2011 while my employer remarketed it's healthcare business. Although so-called insurance "exchanges" mandated by the new healthcare law to be done at the state level should address this starting in 2014, that's still 2 years from now. Even though New York is not among the states that have opted out of the healthcare law (none can opt out of creating the exchanges), small employers are still challenged today to buy healthcare insurance at costs comparable to what large employers can, and the rates of cost increases tend to be in the range of 40% or more PER YEAR.

Anyway, because my employer relies upon professionals with high education levels (our entire staff has a degree of some sort, with more than a few staff members with master's degrees, and even a few doctorates among us), they are acutely aware that they can't get away with Walmart-like benefits and survive. So they actually have a vested business interest seeing healthcare reforms, like insurance exchanges, be launched because they are the very businesses which are being squeezed out of the healthcare market today. Unfortunately, 2014 is a long way off and they have needs TODAY.

The result of the remarketing the company's healthcare business resulted in my employer contracting with what is referred to as a PEO (professional employer organization) to manage various items like benefits, payroll, etc. The biggest benefit is that as a "co-employer", I will be part of a healthcare plan that has over 10,000 "employees" rather than a small company with only 50 or so employees (we also have a few more in our London office, but those employees aren't included as part of the PEO arrangement since they have national healthcare coverage in the U.K. -- in spite of local complaints, it still blows the U.S. system away in terms of long-term patient outcomes AND actual cost according to many studies). Starting January 1, 2012, my healthcare provider officially became United Healthcare. I had United a number of years ago, and although I would never use the term "love" when it comes to any, for-profit healthcare insurance company, my past experience with United Healthcare was pretty positive, especially when compared to WellPoint/Anthem, which I cannot say enough bad things about.

All of this brings me back to the whole Happy New Year theme I began with. In 2012, much of the crap I dealt with with high deductibles, separate HRA, as well as FSA and Transit accounts has been made easier. Now, I can continue to see my own endo, but he'll actually be in-network! This new arrangement also means that the costs of healthcare coverage are unlikely to increase on average 40%-50% every year, as the PEO they've contracted has seen increases in the range of 7% for the last 5 years from what we've been told.

The new arrangement also means that an entire layer of extra bullshit will be eliminated from last year's equation. Another thing I've done when I got my new insurance card was notifying my new pharmacy benefits manager (PBM) United Healthcare uses that I want them to transfer my prescriptions from Medco to (which I believe is also Medco, but it still needs to be transferred) so I don't need to get brand new scripts from my doctor. This way, I was able to start in January when my new insurance plan year begins, I could theoretically fill them on day 1 if I wanted to (I'll wait until the FSA debit card arrives on that). I discovered I could have Rx's transferred from one pharmacy to another last year, when I found Medco's prices for generics to be significantly higher than using Walgreens.com, even if I did have to pay the full cost out-of-pocket and the cost did not apply towards my deductible amount, it was still a much a better deal. To facilitate this, the mail-order pharmacy of your new insurance company must contact the old pharmacy and ask them to transfer the scripts to them.

As it turns out, my endo is part of United Healthcare's network, and even the brands of insulin I prefer to use are on their formulary. I may ultimately have to give up my preferred meter (which was my Bayer Contour USB, but I can live with that) for another brand. On the bright side, a Dexcom CGMS may finally be a realistic option for me with the new plan, so apparently the Great One taketh away while simultaneously giving. I'm still figuring out what labs they use. I think they switched to LabCorp, which may be the nation's second largest laboratory (after Qwest), but that company still has relatively few locations where I live, and I've seen the company build new locations all around for the past few years, a process that's likely to continue.

When it comes to test strips, I am of the opinion that these are all pretty undifferentiated commodities. Most testing supplies (except for the Agamatrix/Sanofi system which I'll get to in a second) of the big brands of regular finger-stick meters all use the same basic electrochemical technology.

Hence, few products that have any true points of differentiation, rather they have come to rely on lame marketing gimmicks like coloring the strips blue and using truly unbelievable ploys such as "Double-Sure" technology, which I see as negated and made completely irrelevant by rules of proper testing, namely washing your hands before testing, but hey, it sounds catchy, doesn't it? (Whoever their ad agency is stinks IMHO!), but as noted, that doesn't do much to encourage me to stick with J&J. My endo gave me samples of both the J&J OneTouch Utra meter (I tossed my old one out when I switched to Bayer Countour USB) and Roche Accu-Chek meters since both of them are "preferred" brands on United Healthcare's formulary. I'll sample them both over the next month, and let my endo which one I want to continue with for the next few months.

Who knows, maybe Sanofi's i-Thing (also known as the iBGStar [http://www.ibgstar.us/]), which right now only works on Apple's iPhones and iPodTouch devices [I have the latter at least], but hopefully someday Sanofi will come the the realization that Apple's much-beloved iOS only has around 16% of the global SmartPhone market compared to Google's Android which now has over 52% of the market, see HERE) and is growing much more rapidly than Apple's iOS is) might actually be covered by then. Since it has only had FDA approval for a few weeks, that may be coming before too long. I could always go back to J&J's OneTouch Ultra piece-of-crap for a few months until that happens, after all, I lived with their product before switching meter brands (see HERE), even though there was absolutely nothing I liked about their product which would make me a "loyal" user. I suspect with the Sanofi moves, as well as some smart technology Roche has to help track insulin on board without the use of an insulin pump (see HERE) which is already being sold in the U.K. but is pending FDA approval may someday render the present oligopoly J&J has on the U.S. home diagnostics history in the not-too-distant future unless J&J cleans up their act. Besides, J&J has had an unprecedented number of recalls across the company, raising questions in my mind as to whether it deserves my business. Accu-Chek has a genuine shot this time, although depending on what Sanofi does, I make no guarantees on staying with the brand for the entire year.

Anyway, with that, I'm hopeful 2012 will bring fewer healthcare coverage hassles! Wishing my readers similar hassle-free coverage in 2012.

Wayback Wednesday: Holiday-Themed Posts at Scott's Web Log

2011-12-21T22:20:00.007-05:00

One of the things I pride myself on here at Scott's Web Log is that a visitor can visit virtually any post from years ago, and virtually all of the links contained in my old posts still work. I say most because keeping the links "alive" is no small task, especially since I've been blogging since 2005. Although I don't blog as often as I once did (I'm still on Twitter pretty much daily), over time, with the internet being one of the most ephemeral of media, news items move, YouTube videos are taken down, or a news organization that publishes items reorganizes their own website and all their link addresses change. Hence, maintaining the links in my posts is an ongoing effort!

To a large extent, I have come to rely on the Internet Archve "Wayback Machine" which is nicknamed for the time-travel device featured in "Rocky and Bullwinkle" cartoons (which ran on TV from 1959 to about 1973, but were replayed in syndication throughout the 1970s). I elaborated more on that when I told visitors how they could retrospectively visit my recently-departed (see HERE if you missed the news) friend Deb Butterfield's site, and while my original page on that disappeared with free webhosting by Geocities, it remains permanently available, see HERE. Incidentally, while Geocities' days of free website hosting may be history, some of us have discovered that Google presently offers some limited free websites at Google Sites which happens to be where I host my disclosure policy. So for those of you with a desire to build your own website without paying for it, thanks to the Google advertising machine, you can still do so!

Back to the Wayback Machine.

These days, I don't think Rocky and Bullwinkle cartoons can even be found on Cartoon Network's Boomerang cable channel, as kids today seem to prefer computer animation or at least top-rated classics like Warner Brothers' Looney Tunes over the old-school cartoons, but Rocky and Bullwinkle are preserved forever on DVD, and I would imagine are therefore available for streaming via Netflix (although I'm still new to streaming videos having just acquired a Sony Streaming Media Player, so those may or may not be there yet, I'm not certain). Anyway, keeping my all of my links in old posts active is a full-time job, and while I try to stay on top of it,every once and a while, a link stops working. Just know that those are relatively rare when you visit the archives of Scott's Web Log.

Anyway, over the years, I have posted a few "holiday" themed blog posts, and in honor of the "Wayback Machine" noted, I'm referring to today's post as a "Wayback Wednesday" post featuring some holiday-themed posts from years past. Have a look at a few of my former holiday posts (along with some comments I'm adding) here:

Season's Greetings 2008
(Includes some parodies of classic holiday videos)

On a somewhat (marginally?) related note, check out this post entitled "10 Things You Probably Didn't Know About 'A Charlie Brown Christmas' HERE for some interesting things you might not know about the Charles Schultz classic holiday special.

Then, last year, I did this post which I'm still kind of proud of. Re-writing the lyrics to the holiday song "Santa Baby" really stretched my creative imagination!

Santa D-Baby (the D stands for diabetes)

For some more retro stuff, check out the site entitled BetamaXmas.com (Get it? Betamax, the now defunct rival VCR format to VHS from Sony ... a few years from now, readers may even ask what a VCR is/was!) which I learned about from another blog known as GenXTinct.com. More details can be found at their site, which is at http://www.genxtinct.com/2011/12/betamaxmas.html.

I hope to have time to write again before the New Year, but to everyone in the diabetes online community, please enjoy this holiday retro-moment and have very happy holidays!

Dollars for Docs Discussion

2011-11-18T22:45:00.001-05:00

First, I want to acknowledge Ellen Ullman (@CureT1Diabetes) who tipped me off to this event on Google+. Although I might have enjoyed the opportunity to attend this in person and ask questions of the presenters, alas, I had other plans that evening.

My readers may recall that earlier this year (on Valentines Day, no less!), I wrote a post (see HERE) about a new database that was assembled by ProPublica, which is a non-profit corporation based in NYC. ProPublica describes itself as "an independent non-profit newsroom that produces investigative journalism in the public interest". That database is known as Dollars for Docs.

ProPublica senior reporters Charles Ornstein and Tracy Weber, both past winners of the Pulitzer Prize, are the lead reporters on the Dollars for Docs project that examined how pharmaceutical company payments to doctors for consulting, speaking, research and other expenses can have undue influence on the drugs they prescribe to patients. This was a discussion with someone else whose opinion I respect, specifically former editor of the New England Journal of Medicine and author of "The Truth About the Drug Companies", Dr. Patricia Angell. My readers may recall that I've quoted her from a 2007 editorial she wrote for the Boston Globe (see http://bo.st/t9B90w for that) entitled "Taking back the FDA" about how much of the FDA and much of its staff are now indirectly on the payroll for the very industries it is supposed to be regulating. In this video, Dr. Angell speaks with ProPublica senior reporters Ornstein and Weber.

In my opininion, the biggest and most important component of this research was the development of a searchable database that shows over $760 million worth of payments from pharma companies to doctors. Dr. Angell, who teaches in Harvard's Division of Medical Ethics, also wrote a book that explains how "Big Pharma" uses much of their revenue for big marketing campaigns instead of research and development.

In the following video, the trio talk about why pharma makes payments to doctors, whether the new healthcare law might help make these payments more transparent, what patients should ask their doctors about their prescriptions, and who benefits most in the end. I would just paraphrase a relevant paragraph from my original post covering the Dollars for Docs database post that's worth repeating:

Under the new U.S. healthcare law, starting in 2013 [that's next year!], ALL drug/biotech/medical device companies selling products in the U.S. will be required to disclose this data in a public database to be operated by the U.S. Department of Health and Human Services. Let's just call the Propublica "Dollars for Docs" database a sneak peek at what we're likely to see much more of in the next few years.

However, there are legal challenges to portions of this landmark legislation (the healthcare law), and it's popular in some circles to talk about dismantling it, but it's clear that it's not going away anytime soon, even while 26 states try to challenge the law and the federal government. In fact, earlier this week, The New York Times published an infomative article (see http://nyti.ms/rVL7cE) which indicated that although the U.S. Supreme Court agreed to hear a challenge to the 2010 healthcare law, it only agreed to hear appeals from just one decision, which was from the U.S. Court of Appeals for the 11th Circuit in Atlanta, which was the only one so far that struck down the so-called "individual mandate" which obliges everyone to purchase healthcare insurance. The appeals court went no further, severing the individual mandate from the rest of the law, at least for the moment.

Sidenote (you can skip the next 2 paragraphs if you're pressed for time):

This ProPublica discussion with Dr. Patricia Angell took place earlier this week, on Tuesday, November 8, 2011 at 6:30 pm EST in a former tenament that was restored as a museum and public space on Manhattan's (NYC) Lower East Side. The Lower East Side of Manhattan has, in recent years. become a pricey neighborhood (in fact, most of Manhattan is pricey these days, with former areas that were as recently as the 1990's considered, shall we say, dicey becoming playgrounds for the wealthy, complete with the neighborhood's own Whole Foods Market and everything). In other words, the area has gone from dicey to pricey, but was once a storied area of how immigrants once lived in cramped tenements – today's immigrants are more likely to live in places like the Bronx, Queens, parts of Brooklyn as well as parts of Northern New Jersey, having been completely priced out of Manhattan. We may like to think that things are much better for immigrants today, but things aren't really much different today, rather, they have changed form.

Today's immigrants to New York City often live in what appears to be regular housing (such as the rows and rows of two-family homes that characterize the Borough of Queens), but a growing amount of housing stock in these areas has been carved up illegally, which is a big concern in the area I live. I see many old homes around me with an unbelievable number of tenants living there, often with children. In effect, the buyers of these properties have created one or more additional dwelling units within a home without first receiving the approval of, and permits from, the NYC Department of Buildings. Some were formerly 2 family homes have been illegally converted into spaces that now are home to three or more families (see HERE for more). I think of this and compare it to a "whack-a-mole" where you hit one that pops up, and as soon as you do that, another one pops up in another location. But the discussion tenements are digression, other than the tenement museum was the location where the Dollars for Docs Discussion took place.

Back to the ProPublica Dollars for Docs Video

I should forwarn you that you can actually skip ahead about 6 1/2 minutes into the video through all the obligatory introductions in order to get directly to Dr. Angell's speech and the rest of the conversation. In this video, Dr. Angell and the ProPublica producers of Dollars for Docs discussed what they found. The short link to this video can be found at http://ustre.am/:1fbSD:

I will close by once again including access to the Dollars for Docs database HERE:

In all, I think this videocast was an informative discussion. Please, share your thoughts!

The Business of Diabetes: Geron No Mo!

2011-11-15T20:45:00.030-05:00

I hope you'll pardon my title (its supposed to be a pun meant to sound like "Geronimo!", an exclamation used by anyone about to jump from great heights, which I thought was fitting this case). The company conducting the first-ever FDA-sanctioned human clinical trial in the U.S. of a therapy using human embryonic stem cells said that it was stopping that trial and exiting the stem cell business (see http://nyti.ms/rTNktH for The New York Times article on this) altogether. Like many biotech startups, Geron Corp., a Menlo Park, California-based company, isn't yet profitable. While this company helped pay for the initial derivation of human embryonic stem cells at the University of Wisconsin in the late 1990s, which gives it access to some patent rights in the field, like all startups, venture capitalists and shareholders want to see concrete progress and be assured that their investments might actually yield something in the foreseeable future.

Hence, on Monday, November 14, 2011, Geron Corp. announced that, effective immediately, the company would focus on its oncology programs, and pull the plug on any further development of its stem cell programs. However, the company is now seeking partners for its novel stem cell assets. Of particular interest to the type 1 diabetes community is what Geron referred to as pancreatic islet cells (known as "GRNIC1") for diabetes. Geron was granted U.S. Patent No. 7,033,831 in April 2006 covering the production of insulin-secreting cells from hESCs as well as two U.K. patents covering similar production methods. Geron also has a worldwide exclusive commercial license covering hESC-derived islets from the Wisconsin Alumni Research Foundation.

Geron once boasted that not only had it differentiated human embryonic stem cells into islet-like clusters ("ILCs"), but unlike many other previous efforts to culture islets in vitro, Geron also claimed that its (along with its collaborators at at the University of Alberta) ILCs actually secreted insulin in response to elevated glucose levels (meaning they were appropriately glucose-responsive). Many other similar efforts to differentiate stem cells into insulin (and amylin) producing pancreatic beta cells had failed to respond properly to blood glucose levels. The protocol Geron used to to produce the ILCs supposedly involved a series of different cell culture steps that were supposed to mimic the progressive differentiation stages during development of the pancreas in humans (described in the journal Stem Cells in May 2007, see HERE for the journal citation). Other pancreatic cell types resembling those of the exocrine pancreas were also observed during the differentiation process. Also of note is the fact that the protocol supposedly does not utilize serum or feeder cells of any kind. Many others have used feeder cells from mice or other animals, raising questions as to whether cells derived from those processes would cross the line into xenotransplantation, and how regulators might view them as a result.

Geron did NOT receive U.S. taxpayer dollars for its work (nor did it rely upon funding from nonprofit organizations like the JDRF), but the company did receive funding from the State of California for its stem-cell efforts. In May, the California Institute for Regenerative Medicine announced a $25 million loan to Geron to support the spinal-cord injury trial. However, on Monday, Geron reported that the company had repaid the $6.4 million it received for the loan, along with with accrued interest. My readers may recall that the California Institute for Regenerative Medicine was started, in large part, by families with type 1 diabetes. This was discussed in a chat I hosted with the former Vice Chair of the U.S. NIH Stem Cell Task Force Dr. James F. Battey, MD. You may catch the transcript HERE.

Getting back to the topic du jour, many Californians were fed up with the promising field of regenerative medicine research being held hostage by national politics, hence they helped push for the State of California to fund it since the research was being stymied at that time by the Federal government and President George W. Bush's decision to limit Federal funding for the research to a handful of stem cell lines developed by the arbitrary date of his announcement. Although President Obama has since lifted those restrictions, it remains controversial, but California can do what it wishes regardless of who's in the White House (and this was funded specifically by a voted-sponsored proposition hence it's not subject to state lawmakers' whims ... yet). Because of the controversy, it's likely to be funded inconsistently subject to the personal views of lawmakers, which does little to advance the field.

There remains some skepticism among many researchers on the credibility of Geron's lofty claims, in part, because the methods used by the company have not (to my knowledge) been widely replicated by other scientists. The reason for focusing on oncology was that the company concluded that its cancer treatments were the most likely to generate cash soon, and management also expressed concern that capital for its stem cell research would be harder to attain today, so the company is laying off 38% of its relatively small staff to conserve the capital it already has. The Wall Street Journal reported (see http://on.wsj.com/tCmef9) that Geron's decision to exit embryonic stem cell research was due more to financial constraints rather than any scientific setbacks in the emerging, yet still controversial research field.

Roth Capital Partners analysts wrote that it's difficult to predict whether Geron will be successful in finding a partner (or buyer) for the stem cell assets. However, the Wall Street Journal speculated that one potential corporate buyer might be drug giant Pfizer Inc., which in 2008 created a Regenerative Medicine research unit in Cambridge, UK, and earlier this year started a clinical study of a stem-cell therapy for ulcerative colitis (another autoimmune disease). A Pfizer spokeswoman was not available to comment for the Wall Street Journal.

In the Phase I clinical trial which Geron struggled to gain FDA approval for (but was ultimately successful in attaining last summer, see HERE for more), which was for nervous system cells derived from embryonic cells, the cells were being injected into people with severe spinal cord injuries. So far, just four patients have been treated with these stem cells. However, Geron's CEO Dr. John A. Scarlett said there were "no signs" that the treatment was yet helping patients, but he added that was not expected in the early-phase initial trial, which mainly focuses on safety. So far, he said there had been no sign of any safety problems.

Dr. Scarlett also said in the interview with the aforementioned New York Times reporter: "I deeply believe in the promise of stem cells. I don't think that promise [of stem cell therapies] is in any way, shape or form changed by what we're doing" adding that Geron was not divesting itself of the stem cell business because of trial results. Dr. Scarlett, who took over as chief executive less than 2 months ago, said with money scarce, the company decided to focus on its experimental cancer therapies, which are further along in development, adding that Geron needed to conserve resources at a time when it was difficult for small, unprofitable life science firms to raise capital. Geron currently has no products on the market, and would have spent $25 million per year to continue its stem cell program.

There are still a few companies pursuing this research. Another one I've mentioned before is also a California-based company in San Diego known as ViaCyte (formerly known as Novocell). But the soonest ViaCyte's technology would begin human trials would be 2013, which is optimistic.

Some respected diabetes researchers helpedput the status of this field of regenerative medical research into perspective:

Dr. Camillo Ricordi, an islet cell transplantation expert at the University of Miami Diabetes Research Institute told the Los Angeles Times "There was too much hype for this type of technology. There are no shortcuts in this kind of research." But he added "Next century, when you look back at it, two decades won't seem like much. But for those affected right now, every month is too long."

Dr. Gordon C. Weir, a diabetes researcher at the Joslin Diabetes Center in Boston seems to share both the researcher and patient perspective, saying "It's maddeningly simple as a concept. It's been incredibly frustrating that we can't bring this to the clinic more quickly."

Even though skepticism about Geron's technology remains, there also appears to be an opportunity for nonprofit organizations such as the Juvenile Diabetes Research Foundation, the Diabetes Research Institute Foundation where Dr. Ricordi works, and even the American Diabetes Association to license Geron's proprietary stem cell regeneration methods, test them and possibly bring them to trials, which might be preferable to a company like Pfizer buying the assets and keeping them sealed in a vault. I reached out to each of these nonprofit organizations, but none had responded to my inquiry at the time I prepared this posting. Stay tuned for more!

Meet Snowball

2011-10-26T12:15:00.008-04:00

My readers may recall in my last blog post, I touched on the subject of Invisible Illness Week about 2 months after that blog-themed event actually took place. I also shared my rationale for that, by writing: "limiting ourselves to just a week to acknowledge invisible illnesses does a bit of a disservice to the concept, so I theorized 'why not address invisible illnesses some other time?!' (I have the same feeling about No D-Day, which I hope to cover at another time). With that, I decided I would do it when time enabled me to do it, not according to someone else's calendar."

Hence, today's posting: No-D Blog Day 2011 (see HERE for some additional information).

This is one of the few themed blog days I actually look forward to. In fact, a few years back, George Simmons didn't do one and I was one of the individuals who asked him why he didn't do it, and to the best of my knowledge, that themed day has since been continued annually ever since. But I was actually really busy with my aunt and uncle in from Seattle (and I don't get to see them very often), so I didn't get to writing about it on October 7, 2011 -- the "official" No D-Day. It doesn't matter -- in fact, you might actually remember MY posting for No D-Day vs. the something like 40 other No D-Day posts from October 7, 2011! (See, there's a method to my madness!)

Back in January, I wrote about the loss of 17 year-old cat Phyllis (see my post HERE). I really agonized over the decision to have her euthenized, but in hindisght, I know that I chose to put my longtime pet's well-being first over of my own selfish desires to keep her around for just a little while longer while she would have suffered in agony. I don't regret that decision, but it still makes me very sad.

I wasn't in big a rush to get a new cat (or kitten). I had a fairly busy travel schedule ahead of me, and I was still mourning the loss of a longtime pet, so I decided to take a break and maybe look at adopting new pet at a later point in time. I actually waited over 6 months before I even considered getting a new pet.

I really wanted to go the route of adopting a kitten, in part, because they can be trained more easily than adult pets who tend to be much more stubborn (to the extent that any cat can really be trained). I visited a few animal rescue centers including the well-known North Shore Animal League which is based in the town I lived in when I first moved to New York (so I KNEW where it was located) and is billed as the world's largest no-kill animal rescue and adoption organization. I also visited a few other animal rescue and adoption centers in the NYC area. When I visited those, it became painfully evident to me that kittens (and puppies) have little if any problem getting adopted, but far too many adult animals are often overlooked, and sit in cages for months at a time waiting for a new owners. There were a few that had no problem, but there were also some mother cats whose kittens had been adopted while the poor mothers remained in their cages, sometimes for many months.

While that's all very touching and emotional, I wasn't going to take just any ~~fleabag~~feline with a sob story home with me, especially if I have to live with this animal for many years to come. The animal had to be alluring, yet appear to have some kind of colorful personality behind a cute face. Shortly before Labor Day, I visited a local adoption center for another local animal rescue organization and saw a little girl cat known as Snowball. She has very stunning blue eyes (definitely a Siamese mix) with a beautiful, tan, domestic shorthair coat. Snowball was definitely an adult at around 4 years old, but seemed to have a compelling personality.

The weekend before Labor Day, the animal adoption folks interviewed me (they interview adoptive families to make sure the new owners aren't living in squalor), and brought this new cat home to live with me. I learned that Snowball's owner had passed away, leaving her homeless. Fortunately, she was rescued (or taken to a rescue facility) that does not destroy animals, but learned she had been in the adoption center for a while. As I said, kittens and puppies have little problem finding new homes, but adult animals struggle.

Since bringing Snowball home, she has taken some time to get assimilated, and although she's not a lap-cat, she does like hanging out with me and can sometimes get underfoot. She also has some really nice personality traits. Most notably, I bought a special cat bed for her (my former cat couldn't be bothered with those; she slept on my bed, and I was fortunate that she permitted me to do the same!), and she actually uses it regularly. I put it on a chair that's even with the mattress at the foot of the bed, and she seems to like the fact that she can sleep there without me moving my feet and waking her up.

She has also proven to be a very good verminator. Since moving in, she has caught two mice which I didn't even know had moved in with me! Both were baby mice and were really tiny, but Snowball's rodenticidal skills are proving to be a great asset! She is also pretty quiet, although she has definite Siamese vocal skills when she needs them. Each evening, when I get home from work, I hear Snowball at the door excited and greeting me with her voice, apparently excited that I'm home. I don't know how she knows it's me, and not someone else in the building, but apparently, she does! This cat seems to have hidden talents! Meet my new cat Snowball!

A Parallel Autoimmune Online Community

2011-10-11T17:20:00.005-04:00

Back in early September (September 12-19, 2011), it was national "Invisible Illness Week". The theme for 2011 was "Deep Breath, Start Fresh" and the basic idea behind the theme was that sometimes, it's very easy to get caught up in the day-to-day roller coaster of emotions, doctor's appointments and the like, so the organizers hoped to use the week to help remind everyone with a chronic, invisible illness to take care of themselves, and possibly share some healthy ways of actually doing that … but also to try and add some more joy (and even sunshine, hence the logo) into life! Truth be told, I joined Invisible Illness Week late anyway, so I did not really do anything with it at the time, but my feeling is that limiting ourselves to just a week to acknowledge invisible illnesses does a bit of a disservice to the concept, so I theorized "why not address invisible illnesses some other time?!" (I have the same feeling about No D-Day, which I hope to cover at another time). With that, I decided I would do it when time enabled me to do it, not according to someone else's calendar.

So I did not officially "participate" this year as some of my fellow diabetes blogging counterparts did, but shortly before Invisible Illness Week, I did something else. I began following a few individuals with various OTHER autoimmune diseases besides type 1 diabetes. This has been an area of interest for me for a while, and that was how I decided to acknowledge Invisible Illness Week in 2011.

New research suggests that there may be a kind of 'master key' that may help unlock new treatments for many different autoimmune disorders (see HERE for details). Plus, most (except, perhaps psoriasis) autoimmune diseases are actually invisible illnesses, not unlike type 1 diabetes. Hence, my reason for "reaching across the autoimmunity aisle" was because sometimes those of us in the diabetes community tend to view our diseases with a bit of tunnel-vision, almost oblivious to the fact that there are some 80 other autoimmune diseases out there, and I think it's safe to say having those diseases, sucks too! However, I discovered that many of them have a lot of the same issues, complaints and concerns!

A Parallel Universe or Another Earth?

Some of this kind of reminds me of the film that won the Alfred P. Sloan Feature Film Prize (see HERE) at this year's [2011] Sundance Film Festival, specifically a film entitled "Another Earth". Another Earth was a science fantasy/drama film directed by Mike Cahill (and much of it filmed not too far from where I grew up in Connecticut) and starred William Mapother and up-and-coming star Brit Marling. Long story short: the film was about a bright young woman who is accepted into MIT's astrophysics program and aspires to explore the cosmos. Brit Marling's character goes on to discover a duplicate of the planet Earth. I'm including the trailer at http://youtu.be/N8hEwMMDtFY because it's not often that SciFi films are so interesting IMHO.

In the process of following some of the other bloggers with a host of other autoimmune diseases, I realized that there are actually a surprising number of similarities not just in what causes our diseases, but also in how we deal with the day-to-day of trying to live life with a chronic, presently incurable disease. Some of these discoveries I probably should have realized, but just didn't (to be truthful, I sometimes have difficulty understanding what each autoimmune disease is best known for because there are over 80 of them). But the fact is that symptoms of various autoimmune diseases often cross many medical specialties, and therefore affect all body organs, just as in the case of type 1 diabetes. Patients don't just have to deal with specific types of symptoms, but a host of other long-term health issues that are caused by their autoimmune diseases.

For example, were you aware that people with Sjögren's Syndrome are much more likely to suffer from peripheral neuropathy? Or that people with psoriasis are significantly more likely to suffer from cardiovascular diseases (including strokes)? It's true, although unlike diabetes, I usually don't hear people making rude comments at funerals of people with these other autoimmune diseases for their failure to manage their diseases as so many people who don't have a clue what's involved with managing a chronic condition sometimes feel justified in doing when discussing people who lived with diabetes. For that, we can blame the mass media for turning our disease into a short sound-bite. But as you might imagine, regardless of our diseases, we all bitch about insurance companies!

At the same time, most medical education provides would-be doctors with pretty basic learning about autoimmune diseases, and most physicians (including many specialists) are generally unaware of interrelationships among the different autoimmune diseases or advances in treatments outside their own specialty areas unless they have taken Continuing Medical Education (CME) credits on specific topics related to these other autoimmune diseases. In the case of type 1 diabetes, far too many specialists presume they know more than they actually do. Still, most research being conducted tends to be disease-specific and rather limited in scope. More information-sharing and crossover among research projects on all different autoimmune diseases is clearly needed.

Lurking In Other Autoimmune Disease Communities in the Social Media Space

The result of my blog (and Twitter) "lurking" on some of these autoimmune disease bloggers and communities was the realization that there's actually a number of groups that are a lot like the Diabetes Online community (or "D-OC") for people who suffer from, for example, Rheumatoid Arthritis (a.k.a. "RA", or on Twitter typically designated by the hashtag #rheum).

Beyond having created similar social circles of fellow patients who blog about life with RA, many also carry around similar baggage from know-it-all ignoramuses in society (much like those who assume that life with type 1 diabetes is exactly the same as life with type 2 diabetes) who assume that the autoimmune form of arthritis known as RA is exactly the same as osteoarthritis which is commonly associated with aging (for the record, RA is NOT the same as osteoarthritis, just as type 1 diabetes is, in at least a few notable ways, a rather different disease from type 2 diabetes).

Aside from dealing with public misperceptions of their disease, the RA community also has a similar recurring theme we've seen in the diabetes community, specifically the idea of portraying RA patients as "Superheroes" (which we ARE, after all!!).

In the Diabetes Community, catch Chris Bishop's [from the D-OC] more recent post on that topic HERE, some of his earlier iterations of the Diabetes Superheroes can still be found on the Internet Archive (my personal superhero avatar can be viewed HERE), and of course, there's the Diabetes Duo (Captain Glucose and Meter Boy):

One RA blogger has assumed a role of highlighting the RA superheroes (see HERE), although there are not the cool graphics the D-OC has seen in some iterations, but the point behind the listing is similar. What's more, the unacknowledged baggage many people with these other autoimmune diseases are forced to carry around is, in many cases, surprising similar to life with type 1 diabetes. I also discovered there are even a few Podcasts, BlogTalkRadio programs and many people with these various autoimmune diseases who also participated in Invisible Illness Week.

Imagine that ... a parallel universe of people living with other autoimmune-mediated diseases in the blogosphere, on Twitter, BlogTalkRadio, Google Plus, Facebook, podcasting, etc.!

A Need for United Efforts Across the Autoimmunity Community (gee, that rhymes!)

Although there are some umbrella organizations such as the American Autoimmune Related Diseases Association which is dedicated to the eradication of autoimmune diseases and the alleviation of suffering and the socioeconomic impact of autoimmunity through fostering and facilitating collaboration in the areas of education, public awareness, research, and patient services in an effective, ethical and efficient manner. However, IMHO, there's much work remains to be done as far as research coordination (especially with the U.S. National Institutes of Health). One of ARDA's objectives is also too address some common themes impacting ALL autoimmune diseases.

Still other organizations, such as the FAIR Foundation aren't specific to autoimmune diseases, but work for attaining fair and equitable distribution of bio-medical research funds allocated by the U.S. government for ALL diseases, a fair number of which are autoimmune diseases. For example, although the U.S. Federal government will allocate $1 billion to diabetes research in in 2012 according to Government statistics, when one examines how much is being spent for each person with diabetes, it equates to just $42 per patient, compared to an unfathomable $46,890 for each person with West Nile Virus, $4,901 for each person with some form of cancer (including $3,721 for each person with breast cancer specifically compared to $177 for each person with prostate cancer), and $3,047 for each person with HIV/AIDS. Their objective is to change the current budgeting system into one that actually takes into consideration the incidence, mortality, suffering, morbidity, communicability and preventability of each disease, and secondarily, to help eliminate America's organ-donor crisis. (see HERE for references on these stats)

Although a few diabetes non-profit organizations, such as the Juvenile Diabetes Research Foundation (JDRF), have in recent years begun collaborating with research organizations associated with other autoimmune diseases on mutual areas of interest on the autoimmunity front, including the JDRF's partnership with Fast Forward, LLC (which is a wholly-owned subsidiary of the National Multiple Sclerosis Society) in a collaborative partnership with an Italian company known as Axxam SpA to develop new treatments for both autoimmune diseases (multiple sclerosis and type 1 diabetes, see the press release HERE), most of these collaborations are still pretty recent. Because most of these collaborative efforts are still quite new, few have yielded much in the way of progress so far, although these could yield some very important results in the future. Such partnerships are, IMHO, long overdue. Ideally, one might presume that the U.S. National Institutes of Health (NIH) would be coordinating research efforts across diseases with very similar etiologies, but as I hope to demonstrate in the next section, that doesn't seem to be the case.

NIH Autoimmune Disease Coordinating Committee's Absent Participant: NIDDK

To facilitate collaboration among institutes of the NIH, other Federal agencies, and private organizations with an interest in autoimmune diseases, both the U.S. House and Senate Appropriations Committee reports in June 1998 encouraged the establishment of an NIH Autoimmune Disease Coordinating Committee under the direction of the National Institute of Allergy and Infectious Diseases (NIAID).

Ironically, you might be surprised to learn that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) responsible for diabetes research has committed few dedicated resources to the autoimmune disease coordinating committee except when it's been required to do so by law. There is NOT a dedicated NIDDK representative on this committee. We can probably thank the Special Statutory Funding Program for Type 1 Diabetes Research which dedicates substantial taxpayer dollars to research on the topic of autoimmunity for almost all of the NIDDK's involvement to date.

The Special Statutory Funding Program is a very unique appropriation that the NIDDK administers on behalf of the Secretary of the Department of Health and Human Services, in collaboration with multiple NIH Institutes and Centers and the CDC for research on the prevention and cure of type 1 diabetes in the amount of $1.89 billion for Fiscal Year (FY) 1998 through FY 2013. However, beyond that appropriation, there is now some evidence to suggest that type 2 diabetes may actually have an autoimmune basis (see HERE).

New Data Also Suggests Autoimmunity in Type 2, Albeit With Different Immune Response Targets

The immune response in type 2 diabetes does not specifically target insulin or the islet cells as is the case with type 1 diabetes. In type 1 diabetes, autoreactive T cells targets insulin and other normal, "self" beta cell proteins as if they belonged to dangerous microbes, whereas in type 2 diabetes, the immune response involves two different types of immune system cells, specifically T cells and B cells in addition to macrophages. In other words, individuals with insulin resistance would NOT test positively for ICA's (or islet cell antibodies) — one of several different lab tests that may be done to confirm an appropriate diagnosis of autoimmune-mediated type 1 diabetes, but the research does suggest that people with insulin resistance actually DO make antibodies to a select group of their own proteins which sets off a cascade of metabolic abnormalities.

This logically suggests that type 2 diabetes may also have an autoimmune basis as well (see the April 17, 2011 scientific/medical journal Nature Medicine for more background on that). Hence, although interventions and/or treatments to induce self-tolerance might be different for type 1 and type 2 diabetes, because both diseases have an inherent interest in autoimmunity, it's logical to presume that the NIDDK would have a permanent member with some leadership role on the Autoimmune Diseases Coordinating Committee.

That presumption would be mistaken.

The closest representation we have was revealed in the National Institute of Allergy and Infectious Diseases' (NIAID) Autoimmune Disease Coordinating Committee's 2005 report to Congress (see HERE), yet in the staff bio (see HERE) for Dr. Stephen P. James, MD who is cited as the NIDDK's committee participant, there is no mention of the Autoimmune Disease Coordinating Committee as part of his "Current Portfolio/Responsibilities" or under "Committees/Working Groups" he works in, or in "Other Activities" listed among his duties. This suggests he is NOT a permanent NIDDK participant on this important committee. Yet he was rightly chosen because he has the most experience within the NIDDK in issues pertaining to autoimmunity.

My response was: WTF is going on here?

In other words, the NIDDK does NOT seem to have permanent membership on this seemingly important committee, especially since the NIDDK has interest in autoimmunity for BOTH type 1 AND type 2 diabetes, but NIDDK management has literally had to be forced (by law) into participating.

NIDDK & Autoimmunity Coordination: Only When the Law Requires Our Participation

Federal records indicate that although the NIDDK is obliged to have some representative on the Cooperative Study Group for Autoimmune Disease Prevention (CSGADP) efforts and a handful of other programs and committees, each meeting's attendance from the NIDDK has been a completely different individual. Even more WTF? from my perspective!

In fact, it appears that because the NIDDK is required by the Special Statutory Funding Program for Type 1 Diabetes to have representation on the Cooperative Study Group for CSGADP within the NIH that may very well be the ONLY reason the NIDDK even bothered to send someone to these meetings. The NIH autoimmune disease prevention effort was established in 2001 as a collaborative network of investigators with a focus on prevention of autoimmune disease, defined as halting the development of autoimmune disease prior to clinical onset by means other than global immunosuppression, and a particular emphasis on type 1 diabetes.

Indeed, I think it's safe to say that it’s only because of the Special Statutory Funding Program, which enables the creation of unique and collaborative research consortia and clinical trials networks focused on the prevention, treatment, and cure of type 1 diabetes specifically, that NIDDK even participates.

Why?

The bigger question we should be asking is whether the NIDDK the leadership considers autoimmune research something that is even core to the institute's mission?! I blame the current leadership for this lack of involvement. Here again, we see that the person running the NIDDK is a long-term bureaucrat (albeit a person who is a medical doctor), Dr. Griffin P. Rodgers. One might presume that the man running the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to be, oh I don't know, maybe a person who's an endocrinologist, a gastroenterologist or perhaps a nephrologist?

No!

Dr. Rodgers is, by training and Board Certification, a hematologist (in other words, he's a blood doctor). The previous Director of the NIDDK, Dr. Allen M. Spiegel, was logically a Board-certified endocrinologist. While all medical doctors have a basic understanding of the various body functions and disease, is it really that difficult to find someone with training in diabetes, digestion or the kidneys to run the organization known as the National Institute of Diabetes and Digestive and Kidney Diseases?

Apparently so.

Although the layers of government bureaucracy are deep, Dr. Rodgers is in my opinion, not the most appropriate selection to run one of the world's largest funders of diabetes and kidney research since his knowledge is really not much deeper than that of many family doctors. This is an appropriate question to be asking your lawmakers in Washington the next time you reach out to them for some other advocacy issues pertaining to diabetes.

While I would welcome comments on this topic, getting back to my parallel universe theme, I plan to reach out to some of the other autoimmune disease bloggers I've connected with since Invisible Illness Week because their stories are actually very interesting, and there may be opportunities for the Diabetes Online Community to collaborate with them on different areas of mutual interest. I hope you will return for my next posting I do on this topic!

Puncture (The Movie) Starring Chris Evans

2011-10-06T12:00:00.003-04:00

Over the years, there have been a handful of groundbreaking movies that address a variety of topics of interest to people within the diabetes community. For example, there was "Supersize Me" (2004) and "Fast Food Nation" (2006) which addressed how obesity is frequently driven by the prevalence of fast food. However, many people never patronize fast food joints, although these films did help pave the way for more critical exposes of the nation's industrial food supply system and its adverse effects on the nation's health. King Corn (2007) addressed issues with America's most overly-subsidized food crop and the adverse effects it has on such unrelated areas like beef production today, or Food, Inc. (2009) which shed light onto our less-than-pretty industrial food supply system, and of course, Michael Moore's SiCKO addressed the fact that not only does the U.S. have the world's most costly healthcare system, but we also have the highest percentage of individuals left completely out of this system thanks to runaway costs and non-universal insurance coverage (although the Patient Protection and Affordable Care Act should help to address that major hole starting in 2014).

On September 23, 2011, another movie called "Puncture" opened in select cities, and is expected to open on a national basis this weekend. As Metro NYC described it: "At first blush, the words 'health care industry' and 'thriller' seem like two terms that should never be in the same sentence together." In essence, the movie is loosely based on the true story of two struggling young lawyers, Michael Weiss and Paul Danziger, who were hired by an eccentric inventor/manufacturer to find out why he couldn't sell his remarkable, lifesaving safety syringe to U.S. hospitals. The real case was actually settled before trial for $150 million dollars.

It began when a nurse who, while dying of AIDS due to an accidental needle stick went to two lawyers proposing a lawsuit. The accident could have been avoided if the hospital carried safer, single-use needles with protective sheaths. But hospitals refused to carry the device because of their long-standing relationships with big medical device suppliers brokered by so-called group purchasing organizations (GPOs).

In the process, the film reveals that in order to sell to many big hospitals, startups have to effectively bribe GPOs with financial kickbacks to hospital bigwigs which enables the existing suppliers to basically keep other suppliers out of the hospital supply chain altogether. In fact, the inventor of the new device was barred from even showing it to hospital purchasing agents. The lawyers discovered a very corrupt arrangement between monolithic hospital purchasing cartels and a big needle maker, in which the industry giant was able to pay millions in kickbacks to the cartels to make sure its less safe products — and only its products — were used in hospitals. They also found that these cartels, known as hospital GPOs, effectively blocked the introduction of all kinds of innovative medical products, not just syringes, costing the U.S. healthcare system over $37 billion each year. For the record, Metro NYC also reports that GPOs are now a $100 billion/year business in the U.S. today.

I have not seen the film personally, but with a cast including "Captain America" hottie Chris Evans who plays character Michael Weiss (who's character is actually a drug addict) and Mark Kassen who plays Paul Danziger, this film might be worth seeing, and on a broader level, revealing how much business is really transacted in the U.S. today, painting a slightly different picture than politicians would have us believe, and raising new questions about just why healthcare in the U.S. remains so incredibly expensive.

Check out the movie trailer at http://youtu.be/9wLQCOqzLv4:

The Business of Diabetes: Biodel Linjeta Update

2011-09-27T21:45:00.003-04:00

It's been some time since I posted a "Business of Diabetes" update, so today's post is probably overdue. Today's subject is particularly timely since Dr. Errol De Souza, President and CEO of Biodel, Inc., presented this morning (see the presentation deck HERE) at 8:30 AM EST at the 6th Annual JMP Securities Healthcare Conference at the St. Regis Hotel in New York. My experience has proven that a fair number of presentations made at similar investor "events" like these can quite repetitive (for example, if a company presented a month earlier for another investment bank, whether its Morgan Stanley, Goldman Sachs, JPMorgan, Sanford Bernstein, Credit Suisse, Jeffries or any of the others), many presenters are already very well-rehearsed and prepared for questions. This means that often, they may simply re-present the same content, making the Q&A that follows their actual presentations the main point of differentiation (sometimes you can listen to these online, but not always). Still, I always try to review the content from these events when time permits because there may be occasional nuggets of interesting information that are shared. However, we can expect more detail from rivals including Halozyme Therapeutics made tomorrow at the same event.

Truth be told, I already reviewed this morning's JMP Securities Healthcare Conference presentation, and there really wasn't much in the way of new news that wasn't already in the public domain, but my readers may not be aware of where things stand, so if you're interested, you can view the webcast for about the next month by visiting Biodel's investor relations site HERE. I will address the most salient points that people with diabetes may want to know about in this post.

Taking a quick step back, my readers may recall my POST from early 2010 in which I addressed a number of startups eager to stake a claim in the multi-billion dollar insulin market (notably, rapid-acting "prandial" insulins is now approaching $5 billion per year, so there's VERY big money involved). A fair number of the startups I wrote about experienced delays (all for different reasons), one of which was Biodel, Inc.'s Linjeta™ [formerly known as VIAject] which is the subject of today's post and was the first to seek regulatory approval. The other was MannKind's Afrezza® which I will not really address in today's post. Both experienced some delays with the agency many (most?) of us love to hate (although a few of us dislike them for entirely different reasons!): the U.S. ~~Fatal~~Food and Drug Administration.

However, in both of the aforementioned cases, I think it's safe to say that the delays were pretty much the fault of the companies that were seeking product approvals (see HERE for my update on Linjeta). When former FDA Chief Andrew von Eschenbach ran the agency, I don't believe either would have been delayed, but his leadership (thankfully) is history now. Under Andrew von Eschenbach's leadership, the FDA's staff was instructed that the FDA should not be viewed as an agency to protect the public health per se, but an agency to serve the needs of the industries the agency regulated (especially since most of the funding for the FDA now comes from user fees paid for by the drug, biotech and medical device industries except in the case of generics, which are incredibly backlogged) and that the FDA should be working to address the needs of these "clients". While that was good for pharma, and user fees did fund a lot of FDA staffing, the biggest beneficiaries of those fees were pharmaceutical/biotech/med device companies, although few lawmakers seem to agree this means the FDA is on pharma's payroll even though they pretty much are. Fortunately, under the leadership of Margaret Hamburg, the agency is returning to its mission of actually trying to protect the public health. While many complain the FDA has moved too far on the side of caution, especially in comparison to other regulatory agencies around the world such as the European Medicines Agency, I'll reserve judgement on that when I have the benefit of hindsight! Let's just be glad we don't have evidence of recent approvals for truly dangerous drugs like Vioxx or Avandia (so far, anyway) that were approved while Dr. von Eshenbach was still on the FDA's payroll.

Still, more than a year has passed since I wrote my original post on startups in the insulin field, and I think its time for an update on at least one of them since details are finally in the public domain. So today, I'll cover the product that applied for FDA approval first: Biodel's rapid-acting Linjeta insulin formulation.

Where Things Stand Today

On Tuesday, August 16, 2011, the insulin startup Biodel, Inc. presented (see HERE for the presentation) at the Wedbush Securities' 2011 Life Sciences Conference in New York. Although I did not attend, the presentations themselves usually appear on each of the presenters' investor relations department (at least for those companies that are publicly-held) shortly after these events take place, so I try to read through these for clues on where things stand. Typically, more is revealed there than will EVER come from the FDA itself (another practice which I'd like to see change to look a bit more like Europe, but I digress ...).

My experience has proven that a fair number of presentations made at similar investor "events" like these can quite repetitive (for example, if a company presented a month earlier for another investment bank, whether its Morgan Stanley, Goldman Sachs, JPMorgan, Sanford Bernstein, Credit Suisse, Jeffries or any of the others), many presenters are already very well-rehearsed and prepared for questions. This means that often, they may simply re-present the same exact content, making the Q&A that follows their actual presentations the main point of differentiation (sometimes you can listen to these online, but not always). Still, I always try to review the content from these events when time permits because there may be occasional nuggets of interesting information that are shared. I actually found quite a bit of information about Biodel, Inc., so today, I'm sharing a few of those take-aways as an update.

For Biodel, since the FDA move to delay its decision on Linjeta™ earlier this year, the news has been quiet as the company addresses the FDA concerns and prepares for worldwide commercialization. I should note that Biodel's rapid-acting insulin formulation, unlike ALL other competitors on the market today, is NOT a genetically-modifed, man-invented insulin-like molecule that is commonly referred to as an insulin analogue, but regular biosynthetic human insulin which has been made faster than today's analogues thanks to some proprietary technologies (in theory, the same technology could also be applied to old-fashioned highly-purified insulin formulations sourced from abbatoir animals rather than using agars derived from abbatoir animals used in making biosynthetic human insulin and its analogues, thereby making them faster than today's analogues if the company ever chose to offer such a thing -- unlikely, but the point is that the technology makes even old-fashioned insulin varieties work a LOT faster).

Of course, Linjeta is reportedly only slightly faster (we're talking a few minutes faster here: Linjeta starts to work in about 8-18 minutes (8-13 minutes for the formulation used in the company's new drug application with the FDA) compared to about 25 minutes for most of today's rapid-acting analogues, and about 45 minutes to an hour for regular insulin. Whether that's enough to convince insurance companies to pay for it remains to be seen, but Linjeta differs because the way it accomplishes this is not be altering the insulin molecule itself via genetically modification, although as Close Concerns once said, "in this business, time is money". I have long suspected the company viewed Linjeta as an interim product that could be marketed very soon, but sees the real opportunity to get insurance coverage for their product by making today's analogues slightly faster using their technology, which is patent-protected making Biodel itself potential acquisition bait for a big pharma company like Lilly, Novo or Sanofi. At least one analyst has already gone on record as saying Sanofi is a likely buyer because even though its Apidra rapid-acting analogue still enjoys several more years of patent protection relative to Humalog and Novolog, what insurance company will pay a premium for it when generic versions of the other product are expected to become widely available? This means aquiring Biodel may protect its products (and give them some technology for Lantus as well ... see HERE. The other firm he discusses is Halozyme, but that company is slightly behind Biodel from a development standpoint. He has a valid point.

About Biodel and Linjeta™: How It Works Differently From Today's Analogues

Biodel makes regular insulin faster than today's analogues by removing zinc ions via EDTA, which destabilizes the hexamer of insulin; then by adding citric acid (you know, the stuff found in many powdered lemonade formulations which makes them taste "tart") which also happens to masks surface charges on insulin monomers, which in term prevents re-aggregation and facilitates more rapid absorption into the bloodstream (wow, that's a run-on sentence, but I make no apology for it!). EDTA stands for ethylenediaminetetraacetic acid (which is a real mouthful, hence the acronym is more widely used), and its a compound of amino carboxylic acids that's water-soluble. It is used in various drug and biotech medicine manufacturing to bind to metal ions in order to remove these metal ions from various drug formulations which contain them -- I guess one could liken this to a magnetic substance that removes the traces of zinc from the the insulin protein (note: its not really magnetic, but I thought the analogy made sense in this case).

Note that zinc has long been associated with insulin. In fact, before the days of geneticially-modified insulin analogue formulations such as Lantus and Levemir, zinc was widely used as an additive to delay regular insulin's action in Lente (meaning Lente and Ultralente) formulations, hence Lente is known generically as "insulin zinc suspsension", but even in non-Lente formulations (particularly in regular insulin, as well as in virtually all analogues), tiny zinc ions remain. These ions are one reason it takes regular insulin so long to be absorbed into the bloodstream.

Technology issues aside, the company (Biodel, Inc.) is now completing a small, additional study in order to resubmit Linjeta for FDA approval. I would describe as follows: to compensate for their botched human clinical trial in India which was supposed to save the company lots of money, but the actual cost savings were nothing more than a mirage, and they would probably would have been better off just doing the entire clinical trials in the U.S., Canada and Europe, but I digress. Of course, this company (as well as the established players) bitch and moan that using regular insulin means it's tough to recruit participants in their rapid-acting insulin trials and are trying to convince the FDA that future trials should be against rapid-acting insulin analogues like Humalog/Novolog/Apidra. I don't agree about that is appropriate, but they are lobbying hard to make that the case, and in Biodel's case, for the newer, fix-up version they're now trialling, they've already proved Linjeta is comparable to regular with the first trial, hence the fix-up trial is a quickie that can be done against Humalog instead of regular because they've already established it's comparable to regular, hence fix-up trial was able to recruit faster against Humalog. Slippery slope? You be the judge on that.

While that's gone on, the company also hired a new CEO named Errol De Souza who I noted above was giving this morning's JMP Securities Healthcare Conference presenation (Solomon "Sol" Steiner who was the CEO since the company's inception in 2003 was Chief Scientific Officer for a period, but he retied late last year and is still on their scientific advisory board ... FYI, Dr. Steiner previously worked for another startup company that was once known as MiniMed, Inc. if that tells you anything, and Dr. Steiner also remains on Biodel's Board of Directors). In addition to Biodel's lead product candidate Linjeta, they also have not one but TWO long-acting insulin formulations, one being an extended version of Lantus, and the other is perhaps more compelling (in my opinion) since it enables adjustment of just how long the basal insulin product will actually work, because not all patients need or want 24 hours of basal coverage, nor do they want a pump device attached to them at all times (or they simply cannot afford such a device). Although Novo Nordisk's Levemir is a competent 8-10 hour insulin formulation, most doctors view it as less appropriate for many patients with diabetes than Sanofi's blockbuster Lantus unless the patient needs less than the typical 18 hours of basal coverage offered by Lantus (few believe either lasts 24 hours as both are advertised to) even though the basal needs vary widely from patient-to-patient.

The primary patent for Lantus expired in 2010, although various other patents will remain in place until 2014 (which is right around the corner in pharma-speak), plus Biodel also has a "stablilized" glucagon analogue now in development (one which would not need to be reconstituted prior to use). While it might not be available soon enough to compete with Enject's GlucaPen [http://www.enject.com/] for hypoglycemic emergencies (that's not yet approved, either, but since it is a device for delivery of an already-approved drug, the FDA review and approval process is likely to be faster ... knock on wood!), and if it gains approval, it could be used for that as well as in a bi-hormonal pump which have been studied in a few clinical trials and have provided patients with superior glycemic management and added security).

So where do things stand with Linjeta Today?

1) Tweak the Formula of Linjeta to Ensure Injection Site Discomfort Matches Competitors

First, Biodel is making some slight changes to Linjeta which company management believes will help it's finished product sell better. To quote this morning's presentation: "It is prudent to incur the marginal cost and time delay to move forward with a new formulation(s) to optimize the product's label." Specifically, a fair number of patients in the clinical trials for Linjeta complained of an annoying "stinging" or "burning" sensation following an injection of Linjeta, and that incidence was higher than with existing insulin analogues. While the stinging was not sufficient to deter continued use of Linjeta in the trial, the company believes it is nevertheless prudent to incur the cost and time delay the ultimate introduction slightly in order to move forward with a slightly modified new formulation(s).

Specifically, the pH of Linjeta used in clinical trials was around 4; most other insulin analogues are closer to zero, so the new formulations will have a "neutral" pH, which the company has data showing will reduce injection site discomfort. What's behind the injection site discomfort? The company believes it is caused by the EDTA used to remove the zinc ions, so the company is now undergoing trials with either calcium disodium EDTA or disodium EDTA + calcium, which it believes reduces injection site discomfort, as both had significantly reduced injection site discomfort in other studies.

In other words, the company wants the launch version of Linjeta they plan to market to be fully comparable to the alternatives as far as injection site discomfort. These changes have delayed the finished product from going to market slightly, but are likely in the best interests of becoming a true competitor in the field. Also, the delay is marginal, because it can be class 2 resubmission, which the company expects will result in a 6-month review time, and is already being reviewed by the FDA now.

2) Trials To Position Linjeta Against Humalog and In Insulin Pumps

Beyond that, Biodel has also undergone some additional clinical trials against Humalog (insulin lispro rDNA origin) and also in insulin pumps, so the product will be ready to market in all scenarios current competiton can. In other words, if trials against Humalog work as anticipated, then Linjeta can advertise that it works better than a key analogue competitor, and the pump trials will enable Biodel salespeople to promote its use in pumps (rather than an off-label use as many analogues were promoted initially; in recent years the FDA has cracked down on off-label promotions for drugs). Neither is a big deal, since doctors can prescribe most drugs for uses that are not specifically approved, but having these studies will enable Biodel salespeople to promote this insulin in a manner that is consistent with this insulin's label. Personally, I don't see this one as really necessary because every endocrinologist I've ever seen prescribed insulin analogues "off-label" (meaning before they had approval for use in insulin pumps), and I would not expect anything different with Linjeta, but they're doing the trials anyway, which will enable the products to be marketed -- legally -- for use in insulin pumps.

Both of these items should position Linjeta to be promoted from almost the minute it is approved head-to-head with its key competitors. However, a word of caution for anyone who is thinking of investing in Biodel: note that while these moves are smart business moves, the party may not last long, because the new healthcare law mandates that the FDA outline a way for "follow-on" versions of biotech medicines including insulin analogues. As Medco's CFO (although an offer to acquire Medco was recently made by rival Express Scrips) believes we will see generic versions of Humalog, Novolog, and Lantus by 2015, see my post on that HERE for details), and it's been written into a law that's been on the books for over a year now and the FDA is due to release guidelines for follow-ons anytime according to the press. This means we may FINALLY see follow-on versions of various insulin formulations in the next few years, which I see as a big threat to the oligopoly Lilly-Novo-Sanofi have enjoyed for the last 30 years. Although I still have concerns about follow-ons (or "biosimilars"), my belief is that the world will ultimately be a better place when the choices for patients are expanded ... provided the choices are made by patients and their doctors, not penny-pinching insurance companies.

Challenges Ahead

Biodel is on record (in one of the company's SEC filings, though I don't recall which one) in noting to investors that "since Biodel started the Linjeta program in 2005, Sanofi, Novo Nordisk and Halozyme have all announced programs or active in-licensing efforts in the ultra-rapid-acting insulin space" (although truth be told, Halozyme has been planning to enter this space via partnerships for quite a while). Nevertheless, it may be a challenge to gain traction in this market with insurance companies growing increasingly penny-pinching, but company management appears cognizant of what they're up against. Some analysts believe that many biotech startups in this space would likely be acquisition bait for companies like Sanofi Aventis, which faces patient expirations on its key insulin products Lantus and Apidra but lacks much to protect this franchise thanks to their own lack of investment in it (I already noted this, but again, you may refer to that article HERE which positions these both Biodel and Halozyme favorably to be acquired by the company. That remains to be seen, but these companies are eager to have a slice of the growing worldwide insulin market.

However, in today's presentation, just as I suspected, the very same technology used in Linjeta is also planned to expedite today's rapid-acting analogues to make them slightly faster -- most likely when the patents expire beginning next year. However, we shouldn't expect this to deliver significant speed increases (like those we see with regular) given that these molecules are already genetically-modified to prevent the insulin molecules from forming hexamers which delay absorption because the hexamer must equilibrate back into monomer form in order to bind to the insulin receptors. Most likely, this will enable the company to gain insurance coverage which could be a more difficult sell for today's version of Linjeta, although there is no doubt the company will work to make that happen, too. After all, it will be a few more years before they can market more rapid-acting analogues, and the company will need to start generating revenues if investors have anything to say about it.

Bottom Line: (sorry, this one isn't a link) The steps needed to gain regulatory approval are already well underway, although the commercial launch of Linjeta may be delayed slightly to make the finished product more marketable. Biodel expects be able to sell a slightly less "painful" version of Linjeta upon approval, and also expects to have approval to market this insulin for use in insulin pumps from the get-go. New management is very experienced in working with the FDA and has revealed that the FDA does not expect further delays once the fix-up trial results are ready. Biodel management also seems quite confident in their strategy, and has secured additional funding to keep things moving. What's more, because the company has a considerable scientific staff in Germany, we're likely to see it launch pretty much concurrently in both the U.S. and Europe barring any unforseen (and nondisclosed) issues. If I had to guess, I would say we could see an FDA New Drug Application (NDA) decision by early 2012, and we can anticipate they will be ready to start marketing Linjeta very shortly thereafter (remember, the company outsources the actual manufacture of rDNA insulin to Merck's Organon unit, and a few other subcontractors including Albany Molecular Research/Hyaluron who manufactures the vials they will use for Linjeta and and Wockhardt Ltd. who makes the insulin pen they plan to sell [after a few unnamed modifications Biodel made to the product design which I am guessing is to enable 1/2 unit dosages) and these suppliers are already being reviewed for approval by the FDA as I write this.

Tribute to "Showdown With Diabetes" Author Deb Butterfield, 1960-2011

2011-09-07T20:50:00.012-04:00

It is with tremendous sadness that I share news of the passing of a true pioneer within the diabetes online community, Deb Butterfield who authored the diabetes memoir "Showdown With Diabetes" back in 1999. Deb is someone I considered a friend, and she was also a role model to many of us in the earlier days of the Diabetes Online Community. According to Bermuda's Royal Gazette, she died on August 26, 2011 after a long illness near her home in St. Louis, MO. Deb was age 51, and she is survived by her husband Tom Wendel and their two daughters, as well as several siblings.

Deb Butterfield (Deborah Darrell Butterfield), author of "Showdown With Diabetes" (see also http://goo.gl/WptSl)

1960-2011

Deb Butterfield was diagnosed with type 1 diabetes in 1970 at age 10. After receiving a Bachelor of Arts in Economics from the University of Colorado, Deb worked for an executive search firm in New York City before starting her own consulting practice specializing in recruiting and strategic planning for financial brokerage firms in New York and London. But from 1992 to 1994, Deb's career was interrupted by the secondary complications of diabetes and a failed kidney and pancreas transplant. In 1994, she had a successful kidney and pancreas transplant. She used her experience as the basis for a memoir she wrote entitled "Showdown With Diabetes" which was published by W. W. Norton & Company in 1999.

Although Deb and I had never met face-to-face, I felt a kinship with her because we both viewed diabetes management and the state of diabetes research the same way, and we spoke by telephone a number of times over the years, as well as exchanging holiday cards. We hadn't spoken in a while, but I was asked by someone if I could facilitate an introduction, so I e-mailed Deb but never received a response. I presumed she had changed e-mail providers, so I called her home phone number and Deb's husband Tom gave me the sad news that Deb had recently passed away.

Deb was a true pioneer in the diabetes community in a number of different ways. Her autobiographical memoir "Showdown With Diabetes" was one of the first-ever memoirs written by a person who has actually LIVED with diabetes themselves, rather than yet another repetitive tome by yet another so-called diabetes scholar who has never lived a single day of their existence with the treatment plans they are prescribing for patients. Even more important (in my opinion): Deb's book called for a fundamental shift in the way the diabetes is viewed by the establishment. She once wrote:

"In order for this disease to be cured, there needs to be a fundamental shift in the way diabetes is viewed. We need to close the gap between the perception of diabetes as a controllable condition and the reality that it is one of the world's oldest, deadliest, and most pervasive diseases."

Deb spoke very competently, eloquently and authoritatively on these views, and as a result, she was respected by doctors and researchers in the field, hence she was able to forge relationships with many of them for her charitable venture.

For example, in May 2000, former President and CEO for the Juvenile Diabetes Research Foundation (JDRF) International Peter Van Etten wrote a BOOK REVIEW of "Showdown With Diabetes" on Amazon.com, in which he gave the book 5 stars out of a maximum of 5, and he had this to say about Deb and her groundbreaking book:

This review is from: Showdown with Diabetes (Hardcover)

"Of all my readings, none was as important as your book"
By Peter Van Etten

Before a few months ago I did not have a detailed knowledge of diabetes, although I have worked for academic medical centers for over twenty years.

I did a good deal of research when I was asked to consider the position of President and CEO of the Juvenile Diabetes Foundation. Of all my readings, none was as important as Showdown with Diabetes. Most important of all, it enabled me to understand the passion for a cure that has driven JDF's volunteers and staff for over 30 years.

Thank you Deb for sharing your experiences. I hope that, in my new position, I can help to accomplish the goals you have so articulately described in Showdown with Diabetes.

With the proceeds from "Showdown With Diabetes", Deb (and her husband) pioneered something else: in 1996, she founded the nonprofit Insulin-Free World Foundation, and in 2000, she co-founded "DiabetesPortal.com", the showcase of which was one of the earlier iterations of diabetes online communities. One of the most-fondly remembered aspects of that online community was something that was known as "DiabetesStation.com" which featured online 'chats' with an unprecedented number of luminaries from the diabetes research field as guest stars (including a few before they became diabetes "celebrities" such as Dr. Denise Faustman of Harvard University/Massachusetts General Hospital).

DiabetesPortal also published a quarterly, online magazine known as "Insulin Free TIMES" (archives can still be found HERE). Unlike most of the superficial content produced for patients that was available previously, Deb believed that patients with diabetes were intelligent enough to speak and read about the science as well as ask questions directly of researchers in the field. No organization has since assembled such an impressive roster of guests that patients could interact with directly, the schedule was packed with online chats several times each week.

Deb was also a leading advocate for pancreas transplantation, the only surgery that actually DOES eliminate a need for exogenous insulin in patients with type 1 diabetes. Unfortunately, few doctors will EVER discuss this surgical option with patients, believing that immunosuppressants are somehow worse than a lifetime of insulin replacement therapy. Of course, that doctrine is not always the case for patients with some crippling side-effects of insulin replacement therapy, such as hypoglycemia unawareness, yet few ever speak with patients about the option of pancreas transplantation as a treatment alternative to insulin, hence one of Deb's objectives was to change that paradigm, and to a large extent, she succeeded in doing just that.

A few years ago, Deb lost her transplanted pancreas and was again on the registry for a new pancreas, but my sense was that her own health issues kind of took a back seat to a new joy she found in raising her two daughters (as well as being the wife to her loving husband Tom), something she described to me as the life she once thought that she'd never be able to enjoy. She sent me a few photos and wrote:

"I am so happy to be living a life in my 40s that I dreamed of in my 20s and never thought I could have! I've attached two pictures of my daughters ... there are not words enough to tell you how much joy they have brought us."

Today, heart goes out to Deb's family, and I can only hope they realize how enormous her legacy is within the diabetes community. Her presence will be felt for a long time to come even though Deb is no longer with us. In fact, Deb was the individual who encouraged me to start blogging when that was still a brand-new phenomenon, and there are a number of others who did the same thing. Whether Deb had the foresight to realize it at the time, an entire group of like-minded individuals who were blogging about diabetes emerged to become what is today sometimes referred to Diabetes Online Community (or "D-OC" or even "DOC"). I owe a tremendous debt of gratitude to Deb for shattering the invisible wall I once felt separated diabetes researchers from patients, and for that, I am eternally grateful.

P.S.: For those who are interested, I've added a memorial page for Deb at: http://ourdiabetesmemorial.com/Memorials/Deb_Butterfield.htm

Incidentally, Deb's site formerly hosted a memorial, and some of those were very moving. The archives for that can be viewed on the Internet Archive using this URL (or you may simply click on the link below):
http://www.insulin-free.org/memorial/memorial.htm

Connecticut Screwed Patients With Chronic Diseases Yesterday

2011-08-25T11:56:00.001-04:00

Yesterday, the state of Connecticut made news on the new healthcare law that requires states to create exchanges where insurance plans can be purchased when the requirement to buy healthcare insurance goes into effect in 2014. But the reason the state made news is not for a good reason: the State of Connecticut effectively screwed its residents by ignoring a requirement in the Federal laws that requires that there be a CONSUMER REPRESENTATIVE on the Connecticut insusrance exchange. Insurance exchanges must be in states which have not opted out of the law (and that includes Connecticut) established to offer state-regulated and standardized health care plans, from which individuals may purchase health insurance plans that are eligible for Federal subsidies when they required by Federal law to do so in 2014. The exchanges are the quasi-public authority that govern these insurance exchanges.

Let me go on record as saying that Connecticut is no red state. To cite a rather vivid example: same sex marriage has been legal in Connecticut since 2009, and there were never protests of angry citizens marching in the streets arguing to stop it. In fact, after the courts determined that prohibiting same sex couples in Connecticut from receiving a marriage license was a blatant violation of the state Constitution's guarantee of equal protection under the law (the judge wrote "The Connecticut Constitution requires that there be equal protection and due process of law, not that there be equivalent nomenclature for such protection and process"). After that, the only legislative debate that really occurred was over a rule which exempted churches and other religious institutions from being required to facilitate same-sex marriages (the State does not require religious institutions to perform same-sex marriages, but a Town Clerk may not legally deny a same sex couple a marriage license because of his or her personal religious beliefs since they are civil servants on local government payrolls, they are NOT workers for private religious institutions, hence they are not permitted to let their personal beliefs interfere with doing their jobs). Socially, the state (which is sandwiched between New York, Massachusetts and Rhode Island) is of the "live and let live" persuasion; which means keep your nose out of our personal business, and you can expect the same courtesy in exchange.

A majority of citizens in Connecticut voted for President Obama, and surveys also show overwhelming support in the state for the The Patient Protection and Affordable Care Act (PPACA) which became law last year. Yesterday, the list of members of the Board of the Exchange for the State of Connecticut were revealed (see HERE), and many people with chronic illnesses in Connecticut were justfiably p!$$ed off. The reason: there is NOT ONE single consumer representative is on the exchange right now -- not one, yet Federal law actually requires that a consumer representative be on the exchange board. As Connecticut lawmakers selected the exchange members, they staffed the board exclusively with people who either work for the health insurance industry (the state being home to giants like Aetna make them plentiful), state government or other industries like hospitals that profit from providing healthcare.

Yet the federal Exchange regulations say, in the preamble, as follows: "Exchanges are intended to support consumers, including small businesses, and as such, the majority of the voting members of governing boards should be individuals who represent their interests." 76 Fed. Reg. 41872 (7/15/2011).

As a prominent blogger who writes the blog "Advocacy for Patients with Chronic Diseases" (she happens to be a patient with Crohn's disease and gastroparesis, and is also a lawyer more than 25 years) and is based in Farmington, Connecticut (near the state capitol Hartford) eloquently WROTE:

"I don't know about you, but that surely reads to me as though there should be -- oh, I don't know, maybe ONE consumer representative on the Board? Maybe one public official could have appointed someone who would join Vicki Veltri in expressing the consumer point of view?"

In fact, all of the 14 individuals selected for the Board are either members of Governor's administration, former insurance company executives, or individuals with political connections, but none, aside from the non-voting state Healthcare Advocate, are consumer advocates.

What does this mean?

Well, think about it. The Board is made up of government workers and insurance people, so how likely is it that the state's insurance exchange is going to represent the interests of PATIENTS, rather than the insurance industry? Do you trust a former Aetna executive to make choices that represent the interests of patients, or of the industry they have so many personal connections with? The Board also determines how the providers in the exchange are selected, what criteria will be used for selection, etc.

All of this certainly seems like an invitation for a lawsuit, doesn't it? In the meantime, if you live in Connecticut and a actually have chronic illness like say, diabetes, you might consider calling your state lawmakers and giving them an earful about finding ONE patient representative on this board. To find your local state government representatives, visit http://www.cga.ct.gov/.

Pop Culture Anniversaries: Willy Wonka at 40

2011-08-03T08:00:00.013-04:00

Monday (August 1, 2011) happened to be the thirtieth anniversary of MTV. While I cannot say that I actually watched the premier (my parents didn't even subscribe to cable until a few years later, and even that took some convincing!) of the cable network, I certainly do remember watching all of the original VJ's: Martha Quinn, Mark Goodman, Nina Blackwood, Alan Hunter and J.J. Jackson. It wasn't until 1992 when MTV introduced "The Real World" and a number of similar shows that have nothing to do with the "M" part of it's name ("M" originally stood for "music") when music on MTV started to fall by the wayside, and it wasn't until late 1990's when the network would stop showing music altogether (at that point, I pretty much stopped watching MTV and I have little use for MTV these days), but I still figured it was worth sharing the anniversary since it was every bit as important as diabetes was for me growing up.

Happy Pop-Culture Anniversaries

By now, I'm guessing most of my readers say my July POST that commented on my own 35-year anniversary of a type 1 diabetes diagnosis, and how I didn't much feel like celebrating in spite of having every reason to. I would also presume that nearly everyone has already seen the YouTube clip commemorating the 30-Year Anniversary of MTV's launch (see http://youtu.be/Cw6xesXLIAA if you haven't, but would like to do so) so I won't be sharing that stale clip here. However, I will share the ABC News clip on MTV's original VJ's (video jockey's, similar to DJ's for disc jockeys): "Where Are They Now?" which I doubt many of my readers caught on the news. The clip can be viewed on the blog http://www.80svjs.com/?p=269 (see also http://t.co/GeSNVaq):

As it turns out, there was also another anniversary in June, that being the 25th anniversary for the John Hughes film "Ferris Bueller's Day Off" (hat tip to the GenXTinct blog on that news) which starred Matthew Broderick (who achieved teen fame starring in another movie known as "War Games" a few years earlier playing a computer nerd who accidentally nearly started World War III on his personal computer with a dial-up modem, a testament as to how long the online community has really been around in one form or another). Truth be told, I had already graduated from high school when that particular movie came out, but I could still appreciate its humor as a college freshman.

However, today's post really has nothing to do with MTV, Ferris Bueller or War Games. Instead, today's post is to commemorate another entertainment anniversary which took place back on June 30, 2011: The 40th anniversary of the original Willy Wonka & the Chocolate factory movie which premiered on the same date in 1971 (and to share a "Where Are They Now?" video segment on the child cast of that film, all of whom are now certifiable adults).

The movie, which was based on a popular children's book written by British author Roald Dahl named "Charlie & the Chocolate Factory" was first published in 1964. The book was about a boy named Charlie Bucket who lived in a poor, ramshackle house (his mother was widowed in the book) who wins one of just five "golden tickets" into the famous but highly-secretive Willy Wonka's Chocolate factory. (The author also wrote several other books which remain popular with the grade-school set even today, including Charlie & the Great Glass Elevator, one of my favorites James and the Giant Peach which was made into a movie back in 1996; that film was also directed by Tim Burton who produced the second film version of Charlie & the Chocolate Factory starring Johnny Depp in 2005, plus the book The Fantastic Mr. Fox which also made it to the big screen in 2009). The 1971 movie was a musical of sorts, and has soundtrack and everything.

Pure Imagination

When I was growing up, there was a Peter Paul chocolate factory in a nearby community, a company that was perhaps best known for selling chocolate covered coconut candy called Mounds (and another variety that contained almonds known as Almond Joy, and the company also successfully marketed another candy mainstay known as the York Peppermint Patty, although they technically acquired that brand, but they were the company to launch it nationally in the late 1970's). Occasionally, they would actually have factory tours at the facility. One summer, my local library announced a recreational program, one of which was a factory tour of the Peter Paul chocolate factory, and I eagerly awaited my sneak peek into those hallowed halls! However, the Connecticut-based chocolate maker Peter Paul had been acquired by British candymaker Cadbury in 1978 (Cadbury later sold it to Hershey a decade later), and as part of a multinational conglomerate, they basically ended tours for local schools. The tour being arranged by my local library was shelved, so I never got to tour the place!

I have little doubt why the story of Charlie & the Chocolate Factory is so positively alluring to children: to be selected as one of just 5 lucky winners to get into see a chocolate factory that is essentially closed off to the public. You can imagine the appeal to almost any child -- it's pure fantasy (or, in the words of one of the film's songs, "Pure Imagination"), and to a kid who was recently diagnosed with diabetes and told they were basically forbidden to eat candies (yes, they did try to claim that back when I was diagnosed), it has always held a special place in my childhood memories.

The following MP3 is the song "Pure Imagination" that was featured as one of the songs in one scene from that movie (which is only available if you're reading this from my actual blog):

I should note that my mother more than made up for it when I was growing up. For example, she had learned how to make chocolate from some of the women at our church (back in the days I actually went) and decided to take those candymaking skills home. She acquired a number of candy molds so my sister and I (both of us have type 1 diabetes) could also be able to enjoy an Easter basket that included candy just like my younger brother received. She found a local supplier of sugar-free chocolate (bulk which had to be melted down), and effectively enabled me, my sister and younger brother to have our own candy factory right at home. That was, at least in my experience, as good as visiting some commercial candymaker's factory!

Now, I was only 2 years old at the time the original film premiered, so I never actually saw the movie on the big screen, but I can remember that it was a really big deal when it made it to network television a few years later, and I was in the right age group (in the second or third-grade) when kids were first started reading books like "Charlie & the Chocolate Factory". The film's producer's took some creative liberties with the title (for example, naming it Willy Wonka) and also with some parts of the story, including adding a scene where Charlie and his grandfather drink fizzy lifting drinks and must burp to keep from floating away, which the author told the British press he absolutely detested, hence he avoided licensing any of his other books to be made into films while he was still alive.

As I noted, Hollywood remade the film in 2009 and the star was Johnny Depp (they also called the film Charlie & the Chocolate Factory which was the real title of the book, not Willy Wonka & the Chocolate Factory, in part because the author said he felt the other title diminished the story about the child's experience and focused inappropriately on the owner of the factory instead, which was probably a fair criticism). While there was lots to like about new version, I suspect the author might also have hated the remade version, too. The reason: the part about Charlie's father being a dentist was NEVER in his original book. In fact, in the original book, Charlie's mother is a widow raising her son, parents and in-laws in a tiny house with a low-paying job, so Tim Burton took some creative liberties with the story as well, which was why the British author reportedly hated the 1971 version. However, I think the script of the original film follows the book more closely than the new version.

Willy Wonka Cast: Where Are They Now & A TV Reunion

In any event, to commemorate the original film's anniversary, I happened to notice a while back in one of the New York daily tabloid newspapers, in this case The Daily News, has run a series of "Where are they now?" updates on various movies and TV shows over the years, and they did one about Willy Wonka & the Chocolate Factory back in May (probably in anticipation of the film's anniversary). You can view the NY Daily News feature (which includes a cool slideshow presentation on many cast members both then and now) for the original Willy Wonka movie at http://goo.gl/VKrL.

While reading up on this, and in exploring some blog links from the author of book that I noted in my PRECEDING POST "Whatever Happened to Pudding Pops" I discovered that back around the time of the original Willy Wonka movie's 40th anniversary, NBC's Today Show had a cast reunion (including the cast of children from the film; curiously, Gene Wilder who played Willy Wonka in the flick was not there) which can be seen at http://www.msnbc.msn.com/id/21134540/vp/43038138:

They've also established a website at http://www.willywonkamovie.com (which they aren't yet promoting) where you can view the trailer for the revised version, and will be adding some games and miscellaneous information in the not-too-distant future. According to one of the PRESS RELEASES, "To honor the 40th anniversary of the film, Warner Brothers has digitally remastered the original movie and will be re-releasing a high-definition, BlueRay version on October 4, 2011. Willy Wonka & the Chocolate Factory: 40th Anniversary Ultimate Collector's Edition will contain more than an hour of extras, including Mel Stuart's Wonkavision, a new interview with the director; a new featurette about Roald Dahl, author of the book upon which the movie is based; a 144-page production book reprint filled with photos and notes; and archival letters. The package also will contain a retro Wonka Bar-shaped tin box with scented pencils and eraser, and a limited-time Golden Ticket Instant Win Game piece for a chance to enter and win a trip for two to Los Angeles. As in the movie, there will be five grand-prize winners. There also will be 40 reproductions of the original theatrical poster given away as runner-up prizes." I've included the trailer below (again, you must watch it from my blog, not your RSS reader, otherwise visit the aforementioned link!):

That should satisfy any cravings for chocolate I may have for a while!

Mid-Life Crisis? No, Just D-Burnout

2011-07-19T21:00:00.018-04:00

Saturday (July 24) marks my 35th anniversary living with type 1 diabetes, and although I have plently of reason to celebrate (I'm still largely complication-free after 3 and a half decades of living with this f'ing disease), but I don't really feel much like celebrating. (My CWD Quilt Square can be seen HERE [my sister's follows mine, FYI]).

No, it's not about all the unsubstantiated "cure will be here in another 5-10 years" fiction that medical people once told me regularly; after nearly 4 decades with this disease, I'm no longer a naïve fool. Good control does not eliminate the possibility of complications, but merely reduces the odds of getting them.

My current funk could just be another round of diabetes burnout, which frankly hits most people living with a chronic illness for any duration, but I think my fellow diabetes blogger colleague Bernard Farrell said it best at the 2011 Roche Social Media summit which I attended last month but have yet to write about: it becomes overwhelming and even depressing to live, breathe and think about diabetes 24/7/365 including blogging and elsewhere online (I'm paraphrasing quite a bit here), and sometimes we need to take a break from it just to keep our sanity. The reality is that even a "model patient" gets damn sick of talking about it all the time, and if they don't, my guess is they will at some point. As much as I enjoy being a part of such a terrific community, there's more to life than diabetes, or at least there SHOULD be in order for there to be any life balance.

I have NOT abandoned self-care, nor have I abandoned my presence in the diabetes online community. My acclaimed Twitter feed continues (that comes pretty easily to me), and I've done the weekly chats, too, but blogging: not so much as of late. It's not that I've given up on blogging and I must admit I miss a few of the earlier bloggers who have since given it up, including Vivian Schaffers (@RedbudMama) of DanielDoo who decided to stop blogging recently, but I'm of the mindset that if I don't have anything really new or interesting (from my perspective) to write about, then I don't really want to write. Some of my readers miss me, but rest assured, I have not abandoned this blog, only that I need some break time to provide me a fresher perspective on things before I start writing again with any frequency.

When I first started blogging back in September 2005 (you can catch my very un-glamorous early posts HERE), my goal was never specifically to talk about MY life with diabetes, but to fill what I saw as an enormous void in the media about legitimate news on diabetes, and also to use this to vent some of my well-deserved frustation with the media's blatant disservice to diabetes coverage. The media has been preaching the same monotonous story when it comes to diabetes, and it really is starting to sound like a broken record (for the iTunes generation: in the old days, when music was recorded on plastic records and when those records were scratched — hence the term broken — part of the recorded music would repeat itself). No wonder no one cares about diabetes — the media are simply unable to make the news remotely interesting. My goal was twofold: 1) communicate useful, interesting information about diabetes and 2) provide a patient perspective to that news. I believe I've accomplished that, and not just with my blog, but also my Twitter feed which now has over 700 followers.

Plenty To Write About

I have plenty of stuff I COULD write about. For example, the recent social media summit, which I'll cover ... eventually. In the interim, if you're interested, I would refer you to Wil Dubois' coverage of the events, because his take-away was very similar to mine. Catch his post HERE for a good slice of that, and at some point, I hope to share some things that my peers have not yet covered.

Another example of some coverage-worthy stuff: diaTribe recently published a free book entitled "Targeting a Cure for Type 1 Diabetes" which I actually thought was pretty darn good IMHO, although I take issue with a few points in their assessment (what kind of honest critic would I be if I didn't have any issues?).

What points, you ask?

Well, perhaps I'll save them for a formal book review when I feel like writing again, but most notable are the four pages of "Advance Acclaim" from so-called diabetes experts which struck me as more trumpeting the organization's own horn about their contacts in the field rather than adding any incremental value to the contents of their work.

I mean really, who's their audience for this book, and do they really think we care what these people thought of the book? Some acknowledgement is OK, but FOUR pages worth? That was overkill. But once you pass that, there is some great content there.

I also continue take issue with the incredibly naïve presumption that a closed-loop insulin pump system or Roche/Genentech's costly new drug for diabetic macular edema will, in Aaron Kowalski's (of the JDRF) words from the "Forward" statement he wrote for the book "... will significantly ease the burden of diabetes, reduce the risk of complications, and keep people healthy while we drive toward a cure." I get the logic, but it's a pretty daring presumption that all who want or need access to these treatments will actually have them, especially when the data suggests otherwise.

For that reason, I think devoting so much content of the book — indeed, an entire chapter — dedicated to a closed-loop insulin-delivery system also seems like overkill. I know diaTribe/Close Concerns is intimately familiar with this, but that does not render it appropriate content for a book on CURES. Besides, while these devices are very alluring to technology folks and, yes, even some doctors, a number of interviews has consistently shown that few patients (or parents of kids with type 1 diabetes) actually view this as a cure. Also, knowing that so many patients who might benefit from such a device will be unable to afford is more typical of consultants who may have a perspective which simply out-of-touch with the way things really work. So far, the JDRF is pushing hard down this path, but the money-is-no-object attitude towards treatment and care is an area I will continue to call the organization's attention to because it's an unfortunate reality today, unlike a yet-to-be-approved closed-loop insulin delivery device, which still faces significant challenges attaining U.S. regulatory approval.

Let me offer the following to support my position:

Today, more than 3 million Americans who live with diabetes lack ANY form of healthcare coverage according to my conservate estimations using data from the Kaiser Family Foundation and the CDC, and whether these people (many of whom actually work full-time in jobs such as waiters/waitresses, cashiers, and other laborers) will be able to afford coverage when state insurance exchanges are established remains to be seen. Many will (whether willingly or not) likely take the most rational choice to pay a fine because it's most likely to be far less costly than the insurance would be, and if Congressional born-again budget hawks get their way, subsidies via tax breaks for these people will be one of the first elements of healthcare reform to be killed because they believe the U.S. Federal Budget cannot afford it (I have to ask where these people were when we went from having a budget surplus when President Bill Clinton left office to the budget-busting deficits President Barack Obama actually inherited when he took office?). That's a sad reality in the U.S. today. What's more, the out-of-pocket costs being passed on even to employees who actually receive healthcare insurance via their employers is growing far beyond the rate of inflation. In fact, the median deductible for traditional PPO plans (the most common type of insurance offered by U.S. employers) doubled in 2008 to $1,000 according to a study from Human Resources consulting firm Mercer (see HERE).

With U.S. unemployment (and underemployment) at levels not witnessed since the late 1970's (that seems to be a recurring theme in this post, meaning the 1970's) and job growth unlikely to pick up at a pace needed to put many back to work before 2014 as the economist's consensus seems to suggest is likely, so the access issue isn't going away anytime soon.

Finally, Chapter 4 is a bit empty from my perspective. While it is indeed early on the regeneration front, I cannot help but get the impression that the writers didn't have many contacts at any of the companies in the regeneration front, so they covered a few studies already published in the scientific and/or medical journals, but beyond that, not much is very new.

By and large, however, I really DO recommend downloading their book and having a look at it. Most is excellent and provides a realistic assessment of where things stand, and their conclusions that various cure components are likely to require some combination of new therapies (such as autoimmunity treatments) to be effective. While their time assessments are excellent, I would just note that diaTribe failed to address anything on the topic of cost. For more added assessment on that, I recommend visiting my November 2010 post entitled "The $100,000 Diabetes Cure" (After all, why not plug my own work? I think I have reason proud of it).

A Departure from Typical Scott's Web Log Content

Beyond that, I am taking a bit of a departure from my usual diabetes-related stuff. It's my blog, so I'll write about whatever I feel like! With my 35th dia-versary, perhaps I've been having a bit of a middle-age crisis. After all, I now have a few grey hairs on the temple, and although age also brigs wisdom, it brings other less-desirable stuff, too. (I cannot help but think of the Sex In the City episode where Kim Cattrall's character discovers a grey hair — "down there" — and says that if she were to pluck that hair, four more could come to it's funeral, so she decides to use Clairol hair-coloring to eliminate the problem and unfortunately leaves the hair dye in too long so it's now bight red like Bozo the Clown, hence she believes she has "Bozo the Bush") ... and now that I've offended at least a few readers, back to my own mid-life issues.

I will say that when I was in San Diego last month, I went to Cost Plus World Market which was around the corner from the hotel. Cost Plus is kind of a cross between Pier One Imports and Trader Joe's which is mainly located in California. I went there occasionally when I lived in the Golden State, so that in itself was a step back in time for me (sort of). While I was there, I made a huge purchase: a package of Fruit Stripe gum which is still made, only today, it's exclusively sugar-free (that part may be diabetes-related). The TSA agent at the airport asked me where I got it, so I told her ... evidently, she thought it had disappeared. She smiled so I offered her a stick (she declined, but said she was going to get some for herself). Evidently, there is something to be said for revisiting life from days gone past, the only difference for me is that I always associated that with my parents and grandparents, so it took some getting used to for me.

Acknowledging the issue is the first step towards dealing with it, so I decided to celebrate (as fellow d-blogger Wil Dubois said at the Roche Social Media Summit, his family celebrates not only successes, but also really big failures, too) so just maybe my mid-life funk could be included among those things.

Apparently, I'm not alone in celebrating or at least acknowledging the period when discos and mood rings, halter tops, and bell bottoms were still in vogue. Recently, a book co-authored by Gael Fashingbauer Cooper (she blogs at http://pcjm.blogspot.com/ or on Twitter @genxtinct, and has another book-related blog called GenXTinct) entitled "Whatever Happened to Pudding Pops? which was recently featured on NPR's popular "All Things Considered" program. You can listen to that story at NPR News HERE (if you search NPR, use "The Sweet Taste Of 'Pop' Culture Nostalgia" in the search field):

My opinion on that book: a definite read if you fall within the relevant age group, and although there are few facts that are incorrect (for example, they failed to note that several TV shows are now available on DVD), it's not heavy reading. The book is a series of vignettes of maybe 2-3 pages each covering some aspect of pop culture that was prevalent in the 1970's and 1980's, so it can be read in bits and pieces — perfect bathroom reading (comedienne Joan Rivers used to say the same thing about the National Enquirer, and how it was replacing bran muffins, but I digress). I guess that means I'm really officially middle-aged, as there's now even a book to chronicle it! On the subject of stuff from the 1970's, readers may be humored to learn that a fair number of the products that were sold in the 1970's is actually still available in what's pretty much their original formats.

For example, if you were one of those people who used the ORIGINAL Clairol Herbal Essence shampoo (you know, the green stuff in an unimaginative shaped bottle) that featured a cartoon of a blonde hippie woman on the bottle, or "Gee, Your Hair Smells Terrific" shampoo, "Body On Tap" shampoo featuring a magical haircare ingredient: beer, "Lemon Up" shampoo, and even a variety of "Agree" shampoo to help fight the greasies, even though regular hair-washing also takes care of that 1970's personal grooming challenge — apparently, there may have been an oil shortage back then, just not in people's hair!) which they call "Flat to Fluffy" shampoo, even a recreated version of the Farah Fawcett-endorsed Fabergé Organics Wheat Germ Oil & Honey Shampoo, you can still buy all of that stuff! But it's not limited to shampoo, and has numerous other relics and throwbacks from the 1970's ranging from vintage monopoly games and Fisher Price toys, know that you can buy many of those items at the online "Vermont Country Store" which describes itself as "Purveyors of the Practical and Hard-to-Find Since 1946" carries these items. To be sure, a bottle of "Gee, Your Hair Smells Terrific" (apprently, Vermont Country Store is actually licensed to use that registered trademark) or the original green, Herbal Essence shampoo (they call it "Country Herbal Shampoo" since Procter & Gamble still sells a reformulated version and still owns the trademark) isn't cheap.

Expect that a trip to the beauty salon of your past to be rather costly indeed: a bottle of "Gee, Your Hair Smells Terrific" will set you back $14.95 plus another $5.95 for shipping. At that price, you could just as well buy salon haircare products, but it might not transport you back to "the garden of earthly delights" in the same way as one of these products will.

While I'm on the subject of the 1970's, I've prepared a playlist of some tunes from that decade, which you may listen to HERE:

Anyway, with that deviation from life with diabetes, I think I may be ready soon to return to blogging about it, only perhaps with an occasional deviation to clear my mind!

Scott's Web Log Goes Mobile

2011-07-01T11:30:00.001-04:00

As hard as it is for me to believe, as of yesteday (June 30, 2011) I realized that I had shared over 6,000 Twitter "Tweets", and along with that, I also had some 680 followers on Twitter (give or take a few; which always happens in a dynamic environment like Twitter). The scary part is, I really did not do ANYTHING out-of-the-ordinary to acquire that many followers -- no advertising or cooperative promotions that so-called social media authorities tell me I should be doing. I just my do what I always done. Yes, I do screen most every link I share with my followers before sharing something (or I know my sources very well), and most -- with the exception of a handful of Reuters news items, of my Tweets are diabetes-related, and most still work as well today as when I first posted them, which I believe does make a difference. I choose news sources that will likely be around tomorrow.

The weird part of my Twitter presence was that initially (I think around 2006), I had just staked out the "sstrumello" name on that social network, but it was over a year after grabbing that Twitter identity that I even posted anything on Twitter. But I saw potential in a social network service that did not require a special cell phone (it IS possible to communicate on Twitter using a regular-old cell phone via text-messaging, which is also known as SMS messaging, hence the 140 character limit). Naturally, if I were to suddently stop doing what I've been doing online, my following could dwindle, but since I'm not doing this as a business, that's never been terribly important to me - sharing relevant info, mostly about type 1 diabetes (although not exclusively) - has been my goal.

The other day, Todd Siesky from Roche Tweeted to Mike Hoskins about whether R2D2, one of the robots in the 1977 George Lucas film Star Wars, came with an accurate blood glucose reading (or meter). I noticed this Tweet and responded that in 1977, I was still testing urine as many people with diabetes were because self monitoring of blood glucose meters really became available in the 1980s. Talk about change in perspective!

Access Via Mobile Devices

Anyway, it had occurred to me that my blog (and my Twitter feed) was not really optimized for mobile followers (meaning people who access my content from a mobile device such as a smart phone). I'm not exactly the most techno-saavy person, nor am I technologically illeterate, but I can hold my own for a middle-aged 40-something. Yes, my blog website and Twitter posts (like most all websites) could be accessed from a mobile device, but I had not really done anything to make them truly accessible for many mobile users, and it showed. Also, many web features on my blog such as Javascript and Adobe Flash aren't really accessible on some mobile devices (yes, I mean Apple's iPhones/iPads and iPod Touch devices ... Apple has some kind of dumb vendetta against Adobe, which remains a powerful software company located just a few miles from Apple's HQ). Unlike many of Apple's arguably rapid groupies, I have a hate-love relationship with Apple. Its products are nice and function well, but that's the extent of my relationship with Apple and I really consider myself more of a Google guy than an Apple man. What else can I say? I have an iPod Touch, but my phone is a rival Google Android Device (see my post from earlier this year HERE for more background), and increasingly, I realize that's how more and more readers are (or are NOT) visiting me, or will be in the future. So I've made at least some effort to make my blog posts and my online presence more mobile-friendly (or at least not so mobile unfriendly).

I have a functional sample (or "emulator" as they call it) below (this doesn't work so well from an RSS feed) that shows how my new "mobile" domain will work on a mobile device. Check it out below (or visit HERE):

Although I made a slight slip-of-hand with my abbreviated domain name (meaning the .co designation) and my domain-name registrar, forgetting to put the "s" in the http (secured) URL - I added the .co with the intent of that being my "mobile-friendly" domain, even though it's really just a single letter shorter) when I was setting it up so that was pointing to my regular blog address, that has been fixed and should also be working by this 4th of July weekend.

Scott's Web Log (Mobile) Access

So here's the deal. Scott's Web Log, including my acclaimed Twitter Tweets, are now accessible via a special mobile device page I've established. The domain you may bookmark is:

http://m.sstrumello.com

or

http://m.sstrumello.co
(The .co URL above should be functional by July 4, 2011)

I have essentailly utilized a third-party provider to ensure my various online presence via my blog and Twitter are more easily accessible from a mobile device. So bookmark "Scott's Web Log (Mobile)" away on your mobile device!

Teplizumab and DPT-1: "Not Dead Yet"?

2011-06-09T11:30:00.009-04:00

Hopefully, Phil Southerland will pardon me for borrowing the title to his new BOOK (as far as I know, he cannot copyright a mere 3 words, although they can be trademarked, but that process takes a number of years of using the term consistently as a brand name before the U.S. Patent and Trademark Office will even consider it), but I felt like it made a compelling headline for today's post.

How many of my readers remember an experimental anti-CD3 monoclonal antibody treatment called teplizumab that had trials with a cutesy name: Protégé? That trial was being undertaken by a closely-hold, Maryland-developer named Macrogenics, Inc. and it's big-pharma partner Eli Lilly and Company (a marriage that was the result of the JDRF pairing the two companies together). You might, because this product has been promoted as a promising autoimmunity treatment for type 1 diabetes for a while now.

Unfortunately, last October, the teplizumab Protégé trial was the first of several recent failures for late-stage autoimmunity treatments (and the first of TWO that that the JDRF worked to help find big-pharma partners for) that FAILED to meet their clinical endpoints (the other was the also-cutesy trial name DEFEND sponsored by Massachusetts-based Tolerx, Inc. and it's big-pharma partner GlaxoSmithKline, also facilitated by the JDRF ... the third was the Diamyd trial which was NOT facilitated by the JDRF). The results of these trials, because they were funded (in part) by the JDRF, fortunately, will actually be published in medical and/or scientific journals and are due to be discussed at the forthcoming ADA Scientific Sessions in San Diego in late June.

I found one of the endpoints that pharma partner Eli Lilly and Company insisted on using for the Protégé teplizumab trial to be inappropriate: they used a composite of a patient's total daily insulin usage and HbA1c level at 12 months as the efficacy endpoints, but curiously, not a patient's C-Peptide count, nor did the trial exclude participants who had good glycemic control, raising questions just how they could realistically expect to see any improvement in HbA1c for some participants -- after all, this was NOT a noninferiority trial. A patient's daily insulin requirement might be an acceptable measurement, but I still find the absence of C-Peptide count perplexing because they have no quantitative measure of how much endogenous insulin is even being produced without it. Whatever the measures, the teplizumab treatment failed to meet the defined endpoints.

The reality is that when it comes to measuring whether the pancreatic beta cells function, really, the ONLY appropriate measure is C-Peptide, and the former head of the FDA's Metabolic Group including diabetes (for some 12 years, I would add), Dr. G. Alexander Fleming has made just that argument (he's now CEO of Kinexum LLC, which is the angel-investor for a company known as Exsulin, Inc. which is developing a beta cell regeneration therapy (see his scientific journal article which makes this very argument, as well as the self-imposed quandry the FDA has historically had in trying to approve type 1 diabetes autoimmunity treatments HERE), although until fairly recently, there have been relatively few applicants for type 1 diabetes autoimmunity treatments the FDA has even had to evaluate.

In any event, Tuesday's (June 7, 2011) Wall Street Journal had an interesting article entitled "Trying to Prevent Type 1 Diabetes" by Shirley S. Wang. For readers who have paid access to the Wall Street Journal's content, the link to this article can be viewed at http://goo.gl/iyjJT (it's a long link, so I've shortened it for ease-of-use).

I won't share the entire WSJ article here, but the Wall Street Journal had a video clip that nicely summarized most of the key points shared in that article HERE:

One of the most noteworthy take-aways (for me, anyway) in this story was the fact that it was citing two clinical trials that were presumed to have failed, including the Diabetes Prevention Trial (a.k.a. the "DPT-1") using insulin that was pretty much declared dead several years ago (there was a leg of that trial that used injected insulin, and another that used insulin given orally -- the idea being that introducing synthetic insulin might help create a state of immune tolerance to the insulin-producing beta cells the body's immune system is likely to destroy in patients who are at high-risk for autoimmune-mediated type 1 diabetes). The other clinical trial cited was for teplizumab (noted above) which made news last autumn (in October 2011) because that Phase III human clinical trial had failed to meet it's primary endpoint (see HERE for details on that), which was a composite of a patient's total daily insulin usage and HbA1c level at 12 months.

In April 2008, Eli Lilly and Company's chief executive officer (CEO), John Lechleiter, referred to teplizumab as one of that company's three most promising experimental drugs in the company's pipeline in an investor event, yet Lilly rapidly dumped it following the failure of the Phase III clinical trial.

This is why the news that the drug might not be dead after all is so interesting.

It's important to note that Lilly hasn't exactly been a good pharma partner for the JDRF or in pursuit of type 1 diabetes treatments; frankly, in my honest opinion, they've been a downright $#!tty partner -- having screwed the JDRF over twice in two partnerships the organization facilitated. In my post last autumn entitled "The $100,000 Diabetes Cure", I cited evidence of another JDRF partnership with Lilly in which the Indianapolis-based drugmaker essentially screwed the JDRF over by turning a therapy designed to regenerate islets in patients with type 1 diabetes into a trial for patients with type 2 diabetes (most likely because Lilly saw more potential dollars as a type 2 treatment; it is a company that has a fiduciary responsibility to its shareholders), but when the trials in type 2 didn't work out, Lilly dropped the gastrin-based therapy (with the unglamourous name "TT-223") faster than a hot potato (see HERE for more detail) -- in spite of receiving initial financial support from the JDRF!

Shortly after that event, me and another diabetes blogger (Joshua Levy) reached out and the JDRF confirmed that the evidence still suggested that TT-223 may indeed work in patients with type 1 (and also in type 2, as the endpoint measurements in the type 2 trial were again, quite suspect). The Toronto-based developer of that drug, Transition Therapeutics, Inc., was forced to regroup and the JDRF may again play matchmaker with another company (assuming, of course, that Lilly's dumping the molecule hasn't poisoned others from touching it). However, as I suggested in my "$100,000 Diabetes Cure" post, I believe the JDRF has learned some lessons from the early experiences and has indeed made changes to more recent industry partnerships, making funding contingent upon meeting various milestones rather than up-front payments, for example.

An excellent example of that is contained in a brand-new partnership announced this morning (also for autoimmunity) between the JDRF and Massachusetts-based Selecta Biosciences, Inc. The news of this partnership can be viewed HERE, HERE and HERE. Of note is the fact that with this latest industry partnership (which, incidentally, JDRF plans to increase fairly dramatically the number in the next few years). I heard this from the source, when I met face-to-face with Richard Insel and Karin Hehenberger a few weeks ago at JDRF headquarters a few blocks down the street from my office (I haven't addressed that meeting in a post yet, but I will!). In particular, note the language in one of the JDRF press releases on the Selecta Biosciences noted above:

"Through the research partnership, JDRF will provide milestone-based [emphasis mine] financial support and expertise, with the goal of applying Selecta's vaccine technology toward the development of vaccines for type 1 diabetes."

The key term here is MILESTONE. In effect, the JDRF is telling the partner "we'll give you funding, but it's contingent upon your meeting some requirements, it won't be a lump sum distribution up-front". This is a pattern that has been evident in several recent JDRF-announced industry partnerships. Without getting too far off topic, I would like to say that had these negative experiences with the Lilly partnerships not occurred, the lesson of milestones would not have been taught. After all, there really was not much experience in industry partnerships among other nonprofits, so JDRF was indeed charting a new course. Hopefully, the Selecta partnership will be beneficial for all parties involved.

Getting back on topic for "Not Dead Yet"

The Wall Street Journal article also cited the presumed-dead DPT (Diabetes Prevention Trial for type 1 diabetes), specifically the leg of the trial involving oral insulin. As journalist Shirley S. Wang noted, although taking insulin orally has absolutely no impact on glucose level (there's no therapeutic benefit), but taking insulin (in it's current form) orally may introduce self-tolerance to the beta cells that produce and effectively stop the body's immune system from attacking itself. Although one leg of the DPT-1 had already failed to meet it's efficacy endpoint, there was plenty of skepticism that the trial wasn't working. One thought was that perhaps the dosage of insulin was insufficient, others believed that the efficacy measurements weren't correct.

In any event, the trials are apparently not dead -- yet. The reality is full trial details have yet to be disclosed for many of these, but the JDRF did ensure that the trial results do not get buried in the pharma and biotech cemetery. Typically, results for government-funded trials get published in medical and scientific journals, but drug trial results are buried by the companies and the FDA. For the oral insulin trials being pursued by the U.S. National Institutes of Health's National Institute of Diabetes and Digestive and Kidney Diseases, apparently there there is sufficient evidence that a follow-up trial is worth the cost to taxpayers. Some of the early critiques of the DPT-1 was that the dosage may not have been sufficient to have a measurable difference. The same holds true with the Macrogenics teplizumab trials, even though that trial did not involve U.S. Government funding.

Back in March, I asked the JDRF some specific questions about not only the teplizumab trial, but also the failed Tolerx/GlaxoSmithKline otelixizumab DEFEND-1 study which also failed in March 2011 (see HERE for details on that). This leaves the JDRF with relatively few late-stage trials in the autoimmunity front (one of which is Bayhill/Roche, which the former Genentech executives were claiming is being delayed not due to lack of interest, but resource constraints at the company. I don't necessarily believe that explanation, but again, because it was an earlier partnership, the JDRF may not have had milestone requirements for payments built into the agreement. Call it a lesson well-learned).

However, its typical that full trial results for any drugs in development are rarely (if ever) published in medical journals in their entirety, rather pharmaceutical companies are quite notorious for selectively releasing data which make treatments appear most favorable, although the results must still be submitted to the FDA and TrialNet, that's the extent for which trial data is actually shared.

So I asked the JDRF to comment.

My first question was whether JDRF had any rights to full-scale trial results (data, etc.) for both otelixizumab and teplizumab? After all, there is considerable learning that can be attained from these trials even if the drugs failed to gain FDA approvals?

Second, it may still be possible that these medicines worked in certain subsegments of the trial population. If that is true, it might be important for JDRF to know which segments the drugs worked in. Again, having access to the full trial results would be critical to know this, and perhaps more importantly, having these trial results published in medical/scientific journals would be even more important to advance type 1 diabetes research, and autoimmunity treatments in particular. What, if anything, can JDRF do to ensure these trial results are published?

I believe the JDRF appreciated my questions, but did have to research before responding to me, which they did (Bennet Dunlap and I were also able to meet some of the JDRF's Scientific leaders shortly after that, catch his post HERE). Here is how the JDRF responded to my questions:

"Thanks for getting in touch about this. Your questions are very thoughtful. I’m sure you saw JDRF’s statement on the DEFEND-1 trial that we posted on our website last week when the results were announced (http://www.jdrf.org/index.cfm?page_id=115376); however, you’re seeking more in-depth information. I will discuss your questions with our internal Research team and get back to you with a response."

A follow-up e-mail with the following was sent a week or two later:

"Hi Scott,

I spoke with our Chief Scientific Officer, who provided some information to help me respond to your questions. JDRF agrees that sharing and understanding the data from the DEFEND-1 trial is important, in order to provide context for the results and help us understand what didn’t work and what, if anything, did. As you know, the data we glean from therapeutics like this one that don't succeed in trials is still important to inform our research efforts, especially for planning future new onset type 1 diabetes trials.

Specifically, JDRF plans to review the data from the trial once it has been thoroughly evaluated by our partners Tolerx and GSK to help us determine what the results mean for otelixizumab specifically, and anti-CD3 in general. Our understanding all along has been that Tolerx has been planning to present the data from the study at a major diabetes conference [the ADA Scientific Sessions in San Diego], and/or submit it for publication in a peer-reviewed journal. We will certainly look forward to the data being presented in one of these forums.

Regarding the MacroGenics Protégé trial, it’s true that teplizumab did not meet its primary endpoints in people with recent onset type 1 diabetes as well. However, the NIH is recruiting for a new trial to test teplizumab for preventing type 1 diabetes in people at risk: http://www.diabetestrialnet.org/studies/ACD3.htm. So there is still an opportunity to learn more about this anti-CD3 treatment and whether it is effective in slowing down or stopping the autoimmune response that causes type 1.

I hope this information answers all your questions. We will be sure to communicate further if we learn any new information about these trials, or anti-CD3 in general."

I appreciate the JDRF's candor, and I honestly believe these experiences and the fact that people like myself, Bennet Dunlap, Joshua Levy and others who are challenging the organization on these issues is indeed being recognized. The fact is that JDRF's new CEO Jeffrey Brewer is also cognizant of these issues, and changes appear to be moving in the right direction. Let me add that we are entering a brand new era for industry-nonprofit partnerships, so the early (negative) lessons learned have been valuable, and its better that these lessons are learned early so that future agreements address these, and the evidence of milestones (payment contingencies) is evidence of that.

It Get's Better for People With Diabetes: You Can Do This!

2011-06-01T12:55:00.003-04:00

On Weds (5/5), Kim Vlasnik at "Texting My Pancreas" had a POST about a recent Google-sponsored TV commercial for the "It Gets Better" campaign which was started by Dan Savage. Mr. Savage is known for an online (mostly YouTube videos) campaign he started which began as a response to growing numbers of teen suicides for sexual orientation that were taking place across the country, from Billy Lucas' suicide in Indiana, to Justin Aaberg's suicide in Minnesota. Then there was the Tyler Clementi suicide at Rutgers University in New Jersey that coincided just as "It Gets Better" campaign was taking off.

The TV commercial for Google's Chrome browser (which is, incidentally, my browswer of choice these days, and has been for about a year now because of it's speed) features the "It Get's Better" project, and the spots premiered during the show Glee, which Newsweek called "the gayest show in the history of network TV." Whether that's true or not, Glee does focus on the perceived misfits and losers of an Ohio high school and their favored school social activity, the high school Glee Club. I am referring, of course, to the Newsweek interview issue in which the magazine featured Dan Savage and actress Jane Lynch (who stars as the cheerleading coach Sue Sylvester on Glee). To read that interview, please see http://goo.gl/ljKGt. The mere fact that former Fox News TV talkshow host Glenn Beck feels threatened by "Glee" (see HERE) is even more reason for me to want to watch it ... with glee!

In that interview, Mr. Savage said something I found very interesting: "I think the gay community does a disservice to a lot of gay kids when we beat the drum of 'come out, come out, come out.'" and Jane Lynch echoed his sentiment by adding "It can be really dangerous to come out to families and to school" because, the article noted, quite frequently, those institutions are the biggest part of the problem. Of note is the fact that 40% of all homeless teenagers are actually kids who were thrown out by their parents when they came out or were outed by someone else. Good, Christian parents, ready to discard their kids for being something THEY don't believe in. But this story isn't about the "It Get's Better" project, it's about something kind of like it for the people with diabetes (PWD) community.

You Can Do This

Kim's thought was that perhaps the diabetes community deserves a program like the "It Gets Better" campaign. I very much like that idea, but I would kind of like to echo Dan Savage and Jane Lynch's caveat from their Newsweek interview, I would support a similar initiative in the diabetes community only if we didn't try to "sugar-coat" everything the way doctors and CDEs too often do, depicting life with diabetes as if it was a mere inconvenience -- talk about misleading patients! Dan Savage was truthful when he told Newsweek "There's no promise that it's going to be a birthday party for you thrown by your mother for all of your life. Bad things happen, and we all die eventually. But there's enough space for you to create a life for yourself, to find friends, lovers, and a community."

Diabetes According to the Medical Profession, Featuring a Lack of Honesty

That's also my take on life with diabetes, and I think it echoes what Kim is doing with The "You Can Do This" effort which mirrors the sentiment about honest talking about life with diabetes. Rather than yet another campaign by doctors, CDEs, nutritionists who tend to marginalize the amount of ongoing effort is required to manage this disease for the rest of people's lives, we as PWD's are going to offer something that hasn't been done before: honesty about life with a chronic disease like diabetes. Anyone expecting Sprinkles the Unicorn is going to fart glitter all over the place when you have diabetes is living in Never, Neverland. I agree that we need to speak the truth in a way that the medical profession simply doesn't have the balls to do themselves: by telling things like they ARE. A comment I received on a blog post said it best: "Diabetes is not a death sentence, but it IS a life sentence." (Get used to it!)

While that's funny on the surface, the reality is that no one frankly admits what a CHRONIC disease really means. But, just as Dan Savage said, bad things happen (like diabetes) but there's enough space for you to create a life for yourself (with diabetes), find friends and a community (like the Diabetes Online Community). But we get enough misrepresentation of the truth about how livable with diabetes is from doctors and CDEs. Living with a chronic disease is neverending, and $#!tty things happen even when you follow the rules. To succeed with diabetes, this really is a marathon, not a sprint, so beating the drum of who has the lowest HbA1c is actually very destructive in my opinion, and I have NEVER shared that on any social media community (TuDiabetes, DiabetesDaily, etc.) because I think it sends the WRONG kind of message IMHO. Guess what? I have opted NOT to join these efforts!

Your HbA1c is YOURS; Don't Feel Obliged to Share It

Personally, I don't want to share that information, and I choose not to, and I find medical researchers lusting after this data to be kind of deplorable. Incidentally, while I'm on that subject, the TuDiabetes campaign that I avoided like the plague was recently chronicled in the online, open-access scientific journal PLoS ONE, see HERE for details. The authors refer to us as an "an early adopter community" claiming that success with them "may comprise efficient platforms for bidirectional communication with and data acquisition from disease populations". David Mendosa wrote about it HERE. I have always been a big privacy advocate, and let me go on record as saying, don't share ANYTHING you don't want to. If it's none of anyone's business, don't feel compelled to share it. I don't, and guess what, I still see myself as an active, longtime member of the diabetes online community.

Don't Publish Details Online You Don't Want to Share, You're Not Obliged to Share Everything

Since when did personal privacy disappear just because of the internet? Seriously. For example, my readers may be somewhat shocked to learn that they won't find my personal e-mail address online even though I am what could arguably be called a diabetes blogger veteran (since 2005!), and I'm on most social media including some diabetes-specific outlets like the JDRF's Juvenation, TuDiabetes, DiabetesDaily and a few others. It's true, because I don't publish my e-mail address, and you shouldn't feel compelled to share yours, either! (There are ways around that, as I have recently added a feature that enables me to have people contact me from my blog without publishing my personal e-mail address). This comes down to not wanting to share every intimate detail about yourself just because of online social media. You are entitled to have things you keep for yourself and you don't have to share EVERY single detail. Also, I have been known to decline Facebook friend requests from people I've never met. I would recommend that everyone think about these things, because the way things are online, there are starting to be some permanent footprints that you cannot simply erase because you think you're done with social media!

I have a camera, but haven't recorded my own "You Can Do This" video ... yet, but I'm working on it. In the meantime, have a look at some of the videos posted already on the "You Can Do This" YouTube channel (more details can be found HERE). Hopefully, this will enable a large and growing group of us in the online space to make sure others know that they are not alone in living with this chronic disease!

Diabetes Blog Week Day 7: What We've Learned

2011-05-15T21:15:00.001-04:00

Like some of my d-blogger peers (I'm thinking of Cara at Every Day Every Hour Every Minute, today's last Diabetes Blog Week post is going to be short & sweet.

This 7th post: What We've Learned. Last year, one d-blogger made a suggestion for this topic. She commented that "Day 7 should be a post about stuff we've learned from other blogs or the experience of coming together online..." So today, let's do just that! We're writing about what we've learned from other blogs, this week or in full since finding the DOC. What's the experience of blogging been like, and what's the DOC done for you? This post could even be used to look ahead and talk about what the future holds.

This post is supposed to be about what I've learned. Basically I've learned one very important thing about myself & my diabetes since I found the D-OC. That is that I am NOT ALONE! Beyond that, I've learned that there are so many creative, interesting and dynamic Diabetes Blogs out there and their numbers continue to grow! Neither is a small discovery!

Well, that's all for today. More to come after I've managed to digest all of the posts from this past week!

Diabetes Blog Week Day 6: Saturday Snapshots

2011-05-14T23:30:00.002-04:00

As a participant in Diabetes Blog Week, today's topic is Saturday Snapshots (meaning photos). This is a topic that was brought back from last year. Inspired by the Diabetes 365 project, this idea is to snap a few more d-related pictures and share them again. We can post as many or as few as we'd like. Be creative! Feel free to blog your thoughts on or explanations of your pictures. Or leave out the written words and let the pictures speak for themselves.

I'm not a huge fan of photos of myself (I hate having my picture taken, and no picture of me ever looks good in my opinion), so this is one of those occasions where I thought it best to share some miscellaneous diabetes-related photos that I think may look familiar to a few people in the diabetes online community (don't worry, I'll include some captions, but sorry about any red-eye, I didn't have time to try and fix that). Over the years, some of the greatest events have been face-to-face meetups, summits and other get-togethers with fellow diabetes bloggers. Here are a few I had handy:

In Front of the Capital at the ADA Call to Congress, 2006

Photos of My Sister's and Mine, CWD Quilt for Life (At Home)

A photo from the DRI Diabetes 2.0 Summit in NYC in Fall 2008

Another Diabetes 2.0 Summit, This One in Miami, Fall 2009

Another Diabetes 2.0 Photo from 2009, I'm the Guy on the Right!

Me and Ninjabetic at Roche Summit-Orlando 2010

Dinner at Medtronic Summit, Los Angeles, March-April 2011

After Medtronic, I Went to Hollywood hills for a Photo Shoot!

D-Myths (D-Blog Week, Day 5): What I'll Be Doing Post-Cure

2011-05-13T23:30:00.001-04:00

Today's topic for Diabetes Blog Week is Awesome Things Friday (see HERE for more). In February the #dsma blog carnival challenged us to write about the most awesome thing we'd done DESPITE diabetes. The topic challenges us to today, so we've been asked to put a twist on that topic and focus on the good things diabetes has brought us. What awesome thing have you (or your child) done BECAUSE of diabetes? After all, like Karen's blog header says, life with diabetes isn't all bad! (Catch my Diabetes Blog Week posts from Day 1, Day 2 and Day 3, and Day 4).

I just don't have it in me after a long week of work to approach that topic on a Friday night. Instead, today, I've decided to use one of the "wild card" topics, because even though I hate to say it, some of them are starting to sound a little on the repetitive side (I've got to call them like I see them). Besides I don't really think of anything I do in spite of diabetes as particularly awesome, because I don't really recall much of life before this disease. I remember bits & pieces, but the reality is that was 35 years ago and I was just a kid of 7 years old at the time.

The wildcard topic I'm going to go with: Let's PROVE some fun d-myths like #dprom (the prom for diabetics around the world), Sprinkles (the glittery unicorn of advocacy), or Blünt Lancet (the diabetic heroes of rock)! Choose one of these "d-myths" (or create one yourself) and take it someplace creative! Write about any "myth" or story-line you can dream up! Let's bring those "myths" to life!

Now, I've spent a fair amount of my blog content proving that there WILL actually be a cure for type 1 diabetes (someday), and providing evidence of progress being made towards that objective (see HERE and HERE for two such examples), even if it may be unaffordable if and when it does arrive. I really DO believe it will actually happen (someday), but I'm no longer convinced it will necessarily happen in my lifetime. The reason: I am 42 years old, and have spent 35 years of my life (or 83% of my life) living with type 1 diabetes. The odds are (and time) is kind of working against me.

But ... suppose all the cards did work out right, and one of the autoimmunity treatments JDRF investigated which failed today were re-examined, leading to a stunningly simple, inexpensive treatment for the autoimmune response that causes type 1 diabetes. With that major problem solved, a number of different regeneration and/or transplantation treatments would restore us to euglycemia for the rest of our lives, without ongoing treatments, costs or refreshers.

My D-Life, Post-D

What will I pursue? What will happen to the Diabetes Online Community that has brought so much joy to so many people living with diabetes? Damn good question!

First, let's note that I might be cured, but many people in the U.S. (and elsewhere in the world) will still suffer from type 1 diabetes (which is now a curable disease) simply because they cannot afford the $100,000 cure and insurance won't cover it unless you have a gold-plated healthcare plan. That's a function of the lame U.S. sick-care system, so for the immediate future after this cure is found, I will (and many others will) still have our work cut for us. JDRF Walks will still be to cure diabetes, but instead work to bring the cure to the many who cannot afford it. The good news: they remain as popular as ever, and they do a damn good job. Within 5-7 years, nobody (in the U.S. or Canada, anyway) diagnosed with type 1 diabetes will have to suffer because they cannot afford the cure.

By that time, I'll be in my early 60's, and approaching retirement. The good news is that I've planned pretty well for my retirement, so unlike much of the Baby Boom which is not well-prepared for retirement and planned to live on the equity in their homes, I should have enough to spend my golden years without too much worry about money. Yes, I will have to live on a fixed-income, but I should be well-prepared, and without a money pit like type 1 diabetes to worry about, I can spend my retirement years pursuing other causes with my time.

Top on my list will be working to prevent any chronic disease. Unfortunately, because medicine no longer cures any diseases, just treats them for perpetuity, there's plenty to do!

While some of the D-OC is still around to work on it, sadly, many have decided to become typical retirees, pursuing early-bird specials and moving to senior condo complexes in places like Florida and Arizona. But many retirees have been priced out of retiring in the U.S., so they stretch now their retirement funds further by moving to places like Costa Rica, many places in the Caribbean, the Philippines, etc. That's a reality. Fortunately, the internet exists in these places, so we still do periodic chats online (no longer weekly, but every few months).

While I work to prevent more chronic illnesses, time passes, and I'm getting old. I'm now a genuine senior citizen. Sadly, many of us are getting old. Some live with their children, others health is ailing for reasons other than diabetes. A few have Alzheimer's and no longer remember life before a cure, or even their families. They are still the minority. The rest of us reminisce about the old days before a cure, and before everyone had access to a cure. We still chat online, although nowadays it's video conferencing and we do it with our mobile devices which we wear like a visor.

Now I hate to think about it, but someday, we'll all die. But the days we complained about life with diabetes are happily a distant memory. We call them the "bad old days"!! But many of us still have "Sprinkles" stuffed animals sitting on our beds today to remind us never to let chronic diseases happen to anyone ever again!

Diabetes Blog Week Day 4: And Top on 10 Things I Hate About Diabetes Are ...

2011-05-13T13:05:00.007-04:00

Before writing today's Diabetes Blog Week topic du jour, I actually read a fair number of my fellow PWD's blog posts (see HERE for all of them) on today's topic (see HERE for the entire week's topics, and for my posts from Day 1, Day 2 and Day 3).

Today's Assignment: Ten things I hate about you, Diabetes – Thursday 5/12: Having a positive attitude is important ... but let’s face it, diabetes isn't all sunshine and roses (or glitter and unicorns, for that matter). So today let's vent by listing ten things about diabetes that we hate. Make them funny, make them sarcastic, make them serious, make them anything you want them to be!!

Interestingly, avoiding injections was not top on anyone's list -- in fact, fingersticks associated with testing are/were much more consistently mentioned. Yet, to those who do not live with diabetes, that's ALWAYS what outsiders believe we all want. Venture capitalists and angel investors in biotech companies seem to believe it, too, and they've poured millions (billions?) into largely failed efforts. I wonder when they'll get a clue?!

Sure, a few people with diabetes noted that they're sick of all the piercing, pricks, injections and the like, but it's almost always part of a combined dislike for all the bull$#!t that goes along with this disease.

Here's a news flash for investors: before investing money, try actually speaking to people who live with the disease, and if the investment involves the hormone insulin or insulin receptor ligands as they FDA calls them (meaning analogues), you had better be dam sure that you have appropriate representation for people who live with type 1 diabetes, because we constitute at least 75% of all the current insulin users according to the U.S. Centers for Disease Control (CDC), even though we're probably only 10% of patients with diabetes because there is no other treatment option.

This brings me to one the ten things I HATE about diabetes. While Picking just 10 is really more like picking the worst of many evils, I am sharing 10 of my dislikes about this disease.

Top on my list: widspread ignorance among the investment community about what constitutes an "unmet clinical need" (I'll give you a hint: don't only speak to doctors about this!). Avoiding injections usually isn't on the list, except among the newly-diagnosed who have yet to realize that's the easiest part of managing diabetes -- really. Also on that list should also be any new drug or insulin that delivers marginal improvement in glycemic control (were talking a few basis points in HbA1c reductions). Sorry, that doesn't warrant a big increase in expenditures, either, and with healthcare budgets under incredible scrutiny on a worldwide basis, it might make for a tough sell, too.

A recurring theme that seems to be routinely written-off, ignored or otherwise dismissed as insignificant actually WAS avoiding hypos. That means insulin that cannot cause hypos. Beyond SmartCells (see my interview with the CEO HERE, which was recently acquired by Merck last December (see HERE), there's at least one Canadian company working on it known as Dibecore Medical, Inc. of Toronto, although there have been few details about the company's Hypoguard Insulin which was still in preclinical trials. I have no other knowledge about this, so don't ask!

Beyond that, in no particular order:

2. Doctors who say "we" when discussing MY diabetes. You know the statements "How is 'OUR' diabetes?" or "What are 'WE' going to do about this HbA1c?" Please. I see my endo for rougly 15 minutes every quarter. He may make a few suggestions, but unless he's going to take responsibility for when things don't go right, don't try and get cute and call it "our" diabetes, when we all know they have little real ownership for it.

3. I'm stealing this next one from Kelly at Diabetesaliciousness(TM):

Insurance companies who dictate how many test strips a person is allowed to use per day.
NEWS FLASH: Diabetes is not a one size fits all disease, nor is it the same disease two days in a row.
Some day require more testing, PERIOD.

And speaking of insurance companies - SCREW your pre-existing conditions clause.
Being an asshole is absolutely a pre-existing condition but being an @$$shole doesn't get you penalized regarding a pre-existing health insurance clause.
Look, you can't tell me that being an asshole isn't a pre-existing condition, because I know for a fact that it is.

4. This next one is for all of my fellow PWD's who think they have broken pancreases and keep saying this. Guess what, your pancreas still works, only your islets and beta cells are broken. The beta cells which make insulin (and amylin) actually constitute less than 1% of the mass of the pancreas, and while we're accustomed to thinking about it this way, glucose metabolism is NOT the only function of the pancreas. It does a lot for digestion, too!

5. I hate biosynthetic insulin and it's analogues. I've written about this in the past, so I won't bore you with it here, but let's just say that today's insulin analogues are no closer to human insulin than porcine insulin many of us used without problems when diagnosed, and there have been a number of comprehensive meta-analyses (in the UK, Germany, and Canada just to name a few) on the clinical trials for all analogues, most of which raise questions just how much better this overpriced, new insulin really is. Some people like it, and I'm happy for them, but I did pretty dam well on the old stuff, and have suffered from hypo unawareness since this fancy new shit arrived. The UK organization the Insulin Dependent Diabetes Trust (IDDT) has a boatload of data supporting the evidence the manufacturers tried to bury. (see my book review of Invisible Frontiers for more HERE) They pulled the old stuff off the market for one reason: fatter profits. Fuck you, big pharma. I can't wait for tons of new competitors to start eating your lunch!

6. Test strips, their lack of accuracy and high price tags. The manufacturers make a tidy profit on this strips that aren't even all that accurate. They do everything in their power to make excuses on why they can't, when we all know it's about potecting the bottom line. That, along with the total cost of being a PWD. I'm not made of cash, and for whatever reason, the medical profession seems to respond to diabetes management with a "money is no object" behavior. I cannot even get a freaking CGMS monitor covered, and I had to fight to get my prescribed number of test strips. Any bets on what you'll go through to get an artificial pancreas covered?!

7. Insulin "Pump Evangelists". I didn't make this term up, but suffice to say, it's not a term of endearment. Many people love their pumps, but just remember, it does not eliminate diabetes and it IS possible to do just fine on multiple daily injections (I do, as do many people in Europe who love their insulin pens). See HERE for more background.

8. Did I mention all the $#!t I have to carry around? WTF. I'd like to be able to go out without carrying a fucking suitcase once and a while, diabetes. (For more, see HERE)

9. The mass market media. Editors who cut key facts from stories about diabetes to fit a headline in, while perpetuating misinformation. Soundbytes for the dumbing of America and people whose primary information comes from watching Oprah (the Dr. Oz diabetes debacle was on her watch).

10. I'm stealing this one from George "Ninjabetic" Simmons (see HERE): I hate you (diabetes) for the fact that the person reading this either has you or someone they love has you.

So there you have it, and although I just made it before midnight, Google's Blogger was not cooperating (don't believe me, see HERE) so this is going up late! Seriously, work is really keeping me busy this week, and blogging, while I enjoy it, has required a genuine committment from me this week, but I really have tried to participate.

By the way, this isn’t diabetes-related, but I cannot STAND people who send me Facebook friend requests (who I don’t even know) and don’t have the courtesy of writing anything in the request. If we’ve never met face-to-face, and I don’t know anyone you know, what makes you think I want to add you to my list of FB friends? That’s called common courtesy, folks!

Diabetes Blog Week Day 3. Major Dia-Blunders, Diabloopers.

2011-05-11T22:29:00.000-04:00

For today's topic in Diabetes Blog Week (see HERE for the different topics and wildcard subjects, and HERE for my post on the first day, and HERE for Day 2).

Whether you or your loved one are newly-diagnosed or have been dealing with diabetes for a while, you probably realize that things can (and will) go wrong. (that's part of life with a chronic disease) Sometimes the things that go wrong aren't stressful – instead sometimes they are downright funny! Go ahead and share your Diabetes Blooper – your "I can't believe I did that" moment – your big "D-oh" – and let's all have a good laugh together!!

I wish my bloopers were funny, but they usually aren't. But I've done them, and others might laugh at the sheer stupidity of them, or maybe empathize.

-Not being sure if I've dosed or not. That sucks, and I use waaaay to many test strips to figure it out. It's one time I wished I did use a Humapen Memoir or pump so I had a record of whether I dosed or not!

-Poking finger for blood test without putting a strip in the meter. Done that many times, usually I can just wipe it clean, put the strip in fast, and then squeeze my finger again. But it still sucks!

-Mixing up my Levemir and Humalog (dialing the wrong pen, just not paying attention) and taking a big dose of the wrong insulin. Luckily I test a lot and figured it out. But that resulted in an entire half-day eating sugar, Pepsi, apple juice ... you name it, even using up my glucagon pen, too (that's OK ... I guess it's better to use them once and a while!) Not fun, until it's done and can look back at it and laugh.

-Leaving home with an empty pen or no test strips. Done that, too. It blows, ruining the day. I have backups in the fridge at work, but it still sucks.

Anyway, there's been plenty of screw-ups over my 34 years with type 1, but I try to keep them to a minimum. Hopefully you'll find them funnier than I did at the time!

Diabetes Blog Week: Letter Writing Day

2011-05-10T21:40:00.004-04:00

For today's topic in Diabetes Blog Week (see HERE for the different topics and wildcard subjects, and HERE for my post on the first day). Today's topic was borrowed from a February Wego Blog Carnival that asked participants to write letters to their conditions.

Particpants can write a letter to diabetes if they'd like, but the Diabetes Online Community was also taking it one step further. The suggestions: "How about writing a letter to a fictional (or not so fictional) endocrinologist telling the doctor what you love (or not) about them. How about a letter to a pretend (or again, not so pretend) meter or pump company telling them of the device of your dreams? Maybe you’d like to write a letter to your child with diabetes. Or a letter from your adult self to the d-child you were. Whomever you choose as a recipient, today is the day to tell them what you are feeling."

Wow!! Really.

I wish this was the topic all week, and certainly on day one, because I could write letters to so many parties, which can be incredibly therapeutic in it's own right. My letter to type 1 diabetes would certainly NOT be a love letter. I love nothing about diabetes, and it has sucked so much joy and happiness from so many lives in spite of reasonably good glycemic management. You can have all the inputs correctly, and still not get the outcome it is supposed to yield. WTF is that all about? I would describe diabetes kind of like having a second anus that could not truly be controlled, so get your Depends adult diapers ready!!

But I'm not going to do that today. Frankly, I have sooooooo much going on at work that I will be spending most of my evening finishing up several projects that are due in the next few days. As a result, I may still revisit this idea of writing letters again when time permits, but today I am going to write a letter to the Diabetes Online Community. Read on for more ...

Dear Diabetes Online Community,

First, thank all of you. This community has provided me and countless other individuals with diabetes with far more than the medical profession acknowledges. Perhaps the biggest contribution has been, for me anyway, the mental therapy you provide. I don't have to explain how managing type 1 diabetes frequently does not follow rules it's supposed to. Or how doctors have this insane notion that simply following the rules will yield consistently predictable outcomes. Or why the clinical question medicine SHOULD be answering is not why so many individuals with diabetes suffer from depression, but rather why a majority manage to escape depression?

My letter tonight is short and sweet. But I appreciate all of you and hope that collectively, we will be able to someday prove the clinical worth of having a community such as ours. The benefits are indeed genuine, and we will prove it someday, even if we don't have a medical journal submission ready today!

Beyond that, I will continue to enjoy our daily Twitter communications, weekly chats via Twitter on Wednesday evenings, reading your blogs daily, the radio show on BlogTalkRadio, pehaps video chats online at MyMeetingHub.com (Note: MyMeetingHub's services were discontinued at 9PM on October 30, 2011, but alternatives have emerged, such as Google Plus Hangouts enable video chats for up to 10 people ... on the fly) ... who knows what tomorrow might bring?!

I really must sign off now. Stay tuned for another letter (or two) at some point in the future!

Regards,
Scott Strumello

D-Blog Week: Admiring Our Differences

2011-05-09T21:00:00.003-04:00

My friend and fellow college alum (the irony is we didn't really know each other until we met via the D-OC!) Karen Graffeo at "Bitter-Sweet" had an idea last year to do Diabetes Blog week and recruit a bunch of fellow diabetes bloggers to participate. Needless to say, last year's event proved to be very popular and successful, so she's decided to do it again this week, which marks the second annual diabetes blog week.

The topic du jour (Monday, 5/9/2011) is Admiring our differences. Although like last year, there is an option for wildcard posts within a few, pre-defined topic ranges. The basic overview of today's topic is as follows (in Karen's words): We are all diabetes bloggers, but we come from many different perspectives. Last year, Diabetes Blog Week opened eyes to all of the different kinds of blogs (and bloggers) out there – Type 1s, Type 2s, LADAs, parents of kids with diabetes, spouses of adults with diabetes and so on. Today let’s talk about how great it is to learn from the perspectives of those unlike us! Have you learned new things from your T2 friends? Are D-Parents your heroes? Do LADA blogs give you insight to another diagnosis story? Do T1s who've lived well with diabetes since childhood give you hope? Pick a type of blogger who is different from you and tell us why they inspire you - why you admire them - why it's great that we are all the same but different!!

I must admit that when I first began blogging about type 1 diabetes way back on September 15, 2005, I wasn't really looking for people who were different from me -- in fact, I was looking for quite the opposite -- I was looking for patients who were just like me, and indeed, I found them! Of course, in those days, the Diabetes Online Community was still very much in it's infancy.

For example, it would be a fair number of months before David Edelman of Diabetes Daily would create a widget with blog post "headlines" from fellow members of the diabetes blogging community, so in those days, simple blog searches and word-of-mouth were the way this community really began. Also, an early crash in the Diabetes Daily headline feed proved to me at least that my own blogroll would prove to be as important as a third-party source, a practice I have maintained since then!

Among the earliest bloggers I remember on the topic of diabetes included at least a few who remain with it today (more than six years later), although many of us have subsequently acquired our own domain names, changed hosts, blog designs and whatnot. Keeping track of all the changes is an ongoing job! I won't mention any names of the early bloggers specifically (I think most of you know who you are already) and we've been fortunate to have a dynamic and ever-expanding number of great new members in this community, each of whom have added in ways that are impossible to articulate in just a few words.

But the topic for today is more about admiring our differences.

Of course, here's where I may deviate a bit from Karen's perspective just a bit on the topic. My perspective as one of the d-blogger veterans out there is that collectively, I think the community has learned a lot more about respect for one another over the last 6 years.

In the early days, many (or all?) diabetes internet message boards would have regular debates (monthly or even weekly) about the differences between type 1 and type 2 and why one group didn't want to be associated with the other. Often, those debates would end up with insults or annoyances for failure to appreciate the challenges on either side of an issue, and just when I thought the debate had been put to rest, another one would re-emerge with the same basic discussion.

Learning From Each Other, and Hopefully Learning Mutual Respect

Since that time, I can say that I think the incidence of these "debates" have subsided dramatically. They still flame up every now and then, but it seems that the interest in participating in those debates has subsided a lot. Instead, I have seen a lot of growth within the community where even if participants don't share a perspective, today it doesn't end up (at least not as often as it used to) in insults or flame wars.

Much of credit for that, if I may be so bold, really belongs to two things: first, a few, brave type 2 bloggers who have gone a long way towards venturing in a community that so far, remains disproportionately stacked with type 1 bloggers. But as important, I think the community has collectively no longer seems interested in debating about which type of diabetes is more challenging or finds it easier to manage or take care of. The bottom line is clear (it should have been all along, but no one ever said there would not be a learning-curve, apparently): no person asked for diabetes, and while the challenges are unique to the individual in managing diabetes, it's a full-time job that never goes away. Similarly, no form of diabetes can be eradicated with some kind of diet or exercise plan. In fact, the medical establishment is clear that medically, cure may be defined as restoration to good health, while remission is defined as abatement or disappearnace of the signs and symptoms of a disease, hence at present, the only option for any type of diabetes is to put their disease into remission. In summary, the type 2 bloggers who have braved a blogging community that is disproportionately type 1s in the online community, as well as the community's willingness to hear different perspectives and lack of willingness to turn the conversation into a debate has enabled me and many others to admire our differences.

Collectively, I would say this has been one of the D-OC's greatest accomplishments to date!

D-Blog Week: Admiring Our Differences

2011-05-09T21:00:00.000-04:00

PWD's Not Crazy About Can-Am’s New Dex4 Packaging; Changes Being Tested Now

2011-04-22T12:00:00.001-04:00

With it being the midst of spring holidays, notably being the Lent/Easter Holy Week and Passover, I figured this might be an opportunity for me to do a little bit of looking back at some blog posts of the past, such as one I called "Easter Basket Case: Equal Sues Splenda" from April 2007. By itself, there's nothing remarkable about that post, so you may be asking what it has to do with my post du jour?

Well, I'll tell you.

Early in my old post, I referenced an even older post from the preceding Halloween [2006] (see HERE) where I revealed a then still-new competitor to the giant in that space (Can-Am Care) that continues to operate in the market for what we refer to as "glucose tablets" (elsewhere, including the UK, people call them "dextrose" tablets, which is basically the same thing). Which leads me into today's topic.

The difficult-to-open packaging changes on Can-Am Care's 50-count bottles of Dex4 glucose tablets (as well as many retailers who happen sell Can-Am's glucose tablets under their own brand names) plus the tubes of 10 tablets. The perfs on those plastic seals are tough to find and don't always work properly. Personally, I struggle to open those darn packages when I'm NOT hypoglycemic, and when I am already low, I really have to rely on an already opened bottle, or something from my stash of Smarties.

I take small comfort in knowing that many people across the Diabetes Online Community seem to hate the new packaging as much as I do. But like any good investigative reporter, I wanted to see what was really behind the new packaging from hell, who or what was behind the change, and whether we might find any relief from it.

Read on for more!

Can-Am's New Dex4 Packaging Leaves PWD's Unhappy; Changes Being Tested Now

Rocker and reality TV star Brett Michaels generously calls it a "pet peeve".

D-Blogger Bernard Farrell thinks the new packaging represents an area where design can be improved.

I'm talking about the nearly impossible-to-remove, heat-shrunk outer-plastic seals that now surround new bottles of 50-count glucose tablets, as well as the perhaps equally impenetrable inner-seal on these products. Sure, the packages are bright and colorful, and protect the contents, but they also make it damn tough to access the contents, too. That might be tolerable if a person was not in such a fragile state of condition as hypoglycemia, but too frequently, patients struggle to open the packages when they most need to access the contents with ease.

During the past year, Can-Am Care, which sells the Dex4 brand of glucose tablets, as well as private-label brands for such retailers as Walgreens, CVS, Rite Aid, The Medicine Shoppe, Good Neighbor Pharmacy, Walmart Stores, K-Mart, Target, Costco, Acme supermarkets, Jewel-Osco, Shaws/Star Markets, Lucky Supermarkets, Safeway Stores, Publix, Albertsons, Meijer and many others has revamped it's packaging, and more than a few people with diabetes are not happy with the changes.

Quite frankly, this is one package design modification that stinks, and rocker Brett Michaels admits that he struggles with it even when he isn't hypoglycemic, claiming that only "through sheer power, I tear the container apart to get to them" so you can just imagine what a person whose hands are literally shaking from low blood glucose levels thinks of the new packaging.

Supposedly, these changes are to ensure that the products haven't been tampered with. But was that really a widespread problem prior to the new packaging? I never read any incidents of tampering from the FDA or in the news, including the local press near Can-Am's U.S. headquarters in Alpharetta, Georgia (such as the Atlanta Journal-Constitution).

I was more than a bit curious whether the company had modified its packaging because a powerful, influential retailer like Walmart had pushed for it, or whether perhaps there was evidence of tampering that prompted the new packaging?! I wanted to find out, so I did what any investigative reporter would do: I made some phone calls, knowing that I had a high-level contact at the company if my own research was less-than-productive.

Reaching Out to Can-Am Care

I called Can-Am Care, LLC, the manufacturer of the most-widely sold brands of glucose tablets (as well as their awesome but expensive liquid blast products) in the U.S. and Canada and spoke with Cliff Durham who is the product manager for the Dex4 brand of glucose tablets, gels and liquid blast drinks. I told him frankly that I found the plastic seals to be a bit like breaking into Fort Knox. I also explained the challenge this can present when a person is actually dealing with hypoglycemia.

FYI: Can-Am Doesn't Actually MAKE Dex4 Products

Incidentally, you may not be aware of it, but Can-Am's tablets are actually manufactured by a contract manufacturer at a factory owned by P.J. Noyes Company, Inc. located in in Lancaster, New Hampshire, which is located in the northern part of the state near the Vermont border. (Robert Oringer, the President of AMG Medical, Inc., the Canadian investment company that actually owns Can-Am Care, shared the tidbit that their tablets are actually manufactured in New Hampshire with me when I met him in New York a few years ago, and I was able to uncover the specific details about exactly which contract manufacturer the company uses on my own; as there aren't all that many companies that do this sort of thing in New Hampshire, so it was actually pretty easy to find! See HERE for some additional detail).

Since this post isn't very long, I am going to include a short video from P.J. Noyes Company that talks a bit how they have evolved, thanks in large part, to their contract-manufacturing relationship for Can-Am Care including some scenes from the manufacturing assembly line; see HERE to watch it.

The Dex4 Product Manager Speaks!

I half expected that Can-Am Care would take my comment, but share little (or nothing) else. After all, I was the individual in the Diabetes Online Community that disclosed that a little-known New Jersey-based start-up known as Raritan Pharmaceuticals had started to chip away at Can-Am Care's dominant position in the glucose tablet market with their extremely popular "Tropical Fruit" multiple-flavored glucose tablets and has not only landed part of the enormous Walmart business, New York's Duane Reade drugstores (which was recently acquired by Walgreens) and more recently has landed deals with Royal Ahold's Stop & Shop unit just to name one (those retailers also continue to use Can-Am Care's products too, as these are not exclusive supplier arrangements). This is a very competitive business and companies from Smarties (see HERE and HERE for more background) candies, to SweetTarts, to Coca Cola and Pepsi, juice boxes and countless other sugar-laden food products that are so ubiquitous in U.S. society today are all viable competitors.

Retailers are most concerned about what sells, at what price, and whether their suppliers can meet the demand. Can-Am Care came back with it's own mixed flavor varieties, but their flavor selections in these mixed flavor containers (which contain cherry which I'm not a big fan of, as well as sour apple which is just gross -- why not just drink regular apple juice?), quite frankly, leave something to be desired.

Can-Am's website indicates "We have devoted countless hours and resources to support our customers, suppliers and partners in their efforts to improve quality and safety. FDA-registered manufacturers, who meet or exceed the Quality System Regulations, supply all of our products." I wanted to see if that was just words, or if the company actually stood behind those words.

Ultimately, I was connected with Mr. Cliff Durham, who said he was the Dex4 product manager. He was very candid in telling me that I was not the first person with diabetes to contact the company and express these concerns about the less-than-friendly-to-PWDs packaging. But he also admitted that the retailers were at least partially behind the change, demanding brighter, more colorful packaging to stand out on their shelves, and to help reduce shrinkage. On the latter point, retailers don't want packaging that can open easily on the shelves, or is messy, and suppliers usually do what it takes to keep their retailers happy. After all, a company that relies upon third-parties to distribute it's products needs to keep those relationships going! Mr. Durham shared with me that the company has indeed heard from plenty of people with diabetes and their comments have NOT been been ignored.

Changes to Dex4 50-Count Containers Now Being Tested

While we should not look for new packaging in the next few months, he did indicate that they have been testing a number of changes to the packages.

What kind of changes?

He did not give all of the specifics, and they are still testing them now, but I am told that we could see the plastic outer seal around the TOP part of the containers disappear altogether. Another alternative packaging change now being tested is some changes to the perforations on the containers. If that's the design change that is ultimately selected, he hinted that the inner seal might disappear altogether since it is indeed redundant.

So when can we expect to see one of these changes?

Well, it may take a few months for the existing inventory to be used up. But Mr. Durham hinted that sometime in the next 4 to 6 months, consumers may begin noticing some changes to the packages of glucose tablets. Higher-volume retailers like Walmart may see the changes sooner than lower-volume retailers, as their inventory turns over more quickly.

For some PWDs, including Brett Michaels, these changes won't be implemented a moment too soon!!