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!!
Friday, April 22, 2011
PWD's Not Crazy About Can-Am’s New Dex4 Packaging; Changes Being Tested Now
Monday, April 18, 2011
Medtronic Visit Update
I know I've been a total delinquent when it comes to writing about the Medtronic conference I attended (or writing about much anything else), but I'd like to share some of the things I took from the Medtronic North American Diabetes Advocacy Conference on April 1, 2011.
As I already disclosed, I travelled to Los Angeles as did a number of other diabetes advocates (that's how our host, Medtronic Diabetes, referred to us, although the Diabetes Online Community, or "D-OC" is the term many have unofficially adopted to describe ourselves collectively). Medtronic actually has their own blog post with photos from the event which can be visited HERE.
The agenda was not shared with us until the day before we travelled. I presumed it would be somewhat similar to what took place with Roche (another event I attended, see HERE for more on that event), where we introduced ourselves and what we've done in the diabetes space, then our hosts did the same, and perhaps had some conversation about issues impacting both us as patients, and Medtronic as a company operating in the space. That was mostly the case, although we as diabetes advocates did not have quite as much involvement (initially) as I might expect a medical device company would want from us. Not that it stopped anyone from chiming in; this group isn't (and wasn't) exactly shy about asking questions!
Karmel Allison from "A Sweet Life" already covered many of the items I was thinking of, so rather than simply rehash those, you may visit her excellent write-up of the conference at http://goo.gl/aLrje.
Holding Onto Leadership In An Evolving Pump Market
I often write about "The Business of Diabetes" (which is collectively an industry valued at billions of dollars in sales per year on a worldwide basis). Medtronic (Minimed) Diabetes is pretty much the market share leader in the insulin pump space, as the first-to-market for commercialized insulin pumps (with about 70% share of the U.S. market), and while the company defends it's leadership position (and having longstanding contacts and processes with hundreds of insurance carriers does make the company a force to be reckoned with), there is no lack of competition eager to capture a slice of the growing insulin pump market, and some nimble startups have captured a slice of the market Medtronic has not really considered: people who hate pump tubing. (More on that in just a minute ...)
But the insulin pump market is evolving.
Notably, many consumers are moving from multiple daily injections, but the key to their making the move may not be the same as what it used to take to lead in this space, in part because those are confirmed expectations today. Specifically, pump reliability is expected, as is excellent customer service if there's a problem, and any company that wants to compete absolutely must work with insurance companies to get coverage. But today, other factors like product design and ease of use are becoming more important to newer buyers, so pump makers must evolve, too.
Growing Market for Insulin Pumps Lures New Competition, Innovation
Medtronic's insulin pump competiton includes longtime rival Roche which began as a Swiss company formerly known as Disetronic back in 1984 and entered the U.S. insulin pump market in 1991, but has since been expanded to include a startup firm planning to market a new, tube-less pump with some new features (like the ability to bolus without the remote control -- gee, has anyone ever misplaced a remote?!) known as Mendingo Solo (see http://www.solo4you.com/ for more) which Roche acquired last April ... I can only hope that Roche does NOT try to rebrand it AccuChek, since insulin pumps don't actually CHECK anything). Others include Animas/Johnson & Johnson which has considerable resources at its disposal to compete effectively; a Japanese-owned company named Nipro Diabetes Systems (which last year acquired a Florida-based company formerly known as Home Diagnostics, Inc. best known for making low-cost meters and strips sold under various pharmacy chain's brand names, see HERE for more details on that acquisition); a Korean firm named Sooil (banded as Dana in the U.S.) Diabetes Care -- perhaps best known for selling a relatively low-price traditional pump (the kind with tubing). Another firm known as Smiths Medical which previously marketed the Deltec Cozmo pump decided to quit the insulin pump business in March 2009. More recently, an innovative Massachusetts startup known as Insulet Corp. whose Omnipod is a disposable pump without tubing has arguably paved the way for others wanting to enter the market. Unlike the others, Insulet relies almost exclusively on contract-manufacturers to bring it's product to market.
These are just the firms presently operating in the space, but several more have expressed interest to join the fray, including Tandem, Cellnovo and a joint-venture to be branded as "Jewel", all aiming to become players in the insulin pump space. I was not really surprised that Medtronic was unwilling and/or unable to share anything they might have in their development pipeline; technically, the FDA prohibits the marketing of devices that aren't yet approved, although discussing the wants and needs of patients is really not marketing, but market research). Karmel Allison correctly notes that Medtronic most likely has it's work cut out for it.
As I noted in my comment on Karmel's post, back in the days when I was still wearing an insulin pump (in the mid to late 1990's, see HERE for some more background), I decided to go with a Pennsylvania-based startup known as Animas which began in 1996. My reasons were entirely rational: back then, Minimed was still selling the 508 pump, and the smallest basal rates on that model, if you can believe it, was a whopping 1 unit/hour -- enough to make me hypoglycemic with all that insulin delivered every hour. I've always had minimal basal insulin requirements, as 90% of my total daily dosage was (and still is) prandial (mealtime) insulin. If I don't eat, I have almost no need for insulin except in the hours before I wake, sometimes called the Dawn phenomenon, but technically, even that's not entirely accurate. The notion that individuals require so much basal insulin isn't technically factual, because if I don't eat any protein, my basal needs decline precipitously. Proteins are metabolized into the bloodstream much more slowly than carbohydrates, typically they take 6-8 hours to be converted to glucose that the cells in the body can use. The notion that half of one's total daily insulin dosage should be basal actaully caused my first day on an insulin pump to be filled with hypos.
I called my CDE the day after starting on an insulin pump, shared my experience with her, and she admitted that the guidelines were only recommendations but that clearly did not work for me. My basals were cut to the lowest possible level (as I already mentioned, at the time, the Minimed 508's lowest basal rate as 1 unit/hour, but the Animas pump I chose enabled basals in 1/2 unit increments, and even that proved to me more than I required). Today, pumps enable delivery in tenths or even 100ths of a unit, so clearly, much has changed over time!
For the past decade, there have been a number of startups which have emerged, and likely more will come come given the size and appeal associated with this market (for companies, that is). At least 1 company changed it's mind (Deltec Cozmo, anyone?), but other newcomers have proven to be been pretty fierce competitors with innovative design.
Startups Expand The Pump Market Overall, Not Necessarily Steal Customers From Medtronic
In my assessment, the nimble startups haven't so much stolen market share from Medtronic, but have expanded the overall market to include consumers who might not otherwise consider an insulin pump.
Most notably, I'd point to Insulet Corp. whose tube-less Omnipod system now has an estimated 10% of the global market for insulin pumps. Unlike most of it's competition, Insulet relies almost exclusively on third-parties to make most of it's product. Notably, a Singapore-based company named Flextronics International Ltd. actually manufactures the disposable Omninpod pod-pumps in accordance with their design secifications at a partially-automated manufacturing line in China, and a Wisconsin-based firm named Phillips Plastic Corp. manufactures and supplies a number of injection molded components, while an Austin, Texas company named Freescale Semiconductor, Inc. makes and supplies the application-specific integrated circuit for the OmniPods. This business model has some clear risks, but also enables Insulet to operate as kind of a virtual company.
I should also use this opportunity to add that on March 31, 2011, one of Insulet's co-founders, John L. Brooks, III, was recently named President and CEO of the well-known Joslin Diabetes Center (see HERE for more). Mr. Brooks has been Joslin's acting CEO since Joslin's prior CEO retired in October. Mr. Brooks had not been working at Insulet for several years, but is once again back in the diabetes spotlight with his new role at Joslin.
Medical device giant (which is based in Minnesota) Medtronic pretty much bought it's way into the insulin pump business by acquiring Minimed, which was founded by Alfred Mann (the same guy behind MannKind which hopes to commercialize Afrezza inhalable insulin) back around 1980 or so, and Medtronic bought Minimed in August 2001. Medtronic recognizes the challenges facing it's business, and has brought in a number of new executives including Dr. Francine Ratner Kaufman as Vice President of Global Medical Affairs in 2008.
In Dr. Kaufman's position, as I understand it, she is responsible for much of the research that the company requires to seek approval from regulatory agencies around the world -- which is no small task. In addition to her, the company has also added some expertise from outside of the medical field which I found impressive. Specifically, Lane Desborough was hired as a product strategist for Medtronic. He spoke about process control in a way much like my brother-in-law does, and Mr. Desborough has worked for a number of companies developing closed-loop systems for companies such as GE and Honeywell (unrelated to medical applications). But he has a personal connection to diabetes, with a young son trying to manage diabetes and sees the benefits of a closed-loop in this instance. Mr. Desborough's perspective brings expertise on how other, unrelated industries have responded to various regulatory and profound market changes of the sort now facing Medtronic's insulin pump business.
Dr. Kaufman Proves Non-Inferiority for Insulin Delivery Shut-Off Function; I Ask: When Will the FDA Buy Into It?
I've known about Dr. Kaufman as a well-published endocrinologist. However, like so many former ADA Chiefs, I find her "get on the diabetes control bandwagon" a bit too intense for my liking. I realize many PWD's do not adequately manage their condition, but that's as much a public policy issue as it is a medical issue, and placing most of the blame on patients for a pretty dysfunctional medical delivery system is a tad misplaced in my opinion.
Some of us in the community of people with diabetes would like to change the mindset in the medical profession to shift the focus away from ineffective and unsustainable scare-tactics which were so prominent in Dr. Kaufman's book Diabesity. For, example Riva Greenberg touched on that in an eloquent Huffington Post story (see HERE). Speaking of Riva, I really loved the quote from Diabetes Research Institute's Dr. Camillo Ricordi's quote when he told Riva Greenberg "It's easy to think diabetes is acceptable if you don't have it". OK, I've deviated off topic yet again. Anyway, back to Dr. Kaufman's presentation ...
I listened to Dr. Kaufman's presentation, and at first, I must admit that I was more disturbed by the the company's use (the term data mining readily comes to mine) of patient data for commercialization purposes (I have long been a privacy advocate, such as my fighting the NYC Department of Health and Mental Hygiene's involuntary registry of HbA1c results for patients with diabetes -- see HERE, HERE, HERE, and HERE for some background on that) -- I did not win that battle, and the guy responsible for that egregarious breach of personal privacy is now heading the U.S. Centers for Disease Control (we were on TV together, see HERE for that news clip from Canada's CBC). Ironically, the City of New York Department of Health and Mental Hygiene has yet to show any compelling link proving the benefits to that registry and invasion of patient privacy.
However, in the case of Medtronic, patients DID sign away their rights to the data (whether they realized it or not -- that's a separate conversation). However, as I listened, Dr. Kaufman presented a VERY compelling story with with all of that data. I listened closely and found her presentation on the pump suspend function when hypoglycemic to be absolutely riveting.
Dr. Kaufman really didn't need all of that data to convince me of the logic, yet what she was doing is walking us through the story they as a company are using to convince the FDA on why it makes sense and is really more of a safety feature. So far, the FDA isn't moving! The FDA's logic on this makes no sense whatsoever, at least in my mind.
Oath of Hippocrates: First, Do No Harm.
The Hippocratic Oath is first and foremost about doing no harm, yet the FatalFood and Drug Administration (FDA) which is staffed by so many doctors, seems oblivious to this. I find it troubling that regulators at the FDA could be so mirculously blinded to genuine short-term risks of intensive insulin therapy (namely, hypoglycemia), or at least they seem only too willing to overlook those risks over worry about longer-term dangers.
In my mind, having a suspend function on an insulin pump should only be considered as a safety feaure, not viewed as some kind of risk. This does not introduce a new risk, but does help eliminate an old risk of a drug category (insulin) that is responsible for sending some 56,000 people with diabetes to the Emergency Room each year, mostly due to hyPOglycemia, not hyPERglycemia (see HERE for the story I did about that referencing the Journal of the American Medical Association citation where these stats were attained). I was left wondering just how many reminders this agency needs of that?!
Strange Logic: Why the FDA needs to be Convinced that Delivering Even More Insulin to Someone who is Already Hypoglycemic is A Safety Feature
The FDA's fixation and senseless worry about anything that could remotely even slightly INCREASE glycosated hemoglobin (a.k.a. "HbA1c") seems almost like using a dirty word to this agency. The FDA sees that as artificial intelligence and has to be convinced that can be done safely.
I have already written about how the FDA rushed-to-market biosynthetic human insulin back in 1982 which has almost killed countless patients including me. Indeed, an entire organization based in the UK called the Insulin Dependent Diabetes Trust (IDDT) has made a mission of addressing a number of the facts the FDA has conveniently swept under the rug (and has worked very hard to keep them there) to enable the biotechnology industry under it's watch to flourish.
Notably, a former FDA employee named Henry I. Miller actually admitted (OK, he bragged) in his book that he single-handedly ushered in the U.S. biotech era by waiting for his boss to go on vacation, and then took Humulin's (rDNA origin) approval to his boss' boss, who then approved the drug without a thorough review of the drug's adverse impacts in clinical trials. True, a vast majority of patients do not experience these problems, but some 10% do -- isn't doing harm to a minority of patients a violation of the Hippocratic Oath? But this post isn't about Henry Miller, it's about Medtronic and what the company is trying to convince the FDA of, and what the company shared with those of us who attended their recent conference.
Having a suspend insulin delivery during function during hypoglycemia (especially nocturnal hypoglycemia, which keeps many parents of kids with diabetes up many nights, not to mention spouses and partners of adults with this disease): sounds perfectly logical -- except to the FDA decision-makers.
Based on the FDA's sordid history on that not-so-little issue, I find the agency's stance on the artificial pancreas and the suspend insulin delivery function to be nothing short of miraculous.
Yet, in the strange world the FDA operates in, the reviewers see this functionality as crossing some sort of mysterious line for artificial intelligence on drug delivery devices, and they've been unwilling to specify what criteria they will use to evaluate such functions.
As I've noted, ordinarily, I woundn't be rushing to defend the so-called artificial pancreas because I feel all of the time, money and effort spent on this initiative might have been better allocated to an area like autoimmunity research, which remains starved for research funding. I was also not crazy about a company data-mining patient's results, but after seeing the FDA's position on this, I was actually quite glad Medtronic had access so much patient data and could use it, because Dr. Kaufman and colleagues have so much, rich data to build a compelling case for the FDA on why the FDA needs to abandon it's almost exclusive use of surrogate endpoints (meaning HbA1c) to make what is such a common-sense decision: to suspend insulin delivery when a patient is hypoglycemic.
This should NOT be viewed by the FDA as being some sort of ethical dilemma, yet the agency is depicting it that way. Today, the technology already exists to combine a continuous glucose monitoring system (CGMS) and an insulin pump to to this, yet the FDA remains fixated on anything that might contribute to an HbA1c increase. Nevermind how many more lives could be saved during the middle of the night while the remote risk of complications which may (or may not be; there's already some data suggesting that glycemic variability, as well as inflammation associated with autoimmunity in addition to hyperglycemia may be behind these complications that are basically presumed to be due to sustained hyperglycemia) due to hyperglycemia decades from now. So Medtronic first built a case that the suspend function is not inferior (a noninferiority study) to user-controlled functionality by itself.
Dr. Kaufman's presentation eloquantly validated what is already approved by the European Medicines Agency (EMEA) and is already permitted for patients in Europe: for an insulin pump's delivery of insulin to be suspended automatically (without patient intervention) during hypoglycemia.
If a continuous glucose monitor detects a hypo, the device should instruct the pump to stop delivering insulin, which would make a person's blood glucose level drop even further. It all makes perfect sense, unless you are the FDA. The FDA is charged with keeping patients safe, or at least that's what the agency claims. So one should be asking what logic they're using when they argue that suspending insulin delivery during a hypo would adversely impact a patient's HbA1c, and that it crosses a line on artificial intelligence for drug delivery?
Note that the FDA has pretty much been on autopilot when it comes to ALL diabetes drugs that should reduce HbA1c and that's all that has ever needed to be proven. I would also remind my readers that the FDA approved, then changed it's mind, on type 2 drugs like Avandia which indeed reduced HbA1c (never mind that it increased cardiovascular events, that wasn't the "surrogate" endpoint they needed to look at to evaluate diabetes drugs of any type). But the FDA claims that only human beings should be making decisions on insulin delivery, and that machines are not ready to do so and should therefore NOT be permitted to do so, all in the half-baked name of patient safety.
Under what criteria is it EVER safe to permit a device to continue deliver a drug (insulin) that the agency knows will continue reducing a patient's blood sugar when it's already too low, especially when the agency has data to show it should temporarily stop doing that?
While awake, for example, a patient CAN override such a recommendation if they want it to continue delivering insulin. What device makers and the JDRF want is to enable the device to stop delivering insulin when they have data to show that it would be harmful, such as when the patient is sleeping.
Using data from a boatload of real patients, Medtronic actually has data to prove noninferiority for the suspend function during hypos.
Now, we just need to convince the FatalFood and Drug Administration they need to go along with it. Medtronic is quite confident they can convince the FDA to go along, and they have a LOT of data to prove it. Now they just need the FDA, which is a bit gun-shy thanks to scrutiny for approving dangerous drugs under the former leadership of Andrew von Eschenbach, now wants to prove it's looking out for the best interests of patients. But don't do that at the cost of making WISE decisions, Ms. Hamburg (who is the present Chief of the FDA) -- please!
The JDRF's Government Advocacy Website actually had a page to address Artificial Pancreas Guidance that's still worth visiting.
I've always been only luke-warm to the idea of an artificial pancreas because the JDRF has repeated failed to disclose how much of fundraisers' money they've spent on the project which will ultimately benefit for-profit companies as much (if not more) than it will patients who still struggle to get insurance coverage for fancy new devices. The FDA has yet to say what it will be looking for when they are submitted for approval. The JDRF's new CEO Jeff Brewer has told the press he donated $1 million of his own money for the project, but why the organization cannot disclose this remains a mystery to me, unless they've gone way over-budget on this project and are now embarrassed to disclose that information.
BUT ... I do think that the FDA owes it all Americans for clear guidance on exactly what criteria they'll be using to evaluate such a device so that device makers can actually meet that criteria. When the criteria is nebulous, hazy and vague, it's almost impossible for any company to adequately address that. It's a bit like trying to study for a test when you don't know what the subject matter will be!
The JDRF's advocacy recently asked lawmakers to write to FDA commissioner Margaret Hamburg to provide clear guidance on what things they'll need device-makers to provide to agency with in order to get an approval. Visit http://takeaction.jdrf.org/apfda where there's more info. The great news is that thanks to JDRF Advocacy efforts, on Wednesday April 13, 2011, the House letter closed, but 240 House Representatives had signed on (see HERE to see which members signed)! That number is well over a majority for that chamber. The Senate letter to the FDA remains open, so JDRF Advocacy is asking everyone to please call their Senators today and urge them to sign on.
It's not asking for the world here, only for some clarity on the criteria the FDA will be using to make it's decision on these devices so applicants may address these things. Is that really asking for too much?
My voice alone isn't enough to move the FDA, but collectively, we CAN convince them! We have influenced this organization in the past, such as on the guidelines for diabetes drugs that came out a few years ago, and I am certain we can do so again, but we need to act collectively!
I hope to address some of the other highlights from that conference in another post (such as the tour of their sensor manufacturing facility), but I hope that my readers -- whether they support the artificial pancreas project or not -- will still see the logic in advocacy to help push the FDA to outline what they will be reviewing on these devices and why it is important!
Tuesday, April 12, 2011
Realistic Limits of Glycemic Management?
There's a lot of talk these days within medical profession, and among healthcare providers, lawmakers and public policy wonks about chronic diseases and diabetes (mostly, they seem to talk $#!t about diabetes -- and much of what they say is either wrong or only partially correct, but the belief among some self-appointed diabetes advocacy organizations comprised exclusively of doctors or nurse educators) seems to be the old saying "there is no such thing as bad publicity except your own obituary".
To be sure, this conversation is not without reason: according to the U.S. Centers for Disease Control and Prevention (CDC), chronic disease now accounts for about 75% of the nation's aggregate health care spending -- or somewhere around $5,300 per person in the U.S. each year, and it's growing more expensive each year (see HERE for more). But "medicine" (a collective term I use to describe the medical profession, the drug/biotech industry and various other related professions and industries) has only actually CURED a handful diseases overall. Increasingly, the modus operandi (M.O.) for everything in medicine, whether it's cancer, AIDS, Lyme disease, or heart disease seems to be to transform once fatal-conditions into permanently chronic ailments. From a business perspective, this makes perfect sense.
But at the same time, the medical profession has managed to deflect much of the blame away from their own failures to patients instead, often with condescending comments to the effect that "his or her failure to adequately manage their condition(s) was responsible" with the very expensive (without much regard for cost) and too often, less-than-adequate tools which are overpriced to begin with. We are living in an age when so many people seem to have chronic ailments, and increasingly, more and more will have multiple chronic ailments, all of which will require multiple, ongoing treatments until they die. At least a few cash-strapped states are, in effect, hoping people with chronic ailments will die because their deaths would cost taxpayers less than keeping them alive (see HERE for an example). Supposedly, the U.S. is more advanced than other countries, yet when it comes to healthcare, U.S. taxpayers might receive better care with our dollars in Mexico than we would in the U.S. -- go figure that one out (if you don't believe me, visit PatientsBeyondBorders.com for more quantifiable details, and for more behind this trend, see HERE).
The basic arguement when it comes to public policy is that unless chronic disease spending is controlled, then there's simply no way to reign in runaway healthcare spending. That is a seemingly rational conclusion -- but vastly over-simplifies the situation to a short tagline, and the situation is far more complex than that. Indeed, organizations such as the Partnership to Fight Chronic Disease (PFCD), which calls itself a "coalition" committed to raising public awareness of the issues related to chronic diseases has made that a cornerstone of it's strategy.
Not surprisingly, diabetes is one of the 5 chronic diseases (the others are heart disease, cancer, stroke, and chronic obstructive pulmonary disease) that fall into the organization's dialogue, even though heart disease and stroke are every bit as preventable as many cases of type 2 diabetes are, yet those speaking about diabetes seem to give diabetes its own special category because it's widely portrayed by the mainstream media as more of a character flaw than a "legitimate" disease. Shame on them!!
While it's true that chronic diseases contribute to contribute a disproportionate share of healthcare spending, what PFCD fails to acknowledge is that historically, no society has ever been able to PREVENT its way out of an epidemic already underway! At best, we can try to contain the losses and take corrective steps to prevent it from happening again in the future, but that requires action -- something the organization has been remarkably short on. So far, their efforts seem to have done more to fight patients with chronic disease, rather than address the root cause behind the problem. On the prevention score, perhaps their efforts on this front can prevent another epidemic from occurring, but as for the diabetes epidemic already underway, they seem blissfully igorant of the fact that treating diabetes itself is nowhere near as expensive as paying for the health complications of uncontrolled blood sugars, and that our healthcare "system" (a term I use very loosely) does a remarkably poor job of coordinating care for people who already have diabetes, and statistics back me up on this.
A November 17, 2008 editorial in The New York Times summarized it all in less than a sentence: the U.S. is "The Wrong Place to Be Chronically Ill" which cited a study I also mentioned a previous posting a while back. According to at least one international comparison, the U.S. ranks well below virtually every other developed nation on it's care for chronic diseases, hardly something the U.S. can brag about when trying to call itself a "world-class" healthcare system.
It's sad and ironic that insurance companies will readily pay for surgery for, say, amputations necessitated by unmanaged blood glucose levels -- often without as much as a preauthorization requirement, or even a co-payment -- yet will place numerous, challenging restrictions on patients trying to get coverage for their basic treatment needs -- all done in an effort to save the insurance companies money. For example, testing supplies often are limited, and/or restrictions are placed what will be covered, and payments with high co-payments and supplier restrictions and/or brand requirements, resulting in patients having to jump through hoops to get such basic tenets of self-care even covered. Consequently, many patients simply give up rather than deal with numerous appeals for coverage they are often rightfully entitled to. Unfortunately, U.S. Healthcare "reform" does not seem to be reforming any of those not-so-little cost issues, but we should acknowledge that it IS a work in progress, and refinements will no doubt be required over time anyway.
Fact: Private Insurance Has Little (If Any) Genuine Financial Incentive to Ensure Good Long-Term Patient Outcomes
While some might be shocked to read this, part of the challenge is that long-term health outcomes are really a non-issue for the average healthcare insurance company. As a result, it makes more financial sense to place such limits on a costly component of routine self-care becuase it impacts the bottom line immediately.
Why are long-term outcomes a non-issue for heath insurance companies?
Because, as their actuaries will tell you, odds are, the average person will switch carriers 5 or more times before they're ultimately covered by Medicare, at which point, they effectively become healthcare wards of the State with government-funded healthcare. (Some in Congress want to gut that, too). As an insurance company, their job is to keep the person healthy enough to avoid any costly catastrophic expenses, all while limiting the expenses incurred to do that. Anyone who believes the insurance industry has a vested financial interest in keeping people with diabetes healthy is likely suffering from a condition known as wishful thinking -- it just isn't so!
Odds Are Great Complications Won't Set In Until Patients Are Covered By Someone Else, or Even Better ... Medicare!
As a result of this peculiar system, there is every incentive to minimize the line items on expenses for these basic care/supplies, because odds are pretty small that this person will be with this same insurance company for life. Any complications will likely be incurred by someone else (such as Medicare). People regularly change jobs, they move, their companies switch healthcare providers, etc. Its more about managing the odds that those big expenses for treating complications will occur under their coverage, and that's a risk that insurance companies can manage. Of course, increasing industry consolidation increases those odds, which is one reason costs have continued to outpace the rate of inflation, but flipside of that equation, meaning the benefit of maximizing the risk pool with a larger base of customers, is as you might expect, not exactly shared with patients.
Public Misinformation About Diabetes Adds to the Challenges To Effectively Address the Problem
The mainstream media have played a huge role in helping to make things this way, and the Oprah Winfrey Show debacle in 2010 (see Sheri Colberg's well-written commentary from a medical perspective at Diabetes in Control on that, or Riva Greenberg's eloquant commentary on the Huffington Post from a patient perspective HERE for more on that) did very little to clear things up, and probably added to the existing misconceptions, making them harder to resolve. Instead, the "Big O" tried to do what 75+ years of the same scare tactics have completely FAILED to do: translate treatment recommendations into actionable recommendations that can be widely-utilized by patients, and in the process, she also continued to perpetuate misinformation in the process.
In many respects, type 1 diabetes is unique among diseases in that it was really the first disease transformed from a fatal disease into the world's first chronic disease. But while insulin, hailed in 1921 as a "cure" for the disease, was later redefined as only a partial victory against the disease (it falls short of restoring patients to the health they had before the disease struck, and too often ends up with so-called disease complications many years later). While patients can and do live long reasonably healthy lives with the disease, fixation on glycemic control is seen by critics as a misplaced priority that has many practical limitations that the medical profession does not seem to want to recognize. In fact, the medical profession didn't even agree on the merits of glycemic control until the DCCT concluded in the late 1980's, followed several years later by the UK Perspective study on type 2 diabetes. But with those two studies, most of the medical profession shifted its focus and efforts away from disease eradication to glycemic control, and the manner that healthcare delivers care in a HMO/PPO dominated landscape has only recently been looked at, and the news so far so isn't so pretty.
Funding Disease Management at the Expense of Disease Prevention
Glycemic control, along with improvements in treatment (not only for the symptoms of diabetes itself, but also treatments for a number of different complications) has helped to solidify the public fixation on glycemic control. But that same fixation on glycemic control has simultaneously occurred at the expense of preventative measures that might have helped prevent (or at least help minimize) the diabetes landslide that now faces not only the U.S., but most of the world (including such places previously better known for starvation as India and China).
That disconnect needs to be reconciled, and I hate to say it, but we're really a day late and a dollar short for that. Those investments should have been made decades ago, but they weren't, and while they need to be made now to prevent many future cases, it's really too late to prevent our way out of the epidemic already underway. We now have to reap what those lack of investments decades ago have sowed. That's where there's a really big disconnect.
To be sure, glycemic control has reduced (and will continue to save) billions in medical expenditures, but glycemic control comes at a price, too -- its definitely not free as many naïvely seem to believe -- and cost-sharing has been disproportionately been placed on the patients, rather than the healthcare providers, although as I reported (see HERE for more), at least one provider (United Healthcare) seems to be rethinking that strategy, albiet with only with a handful of it's biggest clients, right now. But their findings could pave the way for some real, necessary changes if they turn out positive. And in the U.S., our healthcare "system" (a term I use very loosely) was really built to treat acute illnesses, not chronic illnesses -- which incidentally, are growing very rapidly, as medicine has transformed many once-fatal ailments such as cancer and HIV into chronic diseases without actually curing them.
Limitations of Glycemic Control Seldom Acknowledged
Consider one of my all-time favorite posts, by Scott K. Johnson entitled "14 Chips?" (see HERE for the practical implications). Over the last 24 years, I have met with many nutritionists who boldly claim it can be done, yet relatively few have themselves lived with their own recommendations, which is a problem -- but I've also had several who had type 1 themselves and they admitted their recommendations are far from scientific. Those who do seem to acknowledge that much of the recommendations are just that, but face practical challenges that really don't work well in our busy, increasingly mobile society. In the days when every meal was eaten at home, it was somewhat easier to deal with, although in an effort to address the nation's obesity epidemic (which, BTW, is a different challenge from it's diabetes epidemic, as many obese individuals do not have any form of diabetes, and the two often do not go hand-in-hand, in fact, obesity is now seen as the body's innate protection from a nutrient-dense diet without corresponding energy expenditure), disclosure for nutrition facts, and regulators walk a tightrope in trying to weigh how to properly disclose those facts with how they are delivered, while not suggesting that Americans consume MORE calories. This year, the U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) jointly issued and updated Dietary Guidelines for Americans (DGA), which are updated every 5 years. Theis year, those guidelines provided advice about consuming fewer calories, making informed food choices, and being physically active to attain and maintain a healthy weight, reduce risk of chronic disease, and promote overall health -- for the first time EVER.
But many believe the recommendations have continually been weakened by the food processing industries. In fact, in February, I REPORTED that a doctors group sued the USDA for conflicts-of-interest over the new DGA. Although it was a somewhat radical group (doctors seeking to promote a vegan diet) who filed the suit, most other doctors pretty much disregard the new U.S. DGA altogether, in spite of the guidelines' major influence on everything from school lunches to the kinds of foods carried by large U.S. supermarket chains.
Practical Challenges to Glycemic Management
We need a more realistic examination on the limitations of glycemic control (I prefer the term "management" because patients only control a few of the many variables that can influence blood glucose levels), especially in the context of how healthcare is actually delivered in our society. If and when that is done, the conclusion might be that many patients are likely doing what can be done with, and so far glycemic control, but those limitations, if they haven't already, could reach a point of no further improvement, and it's not as far as the over-optimistic proponents seem to believe. The treatment protocol is demanding and relentless, and success and the rewards for this effort can't even be guaranteed. You may improve your odds, but counting carbs, errrrr, counting carDs, is not allowed at the casino of real-life!
Conclusion: We Need to Reprioritize Our Collective Diabetes Agenda Because "More Talking" About It Just Isn't Working
I promised to keep this editorial positive, and I think the conclusion is remarkably obvious. Rather than piss away another $200 bajillion bucks on another stupid study proving the benefits of glycemic control, and then giving it a cutesy name like ADVANCE, my advice to these researchers is to try leaving your home-schooled social environment and observing how life with this disease really plays out in real life.
Patients with chronic diseases are nickel-and-dimed for everyday expenses, while catastrophic expenses are paid without question, precertifications or any hassles whatsoever. This is reality, yet the U.S. medical profession has been sooooo slow to acknowledge this reality. At least one big U.S. company (in this case GE) is testing a new tactic: reducing or even eliminating co-pays for people with diabetes with the idea that by removing some of the many self-care barriers, they might actually reduce healthcare expenditures in the short-term (see HERE for more). Instead of doing yet another study on how to incrementally improve glycemic control by a few basis points, try instead to remove practical barriers to achiving this lofty goal. Get rid of excessive paperwork, approvals, precertifications, co-pays, etc. that stand as obstacles in chronic care delivery, and we might discover a shockingly simple truth: the easier we make it for patients with chronic conditions to care for themselves properly (within reason), the better the results will be and the lower costs will be for the healthcare system.
Just don't expect a payoff on it immediately!
Monday, April 11, 2011
Android Beats iPhone to One Diabetes App
Sometimes, it's easy to get the impression that Apple Computer's iPhone (and a few iPhone users, too) has a smug attitute of superiority over the competition. (some of this comes from the fact that Apple Computer's stock market valuation surpassed rival Microsoft's for the first time ever last year, see HERE for detail on that) Still, all of this kind of reminds me of the days when Apple's Macintosh and the PC standard (based largely on Microsoft's operating system — initially DOS, followed by Windows of countless iterations) duked it out for desktop supremacy. Apple ultimately lost that battle and today, the market share for Windows computers is around 93% while it's about 5% for Mac, and the open Linux system has about 1% (but is much larger for certain types of computers, such as servers) and all others share the remaining 1%.
Sales of Smart Phones Set to "Explode" in 2011
Because of iPhone's early-to-market advantage in smart phones, there are presently some apps that remain exclusive to iPhone/iPod Touch devices, and iPhones aren't at risk of becoming "niche" mobile phone devices anytime soon. But my point is that application innovation for Android and other mobile platforms will likely outpace iPhone development in coming years. In fact, Fortune's Seth Weintraub predicted that 2011 would be the year sales of Android devices explodes, and along with it, applications.
According to ABI Research's estimates, although the iPhone interface had more than 5.6 billion accumulated application downloads by the end of 2010 (thanks largely to having such a successful head start in the mobile device space), compared to nearly 7.9 billion total downloads from all stores during that year. But ABI Research is predicting that Apple is set to face much more intensive competition in 2011 in the mobile space. Adding to this trend is much more proactive involvement in app store development from other platform providers such as Google's Android, Blackberry and Windows Phone. According to the Millennial Media November 2010 Mobile Mix report, Android applications now account for 54% of all apps sales, compared to 39% for iPhone. Not everyone is crazy about the emerging duopoly of mobile platforms, and a new consortium of mobile carriers, developers and manufacturers called the Wholesale Application Community (WAC) hopes to shake things up in the smart phone apps market. Only time will tell, but more competition is always healthy from my perspective.
Regardless of your feelings on the Android/iPhone battle, my point was that until recently, most of the innovation on applications was for iPhone. Those days are coming to an end.
"Glucose Meter" for Android (vers. 2.0+) Mobile App
I recently tried an Android app for diabetes management that is not presently sold on iTunes called "Glucose Meter" which is descriptive, although not necessarily catchy. The developer is a Spaniard named Francisco José Belchí (you can follow him on Twitter at @fjbelchi and/or @mGlucoseMeter) who's an Android Developer at a firm called Grapple Mobile in London. The "Glucose Meter" app seems to be his personal project, however, hence the app's website hosted on Google Sites, which offers free web hosting. The Glucose Meter app was a finalist in last year's (2010) DiabetesMine Design Challenge among the most creative ideas called "Glucose Meter App for Android".
Although there are other diabetes applications available on the Android Marketplace (such as OnTrack Diabetes), I find most of these apps are still pretty labor-intensive, requiring the user to enter all of the data manually, so really it's just putting this data into a phone rather than a computer app. But what makes this app one worth looking into is that at it's core, it enables Bluetooth connectivity for really easy data entry, hence eliminating the one task I despise most about testing: logging. The real key to this working seems to be something made by a Tucson, AZ-based firm called Polymap Wireless which makes a peripheral device called Polytel® Wireless Glucose Meter Accessory (GMA). I'm not certain what this company's primary market for this device is, but I believe it's used in a fair number clinical trials to automate collection of test results from participants. The app (along with the peripheral device) automates the highly-annoying and burdensome function of logging test results by wirelessly transmitting the test results to your mobile phone, and also enables the results to be shared electronically with a doctor by e-mail. One complaint: not all meters that have potential to work with the app have been tested to actually work with it. Presently, only the Johnson & Johnson Lifescan OneTouch Ultra meter family is confirmed to work with it. Still, it does help bring a very widely-used (if slightly antiquated meter that J&J has invested little in to keep it modern) into the 21st century.
This was NOT a free application. But the price was a mere $2.75 when I downloaded it (the price is €1.99, so may vary based on current exchange rates), which seemed like a small investment in something which could save me hours of logging down the road. Still, on a 5 point scale, where 1 means "I think the developer needs to go back to the drawing board" and 5 means "I think this application is perfect", I would give this application 3.5 stars, which isn't terrible for the app itself. There are a few reasons I gave it less than 5 stars.
The Polytel® Wireless Glucose Meter Accessory (GMA) Bluetooth device isn't cheap. That costs another $95.00 (and you can now buy some Android phones without a plan contract for roughly that price), and Polymap Wireless does not yet have an e-commerce website enabling people to order the device online. However, with a quick phone call to the company, the receptionist put me in touch with a guy named Pierre Landau, who was able to send me a PayPal link to pay for the device itself, and they did that quickly once I was able to reach him. Mr. Landau told me the company is working on an e-commerce site, but the demand for the devices from individuals is still pretty tiny right now, so it's not a high company priority at the moment. Connecting was anything but self-explanatory; it took me a number of tries to get it right but once it worked, it was great! But the cost of the additional device is an issue, especially when it costs almost as much as some Android phones do. Still, the developer deserves compliments for putting the all of the pieces together.
According to the "Glucose Meter" app's website, they have had somewhere around 10,000 downloads to date. But much of the onus is placed on the individual to figure all of this out, as it was not exactly spelled out on the site (and the developer admits that he came to the UK to improve his English-language skills). A listing of requirements and steps required to fulfill these requirements would be a nice addition to the website.
Still, if you're like me, the price of the peripheral device was worth it to save me from the annoying transcription required thanks to J&J/OneTouch Ultra's non-standardized data formatting in their own download format. Once the app is uploaded into your Android phone (Note: you must have Android version 2.0 or higher), the data can be shared via Google Health (I'm not 100% comfortable with Google's lack of willingness to keep my medical data private since they are NOT a "covered entity" under HIPPA), but the basic idea is to automate the endlessly annoying tasks that doctors expect routinely from people with diabetes (PWDs).
Second, as noted previously, I think the biggest opportunity is for the developer incorporate data from other brands of meters, so I deducted a point for that. Finally, another complaint is that keeping the Bluetooth function open 24/7 on my phone did tend to use my phone's battery up faster than it when I did not have Bluetooth enabled (it's an easy settings change, so I used Bluetooth on an as-needed basis, such as to share a picture or something). In fact, when I checked what was using my battery, the Bluetooth functionality ranked second after the core Android operating system, and surpassing standby for calls. Therefore, I conclude that another app improvement might be better integration with the Android operating system to enable the app turn the Bluetooth functionality ON when it requires it, and then turning it off once it's finished transferring the meter test reading to my phone. I suspect that code could help preserve a phone's battery life for a longer period of time.
Having said all of that, the developer has been very responsive to user comments (for example, I noted that I have both an endo AND primary care doctor, yet there was only a single e-mail field in the app for doctor. He has promised this would be addressed in the next app revision, but did provide me with a work-around until that happens). I'd also like to see something other than Google Medical as the data platform of choice, but as I said, the developer has been very responsive to input from users. Overall, "Glucose Meter" is a good start, and does accomplish a big task of automating the logging function in a non-intrusive way, but I'd like to see the suggested improvements I've noted here incorporated in future app updates. If you'd like to download this application from the Android Marketplace, visit: http://goo.gl/oBEjh.
