Sunday, November 29, 2009

Supernanny to the Rescue?

Last Tuesday, I received an e-mail from Jill Lubarsky with the Media Relations Department at JDRF that on Friday, ABC's hit television program "Supernanny" was going to feature a family where Jo, the Supernanny, is called in to assist Bill and Tammy McGrath of Hamlin, NY. The Supernanny's assignment is to help the family regain control of their lives after they learn that their 5-year-old son, Aiden, was diagnosed with [type 1] diabetes, and introduces entirely new burdens on a family with 3 children that few people ever see until they're experiencing it for themselves.

Unfortunately, with the holidays, I wasn't able to catch the episode live, but thanks to the Internet, those episodes are readily available within days online, so here (catch the brief synopsis here) it is:

Hulu is limited to only recent video clips of Supernanny, but ABC has the original which can be found HERE

As JDRF's media relations wrote in their e-mail:

"I had a chance to view this episode before final production (as did our research department) and believe the show does a good job explaining type 1 diabetes and demonstrating the diligence required by the individual and family to manage blood sugar levels. ABC viewers will have the chance to see the highs and lows (no pun intended) on how parents must learn to work with their child during these tough times."

I thought it might be worth sharing with everyone else, especially those who weren't on the JDRF e-mail distribution list. What do you think ... does it do an adequate job of depicting the burden of diabetes management with the average person?

Wednesday, November 25, 2009

Smarties®: Revisited

First, if you haven't visited my post from earlier this week, please visit it at here and make a $1 donation to the Fight It! Friday campaign. On to my second post this week ...

In early 2008, I posted a story about my then new-found "discovery" of buying Smarties® in bulk (42 lbs. worth, more on that later) as a far more price-effective treatment for hypoglycemia. (Catch my post here for more details)

Well, after several years, that bulk supply is nearly empty, plus I have some money remaining in my Flexible Spending Account (FSA) that I'll lose if I don't spend it by the end of the year, so its a good opportunity to "kill two birds with one stone" as the old saying goes and replenish that supply. As I told my endocrinologist, not only did that bulk order serve my needs very cost-effectively for several years, but it also worked for more than a few trick-or-treaters (to be honest, I've also left quite a few in pants pockets, so they’ve been washed or crushed, as might be expected, which is perhaps the single biggest downside of this hypo treatment). Anyway, that supply of candy is now nearly depleted, so it’s time to order more, and I'm planning to do so, perhaps with some minor changes.

Since that massive order, which Scott K. Johnson also wrote about
, although I'm not 100% certain what happened to the photos on the old site, as that post was before he relocated his blog to Diabetes Daily, and after using Smarties as my primary hypo remedy for the past few years, I wanted to share a few lessons I've learned along the way.

Lesson 1: Smarties May Be Called Candy, But They're Basically the Same Thing As "Glucose Tablets"

I hinted at this in my original post, but I just wanted to first remind everyone that Smarties aren't the ONLY candy made from mostly dextrose, there are others. Among them: SweeTarts (sold in rolls at the register in most drug stores), I even found them in a $1 store. The company that makes SweeTarts was acquired a few years ago by Swiss food conglomerate Nestlé. Nestlé has since rolled the SweeTarts brand into it's already-existing Willy Wonka Candy Company family of brands. However, I have not found it as easy for consumers to obtain bulk supplies directly from Nestlé/Willy Wonka Candy Co. as it is from Smarties, plus Smarties remains a family-owned business based in New Jersey, and they sell their products directly to nearly anyone who wants to buy from them via their very convenient website.

But as Scott K. Johnson commented on my original post back in 2008, keeping Smarties intact in pockets filled with change and keys without crushing them can be a challenge. Indeed, I have discarded more than a few cellophane-wrapped rolls of Smarties that became pulverized over the past few years, which is essentially a waste. I can't really quantify it, but my belief is that the cost savings nevertheless justifies that waste. But perhaps the biggest hassle is that Smarties aren't always quite as convenient as the de facto-standard 4 gram tablets in terms of size. For caregivers (type 3's), for example, its often easier just to hand over a few tablets rather than struggling with opening a few rolls of Smarties. Also, hands trembling from hypos can find it frustrating to open the tightly-wrapped cellophane, occasionally dropping some of the tiny-sized Smarties tablets in the process.

Lesson 2: The Rule of Three (3)

First, Smarties sells several different sized rolls. In truly bulk-sized boxes, among the most economically-sized options is a box of Smarties 15 tablet rolls, which the website says contains approximately 2,400 rolls per case. Each of those rolls contains 6 grams of dextrose, the same ingredient in glucose tablets sold under the Dex 4 brand name, as well as under the names of your primary retailer (Walgreens, CVS, Target, Wal-Mart, Publix, Safeway, etc.) branded glucose tablets. Although the treatment recommendation is usually 15 grams of fast-acting carbohydrates for a reading of 60 mg/dL, if it's lower, you may require more. Generally speaking, I have found "The Rule of 3" works remarkably well, and is easy because the same rule also generally applies for the number of traditionally-sized glucose tablets. Depending on the individual, you may need to follow up with some "real" food, as the durability of a recovery based on pure dextrose does not generally last for most people with type 1 diabetes, although I cannot speak for everyone, and if you have type 2 diabetes, it really depends on how your doctor has you treating your diabetes. Just remember, as a short-acting carb, its here one minute, but gone the next!

Lesson 3: New Smarties Innovations

Tropical Smarties and Mega Smarties

Since I last ordered, I have discovered a few Smarties innovations you might wish to consider.

First, Tropical Smarties. For example, if you're sick and tired of the plain old flavor, last year, Smarties introduced what it's calling Tropical Smarties which taste a bit different than the original, although in my opinion, not dramatically different. (They aren't quite the coconut/piña colada flavor I know more than a few people with diabetes call their favorite glucose tablet flavors, but still slightly better, or perhaps I should really be saying "different" than the original flavor).

I would have ordered a bulk-sized 42 lb. box of the Tropical Smarties, but alas, the company only sells them in cases of bags which contains a case of 12 bags each, each consisting of 7 oz. of the Tropical Smarties, but the true bulk sized box, the only flavor is the original. Still, if you want a different flavor, you might consider visiting a retailer who sells candy nearby and seeing if they sell Tropical Smarties before making a commitment to buying an entire case!

Second, Mega Smarties. The other innovation is perhaps even more noteworthy, that is the fact that Smarties has bulked up their tablet size to what they're calling "Mega Smarties" and each tablet is exactly 2.5 grams of carbohydrates (most glucose tabs contain 3 grams of carbohydrates), generally comparable to the glucose tablets sold by most drugstores (although they don't fit perfectly into their pocket-sized tube containers, unfortunately, but on the upside, its MUCH easier to measure 15 grams). These are sold in the usual cellophane wrapped-rolls, but cost-wise, they're about $1.50 each in a store, but each roll contains 15 tablets vs. the 10 contained in a store-branded or Dex 4 roll does. Flavor-wise, again, its the same old variety, but it really is a pretty convenient and lower-cost treatment option.

Incidentally, I picked up my first "Mega Smarties" roll at my local Bed, Bath and Beyond store (right at the register), so these appear to be quite widely distributed. Plus, Smarties will sell you an entire case of "Mega Smarties" from their online store under "Cases of Boxes & Jars" heading (each case sells for $144, but keep in mind that this consists of a case consisting of 12 boxes of "Mega Smarties", each with 24 rolls per box, which is 288 rolls (each of which has 15 "Mega" sized tablets). These tablets WILL fit into an empty bottle-sized container of the 50-tablets sold in stores, but the width of each tablet is different, so the tubes probably won't work. For convenience sake, I am really considering this option instead of the smaller-sized rolls, so I'll have to let you know how that works out!

Lesson 4: If You Want to Pay for Smarties With Your FSA, Get Your Doctor to Write a "Letter of Medical Necessity"

One important lesson I learned the hard way was exactly what it takes to seek reimbursement from your Flexible Spending Account (FSA). The first time around, when I tried to get my last bulk-order of Smarties that candy wasn't automatically considered by IRS rules to be a reimbursable expense even when used to treat a medical condition (hypoglycemia). But it CAN be, with some appropriate planning. If you get a prescription and/or letter of medical necessity for Smarties (or SweeTarts, or whatever you like to use as a hypo treatment), then you CAN seek FSA reimbursement and have the expense covered, because that letter turns, in the eyes of IRS auditors, candy into a legitimate medical treatment that is expensible under IRS guidelines.

I wasn't able to pay for my original order with my FSA, although from a purely economic standpoint, I was still better off even without being able to expense it. But this time around, I have covered all the necessary bases and asked my endo to write me a letter of medical necessity for Smarties candy, which my FSA administrator has told me WILL enable me to expense the candy using my pre-tax dollars this time around. Call it a lesson well-learned, but one you can use to avoid the hassle I went through the first time around, with a request from your doctor.

As an FYI, here is what was written on my endocrinologist's letterhead:

To Whom It May Concern:

[Insert Patient Name Here] is under my care for insulin-dependent type 1 diabetes mellitus. At this time, I have recommended that he/she treat recurrent hypoglycemic episodes with "Smarties" which contain a dominant amount of glucose (dextrose) and is less expensive than the glucose tablets otherwise available.

If I may be of any further assistance to provide any further information, please feel free to contact me.

[Insert Doctor Signature and Title Here]

The other slightly challenging part is getting an actual receipt from Smarties. Sometimes a credit card statement is, depending on your FSA administrator, not considered acceptable, whereas a printed receipt would be considered acceptable. You may wish to place your order for Smarties by mail (keep copies of the order form) in that case, because you'll have the a copy of the order, the shipment receipt and the canceled check plus the doctor's letter of medical necessity to use collectively for reimbursement. Frankly, this is a case of FSA administration can be a bit testy about what they deem as "acceptable" proof, but its worth investigating before rather than having a hassle to get it reimbursed after-the-fact, so ask questions!

Anyway, given this experience, you now have some options available. I think this time around, I may skip the 42 lb. box of Smarties and go for a case of Mega Smarties for some of the reason's I've already mentioned. It's more expensive, but the option might work better, plus I have enough remaining in my FSA to make it practical. But if you're looking for a truly cost-effective option, there's nothing wrong with a big box, even if you end up discarding a few broken rolls. The markup on retail "glucose tablets" is nothing short of highway robbery, but the rule in retailing is sell for what the market will bear, so this option is definitely a c

By the way, for those of you who follow me on Twitter, my alter-ego (at least for the holiday season) is Gingy from Shrek movies, at least for the holiday season. I've always had an affinity for gingerbread men, so I kind of like the image!

Monday, November 23, 2009

Holiday Treats: Including A Nice Hawaiian Punch

Spending $1 to Buy Someone (in the U.S.) Insulin this Friday

Christopher Thomas, of Diabetic Rockstar fame, has a small but very admirable goal this Black Friday: to seek contributions of $1 to raise money for those working individuals without insurance to enable them to get affordable insulin and other diabetes supplies this year. He's calling it "Fight It Friday", and it's a very admirable goal, and one I am personally supporting, which is why I'm writing about it here.

I've placed a donation widget here.

But I sincerely hope he raises enough to remove all references to this very soon!!

I'm Thankful for Hawaiian Punch Singles to Go!

Beyond that, with Thanksgiving being celebrated here in the U.S. on Thursday, November 25th (many Americans don't realize that Canada has it's own Thanksgiving which is on the second Monday in October, October 14th this year), I am using this opportunity to give thanks for a few things. (No, insulin and meters AREN'T on the list, but I digress)

Occasionally, I cover some "new" products that may be of interest to people with diabetes. Although as of late I have taken a liking to Powerade Zero (a zero-calorie sports drink) as you may recall, a while back, I wrote about 4C Totally Light 2Go Drink Mix Just Apple flavor, and the 4C Apple flavor remains one of my favorites because I think it tastes just like apple juice (or at least what I remembered apple juice to taste like; its been decades since I've had real apple juice, which really does not deserve the label of a "healthy" beverage because it's a calorie-laden beverage that is no more healthy than Diet Coke Plus, which was reprimanded by the Fatalood & Drug Administration, see here fore details). Incidentally, Chrissie Engelbrecht in Belgium, although she's no longer actively blogging at Chrissie's Diabetes Blog anymore, remains a VERY active reader at Good Reads, so for those of you who followed her blog, you may want to join Good Reads and follow her there. I personally can't keep up with all the books she reads, but occasionally she posts photos of her new puppy, for example, so its also worth checking out.

Anyway, today I'm going to address another, similar product to 4C Apple, this one being Hawaiian Punch® Singles to Go!, which is a similar to the 4C Apple ones noted above, in individual-sized powdered drink mix that can be mixed into any standard 16.9 oz. water bottle. Of course, those concerned about BPA in their water bottles can use them as a measurement only, if they like. Supposedly, the manufacturer, Jell Sert Corp. under license from the Dr. Pepper Snapple Group, Inc., also sells canisters in larger 2 quart sizes, although I have yet to find those offered at any retail stores near me. The reason I am thankful to see these products finally being offered is because when I was a kid with type 1 diabetes, I didn't have these things. Fortunately, kids diagnosed today won't have to endure the same kind of denial that I endured when I was diagnosed back in 1976 (not that it's all that much easier today, but at least they can still have Hawaiian Punch).

For me, part of the attraction of Hawaiian Punch is the fact that while all the other kids in the neighborhood got to slug Hawaiian Punch during the hot summer days, as a kid in the 1970's, I had the displeasure of having type 1 diabetes before the nation's diet craze kicked in and sugar-free anything remained pretty uncommon. About the only thing besides water that was around then was unflavored Kool-Aid packets, to which my parents could then add nasty-tasting Sweet & Low (saccharin) to for semi-sweetness. There were also a few (and only a few) diet sodas, including Coca Cola's Fresca, a grapefruit-flavored soda which has since been resurrected and is enjoying newfound popularity, and Tab (which is STILL AVAILABLE, believe it or not, yummy!), but I grew up in a household where soda was only available as an occasional treat, not an everyday food. We also had a sugar-free gelatin at the time called D-Zerta, which was made by General Foods (a company my great grandfather had a hand in developing), today part of the U.S. food conglomerate Kraft, Inc., and has long since been replaced with Sugar-Free Jello, but back then, food companies were worried about brand erosion to their major brands, especially with artificial sweetners which carried dangerous-sounding warning labels on foods containing saccharin.

(Supposedly, a company, perhaps it was even Jell Sert, made an unsweetened version of Hawaiian Punch back in 1977, but I don't ever recall seeing that anywhere, but here's the TV commercial to prove it's supposed existence between 1977 and 1983)

Diabetic Foods that Caused Cancer?

But in the early 1970's, there was actually an effort to ban artificial sweetners like saccharin. Throughout the 1960's, a number of different studies had suggested that saccharin might be an animal carcinogen. That concern peaked in 1977 (the year after I was diagnosed), after the publication of a study from The National Cancer Institute (NCI), an agency of the U.S. Department of Health and Human Services, found that laboratory rats fed large amounts of saccharin developed cancer. As a result, Congress (in it's infinite wisdom) mandated that further studies of saccharin be performed and required that all food containing saccharin beared the rather ominous-sounding warning label: "Use of this product may be hazardous to your health. This product contains saccharin, which has been determined to cause cancer in laboratory animals."

When I asked my pediatrician at the time why all the "special" diabetic foods caused cancer, showing him the label of a package I had read, he responded by telling me not to worry about it. I was NOT comforted after seeing my grandmother die of cancer, even if he was correct in telling me not to worry about it. What can I say, I was a demanding child when it came to information!

Only after these Congressionally-mandated studies wrapped up many years later did we learn that the basis for some of these inaccurate studies were files from the FDA's investigations of 1948 and 1949, which had originally argued against saccharin use, but were were later shown to prove almost nothing about saccharin being harmful to HUMAN health. The Congressionally-mandated studies which examined how a substance actually works in the body have shown that these results applied only to rats, thanks largely to how rodents metabolize sodium. But human epidemiology studies (studies of patterns, causes, and control of diseases in groups of people) have shown no consistent evidence that saccharin is associated with bladder cancer incidence. In 1991, after fourteen unnecessary years, the FDA formally withdrew its 1977 proposal to ban the use of saccharin, and in 2000, Congress finally repealed the law requiring saccharin products to carry health warning labels. Of course, by that time, the FDA approved aspartame, which tasted better, although that Monsanto-developed sweetner remains the subject of persistent adverse health claims even today, after Splenda has taken over as far as market share is concerned.

Anyway, with that as a background, it's not hard to understand why almost no one in the food industry at that time dared recommending that artificial sweetners be used, especially for children (even those with diabetes). Today, there are all sorts conspiracy theories abound that it was prompted in large part by the influential U.S. sugar lobby, whom I wouldn't put it past, but evidence is hard to come by since lobbyists weren't tracked like they are today.

Anyway, with that as my historical background, I should note that the Hawaiian Punch brand goes back a number of years, but at present, the brand and it's related characters such as "Punchy" (who was featured in TV commercials during the 1960's and 1970's) is owned by the Dr. Pepper Snapple Group, Inc., which is the beverage division that was spun off from what was formerly known as Cadbury Schweppes PLC before demerging in May 2008, thereby separating the global confectionery (mostly chocolates, now fending off an acquisition attempt by Kraft) business from the U.S. beverage unit. Dr. Pepper Snapple Group, Inc. has licensed the manufacture of Hawaiian Punch Singles to Jell Sert Corp., a privately-held, Chicago-based food company that has acquired a number of cast-off food brands, including Wylers drink mixes, My-T-Fine/Royal gelatins, and pudding mixes Flavor-Aid frozen treats just to name a few. In 2003, the company signed licensing deals for the Hawaiian Punch and Snapple brands, and in early 2005, the first sugar-free Hawaiian Punch variety in the brand's history emerged (remember, the unsweetened variety was not "sugar-free", it was unsweetened).

Hawaiian Punch Singles to Go! first launched on a nationwide basis a few years ago. I stumbled upon them in a Dollar store, only to not see them again for a few years. Today, however, a number of national retailers sell these products, including such retail giants as Wal-Mart Stores, Inc. and Walgreens Corp. just to name two. I have also seen them in major supermarket chains from California to Connecticut to Florida, so I know it's widely available.

Although the drink is rather sweet (it's supposed to be a combination of seven natural fruits, including such tropical favorites as pineapple, passion fruit, papaya and guava) beverage, this variety contains zero carbs (see the Nutrition Facts here) and is an indulgence that even kids with diabetes can share!

Hawaiian Punch 1970's Commercial:

Also, catch this lame 1981 Donny & Marie TV Holiday Commercial featuring Punchy here:

OK, that's waaay too much detail on my childhood Hawaiian Punch fantasies.....

Beyond that, Amy Tenderich at also kicked off her annual holiday contest. Amy's post, 'Tis the Season has all the details. There are some pretty cool prizes from, HAH Originals, StickMeDesigns, Blue Bunny Ice Cream, and HealthiFeet, so check it out.

What is the contest about? There are two main categories: The "Best Of" which asks people with diabetes (PWD) to share their triumphs and successes from their holiday seasons, and the "Worst Of" for which PWD's can share something that went totally wrong (which are probably more amusing to read about, but hopefully they can smile about these experiences now).

Allison Blass & Scott K. Johnson have been invited to be judges in that contest, so please make sure there's some competition for the prizes, folks!

Anyway, I may or may not do anymore posts this week, but I'll be back here, at the same bat channel, so be sure to have a great holiday and I'll catch up with everyone very soon!

Saturday, November 21, 2009

The Business of Diabetes: Generex vs. MannKind, Will Either Win?

Earlier this week, Bennet Dunlap (YDMV) asked me to comment on a business story related to the debate over Generex' Oral-Lyn and MannKind's Afresa (see his post "FTNW: Oral/Inhaled Insulin"). Neither of these two products is on the market yet, but at least one opinionated writer, R.J. Steffens, posits that Generex is likely to be more successful than MannKind's Afresa. (see that article here). His logic, explained in the article, is based largely on the FDA, but he does little to comment on the logic based on the soundness of either company's business strategy.

I commented on Bennet's post, but I really didn't have sufficient space in a comment to do this topic justice, as this really more of a business review of the insulin market, thus my latest "Business of Diabetes" posting.

First for some relevant background, you may wish to catch Amy's recent interview with MannKind's chief, Alfred Mann. Amy closes with an appropriate question: Afresa: Dreamboat or shipwreck? She also appropriately notes that "only time will tell". Amen to that.

But R.J. Steffens seens to have already reached the conclusion that Toronto, Canada-based Generex, which has an oral-insulin (technically, its absorbed through the cheeks), so the term medical term "buccal" insulin applies) is going to be the winner of this race.

My response: I wouldn't bet my hard-earned dollars on either company at the moment.

First, let's look at his perspective that FDA approval is getting harder to come by. Actually, more recently, the Fatalood and Drug Administration has been cracking down on many of it's formerly minimalist (or non-existent enforcement of) regulations of the not-too-distant past. But that doesn't mean its gotten much tougher to get an approval, only that the free handouts from the FDA might be over.

The reason: over the past decade, far too many embarrassing safety debacles have occurred under the FDA's watch, including: e-coli laced fruits & vegetables and salmonella-tainted peanut butter under the "food" safety responsibilities at the FDA. On the drug/biotech side of the FDA's responsibilities, the FDA has a track record that is almost as bad, involving huge problems with already approved products such as Heparin (sourced largely from China, from plants that had not been recently inspected by the FDA and which were not adhering to FDA-mandated "Good Manufacturing Practices"), as well as a number of after-the-fact discoveries pertaining to already-approved drugs, beginning largely with the Vioxx scandal in 2004, but continuing with the type 2 diabetes drug Avandia (both of which, BTW, could have been avoided with appropriate post-market analysis that the FDA never bothered to insist upon getting from the manufacturers). Collectively, these things point to beginning of the FDA's "fall from grace" with lawmakers in Congress, and the view that the FDA is no longer an effective protector of the public's foods and drugs.

But none of this means the FDA has gotten stricter; only that it's harder to get a truly dangerous drug approved with poorly designed clinical trials. But if the underlying science for and business model for a new drug is good, I don't think companies will find navigating the FDA all that much more difficult.

Let's have a look at what Generex and MannKind hope to sell: synthetic fast-acting insulin that is delivered without injections. Big whoop. This is viewed by people without diabetes as THE greatest innovation that they believe every person with diabetes longs for; but for most people WITH diabetes, we respond with a yawn. Besides, most insulin-requiring people with diabetes will also need a basal insulin as well as prandial insulin, so we aren't completely avoiding needles just by switching to Afresa or Oral-Lyn (oh, yeah, and don't forget the finger lancets required for testing, so even if you can swallow or inhale your insulin, you're still going to have to puncture your fingers to test). On safety, insulin itself has been used since the 1920's, and synthetic insulin has been used since 1982, and therefore has a very long track record of relatively safe use. But insulin has only ever been delivered into the bloodstream either intravenously (such as in a hospital IV) or subcutaneously, except in the short-lived case of Exubera.

Exubera bombed mainly because Pfizer really didn't know the first thing about the insulin market, and never bothered to research it thoroughly, either (catch two of my posts on Exubera here and here).

Wrong Target?

Despite what Alfred Mann and Generex claim, neither company is really targeting the type 1 universe. If they were, the products they're pitching would look a bit different than they do now. For example, if Generex really wants to reach the type 1 audience, they need to enable dosages in increments smaller than 1 unit, preferrably in tenths of a unit. My basic argument has always been that if a company wants to effectively compete in the insulin segment, they simply cannot afford to ignore the type 1 audience. Pfizer ignored the type 1 audience, and Exubera went bust, costing the company billions. Far too much advertising for insulin, (especially ads for Sanofi Aventis' Lantus product) might even be viewed by some as offensive to type 1 patients -- talking about insulin as a wise "choice" in treatment. I don't know of a single type 1 patient who was given insulin as a treatment "option" or "choice" because it isn't a choice, so ads that address it as such are kind of insulting because they leave the type 1 patient out of the equation altogether. Its almost as if the leaders of the pharmaceutical industry take the type 1 business for granted because we have no other treatment alternative.

Pfizer really screwed up the launch of Exubera up by its decision to completely ignore the type 1 audience, the "blisters" for each dose gave a MINIMUM dosage of 3 units each, which meant that many insulin-sensitive type 1 patients couldn't refine the dosage well enough to even try it. The product bombed with type 1s, a segment that might theoretically have been an attractive target. The CDC estimates that perhaps 75% to 80% of all insulin buyers have type 1 diabetes, although type 2 patients who use insulin generally require a significantly higher volume of insulin because their disease is insulin-resistance. As a result, type 1s consume maybe only 40-50% of all the insulin sold, and type 1s make up a disproportionately large share of all insulin buyers even though we use comparatively little by volume.

Still, we should examine the prospect for these yet-to-be released insulin formulations (and the companies backing them) based on what insulin sales data indicates. First, let's look at a simple fact: both Afresa and Oral-Lyn are both prandial (mealtime) insulins, but neither addresses basal insulin requirements. Increasingly, type 1 patients are turning to insulin pumps which enable them to micro-manage dosages with an unprecedented level of precision. I categorically disagree with R.J. Steffens in his assumption that because Oral-Lyn has not encountered any significant delays in approval, it is likely to be a bigger success. His sister may have suffered from type 1 diabetes complications, but that does NOT render him an authority on life with the disease; you have to live with it personally to make such an assessment.

I believe the bigger issue for both MannKind and Generex and their success in the insulin market will be the fact they are selling prandial vs. basal insulin. The reality based on sales data (companies like IMS Health compile sales statistics on this) is that the biggest (and growing) share of all insulin being sold isn't prandial insulin, it's basal insulin, which helps explain why Lilly's market share in this market has plunged (Lilly doesn't sell a truly basal insulin today, only NPH, which is a mid-range insulin in terms of time-activity profiles).

Have a look at this chart below which is merely repeating a well-established fact on on worldwide insulin sales:

The reasons for these sales trends are many, but it's mostly due to the fact that insulin-using type 2 patients tend to start with basal insulin like Lantus or Levemir only, and may ultimately adopt prandial insulin when that is no longer sufficient. But if you wish to capture some of that volume, prandial insulin is NOT the way to do it, basal insulin is the key. But even Eli Lilly & Co., which has been in the insulin market for nearly 90 years, failed in its efforts to develop a basal analogue insulin, which explains why that company's market share (according to the Indianapolis Star) has fallen from about 83% a decade ago to a bit over 40% today.

Competitive Landscape

Even if more type 2's should be using prandial insulin, they aren't doing that now. To convince them to do otherwise will require old fashioned salespeople knocking on the doors of doctors' offices, a costly proposition to say the least. Or costly (but mostly ineffective) Direct-to-Consumer marketing combined with salespeople. I don't know how many salespeople either have, but its worth noting that both Eli Lilly and market share leader Novo Nordisk have recently beefed up their sales forces in the diabetes segment.

Looking at these insulin products, one could effectively argue that neither is really a "new" product; they're the same old insulin products just being delivered in a different manner. The issue of safety with oral vs. inhalable insulin is perhaps better defined as whether the method of delivering the insulin causes any adverse events? Since long-term usage studies are not required for FDA approval, these questions have yet to be determined, although the FDA may require post-market analysis now, whereas in the past, they rarely bothered.

If these companies hope to capture share of the prandial insulin market, I would suggest that both should have spent some more time observing the issues that are different between type 1 and type 2 patients. They might realize that the challenges facing both groups aren't always the same, even if the marketing folks at these companies want to speak with them collectively. Most fail to reach either audience.

Whether Generex's Oral-Lyn is faster to market ignores the fact that by sales volume, basal insulin is what's selling. And for the type 1 audience, many have migrated to using only a rapid-acting insulin by pump, so the hopes of converting any of those patients to oral or inhaled insulin is next to nothing. For those on MDI, its possible some might find Oral-Lyn or Afresa attractive, but its a lie to position the product as needle-free, because their basal insulin must still be injected the old-fashioned way. And the dosage precision with both products isn't as great as the existing rapid-acting analogues, of which there are now three: Lilly's Humalog, Novo Nordisk's Novolog/Novorapid and Sanofi Aventis' Apidra.

Also, another competitor is now in very late stage development, namely Biodel's Viaject from a Danbury, Connecticut biotech company, which is as close as (if not closer) Oral-Lyn to receiving FDA approval, and because it's injectable insulin, there is no special FDA guidance to obtain approval. This means both will be competing in an already crowded market (with 3 already approved products, and another candidate that is likely to emerge in 2010). All told, there is likely to be 4 rapid-acting insulins on the market when the first of these products hits the market, and because Oral-Lyn and Afresa are not delivered subcutaneously, these products have the disadvantage of having no hope to compete for the business of insulin pump users.


The question investors SHOULD be asking of both Generex and MannKind is whether either of them have done sufficient homework on the U.S. and worldwide insulin market. Based on what I've seen so far, I'd say the answer is no. I'd put my money into a Beverly, Massachusetts-based SmartCells, Inc., a company that is developing an insulin that does not cause hypoglycemia as an adverse event. From my perspective, Todd Zion's company, combined with a strong venture-capital investment as well as funding from both the NIH and the Juvenile Diabetes Research Foundation suggest that this company's prospects are far better than Generex's or MannKind's, at least in the insulin market.

Wednesday, November 18, 2009

Fantastic Voyage 2.0 at the DRI

About 2 weeks ago, I was in the Miami-Ft. Lauderdale area to attend the Diabetes Research Institute's Diabetes 2.0 Conference. I have attended several of their New York conferences in the past, but I had never been to their home-base in Florida before (ironic, considering my brother and sister both live nearby). Anyway, I was given a rare opportunity, along with some of my D-Blogging peers including Gina Capone, Allison Blass, Kerri Sparling, Manny Hernandez, Ellen Ullman and Jeff Hitchcock to go on a guided tour through the DRI's research facilities. That was very cool, and enlightening to see the work going on first-hand.

The DRI's researchers are among the most gregarious hosts to visitors I've ever encountered, and of course, they have made more than a few groundbreaking discoveries in their laboratories. Their world-class research facility and also their approachability are very impressive.

To put things into relevant context, let's start by noting that the 2008 Nobel Prize for Chemistry was awarded for the development of the green fluorescent protein (GFP), which has since gone on to play a crucial role in the identification and understanding of various proteins, which includes pancreatic beta cells, glucagon-producing alpha cells, insulin, etc. This discovery was quickly followed with not only green color, but also with fluorescent red and blue colors, which now enables scientists to stain various proteins with different fluorescent colors and examine them under high-powered microscopes and easily see the tiny specs in technicolor details.

Researchers now stain the insulin-producing pancreatic beta cells in fluorescent green color, the pancreatic glucagon-producing alpha cells in fluorescent red color, and the and the nuclei in fluorescent blue color. This enables the most relevant parts of the Islets of Langerhans to be seen in distinctive colors, and observed. OK. This was deployed and the key components of the Islets can now be observed in amazing Technicolor detail, and in real-time! Awesome stuff that researchers back in Banting's day could only fantasize about.

Have a look at a photo of the fluorescently-stained Islets of Langerhans at Wikipedia, and in particular, the photograph. Note the different colors (Green, Red, Blue) being used to depict different components of the Islets.

But here's the really cool part.

The DRI has partnered with The Karolinska Institute in Sweden, and researchers at Karolinska have developed a technique that involves transplanting the Islets of Langerhans into the eyes of a Non-Obese Diabetic Mouse (NOD), which enables them to see how the Islets work (and get attacked by the body's immune system). The sedated mouse is placed under a microscope) and the lens of the microscope zooms in to watch all this stuff in real-time, and thanks to the computerization of microscopes today, the images can be transported instantly and shared between researchers in Stockholm and Miami (in fact, I believe researchers in Stockholm can control the zoom of the microscope in Miami remotely). But these observations can also be recorded on the computer and are often used in scientific presentations. The DRI is planning to feature some of these video images on their website in the (hopefully) not-too-distant future!

If I'm not mistaken, this technology is being used to observe the autoimmune process in action, which could enable the development more effective treatments to induce tolerance to the Islets of Langerhans (and that also includes those Islets regenerated by the body itself, so it's not limited to transplanted). Very high-tech, but also the kind of a "Fantastic Voyage" inside the body that was first depicted on the big-screen in the classic 1966 sci-fi film of the same name. If you prefer, there was the slightly more modern 1985 Steven Spielberg film "Innerspace" which was very similar in nature, or in 2002, a B-movie called "Antibody" starring Robin Givens was yet another adaptation of the same basic movie theme.

During the tour, I asked the researchers about whether they had considered putting a DVD of these observations (perhaps selling the document as a fundraiser for the DRI Foundation), and I was told that the DRI is planning to do even better: they hope to have recorded movies of the stuff being observed under the microscope on their website in the future! Of course, such images need to include excellent narration so that the average layperson can follow along, but the stuff they're doing today is light-years beyond the stuff they were doing as little as a decade ago.

Taking a step back, below is a clip from NBC News that features one of the researchers at the DRI who showed us under his microscope, Dr. Juan Dominguez-Bendala, Ph.D. who is a DRI Researcher. Videos for each presentation, including the panel I appeared on at lunchtime can be viewed at the DRI's website here (or click on the header above).

Another thing that most impressed me from my visit to the DRI, and in getting to meet many of the researchers in person was the pace at which diabetes research occurs today. As noted, researchers can watch the body's (at least in a NOD mouse) immune system actually infiltrating the Islets and can also see if theoretical interventions they're pioneering at the DRI work, and if so, HOW they work.

Not too long ago, most of this stuff was indeed only science fiction, as the aforementioned movies seem to suggest. But today, thanks to some truly revolutionary discoveries and some very smart partnerships with leading researchers around the world, the DRI truly has made a number of astonishing advances. The rate at which new knowledge about type 1 diabetes accumulates related to the autoimmune response and immune tolerance treatments, cell culture and development, and watching how these various interventions work (or sometimes, do NOT work) has indeed accelerated the advancement of progress being made to cure diabetes. Another quite admirable quality is the fact that most DRI researchers aren't pursuing their research for publishing rights to advance their own careers, or advance shares they own in for-profit biotech and drug companies (for the most part; I have some reservations about using this description for Dr. Jay Skyler), and seem willing to cooperate with almost anyone willing and able to collaborate to advance the DRI Foundation's mission: to provide the Diabetes Research Institute (DRI) with the funding necessary to cure diabetes now. This is truly an impressive organization and they are doing some groundbreaking research!

Monday, November 16, 2009

Big U.S. Drugstore Chains Working to Shake Up Diabetes Management

While the benefits of intensive diabetes management are well-established, overall, the U.S. healthcare system receives failing scores relative to most other developed countries when it comes to diabetes care. (catch my post from last year here). It's not for a lack of spending; We spend more per capita than any other country on earth, yet U.S. patient outcomes for most chronic diseases (including diabetes) is worse than most other countries, and merely on-par with such developing countries as Brazil or Jordan, in spite of significantly outspending these countries. One reason is a lack of care coordination and what I refer to as the "compartmentalization" of healthcare in the U.S. (By that, I mean that patients see a primary care doctor, an endocrinologist, perhaps a diabetes educator, nutritionist, ophthalmologists, and potentially cardiologists, dermatologists, gastroenterologists, gynecologists, and a number of other specialty doctors, with no one who can really oversee the overall coordination of all of this "care", which is a job usually left to primary care doctors, but a lack of decision-making authority on whether the care will even be paid for effectively limits U.S. Primary Care doctors' ability to truly coordinate patient care in an effective manner).

Last year, The New York Times featured an editorial which concluded that our abysmal rankings for chronic disease care was best summarized in a single sentence: "The care Americans with chronic conditions received — or more often did NOT receive — ought to be a cause for shame."

These findings are a surprise to some, who love to trumpet U.S. healthcare as being "the best in the world", and while that description may be appropriate in some cases, the claim really should contain a footnote similar to those in drug advertisements which says something along the lines of "Results are not typical. Generally, U.S. Healthcare rates are the top of the world for those who can afford it, but the vast majority of patients with chronic conditions receive care that is comparable to developing countries."

How did we get into this predicament?

James Hirsch, in his book "Cheating Destiny: Living With Diabetes, America's Biggest Epidemic" describes the U.S. healthcare system as one that deals extraordinarily well in dealing with acute illnesses, but not really designed to handle chronic conditions which are becoming increasingly common as medicine moves away from a model of eradicating diseases to a model of managing diseases on a chronic basis, without actually curing very many maladies.

The disconnect is that the U.S. system will readily pay to amputate limbs or will readily pay for heart bypass surgery, but will make patients jump through all sorts of hoops to cover the very things (including coverage of education, medicines, and testing supplies, while simultaneously nickel and diming them for such basic care) that could easily prevent such drastic treatments from ever being a necessity.

Aside from the cost, the main issue of lack of coordination among the various medical providers involved. After all, doctors can make recommendations, only to have their recommendations overruled by those who actually pay for patient care. Referrals and pre-approvals are perhaps two of the most notable examples of just how the disjointed U.S. healthcare system creates barriers to effective chronic disease care.

A handful of U.S. healthcare providers, most notably Kaiser Permanente, scores very well in this regard (in spite of frequent complaints about getting insulin pump coverage from many patients in the Kaiser system). But Kaiser is somewhat unique in the world of healthcare in that everyone (doctors, nurses, lab technicians, pharmacists, specialists, educators, etc.) in the Kaiser system is on Kaiser's payroll, and there is excellent system-wide coordination of care. But in the more typical U.S. healthcare model, the PPO (preferred provider organization) plan, there is no centralized coordination of care, rather the care-givers are paid for each treatment procedure performed, but they are generally not rewarded (financially, at least) for overall patient outcomes. And for those left completely out of the system due largely to costs, the health outcomes are quite poor, which helps to explain the comparatively low U.S. rankings.

As politicians promote their healthcare agendas, however, another potentially important player is stepping in and could profoundly impact this equation: large pharmacy chains.

In much the same way as small corner grocery stores and bodegas are increasingly being seen by public health officials as linchpins in public health campaigns [see here for details] as part of the solution rather than part of the problem, we are seeing some fundamental but important changes in the way healthcare is delivered, we may soon see another important player use its influence on care for some with chronic conditions.

Walgreens Takes Care

In July 2009, one of the nation's largest pharmacy chains, Walgreen Corp., announced plans to pilot a program offering chronic disease care in its 345 "Take Care" walk-in health clinics found in 19 states. Until this plan was announced, these had mostly focused on routine health problems, like sore throats, ear infections, etc. rather than dealing with chronic care.

Although company CEO Greg Wasson declined to specify where the pilot program would run, we do know that these programs will focus (at least initially) primarily on the more common type 2 diabetes, probably with focus on how patients can incorporate different elements of their care ranging from diet management and exercise into patients' treatment plans. Although that still leaves nearly 3 million Americans with type 1 diabetes out of the equation, if the type 2 treatments work, we could see type 1 treatment added down the road.

CVS Maintenance Choice

Meanwhile, although rival CVS has similar Minute Clinics in many of its stores, that company hasn't created a chronic care platform yet, but could depending on the Walgreen's experience. But CVS has been working on an issue that is a barrier to drug compliance, specifically working to better integrate its large pharmacy benefits manager (Caremark) seamlessly into its retail stores. According to the company, CVS Caremark is now presenting its [relatively new] "Maintenance Choice" offering to payers. Maintenance Choice allows consumers to purchase 90-day prescriptions [for chronic conditions] at CVS stores for the same price as at mail."

Although analysts still question the economics of the CVS Maintenance Choice program, there is no denying the program's growth. Patients don't really care how CVS makes money, however, but the program does deliver genuine patient benefits. Rather than dealing with cumbersome mail-order delivery which is often a deterrent to drug compliance (that, along with cost), increasing numbers of patients can walk into their local CVS retail pharmacy and pick up a 90 day supply of insulin and other diabetes-related prescriptions and pay the same price as if they ordered them from Caremark by mail.

(This might also help to resolve the complaints of improperly shipping insulin without temperature-controlled shipping packages, but also makes it easier for patients to deal with.)

Both programs are still in their infancy, but both have potential to influence patient outcomes, especially for patients with chronic conditions such as diabetes.

Only time will tell.

Friday, November 13, 2009

The Other 364 Days A Year

In recognition of World Diabetes Day (WDD), which is on November 14th, I'm going to use this opportunity to (in my typical fashion) to call attention to what World Diabetes Day (and Diabetes Month) has become in the U.S. today (and quite possibly p!$$ a few people off in the process, but I'm used to it).

It's become an excuse.

An excuse for the media and the rest of the world to continue being blithely ignorant about diabetes for the other 364 days each year. Bennett Dunlap's recent post entitled "Dear Nate" unfortunately makes this abundantly clear (catch their lame response here). Bennett isn't the first one to go down this road, and will almost certainly not be the last.

In fact, on my inaugural WDD post back in November 2005, I made a very similar point to a Boston Globe editorial writer, who incidentally never responded to my letter. But this is a battle that needs to be fought because our failure to do so will ensure that misinformation and ignorance rule the entire public discourse when it comes to diabetes (all types).

You know what I'm talking about: the one where the PATIENT (and/or their caregivers) -- NOT their disease -- assumes all of the blame for anything bad that happens related to diabetes. In effect, public spending on diabetes research is already dwarfed by far less common diseases (according to the FAIR Foundation), and that is partially a function of the fact that diabetes is widely regarded as a character flaw, rather than a real disease, according to most in the mainstream media. I think this is because diabetes has been defined by people other than those who actually live with diabetes.

Don't get me wrong, these events were started with the most admirable of intentions, and World Diabetes Day in particular was groundbreaking in at least one respect: being the FIRST non-communicable disease to be recognized by the United Nations and the World Health Organization. From that perspective, WDD does get diabetes on the radar screen of the public for a brief time each year. But in the U.S., today we have a culture that is driven by short sound-bytes and short attention spans. We can be appreciative for a single day in the public spotlight, but what about the rest of the year?

I happen to agree with Jenny Ruhl that pollutants and chemicals have become so prevalent in our everyday lives, but unfortunately have long-term impacts that we have yet to even quantify (or even acknowledge). In addition, World Diabetes Day is becoming a marketing event along the lines of Valentines Day for the multi-billion diabetes industry to promote is latest products and get some free publicity, which unfortunately, hurts the original intent behind it.

I'm also quite concerned that blue circles everywhere don't do anywhere near enough to convey much useful information about diabetes or its treatment. This situation means far too many people actually believe that what they watch on the news or read in the newspaper. But they don't necessarily get accurate information about a disease that threatens to become an ever-more-costly drain on a healthcare system that is already struggling to manage runaway costs. Instead of blaming a healthcare system that is an uncoordinated collection of self-interested parties pushing hard in Washington to represent their interests, the media has bought into the idea that the patient, and not their disease, that is ultimately responsible for everything related to diabetes. Too bad it wasn't quite so simple.

Don't misunderstand my objective with this posting: I am NOT dissing World Diabetes Day, but I AM dissing what World Diabetes Day has actually become in the United States: a media circus, only it's a circus without a ringleader.

(Here's where I include some relevant circus-related music you can listen to now -- one is traditional circus music, the next one is the current pop hit "Circus" from Britney Spears, the last one is a song called "The Circus" from Erasure, which is a little bit slower, but more circus-like as far as the music's concerned than Britney's "Circus".)

Until the public discourse involves more people who actually live with diabetes, and is not controlled exclusively by companies that profit from the disease, nor limited mainly to doctors and healthcare providers, then the intent of World Diabetes Day is getting lost in the shuffle. Too often, most of speakers on World Diabetes Day events are too isolated from the day-to-day realities of what it's actually like to live with their prescribed treatments, but like to get themselves in the press anyway, which is just sad, but not terribly helpful.

My discussion aims to change that dynamic, not criticize it.

Thursday, November 12, 2009

Diabetes: You Keep Me Hangin' On

So for those of you who follow me on Twitter, last week, Kelly (also here), George (also here) and a few others have been toying with the idea of a band called the "Insulin Whores".

I joked that I had absolutely no musical talent, which is a lie, the reality is that that in high school, I played the lead role in my high school musical "Bye Bye Birdie", and yes, I was a choir boy for many of my earlier years, so I've always had a bad-ass affinity for music. Anyway, the Insulin Whores are a musical bunch and we're now toying with the idea of forming a band of some sort (whether it's a rock band, or something else is still a work in progress). But since Kelly has already covered the topic of diabetes themed music (catch her post on that topic). Anyway, yesterday, I mentioned the topic of a Glee-esque video. I like Kelly's song list, but not sure we need to be so completely fixated on sugar. I'd like to mix things up a bit and pursue some deeper-meaning songs.

This week, my selection is a classic by The Supremes called "You Keep Me Hangin' On". I think the lyrics speak directly to my type 1 diabetes and the lure of a cure, but have a look at this clip from the TV show Glee and let me know if it means anything to you relative to diabetes. We may need to rework the lyrics on some songs, but there are some that fit naturally with diabetes. Have a look:

You Keep Me Hangin' On
By The Supremes

Set me free, why don't cha babe
Get out my life, why don't cha babe
'Cause you don't really love me
You just keep me hangin' on
You don't really need me
But you keep me hangin' on

Why do you keep a coming around
Playing with my heart?
Why don't you get out of my life
And let me make a new start?
Let me get over you
The way you've gotten over me

Set me free, why don't cha babe
Let me be, why don't cha babe
'Cause you don't really love me
You just keep me hangin' on
Now you don't really want me
You just keep me hangin' on

You say although we broke up
You still wanna be just friends
But how can we still be friends
When seeing you only breaks my heart again
And there ain't nothing I can do about it

Woo, set me free, why don't cha babe
Woo, get out my life, why don't cha babe
Set me free, why don't cha babe
Get out my life, why don't cha babe

You claim you still care for me
But your heart and soul needs to be free
Now that you've got your freedom
You wanna still hold on to me
You don't want me for yourself
So let me find somebody else Hey!

Why don't you be a man about it
And set me free
Now you don't care a thing about me
You're just using me
Go on, get out, get out of my life
And let me sleep at night
'Cause you don't really love me
You just keep me hangin' on...

Tuesday, November 10, 2009

Timewarp Tuesday: Pets and Diabetic Owners

Today, I've decided to repost a previous posting I did entitled "Pets and Diabetic Owners" from April 16, 2007. This posting was prompted by a conversation I had with Kerri at the DRI Diabetes 2.0 Conference this weekend (this re-post is for you)!

This weekend, while I was filing my taxes, I also re-discovered some pictures that were buried in an out-of-the-way directory location on my computer's hard drive. Since few of my readers have ever met my cat, Phyllis, I figured it was time to introduce her below:

They say that many people start to look and behave like their pets while their pets acquire similarities to their owners. I'm not completely sure about that, but see what you think about my recent photo:

Seriously, I had this photo taken at Epcot Center about 2 years ago, but have never shared it with anyone. But this post seems to be an appropriate time. Phyllis does not have type 1 diabetes, but she has served as my lookout on occasion. For example, sometimes when I have gone low while sleeping, she will jump onto me and start kneeding gently to wake me up. If that fails, she then starts with her claws very lightly. Since Phyllis' mother was Siamese, she acquired her exquisite vocal skills from that side of the family, and she will begin talking incessantly until I get up to test. Sure enough, she is usually right.

Cats aren't as easily trained as dogs, but nevertheless, they do have the keen sense of smell that their canine counterparts have. I wanted to let my readers know that there are a few organizations that will train dogs (or provide instructions for you to train your own dog) in order to wake their owners with diabetes in the event of hypoglycemia. Given the recent study that showed people with type 1 do not wake from hypoglycemia, it can be very useful (especially for people who live alone) to have a pet with this type of skill.

There are two organizations I am aware of who help people seeking dogs (so far, cats haven't been trained for the reason noted previously), and I wanted to share these with you. These organizations are as follows:

Heaven Scent Paws
An organization that provides trained diabetic alert dogs, or provides instruction on dog training so that the dog is able to detect & alert their diabetic partners and support team (parents, spouse, friend, etc) to both low blood sugar (hypoglycemia) & high blood sugar (hyperglycemia). Heaven Scent Paws operates nationwide for those who are interested.

Dogs for Diabetics
An organization that provides dogs who are trained to detect hypoglycemia in patients with type 1 diabetes. The organization is based in the San Francisco Bay Area, and presently only offers its services locally. Their address is 1647 Willow Pass Road, #157; Concord, CA 94520-2611; e-mail:

Finally, one of our own D-bloggers, Molly, recommended the following organization which is based in the Midwest. Her blog features more information about her experience with them and her dog. The organization's website includes info. about dogs for people with diabetes, although I did not find detail on whether they only serve a particular geographic area. Feel free to call them for more information if you're interested.

Great Plains Assistance Dog Foundation
The Great Plains Assistance Dog Foundation trains dogs to assist people with a variety of disabilities, including diabetes. Their mission is to assist individuals living with disability to gain greater independence and opportunity by use of trained working assistance dogs. Their address is 920 Short Street, PO Box 513, Jud, ND 58454, tel: (877) 737-8364 (toll free) or (701) 685-2290, e-mail

Monday, November 09, 2009

Happy D-Blog Day + Disease Management 2.0

First, let me acknowledge the fact that today is D-Blog Day. In essence, it's a day dedicated to a vibrant diabetes blogging community which has organically grown to include several hundred individuals, and continues to grow. If you're interested, you can start your own blog, or just comment on some of the many posts out there. OK, with that addressed, now for my regular post.

Disease Management 2.0

I was on the plane headed to the Diabetes 2.0 Conference at the Diabetes Research Institute on Thursday (I'll be covering that in more detail soon), and picked up a copy of last week's edition (November 2, 2009) of BusinessWeek (the one with the cover on smartphone apps) while I was at the airport.

As I was flipping through the magazine on the plane, I stumbled upon on interesting article entitled "Tough Love, Lower Health Costs" by Arlene Weintraub. This article coincided with a release last Wednesday from United Healthcare, Inc. proclaiming "More Employers Turning to UnitedHealthcare's Diabetes Health Plan to Help Improve Health, Control Costs".

I had read UnitedHealhtcare's January 15, 2009 press release on this program, and had pretty much dismissed it, assuming it was yet another example of the typical so-called "disease management" programs of the sort that is outsourced to third-party vendors. A video by UnitedHealthCare was prepared and can be viewed HERE (and below).

In my own experience, these third-party vendors provide automated reminders to patients (often computer-generated phone calls and e-mail blasts to remind patients to show up to their doctor's appointments, take their medications, exercise and perhaps a nearly useless newsletter on diabetes management aimed at people whose knowledge of the disease is next to nothing).

As might be expected, there is a trade association of these vendors for this industry called the Disease Management Association of America (DMAA) (Note: since September 2007, the organization has been working to re-brand itself as the Care Continuum Alliance) which has released countless so-called "studies" which they claim proves the value and worth of these programs. But the evidence is clearly mixed.

For example, back in 2007, I wrote a posting about yet another study that had raised questions on whether these third-party disease management programs do anything to reduce costs. A number of studies including one by the RAND Corporation and another done by the U.S. Government's own Congressional Budget Office (CBO) determined that the value of these programs could not conclusively be quantified in dollars. Part of the problem is that patients are expected to pick up the cost of compliance with these programs (which is costly), but are seldom provided much financial incentive in terms of reduced co-pays, or even ease in navigating through the insurance coverage process.

Speaking from my own experience, I received dozens of irritating e-mail reminders and robo-calls, and had continued hassles in getting the very insurer who enrolled me in the program to pay for testing supplies I needed to maintain glycemic control, or get them to pay for an insulin pump, for example. On that basis, the program was more of a hassle that did almost nothing for me, but a third-party vendor was paid handsomely to administer the so-called "disease management" program. Eventually, I requested to be removed from the program which provided me no financial incentive, yet rated high on the annoyance factor.

That isn't to say that the programs are of no value, but clearly, if we're looking to save money on healthcare, we need to consider the way we quantify success. But what makes the BusinessWeek story most interesting is that some big employers, such as GE and Hewlett-Packard to name a few, have had a role in the design of the program, not the healthcare insurer alone. As a result, there have been some pretty profound changes in the "new" UnitedHealthCare Diabetes Health Plan.

What's different?

First, UnitedHealthCare is offering the Diabetes Health Plan only to large companies that are self-insured, meaning the employers bear the entire risk while the insurer administers the plan. Second, although the program is flawed on the use of "surrogate" markers for disease outcomes without considering the big picture, those are already used in the basis of approving or denying coverage. While this plan aims to get patients to adhere to treatment guidelines and to agree to be tracked by the company to ensure they're compliant, it also provides real financial incentives, making it unusual. If that sounds a bit big-brotherish, consider that the reality is that insurance companies are already doing that anyway, and HIPPA allows them to do so without disclosure to the patient, as they're considered "covered entities" exempt from disclosure to the patient. But the key difference is that those who stick with the program will receive significant discounts on out-of-pocket expenses such as co-pays for diabetes-specific treatments which can reduce the person's healthcare costs significantly. Those who don't "comply" are kicked out of the program and put back into their company's standard plan, the one without the financial benefits.

According to the BusinessWeek article, UnitedHealthCare provided the following hypothetical scenario: Say a company's standard plan charges co-pays of $30 to $50 for prescription drugs; those fees would be completely waived on insulin, insulin pens, possibly even insulin pump infusion sets or syringes/pen needles, and/or oral drugs that diabetes patients use to control their blood sugar and on glucose meters for testing their blood. Deductibles might also be reduced, and these are growing increasingly common across healthcare plans nationwide. Patients must agree to twice-yearly physician checkups (for those already doing this, its really just a huge price break) and other preventive measures, and they have to sign to allow United to keep an online scorecard that uses claims data to keep track of their compliance. As I've noted, UnitedHealthCare already tracks patients who order diabetes medicines through their pharmacy benefits manager (PBM) and knows far more about patients than most realize, so the risk to patients in terms of privacy is vastly overstated, but the rewards are significant.

The financial benefits to patients participating in the program are rather significant, and can add up to quite a bit in out-of-pocket expenditures, saving patients a LOT of money. Whether the program helps patients navigate through UnitedHealthCare's maze of approvals, appeals, etc. remains a mystery, but it is clear that program enrollees have access to a dedicated staff who CAN help patients deal with such matters.

For the moment, UnitedHealthCare is offering the Diabetes Health Plan only to large companies that are self-insured, meaning the employers bear the entire risk while the insurer administers the plan. But if this program proves successful, other insurers are almost certain to mimick the program, and potentially improve it.

UnitedHealthCare acknowledges that the biggest opportunity comes not so much from people with diabetes, but those with a condition whose very existence is disputed: pre-diabetes. Indeed, David Kliff, the Diabetic Investor, argues:

"'Pre-diabetes'" is like a woman being sort of pregnant. Either you have diabetes or you don't. The fact that the popularity of 'pre-diabetes' has taken hold is further confirmation that the people who are supposed to be helping with the diabetes epidemic have lost touch with the real world."

Patients with "pre-diabetes" have not officially been diagnosed with a disease, so enrollment in such a program raises questions of ethics on how best to spend limited healthcare dollars (pursuing those who aren't officially sick, or treating those who actually have a disease?), not to mention exposes the employers and their healthcare providers to potential lawsuits challenging the efforts. However, as long as the program enrollment remains voluntary, that isn't a real issue.

Whether pre-diabetes is genuine or not has little to do with the opportunity to save significant money. According to BusinessWeek:

"... the biggest potential savings for the employer, according to United, come when you prevent people with 'pre-diabetes'—who are also eligible for United's plan—from developing the full-blown illness. 'We know if a pre-diabetic loses 7% of their body weight, the chance they'll become diabetic goes down by 58%,' says Dr. Deneen Vojta, vice-president and medical officer at United. 'The numbers get astronomic.'"

Is there a downside? At the moment, the lower-cost diabetes patients (those deemed "compliant") aren't restricted. But if the insurers decide to shift focus away from patients with diabetes concluding that once they're diagnosed, it's a lost cause in an effort to save money, then challenges could emerge down the road.

But right now, the lure of immense cost-savings across the board in diabetes management suggests that is not likely to emerge as a problem anytime soon.

Monday, November 02, 2009

Book Review: Dan Hurley's book "Diabetes Rising" Disappoints (Just a Little)

I picked up an advanced copy of the book "Diabetes Rising" by Dan Hurley. I'm fortunate to live in the center of U.S. publishing, New York City, so there are many bookstores in town which have dozens of advanced copies of books which are sold as used -- I only paid $5 for a book with a list price of $26.95, although the book clearly states: "This is an advanced uncorrected proof. Please do not quote for publicity or publication without checking against the finished book. Not for reseale." (Since it was resold, I have few reservations about quoting from the advanced copy of the book, besides I can be a more objective reviewer this way) I bought an advanced copy well in advance of the official January 2010 release date, and many of the NYC bookstores will also sell to anyone with internet access, FYI). Amy Tenderich reviewed and subsequently interviewed the author back in September (see here, here and here).

After reading Amy's reviews, I was actually optimistic that this book would be along the lines of James Hirsch's "Cheating Destiny: Living With Diabetes, America's Biggest Epidemic" and take Hirsch's book to a new level. Hirsch's book, which IMHO is a very well-written account not so much about diabetes exclusively, but the state of the U.S. healthcare "system" (a term I use very loosely, because its really not so much a system as a collection of different interests that lack any sort of coordination at all) and how that "system", which was really built to address acute illnesses effectively short-changes patients with chronic illnesses in the process, and chronic illnesses are becoming ever more widespread in American society thanks to medicine transforming a number of formerly deadly diseases into chronic illnesses that have to be managed, rather than cured.

Anyway, with Mr. Hurley's book "Diabetes Rising", I was a bit disappointed, and I really wanted to LOVE this book. I didn't love this book. I didn't hate it, either, but I had a mixed opinion overall. I feel that the amount I paid for the book ($5) was worth it, but if I'd paid the list price ($26.95), I might have felt I'd been ripped off. Why? I was most struck by a few issues.

Issue #1: Too Much Coverage of Topics Which Aren't Interesting Reading

The first issue is that the author dedicates the first third of the book to the history of diabetes, along with countless factoids and statistics about the history and prevalence (the "Rising") of diabetes and the author's theories behind the growth of diabetes. Although interesting (Hurley is a good reporter), it does not add much to the story, I'm afraid. My impression that that this was kind of an effort to try and build a case for why diabetes should be cured as opposed to giving it chronic treatment without a cure, as is the case today. The author's writing style is interesting, but I have to admit that I found this section incredibly boring, and the information, while accurate, failed to convince me -- and I actually live with type 1 diabetes! I thought "Gee, if he can't win my support, then I question whether this book will help to convince policymakers and healthcare leaders?" He spent far too much time on this subject, which in my honest opinion, really wasn't necessary, but did increase the annoyance factor.

A lot of the time, he talks about diabetes collectively (type 1 and type 2) and that's part of the problem, although he clearly notes the differences when relevant. But the overwhelming consensus is that aside from sharing a similar similar name (due to an inaccurate historical medical assumption that it was, in fact, the same illness), but cures will likely require a very different approach for each type of diabetes thanks to the distinct and different underlying etiologies for both type 1 and type 2 diabetes. From my perspective, this part of the book was really a lost opportunity to make a more compelling case for why it makes sense to cure rather than continue treating diabetes, and from my perspective could have been addressed more succinctly. I sooooo wanted to skip ahead, but instead, I kept reading, but did not enjoy this section and really had to struggle not to skip ahead. It was like re-reading all the other annoying books diabetes, but I did not find this section enlightening or entertaining, just annoying.

By comparison, Jim Hirsch's book combined his own personal experience weaved together with actual facts makes for a more compelling and interesting story than Dan Hurley's does, which is written more as a third-party observer. Incidentally, if it wasn't in the forward section, throughout the entire first section, we'd hardly even know that Dan Hurley himself has type 1 diabetes. I can't be too critical, that's usually the way I write, too, except that I haven't been published. But I'll take that as a note should I ever decide to write a book that personal stories add infinitely to the credibility and readability to the story.

Issue #2: Too Much Focus on Disputed Theories Behind the Cause of Diabetes

The second key issue for me was addressed mainly in the next section of the book, which looks into the "Reasons" (hypotheses for what causes diabetes). In this section, Mr. Hurley focuses on a handful of theories (and they're are all just theories right now), but there is almost no justification for his selection of the particular theories he's selected, rather the reader is supposed to trust the author and those he's interviewed have made the correct assumptions. But faith in the author alone doesn't work for me.

This is, perhaps, my biggest gripe about the book.

First, I disagree with his selection of several theories, in part, because the logic behind why he chose those theories is a complete mystery, and the theories themselves are hardly the consensus view, and the evidence he presents is, in many cases, disputed.

One theory he posits, the so-called "Accelerator Hypothesis" (the word "hypothesis" should tell you something) which is summed up very succinctly in the journal Diabetes Care (published by the American Diabetes Association). I already wrote about this theory back on July 14, 2008, in which I called attention to that particular hypothesis' shortcomings, so my disdain for that particular theory is hardly new. Also, I don't need to tell anyone that the ADA's journals have been repeatedly subject to claims of lack of objectivity, occasional impropriety and frequent conflicts-of-interest among many of the journal's submissions, and while focused exclusively on diabetes, they remain less objective, than say, The New England Journal of Medicine or The Lancet would be. But beyond citing less credible sources (or certainly ones regarded as less subject to dispute), and the Accelerator Hypothesis is among the most provocative but disputed and contested theories even among diabetes researchers. When that theory first came out in 2003, I immediately questioned the core logic, and over the next few years, I read study after study which disputed various elements of the Accelerator Hypothesis.

In fact, Mr. Hurley spends considerable effort trying to build support for the Accelerator Hypothesis, and presents like it's presumed (or should be presumed) to be fact. My take on it is that the Accelerator Hypothesis predicts earlier diabetes onset in heavier and/or taller people, without necessarily a change in risk, and views type 1 and type 2 diabetes as the same disorder of insulin resistance, set against different genetic backgrounds. But the authors of that theory admit that most diabetes registries fail to track adults along with children, leaving them with little to substantiate their theory. But the basic logic is that if the age of diagnosis is becoming lower, there must be a reason; hence, the Accelerator Hypothesis. Early weight gain and increasing BMI of young children may lead to increased insulin resistance and an earlier destruction of pancreatic beta cells in a person who may be genetically predetermined to develop diabetes. But they fail to address the issue of autoimmunity and many doctors are left questioning the core logic behind the theory of insulin resistance based on basic dosage requirements among patients with type 1 relative to those with type 2, which are considerably smaller on a per kilogram basis, suggesting that insulin resistance is not the problem in type 1, insulin insufficiency caused by an autoimmune response is. Unfortunately, the authors of this theory also note that relatively few of the children in their own sample were overweight, raising even questions on the basic argument of the theory, as well as many other shortcomings. I find the use of largely disputed evidence to be perhaps the most troubling aspect of the book.

But this is not limited to the Accelerator Hypothesis alone. He also presents a few other theories, such as the Sunshine Hypothesis, also known as the Vitamin D hypothesis. Again, his selection of this particular theory is questionable or debatable, in part, because Vitamin D is among the most supplemented vitamins anywhere, although there are questions as to whether there's a legitimate difference between the vitamin D attained from the sun and the man-made supplements that exist in everyday foods. Unfortunately, hard evidence showing that low levels of vitamin D lead to disease or that high levels of Vitamin D prevent it are almost completely lacking, although it's presently a burgeoning area of research. As I've reported in the past, some (not necessarily the mainstream) organizations, such as the California-based Autoimmunity Research Foundation, posit just the opposite: that excessive amounts of vitamin D actually leads to an increase in a host of different autoimmune diseases, including type 1 diabetes mellitus. As I noted, that is subject to dispute as well, but exactly how much vitamin D children and adults should get, and defining when they are deficient, is also under widespread debate. Doctors use different definitions, and many are waiting for "official" guidance on the subject expected in an Institute of Medicine report on vitamin D which is due out in 2010. The institute is a government advisory group that sets dietary standards. (Author P.S.: On November 30, 2010, the IOM determined that too much vitamin D can indeed be counterproductive, see HERE for detail.) But to select this hypothesis, which is also subject to such widespread uncertainty, raises questions in my mind, but fails to answer anything for me.

The Cow's Milk Hypothesis, which asserts that giving babies cow's milk-based foods too early in life is what wreaks havoc on the immune system, is a somewhat more logical theory, but remains only a theory that has already been dismissed by some, although other studies seem to back this theory up. But if I were to make an argument on the reasons behind the rise of diabetes, I would try to choose some theories that were not the subject of such widespread conflicting evidence.

About the ONLY hypothesis Mr. Hurley presents as contributing to the rise of diabetes that I can even rest comfortably with is the POP (Persistent Organic Pollutants) Hypothesis, which assumes that man-made environmental toxins may be the cause. But an interesting and unexplained paradox of this theory is that many countries with the most pollutants on earth, such as China, also have some of the lowest incidences of type 1 diabetes anywhere on the planet. A more compelling argument might be made for a combination of different theories, rather than taking any of these unproven theories by themselves. Take the POP Hypothesis combined with the hygiene hypothesis, which Mr. Hurley fails to even address (even though it's perhaps among the most logical and least disputed theories around) is that when children are exposed to many viruses, bacteria, etc. at an early age, their immune systems are better able to distinguish "self" from "non-self", so kids growing up in say China, have immune systems that are less likely to attack themselves and cause type 1 diabetes than kids in places like Finland or Sweden, two countries that are really, really clean and affluent.

But even if these theories collectively make sense, the POP Hypothesis also remains one of the few theories where the resolution is perfectly clear. The problem is that world lacks any collective willingness to effectively address the problem. With that being the case, why spend so much time writing about it, when one country cannot do it alone (and often, the U.S. has been among the least willing countries to cooperate)? All of these strikes me as somewhat irrelevant to the case to be made as to why diabetes should actually be cured rather than maintaining the status quo, although he does raise a number of compelling arguments why treatment alone is insufficient.

But all of the theories "Diabetes Rising" presents, even if they are in dispute, also raise questions as to what relevance they even have on the current situation? Again, he spent a lot of time on this particular issue, and much more than I thought was really necessary.

Issue #3: A Lost Opportunity?

The core issue is that diabetes is extremely costly to treat using current methods, and the incidence of all types of diabetes is rising rapidly worldwide, which spells trouble. The sad fact is that we cannot prevent ourselves out of an epidemic already underway, its already a day late and a dollar short for that, something Hurley fails to even address. Therefore, the challenge is for society to evaluate the continued and growing cost of investments made in treating the disease relative to investments in finding cures for the disease. At present, investments in treatment relative to cures are about 500 times higher than cure-related research. That should, in theory, make curing diabetes easier to justify, and he should spend more time talking about misplaced research priorities in diabetes and why that is a poor use for limited research dollars, but he really doesn't spend much effort or focus on doing so, and I think misses a huge opportunity for what could have been a truly "epic" book as his publicist refers to it. Instead, I see it as yet another tome about diabetes that could have met the description, but instead misses the mark on several levels.

Positives: Coverage of Cure-Related Research & Progress

The third section of the book talks about what he suggests are the "Remedies" (theories that might lead to a cure). I would believe this section is the most interesting, most logical and best-written, and my preference would have been for him to spend far more time and effort to beef this section up, rather than having spent so much time and effort on the rising and even the reasons for the growth in all types of diabetes. This section, in my opinion, gets too little attention and detail, and again, contributes to a book that is less balanced overall.

For example, he talks somewhat about what he refers to as a "computer cure" (meaning the artificial pancreas) in which the author Dan Hurley himself was in a clinical study organized by the JDRF. ("For 15 hours, I was no longer diabetic," he wrote, and he also lamented about how the FDA has consistently dragged its feet on approving a simple but key feature: automatic shut-off for a combined glucose-insulin system that detects a low). Of course, he does not address the fact that the reliability of these devices is widely regarded as insufficient, and he also fails to address the tests that JDRF-funded researchers at Boston University (see JDRF's March 2007 Frontline for details) have done on combining insulin and glucagon in the same device, which I would call a significant research oversight on this very subject. JDRF's Aaron Kowalski was interviewed, and I think Aaron is a great personality who adds a great perspective (both Aaron, and his brother have type 1, and Aaron's brother suffers from hypoglycemia unawareness) so his perspective is very valuable to this topic.

It is in this section where Hurley is at his best, weaving parts of his own personal story in with the facts makes it much more interesting reading. But I also feel that Mr. Hurley does disjustice (is that even a word?) to the discussion on the controversy over bariatric surgery as surgical cure for type 2 diabetes, with an inappropriate comment "By golly, it works". Aside from the problems with this surgery, I think he places too much faith in a handful of studies undertaken by doctors who stand to benefit the most by performing this surgery, when, in fact, it's very radical surgery and not without risks (although he does nothing to address the risk of doing nothing as a point of comparison). Again, if he had focused only on type 1, that would be a non-issue, and I believe the subject of type 2 has less relevance to this book as an overview of the situation. Again, self-management pertains to both, but Hurley has no real expertise on the subject of type 2 and I don't think these two always fit together unless it's in the context of public policy and the tendency to blame the patient rather than the disease itself.

I did LOVE Hurley's personal observation on insulin pumps and closed-loop systems:

"I finally decided to go on a pump in 1999, after my insurance company agreed to pay much of the cost. On balance, I found it made life easier by allowing me to make minor adjustments in my insulin rates on the fly, but resulted in little change to my A1C numbers. And my lows remained every bit as common as my highs. Essentially, it was just another way, albeit incrementally better, to get the same old insulin I'd always used. And while friends and family often assumed that the pump worked like an artificial pancreas, giving me only as much insulin as I needed, in fact, it was as dumb as a brick, following only the instructions I gave it."

Finally, in the section which he describes as a "Biological Cure", he does address some of the potential autoimmunity treatments including lengthy coverage of teplizumab which is being developed by Macrogenics in combination with Eli Lilly & Co. thanks to a partnership facilitated by JDRF, but doesn't do sufficient (actually any) justice to the legitimate concerns about related to adverse effects. For example, I am fond of the quote of my friend Ellen Ullman, who wrote:

"Dr. Harlan from NIH wisely pointed out at Children Wtih Diabetes Friends For Life Conference that the anti-cd3 drugs [which includes teplizumab] can cause recurrent mononucleosis which can increase one's propensity to develop lymphoma. Why would someone put their child at risk for that simply for a year and a half of extended honeymoon?"

Of course, there are several other similar treatments now in late-stage clinical trials, included one by Tolerx, Inc. and GlaxoSmithKline called otelixizumab. In fact, Tolerx's CEO Doug Ringler's blog called "The Green Chair" recently wrote a posting entitled "Dose Optimization Presentations On Otelixizumab: Finally!" suggesting that the GSK/Tolerx treatment is further along in development that the Lilly/Macrogenics treatment teplizumab is. Whether that is true remains to be seen, it could just be that Tolerx is more forthcoming that Macrogenics is.

Still others have a few other products being tested, among them, including Denise Faustman's use of the BCG vaccine. Whether any of these treatments will work long-term in patients remains to be seen, and the adverse events, especially with repeated, long-term usage, remain hurdles that are worthy of further exploration. But as noted, I don't believe this section got the attention it really deserved, and this is an area patients with diabetes really want to know about. But he did spend too much time talking about stuff that many of us really don't care about.

Having said all of this, I DON'T want to give the impression that I completely disliked the book, or that I think it is poorly written.

Quite the contrary.

I believe Dan Hurley does an excellent job of researching those topics he chooses to focus on. My issue is that I think he focuses on some (OK, many) areas that I don't happen to agree with. That doesn't mean he's done a bad job. In fact, he writes in a manner that might make someone really believe the stuff he's written, which I think is part of the problem. I wouldn't want someone to walk into Barnes & Noble, pick this book up, and believe that he's answered everything, because he most certainly hasn't. As with anything, there are two sides to every story, and I believe he's done a good job of presenting one side of the facts. But as I am fond of saying, that might be "selective disclosure of the truth". Is it wrong? No. Is it always a fair representation of the facts? No, but it's a book, so it doesn't have to. Is it an interesting read? Certainly.

One thing I must give Mr. Hurley credit for is that he writes well, in a manner that is very readable and he does know how to interview (or give the impression when he hasn't interviewed) on various subjects all within the context of the subject he covers. He's obviously an experienced journalist.

I also agree wholeheartedly with his conclusion:

"But it's just as clear ... that focusing on personal responsibility alone has not stopped, and will never stop, the rise of diabetes. Something more is needed; recognition that forces beyond the individual's control are at play, and that united action is necessary to face down what is a public, and therefore political, danger to our well-being, and to the well-being of our children."

He probably could have dedicated an entire chapter to that subject, but only touches upon it, which is IMHO, another lost opportunity.

My Conclusion: A Good, But Not A GREAT, Book About Diabetes

My conclusion is that Mr. Hurley and his editor have chosen to focus on on certain topics, and he does present those subjects well. In fact, they are presented too well, so that an uninformed reader might reach the wrong conclusion about those topics. There's no shortage of opinion about the causes behind diabetes, or what to do about it. I just disagree with his theories on the causes. But I DO like his book overall, but I think he could cover some subjects in more depth and spends way too much time on some subjects that aren't really necessary. That doesn't make it a bad book; the goal of the publisher is to sell books, not be a balanced story. In fact, the book is quite well-written and researched, and the length is about right, I only wish he'd dedicated more time to certain content, and far less to other content.

"Diabetes Rising" is definitely worth reading, and there's definitely a big shortage of writing about diabetes. In spite of the amazing growth in diabetes prevalence, diabetes gets far less publishing coverage, than say, cancer, which has sooo many books, and too many of the diabetes books are about diet and cooking. I would have liked Mr. Hurley to focus more in-depth on topics where there's a genuine lack of coverage (such as cure-related research and progress being made there), and focus far less on those topics where there's no lack of coverage on (such as the disease history and prevalence of diabetes, both topics have been beaten to death by the press).

While I hope that Diabetes Rising sells well (because a success will pave the way for more to be written on this subject). Too often, books on the subject of diabetes don't sell well, which tells the publishing industry that its a subject that does not deserve more attention. Nothing could be further from the truth. We need more, much more to be written on the topic of diabetes, and some of that's because the books which have been written on diabetes have been poorly chosen. "Diabetes Rising" is definitely worthy of being published, and deserves to be a hit with booksellers. But my recommendation is NOT to buy the book at that ridiculous list price (maybe read your library's copy instead). Diabetes Rising a good book, but not a great book about diabetes.