How Patient Advocacy Helped Persuade Medicare to Cover Dexcom

This week, there was some very good news from the Centers for Medicare & Medicaid Services (CMS) and the JDRF, notably for people with Type 1 diabetes who rely on Dexcom CGM devices.  Essentially, CMS has accepted FDA labeling for the system and will no longer prohibit coverage.

JDRF did a press release which can be seen at http://www.prnewswire.com/news-releases/jdrf-encouraged-by-medicare-decision-to-take-first-step-toward-coverage-of-continuous-glucose-monitors-for-people-with-type-1-diabetes-300390684.html.

Dexcom had its own release which can be seen at http://www.businesswire.com/news/home/20170112006146/en/Centers-Medicare-Medicaid-Services-CMS-Classify-Therapeutic.

This really began last year when Dexcom submitted a supplemental application to its existing FDA premarket approval to add a new indication for use of the Dexcom G5 Continuous Glucose Monitoring System, asking that it be officially approved for making insulin dosage decisions.

Previously, the Dexcom G5 was only approved to measure glucose in interstitial fluid as an adjunctive device meant to complement, but not replace, the information obtained from more traditional fingerstick blood glucose monitoring devices.  According to an FDA briefing document (see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ClinicalChemistryandClinicalToxicologyDevicesPanel/UCM511810.pdf for more detail), the level of accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system is "close to, but not as good as, typical self-monitoring blood glucose meters in the U.S. market."

I agree with the FDA briefing document and won't use my Dexcom for dosing decisions, but some do and they find the trending info. CGM's provide to help in their decision-making.  But the Dexcom application request raised some questions as to whether the FDA would even agree to re-label the device.  At a hearing held on on Friday, July 22 2016, the FDA's clinical chemistry and clinical toxicology advisory panel voted 8 to 2 in favor of safety, 9 to 1 for efficacy, and 8 to 2 that the benefits (see http://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-favor-of-non-adjunctive-label-for-dexcom-g5-mobile-cgm-system-300302609.html for more detail) of the proposed new label indication would outweigh the risks.  Although the FDA is not bound by its advisory panels' votes, it often heeds their advice in making its decisions.

There was some patient activism involved in helping to persuade the FDA to re-label the device.  For example, in early July 2016, the diaTribe Foundation (see https://diatribe.org/sign-diatribes-letter-fda-supporting-use-cgm-insulin-dosing for the recommended letter text) began seeking signers for a letter it had drafted in support of the new indication Dexcom was seeking, and it aimed to get at least 1,000 signers to the letter (apparently, their letter was signed by over 10,000 people with diabetes and their families, see http://ow.ly/M69L3085eZb for more).  There were also advocacy efforts by the Diabetes Hands Foundation, Diabetes Daily, Diabetes Patient Advocacy Coalition (DPAC), the JDRF and others (Insulin Pumpers, for example).  Personally, I liked the diaTribe Foundation's letter, and I used that as the basis for my own comments on why I felt the new label indication was appropriate when I submitted my own comments to what was then an open-docket at FDA.  But, I think what was unique (and encouraging) about all of the efforts was the degree of spontaneous organization and collaboration amongst all the parties involved.  Instead of contradictions and bickering, most of the initiatives built upon the efforts of one another.

Just before Christmas 2016, we got a decision.  FDA agreed to expand the approved use of Dexcom's G5 Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment (insulin dosage) decisions in people 2 years of age and older with diabetes (see the press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534056.htm for details).  This was definitely something many patients with diabetes wanted to see happen, although maybe not for the reason of avoiding a fingerstick as some writers erroneously presume.  Rather, it's the implication the decision might have on securing Medicare coverage of the Dexcom G5 system.  Of course, an FDA label is one thing, but getting Medicare to cover these devices was an entirely different matter.  Medicare is huge, but is frequently difficult to work with and is sometimes unpredictable.

This week, the Centers for Medicare & Medicaid Services (CMS) re-classified therapeutic Continuous Glucose Monitors (CGM) as "Durable Medical Equipment" under Medicare Part B, which means that for some patients with diabetes who are on Medicare, they actually might be able to get coverage now.  It's not a blanket decision, but the direction seems clear.  Also, many insurance companies base coverage decisions based upon what Medicare does, so this might help some gain coverage with private insurance, too.

Here's the CMS link to the coverage details:  https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682R.html.

A downloadable document link to the full CMS Ruling No. CMS-1682-R can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf.

Changes in the Price of Insulin, In Graphics!

In September 2016, the media was flooded with stories about the rediculously expensive price of EpiPens, which is basically epinephrine used to treat severe allergies (such as when some people get stung by bees or encounter peanuts), as the pens cost more than $600 for a package of two.  The news was that the price of EpiPens had skyrocketed, which is a generic drug with an innovative delivery device that enables even people unfamiliar with doing so to give an epinephrine injection in order to rapidly address allergic reactions.  Prices for the devices had increased by 600% over the past decade.  Suddenly, everyone was remarkably empathetic to the persons who need to pay more than $300 for an EpiPen.  But as I already noted in my preceding post (see https://goo.gl/cWvNRz for my post), that incident was remarkably familiar to people who have to buy insulin, glucagon and supplies needed to manage diabetes.

I pointed to a Bloomberg article (see http://www.bloomberg.com/news/articles/2015-05-06/diabetes-drugs-compete-with-prices-that-rise-in-lockstep for that) which showed a sickeningly similar trend of dramatic price increases for insulin (especially) and other diabetes-care items.  The Washington Post finally addressed this issue with an article of their own (see https://www.washingtonpost.com/news/wonk/wp/2016/10/31/why-insulin-prices-have-kept-rising-for-95-years/ for the article), so did the Wall Street Journal (see http://www.wsj.com/articles/insulin-prices-soar-while-drugmakers-share-stays-flat-1475876764 for the article), and NBC News did so today (see http://www.nbcnews.com/business/consumer/insulin-new-epipen-families-facing-sticker-shock-over-400-percent-n667536 for the article).  [Finally, Business Insider covered the story on May 15, 2017, see their article at http://www.businessinsider.com/insulin-prices-increased-in-2017-2017-5 for more detail.]  One of the articles noted that one version of insulin carried a list price of $17 a vial in 1997 is now priced at $138 today. Another that launched two decades ago with a sticker price of $21 a vial has been increased to $255.

Since I've seen some stunning charts and graphs in these articles, I thought it might be worth sharing the story ... graphically.  The images below are courtesy of Bloomberg and The Washington Post, the WSJ and NBC News, but paint a graphic picture of what's become of the insulin market in recent years.  The trends are even more stunning with these graphics!  Note that if you click on many of the charts, that will take you to the original articles.

On April 8, 2016, NPR's Science Friday covered the rising prices of insulin in a segment entitled "Diabetes Drug Prices Tripled in a Decade" (listen below, or by visiting http://bit.ly/2mlI95Z for the story).


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Obviously, the trend from biosynthetic "human" insulin to patent-protected insulin analogs was part of story, but those patents are all expiring.  The biggest-selling basal insulin known as Lantus (U-100 insulin glargine rDNA origin) will see the first knock-offs being launched by the end of 2016, and CVS has already pulled Sanofi's costly basal insulin from next year's formularies.  Although I hadn't anticipated biosimilars coming from other big pharma players, the fact is that pharmacy benefits managers including CVS, Express Scripts and United Healthcare's own OptumRx unit (which bought Catamaran in March 2015, see the news at http://www.wsj.com/articles/unitedhealth-to-buy-catamaran-for-12-8-billion-in-cash-1427709601 for more) are now pushing for lower prices, and getting them.  This has hurt players like Novo Nordisk very badly.  The only problem is that the lower prices they're getting come from rebates, so the discounts are invisible, meaning they're done without any changes to list prices for insulin.

That's good for big payers, but not so good for the rest of the market.

American Public Media's Marketplace had a great radio segment dedicated to this topic.  See below, or visit http://www.marketplace.org/2017/01/31/world/drug-makers-insulin-accused-price-fixing:

A law firm is seeking to have its case against the big 3 insulin makers classified as a class action, and if that happens any insulin user can be a part of the class, so stay tuned for more. For more detail, visit the following website: https://www.hbsslaw.com/cases/insulin-overpricing.

Novo's Ills Are Indicative of Something Other Than A Free Market for Insulin

As I've already addressed, a few weeks ago (see my post at http://blog.sstrumello.com/2016/08/the-business-of-diabetes-cvs-caremarks_5.html for more), Novo Nordisk's CEO Lars Rebien Sorensen rather unceremoniously announced he was retiring early (see http://fortune.com/2016/09/01/novo-nordisk-ceo-retire-insulin/ for more) which was kind of an acknowledgement that the era of easy price increases for its products in the U.S. is over.  Already, CVS Caremark and United Health announced that they are dropping Sanofi's Lantus in favor of biosimilar versions from Lilly/Boehringer or Merck/Samsung, and there's reason to presume that biosimilars will pressure Novo's products even more.  This week, Novo also announced it was taking the very rare step of laying off approximately 1,000 employees, something the Danish company has almost never done, including about 500 people in its R&D department.

When a reporter asked him if that meant the company was cutting into the bone of the company, rather than the fat, the response he gave was rather interesting:

"The next line of products have to have an even greater height of innovation, which means those that do not have that height of innovation will have to be culled," Soerensen said. "Otherwise, it's going to be difficult for us to get reimbursement for our drugs. Me-too or me-better drugs will not be good enough in the future and hence we need to prioritize."

That kind of sounds like an acknowledgement (to me, anyway) that some of its newer products, most notably Tresiba (U-100 insulin degludec rDNA origin) is acknowledged even by the current leadership to be a "me-better" product, rather than anything really truly innovative.

Indeed, Jeremy Greene, an associate professor at the Johns Hopkins University School of Medicine said "If any drug should be available generically, it should be insulin." adding the new insulins are "not so much better that it justifies the presence of people who can't afford any drug."

In August, the $#!t hit the fan over EpiPen price increases.  In effect, the price of the EpiPen, which treats emergency allergic reactions and things like bee stings, but is not really a drug that must be taken daily, had climbed sixfold over the last several years. At drug price-comparison website GoodRx, the cheapest price at the time was $614 for a package containing two, or more than $300 per EpiPen, up from about $100 for two EpiPens not too long ago.

The story was an all-too-familiar one: a company buys an old drug that no one else makes anymore, raises prices and impedes patient access to life-saving treatment in the process.  We saw a similar situation when "Pharma Bro" Martin Shkreli made news a few weeks earlier.  As the then-CEO of Turing Pharmaceuticals, he acquired an old anti-parasite medication called Daraprim and immediately increased the price from roughly $13.50 to $750.  He seemed to relish in giving his middle finger to people impacted by the decision.

In the case of the EpiPen, the target of that tired narrative was a medical device with an unusual amount of brand name recognition, no real alternatives and a growing patient population — Mylan Inc.'s EpiPen.  Epinephrine is a generic medicine, and is widely available but the delivery device (in this case, a pen) was unique and made it easy for people who aren't medical professionals to administer.

People with diabetes kind of looked at all the news and thought to ourselves "So what? Welcome to the club, EpiPen folks ... have you seen the insane prices of insulin lately?"  Of course, we didn't have much data to back it up, and since most people really have no clue what the real prices are for medicines we rely on, its a pretty tough claim to substantiate.

But earlier this year, Bloomberg had an interesting article entitled "Hot Drugs Show Sharp Price Hikes in Shadow Market" [http://www.bloomberg.com/news/articles/2015-05-06/diabetes-drugs-compete-with-prices-that-rise-in-lockstep] which interestingly enough, looked at insulin prices.

On May 30, 2015, the price for a vial of the blockbuster diabetes medication Lantus (U-100 insulin glargine rDNA origin) went up by 16.1%. On the very next day, Lantus's only direct competitor, Levemir (U-100 insulin detemir rDNA origin), also registered a price increase -- of precisely 16.1%.

The pattern repeated itself six months later when Lantus, from French drugmaker Sanofi, was marked up 11.9% percent, and Levemir, made by Novo Nordisk A/S, matched the price increase again exactly.

Clearly, this is not how competitive, free markets are supposed to work.

I should acknowledge that insulin was definitely not the only type of medicine to exhibit this type of price inflation.  But it is indicative of a market that is definitely not a competitive one, not exactly a free market.

Some of this comes directly from Bloomberg, but its worth sharing with the diabetes community.

Is this price-matching a coincidence?  I think not.

Bloomberg's analysis revealed that in 13 instances since 2009, prices of Lantus and Levemir -- which dominate the global market for basal insulin with approximately $11 billion in combined sales -- had gone up in tandem in the U.S., according to SSR.

The article also discusses the shady world of "shadow pricing", and rebates given to big payers and how prices outside the United States, which arguably subsidizes the rest of the world with the prices paid.  Ironically, the drug and biotech industry lobbied very hard to prevent one of the biggest payers in existence, Medicare, from negotiating drug prices under the Medicare drug benefit signed into law by President George W. Bush.  Most other countries have price controls, or at least are able to negotiate based on how much they are buying.

For example, in Germany, almost every German belongs to one of some 160 nonprofit "sickness funds," or nonprofit insurance collectives. The sickness funds cover both medical visits and prescription drugs. Drug prices there are already lower than in the U.S. because sickness funds negotiate with both physician groups and drug manufacturers to set costs of all treatments across the board. But in the U.S., Medicare isn't even allowed to negotiate lower drug prices.

As for prices, Sanofi and Novo "are taking the same price increase down to the decimal point within a few days of each other," said Richard Evans, an analyst with SSR. "That is pretty much a clear signal that your competitor doesn't intend to price-compete with you."

A pattern of insulin makers matching each others price increases “certainly indicates a market that isn’t competitively healthy,” said David Balto, an antitrust lawyer and former Federal Trade Commission policy director. However, if two companies act independently to follow each other’s price increases, it’s not an antitrust violation, he said.

But Lilly, which once dominated the U.S. insulin market with an estimated market share of 85% for insulin sold in the U.S. back in 1985, basically ignored the diabetes business as it pursued neuroscience with drugs like Prozac and Zyprexa.  Lilly had to partner with the German drug company Boehringer Ingelheim for most of its newer diabetes medicines, but since bringing in Enrique A. Conterno to run the diabetes business a few years ago, has suddenly started appearing on more drug formularies than it has in years.  But Lilly's willingness to compete on price, at least with some big payers like United Healthcare and Kaiser Permanente, doesn't mean retail prices are likely to show any decreases.

For their part, drug manufacturers like to keep prices as secret as possible.

"How much a patient pays is based on a negotiation between the payer and the pharmacy," said Ken Inchausti, a Novo Nordisk spokesman. He said the company couldn't comment fully without knowing details of a patient's health plan.

Have a look at this video (see below, or by visting http://bloom.bg/1IjpdgL for the link).



Author P.S., October 8, 2016:  The Wall Street Journal acknowledged big price increases for insulin but seems to lay responsibility for the increases on drug wholesalers like McKesson and AmerisourceBergen for the price increases, not the manufacturers who offer PBMs big "rebates" which reduces the end prices paid for by insurance companies.  For details, refer to the article at: "Insulin Prices Soar While Drugmakers' Share Stays Flat" http://on.wsj.com/2dl1znP

A Tribute to Kathy Putzier

It seems like these days, half of my posts are tributes (actually, its true, though I have a few others mixed in), and today, unfortunately, will be another one.  This one is for Kathy Putzier.  Her sister Joan Meece shared the news on Facebook on Wednesday, August 17, 2016, so I presume the actual date was sometime around that, although details are still trickling in right now.

One irony, which I think perhaps Kathy would have appreciated, is the fact that another person also named Kathy Putzier who was also from the Twin Cities area passed away around the same time, although the other Kathy was 82 years old, so it definitely wasn't the same woman that the diabetes community knew and loved, as the Kathy Putzier we knew was just 63 years old.

Early d-bloggers knew Kathy first as "Minnesota Nice" (not a bad term based on my knowing her!) and her blog was known as "Purple Haze" (see http://kathy4762.blogspot.com/ for her archived posts).  In 2012, Kathy decided to devote her time to other pursuits, so she decided to stop blogging, although I believe she remained pretty active on TuDiabetes, which was the place she decided to continue her online diabetes work.

Like me, Kathy was one of the earlier members of the d-blogging community as a person with Type 1 diabetes, and many in the Minneapolis area including Scott K. Johnson and others had met up her quite a few times.  No doubt, their sense of loss is bigger than mine.  But a few years ago, I went to Minneapolis for a long weekend (I think it was Memorial Day weekend), and Kathy and I were going to try and get together that weekend (I did get to reconnect that weekend with Allison Nimlos during that visit, which was great, but others like Scott Johnson were out-of-town that weekend).  As things sometimes happen, when Kathy and I spoke on the phone, the timing just did not enable us to meet in person during that visit, as she had some family activities going on that weekend, too.

As a result, my memories of Kathy were mainly of her personality expressed online, which I think were a genuine representation of her as a person ("Minnesota Nice" was a good name, based on my phone conversations with her!).  Kathy was also dealing with some kidney problems, although I don't know for certain if that was the cause of death for her, but as someone who was also diagnosed in the so-called "dark ages" of diabetes care a few years before me (she was diagnosed in 1973, I was diagnosed in 1976), so also she saw the evolution -- and in some cases, the de-volution, of diabetes care, just as I have over the years.  We would sometimes reminisce about those days, which as I've blogged in the past, are not quite as terrible as many newcomers to the world of Type 1 diabetes have been taught to believe (catch my post at http://goo.gl/UQRIfK for more details).

Kathy with World Diabetes Day postcard (I think!)

Kathy and some Minneapolis D-friends.

Kathy (second in on the left side) and the Minneapolis D crowd.

Kathy circa 1975. She looked pretty much the same in 2016!

Anyway, this was an event from this week, although I haven't yet found an obituary for Kathy, as details become available, they can be found on TuDiabetes.  Kathy's Facebook page was at https://www.facebook.com/kathy.putzier though if you weren't already Facebook friends with her, I think it might be too late.  Also, a tribute page was created for her on TuDiabetes at http://www.tudiabetes.org/forum/t/share-memories-of-kathy-putzier/55526 which you can check out.

I'm sorry to hear about Kathy's passing, but just as I noted in my post a few weeks ago about Kitty, I know that today, Kathy is now in perfect health and can look down at her vast network of friends here on earth and smile at how many are missing her now.  Kathy, I'm glad to have known you, even if it was mainly online!

The Business of Diabetes: CVS Caremark's Salvo in Biosimilar Insulin for 2017

Its already mid-2016, and for nearly the past decade, I've been pushing for so-called "biosimilars" or "follow-on biologics" like insulin to be legalized and then introduced in the U.S. (I first investigated this issue back in 2006, and published an article on it in January 2007). The reality is that without any form of generic competition, prices continue to rise with absolutely nothing to stop them.  In recent years, there have been some hyper-aggressive price-increases from the insulin oligopoly, especially within the last 3 years or so.  The reason: they all KNOW that their insulin analog patents are about to expire soon, so they've made a shameless money-grab with huge price increases before that happens.  The retail cost of a vial of insulin is now over $125 a vial, and that's for old varieties like Regular or NPH which have been on the market for like 95 years.  I haven't even bothered to price insulin analogs!

The Affordable Care Act (a.k.a. "Obamacare") finally legalized biosimilar medicines in the U.S. Before that, there was a lot of complaining and bellyaching from pharmaceutical and biotechnology companies that there was no regulatory pathway, which was only true for some newer biotech medicines.  Because insulin was the very first biotech medicine ever approved by the FDA, its grandfathered under the law as a "small-molecule" drug (along with human growth hormone, another very early-generation biologic medicine), so there was no legal impediment for biosimilars.  Consider the case of a very early biosimilar version of human growth hormone known as Omnitrope, which was approved on June 1, 2006, several YEARS before the Affordable Care Act was passed into law on on March 23, 2010 and later implemented in 2011.

The industry bellyaching was more excuses than anything else as far as insulin was concerned.  Frankly, there just wasn't very much incentive from pharma to pursue biosimilar insulin products like Regular and NPH because most American patients were already being switched to more expensive, patent-protected insulin analogs.  But its now fair to presume that this particular money tree has just dropped its last leaf for the likes of Lilly, Sanofi and Novo Nordisk.  The real question is how patients with diabetes will be impacted?

On Monday (August 2, 2016), Express Scripts notified (see HERE for the news) its PBM customers that starting in 2017, 85 medicines would be excluded from its national formulary, and, as a result, that company anticipates about $1.8 billion in savings, up from $1.3 billion in 2016.

Then, the very next day [on August 3, 2016], competitor CVS, which is a large retail pharmacy with an equally large pharmacy benefits manager (PBM) business named Caremark (which competes directly with Express Scripts) levied the first salvo in this battle, announcing that it would recommend to its PBM clients that they drop Sanofi's Lantus (U-100 insulin glargine rDNA origin) from their formularies.  (See the news HERE).  Realize that PBM corporate clients are under zero legal or in many cases even contractual obligation to do so, and they can certainly choose to continue covering Sanofi's U-100 Lantus if they wish.  But as a practical reality, given the big cost-savings expected from following the recommended PBM formularies, most companies will likely follow Express Scripts' and CVS Caremark's recommendations.

CVS Caremark wrote to its PBM clients "CVS Health is taking a stand against egregious drug price increases that unnecessarily add costs for clients and their members.  On a quarterly basis, products with egregious cost inflation that have readily available, clinically appropriate, and more cost-effective alternatives may be evaluated and potentially removed from the formulary."

There was some murmur from people with diabetes about another choice being taken away from them, especially since formularies have become ever more aggressive in pursuit of lower prices for "therapeutically equivalent" medicines in recent years.  For example, over the last 7 years, my employer's insurance company PBMs have switched from Lilly Humalog (U-100 insulin lispro rDNA origin) to Novo Nordisk Novolog (which known as Novorapid in many other markets, but is U-100 insulin aspart rDNA origin) back to Lilly, back to Novo Nordisk, and back to Lilly over a few years.  I just got tired of routine switching to similar, but not identical, insulins that require new ratios and testing to make the switch to a new brand of insulin happen (insurance fights to give me any more test strips as it is).  True, one of the brand switches involved a switch to new insurance carrier, but the point was that I was being treated like a ping pong ball, and I grew tired of routine annual switching to save the insurance company money while my co-pays go up, so I pushed my endo to challenge the switch to slow-mo-log (slow motion from Novo), and after a few appeals, I did manage to get my way.  But that should not have happened, what doctors prescribe is supposed to based on medicine, not necessarily costs unless patients have a need.

I made a number of comments to the FDA on labeling and the like when the docket opened for biosimilars a while back, and I think FDA has tried to incorporate patient concerns into its final guidance.  But the business environment is something FDA has very little control over.  The CVS Caremark move to drop Sanofi's Lantus from its 2017 formulary is an acknowledgement that big pharma has gotten a little too greedy with the price increases.  I would add that market share leader Novo Nordisk has started paying a price for it.

When Novo Nordisk announced its earnings today (on August 5, 2016), the company's shares fell by 8% after Novo cut its forecast for 2017 full-year profit growth, and said it expected tough competition in the U.S. to pressure prices next year.  As a point of reference, Novo Nordisk gets around half its revenue from the U.S.

Diabetic Investor David Kliff has been warning of this for several years, arguing in 2013 that:

"The insulin market, both short and long acting, is transforming itself into a commodity market where price trumps performance. The GLP-1 is also undergoing this transition albeit at a slower rate."  He was also quite critical of Novo Nordisk management for naïvely believing that it could maintain very aggressive prices/price increases for its products faced with the genuine possibility of "generic" (biosimilar) competition for the first time.


Today, Novo Nordisk chief executive Lars Rebien Sorensen told investors "In the USA, the market environment is becoming increasingly challenging and contract negotiations for 2017 have reflected an intensifying price competition."


"Because of competition and biosimilar entries, we've had to increase our rebates to retain that level of access in the marketplace," Soerensen said by phone on August 5, 2016 (see HERE). "In reality, the only way you can insulate yourself from pricing pressures are by, long-term, introducing new and better products."

Meanwhile, rival Lilly, much as David Kliff told investors in 2013, anticipated that the insulin market was transforming into a commodity business, and in recent years, Lilly has aggressively competed on price to win a spot on various insurance company formularies ranging from Kaiser Permanente to United Healthcare.  Previously, Lilly hadn't paid very much attention to insulin, and that lack of attention allowed rival Novo Nordisk to usurp Lilly insulin from so many insurance company formularies.  But in December 2016, Lilly and its German partner Boehringer Ingelheim will introduce their own Lantus biosimilar (U-100 insulin glargine rDNA origin) branded as Basaglar.

Lilly isn't alone, either.  Rival Merck (along with its South Korean partner Samsung Bioepis) will also introduce a Lantus biosimilar, too.  Although they haven't yet come up with a brand name or logo yet, its Lantus biosimilar is now called MK-1293, which received the same FDA pre-approval as Basaglar did a a while ago (see the news HERE and HERE) and both Lilly and Merck's versions of Lantus are expected to compete aggressively with Sanofi's Lantus on price, hence CVS Health (Caremark) will have a few new choices for the best-selling insulin Lantus that it never enjoyed before.  The thing is, these are biosimilars, which are better than "therapeutically equivalent" switches that insurance has routinely put patients through recently.  But Lantus is merely the first and biggest insulin; products like Humalog, Novolog, Levemir and Aprida all face patent expirations soon.

Other potential competitors for biosimilar insulin include the Sandoz generics unit of Novartis, as well as Israeli drug giant Teva.  Although I did not anticipate competition coming from fellow big pharma giants like Merck and Lilly, the day of biosimilar insulin will indeed be here in early 2017.

For me, the main issue is not who makes the insulin, but the insurance companies routine switching that is starting to get on my nerves!

Update, September 1, 2016:  The news that Novo Nordisk's longstanding CEO, Lars Rebien Sorensen will retire early (at the end of 2016) was a direct result of pricing pressures mounting for the company (see HERE for more), as noted above.  Novo is much more reliant on fat profits from the U.S. even though it operates worldwide, profits outside the U.S. are much smaller.  The recent news is something of acknowledgement that the era of easy profits from the U.S. are going to be much harder in the future as large U.S. payers flex their muscles as described above.

Update, September 22, 2016:  In addition to PBM CVS Health (Caremark), there was news today that United Healthcare will be dropping Sanofi's Lantus (U-100 insulin glargine rDNA origin) from its formulary (see the news at HERE for more detail).  As the giants like CVS and United Healthcare drop costly insulin varieties, 2 possible responses could occur: either more follow suit, or Sanofi gets aggressive and lowers its prices.

Foracare TN'G Voice Meter: Great Option for PWD's With Visual Impairments (others, too!)

I pretty much limit my diabetes blogging these days, except when I think there's something REALLY important or unique to share, although much of what I began with now has several nonprofits and organizations to advance the issues.  Most of my diabetes-related stuff these days can be found on my Twitter feed, which is updated pretty much daily.  Still, when I need more space to share information, this blog is still where I turn.

As I last blogged a few weeks ago (see http://goo.gl/mi5nEm for my post), I was very sorry when my good friend Kitty Castellini passed away, not from diabetes or diabetes-related issues, but from a type of cancer.  Her passing is truly a loss for the broader diabetes community.  That's one reason I'm dedicating my post for today to her.  Kitty was unique for her concern about some under-served segments of out community, and I thank Kitty for that!  Incidentally, I did tell Kitty about this before she passed (or more specifically, I told her husband to share the news with her, but she was already pretty ill by that time, but I hope she was pleased to learn of it -- I think she would be).

Several years ago (in 2010), a bunch of us attended a diabetes social media conference which if I recall correctly was hosted by the pharma and medical device giant Roche (I think the one was held in Indianapolis).  One of the heated discussions that came up in that meeting was one that Kitty demanded to know more about: what the company was doing about blood glucose meters for the visually-impaired.

Mike Hoskins, yours truly, and Kitty at a  conference in 2010

Virtually all of the big manufacturers including Roche, Johnson & Johnson, Abbott, the former Bayer unit (now known as Ascensia Diabetes Care if I'm not mistaken) and others have basically abandoned that market, even though they all have a social obligation to do so in my opinion.  Kitty was the ONLY person at the event to raise that issue at that meeting, and Roche really had no good response.  Still, the visually-impaired market is a relevant and important segment, its just that the big manufacturers don't see a social obligation to serve that market I guess.  That, I think, was a good example of the kind of person Kitty was: concerned for others in the diabetes community.

Anyway, I seldom (if ever) review products because that's never been why I started blogging in the first place.  But a few weeks ago, I received an email from a company trying to compete in the blood glucose testing space, and what intrigued me about the product was not their mobile phone apps or even their meter's Bluetooth capabilities (even though those are interesting), but the meter's audio which indeed enables the visually-impaired (and others) to test their blood sugar levels by themselves and to know the results without assistance from someone with vision.

The company is called Foracare and they have U.S. headquarters in California, although they manufacture their products offshore (the product I tested was made in Taiwan, not mainland China, which is interesting itself).  Specifically, I tested the product called the Foracare TN'G (for Test N' Go) Voice blood glucose meter and test strips.

The basics of the product are pretty standard, although I compared the results to both meters by Roche and Johnson & Johnson, and guess what?  The results were pretty darn close, and that presumes that the Accu-Check or OneTouch meters are any more accurate to start with, which is actually a big presumption in the first place.

Suffice to say, I felt the accuracy of this meter and strips was quite good, and compared very closely to other major brands now on the market.  More importantly, however, is the fact that test results are read aloud to the user in audio, which I told the company I thought was a relevant fact that they were not marketing previously (now, they are!).  I also gave some feedback on apps which weren't specific to theirs, but apps generally, and my take is that an app isn't useful unless it either does something that cannot be done now, or saves on the laborious data-entry process that's expected of the diabetes population.  As I understand it, the Bluetooth capability also enables the results to be transmitted to a smartphone, though I did not test that as I wasn't really interested in that product feature.

All said, I would say that this product would definitely serve the needs of the visually-impaired diabetes market very well, and the accuracy is comparable with the big brands.  Also, the product is not only a viable competitor to big-name brands, but the company seems interested in what patients are asking for, at least from what I've seen.

I did struggle a bit with the audio defaults myself (then again, my hearing isn't the greatest, so not everyone will have difficulty with this), and it IS possible to increase the volume that readings are given to users, although its buried on page 14 of the manual http://www.foracare.com/testngo/FORA-TNG-Voice-manual.pdf) so just beware of that.  I would say that a CDE or doctor's office may be able to assist patients with a legitimate need, but once I figured that out, I was pleased.  At present, the audio options are available in English and Spanish (sorry for my Canadian friends seeking a Francophone option right now).  In fact, there's a button inside the battery compartment that enables you to adjust the volume and some other settings, just push that a few times and volume comes up there) Still, this is a hugely under-served market, and having a product available today serves an unmet need that was (and still is) all but ignored by the big manufacturers.

I did ask at the Roche Social Media summit a few years ago about Bluetooth capabilities, and they suggested that does seem to be the direction that meter manufacturers seem to be moving, which would to enable any Bluetooth-enabled meter to feature vocal applications, technically, anyway), although no company I am aware of has yet enabled this basic feature.  Frankly, that seems kind of like a lame excuse for a business decision to abandon the visually-impaired market.

However, in all, I am very comfortable recommending the Foracare TN'G Voice blood glucose meter and test strips to people with diabetes (PWD's) who are visually-impaired.  Its accuate, and the product offers something no big manufacturer does: the meter reads in audio the test results to the user.

That said, what about the meter and strips themselves?

Well, no calibration is necessary (thankfully that seems to be most all strips/meters these days, the fact that it was ever required was because manufacturers were lazy FYI), and the sample size required is tiny (0.5 microliters), plus it takes just 5 seconds or so to get a reading.  Again, most of that seems to be pretty standard these days, at least from big meter companies.  The Bluetooth app is an interesting, and potentially valuable, feature, but it does require the readings to be uploaded to the manufacturer-hosted site, and I have not investigated whether results can be downloaded into a spreadsheet or csv file, an area of ongoing frustration for PWD's.

As for insurance coverage, that seems to be an area the manufacturer is still working on.  But, I do believe that all insurance companies must offer coverage for a meter with audio if a person is visually-impaired regardless of the formulary brands under a plan (in other words, if a formulary brand doesn't have a meter the blind can use, they're obligated to cover one that blind patients can use).  How that is handled via appeals and the like, I'm not terribly familiar with, but as I understand it, its guaranteed under Federal law (imagine an insurance company that would not cover a wheelchair for someone who could not walk ... that's the equivalent in this case, of not covering a meter and strips that will read test results for someone who is blind), but for others, I think some work remains in terms of coverage for other insurance plans, so just beware of that, and I have not investigated Medicare issues, although aside from the mail order issue that DPAC http://diabetespac.org/ is already working on (search for the campaign to "Suspend Medicare's Competitive Bidding Program For Diabetes Testing Supplies"), gaining coverage via insurance is a more laborious process for the company.

I should also note while I'm on this subject that there is another meter/test strip brand that offers speaking meter that provides audible test results.  A press release came out  in 2013 about  (see the release at http://bit.ly/2b74UIN for more details).  Its called the Gmate® VOICE system from a company called Philosys, Inc. based in South Korea, and they have a webpage with details about their voice meter which can be found at http://www.gmate.com/voice.  I have personally never tried that meter, so I can't comment on it, and I also don't find their test strips in pharmacies anywhere although I believe they are actively selling it outside the U.S., but I can't really comment on how easy or difficult it may be to get their products, but readers may be interested in knowing it exists.

In short, I realize PWD's pretty much choose the formulary brands because there's a huge financial incentive to do so, but for people with visual-impairment today,  the Foracare TN'G Voice blood glucose meter and test strips is a great option.  In the future, once they get on Medicare's and various insurance company formularies, others may opt for these products, too.  They are quite accurate and good quality, too.

A Tribute to My Dear Friend, Kitty Castellini

Between out-of-town guests staying with me for the month, and various other issues going on in my personal life, I've been busy as of late.  But I was really saddened when I learned that my good friend Kitty Castellini passed away on Sunday (June 19, 2016).  I'd met Kitty quite a few times at various diabetes conferences and meetings over the years, but we continued to speak by telephone in between.

Kitty's most widely distributed photo
from Diabetes Living Today®

Kitty, me and my spouse enjoyed the Indianapolis Indians minor league baseball game we attended in Indianapolis a few years ago, and we spent most of the time talking and laughing.  Kitty couldn't drink with her health ailments, and I chose not to drink (I think we were among the few conference attendees who weren't drinking and boozing it up).  I drink occasionally, but beer has never really been my thing, and my spouse doesn't drink, having grown up in a household with too many bad memories of an abusive and alcoholic father, so that kind of ruins the pleasure aspect of drinking.

She did a video when we attended one of the Roche conferences, which can be viewed HERE:



As you might have guessed, Kitty was a fellow person with Type 1 diabetes (having lived with it for some 50 years) perhaps best known for the weekly radio show she previously hosted known as "Diabetes Living Today®".  People need to know that the show was entirely her creation, and she really largely did everything, from identify and subsequently booking guests for the show, design and maintenance of the show's website and in 2007, she even registered for legal trademark protection of Diabetes Living Today®.  But she enjoyed her work, although she was also very protective of it.

Several years ago, her then-business relationship with her former radio co-host Dr. Joseph J. Fallon started to deteriorate.  He, in Kitty's own words, "thought he was going to be the next Dr. Oz" and he tried to claim ownership rights to "Diabetes Living Today®", which as I noted, Kitty started, owned, arranged all of the guests, came up with the agenda for the program, managed the show's website, even owned all the trademarks.  Just because she wasn't an MD didn't mean she was clueless.  When Dr. Fallon tried to claim ownership of the program (my impression was he tried to bully her), Kitty did not take the threat lying down, even though she was beginning to have her own health issues.

Happier times with Kitty and Dr. Fallon

I think they basically ended up in court (or at least she threatened to sue him with a boatload of legal documents) and because Kitty had mountains and mountains of documentation to support her rightful ownership of the program, and because Dr. Fallon lacked any of Kitty's expertise in actually running the show, he wasn't able to start his own competing show, so he somewhat unceremoniously went away without getting his own celebrity doctor show he envisioned, or much else.  Kitty joked about it after-the-fact, but it was a very stressful period for her.  Incidentally, the archives of her radio show are still available for the time-being at http://diabeteslivingtoday.com/ so I'd encourage you to listen to some of the archived shows.  I'm likely to download a few so I can still hear her voice when I'm in a nostalgic kind of mood and still want to hear her voice, but its not like talking to her on the phone was.

I mentioned that Kitty was having some health issues.  Actually, Kitty underwent a Pancreas transplant in 2004 (I don't recall that being diabetes-related even if she got a break from using insulin for a few years).  Indeed, at the time, she was the longest pancreas-alone transplant patient in the entire world, but her transplanted pancreas failed in 2013 from a virus, which meant she went back on an insulin pump.  Fortunately, she took it all in stride, and because she knew all about insulin and pumps having used them for decades, she was able to return without too much difficulty.  But then, to make matters even worse, in July 2015, Kitty found out she was no longer just dealing with diabetes and a failed pancreas transplant, she had leukemia too.  Her husband Gary was really wonderful through the entire experience, if Kitty's phone calls were any reflection.

Kitty and Gary Kleiman.  Look how long her hair was then!

I'm personally very heartbroken about Kitty and I'll miss her, but as I mentioned on Facebook, I know that now, she is in perfect health and able to look down at her many, many friends and family.

Tonight are the services for Kitty in South Jersey.  I wish I was able to go and pay my respects, but its a several hour drive and I have several guests who are in from out-of-the-country whom I can't just dump.  I will instead honor her wishes with a gift to one of both the charities she asked people remember her with.  Her obituary is HERE and she asked that memorial donations be made to the JDRF or the Cumberland County SPCA.  She continues to be remembered on social media, and the following hashtags have been generated in honor of Kitty: #DOC4Kitty and #welovekitty  - as others have mentioned, use them with love and across all social media platforms.

Why I'm Not (Yet) Supporting #MyPumpChoice

This week, there was a bit of a brew-ha-ha over the joint announcement [see HERE for the news] from United Healthcare (the largest for-profit healthcare insurer in the U.S.) and Medtronic over insulin pump coverage, specifically that United Healthcare had chosen Medtronic to be the company's "preferred" insulin pump supplier, hence other pump and pump supply brands like Roche, Tandem or Animas would generally not be covered.  Yes, they buried it on page 7 and kind of did it on the down low which was sleazy, kind of like banks do with changes in terms to credit cards or new fees being added on your checking account.  That wasn't the best way to share the news.

Being a former Animas (now Johnson & Johnson) pump user, I guess could have been a little upset over the matter, but my reaction was much more of "so what?" instead.

Why?

Well, my perspective has been shaped by my 40 years of living with Type 1 diabetes (yes, the summer of 2016 will be my 40th diabetes anniversary, but I haven't claimed any medals that I'm probably entitled to from either Joslin or Lilly, and I'm not sure I even want to, but that's a separate discussion).  When I was diagnosed as a 7-year old child in 1976, things were a little different, but frankly, in spite of the many claims about how much different things are today, treatment today is really not different by all that much.

Relevant History

For one thing, when I was diagnosed, there were exactly 2 brands of insulin sold in the U.S., made by Eli Lilly & Company and E.R. Squibb & Sons, Inc. (better known as Squibb, now part of Bristol Myers Squibb).  Our Canadian neighbors had their own insulin manufacturer since they actually discovered insulin, and Connaught Laboratories (part of the University of Toronto until 1972), later became a crown corporation of Canada which was ultimately sold off in a privatization effort as were many other crown corporations, mainly under the leadership of then-Prime Minister Brian Mulroney.  Today, the Canadian birthplace of insulin is part of Sanofi, which has the distinction of now being home to both the Canadian and German companies originally granted licenses to make insulin from University of Toronto back in the 1920's.

As a practical matter, however, Squibb's insulin was really more of an afterthought at the time.  In the U.S. market, which was estimated to be 40-50% of the world market, Lilly held an estimated 83% share in those days.  But since the early eighties, the insulin industry has steadily consolidated, although a few companies have entered the world market, only to later be acquired by one of the three giants.  Anyway, in 1981, five companies (Novo, Nordisk, Eli Lilly, the German chemical and pharmaceutical company Hoechst [which later became Aventis, now known as Sanofi] and of course, Squibb, which would sell its insulin business and exit that market) accounted for more than 90% of the world insulin market.  I should also note that at that time, Novo Nordisk was two separate companies (both based in Denmark).  In 1989, the CEO of Nordisk Gentofte approached rival Novo Industri A/S with a proposal to merge their companies, hence they became known as Novo Nordisk in 1989.

Realize that in the late 1970's, Squibb's fortunes in insulin were somewhat plagued by various manufacturing problems, and purity was an issue.  Ultimately, they partnered with Novo (or was it Nordisk?) to solve those problems.  Novo Nordisk only entered the U.S. market in the mid-1980s with a 50/50 joint venture then known as Squibb-Novo, which Novo Nordisk later bought outright from Squibb.  Insulin pumps only emerged a few years after that, but just one company existed at the time: Minimed, a then-startup based near Los Angeles, which years later would be acquired by medical device giant Medtronic in 2001.  The reality is that Medtronic-Minimed as it was known for some time has a great deal of expertise in the insulin pump market, perhaps moreso than many of the startups in the space.

Back to Coverage Issues

Anyway, when the "preferred" announcement that United Healthcare would cover Medtronic pumps, largely because both companies had negotiated preferential pricing agreements, social media was alive with comments, mostly complaints.  As I understand it, Insulet products are excluded from this decision, hence tubeless pumps will still be covered.  My response to all of the bellyaches online was that was really no different from preferred brands of insulin or blood glucose testing supplies.  Do you have much choice in those things?  Not really.  I ask why insulin pumps are any different?

For insulin, you can still get coverage of other brands, but you'll pay a lot more for the non-preferred brands.  However, medications like insulin, including the relevant preservatives used in those products can have some very serious adverse effects, so most plans will cover them, but you'll pay a lot more, and they'll likely make it quite difficult to get coverage for those non-formulary brands, but it CAN be done.

But for testing supplies, which are a medical device, I think you're $#!t out of luck getting any coverage for non-preferred brands, folks.  The insurance company is under almost zero obligation to even cover those things, although some states impose more restrictions on insurance carriers than others (rates in those states tend to be higher than in less regulated states, including much of the South).  For coverage of continuous glucose monitoring devices, the policy is somewhat less clear.  Right now, Medtronic doesn't even make a standalone CGM, hence it appears that Dexcom is still covered, especially if patients use pen devices rather than a pump.  But all that could change in the future if Medtronic gets its act together and starts selling a standalone CGM device and sensors.  The company has hinted it could move in that direction in the future, but right now they simply aren't ready, and my sense is that won't be ready in the near future, either.

Shame on you? Really, that's the best you can do?  Come on.  They're both public companies with a fiduciary responsibility to shareholders, so you need more substance than that.



The main issue from my perspective is that while such preferred relationships are routine in today's healthcare market, many patients are getting pissed off because choices are being taken away from them.  Pumps can contain a variety of different features, and in the past, there were some very legitimate differences.  For example, when I pumped insulin a number of years ago, at that time, Minimed pumps could only deliver insulin in complete 1-unit increments, so I went with an Animas pump because it enabled 1/10th of a unit increments, which was a very big deal for me.  While this particular difference no longer exists, it did back in the early 2000's, and we might see potential new innovations, such as smarter bolusing technology, etc. so the differences aren't always cosmetic as some are implying.

Also, some prefer Omnipods over pumps with tubing (a legitimate issue for some people, think of athletes who might find it the only viable technology for them), which is why Insulet pumps are exempted from this decision.  In the end, much of the bellyaching is just complaints from people who seemingly readily switch from say Abbott test strips to J&J One Touch strips without much complaining.  But occasionally there are some significant differences in areas like accuracy at different blood sugar levels, but you basically have to read the fine-print disclosure in mice-type to see that, and accuracy details are limited in many disclosures.  But the old J&J One Touch Ultra test strips, for example, showed statistically less accuracy at hypoglycemic levels than did Roche's Accu-Check strips did at that time, yet I don't recall there being a campaign to protest that.  Why not?  I have hypoglycemia issues, so that is a big deal for people like me.

I realize that an insulin pump is with you 24/7/365 so it's very personal for many, but how is not having a choice of pump any different from not having a choice of test strips when certain brands aren't as accurate?  So far, the campaign about #mypumpchoice rings pretty hollow to me, but I'm open to a truly persuasive argument.  The only thing is that so far, I haven't heard any arguments that are very persuasive.

I'm covered by United Healthcare, and I don't feel as if I've been screwed out of anything.  It might limit my choice on pumps, and that might not sit well, but I also really don't like limits on my choice of testing supplies or insulin, and yet that's done all the time and people seem willing to accept that.  As I said, I can be convinced, but so far, the diabetes patient community hasn't even convinced me, and I'm one of you!

Author P.S.:  I'm not interested in a campaign that's about pumps exclusively.  We need to address the issues that also include insulin brands, strips and medical care more generally.  This is a broader effort, but one that needs to be addressed.  Don't ask for my help in something more narrowly focused.

Calling the CEO's Office Yet Again

What a difference a year makes!  Last year, I'd written (see my post at http://goo.gl/ST6wtC to read the first on this ongoing saga) about a lengthy delay in getting the blood glucose test strips my doctor prescribed for me.  Ultimately, I ended up getting what I needed by calling Executive Office Complaints (e.g. the CEO's office).  Yet in spite of Aetna receiving approval from various state insurance regulatory agencies to acquire Humana (including the largest state Humana operates in, Florida), Aetna (like all for-profit insurance companies) decided that saving a few bucks in pharmacy benefits was worth them having to pay a much larger claim for ER assistance to treat a hypoglycemic event I wasn't able to detect, mainly because it impacts another line of business at the company.  True, its a new plan year for me, although last year, I'd asked if that my pre-certification for extra testing supplies could be kept in effect permanently since I haven't been cured of autoimmune Type 1 diabetes just yet, therefore the need does not suddenly disappear because its a new plan year, but I was told pre-certifications may only be in effect for one calendar year, and that expired a few weeks ago, so I started again as if all that I went through in 2015 never even happened.

My endocrinologist handled it as requested (he's really good about this), and he had his staff requested a "new" pre-certification request, yet apparently, his request was denied.  However, at least in New York State where I live, an insured's right to both an internal appeal and/or an external appeal of a final adverse determination by a health plan exists by law, yet I need a decline letter to dispute it.  When I pressed Aetna Rx Home Delivery on this (which is operated by CVS Caremark), I was told that the doctor's pre-certification request was not approved.  So I asked why a month had gone by and I still had not received an Explanation of Benefits (or a denial notice of any kind) notifying me that the doctor's request was declined.  At that point, the Aetna rep (she may have been a Caremark rep for all I know) got kind of bitchy with me, claiming I was not entitled to an EOB for this.  I responded by telling her that New York State Insurance Law § 4910 indicates that I AM entitled to this so that I may appeal the decision (if its decline again, I can re-appeal it again before a neutral third-party).  Only at that point did the process of even getting my denial letter begin.  Maybe its not an EOB, but a denial letter, but its only fair that I be notified.

Truthfully, I am really so fucking tired of dealing with this shit - endlessly, folks.  Every year I deal with this, and spend HOURS on the telephone, writing letters and whatnot.  A CHRONIC illness does not disappear simply because a new plan year begins, or because an employer suddenly switches healthcare plans, and yet I am required to spend hours and hours on the telephone just to get what state law requires a health plan (in New York, anyway) to cover if they wish to do business in this state.  That's one reason insurance rates here are so much higher in New York than they are in say, Kentucky, but then again, if I were in Kentucky, I'd be completely shit out of luck if this was denied.  In New York State, insurance companies have rules they must follow, and that's one reason we pay more for insurance here.

Fortunately, the Executive Office Complaints team has been relatively pleasant enough to work with.  They did manage to get Aetna Rx Home Delivery to fulfill 60 days worth of testing supplies so I'm not stuck with nothing, but I still have a few questions:

1. Why do insurance companies have rules in place designed to treat people with chronic conditions like second-class citizens?  I know they don't want to have to cover us, but try and pretend a little better!
2. Why do insurance companies treat people with chronic (uncured) diseases as if their conditions suddenly just disappear?
3. What bean counter (accountant/actuary) determined that a denial with pharmacy benefits is the right thing to do when only one trip to the ER would not only erase those savings, but cause the company to pay MORE in benefits than if they had just covered the damn test strips?

I realize I won't get any answers on this, but the math just doesn't add up, and yet I have to keep doing this forever.  Sorry, but I can handle a chronic disease, but I cannot handle this endless bickering with insurance companies to get what they're required by law to cover.  I'd say that's a major reason why I want a cure.  Its not the fingersticks, the insulin injections or the hypos I'm so sick of (and from), its the damn insurance companies that try and cut costs to give their CEOs retirements in Palm Springs or Palm Beach and a platinum healthcare plan so they never deal with the shit ordinary patients have to endure.  Whether its Aetna, United Healthcare, Anthem or some other plan, all of them behave like a bunch of fucking idiots.

Whoever claimed the U.S. has the "best" healthcare system in the world has obviously never been to Europe (actually the U.S. rates rather poorly as I reported on in 2008, catch my old post at http://goo.gl/kE59f for more background), but I have, and in spite of complaints from the Swedes, Danes, Finns, Frenchmen and others, they don't seem to have to deal with all of this petty bullshit.  Sorry if my language offends anyone, but I've about had it dealing with this stuff.  It never goes away.

Just Who Is JDRF Therapeutic Ventures, LLC? Why is it such a secret?

You might not have realized it, but a few years ago, the folks at JDRF secretly (it wasn't generally publicized, although some organization bigwigs, board members, etc. knew about it) established a legally separate organization to handle their industry partnerships which is legally organized as an LLC rather than a non-profit organization.  This enables the JDRF to not have to disclose much detail in the nonprofit's 990 tax returns which are subject to more scrutiny from just about anyone, as the tax returns for the nonprofit must be disclosed to the public.  Some this quite beneficial and perhaps even useful, as industry partners often demand a level of secrecy that really wasn't feasible as a nonprofit organization.  That's probably the "official" line the organization would give you if it was ever pressed on it.  But some of it also enables the organization to effectively hide (from financial scrutiny, anyway) where its putting at least some of your money as a fundraiser because the LLC has absolutely no legal obligation to disclose anything, even if the LLC is run by JDRF.  If the LLC was consuming a top-5 slot among recipients of JDRF's funding, we might see some clues in the organization's tax returns, but that seems unlikely, hence its really a big black hole that the JDRF can use to shield itself (and industry partners) from greater financial scrutiny -- and its perfectly legal.

The organization is known (un)officially as JDRF Therapeutic Ventures, LLC.

That's about all you'll hear since LLC's are not required to disclose much else to the public.  As long as its not one of JDRF's biggest recipients of funding, it also stays out of the organization's 990s, even if JDRF is putting millions into this entity.  Pretty neat, huh?  Well, maybe not if you'd like to know what the organization is doing with the money you raise for them.  But you should know how the trusted nonprofits are getting around legal disclosure requirements, just in case.

As I said, I have no reason to believe that anything unethical is being done here (and I don't), and there are very legitimate reasons for creating such a legal entity, including to work with industry partners who often demand incredible privacy.  But the fact that the organization did this, and then kept it so quiet, does raise questions in my opinion.

I've also witnessed how other organizations, some which have been designated as hate groups, have done remarkably similar things to try and hide what they're doing from public scrutiny, and it often works, until they are taken to court and some of the results then become part of the public record.  Incidentally, this was also the way we also recently learned that tech giant Google, I mean Alphabet, does something quite similiar with its market-leading Android operating system, and its all perfectly legal.  For example, we recently learned that Alpahabet's Android operating system has generated revenue of $31 billion and $22 billion in profit, a lawyer for Oracle said in court while disclosing figures Alphabet/Google says shouldn't have been made public.  Alaphabet has no legal obligation to reveal such data to investors, and JDRF can keep a lid on what it does with JDRF Therapeutic Ventures, LLC a secret, too -- its perfectly legal.  It claims that its a separate entity for liability purposes; initially staffed by Steven Griffen, MD, JDRF VP, Translational Development & Jit Patel, JDRF VP, Research Business Development; facilities, although administration and finance contracted from JDRF.  Increasingly, we are seeing the use of separate legal subsidaries to effectively hide data from investors and the public.  Now, JDRF shows they're doing the same in the nonprofit world.  But that doesn't mean we as fundraisers do not deserve more transparency from an organization that people with Type 1 diabetes (and their caregivers, in the case of parents of children with T1D) have been bankrolling.  Really, we should be asking our lawmakers in Congress to address this with disclosure laws, but I don't expect that to happen anytime soon because they're kind of in on keeping things a secret, too.

Below is a presentation of JDRF Therapeutic Ventures (unless the organization tries to have it banned from public scrutiny by contacting the host I'm using, but they should realize that I can and likely will just keep moving it, so I recommend that JDRF doesn't try making complaints to Scribd, SlideShare or any of its growing number of competitors, in which case I might have to distribute the presentation another way, so just beware!) that I managed to get my hands on and I won't tell you how I did that, but let's just say I did, and JDRF hasn't exactly kept this presentation completely secret - it just hasn't put it on the non-profit's website or given it to its fundraisers.  Look at page #7 (or see it at https://goo.gl/TOD8mQ, if JDRF puts up a stink, I may have to move it):

JDRF Therapeutic Ventures, LLC from sstrumello

It gives some details about the legal structure, although not very many.  But as a JDRF fundraiser for the organization for the last 40 years, I make no apologies for making this public.  The organization should have been more transparent about it, after all, I've been bankrolling them for decades.  As I said, there are very legitimate reasons to want to do this.  But we can see that the JDRF and its various legal entities has spent vastly more on the so-called "artificial pancreas" than it has glucose-responsive insulin (so-called smart insulin), so its little wonder that's much further ahead in development.  Just don't give us the line that smart insulin is so much harder to develop than an AP system.  If JDRF was serious about it, it would put its money where its mouth is, or in the case of JDRF Therapeutic Ventures, LLC; ISN'T.

Something for the broader diabetes community and JDRF fundraisers to think about, no?

My Evolution and D-Blogging

A few years ago, I announced kind of a break from diabetes blogging. At the time, I felt I’d gotten what I wanted to from it, and I even started an unrelated blog (which is still out there) on retro pop culture. I still update that blog every so often, but it’s certainly not regularly, mainly when I’m motivated to do something. Most of my diabetes-related social media activity is on my Twitter feed these days. That’s still very much alive and well, no thanks to Google’s effort to kill RSS in favor of proprietary APIs similar to what Facebook was doing. That effort failed spectacularly, and now, Google Plus is teetering on the edge of irrelevancy and there are rumors of Google acquiring Twitter.  These days, I only blog when I have something to say about diabetes that no one else has -- and it’s much harder today because there are sooooooooo many d-bloggers nowadays! So I’m now planning to take Scott’s Web Log in a broader direction. Sometimes it will be about diabetes, but sometimes it will be about other things I’m interested in. Part of it is because my perspective on a diabetes “cure” is that it’s not likely to happen in the foreseeable future. In spite of some promising avenues, too many have bombed in clinical trials, which says to me there’s still a lot that needs to happen before a cure occurs.

Part of the reason I’m thinking about my own future is that 2015 was my parents’ 50th wedding anniversary, which has made me think more about my own future.  Aside from a big surprise party we threw for them, we also sent them to San Diego to commemorate the occasion.  My dad was in the Navy during the Vietnam days so my mom and newborn sister lived there for a few years back in the mid-1960s.  While my parents visited me several times when I lived in the Bay Area of Northern California back in the 1990s, they haven’t been back to San Diego in a half century. So much has changed since then, they hardly recognize the place anymore, although they did get to visit a park down the street from where they used to live, but that’s about all they recognized. They extended the trip and went to Grand Canyon and Las Vegas which they might not have done otherwise (with my aunt and uncle who live near Tacoma, Washington), so I’m really glad I was able to give them the opportunity.

Fortunately, my parents are still relatively young and they've done a lot to prepare for their own senior years including remodeling their house to enable everything to be on the first floor, but a few years down the road, who knows what their condition will be? My aunt and uncle are a number of years older, and my aunt’s health is deteriorating, which is sad.  It also has me thinking about when I reach that age.  Back to my parents, at one point, I lived farthest from my parents, but now I happen to be the sibling who lives nearest to my parents; my sister and brother both live more than 1,700 miles away (by comparison, I live about 70 miles away). Care for them when they need it is most like going to fall on me and my spouse. That has me thinking more about my own future.

Diabetes: When They Call It A Chronic Disease, They Really Mean Permanent

I don’t want to sound like a big pessimist, but the reality is there’s nothing close to a type 1 diabetes (or type 2 diabetes) cure imminent, at best, we have some moderately improved treatments on the horizon. I remain hopeful, naturally, but I’ve already lived 85% of my life on earth with autoimmune type 1 diabetes, so the odds are not in my favor.  My friend Scott Strange once gave me one of the best sayings about diabetes: "Diabetes is not a death sentence, but it IS a life sentence".  We keep getting promises (usually to support someone's fundraising efforts), but to a large extent, I’ve voted with my time and dollars. It’s been a few years since I last walked in the JDRF Walk to Cure Diabetes.  JDRF is an organization my parents were among the earliest supporters of back in the early 1970s, by the way, starting a few years after Lee Ducat and Carol Lurie (Carol passed away in 2013, incidentally) started the organization (my sister already had Type 1 at that time, but there weren’t yet local chapters in communities across the country). I still support their mission, but I’m fine letting another generation of people do the fundraising for the organization. They've have had a CEO carousel in recent years, and I’m tired of the routine CEO shuffle the organization now represents. I’ve been doing fundraising for nearly 40 years, so I really have no obligation beyond what I’ve already done unless I have the time or motivation to continue. For JDRF, that should be a warning sign. The former CEO acknowledged that there were more adults living with type 1 than kids, but I’m not certain Derek Rapp quite gets that.

My Evolution and D-Blogging

In recent years, I haven't paid very much attention to this particular blog. To be sure, the entire diabetes online community has evolved a great deal since blogging began more than a decade ago, and only a few of the original gang are still doing it -- at least routinely -- largely because diabetes has become something of a career for them. The others have done other things. But the bigger reason for my not blogging regularly these days isn't because I'm not actively involved in the diabetes online space anymore, but more because I've been putting more of my time into activities I did not do for years, but I now wish to spend more time on. I mentioned I got married two years ago (catch my post at http://goo.gl/RYIcK), and with that comes the typical things that any couple does to establish themselves as a household. But less acknowledged is that I'm 46 years old, and my spouse is 52 - neither of us are twenty-somethings (or even thirty-somethings) anymore, but people who really should really be concerning themselves with preparations for the next phase in life: retirement, which for me is likely somewhere around 15 years away (yippee on that!!).

A New Phase in Life; Albeit A Delayed One

I am not overly worried about retirement (I alone already have saved the nearly amount most experts say individuals should have by the time they retire - and I'm still working - plus my spouse has even more put away than I have, as should be the case given the age difference). In spite of having already saved more than 1000% (yes, that's the correct number of zeros) of what the median middle-class American has saved for retirement, like all people, I still have concerns about retirement and making sure I have enough to live on comfortably in my golden years. New diabetes technology is prohibitively expensive, and for the most part, Medicare doesn't pay for a lot of it, so I do support JDRF advocacy efforts for that.  However, unlike some people, my concerns aren’t that I'm decades behind where I need to be or worrying about volatile investment markets.

Many people my age and older have too little saved for retirement and their opportunities for playing catch-up on something they should have been doing decades ago are more limited. But I just started a household a few years ago, while some of the people I graduated with have kids who have finished college already (paying for that, I'd guess, is a big reason they are among the people who have NOT saved as much as they really need to retire, but I digress).

My Next Phase?

One of my concerns is that I still rent. True, I live in New York City where homeownership rates are significantly below what they are nationally. Homeownership is no guarantee for the future; but its an asset I don't have yet. I take comfort in knowing that outside the U.S., many people live very comfortably without actually owning a home -- ever. Switzerland, for example, has a homeownership rate of just 44%, and yet no one is claiming that the birthplace to Rolex watches represents an underdeveloped backwater. Germany, home of Mercedes and BMW, has levels that are nearly as low.

Still, a home is an asset I cannot (yet) count on -- although I could still change that and enjoy the corresponding tax benefits (which are significant) that go with it. Aside from a lack of homeownership, a more significant concern is that we also have no children (truth be told, that's not something either of us consider an imperative; having children was never one of life's ambitions for either of us). Don’t get me wrong, I love children, but they don't have to be mine. Still, not having kids means one of the safety nets people tend to fall back on when they get old isn't going to be there for me and my spouse. Its something that many other couples don't have as a possible safety net when they get older (and the incidence is growing according to a number of media outlets, see http://ow.ly/NpGsp for one example), including couples who choose not to have kids or are unable to have kids for whatever reason (such as they’re too old) and that also includes many (but not all) LGBT couples. AARP has been looking at the issue (see the AARP study at http://bit.ly/1zi1R7i, and a New York Times article at http://nyti.ms/1BlVNHf) as have others, and the reports on this looming crisis are something to consider.  The issue is that the caregiver ratio to retirees is down significantly and declining (blame the Baby Bust that happened following the advent of the birth control pill in the 1960s for some of that).

I'm no fool (heck, I have more than 1000% than the median middle-class American has saved for retirement, and I'm not even 50 years old yet), and I recognize the issues that lie ahead. Being aware of these things enables me an opportunity to plan accordingly.  Hence, those are areas I'm focused on right now.

News Flash: No One Is Streaming Across the Border to Steal American Jobs at Walmart 

I will say that priority #1, since I was married, is already underway. Namely, getting citizenship status for my spouse. (It doesn't happen automatically, by the way).  Permanent residency is a fairly straightforward matter, but citizenship is more complex. I listen to the non-debate in Congress on this matter, especially among the xenophobic lawmakers, and shake my head in disbelief -- and disgust. Key is they have no intention of fixing the very system they broke in the first place.

This isn’t meant to be a political debate, but this is a reality I’m actually dealing with. Going through it personally, I'd say I'm more qualified to speak on the topic than many others. The immigration issue for me and my spouse will resolve itself in time; we have a very experienced attorney handling things for us and she’s been wonderful to work with. However, I am still offended to hear the things some people who have no clue what they’re talking about say when they speak on immigration issues. On the other hand, this isn’t new: it’s been going on in the U.S. for over 100 years. Once upon a time, it was about immigrants from Ireland, Italy and Poland, now its immigrants from Mexico, China, India, the Philippines and elsewhere. Not much new has emerged in the conversation.

Next: A Place Called Home

As I noted, having a place to call home is something all couples deal with at some point. While there’s no imminent rush, the tax benefits would be very real. I’m not looking for a McMansion in exurbia (I hate caring for a big lawn; mowing it, raking it ...), nor am I necessarily considering something in the middle of the city. I live in NYC now, but I’m not sure I want that’s the place I want to retire. Its expensive, noisy, crowded, somewhat dirty, and I’m at an age where I no longer live for the nightlife (as I said, I’m 46). But something I’ve been researching is some modern alternatives to the traditional American housing model.

One thing on my radar is a type of housing that originated in Denmark (home of Novo Nordisk). The term in Danish is bofællesskab (which means living community), but in English, the term “cohousing” is the term usually used to describe these types of housing developments. Cohousing is a model of community that originated in Denmark, and includes private homes (most are organized legally as condominiums) on shared land, with a common house that may be used for functions that the community defines. Virtually all common houses include a large group kitchen and meeting space in the community-owned building. Typical activities in shared spaces includes group meals, meetings, music, guest lodging, laundry facilities, childcare, library space, or computer labs.

Cohousing provides a choice between both privacy and community, and residents/owners can switch between the two as often as they wish. These aren’t some weird, hippie-dippie communes from the 1960s, but very modern arrangements. Think of them as condos with a community. The only real obligation is to take part in some meetings to govern the property. You can read a brief intro. at http://bit.ly/1eqvcny which is worth having a look at.

Aside from that, you can be as involved (or not involved) as you wish. Not having children is a big reason these communities are more appealing than a stand-alone house or condo might be. Having more of a neighborhood helps to ensure residents are never completely alone as may be the case in other forms of housing. For an LGBT couple without children, this may fill a void that doesn't exist elsewhere; there's a built-in community, so you won't be alone even as you age (without kids).  Ultimately, cohousing may potentially allow residents to age in place and hopefully skip the dreaded nursing home.  By definition, these are communities that cannot be created by developers, as a result, developing them is a more laborious process. But the good news is that if you can get into one, the resale values are vastly superior to what a similar condo would be, and the resale values are universally excellent (assuming you ever want to leave).

Its is not perfect, but neither is any other form of housing. But it’s unique in that it may enable us to live there longer-term even without children. While these communities aren’t everywhere, there are over 120 nationwide.

Home Again? Perhaps Someday.

Cohousing communities are especially popular out west (California has more than any other state, although Washington ranks among the tops on a per capita basis, as does Colorado). On the East coast, New England has quite a few (Vermont has more per capita than any other state), but outside of Virginia and North Carolina which both have quite a few, there are relatively few elsewhere in the south (for example, there are none [yet] in either Florida or Texas, although some are in various stages of development). The first one in my home state of Connecticut is being built just 6 miles from my parents home, and I’m at least thinking about it. However, I’m not quite ready to buy a home just yet.

As I said, right now, buying a home is only a consideration and right now, I still have the immigration issue to deal with, so we’ll see what happens. But, as part of this, my real objective is to be able to share some of this journey on this blog. Just as some friends from the diabetes online community are speaking about their own issues (see Manny Hernandez’s eloquent post on his mother’s Alzheimer’s disease at http://goo.gl/5XV0u3). Type 1 diabetes isn't disappearing unless we happen to see a viable cure developed (and I’m not counting on one in my lifetime), so I’ll still write about that when I have something to add, but I also plan to broaden my editorial focus a bit beyond diabetes. I may try to code my posts somehow, so readers will know whether a post is diabetes-related or not, but I still have to look at how to execute that. So, that’s the direction for Scott’s Web Log going forward. It will be part diabetes, part other stuff.

Who knows … maybe you’ll find the other stuff interesting reading!