Kill [This] Bill in Congress: The Research Works Act

Back in December 2007, I wrote a blog post entitled "2007 Seasons Greetings from U.S. Congress!" where I shared some news that after many years of advocacy efforts and outright lobbying of lawmakers in Congress, U.S. lawmakers had finally put into policy that U.S. taxpayers must be able to access research results published in academic/scientific/medical journals that taxpayers had already paid for with no additional fees or charges for access. In particular, that legislation allowedg the public (patients and physicians, students and teachers) to read about the discoveries our tax dollars had already paid for.

Historically speaking, medical journal publishers (which at one time were the actual medical associations, but in more recent years, for-profit publishers such as Reed Elselvier, Wiley-Blackwell, and Wolters Kluwer have acquired the publishing rights to countless academic, scientific and medical journals) charge very handsomely for subscriptions and even for individual article access (a single journal submission, for example, may cost anywhere from $30 to $50, while subscriptions to medical journal publications may cost several hundred dollars (or in some cases, thousands of dollars) per year. These fees are collected in spite of the fact that U.S. taxpayers had already paid for the underlying research. What's more, the journals actually receive billions of dollars in subscription payments derived largely from public funds. The value they say they add lies primarily in peer review, a process through which works are assessed for validity and significance before publication. But while the journals manage that process, it is carried out almost entirely by researchers who volunteer their time.


Recent History of Access to Taxpayer-Funded Scientific and Medical Research

Back in 2005, under growing pressure from a number of advocacy groups, the U.S. National Institutes of Health established a strictly voluntary policy meant to encourage (but not require) NIH-funded scientists to publish the findings from Federally-funded studies in open-access journals. As noted, the NIH Public Access Policy was a strictly voluntary measure and resulted in a deposit rate of less than 5% by individual investigators according to The Washington Post, hence we can conclude that the VOLUNTARY submission policy had very clearly failed — some would argue abysmally.

Academic scholars and patient advocacy groups realized that valuable research findings — already paid for by U.S. taxpayers — were effectively being hidden from the very taxpayers who had actually PAID for this research, and what's more, keeping the findings hidden was not advancing the fields of research as intended. So a number of groups began lobbying lawmakers for more "open access" to this research. Federally-funded biomedical research [in PubMed Central] could be accessed via the U.S. National Library of Medicine, which is funded by National Institutes of Health using a link in PubMed.

Many people, including myself, found that was frequently confusing because several links to the citations were listed, including links that actually required subscription (paid) access as well as the "free" (note: it wasn't FREE, as taxpayers already PAID for the research itself) links which were known to work very inconsistently, especially for documents hosted by Dutch specialty publishing giant Elselvier, which clearly did not like the policy based on statements made by company management in Amsterdam. A bill now in Congress (http://1.usa.gov/zSEqmv) which was lobbied for by for-profit journal publisher Elselvier, whose products include such medical and scientific journals as The Lancet, Cell and the subscription-based online archive ScienceDirect, threatens to undo all that patient advocacy groups worked for years to get: access to the research our tax dollars paid for!

Even more troubling than that is the fact that keeping these works locked up in a vault only accessible with high-priced subscriptions also threatens to advance the science. In effect, the same mistakes will be made unless we open access to these works, while others will effectively be prevented from advancing these scientific and medical discoveries. You also have a right to know if your lawmakers in Congress are working against you and the quest for diabetes cure-related research. The bill is being sponsored by Rep Darrell E. Issa from California's 49th Congressional District, which is just south of Orange County but north of San Diego in Southern California. The bill was co-sponsored by Rep Carolyn Maloney who represents New York's 14th Congressional District, which is sometimes euphemistically referred to as the "silk stocking district", including most of Manhattan's East Side; as well as a few parts Mrs. Maloney has reportedly not stepped foot into for several years, including Roosevelt Island, Astoria and Long Island City in Queens.

Maloney co-sponsored the 2009 reintroduction of the Fair Copyright in Research Works Act (H.R. 801, originally introduced as H.R. 6845 in 2008) as well as the Research Works Act (H.R. 3699) introduced in 2011. Both bills aim to reverse the NIH's Public Access Policy, which mandates open access to NIH-funded research. The Association of American Publishers-backed Research Works Act has been heavily criticized by many scientists. In a New York Times op-ed (see HERE), Michael Eisen described how that bill would force the public to pay $15–$30 per paper to read the results of research we have already paid for as taxpayers. (Such results must now be published in Pubmed Central [PMC]) after an embargo period of up to 12 months: this embargo period was imposed to minimize financial harm to publishers who were concerned that their readership might diminish if the results appeared concurrently in PMC, although authors of the paper are required to submit their papers to PMC as soon as their paper gets accepted for publication by a peer-review journal).

Some have suggested that Mrs. Maloney supports the measure because she's been the recipient of campaign contributions from Elsevier, the largest scholarly publishing company. On February 27, 2012, following a boycott of the organization, Elsevier officially withdrew it's support (see HERE) for the legislation, although most still believe that the organization's management still unofficially supports it.

It has been a few years since I have written about matters like this, but this is one that I would urge ALL of my readers make sure dies a painful death in Congress. The bill should not even be voted on. Write to your Federal lawmakers in Congress and make sure it does die.

iBGStar Finally Arrives on American Shores, Should We Celebrate Yet?

This week, a big news item within the diabetes online community was the official U.S. introduction of the iBGStar blood glucose meter – the one that plugs into an Apple iPhone.  If you hadn't heard the news, don't worry.  The news is interesting, but don't crack open the champagne bottle just yet.  Read on for details ...

My followers may recall that late last year (on December 7, 2011, to be precise) I was the first one to share the news to the diabetes community via Twitter that Sanofi and AgaMatrix had announced that the U.S. Food and Drug Administration (FDA) had granted it 510(k) premarket clearance for the iBGStar Blood Glucose Monitoring System. Effectively, that meant an approval was forthcoming, and the companies could actually start talking about the device – legally.

After a gestation period seemingly rivaled only by Jessica Simpson's pregnancy (see HERE), Tuesday, on May 1, 2012, Sanofi finally announced that it had officially become the first (and so far, the only) FDA-approved blood glucose meter that connects to the Apple iPhone and iPod touch (see the press release HERE).  It was only a matter of time before the company would start selling that product here.  I can honestly say that for many, this has been one of the single most anticipated product launches in recent memory.

Sanofi: A Long History in Diabetes Care (With Routine Rebranding)

This company has a lengthy history in the diabetes market, going back nearly as long as Lilly and Novo with an original license for insulin from Banting himself.  The most noteworthy predecessor to today's Sanofi based in Germany was known as Hoechst, and that company was one of the first to commercialize insulin in Europe, and they still dominate the German and Austrian markets for regular human insulin with the "Insuman" brand, as well as selling newer analogues like Lantus and Apidra.  Hoechst merged with French pharmaceutical company Rhône-Poulenc in the late 1990's, changing it's name to Aventis Pharmaceuticals.  For a number of reasons, Aventis elected to sell only insulin analogues in the U.S. market back in the late 1990's, and one product in particular remains the world's best-selling insulin (at least until it's patent expires in a just a few years) known as Lantus.  Frankly, the reasons for that #1 position aren't great news: millions are developing type 2 diabetes, and unfortunately, many general practitioner/family doctors who put their type 2 diabetes patients on insulin tend to take the easy way out and load them up on basal insulin alone, hence Lantus is the product of choice to do that (most studies suggest that a majority would be much better off on a basal/bolus regimen, but that's a separate conversation).

Merger upon merger resulted in many name changes for the company over the years, hence Sanofi-Aventis dropped Aventis a few years ago (a merger with another French pharma company by the name Sanofi was orchestrated by the French government to ensure that France kept a global pharmaceutical company based in that country), but Sanofi's forray into testing supplies is still pretty new, and is one area European rival Novo Nordisk has little involvement in (the closest thing was Novo's partnership with J&J OneTouch in a now discontinued combo injection/testing device known as InDuo, see http://goo.gl/xc30c for details) which launched in 2001 but was discontinued several years later.

More directly to point of this post, back in March 2010, Sanofi and AgaMatrix had signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring.  The company known as AgaMatrix received seed funding from AMG Medical, a Montreal-based venture capital company best known for it's association with Robert Oringer, a man perhaps best known for commercializing private-label lancets to market back in the 1980's, but also helped seed many d-related companies including Can-Am Care Corp. (now Dex4, which was acquired by Perrigo in January 2012) and various others to market.  In any event, the AgaMatrix deal with Sanofi was seen as helping bring this product to a global diabetes market.  iBGStar was the result of this partnership agreement.

Sanofi's Goal: Global Leadership in Diabetes Care

A few years ago, when Sanofi announced it aimed to unseat Novo Nordisk as the world's largest diabetes company (see HERE), many Wall Street investment analysts laughed.  Even today, many remain skeptical of that goal.

To be sure, the approval and introduction of iBGStar was widely anticipated (most presumed it was more a matter of WHEN, rather than if); in fact, the approval had been anticipated since the same product was granted approval and marketed for sale in Europe last year.  Since I use a Samsung Android phone as the majority of smartphone users do, it's not exactly my dream machine, in spite of how attractive the concept is.  True, I have an iPod Touch that I use fairly often, but the bigger downside, in my opinion, is the fact that the testing supplies for iBGStar still aren't on very many insurance formularies even today.

iBGStar Supplies Still Not Covered By Many Insurance Plans

Sanofi still has it's work cut out to get it's iBGStar testing supplies (like strips) on a majority of the big insurance formualaries.  A quick, non-scientific internet search of various insurance company formularies revealed that iBGStar test strips don't appear to be covered (yet) by most of the U.S. biggies: United Healthcare, Wellpoint, Cigna, Humana, Aetna and Kaiser, just to name a few of the major carriers who collectively dominate the U.S. healthcare landscape today who still don't cover them.

J&J overwhelmingly dominates there, with it's not-so-great OneTouch Ultra product line having an estimated coverage of 90% of all healthcare plans as they like to tout in the company's advertising.  I was also surprised to learn that another player, Roche's Accu-Chek, has nearly as widespread coverage – I would put them at around 80% to 85% coverage – suggesting that Roche has done much of the hard sales work, even if it's product line doesn't yet thrill consumers like Sanofi's new product does.  Other testing giants, like Abbott's Freestyle and Bayer's Contour also don't seem to have anywhere near the same level of insurance coverage of the market, which is a very tough but necessary job.

Want Versus Need

While I believe Sanofi does have the staff and the willingness to gain widespread insurance coverage for its testing products, they simply aren't there yet.  Patients may want the product, but how many are willing to pay for strips out-of-pocket when insurance will pay for strips on another meter brand? Having a really cool product doesn't mean all that much if no one pays for their testing supplies.  Also, an estimated 80% of the testing supplies sold in the U.S. market are paid for by private insurance, with the remainder being paid for by the government (Medicare, primarily, and Medicaid) and a tiny handful who still pay for these things out-of-pocket.

Work Around For Lack of Coverage: Star Savings Program

To counter the not-so-small problem of coverage (or lack thereof), Sanofi has announced what it's calling the "Star Savings Program" to try and subsidize those with higher insurance co-pays to help with the co-pays so out-of-pocket expense won't be more than $20.  Whether that even gets the strips at the mail-order supply firms used by the big insurance companies is unclear (my old plan's supplier didn't even carry them or any others from AgaMatrix), and I haven't fully investigated how the subsidy plan works if the strips aren't covered at any level by some plans, but clearly, Sanofi acknowledges they have work to be done in the coverage area and is offering this as kind a work-around until they manage to secure more widespread coverage.

They know their product is on the wish list for a fair number of patients, and they now have the inventory to supply them to most anyone who wants one.  Now, the key is getting insurance to pay for it.

Sanofi Cannot Hitch Diabetes Growth Aspirations to Apple Alone; Try Samsung

Now, Apple's share of the smartphone market is widely believed to slipping (it has less than half of global sales in spite of continued robust growth for Apple).  Google's Android, which numerous other manufacturers use because of it's open system architecture, lacks much of the standardization in terms of product design or even the core operating system, making it a much tougher nut to crack.  Unlike Apple, one cannot develop something like they can for iOS because of differing hardware, countless versions of the operating system, etc.  Yet Android is something like Windows for smartphones, whereas iOS is more like Macintosh.  Technologically prettier than Windows, Macintosh (and, likely iOS) is probably better (and easier to develop software for), but isn't widely used by anyone except Apple and a few specialist industries like graphic designers.  Yes, Apple's financials are very healthy these days.  But who remembers the ill-fated days when Apple tried to license the Macintosh operating system?  Yes, former CEO John Sculley did license it for a time, but by then, few manufacturers could even be bothered with it.  Today, Macintosh has about 5% share of the personal computer/laptop market.  Microsoft's Windows rules the market even if it's an inferior imitation of the Mac.  Licensing Mac operating system did happen (albeit briefly) before Mr. Jobs returned to turn the comany he helped start around.  He managed to do that, and today, Apple is one of Silicon Valley's stars, but that doesn't mean Sanofi can rely on Apple alone to become leader in the market.

The market doesn't work like that.  Will Sanofi's leadership aspirations hitch it's growth hopes and aspirations to a single, premium-player like Apple's iOS, or diversify beyond Apple to sell billions more?  If I were Sanofi, I believe the answer to that question would be very darn clear.

Strips Is Where the Money Is Made, But It's A Volume-Driven Business

Let's face it: the margins on test strips (which is where everyone in the business makes their money) are very, very low.  That means to make any real money in this business, you really have to sell millions (or better yet, billions) of them every year.  The reality is that partnering with Apple alone won't be enough to help Sanofi sell billions of test strips, which is how they're likely to make money (and become a market share leader).  Yet with Android, its not as easy to work with as it is with Apple iOS.  Yet among the Droids, Samsung is emerging as the dominant player  (see http://on.wsj.com/Ifrnfa for the Wall Street Journal article covering that news).  Others, like HTC (and even Motorola, which will likely become part of Google assuming antitrust regulators give it the go-ahead is likely to remain a player, but that's not why Google wants to buy them, its for the patents) don't seem to have Samsung's growing presence in the smartphone market.  How easy would it be to work with Samsung?  Sanofi won't know until they ask.

Lessons From The Mobile Apps Market: Ignore Android At Your Own Peril

Consider the case of Starbucks' mobile payments application.  American Banker reported that back in 2011, Starbucks had an app for iPhone that enabled consumers to swipe their mobile phone at the register for payments (they also had one for Blackberry, but few Blackberry users had downloaded the app).  Demand for Starbucks' payment application, which was not available on Android was so high that a private developer created his own version of the Starbucks app for Android smartphones. His app was downloaded more than 160,000 times by April 2011, in effect, FORCING Starbucks to develop one for Android even though Starbucks wasn't in a rush to go there.  Within a matter of a few weeks, the company launched an "official" Starbucks app for Android, but it was only because the company had no other choice in the matter.

While technology isn't always easy, it seems clear that there are a few dominant Droid players (notably Samsung) which Sanofi might be advised to consider working with to get its product to millions more.  They can work with others like HTC if they can't get anywhere with Samsung, at least that offers an entree.  After all, testing supplies are sold in volumes, and if only a few people are using the product, then its not going to become the market leader, whereas if millions and millions use them, they have a chance to rival J&J.

iBGStar Still Represents A Developmental Milestone

Still, I will go on the record as saying that I think the iBGStar approval is a major victory for patients in spite of not being covered by most insurance plans yet.  The reason: clearly, the door has been opened for add-on products to things like mobile phones – the genie has been let out of the bottle!  It's theoretically possible that others could emerge in the not-too-distant future (such as a OneTouch Ultra plug-in for your Samsung Android phone?  Don't discount the idea!), and that was a major psychological hurdle for the FDA to get it's collective head around.

Is there any reason the future we cannot have testing plug-ins built into your car, your PC at work, or even your TV remote control?  Maybe these are just wild visions now, but the notion that a meter could be plugged into a computerized device intended for another purpose has already gained approval, and there's really no reason why the same porting technology couldn't be added to most anything.  The meter can theoretically be ported most anywhere now.  What's more, having them as add-ons eliminates one more piece of diabetes crap we have to carry around with us, so that's a big victory even if no one pays for it ... yet!

While technology issues aren't always easy, it seems clear that there are a few dominant Droid players (notably Samsung) which Sanofi might be advised to consider working with to get its product to millions more.

The lesson hasn't yet been learned by Sanofi, but it's still early.  Sure, people may long for the product, but it has to be widely paid for by insurance plans.  Sanofi isn't there yet.  Maybe someday they will be ...

Do YOU Know How To Check The FDA's Website For Recalls?

I am certainly not the only blogger to note how easy it is to become complacent with diabetes care. After all, with 35 years of type 1 under my belt, the never-ending nature of this disease makes it easy to want to forget. But unlike some fellow d-bloggers or preachy diabetes educators, today I'm NOT referring to self-care. As Americans, we tend to PRESUME that the drugs, biotech products, and medical devices we rely on to keep us healthy will be usually be safe.

And for the most part, that's been a safe presumption. The U.S. Food and Drug Administration's job is supposed to keep us safe. And for the most part, that organization does it's job reasonably well.

When things go wrong, it's our fault, right?

Not always.

In recent years, the number of recalls issued by the FDA has gone from next-to-nothing to quite an astonishing number if I do say so myself.

Perhaps it's because the FDA finally has new leadership that has decided to crack down on it's loosey-goosey policy enforcement that became so prevalent under the leadership of former FDA chief Andrew von Eschenbach. Or maybe it's because the companies that provide these products have become too damn big and complex thanks to relentless mergers and acquisitions and cannot catch things as quickly as they used to, or maybe drug and medical device companies have simply put profits before patients in recent years.

For example, Johnson & Johnson has had an almost weekly stream of recalls since the beginning of 2011, and the law has caught up with that shareholder-first behavior. Last June (2011), a judge in South Carolina named Roger Crouch ordered the company to pay more than $327 million in penalties for deceptively marketing the antipsychotic drug Risperdal as safer and better than competing medicines, which is a violation of that state's consumer-protection laws.

Johnson and Johnson's execs had "allowed the profit-at-all-costs mentality to cloud" their judgment in connection with the drug's marketing campaign and its labeling, Couch said in a particularly egregious, 17-page ruling (see HERE for the ruling) against the company. Judge Crouch added that J&J exhibited what he called a "callous disregard to a patient's right to have all information available, and in the hands of their physician, before deciding to use or continue to use the drug. Further, I find that the defendants allowed the 'profits at all costs' mentality to cloud the vision of their own responsibilities as acknowledged in their credo." [that famous credo can be seen HERE] He concluded that bad faith was considerable when it came to labeling matters.

Ironically, in spite of an astonishing number of recalls in the past year from J&J alone. J&J's diabetes care products (so far, anyway) have NOT really been among it's numerous recalls. But several of it's rivals have had recalls in 2011, including Abbott Diabetes Care, Roche and others.

Were you aware of any of those, and if so, how did you hear about them?

In December 2011, the FDA mandated a recall for some of Abbott's Glucose Test Strips (as many as 359 million test strips according to the FDA) made by that company could give false low Bbood glucose results (see HERE).

March 2011 brought us a recall from Roche for that company's ACCU-CHEK FlexLink Plus Infusion Set as having the potential for under-deliver insulin (see HERE).

Then, at the beginning of June 2011, the FDA required a recall of Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks which are commonly used to disinfect prior to an injection (although truth be told, many diabetes veterans have given up on doing that). Many distributors such as CCS Medical provide these with most orders. The reason for that recall: "potential microbial contamination" from those products (see HERE).

Also, in 2010, there were FDA safety alerts for several type 2 diabetes drugs, including Actos and Avandia (see HERE and HERE).

Also in 2010, an FDA mandated recall on Nipro GlucoPro Insulin Syringes because the syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it could become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. (see HERE).

Let's not forget the FDA fines against Eli Lilly and Company's Puerto Rico manufacturing facility of Humalog for a dirty ("adulterated") facility (see HERE).

If it seems like the number of warnings, recalls and safety alerts has increased, that's because it does seem to be the case. I can remember reading about a rare recall in Diabetes Health (formerly Diabetes Interview) magazine (often for brands of syringes and the like which I had never heard of), but those seemed to be relatively rare until the last few years.

However, nobody bothers telling you about these things until you hear them on the six o'clock news, or read it online. Your local pharmacist might share this information if he/she knows about it. However, because many for-profit insurance companies are effectively forcing patients to use mail-order with tiered pricing arrangements and in the name of "efficiency", do you really think Medco's massive mail-order pharmacy will do robocalls to advise you of a recall? I wouldn't hold my breath waitng for that to happen. I'll bet Adam Fein probably doesn't have an answer to that (since he's such a huge fan of mail-order pharmacies), either!

All of this makes me wonder. Scott's Web Log has long had a widget from the FDA containing links to check for recalls for readers (or report adverse events to the FDA), yet I haven't personally checked them for myself for a while.

Would you know where to look? I didn't think so!

Hence today's writeup.

Do YOU know where to find news of FDA-mandated recalls, warnings and safety alerts? Merely visiting the FDA's poorly organized website might not make that an easy task. Incidentally, the FDA was cited by the U.S. Government Accountability Office in 2006 for a need to better communicate these issues (see HERE) on postmarket analysis and communications, and again in 2009 for the need to establish a plan to modernize their antiquated information systems (see HERE for that report).

In any event, you can indeed find warnings, recalls and the like for the FDA by visting:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm

I'm including the widget (which normally appears towards the bottom of my blog's right-hand margin) here for reference:



For my Canadian readers, know that issues impacting U.S. drugs and medical devices are not necessarily relevant in Canada. However, the regulatory agency (Health Canada) also has a website for these issues.

Health Canada Advisories, Warnings and Recalls can be visited at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-eng.php

For my readers in Europe, Australia and New Zealand or Asia, I don't have a ready place to refer you, but I can say that the European Medicines Agency does have a nicely organized website (which frequently has far more info. on medicines sold than the FDA ever seems to publish) so finding this may not be the challenge it is in the U.S. Oceania or Asian residents should check with their local regulatory authorities to determine if there are comparable sources for recalls, warnings and safey information.

In a small way, I hope this little tidbit of information will help you be better advised of product recalls in the future.

The Business of Diabetes: Today, I Believe Amylin's Days Really ARE Numbered

Back in August 2008, I wrote a post entitled "The Business of Diabetes: Are Amylin's Days Really Numbered?" in which I disclosed some early news about Mr. Icahn's acquisition of Amylin shares and what that might mean, or not mean. In my assessment, I didn't think it meant very much at the time. I also did not agree with Diabetic Investor David Kliff (who was interviewed in the Indianapolis Star article I cited) that Lilly would necessarily buy Amylin. However, I posited that even if Amylin disappeared tomorrow, it's products will persist long afterwards. However, my comments were made nearly 4 years ago, and Amylin didn't disappear at that time (Mr. Icahn was busy with Biogen and a few other companies at the time), but a whole lot has changed since that posting.

Today, I really DO believe Amylin's days (as an independent company) are numbered. I would not be surprised at all if Amylin does disappear in the not-too-distant future. The handwriting is on the wall, as they say. Things are different today. The big question is WHO will buy the company? Amylin's management basically told Bristol Myers Squibb to take a hike, but now that the news has leaked to shareholders, including activist shareholder Carl Icahn, all bets are off.

How are things different? For one thing, Lilly dumped Amylin for a competing company, and Amylin then sued them for breach of its partnership agreement. (How many times do I have to say I think Lilly is a downright $#!tty partner, both for nonprofits like JDRF and for companies like Amylin? Management there would push their own mothers under under a bus if it meant fattening Lilly management's compensation. They have proven repeatedly they don't care about anyone but themselves, catch some posts HERE, HERE, and HERE for examples. However, that is a digression. Today's post has little to do with Lilly.) Another thing, Amylin's management, quite frankly, really did screw it's investors with refusing to talk with Bristol Myers Squibb.

Carl Icahn's Blistering Letter

Today, Carl Icahn published a very blistering letter (see HERE) to the Amylin Board of Directors that he thinks the company should be sold -- quickly or risk a proxy fight.

However, this time I think Mr. Icahn's points really ARE valid. Plus, he has a history of trying to embarrass and shame management of companies he thinks are not well-managed, and over the last few years, Mr. Icahn has moved to get at least two Board members that are sympathetic with his point of view on Amylin's Board, but apparently not enough to make sure that shareholders were kept apprised of acquistion offers! Still, a proxy fight would benefit Mr. Icahn because shareholders would evaluate things from the perspective of what their stock is worth, and a compelling case can be made that selling the company would increase the value of Amylin's shares dramatically. Bristol Myers Squibb already put $22/share on the table.

The $#!t has hit the fan with Amylin. Let's see how long this fight takes!!

News was out last week and Amylin's stock spiked when it was reported that Amylin's management had turned down an unsolicited $3.5 billion unsolicited acquisition offer from Bristol-Myers Squibb Co. earlier this year (see HERE). The board turned the offer down in February, said the people (who declined to be identified because the approach was private). The offering price was 43% more than Amylin's closing stock price of $15.39 on March 28, 2012 when the story broke. Amylin's shares then spiked when the news broke, fueled by speculation that an aquisition of the company was very likely as a result.

The logic behind Bristol Myers Squibb's offer makes sense, providing the company doesn't overpay for the acquisition. Bristol Myers Squibb's diabetes business, frankly, is almost non-existent today. Once upon a time, a forerunner to that company known as E. R. Squibb and Sons actually sold insulin just like Lilly and Novo do today. But Squibb insulin wasn't the greatest and they turned to a third-party supplier known as Novo Industries (which later merged with Nordisk) to help it with both supply and and quality problems. Initially, it began as a joint-venture in the U.S. (known as Squibb-Novo), but over time, Squibb ultimately sold it's share of the North American insulin business to Danish insulin giant Novo Nordisk, and they basically left the market back in the 1980's.

Beyond that, Bristol Myers Squibb doesn't really have much for type 2 diabetes, either, having had at least one type 2 treatment fail in clinical trials, so it relies primarily on a product known as Onglyza which is technically co-marketed with AstraZeneca. But aside from its lack of presence in the market, I suspect the company saw Amylin as a mismanaged company that could be picked up for a fair price. But no one anticipated that Amylin's Board would turn down a price that was a 43% premium to where it's shares were trading at that time. Also, management then pushed to sell more shares of stock (Amylin's offering on March 8, 2012 of 13 million shares, or about 10% of shares outstanding, priced at $15.62 apiece, without disclosing the Bristol-Myers offer to shareholders), which further diluted the value of the existing shares already out there.

Last week, Bloomberg News REPORTED that Amylin's executive management felt that the offering price, reported to be $22/share was "too low" for the company, in spite of the fact that Amylin hadn't been making a lot of money, and also lost it's partner last summmer when Eli Lilly and Company signed a deal with Boehringer Ingelheim, which had a competitor to Byetta in development as well as some long-acting (like Lantus) insulin formulations in development which Lilly desparately needs. Amylin sued Lilly to get out of it's contract and the courts agreed that Lilly was in violation and should therefore release Amylin from it. Lilly's move with Boehringer Ingelheim was driven by that company's need to shore up a business it had mismanaged for over a decade. The Amylin-Lilly product for type 2 known as Byetta has been losing share to Novo Nordisk's Victoza, and today, Lilly is pretty much a one-trick pony when it comes to insulin, selling only Humalog and some first-generation insulin varieties like Regular and NPH. Those still make money for the company, but Lilly has struggled to get on formularies for insurance companies because they don't offer a full portfolio of insulin analogue products, while Novo Nordisk and Sanofi do. Much of that is because the company failed to invest in the diabetes business after Humalog, pouring most of its R&D money into nuerosciences and other disease treatments like Erectile Dysfunction (like Pfizer couldn't handle that itself?). Anyway, Amylin's stock surged following the Bloomberg News report that it declined the Bristol Myers Squibb acquisition offer, based largely on the presumption that another big pharma player would likely step in to buy Amylin and push the share price even higher. Also, there was speculation that Amylin investor Carl Icahn would push the company to sell itself, which is exactly what happened.

Carl Icahn to Amylin: Begin the Sale Process Right Away

Today, Carl Icahn, a man best known for pushing companies to sell themselves and embarrassing management at the same time, seems to be agitating for an outright sale of Amylin, and the chances are looking pretty good that he'll succeed. Amylin's stock has lagged and the company hasn't exactly been a winner for shareholders. Aside from the senior execs who are on the board, as well as the puppets on the board who basically do what management wants, Mr. Icahn has pushed to get people who are of a similar mindset on the board over the last few years, and he's managed to get two on the Board. The other question is how much management is willing to struggle to go it alone? As Mr. Icahn's letter states:

"In my view, a proxy contest at this time would be a costly distraction – but I would not shy away from that possibility if I felt that the Board was not pursuing seriously the opportunity to sell the company. While I am hopeful that the Board is cognizant of doing the right thing for shareholders and that all strategic alternatives will be considered, in light of the reported Bristol-Myers Squibb offer, I am (and I believe other shareholders should be) unwilling to sit idly by with the mere wish that the Board will fulfill its fiduciary duties."

Basically he's telling the Amylin Board and management team "Now, you are ADVISED to play nice, or I WILL call for a proxy contest. Care to bet who will likely win that?"

In the meantime, several possible suitors have been named by Wall Street analysts. They've put together lists, including AstraZeneca, Merck, Forest Laboratories, Takeda Pharmaceutical, Sanofi and, of course, Bristol-Myers. Some of these companies would be better positioned to "achieve significant synergies," namely those that already shop products in Amylin's key market, diabetes. And they could afford to pay more than the $22/share that Bristol-Myers reportedly bid. Some analysts believe the company could fetch as much as $31/share if it is sold.

Let the posturing and fighting begin!!

Follow-Up: On Monday, April 9, 2012, Mr. Icahn filed a legal complaint in a Delaware court seeking an extension of the nomination deadline for directors, and also make proposals at the 2012 annual meeting of Amylin shareholders. The full press release can be viewed at http://prn.to/IaNCmh.

On Darby O'Gill, Uncle O'Grimacey, Rotten Apples and Low-Carb Shamrock Shakes

Once upon a time, when I was a kid, society made a bigger deal of St. Patrick's Day than a parade and an excuse to get drunk. For example, there was usually some kind of acknowledgment in the public school I attended (today, a day honoring a Catholic saint would probably be verboten, but back then most of my classes were filled with Catholic kids, either Irish, Italian, Polish, Lithuanian and a few Portuguese families thrown in for good measure). Those of us non-Catholic kids (and our parents) who attended Lutheran, Congregational, or Methodist churches and even the few Jehovah's Witnesses and Jewish kids didn't find it terribly offensive, and most even found it kind of fun because they were learning about something that wasn't too familiar to them. Some teachers would wear green, and on TV, Captain Kangaroo would have Mr. Green Jeans on to teach kids about the history of the first Irish Saint, and inevitably, reruns of Disney's 1959 movie Darby O'Gill and the Little People would show on one of the independent (non network-affiliated) broadcast TV stations. It was a simpler time, to be sure.

Along the way, in 1970 in fact, a rapidly-growing fast-food chain named McDonald's introduced a seasonal product that gained something of a cult following which is akin to the peculiar McRib sandwich (which is supposedly a barbecue pork sandwich that has been periodically sold by the chain, but was introduced long after the item I'm referring to): a minty-flavored, green milkshake in honor of St. Patty's Day: the Shamrock Shake.

The Shamrock Shake, unfortunately, rightfully deserves a place on the company's already lengthy list of bad-for-you foods, even though the item is one of those things people who might otherwise never go to McDonald's might step in (or Drive-Thru) for. Indeed, if memory serves me, they were quite tasty! There have been some complaints about changes to the formula in 2010 with McDonald's introduction of the McCafe concept, specifically that they now taste less minty and more like vanilla and are less solidly green in color, but I can't comment as to whether those are accurate. But take a look at the Nutrition Facts panel from 12-oz sized Shamrock Shake in 2012, and you might want to reconsider indulging for the green!! (this item may disappear from the products list after the spring, so I'll list the nutrition facts from 2012 for the Shamrock Shake here, too, for reference):

Serving Size 12 fl oz cup (the smallest size) of McDonald's Shamrock Shake (2012)

Calories: 540
Calories from Fat: 150
Protein: 10 g
Fat: 16 g
Saturated: Fat 10 g
Trans Fat: 1 g
Carbohydrates: 88 g
Sugars: 74 g
Dietary Fiber: 0 g
Cholesterol: 45 mg
Sodium: 160 mg
Calcium: 350 mg
Iron: 0 mg
Vitamin A: 960 IU
Vitamin C: 0 mg

Not only is this item super-caloric, but also has a host of other bad-for-you items, including cream which is indulgent to begin with, and the small size also includes a whopping 88 grams of carbohydrates (74 grams of which come directly from sugar or sugar-like substances), and 45 mg of Cholesterol! The minty syrup itself is made from high-fructose corn syrup and hydrogenated fats, two other not-so-great food choices. Fortunately, this item is only sold once a year, but with a nutrition profile like this, even that may be too frequently!

When the product originally launched in 1970, and the sizes were much smaller, and served in paper cups (including a tiny child's size small!), so the super-sizing is definitely not a myth in this case. Today, it's served in a jumbo plastic cup and the small is twice the size of the original. Supersize me, indeed! The early marketing for the product featured Grimace's Irish Uncle O'Grimacey (Kerri Sparling of Six Until Me once did an infamous post on Grimace which I still wonder what prompted, so I'll spare you the intimate details of who or what a Grimace is by simply providing the link to her October 2007 post HERE).

Still, as a nostalgia buff, I can admit that I have memories of my grandmother, who wouldn't be caught dead in McD's for anything else, making a pilgrimage to the Golden Arches for the sweet, green concoction. She has long since passed away (she died of cancer in 1980), but even my mother will occasionally mark the season in her honor with a Shamrock Shake.

Given the fairly toxic nutritional profile of even the smallest-sized Shamrock Shakes, I haven't had one of these in a long, long time, but I saw a TV commercial last night suggesting that Shamrock Shakes were now around across the U.S. for a limited time.

Low Carbers Re-Invent the Shamrock Shake ... For the Better!

I happened to catch a very interesting post this week from the low-carb blog "Your Lighter Side" which offered a very low-carb remake of this toxic, green treat with a much, much healthier version. She uses iced, mint tea as the base, and the ice does most of the rest, although she adds some high-calorie cream which I'd say could be replaced with a lower calorie version without much difficulty (some thoughts: a few tablespoons of plain, Greek-style yogurt gives it some creaminess). Have a look at low-carb blogger Jamie Van Eaton's remake of the sweet, green treat, which she's dubbed "Mint Tea Frappuccino", and contains just 1.7 grams of net carbs!! Seriously, it's worth trying! I've copied her recipe (and her commentary on that creation) below for easy reference:

Mint Tea Frappuccino

As soon as I saw McDonald's had Shamrock Shakes available for March, I wanted one in the worst way. I went one better; why not a Shamrock Frappuccino? It's pretty yummy, so bless yer lucky charms for that!

Really, though. Seriously. Right now. Do it ... I'll even share ... yours ...

Some ideas:

You can sub dairy for nondairy in this beverage. Almond milk, coconut milk, you name it; the real thickener is the ice, so go a little lactoseless if need be.

You can skip the green food coloring. The real color of this frappe is a bone white (yes, I'm the person who hugs the paint swatches at Home Depot). I just like the color, especially around St. Patty's Day. The only thing green and funky around my house shouldn't be the laundry. Am I wrong here?

This drink is seriously, superbly low carb, at only 1.7 net carbs for the drink. It's filling and I didn't even go for the heavy whipped cream or the chocolate. I went full frontal minty. I might not even brush my teeth now.

Mint Tea Frappuccino

4 ounces warm water
Spearmint tea bag
1/4 cup heavy cream
4 Tbsp sugar equivalent in a substitute
1-1/2 cups crushed ice

Optional: Chocolate syrup
Optional: Sweetened Whipped Cream

1. Combine powdered sweetener, tea and water. Let steep for 5 minutes. Squeeze excess tea bag into water after removing to get the most of the flavor and color.

2. Crush ice in blender (or, better yet, use the crush setting on the ice maker). Combine all ingredients in blender and mix until frothy.

3. Top with whipping cream and chocolate syrup if desired.

Makes 1, approx 12 ounce frozen frappuccino.

Nutritional information (without the cream and chocolate): Calories: 103, Carbohydrates: 1.7g, Fat: 3g

Nutritional information (with the cream and chocolate): Calories: 206, Carbohydrates: 2.7g, Fat: 6g

URL for this blog post:
http://yourlighterside.com/mint-tea-frappuccino/

Again, I would avoid the heavy cream and choose a lower-cal version myself, but like everything on her site, the goal is to be creative in the kitchen!

Other Variations

To be sure, there are a variety of ways you could go with this, and there are other versions online. Another one is the Hungry Girl's recipe makeover of this green favorite. She swaps reduced-fat vanilla ice cream with light soy milk and peppermint extract for a more guilt-free take on this seasonal treat.

Catch her post at:
http://www.hungry-girl.com/newsletters/raw/1212


However, she still relies on sugar-free ice cream. As an alternative, might I suggest the yogurt instead (frozen is even better, but plain or plain Greek-style works)? She also includes 1 tbsp. of Coffee-mate Sugar-Free French Vanilla powdered creamer to make it slightly thicker (Coffee-mate does have hydrogenated fats, but a tablespoon is unlikely to do serious damage), and she also uses peppermint extract to give it more intense minty flavor which I highly recommend. Again, the point with this St. Patty's day pilgrimage is to encourage experimentation in the kitchen. It's usually always better to make it yourself since you have complete control over what goes into your recipes.

With that, I'll sign off with a TV commercial featuring the long-lost Uncle O'Grimacey, or catch the YouTube video at http://youtu.be/Zu6q8HzmQ7Q:



Rotten Apples?

On a totally unrelated note, I was a bit shocked this week that a bunch of rotten Apple addicts were camping out in front of Apple retail stores for a new version of the iPad (see http://usat.ly/wDWCxu for the news story). Most were (legal) adults, too, and some even had college degrees, too.

Seriously?! WTF?

I sort of camped out for a product once for a product, but only for about an hour before my local Atari 2600 dealer got the first-ever home version of Pac Man way back in 1982. But I was like 12 or 13 years old at the time, and being one of a limited number of people who had Pac Man at home did make me king of the nerds for a brief window of time. And it's a different story when you want concert or event tickets for which there are only a finite number available - ever. But what do these iPad owners get, a few marginally-improved new product features over the old version?

Big freakin' deal.

The average person cannot distinguish the old iPad from the new one, and I would dare say that it's not worth camping out for a new $600 device that will be widely available soon anyway. People in China are working almost around the clock to make more of them, folks. Don't give up your job at Applebee's anytime soon for a new iPad because it's not all that special, and in a few months, you'll find plenty of them in your local Walmart or Target store anyway.

My household has an iPad, and while it's a competent tablet computer, it is hardly worth camping out for a newer version of it. Often, the device remains plugged in its charger for days at a time.

The cult-like following for these products is impressive ... for Apple shareholders ... but the people doing this are what could only be called morons. What kind of curmudgeonly old person would I be if I didn't denounce this kind of behavior? I don't want to hear about it on my TV newscast, or read about it in the paper. It's not news, it's stupidity, folks.

Anyway, before I get too far off topic about Apple groupies, get back to your blenders to try some of these low-carb Shamrock Shakes, and have a Happy St. Patty's Day!!

Immunologist Matthias von Herrath to Work for Novo Nordisk

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

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

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

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

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

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

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

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

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

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

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

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



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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Back to the Wayback Machine.

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

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

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

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

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

Santa D-Baby (the D stands for diabetes)

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

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

Dollars for Docs Discussion

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

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

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

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

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

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

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

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

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

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

Back to the ProPublica Dollars for Docs Video

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



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

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

The Business of Diabetes: Geron No Mo!

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

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

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

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

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

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

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

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

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

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

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

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

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

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