On World Diabetes, A Tribute to Mary Hunt

The diabetes community lost another member recently.  I knew her as Mary Hunt, and she died at age 66.  She had been hospitalized for illness recently, so her passing was not a complete surprise to her family, but its always sad when we lose someone of any age.  Her husband Dave shared the news via email the other day.  In many ways, Mary was one of the developers of today's Diabetes Online Community.  She helped start the Diabetics International Foundation [http://members.tripod.com/diabetics_world/], which worked tirelessly for the many patients who suffered hypoglycemia unawareness attributed to biosynthetic insulin (an adverse effect the drug industry would prefer no one knew about, and has worked tirelessly to silence, although organizations such as The Insulin Dependent Diabetes Trust have made that impossible), helping to establish processes with the U.S. Food and Drug Administration to enable patients to import natural insulin varieties from the UK and Argentina.

On this World Diabetes Day, I am sharing Mary's obituary (see http://goo.gl/Y7LMRQ).  I am saddened by Mary's passing, but eternally grateful to her for the work she did over the years to help others, as well as her kindness of spirit.  Much of what she did helped me in the work I've tried to do with Diabetes Advocates with the FDA, and I believe patients with diabetes will remain an important constituency for the FDA to consider.  On the latter note, please consider signing a petition to the FDA to sponsor a Patient Meeting on Diabetes (they have only 2 spaces remaining, but somehow aren't convinced a meeting dedicated to diabetes is necessary).  Visit http://diatribe.org/petition to sign the petition.

Without getting too far off-topic, below is Mary's obiturary:

Mary Sebastian-Hunt

Mary Sebastian-Hunt

Mary Sebastian-Hunt, 66 of Clinton, Michigan passed away peacefully Saturday November 9, 2013 at Saint Joseph Mercy Hospital.  She was born on August 3, 1947 in Pontiac, Michigan to Charles E. and Thelma (Hazelton) Sebastian. On March 24, 1990 she married David L. Hunt, a life-long Clinton resident.

Mary lived in the Lansing and Mason area for many years. She was a gifted artist who loved oil painting and interior design. Mary was also an Outdoors Enthusiast and loved fishing and animal watching. Her greatest passion was helping others, including her help in diabetic research and the start of the Diabetics International Foundation.

Mary is survived by her husband, Dave;  her son, Jim Alexander of Tecumseh;  stepson, Darin L Hunt;  stepdaughter, Kimberly E. Hunt-Murphy;  and her sister Susan Mellentine, of Lehigh Acres, Florida.  In addition to her parents, Mary was preceded in death by her brother, Karl F. Sebastian; and her son, Matthew Scott Alexander.

According to her wishes, Mary has been cremated.  A Celebration of Life Service has been planned for Saturday, November 30 at 11 a.m., to be held at the Clinton United Methodist Church, 10990 Tecumseh Clinton Rd, Clinton, MI 49236.  Phone: (517) 456-4972.   A luncheon will follow at the church.

Memorial contributions may be made in Mary's honor to the Clinton United Methodist Church.

Condolences may be offered to the family at http://www.handlerfuneralhomes.com.

Should Have Known Better ...

One would think I should have learned my lessons over the years in maneuvering through the byzantine world of American healthcare delivery (trust me, its not a SYSTEM, folks, but a world where every party involved tries to skip a little extra profit off the ridiculously high premiums Americans already pay), but I routinely find out that's not the case.

Over the years, I have shared stories of how I had like 4 different healthcare plans over the past six years yet have been with my employer for the past fifteen, and it wasn't because I switched plans in open enrollment because the only choice I had was to be covered or not.  Each change brought new rules, new formularies and new appeals processes.  I switched to United Healthcare a few years ago and compared to Wellpoint/ Anthem, I'd say they've been light years ahead.  Its hard to believe, but I've been the proud owner of a Dexcom for almost a year now, something that wouldn't have been a possibility with my old insurance plan.  There are things about the Dexcom that drive me crazy, but in the grand scheme of things, its been key to a much better night sleep for me and my spouse.  It also helps refine overnight basal dosages and insulin-to-carb ratios, and, the kicker is that there have been no severe hypos while I've been wearing the thing, which alone could be saving the insurance company thousands of dollars (one ambulance call would erase any savings they save by denying me a Dexcom).  Why any insurance company would choose to fight this is beyond me, but I've been glad to enjoy it.

Anyway, a while ago, United Healthcare switched me from Medco (which was acquired by Express Scripts anyway) to a Pharmacy Benefits Management company they acquired known as OptumRx.  For the most part, the transition (for me) was seamless, but OptumRx isn't the greatest, and they are moderately better than Caremark ever was.  Over the years, I had stockpiled a bunch of lisinopril when using cheap mail order pharmacies like Walmart (in the days I had an ultra-high deductible plan of $2,500 for me and only me, nothing was covered until I met that threshold, so I found cheap places to get some prescriptions and order there), which is a small-molecule ACE inhibitor whose primary purpose is hypertension (which fortunately, I've never had), although they are prescribed off-label because studies have shown they can have a prophylactic effect on kidney issues common in people with long-term diabetes.  I use a very cheap generic called lisinopril at the lowest dosage, and it's worked damn well because my kidneys seem to be working great after a urine test over a decade ago showed trace elements of protein which is supposed to be a very early warning sign of kidney disease.

Anyway, my stockpile has been running down and I thought I should refill, but I learned firsthand of the profiteering that goes on in the generics business.  As I know for a fact, even without insurance, I could get lisinopril for $10 for a 90-day supply just by ordering from CVS Pharmacy, Target pharmacy, Walgreens or Walmart pharmacy.  So I wrote to United Healthcare and OptumRx (I addressed my letter to the CEO's office; in my experience, its much faster to go from the top down rather than the bottom up), and said I would transfer the prescription to another pharmacy if they weren't willing or able to match the co-pay amount of $10 (OptumRx charges $25, and supposedly United Healthcare is picking up a portion of the total amount, so the unknowing patient is being screwed deep and hard here) - without having to submit a claim to United Healthcare at all, so why the hell would I agree to pay 150% more for a drug that can be bought without insurance for next to nothing?  That makes no sense.  I guess that's what is supposed to happen with healthcare insurance, but it seems stupid to me.

I got a strange response that looks pretty much like a denial, but its so poorly written I can't be certain.  But I decided I won't bother appealing it.  I just called Walmart's mail order pharmacy and the woman on the phone couldn't have been more helpful.  I told her I wanted to transfer my prescription from OptumRx to Walmart's mail order pharmacy and asked her what I needed to do or provide her.  I gave her the Rx number, the name of the medicine, the quantity, strength and the doctor's name, phone number and his fax.  They do the rest.  And, I'm getting this medicine for $10 instead of $25, mailed to me.

I should have known better and just sent it there in the first place!  Note to self: make it easier on yourself next time and do it that way, Scott!

Americans and The Affordable Care Act

Its little secret that the Patient Protection and Affordable Care Act is controversial, although dozens studies and surveys show unequivocally that Americans aren't so much opposed to the law, rather, most have mixed feelings on the law.  Further analysis shows many of those mixed feelings can be attributed to the fact that so few Americans truly understand the law, and the reasons are because of the messaging lawmakers (most notably opponents) have used to describe the legislation.  Also, supporters of the law have done a downright terrible job countering depictions of American opposition as somehow being the common opinion of this law.

If you think back to similar efforts to try and reform the byzantine healthcare industry in the U.S., most notably the 1993 Clinton healthcare plan (known officially as the Health Security Act), a reform package proposed by the Clinton administration, but was more closely associated with the chair of the task force devising that plan, then-First Lady of the U.S., Hillary Clinton, and you see clues as to why efforts to reform the U.S. healthcare "system" (a term I personally use very loosely, because U.S. healthcare is less of a coordinated system than it is a group of entities trying to skim a profit off the illnesses of others) have struggled to win favorable public opinion.  That also explains why the Patient Protection and Affordable Care Act ("Obamacare") has has such mixed opinions.  But the Clinton plan was never implemented, and importantly, the Affordable Care Act's supporters learned a few things from that experience when they tried again in 2010, sewing the seeds to the latest last-ditch efforts by the losers to get their way one last time.

The British magazine The Economist recently featured a chart on this important law (and it IS U.S. law; it went all the way to the U.S. Supreme Court and was upheld there as lawful).  The Economist notes that new computer analysis (see HERE) counts the GOP policy ideas that overlap with other bills that made it into the law: 3% from the House and 8% from the Senate. In fact, when "mark-up" bills are excluded — basically, amendments and legislative re-writes—11% and 28% of policy ideas from Congressional and Senate Republicans, respectively, align.  John Wilkerson of the University of Washington and his colleagues studied the legislative history using big data. They ran the PPACA through a text-analysis system that could spot similar wording in previous legislation with a better than 90% accuracy. That let them identify the date and sponsor of earlier bills that ended up in the law, indicated as circles in the chart. Hence, proposals by Republican Senator Chuck Grassley of Iowa on nursing home transparency in March 2009 were incorporated by Democratic lawmakers in later bills, before appearing in the law.

Hence, The Economist notes that on the surface, Obamacare looks totally partisan, largely because not a single Republican voted in favor of the legislation when it was still a bill.  However, the analysis shows that the law is filled with a lot of concessions to Republican opponents, which helps explain why many continue to oppose this law like sore losers: much of this law uses Republican ideas, making their defeat on this even more humiliating.  Add to that a stunning defeat by the Supreme Court, and you have the recipe for ridiculous Congressional theatrics like Texas Senator Ted Cruz's recent non-filibuster (it can only be considered a filibuster when legislation is actually pending a vote).

When researchers look into it, the reality is that the American public loves much of what's in Obamacare.  For example, the Los Angeles Times recently ran a fascinating article entitled "The truth is, Americans love Obamacare" (see http://lat.ms/19eIA9J).  While the title of that article is misleading (in my opinion), the author reports that research from the nonpartisan Kaiser Family Foundation tracking research from March 2013 showed (see that study at http://bit.ly/18BQtAx) the following:

• 88% of Americans are in favor of extending tax credits to small businesses in order to buy insurance for their employees
• 81% of Americans favor closing the Medicare drug benefit doughnut hole
• 75% of Americans favor extending dependent coverage to children up to age 26
• 71% of Americans are in favor of expanding Medicaid
• 66% of Americans favor banning exclusions for preexisting conditions (although when you actually tell someone what qualifies as a preexisting condition, other surveys show that more like 75% favor this)

Yet when respondents are asked how they feel about "Obamacare," they're overwhelmingly against it.

Still other research shows shows some big demographic differences.  For example, Americans in the 18-29 age group are the most likely to be uninsured (22%) also, perhaps not surprisingly respond most favorably to Obamacare, with 51% opting to keep it. By contrast, Americans age 65 and older are the least likely to be uninsured because they're collecting Medicare (3%) are also the most likely to object to Obamacare, with only 32% electing to keep it.  These results are from a recent Bankrate survey on the topic which can be viewed at http://prn.to/1bCtdtt.  There are other studies which show that Hispanics, another group less likely to receive employer insurance coverage, also like the law.  Simply stated, Americans' views of the law varies considerably depending on how it is described, and whether a person is insured already or not.

With that in mind, consider the following:

First, The Affordable Care Act now the law of the land, so disregard suggestions (and Congressional theatrics) to try and defund it.  That train left the station several years ago, and some are sore losers about it.  However, my readers may recall that on September 24, 2013, I Tweeted a Bloomberg article by Paula E. Dwyer entitled "Five Republican myths on defunding Obamacare" (see the article at http://bloom.bg/16EYMuL).  Myth No. 1 was that shutting down the government would somehow stop the healthcare law from taking effect.  As it turns out, most of the health law's funds come from the entitlement programs Medicare and Medicaid, which don't need Congress's annual blessing, so a shutdown would do almost nothing to "defund" the law because the funds for Obamacare aren't even subject to Congressional debate.

The reality is that in spite of technical issues, the marketplaces were opened, and the government reported that within 24 hours of its 12:01 a.m. launch, the Department of Health and Human Services' health-care website (http://www.healthcare.gov/) had received 4.7 million unique visitors. By the end of Day Two, the number was greater than 7 million. (HHS has not yet released the number of those who have actually signed up for coverage.)  By week's end, demand was still so great the website, HealthCare.gov, remained difficult at times to get into, despite the addition of more computer servers.

Second, if you're someone with a chronic medical condition like diabetes, you are a major beneficiary of this law.  You can now buy healthcare insurance whereas in the past you weren't even permitted to buy insurance at any price except in states which had laws prohibiting insurance companies from doing so.  As it turns out, such laws also significantly increased the costs of plans in those states, but those same states also saw the smallest increases or even decreases after "Obamacare".  Discussions about the cost have generally ignored this not so little fact; many people can now buy insurance who were discriminated against in the past, a major, major factor in the reasons why rates for many were so low in the past.  Now, if you have diabetes, you CAN buy healthcare insurance, whereas in the past, you were out of luck.  Is that how free markets are supposed to work?

Indeed, several states including California, Colorado and Connecticut which are running their own exchanges have reported significant interest.  Connecticut, for example, reported that the number of of people looking into healthcare plans online or by telephone was far more than Access Health CT CEO Kevin Counihan had anticipated.  There were even reports from HHS that in states like Kansas which have deferred all Obamacare administration to the Federal government, also had high consumer interest in Obamacare.  Opponents claim they will see a different picture when the bill for Obamacare come due, neglecting the fact that in the U.S. today, bankruptcies resulting from unpaid medical bills are forecast to affect nearly 2 million people this year—making health care the No. 1 cause of such filings, and outpacing bankruptcies due to credit-card bills or unpaid mortgages, according to data derived from the U.S. Census, Centers for Disease Control, the federal court system and the Commonwealth Fund and crunched by NerdWallet Health.  That suggests that the cost of insurance is more than offset by a single costly hospitalization.

The reality is that the United States is the only advanced, industrialized economy that did not offer universal healthcare until the Affordable Care Act became law, and while there will be refinements that can be made over time, yet nearly 6 in 10 Americans disapprove of trying to stop the law by cutting its financing.  Besides, Congress has already funded it, and the chance to defund it ended in 2012.  Lawmakers who are opposed lost their opportunity to do this over a year ago.

Even among those Americans who don't especially like the law, less than half want their representatives in Congress to try to make it fail.  The reasoning seems to be it was passed into law by legitimate means (indeed, the Republican party itself had used the same Congressional procedure in the past), and it addresses a legitimate U.S. need, so they want to see it have a chance.  Since the repealers have suggested no alternatives other than to kill this law, they have failed on several levels.  Most Americans want to see how things end up working with Obamacare, and expect their lawmakers to do the same.

Author P.S., October 30, 2013:  Its not really a secret, we've known that once the Affordable Care Act was implemented, substandard insurance plans would be replaced with better, stronger coverage.  That also means that the really low-cost healthcare plans are likely to disappear, although such plans are insurance in name only.  Bare-bones insurance coverage tends to cover only outpatient hospitalizations, and they don't typically cover ambulance service or even basic prenatal care.  The so-called benefits that such plans actually do provide may include generic drugs (many of which can be attained from major pharmacies for as little as $10 for a 90-day supply without insurance), and certain doctors' appointments are covered with a $50 co-pay.  The price for such an "insurance" plan: $54 per month, which is low by almost any definition, although certain media outlets are describing the fact that the individuals impacted cannot afford more.  The Washington Post recently reported one example (see http://wapo.st/1aPebdz for the article) that Fox news highlighted.  However, the bare-bones plans which are disappearing and are really better described as a "pray-that-you-don't-really-get-sick 'plans'" because those plans (if they even deserve the description of insurance at all) don't cover cover much of anything.  The example cited failed to cover “extended hospital stays" whereas hospitalization is among the core requirements for health-care plans under Obamacare.  As the Rachel Maddow show described it (see http://on.msnbc.com/1g9gteR), "In other words, the new horror story for critics of the health care law features a middle-aged woman trading a bad plan for a good plan, and health care insecurity for health care security."  Many of the sensationalized stories of complaints (highlighted by Fox News) by people who are seeing their monthly costs jump under the new Obamacare plans are conveniently omitting the fact that many people including the woman featured in the Fox News story, will actually be eligible for subsidies under the Affordable Care Act, hence the cost of the coverage being reported isn't what these so-called "victims" of Obamacare will actually have to pay out of their own pockets.

No D-Day Blog Post 3013

My friend George Simmons (a.k.a. Ninjabetic) created No D-Day a while back and I've done most if not all of them, plus its probably one of my favorite meme-themed posts because its supposed to have nothing to do with diabetes, even though I probably have plenty to discuss on that today, too (for example, I've been a Dexcom user since early this year, but I'm not allowed to talk about that in today's post, so I'll zip it on that topic for now).

My friends who know me know that in a addition to being a retro pop culture junkie (hence my other blog, hgm.sstrumello.com, I'm something of a culture vulture, too.  I go to the theater pretty regularly, and why wouldn't I?  I'm lucky to live in New York, where there's a lot of theater to choose from.  My personal preference is the off Broadway or the off-off Broadway stuff, because not only are those shows more daring and creative, but they're usually cheaper, too.  But I get to see a lot of big-time Broadway shows, too.  Most recently, I saw Spider-Man, Turn Off the Dark, a show that got off to a really rocky start with a lot of cast injuries.  The show itself was really impressive from a technical features standpoint, though the script was only so-so.  But, if you visit NYC and pay full-price for show tickets, you're paying too much as any New Yorker will tell you (OK, I'm not a native New Yorker, I come from the Connecticut exurbs, but I digress).

Beyond that, work has been keeping me more than a little busy.  I actually don't mind that part of things, because the days go by really fast, but I struggle a bit with a manager who's an ocean away and we don't always get to communicate as I'd like to see.  Outside of that, I'm looking around see opportunities in working with the elderly and hopefully getting them up-to-speed on technology.  Its kind of a big deal, actually.  People like to think that stuff like iPads are sooo user-friendly, yet haven't seen an older person struggle with the technology or how intimidating that can be.  Even such things as changing the font size to make it easier to see are difficult, and they don't always feel fearless in looking around for information.  I see my own mother and how she gets nervous using technology, and it struck me that there's a need out there.  Plus, the so-called Apple store Geniuses don't seem all that approachable when you're older.  Then, no one tells them there are alternatives like Google Nexus 10s are far less costly, and many of them are living on fixed incomes.  So, I've reached out to a community center to see if they're interested.  They only do orientations for volunteers once per quarter, so I missed the last one, but I want to see if that's something I can do to give back because it won't be too long before I'm that age, and having someone who can patiently work with them might be welcome.  I like to see it as paying it forward, so we'll see how that pans out.

Anyway, that's not d-related, but I think that's a good thing!

Stripping Safely and What Medicare Has to Do With It

At this point, I won't try to repeat what others in the community have already said about the "Strip Safely" [http://www.stripsafely.com/] campaign other than to reiterate some of what I think are their key points, as I have a few points I think are worth noting.  The folks at diaTribe have a very well-written summary of what's at stake (see HERE).  Also, my friend Riva Greenberg discussed the recent move by Medicare in her Huffington Post column (see http://huff.to/13avkif for details).

Let me take a step back and give you some relevant background which is important for my readers to understand the issues.

Back in 2009, the New York Times reported (see the article at http://nyti.ms/Ddz7L) that the FDA had pressed the international organization, which happens to be the Switzerland-based International Organization for Standardization (ISO) [http://www.iso.org/], which happens to set the standards on accuracy for blood glucose testing supplies that patients use to check their blood sugars.  The article noted that the FDA might press ISO to tighten them. The NYT also stated that if ISO refused to act, the FDA suggested it "may instead recognize other (higher) performance standards" on its own, according to a June 2009 letter from Dr. Margaret A. Hamburg, the agency commissioner.  Indeed, I personally helped lead the charge that we push our regulators to adopt the tighter standards (catch my post at http://goo.gl/uRPhG for details), something the FDA has not yet done.

What Are Current Accuracy Standards?

The FDA currently uses the 2003 ISO Standard, which requires that 95% of all measurements be within (+/-) 20% of the lab value for values over 75 mg/dl or within (+/-) and 15 mg/dl of the lab value for values under 75 mg/dl.

However, as I've already noted, several years ago, the FDA pressed for tighter standards from ISO, and in April 2013, ISO finally got around to adopting new, stricter accuracy standards.

The new ISO standards require 95% of all measurements to be within (+/-) 15% of the lab value for blood glucose measurements over 100 mg/dl and within (+/-) 15 mg/dl for values under 100 mg/dl.  The new standards also require that 99% of blood glucose values must fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.  The CEG defines different "zones" of error and how much that error could cause the person to make a treatment decision that could be dangerous.

In other words, ISO went from a standard of +/- 20% on high readings to +/- 15% on all other readings, and it now requires those standards to be met 99% of the time (rather than 95% of the time).  However, right now, the FDA is still using the older, looser ISO standards from 2003.  I believe the FDA will eventually adopt the newer standards (after all, they pushed for them in the first place), but like any government entity, they'll have to open the new rules up for public comment.

Beyond the FDA's slowness to tighten the very standards it had pushed ISO to implement several years ago, there is also a growing consensus that the FDA isn't even effectively policing adherence to those standards, but is instead relying on the integrity of manufacturers to ensure those standards are being met.  The big players (J&J, Roche, Bayer, Abbott, Sanofi and Nipro) generally do a good job, but FDA needs to crack down on some of the marginal players which sell their products at very low prices (using a lowest-possible-cost business model); their accuracy is presumed to be under the regulatory scrutiny of the FDA, but we know that's not happening right now.

That's where things get messy.

At a recent public meeting, the FDA acknowledged that there are indeed a number of 510(k)-cleared blood glucose (BG) meters and test strips that do not even meet the accuracy standards for which they were originally approved, nor is there a clear course of action to ensure that people with diabetes are using blood glucose strips that even meet current regulatory requirements.  Its basically an honor system, but some low-cost players are cheating, and the FDA isn't able do much to make them play by the expected rules of the game.

On May 21, 2013, the Diabetes Technology Society's (DTS) held a conference entitled "Do currently available blood glucose meters (BGM) meet regulatory standards".  Diabetes industry reporters from Close Concerns, which publish an industry newsletter called "Closer Look" (in addition to the patient-centered newsletter diaTribe) said of that meeting, "Representatives from academia and industry consistently identified low-cost meters as the source of device inaccuracies on the market."

diaTribe's Adam Brown had this to say (see http://diatribe.us/issues/56/new-now-next/2):

"... the recent 68% price cut in the amount Medicare will pay for glucose strips. In our view, this change will hurt patients in the long run. First, it could mean that unproven and potentially lower-quality manufacturers will become the primary suppliers of test strips for people with diabetes on Medicare. Private insurance providers could follow in Medicare's footsteps and adopt these changes, which could mean limited choices for all patients. Second, the dramatic price cuts stand to reduce the ability of companies to develop next-generation, advanced glucose testing products. We hope the decision is a not permanent, as we also do not see it significantly benefiting healthcare expenditures in the long term (i.e., most healthcare expenditures on diabetes in the US go to hospital visits and services, not to technologies like glucose meters and strips)."

Therein lies several problems, which are listed below:

Problem #1: In 2009, the FDA pushed ISO for tighter standards, and in the spring of 2013, ISO responded with tighter standards.  Since then, the FDA has not (yet) followed suit.  They need to do so.

Problem #2:  Although manufacturers must meet accuracy and good manufacturing practices standards at the time they are seeking approval, there is little (if any) enforcement from the FDA on suppliers outside North America, Europe and Japan to ensure those standards are even being met.  Right now, only the risk that the FDA could march in, unannounced, and inspect a facility, keeps manufacturers in-line.  But once cheap Chinese suppliers have 510(k) approval, they can do pretty much whatever they want, including not adhering to the very standards which got them an approval in the first place.

The FDA notes that for manufacturers outside of the countries they have worked to "harmonize" regulations with (meaning the NAFTA countries including Canada, Mexico and certain other markets in Latin America and Caribbean basin, Western Europe, Japan, Australia and New Zealand and a few others, although China is absolutely NOT on that list), the FDA cannot simply walk in and inspect a facility without pre-arranging the visit.  In some cases (China, most notably), the government must arrange for the inspection to take place, and there are countless stories of how manufacturers routinely "dress up" for the regulatory visits, only to revert back to their regular sloppy conditions after the FDA inspectors leave.

Problem #3: The FDA has no post-marketing auditing authority outside of the aforementioned markets to ensure that low-cost suppliers are even meeting FDA standards, nor is there an independent governing or auditing body (or required membership in such a body) to self-police.  But, the FDA could mandate there be one … IF they had one they could require membership in.  Right now, no such organization exists.

There is a public meeting of the Diabetes Technology Society (DTS) in just a few weeks, on September 9, 2013. The name of that meeting is "Verifying the Performance of Blood Glucose Monitors following FDA Clearance", (see also http://1.usa.gov/35qB5F) and the FDA will be attending this meeting.  If patients can unify behind this cause, we have potential to change this for the better.

We need our elected officials and FDA regulators to do several things.  But let's start with what Federal lawmakers have encouraged Medicare to do.

Medicare Slashes Mail-Order Prices, But Taxpayers Likely Won't Realize Much Savings

Beginning on July 1, 2013, a new, nationwide mail-order system for Medicare patients supposedly based on competitive bidding went into effect.  (see http://nyti.ms/12J2SWV for an article which outlines the change, note that this was not the best-researched article on this subject, but it was widely-read).  Its being called the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program, and was based on a tiny trial in just nine areas of the country.  The program aims to limit Medicare's expenditures on various supplies, among them blood glucose (self monitoring) testing supplies.  Medicare has a sheet describing the change which can be viewed online at http://go.cms.gov/19Xmwi1.  I understand the reasons; lawmakers have been avoiding the fact that demographic reality means 10,000 new people become eligible for Medicare every day for the next 20 years.  The Baby Boomers are headed into retirement en masse, so lawmakers want them to save money.

According to Medicare, suppliers are currently paid based on fee schedule amounts that averages $77.90 per month for mail-order diabetic testing supplies (100 lancets and test strips) of which the beneficiary pays 20% (approximately $15.58 per month on average).  The new program DMEPOS will reduce the average Medicare allowed monthly payment amount for these mail-order supplies from $77.90 to a new national rate of $22.47, which amounts to a reduction of approximately about 70%.  However, and this is a HUGE deal, right now, the change applies to Medicare beneficiaries who order diabetes supplies by mail-order, which the New York Times indicates only accounts for about half (maybe 60% at most) of all purchases anyway.  However, the remainder can still go to any local pharmacy that's enrolled with Medicare and buy their testing supplies from there, and Medicare will likely end up paying more through that channel.

Medicare is already promoting this as a big victory for U.S. taxpayers.  Laurence Wilson, director of Medicare's chronic care policy group said in an interview "The large mail-order suppliers recognized this was a huge market and they could afford to accept a lower price to reach that volume of customers.  The taxpayer wins."  However, such exuberance is premature.

That, like other well-publicized government procurement initiatives for the U.S. military back in the 1980s which found that U.S. taxpayers had ended up spending $640 on toilet seats, $7,600 on coffee makers, and $436 on plain old hammers, is probably wishful thinking.  Simply put, this particular program has not been very well thought out or tested, and I would argue is unlikely to produce the major cost savings that are now being promoted.

Diabetes Self Management magazine observed (see http://bit.ly/168xxdX):

"According to Peter Cramton, an economics professor, a person who can no longer buy test strips from his preferred mail-order supplier may switch to a local pharmacy, in which case Medicare would end up paying about 260% more.  And according to Andrea Bergman, a representative for a coalition of product manufacturers, pharmacies, and other groups that take issue with the new program, the bidding process may lead suppliers to narrow their offerings under the new program, possibly making certain types of test strips unavailable by mail order through Medicare."

However, the biggest problem is that the preferred mail-order suppliers are able to slash their prices by 70% by doing two things.

First, they provide little (if any) customer service, which is no big deal for taxpayers, although Medicare recipients might find it challenging (if not impossible) to check on the status of an order.

Second, and this is perhaps more important, the 18 vendors that were selected could disappear down the road because they aren't making any money (remember, they aren't charities ... that hasn't happened ... yet ... but as the program matures, we could see the number fall from 18 to just a handful, or we could see them try to negotiate better deals with suppliers resulting in the major brands refusing to cut any more deals, leaving only cheap suppliers).  However, that may leave only sub-standard providers still in business.  Of note:  right now, surprisingly few of the major brands are actually manufactured in China because the process is largely automated and can be done domestically or at places like Johnson & Johnson's massive facility in Scotland.  But, as diaTribe rightly observed:

"In 2013, as part of a process dubbed "competitive bidding", CMS chose a non-U.S. provider of test strips that resulted in a 72% reduction in the price to be paid for glucose monitoring test strips which won on the basis of price, not quality."

I totally understand the issues Medicare is facing with an onslaught of Baby Boomers threatening to bankrupt a system that U.S. lawmakers have pretty much avoided doing anything to fix for decades (in spite of their knowledge of the demographic reality we now face).

Pound-Wise and Penny-Foolish

Unfortunately, the CMS decision appears to be pound-wise and penny foolish.

CMS is pointing to a big reduction in price and declaring the program a success on that basis alone.  However, there is already considerable evidence showing that non-branded glucose test strips do not even meet current accuracy guidelines required by FDA, and the FDA's hands are tied somewhat on the matter.  Unlike in the U.S., the FDA cannot simply walk in, unannounced, and inspect a facility based in China to ensure compliance with good manufacturing standards.  Instead, inspections must be pre-arranged so that the company being inspected is aware well in advance of the date their facilities will be inspected, and can clean its act up to give the illusion that they are adhering to the FDA's standards, when we know as soon as they leave, they return to the same poor quality control standards and routine adulteration (an FDA term) that existed prior to the inspection.

We may save something today, the longer-term impact may not provide the savings now being promoted.  The reason? [Note: I've used Jeff Hitchcock's letter to his own Senator, and build upon his letter as a foundation for my letter, which is below]

Dear Lawmaker:

Life-and-death medication dosage decisions for insulin in treating diabetes are made several times each day based on the results of blood glucose test readings.  The FDA is tasked with outlining the standards manufacturers must meet on such productions.  However, if current accuracy standards aren't being met, and the blood glucose readings aren't as accurate as the FDA requires, dosage errors are certain to occur.  Unfortunately, those mistakes will prove to be very expensive for us as taxpayers, and a recent move by the new Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program implemented on July 1, 2013 by the Centers for Medicare & Medicaid Services (CMS) is something I believe Medicare really needs to consider BEFORE it promotes the program to taxpayers as delivering big cost savings on its mail-order system.  The data is likely to prove otherwise.

According to the U.S. Department of Health and Human Services' Medical Expenditure Panel Survey (MEPS), in 2012, the average/mean cost for an Emergency Room (ER) visit was $1,318 and in 2009, and the median cost was $615.  In other words, we may have saved a little bit on the cost of blood glucose testing supplies up-front, but a few ER visits due to mistaken medication dosages (on things like insulin for treating diabetes) is likely to erase those savings very quickly.  As a point of reference, according to an October 18, 2006 study published in Journal of the American Medical Association (JAMA) [see HERE for complete details], an estimated 56,000 "adverse events" requiring patient emergency room treatment (most due to hypoglycemia) are reported each year, making insulin the medicine with the highest level of adverse effects. No other medicine even matches it!

People like me in the diabetes community are justifiably fearful that the glucose test strips from the winning bidder, as well as other low-cost bidders from outside the United States, some of whom will be new to our marketplace, will not be sufficiently accurate to allow the safe dosing of insulin.  Adding to this concern is the absence of any regulatory rule that requires FDA to monitor incoming glucose test strips on a routine basis to ensure that the strips meet the accuracy requirements that were required for marketing approval in the United States.

Finally, I ask you to encourage the FDA to adopt ISO's 2013 accuracy standards for self-monitoring of blood glucose testing supplies.  Commissioner Margaret Hamburg pushed ISO to adopt these standards in 2009.  Also, as a U.S. lawmaker, I urge YOU to grant the FDA the authority to impose penalties and/or remove inaccurate blood glucose strips from the market. Currently, the FDA does not have a mechanism to make this happen, unless a product is recalled.


Sincerely,
Scott Strumello


That's the letter I'm sending to my U.S. Congressmen/women which deals primarily with the Medicare issue first.  My recommendation to my readers is as follows:

1)  Write to your letter about CMS' (Medicare's) new mail order program delivering illusory savings to taxpayers.  The reality suggests the savings will be a mirage.

2) Separately, you should write to U.S. Food and Drug Administration (FDA) addressed to Margaret Hamburg and ask her to push for the FDA to adopt ISO's 2013 accuracy standards; after all, they pushed for these!  Her address is:  U.S. Food and Drug Administration, Dr. Margaret A. Hamburg, MD, Commissioner of Food and Drugs, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.

3)  Finally, join in the StripSafely campaign at http://www.stripsafely.com/ (@StripSafely on Twitter) which is advocating that patients with diabetes (and/or their caregivers) to do pretty what I've noted in my letter above (although the Medicare issue was not addressed).

The StripSafely campaign urges the FDA to:

1. Perform ongoing tests of blood glucose strips to assure compliance with regulatory accuracy and quality standards. Currently, glucose test strips are only tested before approval, and these tests are done by the manufacturers themselves - it would be great to have an independent body test quality and accuracy on an ongoing basis;
2. Tighten blood glucose meter accuracy standards to ensure that strips are more accurate than the current requirements. The International Standards Organization (ISO) just recently adopted a tighter accuracy standard, though the FDA has not yet adopted it. The current US standard is looser than the new ISO Standard* and the field has been waiting for years for tighter standards to be announced.
3. Impose penalties and/or remove inaccurate strips from the market. Currently, the FDA does not have a mechanism to make this happen, unless a product is recalled.

Feel free to use my sample letter as the basis for your own letter to Congress about the Medicare issues.  Separately, the StripSafely has some letter templates you can use to contact the FDA as well as your lawmakers to move on the issues.  To contact your Congressmen/women, please visit http://www.usa.gov/Contact/Elected.shtml where you can find out how to reach your own elected officials.

On RSS Readers, Divorce and Marriage

In just a few days, Google Reader will be history.  I've used it to create over 18,000 Tweets, so yes, I will miss Google Reader.  The end has pushed me into a divorce (or maybe it's just a separation?!) — from Google.  I describe my Google divorce as kind of like when a married couple with children decide to separate … they still have to see their exes for the sake of the kids (and I still have my blogs with Google's Blogger, for now anyway), and it may be a cordial, but not quite blissful separation, but is still necessary.

A number of my fellow diabetes blogging peers have already migrated from Google's Blogger to Wordpress (which offers its own RSS reader, incidentally) over the years because of the expanded functionality there.  I've actually thought about doing that, too, and I've had a Wordpress account for several years (mostly to claim the user name), so it remains theoretically possible that I could someday move my blogs there (I have another blog called "Harvest Gold Memories" which shares the sstrumello.com domain name, the difference being that's at "HGM" rather than "Blog" at the beginning, in other words http://hgm.sstrumello.com, rather than http://blog.sstrumello.com), but I've got so much going on right now, I don't want to deal with trying to import my customized blog templates over to Wordpress, so I'll stick with Blogger right now.  Down the road, all bets are off.

By the way, feel free to skip around this post; there's a lot of stuff here.  For example, you can read about my marriage in the last paragraph.  I've included headings of what I cover, and you can always come back!

iGoogle: i'm History

My Google separation began late last year.  It all started when I had to start looking for alternatives to my web start page, iGoogle, which the company will officially be retiring on November 1, 2013.  I don't understand why they're keeping this product around for so long as the announcement was almost a year ago, but I can keep using it until its gone.  I've found one (actually I've found several alternatives, and signed up with all of them for redundancy) that's perfect for my needs and I've gotten it all configured so its ready to use now (indeed, I've been trying to transition myself to that already so that I'm ready when Google officially cuts the cord on iGoogle).  That part of the transition, once I did all of the work to set it up the alternatives and configure them properly, was pretty seamless for me.

Google's reasoning for killing iGoogle (see the official announcement at http://goo.gl/GZRWm) is as follows:

"We originally launched iGoogle in 2005 before anyone could fully imagine the ways that today's web and mobile apps would put personalized, real-time information at your fingertips. With modern apps that run on platforms like Chrome and Android, the need for iGoogle has eroded over time, so we'll be winding it down. Users will have 16 months to adjust or export their data."

No offense, but I don't especially like looking at content from a microscopic smartphone screen; that's not how I want to consume and certainly not how I plan to share content.  iGoogle enabled me to see my top news stories, all the diabetes blogs I follow, gave access to a few, very frequently used links, as well provided instant access to stuff like Google Music (now branded Google Play Music) at a single place.  The experience on a phone just isn't the same (and my eyesight isn't what it used to be), and frankly, I don't want to use up my phone's batteries doing stuff like that.  For me, those tasks are better suited from a genuine computer with a real keyboard.

"We're not Google's customers. We're Google's product."

That raises an interesting issue: John Simpson, director of the privacy project at Consumer Watchdog, an advocacy group put it this way: "People need to understand the fundamental business model of Google. We are not Google's customers. We're Google's product."

Well, maybe so, but when Google kills the stuff I came to them for, I'm no longer their product.  The logic of killing iGoogle escapes me because I was a captive user of most of Google's services with it, but now I'm kind of cutting them out of the equation.  Oh well … that's not really my problem, its Google's.

Goodbye Google Reader

Then, to add insult to injury, Google also announced it would discontinue Google Reader as part of its spring cleaning exercise, which means that effective July 1, 2013 (see http://goo.gl/ePgrf for details), Google Reader will be gone, and their speed in killing this app was remarkably quick; as they're shutting the service down only about 6 months after the announcement, so they really didn't give Google Reader users very much in the way of advance notice, which annoyed the hell out of me.  That decision really pissed me off a lot more than killing iGoogle did, and I, like a lot of other people called journalists, who used Google Reader quite extensively as a giant mailbox to gather news content from all over the web (and from all over the world) enabling me to quickly sift through all of it, but apparently, Google couldn't turn RSS readers into a profitable revenue stream (see http://bit.ly/ZRySDr).

Here's the official word from Google about killing Google Reader (see http://goo.gl/ePgrf for details):

"We launched Google Reader in 2005 in an effort to make it easy for people to discover and keep tabs on their favorite websites. While the product has a loyal following, over the years usage has declined. So, on July 1, 2013, we will retire Google Reader. Users and developers interested in RSS alternatives can export their data, including their subscriptions, with Google Takeout over the course of the next four months."

To be sure, RSS is far from dead as some are suggesting.  RSS was developed in 2000 and provides a format for simple and structured, standardized disclosure of changes on websites such as news sites, blogs and other sites.  Once you've subscribed to an RSS feed, whichever feed reader you use searches in specified intervals (Google's Reader was great for that, updating content constantly).  Relax, RSS isn't going anywhere because it works so efficiently, but its akin to your local post office being closed even while the U.S. Postal Service still operates.  To send your mail after your local post office disappears means you'd need to trek to a post office located someplace else which is still in operation.  Its a hassle, but the postal system doesn't stop just because a local post office is gone.

Twitter: Not a Viable Alternative to RSS Readers

I already follow most (not quite all, as not everyone has migrated) of the entities I have in my RSS feed on Twitter (I did that very early on), but contrary to what Google may be implying, Twitter and social media outlets like it are NOT perfect replacements because using Twitter  means I have to stay glued to those networks all the time or else sift through all of the Tweets for each of the over 1,700 entities I follow separately, which is slow and cumbersome (especially if they respond or retweet someone else) — a real pain in the @$$ and most of the software apps out there don't make the task any easier, and certainly no faster.  I prefer the bare-bones aspect of RSS readers because I can make a decision on whether to read an article in a matter of seconds, rather than opening something, waiting for the damn article to load up, only to learn its irrelevant junk.  Through its various incarnations, Google Reader has remained a solid and reliable tool for those of us want to ensure we're getting the content from our favorite sections of the Internet.

For the record, my Twitter feed wouldn't even exist if it weren't for an RSS reader, whether its Google's, Yahoo's or some other provider's.  I use an RSS reader to sift through literally hundreds of articles daily (several thousand weekly), so finding suitable replacements was very important to me, and I should note that I sort through an awful LOT of junk, so I actually filter out the most relevant news for my Twitter followers (lucky you!).  Most of the recommended alternatives like Feedly (which has a cloud reader accessible from the web at http://cloud.feedly.com/) and Flipboard were not at especially well-suited to my needs because they are designed exclusively for use of consuming media on mobile devices, and while I've adopted Feedly for use on my mobile devices (phone/tablet), I honestly don't love it.

Let me go on record as saying I don't really like smartphone apps for sifting through a LOT of content like I subscribe to, I prefer a real computer (I did migrate to a laptop, but even that took some getting used to and I still plug in a mouse, and I'm not crazy about the small, built-in keyboard, either).  As much as I like my tablet computer for consuming media content (and maybe if I were like twenty years old, I might enjoy looking at a 3 inch screen all day long, but my middle-aged eyes find that annoying as hell).  Using a smartphone, whether from Apple or otherwise, is NOT where I want to be spending my whole day.  Also, I hate typing on a virtual keyboards (whether its on an iPad or an Android device, those things still suck!), and don't even start me on autocorrect!

After looking around and sampling the different options, I found that a number of the alternatives for Google Reader suggested by magazine and newspaper reports (see http://nyti.ms/10rOfVn)  seem to be designed for people who are in love with Instagram and their mobile phones, and those people probably can't read (or spell), with annoying graphics and designs that are supposed to look like magazines from a phone, but they really just take up too much bandwidth and are cumbersome, clunky and inefficient to use.  Those apps aren't at all suited for my needs - they stink.

Viable Replacements: Bloglines, The Old Reader, NewsBlur, AOL Reader, Digg Reader, G2 Reader

There are a few replacements for Google Reader I've been experimenting with.  Below is a quick summary of the options:

Free RSS Readers

Bloglines http://www.bloglines.com/.  This RSS reader pre-dates Google's reader (since 2003, Google Reader wasn't launched until 2005), but has a new lease on life.  It was announced that MerchantCircle is planning to keep Bloglines up and running after facing a near-death experience in 2010.  The functionality here is excellent, but there's no mobile apps … yet.  Still, its a very solid replacement and its free.

The Old Reader http://theoldreader.com/.  The Old Reader feels a lot like Google Reader.  Its experiencing some major growing pains right now so it took a really, really  long time for my feeds to upload when I did it a number of months ago and they'll likely have the same issue when the flood of Google Reader users start to panic soon.  But I enjoy using this product, and while there are a few quirky things I've encountered with it, they're nothing major.  There's no mobile apps (yet), although the developers promise those are coming in the future.  Author P.S. as of July 29, 2013:  It looked like the developers were close to shutting the public site down (slated for August 12, 2013, see http://goo.gl/EUNWaJ for details, but then, on August 3, 2013, the news was looking decidedly better, see http://goo.gl/wrUIZK for that).  I enjoy using the mobile app gReader which uses The Old Reader's API, and the interface is pretty much a resurrection of Google Reader's with a few minor differences.  Fortunately, if you aren't into Feedly's app (and you can count me among them), you can actually use Feedly's Cloud Reader with the gReader app on your Android mobile device(s), which makes it much easier for some of us to use.

AOL Reader http://reader.aol.com/.  This one was a very, very pleasant surprise for me.  AOL Reader is another new reader hoping to cash in on Google's exit.  This one came as a surprise, but keep in mind that these days, Arianna Huffington whose Huffington Post was acquired by AOL is now a big executive at the company.  AOL Reader is fast, and the layout is familiar yet slightly modernized.  On the topic of speed, my full Google Reader subscription library was uploaded in just a few minutes compared to a process that took well over a  week with The Old Reader.  There was some speculation that the AOL reader might be a subscription-based product, and perhaps the launch version will be.  But the company is really no longer a subscription-based business, but an ad-driven business (much like Google).  The beta reader was gratis, and I've been impressed with it so far.  Native Android and iOS clients are promised for the near future, but right now it's web-only on both mobile and desktop.

Digg Reader http://digg.com/reader.  This one has been hyped ever since Google first announced plans to kill its RSS reader.  It launched officially on June 26, 2013, but beta tester reviews were few and far between.  I finally received my invite on June 26, so I've had only a day or so to try it.  So far, I've been impressed.  The speed and interface are very easy-to-use, and its an uncluttered looking RSS reader which is also appealing to me, too.  They say it will be a 'freemium' product, which means they'll have a paid version of the product, which is less likely to be killed off, so maybe this one can be included in both the "free" and "paid" categories?  Digg described the 'freemium' aspect HERE.

So far, my assessment is that this reader has indeed been worth the wait.  Speed and ease of transferring my Google Reader library couldn't have been easier.  The interface is clean and easy to use.  Supposedly they've built a an accompanying mobile app for both iPhone and Android, although I don't believe those haven't launched yet, but we can expect them soon.  Either way, Digg Reader is definitely worth a look.

G2 Reader http://www.g2reader.com.  This one is, right now, my personal favorite.  It resembles Google Reader in layout and function, and it gives accurate counts of unread posts in each folder you create.  The biggest downside is that updates can lag a little, so the latency issue (if you rely on it for breaking news) may be an issue.  But if you use it to aggregate content that doesn't have to be as fast as a story or press release breaks, its ideal.  There's no mobile app for it, but they do have a special mobile version of the site (making it more conducive to small screens without mouse access).

Paid RSS Readers

I guess Digg Reader could (potentially) fit into this category, but details on the paid product have not yet emerged.  But, the key is they say paying customers have a different relationship with them, so there might be a benefit.  For example, its possible mobile apps will be available only to paid customers, so stay tuned!

NewsBlur http://www.newsblur.com/.  This one is a bare-bones but highly-functional product.  Its not free (it is if you follow less than 65 blogs or news feeds), but the cost is cheap enough ($24/year) to justify itself.  There are also a few nice features, such as the ability to save articles to read in the future.  I don't especially love this reader, but I do like the fact that it already has mobile apps, and its fast, plus I've paid for it, so I don't think they'll be cutting me off as Google did.

Privacy?  For Free?!

The broader issue of privacy has been bugging me a bit lately.  Late last year, I heard American Public Media's Marketplace program (see http://bit.ly/V6W7n1) which talked about how pervasive data snooping is online, and rather than resign myself to passive submission, I realized I don't have to let big web data miners know everything I'm doing, nor do I even want to.  I didn't mind it when I got something in exchange, but when Google kills some stuff I happen to like, all bets are off.  The relationship exists as long as its mutually beneficial.

One recent example of how big data snoopers are now mining your web browsing history in creepy ways is that airlines now base the pricing they extend to you on flights based on the sites you've visited in your browser's cache file, which I find kind of creepy.  That means you're likely to get worse prices for things like airline tickets booked online because the sites you've visited by using your browsing data determine prices for you, and even if you empty out your browsing history folder, they still know where you've gone thanks to partners they buy data overlays from.  (see the USA Today article about that practice at  http://usat.ly/13PFdn5).  

My unease was further validated when I listened to "On The Media" in January, see http://wny.cc/WkkG0q to listen to that particular program, and I grew even less comfortable with just how much data I had allowed Google (and many others I wasn't even aware of) to access.  They do most of it behind the scenes, so the result may not be obvious.  I know Google has a corporate saying of "Do no evil", but I still think its a bit too "big brother" for my tastes (in Orwellian terms, that is), plus Google really pissed me off with those 2 moves to get rid of some services I had used pretty faithfully each day, multiple times per day for years, so I decided to separate myself from Google.

Diversify Your Online Presence

The lesson for me was a reminder not to put too much of my online existence in the hands of any particular provider (like Google).  I've learned over the years that online, very little (online) lasts forever (does anyone remember search engines like Excite.com or HotBot.com?  I didn't think so, although both still exist), so I'm diversifying my risk of relying on a single provider by having multiple backups.  This exercise forced me to find several suitable replacements for both iGoogle and Google Reader, so today, I'm not worrying about the shutdowns for either, but my usage of Google products has plunged, too.

As I've hinted, I'm open to good alternatives.  All alternatives.  Multiple alternatives.  The only thing is, Google won't be playing a very big role.  Too bad for Google!

Naturally, I have preferences for the interface and mechanics of certain alternatives.  Let me also remind my readers that I do NOT publish my contact information anywhere online, and sometimes I think I'm one of the few who doesn't.  True, mobile tracking has really just begun, but its pretty much leading to the same place.  Google makes most of its money from advertising, even more than media giants like Viacom, for example.  It's also doing its Orwellian big brother act from your mobile devices, so just keep that in mind.

Ghostery Cuts Google (and others) Off, New Search Engines Help, Too

To gain a sense of control over my online usage, last year, I started using a software application Ghostery to cut off Google and many other snoopers (I wasn't aware how many others were even looking at my online behavior, but there were lots and LOTS of them) from using all of my browsing history (the app runs in Chrome, but they also have ones that run in Mozilla Firefox).  Perhaps not coincidentally, the nonprofit developers of the Mozilla Firefox browser which ultimately unseated Microsoft's Internet Exlorer (before ceding the top spot to Google's Chrome) have also announced (see the news at http://wapo.st/14iXxBc) plans to enable users to block the most common forms of Internet tracking, allowing hundreds of millions of users to limit who watches their movements across the Web.  Says Brendan Eich, chief technology officer for Mozilla, "We're trying to change the dynamic so that trackers behave better."

I liken my adoption of Ghostery to cut out snoopers to returning the favor to Google management for shutting down some of my favorite Google apps, but I also like the fact that I am controlling (slightly more) who sees what I do ... virtually.  Beyond that, however, is that its actually expedited my web searches.  I've discovered that all those third-party snoopers adding cookies tends to slow my search results down quite a bit.  You will have to enable these things to permit certain social media sites or other sites to work properly, but I'd say its been a good move.

I've also been more willing to switch search engines lately in part because of Microsoft's effective Scroogled ads, but I'm using not just biggies like Yahoo! and Microsoft's Bing, but some lesser-known providers like DuckDuckGo.com [http://duckduckgo.com/], which is a Pennsylvania startup which claims that it doesn't track users (yet, see http://donttrack.us/ for details on their policy) and Startpage.com [http://startpage.com/], which is based in Europe and must adhere to Europe's tighter privacy standards.

The bottom line for me is that I'm more than willing to diversify my online business with others because the Google relationship had been very one-sided, with Google getting most of the benefit, which I didn't mind when they offered the apps I liked, but when they killed those, it bothered me.  Google made a strategic decision to eliminate services I liked, rather than something that was mutually beneficial (such as offering them for a fee), so I've returned the favor.  For the immediate future, I will still be using Google's Blogger and YouTube, and while I do have an Android phone and tablet (Nexus) computer, I realize that I simply cannot rely on a single company to provide all that I want or need online, so Google won't be seeing ALL of my online behavior, which is just fine with me.  To be sure, I am composing this on Google Drive's Write document, but I'm actually very happy for Google to read every word of this, not that it would change the outcome.

Tying the Knot

So that's the first part of my post, the other big deal is that I tied the knot earlier this month (June 7, 2013 to be exact).  I'm kind of casually mentioning that because I've been with the same person for 11 years and we both felt the time was right to do something official.

Neither of us wanted to make a big production out of a wedding (that's a Bridezilla thing), so we decided we'll do something to acknowledge the occasion with family when the time is right (that will be in mid-July).  Unlike some diabetes bloggers who have shared stories of their elaborate wedding plans and hiding insulin pumps in wedding gowns, ours was a very low-key, private event.  However, I consider the diabetes online community like extended family, so I'm sharing the news.  As I noted, we'll be having a big party for our families when we're on vacation in July, and I expect that during that week, I'll have some time to experiment with all of the different replacement RSS readers, so if my Twitter feed is a bit erratic in the coming weeks, don't panic.

Anyway, that's my story about divorces, RSS Readers and marriages for today.

Coming Soon: Ever-More-Concentrated Varieties of Insulin. Buyers Beware!

Recently, Lilly held what it called its second diabetes social media summit, although in truth, the company did not fly anyone into Indianapolis for the first summit (that was a forum gathering at Friends for Life with people already there), so in reality, this was the company's first.  I was not invited, which frankly doesn't surprise me, because I've been critical of the company and I honestly think they're terrified of me - seriously, they were looking for people who wouldn't challenge them on much (like their decision to outsource some insulin manufacturing away from its own plant in Indianapolis to Hospira in McPherson, Kansas only to bring it back in-house this year), and that's probably not me.  I ask pharma difficult questions and they prefer bloggers who generally won't challenge them on such issues.

On Twitter, the hashtag #LDSummit13 has some of the Tweets from participants regarding the Lilly summit.  DiabetesMine covered it HERE.

Having said that, Lilly really just kind of danced around the topic of glucose-responsive insulin, and company executive David Moller made a point of noting that Lilly had an active research program on smart insulin, claiming "we are looking at the science that would allow us to pursue it in a smart way".  However, both he and David Kendall kind of bad-mouthed the concept saying "Smart insulin was 'aspirational' and over-hyped on timeframe."

See the following Tweet:

Smart insulin is "aspirational," over-hyped on timeframe. But faster insulin is doable, & next. -David Moller & David Kendall #LDSummit13
— DiabetesMine (@DiabetesMine) April 29, 2013

I responded that's a logical response for a company that doesn't have anything real in its pipeline for glucose-responsive insulin.  Lilly had to bring in Boehringer Ingelheim to offer a long-acting analogue to market -- they didn't have one that was anywhere close to market from their internal researchers.  That's because resource reallocation internally largely gutted the R&D in the diabetes business.  In other words, they had to bring the Germans in to help them develop a Lantus-like product.  Its worth noting that most of the company's brightest have moved elsewhere.  Insulin legends like John Galloway retired years ago, and countless others have left the company to start their own businesses or work for competitors.  Lilly pursued neuroscience in the 1990s which brought them blockbusters such as Prozac and Zyprexa while they invested little in diabetes.  The partnered with Amylin before dumping that partnership for one with Boehringer Ingelheim.

The company realized its diabetes business had not been prioritized and brought in a new executive named Enrique Conterno to turn the flagging business around.  He's done what was necessary, even though most of it has been to turn to partners to do what Lilly hadn't done on its own.

But this post isn't about Lilly specifically, but a trend Lilly and rival Sanofi Aventis are pursuing: selling ultra-concentrated versions of existing insulin products to market those products to the booming, insulin-resistant type 2 market.  On April 24, 2013, Lilly released its quarterly earnings to investors.  They realized net income of $1.55 billion, or $1.42 per share, which compared to $1.01 billion, or $0.91 cents per share at the same time last year. The company credited sales of its treatments for diabetes, depression and lung cancer. Among the insurance companies it had landed was the big Kaiser Permanente account, and it had become more aggressive in competing with Novo Nordisk on price. But the transcript of the recent conversation revealed another important take-away (see http://goo.gl/2hYGi for the full transcript).

Specifically, that Lilly had applied for FDA Approval to Sell U-200 Humalog (insulin lispro).

Philip Johnson, Vice President of Investor Relations said:

"We also submitted in lispro U-200 in the U.S. for type 1 and type 2 diabetes patients and we are pleased to announce that [indiscernible] patient with the FDA we received Fast Track designation and have initiated BLA submission for ramucirumab as monotherapy treatment for second-line gastric cancer."

In other words, they've applied for approval of U-200 Humalog, which is twice as potent as U-100. And, the FDA is fast-tracking it.  Lilly already sells U-500 Humulin R which has seen sales grow in recent years with almost no marketing.  That's supposedly for a product that's been described as a dinosaur (specifically regular insulin) in an era of ultra-rapid acting, patent-protected insulin analogues.  While some people with severe insulin resistance might benefit from that (although some might argue that point, but its irrelvant to my post).  The point is we can expect more-concentrated insulin varieties in the coming years.  There's zero new technology involved, its just an effort to sell more of an existing product - most likely for a higher price.

Lilly isn't alone.  Rival Sanofi just announced it, too, is looking at a more-concentrated variety of an existing insulin product.  Specifically, they've been toying with a U-300 version of Lantus.  (see the June 22, 2013 press release entitled "Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300" http://prn.to/11HtaTd).

Novo Nordisk is likely to move in this direction, too, although they've been much tighter-lipped about it.  But if big rivals do it, they'll undoubtedly launch a "me-too" version of its products.  They're still stinging from the fact that their latest generation "Lantus Killer" known as Tresiba (insulin degludec rDNA origin) was not approved a few months ago when the FDA demanded additional studies on cardiovascular disease risk.  The company once arrogantly predicted it would "likely" be sold in the U.S. by 2014.  But if the FDA fast-tracks double or even triple-strength  varieties for Lilly, why wouldn't the regulators do the same for Novo?

Let me remind you that back in 2011, there was some trouble with pharmacists. or far more likely, lower-skilled pharm-techs who may only have on-the-job-training depending on where they work.  In 2011, there were reports of many pharmacies mixing up U-100 Humulin R and U-500 Humulin R (both Lilly products), so the Institute for Safe Medication Practices (ISMP) reissued a safety warning about mixups (see http://www.ismp.org/Newsletters/ambulatory/archives/200708_2.asp)

This was the summary of ISMP's warning on mixups with the highly-concentrated U-500 insulin with standard U-100:

Mistakes have usually occurred when doctors accidentally selected U-500 regular insulin from computer screens instead of U-100. For example, sometimes the two dosage forms appear one line apart on the screen, which makes it easy to select the wrong one. Also, depending on the screen size, the prescriber may see only the first few words of the product listing, so the drug concentration may not be visible. And finally, since the use of U-500 insulin is not common at present, prescribers may just assume that the only regular insulin that's available is U-100 and not even look for the concentration on the screen.

ISMP suggested that the use of U-500 insulin may be increasing due to the higher prevalence of [insulin resistant type 2] diabetes, especially where patients are seriously overweight and may need higher insulin doses where they need U-500. The use of insulin pumps, and need for tight control of blood sugar in hospitalized patients are other reasons.

ISMP asked the major suppliers of drug information systems to add the word "concentrated" on their selection screens, immediately following the drug name and preceding "U-500", which they said should help solve the problem. The companies did agree to do that.

U-100, U-200, U-300, U-500 Will Soon Emerge

However, I have major concerns with U-100, U-200, U-300 and U-500 insulins on the market, the likelihood of mixups increases exponentially.  I, for one, intend to speak personally at the FDA on these approvals given the growing numbers of increasingly-concentrated insulin varieties and what safety issues need to be addressed.

Back in 2008, I wrote about what role color should play in insulin packaging.  I cited some meetings the FDA held back in 2005 on this subject.  See my post HERE for more background.  I would also remind my readers that in 1997, when Lilly gained approval for the first insulin analogue, they used a different color cap on the vials (purple instead of orange) intended to communicate there was something dramatically different about Humalog.  The other manufacturers did not do the same, but the point is, Lilly of all companies has experience with the use of color in packaging.  I expect the same with all the new varieties of insulin concentrations.

This is one area where I think patient safety could be a genuine issue because of how these Rx's are filled.  Put this on the "to-do" list for pending FDA applications.

Patients Should Ask the FDA the Following Questions:

1. I expect the FDA gives consideration to revisiting the use of color in labeling.  Right now, color is voluntary.  It needs to be mandatory, will all companies adopting the same color-schemes.
2. I think the companies also need to fund educational efforts to instruct patients to look for the correct concentration, and more importantly, education to all the pharmacy technicians about the potential for mixups and how they can avoid such mixups.

Both of these need to be part of any approvals IMHO, the risk is potential recipe for disaster unless the regulators  consider these issues when reviewing an drug application for approval.

ALL People With Diabetes Should Write to Their Senators About Signing the Casey-Burr Letter Today!

Today, I got an email from JDRF about asking me to contact my Senators to sign onto the so-called Casey-Burr letter to maintain a strong commitment to medical research funding at the National Institutes of Health (NIH).  Senators Bob Casey (D-PA) and Richard Burr (R-NC), who, incidentally, happen to be working on a nice, bi-partisan initiative (something we don't see very much of these days in U.S. Congress) asking fellow Senators to sign their letter to the Senate Appropriations Committee supporting funding for NIH in fiscal year (FY) 2013.  The letter requests that the Senate Appropriations Committee maintain a strong commitment to biomedical research and NIH in the FY 2013 Labor-Health and Human Service-Education Appropriations bill.  There's a risk funding which keeps researchers working on treatments and cures could be shut down entirely for a period of time due to the budget sequester if something isn't not done.

This impacts ALL people with diabetes (not type specific)

JDRF did not have a pre-written letter for this one but there was a LOT of room for personal comments in the form.  However, as I thought about it, I realized (thanks to Bob Pedersen's [@rpederse] very eloquent post, that this is not a type 1, type 2 or gestational diabetes issue, it's a DIABETES issue, and by that, it means it affects any person with diabetes.  True, JDRF has a reasonably well-organized government relations system (although the organization sucks at the state-level, incidentally, on September 23, 2004, Larry Soler admitted to me in an online chat which I blogged about HERE  [you read the old DiabetesStation.com transcript by clicking HERE] that the organization's advocacy initiatives are primarily at the Federal level.  Incidentally, Cynthia Rice is Larry's successor) which helps to get the word out about things like this, but doesn't it also make sense to ask why the ADA and others aren't advocating for this?  Perhaps that's asking for too much, but I don't really think so.

But I felt it was worth sharing what I wrote and the perspective I shared with my two Senators:


Dear Senator [Last Name]:

This issue is important to me personally.  In spite of a rapid rise in the incidence of diabetes (both type 1 and type 2), federal funding for diabetes has simply not kept pace.  For example, were you aware that the U.S. Federal Government's Bio-Medical Research Allocations by the National Institutes of Health totals $1.1 billion for diabetes research 2013?  On the surface, that SOUNDS like a generous allocation, but when one looks at the money on a per-patient or per-patient death basis, diabetes funding is significantly smaller than it is for other diseases including HIV/AIDS, Breast Cancer and even the West Nile Virus.

For example, using NIH statistics along with CDC's National Vital Statistics (Report Vol. 60, number 3 for the number of deaths attributed to diabetes), combined with the CDC's report of 23.6 million patients with diabetes at the CDC site (http://www.diabetes.org/diabetes-basics/diabetes-statistics/) reveals that we spend a mere $47 for each patient with diabetes, while on a per-patient death basis, the number works out to a more respectable $16,010 (although I would note that the cause of death for largest portion of people with diabetes is not diabetes itself, but from cardiovascular disease, hence the actual number per patient death associated with diabetes is likely to be far smaller).

Still, when one compare this to our spending on other diseases, such as HIV/AIDS, where the U.S. will spend an unbelievable $3.1 BILLION this year, which amounts to a stunning $2,818 per patient with this disease, or $329,576 per each patient death attributed to AIDS.  Breast Cancer figures, while not quite as generous as spending on HIV/AIDS, nevertheless amounts to a total of $711 million, and on a per patient basis, it amounts to $3,401 per patient or $17,308 per patient death attributed to breast cancer.  Each diabetes patient gets a mere $47 (that's right, just forty-seven dollars).

Can we really say the amount spent on diabetes is fairly allocated?
I don't think so.

The bottom line is this: the cost of TREATING diabetes is hitting the Federal Budget via money allocated to Medicare in a significant way (and with Baby Boomers retiring in record numbers, the numbers aren't likely to decrease any time soon), and yet the money we allocate to diabetes on a per patient or per patient death basis is really tiny.  But perhaps more importantly, the Casey-Burr Letter in Support of NIH Funding will at least ensure we don't allow this critical spending to be cut because of Washington's inability to agree on much of anything.  I urge you to sign the Casey-Burr Letter in Support of NIH Funding today.

Sincerely,
Scott Strumello
Your Constituent and a Regular Voter


Now, let me admit that I didn't bother to do the math myself; I rely on The FAIR Foundation's statistics (see http://www.fairfoundation.org/ for their site), but basically, if you do a comparison, here's what things look like when we compare our tax dollars allocated to the diseases I mentioned in my letter, but have a look at this graphic from The FAIR Foundation:

Note how I've circled (in red) the amounts allocated per patient for diabetes, HIV/AIDS and Breast Cancer.  Everyone with diabetes should be pissed off that our government thinks its being so generous that it spends $47 on each one of us, yet spends like $3,000 on each person with AIDS (which these days, is a chronic illness which is largely preventable) and even more on people with breast cancer.

You may find your Senators by visiting http://www.senate.gov/pagelayout/general/one_item_and_teasers/contacting.htm.  You can copy my letter, or write your own, but the most important element is to ask them to sign onto the so-called Casey-Burr letter to maintain medical research funding at the National Institutes of Health (NIH).

Spare a Rose, Save a Child

I wouldn't describe myself as a particularly sentimental guy.  However, there's an awesome initiative now underway that benefits the International Diabetes Federation's "Life for a Child" program and its nonprofit partner "Insulin for Life" (I covered both back in 2008, catch my post HERE for details) which I would encourage my readers to support this Valentines Day.  The idea is to take the typical "dozen roses," which are so popular on Valentine's Day, and save just one rose to spare the life of a child. "Spare a Rose, Save a Child" is simple:  Buy 1 less rose this Valentine's Day and share the value of that flower with a child with diabetes in the developing world.  Your loved one at home still gets flowers and you both show some love to someone across the world who needs it.

All you need to do is make a donation by visiting the IDF's Life for a Child website.  We've created a short link you can visit at http://bit.ly/SpareRoseSaveChild.

The reason this is such a huge issue is because if you live in North America, Europe, Japan, Australia/New Zealand or even most South American countries like Brazil, Argentina, Uruguay and Chile, and you have type 1 diabetes, you're alive because you were lucky enough to have been born in the right location where you have ready access to life-saving insulin and you can probably afford it, too.  But many children born in other parts of the world aren't as fortunate.  While some parts of the world (notably sub-Saharan Africa which not only lacks the funds for this lifesaving hormone, but beyond that, distributing insulin is limited by a lack of basic infrastructure such as roads.  In other parts of the world, although the infrastructure exists, the cost is simply out-of-reach.  On the latter point, we can blame the diabetes industrial complex for its pursuit of profit above all else, and their admitted goal of replacing non-patented first generation insulins with so-called "modern insulins" which cost more than twice as much.

Progress has been made, and its really a function of the developing world moving to sell its own products in the parts of the world it knows best.  Companies like Argentina's Laboratorios Beta, India's Biocon and Wockhardt, and Poland's Polfa Tarchomin (which first began making insulin in 1923) and rival Bioton, which has grown mainly by expanding into Russia, Ukraine and elsewhere in the former Soviet Union, plus India, Israel and having operations further afield in the Pacific region, notably in Australia, Singapore and China.  However, as I wrote previously (see HERE), Bioton has substantial debt, so its growth prospects are likely to be limited until the company can de-leverage itself somewhat.  There are a few others, notably China has 2 insulin manufacturers of its own (specifically Wanbang Biopharma and one whose name escapes me right now), although China is a regulatory free-for-all there, meaning Chinese consumers can't be 100% certain the product they're buying is really insulin or just plain water, as the case of deadly infant formula in that market a few years ago proves.  Consumers with the means are buying insulin from Western joint ventures to ensure they aren't buying water in a bottle that's marketed as insulin.

The companies based in the developing world are selling lower-cost first generation insulins in parts of the world where Novo Nordisk, Lilly and Sanofi aren't really targeting.  I suspect they will succeed because their goal is to serve the markets they know far better than the big 3 know.  However, we've seen how the big manufacturers have responded.  For example, Novo Nordisk acquired Brazil's Biobras back in 2002, and has subsequently been pursuing its strategy of discontinuing older insulin varieties that sell for lower prices with higher-margin products.  They won't get their hands on Argentina's Laboratorios Beta because the Argentinian government won't allow it.  They saw what happened when the local currency collapsed and Lilly did nothing about it, so they've made it a priority to protect their indigenous company from global giants walking in an snapping the company up.

My partner is originally from Manila, which is a fast-growing city in the Philippines which has most of what you can find here in the West, including a number of Starbucks locations which his nieces patronize pretty regularly, although the locations aren't as ubiquitous so its more of a treat rather than a daily occurance as it is in the U.S. for many of us.  Niece Jorene will be getting an iPhone 5 in about 2 weeks (hopefully she doesn't read this blog regularly!), which compares to the 4s that Jojo has.  They're pretty lucky to live in Metro Manila, but for kids that live in less developed islands of that country, things aren't so easy.  They lack the money to buy insulin, so it's hit or miss as to whether the family can even afford it.

Check out this thank-you note from a kid that has benefited from "Life for a Child":

http://www.idf.org/lifeforachild/countries/philippines

Even though I'm not sentimental, I absolutely melted when I saw that ("Salamat Po" is Tagalog for "Thank you", although you also see the word glucose and a simple message, and the reason is because the kids in the Philippines are taught in English, which explains why Filipino call centers like the one Jorene manages have done so well).  But other parts of the country are very much like where the most recent season of Survivor (in which Blair Warner, errr I should say Lisa Whelchel recently competed).  These are remote islands, and share little in common with the bustling city of Manila.  The families struggle on very little income.  Some Filipinos are writing news stories for American newspapers which they're paid pennies for (check out this NPR news story at http://tal.fm/468/2 for more). A U.S. company known as Journatic placed an ad seeking Filipino writers offered them $0.35 to $0.40 per story, and slightly more for longer stuff, but they complain they don't make enough for their work.  It doesn't take a rocket scientist to figure out that they cannot easily afford a vial of insulin at $70 each.  But when its all said and done, these are adorable little children, and the Life for a Child/Insulin for Life program saves their lives.

The next time you check your blood sugar, dose your insulin, or see someone you love doing one of these things, you'll know that you helped save a child like the one above by "sparing a rose".  Help spread the word about Spare a Rose, Save a Child on Facebook, Twitter (use #sparearose) or your blog if you have one.  Please spread the word about this initiative, for more background, read Kerri Sparling's post for details!