Brave New Commercials?

I'm not 100% certain how I was added to the e-mail distribution list of a New York City organization called The Private Health Insurance Must Go! Coalition (PHIMGC), also known as Healthcare-NOW!, but the e-mails since the debate over U.S. healthcare reform began in Congress earlier this year have been almost non-stop. In fact, I've deleted most of them, because I frankly don't have time to attend rallies in Manhattan to protest for a government-run healthcare plan (I work in the suburbs and live in the city, although my office is moving to Manhattan at the end of the year, which I'm psyched about). Although I find the organization's objective of "education and advocacy organization that addresses the health insurance crisis in the U.S. by advocating for the passage of national, single-payer healthcare legislation" perhaps a bit more leftist than I believe. For example, I am not of the opinion that healthcare reform is contingent upon a single-payer, government-run system, as I believe that meaningful reform CAN actually be achieved with private healthcare insurers, in much the same way as healthcare systems function in countries like Switzerland or the Netherlands (to name two countries with universal healthcare coverage that is operated by private enterprises).

Having said that, I also believe that the age of continued corporate welfare we've observed for more than the past decade has to end -- soon. We simply cannot afford to continue giving-away tax dollars to companies that set up subsidiaries around the world to minimize the amount of U.S. taxes the companies pay and then call themselves "multinational" corporations, in spite of the fact that 90% or more of their revenues are generated on U.S. soil. The U.S. is now so controlled by corporate and special-interest lobbyists that any genuine discussion of the reform issues seems to be largely absent from the current debate. All that seems to be on the table right now is how to add 46 million new people to what is arguably the world's most overpriced, inefficient and dysfunctional system. Many lofty claims about how billions will be saved with electronic medical records have already been called into question by such respected medical journals as The New England Journal of Medicine. But the future of many genuine "reforms" to this dysfunctional "system" (a term I use very loosely) are relatively few, and the outlook for passage of those seems questionable at best. As the Massachusetts experience demonstrates, universal healthcare coverage by itself does not reduce out-of-control costs that have grown significantly faster than the rate of inflation for decades, and that type of "reform" merely adds more people to the system, often at significant taxpayer expense.

I do believe that I'd personally be better covered under Medicare, for example, than I am with my present healthcare plan (my third new plan in the past 3 years with the same employer -- the same employer I've been with for the past 9 years, incidentally). Ironically, at a January 2009 rally in Holmdel, NJ, President Obama stated: "Let me be exactly clear about what healthcare reform means to you,” the president said. "First of all, if you've got health insurance, you like your doctors, you like your plan, you can keep your doctor, you can keep your plan. Nobody is talking about taking that away from you."

Really? That sounds like pure BS to me -- and I'm one who might be inclined to side with the President! I have experience to prove it!

The President has since retracted somewhat from that claim, instead stating "When I say 'If you have your plan and you like it, ... or you have a doctor and you like your doctor, that you don't have to change plans, what I'm saying is the government is not going to make you change plans under health reform." That admission was made to ABC News when the President was pressed on that issue.

Maybe, but with the current system, the choice still will not lie with the individual.

Back to the reference I made about possibly getting better coverage under Medicare, the truth is, given my age, unless I go into acute renal failure, the possibility of my getting coverage by Medicare seems increasingly unlikely, perhaps ever. Congress even likes to talk about raising the age of Medicare eligibility to prevent insolvency of that system by 2019 thanks to a massive baby boom flooding into the Medicare system with fewer workers wages being taxed to pay for it, and if (and when) that happens, me and many others my age (or younger) could realistically die before EVER being covered by Medicare.

On the other hand, I understand the logic behind the arguments made by the insurance industry, and let's just say, I'm not convinced. At issue: a mandate to buy healthcare insurance by everyone, the so-called "individual mandate". The core argument is that only by requiring younger, healthier consumers to buy into the system can costs be contained. But this is not like driving a car, and requiring insurance coverage (ironically, my auto insurance premiums include a line-item for "uninsured motorists", something which has always p!$$ed me off, since mandatory coverage is theoretically supposed to address that) should not be a mandate for life, which is not a luxury like an automobile actually is. Healthcare Now! refers to this as a "mandate" and "subsidize" plan. The mandate part means that the government forces you to buy the insurers' defective product. And the subsidize part means your tax dollars will be handed over to the insurers, boosting their bottom line.

My opposition is libertarian. Some individuals truly cannot afford the system, even with subsidies, and others prefer not to buy into the Western medical system, preferring naturopathic and/or homeopathic treatments and generally live lifestyles that do not follow conventional medical practices (these are the granola-eating, Birkenstock-wearing, commune and co-op types, who have a right to their opinions provided these behaviors do not endanger the lives of others, such as children) If you recall, a court ordered parents of a type 1 diabetic child to provide insulin after ruling it was effectively parental negligence. In fact, those parents made a critical mistake for failure to understand there is a critical difference between type 1 and type 2 diabetes, but in general, most are more informed about their choices than the average citizen. Should these individuals be obliged to buy into a system the do not wish to use (and have no intention of using) or is inconsistent with their own beliefs? Unlike auto insurance, they cannot simply choose alternative transportation methods, including walking.

Interestingly, deliberations last week on the healthcare reform bill introduced by the Senate Finance Committee seem to raise the possibility that an "individual mandate" could potentially be weakened, perhaps significantly. One group opposed to "individual mandates" isn't surprising: Republicans criticize any "individual mandate" provision as an affront to individual liberty. That's the first argument they've made that I'm inclined to agree with!

The Wall Street Journal reports that Senator Max Baucus, the finance committee's chairman, actually proposed reducing a fine that he originally proposed for uninsured Americans who fail to comply with the mandate. The newspaper writes "That raises the possibility that some healthy Americans will do the math and conclude that it is cheaper to remain uninsured -- paying the fine and avoiding the coverage premiums."

So why doesn't the logic behind an "individual mandate" convince me?

Have a look at the following videos created by another organization called "Sick for Profit":



Now, ask yourself if these don't raise questions on the legitimacy of this argument. Before we get there, have a look at an actual TV commercial by the healthcare insurer CIGNA:



Now, have a look at the following parody commercial produced by Brave New Films, a San Francisco-based "progressive" organization that claims to have "created a quick-strike capability that informs the public, challenges corporate media with the truth, and motivates people to take action on social issues nationwide" who produced the CIGNA parody commercial:



One has to wonder if lavish CEO compensation, and consistent profitability (even while the rest of the economy is struggling) should raise questions about the legitimacy of the industry's claims on the universal mandate issue.

Now, it might seem that CIGNA, the company whose former PR executive, Wendell Potter, blew the lid off his former employer's business model by testifying before Congress by admitting that denial of claims is a business practice aimed at maximizing shareholder value. He also repeated this statement value on PBS' Bill Moyers program (see my post here for more background), is the sole recipient of this critique. CIGNA is probably an easy target because the CEO of that company is compensated quite a bit more generously than many of his insurance company CEO peers.

But rest assured, CIGNA isn't the only company being targeted. There are also videos on Sick for Profit's website about Minnesota-based United Healthcare, too (see here) including the CEO of that company's lakefront McMansion in the affluent suburb of Wayzata, MN. There is little doubt that others, like WellPoint, Aetna, Humana and others are also on their radar screens.

The real question all of this raises is just what the final bills will look like? Already, we know that Congress has taken drug price negotiation for Medicare, in part because of the industry's deal with President Obama, off the table.

Interestingly, The Wall Street Journal reported that business seems to be parting from its traditional allies in the Republican Party on healthcare as companies and big corporate lobbyists are lending tentative support to a congressional overhaul that so-called conservative lawmakers staunchly oppose.

I would refer back to my argument that a reform bill need not address EVERYTHING. This is very much a work-in-progress, and will take consistent changes. But a recent Wall Street Journal/NBC poll (see here) should guide our lawmakers on what the public sees as critical: namely, that pre-existing conditions cannot be used to deny coverage (by a wide margin, no less) while the "individual mandate" is very low on the list. Let's just hope that our Congress can see through the lobbyists and focus on the issues that matter to their constituents, or they could pay for it when elections come!

Is Healthcare Privacy Really "Too Complicated"?

This morning, I received an e-mail from Patient Privacy Rights, which is a non-profit organization based in Texas that was founded by a physician named Dr. Deborah Peel. I've mentioned Patient Privacy Rights before because it is one of the few organizations that works to ensure adequate protection of consumer healthcare data and it was started by a healthcare industry "insider". Plus, the Federal Government seems to think patient privacy rights is a non-issue, and even a GAO report revealed that the U.S. Department of Health and Human Services is woefully unprepared to deal with issues like insurance identity theft, for example, lacking even a medical record dispute resolution policy.

The e-mail shared an interesting report that showed that in over 20 nationwide consumer focus groups examining the subject of health IT and privacy showed overwhelmingly that consumers feel WE should control our own healthcare data, and that we as patients should also be able to decide how our healthcare information is used AND shared.

But the debate in Washington consists mainly of advocates for the IT industry along with their highly-paid lobbyists and, of course, lawmakers -- with almost no representatives of patient advocates representing our concerns. The IT industry makes a boatload of money selling, for example, our prescription history (minus our personal identification, such as name or insurance number) to private companies who analyze and re-sell that data to private-companies such as IMS Health and Wolters Kluwer Health. In other words, the pharmacies sell them OUR Rx data, and the companies aggregate it and then turn around and sell it for millions of dollars every year.

But were you ever asked if you wanted your data used in this manner?

I can assure you that the answer is definitely NO, because all of the parties involved are excluded under the "covered entities" exclusion outlined in the Health Insurance Portability and Accountability Act (HIPAA). Covered entities may also include billing and coding data entry folks based offshore, including places like India, Pakistan and China. Now isn't that comforting to know?

According to Patient Privacy Rights, what they are hearing from Washington industry insiders is "it's too complicated." To be sure, no one is belittling how complicated healthcare is, but health information technology without privacy is a deal-breaker.

The baseless claims being used are that healthcare involves numerous parties, both public entities and corporations like insurance companies and their subcontracted vendors.

But those claims sound pretty lame, actually. There is even an example of a similar public-private cooperative mandated in the law, and that has worked (surprisingly) quite well for all parties involved. What is that?

Why not model the effort after the Fair Credit Reporting Act (FCRA) which obliges privately-held credit reporting agencies to maintain accurate records (including the thousands of U.S. lenders who supply them with that information), while protecting the privacy of our info by limiting access to it. By limiting who can use the credit reports, and requiring timely resolution of disputes, we have a system that private entities (including banks and credit reporting agencies) can rely upon while simultaneously protecting the rights of consumers, and provides a way that disputes can be resolved in a timely fashion that satisfies all parties involved.

The FCRA is an example of government-mandated protection of private data that is maintained by unrelated third-party entities which, by and large, is a model for the healthcare industry which claims "it's too complicated", which reflects not so much the technological difficulty involved, but an entrenched industry that is extremely resistance to change unless they benefit from that change.

You can do something about it. Visit Patient Privacy Rights and give them a sort of Tweet (as in from Twitter) limited to 255 charahters with YOUR questions for the key decision makers in Washington. See here for your opportunity to make your voice heard on this very important issue!

A New Diabetes Study? Why Not?

In recent years, the medical profession seem to view themselves as writers (or comedians/comediennes) by giving their medical research studies cute names that fit conveniently into an acronym. Consider some recent examples, such as the ACCORD study, which was conveniently named for the acronym of "Action to Control Cardiovascular Risk in Diabetes", a type 2 diabetes study that didn't quite pan out as well as the researchers were hoping. But all of these cutesy names for studies have gotten so out of hand lately it's almost sickening.

At present Macrogenics and Eli Lilly & Co. have a study with a on the CD3 antibody treatment teplizumab that they're calling Protégé.

What is that supposed to stand for?

Officially, it means "Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus". Sure, that's a mouthful, but I find it incredibly annoying and frankly kind of stupid that medical researchers are coming up with the trial names and later fitting words into the trial, rather than naming the trials, then seeing if an acronym applies. This is idiotic, and it belittles the intent to these studies for the sake of a press release.

The latest example was in the press today for a study called, if you can imagine, "BLOSSOM" for weight-loss drug called lorcaserin made by Arena Pharmaceuticals Inc. The BLOSSOM study reported some success in a large late-stage study, but apparently the strength of the results of that study disappointed Wall Street relative to other weight-loss drugs being developed.

For this reason, I'm seriously considering sponsoring my own study with an acronym called "ASSHOLE", which will stand for:

A
Study of
Seemingly
Hopeless
Old
Lente's
Efficacy

Not only is the research topic valid, but wouldn't that study acronym make for a great press release?!

The Business of Diabetes: Lilly Layoffs, Re-Org

It's been a while since I did one of my "Business of Diabetes" postings, but on Monday, September 14, 2009, Eli Lilly and Company announced it would eliminate some 5,500 jobs (or about 14% of its workforce) over 2 years and reorganize the company into 5 business units. The move was mainly an effort to to slash $1 billion in costs, which was big news for Wall Street as well as for Indiana, which has the lion's share of the company's employees. However, the layoff figures exclude hirings in high-growth emerging markets and Japan.

The company said the cuts and restructuring would (somehow) help it speed medicines from its pipeline to patients (although it is arguably more about slashing overhead costs than it is bringing products to market faster).

"It's clear we need to accelerate the flow of new products," said John Lechleiter, Lilly's chairman and CEO. "We really need to make some significant changes."

However, for diabetes patients, the layoffs aren't really a concern unless you happen to live in Indiana, but the latter part of the announcement is probably more meaningful. Until this reorganization, Lilly was organized around "functions," with separate U.S. and global marketing operations for each drug.

The 5 new Lilly business units that were announced are 1) cancer 2) diabetes 3) established markets 4) emerging markets and 5) Elanco, its animal health business. In a rare change, this move will leave the developer of Prozac and Zyprexa without a separate business unit devoted exclusively to mental health, as the neuroscience business will now be folded into the "established markets" business unit (the largest of the 5 businesses named). Meanwhile, diabetes, which was previously folded into a more generic "endocrinology" business with separate marketing organizations around the world, will now be given its own business unit which reports directly to CEO John Lechleiter, with profitability responsibilities.

The stated criteria Mr. Lechleiter used to establish Lilly's new diabetes business unit was as follows:

"Diabetes - Lilly has long been a leader in diabetes care, with a dedicated asset base and a portfolio of commercially successful products and promising pipeline opportunities. The need for new and improved treatments for patients with diabetes is great: an estimated 246 million adults are affected worldwide. In addition, Lilly remains one of only a few global insulin suppliers."

Company spokeswoman Angela Sekston said there was more room for growth in the diabetes market, as incidence of the disease, which is associated with other health problems, are mushrooming.

For patients with diabetes, this re-organization establishes a diabetes business unit which reinforces not only the company's commitment to the diabetes business (some speculators a few years ago had questioned whether Lilly might consider selling the insulin business, one of the core businesses upon which this company was built), but it also ensures more consistent investment in and prioritization for the diabetes business, which had been eclipsed by mental health and other businesses in recent years which were deemed faster-growing and therefore more deserving of research dollars. Perhaps with responsibility and a budget, Lilly can re-establish this as a core business, but the path will not be easy thanks to numerous missteps taken by the company over the past 15 years.

The leader chosen for the diabetes business, is Enrique A. Conterno. Conterno has served as president of Lilly USA, the company's U.S. business operations since January 2009. Conterno served as senior vice president of healthcare professional markets for Lilly USA.

Mr. Conterno was Born in Lima, Peru, and earned his bachelor's degree in mechanical engineering from Case Western Reserve University in 1989 and then earned an MBA at Duke University in 1992. He joined Lilly as a sales rep in 1992, and rose through the ranks at Lilly over the years. For example, from 1993 to 1995, he held roles as a financial analyst, marketing associate, and business development manager. In 1996, Conterno became sales and marketing director for the Peru affiliate for Lilly, and in 1998, he became the sales and marketing director for Lilly's affiliate in Brazil. In 2000, Conterno was named executive director of marketing for the intercontinental region and Japan. Conterno served as president and general manager for Lilly's operations in Mexico in 2003, and was named vice president of Lilly USA's then-neurosciences business unit in July 2006.

Clearly, Mr. Caterno brings practical, first-hand experience (especially in marketing and international operations), but he's not a medical doctor or scientist, he's a businessman. Given his experience in developing markets such as Peru and Brazil, he undoubtedly has a global perspective. But his perspective which may be different than Novo's, which aims to "convert" the world (regardless of cost) to proprietary, patent-protected proprietary molecules (e.g. "analogues"). Lilly's recent focus has been mainly on the type 2 market, which explains why the insulin business has been allowed to see such radical market share declines. Hopefully, this move will enable the company to refocus its efforts on sales channels it has long ignored, notably the pharmacy benefits managers (PBMs) who pay for 80% of all drugs sold in the U.S. today.

Because Lilly was late to negotiating deals with PBMs who manage the formularies for many insurers, it has lost market share rapidly to rivals Novo Nordisk and Sanofi Aventis, both of whom have cut deals with this enormous but largely invisible player in the supply chain. Most insurers want deals that include both a rapid acting analogue and a long-acting analogue, and because Lilly only offers Humalog, PBMs are forced to cut deals with either Novo Nordisk for Levemir or Sanofi Aventis for Lantus, and most healthcare formulary managers prefer to minimize the number of different suppliers they deal with, not increase them.

Although Lilly's diabetes business remains big, it has arguably been poorly managed in recent years. For example, its insulin business has fallen from #1 in U.S. insulin market share with about 83% share to #3 with less than 40% share today. It's Humalog rapid-acting insulin analogue has lost share to rivals, and to make matters worse, it's patent expires in 2013, a little over 3 years away. Lilly's insulin business has lost significant market share to Danish rival Novo Nordisk in recent years (as well as Sanofi Aventis, which does not even offer a full insulin product line in the U.S.), and it stands out as the only one of the global insulin manufacturers that does not presently have a long-acting insulin analogue -- in fact, the company offers no basal insulin today. Although the company claims to working on something to compete with Lantus, the fact is that there is nothing imminent. In fact, the company's basal insulin analogue is not even yet in Phase 1 human clinical trials. Interestingly, the company has 2 products, one being an autoimmunity treatment, and another being a beta cell regeneration treatment, both of which are further along in development than it's competition to Lantus and Levemir. Most of it's diabetes innovations have come from partnerships, particularly with Amylin, and more recently with Macrogenics on an autoimmunity treatment and Transition Therapeutics, which signed a commercialization agreement for a beta cell regenerative therapy. Both are now undergoing late-stage clinical trials.

Last year, I reported that Lilly had "returned to its roots" in the diabetes business and had finally allocated some research dollars to that business.

What is not clear, however, whether Mr. Caterno can make up for years of under-investment in the diabetes business. Lilly may be forced to partner with others besides Amylin to bring products to market sooner, rather than the traditional path of doing everything in-house. Activist investor Carl Icahn has bought a significant stake in partner Amylin Pharmaceuticals, Inc. but the fact that Lilly's cash was used to buy ImClone Systems, Inc. last year limits its ability to buy another company so soon after a major deal.

As I wrote a few years ago, these JDRF-sponsored partnerships suggest that Lilly's type 1 diabetes business strategy is evolving, and evidently, is quite different from Novo Nordisk's (which aims to keep patients with type 1 diabetes on insulin for as long as possible, and start those with type 2 diabetes as soon as possible). But the the work will not be easy, and as Lilly's patents expire rapidly in the coming years, there will be tremendous pressure on management to get new products on the market as soon as possible.

That, however, may not be in the best interests of patients, and the drug industry has a bad habit of rushing drugs to market by hiding research reports of adverse events and expanding drugs applicability to new patient groups too quickly. This means that Macrogenics teplizumab CD3 monoclonal antibody treatment could potentially be rushed through final-stage trials on newly diagnosed, and likely expanded to established type 1 patients as soon as possible (assuming it is FDA approved). But the question is whether we will learn about the adverse events of these treatments? That remains to be seen.

Timewarp Tuesday: A Chat with NIH Stem Cell Guru Dr. James F. Battey

This is my second installment of "Timewarp Tuesday" (catch the first one here). The year was 2004, and following former President Bush's decision to limit the National Institutes of Health (NIH)-funded embryonic stem cell research only to a few cell lines that were created prior to the completely arbitrary cutoff of August 9, 2001, many patient advocates were still struggling to work around the delays caused by that policy decision and keep this research moving forward. In particular, the scientific community expressed frustration not with the lack of NIH funding for embryonic stem cell research per se, but because of the restrictions that accompanied the policy. For example, entire new laboratories that were funded separately from the NIH needed to be established to conduct stem cell research at universities, because non-approved stem cell lines could not even come into contact with a microscope paid for (even partially) by the NIH, or even be in the same room as an "approved" cell line. That made scientific work unnecessarily complex and not terribly productive.

The reason embryonic stem cell research was viewed as having the potential to cure type 1 diabetes is because in theory, we could use stem cells to grow an unending supply of new pancreatic beta cells that then could be transplanted into patients who lack these (or other) cells, as is the case in patients with type 1 diabetes. Of course, this assumes that we can resolve the autoimmunity problem, and as I have written previously, there are a number of different autoimmunity treatments in various stages of clinical trials to address this piece.

Note that since the time of this chat, a company called Geron Corp. has since managed to culture pancreatic beta cells in a laboratory using embryonic stem cells. Unlike earlier efforts, the Geron beta cells are reportedly sensitive to glucose levels, a problem which plagued earlier stem cell research efforts to culture pancreatic beta cells by researchers in Israel. But the Geron development occurred in spite of the Bush stem cell policy, not because of it. In January 2009, Geron announced that the company had received FDA approval to proceed with the first-ever human embryonic stem cell studies (these particular trials, however, do NOT involve diabetes).

In June 2004, I hosted an online chat on DiabetesStation.com with Dr. James F. Battey, MD who today is the Vice Chair of the U.S. NIH Stem Cell Task Force (see here for more on that role), although he was the Chairman of that Task Force back in 2004.

The DiabetesStation.com chat was undoubtedly geared specifically to the diabetes community, but many of the challenging questions we asked Dr. Battey were of interest to a larger stem cell advocacy community. Thanks to the Internet Archive Wayback Machine (which, according to The Wall Street Journal -- see here for the article noted), is named for the time-travel device featured in the "Rocky and Bullwinkle" cartoons back in the 1960's), I am able to retrieve the transcripts to the chat I hosted with Dr. James F. Battey in 2004.

To see the transcript of the chat with Dr. James F. Battey, please use this link, or click on the "Wayback Machine" logo below (a word of advice: be patient, at times, it can take longer-than-usual for archived pages to load).

Tueday Tirade

I admit to nothing!!

The other day, my pal Scott Johnson wrote about his unfortunate recent DKA experience and I commented that there was no room for guilt (or the related self-blame) in his conversation, and I really meant it. The simple reality is that the patient cannot always be blamed for this stuff, and attempts to do so really work against effective self-care. But I'd be willing to bet that someone at the hospital he visited probably asked him what happened that lead to that situation, as if the patient was assuredly responsible (at least in part) for that situation. But I'd be willing to guess those same healthcare professionals would never dream of asking a cancer patient what they did to cause their disease.

On a similar note, a number of diabetes bloggers (including Kerri Morrone-Sparling, Rachel Baumgartel and Cherise Nicole have written posts recently about things they call diabetes "bad habits" or some other euphemistic term which frankly, seems to transfer or imply guilt and shift the blame away from the disease they are unfortunate enough to live with to the person with the disease instead. (You will note that I refrain from saying "their diabetes" because that implies ownership as if it was a house or car or pair of shoes they decided to buy, which couldn't be further from the truth -- I would never "buy" a disease like diabetes or exchange it for any other ailment, thank you very much).

About the only "bad" habit I actually agree with is Kerri's #6 item:

"6. Blame Game. And a sixth (but certainly not the last) bad diabetes habit that I have is my role in the blame game. I put a lot of pressure on myself to get things 'right' and when the diabetes outcome isn't what I'm hoping for, I tend to blame myself. I have to constantly remind myself that strong efforts and a decent attitude go a long way in this marathon, and I can't beat myself up for every low or high that crops up randomly. Diabetes isn't fair, and it isn't easy, and it sure as hell isn't my fault, so I just need to roll with the punches as gracefully as I can."

But it really p!$$es me off when individuals without diabetes (especially healthcare professionals such as doctors, public health officials, medical associations, insurance companies, nurses, diabetes educators, nutritionists, etc.) use such stupid and damaging terminology as "your diabetes" and instruct patients that it is their disease and they must "own" it.

My response: F.U.!

To the American Association of Diabetes Educators (AADE), let me make something perfectly clear: no place in the organization's Guidelines for the Practice of Diabetes Self-Management Education and Training (DSME/T) mentions "ownership" of diabetes, yet so many CDE's I have encountered over the years seems to believe that the patient needs to "own the disease" in order to manage it effectively.

Not true!!

One can be a very effective business manager without actually "owning" that business (although generous stock options and various other evolutions have blurred the distinction for many in recent years), ownership is NOT a requirement to be an effective manager, and the evidence on that, quite frankly, is pretty mixed and anything but clear-cut and decided either way.

Seriously, it's not MY diabetes, and the ONLY reason I have this stupid disease is because the medical profession has FAILED to cure me. In effect, that monumental failure to make me better and the resulting forcing me to live with a treatment protocol that, is only partially effective is a lame excuse for someone else's failure that is routinely passed off on the patient.

In the words of the former FDA Diabetes Care Chief Dr. Alexander Fleming in his journal submission to the March 2007 edition of the Journal of Diabetes Science and Technology (entitled "Prospects and Challenges for Islet Regeneration as a Treatment for Diabetes: A Review of Islet Neogenesis Associated Protein"):

"Despite the significant advances in insulin manufacture, modification, and delivery since that time, the treatment of the absolute insulin deficiency resulting from T1DM is very challenging. Insulin administration remains relatively hazardous and not fully effective in preventing complications, even if managed meticulously."

In this particular quote, Dr. Fleming and his colleagues also cited another study by SC Gough entitled "A review of human and analogue insulin trials" which was published in the November 15, 2006 edition of the medical journal Diabetes Research and Clinical Practice which demonstrated some sobering statistics to confirm intensive control's failure even when managed "meticulously".

Now, I could diatribe further on any number of these topics, but the reason I believe the medical/disease nomenclature currently used with diabetes is long overdue for major changes, starting with framing the disease as somehow belonging to the patient, is as follows.

The Oath of Hippocrates taken by all doctors is usually translated to include some language that says something along the lines of "I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone."

But while teaching patients how to manage a disease you cannot cure or eradicate may be the best they can do, I believe that the language deliberately chosen by the medical profession causes tremendous psychological harm and desparately needs to change. Ironically, as my friend Deb Butterfield (author of "Showdown with Diabetes") once eloquently wrote (I 've added a few words in brackets "[ ]" to emphasize some items worth calling attention to):

"To succeed with intensive therapy a person must take three or more daily injections of insulin (or insulin pump therapy), four or more daily blood glucose tests, and follow dietary instructions. The principle underlying the belief that more diabetes education will improve a person’s ability and/or desire to practice intensive insulin therapy is grounded in the [flawed] assumption that it is reasonable to expect a person to perform these acts every day for the rest of his or her life."

Deb goes on to write:

"Of course, in the absence of a cure, diabetes management is important to slow the progression and delay the onset of complications as much as possible, but we should not delude the public, or ourselves, that management is sufficient. At best, it is an inadequate treatment until a cure is found.

Diabetes is big business with powerful economic, social and political forces opening and closing doors to our treatments and cures. Billions of dollars are made from selling products to the diabetic community. Developing a cure costs money, and until there is a cure, there is no product to market. There is nothing to sell. At the large diabetes conferences, healthcare professionals are inundated with information about more accurate and simpler blood glucose monitors and insulin delivery systems, but the advocates for curing diabetes, and scientific advances to that end are woefully underrepresented."

Deb closes with the following statement:

"In order for this disease to be cured, there needs to be a fundamental shift in the way diabetes is viewed. We need to close the gap between the perception of diabetes as a controllable condition and the reality that it is one of the world’s oldest, deadliest, and most pervasive diseases."

The sobering part is that her quotes were written in 2004, and we really need to ask whether we've seen ANY fundamental changes in attitude since that time? Not much, I'm afraid.

Even more important, I fundamentally believe that the continued framing of diabetes management as somehow "belonging" to the patient and routinely using terminology to suggest or state disease ownership causes subtle but irreparable psychological damage (though researchers never seem to look into that little subject), which contributes to the widespread incidence of depression in patients with diabetes.

As Deb Butterfield said in another article on the DCCT (with my additions in brackets):

"When all is said and done, the fact remains that the rate and incidence of blindness, amputation, heart attacks, and kidney failure caused by diabetes—as reported by the NIH—continue to rise. Insurance companies and healthcare providers ponder this failure and, with few exceptions, conclude that 'educating diabetics' to adhere to an intensive regimen of injections and diets will [miraculously] solve the problem. This philosophy has been the cornerstone of diabetes management and consequently the 'blame' for secondary complications has shifted [away] from the disease itself to the person who has it."

We have more than 30 years of this philosophy in clinical practice, and the reality isn't all that convincing. The statistics, by and large, are pretty sad, actually. I could cite many statistics (just look at the ADA's website if you need some), but I don't feel compelled to do so. The reality is that after decades of this, the numbers don't look great. It's time to shift some focus away from trying to improve glycemic control towards curing diabetes, and by that, I mean all types.

People with type 1 diabetes have lead the way, incidentally, with the charitable organization known as the Juvenile Diabetes Research Foundation, which aims to fund $1 billion/year in cure-related research. That's a lot of cash towards curing one form of diabetes, but we cannot do it alone. Funds must also come from the pharmaceutical, biotechnology and medical device industries, as well as the U.S. National Institutes of Health, which frankly, sets much of the research agenda. Add to that, the Food and Drug Administration, which too often, have relied on using a reduced glycosated hemoglobin (e.g. "HbA1c") as a "surrogate" for improved patient outcomes, rather than a more intelligent approach of using multiple evaluation criteria.

The medical profession seems to enjoy giving themselves plenty of credit for what they refer to as "progress" in diabetes are over the years, while simultaneously not living up to some of their own monumental failures. In fact, when I attended the ADA Scientific Sessions in Washington, D.C., my reaction after the first night was one of, well ... disgust. I attended a cocktail party that was attended by all kinds of diabetes bigwigs, the likes of which included Robert Rizza, John Buse, and a few other self-proclaimed diabetes experts. I left that meeting with the sense of nausea and thinking that those individuals have given plenty of excuses for that failure, but that doesn't entitle them to transfer their failure to me as a patient.

One of my favorite quotes comes from a book review of the book "Bittersweet: Diabetes, Insulin, and the Transformation of Illness" by John Christopher Feudtner (a book I also reviewed here on this website a while back), and you'll find this quote in my list of "D-Quotes" in the right-hand margin of my blog. It comes from The New England Journal of Medicine:

"The transformation of disease, as exemplified by the case of diabetes, is a valuable and elegant concept that serves to remind us that the tally sheet for medical science must carry a column for debit as well as credit."

That debit column is presently missing from their conversation, as we see a lot of blame transference and shifting, but seldom (if any) owning up to it.

Now, the following is part diatribe, and part brutal fact. Diabetes remains as a disease, because of a failure to cure it, and also because of a continued fixation (above all else) on glycemic control rather than a fixation on finding one or more cures. One look no further than the medical journals to see how disproportionate the publications are weighed towards glycemic control rather than studies and commentaries related to disease eradication and cures. For heaven's sake, how many more studies do we really need on glycemic control? That needs to be a closed chapter, folks. The benefits are known, but there are seldom studies into why so few patients actually achieve this lofty goal. When they do look into it, the result is usually to transfer blame away from the treatment protocol itself to say, lack of insurance coverage or some other convenient excuse. Why not just admit it's a lofty theory that's incredibly hard to achive, even with all the tools that exist (many of which patients must struggle to get coverage for, BTW)? I won't even address conflicts-of-interest, but the medical profession has a sloppy track record there, folks.

Also, the medical profession is quite afraid to actually use the term "cure" in almost any context, a practice that really needs to be questioned. They need to abandon the fear to use that term, and to start using it more freely, or, I believe, we'll never actually see a cure emerge.

The language of diabetes has been shaped almost exclusively by individuals who do not have diabetes. That's a big, huge problem, and one which needs to change. Patients with diabetes need to be a part of the equation, or there is risk that the medical profession's already abysmal track record on this disease will continue.

Let me just close by noting that I am ENTITLED to complain about this disease, because I never, ever, ever, ever get a break from it. That, my friends, is entitlement.

Don't anyone dare try to deny me that right, or you'll get an earful you might not be prepared for. I require an outlet to deal with it, and if complaining to anyone who will listen helps, so be it.

Plus, I'm sick of hearing comments about how "so and so really didn't take care of themselves, if they had, they wouldn't have lost their leg, their vision, or whatever other horrible diabetes complication they may have suffered" from people whose diabetes knowledge comes from watching daytime television and maybe an occasional newspaper article. No one with cancer takes blame for their disease, and no one with diabetes shouldn't have to, either. Ironically, recent research has showed that eating a diet loaded with carbohydrates may actually help to fuel cancer, but the same cannot be proven unequivocally about any type of diabetes.

I feel SOOOOOOOO much better after getting that off my mind!

If feeling "in control" helps you to deal with diabetes, great, but just because it works for you doesn't mean it will work for me or anyone else with diabetes. I need an outlet to vent my frustration.

BTW, I'll take compliments and even legitimate (meaning substantiated) critiques, but don't even bother if you just want to disagree but aren't willing to back your comments up with actual data or science. I'm really not in the mood for that kind of conversation, and I do moderate comments on this blog.