Beyond the Medco Headline

Companies report things every day, but when Medco Health Solutions Inc. (the nation's largest pharmacy benefits manager, a.k.a. as a "PBM"), rivals Express Scripts, Inc. or CVS/Caremark Inc., or lab companies Quest Diagnostics or LabCorp issues a report, we know that they have mountains of data to back their claims, so their results are usually indicative of the nation's health as a whole -- one reason I'm more likely to rely on them for reliable information rather than the results from a small, tightly-controlled study with a shocking headline.

For example, in 2006, Quest Diagnostics issued a Health Trends™ Diabetes Report which showed that people with diabetes who visit health professionals regularly were actually doing a better job of managing their disease (albiet only slightly better) -- in fact, the proportion of test results deemed to represent "good" diabetes control increased from 36% in early 2001 to a high of 56% in late 2005. Quest's data was in direct contrast to the persistent doom-and-gloom forecasts from the ADA and many others. But unlike some of those who made claims to the contrary, Quest actually had data from 14.3 million HbA1c test results to prove their claims!

That's one reason I was interested when Medco Health Solutions issued its Drug Trend report the other day. Medco Health manages the prescription benefits for about 1 in 5 Americans, and they examined prescription records from 2001 to 2007 from a representative sample of 2.5 million customers, ranging from newborns to the elderly.

The headline was really no surprise: diabetes medicines have become the leading driver of prescription drug spending growth. How could they not be? We hear stories all the time about how diabetes has become epidemic and that more and more people are being diagnosed, so its hardly shocking. But beyond the headlines, the report actually reveals several more troubling trends.

First, Medco's data shows that during 2007, 51% of American children and adults were taking one (or more) prescription drugs for a chronic condition, up from 50% the previous four years and 47% in 2001. In essence, this means that we have finally reached the point where a slight majority of all Americans will now be taking medicines for the rest of their lives -- and these aren't the elderly, but people in the prime of their lives. This is a scary finding that somehow only made the news coverage in the Washington Post -- everyone else was beating the headline about diabetes spending to death.

What's more, when you peel away the headline about diabetes drug spending, there was another troubling finding that was hardly even acknowledged: while use of diabetes drugs increased only 2.3% last year, spending rose 12%. Meanwhile, thanks to cheaper generics, spending on cholesterol drugs fell significantly. What does this mean? The Wall Street Journal Health Blog said it best: "the introduction of new, expensive medicines that replace or are added to older, cheaper ones" is what's driving this spending, NOT the fact that more people taking these drugs.

We can thank more costly insulin analogs (the report cited Novo Nordisk's Novolog specifically, as Sanofi Aventis' Apidra had considerably less influence). Although it wasn't mentioned, we can also conclude that Medco has cut themselves a very big bulk discount from Novo Nordisk as one of the biggest buyers of these medicines. Several years ago, United Healthcare pushed Lilly's Humalog to its third drug tier (which have the highest co-pays), which no doubt contributed heavily to Lilly's market share slide. Regardless, this should call greater attention to the need for generic biopharmaceuticals which I first reported on a few years ago.

One thing I find very curious that there is a lack of compelling evidence that costly, patent-protected insulin analogs actually deliver superior glycemic control. We already know that Germany's Institute for Quality and Efficiency in Health Care (IQWiG) conducted a comprehensive meta-analysis of virtually all of the clinical trials that were undertaken for insulin analogs and IQWiG determined that there was NO reliable scientific evidence available of the superiority of rapid-acting insulin analogs over regular insulin in the treatment of adult patients with type 1 diabetes. Furthermore, the nation's healthcare system is paying, on average, 50% more for insulin analogs, yet no one has determined whether the incremental cost is justified? Perhaps we should take a look at Quest's data and examine whether the reduction in HbA1c is sufficient to justify the cost associated with these more costly new drugs? There are a number of new, and costly type 2 medicines which are also helping drive these costs.


The chart above merely shows the percentage of people who had HbA1c's below the 7% threshold, but its theoretically possible to probe into whether the decline is statistically significant, and whether these costly new drugs can be attributed. Perhaps its about time for our leaders in Congress and the Department of Health and Human Services to take a closer look at this data? Clearly, the information is out there, but someone should be investigating these issues. After all, we can talk about controlling healthcare spending all we want, but it actually takes someone to actually do the hard work and examine these issues -- something that we have yet to see happen. But the investment might just be money very well-spent!

The ADA's Silence Is Deafening

It seems that almost every month, we hear yet another news story about problems at the U.S. Food and Drug Administration. Last December, even an internal report produced by the FDA itself entitled "FDA Science and Mission at Risk" (which can also be found at the Food and Drug Administration's website) concluded that the FDA was desperately short of money and poorly organized, which is putting people's lives at risk. This has Congressional lawmakers finally giving more serious consideration to their oversight (or rather, their lack of oversight) for the FDA, but money won't solve all the Agency's issues, more careful oversight is needed, too.

Back in early March 2008, I wrote that the U.S. Food and Drug Administration was soliciting public comments on the Agency's Draft Guidance for Diabetes Treatments (relevant to both drugs and biologic medicines). If ever there was an issue of importance to patients with diabetes, it is surely regulatory guidance on diabetes medicines. The deadline for public comments ended 2 weeks ago.

Naturally, I submitted a host of comments (8 pages to be precise) related to the draft guidance, although most of my comments pertained to type 1 diabetes since that impacts me personally. Although the FDA has not included individual comments in the docket (I suspect because they'll need to redact personal address information before making it available to comply with Federal policy), you might find the comments submitted by the pharmaceutical industry and their trade organizations such as PhRMA and BIO interesting reading (see the regulations.gov website here). I was heartened by the fact that the Juvenile Diabetes Research Foundation (JDRF) even submitted comments (although I think they missed many opportunities to advocate towards guidance that encourages cure therapeutics), but the organization did respond to the issue, and for that, they should be commended. Amazingly, however, the nation's largest, self-appointed diabetes advocacy organization, the American Diabetes Association was silent on this issue.

SILENT!

As my title suggests, the ADA's silence was deafening. How can an organization whose 501(C)3 status claims that its mission statement is "to prevent and cure diabetes and to improve the lives of all people affected by diabetes" have remained silent on this issue? These guidelines will outline how drug and biopharmaceutical companies develop, test and validate the safety and efficacy of new diabetes treatments for the next decade (if not longer) and the American Diabetes Association had no comments?!!? This is unacceptable!

EVERYONE in the diabetes community should be asking who's asleep at the wheel over there at the ADA's headquarters in Alexandria, Virginia?

If ever we needed validation that the American Diabetes Association is a wholly-owned subsidiary of big pharma and agriculture, surely this is it. You can, and should express your displeasure by writing to the ADA. But I would encourage you to avoid their general correspondence address, and instead direct your letters to the executives who run the organization (including John Buse, the current President) at the organization's headquarters' address:

John B. Buse, MD, PhD
American Diabetes Association
1701 N. Beauregard St
Alexandria, VA 22311
Tel: (703) 549-1500

The ADA also offers a toll-free support line at 1-800-DIABETES (1-800-342-2383) which is operational from Monday-Friday, 8:30 AM - 8:00 PM EST, but realize you are calling a call-center, not the organization's headquarters. By the way, the American Diabetes Association's IRS tax filings are available for the public to view at the Foundation Center's website, there you can see exactly what the ADA is spending its money on, where the money is coming from and how much key executives are being paid for their work.

Another Argument for the Conservation of Insulin

New research continues to demonstrate that our creator, science or evolution (depending on your perspective, naturally) knew what it was doing when it came to insulin. The hormone works almost the same way in all animal life, and differs very little between species. In fact, very recently, scientists at The Salk Institute in San Diego have managed to prove that the humble fruitfly also relies on the same insulin-regulated molecular pathway to maintain its energy balance. The journal Cell Metabolism recently documented this discovery:

Biao Wang, Jason Goode, Jennifer Best, Jodi Meltzer, Pablo E. Schilman, Jian Chen, Dan Garza, John B. Thomas, and Marc Montminy; "The Insulin-Regulated CREB Coactivator TORC Promotes Stress Resistance in Drosophila"; Cell Metabolism, Vol 7, 434-444, 07 May 2008.

Although fruitflies lack a pancreas, researchers have discovered that they do have specialized cells in their brains that produce hormones remarkably similar to insulin and glucagon which mimic the functions of their human counterparts.

This is not the only study to find metabolic similarities between humans and bug-like creatures; previous research has also found that the insulin signalling pathway is also fully conserved between humans and nematode worms, too (see here and here for more details on that). This means that in some form or another, insulin exists in virtually all forms animal life, and it works just about the same in creatures ranging from the fruitfly and nematode worms, to more complex animals including fish, and the most complex of them all: mammals like us.

Marc Montminy, Ph.D., a professor in the Clayton Foundation Laboratories for Peptide Biology, who teamed up with fly expert John Thomas, Ph.D., a professor in the Molecular Neurobiology Laboratory for the current study, said it best: "Basic biological processes are remarkably well conserved through evolution."

In the fruitfly, the researchers found that after eating, the cells release insulin into the circulatory system, which signals the "fat body," the flies' energy-storing organ, to store away fat and sugar. In humans, these functions are handled by multiple organs, including most notably the liver which stores sugar, as well as in certain fat cells. But clearly, the basic mechanism and the key to that mechanism -- insulin -- is the same in both cases.

(see also http://www.sciencedaily.com/releases/2008/05/080506120946.htm for more)

This should be raising questions on the value of insulin analogs. Its fairly well-established that insulin analogs, an entirely man-made creation which exists nowhere in nature, has some benefit of more rapid absorption, distribution, metabolism, and excretion (ADME) characteristics, but the true value has really been in fattening the bottom lines of manufacturers, as the clinical evidence has not been as favorable in terms of improved glycemic control. But the fact is that regulators have said the only criteria they wish to use to evaluate diabetes medicines is lower HbA1c's. In fact, I reported before, that most diabetes clinical trials ignore everything BUT blood sugar control, as if everything else is irrelevant -- too bad that wasn't the case!

But the U.S. Food and Drug Administration continues to argue that glycemic control, as measured by HbA1c (or possibly fructosamine) is an effective "surrogate" for improved patient outcomes, when in fact, the actual results of using HbA1c have been, well ... mixed. In many cases, drugs have lowered blood sugar only to create other problems, including among other things, increased cardiovascular risk. In other cases, the drugs/insulin increases the rate of noncompliance because the side effects are worse than the disease they are supposed to be treating. In the most recent "Draft Guidance" the Agency published for diabetes medicines and biopharmaceuticals, the FDA repeatedly mentioned using HbA1c as a "surrogate" for patient health, as if nothing else matters. In my formally submitted comments on this guidance, I wrote that the FDA can no longer afford to rely solely on HbA1c to evaluate new medicines to treat (not cure) diabetes, and that the agency needs to consider the bigger picture. Whether my comments are seriously considered remains to be seen.

The FDA's definition has evolved away from strictly "insulin" to what they now call "insulin receptor binding agonist", and the agency has stated that anything which binds to the insulin receptor and enables glucose to enter the cells is perfectly acceptable for the treatment of type 1 diabetes. Although they still must prove efficacy and safety, new treatments need not be insulin as such. Insulin analogs are one such example, but its hard to say what tomorrow will bring.

But we should question whether using HbA1c is the best measure of efficacy. After all, shouldn't side-effects also be considered? What about other benefits, including reduced hypoglycemia, weight-loss or maintenance, improved cardiovascular health, or beta cell regeneration? Although the deadline for submissions on the FDA's guidance has passed (I notified everyone about it in March). A growing chorus of doctors have already moved in this direction, but the simple fact is that we need our regulators to get with the program if we expect to see any changes to the status quo.

Interview with Immunologist Extraordinaire: Dr. Norma Kenyon

A few weeks ago, I had the great pleasure of sitting down and talking with Dr. Norma Sue Kenyon, who is in her official capacity a professor of surgery, medicine, microbiology and immunology at the University of Miami Miller School of Medicine, but is perhaps better known an immunologist who works at the affiliated Diabetes Research Institute (DRI), and also as the director of the Wallace H. Coulter Center for Translational Research (named for Wallace H. Coulter, who was the co-founder, former chairman and president of Coulter Corp. where Dr. Kenyon once worked). She's also the mother of two daughters.

I had met Dr. Kenyon previously, but only to shake hands and say hello. Dr. Kenyon is completely charming, and her connection to type 1 diabetes goes beyond her professional interests, she also has a teenage daughter (Laura) who lives with type 1 diabetes, too. Dr. Kenyon knows all too well what the medical issues are at the cellular level, but like so many parents of kids with diabetes, she also understands the very real practical limitations which are associated with the prescribed treatment for type 1 diabetes, perhaps far better than most other researchers. This makes her particularly well-suited for her role in "Translational Research", which is defined as translating scientific discoveries into practical applications. JDRF likes to refer to this as taking research "from bench to bedside". She works to unite the intellectual challenge of academic research with the satisfaction of finding real-world uses for those scientific advances.

Background

Dr. Kenyon studied at Duke University, and in 1986, finished her Ph.D. in immunology at the Medical College of Virginia. She returned to Miami to do a fellowship at the DRI, but then went to work as a researcher at Miami-based Coulter Corp. (part of biomedical giant Beckman Coulter since October 1997). By 1993, Kenyon had two daughters: Laura and Caroline. She left Coulter that year and took a job as an associate professor at Duke.

Shortly after accepting the job at Duke, she flew from Miami to North Carolina for a week-long trip to scout out her future lab; her kids stayed with family in Miami. On the last day of her trip, Kenyon learned that her daughter Laura was in the intensive care unit and had been diagnosed with type 1 diabetes. The experience had a very big influence on her understanding of exactly what goes on outside the doctors' offices, and why glycemic control is so often a lofty theory that doesn't always translate well into clinical practice. As a researcher, however, she expresses frustration because of the cellular damage that ongoing hyperglycemia causes to the various cells in the body.

Although I had prepared a list of questions I wanted to discuss with Dr. Kenyon, instead, I decided to simply talk with her and get her perspective on various things. One question I asked her was if she could put the DRI's research prioritizations in perspective, particularly with regards to immunology.

She responded by noting that she felt that the success of any cure-related treatment requires something to address the issue of autoimmunity. She told me that her work (and that of others at the DRI) is never done in isolation and draws heavily upon relevant work outside the DRI as well. That explains the DRI's willingness to partner with researchers elsewhere, such as the Stockholm, Sweden based Karolinska Institutet. She noted several key areas the DRI is pursuing concurrently, including: islet transplantation, "tolerance" (which I described as "hospitality" towards regenerated or transplanted beta cells -- Dr. Kenyon liked that description, BTW), and perhaps most notable, the DRI's local drug discovery program.

Local Drug Discovery Program

The local drug discovery program aims develop safe and effective methods to prevent the immune system attack on the insulin-producing beta cells. While newer drugs have been developed and are in use, many still cause unwanted side-effects and are toxic to the body's organs, tissues and cells. The current drugs also suppress the entire immune system, leaving patients at risk for infections and even cancer. A more detailed announcement about the DRI's drug discovery program can be read here, along with a link to a television interview with Dr. Kenyon.

With that, I asked her about the recent JDRF-sponsored deal between MacroGenics and Eli Lilly and Company in which the two companies entered a global strategic alliance to develop and commercialize teplizumab, an anti-CD3 monoclonal antibody. JDRF's support was a critical factor because the organization helped fund the pivotal Phase II and plans to continue support of the Phase III clinical trials (see here for more information), although Lilly will fund some of the Phase III research and share any profits with Macrogenics. It is worth mentioning that anti-CD3 monocloncal antibody therapy has shown some success in JDRF-funded studies in Europe, although some of the pioneering work had been done by Jeffrey Bluestone at UC San Francisco. While these discoveries show success, the treatment itself remains largely out-of-reach because no company manufactures it or sells it; it remains a labor-intensive, hand-manufactured treatment. Furthermore, no one is looking at whether it might work on longstanding patients with autoimmune diabetes, but with a commercial partner like Lilly, I would expect to see this change.

Dr. Kenyon acknowledged that the deal could make such treatments more widely accessible beyond limited research and could enable further research so she was therefore excited by it, but also added that they were also interested into ways of further refining these treatments, and also seeking to identify if they could find out why they work better in certain groups of patients, then to determine whether occasional "booster" treatments could keep the errant immune system at bay.

INGAP and Who It Might Work Best For

At one point, Dr. Kenyon herself mentioned the work of Dr. Aaron Vinik who is perhaps best known as one of the co-discoverers of INGAP, or Islet Neogenesis Associated Protein. You may recall that I wrote about INGAP back on March 19, 2008 providing some historical background and an update. Of particular relevance is a news release today about the company who is now developing INGAP, Kinexum Metabolics, Inc. and an agreement that company is reached with another company to jointly develop a new combination therapy that has shown, in PREclinical studies, to cause type 1 diabetes to go into remission by protecting and promoting the growth of new insulin-producing cells.

Dr. Kenyon felt that INGAP may have particular relevance for patients who still have remaining beta cell function, such as myself (after almost 32 years with type 1, I still have a fairly detectable C-Peptide of 0.7, which is fairly high). She suggested that with the right treatment for autoimmunity, INGAP might work very well for people such as myself. However, she felt that her daughter would probably not be a good candidate for INGAP, as her daughter's C-Peptide level is virtually undetectable. Her thoughts were very interesting, because she felt that INGAP might work particularly well for people who still have fairly high levels of functional beta cells. She indicated that it might be easier to restore insulin independence in people like myself, and she even noted that a combination of INGAP and teplizumab (mentioned above) could work as a 2-pronged treatment, but the key, at least in her opinion, was the necessity to have some remaining beta cell function.

Thoughts on Denise Faustman

I also asked Dr. Kenyon about another female immunologist who has received a lot of (unsolicited) press for her work: Denise Faustman at Harvard/ Massachusetts General Hospital. My reasons for asking was because Dr. Faustman has already achieved a degree of celebrity which seldom occurs in the field of immunology, and also because like Dr. Kenyon, Dr. Faustman is a woman in a field that is largely dominated my men.

Dr. Kenyon gave me some interesting information I was largely unaware of. She described Denise Faustman as a "child genius" who was admitted to medical school as a teenager. Its no secret that Dr. Faustman worked with some of the true pioneers in the field of diabetes cure-related research, including the late Paul Lacy, who is sometimes credited as being the father of islet transplantation.

Dr. Kenyon acknowledged the gender issue that Dr. Faustman ran into, suggesting that the response to her work was essentially pooh-poohed, and to some extent, Dr. Kenyon felt that might not have occurred if Denise Faustman had been a man. She said that unfortunately, the field of medicine still remains something of an "old boys network" and that the receptivity to Dr. Faustman's ideas might have not have been so quickly dismissed if she was a man. On the positive side, however, Dr. Kenyon expressed hope in Dr. Faustman's work, but also cautioned that it may not work, or if it does work, it may work only in certain people -- all things to consider. The immune system is pretty complex, and even immunologists haven't yet discovered all they need to know, and Dr. Faustman herself is the first to admit that there may be several different ways to cure type 1 diabetes. Dr. Kenyon certainly agrees, and hopes that there will soon be a variety of cure choices for everyone, but in the meantime, she admits there's plenty of work to be done!

Mandatory Registries for Diabetes Patients Aren't Worthwhile

In 2005, I wrote about the blatant invasion of privacy of with patients with diabetes' health records happening in New York City. Yours truly represented (see p. 49) the interests of people with diabetes at the 2005 public hearing on what was then a proposed registry, and I have remained outspoken on this issue. But thanks to a complete lack of representation from the representatives at the American Diabetes Association, and the American Civil Liberties Union who were handling the case until internal turmoil at the ACLU New York chapter resulted in a resignation of the woman handling the case, there has been little challenge or even media attention about the issue. Even fellow New Yorkers, never a group that keeps their opinions to themselves, expressed an inexplicable non-interest in the subject. In fact, there has been far more media interest in Google's plans for electronic health records. Canadian television interviewed me on the subject (see the interview below):




I also spoke to a newspaper in the U.K., but for whatever reason, the U.S. media continues to remain silent on the issue -- I guess they'd rather talk about Britney Spears' latest stupidity than report news.

It may come as a surprise, but people cannot opt out of this registry, although they may choose not to receive any correspondence consisting of weight loss and diet tips from the NYC Department of Health and Mental Hygiene. But their HbA1c records are still being seized even after opting out of that. There IS a legal basis for challenging the registry, based largely on New York State privacy laws which were passed in the 1980's to protect people who tested positive for HIV, but the same laws nevertheless require the Health Department to provide disclosure that their health information is being seized, something which is not currently happening today.

Since I work in the suburbs, I just have my bloodwork done there, which exempts me from having my results seized, but suburban residents -- even residents of other states like New Jersey and Connecticut who have labwork done in the city are being included, even though the law does not apply to them, a clear HIPAA violation if anyone wants to file a lawsuit! BTW, most of the major labs (Quest Diagnostics, LabCorp) which do the testing are physically based outside of New York (in New Jersey, as a matter-of-fact), and are therefore really under no legal obligation to comply with the NYC law, but they have decided to play nice and comply to keep the Department of Health off their backs.

Anyway, I had pretty much given up much hope on this issue until last week. Then, the April 28, 2008 edition of the medical journal Archives of Internal Medicine featured a barely-noticed submission which was written by two upstate New Yorkers, Paula Trief and Richard Ellison, who oppose mandated, involuntary and non-disclosed diabetes registries. The authors wrote that the involuntary (and non-disclosed) NYC registry won't work and could undermine the relationship between doctors and patients.

Their article, entitled "Mandated Diabetes Registries Will Not Benefit Persons With Diabetes" made some fairly convincing arguments about why such registries are unlikely to yield success. Naturally, NYC Health Commissioner Tom Frieden's personal friend, Benjamin Littenberg wrote a rebuttal in favor of the registry, conveniently overlooking the fact that the Vermont trial funded by the NIH which he headed required an opt-out provision, but the defense seems especially weak considering the registry has accomplished absolutely none of the objectives promised since being implemented 2 years ago.

The Wall Street Journal's health blog featured a post on this matter last week. I submitted my comments (naturally), and to my surprise, virtually all of the comments were in agreement with ME, not the NYC Department of Health and Mental Hygiene.

Interestingly, today's New York Times had an article about a continuing decline in the number of neighborhood supermarkets in NYC has made it harder for millions of New Yorkers to find fresh and affordable food within walking distance of their homes, according to a recent city study. Why, then, isn't the Department of Health and Mental Hygiene jumping all over that issue? I think perhaps its time to revisit this issue since its once again being debated in the public domain.

In Defense of Insulin Pumps?

I never thought I would write something with a headline like this -- as a former insulin pump wearer myself, I usually argue that the benefits of insulin pumps are too often vastly overstated and that I've attained comparable glycemic control without the expensive device. That's not to say that some people don't benefit from them, particularly people whose basal rates vary considerably throughout the day, or those whose sensitivity to insulin is such that they require dosage precision smaller than 1/2 units, but I still believe that pump evangelists suggest that the answer to everyone's diabetes management can be answered with a pump.

Regardless, at the beginning of every month, when the new editions of various scientific and medical journals are released, my RSS reader is bombarded with news stories. I typically scan the headlines for these, and then promptly discard a vast majority of these stories.

The May issue of the medical journal Pediatrics features an FDA study (which is by itself, unusual, since the FDA has largely been criticized for its failure to examine Adverse Event data involving all of its approved products, we need look no further than last year’s scandal involving the type 2 diabetes treatment Avandia as an example). Nevertheless, this month, a submission entitled "Adolescent Use of Insulin and Patient-Controlled Analgesia Pump Technology: A 10-Year Food and Drug Administration Retrospective Study of Adverse Events", the full text is available free) by Judith U. Cope, et al happened to make the Associated Press (AP) headlines yesterday. The headline read: "Insulin Pumps Linked to Teen Deaths".

Ignoring the headline for a moment, readers should know that the study looked at Adverse Events in the FDA's Manufacturer and User Facility Device Experience Database reported between January 1, 1996 and December 31, 2005. It looked at 1,674 reports, of which 1,594 were specifically pertaining to insulin pumps. Pediatric patients aged 12 to 21 years were the focus.

The AP article and headline implies that there is a huge, perhaps previously undiscovered risk associated with insulin pumps, yet the statistics in the journal article suggest otherwise. The study found 13 deaths reported, and simple math applied here indicates the incidence of actual deaths was 0.81% (in other words, less than 1%), but when compared to Adverse Event reports involving insulin without a pump, the number cannot even be considered statistically significant. Why, then, the headline of "Insulin Pumps Linked to Teen Deaths"? Because that creates controversy, draws readers and hopefully leads to advertising revenue for the newspapers.

Interesting enough, the most significant finding was that almost 62% of the reports involved patient problems of HYPERglycemia, and nearly 47% of those indicated that the patient had DKA. 7.4% of the reports revealed problems of underinfusion, although in truth, the pump may have been blamed for problems with subcutaneous infusion. The device problems included error messages (n=55), incorrect use (n=24), alarm problems (n=29), loosening and/or occlusion of the catheters (n=22), bent cannulas (n=22), and screen display problems (n=14). There were also 31 reports of the device’s need for repair, replacement, or removal and 19 reports of device failure and/or failure to deliver insulin.

Less than 11% of the reports involved HYPOglycemia or overdelivery of insulin. Interestingly, in around 36% of the hypoglycemic reports, the device problem was coded as "unknown" (revealing by itself in that many Adverse Event reports are inconsistently coded), so they may have been linked to patient dosage errors, perhaps when hastily entering a bolus amount, or simply an error in calculating the dose ... again, is this the fault of the pump manufacturer, the patient or simply the overly-complex method of treatment being demanded of pediatric patients? Let me add that these are only those reports that were filed with the FDA, but we know from experience that a vast majority of reports are never recorded for a host of different reasons, most notable are that #1, reporting is strictly voluntary, even among Emergency Rooms and #2, the reporter must have reason to think the Adverse Event is linked to the device rather than patient noncompliance or error, which seldom happens.

It would be even more interesting to see whether these same reports correlated with a similar Adverse Event filing for insulin – my suspicion is that they would not, but somehow those questions are never asked by our regulators!

Back to the Pediatrics analysis on insulin pumps: approximately 80% of the reports resulted in hospitalization. But the top 3 issues associated with these reports were all linked to patient education, noncompliance, and perhaps most troubling, problems during sports or other activities. Just 4 reports suggested risk-taking behaviors (including 2 reports of insulin overbolusing that were thought to be suicide attempts), but we already know that suicide rates tend to jump during the teenaged years for a host of different reasons, but none can be clearly be "blamed" on the insulin pump itself, but the method of insulin delivery, which is subcutaneous delivery of insulin, the very same way insulin is injected with syringes or pens.

The study's author took pains to note that they did not advise against using the devices, but did call for more study to address safety concerns in teens and younger children using pumps. They wrote "This large number of reports may reflect the expanding use in the pediatric age group, but the unique challenges posed by adolescent users should be considered."

The FDA's Dr. Judith Cope, lead author of the analysis told the AP "Parental oversight and involvement are important. Certainly teenagers don't always consider the consequences."

Our own Kelly Close was also quoted in the AP article, although I suspect her quote might have been taken a bit out of context. Her sound bite was reported as follows: "The pumps allow young people to live more normal lives, giving themselves insulin discreetly in public. And they're a growing segment of diabetes care, with $1.3 billion in annual sales worldwide." She said 100,000 teenagers may be using them. The reason I suspect that statement was taken out of context is because it's unlikely that knowing Kelly, I doubt would say that the main benefit of insulin pumps is the be able to give insulin to themselves "discretely in public", most likely she told the interviewer a number of benefits pumping can provide, and this was an easy one to excerpt.

Regardless, the AP article is guilty of reporting only half-truths to get a headline, but the full report beneath the headlines are usually far more informative, as was the case here. However, I would mention that Adverse Event reporting is an area the FDA has done a poor job of gathering information in the past, although the Agency held a workshop on this very subject earlier this year and even sought public commentary on the matter -- I know, because I submitted a lengthy document myself, co-authored with a number of other people. The workshop transcript from the FDA's recent workshop can be found online here, but clearly, the Food and Drug Administration has a l-o-o-o-o-o-o-o-n-g way to go when it comes to gathering information about adverse events. But blaming the pump itself for problems that are not clearly tied to these Adverse Events seems to be irresponsible reporting at its worst.

5 More Things You Won't Find in a Book

Elizabeth Edelman tagged me for this meme, but I've been really busy and didn't even want to deal with this yesterday, but must admit that I gave in anyway because over the last 32 years, I've learned more from my experience and unpublished works than I ever did (and likely ever will) from any book.

Meme:
Five Most Important Pieces of Advice ... You Won't Find in a Book!

Rules:
Post five of the most helpful pieces of diabetes management advice on your blog.

Link to this Wikibetes entry where we will be tallying up all of the great advice. You are welcome to add your advice directly.

Tag 5 bloggers by leaving a comment on their blog.

My Five:

1) Always remember: its only a number, NOT a report card! This applies to meter readings as well as HbA1c results. Use these numbers, but don't interpret them as a reflection of your personal accomplishment or lack thereof. Use the number to guide your next action, but don't think of it as a reflection of something you did or didn't do correctly, only as a guide to help you decide what you might need to do next. Parents of kids with diabetes need to remember this rule especially!

2) Its perfectly acceptable to "fire" your endocrinologist or CDE for bad performance, and more people probably SHOULD do this. For a moment, forget about a shortage of these diabetes professionals, and realize that if your endocrinologist or CDE is not helping you, blaming you, or when you leave your appointments with them you're feeling frustrated or depressed, then think about whether this is due to the way these professionals make you feel. Next time, tell them about how their interaction with you is making you feel, and if they don't respond (or respond negatively), use Donald Trump's signature line: "You're fired!" (and, tell them not to even THINK about billing you for that appointment). You should leave your appointments feeling empowered and positive -- its their job to make sure that's what happens!

3) Carbs. Forget about the official, ever-changing position of the American Diabetes Association and many nutritionists on dietary recommendations. Carbs will raise your blood glucose levels, and the more carbs you consume, the more insulin (unless you're type 2) you'll need to offset them. But remember what I consider to be the best advice Dr. Bernstein gives, he calls it the law of small numbers: big inputs means big uncertainty, small inputs means small mistakes. Always keep this truism in mind!

4) People Carry Baggage, Not Words. I absolutely despise using the term "control" in reference to diabetes because my belief is that the disease cannot be controlled, only managed. The dictionary defines "control" the verb, as "to exercise restraining or directing influence over." The medical profession just LOVES to use the word "control" when it comes to diabetes. But my response to that is I can only "control" what I eat, how much insulin I dose, and what my activity levels are going to be -- the rest is basically a crap shoot. To me, unless it always yields an absolutely predictable result, then you're not entitled to call that control. One of my favorite lines was from Showdown with Diabetes author Deb Butterfield, who once wrote: "Knowing what dose of insulin to take was not then, and is not now, a precise science. It is not a simple analog of food, exercise, and insulin; rather it is a complex and seemingly random theory of chaos with a few discernible known variables."

Some say I'm debating semantics here, but there is no denying that words wield enormous power, and when it comes to diabetes, it seems words also carry a lot of baggage, probably because of widespread ignorance about the disease. Think about this for a moment. A while back I responded to a blog post and someone quickly chastised me for using the word "diabetic". They said that I should be referring to them (including myself) as a "person with diabetes." That kind of pi$$ed me off because there's no value judgment in the words themselves, so the complaint was about their own value judgment assigned to the word, not mine. The bias is with whoever reads or hears the word, yet they blamed me for using what they considered to be a politically incorrect word. Just remember, try not to let words carry any baggage!

5) Expect the unexpected, and you'll never be disappointed! Do I need to elaborate on this one?

I am tagging: Barry (a.k.a. BetterCell), Allie, Khürt, Susana la Banana, and Vivian (a.k.a. DanielDoo).

Lifting the Curtain on Insulin Manufacturing

Have you ever wanted to take a peek inside a factory that makes insulin? It might be an interesting tour, but Factory Tours USA does not list such a tour among those people can visit.

In fact, even visitors to Eli Lilly and Company's corporate headquarters in Indianapolis don't really get a look inside the manufacturing facilities (that's because the FDA does not permit it, and for very good reasons), although the company occasionally gives guided tours of Lilly's Parenteral Packaging (which means "injectable") facility. AmyT described her visit a while back, with a photo provided here):

This is known, in industry parlance, as a "fill and finish" facility (I wrote in January that Biodel, Inc. had built just such a facility in Danbury, Connecticut).

A while back, when I first started this post, I discovered an online video tour entitled "Science and biotechnology for a patient's care" which offered a sneak peek into an insulin manufacturing facility and I planned to include that video here. The facilities happened to be those of Bioton, S.A., a Polish biotechnology company which announced its intention to enter the U.S. insulin market by 2010. However, Bioton did a major website redesign, and the video was gone as of early April. Luckily, the company does not have a simple robots.txt file on their web server, which would completely remove archived web content from the Internet Archive , a massive archive of web pages and related content dating back more than 9 years. According to Wayback Machine's website "The Internet Archive is building a digital library of Internet sites and other cultural artifacts in digital form. Like a paper library, we provide free access to researchers, historians, scholars, and the general public." This means that the video remains available, but only the Polish version remains. Still, the video picture tour is identical regardless of what language the narration is in. So, if you turn the volume off (unless you speak Polish), I've uploaded the video on
TuDiabetes and you can watch it there for yourself. You may have to subscribe to TuDiabetes to watch, but I must say as a member myself, that's not really a bad thing! The link can be found
here.

The primary differences are the size of the bioreactors in each facility. These can range in size from as little as 15 liters to 8,500 liters or more. Shown below are the bioreactors at India's Biocon, Ltd., which currently has FDA-approval to manufacture synthetic insulin in the U.S., although the company has yet to take advantage of that approval, as they do not currently manufacture insulin being sold in the U.S. today. Perhaps once biogenerics ("follow-on" protein drugs as the FDA likes to call them) the company will take advantage of their FDA-approval. They won't be alone, as Israeli generics giant Teva is getting into injectable drugs, too. Yesterday, it was announced that Teva received FDA approval on its Abbreviated New Drug Application (ANDA) to market epoprostenol, the first generic version of GlaxoSmithKline's Flolan, an injectable drug for intravenous treatment of primary pulmonary hypertension. Regardless, the basic manufacturing technology is the same regardless of where the facilities are located, or who makes the drug (unless, of course, they are one of the few players who still make insulin the old-fashioned way, and these companies are limited to Wockhardt U.K. Ltd., Laboratorios Beta S.A., Polfa Tarchomin S.A. or Wanbang Biopharma Ltd.).



I would note that in reference to the only U.S.-based insulin manufacturer, Eli Lilly and Company, on April 16, 2008, the company announced it would be closing its last remaining Indianapolis insulin manufacturing facility which made Humalog and Humulin insulin varieties. The company will transfer production to its more modern facility in Puerto Rico (largely because of the huge tax benefits drug companies get for operating there), France (mainly for insulin cartridges), and will most likely outsource any additional capacity it needs to Hospira, Inc.'s facility in McPherson, Kansas. This is a loss that Colonel Eli Lilly himself would probably not be very thrilled to see happen. But on the upside, I recently read that Lilly is now working to develop a long-acting insulin analog of its own similar to Lantus or Levemir. This was eluded to in a recent Indianapolis Star article describing how Lilly was "returning to its roots" in diabetes care, but I said it would take more than some fancy insulin pens to turn that business around.

You may recall that in my letter to then-CEO Sidney Taurel, I identified a number of things the company needed to do, one of which was to sell a long-acting insulin product if they want to remain a viable player in the insulin market, otherwise insurers find it easier to deal with rivals. But its worth noting that an article published a while back in the Indianapolis Star claimed that Lilly Labs had already previously attempted to develop its own long-acting analog, but they reported that the company was "unable to develop a comparable product to Lantus." Apparently, its back to the drawing board, but maybe this time the company won't starve the research budget for this critical business line!

While it sometimes appears that biotechnology is a wave of the future, its interesting to note that perhaps sometime in the not-too-distant future, costly bioreactors could someday become a thing of the past, too, at least when it comes to making insulin. As I reported in my 2007 annual review, researchers have developed not one, but several different ways to have the complicated cellular work done by plants and animals, including lettuce, safflowers, and even in cow's milk. These methods could substantially reduce the production costs for making synthetic insulin.

One of the biggest myths of using biotechnology to manufacture insulin was that it would substantially reduce the cost of insulin. That never happened in spite of those promises. In fact, the International Diabetes Federation conducted a study on the cost of insulin, and found that the cost of synthetic human insulin is significantly more expensive than the equally-as-effective (at least according to a number of meta-analyses which have studied the issue) older stuff. In essence, the big savings went to the shareholders of the insulin manufacturers, not patients or their healthcare providers. But Canada-based SemBioSys believes its product would require about $80-million in capital investment to make 1,000 kg of insulin, compared with $250-million per 1,000 kg for traditional synthetically-manufactured insulin. This could potentially reduce capital costs compared to existing insulin manufacturing by up to 70%, and product costs by 40% or more. While it remains to be seen whether these promises are delivered on, but we do know that the curtain has been lifted on the technology and processes. Maybe sometime we'll finally see less costly varieties emerge if Congress gets around to passing legislation on biogenerics/biosimilars. Its worth mentioning that the patents on the first approved insulin analog, Humalog, expires in just 4 years, so this issue should be of interest to anyone who uses insulin -- regardless of the type.

Previewing "Life for a Child" Film at Tribeca Film Festival

This evening, I've been invited (along with Allison and Kerri, although I believe some others were invited but were unable to attend) to attend the "Life for a Child" documentary film being screened at the Tribeca Film Festival. The film will later be available online at the Life for a Child website (see the bottom of the page for details on where).

The documentary film, produced by the International Diabetes Federation (IDF) and sponsored by Eli Lilly and Company to raise awareness of the devastating impact of diabetes in the developing world, is being screened at the 2008 Tribeca Film Festival in New York from April 23 - May 4.

The film, directed by Academy Award nominee Edward Lachman, has been selected to compete for the honor of Best Short Documentary. It follows the journeys of children with type 1 diabetes amid the verdant mountains and bustling streets of Nepal, one of the world's poorest countries.

Why do I mention this? Because presently, big-named celebrities like Madonna, whose new documentary, "I Am Because We Are" which is all about Malawi, the AIDS-ravaged country where she controversially adopted her third child is receiving a lot more press attention -- in fact, she graces the cover of this month's Vanity Fair extolling the virtues of charity (particularly for orphans in Malawi), her new album, etc.

I don't dispute the importance of those issues or her right to bring attention to them, but I do find it a bit troubling that we so often hear about the AIDS epidemic in places like Africa (anyone who watched American Idol last week also saw that issue highlighted on tabloid television). But how many of you knew that International Diabetes Federation (IDF) estimates that 3.8 million people died as a result of diabetes in 2007? This is more than deaths from HIV/AIDS and nearly four times the deaths from malaria. What makes this so sad is that doesn't have to happen.

The IDF "Life for a Child" campaign aims to address this huge discrepancy in media coverage and call attention to the fact that around the world, many people are dying -- unnecessarily -- because of diabetes. The reason is because many people mistakenly believe that the issue has been a non-issue since the discovery of insulin in 1921, conveniently overlooking the fact that the logistics of getting basic supplies to some of these places makes it an unnecessary death sentence for these children. The "Life for a Child" program was established in 2001 with support from Diabetes Australia and HOPE worldwide.

Participants in "Life for a Child" part-sponsor the most needy children at diabetes centers in these countries. This sponsorship enables the children to receive the clinical care and diabetes education they need to stay alive. The centers provide thorough clinical and financial feedback.

The goals of the program are to provide:

• Sufficient insulin and syringes


• Blood glucose monitoring facilities


• Appropriate clinical care


• HbA1c testing


• Diabetes education


• Technical support for health professionals (if requested)


• Some centers need support for all these areas, others need support for some components.

This is a big reason for the IDF "Life for a Child" program -- to raise awareness of the people who do not have access to even the most basic healthcare that so many of us take for granted. I hope you'll take a few minutes to look into the "Life for a Child" campaign.

Why A Recent FDA Decision Should Have You Concerned

Today, the Boston Globe reported that the U.S. Food and Drug Administration rejected Genzyme Corp.'s request for permission to sell in the U.S. a version of its Pompe disease (a rare inherited and often fatal disorder that disables the heart and muscles) drug, called Myozyme, the company wanted to make at its Allston, Massachusetts manufacturing plant. Presently, the company can only make this drug at a smaller facility in Framingham, Massachusetts. The FDA ruled that any Myozyme made at the second plant should be considered a different product because of small differences in its chemical structure, and in order to receive FDA approval, the company needs to file another application with new data showing the drug is safe and effective in large numbers of patients. That means costly clinical trials and a lengthy approval process for the company.

But this decision demonstrates that drugs made with biotechnolgy via recombinant DNA manufacturing, even made by the very same company at a different facility, suggests that regulators are reluctant to approve other versions without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds.

So what does this have to do with diabetes?

Well, since 2005, all of the insulin manufactured for human use in the U.S. is made by recombinant DNA technology (some FDA-approved animal insulin is still sold legally in the U.S. for veterinarians, but it is imported from the Netherlands), so insulin is a biotechnology drug -- sort of.

The regulation of insulin is an anomaly even within the FDA. Insulin, along with human growth hormone (HGH) are grandfathered as small-molecule drugs governed by the Federal Food, Drug & Cosmetic Act, while virtually all other biotechnology drugs including vaccines are ruled by the amended Public Health Service Act. The law considers insulin and HGH small-molecule drugs even though their manufacture is covered by the Center for Biologics Evaluation and Research (CBER) within the FDA, which is one of six main centers at the FDA responsible for assuring the safety, purity, potency, and effectiveness of biological and related products. Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed.

Some History

Congress enacted the insulin amendment in December 1941. This law served patients very well, had a very marginal cost to manufacturers and also helped to establish insulin as one of the safest drugs regulated by the FDA. A much more complete history of the insulin certification process can be found at the PubMed website.

But in 1997, the geniuses in Congress passed the Food and Drug Administration Modernization Act (FDAMA) of 1997. The FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the FDA certified drugs containing insulin. As a result, in 1998, the FDA repealed virtually all of its regulations governing certification of drugs containing insulin and made amendments to other relevant sections of their regulations. In effect, governance of insulin had to comply with the FDA's good manufacturing standards, but the batch testing mandated on virtually all other biotechnology drugs became strictly voluntary.

Novo Nordisk: The Manufacture of Insulin Must Be Monitored Closely

Some manufacturers, such as Novo Nordisk continue to adhere to stringent manufacturing standards. On March 26, 2007, Novo Nordisk A/S sent one of its executives, Inger Mollerup, Vice President for Regulatory Affairs to testify before Congress. Mollerup said "While some of the best known peptide molecules - like insulin - can be largely characterized with today's technology, we do not yet have the tools and models that enable us to predict safety and efficacy from that characterization without undertaking human clinical trials."

That admission was important, because it suggests strongly that the FDA's decision regarding Genzyme Corp.'s request to make Myozyme at its Allston, Massachusetts manufacturing plant was correct. However, not all insulin manufacturers adhere to the same stringent manufacturing standards as Novo Nordisk does. For example, in February, I reported that Indianapolis-based drug giant Eli Lilly and Company has been farming out the manufacture of at least some vials of Humalog and Humulin R to a third-party.

If we are to believe rival Novo Nordisk's testimony before Congress, then the reality is that while Lilly is not violating any law, it seems clear that the 1998 removal of regulations regarding insulin certification was a dangerous decision which needs to be changed urgently to ensure the safety of patients. Why is it that Genzyme's manufacture of Myozyme made at a facility other than Framingham, Massachusetts needs trials to prove its the same drug, but Lilly can so easily have Hospira, Inc. manufacture Humalog and Humulin R in Kansas and its considered exactly the same drug? The simple fact is that it is NOT the same drug, and if we're going to insist that generic biotechnology drug manufacturers must undergo clinical trials, then the same needs to apply to Lilly's Hospira contract manufacturing.

What Needs to Be Done?

There is a simple way to resolve this issue. Congress must amend the section of the Food and Drug Administration Modernization Act (FDAMA) of 1997 which removed the Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin. This will require more intense monitoring of these medicines to ensure consistency in the potency and safety of insulin. Another way is to pass a law mandating that insulin and HGH can no longer be governed by the Federal Food, Drug & Cosmetic Act, but must be governed by the Public Health Services Act like virtually all other biotechnology medicines. But in order for these changes to occur, you must write to your Representatives and Senators in Congress demanding that these changes be made. Tell them why it is important to you personally (they find personal stories very useful in letters they receive because it helps them to address these issues in Congress. If you suspect that your dosage for Humalog differs from one vial to the next, tell them it may be because its made by a different company!) To find your Congressmen/women, visit http://www.visi.com/juan/congress/.

The Business of Diabetes: Diabetes OC Bloggers Influence the Media

Several weeks ago, The Wall Street Journal Health Blog wrote that the State of New Jersey had given more than $65 million in subsidies to Bristol-Myers Squibb, Pfizer and Novartis in the name of economic development over the past 11 years. But recently, those three drug makers turned around and laid off employees in the Garden State.

Unfortunately, New Jersey is hardly alone in the largess extended to the drug industry only to be screwed by the industry while company executives ran away with boatloads of stock options, cash and other perks. Yesterday, pharmaceutical company Eli Lilly and Company announced that the company would be eliminating 500 jobs in its hometown of Indianapolis. Those Indiana jobs would primarily impact affect sites that manufacture active pharmaceutical ingredients for the insulin products Humalog® and Humulin® and for the osteoporosis medicine Forteo®. Initially, the Indianapolis Star reported the news as follows:

Lilly to eliminate 500 jobs in Indianapolis
By John Russell, Indianapolis Star
April 16, 2008

Under pressure to reduce costs, Eli Lilly and Co. said today it plans to cut up to 500 jobs in Indianapolis through a buyout program.

The cuts, which will take place in coming months, would bring Lilly's headcount in Central Indiana to about 12,000, down from more than 14,000 in 2004. It represents the largest single job-reduction action by Lilly in Indiana in recent years.

Most of the cuts, up to 430 jobs, would come in the company's manufacturing operations, at facilities that make the active pharmaceutical ingredients for insulin products Humalog and Humulin as well as for the osteoporisis medicine Forteo. The remainder of the cuts, up to another 70 jobs, would come from Lilly's research and development operations.

"For several years, we have focused on strategic efforts to lower costs, increase flexibility and improve productivity across the business," said John C. Lechleiter, Lilly's president and chief executive, in a statement. "This strategy calls for reducing investments in some areas while increasing investments in others, and the streamlining decisions announced today are an example of this."

The Indianapolis based drugmaker said it is not shifting the jobs or production elsewhere, or hiring new outside vendors to take over the manufacturing. The move is designed to realign manufacturing capacity in certain products, Lilly spokesman Phil Belt said. The company's manufacturing has become efficient and productive in recent years, reducing the need for workers, here.

"It's not as if we're picking up these jobs and moving them somewhere else," Belt said.

The company's decision last month to abandon its inhaled insulin program contributed to the decision to reduce manufacturing headcount here, Belt said. The experimental drug was in late-stage clinical trials.

From a peak worldwide employment level of 45,800 in 2004, Lilly has reduced its global headcount by 12 percent, or about 5,500 people. Most of the cuts have come by not filling jobs that became vacant through retirement and resignation.

Lilly said it will take an accounting charge in the second quarter, but the amount has yet to be determined. It will depend upon the number of employees that choose to take the exit package, the company said.

Frankly, I couldn't believe what I'd read, and blaming the discontinuation of inhaled insulin was a convenient excuse, but the numbers just don't add up. As my readers know, telling locals that they aren't shifting the jobs elsewhere is a complete lie. In February, I reported that Lilly had been outsourcing the manufacture of Humulin and Humalog to Hospira, Inc.'s "One 2 One Contract Manufacturing Services" (known previously as Abbott Laboratories' One2One Global Pharmaceutical Services which was spun-off as an independent company in 2004). I made a point of posting a comment on the Indianapolis Star's article to point that out (my comment was done under the name "CScott"). Here's what I wrote:

Indiana residents have been scammed by the greedy execs at Lilly. The huge loss in Lilly's market share (down to 43% in 2005 from 82% in 2000) for insulin explains why the company pulled out of plans to build a facility in Virginia last year. But in the latest news release, the company was careful to imply that they weren't shifting these jobs elsewhere.

Since 2003 at least, Lilly has had FDA-approval for Hospira, Inc. (formerly Abbott One2One, which was spun-off as an independent company in 2004) which is based in McPherson, KS to make Humulin and Humalog for the company (the company still operates its own manufacturing facilities in Puerto Rico & France). But the outsourcing documents are on file with the Food and Drug Administration.

It's going to take more than some fancy insulin pens to turn this sagging business around, and shareholders should question the company's rosy forecasts for the diabetes business -- most of Wall Street is already skeptical.
4/16/2008 4:10:51 PM

Wouldn't you know it, the Indy Star article by John Russell was re-written to talk about how Eli Lilly and Company had been outsourcing jobs to third-parties, yada yada yada ...

Next time, I'll certainly include more personally-identifiable information so I can get attribution! I should have known better. In January, Peter Rost at the now-defunct blog BrandWeekNRx reported that mainstream media journalists monitor blogs on a regular basis, and perhaps reporters at the Indy Star read the comments posted on their articles. I don't really don't mind in this case, but next time I'll know better!

My Spin on Type 1 Diabetes Awareness Day

Today is Type 1 Diabetes Awareness Day, and while there are likely to be dozens of blog postings on this subject today, I am never one to follow convention with more of the same, so I've chosen to acknowledge this day without being redundant.

What are the origins of this day? Well, because "diabetes" is a generic term that describes the symptoms of a disease, rather than the etiology (origin), diabetes blogger Kerri Morrone suggested that we use this day to clarify the distinction and make it clear that not all "cures for diabetes" or "new diabetes drugs" benefit the type 1 community.

Can't Type 1 Diabetes Be Controlled?

That really depends on how you define "control". Type 1 is an autoimmune disease which cannot be prevented with diet or exercise -- in fact, medicine does not know of ANY way to prevent type 1 diabetes from occurring yet (they are working on it, but none of the trials so far have yielded success). While these elements help in managing the disease, it is important to note that "managing" diabetes does not necessarily mean the disease is controlled. The definition of "control" is to exercise restraining or directing influence over, to have power over. Thus, the term "control" of type 1 diabetes is kind of a misnomer, as people with type 1 diabetes can only "control" just 3 variables (food consumption, activity, and insulin dosage) while there are literally dozens of variables out there, including the presence of various hormones in the bloodstream which we cannot even measure, let alone exercise control over. I would argue that "control" is a very poor word choice, and that "manage" is a more appropriate term.

No dount, some people may debate the semantics of the term "control", but it is important to realize that what is frequently called "control" is perhaps better described as a constant act of juggling -- an act which one can never, ever take a vacation from -- ever. Fellow type 1 diabetes blogger Scott K. Johnson quotes another person with type 1 diabetes: Marlene Less from 1983 in saying "diabetes is like being expected to play the piano with one hand while juggling items with another hand, all while balancing with deftness and dexterity on a tightrope."

Another diabetes blogger, Will "Printcrafter" (or Lee) puts it another way: "Living with diabetes is like living with a tiger. If you feed it, groom it, never turn your back on it; you can live with a tiger. If you neglect it; it'll pounce on you and rip you to shreds."

Aren't There New Treatments for Diabetes?

Again, here's where public ignorance is the rule, rather than the exception. Since the discovery of insulin in 1921, the U.S. Food and Drug Administration has approved just one new treatment for type 1 diabetes, which is Symlin (pramlintide acetate), which is an analog of the naturally-occurring beta cell hormone amylin -- which was approved on March 16, 2005. That brings the grand total of current treatments for type 1 diabetes to two (actually, Symlin can only be used as an adjunct to insulin -- it cannot be used alone, so does that even count as a whole treatment?). Its kind of like adding a fourth ball (to the 3 I mentioned before) we are now asked to juggle!

As I noted in my most recent post, no study, not even the Diabetes Control and Complications Trial, has ever been able to show that diabetes management can prevent complications. For example, we now have solid evidence that two so-called complications of type 1 diabetes: neuropathy and cardiovascular disease are believed to have an autoimmune basis, so while managing diabetes may help slow the acceleration of these terrible outcomes, it cannot necessarily prevent them from occurring.

This is not to say that the outlook isn't good for type 1 diabetes. In fact, in January 2008, Reuters reported that that the percentage of U.S. adults with diabetes who have their blood sugar levels under "control" (their word, not mine!), as indicated by glycosylated hemoglobin (A1C) levels of less than 7%, increased between 1999 and 2004. This means that for those of us who manage our condition aggressively, the outlook is better today than it has been at any point in the history of this disease. Furthermore, research suggests that the incidence of kidney disease in patients with Type 1 diabetes has improved significantly.

But there's still plenty work to be done. As a 2007 article published in Diabetes Care notes, medical students' knowledge of diabetes is not up-to-date, and that a majority of medical students frequently recommended the sole use of a sliding scale for insulin in the management of diabetes (a treatment that some prominent experts in the field believe should be abandoned), and that the students were less likely to recognize hyperglycemia in patients who were not known to have diabetes.

In recognition of Type 1 Diabetes Awareness Day, I would like to raise awareness of these very issues and call attention to medical students to brush up on the subject as well! And, as Bernard wrote, while you're at it, why not give a hug to anyone with type 1 diabetes today?

Perceptions vs. Reality

Sometimes, there are works that stand the test of time better than others. In the case of diabetes writing, Deb Butterfield, author of "Showdown With Diabetes" wrote the following article in 1992, yet to me, it feels as if her words were never more true than they are today. What do you think?

Perceptions vs. Reality
By Deb Butterfield
Original URL for this article:
http://www.insulinfreetimes.org/itimesv600.htm

Perceptions are often quite different from reality, yet perceptions wield enormous power. Diabetes is widely perceived to be a manageable condition. Most people believe that diabetics will live a full and normal life if they follow the rules of diabetes management. Yet the reality is that diabetes kills one American every three minutes, and every three minutes, four more are diagnosed. Diabetes is the leading cause of blindness, amputation, and kidney failure. Sixteen million people in the United States have diabetes and 35% of them will suffer from kidney failure at which point the chance of survival is less than that of surviving ovarian cancer. The chasm of silence and misinformation between the reality and perceptions of diabetes goes a long way to explaining why diabetes has not received its share of government research funding, nor the public outcry to find a cure.

Two years ago [in 1990], the National Diabetes Education Program (NDEP) initiated a multi-media blitz that announced, "Control Your Diabetes. For Life." Just like that. It's up to you. It's your disease. If you control it, you'll have a life, if you don't you won't. According to Dr. Phillip Gorden, the then director of the National Institutes of Diabetes and Digestive, and Kidney Diseases, the purpose of the campaign is to, "get the message out that diabetes is serious, common, costly, and controllable." Via radio, television and print, our neighbors, coworkers, friends, and relatives learned that diabetes is controllable. The theme reinforced the belief that diabetic disabilities and their associated economic costs are caused by diabetics — not by diabetes.

Now think for a moment what would happen if the campaign had announced, "Diabetes disables and kills. Only a cure can stop the suffering," with pictures of a little boy leading his blind mother around a grocery store and a voice-over explaining that diabetes is suffering. This campaign would create a fundamental shift in the way diabetes is perceived. The public would see diabetes as the enemy, as we see cancer and AIDS as enemies. They would worry that if it isn't cured, it could happen to them, or to their children. A "Diabetes Disables and Kills" campaign could change the face of the disease by removing the smile that has so long been attached to it in product advertising and brochures in doctors' offices and pharmacies. Perhaps public outrage that there is no cure yet would create political pressure to increase funding for cure-focused diabetes research.

Many parents of diabetic children and people who have diabetes would be outraged and shocked by such a campaign, in part because we too believe, or want to believe, that if we follow the practices of good control, we are guaranteed a life free of diabetic complications. Not only do we want to believe that; we have been taught to believe that. Just last week at a small "diabetes family night," three of the five mothers of diabetic children there said that they had been told not to worry too much about their children's blood sugars, that children are resilient to complications. No doubt, the doctors, with good intentions, are trying to ease the worries of the mothers and children with their platitudes. Using reassuring voices and sweet smiles, nurses convey the message that if you do as you're told, then everything will be okay – just as in the NDEP campaign, they are telling their patients that diabetes is controllable, and if they control it, they will be fine. But the truth is that no study, not even the Diabetes Control and Complications Trial, has ever been able to show that diabetes management can prevent complications. 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.

Unfortunately, without the attention-grabbing gimmicks of the companies selling diabetes management products, the message about curing diabetes gets lost and healthcare workers return home, telling their diabetic patients only about all the new technology that can help them manage their condition. This year [1992] at the American Diabetes Association convention in San Antonio, non-profit organizations are not even permitted to be on the convention hall floor, but have been moved to another floor to make room for the for-profit companies that will pay more for their display booths.

Is diabetes as life threatening as cancer or AIDS? The answer is an