I was, however, giving the finger to diabetes -- something everyone I think everyone with diabetes really should do, as its very therapeutic! Seriously, though, I just don't do hand signals very well -- I'd really be stuck if I ever had to learn sign language! I realize my posting is kind of delinquent, but this week was busy at work and I had a lot of stuff to do at home, too, so the blog took a back seat. Anyway, last weekend, I went down to Philly and participated in the TuDiabetes/Diabetes OC Blogger Meet-Up down there.
I should note that my #1 motivating factor for me to actually trek down there was the fact that I have been communicating with the fabulous Betty Jackson for nearly a decade now (since the days of Deb Butterfield's DiabetesStation, which has been out-of-service since 1997). Betty has lived with the type 1 diabetes for over 45 years and serves as a great inspiration for me and many others (incidentally, she's also on TuDiabetes, see her profile here for details), but for a host of reasons, we've never been able to meet, so I decided it was finally about time!
I have enjoyed most of the various meetings I've been lucky enough to attend during the past few years, and I am hoping to attend the 1st Annual New England Diabetes Meetup (check out the "Events" page), which will take place in Waltham, Massachusetts (the town I spent my college years in having attended Bentley College), which will take place on July 12. I'm not sure I'll be able to make that one, as I'll be headed to my family's summer cottage in New Hampshire the following weekend and I'm not sure I can make the trek up there from NYC two weekends in a row, but I'd like to try.
Anyway, although I still lag behind Allison (who I first met at the OC Dinner in NYC over a year ago, but many times since then) in terms of meeting Diabetes OC bloggers face-to-face, I have nevertheless managed to add to a few since my last posting on this subject back in April 2007. So here is my updated list, including where I first met them:
Allie (I swear I first met her at the Starbucks across from my office in Westbury, but she doesn't recall that ... its been more than a few times since then anyway)
Amy Tenderich (at the ADA Scientific Sessions in Washington, DC in 2006)
Kelly Close (when I was in San Francisco in summer 2006)
Kerri (at the dLife Roundtable Discussion and a few times since then)
All I can say is that the Philadelphia OC Community rocks!
Even though I was sort of weirded out about trekking all the way down to Philly to go out to Applebee's, it turns out we just about had the place to ourselves and the company more than made up for a chain restaurant!
Although I planned to visit Marrakesh since I'd been there with a group of friends when I lived down there and it is one of my favorite restaurants there (especially for a group), I wasn't sure anyone else would want to go, but it turns out most of the group decided to re-convene later in the day at this South Street restaurant (well, a side street away) which was featured in Real World Philadelphia (I discovered it a few years before that show aired, incidentally), and we had a Belly Dancer and way too much food, but Hannah decided to join her as part of the entertainment, which gives you some idea of just how much fun this group is!
Anyway, there I had many other pictures (some of which the others shared, see their links above). Seriously, I know Scott Johnson and some of the Minnesota bloggers have met (see here for the announcement, I couldn't find the photos, maybe Scott will help me out with that), and we're working on a national meeting, but seriously you guys out west and elsewhere in the country REALLY need to do this -- I cannot recommend it enough!
Recently, Kerri has chronicled her struggles to get insurance approval of a continuous glucose monitor. She is hardly alone in her battle with healthcare providers to get coverage; many people struggle with this very issue. In fact, late last year, cgmscentral.com went live on the web as the only site dedicated to helping people secure reimbursement for their continuous glucose monitoring systems.
Manny at TuDiabetes sent out a request yesterday asking if we would post his video on this subject. At first, I was resistant to the idea, not so much because I disagree with him, but more because I think the insurance companies have been demonized, I think unfairly.
To some extent, I think the technology does deliver improved management for certain people, but in my opinion, the frustration over coverage (or lack thereof) should not really be directed at the insurance companies, but to the manufacturers, who frankly, have done next to nothing to get their product covered. In fact, they have largely left the task of justifying coverage to the Juvenile Diabetes Research Foundation to conduct the studies, rather than doing it themselves.
I have found myself playing the role of devil's advocate, asking people to look at the situation from a business perspective. The insured patients are, 99% of the time, NOT the insurance company's customer, rather it's the employers who buy the policies, and they are under enormous pressure to keep costs under control or they risk losing their customers to rivals. It's no secret that the insurance companies have a fiduciary responsibility to make a profit for their shareholders (which, by the way, are what many of you're 401K's and/or pensions are invested in, incidentally), and frankly, they make money, but not on a ROI basis at a comparable level to the drug and medical device companies. The insurance companies are essentially forced to make their decisions from this business perspective. It's true that they would for the most part, rather us have complications, but its NOT because they haven't fully analyzed the economics.
Insurance is all about managing odds, and the simple fact is that by denying this coverage, the odds are in their favor, because chances are extremely high that you will not even be covered by them when complications actually do strike. First, many people are likely to have several insurance carriers over the years due to job changes, or simply because employers negotiate deals with new companies (see my post here for more on that). The simple fact is that in most cases, those costs will be soaked up and paid for by Medicare, so our tax dollars end up absorbing that cost, but few if any insurance companies will be saving much of anything by actually paying the cost of this costly technology. In other words, they have everything to lose by paying it and stand to gain little if anything by covering it.
In my opinion, the real crooks here aren't the insurance companies, but the manufacturers of this costly technology -- no one is trying to deny them the chance to earn a profit, but they don't need to rape, pillage and plunder us and our healthcare providers in the process! Let me also add that the only way to really effectively address this is to abandon the for-profit insurance system we now have ... something I'd LOVE to see happen, but I doubt we'll ever see that because of industry lobbyists in Washington! The odds are that we still also won't have any form of universal coverage by the end of 2009, regardless of who wins the White House, because we're now so far into debt for the Iraq war that whoever is in the White House or in Congress will really have their hands tied as to what they can realistically hope to accomplish given the budget situation. Who should we be thanking for that?
Others have justifiably argue that the U.S. tax code also should share some of the blame, and they have valid points. The U.S. government does not allow this medical expense to be tax deductible until it has reached 11% of your gross income. Think about what that means -- taxing my medical supplies that you might be forced to pay cash for is not sound policy under any circumstances, yet its done and no one is complaining to their Congressional reps about it while they have no problems blaming their insurance companies. Let's also remember that consumers pay anywhere from 35%-40% more than the list price of the sensors, so true cost of the sensors may be even more when considered at the after-tax cost.
To be sure, the insurance companies are hardly guilt-free; but I would argue they are being blamed unnecessarily for tax policies and poor healthcare policies that are really decided in Washington and in State Houses across the country.
Sooner or later, I suspect that almost everyone is impacted by the rising cost of healthcare. The U.S. has an estimated 47 million uninsured, and according to a study in this month's Health Affairs journal, another 25 million people are underinsured. In fact, Families USA, the national organization for health care consumers recently released a 50-state survey, which revealed that insurance companies in most states are not prohibited from denying health coverage to people with pre-existing conditions, refusing to pay for services needed to treat common ailments, adding huge premium surcharges for people with family histories of health problems, and yanking policies and denying payments when consumers face a rash of medical bills. The issue has grown so large that today, even Federal Reserve chairman Ben Bernanke commented about the subject in a lengthy diatribe on this matter. Fortunately, I am not one of the un- or under-insured people, but that doesn't mean rising healthcare costs don't affect me. Unlike when someone changes a job and they can anticipate certain changes, occasionally, the cost issue forces itself upon us. For example, on June 1, 2008, my employer switched to a different healthcare plan. The new provider (Empire Bluecross/Blueshield) made them a deal they simply couldn't refuse, so my coverage with Oxford/United Healthcare ended. Of course, such changes can create a degree of confusion for anyone, but for those of us with diabetes, the changes can be particularly burdensome, and I didn't really have a choice in this matter.
The first issue is the little issue of compliance with the various policies imposed by our healthcare plans. Most healthcare plans give significant financial incentives to use mail-order pharmacies which they own outright or else contract with, so ordering 90-day supplies is the norm. My 90-day supply happened to be finished on May 30, so this time I was caught in the neverland of not being on the computers of my new healthcare plan on June 1, even though I was pretty close to running out of insulin by then. Fortunately, I was not removed from my old plan's computers, so I was able to order a 90-day supply from Medco on June 3, even though I knew that I was no longer covered, but I didn't have the luxury of waiting around for someone to enter me into the new plan's computer -- I figured I'll eventually be billed in full for this life-sustaining substance, at which point I'll submit it as a claim for my new plan. Although I don't know whether my brand of insulin is one of the new plan's "preferred brands" on their formulary or not, I simply don't have the luxury if wait for logistics to be resolved, and in this case, its Medco who will be waiting to be paid, not me. But I could have been stuck buying the stuff out-of-pocket while bureaucratic systems get us member ID numbers and all.
For people with diabetes, plan changes are also about more than just whether our doctors are on the new plan, but the manner in which we live life from day-to-day is also impacted in a way that I suspect the average person fails to appreciate. Cash in point: pharmacy benefits manager (PBM) coverage, which my life quite literally depends upon. Unlike people who use medications to manage the symptoms of a condition, most people with type 1 diabetes would quickly go into DKA which can be fatal without insulin, so its not simply a matter of following doctors orders, or alleviating symptoms, but its about survival.
My old plan used Medco Health, whereas my new plan uses Caremark. Aside from any changes in formularies (for example, my old plan considered Lilly insulins to be "tier 3", their most expensive, and essentially encouraged the use of "preferred" brands from Novo Nordisk or Sanofi Aventis). I'm still waiting for the formulary on my new plan to determine which brand products are the "preferred" brands, but it looks like the new plan is very similar, except they might actually cover Lilly (or is that Hospira?) insulin as a "preferred" brand.
Anyone whose very life depends upon an external source of insulin knows this isn't simply a brand switch; there are often legitimate differences in the time-activity profiles associated with each insulin brand, and I may require additional testing to make it through the transition -- safely. Will my new plan cover the cost of any extra supplies needed? Probably not, but realistically, they should as part of landing the account, but in the dysfunctional U.S. healthcare system, the burden is placed on the patient, not the healthcare plan.
Then there is the matter of "in-network" vs. "out of network" physicians. In my case, my PCP (primary care physician) was "in network" under both plans, but my endocrinologist is not. However, I tend to view this as an opportunity to find a new endo whom I might like better -- my old endo was convenient, but it took forever to schedule an appointment and the staff at his office could occasionally be a bit rude. Incidentally, I've found a new endo, someone I met a few years ago at the ADA Scientific Sessions and his office is only a few miles away, and even better, he's seeing new patients who are not pediatrics, so I don't think I'll be traumatized since I've had the chance to meet many great physicians over the years (having relocated including 2 cross-country moves over the past 20 years, I've become used to change). Others, however, might not be as flexible or optimistic about the situation as I am.
Now, when Americans call the U.S. "the best healthcare in the world" I often wonder how many other countries' healthcare systems they've ever actually sampled? For example, in 1987, I lived in Finland for a while, and I can honestly say, their healthcare system blows ours away! But many defenders of the current U.S. system often have never even left the confines of their own state, let alone left the country, and I wonder what life would be like to be so incredibly naïve about the world.
Anyway, taking all of this in stride, I've actually found a way to take advantage of this situation. For example, I need new prescriptions for everything: test strips, insulin, pen needles, syringes, an ACE inhibitor ... everything, so I've asked my PCP to write these for me so I do not run out before I can meet my new endo. Since I just fulfilled my last 90-day order about 2 weeks ago, I will be placing another this week, so I will likely be getting about 180 days worth of supplies all at once. Not that I won't have to pay for it, I'll have to deal with claims for my order with Oxford/Medco sooner or later, but in the meantime, I won't be running short of supplies! I am also using the opportunity to take advantage of differences in policies, such as the fact that my new healthplan does not appear to require doctor authorization to exceed an arbitrary number of test strips used each month. I wish others could walk away from this type of situation as positively as I have!
A somewhat important news development which was largely overlooked due to its poor timing (overlapping with the end of the ADA Scientific Sessions), the June 2008 issue of the American Journal of Transplantation featured the results of an important advancement in islet transplantation.
To date, one of the main issues limiting progress in islet cell transplantation has been limited by the severe shortage of donor organs, said Dr. José Oberholzer, who is the director of cell and pancreas transplantation and lead author of the study, and also associate professor of surgery, bioengineering and endocrinology at University of Illinois at Chicago (UIC).
UIC is one of only seven federally funded National Institutes of Health Islet Cell Resource Centers across the country that provides researchers with human pancreatic islet cells for transplantation into diabetic patients and for basic science research on diabetes. But UIC is one of only a few centers worldwide that have been able to achieve reproducible and consistent insulin independence in "severe" type 1 diabetes patients (meaning the patients suffered from severe metabolic instability characterized by sudden, frequent hypoglycemia without symptoms).
UIC researchers have slightly modified the Edmonton Protocol procedure for islet cell transplantation and achieved insulin independence in diabetes patients with fewer but better-functioning pancreatic islet cells.
"This study is extremely promising and shows that we can achieve success with fewer islet cells, freeing patients from the need to check their insulin, even after 20 or 30 years of suffering from diabetes," Dr. Oberholzer said.
What did they do differently from the widely-tested Edmonton Protocol? Six patients received the slightly-modified UIC protocol -- which was a combination of etanercept (an anti-inflammatory drug developed to treat rheumatoid arthritis) plus the inclusion of exenatide (a drug approved for use in type 2 diabetes, better known as BYETTA) -- in addition to the Edmonton regimen. The new procedure allowed patients to get off insulin with only a single transplant versus the two to four transplants that were needed using the older protocol, said Oberholzer.
By comparison, the four patients who received the standard Edmonton protocol needed either two or three sequential islet cell transplants to achieve insulin-independence. The six patients who were treated using the UIC protocol initially achieved insulin-independence after only one islet transplant. Two of these patients required a second islet cell transplant, and one resumed insulin five months after the second transplant due to other complications.
The bigger question is how long will their insulin-independence last? Many people have attained insulin independence with islet transplants, only to see that last for only a year or two at most. The big difference with the UIC Protocol is the addition of BYETTA, which is largely viewed as a Type 2 diabetes drug, but one which also encourages the transplanted beta cells to replicate themselves, thus potentially enabling the newly transplanted cells to replicate and possibly extending their insulin-independence. Last year at the ADA Scientific Sessions in Chicago, researchers with the Diabetes Research Institute showed that including exenatide prolonged insulin independence. Now, the key will be to watch the follow-ups on patients receiving transplants with the UIC Protocol to determine how much longer insulin independence is sustained with the new protocol. Only time will tell!
This past weekend, the American Diabetes Association's 68th Annual Scientific Sessions began in San Francisco and today (Weds., June 10, 2008) they end. The press releases and reporters were on overdrive, largely releasing the same, recycled stories containing tidbits from the ill-fated type 2 studies which also investigated cardiovascular disease -- even though that news came out months ago. Nevertheless, there were a handful of interesting findings revealed in these sessions, although I previewed the extracts about a month ago and decided that this year's event wasn't really worth a trip cross-country to be inundated with more of the same. A fair proportion (if not the majority) of the findings presented at this year's meeting weren't truly "new" findings, but those already published in various medical and scientific journals.
As you might imagine, diaBusiness carefully coordinated numerous press releases to go along with findings of their less-than-vigorous "scientific" findings. Without a doubt, Novo Nordisk was the worst offender (although certainly not the only one; we shouldn't leave out Merck and Eli Lilly and Company from doing largely the same thing). For example, virtually all of the wire services and news headline servers publish the same, carefully crafted press-release, that of Novo Nordisk's new drug liraglutide being "superior" at controlling blood sugar in patients with type 2 diabetes according to a small clinical trial comparing itself to to Eli Lilly and Co's and Amylin Pharmaceuticals Inc's first-on-the-market drug in the same category Byetta (exenatide).
First, let's look at the reality here. Notably, the company reported that in a 26-week head-to-head trial involving a mere 464 people, the reductions in HbA1c was 1.1% vs. 0.8% for Byetta. The company made special note that this was a "statistically significant" reduction. Based on these findings, the San Diego Union Tribunereported on Saturday that Amylin's shares fell more than 8% based on the news.
In a scathing note to subscribers, our own "Diabetic Investor" David Kliff wrote in his newsletter, "With their Bush-league tactics, Novo was deliberately trying to control the news flow, damage Amylin's share price and steal Amylin's thunder." Kliff is a longtime AMLN/Byetta bull. He also says he does not own any stocks of the companies he covers.
Positive results for Amylin's once-weekly version of its type 2 diabetes drug Byetta were released Monday evening, and that may partially erase the damage imposed by Novo Nordisk's press release.
But we should not forget that the same Wall Street analysts also once predicted that Pfizer's Exubera would be a blockbuster, with sales in excess of $1 billion annually, and we need not look too far back to see what happened with that brilliant forecast. Let me disclose that I am not an Amylin shareholder (nor a San Diego resident) so these results don't really impact me one way or another -- but I'd like to think I can be a bit more objective about what this actually means.
As I noted, this was a relatively small study of less than 500 people observed for a relatively short period of time -- a little over 6 months. Whenever you deal with sample sizes that small, the mathematics may indeed indicate that a finding is "statistically significant," but let us not forget just how much that difference actually is: a whopping 0.2%!! No offense, but I've had lab results differ by that much from blood samples taken on the same morning! What does this really mean? Assuming their HbA1c was 9.500 to start with, a patient might expect to see an average HbA1c after using liraglutide of 9.498 vs. 9.499 with Byetta? That may be statistically significant based on a tiny sample of less than 500 people, but frankly that isn't enough to compel someone to even bother switching brands, let alone adjust to a new medication (unless of course, they have a financial incentive, such as insurance coverage). But it might be sufficient to make more doctors prescribe it, and that's exactly what Novo Nordisk wants to happen.
We should also realize that Novo's drug is a "me-too" drug in pharmaceutical industry parlance, which means its not truly novel, rather its a similar copy of an already-existing drug on the market. I would add that Byetta is already well-established in the U.S. and there's a once-a-week version in the pipeline, so the Novo Nordisk has to work very hard to posture its drug to ensure it is successful when it finally launches.
Let us also keep in mind that the market has changed since they launched Novolog (known as Novorapid elsewhere in the world) received FDA approval to market that product in the U.S. in June of 2000 vs. Humalog's approval in 1996. For a variety of different reasons, Lilly was ill-prepared when Novo Nordisk seized upon that opportunity to capture a slight majority (as of September 2005, Novo Nordisk overtook Eli Lilly & Co. in as the market leader in the U.S. insulin market based on the September 2005 data for total insulin sales volume reported by IMS Health, see here for details), but that is not the case today, and I don't expect Eli Lilly to go down without a fight this time around.
Incidentally, Novo's press machine also reported that new data from a head-to-head study "Confirms Once-Daily Levemir Is as Effective as Glargine (known as Lantus) Over a 24-Hour Period in Subjects With Type 2 Diabetes", again, with the company trying hard to present, at best, weak scientific "evidence" to show superiority of its "me-too" product against a very successful competitor. As I reported in January 2007, sales of Levemir have been disappointing for the company. Of note, however, is that Lilly is now working to develop a long-acting insulin analog of its own similar to Lantus or Levemir, but they are at least a decade behind the curve here, so anything they come up with must be offer an improvement upon what's already out there. On the other hand, if the company wants to remain in the insulin market, they really do not have a choice. But as I reported quite a while ago, Levemir has done little damage to Sanofi Aventis' market share lead, which remains far and away the leader among long-acting insulin analogs.
Coming Soon: Humalog Plus?
Perhaps more interesting was what is undoubtedly a glimpse into the future. While the press didn't really cover it, but I think we can expect to see a "Humalog Plus" come out in the coming years. I base this on one of the late-breaking abstracts (I'm not certain how long it will remain available online):
Pharmacokinetics and Glucodynamics of an Insulin Analog Injected with Recombinant Human Hyaluronidase: Fast-Acting Insulin Analog Made Faster RICHARD C. YOCUM, BARRY SUGARMAN, DANIEL VAUGHN, ANDREW VICK, ROCCO BRUNELLE, GREGORY FROST; San Diego, CA, St. Charles, MO, New Palestine, IN
What does this mean? Well, first we need to look at who's behind this abstract. A quick search reveals the following affiliations (as of June 10, 2008, anyway): Richard C. Yocum (Halozyme Therapeutics Inc., San Diego), Barry Sugarman (I'm not sure where he's from), Daniel Vaughn (Daniel Enterprises, Indianapolis, IN), Andrew Vick (Eli Lilly and Company, Indianapolis, IN), Rocco Brunelle (B2S Consulting, Indianapolis, IN), Gregory Frost (Halozyme Therapeutics Inc., San Diego).
In other words, a bunch of current Lilly or former Lilly people, along with some other biotech people in San Diego did this study. It seems almost certain (from my perspective, anyway), barring any major adverse events or problems in larger clinical trials (remember, this is based on a study with just 12 people) that we are likely to see a "new and improved" Humalog emerge in the coming years, one that is faster thanks to the addition of recombinant (meaning synthetic) "human" hyaluronidase (rHuPH20). To be sure, a lot could happen, but keep in mind that we're talking about the addition of already FDA approved ingredients, but this would enable Lilly to extend patent protection for another 7 years on their "Humalog Plus" (MY term, not theirs), as the patent on Humalog expires just a few years from now.
I would dare say that we can expect to see such "New and Improved" versions of insulin analogs trials (Phase I anyway) wrap up around 2010, allowing enough time to effectively kill the old products and make doctors and patients view today's state-of-the-art treatments as "bad" or "less effective" than today's insulin analogs. No doubt, the price tag will also go up appreciably to reflect this! I will be around to tell you "I told you so!".
On Wednesday, the the NIH's National Institute of Environmental Health Sciences (NIEHS) and the National Cancer Institute (NCI) issued a press release saying that long-term pesticide exposure may increase risk of diabetes. (Gee, you think maybe?) The press release did not elaborate into whether this exposure increases the likelihood of autoimmune type 1 or insulin resistance, which is better known as type 2 diabetes, but it seems very likely that some of these influences very likely contribute to the rising incidence of both types, as well as a host of other ailments. In fact, I have seen recent research suggesting that autism which has not historically been considered a disease might actually be attributed to autoimmunity.
The NIH looked at the incidence associated with some particular pesticides, and also noted that although some pesticides and/or insecticides in this study are no longer available on the market, the chemicals still persist in the environment and measurable levels may still be detectable in the general population and in our food products. For example, chlordane, which was used to treat homes for termites, has not been used since 1988, yet can remain in homes treated with it for many decades. More than half of those studied in the National Health and Nutrition Examination Survey in 1999-2002 had measurable evidence of chlordane exposure.
None of this is terribly surprising, but at least we finally have some solid evidence of it, rather than simply relying upon the Birkenstock-wearing, granola-eating "green" pseudo-hippies stating their conspiracy theories. While I do not generally subscribe to such theories, I do believe that massive changes to our living conditions over the past 100 years has had a profound impact that has yet to be fully quantified. The most basic assumption behind this belief is that the power of the almighty dollar often motivates behavior that is not always in the best interests of the public, therefore totally free markets need some intervention (called regulation) to ensure everyone has a level playing field. However, when regulations are not sufficient, it leads to abuse of the system.
The environmental element is an important factor behind autoimmune diseases according to at least one journalist and author, Donna Jackson Nakazawa, who has published several books. Her latest book was published this spring, and is entitled "The Autoimmune Epidemic: Bodies Gone Haywire in a World out of Balance and the Cutting-Edge Science that Promises Hope" in which she discusses the history of autoimmunity and how it was not even acknowledged by the medical profession until the 1970's, and she also discusses cause for the increase. Thursday's Baltimore Sun did an interview with her which was very interesting reading. I have included that article here (since the Sun does not save article content for an extended period of time):
Body wars By David Kohn, Baltimore Sun reporter June 5, 2008
Author Donna Jackson Nakazawa answers our questions about the spate of autoimmune diseases
For 10 years, Donna Jackson Nakazawa has suffered from a range of autoimmune diseases - ailments in which our cellular defense system mistakes friend for foe and attacks the body's tissues. Among the diseases caused by autoimmunity are: rheumatoid arthritis, multiple sclerosis, lupus, Type 1 diabetes, thyroiditis and many others.
A journalist and author who has published several books, Nakazawa became fascinated with autoimmunity and spent the past three years exploring the topic. The result is her latest book, published this spring: "The Autoimmune Epidemic: Bodies Gone Haywire in a World out of Balance and the Cutting-Edge Science that Promises Hope".
How did you decide to write the book?
Three years ago, I developed Guillain-Barre syndrome, an autoimmune disorder that paralyzed my arms and legs. For a long time, I couldn't move. It took me five months to learn to walk again. I decided that if I could ever get back the ability to type, I would write about what causes autoimmune diseases and what we can do about them. After I got better, as I talked to scientists in the field, I realized that the story was actually much bigger. These diseases have become a frightening epidemic. People at [the National Institutes of Health] were telling me this was scary, and no one was talking about it.
So, how big is the problem?
Twenty-four million Americans have an autoimmune disease. That's one in 12 Americans, and one in 9 women. Nine million Americans have cancer, and 22 million Americans have heart disease. So more than double the number of people who have cancer have an autoimmune disease. Scientists around the world have been looking at this, and over the past 10 years, 15 peer-reviewed journal articles have found that rates of autoimmune disease have been doubling and tripling around the world. You begin to see that not only do we have an epidemic, but it's growing.
Why does autoimmune disease remain relatively unknown as a medical phenomenon?
The idea that autoimmune diseases even existed was not widely accepted in medicine until the late 1970s. It wasn't until the late 1980s that the idea was taught in most med schools. So we are late out of the gate compared to our war on heart disease, our war on cancer.
The other thing that happened is that as autoimmune diseases were discovered, they were farmed out to different specialties. The neurologists took over on neurological autoimmune diseases, the endocrinologists took over on endocrine autoimmune diseases, the rheumatologists took over on others. So you have groups of specialists working without any kind of integration.
In your book, you argue that our environment plays a large role in this epidemic.
Between 1940 and 1980, we were engaged in the largest industrial growth spurt of all time. ... We introduced every kind of chemical you can imagine: 80,000 new chemicals have now been approved for use in the U.S.
I talked to scientists all over the world, and they suspect that these chemicals are confusing our immune systems. As you and I are talking, our immune system has been checking out the safety of foreign agents that our body is coming into contact with hundreds, thousands of times, over and over. Usually, the system works.
But what's happening now is that our immune systems are getting so many hits, nonstop - not only from these 80,000 chemicals but from our diets - that they're overtaxed. We're eating very differently than we did 100 years ago. A lot of foods that we're eating are full of chemicals, pesticides and additives as well. So our diet is also putting stress on our immune system.
Think of each new thing, foreign invader - whether it's a bacteria, virus or chemical - that comes into your body as having a bar code on it. The immune system has to read those bar codes and decide if this new invader is safe or not. What's happening with all the chemicals in our environment is that many times our immune system is presented with a bar code that is very similar to tissue in our own body. When our immune system is overwhelmed, mistakes get made. The body mistakes the tissue of the body for the foreign invader and attacks both.
Give me an example of an immune-altering chemical.
I'll give you [three]. Trichloroethylene, a solvent used in dry cleaning, paint thinners and strippers, glues and adhesives; PFOA, a breakdown chemical of Teflon found in nonstick cookware, car parts, flooring, computer chips, phone cables, carpet guard, upholstery, new clothing, grease-resistant french-fry boxes and disposable coffee cups; and bisphenol A, or BPA, a plastics building block used in baby bottles, dental sealants, the resin that lines food cans, eyeglass lenses and food packaging; and phthalates, plasticizers found in cosmetics. Recent studies show that low doses of all of these can alter the basic function of the immune system, and, in many cases, trigger an autoimmune response. What should be done to fix the problem?
National Institutes of Health allocates almost $600 million for autoimmune disease research every year. That contrasts with $5 billion annually for cancer, which afflicts 9 million Americans. The other thing that we need to do is to make autoimmune disease a reportable disease. If your aunt goes in to see the doctor tomorrow and is told she has breast cancer, that must be reported by law to the federal government. Autoimmune diseases are not reportable diseases. Therefore, we really have no idea how big the problem is. Many scientists believe that the 24 million figure is vastly underreported. How has Europe responded to the proliferation of untested chemicals?
Europe operates by what is called the precautionary principle, which says that if you have enough evidence to show that a product is probably doing harm, it behooves us to take that product off the market and do more studies before we bring it back on.
Europe has established a program called REACH (Registration, Evaluation and Authorization of Chemicals), and over the next 10 years, 30,000 chemicals will undergo safety testing. Guess who's paying for it? Not the taxpayer, the chemical companies. In this country, we are light years behind Europe in terms of public policy. We know that certain agents damage the immune system, but we keep saying, "We need more studies to prove it." Until it's harmed enough people like tobacco, we're just not going to do anything about it. What can the average person do in daily life to reduce the threat?
If you think of the problem like a barrel that's too full, you can make small changes without feeling totally overwhelmed. One of the easiest things to get rid of are chemical cleaners. There are so many different nonchemical cleaners on the market now, there is almost no excuse not to clean green. Or make your own: Take one part vinegar, two parts water and a dash of lemon, you've got a pretty good cleaner. Shop for nontoxic cosmetics and use alternatives to pesticides.
We also know that diet can have a profound effect on the immune system. If you clean up your diet, your body has fewer foreign agents to assess. So eat fewer processed foods, fewer packaged foods, more organic fruits and vegetables. And we know that stress hormones play a key role in the onset of many autoimmune diseases. So lessening stress is crucial.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS/National Institutes of Health once published an informative patient brochure on this topic called "Autoimmunity: Questions and Answers About Autoimmunity" (NIH Publication No. 02-4858). Unfortunately, they appear to have removed it from their servers, but because the document is not copyrighted and the NIAMS encouraged widespread distribution of the brochure, I did find it elsewhere online, see http://www.pfwmd.com/Documents/autoimmunity.pdf for details.
Also, to facilitate collaboration among various National Institutes of Health components, other Federal agencies, and private organizations with an interest in autoimmune diseases, the NIH established the Autoimmune Diseases Coordinating Committee in 1998, under the direction of the National Institute of Allergy and Infectious Diseases. [Note: The reason for it being assigned to this particular institute may have something to do with the amount of work allocated to each Institute, with NIAID being one of the least busy, but this was never acknowledged.] Anyway, the Coordinating Committee's Research Plan can be found at: http://www3.niaid.nih.gov/about/organization/dait/PDF/dec2002_ADCC.htm
Finally, let me close by noting something you may not have known. While nearly 75% of the more than 23.5 million Americans who suffer from autoimmune disease are women, millions of American men suffer from these diseases, too. However, autoimmune diseases that develop in men tend to be more severe. For example, few can be treated by taking a simple pill each day to treat hypothyroidism, for example.
There are a few autoimmune diseases that men are just as or more likely to develop as women, including:
Because of this, the American Autoimmune Related Diseases Association (AARDA) in April launched a new public service campaign. The "Men Get Autoimmune Diseases, Too" campaign consists of 30-second radio and television public service announcements (PSAs) and educational materials designed to raise awareness about the fact that, while women are disproportionately affected, these diseases do not discriminate when it comes to gender. Specifically, the PSAs inform men about the importance of knowing their family AQ.
"AQ is a play on IQ and stands for Autoimmune Quotient. It's about knowing how likely you are to develop an autoimmune disease given the prevalence of theses disease in your family," explained Virginia Ladd, president and executive director, AARDA.
"Much more research and many more research dollars are needed for basic research to determine just how gender and sex hormones influence autoimmunity in men; for epidemiological studies to determine the exact number of men who suffer with ADs; and for clinical studies to better understand just how these diseases manifest in men as opposed to women," added AARDA's Ladd.
The May 22, 2008 Edition of the Federal Register had another announcement that people with type 1 diabetes should be interested in. The U.S. Department of Health and Human Services, Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has issued draft guidance similar to the guidance I announced back in March on diabetes drug and biologic treatments -- the very same guidance that the American Diabetes Association thought was NOT important enough to comment on!
Because it is about as succinct as possible, I will simply share the information from the Federal Register:
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products" dated May 2008. The draft guidance document is intended to provide recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus.
The draft guidance is intended to provide assistance by identifying the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA).
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by August 20, 2008.
Submit written comments on the draft guidance to:
Division of Dockets Management (HFA-305) U.S. Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler Center for Biologics Evaluation and Research (HFM-17) Food and Drug Administration, 1401 Rockville Pike, Suite 200N Rockville, MD 20852-1448 Tel: (301) 827-6210
Initial Thoughts
In particular, one element I noted was that the FDA has provided guidance as to what an acceptable eligibility for C-Peptide count should be, insulin requirements, etc. and these may NOT be ideal. For example, by most counts, I would likely be considered eligible:
Subjects enrolled in trials of allogeneic islet cell products should have established Type 1 diabetes with a well-documented chronic history of severe metabolic instability. Subjects most likely to benefit from islet cell transplantation are those who cannot achieve acceptable metabolic control without experiencing multiple episodes of severe hypoglycemia, often with unawareness. Other eligible subjects may have lesser degrees of hypoglycemia, but still cannot be adequately managed with intensive insulin therapy alone. In screening subjects for clinical trials, we recommend that you document that such metabolic instability has persisted despite intensive diabetes management delivered by a qualified diabetes team for at least six months prior to enrollment.
However, thanks to their recommended requirement that subjects have a "stimulated C-peptide should be <0.3 ng/mL", I would NOT be eligible because my own stimulated C-Peptide count is 0.7 ng/mL, therefore I'm disqualified -- why? Because I've maintained sufficient control and therefore preserved the life of my few remaining beta cells, therefore that renders me as an ineligible type 1 diabetes patient? Give me a break. Is this really the best selection criteria? I don't know for sure, but I can tell you that I don't want a bunch of biotech industry geeks and drug company people making these determinations without ANY patient input as they have done historically, therefore I am commenting to make my concerns known.
Let me just close by noting that public comments are due on August 20, 2008 if you wish for your comments to be included in the FDA's evaluation!
While George recently discussed his Nintendo Wii, I found an earlier-generation Nintendo game to focus on for my post today. Thanks largely to Dino on TuDiabetes for sharing a YouTube video on a Super Nintendo game called -- get this -- "Captain Novolin", which according to Diabetes Health, retailed for $59.95! (They should have given this game away, but I digress ...) Here's the TuDiabetes description provided (which is somewhat more colorful than the YouTube description (this one is the nicer version, the video down below uses slightly more adult language ... LOL! Also, you may visit here for a list of videos), although there are a number of other funny reviews there, too!):
OK so you newbies probably have no idea, but a long time ago in the early 90's there was a video game system called the Super Nintendo, (Note: Super Nintendo was Nintendo's second-generation video game console and was sold between 1990-1993). Some genius decided to make a video game about diabetes and actually put it out. The result is what you see here...the mildy disturbing and somewhat insulting creation known as "Captain Novolin"...great...the diabetic superhero. Truly a low point in the world of video games and diabetes alike, although I do applaud the marketing effort. Well please enjoy this video with commentary and try not to laugh too hard.
"Captain Novolin" was, according to one writer, apparently developed by Sculptured Software (developers of such games as "Raid Over Moscow" and "Chavez 2"), published by Raya Systems in 1992 on the Super Nintendo, and funded by the Danish insulin manufacturer Novo Nordisk's U.S. subsidiary. I have no idea how much money they spent on this promotion.
In this game, apprently Captain Novolin is the first superhero to have diabetes. The goal of the game, according to Diabetes Health, was to help him stop the alien invaders and stay healthy by taking insulin, eating properly, and exercising. Jumpin' Jelly John, Fizzy Floyd, Larry Licorice, and Blubberman are just a few of the aliens Captain Novolin fends off during his journey to rescue Mayor Gooden, who has been kidnapped by them. The basic idea is that sugary, diabetes-promoting snacks are the enemies who can only be stopped by Captain Novolin, who is supposedly the diabetic hero (apparently Captain Humulin was asleep, which explains Lilly's insulin market share plunge from 82% in 2000 to just 43% in 2005 according to IMS Health data published in the Indianapolis Star) in the game.
Aside from the fact that there is no evidence that type 2 diabetes is caused by obesity, rather it tends to increase in tandem with body weight, but that does not render it a cause. There are plenty of obese people who do not have insulin resistance or type 2 diabetes, and there are plenty of thin people who do. Accuracy issues aside, the game's critics also claim that all Captain Novolin can do is jump, and what's more, they argue that the best disease tips are revealed at the end of nearly impossible play levels, so you'd have to be a national video game Olympic team member to get a significant amount of medical information from the game. And, if your kids are spending that much time in front of the TV playing video games rather than riding their bicycles or playing ball outside, then this game actually hurts the very message Novo was trying to communicate about healthy lifestyles.
I wouldn't quite call it the lowest point, although it is certainly one of the lower points in diabetes marketing. Aside from being a stupid game (at least in the view of at least one blogger) and mixing elements of both type 1 and type 2 together without explaining the difference, the more critical comments pertain to the message this game sent.
Game blogger SeanBaby called "Captain Novolin" the 4th WORST video game of all time saying "the game is so bad, you'll start rooting for diabetes" (it was, however, rated higher than E.T. for the Atari 2600 if that provides any point of reference). I suspect that the game was never updated because the corporate sponsor, Novo Nordisk A/S has since de-emphasized Novolin in favor of more costly and patent-protected insulin analogs, but we should remember that in the early 1990's, Novo Nordisk was a very distant second in terms of U.S. insulin market share, with maybe 20% share of the market relative to Lilly's commanding 80% share and Aventis didn't even sell insulin in North America back then. As a result, the company was a bit more eager to get their name out there to potential customers.
Anyway, back to the "Captain Novolin" videogame. Here are some screenshots:
And, of course, my personal favorite, the slightly edited version:
Finally, here's the video walk-through of this gem:
What can I possibly add to this commentary? All I can say is that I am thankful that when I was diagnosed in 1976, I received a children's booklet from Miles Laboratories (a subsidiary of Bayer now known as Bayer Diagnostics), the maker of Clinitest urine testing kits, entitled "Mr. Hypo(dermic) Is My Friend" which featured a cartoon insulin syringe that smiled (I didn't find that terribly comforting, but I guess it was someone's idea of "cute") and how to test and respond to the colored vials which ranged from blue (negative, the lowest reading possible) to orange (sometimes referred to as 4+, or ++++, which was the highest possible test result). Never mind that those test results were at least 4 hours old by the time they reached the urine, and that I could have died of a hypo(glycemic) [and you wonder why I thought a book entitled "Mr. Hypo Is My Friend" is a dumb title?] shock before it showed up there! But I can't honestly say that Captain Novolin was a real big improvement on that promotional gem from diabusiness, only that it is possibly a collectors item and I'd like to see as an emulator (apparently an emulator of this game IS available, visit here for details)!
Writer, speaker, brother, son, friend, spouse, advocate for people with autoimmune (type 1) diabetes, thinker, dreamer. Reading and writing is becoming a lost art, but we can learn a lot from reading the medical and scientific literature before drawing conclusions. The press publishes abbreviated facts to fit into limited space, I don't mince words or omit facts.
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I was, however, giving the finger to diabetes -- something everyone I think everyone with diabetes really should do, as its very therapeutic! Seriously, though, I just don't do hand signals very well -- I'd really be stuck if I ever had to learn sign language! I realize my posting is kind of delinquent, but this week was busy at work and I had a lot of stuff to do at home, too, so the blog took a back seat. Anyway, last weekend, I went down to Philly and participated in the TuDiabetes/Diabetes OC Blogger Meet-Up down there.
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