Medical Privacy: Americans Have Justifiable Reason to Be Concerned

As my friends, relatives and blog readers know, I believe strongly that medical privacy is an important but overlooked issue today. New York City is currently seizing the results of hemoglobin A1C tests (largely, although not exclusively, given to patients with diabetes) without even disclosing the results are being taken, providing no means for patients to opt-out of the registry itself, and has refused to disclose how (if they would at all) deal with a breach of patient privacy should that ever occur. Although the registry applies largely to people who live in New York City, the fact is that anyone from the suburbs who has labwork done in New York City or sees a physician in the city may also find themselves on the registry.

In April 2004, President George W. Bush called for the Department of Health and Human Services (HHS) to develop and implement a "strategic plan" to guide the nationwide implementation of health information technology (IT). The plan was to recommend methods to ensure the privacy of electronic health information. The U.S. Government Accountability Office (GAO) was asked to summarize its report which describes the different steps that HHS is (and is not) taking to ensure privacy protection as part of its national health IT strategy and identifies challenges associated with protecting electronic health information exchanged within a nationwide health information network.

According to a study released in late 2006, most Americans want electronic health data, but they fear for privacy. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 provides broad exemptions for "covered entities" to have unlimited access to our medical data, and according to the Patient Privacy Rights Foundation, an Austin, TX-based patient advocacy organization, there are well over 6,000 organizations who are considered "covered entities" which are exempt from HIPAA privacy rules. As some of my first posts of this year suggested, Americans have good reason to be concerned about the privacy of their medical information. Unlike the laws governing maintenence of our financial records (such as our credit reports), which are tightly controlled and have specific rules governing dispute resolution, no such rights currently exist for our medical records. If someone steals our medical information to obtain surgery, for example, the record-keepers are really under no legal obligation to resolve your complaints, and may take years to address them even if they do act in good faith to resolve the issues.

In February 2007, the GAO released its report which showed that overall, the Department of HHS was only in preliminary stages of protecting patient privacy, and has not yet defined an overall approach for integrating its various privacy-related initiatives and addressing key privacy principles, nor has it defined milestones for integrating the results of these activities. The GAO identified a number of key challenges associated with protecting electronic personal health information.

Specifically, they defined the key challenges as understanding and resolving legal and policy issues, such as those related to variations in states' privacy laws; ensuring that only the minimum amount of information necessary is disclosed to only those entities authorized to receive the information; ensuring individuals' rights to request access and amendments to their own health information; and implementing adequate security measures for protecting health information. As of today, few (if any) of these issues has been addressed by Congress.

Even more troubling was that I have learned that the so-called advisory panel of "experts" on patient privacy no longer exists -- all of the members apparently resigned (I would guess in disgust) at the lack of progress being made by HHS. These issues will only receive attention if we bring them to our legislators' attention! If you fail to express your concerns, you'll have no one to blame but yourselves if your medical records end up posted on the Internet because a billing and coding person in Pakistan has decided to use you as a pawn to get better pay unless you urge your legislators to act in your interests!

By the way, a postscript is in order here. Today, The Wall Street Journal's Health Blog featured a posting on the subject of how few doctor's offices have made their health records electronic, but a San Francisco-based company called Practice Fusion is offering doctors a free, web-based electronic medical records system with a few strings attached, the most notable being that the records will be open to data miners, presumably without the patients' consent. Not sure that looks like the best way to go!

Then Again, Maybe I Won't ... Or Will I?

I was thinking about what to call this post, and it occurred to me that the title to the kid's 1971 novel by Judy Blume seemed appropriate, given my mixed feelings right now -- except my dilemma is not about masturbation as the lead character's was in that controversial book, but whether I should return to using an insulin pump.

Last Tuesday, I visited my endocrinologist. Nothing really eventful as it has become so routine over the last 30 years I hardly even give it a second thought, except that on Tuesday, my endo asked me if I would be interested in a continuous blood glucose monitor. My initial reaction was, "Sure, but it kind of depends if can we get insurance to cover it." He told me he's had some success in getting them approved for about 6 patients (all type 1's, few type 2 patients have physiological issues causing hypoglycemia unawareness that plague many type 1 patients) so far, and that the best luck has been with those who have problems with hypoglycemia-associated autonomic failure (HAAF), another way of saying hypoglycemia unawareness. While some journals have reported overconfidently that the condition can be reversed, more comprehensive work done by Philip Cryer at Washington University at St. Louis have suggested that such claims aren't true for all patients with type 1 diabetes. I'm naturally one of the exceptions to that rule, as I cannot recall having the described "symptoms" of hypoglycemia since I was about 10 years old (I'm 38 now). I've dealt with that for quite a while now, and rely almost exclusively on "external" clues as they refer to it in Blood Glucose Awareness Training (BGAT), consisting mainly of knowing the time and activity profile of insulin and when I am most susceptible to undetected lows. But that can easily be screwed up by being busy with other things, or any unusual activity. I also test about 18 times daily, often at the slightest hint that I might be low, as its better to be safe than sorry. I have found that when its dropping rapidly, I may have some weakened symptoms, but if my blood glucose levels drop slowly, there is no sign of it. It makes managing this condition a real walk in the park, I assure you. That also means my insurance company pays a boatload for test strips. So far, they only bothered me once when I got first the script for that many strips, but since then, they've never asked about it. I guess having to pay for EMT service makes the cost outlay for test strips (especially given the deals managed care providers cut with manufacturers) look inexpensive by comparison!

I also have a history with insulin pumping, I wore an Animas R-1000 (or was it R-1200?) -- I don't recall, but the pump is pictured here. I wore an insulin pump for 3 years only to determine that the time and effort associated with it delivered only little improvement in glycemic control (I had great A1C's pre-pump), and fundamentally, I really hated being tethered to that device, my infusion sets pulled out after my first shower, and the whole thing was more of a pain in the ass than a great experience. I also discovered that my basal insulin needs were incredibly small (less than 0.5 units per hour consistently, except overnight - more on that in a second). The big lie that insulin manufacturers claim is that insulin analogs do not last very long, yet Novolog kept working for an agonizing 8 hours, Apidra for about 4 hours, only Humalog had no tail of activity for me, and now, thats not a "preferred" drug on my insurance formulary. As a result, I went back to shots about 2 years ago, and I found the return very liberating.

As I noted, my only real issue was overnight, as I tended to wake with more highs than I cared to remember until my doctor recommended switching to NPH, the "old" insulin that was supposed to become outdated (if you listen to all these insulin salespeople) with the emergence of long-acting analogs. But my morning highs were not due to the much talked-about "dawn phenomenon" that seemingly every diabetes educator loves to talk about, but slow (6-8 hours) digestion of proteins, which had proven itself time and time again while I was on the pump. At least I discovered what the issue was. The morning after Thanksgiving dinner usually resulted in a horrible high if I did not increase my basal rate! Today, if I don't eat any (meat) protein for dinner (vegetarian meals, as well as fish and eggs don't seem to work the same way), then I need to cut my overnight dosage of NPH significantly. Unfortunately, I worry that NPH's time on this earth may be limited. Its no secret that Novo Nordisk intends to stop making it (at least according to their Chief Financial Officer). Unfortunately, all of the long-acting analogs are designed to work for 24 hours, not 12 or 8. Right now, Lilly continues to make the old stuff because many people still use it. Collectively, the old insulin formulations accounted for $226 million in sales for Lilly during Q1 2007 vs. $340 million for Humalog, and that is even more remarkable considering the price tag for Humulin sells for about one-third the price of Humalog, meaning the number of users is significant. I should note that Humulin sales declined 3% in the U.S. during Q1, but grew 8% on a worldwide basis. For the time being, Lilly remains a thorn in Novo's global ambition to eliminate all forms of human insulin, assuring me access to the old stuff for a while anyway.

If they stop making NPH, I will have no other choice to go on bionic beta cells, not because of glycemic variability, but because of manufacturer greed. In fact, the other day, there was news from the UK that Novo Nordisk's Velosulin insulin would be withdrawn from the market earlier than expected, not because the demand wasn't there, in fact, quite the opposite. Novo Nordisk already stopped making the old standby and expected that once announced, British consumers would rush for its "modern insulins" as the company likes to call them, but that did not happen at all, as a result, the existing supplies will run out much faster than the company predicted. I can only congratulate my British peers for their tenacity, but they ended up being screwed nevertheless because that tenacity. OK, can one of the many generics manufacturers step in to fill the void here? So far, blockbuster mentality in the pharmaceutical industry has prevented that from happening, but the tide may be turning.

But back to my pumping dilemma, the good news is that newer insulin pumps enable microscopic basal rates, unlike when I was pumping -- when a pump that delivered as little as 0.5 units per hour broke the mold of the 1 unit per hour minimum standard on the old Minimed 507/508 series (that was why I chose the pump I ultimately ended up with). But if I were to return to pumping, it wouldn't be for improved control or glycemic stability, it would be because it offered the benefit of continuous monitoring and alarms for movements in the wrong direction.

Right now, Medtronic MiniMed offers combination continuous glucose monitor (CGM) and insulin pump called the Paradigm REAL-Time System, or a standalone product called Guardian® REAL-Time CGM. But MiniMed's pumps have little appeal to me with all that annoying tubing and the company's crappy but proprietary infusion sets. If I were to return to pumping, I'd prefer something like the Omnipod, which has no tubes at all. But I've discovered that insurance will routinely pay for a more expensive pump that includes a CGM, but not a CGM by itself. I cannot figure the logic -- the Paradigm REAL-Time System sells for $5,000 to $6,000 vs. about $1,500 for the Guardian alone. I guess past experience has suggested that A1C's come down with pumps, but shouldn't that be based on the starting point rather than an average net reduction? What about for an A1C that really cannot come down any further ... safely?

At this point, I'd really prefer just the Guardian, as if I return to pumping, I don't want the tubing. I can always get the Paradigm combined CGM and pump and not use the pump element, but I wonder if insurance would question paying for the Omnipod system if I already had a pump? Of course, the whole thing would be irrelevant if I changed jobs and had a new insurance plan, so maybe I should get the thing and look for a new job! For now, I am in the information gathering stage, but would welcome hearing from any others who have tried various CGM's, what their experience was in terms of getting insurance coverage, etc.

Copyright and My Cat

The other day, I was searching the Internet for something completely unrelated to diabetes and stumbled upon a posting that looked strangely familiar because it was actually MY 2006 Year-End Annual Review on developments on diabetes, except that none of the links I had in the original post were included, nor was there any acknowledgement or attribution of me as the author or even my blog address.

After investigating further, I discovered at least a half dozen of my other postings had been lifted, again without the links, pictures or attribution. That probably wouldn't have bothered me too much since I discovered that the site was registered to someone in Thailand (although the domain was registered with Yahoo! in the U.S. and hosted by a server in Texas) but what really got me mad was the fact that they lifted my post about my cat Phyllis and didn't even have the courtesy to include her picture!


Anyway, that brought me back to Amy Tenderich's post on the same issue and her recommendations on how to deal with this increasingly annoying problem. I would like to add a few simple, but useful steps. I would add that including some language on your blog about content rights likely helps your position should someone steal your work!

1. First, if you discover one of your posts somewhere online, identify the company that has registered the domain name where the copied post appears. This can easily be done at WHOIS.net. Note that this identifies only what company actually handled the registration of the site in question, not necessarily the company that hosts the site -- sometimes they are the same, but not always. Make note of the information listed -- it may be easiest to print a copy for reference.

2. Next, confirm the company that HOSTS the site in question. After some trial and error on my part, I discovered that you may conduct a domain name lookup at the following site, http://www.networksolutions.com/whois/index.jsp, which enables you to locate the site administrator or host. Again, copy or print the information you find there.

3. Finally, write a letter citing the copyright infringement. Amy recommended filing what is known as a Digital Millennium Copyright Act (DMCA) violation notice, which protects intellectual property and injured parties can file a detailed complaint for review by the web host. If the host does detect copyright infringement, they will issue a warning and can even shut down the offending site if necessary. As Amy recommended, I used the sample provided as my template. Include the web address of the offending site, as well as the site with your post, and send it to the HOST identified in step 2. There should be a mailing address, adminstrator, fax and e-mail address which you may use. I sent both an e-mail complaint, and a fax copy with my written signature just to make sure it gets to their lawyers.

If I have any further updates on this issue, I'll post them, but I hope this additional information saves you time and effort if this ever happens to you!

Don't Miss Tomorrow's Chat!

I'd like to take this opportunity to remind everyone that the first of the "Meet the Author" series of online chats will take place tomorrow (Tuesday, April 24, 2007, 9:00 PM EST) at the DiabetesTalkFest.com chatroom with author, person with type 1 diabetes and parent of a child with diabetes, James S. Hirsch!

There are many authors out there, and many authors have written about diabetes, but only a handful of authors write from actual, personal experience of living with the disease. When the self-help variety are removed from the equation, the number of books by authors with diabetes falls dramatically. Thats why I am especially pleased to announce a series of online chats with three prominent authors who just so happen to have type 1 diabetes. This is your opportunity to "meet the author" and share your experiences about living with diabetes, ask questions, or simply tell them what you enjoyed about their writing!

This will be a series of online chats held from late April through early June. The chats will be held in the DiabetesTalkFest.com chatroom. I previously noted that the site's operators had a registration process, but I now stand corrected. While there is a registration process for the message board, there is no prior registration procress needed for the chatroom at DiabetesTalkFest.com. However, the message board has a bunch of very informed people who are active and opinionated about their diabetes care, so you still may find registation a worthwhile process!

Chat with James S. Hirsch

The first chat will be with James S. Hirsch, author of "Cheating Destiny: Living With Diabetes, America's Biggest Epidemic" on Tuesday, April 24, 2007 at 9:00 PM EST. James Hirsch, a former reporter for The New York Times and The Wall Street Journal, is a best-selling author whose latest book, "Cheating Destiny" was published in late 2006. It is Jim's fourth book.

Jim has lived with type 1 diabetes himself since age 15; his brother, who was diagnosed with type 1 diabetes at age 6, is now a nationally prominent diabetes doctor in Seattle. And in the course of researching "Cheating Destiny," Hirsch diagnosed his son, then 3 years old, with type 1 diabetes, too.

While a diagnosis of diabetes in a child is traumatic for any parent, in some ways, Mr. Hirsch knows better than most parents what lies in his son's future: a lifetime of finger pricks, insulin injections -- and the ever-present risk of disability. Consequently, he brings a powerful, emotional perspective about this condition that goes beyond simply being a well-researched book.

Jim is also a principal of Close Concerns, a consultancy and publishing company that specializes in the business of diabetes. His work includes writing a column for a new patient newsletter on diabetes, called diaTribe. Jim has an undergraduate degree from the University of Missouri School of Journalism and a graduate degree from the LBJ School of Public Affairs at the University of Texas. He currently lives in the Boston area with his wife, Sheryl, and their children, Amanda and Garrett.

Chat with Deb Butterfield

The next chat is with an author who, for many people with diabetes, needs no introduction, Deb Butterfield, author of the book "Showdown with Diabetes". Deb founded the Insulin-Free World Foundation in 1996, and until she adopted her second daughter in 2005, Deb operated the DiabetesPortal family of websites, a group of diabetes-centric websites that was an interactive online diabetes community. The sites included a popular chatroom called DiabetesStation, a quarterly publication called Insulin-Free TIMES and a news page called DiabetesDailyNews just to name a few. Collectively, the websites at DiabetesPortal.com received approximately 3.5 million hits and 350,000 impressions per month.

Deb was diagnosed with type 1 diabetes in 1970 at the age of 10. After receiving a Bachelor of Arts in Economics from the University of Colorado, Deb worked for an executive search firm in New York City before starting her own consulting practice specializing in recruiting and strategic planning for financial brokerage firms in New York and London. But from 1992 to 1994, Deb's career was interrupted by the secondary complications of diabetes and a failed kidney and pancreas transplant. She had a successful kidney and pancreas transplant in 1994.

Deb was the 1998 recipient of the prestigious Scripps Whittier Confidence Award given annually to a person deemed to have made a significant contribution to improving the quality of life for people with diabetes. In June 2001, Deb was the first non-surgeon/researcher to be elected to the council of the International Pancreas and Islet Transplantation Association. In October 2001, she was likewise elected to the council of the Cell Transplant Society.

Deb currently lives in the St. Louis area with her husband Tom and her two daughters. The date for this program is still being finalized, but will most likely occur in early May.

Chat with Lisa Roney

Last, but certainly not least, is a chat with an author who broke new ground when her autobiography "Sweet Invisible Body: Reflections on a Life With Diabetes" was first published in August 1999. I'm speaking of none other than Lisa Roney. As some D-Bloggers may recall, Kerri interviewed Lisa back in February. I've had the pleasure of exchanging periodic e-mails with Lisa since 2005.

Lisa, who grew up in Tennessee, was diagnosed with type 1 diabetes in 1972 at age 11. Since then, diabetes has turned her life into an ongoing balancing act. She began her book after deciding that society had denied diabetes its stature as a serious illness. As she told Kerri in February, "There were books written by the deaf, the blind, those with cancer ... but nothing about diabetes."

Lisa told The New York Times reporter "As I tried to learn to understand myself, it was natural for me to look to books and there was not much out there. All kinds of other ailments have figured in literature and cultural studies, But for some reason, diabetes was not included."

"Sweet Invisible Body" was the one of the first books published during a relatively short timeframe earlier this decade regarding life with diabetes. (Deb Butterfield's "Showdown with Diabetes" was also among the books reviewed by The New York Times back in 2000, as was Andie Dominick's "Needles: A Memoir of Growing Up With Diabetes".) Since August 2003, Lisa Roney has been a professor who is on a tenure track at the University of Central Florida.

Lisa has told me that since her book was first published, she has since become a convert to the pump. She adds that her pump has made life much more "normal". Although she says "It's still a pain, and there are always issues with MiniMed, but I do love the pump. I sometimes even lose track of time now, and though that's not something that most people would think of as an accomplishment, I do!"

As with the "Meet the Author" session with Deb Butterfield, the date for the program with Lisa Roney is still being finalized, but I will be sure to update everyone as soon as I've confirmed dates and times. Consider this your personal invitation to meet these phenomental authors. I hope to see you there!!

Diabetes OC'ers I've Met

I was reading some of the Diabetes OC blog posts over the weekend, and it occurred to me that I have met a fair number (on both the East and West coasts) of fellow D-bloggers, but I'd never really counted them. So, I've assembed a list (I may be missing a few, so please don't take it personally if I've missed anyone -- its a work-in-progress):

• Allison (at the OC Dinner in NYC)


• Amy (at the ADA Scientific Sessions in Washington, DC in 2006)


• Art-Sweet (at the OC Dinner in NYC)


• Gina (at a DTF meeting in NYC)


• Julia & Olivia (at the OC Dinner in NYC)


• Kate (at the OC Dinner in NYC)


• Kelly (when I was in San Francisco in summer 2006)


• Kerri (at the dLife Roundtable Discussion)

I still have a few people I should meet who happen to live nearby, and I'm not sure I've met as many of you as Allison or Kerri, but I certainly hope to meet more of you either during my own travels, or if you decide to come to New York City. Its always great to meet others!

The Business of Diabetes: News from the Diabetes Industry

Just a quick update here on several major players in the diabetes business. More will likely follow, but these two are "hot off the press". My overview differs slightly from the major media's coverage of the same items in that mine are reviewed from the perspective of a person with diabetes.

Eli Lilly and Company Q1 2007 Earnings Down 39%

On Tuesday, Eli Lilly and Company reported a 39% drop in Q1 profit on various charges, although revenue rose 14% on higher sales of treatments for mental illness and impotence. The results were not completely unexpected, as Lilly acquired Icos LLC (a partner since 1998) for $2.3 billion. The acquisition allowed Lilly to gain complete control over Cialis, a drug used to treat erectile dysfunction. The initial attempt to acquire Icos failed under pressure from large institutional shareholders, causing Lilly to revise its inital offer. ISS, a proxy advisory firm, advised Icos shareholders to reject the proposal as "undervalued" but the acquisition was approved by Icos shareholders and Lilly completed its acquisition of the company on January 29, 2007. Also, in January 2007, Lilly entered into an agreement with OSI Pharmaceuticals, Inc. to acquire the rights to its compound for the potential treatment of type 2 diabetes. At the inception of that agreement, the compound was relatively early in the development stage (Phase I clinical trials). The charge related to this arrangement was $25.0 million and was included as an expense in Q1 2007.

Lilly executives said that increased prescription volume for several key products was playing a greater role in the overall sales increase, although Lilly has been relying more on price increases to drive sales growth in recent periods. The company's large endocrinology business, consisting largely of insulin and the new but rapidly-growing Byetta product accounted for just under 32% of the company's total revenue last year. But growth in that business (and insulin, in particular) has been significantly smaller (Humalog up 11% during Q1, Humulin up just 3% during Q1) relative to its other business lines, and that growth most likely reflects the overall growth in the number of diabetes patients worldwide rather than specific progress being made by Lilly in selling its products.

The company noted in its earnings presentation to Wall Street that it is "committed to re-acceleration of the Humalog franchise" and has increased its sales force by 40%, as well as launched 2 new insulin pens. However, given that rival Novo Nordisk already has a full line of insulin pens and announced in November 2006 its intention to increase its own sales force by another 800 (bringing the total to somewhere around 1,900 in the U.S.), analysts had every right to question the sincerity of company's commitment. The recent increases in the sales force for Lilly will most likely only result in putting the company on an equal footing with the Danish giant. Furthermore, Lilly's 2006 Annual Report (see pp. 3-4) said much the same.

"In the U.S., for example, our Sales Force of the Future now delivers true portfolio expertise, while allowing our sales representatives to be more productive than they were under the older system of detailing individual medicines" the report notes. However, some clinicians in the field believe otherwise, at least when it comes to the sales force truly understanding the complexity of diabetes. Another issue is that Lilly has not mentioned any long-acting insulin analog is even in development, therefore the company is lacking what its two global rivals (Novo Nordisk and Sanofi Aventis) do have: both a rapid-acting and long-acting analog, which suggests that the business is likely to struggle for the foreseeable future.

The bottom line is that Lilly continues to have drug development pipeline problems overall (with nothing for type 1 diabetes other than drugs for treating complications), and that the outlook has most analysts rating the company's stock a "hold" reflecting the weak outlook for earnings growth. Lilly said that the FDA had rejected its appeal of an "approvable letter" issued last year for the experimental Arxxant (which is meant to treat diabetic eye disease) which signals that the agency might give final approval to a drug only after certain conditions are met. The FDA reiterated its request for a 3-year study of the drug before considering approval. Lilly said it is considering its next steps for Arxxant, and has withdrawn its application for European regulatory approval of the drug. The Arxxant setback also contributed to an increase in expenses for the quarter.

"Obviously, the probability of success has lessened quite a bit" for Arxxant, said Lilly CFO Derica Rice in an interview.

Abbott Introduces New Blood Glucose Meter

This week, Abbott Diabetes Care announced that the company had received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) and was therefore launching the FreeStyle Lite™ blood glucose monitoring system. The FreeStyle Lite blood glucose monitoring system will be available in the U.S. beginning in May 2007.

At its core, the new system is very similar to the original FreeStyle system, offering test results in just 5-7 seconds and a very similar test strip design with what the company calls coulometric measurement, which is a patented, electrochemical technology designed for measuring tiny blood sample sizes, requiring a sample size of just 0.3 microliter.

However, most people with diabetes find the company's widely promoted advertising claim that its systems deliver "virtually pain-free testing" completely baseless, as the sample size required does not change the necessity of using a lancet in order to pierce the skin for blood, thus the "pain" element required is the same regardless of the sample size required. However, the new Abbott FreeStyle Lite system does have an automatic calibration feature that eliminates the manual coding step usually required by most blood glucose meters before starting a new vial of test strips. And similar to the company's popular FreeStyle Flash system, the FreeStyle Lite system includes a large, high-contrast display and a backlight for easy, on-the-go testing.

Another Drug Trade Group Opposes Legislation on Biogenerics

Today, yet another follow-up to the ongoing coverage I have given to the issue of legislation to support the introduction of generic insulin, including my original post, a follow-up based on NYT coverage, the news that legislators had finally introduced a bill that would force the FDA to permit generic biopharmaceuticals where patents had already expired, a few relevant follow-ups, including a story that a coalition of businesses' expressed their support for the bill in Congressional testimony, another story that outlined the estimated savings that generic insulin could have on the nation's healthcare budget, and finally, a story that the FDA believes that simple generic biologics like insulin may require less data for approval.

Today, a story was published about The Pharmaceutical Research and Manufacturers of America (PhRMA), which is a trade group representing the country's pharmaceutical research and biotechnology companies (including Eli Lilly and Company, Sanofi-Aventis and Novo Nordisk) which was not surprisingly, vehemently opposed to pending legislation that would enable generic biopharmaceutical medicines. The reason is they want to protect the perpetual monopoly their products now enjoy, something which most other medicines enjoy only for limited durations under Federal law. They join the Biotechnology Industry Organization (BIO), making similarly weak claims in order to protect their monopoly. The only problem is that PhRMA's claims are, at best, gross misrepresentations of the truth, if not outright lies. Both industry trade groups have opposition from AARP (formerly known as the American Association of Retired Persons), which is an extremely influential organization in legislative matters. The full story follows below, and you will note that I have added a few "editor notes" throughout the article designed to call attention to issues I believe are relevant to PhRMA's statements.

Let me go on the record as saying, the brand-name drug industry (sometimes referred to as big Pharma) has been treated very, very well in recent years, often at the expense of U.S. taxpayers. Don't expect to stop this, at best, you may be able to delay this legislation. Big Pharma will ultimately fail in stopping a train that has already left the station, as generic biologics WILL ultimately emerge. The real question is whether it will be done with big Pharma's cooperation and therefore in a way that pleases them, or whether it will be done against what is ultimately in the best interests of society as a whole (and therefore in a manner that works against big Pharma). Right now, the ball is in their court, and it looks like big Pharma wants to play dirty. Not a wise move.



Follow-On Biologic Pathway Bill Could Harm Patients, PhRMA Says
By Emily Ethridge for FDA News
April 18, 2007

PhRMA voiced opposition to proposed legislation that would create a pathway for the FDA to approve follow-on biologics because it will not ensure patient safety and will hinder innovation, the group said. While PhRMA does support a regulatory pathway for the products, the proposed bill does not ensure the best process for the FDA or consumers, the group added.

The "Access to Life-Saving Medicine Act" (S.623 and H.R.1038) does not require clinical trials to prove the safety and efficacy of follow-on biologics, PhRMA Senior Vice President Caroline Loew said. The trials are necessary because even minor differences between follow-on biologics and the brand versions would affect patients, she added. [Editor notes: The bill would give the FDA authority to decide on a case-by-case basis what additional clinical information is required before approval will be granted. Also, if PhRMA's statement is to be credible, then PhRMA is also obliged to support legislation mandating that its members must conduct additional clinical trials at their own expense in order to change their own manufacturing processes, something that the FDA has has not required of the industry previously.] The proposed bill would deny the FDA the authority to determine how to monitor an approved follow-on biologic, Loew said. [Editor note: Is this not what the FDA's "Good Manufacturing Practices" are designed to address?]

It would also allow for the replacement of a follow-on biologic with a similar product that could have a different make-up, Loew said. Physicians would not know if the drug they prescribed was that specific product or a similar one that could have different effects, putting patients in danger, according to Loew. [Editor note: This statement is absolutely false. On March 15, 2007, the head of the FDA, Dr. Andrew von Eschenbach said that copycat versions of biotech drugs may be relegated to a status below that of generic versions of traditional chemical drugs, meaning they would be considered only "similar" to brand-name drugs. The FDA commissioner later told The Associated Press that would mean knockoffs would not be interchangeable, or able to be substituted.]

Loew called the Express Scripts' claim that the regulatory pathway will save money "completely wrong." It is based on "unrealistic assumptions, outdated patient information, basic arithmetic errors and a failure to account for existing competition," she said. She refuted the main assumption that the market for follow-on biologics will match the market for small-molecule generic drugs.

The proposed legislation could also hinder pharmaceutical companies from doing innovative work, Loew added. Congress must consider how the proposed follow-on biologic legislation may affect companies' incentives to create new drugs, which is time-consuming, costly and risky, she said. [Editor note: If this statement is true, how does one explain the continued investment into small-molecule drugs, which already have generic competition?] A recent study estimated the average cost of developing a new therapeutic biotechnology product is more than $1.2 billion.

The House Oversight and Reform Committee recently heard a debate on the best way for the FDA to approve follow-on biologics. Lawmakers previously said the bill may be attached to the new version of the Prescription Drug User Fee Act, and PhRMA CEO Billy Tauzin has expressed his concern that it would weaken the act.

Pets and Diabetic Owners

This weekend, while I was filing my taxes, I also re-discovered some pictures that were buried in an out-of-the-way directory location on my computer's hard drive. Since few of my readers have ever met my cat, Phyllis, I figured it was time to introduce her below:



They say that many people start to look and behave like their pets while their pets acquire similarities to their owners. I'm not completely sure about that, but see what you think about my recent photo:



Seriously, I had this photo taken at Epcot Center about 2 years ago, but have never shared it with anyone. But this post seems to be an appropriate time. Phyllis does not have type 1 diabetes, but she has served as my lookout on occasion. For example, sometimes when I have gone low while sleeping, she will jump onto me and start kneeding gently to wake me up. If that fails, she then starts with her claws very lightly. Since Phyllis' mother was Siamese, she acquired her exquisite vocal skills from that side of the family, and she will begin talking incessantly until I get up to test. Sure enough, she is usually right.

Cats aren't as easily trained as dogs, but nevertheless, they do have the keen sense of smell that their canine counterparts have. I wanted to let my readers know that there are a few organizations that will train dogs (or provide instructions for you to train your own dog) in order to wake their owners with diabetes in the event of hypoglycemia. Given the recent study that showed people with type 1 do not wake from hypoglycemia, it can be very useful (especially for people who live alone) to have a pet with this type of skill.

There are two organizations I am aware of who help people seeking dogs (so far, cats haven't been trained for the reason noted previously), and I wanted to share these with you. These organizations are as follows:

Heaven Scent Paws
An organization that provides trained diabetic alert dogs, or provides instruction on dog training so that the dog is able to detect & alert their diabetic partners and support team (parents, spouse, friend, etc) to both low blood sugar (hypoglycemia) & high blood sugar (hyperglycemia). Heaven Scent Paws operates nationwide for those who are interested.
http://www.heavenscentpaws.com/

Dogs for Diabetics
An organization that provides dogs who are trained to detect hypoglycemia in patients with type 1 diabetes. The organization is based in the San Francisco Bay Area, and presently only offers its services locally. Their address is 1647 Willow Pass Road, #157; Concord, CA 94520-2611; e-mail: info@dogs4diabetics.com.
http://www.dogs4diabetics.com/

Finally, one of our own D-bloggers, Molly, recommended the following organization which is based in the Midwest. Her blog features more information about her experience with them and her dog. The organization's website includes info. about dogs for people with diabetes, although I did not find detail on whether they only serve a particular geographic area. Feel free to call them for more information if you're interested.

Great Plains Assistance Dog Foundation
The Great Plains Assistance Dog Foundation trains dogs to assist people with a variety of disabilities, including diabetes. Their mission is to assist individuals living with disability to gain greater independence and opportunity by use of trained working assistance dogs. Their address is 920 Short Street, PO Box 513, Jud, ND 58454, tel: (877) 737-8364 (toll free) or (701) 685-2290, e-mail info@greatplainsdogs.com.
http://www.greatplainsdogs.com

60% of People With Type 2 Diabetes Will Suffer Complications

Its no secret that the risk of complications is high with a chronic disease like diabetes, but the risk can usually be reduced with careful management. Some studies have suggested that in spite of far fewer patients living with the condition, complications for type 1 are as costly as they are for type 2, attributed to the fact that average age of diagnosis for patients with type 1 diabetes is 14 years, whereas the average age of diagnosis for patients with type 2 diabetes is 46 years. This means that while an average 60 year old with type 1 diabetes has lived with their condition for an average of 46 years, an average 60 year old with type 2 diabetes has lived with their condition for an average of only 14 years.

News from a study whose results were presented at the American Association of Clinical Endocrinologists (AACE) meeting in Seattle reported in Saturday's Los Angeles Times featured a very disturbing story. In spite of living with type 2 diabetes for a statistically significant shorter period of time than the average patient with type 1 diabetes, the incidence of complications among patients with type 2 diabetes is simply staggering. Notably, 3 out of every 5 patients with type 2 diabetes suffer from at least 1 significant complication of the disease. One out of every 10 has 2 complications, 1 out of 15 has 3 complications, and 1 out of 13 has 4+ complications. These sobering statistics were derived from the National Health and Nutrition Examination Survey (NHANES) report between 1999 and 2004 and combined with economic data from the Medical Expenditure Panel Survey (MEPS). The economic data came from the government's Medical Expenditure Panel Survey conducted during the same period. I should note, however, that the "complications" may be symptomatic of other co-morbidities associated with type 2 diabetes, not necessarily the condition itself. Still, the incidence suggest major issues for policymakers, especially at Medicare.

"We are using the tools [to control diabetes] too late, and spending too much money on complications," said Dr. Daniel Einhorn of the Sharp Diabetes Treatment and Research Center in San Diego in a teleconference releasing the findings.

"We knew that these complications were out there, but the sheer magnitude was a surprise," he said.

Aside from the human suffering exemplified by these statistics, the real danger is that type 2 diabetes is growing at an alarming (some say epidemic) rate and presents a unique challenge because unlike type 1 diabetes, the disease can be present for years without a diagnosis whereas the symptoms for type 1 develop very rapidly and are virtually impossible to ignore. Also, the challenges for patients to adjust to a new lifestyle required often make the adjustment much more difficult for many newly diagnosed type 2 patients. Even more troubling is the fact that the U.S. healthcare system is a model based primarily on treatment of acute illnesses, not chronic illnesses. This results in many patients struggling to obtain coverage for sufficient testing supplies, while complications such as dialysis resulting from nephropathy are automatically covered under Medicare.

As I noted in my posting earlier this week (see here), Pennsylvania recently took steps to address this issue, but we still have a long way to go before we are adequately prepared for the rapid growth in chronic diseases like diabetes.

Among other findings in the report:

• Congestive heart failure occurs in 7.9% of diabetics, compared with 1.1% of people without the disease. It costs an average of $7,932 per year per patient.


• Heart attacks occur in 9.8% of diabetics, compared with 1.8% of others. They cost patients $14,150 per year.


• Coronary heart disease occurs in 9.1% of diabetics, compared with 2.1% of others. It costs patients $6,062 per year.


• Strokes occur in 6.8% of diabetics, compared with 1.8% of others. They cost patients $7,806 per year.


• Chronic kidney disease occurs in 27.8% of diabetics, compared with 6.1% of others. It costs patients $9,002 per year.


• Foot problems, such as amputations and numbness, occur in 22.8% of diabetics, compared with 10% of others. They cost patients $4,687 per year.


• Eye damage occurs in 18.9% of diabetics. Comparable figures are not available for nondiabetics. It costs patients $1,785 per year.

An Open Letter to Eli Lilly & Co. Chairman & CEO Sidney Taurel

Amy Tenderich's open letter to Steve Jobs certainly created something of an electronic storm. Whether it results in material changes remains to be seen, but its well known that political advisors and increasing numbers of businesses are measuring opinion via the blogging universe (or as I call it, the blogosphere). I am directing my own letter to Eli Lilly and Company's Chairman and CEO Sidney Taurel:

Dear Mr. Taurel,

I write to you as both a shareholder, and a former customer. Recently, The Wall Street Journal's health blog posted a note to board members, executives and others at Eli Lilly and Company saying "You're No Johnson & Johnson". That was a comment on the fact that Lilly benchmarks your salary based on an average of so-called competing companies, including the diversified health care giant Johnson & Johnson, which operates in three separate business segments through more than 250 operating companies. The comments were not pretty, as your company has not exactly delivered superior returns to investors in recent years. Nowhere is this more evident than in your insulin business, which has seen its market share plunge from 82% in 2000 to 43% in 2006 according to data from IMS Health! I don't need to remind you that insulin still accounts for just under one-third of your revenues. In addition, you have recently shelved plans for a Virginia factory to make insulin because executives now believe that existing plants can meet demand.

Although I prescribed a method for Lilly to restore its insulin business, so far, no one has even acknowledged my comments, let alone taken any of my suggestions to heart. As Allie Beatty recently discovered, although her focus has been directed towards the American Diabetes Association, no one at Eli Lilly and Company would even entertain the notion of speaking to her about commercializing C-Peptide in spite of a growing mountain of evidence to support its utility. Instead, Lilly has responded by developing more medicines to treat type 2 diabetes, as well as with drugs to treat diabetes complications, at least according to a letter to the Indianapolis Star from your Chief Operating Officer, John C. Lechleiter. Does he really think we we are going to be thanking Lilly for the company's response to the diabetes pandemic when that consists of trying to sell us more drugs for complications that you might actually have prevented? Sorry, but that just won't fly with me.

Then there is the little issue with the company's reported fix for the sagging insulin business, notably the introduction of several new insulin pens. The Humapen Memoir pen is quite nice, but does not dose in 1/2 unit increments. The Humapen Luxura does dose in 1/2 unit increments, but has no memory. If Matt Beebe, Humalog brand team leader at Lilly USA is reading this, or even if J. Scott MacGregor who handles public relations for the Humalog brand at Eli Lilly and Company is reading, you guys might want to check into an official company response on the issue of why your company has knowingly decided to abandon its research into possibly including C-Peptide in its insulin formulations. I would remind you that nearly a decade ago (back in July 1997), Lilly helped fund a joint study with Washington University at St. Louis and the National Institutes of Health, and your company's own researchers discovered that in diabetic rats, treatment with C-peptide reversed vascular and nerve damaged blood vessels and helped to repair them. In the rats treated with C-Peptide, the nerve cells worked normally and vessels almost completely stopped leaking. Since then, additional studies have confirmed the usefulness of this element in humans, but instead of commercializing it, Lilly has responded to the diabetes pandemic by developing more drugs to treat complications.

The blogosphere is rumbling about your insulin business, but the tone is not one of praise. (For more recent comments, just check out some of the posts by looking at the "Recent Diabetes Headlines" sidebar if you need direction.) For one thing, Lilly has almost nothing in its new drug pipeline for type 1 diabetes, not even a long-acting analog that would put the company on a competitive footing with rivals Novo Nordisk and Sanofi-Aventis. The impression seems to be that the ADA, Lilly and its competitors don't really care about the needs of people with type 1 diabetes. For example, no long-acting analog is in development at Lilly according to recent investor presentations (certainly not in phase II or III trials), so patients are forced to buy products from your competitors. But these days, managed care often has "preferred" brands, and on some healthplans (I'm thinking of the massive United Healthcare account), Lilly is not a preferred brand.

I would also add my own recent posting about why are insulin manufacturers not working to resolve the issue of mixing their insulin analogs (or for that matter, adjunctive therapies such as Symlin, which your company jointly markets with partner Amylin Pharmaceuticals) in the same syringe or pump reservoir? This is a patient need that your company has not bothered to consider. Looking for a way to increase market share in insulin? Why not work on a Humalog/Symlin combination drug? We know that the development timeframes are usually shorter on these, and Lilly seems to like selling premixed insulin formulations (Humulin 70/30, Humulin 50/50, Humalog Mix 75/25, Humalog Mix 50/50, etc.) anyway, in spite of the evidence to suggest these don't really deliver superior glycemic control for patients with diabetes. But you ARE marketing two popular products which cannot presently be mixed, which is surely a lost opportunity. Consider funding studies like the one done at the Barbara Davis Diabetes Center in Colorado that showed that Humalog could indeed be mixed with Sanofi Aventis' Lantus long-acting insulin analog without adversely impacting glycemic control. After all, if you cannot offer a full product portfolio, at least you can make a compelling argument as to why its ok to use your insulin with one from a competitor, thus mitigating some advantages rivals have.

The bottom line is that the opportunity for Lilly to restore your insulin business does not necessarily mean more salespeople, although I realize you must restore those that were cut in 2001 when the patent for Prozac expired and to respond to Novo Nordisk's announcement to expand its salesforce by another 800 people. But the fact is that the Associated Press recently reported that New Hampshire has already, and other states (including my home state, New York) are also moving to ban pharmaceutical companies from using physician-level sales data in marketing to physicians. Besides, our doctors now have so many salespeople that they don't know what to do with them. And patients suffer by waiting a month or more for an appointment while your salespeople are consuming our doctors' time trying to sell your products.

I won't even comment on your Zyprexa business other than to note that this business may not have such an easy turn-around as Lilly's sagging insulin franchise. But in order to turn the insulin business around, you need to start listening to the needs of your customers!

Yours Truly,
Insulin Dependent

------------ END -------------

Type 1 Diabetes Vaccine Being Tested in Australia

While I was still trying to figure out an unexpected 326 mg/dL postmeal reading following the same premeal reading, the same meal and same insulin dosage, much of the blogosphere was discussing the recent news from Brazil.

Make no mistake, I am interested in the Brazilian development, but for long-termers with type 1 diabetes like me, the news didn't seem to offer much hope of remission, and the treatment itself was a type of chemotherapy akin to that used in cancer treatments which has its own risks and uncomfortable side-effects. Also, the treatment failed in the first patient and the authors suspect it was probably because their beta cell count was too low when they started the treatment. If true, that would render long-standing type 1 patients incurable with this method. But it does confirm that curing this disease is all about the immune system. In fact, a quote from the Los Angeles Times confirms my sentiment:

"We all realize that without addressing the problem at the level of the immune system, we'll never really beat Type 1 diabetes," said Dr. Francisco Prieto, who treats diabetics in his Elk Grove, California, practice.

However, my attention was instead called to a recent development in Australia that was announced on my birthday (April 1).


World first: Connor Ahles and mother Janine. According to the press, he is the first child in the world to be immunized against type 1 diabetes. Picture by Rob Leeson.

A boy named Connor Ahles was reportedly the first child ever to be vaccinated for type 1 diabetes. Connor was found to be at high-risk for type 1 using the methods previously used in the unsuccessful Type 1 Diabetes Prevention Trial 1 (DPT-1), which successfully identified "at risk" patients, although was unsuccessful in preventing the disease. However, the researchers believe that the dosage of insulin may have been too small to make a difference. Regardless, Connor Ahles will take an insulin vaccine through a nasal spray once a week for a year. The vaccine was developed by a team that included Associate Prof Peter Coleman from Royal Melbourne Hospital and Prof Len Harrison from the Walter and Eliza Hall Institute of Medical Research. Apparently, early tests have confirmed that the vaccination can encourage immunity against type 1 diabetes by activating protective immune cells which seem to be in short supply in people with some 80+ autoimmune conditions, including type 1 diabetes. Connor will be joined in the test by 300 children and young adults in the next two years. Hospitals across Australia and New Zealand will be involved.

While I think both developments are promising, I will reserve my excitement for the large-scale clinical trial results on both!

Pa. wants to lead in managing diabetes, other chronic illnesses

The latest salvo among states pushing for universal healthcare coverage came from Pennsylvania yesterday. Tuesday's Philadelphia Inquirer reported that Governor Ed Rendell (who was Philly's mayor when I lived there) wants to make the Keystone State a leader in chronic disease management, with particular focus on diabetes in his "Prescription for Pennsylvania" by implementing a model for managing chronic illness across the state.

"The beauty of the cost-savings initiatives is that they will save money and at the same time improve the quality and the caliber of the health care every Pennsylvanian gets," he said.

Ann S. Torregrossa, senior policy director in the Governor's Office of Health Care Reform added "What we are hoping is that by significantly changing the payment structure, we will encourage a really different way of providing chronic care."

While the plan is in its early stages, this does suggest that some large providers (notably the Commonwealth of Pennsylvania) could change the current paradigm by shifting focus away from the current acute illness perspective that dominates the American healthcare system more towards a system better equipped to manage chronic illnesses. Let's hope Governor Rendell is successful!

Will Bionic Beta Cells Be The Cure We're Waiting For?

When I was diagnosed with type 1 diabetes as a 7-year old kid in 1976, two of the popular television shows were The Six Million Dollar Man and The Bionic Woman. In fact, the Bionic Woman began life as her own television series right around the time I was diagnosed, so I hold a special affinity for Lindsay Wagner even if she's now pushing Sleep Number Beds. She still looks great!

In medicine, bionics means the replacement or enhancement of organs or other body parts by mechanical versions. Bionic implants differ from mere prostheses by mimicking the original function very closely, or even surpassing it.

This definition of bionics is best known to the general public in reference to the television series The Six Million Dollar Man and The Bionic Woman, in which the cyborg characters are referred to as the "bionic man" and "bionic woman". In the mid-1970s, when scientists in these popular TV series rebuilt a wounded, barely-living test pilot into the world's first bionic man, they made him "better, stronger, faster", but the field of medical bionics was the stuff of science fiction. Today, this field of science has progressed somewhat. For example, on the TV show Dancing with the Stars we have a contestant with a bionic leg -- maybe its just a prosthetic, but it certainly has not impeded her ability to dance!

As a kid, I was completely fascinated by the possibility of getting superhuman bionic parts (like a pancreas) to replace my own damaged goods. I reasoned that if The Six Million Dollar Man had super, bionic vision which enabled him to see as if he had built-in binoculars, and The Bionic Woman could hear footsteps from a mile away with her bionic ear, and both of them could run more than 60 mph and jump to the rooftops of 12-story buildings, what's not to like? Their bionic body parts were actually improvements upon the real things! In fact, I recall a scene from the Bionic Woman where Jaime Sommers hits a tennis ball so hard that it goes straight through her tennis racquet before skyrocketing into the outer reaches of space. She had super hearing, able to hear wispers from miles away, while Steve Austin had super vision able to see long distances. Plus, the bionic characters looked great.

For more than 30 years, I've been hearing about a so-called "artificial pancreas" (or perhaps better described as bionic beta cells, since the actual pancreas works just fine in people with type 1 diabetes, only the cell functions found in the Islets of Langerhans are compromised), but so far, this idea has remained the stuff of SciFi dreams rather than reality. However, these days, its starting to look like a real-life "artificial pancreas" could finally emerge in the next few years. After all, we finally have continuous blood glucose monitors, so the next logical progression is to close the loop. From what I am reading, however, it seems that what is more likely to emerge is a semi-closed loop system rather than a completely closed loop system. The difference being that unlike a completely closed loop system, patients would still have to input data about their meals into the device so that the computer algorithm doesn't get surprised by unpredictable rapid blood glucose changes caused by meals.

At the present time, the artificial pancreas is designed to deliver insulin, but forget about the other hormones like amylin or glucagon which are also part of a healthy metabolism. JDRF's Aaron Kowalski, who is managing the artificial pancreas project for JDRF was asked about glucagon and Symlin, and he acknowledged that they need to start looking at them. So far, they've made considerable progress with glucagon. In a recent announcement, JDRF noted that they are actually funding research into including glucagon (the necessary counterregulatory hormone that many type 1 patients have lost the ability to make) in its closed-loop system.

Apparently, researchers at Boston University have shown that glucagon can be used effectively in tandem with insulin in a closed-loop setting. In JDRF's studies using diabetic pigs, the insulin-glucagon combination rapidly increased glucose levels and helped maintain virtually normal-range levels without incidence of hypoglycemia! Perhaps the next phase will include Symlin, and maybe down the road, C-peptide, if we are lucky! Regardless, the trial results with glucagon were so encouraging that human tests could begin by the middle of 2007. No word on whether this might require yet another set of tubing and infusion set, but the way things are going, I would venture to guess it would. This raises an important issue the pharmaceutical industry is doing very little about, but really needs to consider.

When I was diagnosed in 1976, most insulin formulations could be mixed in the same syringe, but today, manufacturers caution against mixing any analogs (not that they've even bothered doing any extensive clinical trials to investigate this), and forget about other injectables like Symlin. More surprisingly, even analogs from the same manufacturer, including Novo Nordisk's Novolog and Levemir and Sanofi Aventis' Apidra and Lantus advise against mixing them in the same syringe. But the truth is that researchers at the Barbara Davis Diabetes Center in Colorado did do a small trial of mixing Lantus and Humalog and did not find a significant decline in blood glucose control. The real question is why are manufacturers not working to resolve the issue of mixing their insulins in a syringe or pump reservoir? I am well aware that the mechanism in analogs is accomplished by modifying the genetic structure of the insulin rather than via an additive such as zinc, but the pharmaceutical companies seem so busy pushing expensive analogs to enhance their bottom line, that they have lost sight of what patients need in terms of next generation treatments.

If there is any doubt, I would call attention to a January 2006 interview with Jesper Brandgaard, the chief financial officer of Novo Nordisk, who told CNBC/Dow Jones Business Video "We are taking our portfolio from being generic product, human insulin, onto a patent-protected insulin analogue. We are about to convert the market from human insulin onto insulin analogue. If we look at it globally, we have more than 40% of the market now converting to analogue. So we are actually in a different situation from most other companies. We are taking our portfolio from being generic product, human insulin, onto a patent-protected insulin analogue. So we are actually getting our portfolio on-patent, not off-patent."

Back to the bionic thing. I wish I could say that I'm as thrilled about the prospect of a "bionic pancreas" today as I was 30 years ago, but the way it looks, I doubt I'll be among the first in line to get one. First, there's the issue of all those damn infusion sets and sensors and their accompanying wires and tubes, largely meant to fuel the multi-billion diabetes industry, not make patients feel better about themselves. Who the hell wants to wear all of that shit? Jaime Sommers was an incredible hottie, but if she wore an artificial pancreas, she'd look more like a transistor radio than a supermodel! With the artificial pancreas in its current generation, we'll get multiple tubes, wires and end up looking like dogs with several different leashes still attached. And I won't even discuss the permanent damage to patients' subcutaneous tissue, an issue that manufacturers are claiming doesn't exist in spite of evidence that some doctors like Dr. Bernstein argue is a very real issue.

But the main reason for my reservations about an artificial pancreas is that unlike the bionic parts that Steve Austin and Jaime Sommers had, the early bionic pancreas is, well ... not exactly a huge improvement upon the real thing, and in some ways, is worse than current treatments for reasons I've already noted. There is little doubt it will be expensive, and the manufacturers (such as DexCom and Metronic Minimed) have done very little to get their continuous monitors covered by insurers. Instead, they are leaving most of the work up to nonprofit organizations like JDRF. Aside from the cost, these things will still be subject to mechanical failure. Then there's the issue about the algorithm used -- no matter how many clinical trials the finished product undergoes, they always seem to work differently for me (and not as predicted), which has been my experience with every insulin analog ever created. As a result, I harbor a tremendous terror that it will deliver too much insulin and someday kill me given my issues with hypoglycemia-associated autonomic failure (which incidentally, never corrected itself as I was promised).

Oh, and did I mention the issue of all those unattractive tubes and wires, which is a big negative that seems to be an afterthought? If not, its worth repeating. My cat would probably love all those tubes and wires, but I won't. But in order to keep feeding the diabetes industry with ever more profits, there needs to be infusion sets which must be replaced every few days, as well as a new sensor that also needs to be replaced fairly regularly. Somehow, the whole bionic thing just doesn't look as appealing as it did in 1976. In the television depictions, the bionic characters were "better, stronger, and faster" than ever before, but patients with diabetes will probably not be any of these things. As Amy Tenderich recently wrote, they need to take design more seriously before I will even consider it.

Invitation to 3 "Meet the Author" Online Chats

There are many authors out there, and many authors have written about diabetes, but only a handful of authors write from actual, personal experience of living with the disease. When the self-help variety are removed from the equation, the number of books by authors with diabetes falls dramatically. Thats why I am especially pleased to announce a series of online chats with three prominent authors who just so happen to have type 1 diabetes. This is your opportunity to "meet the author" and share your experiences about living with diabetes, ask questions, or simply tell them what you enjoyed about their writing!

This will be a series of online chats held from late April through early June. The chats will be held in the DiabetesTalkFest.com chatroom. I previously noted that the site's operators had a registration process, but I now stand corrected. While there is a registration process for the message board, there is no prior registration procress needed for the chatroom at DiabetesTalkFest.com. However, the message board has a bunch of very informed people who are active and opinionated about their diabetes care, so you still may find registation a worthwhile process!

Chat with James S. Hirsch

The first chat will be with James S. Hirsch, author of "Cheating Destiny: Living With Diabetes, America's Biggest Epidemic" on Tuesday, April 24, 2007 at 9:00 PM EST. James Hirsch, a former reporter for The New York Times and The Wall Street Journal, is a best-selling author whose latest book, "Cheating Destiny" was published in late 2006. It is Jim's fourth book.

Jim has lived with type 1 diabetes himself since age 15; his brother, who was diagnosed with type 1 diabetes at age 6, is now a nationally prominent diabetes doctor in Seattle. And in the course of researching "Cheating Destiny," Hirsch diagnosed his son, then 3 years old, with type 1 diabetes, too.

While a diagnosis of diabetes in a child is traumatic for any parent, in some ways, Mr. Hirsch knows better than most parents what lies in his son's future: a lifetime of finger pricks, insulin injections -- and the ever-present risk of disability. Consequently, he brings a powerful, emotional perspective about this condition that goes beyond simply being a well-researched book.

Jim is also a principal of Close Concerns, a consultancy and publishing company that specializes in the business of diabetes. His work includes writing a column for a new patient newsletter on diabetes, called diaTribe. Jim has an undergraduate degree from the University of Missouri School of Journalism and a graduate degree from the LBJ School of Public Affairs at the University of Texas. He currently lives in the Boston area with his wife, Sheryl, and their children, Amanda and Garrett.

Chat with Deb Butterfield

The next chat is with an author who, for many people with diabetes, needs no introduction, Deb Butterfield, author of the book "Showdown with Diabetes". Deb founded the Insulin-Free World Foundation in 1996, and until she adopted her second daughter in 2005, Deb operated the DiabetesPortal family of websites, a group of diabetes-centric websites that was an interactive online diabetes community. The sites included a popular chatroom called DiabetesStation, a quarterly publication called Insulin-Free TIMES and a news page called DiabetesDailyNews just to name a few. Collectively, the websites at DiabetesPortal.com received approximately 3.5 million hits and 350,000 impressions per month.

Deb was diagnosed with type 1 diabetes in 1970 at the age of 10. After receiving a Bachelor of Arts in Economics from the University of Colorado, Deb worked for an executive search firm in New York City before starting her own consulting practice specializing in recruiting and strategic planning for financial brokerage firms in New York and London. But from 1992 to 1994, Deb's career was interrupted by the secondary complications of diabetes and a failed kidney and pancreas transplant. She had a successful kidney and pancreas transplant in 1994.

Deb was the 1998 recipient of the prestigious Scripps Whittier Confidence Award given annually to a person deemed to have made a significant contribution to improving the quality of life for people with diabetes. In June 2001, Deb was the first non-surgeon/researcher to be elected to the council of the International Pancreas and Islet Transplantation Association. In October 2001, she was likewise elected to the council of the Cell Transplant Society.

Deb currently lives in the St. Louis area with her husband Tom and her two daughters. The date for this program is still being finalized, but will most likely occur in early May.

Chat with Lisa Roney

Last, but certainly not least, is a chat with an author who broke new ground when her autobiography "Sweet Invisible Body: Reflections on a Life With Diabetes" was first published in August 1999. I'm speaking of none other than Lisa Roney. As some D-Bloggers may recall, Kerri interviewed Lisa back in February. I've had the pleasure of exchanging periodic e-mails with Lisa since 2005.

Lisa, who grew up in Tennessee, was diagnosed with type 1 diabetes in 1972 at age 11. Since then, diabetes has turned her life into an ongoing balancing act. She began her book after deciding that society had denied diabetes its stature as a serious illness. As she told Kerri in February, "There were books written by the deaf, the blind, those with cancer ... but nothing about diabetes."

Lisa told The New York Times reporter "As I tried to learn to understand myself, it was natural for me to look to books and there was not much out there. All kinds of other ailments have figured in literature and cultural studies, But for some reason, diabetes was not included."

"Sweet Invisible Body" was the one of the first books published during a relatively short timeframe earlier this decade regarding life with diabetes. (Deb Butterfield's "Showdown with Diabetes" was also among the books reviewed by The New York Times back in 2000, as was Andie Dominick's "Needles: A Memoir of Growing Up With Diabetes".) Since August 2003, Lisa Roney has been a professor who is on a tenure track at the University of Central Florida.

Lisa has told me that since her book was first published, she has since become a convert to the pump. She adds that her pump has made life much more "normal". Although she says "It's still a pain, and there are always issues with MiniMed, but I do love the pump. I sometimes even lose track of time now, and though that's not something that most people would think of as an accomplishment, I do!"

As with the "Meet the Author" session with Deb Butterfield, the date for the program with Lisa Roney is still being finalized, but I will be sure to update everyone as soon as I've confirmed dates and times. Consider this your personal invitation to meet these phenomental authors. I hope to see you there!!

Easter Basket Case: Equal Sues Splenda

As my readers may recall, on Halloween, I featured another story on recent competition that had emerged in the market for glucose tabs. With today being Easter, perhaps the second or third largest day for U.S. sales of candy (used largely to fill Easter Baskets), I wanted to keep this theme going by informing my readers of a nasty battle that is now underway in the courts between Merisant (the maker of Equal) and Johnson and Johnson (the U.S. marketer of Splenda). People with diabetes are no doubt familiar with both of these products. It is also worth noting that JDRF's new CEO, Arnold W. Donald, is the former CEO of Merisant, so it is indeed a small world, after all, as the Disneyland ride likes to note!

Essentially, Merisant is suing J&J claiming that the claim that "it tastes like sugar because its made from sugar" implies that Splenda is natural, when, in fact, Splenda is no more natural than Equal from a purely scientific standpoint.

Also, the recurrent rumors about Equal causing various cancers and other health ailments have finally been laid to rest by a study released last fall by the NIH which proved that all of these claims unsubstantiated, and in fact, Equal may be safer than Splenda. While some people claim there is a different taste, the reality is that these are personal preferences, not scientifically-backed claims. Regardless, this article from this weekend's Wall Street Journal should be interesting reading.

How Sweet It Isn't: Maker of Equal Says Ads For J&J's Splenda Misled

Chemistry Lesson for Jurors

By Avery Johnson, The Wall Street Journal
April 6, 2007; Page B1

A battle between makers of artificial sweeteners stands to turn bitter next week, as a trial begins over what a judge has termed a veritable "sugargate."

The fight pits Merisant Co., the maker of Equal and NutraSweet, against health-care giant Johnson & Johnson, which sells market-leader Splenda. Merisant alleges that a J&J consumer-products unit, McNeil Nutritionals LLC, deliberately confused consumers over whether Splenda is a natural product.

The dispute could prove to be a black eye for J&J at a time when sales tactics at its drugs and medical-device units are already under scrutiny. Revenue from Splenda is a tiny slice of J&J's $53 billion in annual sales, but the case is the first in a string of pending suits that could threaten the reputation of a highly visible product.

Splenda entered the market in 2000, touted as a breakthrough because the process used to make it includes sugar. Ads for Splenda carried the line "Made from sugar, so it tastes like sugar" followed by "But it's not sugar."

Unlike other artificial sweeteners, Splenda's chemical composition can stand up to heat and freezing, making it suitable for cooking. Capitalizing on that advantage, McNeil has rolled out a series of related products: a baker's bag in 2003, a sugar blend for baking in 2004 and a brown-sugar blend in 2005. The brand is an ingredient in over 4,000 products, including those of Coca-Cola Co. and Nestlé SA's Edy's brand, and it's offered at 65 food chains in the U.S., including outlets of Starbucks Corp. and McDonald's Corp. Splenda was also adopted widely by popular diets such as the Atkins Nutritional Approach. On its Web site, Atkins permits dieters to choose most any artificial sweetener but says, "the Atkins preference ... is sucralose [Splenda], the only sweetener made from sugar."

McNeil and Merisant don't break out sales for their products, but Splenda is now the runaway leader in the sugar-substitute category with $212.3 million in 2006 U.S. sales, according to market-research firm Information Resources Inc., while Equal brought in $48.7 million.

Merisant alleges that Splenda sales shot up in 2003 after McNeil shifted marketing tactics to more aggressively -- and inappropriately -- tie Splenda to sugar. For example, Splenda ads dropped the final "But it's not sugar" statement from their tagline, and, around 2003, a new campaign took off that was packed with sugar imagery. "What are little girls made of? Splenda and spice and everything nice," went one ad. Others featured images of children putting Splenda in their drinks and being fed treats baked with the sweetener. Merisant also alleges that Splenda's sweet taste has nothing to do with whether its chemistry includes sugar. McNeil says that it has used the same promotional claims for Splenda -- "Made from sugar, tastes like sugar" and "Made from sugar so it tastes like sugar," in all packaging and advertising since its launch. It declines to comment on having dropped the "But it's not sugar" line. McNeil stands by its claims. Merisant lodged a complaint with the National Advertising Division of the Council of Better Business Bureaus in late 2004, four years after Splenda's launch and two years after privately complaining to McNeil. McNeil then sued Merisant in Puerto Rico, seeking a judgment that its ads are not misleading, and alleging that Merisant complained after a judge in Puerto Rico had barred Merisant from selling a product with packaging that closely resembled Splenda's. Merisant responded by filing suit in the U.S. District Court for the Eastern District of Pennsylvania in November 2004, where the case will now be heard before a jury. McNeil then consented to the dismissal of its case in Puerto Rico, according to a memorandum by Federal District Court Judge Gene E.K. Pratter.

Jurors will have to endure a heavy-duty chemistry lesson. One of Splenda's main ingredients is sucralose, a chemical entity manufactured in a lab that McNeil makes from sucrose, or table sugar.


Its patented technique replaces some of the chemical groups found in sugar with chlorine, creating a substance that McNeil says is not recognized by the body as a carbohydrate and has no calories. Merisant alleges that Splenda shouldn't be able to claim that it's "made from sugar," since sugar is not one of the ingredients on its product label and the use of the phrase misleads consumers into thinking the product is natural or contains sugar. McNeil said in a statement that Splenda is made from pure cane sugar by a patented process that makes three atomic changes to the sugar molecule.

All sides agree that Splenda is not a natural product. A Web site run by McNeil called Splendatruth.com states that sucralose "is not natural," and that Splenda marketing materials "do not represent the product as 'natural.'" But the chemistry may not be intuitive to the average consumer, and Merisant argues that McNeil has intended for consumers to be confused. Some of McNeil's own documents may bolster that argument, Judge Pratter noted in a March 2 ruling sending the case to a jury trial.

"Merisant cites to internal McNeil documents or third-party documents provided to McNeil that indicate that, at the very least, McNeil was aware that the perception existed among consumers that Splenda was 'natural' or was 'not an artificial sweetener,"' Judge Pratter wrote.

She cited an advertising presentation by an outside consultant for McNeil that listed among "carefully considered decisions" the choice to position Splenda as "not artificial."

The presentation said, "Think of it as sugar without the calories" and the message should convey a "strong 'natural,' 'healthy' playback."

Other documents show company executives walking a fine line. An April 22, 2002, letter from McNeil's then-president Colin Watts told Merisant's then-chief executive Arnold Donald that "Splenda has never been promoted as 'natural.'" But shortly after, a document cited by Merisant from McNeil's files to the court noted that the consumers' perception of Splenda as "not an artificial sweetener" was one of the largest gains in response to the company's marketing.

A May 5, 2004, email from an outside consulting firm to McNeil executives discusses perception research for new packaging for Splenda's sugar-blend-for-baking product. The consultant wrote that there is "some confusion" among consumers about the main Splenda product.

"About 40% to 50% of respondents think that base Splenda contains sugar/is a mix of Splenda and sugar (most likely due to our made from sugar/tastes like sugar messaging)," the consultant's report states.

Eric Paul, McNeil's head of market research, responded in an email on May 6, 2004, that "you're still getting consumer confusion around base product (ie. you put the statement 'contains sugar' in front of consumers as it relates to base Splenda and you're going to get a sizable percentage agreeing with it)." McNeil has sought to have the documents excluded from the trial, arguing that the survey was flawed.

McNeil said in a statement that Merisant's allegations are "based upon its selective, out-of-context quotation from documents obtained by its lawyers from McNeil Nutritionals' files" and that none of them reflect an intention to confuse consumers. "To the contrary, the documents demonstrate that McNeil Nutritionals consistently rejected experimental advertising approaches that might have led to consumer misunderstanding." McNeil's arguments and court filings claim that Merisant waited too long to bring suit, having realized belatedly that it had been outmaneuvered on the marketing front.

The trial will provide a test for some other cases now pending. The Sugar Association and McNeil have filed suit against each other over advertising; the cases are scheduled to be heard in November by the U.S. District Court for the Central District of California.

The Sugar Association's suit claims that McNeil engaged in misleading advertising to draw consumers away from sugar.

McNeil alleges that the Sugar Association and its members engaged in false advertising aimed at misleading consumers about Splenda.

Write to Avery Johnson at avery.johnson@WSJ.com

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