Throwback Thursday: Season's Greetings 2008

In honor of the holiday, today I'm taking the easy way out. Last year, I posted this and although I had to update the video links since YouTube cracked down on copyright infringements, these work (I have to admit that I cheated a bit when I updated virtually every link in my previous postings, so I found updates at that time, but this posting seems appropriate given the date). Best wishes to everyone for a happy holiday! Catch up with everyone again soon!

I'm can't hope to match George's vlog postings (see here or here) or even Kerri's eloquent holiday if not-quite-poetic (it was, after all, similar to an already copyrighted work, but it was still great) posting, but I did think that some humorous, cynical holiday spots from SNL might be appropriate for the day, so here are my contributions:

First, in honor of the annual Charles Schultz "Peanuts" holiday special, is this:




And then, to honor (or make fun of) the annual Rankin/Bass puppet specials (Rudolph The Red Nosed Reindeer, The Year Without A Santa Claus, Santa Claus Is Coming To Town), this is another humorous parody:



More serious content will be featured again in the coming days, but enjoy the holidays!

Timewarp Tuesday: The Needle And The Damage Done

Although it's not something people with diabetes like to think about, the fact is that even by following the rules of diabetes management, sometimes even the most "compliant" patients end up suffering complications. No study, not even the much-ballyhooed DCCT has ever proven that glycemic control alone can guarantee a life free of diabetes complications, whose etiologies may be caused by autoimmunity/inflammation or other factors besides inadequate glycemic control. Renal (kidney) failure is among the most severe so-called diabetes complications, as without an organ transplant, patients must endure routine dialysis several times each week or face certain death. For that reason, any person in the U.S. who goes into renal failure is automatically covered by Medicare, regardless of their age. However, thanks to both kidney AND pancreas transplantation, some of the patients suffering from this terrible disease complication can begin life again, only WITHOUT diabetes.

A number of prominent diabetes advocates believe this is an under-utilized procedure, including Showdown With Diabetes author Deb Butterfield. To be sure it's major surgery, but patients who are already suffering from kidney failure are typically much better off than to go with a kidney-only transplant, as they'll have to take immunosuppressants for life anyway, and to put a transplanted organ into the toxic environment characterized by glycemic instability which destroyed their own kidneys is quite illogical. However, those with living donors may need to wait on an organ registry for pancreas transplant and are eligible to have it done as a follow-on procedure. Still, the experience can be profoundly life-altering, and very often, in a good way!

Back in 2000, reporter Scott Bowles, who was diagnosed with Type 1 diabetes at age 14, chronicled his wait for a kidney-pancreas transplant in the pages of USA Today. At the time, he was a reporter for the Los Angeles bureau of that newspaper. But on Jan. 12, 2000; his wait ended. Scott chronicled his story (or in the book with the aforementioned title, ISBN: 0738846716, which is out-of-print now, but you may try your public library first) which I saved here. I'm not sure how long I'll maintain my version of sight, however, as Mr. Bowles himself has saved me the trouble of maintaining that archive at his own, personal website here. Below is the transcript from his incredibly moving and interesting piece of journalism.



THE HOSPITAL JUST CALLED - YOUR ORGAN IS IN
By Scott Bowles (USA Today, p. 10D)



Nov. 16, 1999

My blood sugar level is soaring, and I have to take an insulin injection before I pass out. I try to stab the needle into my thigh, but it's too blunt. It won't penetrate my skin. I scramble around looking for a razor blade, a sharp pencil – anything to slice open my leg to get the medicine in.

I start awake and find myself rubbing my leg. Another nightmare. I roll out of bed, fix my insulin and grab my right thigh, the place where I have jabbed more than 15,000 shots.

Then I take another.

Dec. 19, 1999

My boss, deputy managing editor Mindy Fetterman, calls me into her office. They want to give me a job in the Los Angeles bureau of our paper.

I'm elated. A national bureau position offers freedom and variety I've always sought on the job. Plus, my wife, Julie, spent four years in California, and the idea of returning has intrigued her since I've known her.

There will be hurdles, though, thanks to my diabetes. For more than a year, I've been on the wait list for a kidney-pancreas transplant. A new pancreas would rid me of diabetes, and a new kidney would restore the function irreparably damaged by the disease I've had for 20 years.

While we don't expect organs right away – some people wait more than three years for a kidney – there's no telling when my time will come. A move would mean changing our health insurance, and there's no guarantee a new carrier will pay for a transplant. And if the organs arrived in the middle of a cross-country move from Washington, D.C., it would be a logistical nightmare.

Mindy and my other editors don't flinch in their support. Address transplant matters when they arise, they say, and bureau matters will work themselves out. Julie and I plan a trip to scout out Los Angeles. One last assignment in New York City and I'm West Coast-bound.

Jan. 11, 2000

I'm sleeping in a Manhattan hotel when the phone rings about 2 a.m. It's Thuan Elston, a copy editor. She's breathless. "Scott, the hospital just called – your organ is in. You have to call them right away."

I'm out of bed in a heartbeat, as confused as I am charged. The hospital had my pager number. Why wasn't I beeped? Then I look at my beeper.

I was so tired from the flight that I had left the pager on its vibrate signal and attached to my belt on a cushioned chair. It had been screaming silently for nearly an hour.

I call the transplant center where I'm on the wait list, Fairview- University Medical Center in Minneapolis, and learn that a 21-year- old man has died in an accident in Fargo, N.D. His kidney and pancreas, the nurse says, "are a near-perfect match" for my body.

I guess the call would have been a shock no matter when it came. Until now, the idea of a transplant, of life-altering surgery, floated beyond my grasp. Until it happens, it's hard to imagine it ever will.

But this call is especially surprising. Doctors had told me that because I was in relatively good health, my best shot at a kidney would be from a living donor. Only four days earlier, one of my closest friends, Michael Ingram, had cleared the final medical exam and was ready to donate one of his. This means he'll stay off the operating table. My greatest transplant concern is not its chances for success but its risk of putting someone I love under the knife.

Without pondering, I tell the nurse yes, I'll take the organs. She tells me I have to move fast. Once organs are harvested from a body, they can survive only 24 hours.

I phone Julie, and excitement overtakes us. We will plan early morning flights for Minnesota and will rush to the hospital.

I call my parents and friends and tell them the news. Finally, I get a chance to speak with Michael. I can tell by his voice he is both happy and deflated. He takes a quiet tone. "I feel like I let you down," he confides. "You don't think I said something to the nurses that ruled me out, do you?"

I'm nearly overcome by emotion. Donating a kidney would have meant getting cut nearly in half and spending weeks in bed. Yet Michael was ready to do this – wanted to do this – for me. I tell him he's crazy, that this is the best we could have asked for. Besides, I joke, he's not out of the woods yet. If this transplant fails, he's still a match.

In my heart, though, I do not worry about failure. Seeing what people have gone through to give me a shot at a new life assures me this surgery will work. I have been too blessed for it not to.

Jan. 12, 2000

This plane is never going to land, I think. Minnesota is in the grips of a snowstorm, and my plane bucks like a mechanical bull on its descent to the airport.

But we do land, and I find Julie waiting for me at the terminal with a car rented and ready to go, as well as maps to the hospital.

Driving there is tricky. The snow is swirling and sticky. Twice I get out to chip ice off the windshield and wipers. Once I drive off the road. Maybe the fates have changed their minds.

When we arrive, the hospital is waiting for me. A nurse leads us into a room, and medical personnel swarm. Some bring paperwork; others, needles and vials. A nurse sits next to me and explains what's to come. Doctors won't take out my pancreas and kidneys; they'll simply add two more organs, right in the belly. Despite the gravity of the pending surgery, Julie and I are in high spirits. We joke that maybe doctors could throw in a new stomach while they're at it. Mine has been acting up.

The nurse laughs, then gives me a more serious look. "It's going to be a rough couple miles ahead for you," she says. Surgery will take at least seven hours. There are risks of infection, reaction to anesthesia, even heart attack. After surgery, I'll be full of tubes, needles and pain. The hospital stay routinely runs three weeks, with six weeks of rest at home. "Down the road, you'll feel like a million bucks," she says. "But it's going to be tough at first."

Still, I'm ready. For 20 years, I've viewed diabetes as an enemy I could never get the best of. My chance to finally confront it, perhaps defeat it, is here.

After being undressed and scrubbed down, I'm placed on a bed and wheeled downstairs, where surgeons and my organs await. The parade of doctors and nurses continues. Some tell me what they'll be doing during the operation; others take my vital statistics.

"I have to say, you're the healthiest transplant patient we've seen here in some time," a doctor says.

For the first time, my confidence wanes. Am I entering this too quickly? Should I have waited to grow sicker or go on dialysis? What if advancements two years from now make transplants unnecessary? I pull Julie close and ask her if I'm doing the right thing. She leans in, tells me it's not too late to change my mind.

I shake my head. In my heart, I know it's right. Being healthy, doctors have told me, will help speed my recovery. And dialysis is a prospect I never want to face.

More important, I'm tired of conceding days to diabetes. I'd rather lose to something like a transplant -- or a train wreck or crazed gunman, anything – than to the disease that I've fought since I was a boy.

Doctors prepare to roll me into the operating room when my mother, father and Michael hustle into the room. My folks are scared, I can see in their faces. But they are also relieved to have seen me before surgery. I hug them all, tell them I'll see them on the other side. Julie squeezes my hand, kisses me, and I'm off.

The operating room, from my horizontal perspective, is all lights and bright ceiling tile. And freezing. They lift me off my bed and onto a narrower pad in the center of the room. "The anesthesia will take effect in a minute," a surgeon says. "The room will start to spin a little, and you'll be out."

It does, and I am.

Jan. 13, 2000

Today I'm not diabetic.

Not that I really know this. I'm barely conscious in my room, doped on painkillers and tethered to every possible tube and monitor. Julie's is the first face I recognize. The surgery took nine hours but went well, she tells me. I nod, barely comprehending. I've got so much morphine in me that she could have said doctors removed my nose and I would have nodded in approval.

By late afternoon I'm more conscious and begin to comprehend what has happened. I look at my stomach and see it's distended and bulging from the new organs. Metal staples, running from my belly to the top of my groin, keep them held in. A blue rubber tube runs from my left nostril into my stomach. Catheters and hoses poke from me. I look like a last-minute science project.

My crude appearance belies a miracle, though. Unlike those of some transplant patients, my new organs began working nearly immediately. The pancreas is pumping me with insulin as if it were my original one. I won't eat solid food for days, doctors say, but when I do, it won't have to come compliments of a needle.

Doctors and family filter through the room to talk, encourage, check on me. For most of the day, though, I'm relegated to my bed and my thoughts. While I realize my life has made a seismic shift, I can't get my mind off the accident that brought me the organs.

I keep picturing the donor's parents, mourning at a hospital, hearing from doctors that their son can't be saved. Yet in the midst of their grief, they managed a decision like organ donation. While my family celebrates the start of a new life, theirs will be forever shattered.

Drifting to sleep, I decide I will send his family my journal articles, if they want them. I want them to know their son isn't completely gone, and I have no intention of letting him die in me.

Jan. 14, 2000

Time to stand. Doctors want me on my feet as soon as possible to get my blood flowing and muscles working. They help me up, and I walk to the foot of the bed. It feels like a marathon.

I turn around, pad back, crawl back into bed to the sound of congratulations. Victories will come like this, initially, in baby steps.

More friends and family arrive in the evening. My sister and brother-in-law come in, as does Spencer Tirey. Spencer had been worked up as a kidney donor, only to be ruled out at the last minute. He squeezes my hand so tightly it bruises.

I'm still weak and out of it, but I can feel my senses returning. I'm trying to joke and smile and beginning to think of life outside the hospital.

Doctors say my kidney and pancreas continue to work well. I'll be on anti-rejection drugs the rest of my life, and much of the next two weeks will be spent determining how much medicine I'll have to take.

It's a delicate balance. I'll need to take enough anti-rejection drugs so my body doesn't attack my new organs. Those drugs, however, have a whole world of side effects. Some can cause weight gain. Some hair loss. Others can make me nauseated, weak, even prone to some cancers.

But there's one thing they'll all do: help keep diabetes at arm's length.

Jan. 15, 2000

Something is going wrong. My breathing is labored, and I feel weaker than the day before. Nurses who were initially making normal rounds through my room are coming by more often to take tests and blood. Here are doctors. My back aches, and I can't stop squirming in the bed.

The pain intensifies, and I descend. This was all a mistake, I think. Four days ago I could play tennis for hours and barely break a sweat. Now I can hardly lift my arms.

A doctor enters the room and tells me that I'm bleeding internally from the first surgery. They will have to operate again. I welcome the news. At least they've discovered what's wrong and can take steps to fix it. Nurses phone Julie at a nearby hotel, and she sprints to the hospital to touch my forehead before I'm wheeled in.

This time, I dream during the surgery. I picture five men standing over me, holding me down. One places his hands over my mouth, suffocating me. I flail, try to struggle, but can't wrench my mouth free. Perhaps I struggled with the surgeons, I don't know.

Finally I come to and find Julie at my side in the recovery room. Once again, I'm told surgery went well. Let recuperation begin again.

Jan. 16, 2000

Television stinks. Even though the NFL playoffs are on -- something that normally would keep me glued to the screen all day -- I've been confined to a bed for four days now, and I'm going stir- crazy.

I haven't eaten anything since I arrived here and must suck on ice chips instead of drinking. Too much water can make me sick, and the last thing nurses want is for me to throw up my medications. A godsend arrives at 5 p.m.: my first dinner. It's broth and gelatin; I'll be on clear liquids for a couple of days.

Still, the beef water and green Jell-O are chef's masterpieces to me. I want to clean both bowls, but my stomach is too sore to put much in it.

Then I realize: The Jell-O was full of sugar. A week ago, eating it would have sent my blood sugar sky-high, maybe even made me sick. Today, it's just another snack. I eat one more cube in victory.

Jan. 17, 2000

Julie and I take our first medication class. The same way I had to learn how to take and adjust my insulin doses as a diabetic, I'll have to learn how to take my anti-rejection drugs. For the first few months, I'll take upward of 40 pills a day, though the amount will dwindle over time.

I will also be a human pincushion. Doctors will keep close tabs on me after my release, which means having blood drawn three times a week. Looks like I'm not quite through with needles.

Jan. 20, 2000

The doctors say recovery is going well. I'm on solid foods, taking occasional strolls to the end of the hall and receiving cards and flowers from friends and family every day.

David Sutherland, a surgeon who performed the transplants, says that on a scale of 1 to 10, he'd give my recovery an 8. The new organs, he says, are functioning a full 10 out of 10.

Logically, I know things are progressing. But being bound to this bed, this room, these intravenous tubes and gowns and antiseptic smells – it's hard to feel like I'm on the way to a better life. I have never taken well to hospitals. I tell myself to be patient. Soon I'll be doing the things I love: driving, playing music, petting my Labrador retriever, Larry. Move around, that's all I want to do.

But it still seems so far off. Julie, as always, can see the restlessness in my eyes. "Let's go, baby," she says, pulling into my room with a wheelchair. "We'll get you out of here."

I get to my feet, bundled with blankets, and collapse into the chair. Even sitting upright can be tiring, but suddenly I feel some strength returning.

It comes from the slight breeze on my face as Julie pushes me down the hall. Technically, we violate the rules of the hospital. Julie is taking me off the floor, down the elevators, out of my permitted range. We don't care. The more we roll, the freer I feel.

We approach a ramp leading to a lower floor, and Julie picks up the pace. We're rolling faster now, the slight breeze becoming a wind on me. I'm cold but tell her to go faster. She's running now, and the tiles of the brick walls blur by. If she trips or loses her grip on the chair, I'll go tumbling out. I can see myself smashing my knees on the cinder blocks.

I close my eyes and smile. For the first time, I'm out of here. I'm on my motorcycle, playing tennis, walking with Julie and Larry through Rock Creek Park. I'm moving again.

She finally slows, and we stop in the hall, laughing. I will leave here soon; I know that now. There's too much life waiting for me at home to pout about the few days in a hospital.

Jan. 25, 2000

My release date is here. Doctors want me to move into a hotel for a few days so I can be nearby for lab tests and checkups. As far as I'm concerned, though, I've gained a full pardon. To sleep in a real bed and walk to dinner are freedoms I haven't known for two weeks.

I haven't had a breath of outside air for half the month. I get my first while waiting for a hospital shuttle. The temperature is in the single digits outside, and as I walk to the van, I feel a gust of wind slap me hard. The icy air feels like it's slicing through my lungs. I wince and gasp and feel my eyes start to tear up.

It's wonderful.

Jan. 29, 2000

After 17 days in the hospital and hotel, it's time to go home. Julie and I can't wait. We've watched so much television that we know commercial jingles by heart. Julie has developed a Judge Judy addiction.

When the plane touches down in Washington, Michael is waiting. He's there not only to welcome us back: I won't be able to lift more than 10 pounds for two months, so he'll help Julie with the luggage. I hug him hard as we step into the terminal.

We pull up to the house, and I can feel it. I'm back home. The 13 steps to our front door exhaust me, but I gain a second wind when Larry comes bounding out. He nearly knocks me backward greeting us.

Inside, Michael has put up a banner and balloons. We drop the bags and, for what feels like the first time in nearly three weeks, relax.

I head upstairs. I want to see some more of the house. I walk into our bedroom, the coziest room in our home. I smile looking at the unmade bed, my clothes strewn on the floor, my music scattered underneath the stereo. I've missed this mess.

Then I see my dresser. Two insulin bottles and a needle sit on top. I grab them, heading to the bathroom to throw them away in celebration.

I stop. I'm not out of the woods yet. If I reject my new organs down the road, I'll be in the same boat I was before, a diabetic with failing kidneys.

It doesn't get me down, though. All my adult life, doctors have told me diabetes is forever. Needles and shots and finger pricks will be a permanent fixture in my life, they said.

More than that, the disease had always given me a grim certainty. I always felt that, over time, my diabetes would worsen, the complications would become more severe, and eventually I would succumb.

Now none of that is clear. For 17 days, I haven't needed a drop of bottled insulin. My kidneys work like anyone else's.

I take the insulin and needle and shove them in a drawer, buried beneath a pile of shirts. That will do for now. I know the transplant raises new risks and issues, but it also holds the possibility of never fishing out those insulin bottles again. And it holds a greater prospect: the chance for a healthy life.

I had forgotten what that feels like.

[Illustration]

GRAPHIC, B/W, Suzy Parker, USA TODAY, Source: Diabetes Institute for Immunology and Transplantation at the University of Minnesota (Diagram); PHOTOS, B/W, Michael Madrid, USA TODAY (7); PHOTOS, Color (2), Michael Madrid, USA TODAY; Caption: Nervous joy: After months of waiting for this moment, Scott Bowles and his wife, Julie, are apprehensive but elated just before sending him off for the surgery that will give him the kidney and pancreas of a young man who died in an accident. Nine hours of surgery: Surgeon David Sutherland, left, prepares the kidney that he and Luis Arrazola, right, will place in Scott Bowles' abdomen. The donor kidney supplements Scott's failing kidneys, which are not removed. Woozy post-op: Julie Bowles gets some assistance from nurse Julie Streitz, left, and anesthesiology resident Dimitry Sintsov when the first glimpse of her husband after his double-transplant operation leaves her feeling faint. A new home, a new life: Surgeon David Sutherland positions the kidney that will change Scott's life. Recuperating: USA TODAY's Scott Bowles chats with a fellow reporter while in recovery from a kidney-pancreas transplant. Bowles has been chronicling has battle with diabetes and his hopes for a permanent solution. New chapter: USA TODAY reporter Scott Bowles, with his wife, Julie, learns about anti-rejection medicine as he recuperates from a double transplant intended to end his diabetes.

© USA TODAY, Gannett Co., Inc.

Weekend Video Parodies

This post is pretty unrelated to diabetes, but it's a weekend, so what can I say?

As my some of my former postings from previous holidays suggest (see here), I have a wry sense of humor, especially when it comes to television. Of course, my appreciation for parody is also extended to my child-like fixation for Wacky Packages, so I guess I never really outgrew it.

But short of the Tina Fey parody of Sarah Palin last year, I don't think Saturday Night Live (SNL) these days is really pushing the envelope. But in the days of its rivalry with MADTv, there was really some funny stuff on that show. Now, thanks to Hulu, I've snared a few of my favorite clips to share with everyone below. If you're offended, you don't need to watch, but hopefully, you will find these clips as funny as I did.

First, for those of you who were kids (or even teenagers) in the 1980's, who could forget the Smurfs, those little blue creatures that lived in a deeply-wooded forest in Europe someplace (like those really exist)? The show was really the last commercial hit for the animation powerhouse Hanna-Barbera before being acquired by Turner Broadcasting, which was itself sold to media conglomerate Time-Warner a number of years later. I like this SNL TV Funhouse version of the "Smurfette Show" starring the only female Smurf to live in the Smurf village. All grown up, the new Smurfette resembled Anna Nicole Smith (before her untimely demise) far more than the innocent little blue creature that she once resembled. See here for that clip:



Then, there is this funny parody of Walt Disney's closely-guarded "Disney Vault" and just how ridiculous these limited-time releases (in the day of eBay, is that even necessary anymore?) on videos really are, which seem more like a vestige of the control corporate America previously wielded, but today have less control over now with the advent of the Internet. Catch that clip here:



And who wouldn't love this SNL clip "Christmastime for the Jews" which depicts animated Jewish characters living it up while the gentiles are tied up in church or in family dinners?



All of this is funny, albiet warped, stuff! Have a great weekend!

World Stem Cell Summit Videos & Presentations

As I've written about in some of my postings this past year (2009), I was fortunate to have been invited to not one, but two extraordinary events this year related to diabetes. Notably, in July, I was able to attend a diabetes social media summit hosted by Roche in Indianapolis, and then in November, I was asked to attend the Diabetes Research Institute's Diabetes 2.0 Conference at the DRI's homebase in Florida, including a guided tour through their facilities. Both were great for different reasons.

Of course, I also have a full-time job, so the mere fact that I was able to fit both of these events into my schedule was no small task! But as I thought about these events and how much the diabetes online community has evolved since I first began in 2005, I also thought about how my own role has also evolved over the past few years. After all, now there are others effectively competing for research news, whereas when I first began, I was one of the only one's doing that. That certainly isn't a bad thing, but it means that the world has evolved and I've had to change with it.

For example, When I began blogging back in the Fall of 2005, blogging was still kind of in it's infancy, and there were only a handful of other self-proclaimed diabetes bloggers, among them Scott K. Johnson, Kerri Sparling (she was known Kerri Morrone back then), Allison Blass, Gina Capone, Bernard Farrell, David Edelman and perhaps a few others. But as the Diabetes OC (online community) has grown, so too has the competition for readership. Although I write mainly because I like to do so, there are now hundreds of eyes looking for any new diabetes stories out there, so sharing a breaking story isn't the same as it was back in 2005, nor should it be.

I have tried to remain true to the integrity of my blog's content, with a few occasional diversions. I don't often tell a lot about myself because that's not the reason I began blogging. I like to keep my personal life to myself.

Today, my blogging role is somewhat different. For example, today, I can help to bring the type of content that was once out-of-reach directly to people with an interest in diabetes research.

A case in point: In September, the 2009 World Stem Cell Conference took place in Baltimore, Maryland. Although I did not attend that event (I was offered an "invitation" -- one which would have cost me several hundred dollars, not to mention travel expenses not paid by someone else), but along with that invitation, I also got updates letting me know that much of that content is now available online, albiet buried and not so easily accessible. There were several very interesting presentations, including ones featuring several prominent individuals from the Juvenile Diabetes Research Foundation as well as the Diabetes Research Institute.

By making those presentations available online, and delivering it via a blog posting, today, millions have access to that content from their computers, and I'm playing a role as helping to deliver some of that content to the masses. To me, that's very rewarding. I took the initiative to add these video links to my blog, as well as several of the online communities I'm involved in, including TuDiabetes.org, DiabetesTalkFest.com and Living Out Loud With Diabetes. As you may recall, this summer, I did something similar with a posting regarding the JDRF YouTube Channel I'd discovered, along with some other sites I felt were worth sharing.

So, without further delay, let me share some recorded content with my readers. As I've noted, this contains some content from the 2009 World Stem Cell Summit held in Baltimore, MD from September 21-23. There's a few links related to the 2009 conference worth sharing with you. First, a report. To access these (and the presentations, you'll need to provide a name, e-mail address and answer 2 questions). Most notable from this event was the fact that the Juvenile Diabetes Research Foundation's (JDRF) CEO Alan Lewis gave one of the keynote speeches, and several other senior executives from JDRF, including Dr. Robert Goldstein and the Diabetes Research Institute's (DRI) Dr. Camillo Ricordi who appear in one of the video segments on a "panel" discussion related to stem cell research and specifically how that pertains to diabetes in one video segment.

In addition, there is also some transcript from JDRF's Larry Soler on why the JDRF supports stem cell research, and of course, Alan Lewis elaborates somewhat on this theme in his speech, addressing how the JDRF's role regarding stem cell research has also evolved in recent years.

First, here is the transcript for Larry Soler's speech (alas, a video of this does not seem to be available), which can be read and/or downloaded on the host scribd.com, which is a social publishing site for documents, spreadsheets and presentations among other things) below:

Federal Funding of Stem Cell Research: Past, Present and Future

Next, I will present the Alan Lewis keynote presentation, which provides a good background (see here):



Another diabetes researcher, Diabetes Research Institute's Juan Dominguez-Bendala gave a speech which was not video recorded, but the transcript from that speech is entitled "Stem Cells and Diabetes: New Trends and Clinical Prospects" and can be read (or downloaded) here:

Stem Cells and Diabetes: New Trends and Clinical Prospects

Finally, below is the interesting panel discussion, which includes the DRI's Dr. Camillo Ricordi, as well as JDRF's Dr. Robert Goldstein and a patient advocate from the Maryland Stem Cell Research Commission named Margaret Conn Himelfarb:



What does all this mean?

Well, first and foremost, all seem to acknowledge that the issue on stem cell research has evolved (see also here) from a situation where voters and politicians alike once needed education on what was at stake to one where public opinion on the subject, by and large, supports with relatively few restrictions on this type of research. That means these charitable organizations can focus on other areas. Today, researchers are more focused on the problem of how to address recurring autoimmunity, and how best to facilitate addressing that not-so-small problem, as well as encouraging industry to pick up some part of the work by de-risking it as much as possible.

Still, the fact that this content is readily available to patients is a sign of progress not just on where the research has gone, but also increasing transparency on progress, milestones, etc. The latter being one milestone that those of us considered diabetes "veterans" can look upon and say we had a role in helping to make possible!

Supernanny to the Rescue?

Last Tuesday, I received an e-mail from Jill Lubarsky with the Media Relations Department at JDRF that on Friday, ABC's hit television program "Supernanny" was going to feature a family where Jo, the Supernanny, is called in to assist Bill and Tammy McGrath of Hamlin, NY. The Supernanny's assignment is to help the family regain control of their lives after they learn that their 5-year-old son, Aiden, was diagnosed with [type 1] diabetes, and introduces entirely new burdens on a family with 3 children that few people ever see until they're experiencing it for themselves.




Unfortunately, with the holidays, I wasn't able to catch the episode live, but thanks to the Internet, those episodes are readily available within days online, so here (catch the brief synopsis here) it is:














As JDRF's media relations wrote in their e-mail:

"I had a chance to view this episode before final production (as did our research department) and believe the show does a good job explaining type 1 diabetes and demonstrating the diligence required by the individual and family to manage blood sugar levels. ABC viewers will have the chance to see the highs and lows (no pun intended) on how parents must learn to work with their child during these tough times."

I thought it might be worth sharing with everyone else, especially those who weren't on the JDRF e-mail distribution list. What do you think ... does it do an adequate job of depicting the burden of diabetes management with the average person?

Smarties®: Revisited

First, if you haven't visited my post from earlier this week, please visit it at here and make a $1 donation to the Fight It! Friday campaign. On to my second post this week ...

In early 2008, I posted a story about my then new-found "discovery" of buying Smarties® in bulk (42 lbs. worth, more on that later) as a far more price-effective treatment for hypoglycemia. (Catch my post here for more details)

Well, after several years, that bulk supply is nearly empty, plus I have some money remaining in my Flexible Spending Account (FSA) that I'll lose if I don't spend it by the end of the year, so its a good opportunity to "kill two birds with one stone" as the old saying goes and replenish that supply. As I told my endocrinologist, not only did that bulk order serve my needs very cost-effectively for several years, but it also worked for more than a few trick-or-treaters (to be honest, I've also left quite a few in pants pockets, so they’ve been washed or crushed, as might be expected, which is perhaps the single biggest downside of this hypo treatment). Anyway, that supply of candy is now nearly depleted, so it’s time to order more, and I'm planning to do so, perhaps with some minor changes.

Since that massive order, which Scott K. Johnson also wrote about
here, although I'm not 100% certain what happened to the photos on the old site, as that post was before he relocated his blog to Diabetes Daily, and after using Smarties as my primary hypo remedy for the past few years, I wanted to share a few lessons I've learned along the way.

Lesson 1: Smarties May Be Called Candy, But They're Basically the Same Thing As "Glucose Tablets"

I hinted at this in my original post, but I just wanted to first remind everyone that Smarties aren't the ONLY candy made from mostly dextrose, there are others. Among them: SweeTarts (sold in rolls at the register in most drug stores), I even found them in a $1 store. The company that makes SweeTarts was acquired a few years ago by Swiss food conglomerate Nestlé. Nestlé has since rolled the SweeTarts brand into it's already-existing Willy Wonka Candy Company family of brands. However, I have not found it as easy for consumers to obtain bulk supplies directly from Nestlé/Willy Wonka Candy Co. as it is from Smarties, plus Smarties remains a family-owned business based in New Jersey, and they sell their products directly to nearly anyone who wants to buy from them via their very convenient website.

But as Scott K. Johnson commented on my original post back in 2008, keeping Smarties intact in pockets filled with change and keys without crushing them can be a challenge. Indeed, I have discarded more than a few cellophane-wrapped rolls of Smarties that became pulverized over the past few years, which is essentially a waste. I can't really quantify it, but my belief is that the cost savings nevertheless justifies that waste. But perhaps the biggest hassle is that Smarties aren't always quite as convenient as the de facto-standard 4 gram tablets in terms of size. For caregivers (type 3's), for example, its often easier just to hand over a few tablets rather than struggling with opening a few rolls of Smarties. Also, hands trembling from hypos can find it frustrating to open the tightly-wrapped cellophane, occasionally dropping some of the tiny-sized Smarties tablets in the process.

Lesson 2: The Rule of Three (3)

First, Smarties sells several different sized rolls. In truly bulk-sized boxes, among the most economically-sized options is a box of Smarties 15 tablet rolls, which the website says contains approximately 2,400 rolls per case. Each of those rolls contains 6 grams of dextrose, the same ingredient in glucose tablets sold under the Dex 4 brand name, as well as under the names of your primary retailer (Walgreens, CVS, Target, Wal-Mart, Publix, Safeway, etc.) branded glucose tablets. Although the treatment recommendation is usually 15 grams of fast-acting carbohydrates for a reading of 60 mg/dL, if it's lower, you may require more. Generally speaking, I have found "The Rule of 3" works remarkably well, and is easy because the same rule also generally applies for the number of traditionally-sized glucose tablets. Depending on the individual, you may need to follow up with some "real" food, as the durability of a recovery based on pure dextrose does not generally last for most people with type 1 diabetes, although I cannot speak for everyone, and if you have type 2 diabetes, it really depends on how your doctor has you treating your diabetes. Just remember, as a short-acting carb, its here one minute, but gone the next!

Lesson 3: New Smarties Innovations

Tropical Smarties and Mega Smarties

Since I last ordered, I have discovered a few Smarties innovations you might wish to consider.

First, Tropical Smarties. For example, if you're sick and tired of the plain old flavor, last year, Smarties introduced what it's calling Tropical Smarties which taste a bit different than the original, although in my opinion, not dramatically different. (They aren't quite the coconut/piña colada flavor I know more than a few people with diabetes call their favorite glucose tablet flavors, but still slightly better, or perhaps I should really be saying "different" than the original flavor).

I would have ordered a bulk-sized 42 lb. box of the Tropical Smarties, but alas, the company only sells them in cases of bags which contains a case of 12 bags each, each consisting of 7 oz. of the Tropical Smarties, but the true bulk sized box, the only flavor is the original. Still, if you want a different flavor, you might consider visiting a retailer who sells candy nearby and seeing if they sell Tropical Smarties before making a commitment to buying an entire case!

Second, Mega Smarties. The other innovation is perhaps even more noteworthy, that is the fact that Smarties has bulked up their tablet size to what they're calling "Mega Smarties" and each tablet is exactly 2.5 grams of carbohydrates (most glucose tabs contain 3 grams of carbohydrates), generally comparable to the glucose tablets sold by most drugstores (although they don't fit perfectly into their pocket-sized tube containers, unfortunately, but on the upside, its MUCH easier to measure 15 grams). These are sold in the usual cellophane wrapped-rolls, but cost-wise, they're about $1.50 each in a store, but each roll contains 15 tablets vs. the 10 contained in a store-branded or Dex 4 roll does. Flavor-wise, again, its the same old variety, but it really is a pretty convenient and lower-cost treatment option.

Incidentally, I picked up my first "Mega Smarties" roll at my local Bed, Bath and Beyond store (right at the register), so these appear to be quite widely distributed. Plus, Smarties will sell you an entire case of "Mega Smarties" from their online store under "Cases of Boxes & Jars" heading (each case sells for $144, but keep in mind that this consists of a case consisting of 12 boxes of "Mega Smarties", each with 24 rolls per box, which is 288 rolls (each of which has 15 "Mega" sized tablets). These tablets WILL fit into an empty bottle-sized container of the 50-tablets sold in stores, but the width of each tablet is different, so the tubes probably won't work. For convenience sake, I am really considering this option instead of the smaller-sized rolls, so I'll have to let you know how that works out!

Lesson 4: If You Want to Pay for Smarties With Your FSA, Get Your Doctor to Write a "Letter of Medical Necessity"

One important lesson I learned the hard way was exactly what it takes to seek reimbursement from your Flexible Spending Account (FSA). The first time around, when I tried to get my last bulk-order of Smarties that candy wasn't automatically considered by IRS rules to be a reimbursable expense even when used to treat a medical condition (hypoglycemia). But it CAN be, with some appropriate planning. If you get a prescription and/or letter of medical necessity for Smarties (or SweeTarts, or whatever you like to use as a hypo treatment), then you CAN seek FSA reimbursement and have the expense covered, because that letter turns, in the eyes of IRS auditors, candy into a legitimate medical treatment that is expensible under IRS guidelines.

I wasn't able to pay for my original order with my FSA, although from a purely economic standpoint, I was still better off even without being able to expense it. But this time around, I have covered all the necessary bases and asked my endo to write me a letter of medical necessity for Smarties candy, which my FSA administrator has told me WILL enable me to expense the candy using my pre-tax dollars this time around. Call it a lesson well-learned, but one you can use to avoid the hassle I went through the first time around, with a request from your doctor.

As an FYI, here is what was written on my endocrinologist's letterhead:

To Whom It May Concern:

[Insert Patient Name Here] is under my care for insulin-dependent type 1 diabetes mellitus. At this time, I have recommended that he/she treat recurrent hypoglycemic episodes with "Smarties" which contain a dominant amount of glucose (dextrose) and is less expensive than the glucose tablets otherwise available.

If I may be of any further assistance to provide any further information, please feel free to contact me.

Respectfully,
[Insert Doctor Signature and Title Here]

The other slightly challenging part is getting an actual receipt from Smarties. Sometimes a credit card statement is, depending on your FSA administrator, not considered acceptable, whereas a printed receipt would be considered acceptable. You may wish to place your order for Smarties by mail (keep copies of the order form) in that case, because you'll have the a copy of the order, the shipment receipt and the canceled check plus the doctor's letter of medical necessity to use collectively for reimbursement. Frankly, this is a case of FSA administration can be a bit testy about what they deem as "acceptable" proof, but its worth investigating before rather than having a hassle to get it reimbursed after-the-fact, so ask questions!

Anyway, given this experience, you now have some options available. I think this time around, I may skip the 42 lb. box of Smarties and go for a case of Mega Smarties for some of the reason's I've already mentioned. It's more expensive, but the option might work better, plus I have enough remaining in my FSA to make it practical. But if you're looking for a truly cost-effective option, there's nothing wrong with a big box, even if you end up discarding a few broken rolls. The markup on retail "glucose tablets" is nothing short of highway robbery, but the rule in retailing is sell for what the market will bear, so this option is definitely a c

By the way, for those of you who follow me on Twitter, my alter-ego (at least for the holiday season) is Gingy from Shrek movies, at least for the holiday season. I've always had an affinity for gingerbread men, so I kind of like the image!

Holiday Treats: Including A Nice Hawaiian Punch

Spending $1 to Buy Someone (in the U.S.) Insulin this Friday

Christopher Thomas, of Diabetic Rockstar fame, has a small but very admirable goal this Black Friday: to seek contributions of $1 to raise money for those working individuals without insurance to enable them to get affordable insulin and other diabetes supplies this year. He's calling it "Fight It Friday", and it's a very admirable goal, and one I am personally supporting, which is why I'm writing about it here.

I've placed a donation widget here:


But I sincerely hope he raises enough to remove all references to this very soon!!

I'm Thankful for Hawaiian Punch Singles to Go!

Beyond that, with Thanksgiving being celebrated here in the U.S. on Thursday, November 25th (many Americans don't realize that Canada has it's own Thanksgiving which is on the second Monday in October, October 14th this year), I am using this opportunity to give thanks for a few things. (No, insulin and meters AREN'T on the list, but I digress)

Occasionally, I cover some "new" products that may be of interest to people with diabetes. Although as of late I have taken a liking to Powerade Zero (a zero-calorie sports drink) as you may recall, a while back, I wrote about 4C Totally Light 2Go Drink Mix Just Apple flavor, and the 4C Apple flavor remains one of my favorites because I think it tastes just like apple juice (or at least what I remembered apple juice to taste like; its been decades since I've had real apple juice, which really does not deserve the label of a "healthy" beverage because it's a calorie-laden beverage that is no more healthy than Diet Coke Plus, which was reprimanded by the Fatalood & Drug Administration, see here fore details). Incidentally, Chrissie Engelbrecht in Belgium, although she's no longer actively blogging at Chrissie's Diabetes Blog anymore, remains a VERY active reader at Good Reads, so for those of you who followed her blog, you may want to join Good Reads and follow her there. I personally can't keep up with all the books she reads, but occasionally she posts photos of her new puppy, for example, so its also worth checking out.

Anyway, today I'm going to address another, similar product to 4C Apple, this one being Hawaiian Punch® Singles to Go!, which is a similar to the 4C Apple ones noted above, in individual-sized powdered drink mix that can be mixed into any standard 16.9 oz. water bottle. Of course, those concerned about BPA in their water bottles can use them as a measurement only, if they like. Supposedly, the manufacturer, Jell Sert Corp. under license from the Dr. Pepper Snapple Group, Inc., also sells canisters in larger 2 quart sizes, although I have yet to find those offered at any retail stores near me. The reason I am thankful to see these products finally being offered is because when I was a kid with type 1 diabetes, I didn't have these things. Fortunately, kids diagnosed today won't have to endure the same kind of denial that I endured when I was diagnosed back in 1976 (not that it's all that much easier today, but at least they can still have Hawaiian Punch).

For me, part of the attraction of Hawaiian Punch is the fact that while all the other kids in the neighborhood got to slug Hawaiian Punch during the hot summer days, as a kid in the 1970's, I had the displeasure of having type 1 diabetes before the nation's diet craze kicked in and sugar-free anything remained pretty uncommon. About the only thing besides water that was around then was unflavored Kool-Aid packets, to which my parents could then add nasty-tasting Sweet & Low (saccharin) to for semi-sweetness. There were also a few (and only a few) diet sodas, including Coca Cola's Fresca, a grapefruit-flavored soda which has since been resurrected and is enjoying newfound popularity, and Tab (which is STILL AVAILABLE, believe it or not, yummy!), but I grew up in a household where soda was only available as an occasional treat, not an everyday food. We also had a sugar-free gelatin at the time called D-Zerta, which was made by General Foods (a company my great grandfather had a hand in developing), today part of the U.S. food conglomerate Kraft, Inc., and has long since been replaced with Sugar-Free Jello, but back then, food companies were worried about brand erosion to their major brands, especially with artificial sweetners which carried dangerous-sounding warning labels on foods containing saccharin.

(Supposedly, a company, perhaps it was even Jell Sert, made an unsweetened version of Hawaiian Punch back in 1977, but I don't ever recall seeing that anywhere, but here's the TV commercial to prove it's supposed existence between 1977 and 1983)

Diabetic Foods that Caused Cancer?

But in the early 1970's, there was actually an effort to ban artificial sweetners like saccharin. Throughout the 1960's, a number of different studies had suggested that saccharin might be an animal carcinogen. That concern peaked in 1977 (the year after I was diagnosed), after the publication of a study from The National Cancer Institute (NCI), an agency of the U.S. Department of Health and Human Services, found that laboratory rats fed large amounts of saccharin developed cancer. As a result, Congress (in it's infinite wisdom) mandated that further studies of saccharin be performed and required that all food containing saccharin beared the rather ominous-sounding warning label: "Use of this product may be hazardous to your health. This product contains saccharin, which has been determined to cause cancer in laboratory animals."

When I asked my pediatrician at the time why all the "special" diabetic foods caused cancer, showing him the label of a package I had read, he responded by telling me not to worry about it. I was NOT comforted after seeing my grandmother die of cancer, even if he was correct in telling me not to worry about it. What can I say, I was a demanding child when it came to information!

Only after these Congressionally-mandated studies wrapped up many years later did we learn that the basis for some of these inaccurate studies were files from the FDA's investigations of 1948 and 1949, which had originally argued against saccharin use, but were were later shown to prove almost nothing about saccharin being harmful to HUMAN health. The Congressionally-mandated studies which examined how a substance actually works in the body have shown that these results applied only to rats, thanks largely to how rodents metabolize sodium. But human epidemiology studies (studies of patterns, causes, and control of diseases in groups of people) have shown no consistent evidence that saccharin is associated with bladder cancer incidence. In 1991, after fourteen unnecessary years, the FDA formally withdrew its 1977 proposal to ban the use of saccharin, and in 2000, Congress finally repealed the law requiring saccharin products to carry health warning labels. Of course, by that time, the FDA approved aspartame, which tasted better, although that Monsanto-developed sweetner remains the subject of persistent adverse health claims even today, after Splenda has taken over as far as market share is concerned.

Anyway, with that as a background, it's not hard to understand why almost no one in the food industry at that time dared recommending that artificial sweetners be used, especially for children (even those with diabetes). Today, there are all sorts conspiracy theories abound that it was prompted in large part by the influential U.S. sugar lobby, whom I wouldn't put it past, but evidence is hard to come by since lobbyists weren't tracked like they are today.

Anyway, with that as my historical background, I should note that the Hawaiian Punch brand goes back a number of years, but at present, the brand and it's related characters such as "Punchy" (who was featured in TV commercials during the 1960's and 1970's) is owned by the Dr. Pepper Snapple Group, Inc., which is the beverage division that was spun off from what was formerly known as Cadbury Schweppes PLC before demerging in May 2008, thereby separating the global confectionery (mostly chocolates, now fending off an acquisition attempt by Kraft) business from the U.S. beverage unit. Dr. Pepper Snapple Group, Inc. has licensed the manufacture of Hawaiian Punch Singles to Jell Sert Corp., a privately-held, Chicago-based food company that has acquired a number of cast-off food brands, including Wylers drink mixes, My-T-Fine/Royal gelatins, and pudding mixes Flavor-Aid frozen treats just to name a few. In 2003, the company signed licensing deals for the Hawaiian Punch and Snapple brands, and in early 2005, the first sugar-free Hawaiian Punch variety in the brand's history emerged (remember, the unsweetened variety was not "sugar-free", it was unsweetened).

Hawaiian Punch Singles to Go! first launched on a nationwide basis a few years ago. I stumbled upon them in a Dollar store, only to not see them again for a few years. Today, however, a number of national retailers sell these products, including such retail giants as Wal-Mart Stores, Inc. and Walgreens Corp. just to name two. I have also seen them in major supermarket chains from California to Connecticut to Florida, so I know it's widely available.

Although the drink is rather sweet (it's supposed to be a combination of seven natural fruits, including such tropical favorites as pineapple, passion fruit, papaya and guava) beverage, this variety contains zero carbs (see the Nutrition Facts here) and is an indulgence that even kids with diabetes can share!

Hawaiian Punch 1970's Commercial:



Also, catch this lame 1981 Donny & Marie TV Holiday Commercial featuring Punchy here:



OK, that's waaay too much detail on my childhood Hawaiian Punch fantasies.....

Beyond that, Amy Tenderich at DiabetesMine.com also kicked off her annual holiday contest. Amy's post, 'Tis the Season has all the details. There are some pretty cool prizes from Fit4D.com, HAH Originals, StickMeDesigns, Blue Bunny Ice Cream, and HealthiFeet, so check it out.

What is the contest about? There are two main categories: The "Best Of" which asks people with diabetes (PWD) to share their triumphs and successes from their holiday seasons, and the "Worst Of" for which PWD's can share something that went totally wrong (which are probably more amusing to read about, but hopefully they can smile about these experiences now).

Allison Blass & Scott K. Johnson have been invited to be judges in that contest, so please make sure there's some competition for the prizes, folks!

Anyway, I may or may not do anymore posts this week, but I'll be back here, at the same bat channel, so be sure to have a great holiday and I'll catch up with everyone very soon!

The Business of Diabetes: Generex vs. MannKind, Will Either Win?

Earlier this week, Bennet Dunlap (YDMV) asked me to comment on a business story related to the debate over Generex' Oral-Lyn and MannKind's Afresa (see his post "FTNW: Oral/Inhaled Insulin"). Neither of these two products is on the market yet, but at least one opinionated writer, R.J. Steffens, posits that Generex is likely to be more successful than MannKind's Afresa. (see that article here). His logic, explained in the article, is based largely on the FDA, but he does little to comment on the logic based on the soundness of either company's business strategy.

I commented on Bennet's post, but I really didn't have sufficient space in a comment to do this topic justice, as this really more of a business review of the insulin market, thus my latest "Business of Diabetes" posting.

First for some relevant background, you may wish to catch Amy's recent interview with MannKind's chief, Alfred Mann. Amy closes with an appropriate question: Afresa: Dreamboat or shipwreck? She also appropriately notes that "only time will tell". Amen to that.

But R.J. Steffens seens to have already reached the conclusion that Toronto, Canada-based Generex, which has an oral-insulin (technically, its absorbed through the cheeks), so the term medical term "buccal" insulin applies) is going to be the winner of this race.

My response: I wouldn't bet my hard-earned dollars on either company at the moment.

First, let's look at his perspective that FDA approval is getting harder to come by. Actually, more recently, the Fatalood and Drug Administration has been cracking down on many of it's formerly minimalist (or non-existent enforcement of) regulations of the not-too-distant past. But that doesn't mean its gotten much tougher to get an approval, only that the free handouts from the FDA might be over.

The reason: over the past decade, far too many embarrassing safety debacles have occurred under the FDA's watch, including: e-coli laced fruits & vegetables and salmonella-tainted peanut butter under the "food" safety responsibilities at the FDA. On the drug/biotech side of the FDA's responsibilities, the FDA has a track record that is almost as bad, involving huge problems with already approved products such as Heparin (sourced largely from China, from plants that had not been recently inspected by the FDA and which were not adhering to FDA-mandated "Good Manufacturing Practices"), as well as a number of after-the-fact discoveries pertaining to already-approved drugs, beginning largely with the Vioxx scandal in 2004, but continuing with the type 2 diabetes drug Avandia (both of which, BTW, could have been avoided with appropriate post-market analysis that the FDA never bothered to insist upon getting from the manufacturers). Collectively, these things point to beginning of the FDA's "fall from grace" with lawmakers in Congress, and the view that the FDA is no longer an effective protector of the public's foods and drugs.

But none of this means the FDA has gotten stricter; only that it's harder to get a truly dangerous drug approved with poorly designed clinical trials. But if the underlying science for and business model for a new drug is good, I don't think companies will find navigating the FDA all that much more difficult.

Let's have a look at what Generex and MannKind hope to sell: synthetic fast-acting insulin that is delivered without injections. Big whoop. This is viewed by people without diabetes as THE greatest innovation that they believe every person with diabetes longs for; but for most people WITH diabetes, we respond with a yawn. Besides, most insulin-requiring people with diabetes will also need a basal insulin as well as prandial insulin, so we aren't completely avoiding needles just by switching to Afresa or Oral-Lyn (oh, yeah, and don't forget the finger lancets required for testing, so even if you can swallow or inhale your insulin, you're still going to have to puncture your fingers to test). On safety, insulin itself has been used since the 1920's, and synthetic insulin has been used since 1982, and therefore has a very long track record of relatively safe use. But insulin has only ever been delivered into the bloodstream either intravenously (such as in a hospital IV) or subcutaneously, except in the short-lived case of Exubera.

Exubera bombed mainly because Pfizer really didn't know the first thing about the insulin market, and never bothered to research it thoroughly, either.

Wrong Target?

Despite what Alfred Mann and Generex claim, neither company is really targeting the type 1 universe. If they were, the products they're pitching would look a bit different than they do now. For example, if Generex really wants to reach the type 1 audience, they need to enable dosages in increments smaller than 1 unit, preferrably in tenths of a unit. My basic argument has always been that if a company wants to effectively compete in the insulin segment, they simply cannot afford to ignore the type 1 audience. Pfizer ignored the type 1 audience, and Exubera went bust, costing the company billions. Far too much advertising for insulin, (especially ads for Sanofi Aventis' Lantus product) might even be viewed by some as offensive to type 1 patients -- talking about insulin as a wise "choice" in treatment. I don't know of a single type 1 patient who was given insulin as a treatment "option" or "choice" because it isn't a choice, so ads that address it as such are kind of insulting because they leave the type 1 patient out of the equation altogether. Its almost as if the leaders of the pharmaceutical industry take the type 1 business for granted because we have no other treatment alternative.

Pfizer really screwed up the launch of Exubera up by its decision to completely ignore the type 1 audience, the "blisters" for each dose gave a MINIMUM dosage of 3 units each, which meant that many insulin-sensitive type 1 patients couldn't refine the dosage well enough to even try it. The product bombed with type 1s, a segment that might theoretically have been an attractive target. The CDC estimates that perhaps 75% to 80% of all insulin buyers have type 1 diabetes, although type 2 patients who use insulin generally require a significantly higher volume of insulin because their disease is insulin-resistance. As a result, type 1s consume maybe only 40-50% of all the insulin sold, and type 1s make up a disproportionately large share of all insulin buyers even though we use comparatively little by volume.

Still, we should examine the prospect for these yet-to-be released insulin formulations (and the companies backing them) based on what insulin sales data indicates. First, let's look at a simple fact: both Afresa and Oral-Lyn are both prandial (mealtime) insulins, but neither addresses basal insulin requirements. Increasingly, type 1 patients are turning to insulin pumps which enable them to micro-manage dosages with an unprecedented level of precision. I categorically disagree with R.J. Steffens in his assumption that because Oral-Lyn has not encountered any significant delays in approval, it is likely to be a bigger success. His sister may have suffered from type 1 diabetes complications, but that does NOT render him an authority on life with the disease; you have to live with it personally to make such an assessment.

I believe the bigger issue for both MannKind and Generex and their success in the insulin market will be the fact they are selling prandial vs. basal insulin. The reality based on sales data (companies like IMS Health compile sales statistics on this) is that the biggest (and growing) share of all insulin being sold isn't prandial insulin, it's basal insulin, which helps explain why Lilly's market share in this market has plunged (Lilly doesn't sell a truly basal insulin today, only NPH, which is a mid-range insulin in terms of time-activity profiles).

Have a look at this chart below which is merely repeating a well-established fact on on worldwide insulin sales:


The reasons for these sales trends are many, but it's mostly due to the fact that insulin-using type 2 patients tend to start with basal insulin like Lantus or Levemir only, and may ultimately adopt prandial insulin when that is no longer sufficient. But if you wish to capture some of that volume, prandial insulin is NOT the way to do it, basal insulin is the key. But even Eli Lilly & Co., which has been in the insulin market for nearly 90 years, failed in its efforts to develop a basal analogue insulin, which explains why that company's market share (according to the Indianapolis Star) has fallen from about 83% a decade ago to a bit over 40% today.

Competitive Landscape

Even if more type 2's should be using prandial insulin, they aren't doing that now. To convince them to do otherwise will require old fashioned salespeople knocking on the doors of doctors' offices, a costly proposition to say the least. Or costly (but mostly ineffective) Direct-to-Consumer marketing combined with salespeople. I don't know how many salespeople either have, but its worth noting that both Eli Lilly and market share leader Novo Nordisk have recently beefed up their sales forces in the diabetes segment.

Looking at these insulin products, one could effectively argue that neither is really a "new" product; they're the same old insulin products just being delivered in a different manner. The issue of safety with oral vs. inhalable insulin is perhaps better defined as whether the method of delivering the insulin causes any adverse events? Since long-term usage studies are not required for FDA approval, these questions have yet to be determined, although the FDA may require post-market analysis now, whereas in the past, they rarely bothered.

If these companies hope to capture share of the prandial insulin market, I would suggest that both should have spent some more time observing the issues that are different between type 1 and type 2 patients. They might realize that the challenges facing both groups aren't always the same, even if the marketing folks at these companies want to speak with them collectively. Most fail to reach either audience.

Whether Generex's Oral-Lyn is faster to market ignores the fact that by sales volume, basal insulin is what's selling. And for the type 1 audience, many have migrated to using only a rapid-acting insulin by pump, so the hopes of converting any of those patients to oral or inhaled insulin is next to nothing. For those on MDI, its possible some might find Oral-Lyn or Afresa attractive, but its a lie to position the product as needle-free, because their basal insulin must still be injected the old-fashioned way. And the dosage precision with both products isn't as great as the existing rapid-acting analogues, of which there are now three: Lilly's Humalog, Novo Nordisk's Novolog/Novorapid and Sanofi Aventis' Apidra.

Also, another competitor is now in very late stage development, namely Biodel's Viaject from a Danbury, Connecticut biotech company, which is as close as (if not closer) Oral-Lyn to receiving FDA approval, and because it's injectable insulin, there is no special FDA guidance to obtain approval. This means both will be competing in an already crowded market (with 3 already approved products, and another candidate that is likely to emerge in 2010). All told, there is likely to be 4 rapid-acting insulins on the market when the first of these products hits the market, and because Oral-Lyn and Afresa are not delivered subcutaneously, these products have the disadvantage of having no hope to compete for the business of insulin pump users.

Conclusion

The question investors SHOULD be asking of both Generex and MannKind is whether either of them have done sufficient homework on the U.S. and worldwide insulin market. Based on what I've seen so far, I'd say the answer is no. I'd put my money into a Beverly, Massachusetts-based SmartCells, Inc., a company that is developing an insulin that does not cause hypoglycemia as an adverse event. From my perspective, Todd Zion's company, combined with a strong venture-capital investment as well as funding from both the NIH and the Juvenile Diabetes Research Foundation suggest that this company's prospects are far better than Generex's or MannKind's, at least in the insulin market.

Fantastic Voyage 2.0 at the DRI

About 2 weeks ago, I was in the Miami-Ft. Lauderdale area to attend the Diabetes Research Institute's Diabetes 2.0 Conference. I have attended several of their New York conferences in the past, but I had never been to their home-base in Florida before (ironic, considering my brother and sister both live nearby). Anyway, I was given a rare opportunity, along with some of my D-Blogging peers including Gina Capone, Allison Blass, Kerri Sparling, Manny Hernandez, Ellen Ullman and Jeff Hitchcock to go on a guided tour through the DRI's research facilities. That was very cool, and enlightening to see the work going on first-hand.



The DRI's researchers are among the most gregarious hosts to visitors I've ever encountered, and of course, they have made more than a few groundbreaking discoveries in their laboratories. Their world-class research facility and also their approachability are very impressive.

To put things into relevant context, let's start by noting that the 2008 Nobel Prize for Chemistry was awarded for the development of the green fluorescent protein (GFP), which has since gone on to play a crucial role in the identification and understanding of various proteins, which includes pancreatic beta cells, glucagon-producing alpha cells, insulin, etc. This discovery was quickly followed with not only green color, but also with fluorescent red and blue colors, which now enables scientists to stain various proteins with different fluorescent colors and examine them under high-powered microscopes and easily see the tiny specs in technicolor details.

Researchers now stain the insulin-producing pancreatic beta cells in fluorescent green color, the pancreatic glucagon-producing alpha cells in fluorescent red color, and the and the nuclei in fluorescent blue color. This enables the most relevant parts of the Islets of Langerhans to be seen in distinctive colors, and observed. OK. This was deployed and the key components of the Islets can now be observed in amazing Technicolor detail, and in real-time! Awesome stuff that researchers back in Banting's day could only fantasize about.

Have a look at a photo of the fluorescently-stained Islets of Langerhans at Wikipedia, and in particular, the photograph. Note the different colors (Green, Red, Blue) being used to depict different components of the Islets.

But here's the really cool part.

The DRI has partnered with The Karolinska Institute in Sweden, and researchers at Karolinska have developed a technique that involves transplanting the Islets of Langerhans into the eyes of a Non-Obese Diabetic Mouse (NOD), which enables them to see how the Islets work (and get attacked by the body's immune system). The sedated mouse is placed under a microscope) and the lens of the microscope zooms in to watch all this stuff in real-time, and thanks to the computerization of microscopes today, the images can be transported instantly and shared between researchers in Stockholm and Miami (in fact, I believe researchers in Stockholm can control the zoom of the microscope in Miami remotely). But these observations can also be recorded on the computer and are often used in scientific presentations. The DRI is planning to feature some of these video images on their website in the (hopefully) not-too-distant future!

If I'm not mistaken, this technology is being used to observe the autoimmune process in action, which could enable the development more effective treatments to induce tolerance to the Islets of Langerhans (and that also includes those Islets regenerated by the body itself, so it's not limited to transplanted). Very high-tech, but also the kind of a "Fantastic Voyage" inside the body that was first depicted on the big-screen in the classic 1966 sci-fi film of the same name. If you prefer, there was the slightly more modern 1985 Steven Spielberg film "Innerspace" which was very similar in nature, or in 2002, a B-movie called "Antibody" starring Robin Givens was yet another adaptation of the same basic movie theme.

During the tour, I asked the researchers about whether they had considered putting a DVD of these observations (perhaps selling the document as a fundraiser for the DRI Foundation), and I was told that the DRI is planning to do even better: they hope to have recorded movies of the stuff being observed under the microscope on their website in the future! Of course, such images need to include excellent narration so that the average layperson can follow along, but the stuff they're doing today is light-years beyond the stuff they were doing as little as a decade ago.

Taking a step back, below is a clip from NBC News that features one of the researchers at the DRI who showed us under his microscope, Dr. Juan Dominguez-Bendala, Ph.D. who is a DRI Researcher. Videos for each presentation, including the panel I appeared on at lunchtime can be viewed at the DRI's website here (or click on the header above).

Visit msnbc.com for Breaking News, World News, and News about the Economy

Another thing that most impressed me from my visit to the DRI, and in getting to meet many of the researchers in person was the pace at which diabetes research occurs today. As noted, researchers can watch the body's (at least in a NOD mouse) immune system actually infiltrating the Islets and can also see if theoretical interventions they're pioneering at the DRI work, and if so, HOW they work.

Not too long ago, most of this stuff was indeed only science fiction, as the aforementioned movies seem to suggest. But today, thanks to some truly revolutionary discoveries and some very smart partnerships with leading researchers around the world, the DRI truly has made a number of astonishing advances. The rate at which new knowledge about type 1 diabetes accumulates related to the autoimmune response and immune tolerance treatments, cell culture and development, and watching how these various interventions work (or sometimes, do NOT work) has indeed accelerated the advancement of progress being made to cure diabetes. Another quite admirable quality is the fact that most DRI researchers aren't pursuing their research for publishing rights to advance their own careers, or advance shares they own in for-profit biotech and drug companies (for the most part; I have some reservations about using this description for Dr. Jay Skyler), and seem willing to cooperate with almost anyone willing and able to collaborate to advance the DRI Foundation's mission: to provide the Diabetes Research Institute (DRI) with the funding necessary to cure diabetes now. This is truly an impressive organization and they are doing some groundbreaking research!

Big U.S. Drugstore Chains Working to Shake Up Diabetes Management

While the benefits of intensive diabetes management are well-established, overall, the U.S. healthcare system receives failing scores relative to most other developed countries when it comes to diabetes care. (catch my post from last year here). It's not for a lack of spending; We spend more per capita than any other country on earth, yet U.S. patient outcomes for most chronic diseases (including diabetes) is worse than most other countries, and merely on-par with such developing countries as Brazil or Jordan, in spite of significantly outspending these countries. One reason is a lack of care coordination and what I refer to as the "compartmentalization" of healthcare in the U.S. (By that, I mean that patients see a primary care doctor, an endocrinologist, perhaps a diabetes educator, nutritionist, ophthalmologists, and potentially cardiologists, dermatologists, gastroenterologists, gynecologists, and a number of other specialty doctors, with no one who can really oversee the overall coordination of all of this "care", which is a job usually left to primary care doctors, but a lack of decision-making authority on whether the care will even be paid for effectively limits U.S. Primary Care doctors' ability to truly coordinate patient care in an effective manner).

Last year, The New York Times featured an editorial which concluded that our abysmal rankings for chronic disease care was best summarized in a single sentence: "The care Americans with chronic conditions received — or more often did NOT receive — ought to be a cause for shame."

These findings are a surprise to some, who love to trumpet U.S. healthcare as being "the best in the world", and while that description may be appropriate in some cases, the claim really should contain a footnote similar to those in drug advertisements which says something along the lines of "Results are not typical. Generally, U.S. Healthcare rates are the top of the world for those who can afford it, but the vast majority of patients with chronic conditions receive care that is comparable to developing countries."

How did we get into this predicament?

James Hirsch, in his book "Cheating Destiny: Living With Diabetes, America's Biggest Epidemic" describes the U.S. healthcare system as one that deals extraordinarily well in dealing with acute illnesses, but not really designed to handle chronic conditions which are becoming increasingly common as medicine moves away from a model of eradicating diseases to a model of managing diseases on a chronic basis, without actually curing very many maladies.

The disconnect is that the U.S. system will readily pay to amputate limbs or will readily pay for heart bypass surgery, but will make patients jump through all sorts of hoops to cover the very things (including coverage of education, medicines, and testing supplies, while simultaneously nickel and diming them for such basic care) that could easily prevent such drastic treatments from ever being a necessity.

Aside from the cost, the main issue of lack of coordination among the various medical providers involved. After all, doctors can make recommendations, only to have their recommendations overruled by those who actually pay for patient care. Referrals and pre-approvals are perhaps two of the most notable examples of just how the disjointed U.S. healthcare system creates barriers to effective chronic disease care.

A handful of U.S. healthcare providers, most notably Kaiser Permanente, scores very well in this regard (in spite of frequent complaints about getting insulin pump coverage from many patients in the Kaiser system). But Kaiser is somewhat unique in the world of healthcare in that everyone (doctors, nurses, lab technicians, pharmacists, specialists, educators, etc.) in the Kaiser system is on Kaiser's payroll, and there is excellent system-wide coordination of care. But in the more typical U.S. healthcare model, the PPO (preferred provider organization) plan, there is no centralized coordination of care, rather the care-givers are paid for each treatment procedure performed, but they are generally not rewarded (financially, at least) for overall patient outcomes. And for those left completely out of the system due largely to costs, the health outcomes are quite poor, which helps to explain the comparatively low U.S. rankings.

As politicians promote their healthcare agendas, however, another potentially important player is stepping in and could profoundly impact this equation: large pharmacy chains.

In much the same way as small corner grocery stores and bodegas are increasingly being seen by public health officials as linchpins in public health campaigns [see here for details] as part of the solution rather than part of the problem, we are seeing some fundamental but important changes in the way healthcare is delivered, we may soon see another important player use its influence on care for some with chronic conditions.

Walgreens Takes Care

In July 2009, one of the nation's largest pharmacy chains, Walgreen Corp., announced plans to pilot a program offering chronic disease care in its 345 "Take Care" walk-in health clinics found in 19 states. Until this plan was announced, these had mostly focused on routine health problems, like sore throats, ear infections, etc. rather than dealing with chronic care.

Although company CEO Greg Wasson declined to specify where the pilot program would run, we do know that these programs will focus (at least initially) primarily on the more common type 2 diabetes, probably with focus on how patients can incorporate different elements of their care ranging from diet management and exercise into patients' treatment plans. Although that still leaves nearly 3 million Americans with type 1 diabetes out of the equation, if the type 2 treatments work, we could see type 1 treatment added down the road.

CVS Maintenance Choice

Meanwhile, although rival CVS has similar Minute Clinics in many of its stores, that company hasn't created a chronic care platform yet, but could depending on the Walgreen's experience. But CVS has been working on an issue that is a barrier to drug compliance, specifically working to better integrate its large pharmacy benefits manager (Caremark) seamlessly into its retail stores. According to the company, CVS Caremark is now presenting its [relatively new] "Maintenance Choice" offering to payers. Maintenance Choice allows consumers to purchase 90-day prescriptions [for chronic conditions] at CVS stores for the same price as at mail."

Although analysts still question the economics of the CVS Maintenance Choice program, there is no denying the program's growth. Patients don't really care how CVS makes money, however, but the program does deliver genuine patient benefits. Rather than dealing with cumbersome mail-order delivery which is often a deterrent to drug compliance (that, along with cost), increasing numbers of patients can walk into their local CVS retail pharmacy and pick up a 90 day supply of insulin and other diabetes-related prescriptions and pay the same price as if they ordered them from Caremark by mail.

(This might also help to resolve the complaints of improperly shipping insulin without temperature-controlled shipping packages, but also makes it easier for patients to deal with.)

Both programs are still in their infancy, but both have potential to influence patient outcomes, especially for patients with chronic conditions such as diabetes.

Only time will tell.

The Other 364 Days A Year

In recognition of World Diabetes Day (WDD), which is on November 14th, I'm going to use this opportunity to (in my typical fashion) to call attention to what World Diabetes Day (and Diabetes Month) has become in the U.S. today (and quite possibly p!$$ a few people off in the process, but I'm used to it).

It's become an excuse.

An excuse for the media and the rest of the world to continue being blithely ignorant about diabetes for the other 364 days each year. Bennett Dunlap's recent post entitled "Dear Nate" unfortunately makes this abundantly clear (catch their lame response here). Bennett isn't the first one to go down this road, and will almost certainly not be the last.

In fact, on my inaugural WDD post back in November 2005, I made a very similar point to a Boston Globe editorial writer, who incidentally never responded to my letter. But this is a battle that needs to be fought because our failure to do so will ensure that misinformation and ignorance rule the entire public discourse when it comes to diabetes (all types).

You know what I'm talking about: the one where the PATIENT (and/or their caregivers) -- NOT their disease -- assumes all of the blame for anything bad that happens related to diabetes. In effect, public spending on diabetes research is already dwarfed by far less common diseases (according to the FAIR Foundation), and that is partially a function of the fact that diabetes is widely regarded as a character flaw, rather than a real disease, according to most in the mainstream media. I think this is because diabetes has been defined by people other than those who actually live with diabetes.

Don't get me wrong, these events were started with the most admirable of intentions, and World Diabetes Day in particular was groundbreaking in at least one respect: being the FIRST non-communicable disease to be recognized by the United Nations and the World Health Organization. From that perspective, WDD does get diabetes on the radar screen of the public for a brief time each year. But in the U.S., today we have a culture that is driven by short sound-bytes and short attention spans. We can be appreciative for a single day in the public spotlight, but what about the rest of the year?

I happen to agree with Jenny Ruhl that pollutants and chemicals have become so prevalent in our everyday lives, but unfortunately have long-term impacts that we have yet to even quantify (or even acknowledge). In addition, World Diabetes Day is becoming a marketing event along the lines of Valentines Day for the multi-billion diabetes industry to promote is latest products and get some free publicity, which unfortunately, hurts the original intent behind it.

I'm also quite concerned that blue circles everywhere don't do anywhere near enough to convey much useful information about diabetes or its treatment. This situation means far too many people actually believe that what they watch on the news or read in the newspaper. But they don't necessarily get accurate information about a disease that threatens to become an ever-more-costly drain on a healthcare system that is already struggling to manage runaway costs. Instead of blaming a healthcare system that is an uncoordinated collection of self-interested parties pushing hard in Washington to represent their interests, the media has bought into the idea that the patient, and not their disease, that is ultimately responsible for everything related to diabetes. Too bad it wasn't quite so simple.

Don't misunderstand my objective with this posting: I am NOT dissing World Diabetes Day, but I AM dissing what World Diabetes Day has actually become in the United States: a media circus, only it's a circus without a ringleader.

(Here's where I include some relevant circus-related music you can listen to now -- one is traditional circus music, the next one is the current pop hit "Circus" from Britney Spears, the last one is a song called "The Circus" from Erasure, which is a little bit slower, but more circus-like as far as the music's concerned than Britney's "Circus".)







Until the public discourse involves more people who actually live with diabetes, and is not controlled exclusively by companies that profit from the disease, nor limited mainly to doctors and healthcare providers, then the intent of World Diabetes Day is getting lost in the shuffle. Too often, most of speakers on World Diabetes Day events are too isolated from the day-to-day realities of what it's actually like to live with their prescribed treatments, but like to get themselves in the press anyway, which is just sad, but not terribly helpful.

My discussion aims to change that dynamic, not criticize it.

Diabetes: You Keep Me Hangin' On

So for those of you who follow me on Twitter, last week, Kelly (also here), George (also here) and a few others have been toying with the idea of a band called the "Insulin Whores".

I joked that I had absolutely no musical talent, which is a lie, the reality is that that in high school, I played the lead role in my high school musical "Bye Bye Birdie", and yes, I was a choir boy for many of my earlier years, so I've always had a bad-ass affinity for music. Anyway, the Insulin Whores are a musical bunch and we're now toying with the idea of forming a band of some sort (whether it's a rock band, or something else is still a work in progress). But since Kelly has already covered the topic of diabetes themed music (catch her post on that topic). Anyway, yesterday, I mentioned the topic of a Glee-esque video. I like Kelly's song list, but not sure we need to be so completely fixated on sugar. I'd like to mix things up a bit and pursue some deeper-meaning songs.

This week, my selection is a classic by The Supremes called "You Keep Me Hangin' On". I think the lyrics speak directly to my type 1 diabetes and the lure of a cure, but have a look at this clip from the TV show Glee and let me know if it means anything to you relative to diabetes. We may need to rework the lyrics on some songs, but there are some that fit naturally with diabetes. Have a look:




You Keep Me Hangin' On
By The Supremes

Set me free, why don't cha babe
Get out my life, why don't cha babe
'Cause you don't really love me
You just keep me hangin' on
You don't really need me
But you keep me hangin' on

Why do you keep a coming around
Playing with my heart?
Why don't you get out of my life
And let me make a new start?
Let me get over you
The way you've gotten over me

Set me free, why don't cha babe
Let me be, why don't cha babe
'Cause you don't really love me
You just keep me hangin' on
Now you don't really want me
You just keep me hangin' on

You say although we broke up
You still wanna be just friends
But how can we still be friends
When seeing you only breaks my heart again
And there ain't nothing I can do about it

Woo, set me free, why don't cha babe
Woo, get out my life, why don't cha babe
Set me free, why don't cha babe
Get out my life, why don't cha babe

You claim you still care for me
But your heart and soul needs to be free
Now that you've got your freedom
You wanna still hold on to me
You don't want me for yourself
So let me find somebody else Hey!

Why don't you be a man about it
And set me free
Now you don't care a thing about me
You're just using me
Go on, get out, get out of my life
And let me sleep at night
'Cause you don't really love me
You just keep me hangin' on...

Timewarp Tuesday: Pets and Diabetic Owners

Today, I've decided to repost a previous posting I did entitled "Pets and Diabetic Owners" from April 16, 2007. This posting was prompted by a conversation I had with Kerri at the DRI Diabetes 2.0 Conference this weekend (this re-post is for you)!

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

Happy D-Blog Day + Disease Management 2.0

First, let me acknowledge the fact that today is D-Blog Day. In essence, it's a day dedicated to a vibrant diabetes blogging community which has organically grown to include several hundred individuals, and continues to grow. If you're interested, you can start your own blog, or just comment on some of the many posts out there. OK, with that addressed, now for my regular post.

Disease Management 2.0

I was on the plane headed to the Diabetes 2.0 Conference at the Diabetes Research Institute on Thursday (I'll be covering that in more detail soon), and picked up a copy of last week's edition (November 2, 2009) of BusinessWeek (the one with the cover on smartphone apps) while I was at the airport.

As I was flipping through the magazine on the plane, I stumbled upon on interesting article entitled "Tough Love, Lower Health Costs" by Arlene Weintraub. This article coincided with a release last Wednesday from United Healthcare, Inc. proclaiming "More Employers Turning to UnitedHealthcare's Diabetes Health Plan to Help Improve Health, Control Costs".

I had read UnitedHealhtcare's January 15, 2009 press release on this program, and had pretty much dismissed it, assuming it was yet another example of the typical so-called "disease management" programs of the sort that is outsourced to third-party vendors. A video by UnitedHealthCare was prepared and can be viewed below.



In my own experience, these third-party vendors provide automated reminders to patients (often computer-generated phone calls and e-mail blasts to remind patients to show up to their doctor's appointments, take their medications, exercise and perhaps a nearly useless newsletter on diabetes management aimed at people whose knowledge of the disease is next to nothing).

As might be expected, there is a trade association of these vendors for this industry called the Disease Management Association of America (DMAA) which has released countless so-called "studies" which they claim proves the value and worth of these programs. But the evidence is clearly mixed.

For example, back in 2007, I wrote a posting about yet another study that had raised questions on whether these third-party disease management programs do anything to reduce costs. A number of studies including one by the RAND Corporation and another done by the U.S. Government's own Congressional Budget Office (CBO) determined that the value of these programs could not conclusively be quantified in dollars. Part of the problem is that patients are expected to pick up the cost of compliance with these programs (which is costly), but are seldom provided much financial incentive in terms of reduced co-pays, or even ease in navigating through the insurance coverage process.

Speaking from my own experience, I received dozens of irritating e-mail reminders and robo-calls, and had continued hassles in getting the very insurer who enrolled me in the program to pay for testing supplies I needed to maintain glycemic control, or get them to pay for an insulin pump, for example. On that basis, the program was more of a hassle that did almost nothing for me, but a third-party vendor was paid handsomely to administer the so-called "disease management" program. Eventually, I requested to be removed from the program which provided me no financial incentive, yet rated high on the annoyance factor.

That isn't to say that the programs are of no value, but clearly, if we're looking to save money on healthcare, we need to consider the way we quantify success. But what makes the BusinessWeek story most interesting is that some big employers, such as GE and Hewlett-Packard to name a few, have had a role in the design of the program, not the healthcare insurer alone. As a result, there have been some pretty profound changes in the "new" UnitedHealthCare Diabetes Health Plan.

What's different?

First, UnitedHealthCare is offering the Diabetes Health Plan only to large companies that are self-insured, meaning the employers bear the entire risk while the insurer administers the plan. Second, although the program is flawed on the use of "surrogate" markers for disease outcomes without considering the big picture, those are already used in the basis of approving or denying coverage. While this plan aims to get patients to adhere to treatment guidelines and to agree to be tracked by the company to ensure they're compliant, it also provides real financial incentives, making it unusual. If that sounds a bit big-brotherish, consider that the reality is that insurance companies are already doing that anyway, and HIPPA allows them to do so without disclosure to the patient, as they're considered "covered entities" exempt from disclosure to the patient. But the key difference is that those who stick with the program will receive significant discounts on out-of-pocket expenses such as co-pays for diabetes-specific treatments which can reduce the person's healthcare costs significantly. Those who don't "comply" are kicked out of the program and put back into their company's standard plan, the one without the financial benefits.

According to the BusinessWeek article, UnitedHealthCare provided the following hypothetical scenario: Say a company's standard plan charges co-pays of $30 to $50 for prescription drugs; those fees would be completely waived on insulin, insulin pens, possibly even insulin pump infusion sets or syringes/pen needles, and/or oral drugs that diabetes patients use to control their blood sugar and on glucose meters for testing their blood. Deductibles might also be reduced, and these are growing increasingly common across healthcare plans nationwide. Patients must agree to twice-yearly physician checkups (for those already doing this, its really just a huge price break) and other preventive measures, and they have to sign to allow United to keep an online scorecard that uses claims data to keep track of their compliance. As I've noted, UnitedHealthCare already tracks patients who order diabetes medicines through their pharmacy benefits manager (PBM) and knows far more about patients than most realize, so the risk to patients in terms of privacy is vastly overstated, but the rewards are significant.

The financial benefits to patients participating in the program are rather significant, and can add up to quite a bit in out-of-pocket expenditures, saving patients a LOT of money. Whether the program helps patients navigate through UnitedHealthCare's maze of approvals, appeals, etc. remains a mystery, but it is clear that program enrollees have access to a dedicated staff who CAN help patients deal with such matters.

For the moment, UnitedHealthCare is offering the Diabetes Health Plan only to large companies that are self-insured, meaning the employers bear the entire risk while the insurer administers the plan. But if this program proves successful, other insurers are almost certain to mimick the program, and potentially improve it.

UnitedHealthCare acknowledges that the biggest opportunity comes not so much from people with diabetes, but those with a condition whose very existence is disputed: pre-diabetes. Indeed, David Kliff, the Diabetic Investor, argues:

"'Pre-diabetes'" is like a woman being sort of pregnant. Either you have diabetes or you don't. The fact that the popularity of 'pre-diabetes' has taken hold is further confirmation that the people who are supposed to be helping with the diabetes epidemic have lost touch with the real world."

Patients with "pre-diabetes" have not officially been diagnosed with a disease, so enrollment in such a program raises questions of ethics on how best to spend limited healthcare dollars (pursuing those who aren't officially sick, or treating those who actually have a disease?), not to mention exposes the employers and their healthcare providers to potential lawsuits challenging the efforts. However, as long as the program enrollment remains voluntary, that isn't a real issue.

Whether pre-diabetes is genuine or not has little to do with the opportunity to save significant money. According to BusinessWeek:

"... the biggest potential savings for the employer, according to United, come when you prevent people with 'pre-diabetes'—who are also eligible for United's plan—from developing the full-blown illness. 'We know if a pre-diabetic loses 7% of their body weight, the chance they'll become diabetic goes down by 58%,' says Dr. Deneen Vojta, vice-president and medical officer at United. 'The numbers get astronomic.'"

Is there a downside? At the moment, the lower-cost diabetes patients (those deemed "compliant") aren't restricted. But if the insurers decide to shift focus away from patients with diabetes concluding that once they're diagnosed, it's a lost cause in an effort to save money, then challenges could emerge down the road.

But right now, the lure of immense cost-savings across the board in diabetes management suggests that is not likely to emerge as a problem anytime soon.

Book Review: Dan Hurley's book "Diabetes Rising" Disappoints (Just a Little)

I picked up an advanced copy of the book "Diabetes Rising" by Dan Hurley. I'm fortunate to live in the center of U.S. publishing, New York City, so there are many bookstores in town which have dozens of advanced copies of books which are sold as used -- I only paid $5 for a book with a list price of $26.95, although the book clearly states: "This is an advanced uncorrected proof. Please do not quote for publicity or publication without checking against the finished book. Not for reseale." (Since it was resold, I have few reservations about quoting from the advanced copy of the book, besides I can be a more objective reviewer this way) I bought an advanced copy well in advance of the official January 2010 release date, and many of the NYC bookstores will also sell to anyone with internet access, FYI). Amy Tenderich reviewed and subsequently interviewed the author back in September (see here, here and here).


After reading Amy's reviews, I was actually optimistic that this book would be along the lines of James Hirsch's "Cheating Destiny: Living With Diabetes, America's Biggest Epidemic" and take Hirsch's book to a new level. Hirsch's book, which IMHO is a very well-written account not so much about diabetes exclusively, but the state of the U.S. healthcare "system" (a term I use very loosely, because its really not so much a system as a collection of different interests that lack any sort of coordination at all) and how that "system", which was really built to address acute illnesses effectively short-changes patients with chronic illnesses in the process, and chronic illnesses are becoming ever more widespread in American society thanks to medicine transforming a number of formerly deadly diseases into chronic illnesses that have to be managed, rather than cured.

Anyway, with Mr. Hurley's book "Diabetes Rising", I was a bit disappointed, and I really wanted to LOVE this book. I didn't love this book. I didn't hate it, either, but I had a mixed opinion overall. I feel that the amount I paid for the book ($5) was worth it, but if I'd paid the list price ($26.95), I might have felt I'd been ripped off. Why? I was most struck by a few issues.

Issue #1: Too Much Coverage of Topics Which Aren't Interesting Reading

The first issue is that the author dedicates the first third of the book to the history of diabetes, along with countless factoids and statistics about the history and prevalence (the "Rising") of diabetes and the author's theories behind the growth of diabetes. Although interesting (Hurley is a good reporter), it does not add much to the story, I'm afraid. My impression that that this was kind of an effort to try and build a case for why diabetes should be cured as opposed to giving it chronic treatment without a cure, as is the case today. The author's writing style is interesting, but I have to admit that I found this section incredibly boring, and the information, while accurate, failed to convince me -- and I actually live with type 1 diabetes! I thought "Gee, if he can't win my support, then I question whether this book will help to convince policymakers and healthcare leaders?" He spent far too much time on this subject, which in my honest opinion, really wasn't necessary, but did increase the annoyance factor.

A lot of the time, he talks about diabetes collectively (type 1 and type 2) and that's part of the problem, although he clearly notes the differences when relevant. But the overwhelming consensus is that aside from sharing a similar similar name (due to an inaccurate historical medical assumption that it was, in fact, the same illness), but cures will likely require a very different approach for each type of diabetes thanks to the distinct and different underlying etiologies for both type 1 and type 2 diabetes. From my perspective, this part of the book was really a lost opportunity to make a more compelling case for why it makes sense to cure rather than continue treating diabetes, and from my perspective could have been addressed more succinctly. I sooooo wanted to skip ahead, but instead, I kept reading, but did not enjoy this section and really had to struggle not to skip ahead. It was like re-reading all the other annoying books diabetes, but I did not find this section enlightening or entertaining, just annoying.

By comparison, Jim Hirsch's book combined his own personal experience weaved together with actual facts makes for a more compelling and interesting story than Dan Hurley's does, which is written more as a third-party observer. Incidentally, if it wasn't in the forward section, throughout the entire first section, we'd hardly even know that Dan Hurley himself has type 1 diabetes. I can't be too critical, that's usually the way I write, too, except that I haven't been published. But I'll take that as a note should I ever decide to write a book that personal stories add infinitely to the credibility and readability to the story.

Issue #2: Too Much Focus on Disputed Theories Behind the Cause of Diabetes

The second key issue for me was addressed mainly in the next section of the book, which looks into the "Reasons" (hypotheses for what causes diabetes). In this section, Mr. Hurley focuses on a handful of theories (and they're are all just theories right now), but there is almost no justification for his selection of the particular theories he's selected, rather the reader is supposed to trust the author and those he's interviewed have made the correct assumptions. But faith in the author alone doesn't work for me.

This is, perhaps, my biggest gripe about the book.

First, I disagree with his selection of several theories, in part, because the logic behind why he chose those theories is a complete mystery, and the theories themselves are hardly the consensus view, and the evidence he presents is, in many cases, disputed.

One theory he posits, the so-called "Accelerator Hypothesis" (the word "hypothesis" should tell you something) which is summed up very succinctly in the journal Diabetes Care (published by the American Diabetes Association). I already wrote about this theory back on July 14, 2008, in which I called attention to that particular hypothesis' shortcomings, so my disdain for that particular theory is hardly new. Also, I don't need to tell anyone that the ADA's journals have been repeatedly subject to claims of lack of objectivity, occasional impropriety and frequent conflicts-of-interest among many of the journal's submissions, and while focused exclusively on diabetes, they remain less objective, than say, The New England Journal of Medicine or The Lancet would be. But beyond citing less credible sources (or certainly ones regarded as less subject to dispute), and the Accelerator Hypothesis is among the most provocative but disputed and contested theories even among diabetes researchers. When that theory first came out in 2003, I immediately questioned the core logic, and over the next few years, I read study after study which disputed various elements of the Accelerator Hypothesis.

In fact, Mr. Hurley spends considerable effort trying to build support for the Accelerator Hypothesis, and presents like it's presumed (or should be presumed) to be fact. My take on it is that the Accelerator Hypothesis predicts earlier diabetes onset in heavier and/or taller people, without necessarily a change in risk, and views type 1 and type 2 diabetes as the same disorder of insulin resistance, set against different genetic backgrounds. But the authors of that theory admit that most diabetes registries fail to track adults along with children, leaving them with little to substantiate their theory. But the basic logic is that if the age of diagnosis is becoming lower, there must be a reason; hence, the Accelerator Hypothesis. Early weight gain and increasing BMI of young children may lead to increased insulin resistance and an earlier destruction of pancreatic beta cells in a person who may be genetically predetermined to develop diabetes. But they fail to address the issue of autoimmunity and many doctors are left questioning the core logic behind the theory of insulin resistance based on basic dosage requirements among patients with type 1 relative to those with type 2, which are considerably smaller on a per kilogram basis, suggesting that insulin resistance is not the problem in type 1, insulin insufficiency caused by an autoimmune response is. Unfortunately, the authors of this theory also note that relatively few of the children in their own sample were overweight, raising even questions on the basic argument of the theory, as well as many other shortcomings. I find the use of largely disputed evidence to be perhaps the most troubling aspect of the book.

But this is not limited to the Accelerator Hypothesis alone. He also presents a few other theories, such as the Sunshine Hypothesis, also known as the Vitamin D hypothesis. Again, his selection of this particular theory is questionable or debatable, in part, because Vitamin D is among the most supplemented vitamins anywhere, although there are questions as to whether there's a legitimate difference between the vitamin D attained from the sun and the man-made supplements that exist in everyday foods. Unfortunately, hard evidence showing that low levels of vitamin D lead to disease or that high levels of Vitamin D prevent it are almost completely lacking, although it's presently a burgeoning area of research. As I've reported in the past, some (not necessarily the mainstream) organizations, such as the California-based Autoimmunity Research Foundation, posit just the opposite: that excessive amounts of vitamin D actually leads to an increase in a host of different autoimmune diseases, including type 1 diabetes mellitus. As I noted, that is subject to dispute as well, but exactly how much vitamin D children and adults should get, and defining when they are deficient, is also under widespread debate. Doctors use different definitions, and many are waiting for "official" guidance on the subject expected in an Institute of Medicine report on vitamin D which is due out in 2010. The institute is a government advisory group that sets dietary standards. But to select this hypothesis, which is also subject to such widespread uncertainty, raises questions in my mind, but fails to answer anything for me.

The Cow's Milk Hypothesis, which asserts that giving babies cow's milk-based foods too early in life is what wreaks havoc on the immune system, is a somewhat more logical theory, but remains only a theory that has already been dismissed by some, although other studies seem to back this theory up. But if I were to make an argument on the reasons behind the rise of diabetes, I would try to choose some theories that were not the subject of such widespread conflicting evidence.

About the ONLY hypothesis Mr. Hurley presents as contributing to the rise of diabetes that I can even rest comfortably with is the POP (Persistent Organic Pollutants) Hypothesis, which assumes that man-made environmental toxins may be the cause. But an interesting and unexplained paradox of this theory is that many countries with the most pollutants on earth, such as China, also have some of the lowest incidences of type 1 diabetes anywhere on the planet. A more compelling argument might be made for a combination of different theories, rather than taking any of these unproven theories by themselves. Take the POP Hypothesis combined with the hygiene hypothesis, which Mr. Hurley fails to even address (even though it's perhaps among the most logical and least disputed theories around) is that when children are exposed to many viruses, bacteria, etc. at an early age, their immune systems are better able to distinguish "self" from "non-self", so kids growing up in say China, have immune systems that are less likely to attack themselves and cause type 1 diabetes than kids in places like Finland or Sweden, two countries that are really, really clean and affluent.

But even if these theories collectively make sense, the POP Hypothesis also remains one of the few theories where the resolution is perfectly clear. The problem is that world lacks any collective willingness to effectively address the problem. With that being the case, why spend so much time writing about it, when one country cannot do it alone (and often, the U.S. has been among the least willing countries to cooperate)? All of these strikes me as somewhat irrelevant to the case to be made as to why diabetes should actually be cured rather than maintaining the status quo, although he does raise a number of compelling arguments why treatment alone is insufficient.

But all of the theories "Diabetes Rising" presents, even if they are in dispute, also raise questions as to what relevance they even have on the current situation? Again, he spent a lot of time on this particular issue, and much more than I thought was really necessary.

Issue #3: A Lost Opportunity?

The core issue is that diabetes is extremely costly to treat using current methods, and the incidence of all types of diabetes is rising rapidly worldwide, which spells trouble. The sad fact is that we cannot prevent ourselves out of an epidemic already underway, its already a day late and a dollar short for that, something Hurley fails to even address. Therefore, the challenge is for society to evaluate the continued and growing cost of investments made in treating the disease relative to investments in finding cures for the disease. At present, investments in treatment relative to cures are about 500 times higher than cure-related research. That should, in theory, make curing diabetes easier to justify, and he should spend more time talking about misplaced research priorities in diabetes and why that is a poor use for limited research dollars, but he really doesn't spend much effort or focus on doing so, and I think misses a huge opportunity for what could have been a truly "epic" book as his publicist refers to it. Instead, I see it as yet another tome about diabetes that could have met the description, but instead misses the mark on several levels.

Positives: Coverage of Cure-Related Research & Progress

The third section of the book talks about what he suggests are the "Remedies" (theories that might lead to a cure). I would believe this section is the most interesting, most logical and best-written, and my preference would have been for him to spend far more time and effort to beef this section up, rather than having spent so much time and effort on the rising and even the reasons for the growth in all types of diabetes. This section, in my opinion, gets too little attention and detail, and again, contributes to a book that is less balanced overall.

For example, he talks somewhat about what he refers to as a "computer cure" (meaning the artificial pancreas) in which the author Dan Hurley himself was in a clinical study organized by the JDRF. ("For 15 hours, I was no longer diabetic," he wrote, and he also lamented about how the FDA has consistently dragged its feet on approving a simple but key feature: automatic shut-off for a combined glucose-insulin system that detects a low). Of course, he does not address the fact that the reliability of these devices is widely regarded as insufficient, and he also fails to address the tests that JDRF-funded researchers at Boston University (see JDRF's March 2007 Frontline for details) have done on combining insulin and glucagon in the same device, which I would call a significant research oversight on this very subject. JDRF's Aaron Kowalski was interviewed, and I think Aaron is a great personality who adds a great perspective (both Aaron, and his brother have type 1, and Aaron's brother suffers from hypoglycemia unawareness) so his perspective is very valuable to this topic.

It is in this section where Hurley is at his best, weaving parts of his own personal story in with the facts makes it much more interesting reading. But I also feel that Mr. Hurley does disjustice (is that even a word?) to the discussion on the controversy over bariatric surgery as surgical cure for type 2 diabetes, with an inappropriate comment "By golly, it works". Aside from the problems with this surgery, I think he places too much faith in a handful of studies undertaken by doctors who stand to benefit the most by performing this surgery, when, in fact, it's very radical surgery and not without risks (although he does nothing to address the risk of doing nothing as a point of comparison). Again, if he had focused only on type 1, that would be a non-issue, and I believe the subject of type 2 has less relevance to this book as an overview of the situation. Again, self-management pertains to both, but Hurley has no real expertise on the subject of type 2 and I don't think these two always fit together unless it's in the context of public policy and the tendency to blame the patient rather than the disease itself.

I did LOVE Hurley's personal observation on insulin pumps and closed-loop systems:

"I finally decided to go on a pump in 1999, after my insurance company agreed to pay much of the cost. On balance, I found it made life easier by allowing me to make minor adjustments in my insulin rates on the fly, but resulted in little change to my A1C numbers. And my lows remained every bit as common as my highs. Essentially, it was just another way, albeit incrementally better, to get the same old insulin I'd always used. And while friends and family often assumed that the pump worked like an artificial pancreas, giving me only as much insulin as I needed, in fact, it was as dumb as a brick, following only the instructions I gave it."

Finally, in the section which he describes as a "Biological Cure", he does address some of the potential autoimmunity treatments including lengthy coverage of teplizumab which is being developed by Macrogenics in combination with Eli Lilly & Co. thanks to a partnership facilitated by JDRF, but doesn't do sufficient (actually any) justice to the legitimate concerns about related to adverse effects. For example, I am fond of the quote of my friend Ellen Ullman, who wrote:

"Dr. Harlan from NIH wisely pointed out at Children Wtih Diabetes Friends For Life Conference that the anti-cd3 drugs [which includes teplizumab] can cause recurrent mononucleosis which can increase one's propensity to develop lymphoma. Why would someone put their child at risk for that simply for a year and a half of extended honeymoon?"

Of course, there are several other similar treatments now in late-stage clinical trials, included one by Tolerx, Inc. and GlaxoSmithKline called otelixizumab. In fact, Tolerx's CEO Doug Ringler's blog called "The Green Chair" recently wrote a posting entitled "Dose Optimization Presentations On Otelixizumab: Finally!" suggesting that the GSK/Tolerx treatment is further along in development that the Lilly/Macrogenics treatment teplizumab is. Whether that is true remains to be seen, it could just be that Tolerx is more forthcoming that Macrogenics is.

Still others have a few other products being tested, among them, including Denise Faustman's use of the BCG vaccine. Whether any of these treatments will work long-term in patients remains to be seen, and the adverse events, especially with repeated, long-term usage, remain hurdles that are worthy of further exploration. But as noted, I don't believe this section got the attention it really deserved, and this is an area patients with diabetes really want to know about. But he did spend too much time talking about stuff that many of us really don't care about.

Having said all of this, I DON'T want to give the impression that I completely disliked the book, or that I think it is poorly written.

Quite the contrary.

I believe Dan Hurley does an excellent job of researching those topics he chooses to focus on. My issue is that I think he focuses on some (OK, many) areas that I don't happen to agree with. That doesn't mean he's done a bad job. In fact, he writes in a manner that might make someone really believe the stuff he's written, which I think is part of the problem. I wouldn't want someone to walk into Barnes & Noble, pick this book up, and believe that he's answered everything, because he most certainly hasn't. As with anything, there are two sides to every story, and I believe he's done a good job of presenting one side of the facts. But as I am fond of saying, that might be "selective disclosure of the truth". Is it wrong? No. Is it always a fair representation of the facts? No, but it's a book, so it doesn't have to. Is it an interesting read? Certainly.

One thing I must give Mr. Hurley credit for is that he writes well, in a manner that is very readable and he does know how to interview (or give the impression when he hasn't interviewed) on various subjects all within the context of the subject he covers. He's obviously an experienced journalist.

I also agree wholeheartedly with his conclusion:

"But it's just as clear ... that focusing on personal responsibility alone has not stopped, and will never stop, the rise of diabetes. Something more is needed; recognition that forces beyond the individual's control are at play, and that united action is necessary to face down what is a public, and therefore political, danger to our well-being, and to the well-being of our children."

He probably could have dedicated an entire chapter to that subject, but only touches upon it, which is IMHO, another lost opportunity.

My Conclusion: A Good, But Not A GREAT, Book About Diabetes

My conclusion is that Mr. Hurley and his editor have chosen to focus on on certain topics, and he does present those subjects well. In fact, they are presented too well, so that an uninformed reader might reach the wrong conclusion about those topics. There's no shortage of opinion about the causes behind diabetes, or what to do about it. I just disagree with his theories on the causes. But I DO like his book overall, but I think he could cover some subjects in more depth and spends way too much time on some subjects that aren't really necessary. That doesn't make it a bad book; the goal of the publisher is to sell books, not be a balanced story. In fact, the book is quite well-written and researched, and the length is about right, I only wish he'd dedicated more time to certain content, and far less to other content.

"Diabetes Rising" is definitely worth reading, and there's definitely a big shortage of writing about diabetes. In spite of the amazing growth in diabetes prevalence, diabetes gets far less publishing coverage, than say, cancer, which has sooo many books, and too many of the diabetes books are about diet and cooking. I would have liked Mr. Hurley to focus more in-depth on topics where there's a genuine lack of coverage (such as cure-related research and progress being made there), and focus far less on those topics where there's no lack of coverage on (such as the disease history and prevalence of diabetes, both topics have been beaten to death by the press).

While I hope that Diabetes Rising sells well (because a success will pave the way for more to be written on this subject). Too often, books on the subject of diabetes don't sell well, which tells the publishing industry that its a subject that does not deserve more attention. Nothing could be further from the truth. We need more, much more to be written on the topic of diabetes, and some of that's because the books which have been written on diabetes have been poorly chosen. "Diabetes Rising" is definitely worthy of being published, and deserves to be a hit with booksellers. But my recommendation is NOT to buy the book at that ridiculous list price (maybe read your library's copy instead). Diabetes Rising a good book, but not a great book about diabetes.

Throwback Thursday: Public Schoolhouse Rock!

I was going to call this a "Timewarp Tuesday" posting, but since it's Thursday, I'll call it "Throwback Thursday" instead. Anyway, since Yahoo! retired it's free web-hosting service Geocities, I used the opportunity to revisit every single post I have done since I first began blogging on September 15, 2005. The reason was because I had archived a host of different files and news articles on Geocities and elsewhere, and because I did not wish to pay Yahoo to house those things (I already maintain another website dedicated to New York City's illegitimate, involuntary HbA1c tracking plan that patients CANNOT opt out of, stopnyca1ctracking.org, and I have a LOT of unused storage space there). Anyway, that required me to visit every single posting I have ever done in order to identify posts that contained links to the now-defunct Geocities sites and migrate the files elsewhere, if necessary.

Although I consider myself a good judge of sources and links I feature in my postings so those I use are much less likely to expire, many do end up being relocated at some point. One example was a 2007 Express Scripts study that evaluated the impact that generic insulin could have on U.S. pharmaceutical spending. Express Scripts remains a vital, profitable company (they've grown, too, having acquiring the PBM business from WellPoint earlier this year), but they relocated the reports I had cited to a slightly altered location, meaning the old links were dead.

The sheer number of links made this a time-consuming and interesting process. The good news is that more than 98% of the links in every archived post has been verified or updated to ensure they still work, and hopefully well into the future. I relied heavily on the Internet Archive (http://www.archive.org/) in many cases, and even used the Internet Archive's links for URL's I felt were likely to expire or be relocated in the future, so they'll remain relevant into the future.

As part of the process, I also had the opportunity to review some posts that I'd long since forgotten about, but still put a smile on my face. One of those is the subject of today's "Throwback Thursday" posting, and that was a rather amusing YouTube posting (one of my first to feature videos) called "Schoolhouse Rock vs. Public Schoolhouse Rock" from October 23, 2007, a little over 2 years ago. The posting says it all, but see if you don't find this one amusing!!

Open Enrollment and The Many Layers of the U.S. Healthcare Bill

As many people know, Congress has supposedly been working to address healthcare reform ever since President Obama gave his first U.S. press conference earlier this year. Much has been said about it, including more than a few legitimate (and illegitimate) critiques. But this bill is really a monster, and includes a number of seemingly unrelated items to healthcare reform. Since Congress hasn't accomplished all that much this year (besides bickering with each other), there is some effort to throw everything into the bill since it may very well be the ONLY piece of legislation Congress actually votes on this year.

But aside from efforts to address universal coverage, what else is in there?

A few things that people with diabetes may wish to beware of.

Well, its October 28, 2009, and we're reaching the last stretch of the year. Presently, this is the time many people are faced with what's known as "open enrollment" for healthcare plans and various other employee benefits.

The New York Times "Well" Health Blog writes that several experts in the field of employee benefits are saying "When Your Open-Enrollment Envelopes Arrive, Open Them".

They argue that "Doing nothing is no longer an option. Many companies insist you fill out open-enrollment forms even if you intend to stay with the same benefits package. What's more, with so many changes and cost increases on the horizon, you owe it to yourself and your family to take a close look at your options."

An article cited offers some suggestions on how to handle the changes and avoid huge cost increases.

In a subsequent NY Times article by Lesley Alderman, the journalist writes:

"The time-honored 'evergreen' option — defaulting to your current plan — may simply no longer be an option. Either your employer no longer even offers that plan, or the terms may be so radically different that you may no longer want it. With so much in flux, this may be the year you will need to switch health plans."

For many of us with chronic conditions, Flexible Spending Accounts (FSA's) are a huge benefit, and if this is an option offered that you don't presently take advantage of, and you have diabetes, you might very well consider participating. These so-called FSA's provide you with the ability to pay for any deductible amounts, as well as all of your co-pays for testing supplies, medicines, numerous doctors visits, labwork, etc. and even things like contact lenses, glasses, or dental work -- all using pre-tax dollars, thereby reducing your income tax liability.

Congressional Healthcare Reform Could Kill Tax-Advantaged Flexible Spending Accounts (FSAs)

This year, I expected to use more of my FSA balance with my high-deductible insurance plan that was introduced this year (in June), and I'll naturally order more glasses and contact lenses as I normally do every year. Although I try to budget things as closely as possible, it's never exactly been a scientific procedure determining co-pays with a brand new healthcare plan, as well as costs for everything else. Most employers set caps on the plan amounts employees can contribute since they have to front-load those dollars for all of their employees, but the caps set may be different for every company.

Although I have a high-deductible insurance plan ($2,500), because my employer picks up the cost of anything over $500 (which is an administrative hassle, but at least I don't have to pay for all of it) that means I'll still have some money left over, and I plan to use as much as I possibly can so I don't have to forfeit much.

Because I expect to have enough left over, I'm seriously considering splurging and getting a high-tech (and expensive) lancet device called the Pelikan Sun. Fellow d-blogger Amy Tenderich reviewed the product a while back. That will cost about $200 plus a few lancet disks at about $50/each (I don't think this device enables perpetual re-usage of the same lancet that most ordinary devices do, but then again, I should remember change the lancet more than once per year anyway). I think this will be an easier claim for my FSA given that it is already an FDA approved device, and it fits clearly within the "diabetes supplies" category as defined by the IRS.

Next year, however, assuming Congress finally gets around to passing a healthcare "reform" bill, The Wall Street Journal is reporting that members of the Senate Finance Committee are proposing to cap tax-free FSA contributions at $2,500 per year.

That's well above the amount typically put in the accounts now, according to a Senate Finance staffer. (Presently, there is no statutory cap, although most employers set caps on the plan amounts since they are required to pre-pay the amount for all of their employees enrolled in the plans at the beginning of the year, even though it's deducted from participating employees' paychecks during the course of the year.)

But what that Senate staffer failed to mention is the fact that the Senate bill would also provide no inflation indexing of that cap, so if medical cost inflation continues at roughly 8% per year, the $2,500 turns into just $1,250 in 9 years, which as a number of editorials have rightly noted, virtually kills the Flexible Spending Account program over time.

The editorials also rightly note that this change unfairly punishes people who have chronic diseases -— people who, according to the Robert Wood Johnson Foundation, incur annual out-of-pocket expenses averaging about $4,400. We are talking about people with diabetes, families with autistic children, asthmatics who need to buy expensive nebulizers and inhalers, and cancer patients and others.

Apparently, Max Baucus want to end the practice of allowing people to put money into FSA's, which allow employees to pay for co-pays, deductibles as well as everything from cosmetic dental work to surgery using tax-free dollars (well, technically, they're pre-tax dollars which reduces your taxable income, not tax-free dollars).

Diabetes supplies ranging from glucose tablets, lancet devices, and a host of other things all fit under this broad umbrella definition, and frankly, this program has saved me a lot in tax liability and has helped me to weather the ever-growing cost increases in healthcare costs much easier than I could have without it.

As might be expected, a trade organization called "Save Flexible Spending Plans" which launched a companion Web site, savemyflexplan.org. The site is the brainchild of the Employers Council on Flexible Compensation, a group of plan sponsors and third-party administrators that want to preserve and expand tax-favored employer-sponsored benefits, as they stand to loose out if these plans are reduced.

Catch the "Save Flexible Spending Plans'" commercial here:



Critics argue that this organization is nothing more than an organization of people who stand to loose if this piece of legislation passes. That may be so, but the mystery is what the final cost of the Healthcare bill will look like for taxpayers. We may see little, if any tax benefits for those of us whose medical expenses have gone up thanks to ever-higher deductibles and employers who continue to deal with cost increases by using a flexible spending account that apparently, Congress wants to kill.

Anyway, for those of you who are now faced with open enrollment decisions, all of this is some food for thought!!

On Google Voice

I have a shocking admission to make: I have a life outside of diabetes. Yes, it's true, and I have interests that have nothing to do with the big D. This post is about one of these items.

I have been what could be described as a fairly heavy Google user. I'm not talking about using Google's core search engine, but my blog is hosted on Google's Blogspot, I rely on Google's reader to keep up with the hundreds of blogs I follow, I've had a Gmail account since they first began offering them a number of years ago (although truth be told, Gmail is NOT my primary e-mail account, I just don't dig its interface), I have a number of documents, spreadsheets, Powerpoint presentations and PDFs on file with Google Docs (and it also doubles as a great tool to convert Microsoft Office documents into PDFs) -- you can also share spreadsheets there which theoretically would make it a potentially useful tool to share your blood glucose logs with a doctor or diabetes educator (assuming they're online, which may not be the case), etc., etc., etc. Sure, other blog hosting services may have newer or better features, and there are some annoying limitations when it comes to Google Docs' spreadsheets that limit its practical usage (too few lines in their spreadsheet, as I've discovered), but for me, the key is having it all located in a central location with a single login. Plus, all of these things are paid for by Google's efficient advertising machine, so it costs me as an end-user absolutely nothing.

Anyway, a few weeks ago, I got my invitation to Google Voice, but it took me a while to warm up to it. For those of who who haven't seen the internet chatter about Google Voice, it's been billed by some fans as the next "category killer" application. Personally, I don't see that happening, but as I've toyed around with the application and become more familiar with it, I've started to realize the potential value of this service and I really do like some of its features.

What does Google Voice do?

Well, in short, it's something of a telecommunications service that officially launched on March 11, 2009. I say something of because it does not provide you with a phone or even the service, and you do need internet access to use it. If the power is out and you don't have a Blackberry/iPhone, then your access to the control panel on Google Voice is more limited, and you still need to pay someone else for basic phone service.

Although Google Voice officially launched, I think for the moment, it's open only by invitation (anyone can request an application, but I believe those with Gmail accounts are considered sooner than those who aren't). In essence, the service enables you to choose a dedicated Google Voice telephone number, which you can control and access online. From there, you can then add many different numbers to which calls made to your Google Voice number are then forwarded. But you can also control which calls go through to you, and which ones go directly to voicemail (which, naturally, you can customize), and you can also set the hours when calls are forwarded to your different numbers. This means you can have calls from family members go through directly all the time to all of your different phones (your cell phone, your office phone, your home landline number, even a "gizmo" as Google calls them) and these will ring simultaneously until you answer one of these phones or the call rolls over to your Google voicemail. From there, it gets even more interesting. For example, your voicemail messages are accessible online, and Google also transcribes the voice message into text for you (if you want that). This sounds nifty if you get hundreds of calls all day, but the real selling point for me was the simple cost of making long-distance calls, which is completely free in the U.S. and Canada (I think Puerto Rico and the Virgin Islands are also included in that).

I realize the days of long-distance costing a fortune has long since gone the way of the Ford Edsel, but have you ever looked at your landline (for those of you who even have one) or your cell phone bill? There are so many taxes and they nickel and dime you on everything. International calls aren't free on Google Voice, but the rates are incredibly low. For example, $0.02/minute to much of Western Europe (except cell phones, which cost more to call), and further, to places like the Philippines, calls are $0.11/minute, and the price you pay does not include any other miscellaneous taxes that occur with regular long-distance services. Plus, these calls can be initiated on your cell or other phone (as well as online), so you could theoretically call abroad on your cell at rates that are among the lowest I've seen anywhere (just pay attention to the minutes you're using!). To make a call, you type in the number you want to call online, or call your own Google Voice number and hit the * key and a menu will guide you through the process. A few seconds later, you get a call back. Plus, the person you're calling will see your Google Voice number on their caller ID.

Although services like Vonage, Comcast Digital Voice, Time Warner Digital Phone, Cablevision Optimum Voice, MagicJack, etc. also do this, these companies also control the rates, which can vary considerably, and they haven't been shy (at all) about raising their rates in recent years. And you pay a minimum even if you don't make any calls. With Google Voice, you only pay if you make an international call, but your domestic calls remain free.

There are some other nifty features. For example, you can conference call simply by having people calling you. There is no apparent limit, and you can conference in only those you want to be in on the call, and add new participants in whenever they call in.

The downsides: well, you are ceding a boatload of data over to Google, and Google's privacy policy doesn't offer tremendous protection. (Some people who are Twittering every mundane detail about their lives may not even consider this a big deal ... until it's too late!) But then again, neither does SBC or Verizon, although one could argue these companies are drowning in data and they have yet to figure out what do do with it all. Google, on the other hand, might. It's also possible that more advertising could emerge on top of Google Voice services. But its a consideration for some.

The other downside, for the moment anyway, is that you cannot yet port your existing number as your Google Voice number, although they claim that is in development. As the various videos online suggest, the service isn't perfect. Transcription, for example, doesn't work perfectly. Oh, and the choice of numbers isn't ideal. For those of us in New York City, for example, you cannot get a number with a 212, 917, 646, or even a 718 area code. In fact, I wasn't sure they even had a NYC area code available, and I didn't relish having a 914 or 516 area code, but alas, I did find they had 347 area codes (which is an overlay prefix for the 718 area code). Anyway, its not perfect, but is pretty cool. Especially the free calls!!

Anyway, that's my non-D related post for today. See, I told you I have interests that have nothing to do with diabetes! To get your Google Voice invitation, visit http://www.google.com/voice.

Catch this NYTimes/CNBC video overview of Google Voice here:

A Letter to Nick Jonas

First, be advised that some of you may not like this posting. If you don't, feel free to read something else. I don't expect Nick Jonas or his Disney-paid publicist to notice it either, but I need to get this off my chest.

I openly admit it: I think Nick Jonas (and his brothers) is creepy, and I also side with comedienne Kathy Griffin on their so-called "purity" rings (the rings supposedly signify that they will wait until marriage to have sex), see her "colorful" comments on that here. As it turns out, the acerbic, red-headed comedienne was right, this is/was pure bull$#!t -- catch this excerpt from a British teen-tabloid for more on that. But I'm not naïve: I realize they're the latest boy-band craze that makes pre-pubescent girls' hearts flutter, and I could live with that. But what gets me is when all of it's just a snow-job presented as legitimate philanthropy.

They're just the latest in a long line of boy-band and singer sensations. History is full of them: the Jonas Brothers aren't the first, and most certainly won't be the last, and like it or not, their days in this role are numbered, as there's many eager would-be stars only too ready to replace them. We need look back no further to 1997 when another brother band called Hanson dominated the charts with a song called "Mmm Bop" that had the same effect on tween girls at the time.

Back in the 1970's, my sister was briefly in love with another teen idol by the name of Shaun Cassidy, when he performed his #1 hit single "Da Doo Ron Ron" and then later appeared on TV on the Hardy Boys/Nancy Drew show, I thought the shreeks coming from her would deafen me. Fortunately, they didn't. Two decades earlier, there was another teen boy-idol named Ricky Nelson, who began his career on his parents' Ozzie & Harriet TV show, and then later cashed in on his celebrity by extending it (quite successfully) to music and enjoyed success into the 1960's. My mother claims she thought (at the time) he was soooo cute.

But the sad reality is that the Jonas Brothers aren't entirely organic (and they weren't all that successful) until a senior Disney exec named Bob Iger came along with lots of cash and a master plan to create and leverage tween "franchises" across multiple media channels that was well-documented in The Wall Street Journal and other business media (see here for one such story). This plan really began with "High School Musical", then "Hannah Montana" and has since been extended to the Jonas Bros. These figures are emblazoned on products galore and it just so happens that the whole diabetes thing fits quite neatly into this squeaky-clean picture. But be assured, Nicky Jonas (and maybe his parents) is cashing in on it.

The Jonas boys (and their parents) aren't stupid, but they aren't exactly as philanthropic to the larger diabetes community as they seem to suggest. In fact, it's rumored that Nick Jonas got a fat check for $500,000 from the JDRF to do the Congressional testimony although detailed evidence to back that up is hard to come by, as the 990 annual filings with the IRS for nonprofits on file for JDRF don't require that level of specificity. That cost (if it was incurred) could potentially be included in another line-item on the financial statements, and even then, it might have been payable to some other entity, like the firm who booked him for JDRF (or even to an advertising agency), and it might also be blended with other expenses in the same broad category, since line-item reporting is fairly broadly defined.

This past summer, there was all kinds of internet chatter on the web, Twitter, Facebook and elsewhere about how Nick Jonas' had testified with JDRF before the Senate Committee on Homeland Security and Governmental Affairs on June 24, 2009 ("Type 1 Diabetes Research: Real Progress and Real Hope for a Cure") about his fairly brief life with diabetes (at least one kid who was YOUNGER than him who also testified has lived more years with diabetes than Nick Jonas has). He also appeared at the National Press Club on August 21, 2009 and the news and video clips were then subsequently shown all over the web (which fits in perfectly with Bob Iger's original plans for the Jonas "franchise"), and plenty of bloggers wrote about it like it was really news. Truthfully, I really wanted to vomit from it all.

Yes, the supposedly über talented pre-teen idol even wrote and performs a 'touching' song about his oh-so optimistic outlook on life with type 1 diabetes called "A Little Bit Longer" about how we'll have to wait just "a little bit longer" for a cure, but that will be alright in the end. That's supposed to be an inspiration to all the other people with type 1 that, in his words (from his Congressional testimony) "they can live with diabetes and still make their dreams come true". More cheerleading is not what people with diabetes lack, what we lack is truthfulness and honesty about the situation from almost everyone. My friend Deb Butterfield (author of "Showdown With Diabetes") once eloquantly wrote:

"Using reassuring voices and sweet smiles, nurses convey the message that if you do as you're told, then everything will be okay – just as in the NDEP campaign, they are telling their patients that diabetes is controllable, and if they control it, they will be fine. But the truth is that no study, not even the Diabetes Control and Complications Trial, has ever been able to show that diabetes management can prevent complications."

It is this lack of honesty that helps to explain the meteoric rise of all the diabetes blogs and various other social networks serving the diabetes community, as thousands now flock to these things to share stories about what a crock the "5 year" promise is, and how no one believes it. But someone hasn't filled Nicky Jonas in on this little tidbit yet!

My response to Nick's supposed philanthropy: fine, if you were paid by JDRF, fess up, give all of it back and admit it, and if you're really so generous to the cause, donate all the money you now get from the Bayer Diabetes Care endorsements to JDRF or the DRI. Maybe, in 30 more years, and there's still no cure (which may be likely), you can then put your songwriting and performance skills into that. I have some ideas I'm more than willing to share (including one for a song listed below)!

Trust me, Nicky, even with millions of dollars from all your endorsement deals and Disney promos, those unsubstantiated claims aren't terribly comforting, they grow ever more irritating as time goes by. Plus, your "simple-wins" (the tagline from your Bayer Diagnostics campaign) may not be enough to protect YOU from complications, bud. Maybe you'll be able to extend your window of fame, but the odds aren't really in your favor -- if you don't believe me, just ask former 1970's teen-idol Leif Garrett, who was once in a similar place as you are now!

I have no complaint about legitimate philanthropy, but when you're getting paid (handsomely) by charitable organizations and also endorsing diabetes products, but acting like it's genuine charity work, then I take issue.

Nick Jonas may or may not be the next Leif Garrett (who got arrested in the Los Angeles subway system for heroin possession, talk about tween idols in decline), but perhaps in 30 years he'll consider writing a different, more honest song about life with diabetes entitled "It's always just 5 more years away!".

Who knows, I might actually PAY to download a song like that to my iPod, and I would definitely promise NOT to change the station if I heard it as I do with all of his music today!


P.S. It's not my intention to turn this post into a flame-war. Everyone is entitled to their own opinions, as am I. But please realize that I DO moderate comments on this blog, so try to keep comments relevant and ideally, substantiated if you try to challenge me on something!

2009 Mid-Year Progress Report: Part 1

At the end of 2008, I didn't do my annual review of the diabetes cure-advancement and treatment landscape (you can catch my 2007 summary, my 2006 summary and my 2005 summary), a tradition I began in early 2006 and continued for several years afterwords where I highlight some of the diabetes-related developments (from my perspective, naturally) during the preceding year and share my thoughts and insight into the coming year. Most of my readers know that my observations are far from casual, they are based on a thorough review of these trends for the past year (often more) and have a solid basis to substantiate them. Since we're now more than 3/4 into 2009, there's little point in trying to recap last year, as we'll be ready for a recap of 2009 in just a few months! But I can provide some perspective on where things stand right now, and perhaps frame where they're likely to be going in the foreseeable future.

Let me begin by saying that I had a very good reason for not writing a summary of 2008. I was in the process of moving into a new place. But United Moving didn't do the work for me, I did the move mostly by myself, and mostly when I had free time (meaning on the weekends and evenings). Of course, I still had a job to occupy my time during normal business hours. That resulted in blogging taking a back seat. Although I've since resumed, I haven't posted quite as often as I did, say, in 2005 or 2006 because the Diabetes OC community has grown so much since then that having thoughtful and unique content becomes more important today. Not all of my posts are the cheery, uplifting ones that some readers are necessarily seeking (that's never really been my focus or specialty ... there are plenty of others to fill that need, however), but from my perspective, I DO believe there is good news on cure-related progress to share. The challenge: where do I begin?

Some Good Sources for Research Progress Updates

First, let me share some places you might wish to be aware of related to progress reports. Ironically, I discovered these not from the JDRF website, but largely by accident. But this stuff is worthy enough of sharing with others -- the JDRF "shareholders"!!!

A while back, I have mentioned the Juvenile Diabetes Research Foundation (JDRF) New England project/blog, which had some very interesting presentations from their annual update near Boston this year. In fact, I lifted some of the New England chapter content and inserted it into my aforementioned blog posting. However, a few days ago, I received my college alma matter's alumni bulletin (the Bentley University Observer, page 12, although I found it took a long time to download). Anyway, that contained an interesting article I wanted to share with everyone (I scanned it, and you can download only that page/article here). Apparently, some faculty and students from Bentley were asked by the Bay State branch of the JDRF New England chapter to help create some online audio and video content for that particular blog. As might be expected, the article notes that the JDRF New England chapter's blog has since been recognized by other chapters throughout the U.S. and as an example of JDRF "best practices". We can certainly hope to see more of this type of stuff from JDRF's national organization in the future, and possibly other chapters following this lead, so that's good news indeed!

While some of my blogging peers (Kerri Morrone-Sparling of SixUntilMe.com, Manny Hernandez of TuDiabetes.com and a few others) have already joined, in 2006, JDRF's National organization evidently established a YouTube channel which anyone can join and follow at http://www.youtube.com/user/jdrfonline. That was done without much fanfare, but they've been better about putting some video content which is available to everyone (I don't find the TV commercials all that interesting, but some of the other stuff is).

Now, I could be mistaken, but the photo of the person on this YouTube channel appears to be Aaron Kowalski, who is perhaps best known for his work behind the "artificial pancreas" project, but has also been involved in the SmartCells/SmartInsulin deal signed last year. Anyway, the YouTube channel has some videos from JDRF's 2009 Annual Research Roundtable which took place in June 2009, including a short speech by international chairwoman Mary Tyler Moore, the new CEO Alan Lewis' 2009 State of the Foundation Address, and one from Dr. Richard Insel who is the Executive Vice President of Research for the organization. To the best of my knowledge, this is the first year that JDRF has featured videos of these speeches and presentations. I hope to see much more of this stuff in the future, but this is indicative of progress being made, although much of the work began under previous CEO Arnold W. Donald.

Finally, I would share a blogger who is relatively new to the diabetes blogging scene, Joshua Levy. He started a blog last June which can be found at http://cureresearch4type1diabetes.blogspot.com/. I knew of Josh, who has type 1 diabetes himself, from the Islet Foundation's Public Message Forum, and he is also a member of the Nathan-Faustman Yahoo! Group. Anyway, in the past, I followed his updates via an RSS feed of his Wiki updates/changes which alerted me of changes to his website related to diabetes. But his blog has some groundbreaking content, with the next item listed being a case-in-point.

JDRF-Backed Transition Therapeutics' Islet Regeneration Treatment Looks Dead for Type 1, Perhaps Not for Type 2

I generally share Josh's outlook and his definition of a cure, and although I don't always agree with everything he concludes, I'd say that 95% of the time, I do. Often, Josh has some observations which are well ahead of the public statements made by the JDRF or the researchers (not ALL research is funded by JDRF, even though much is). For example, he concluded (and I agree with him) that the JDRF's Transition Therapeutics islet regeneration treatment (based on gastrin, as Alan Lewis talks about) looks dead, at least for people with type 1 diabetes. See his posting here for more on that. Note that JDRF's 2009 Annual Update (which took place this summer) was still talking about this treatment, but as Josh writes:

"Transition Therapeutics is researching using a combination of two drugs to cause beta cell regrowth in an attempt to cure type-1 and type-2 diabetes. As of May 2009, they had officially marked their phase-I human trial for type-1 diabetes as closed. I haven't seen any published results for it, but I'm still looking. However, actions speak louder than words, and Eli Lilly (working with Transition Therapeutics) started a clinical trial in February 2009 using Transition Therapeutics's TT-223 product, but only for people with type-2 diabetes.

Also, in May 2009 they announced that JDRF and Transition Therapeutics had agreed that JDRF would stop funding clinical development of TT-223. Transition Therapeutics and JDRF terminated their agreement. Eli Lilly is taking over support for TT-223, but is applying the technology only to type-2 diabetes.

So the news from Transition Therapeutics for type-1 diabetics is not good. I will move Transition Therapeutics to my 'boneyard' of research that has not panned out if there is no good news in the next 6 months."

So far, JDRF has been pretty quiet about their decision to stop funding Transition Therapeutics, but unless something changes, we can probably conclude it is dead (at least for type 1 diabetes). For those interested in more background on this, and perhaps its applicability towards type 2, catch a video here for more details.

Exsulin Is Still Progressing

Not to worry on the regeneration front (at least not yet!), however, Exsulin Corp. (the name given to the treatment formerly known as INGAP) announced it's regeneration treatment is entering a second Phase 2 human clinical trial in people with type 1 diabetes (see here and here), so even if JDRF isn't behind this particular treatment, the progress will continue. The good news is that Dr. G. Alexander Fleming, Kinexum's CEO (and former Chair of professional education and training for FDA's Center for Drug Evaluation & Research [CDER] among other things), which is the company behind Exsulin Corp., is among the brightest people in diabetes research and knows this subject far better than most, as he also has intimate knowledge of the Food and Drug Administration, and can therefore help maneuver through this dysfunctional regulatory agency better than perhaps almost anyone else, so we can expect to hear more news from Exsulin in the coming year.

Before I get too far, though, let me take a step back and note that before we can get to regeneration (that's a separate topic I'll address in another blog posting I'll put in Part 2 or 3 of this subject), we need to acknowledge the not-so-little problem of autoimmunity, for which there are several possible treatments in various stages of clinical trials.

Consensus on What Will Be Required to Cure Type 1 Diabetes

Let me begin by acknowledging something that the consensus among most diabetes "experts" seems to be that a definitive therapeutic approach to a "cure" for diabetes will have to include a treatment(s) to control the autoimmune response that causes type 1 diabetes (T1DM) combined with another treatment(s) to replace and/or restore lost pancreatic beta cells, and in the case of type 2 diabetes, another treatment to also address the underlying metabolic defects as well. As a well-known diabetes (she's actually an immunologist) researcher, Dr. Denise Faustman, suggested in an interview with dLife (towards the end of the interview), that she expects it to be entirely possible for several autoimmunity "cures" to emerge although she declined to speculate on when such treatments might emerge. But we're closer today than we have been in decades!

First, I should begin by noting that the JDRF has a graphically-rich page on it's website dedicated to biotechnology and pharmaceutical "Industry Development and Industry Partnerships" that has updates on cure therapeutics which I highly recommend visiting: (click on the JDRF website and from there, select the "research" tab, and select "Industry Partnerships" or simply see click here. Because JDRF has an unfortunate habit of reorganizing it's website leaving some of its links dead, I felt it was useful to provide more detail than I have in the past).

First and foremost, on the autoimmunity front, inflammation is hot!

It's no secret that the drug industry is in the doldrums these days, with many blockbusters whose patents are due to expire soon and nothing much in the pipelines to replace these cash cow blockbusters. But one therapeutic area which seems to very hot these days is in drugs and biotech medicines to treat "inflammation".

Merriam-Webster defines the medical term "inflammation" as "a local response to cellular injury that is marked by capillary dilatation, leukocytic infiltration, redness, heat, pain, swelling, and often loss of function and that serves as a mechanism initiating the elimination of noxious agents and of damaged tissue."

In short, it's an immune response by the body used to heal infections or other ailments. Under normal circumstances, inflammation serves a protective purpose, so it should not necessarily be viewed as a bad thing. Inflammation helps to rid the body of infections and to heal itself, but too much of anything can have the opposite effect, having a destructive rather than protective effect. Both type 1 and type 2 diabetes have inflammation issues which lead to beta cell destruction, although the origins for inflammation in each disease is apparently quite different, as more recent research seems to suggest. At present, approved treatments for inflammation in each disease are mostly non-existent except for a few ailments such as cancer, although others for different autoimmune diseases have also started to emerge. Several aimed at addressing type 1 diabetes are in various stages in development.

Historically, the medical profession has treated most forms of inflammation the same way. The term "anti-inflammatory" usually refers to the property of a substance or treatment that reduces inflammation. In fact, anti-inflammatory drugs make up about half of all analgesics sold (including many over-the-counter products), remedying pain by reducing inflammation as opposed to opioids which affect the brain. Among the more common, over-the-counter ones are ibuprofin (brand names include Advil and Motrin) and naproxen sodium (brand name Aleve).

But this approach, to use a metaphor, is akin to sending out an entire army (using immunosuppresant drugs that largely shut the entire immune system down) to do the job that a single soldier with highly specialized skills could have done alone, and it also leaves patients prone to infections and other illnesses because the effectiveness of their own immune system has been reduced.

During the late 1980's and 1990's, newer research revealed that we could selectively target certain leukocytes (white blood cells) that caused specific types of cancer. The result was a gold mine for the drug and biotech industries, with extremely costly (and lucrative) medicines which seemed to work wonders for a handful of patients as well the bottom line of drug/biotech companies alike! But that business model has run into limits of governments and healthcare providers worldwide and their willingness to pay outrageous sums of money to save a mere handful of ill patients with specialized cancers. Like it or not, one might call this a form of performance-based medicine.

Certainly, an immunologic intervention resulting in an effective modification of the underlying immune process could potentially interfere with the etiology of an autoimmune disease and thereby preserve beta cell function, and/or set the stage for successful beta cell regeneration and/or replacement, or both. Ideally, immunotherapy offered to type 1 diabetes patients could be aimed selectively at salvaging the remaining beta cell mass (if any exists), while also creating a state of "immune tolerance" for the insulin-producing beta cells as immunologists refer to it. (The term "immune tolerance" collectively refers to the safeguards that the immune system naturally possesses to protect from harming self.)

A Newer Approach to Immune Tolerance

In contrast to immunosuppressant therapies which essentially shut the immune system down, immune tolerance therapies are designed to work in a different way. Rather than suppressing the immune system as a whole, these newer treatments aim to suppress only those parts of the immune system responsible for the autoimmune attack (or perhaps prevent it in the first place). The goal is to stop the autoimmune disease while leaving the body's infection and disease-fighting abilities intact.

Although a variety of approaches to immune tolerance have been successful in rodent (or even in some larger animal) models of autoimmune diseases, or in pilot clinical studies, to date, the achievements in larger human clinical trials have been rather modest. Researchers have learned that the similarities between mouse and human immune systems are pretty limited.

But according to the NIH Autoimmune Diseases Coordinating Committee, the range of potential therapeutic approaches available to treat autoimmune disease is expected to expand rapidly during the next decade as a consequence of progress in genetic and immunologic research conducted in the public and private sectors. These therapies are likely to include drugs, biologic agents, gene-based delivery systems, immunomodulation, cell-based treatments, tissue and organ engineering procedures, as well as therapies based on complementary and alternative medicine.

I've shown the following chart many times, but I use it for a reason: 2010 is the estimated time that some of the newer autoimmune treatments are expected to emerge, with more likely in the following years.



The question is if this is more of a retrospective look with a short window into the coming years, where is the future headed?

Here's where my references to some past efforts comes in. For example, in June 2009, I reported on some progress the JDRF had made with it's Industry Discovery and Development Partnership (IDDP) program (see here), whereby JDRF provides early-stage research funding to drug and/or biotech companies working on technologies and therapeutic candidates in an effort to provide incentives to more risk-averse drug and biotech companies to help commercialize products that would help facilitate JDRF's cure-related goals.

As a result of the trends noted above, a more mass-market approach to treatment seems to be taking place now. The basic idea is that these treatments will be delivered to a larger audience, but in order to do this, the costs must come down significantly. As a result, some are testing meds that were tried and approved for one condition to test their applicability in others. More recently, drug companies have engaged in trials to try and expand the market on certain existing drugs (for example, Gleevec, a drug that treats leukemia and other cancers) is reportedly being tested to treat the autoimmune response that causes type 1 diabetes in recently-diagnosed patients, and more recently, trials were announced to examine the use of several Rheumatoid Arthritis drugs such as Embrel, Remicaid, and Humira to see if they might also work in type 1 diabetes, not to mention other autoimmune diseases. It is very tempting to believe that one drug might treat another autoimmune disease, but as researchers have learned the hard way in the case of Lupus, that some drugs actually made the disease worse, not better. But the basic idea is that by ramping up production by leaving production up to drug and biotechnology companies, the cost can be brought down enough to make these drugs cheaper while also enriching biotech and drug companies by making their drugs applicable towards other types of autoimmune diseases. I could talk about each of these, but the reality is that right now, they're all in various stages of clinical trials. None is ready to address type 1 diabetes autoimmunity, but these could emerge in the coming years.

Autoimmunity "Cures" are Closer, But Not Likely Around the Corner

One of Josh Levy's postings summarizes some possible autoimmunity treatments in late-stage clinical trials. However, he includes some which aren't being tested with JDRF's help. To give you some idea of just how far along these are, consider that the following 4 programs are all now in Phase III Human Clinical Trials (note that there are a number of others in Phase I or Phase II Human Clinical Trials which I haven't even addressed here):

* Diamyd's GAD65 (several different studies; note: Josh considers this which is being trialed as a vaccine to be an autoimmunity treatment, I am not convinced yet, but let's see where it goes!)
* TolerRx/GlaxoSmithKline's CD3 (several different studies)
* MacroGenics/Eli Lilly's CD3 (several different studies)
* Teva/Andromeda Biotech's DiaPep227

He states "Now, make no mistake, these trials do not (emphasis mine) mean a cure is right around the corner." I'll borrow Josh's comment because he said it as well as I could:

"It is important to remember, however, that although there are four treatments in Phase-III trials, we are not close to a cure or established type 1 diabetes. All of the clinical trials in Phase-III and Phase-II are targeted at honeymoon type 1 diabetes; none at established cases. Even with that restriction. None of the treatments in Phase-III trials resulted in cures during their Phase-II trials. They all extended or increased the honeymoon phase in some way."

However, while his caveats are important to keep in mind, they DO demonstrate the type of quantifiable progress that has been lacking for a very long time on the autoimmunity front, and do suggest that quantifiable progress is being made (the same could NOT be said as recently as a decade ago).

A case-in-point: MacroGenics/Eli Lilly's teplizumab treatment is not without adverse events, no matter how glowing some reports may be. For example, a friend of mine who attended the Children With Diabetes Friends For Life Conference in Orlando this year said "Dr. Harlan from NIH wisely pointed out at CWD FFL that the anti-cd3 drugs can cause recurrent mononucleosis which can increase one's propensity to develop lymphoma. Why would someone put their child at risk for that simply for a year and a half of extended honeymoon?"

As I responded, "The issue is that they first seek approval on newly-diagnosed patients for anti CD-3 treatments, and then, will ultimately extend it to others, possibly long-standing T1DM patients if past drug approval history is any guide. This remains an area of discovery, and I suspect, we'll find that some treatments work for certain patients, while others will not. Of course, no one seems to question using Lantus (insulin glargine rDNA origin), a completely man-made creation for an entire lifetime which also has proven mitogenic effects, which I also find questionable for a relatively small improvement in HbA1c ... that logic also escapes me, but I am one of the few who seems to question this." At least there has finally been some attention paid to this, although most Lantus supporters cannot seem to be convinced otherwise, and most seem to make excuses for the technology rather than acknowledging the legitimacy of the question. That's a separate conversation, however.

Ultimately, what is likely to come out of the different autoimmunity-related trials is more refinement and perhaps better definitions on just which patients each treatment is likely to work, and perhaps improvements to these, with more similar types of treatments to follow. Also, hopefully, the adverse events from the early autoimmunity treatments can hopefully be reduced and/or eliminated.

I will follow-up on this Progress Report with a Part 2 in the coming months which will address another part of the cure equation (perhaps regeneration or replacement of insulin-producing beta cells), so be sure to check back!

Fallout from New Healthcare Plans ... Yet Again?!

Last year, I lamented (see here and here) about a new healthcare provider, and many people commented. As I may have mentioned, on June 1, 2009, my employer switched healthcare plans and providers for the third time in the past 3 years. That's why I laugh at President Obama's speeches where he says if you like your doctor, you won't have to change with healthcare reform. He can't make such claims, because it's not necessarily true. Anyway, I can't really blame my employer's decision to switch again this year, as the company has done it's best to contend with healthcare costs which have consistently risen much faster than the rate of inflation. To add to this, as a relatively small employer (fewer than 50 employees), those costs have jumped significantly faster than they have for larger corporations, who can negotiate better deals because their business is big enough to be missed. This year, my employer decided upon a high-deductible ($2,500.00 for both medical and pharmacy benefits, with certain exemptions which I'll address in a minute, but I hadn't realized there were two separate deductibles that had to be met) plan that has out-of-network healthcare coverage, so at least I didn't have to find a new endo or any other doctors, as I did when I was switched to Empire Blue Cross/Blue Shield, part of the Anthem family which is owned by the for-profit corporation Wellpoint, Inc. The new plan is from Emblem Health, which is the product of a merger between two New York-based insurers: Group Health Incorporated (GHI) and Health Insurance Plan of Greater New York (HIP).

While high-deductible plans sound pretty bad, the fact that my employer is picking up the cost of anything over my individual deductible amount of $500.00 means they are paying the 500.01 to $2,500.00 (they are picking up a deductible portion for family coverage as well, but that's not relevant for me, so I don't recall the amount) not covered by my insurer, so it's not as bad as having to meet all of that out-of-pocket. But anything applied towards the medical deductible (or the pharmacy deductible) is not based on the billed amount (or the retail Rx price in a pharmacy) amount, but my new healthcare plan's "usual and customary" plan allowance amounts, which are often much less than the provider's billed (or, as I'll explain in a minute, the retail price of some drugs).

My employer's decision was based on simple mathematics, as the decision to cover the deductible amounts over my $500.00 medical and pharmaceutical deductibles is still far cheaper than it was to renew with the old provider (Empire/Anthem/Wellpoint). However, the administative component of this decision has been cumbersome to say the least. Since June, I've been required to submit claims to my insurance company, as well as to a Health Reimbursement Arrangement (HRA) administrator, who fortunately also handles my Flexible Spending Account (FSA) administration, but sometimes my insurer is slow to process the claims and send out an Explanation of Benefits (EOB), which I then need to send to my HRA and FSA administrator to get my money back and receive the benefits of my employer's assuming some of the costs. Fortunately, I can scan the various documents and send them to the administrator via e-mail, so there aren't extensive delays on that end of things. My insurer does send out an EOB automatically for all medical claims, but does NOT do so automatically for pharmacy claims, so I am forced to request pharmacy EOBs in order to submit them. Now, I can barely keep track of all these acronyms, let alone the claims, so it's kind of an administrative hassle, and yet we wonder why the U.S. "system" is so inefficient?

Fortunately, refills of my prescriptions were transferred from my old insurer's in-house pharmacy benefits manager ("PBM", yet another acronym!), WellPoint NextRx (which was sold in March to Express Scripts) and transferred automatically to my new insurer's PBM, so I was able to order refills without much difficulty or interruption. Fortunately, I ordered a last round of supplies with my old insurer Empire before my coverage with them was terminated, so I was stocked up with a 90-day supply of insulin, needles, testing supplies as well as an ACE inhibitor prescribed to preserve my kidneys, and a statin which my lab results suggest really isn't necessary, but I've been compliant nevertheless as long as I don't have to endure any annoying side-effects like muscle-aches, which I did experience with Zocor (simvastatin). I used Lipitor (know generically as atorvastatin calcium) which was on Empire's most costly drug tier, but had no side effects. My former insurer from 3 years ago also encouraged me to order a strength that was twice of what is required, then simply split the tablets in half (apparently the cost of a 20 mg tablet sells for the same as a 40 mg tablet) which cut my co-payments in half as well. But that isn't even on the formulary for my new plan, so I wanted to find something else, which fortunately are growing (by 2013, Lipitor itself will go generic).

But with my new healthcare plan, I discovered that (fortunately) insulin, syringes and the like are not subject to my new plan's pharmacy deductible, and are priced at a very low co-payment amounts, even though there are no generic insulins sold. I'm not sure why this is the case, but it may be a New York State law that mandates it. If we were allowed to shop for healthplans across state lines, that protection might disappear, as employers could theoretically "shop around" for states that have few insurer mandates. I learned about the separate pharmacy deductible since I'd assumed the new plan would work in a similar manner to my old one, and sent all my prescriptions (including testing supplies) to Medco Health Solutions, the PBM for Emblem Health (my new insurer). I quickly discovered that first, Medco cannot even fulfill orders for diabetes testing supplies for Emblem Health, so I asked my endo for a new script (I suppose I could have asked Medco to return it to me or transfer it to a yet-to-be-identified supplier), and then I made a few calls to my new insurer. I discovered that Emblem Health had an arrangement with CCS Medical, which is a Clearwater, FL based direct-to-consumer provider of medical supplies, with particular focus on diabetes supplies -- CCS is now operating under bankruptcy protection, but it's reorganization plans are focused almost exclusively on direct-to-consumer diabetes supplies and services, as well as ostomy supplies for those who require them. (The company also handles insulin pumps and other related supplies, such as IV prep and the like). CCS handled my testing supplies, and charges no co-payment and covers 100% of the cost, although the company does not carry Agamatrix Wavesense meters, which I would prefer if given a choice, so it's back to the One Touch products. However, Medco still handles drugs for Emblem Health, and I was rudely alerted to the fact that the "usual and customary" price for the ACE inhibitor (used to protect the kidney function in many patients with diabetes) lisinopril or statins are NOT exempt from the deductible as diabetes medicines and syringes/pen needles are.

Aside from the extraordinary markup on generics, I also discovered the brutal world of economics at work here. For example, in addition to the ACE inhibitor, my endo prescribes a statin, but the one I was using was not even on the formulary of my new plan (Lipitor was in the most expensive drug tier of my old plan, but it was still covered), but I averted what would have been a bill for $294 by cancelling the order as soon as I saw it on Medco's website and learned that certain prescriptions aren't covered until the deductible is met. I avoided a bill for almost $300.00 and quickly asked my endo about a generic alternative OTHER than Zocor (simvastatin). He suggested pravastatin (brand-name Pravachol), and I ordered it via the mail-order (virtually all scripts with this new plan must be filled via mail-order, as there is a $500.00 annual cap on scripts filled in retail pharmacies like Walgreens or CVS) and I submitted that via mail-order. When I got Medco's invoice, I also learned just how profitable generics really are for PBMs like Medco. $119.00 for a 90-day supply of a generic statin, and pretty much the same for a generic ACE inhibitor, and that's at Emblem Health's negotiated price. But after doing the math, I've decided that regardless of how close (or far away) I am to the pharmacy deductible amount, it simply isn't worth ordering a generic from Medco again -- even if it does apply towards the pharmacy deductible. Even if I never reach the pharmacy deductible amount, I'd still save quite a bit of money by filling those prescriptions elsewhere.

For example, generics are available at Target, Wal-Mart and even many supermarkets for $4.00 each, so even if I have to pay that out-of-pocket each month (or once per quarter), that's still less than half as costly ($48.00) as my recent 90-day fill of just one generic prescription with Medco.

Fortunately, I am able to absorb the prices using pre-tax dollars with my FSA, but since my employer's HRA only applies to medical benefits (not pharmacy benefits), the wise choice is to fill all of my prescriptions for generic drugs at one of these places. In fact, Wal-Mart's mail-order pharmacy sells a 90-day supply of lisinopril and pravastatin for $10.00 each, which amounts to $80.00/year for a year's supply of both, which even less than the $96.00 it would cost at retail pharmacies. Even though Wal-Mart doesn't have a single retail store anywhere in New York City, I can order these via the Wal-Mart's mail-order pharmacy as easily as I can order from Medco, and let's face it, I would have to use a LOT of costly prescription drugs other than insulin, syringes and testing supplies to meet the $2,500.00 deductible amount, so next time, I'm ordering from Wal-Mart's mail-order pharmacy, and Medco will have to find some other sucker to pay those outrageous prices. That's one reason, I believe, Adam J. Fein, Ph.D., who is founder and president of Pembroke Consulting, Inc., a Philadelphia-based management advisory and business research firm (he also has an informative blog at http://www.drugchannels.net/) and he forecasts that Wal-Mart is expected to grow even more in the coming years, largely at the expense of smaller chains. Right now, Wal-Mart is not even among the top 3 (those are CVS, Walgreens and Rite Aid), He writes that "Wal-Mart has made price matter by starting a generic prescription price war. Wal-Mart is willing to accept lower-than-normal profits on generic scripts in exchange for market share." He also notes that "Walgreens is moving in this direction, too." I live a block from Walgreen's, but I prefer mail-order, as it's easier.

I wish this kind of story wasn't so commonplace, but the simple reality is that my story is hardly unique. I don't know what the future will bring, but for the foreseeable future (at least until June 2010), I will order from a host of different suppliers: insulin and needles from Medco, generic drugs from Wal-Mart's mail-order pharmacy, and diabetes testing supplies from CCS Medical. I will submit these claims to my insurer, my HRA (at least my pharmacy orders), and my FSA, and and I'll have to see what, if anything, happens with plans on healthcare reform. I'm not holding my breath that we'll see any meaningful reform to address runaway costs, because right now, the only thing Congress seemst to care about is universal coverage, not runaway cost containment.

The End of My Reverse Commute May Be In Sight!

So, thinking about my bud George Simmons' "No D-Day" event and what to address in my posting today, and I'm using this opportunity to talk about myself (for a change), and more specifically, my company's planned relocation from the suburbs to the big city, New York City (more specifically, the borough of Manhattan, also known as New York County). I mentioned this in another post from 9/28/2009, but that was only in passing, so you may have missed it.

As more and more businesses have moved out of big cities nationwide into suburban locations, one might assume that a reverse commute would be infinitely easier because theoretically, you're moving against traffic, but the reality isn't quite so rosy. A number of studies over the years have back found that an overwhelming majority of corporate relocations into suburban office parks were typically made within a few short miles of the town that the Chairman/CEOs called their primary residences. Indeed, some suburban locations such as Stamford, Connecticut, are just next door to such infamous towns as Greenwich, CT, which is CEO-Central by most measurements. Earlier this year, The Wall Street Journal reported that Stamford was calling itself (at least locally) "Wall Street North" and has now been forced to try and reinvent itself, mainly to contend with the many problems the financial services industry now faces. Interestingly, that city has successfully landed the filming of several TV shows, among them such trashy daytime shows as "The Jerry Springer Show" and "Maury".

Anyway, the challenge for reverse commuters is first, most transit systems were designed to move large numbers of people into the central cities in the morning and out of the central cities in the evening. The number of commuter trains, buses, subways etc. going in the the opposite direction during those hours are relatively few. Mass transit is simply not coordinated to make reverse commuting in the opposite direction terribly easy. Try taking Boston's "T" commuter trains from Boston into say, Newton, MA in the morning or getting a commuter train FROM the main line into Philly from suburban towns like Haverford, PA at night. It can be done, but the number of trains going in that direction are stacked roughly 8:1 to move commuters INTO the central city in the morning (not so much out) and in the opposite direction in the evening. Traffic patterns validate this, of course, but its a bit like saying that there are no riders because there is no demand, instead of asking if demand might be there if it was more practical to take the train in that direction?

Anyway, one of the downsides of reverse commuting is that it's a big hassle because I HAVE to drive, and my social life outside of work (at least during the week) is pretty limited as a result. One of the supposed benefits of big-city living is supposed to be utilization of frequent, low-cost mass transit, whereby one can read the newspaper or listen to their iPod on the way into work. In the evening, there are plenty of social options that I have foregone to work in the 'burbs, whether it's art exhibits, numerous shows or events, or simply grabbing a beer with friends (who all work in town) after work. In good weather it's great, but in lousy winter weather, its even better because using mass transit means not having to drive on icy freeways or to clear the snow that's accumulated on my car after the snow falls all day on it. Oh, yeah, and its supposedly more "green", too. But since I reverse commute, I'm stuck driving, which I hate. But that's about to end, soon, and I'm pretty psyched about it!!

The lease for my company's Class A office space expires officially in November. Thanks to a weak commercial real-estate market, it happens to be an opportune time to be looking for office space in Manhattan, so this has oppened an opportunity that was once assumed to be out-of-reach for many smaller businesses, including the firm where I work. The only issue now: WHERE in the city will we be? The landlords are seemingly willing to negotiate on most anything that would have been unthinkable just a few years ago, so they haven't signed anything quite yet.

So, with this move, I think my social life will likely improve, my commuting cost will likely decline and most importantly, my commuting aggravation level will plummet. Right now, the only uncertainty is timing (and of course, the final destination, will that be mid-town, downtown -- all TBD right now) of the move. Because the real estate market is weak, the company can also extend the time in our current location on a month-to-month basis so we are likely to remain in suburbia until the end of the year. But the sooner this moves happens, the better!

So I'm really looking forward to having a new office in Manhattan, and not having to drive (or should I say crawl) on the Long Island Expressway (surely that's a misnomer) twice a day. Anyone care to join me after work for a beer when it happens?!

Let me just close by sharing this YouTube clip of Jennifer Saunders (best known for her role as Edina Monsoon on the BBC comedy Absolutely Fabulous, not to mention as the voice of the Fairy Godmother in the animated hit movie Shrek 2). In this video, she parodies Madonna's performance of her video & song "Hung Up":

Brave New Commercials?

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

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

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

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

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

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

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

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

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

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

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

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

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



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



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



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

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

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

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

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

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

Is Healthcare Privacy Really "Too Complicated"?

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

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

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

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

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

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

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

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

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

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

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

A New Diabetes Study? Why Not?

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

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

What is that supposed to stand for?

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

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

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

A
Study of
Seemingly
Hopeless
Old
Lente's
Efficacy

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

The Business of Diabetes: Lilly Layoffs, Re-Org

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Tueday Tirade

I admit to nothing!!

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

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

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

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

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

My response: F.U.!

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

Not true!!

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

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

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

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

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

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

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

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

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

Deb goes on to write:

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

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

Deb closes with the following statement:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Timewarp Tuesday: A Chat with Larry Soler

I'll admit it: I've read some of my fellow d-blogger's "flashback" posts and while some of them were interesting reading, I also said "that's just a cop-out, kind of re-hashing stuff that was already covered". But in retrospect, I must also admit they've proven somewhat helpful to have a look back to see where I was (and my colleagues, some of whom I hadn't met at that point) a few years ago, and what issues still remain open when it comes to the never-ending issue of diabetes management.

From my own perspective, I still remain focused on the prospect of a cure. I'm really no more tantalized about the prospect of an artificial pancreas than I was 5 years ago. My knowledge of the subject has grown, to be sure, and I see what's on the horizon is more of a semi closed-loop system than it is a truly smart artificial pancreas. That's a conversation for another day, however.

I've dubbed my posting today "Timewarp Tuesday", mainly because I was ready to post something last night, but I wasn't quite ready to adopt "Wayback Wednesday" so I needed a somewhat catchy (or maybe just a lame, but easier to say) title, and this was the best I could come up with. If you don't like it, I remain open to suggestions!

Anyway, I remain a tough cookie when it comes to interviewing big names in the world of diabetes. A case-in-point:
Larry Soler, who's JDRF's big cheese on the Potomac. I'd call Larry as the chief political strategist for JDRF, but officially, his title is "Executive Vice President, Government Relations & Operations". I hosted an online chat with Larry back in 2004, and the hot issue of the day was stem cell research.

That was driven primarily by then-CEO Peter Van Etten (JDRF is now on it's third CEO since then, as more recently, Arnold Donald stepped down rather unexpectedly, and has since been replaced by Alan Lewis). Mr. Van Etten's rationale was pretty understandable, at least from a business perspective.

Needless to say, since Yahoo! will be dismantling it's free Geocities web-hosting service, I'll be forced to move all my stuff there (rest assured, I already have a new, paid host I've had for quite a few years, but I still have to move everything before the October 24 deadline, so that's a work in progress), but since I'd saved my DiabetesStation.com transcript of that September 23, 2004 program, I thought it was worth sharing with everyone today. Have a look here!

Why NOT me?

As people who know me will vouch, I have a rather wry (and somewhat cynical) sense of humor. That's why today, Chris Bishop had a blog posting he titled "Why Not Me?", in which he makes some interesting points, but all I could think of when I read that was the scene by drag queen Charles Busch from the movie "Die, Mommie, Die!" entitled, appropriately enough, "Why Not Me?" Although this has really nothing to do with diabetes, it IS my Friday posting, and from MY perspective, I agree with this clip's closing statements when it comes to diabetes:

"The only part of this dump [meaning living with diabetes] that doesn't make me puke is the door, because that's the way I'm getting out!"

With all due respect to Chris, I'd be willing to trade life with diabetes for any number of things (then again, I wouldn't for something like cancer, for example) but I'm certainly not thankful for it. Truthfully, I'm counting the days until we'll be cured and can throw out all of the pumps, the meters, the insulin, the glucose tabs, the food scales, the CDE appointments and all of the other crap that goes with diabetes right in the trash! That's one reason why I, after 32 years of living with type 1, continue to do fundraising for the JDRF -- year after year.

A Staged Healthcare "Debate" Without Any Real Debate

Meet Wendell Potter

In the recent healthcare debate, Mr. Wendell Potter has gained prominence as an outspoken advocate for truly meaningful reform to the existing system, quite unlike some of the recent protests which are backed (financially and otherwise) by lobbyists for the healthcare "industry". The reason for Mr. Potter's recent celebrity: he's an industry "insider" and can testify just what the for-profit healthcare industry does in pursuit of profits, and the picture he has painted isn't quite as innocent as proponents, many of whom are protesting at town hall meetings across the country right now, would like us to believe.

Discrediting SiCKO!

Wendell Potter held variety of positions at CIGNA Corporation for over 15 years, most recently having served as that company's head of corporate communications with a role of acting as the healthcare insurance company's chief corporate spokesman. Prior to joining CIGNA, Mr. Potter also ran communications at Humana Inc. (another large for-profit healthcare insurer). However, after a 20-year career as a corporate PR executive for the healthcare industry, last year, Mr. Potter left his job as head of communications for CIGNA to assist "socially-responsible" organizations -- including those advocating for meaningful health care reform -- achieve their goals. Since May 2009, Mr. Potter has worked for the Center for Media and Democracy's (CMD) Senior Fellow on Healthcare. CMD was founded in 1993 as an independent, non-profit, non-partisan, public interest organization. CMD's mission is to promote transparency and an informed debate by exposing corporate spin and government propaganda and by engaging the public in collaborative, fair and accurate reporting. Potter has since testified before Congress (before the U.S. Senate Committee on Commerce, Science and Transportation) and appeared in several television interviews.

Most notably, on July 10, 2009, Potter was interviewed by Bill Moyers on PBS, and in that interview, he disclosed exactly how the for-profit healthcare industry put profits before patients, sharing some of the sleazier tactics used to drop patients when they are diagnosed with various illnesses, etc. -- including the industry's efforts to discredit Michael Moore's SiCKO movie!! It's pretty shocking!

See here for the full transcript, although the video below contains many of his most shocking admissions:



This week, MSNBC's Rachel Maddow interviewed Wendell Potter, and addressed some of the same topics (all within the context of our bigger debate on how to reform the U.S. healthcare "system" -- a term I use very loosely). We also learn that in 2007 alone, the CEOs at the insurance companies collected combined total compensation of $118.6 million-an average of $11.9 million each. See here for the Rachel Maddow interview with Wendell Potter:

Visit msnbc.com for Breaking News, World News, and News about the Economy

Corporate Control of the Healthcare "Debate"?

Of course, in recent days, what has made the news on America's corporate-controlled (from the likes of Viacom, Time-Warner, Disney, GE, News Corp. and others who dominate much of the U.S. media today) news outlets?

A lot of news about protests (many of which had been staged by opponents) at various town-hall meetings taking place around the country meant to serve as discussions about Congressional moves to address healthcare reform. Absent from many of these stories are the facts that many of these "disruptions" are being staged and funded by organizations that have obvious vested interests in preserving the status quo. Now, I'm not really a die-hard Rachel Maddow fan, but I did happen to catch a clip you should probably catch which aired last night that about summarizes what's going on in this whole "debate":

Visit msnbc.com for Breaking News, World News, and News about the Economy

Personally, I don't have an issue with protests even, but I do have an issue with organizations that are purposely and covertly misrepresenting themselves with a goal of stopping the discussion about reform altogether and presenting it as "news", which our media seem only too willing to suggest actually IS news.

Also, be sure to catch my previous posting on healthcare reform, or rather the lack thereof, here. What does anyone in the Diabetes O.C. have to say about this? Aren't we as a country entitled to a legitimate discussion? What about the media's role here?

The Los Angeles Times' blog is now reporting that supporters of the Obama healthcare reform proposal are now so outnumbered by paid opposition that they too are now recruiting paid supporters on Craigslist. My only response is that if the opposition is going that route, then supporters really have no other alternative unless they're willing to be steamrolled. Unfortunately, this drags the entire discussion into the gutter (literally) and denies Americans a fair and honest discussion about real healthcare reform!

Street Rats and the Future of U.S. Healthcare

Ever Hear of "30 Net 10"?

It's a trade expression, whereby you're given a 10% discount if you pay for your purchase within 30 days, and it's a pretty much standard operating in most trades.

You want to get paid immediately? Gimme a discount.

Increasingly, this is what U.S. healthcare might look like, too -- one where medicine is looks more like a Moroccan marketplace (such as this one from Disney's Aladdin) than a hospital or doctor's office. But it's the road our so-called healthcare system (the word Bazaar comes to mind, or maybe bizarre!) is headed.



That's not a scenario most Americans are accustomed to, but the reality is, it might look that way if Congress doesn't do anything to change things to address the healthcare issue soon.

There's no other place for it to go, as the current growth rates in U.S. healthcare costs are simply unsustainable. And I'm fortunate enough to actually be employed and have healthcare insurance, while many others aren't so lucky.

According to a Kaiser Family Foundation/USA Today Harvard School of Public Health Healthcare Costs Survey (conducted April 25-June 9, 2005), only 11% of Americans actually negotiated healthcare costs (although among the percentage of uninsured Americans, it was higher at 24%). But what's more interesting about this finding is not the fact that some enterprising people have decided to negotiate on price, but how many of them were able to get discounts, 58% of them to be exact. This suggests that's there's plenty of fat in the system that can be trimmed.

Today's Wall Street Journal featured a story that indicated that increasingly, doctors are seeking payment of the entire bill for patient share of the cost up-front. They claim they have to request their fees while patients are still at the office because bills sent later typically recover only about half of what a practice is owed, according to McKinsey & Co. (an even smaller percentage among uninsured patients). But most companies get a discount for rapid payment, in fact those practices are the basis of much of our economy.

At my last endo visit, my doctor asked for the full amount due. Now, I have a new insurance plan that began in July, and it has a relatively high deductible, but rather than switching endos yet again (this would have been the third time in 3 years I'd been required to do so thanks to insurance coverage changes from my employer -- so much for the Congressional argument that you can keep your doctor!), I availed myself to the out-of-network benefit of the new plan. But when I left, the doctor asked for the entire amount of the invoice, rather than a portion of it. Sure, I could have pushed back and said I'd pay only part of the bill that day, but since the total was like $150, and I can pay for it with pre-tax dollars thanks to my Flexible Spending Account (FSA), I just paid it and submitted the claim to my insurance to apply towards my deductible, while submitting another copy to my FSA administrator for reimbursement.

The practice of billing up-front is apparently pretty common, and is growing among doctors. The Wall Street Journal reports that "According to a questionnaire sent to its medical-practice customers by NaviNet Inc., which provides a Web service that allows doctors to communicate with insurers, found that more than half of the 650 respondents in a survey were trying to get money beyond just co-payments during patients' visits."

But suppose I wasn't able to cover this amount?

Knowing myself, I would have pushed back when they asked (in fact, I was a bit pissed they asked for all of it up-front since my insurer doesn't pay them immediately, and next time, I'm going to make them bill me for everything except my co-pay amount because I'd rather earn interest on the money than let the doctor's office earn interest on it!).

Having a closer look at the bill my doctor's office provided revealed some interesting findings. I had a regular appointment, and they drew blood for my HbA1c and other lab tests. Consider just one example of the waste in the system: $10.50 for "specimen handling"? Hello. Quest and LabCorp pick up the blood samples at the office, so basically the doctor's office just holds the blood samples in the fridge until they come the same evening. Needless to say, that $10.50 is a cost that my healthcare plan didn't pay for, and next time, I'm not going to pay for it, either. Plus, I want a 10% discount on everything for paying them up-front (back to the "30 net 10" I mentioned earlier).

I suppose all of this is meant to make us as patients more aware of exactly what we're paying for (and it does this, to some extent) but I'd prefer to have a system like I enjoyed when I lived in Finland, where it's all handled automatically, certainly not this s#!t. Plus all of the administrative work I encounter for submitting the invoices to both my FSA Administrator and another to my insurance company is a pain in the @$$, folks. It does nothing to reduce costs, efficiency and frankly, it's a nuisance. I suppose electronic medical records would partially address this, but as I've written before, these aren't necessarily the big cost-saver the proponents claim they are, plus Congress provides us almost no protections if someone should break into the system and steal these records (none of that is addressed in the bill Congress is blabbering about right now). And for those of you who are uninsured (as 47 million Americans are) this is a cost that's increasingly, out-of-reach.

This so-called "system" sucks, and it's a hassle, too. I'm lucky to have a plan, but it's nowhere near as good as what they enjoy in Europe or Canada (no matter what opposition is saying now in commercials), plus those socialized plans get to the core of what the so-called "system" is supposed to be about: healthcare, NOT how to invoice and pay for it, which is increasingly all the American system is worried about.

Anyway, it is starting to look like we may sooner (rather than later) have a healthcare system that resembles the marketplace in the Disney animated film Aladdin: where those who get the most from the "system" are effectively "street rats" are able to maneuver through (or around/over/under) the system, while others avoid it at all costs.

Welcome to the future of U.S. healthcare, street rats!

Is JDRF A Donor-Centric Organization?

Back in December 2006, JDRF published an interview that Kelly Close conducted with the organization's then-incoming Chief Executive Officer (CEO) Arnold W. Donald. (That interview can be downloaded here.)

I recently re-read that interview because I recalled Mr. Donald making some statements about how he felt that JDRF needed to become more a "donor-centric" organization, and I was looking for the quote. I was also comparing Mr. Donald's view and trying to understand how the new CEO, Alan Lewis will address this issue. I found the quote from former CEO Arnold Donald, and have provided an excerpt from that interview below:

Interview with JDRF CEO Arnold W. Donald, Publish Date: December 2006

KC: Where do you think there is the most potential for improvement in the [JDRF] organization?

AD: Wow. The most potential. I haven't [ranked] it that way ... I come from a continuous improvement orientation, and I see improvement opportunities everywhere. I don't care how good something ism you can always improve, but I would say first and foremost is our ability to live our intent of being donor-centric.

KC: How do you mean?

AD: Every donor or volunteer should feel that they are totally connected to JDRF. They should feel they are proactively communicated with. That their connection to type 1 is understood by JDRF. They should be treated with integrity and caring and know that their opinions count. It doesn't mean we are always going to do exactly what a given volunteer's opinion is, but if they understand why we've done something, even if they would do it differently, it creates the basis of alignment.

KC: Right. But how do you get everyone on the same page?

AD: It requires a lot of components. Number one, it requires orientation of behavior by all of the staff. It requires certain technology, databases, information systems, and what not, that we're working on and we've had some issues with and we're organizing around trying to address. If you don't feel like it's a donor-centric organization when you get the same letter three or four different times, or your name comes and is misspelled, or it comes and it's referencing a child that's not yours, then that's a problem. So having the right information in databases is important.

KC: That counts.

AD. These are little things, but they are symptoms of a more core issue of being truly best in class of being donor-centric. For example, we have tons of communication. I couldn't tell you all the different communications we have. Having said that, I can't tell you how many times I've been told by volunteers, donors, and staff that they don't feel communicated with. So therefore, in that mix somewhere we don't quite have it right, and communication is everything. So we're going to have a difficult time being truly donor-centric of people don't feel like we're communicating effectively with them.

A few months later, in the 2006 State of the Foundation Address, Mr. Donald again spoke about the efforts the organization was making to build it's donor pipeline, especially with it's high-net worth cultivation and stewardship strategy. In his address, Mr. Donald made the following statement:

"We've determined that our donors want information on research that is clear, concise, and targeted to their interests. Information that shows milestones and outcomes on their investment; regular research reports; site visits; and phone conferences with researchers. We're finding that we're engaging both current and prospective donors in an ongoing dialogue that involves them in JDRF's research program in deeper and more committed ways, and motivates them to make new and significant leadership gifts."

Of course, as JDRF's 2008 Annual Report notes that while 2008 was a banner year for JDRF in terms of fundraising and research dollars allocated, the organization expects an extremely tough year in 2009, and is expecting that to continue possibly into 2010.

Now, I certainly do not want to diminish the importance of major donors (who attend some of the organization "galas" to the tune of $500 or $1,000 a plate), and big donors are indeed valuable, but I was curious if everyone in the Diabetes O.C./online donor community feel like JDRF is truly donor-centric, by sharing the latest-and-greatest research news, and presentations with us?

Personally, I've never attended a JDRF gala (frankly, I'm not sure I'd even want to) nor would I spend such an amount to attend a back-tie party, but I have consistently raised a few thousand dollars each year in my walks, yet I get the sense that I'm not a big enough fundraiser to be entitled to get such information. Often, I feel like JDRF is more interested in stupid black-tie parties than in addressing my need to feel like JDRF keeps us as well-informed about different programs the organization funds with the money I help raise.

Case in point: I had to really search out information about Industry Discovery and Development Partnership (IDDP) program and translational research efforts, and most of the information I found came from sources other than JDRF. Is it really so hard to put a Powerpoint presentation on the organization's website? I don't think so.

Well, the great news is that JDRF's New England Chapters (collectively, except for a few chapters in Western Massachusetts and Connecticut) have done an excellent job of addressing this deficit ... with a blog, and that blog has some good stuff you might want to check out. These include presentations, videos, and other information so that anyone can see these things, not a privileged few who managed to attend the original event. Among the items they share is presentation from Todd Zion about the SmartCells program (the bad news: human clinical trials are still quite a way off ... Phase 1a clinical trials are not scheduled to begin until Q2 2010). Also, catch my interview with SmartCells' CEO Todd Zion from back in 2007.

I basically lifted almost all of their content in their update from April 2009, but be sure to catch their archives, too -- they contain some good stuff that should make other JDRF chapters look to replicate! FYI, their blog can be found at http://jdrfne.blogspot.com/, and the specific post I'm referring to can be found here, but also be sure to browse through their archives, too -- there's some good stuff there!

JDRF New England Chapter's Tenth Annual Spring Research Briefing
Wednesday, April 22, 2009

The Tenth Annual Spring Research Briefing was held on Monday, April 6, 2009 at the Boston Marriott Newton. The information shared that night was an inspiration and surely proof that our quest for a cure is closer to reality than ever.

We heard from two excellent presenters: Dr. Alan Lewis, JDRF's new President & CEO, and Dr. Todd Zion, Co-founder, President & CEO of SmartCells, Inc. Dr. Lewis introduced himself to the JDRF family in the New England area and shared his perspective of diabetes research currently and his vision of where JDRF can help expedite progress toward a cure. Dr. Zion focused on research being done on a product being developed at his company, SmartInsulin, a once-a-day, glucose-regulated, injectable formulation for treating diabetes.

Following you'll find video and slides of the evening's presentations, as well as video of the question and answer session with our presenters. A special thank you to Victoria Bergantino, Greg Ford, Geoffrey McLaughlin, and April Watkins of Bentley University (Bentley is my alma mater!), and to their professor, Mark Frydenberg, for making this possible!


Tuesday, April 21, 2009
Dr. Alan Lewis, President & CEO, JDRF


Presentation from Dr. Alan Lewis

Presentation from Dr. Alan Lewis

View more presentations from BringingTheCureHome.

Dr. Todd Zion, Co-founder, President & CEO, SmartCells, Inc.
Tuesday, April 21, 2009


Presentation from Dr. Todd Zion

Presentation from Dr. Todd Zion

View more presentations from BringingTheCureHome.

Question and Answer Session


Clinical Trial Initiative

Finally, I should also just include the organization's Clinical Trial Public Service Announcement (PSA) which coincides with a new tool they've added to find type 1 clinical trials.

To find a cure, JDRF needs people with type 1 diabetes to consider participation in human clinical trials of experimental new therapies.

The JDRF Type 1 Diabetes Clinical Trials Connection is here to help people with type 1 diabetes better understand what is involved in participating in a clinical trial, and to simplify the process of finding trials that may be of interest to them or to their family members.

The goal of this service is to serve as a resource on the latest research advances, new research studies, and information about opportunities to participate in clinical trials.

Participating in a clinical trial is an important way for people to help to find a cure for type 1 diabetes and its complications. That's particularly true today, when JDRF's nearly 40 years of research leadership has brought us to the point where scientific advances made in the laboratory are being tested in people.

Clinical Trial PSA (YouTube video):



Conclusion? Some JDRF Chapters Are Donor-Centric, Others Have A Lot of Work to Do

I don't know about all of you, but personally, I'd like to see more of these online initiatives from the JDRF National Organization, not simply an innovative local chapter (I don't have great affinity for the New York City chapter anyway, they've been able to coast for years on their location which enables them to have a walk that raises lots of money on a per capita basis, even though the local chapter is dominated by rich "mommies and daddies" who frankly, don't care much beyond their own social circle, but that's a conversation for another day)!

What Does Diabetes 'Quality Of Life' Mean To You?

We've all seen those studies, including a number conducted by researchers for the NIH/NIDDK, CDC, ADA, JDRF and others which dare suggest that diabetes has only a "minimal" impact on patient quality of life. The (in)famous DCCT is perhaps the best known example.

But what does than mean, exactly? Medical researchers are often deliberately vague about how they define "quality of life" so as not to interfere with their objectives for their research findings, whatever those happen to be.

The fact is that diabetes is almost always depicted by the medical profession and the media as a disease that is little more than a minor inconvenience, rather than an incessant nuisance filled with uncertainties even when following the rules, and whose management too often consumes enormous amounts of money and time we'd rather spend on something else.

Lifepsychol is a new healthcare initiative from the U.K. which is designed to focus attention on ways to support and improve the quality of life of people with chronic conditions like diabetes. To accomplish that objective, Lifepsychol is conducting a survey to learn what people really mean from the term 'quality of life'.

You have a chance to help by taking this anonymous survey. To do so, vist http://www.lifepsychol.com/lifepsychol_survey.asp (just remember, when they ask about whether NHS [which stands for National Health Service U.K.] makes things easier, you'll have to answer that question even though it's technically not applicable if you live outside the British Isles)!

I Do This For Me, Too!

Once again, I've lifted (and slightly altered it) a title for my post today. I've borrowed this one from Chris Bishop, whose blog I've been following for a number of years, and finally got to meet in person last week in Indianapolis.

Chris specifically responded with his feelings to a ... how do I say this ... let's just describe it as a "controversial" post from a blog I've followed for quite some time written by Jenny Ruhl known as Diabetes Update. Jenny's post was entitled "It's Official: I'm Not An Influential Blogger", which was of course, a headline meant to attract readers and it worked pretty well. (FYI, Jenny later followed that post up with another one you can catch here). A number of people who attended the Roche conference were startled by the issues raised in Jenny's first, notably the potential for conflicts of interest within the blogging community, and the subtle (and not-so-subtle) ways that corporate entities (including the pharmaceutical and medical device industries) influence people.

It's no secret this is going on, and in fact, the diabetes industry is a little bit late to the trend ... NPR reported Monday from the BlogHer '09 Conference in Chicago (that several diabetes bloggers also attended, including Allison Blass and Kerri Morrone-Sparling who were also in Indianapolis last week also attended) that Mommy Bloggers at that conference are also struggling with how to deal with "Blog-ola" (the free goodies, products, trips and other perks many marketers are giving to bloggers in hopes of getting favorable publicity or positive reviews). According to NPR, another a hot topic at the BlogHer conference was recent talk by the Federal Trade Commission (FTC) on whether blogs that review products should offer a disclaimer stating whether they are posting paid reviews or are receiving free products in exchange for positive posts.

Until that happens, I'm not going to worry too much, because until the Roche event, I'd only once received any "Blog-ola" ... a meter with some free test-strips from a start-up known as Agamatrix I was asked to try (Roche didn't even give us meters or strips, FYI). In neither case, was I asked to even review the item or reference the event in my blog. But this is certainly a concern, as it is akin to the kind of marketing that has been going on for years (yet is rarely disclosed) with doctors ... the free sample products, the notepads and pens, etc.

Indeed, before I agreed to attend the Roche conference, I thought about whether I too might be potentially corrupted by this subtle influence. But I concluded 2 things: first, unless it becomes a regular issue, I can't worry much about it. If I receive "Blog-Ola" in my mailbox (electronic or snail-mail) on a regular basis, I'll need to reconsider, but as of today, the diabetes industry hasn't noticed me enough to try and buy my influence (I suspect they don't have to; it's doctors who are on their radar screens, and conflicts of interest are a HUGE problem there).

Second, I started this blog to share items I felt the diabetes community (especially the type 1 community) should either be aware of or be concerned about, and perhaps share news. Along the way, I've found it to be personally very therapeutic express things (even if no one reads them). I'm not looking to be the #1 blogger or attract advertising dollars, and I don't worry about statistics. If someone stumbles about something I read and thinks twice about it, I've gotten something from it. But I think the biggest thing I've gotten from blogging is meeting others who also had this invisible disease, and dealt with the same crappy, never-ending treatment demands.

Which brings me to the reason I started this post. I never sought to influence others when I began writing this blog -- if that happens, great. Already, I've met others who are dealing with the same B.S. day after day and struggle with the same crap, so I've gotten what I came to the blogosphere for. I do this for me -- it's a selfish motive, but if I can help someone along the way, I'm a happy man.

The Scam of U.S. Healthcare Reform (Circa 2009)

This week, NPR reported that one of the most powerful players in health care is PhRMA, which as I've noted before, stands for the Pharmaceutical Research and Manufacturers of America. PhRMA is a trade organization that represents some 32 brand-name drug companies, and NPR also reported that this organization now has so much influence in Washington, that when Congress passes a bill, PhRMA almost ALWAYS gets its way, and we're all picking up the tab (except, perhaps, for big pharma's shareholders). Listen to the story here:



PhRMA Lobbying Efforts Lead to Costly Corporate Welfare

We need look no further to the Medicare Drug Bill, which was one of the biggest pieces of corporate welfare to emerge in the U.S. since the great depression (and without serious efforts to reform to this over the long-run, it COULD potentially make the current Troubled Asset Relief Program [TARP] given to banks look comparatively cheap by comparison). A quick refresher on the Medicare Drug program: On January 1, 2006, Congress passed a bill and then-President Bush signed into law new legislation that authorized the government-run healthcare plan for senior citizens known as Medicare to provide an new optional prescription drug benefit. While the merits of that law bill are well known, the cost is an effective sinkhole (growing rapidly with a massive baby boom now entering retirement), and to make matters worse, Medicare cannot negotiate for lower prescription drug prices directly with prescription drug manufacturers!

To cite an example under the U.S. Government umbrella that proves that the current Medicare drug program is corporate welfare, we need look no further to the U.S. Veteran's Administration (VA) for a lesson. The VA has negotiated drug prices that are 20% to 30% lower than the price of drugs available through the 50 or so private plans that currently provide Medicare Part D coverage, and yet no one from the industry is crying they cannot make any money as a result of of the VA's move. The current system is pure corporate welfare. Governments around the world already negotiating prices, but in the U.S., Medicare can't do the same thing. The current system keeps the profit model going for all groups involved (except U.S. taxpayers, of course), including insurance companies, pharmacies, pharmacy benefits managers (PBMs), drug wholesalers just to name a few of the groups who skims a profit from the current system.

Bills have been introduced repeatedly for the past few years to try and address this "little" issue with the law, yet somehow never seem to make it out of committee, let alone be voted on. The drug industry argues that changing the current system would lead to government price fixing, cost shifting and eventual drug rationing, yet these arguments are fictitious without any real evidence to back them. Countries with nationalized healthcare systems routinely negotiate drug prices, yet I've never heard of a shortage of a blockbuster drug like Lipitor which lead to rationing of that drug anywhere on earth.

Former President Bill Clinton was somewhat more diplomatic about it, but he argues that the U.S. effectively subsidizes the rest of the world's drug prices. In an an interview with Larry King earlier this year, the former President said:

"... We have made a bargain with our pharmaceutical companies. We've said to them for decades now, we love having you in America. We're proud of you. We know you have to spend a lot of money on research and then you market the drugs and all.

So we will eat your research and development costs in American prices so that you can sell exactly the same drugs you sell to us for less money in Canada and Europe.

Even our -- for example, our AIDS clinic down the street here in Harlem, the taxpayers pay $10,000 a year to treat people with the big pharmaceutical companies' AIDS medicine. That medicine costs about $3,500 a year in Canada and Europe -- countries with per capita incomes as high as America."

If the Congress is talking healthcare REFORM, we MUST change that business model, but as I'll demonstrate, that isn't happening thanks to groups like PhRMA.

PhRMA Diabetes Industry Players

Among the better-known members of PhRMA in the diabetes industry include: Abbott, Amylin Pharmaceuticals, Bayer HealthCare, Johnson & Johnson, Eli Lilly & Co., Sanofi-Aventis U.S., and Novo Nordisk Inc., as well as most of the largest drug companies (Pfizer, Merck, Bristol Myers-Squibb, Novartis, etc.). Recently, Roche decided to leave PhRMA to another trade group known as the Biotechnology Industry Organization ("BIO"), which is a biotechnology industry trade group with more than 1,200 members worldwide (see here for details). I have similar view of both PhRMA and BIO, and more often than not, BIO and PhRMA seek the same things from Congress. Of note is the fact that many diabetes companies, including Abbott, Bayer Healthcare, Johnson & Johnson, Eli Lilly & Co., Sanofi-Aventis, Novo Nordisk, Pfizer, Merck just to name a few are actually members of BOTH organizations.

In any event, according to the Center for Responsible Politics, PhRMA is the 6th largest lobbyist in Washington based on total dollars spent over the past decade. As I've reported in the past, the Center for Responsible Politics also rates the Pharmaceutical/Health Products industry (including efforts from both PhRMA AND BIO) as the single biggest lobbying group based on total dollars spent among all of 121 different industry and interest group categories the organization profiles, spending a whopping $1,629,694,750 on K-Street lobbying activity between 1998 and 2009.

The influence of an industry trade organization isn't the only way these companies are influencing government policy, or in the U.S. healthcare reform debate for that matter. In fact, many of big Pharma's biggest names (Pfizer, GlaxoSmithKline, Eli Lilly & Co. and Bristol-Myers Squibb) are also each named among the top 200 all-time donors in political contributions.

As I've written previously, pharmaceutical companies are best described as "fair-weather" friends to whichever party is in power at a given time, readily switching their loyalties (and dollars) between Republican and Democratic candidates with almost no hesitation.

Addressing the Cost of Home Diagnostics?

No doubt, my readers heard that there was a bit of conflict when Roche was confronted about the high costs of testing supplies. In essence, the company executive said he was not at liberty to discuss the issue. While participant Kelly Close did note that her own business estimates that the profit margins on testing supplies were declining (she didn't say this, but I can tell you that this is mainly because managed care providers are demanding - and getting - price cuts from the industry). For a box of 100 test strips, while the low-price retail cost is somewhere around $90 to $100, but by some estimates, insurance companies are probably now paying anywhere from $38 to $60 for these items, depending on how much of a volume-based discount the companies can get. But whether the markup is 900% or only 100%, whether they cost a mere $0.10, $0.60 or even $0.75/strip to make, there is little doubt that this business is one hell of a cash-cow.

As a number of diabetes bloggers have written, when Roche Diabetes was confronted by some patient advocates about the cost of test strips, the company evaded the issue. I, for one, was surprised they didn't have a prepared statement to address that issue. Roche claimed they were not at liberty to disclose that information (although truth be told, the U.S. Food and Drug Administration has little to do with their unwillingness to discuss profit margins; this is a business decision not to disclose this information). It should also be noted that Roche's investors might find this information to be valuable to help assess and determine whether the business is healthy. Which raises the question:

Just Who Owns and Controls Roche?

I couldn't find all of details, but it is known cross-town rival Novartis tried to seek a merger with Roche back in 2004 (according to Bloomberg, Novartis AG owns a 33% stake in the company) -- a move that the descendants of company founder Fritz Hoffman-La Roche did not approve. Apparently, in January 2009, the family agreed to keep its stake in a single voting pool for an unlimited period (their voting pact was to have expired at the end of 2009). The family members' agreement includes provisions on the pool's use of its voting rights and restrictions on the sale of its bearer shares -- which is important because sometimes wealthy families bicker and disagree on how to vote. On January 28, 2009, Bruno Dallo, the family representative at Scobag Privatbank AG, said in a statement that the family pool owns slightly more than 50% of the bearer shares in the Basel-based company. Collectively, this amounts around 84% of the company's shares.

This means that any push for more disclosure on the diabetes business would have to be presented and approved to these two very important shareholder groups, which seems highly unlikely unless there is collective pressure to sell this portion of the business, and given its cash-cow status (albiet the business which is not growing as much as it could in the U.S., but its certainly profitable), so it seem unlikely that a movement to influence the key shareholder groups would yield much in terms of disclosure here.

By comparison, other companies such as Abbott or Johnson & Johnson are largely controlled by big institutional investors (for example, in the case of J&J, State Street Global Advisors US is the biggest institutional shareholder, followed more distantly by Barclays Global Investors, Vanguard Group, Fidelity Management & Research, and State Farm Insurance Companies to name a few of the biggies, while Abbott is controlled by State Street Global Advisors US, Barclays Global Investors, Vanguard Group, Fidelity Management & Research and State Farm Insurance Companies -- although these institutional investors' shares are more even in size than JNJ's are).

Disclosure My Personal Holdings

Now, if you really want to know, a bit more than half of my personal investments are largely in the form of mutual funds, which consist of American Funds New Perspective Fund Class A shares, as well as American Funds Investment Company of America Fund Class A shares, and American Funds New Economy Fund Class A shares. The specific stocks these particular funds hold is a matter of public record if you really care to know. These funds do own a chunk of Novo Nordisk (one of the larger holdings, FYI), Teva, Lilly, GlaxoSmithKline and yes, even Roche, but I would hardly consider this a conflict-of-interest. Also, aside from my recent trip to Indianapolis, I've never received any form of compensation and am not about to change my opinion of the pharmaceutical industry's behavior because of a single event.

Ted Kennedy: A Lifelong Passion? Maybe (Not)

Ironically, in a recent essay in Newsweek, Massachusetts Senator Ted Kennedy, who says he has championed health care reform for much of his long career, writes:

"I believe the [healthcare reform] bill will pass, and we will end the disgrace of America as the only major industrialized nation in the world that doesn't guarantee health care for all of its people - And I am resolved to see to it this year that we create a system to ensure that someday, when there is a cure for the disease I now have, no American who needs it will be denied it."

But as the NPR story I shared suggests, there are legitimate questions about what exectly will come out of Congress.

It is a known fact that the healthcare industry, consisting of countless players including drug companies, insurance companies, pharmacy benefits managers, hospitals, doctors and nurse associations, even individuals who do medical billing and coding for work, have a strong interest in preserving the status quo.

Their livelihoods are at stake.

But the money being spent by PhRMA is obscene, and has already shifted the focus away from actually reforming the healthcare "system" (a term I use loosely) to merely one of covering more people. The healthcare industry stands to benefit handsomely from this part of the equation, which explains why they are suddenly willing to "negotiate" as part of this discussion. With this money, some of the old players are back, like Harry and Louise, that nice middle-class couple that was invented by the health insurance industry to dismember the Clinton plan back in the 1990's. Only this time around, Harry and Louise have switched sides and now sound optimistic about an overhaul that provides "good coverage that people can afford."

NPR reports that Harry and Louise still have deep-pocketed friends in the healthcare industry. The ad is jointly sponsored by Families USA, a pro-reform group, and ... surprise ... by PhRMA! Together, they're spending about $4 million. But as my conversation on this subject at the Roche summit demonstrated (and Roche admitted), so far, there is really no discussion of true "reform" going on in Congress. Its all about covering more people. To be sure, that's important, but it's not reforming what doesn't work with the current arrangement.

Ted Kennedy can easily afford the best medical care on earth. He went to North Carolina to have brain surgery from one of the best. But even if he wasn't sitting on a family fortune, he'd still have what some are now calling "gold-plated" healthcare plans, because Congressmen and women are covered by one of the best plans available anywhere, and for the rest of their lives, no less. They'll never have to live within the laws they're considering now because they've exempted themselves from it.

Some in Congress ARE trying to address this issue. For example, Republican U.S. Representative John Fleming from Louisiana (who is a physician, by the way), is fighting to introduce a resolution that would require members of Congress and the Senate to accept the same healthcare regime that they mandate for the public. Fleming has also placed a petition on his website, http://www.fleming.house.gov/.

Fleming's website has a short narrative explaining his resolution on his home page, and a link to the actual resolution. It's brief and easy to understand. While Fleming makes condescending jabs at the idea of a government-run healthcare plan, at least his bill would mandate that our Congressmen and women live by the same rules they're proposing to mandate on everyone else. At the very least, his simple bill deserves consideration, but so far, most of Congress isn't running to co-sponsor the bill (any ideas why?).

Buying Influence to Preserve the Status Quo

As the NPR story previously noted details, Jerry Avorn, a professor at Harvard Medical School and author of the book about drugs and health care called "Powerful Medicines" says just look at what's NOT on the table during the healthcare reform debate if you want to know what PhRMA is getting:

- Drug re-importation from Canada? Off the table.

- Government-negotiated drug prices? Off the table.

"A lot of those seem to have been resolved even before the public discussion begins," says Avorn. "And usually, as with the other interest groups involved, they seem to have been resolved in favor of the interest groups, rather than in favor of the public."

Real healthcare reform ... Off the table?

So far, all that is being talked about is how to insure and get more people into the system. There is little (if any) real conversation about reform.

Having said this, we need to start someplace. Congress has failed to do anything about the many problems our healthcare "system" faces, and we can always start someplace and then worry about revising it later. But we need to speak about REFORM, not simply how to make more companies with vested interests even richer on an already broken system.

My "Spin" on the Roche Summit

I pretty much lifted the title from Kelly Kunik's Diabetesaliciousness, but I hope she won't mind! I'm pretty late in posting my take on the Diabetes Social Media Summit sponsored by the Swiss pharmaceutical giant Roche at their U.S. Diabetes Care HQ in Indianapolis. That's because I had real work to do on Friday (and into Saturday afternoon), so blogging took a back seat. Because of my delinquency on that, I have the distinct luxury of linking to almost everyone else's review posts on this particular topic! So here's the photo (catch it on Facebook, too!):


(Thanks to Manny Hernandez of "TuDiabetes" for the photo legend)
In the photo above:

1. Riva Greenberg "Diabetes Stories"

2. Ginger Vieira "MyDiabetesCentral.com"

3. Kelly Kunik "Diabetesaliciousness"

4. Fran Carpentier "Parade magazine's Diabetes Daily blog"

5. Crystal Lane "Calpumper"

6. Kitty Castellini "Diabetes Living Today"

7. Sandra Miller "A Shot In The Dark"

8. Christel Marchand

9. David Edelman "Diabetes Daily"

10. Brandy Barnes "DiabetesSisters"

11. Bennet Dunlap "YDMV a.k.a. Your Diabetes May Vary"

12. Lee Ann Thill "The Butter Compartment"

13. Allison Blass "Lemonade Life"

14. Gina Capone "DiabetesTalkFest" AND The Diabetes O.C. (FYI, O.C. stands for "online community")

15. Jeff Hitchcock "Children With Diabetes"

16. Kerri Morrone-Sparlin "Six Until Me" (see here for her photos)

17. Manny Hernandez "TuDiabetes"

18. Chris Bishop "The Big D"

19. Amy Tenderich "Diabetes Mine"

20. Kelly Close of Close Concerns, Inc. and "diaTribe"

21. Christopher Thomas "DiabeticRockStar"

22. Scott King "Diabetes Health" magazine and his editorials "My Own Injection" (see also here)

23. Bernard Farrell "Diabetes Technology Blog" and the Diabetes Search Engine

24. Scott Strumello (Yours Truly, no introductions necessary)

25. George Simmons "The B.A.D. Blog"

26. Scott K. Johnson "Scott's Diabetes Journal"

27. William "Wil", Lee, or Liam Dubois "Life After Diagnosis"

28. David (a.k.a. "Rick") Mendosa and "MyDiabetesCentral.com"

29. Charlie Cherry "Diabetes Power Show"

To be sure myself and a very limited number of diabetes social media people (a total of 29, to be exact) were selected and invited to attend this event, and apparently, the hosts at Roche had to work really hard to "sell" the idea of even having such a risky event to the company's conservative executives, so they deserve a big thumbs up for that.

Now, I have to admit that I have some degree of new-found fondness (that some of my peers may not) for Roche for being the pharma company that happened to end the life of the biotech company Genentech. Even though I lived in the Bay Area for most of the 1990's, IMHO, Genentech was kind of a sleazy company that pretty much shafted countless people with diabetes with their pushing biotech synthetic insulin that caused well-documented problems [see here for more] with hypoglycemia unawareness for countless patients without any undisputed conclusive evidence of benefits over the stuff it replaced. You can catch my review of the book "Invisible Frontiers" by Stephen Hall, to get some idea of why I'm glad Roche is kind of dismantling that company!

Anyway, having said all of this, I do think Roche received as much from this even as those of us who actually attended did. To some extent, the entire social media space (defined as bloggers, social networking communities such as Facebook, LinkedIn, and Twitter as well as more specialized social networking communities focused specifically on diabetes including TuDiabetes, DiabetesTalkFest, DiabetesRockStar, DiabetesFriends.net and others) was/is a bit like stepping into the dangerous, untested waters. Their move was certainly not risk-free, and hopefully they learned some valuable lessons that can help them avoid the missteps some that their competitors (including Johnson & Johnson and insulin manufacturer Novo Nordisk) have made in the social media space which made those companies look pretty stupid. But beyond that, I also believe that Roche received a healthy dosage of patient candor from their customers that corporations are far too often shielded from -- both good and bad, even if these were tangential to the social media aspect, these are lessons that the company should learn.

For example, a while back I
wrote about my encounter with a Madison Avenue advertising person who worked in marketing pharmaceuticals and how their job was making sure the client was happy, which does not necessarily mean selling more products for the client (although it's supposed to be).

The event began Weds., and I believe Gina Capone (of DTF) and I were the first two to arrive at the Sheraton in Indianapolis where we all stayed (on Roche's dime, no less). After we both checked in, we decided to walk across the street to the Fashion Mall and we dared to eat food court grub because we were pretty hungry by then. We had only an hour or so to hang out until the next group of participants started trickling in, so we waited at the hotel bar!

As Scott K. Johnson aptly described these meet-ups, it was kind of like "sensory overload" (at least initially). Without providing every gory detail (you might be bored), I can say that my response was mostly due to seeing all of these people I've really come to know over the past few years via the blogosphere but had yet to meet in person, and that was and always is an incredible experience! Let's just say that I think we can conclude that the seeds have been sewn for some kind of semi-regular meeting (Allison Blass is working on that), hopefully expanded to include many of the people we felt were left out of this particular opportunity.

The first evening, we attended a dinner hosted by Roche, and a few executives gave some speeches. As Wil (a.k.a. Liam, Lee, or Printcrafter among a few of his better known aliases) Dubois wrote (and a pretty good overview of the company):

"Roche's stated purpose for hosting the Summit could be summed up (in my words, not theirs), as follows. Hmmmmm….These D-bloggers are a powerful force. We watched Novo step on their own dicks with the Twitter Debacle and J&J with their YouTube mess. These people shape decisions. We want on in that. But we don't want it to blow up in our faces. We want to know what your sacred cows are. What is holy ground. Where are the mine fields?

They want a seat at the table, and rather than just barge in and sit where ever they pleased, they are asking the maître'd if there are any seats available.

They were, I felt, pretty up front. They promised this would not be a day-long Roche add. They kept their promise. Beyond keeping their word, they treated us well. They paid our airfare. They put us up in suites at the Sheraton. They fed us, with high regard for our varied dietary needs. They treated us with respect. All they asked us for was honesty. And boy, did they get an earful of that!"

Were Roche's questions on social media addressed?

I think to some extent, but it's a work in progress, folks, so the answers aren't necessarily clear-cut. But they took a bold step which will be remembered by those of us who attended this first meeting, and I hope we gave them a perspective they may not have appreciated before! I don't necessarily think that the discussion about pricing of test strips was necessarily out-of-place here, and I was frankly a bit surprised that the company's President didn't have a well-rehearsed answer to that question.

I am looking forward to hearing Roche's perspective on this conference!

Happy D-Anniversary to Me

You may recall that back in May, I shared my experience with what passed as children's diabetes literature circa 1976, the year I was diagnosed (BTW, my 33rd anniversary is Friday, July 24), and I'll be headed back from the Diabetes Social Media Summit hosted by Roche, a perfect way to mark the occasion!

Anyway, considering Mr. Hypo(dermic) was supposed to be my new "friend", I felt like commenting on that ... with a comic which about summarizes how I felt as a 7-year old kid when the nurse at the hospital handed that booklet sponsored by Bayer (then known as Miles Laboratories):



Cheers to anniversaries and social media, but let's face facts, diabetes sucks, no matter how you try to "spin" it. Any 7-year old kid can tell you that!

Evergreening Does Not Refer to Trees

When most of us think of evergreen, usually images of Christmas trees come to mind (or perhaps Barbra Streisand's sappy 1977 tune "A Star Is Born", a.k.a. "Evergreen"). The term evergreen is derived from perennially green trees that retain their rich, green colors even through the coldest winters in places like Alaska, the Canadian Northwest Territories, Siberia, the Scandinavian Lapland or anywhere else these hearty trees happen to call home.

But the term "evergreen" has come to mean something else, especially when it comes to the debate over how to manage healthcare costs. In effect, the term has become a euphemism used by the pharmaceutical, biotechnology, home diagnostics, and medical device industries as a means to perpetually extend the lives of their patent protection by making marginal modifications to the product design (or, a derogatory term if you're a critic). Critics argue companies are abusing the patent and regulatory systems to delay the legitimate entry of generic competition. In effect, these are a low-risk way to extend the exclusivity protection of established products, without bringing much genuine health benefit, although it does delay generics from entering the market.

In pills, for example, the phrase "incrementally modified" drugs is sometimes used by the pharma industry staffers to describe variations on existing pharmaceutical products, such as new formulations (extended release versions, for example, or different dosages which require fewer pills), liquid capsule forms, transdermal patches, etc., of the established, brand-name product) to effectively entitle the brand-name manufacturer to enjoy more time under effective monopoly of patent protection even though the changes made to the core medicine do little to fundamentally change the product. Sometimes, there are pretty standard modifications that can be made which are known at the time the drug is first developed and patented but are subsequently promoted as "innovations" even when the core product remains essentially unchanged.

In 2002, the U.S. Federal Trade Commission (FTC) conducted a study which was scathing of the pharmaceutical industry practice known as evergreening that finally gave some much-needed regulator and lawmaker attention to these industry practices (and abuses). The study also prompted the FTC to issue recommendations for legislative changes to Hatch-Waxman Act to maintain incentives to innovate and facilitate the entry of generic drugs. So far, however, Congress has been agonizing slow to reform this in a very meaningful way (some argue that Washington lobbyists are responsible for that).

Examples of Evergreening in Diabetes Care

One of the most obvious examples of "evergreening" occurs in home diagnostics business, notably with blood glucose testing supplies. As guest-writer David Lazurus fairly recently wrote on Amy Tenderich's blog Diabetes Mine, "the pricing of test strips — a roughly 900% markup over the manufacturing cost, as best as I can tell" adding that "the global market for glucose meters and test strips was estimated at $6.3 billion as of 2005. It undoubtedly tops $7 billion now." This topic alone subsequently prompted a lively discussion on the social networking site TuDiabetes.

Ironically, however, there is not a single generic test strip sold in the U.S. market. It seems pretty clear that we can thank evergreening for that. For example, the companies might reduce the blood sample size required for a test, or modify the type of plastic used to manufacture them, or maybe change the electronic contacts inside the meter, but none of these are what could really be billed as "innovations" to the core product, but nevertheless, entitles them to more time under the protection of U.S. patent law.

The companies who dominate this industry, Johnson & Johnson, Abbott, Roche, Bayer and a handful of others, are for the most part, well-seasoned in the various intricacies of pharmaceutical evergreening, and have arguably used it to effectively preclude any sort of meaningful generic competition in the home diagnostics market. Thus, we have 900% markup on test strips and I haven't seen generic test strips in a good 15 years or more.

My own opinion is that as long as healthcare providers (e.g. insurance companies) continue to tolerate this practice, we are unlikely to see any meaningful reform short of lawmakers addressing the practice via legislation. But when we discuss the costs of managing chronic diseases in the context of healthcare reforms, these practices undoubtedly should be part of the debate, but so far, have not been. However, to reduce the influence of industry and special-interest lobbyists, we as patients need to make our voices heard by contacting our legislators!

Some also say the effective extension of patents on biosynthetic human insulin is also an example of evergreening. Although I disagree on that point (there is no need to evergreen when there is no way for generics makers to seek approvals from the FDA). Nevertheless, last month, the Pharmaceutical Care Management Association (PCMA) released an advertisement lambasting our lawmakers for their failure to move (download the ad directly here).

Whether this is evergreening or not is irrelevant. The main issue is that Congress has consistently debated the topic, but has failed to act. How can they have meaningful healthcare reform when they can't even get their $#!t together to actually vote on a bill that even former President George W. Bush said he would sign?

Evergreening Follow-On Biopharmaceuticals?

In January 2007, with my ground-breaking article (see here for that article) I shared that that the patents on Eli Lilly & Company's Humulin insulin products had expired in 2001, and Novo Nordisk's Novolin insulin product patents had expired in 2002, and yet, in spite of no law preventing generic insulin, we still don't have it several years later (2009).

The FDA has continually delayed outlining procedures for generic manufacturers to apply for and obtain approvals of therapeutically equivalent versions of insulin, making excuses that Congress needs to tell them what to do or saying they want to publish broad guidelines applicable to ALL biopharmaceuticals.

In effect, the Congressional and FDA's failure to act on this extends the life of the original patent, costing taxpayers and our healthcare providers millions of dollars each year. In 2006, Sen. Orrin Hatch (who co-authored the Hatch-Waxman Act permitting generic drugs back in the mid-1980s) admitted that the absence of having a comparable approval path for biotechnology drugs, "essentially acts as a second patent to keep off-patent biological products off the market."

And as then-Kansas Governor (now U.S. Secretary of Health and Human Services, who now has a much more vested interest in controlling healthcare costs in her new role) wrote in the petition she signed back in 2006: "The FDA's delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars."

Concerns About Follow-On Biopharmaceuticals Legislation Needs to Address

I have long been a supporter of legislation that would enable follow-on biopharmaceuticals to emerge, but my support for legislation does not mean I support a free-for-all for generics makers or branded drug companies.

As the political debate on U.S. healthcare turns to cost-savings, there will be growing pressure on lawmakers to do something about so-called generic biopharmaceuticals (they aren't exactly the same, therefore the FDA refers to them as "follow-on" biopharmaceuticals, while regulators in Europe sometimes refer to them as "biosimilars"). Contrary to what the biotechnology industry would have us (and their Congressmen/women) believe, the real concern in this debate is not about balancing the needs of the industry by allowing a longer period with patent protection. The real issue is about enabling competition at an appropriate time while also protecting patients as well.

1. Say NO to Interchangeability

First, we need legislation that will clearly specify that follow-ons are NOT considered interchangeable with the brand-name product, because they aren't. This would mean that no pharmacy could simply give us a "generic" insulin without asking our permission as they can with pills. Anyone who has ever switched insulin brands knows that just because they are both "regular" insulin doesn't mean they work exactly the same way.

The FDA has already suggested that what they call "follow-ons" would not be considered interchangeable. A follow-on is not interchangeable, and we cannot have pharmacies automatically switching us to follow-on versions without our knowledge or consent. The FDA has already suggested this might be the case anyway, although it's up to Congress to specify this in the law.

2. Demand Full Disclosure of the Manufacturer and Ensure Continued Availability from Pharmacies/PBMs

We also need to take this a step further and demand that our legislators let us know more about the manufacturers, and that we will be able to attain the exact same product be from the same manufacturer (not a manufacturer chosen by Medco Health, CVS Caremark, or Express Scripts) based on the simple economics of their business.

We are entitled to know not only who makes the follow-on, but also that we can continue using that particular follow-on if we switch pharmacies (especially mail-order pharmacies who typically provide 90-day supplies). Keep in mind that pharmacy benefits managers (PBMs) make millions of dollars on generics, but they can switch suppliers without telling patients because the FDA says that small-molecule drugs are interchangeable.

Consider the following potential real-life scenario:

Let's say you buy your medicines from Medco Health Solutions (they're the #1 PBM, so many of you already do). Medco may have a deal with Barr (now owned by Teva), but Medco can switch suppliers if they get a better deal from someone else. But if Medco decides to switch from Barr/Teva to say Watson, Mylan, Sandoz or Hospira (... or Dr. Reddy's or anyone else, for that matter), while its usually a non-issue in terms of bioequivalency in small-molecule (chemical) drugs, it is a very big deal in terms of biopharmaceuticals because the unique cell culture used in making these medicines can make for a very different product.

Your insulin dosage with Novo's Novolin R may be 1 unit per 15 grams of carbohydrate consumption, while your dosage of Lilly's Humulin R may be 1 unit for 13 grams of carbohydrate. The difference is real, but if you can't be sure to get the biopharmaceutical from the exact same manufacturer, you could have a dosage management nightmare on your hands every time you order it, thanks to lack of thought by our legislators.

Hyper and/or hypoglycemia might be the rule every time you refill your script if you can't ensure continuity in suppliers. The pharmacy benefits managers (PBMs) aren't expecting biosimilars to result in the same kind of mass-switching that normally occurs when a generic comes on the market. In the article I recently featured on this topic, the CFO of Medco Health Solutions spoke more on the subject of follow-on biopharmaceuticals.

In Q2 interview with Investor's Business Daily, Richard Rubino, Medco's Chief Financial Officer (CFO), admitted that follow-on biopharmaceuticals wouldn't necessarily be the gravy train PBMs saw with prescriptions for Prozac, Zocor and other small-molecule drugs. He said that Medco understands follow-on biopharmaceuticals are not likely to be exact duplicates, as is the case with small-molecule drugs, which are considered interchangeable without patient or doctor permission unless specifically designated "Dispense As Written" by the doctor on the prescription itself.

Rubino said "You won't see the mass switching of a [as we observed with generic] Zocor. That's because the disease states are hypersensitive. They're matters of life and death.

The molecules will not necessarily be identical. They'll be similar but not necessarily identical. So if you are diagnosed with a disease, you will start on the biosimilar. If that works then you'll stay on it."

Rubino's last sentence is especially important to my point about knowing who makes the product, and ensuring access to continued availability of that biosimilar from Pharmacies/PBMs such as Medco, CVS/Caremark or Express Scripts. But unless Congress mandates in the law that biosimilar manufacturers must be clearly disclosed, and that the supplier will guarantee continued availability from the same manufacturer, people with diabetes are lacking simple protections that any "Access to Lifesaving Medicines" legislation need to address -- so share this with your lawmakers and make the issues known to him or her!

New Hampshire Libertarians Score a Victory for Patient Privacy Rights

I have done book reviews on different tomes related to diabetes, but I also read content unrelated to diabetes -- it's just that I don't usually write about it. One of my favorite books is Joel Garreau's "Nine Nations of North America", a book written in 1981. The author, a senior writer for The Washington Post, president of his company, The Garreau Group, writes (convincingly, I might add) how the continent of North America really works right now, not as if it were 3 nations -- the United States, Canada, and Mexico; not as if it were 50+ states and provinces; not as it should work, as an academic might have it; but how it is really working. In the book, Garreau argues that North America can really be divided into 9 regions, or "nations", which each have distinctive economic and cultural features -- and each has it's own capital city. You can visit the Garreau Group's website for more detail on the book, but interestingly, few people who have ever read this book seem ever seem to argue or disagree with it.

Joel Garreau's Nine Nations of North AmericaFor example, he argues that the states of Florida and California don't really exist functionally, but are conglomerations of different nations, each with different loyalties, economic and social priorities and alliances. Consequently, there are sometimes disagreements between two big California "nations" Ecotopia and MexAmerica (represented by their respective capitol cities, San Francisco and Los Angeles), for example. Political gridlock in Sacramento is often an example of this.

Don't Mistake Libertarianism for Liberalism

He also argues that with the possible exception of the southwestern portion of Connecticut and parts of Maine which border Quebec, only New England's political boundaries have any genuine meaning. Maine and Nova Scotia (Canada, for my geographically-challenged readers) share a host of similarities -- an Atlantic coastline, similar climate, etc. Aside from being the best source for lobster in North America (and possibly Maple Syrup, although not the ideal food for people with diabetes, unless you're treating hypoglycemia). Politically, in spite of being in 2 different nations, same-sex marriage will be permitted across the entire region both in Canada's Atlantic Provinces as well as in the U.S. New England states (except Rhode Island, whose legislature remains very heavily influenced by Catholic leaders, and has therefore not voted on the issue, but lest anyone consider this social conservatism, think again: Rhode Island is a renegade in New England in that there are no laws prohibiting prostitution in the state, only a law that prohibits public solicitation). Outsiders sometimes naïvely mistake this for liberalism, but the reality is far more libertarian than liberal. This political philosophy is noted on each New Hampshire license plate with the state motto "Live Free or Die". The prevailing view across the region is that the government has no right to meddle in personal lives and that laws cannot and should not favor any particular type of relationship between two consenting parties. Fortunately, this libertarian view also extends to doctors' drug prescribing habits.

In recent years, at least on the U.S.-side of the "nation" known as New England, has been a move in Northern New England (Maine, New Hampshire, and Vermont) to limit access to doctor's prescription-writing by data-mining companies that analyze and then sell prescription dispensing information (I'm not 100% certain how Canada regulates this), which is then used by salespeople to focus on certain "underperforming" doctors who suddenly get lots of attention from salespeople than do doctors who prescribe a given drug at "normal" rates (as determined by the drug companies).

New Hampshire's Strike Against Prescription Data-Miners

Several years ago, the New Hampshire legislature was concerned about this practice, and in an effort to reduce health-care costs, passed a law aimed at making it more difficult for drug companies to engage in targeted marketing pitches to particular doctors, which the state believes results in expensive brand-name drug use (BTW, there ARE medical journal references which seem to validate this belief). New Hampshire passed a first-in-the-nation prescription privacy law that made doctors' prescription-writing habits confidential, barring the data-mining companies from providing drugmakers with doctor prescription histories for use in detailing. The measure applies only to information the data-mining companies acquire within the state, typically from pharmacies (especially major pharmacy chains such as CVS/Caremark, Walgreen's and Rite Aid Pharmacies, who sell Rx data to data-mining companies for a profit).

New Hampshire's Nashua Telegraph newspaper reported that "State Rep. Cindy Rosenwald, D-Nashua, wrote the bill at the behest of doctors who complained about these companies wanting to know their drug-dispensing habits."

She also said that blocking access to this information prevents major pharmaceutical companies from trying to influence doctors on their drug choices by sending them gifts or awarding them lucrative trips.

Since New Hampshire passed that groundbreaking law, both neighboring Vermont and Maine have also adopted very similar restrictions to prescription-writing data, and reportedly, similar legislation is now also pending in as many as two dozen other states.

Not surprisingly, the New Hampshire law was greeted by lawsuits filed by the 2 biggest aggregators of this data, IMS Health Inc., of Norwalk, CT, and Verispan LLC, of Yardley, PA which was begun by drug wholesaler McKesson (incidentally, both of these companies are physically located in the "nation" known as the Foundry, at least according to Mr. Garreau, not New England, even though Norwalk, CT is in the New England state of Connecticut).

Two years ago, after a trial in Concord, New Hampshire the drug marketing companies managed to convince Judge Paul Barbadoro to strike down the constitutionality of New Hampshire's Prescription Privacy law. But 6 months later, an appeals court in Boston overturned that decision, setting up the request for the U.S. Supreme Court to hear it. The data-mining companies challenged the law on the basis that the statute violated their constitutional free-speech rights. They also claimed that money made by selling the information to drug-makers allows them to provide the same material to researchers and humanitarian organizations at little or no cost.

The companies also warned in court papers that the law could be broadly applied to newspaper publication of stock market information and many other services that gather large amounts of information.

Meanwhile, the 2nd U.S. Circuit Court of Appeals is allowing Vermont to enforce a law similar to the New Hampshire ban on data-mining prescription information. The case is: IMS Health Inc. and Verispan LLC v. Ayotte, 08-1202.


Not surprisingly, drug and biotechnology industry trade groups supported their appeal.

But on Monday, the U.S. Supreme Court responded (sort of) to the appeal. The Supreme Court ruled that it would not stop the state of New Hampshire from making doctors' prescription-writing habits confidential over the objection of companies who analyze and sell that information. This also means that Vermont and Maine's prescription privacy laws cannot be challenged, either.

The issue of state's rights has been favored even by so-called conservative justices, who tend to favor the rights of states to govern themselves as they see fit without too much of Washington's influence (especially their recent efforts, which have been dubbed as "unfunded mandates" placed on the states without any money to support the Federal government initiatives).

Although similar legislation is now pending in two dozen other states, so far, the impact of 3 relatively small (population-wise) states is unlikely to influence the practice significantly. But the Supreme Court's refusal to hear the case represents a major victory for patients, doctors and the right to privacy!

What Else You Can Do

For those of you who are concerned about patient privacy, you may also wish to ask your Congressional representatives to support H.R. 2630 "Protect Patients and Physicians Privacy Act" today. This bill would:

• Grant individuals the right to opt out of any federal electronic system that tracks/stores their personal medical information
• Require informed consent for the sharing of electronic medical records (for federal programs)
• Prohibit health information from being placed in a federally mandated, created, or funded electronic system without a patient's written, informed consent

These are common-sense protections which are not protected by current Federal laws, but with this new legislation, some of these glaring privacy omissions would be addressed properly for the first time!

JDRF Reports New Progress in Translational Research

Last week, the Juvenile Diabetes Research Foundation (JDRF) reported that for the fourth time in 18 months, one of the non-profit organization's biotechnology partners had signed a collaboration agreement with a large pharmaceutical company to move research on type 1 diabetes into the final phases of clinical trials.

According to the JDRF, the newest development is the latest example of success in its Industry Discovery and Development Partnership (IDDP) program, through which JDRF provides early-stage research funding to drug and/or biotech companies working on technologies and therapeutic candidates.

The latest example was JDRF's industry partner Bayhill Therapeutics Inc., which just entered into a collaboration agreement with Genentech, Inc., a wholly-owned subsidiary of the Swiss pharmaceutical giant the Roche Group, to further develop and potentially commercialize a novel antigen-specific immunotherapeutic which aims to reverse the immune response that causes type 1 diabetes.

Other IDDP partners that have created similar commercialization agreements with big drug and biotechnology companies during the past 18 months include: Tolerx, which joined with GlaxoSmithKline to develop an anti-CD3 antibody to preserve beta cell function in newly-diagnosed patients; MacroGenics, which is developing a similar antibody with Eli Lilly and Company; and Toronto-based Transition Therapeutics, which has also signed a commercialization agreement for a beta cell regenerative therapy with Eli Lilly & Co. To date, JDRF has awarded more than $29 million in research funding to 25 companies through its IDDP program.

Collectively, these are just the latest examples of JDRF's program which first made public headlines in a front-page Wall Street Journal story on January 26, 2007 describing the organization's new push to help fund for-profit companies doing drug research.

These follow a number other deals that JDRF unveiled in preceding years, including a deal announced in October 2006, in which JDRF announced it would pay up to $3 million to Sangamo BioSciences Inc. for a phase-2 clinical trial of a protein drug that showed promise against diabetic neuropathy. Just a few weeks ago at the ADA Scientific Sessions in New Orleans, Sangamo BioSciences Inc. presented (abstract entitled "Reappearance of Nerve Potentials in Severe Diabetic Peripheral Neuropathy Patients with Unmeasurable Nerve Conduction Using Vascular Endothelial Growth Factor Zinc Finger Protein Activator") positive Phase 2 therapeutic data which resulted from this early JDRF-IDDP partnership.

In that presentation, they reported that the trials resulted in statistically significant and clinically relevant improvements in subjects with moderate and severe diabetic neuropathy as compared to placebo. The biotechnology medicine was referred to as "SB-509" and was reportedly well-tolerated in both multi-dose studies.

The logic behind these deals is simple: they're examples of what's known as "translational research", which is sometimes also referred to "bench-to-bedside" research which aims to assist in bringing promising therapies that might not otherwise ever see commercialization without JDRF's assistance to market.

In effect, JDRF is helping to, as the banking industry sometimes refer to it, "de-risk" the development of these products, and in doing so, make these therapies more attractive to companies which might bristle at the cost of bringing them to market.

Although JDRF aims to assist a variety of potential treatments with this IDDP program, fundamentally, the organization is pushing hard to to treat the root-cause of type 1 diabetes, rather than simply more palliative treatments, which is what virtually every type 1 diabetes treatment to date has been for nearly a century (88 years, to be precise). Palliative treatments simply treat the symptoms and manifestations of the disease, without ultimately eradicating the disease(s) which made the patients sick in the first place.

Increasingly, there is a growing consensus with Alexander "Zan" Fleming, MD's assessment (who formerly headed diabetes drug review at U.S. Food and Drug Administration) and now serves as Chief Medical Officer of Kinexum, which is the firm behind the newly-branded start-up known as Exsulin Corp. of the current situation:

The development of therapies for T1D has been neglected in favor of efforts in advancing therapies for the larger T2D population. Pharmaceutical companies have also been deterred by lack of clarity around the regulatory expectations for such therapies.

The U.S. Food and Drug Administration (FDA) and other regulatory authorities have long been in a quandary about how to approve therapies directed at the underlying autoimmune cause of type 1 diabetes (T1D). Therapeutic targeting of islet autoimmunity has been focused to date on persons with some remaining beta-cell function, essentially those just diagnosed with T1D. This target population requires reenrolling in a registered clinical trial, which are relatively long and difficult to conduct. These and other challenges have slowed the pharmaceutical industry's pursuit of T1D therapies, even though it afflicts more than 1 million North Americans.(Footnote #1) The larger type 2 diabetes (T2D) population has dominated the attention of regulators and pharmaceutical companies alike. For T2D drugs, the regulatory efficacy end point, hemoglobin A1c (HbA1c), was validated by landmark trials as predictive of microvascular benefit, (Footnotes #2 and #3) and the design of T2D registration trials has become standard. For some time, the FDA assumed that HbA1c should also be the primary end point for T1D therapies.

Footnotes:

#1. National Institute of Diabetes and Digestive and Kidney Diseases.
2003. National Diabetes Statistics Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2003. U.S. Department of Health and Human Services, National Institutes of Health. Bethesda, MD.

#2. The DCCT Research Group. 1993. The effect of intensive diabetes treatment on the development and progression of long-term complications in insulin dependent diabetes mellitus. N. Engl. J. Med. 329: 978-986.

#3. The UKPDS Study Group. 1998. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications complications in patients with type 2 diabetes (UKPDS 33). Lancet 352: 837-853.



To be sure, there is some debate on whether all of the new type 2 therapies represent genuine progress. Some drugs, such as Merck's Januvia (sitagliptin), are extremely costly to the nation's healthcare "system" and this drug's benefits are somewhat questionable. Regardless, no one can deny that when it comes to new and improved diabetes treatments, the rule in the pharmaceutical and biotechnology industries is follow the easy money, with particular emphasis on the word EASY.

It took 43 years for the first fundamentally new insulin variety (Eli Lilly & Co's. Humalog, or insulin lispro rDNA injection) to hit the market. Prior to that, the last fundamentally new insulin product was the Lente series (insulin zinc suspension), which was considered by most doctors to be far superior to NPH (insulin isophane suspension) in terms of predictability of time-activity profiles yet is no longer marketed today. NPH only remains on the market today because it's easy to sell in pre-mixed varieties such as 70/30, 50/50, etc. (it can be pre-mixed without changing the activity profile of the 2 insulins, while Lente products cannot). The pharmaceutical industry sees a potential goldmine in the massive type 2 market if they can convert even a small percentage to using those products, and not having to mix insulin is a key feature used to sell to millions of primary care physicians worldwide. Of course, these products do not deliver superior glycemic control, but they help to convert these "insulin naïve" type 2 patients into insulin users, which is the business objective.

Market leader Novo Nordisk A/S reportedly has several insulin products in various stages of development right now, and these are designed to be "weight neutral" products, another pitch aimed more at converting the type 2 market into insulin users rather than a fundamental advance in treatment. But beyond almost non-existent insulin development, Novo only recently set up a biotech unit outside of Seattle (see here and here for details) to pursue "inflammation" drugs aimed at the root cause of insulin insufficiency (there are different forms of inflammation in type 1 and type 2 diabetes, but ultimately, no current drugs on the market can stop either of these destructive inflammation processes). Novo's move was more sizzle than steak, as the company really has nothing in it's inflammation drug pipeline, while rival Eli Lilly & Co. has 2 partnerships for potential autoimmunity treatments and beta cell regeneration therapy in various stages of development. At present, these target newly diagnosed patients, but there are a number of different efforts which ultimately hope to be effective in long-standing type 1 diabetes as well. However, in order to measure the effectiveness of these treatments, it's necessary to see if they work on newly-diagnosed patients first, then perhaps they can be expanded to include the majority of patients who are long-past the honeymoon phase.

Regardless, it is heartening to see solid progress being made by these efforts; the JDRF should be commended on helping to bring new therapeutics to market beyond palliative treatments like a closed-loop insulin delivery system, which has plenty of critics (not the least of whom are the healthcare providers who will be expected to foot the ongoing costs, which will be much higher than current treatments). Whether the JDRF/Bayhill Therapeutics Inc. drug effectively arrests autoimmunity remains to be seen, but so far, the initial results appear promising. That, combined with several other therapies in various stages of development (see here and here for more background on some of these), perhaps combined with Exsulin's INGAP product (see here for some additional background) could spell the first fundamentally new forms of treatment for type 1 diabetes since the discovery of insulin in 1921. So far, this looks like the folks at Boston Consulting Group who created the following diagram (with a few additions of my own, noted in red) looks to be pretty much on target!

Another Movie Looks Into America's Food

If you thought the critical exposés into America's industrial agri-business were over, think again. First, we had "Supersize Me" (2004) which was a serious if somewhat humorous look into the fast-food industry, then we had a very similar (more serious, but less humorous) documentary "Fast Food Nation" (2006), followed by "King Corn" (2007) which examined a specific crop's impact on the nation's diet.

Today, another new movie called "Food Inc." premiers in selected theaters, and according to the movie's website this new documentary "exposes America's industrialized food system and its effect on our environment, health, economy and workers' rights." According to NPR, this film "takes aim at corporate giants behind the U.S. food supply. It makes a fierce argument for Americans to pay attention to where their food really comes from."

A preview can be seen here:



The filmmaker (and food advocate), Robert Kenner, features and builds on the testimony of authors Michael Pollan, who wrote "The Omnivore's Dilemma," and Eric Schlosser, who wrote the book "Fast Food Nation."

Although I haven't seen the movie (yet) ... but since it's raining this weekend, it might be a good time to catch this flick! I suspect it will be similarly as eye-opening as the others (already noted above) in this genre were. We can expect to see exactly what a factory farm looks like, as well as just how much growth hormones are used, and the impact that genetically-modified seeds has. NYC's NY1 reviewer says "Kenner does not rant, but rather connects the dots."

I suspect it will be a good look beneath our current food-supply system, and as my local NY1 reviewer put it:

"A big-picture vision of corporate duplicity and control, 'Food, Inc.' is a hard movie to shake. Days after you've seen it, you'll find yourself eating something - a cookie, a piece of chicken, cereal out of the box, a perfectly round waxy tomato - and you'll realize you have virtually no idea what it actually is."

As is often the case, this will be an art-house movie, premiering in selected theaters in major cities around the country this week, followed by a broader distribution in the coming weeks, followed by a release on DVD later this year or perhaps early next year.

For All You Twits Out There

Ordinarily, I consider myself a pretty mellow guy, usually looking for a way to make everyone happy and being more likely to bite my tongue rather than making a fuss when someone makes a scene. But sometimes, when people rub me the wrong way (or they approach me the wrong way), look out! The outcome is not going to be pretty -- for you!!

Not long ago, I received what I consider to be one of the most irritating "Tweets" (I should go on the record as saying it's technically not even a "Tweet" but a notification that someone was now following me on Twitter, and I even considered blocking this user from following me (although I haven't rushed into anything) from someone who follows more than 500 people, which will probably be 750 users before the week is over. This person's Twitter user name was "Diabetes Helper (diabetesnomore)".

The user name almost made my stomach turn. Naturally, I chose not to follow this person. But some of their stupid "Tweets" included the following comments:



# Diabetes doesn't need to stop you from traveling this summer, but its a good idea to stop by the doctor before you go : )

# 17 million americans suffer from diabetes, but knowledge is power, Knowing how to battle it can put you in control of your diabetes

# Sometimes we overeat because of the number of people we eat with, we don't have to eat alone, but lets be careful! :)


First of all, let me go on the record as saying that I don't need any "Diabetes Helpers" unless they've suddenly found a cure for autoimmunity which hasn't yet been shared with the scientific and medical communities. Nothing this person does is going to make my diabetes vanish (so much for their poorly-descriptive name "diabetesnomore"). Furthermore, I don't want any diet or exercise tips from them.

What I DO want is someone who actually bothers to understand that diabetes is not a single disease, and sending such ill-conceived advice is probably not going to help me at all and is far more likely to p!$$ me off. I'm willing to bet that I have more diabetes and nutrition information than they do, and I certainly won't be buying anything from them. (OK, I may very be a fossilized old troll, but I admit it!)

Why such a harsh assessment?

Perhaps I should give you some background on what I actually think about Twitter. Feel free to skip ahead if you don't want to read it -- I won't be offended.

Although I signed up for my user name on Twitter close to a year ago, my only motivation was to secure the login name so that no one else grabbed it! I think Twitter is way too overhyped and frankly, it has potential become tomorrow's MySpace (a social media community now owned by Rupert Murdoch's News Corp., and one that is generally viewed as dying. -- Don't believe me? Traffic at that site is down. So are revenues. Senior executives are leaving in droves ... need I say more?). To be sure, Twitter is somewhat different from MySpace. At it's core, Twitter is really a facilitator of what I call "micro-blogging", so that is one positive for it.

For those who don't already know it, Twitter enables users to send (and read other users' updates) which are known as "Tweets". Tweets are text-based posts which are limited to a mere 140 characters in length and are displayed on the user's profile page and also delivered to other users who have subscribed to them (those people are known as "followers"). What makes Twitter different is that it's designed to handle very short posts sent via text messages (from one's mobile phone). That much is unique.

But let's be honest, from what I've seen, a lot of "Tweets" are really pretty inane. So much so, there's now a blog called "Twitter Backlash" which is dedicated to this very subject. Many Tweets could probably be called idiocracy (and that's being generous!). For example, kids who Tweet where they're going at every second of the day, which I find to be a complete waste of otherwise productive time. Franky, who gives a sh!t if you just got home from school, or walked the dog. IMHO (in my humble/honest opinion), this is useless information taken to a new level.

I only reluctantly joined Facebook (or "FB") but have since rediscovered & reconnected with many people I knew when I was growing up, so that has proven to have some utility I hadn't really expected. Of course, my experience appears to be similar to others, which I suspect is what prompted one Wall Street Journal writer to claim that Facebook was pretty much a social application for middle-aged people anyway!

Let me go on record as saying that I haven't sent a single "Tweet" on Twitter since signing up (well, 1 which I had to do when I signed up, 276 days ago), yet in spite of that, I still have nearly 100 followers anyway! That isn't to say I will NEVER send a Tweet, but my view is that I plan on reserving my Tweets for appropriate opportunities, but just don't expect me to send Tweets just for the sake of doing it. I have things I'd rather be doing.

Not long ago, I did login to Twitter in order update those I actually follow. There are occasionally interesting comments and thoughts that emerge, but mostly they're it's like listening into a conference call on a subject you have limited interest in. Anyway, when I logged in, I also added a bunch of familiar people to my Twitter list. Like anything in social media, there is a tendency to do what your friends do on the site, but my rule has generally been only to follow people I actually know, which means that I am quite unlike Ashton Kucher in that I don't have a million followers nor do I follow a million people -- I don't want that many. I have no interest in following people I don't know, and I don't care if they follow me, either.

A while back, I posted an NPR commentary regarding Twitter on my Facebook page entitled "Keep Your Tweets to Yourself" (or, in plain text, it's a lot faster, see here)

I received a few comments from my followers on Facebook about their reasoning for using Twitter and why it can be valuable.

Fair enough. (I never said it was a totally useless application.)

As for Tweets, you may notice that I've added a widget to my blog in the right margin to display a few Twitter Tweets (I've limited it to just 2). I DO plan on using Twitter (sometime), but I expect to do so only on occasions that probably deserve it! For example, next month, I'll be attending the Roche Diabetes Social Media Conference in Indianapolis, and may find that to be a useful venue for 140-character micro-posts -- provided I figure out how to do so from my cell phone (I need to find the appropriate number to text to)! I will have limited access to the Internet while I'm there, but will have my mobile phone so I can send theoretically send short Tweets about things that are going on at that event.

For those who want my Tweets, yes, you can catch me at "sstrumello" on Twitter, but expect my Tweets to be very limited to specific occasions where they're likely to be a useful format for sharing information. Otherwise, I'm inclined to agree with NPR's John Ridley:

"We claim to be a nation of people who take our privacy very seriously. Just mention the idea of warrantless wiretaps and expect to get hit up with a congressional investigation.

But give somebody an avatar and a URL, and he can't tweet, post or hyperlink enough personal information about himself to as many people as possible.

Seriously, does valuable broadband space need to be taken up with announcements in that creepy Facebook third-person-ese that "John is enjoying two-for-one margaritas with the rest of the IT Team at T.G.I. Fridays"?

Where is the expectation of privacy anymore? Or, more correctly, where is the expectation that people will keep their private nonsense to themselves so that those of us who still like to communicate personal information with one person at a time don't have to get caught up in somebody else's e-mail circles or listen to their one-sided cell phone conversations?

No, I don't know what's hipper; to Facebook or to Twitter. I just know for me, personally, discretion never went out of style."


I won't be using Twitter to update much about my personal life, as I really don't feel Twitter is the appropriate venue for these kinds of posts. Also, I think some topics deserve more than 140 characters, and for those, don't expect to see any Tweets from me! But you can expect Tweets from me where I don't have access to the Internet or where timing of the message will be more important than the content.

So those are my thoughts on Twitter. Aren't you glad I shared that?

Diabetes & Bankruptcy: Average Diabetes Expenses Among Bankruptcy Filers is Second Highest Out-of-Pocket Expense Category at $26,971

My career in involves a lot of time doing research online looking for statistics, etc., so I spend a lot of time on the Internet. My own day-to-day diabetes care is a factor more often than I would like it to be, but that's just the way things are. But beyond my own daily care, it is not all the time that my research for work overlaps directly with diabetes. This is one such time.

As someone who works as a consultant for the consumer finance industry (primarily banks, but I've done work for a range of other companies such as Sony, Disney, etc.) and it's long been a been common knowledge that medical bills have long been a major factor behind consumer bankruptcies. That part is not really news, even if it doesn't get mentioned nearly as often as it needs to in the debate over healthcare reform in the United States.

One observation I've seen in spite of a major reform to bankruptcy law back in late 2005 (which banks lobbied legislators for years to put into law -- the idea behind that was supposed to be that by implementing means test to bankruptcy law, the bankruptcy courts could theoretically push more consumers into chapter 13 which obligates some repayment of debts rather than into chapter 7, in which consumers' debts are totally absolved). However, since that reform occurred, we've seen a steady increase in bankruptcies (albeit at a slower pace), and surprisingly, more have been chapter 7 filings, which was not expected by the banking industry. However, I had long suspected that healthcare expenses played a role in that, too. Hospital bills add up very quickly.

I'd pretty much assumed that catastrophic illnesses like cancer, heart attacks, and stroke were a major factor behind these filings because these things tend to happen suddenly and people are often in recovery for quite a while.

But a recent study published online in The American Journal of Medicine with data compiled by researchers at Harvard Law School, Harvard Medical School and Ohio University revealed that even among people with insurance, many are still left with medical bills that drive them into bankruptcy. The latest statistics show that in 2007, medical bills contributed to 62.1% of all bankruptcies. Between 2001 and 2007, the proportion of all bankruptcies attributable to medical problems rose by about 50%.

Contrary to my assumptions, chronic illnesses dominate the top 2 catagories, and to my surprise (and dismay), diabetes ranks second, following only nonstroke neurologic problems (i.e., multiple sclerosis). But the study also indicates that the health problems that left patients with t