Wednesday, July 05, 2006

ADA 66th Annual Scientific Sessions

It has been a few weeks since I updated my blog. The main reason I haven't updated it is because I've been rather preoccupied with other issues, as a result, my blog has been given a low priority. My apolgies for anyone looking for a publishing calendar, I try to update it when time permits. Without going into too much detail, I should start by mentioning that about a month ago, I was in Washington, DC for the ADA Call to Congress and 66th Annual Scientific Sessions sponsored by the American Diabetes Association. The event was worthwhile, although quite frankly, I found the Scientific Sessions a tad frustrating. Why?

Most notably, I found the amount of research that was simply a repeat of previous research particularly unsettling, especially considering that a number of the previous studies were announced at the 65th Annual Scientific Studies in San Diego only last year. I could understand it if the research was done in some obscure lab abroad and did not make it to prominent medical journals, but I find it troubling that the American Diabetes Association fails to even require a meta analysis of previous research into the topic before giving a venue for this type of wasteful research. Want an example? (I knew you would ask), OK, here:

Abstract Number 278-OR: "Positivity of C-peptide, GADA and IA2 antibodies in Type 1 Diabetic Patients with Extreme Duration" by by Hillary A. Keenan, Alessandro Doria, Lloyd Paul Aiello, George L. King.

Joslin and others were crowing about what a discovery and a breakthrough this research was. My response was "huh?"

At the 2005 ADA Scientific Sessions in San Diego, researchers headed by Dr. Butler from UCLA and some others at the Mayo Clinic in Minnesota also published results from an extract under the title "Evidence for Sustained Islet Turnover in Humans with Long-Standing Type 1 Diabetes" which showed that even patients with long-standing type 1 diabetes (50 years was the longest duration in the test group if I recall correctly) had evidence of beta cell generation, but that the immune system continues to destroy the new cells. Although these results were never published in a medical journal, a small page was published last year on the "Join Lee Now" website.

To be sure, the presentation at the 2005 Scientific Sessions may have been the impetus for Joslin to examine its medalists. Also, the initial study was very small (just 42 patients with diabetes), whereas the subsequent research was done on 326 patients. Also, diabetes duration on the Joslin study was done exclusively on patients with type 1 diabetes duration of 50+ years, whereas the initial study was done on a variety of age groups and diabetes duration. But the latest Joslin study just validates what was already presented last year, and it still raises the question "What part of 'yes' do scientists fail to understand?" (see the Jan. 2, 2006 Washington Post article on this subject here). We see this cycle over and over, but at least some of the major medical journals (the Lancet, for example) now require a meta analysis of research already done on a topic before they will publish the results. Now, if the ADA wants to be recognized for its leadership in scientific research, they must do a better job of the same thing. Anyway, I find it difficult to call the Scientific Sessions the ultimate venue for diabetes research when so much of it was simply more research into topics that have been researched over and over and over. I have been something of a maverick in my calling attention to wasteful diabetes research. Last year, for example, I started a collection of such wasteful research and asked people with diabetes to vote on the "Dumbest Diabetes Research for 2005" on DiabetesTalkFest.com, and I now have other people on the lookout for such wasteful research. I ask why researchers do not spend the time and money on topics that have a relative scarcity of research attention, like, say, psychological damage caused by current diabetes management techniques and unrealistic expectations, or perhaps something like hypoglycemia ... a topic that has seen comparatively little investment in spite of the fact that it is caused by current treatment modalities.

One element I did enjoy was attending the vendor presentations, since the Diabetes Expos sponsored by the ADA seldom provide the same level of coverage or information (I attended one Diabetes Expo, and vowed never to go again). For one thing, the number of free samples at these events is virtually non-existent, and I also found the Expo provided little genuine information for patients to justify the cost of entry. However, the vendor venue at the Scientific Sessions is aimed primarily at health-care providers (doctors, CDEs, etc.), and many of these products will be pitched to doctors, who act as gatekeepers deciding for themselves what products patients should have access to learning about. My suggestion is for anyone interested in seeing what the market has available to skip the for-the-masses Diabetes Expos sponsored by the ADA and instead try to attend the Scientific Sessions. The difference is truly incredible, and you will find people who can actually answer real questions about the products there, and finally, you will get a glimpse of what may soon be on the market in terms of diabetes management.

I have abandoned Lilly insulins (so have many others, based on market share statistics from IMS Health) because United Healthcare has moved Lilly insulins to the bottom tier of its drug formulary and I found that Humalog wasn't even the best physiological fit for me anyway. Regardless, later this year, Lilly will introduce a very cool new insulin pen to be called Lilly HumaPen Memoir. To see the FDA application, just click here for more information. This pen will come to market in the fall, and will include a digital date and time stamp squeezed into a ballpoint pen sized device. While conceptually similar to Novo-Nordisk's Innovo product which contained a limited memory, the Memoir pen looks more similar to the NovoPen/NovoPen Junior in both design and size. The Memoir pen will store information on up to 16 doses, rather than just the last one as the Innovo device does. For the core type 1 market that are sensitive to small changes in dosage, and in spite of the FDA application, Lilly reps told me that the Memoir pen would enable dosages could be fine-tuned in 1/2 unit increments, unlike many of the pen devices which are clearly aimed at the insulin-resistant type 2 market. We'll have to see on that one. Nevertheless, I give the Lilly Memoir product a thumbs-up, although Lilly told me that only Humalog products (not Humulin) would work with this pen device ... probably because these carry higher price tags, which will limit the market potential at least initially. Although I am unlikely to switch from Sanofi-Aventis' Apidra insulin, I still think Lilly's effort resulted in a great product. We need more innovation like that, as type 1 treatment has seen relatively little innovation since the introduction of the first insulin analogs in 1996.

I also got to meet some of the B-D marketing people (as well as Gary Hall, Jr.). I told them how I was disappointed that B-D stopped selling insulin pens about 5 years ago, and told them that their pen designs had some really great innovations that the rest of the market would only adopt several years later (like the ability to reset the dosage if the patient accidentally dialed the wrong dosage), or dosing in 1/2 unit increments. B-D's pens were tough plastic and very lightweight, but to some extent, they were forced out of the pen market by the pharmaceutical companies decision to develop proprietary insulin cartridge design in an effort to control every aspect of patient treatment. B-D still sells a reusable pen system in Europe (see http://www.bd.com/pharmaceuticals/products/BD_reusable_pen.pdf), so perhaps if someone could sell an adjunct of sterile, empty reservoir cartridges for use in their pen device, they might reconsider. Although they did acknowledge my feelings, I told them they could have remained in the market if they simply sold empty cartridges (which would have enabled Symlin users to have a pen the day that product hit the market -- those will be out later this year BTW), they seemed only moderately interested, feeling that the meter market was where they wished to focus the company's resources (though I have heard only lukewarm reviews about B-D's meters, and decided not to try them for myself as a result). I did get to meet Gary Hall at the event, and spoke with him for a few minutes. I didn't have the heart to tell him that I thought the B-D Logic and/or Latitude Diabetes Management Systems are too big, error prone and generally less desirable than similar products from the likes of Johnson & Johnson or Roche. Also, the fact that they partnered exclusively with Medtronic Minimed was a limiting factor in their success, since I had an Animas pump (and Animas' recent acquisition by Johnson & Johnson would put them in cahoots with Lifescan meters), but I can only offer my suggestion, whether they choose to make use of it is their choice.

I also conveyed my thoughts to the folks at Owen-Mumford, who had a pen device which worked with Roche's Disetronic (now known as AccuChek, in what was perhaps the dumbest rebranding effort ever attempted) pump dTron catridges. They explained it was not by design, and that they did not encourage that use, but acknowledged the value in someone providing empty cartridges, especially since the Disetronic pen was removed from the market about 3 years ago, but did not commit to doing anything more than forwarding the idea to headquarters in the UK.

Based on the lukewarm reception my idea had, I am really tempted to develop a product that enables people to fill their own cartridges which work with Novo Nordisk's or Lilly's slick new pen devices (I am using Sanofi Aventis' OptiClik pen system, which I do not have many positive things to say about.) It only works with B-D needles, which is not really a negative except that I have 4 boxes of Novofine pen needles which have been rendered useless. The OptiClik pen is also big and clumsy to carry around, the cartridges are far too big and must be safeguarded because of mechanical necessity, and they cannot be refilled using a vial and syringe. The bottom line is their pen stinks, but I like Apidra insulin better than Novolog, so I'm now stuck with it, unless I develop my own pen/cartridge system. I am seriously considering the idea. The cost for insurance providers could be significantly reduced, since the cheaper vials would be sold with some syringes to fill the empty "reservoirs" or cartridges. If anyone want to go into business with me, e-mail me to discuss!

Anyway, that's about all for today's update. I will try to be more diligent about updating my blog going forward.

Regards.

6 comments:

BetterCell said...

Welcome back Scott and thanks for all the current information, The photo of the "new"(HumaPen Memoir) Lilly Pen looks great and is something I might be interested in, since I am still pen-injecting myself. I totally agree with you about the bulky/ugly design on the Sanofi- Aventis Pen for Lantus. Do you find any diffrenece in now using Sanofi- Aventis Aphidra insulin compared to what you were injecting before(Novolog) regarding bs levels and hypoglycemia?

Scott said...

Having tried all 3 rapid-acting insulin analogs, my assessment is as follows: (1) Humalog (insulin lispro by Lilly) was the fastest acting, but also has the shortest length of duration. After 2 hours, Humalog did not work at all for me. Unfortunately, I seldom even finish digesting my meal completely at 2 hours, so it was not a great physiological match. (2) Novolog (insulin aspart by Novo Nordisk) is the slowest -- and I do mean SLOW -- I would inject and not see any reduction in blood glucose levels for at least 3 hours (and sometimes it would even rise), but Novolog also continued working for at least another 4 hours. If I wanted an insulin to behave that way, I could just as easily have used regular for half the price. (3) Apidra (insulin glulisine) seems to fall in between Humalog and Novolog both in terms of speed, and length of activity.

Apidra is not perfect, but it is better for me than the other two were. I find that I do not go low before I've even digested my meal, nor does my blood glucose level rise after the insulin has finished working, so it seems to be a better fit -- for me. Finally, since Oxford/United Health Care considers Sanofi Aventis (and Novo Nordisk) insulins "tier 1" drugs, the co-pays are cheaper than the co-pays for Lilly insulin, at least in my health plan.

I do find that the better fit has resulted in fewer hypos unless I misjudge the carb content of a meal or something, but thats not due to the insulin working out-of-sync with my digestion, which was a regular problem with the others. Finally, Apidra has undergone clinical studies that show that it actually CAN be dosed after eating, something that neither Humalog or Novolog can claim.

Bernard said...

Scott

Thanks for the interesting summary of what went on.

Before I went on the pump I was an avid pen user. In fact I just recently threw out some old pens from Novo. Beautifully engineered, rock solid, able to dispense in 1-unit increments and able to reset. I loved these.

I'd never even considered the ability to use them for Symlin, that's a great idea. I'd be most interested in that.

Davor said...

Hi,
I just tested new Pen Memoir in an IDF Conference in Capetown - it was great! They didn't have it officially, but some Lilly lady had her private (thanks). It is really cool and must have thing. My phtoto of it is available on http://www.zadi.hr/diabetes/displayimage.php?album=20&pos=15

Scott said...

Thanks for the comment! Lilly's new pen is indeed very cool. The website I have listed is Lilly's site in Finland (a country I've had the pleasure of visiting a half dozen times!), where apparently, the Memoir pen is already available. In recent years, the manufacturers have moved from universal pen designs which are interchangable with insulins from all manufacturers to proprietary designs compatible only with their own insulins, or as their FDA application states "intended for use with Eli Lilly & Company Humalog and Humulin 3.0 mL cartridges," which is really not patient-centric but understandable from a business standpoint.

Still, I see a business opportunity for some enterprising person to sell sterile, empty cartridges. Want to go into business with me ... LOL!

Davor said...

Yea you are right about patient-centric and business point. But I think that even in the past you couldn't mix pens from one insulin maker with the another. Only, for example here in Croatia we had only Novonordisk insulin producer.

These sterile, empty cartrages could be problematic from legal/patent point of view, but I think that there is lot's of money in that :)

Are you saying that if I fly to Helsinki (not to far from Croatia) I can go in a pharmacy and buy this peace of art (memoir)??

I am asking because I changed from Humalog to Novorapid only because of Innovo. Actually I believe that Humalog is much stronger and faster than Novorapid. my email: ds@comping.hr (please erase it when you get it)