Close Concerns Weblog

Sanofi-Aventis Company meeting - de-emphasizing Exubera, highlighting Acomplia - unsurprisingly!

News flash on Sanofi-Aventis! The company hosted a meeting in Paris earlier today at the excellent George V (we love the bar here) and Erin Kane was present to document key diabetes items. About 150 investors and analysts were present and the mood was positive, reflecting the reported 26% increase adjusted earnings per share in the first half. An update on key items of note:

1. Inhaled insulin: In the presentation, the company said virtually nothing (commentary in and of itself) except it noted the upcoming September 8 advisory meeting and said there would be news in the near future – we’re already looking forward to that meeting as we think it’ll give us some great clues directionally as to where and how the FDA is headed. We think the Agency will pay more attention than ever to what the advisory panel says, particularly in this Vioxx vortex era. While we personally wouldn’t take inhaled insulin (why!?) until we saw 20-year data, we do think inhaled insulin has conceivably great (and at the very least, some) potential to increase compliance, which matters tremendously and even more importantly, given the very poor outcomes (only about one third of type 2 patients with diabetes are at goal, 7% or less – and even that goal has some downward pressure in our view, meaning that an even lower percentage of patients are really where they should be in terms of glycemic control).

When directly questioned on the collaborative relationship with Pfizer, however, and on Sanofi’s dedication to commercializing the product should it be approved, CEO Jean-Francois Dehecq and VP of Pharmaceutical Operations Hanspeter Spek hedged, stating that they were “trying to be as neutral as possible” and that they “couldn’t really say anything else.” Interesting – remember a few months ago when questioned, S-A characterized inhaled insulin as charming at first glance! (We have tried often to work that into our vocabulary – doesn’t it speak volumes!)

Of course, they did say a bit else, characterizing inhaled insulin as a “very interesting product’ (they can say that again) and noting that patients would welcome an alternative to injections but that future devices will have to be more simple and portable. This couldn’t be more apt, especially coming from the makers of Lantus, the blockbuster long-acting insulin analog that we feel owes its incredible success - over $1.0 billion in global sales in 2004, just its third full year on the market. Management also stated that while the partnership could be mutually beneficial, Pfizer might consider itself to be ‘so big, and so strong, that they can take the product themselves.’ Interesting! Overall, the half-hearted concessions to the utility of the product paled in comparison to the critiques and tone toward the Pfizer relationship, and we will be interested to watch the inhaled insulin drama continue to unfold.

We are still trying to figure out the managed care equation, ourselves. Our bet is that if approved, the label will be narrow – no type 1s, no people who are already on insulin and enduring it, but really more type 2s who obviously need to be on some more aggressive therapy but aren’t, ostensibly due to fear. We don’t even know whether we really buy the fear story, but then again, we don’t really have to – all we have to do is look at the $92 billion in direct costs spent every year and see that the bulk is from patients with diabetes who are out of control and racking up large complications costs. This isn’t a huge percentage of patients, but the costs for these patients are enormous because they didn’t learn early the importance of control and because they aren’t properly engaged. We think now there are so many type 2s out of control that it doesn’t matter anymore if they won’t belong to a certain insurance plan for long – insurers must start to get at some point that even if their type 2 patient leave, they are going to get someone else’s in equally bad control! That said, we also point out the “they’re-only-in-my-plan-for-three-years-anyway-who-cares” argument is a bit of a myth – diabetes patients who receive good coverage tend to remain in good plans longer than average because good plans for such patients are so hard to find.

2. Rimonabant: Sanofi was much more eager to discuss this product, and management expressed significant confidence that it will land on their list of flagship products and that the company was on schedule with pre-marketing activity. Sanofi implied that the drug was particularly attractive to payors, especially U.S. payors, as they are seeing a lot of tier 2 access overall for their drugs. Interestingly, Spek alluded to the August 25 joint announcement of the EASD and ADA disputing “metabolic syndrome” as a legitimate diagnosis – we’ll be writing about this in our next issue of DCU – very interesting to see this pronouncement. Rimonabant’s potential as a powerful treatment for metabolic syndrome was featured prominently by the company in studies and published literature. Spek was dismissive of the controversy over the metabolic syndrome diagnosis, calling it “an academic debate” that was “interesting but not vital” (they are so good as being dismissive – doesn’t that have the same ring of “charming at first glance”?) to the future of the product. Certainly, it is true that the five studies currently underway are investigating an extremely wide range of possible applications for rimonabant, including weight loss/obesity treatment, smoking cessation, and use in patients with Type 2 diabetes, cardiovascular disease, or dyslipidemia. We expect to see Sanofi-Aventis continue to shift focus from metabolic syndrome to cardiovascular disease in future presentations and rimonabant studies. Indeed, we point out the controversy over “metabolic syndrome” isn’t a question of whether or not these patients have problems—they certainly do—but whether there is any clinical significance to a clustering of CVD risk factors, insulin resistance, etc., that would require a separate diagnosis.

In response to a question about combination agents, Sanofi stated that they preferred to develop Acomplia as a single therapy, but confirmed that, in theory, Acomplia could be marketed in a combination therapy with a product that acts on nicotine receptors. We can think of many other potential types of combination therapy for Acomplia and we guess it wasn’t stressed since that’s not the point of the NDA at present.

3. Lantus/Apidra: Little was said about Sanofi’s basal insulin or the impact that the marketing Novo Nordisk’s Levemir, with its lower variability (and weight gain) status, might have on Sanofi’s Lantus sales. Lantus was discussed in conjunction with Sanofi’s increasing U.S. tier 2 access, as Lantus tier 2 access rose to 84% in June of 2005 from 79% six months earlier. Sanofi attributed this stellar U.S. market performance—growth rate two times the overall market rate—in part to this increased presence in managed care and alluded to preparation for the Medicare Modernization Act. With extended drug coverage, Sanofi hopes for acceleration in the U.S. insulin market in 2006. Sanofi also reported Lantus sales at a whopping 52% increase from last year’s first half, comprising 20% of the worldwide market share. 20% in fewer than five years – that is really something. We’ve been waiting, of course, for the Apidra (rapid acting insulin recently approved) pen and to see what happens with marketing – will it turn automatically? Will rapid acting continue to be ignored?

4. Amaryl: Likewise, Amaryl was not a point of focus during the meeting, except that it was noted that its U.S. patent expires in the second half of this year. Sanofi-Aventis is looking into launching its own generic. One thing we would point out – Sanofi had previously sold Lantus (unofficially of course) with the slogan “one shot a day, one pill a day …” – we’re very curious to see how this changes over time as basal bolus is pushed more aggressively.

F is for fat

So check out the new blog about FAT in America! Who did this, anyway, we’re being asked, given the headlines about the report. Trust for America’s Health (www.healthyamericans.org) is a non-profit organization whose stated mission is saving lives by protecting the health of every community and working to make disease prevention a national priority. The organization’s 2005 report "F as in Fat: How Obesity Policies Are Failing in America" is an in-depth compilation of state and national policies and legislation intended to curb obesity and help Americans live healthier lives. The report is divided into six sections that review statistics related to obesity and its complications and the state, federal, health insurance and private sector initiatives to combat obesity. The final section contains TFAH recommendations to policymakers for reducing obesity in America.

TFAH believes that government must intervene in people’s diets and physical activity levels for any progress to be made against curbing America’s obesity epidemic. The sad implication is that America’s shifts towards obesity in culture, public policy and infrastructure have grown so large that personal choice is rendered ineffective against them. TFAH stresses the importance of individual behavior but claims that the epidemic itself is growing also because of ineffective government strategy-and that the U.S. government can instead shift Americans towards a healthier society.

Obesity in America is rapidly changing America’s entire current health profile. 64.5% of Americans are considered “overweight,” with 24.5% percent of the American population falling into the category of “obese.” Pathetic! As we know from NIH and CDC work, being overweight increases people’s risks of developing over 35 major diseases ranging from Type 2 diabetes, heart disease, and sleep apnea to osteoarthritis and gall bladder disease. The total cost of obesity is estimated at over $117 billion dollars annually in medical costs and lost productivity.

The price of obesity is obviously high. That does not seem to be slowing the incidence of obesity, however. In 2004, obesity levels rose in every US state except in Oregon, where the obesity level remained the same. Over 52% of adults in every state are considered overweight or obese. Incidence of obesity is increasing most rapidly in children though, with the obesity rate in children doubling between 1980 and 2002.

Notable is that the report contained a much larger proportion of pictures of obese children rather than obese adults - intervention should certainly be starting at an early age. School policies targeting obesity comprise a large part of this report, with physical education programs and school lunches under great scrutiny. The emphasis was placed primarily on “competitive foods,” foods sold through vending machines, a la carte menus in cafeteria and school stores. Only eleven states have nutritional standards for competitive foods - again, pathetic! A table outlining the restrictions set by each of the eleven states is included in the report, along with physical education laws for the 50 states. It was encouraging to read that four states have passed legislation requiring students’ body mass indexes to be measured and two states have even enacted legislation requiring non-invasive diabetes screenings for all students although we know there is already grumbling about this due to privacy – again, pathetic in our view.

The section on state policies and actions was arguably the most interesting of the entire report because therein lies the fiercest debate over whether obesity is primarily a consequence of personal choice or government and private practices. Snack taxes on unhealthy snack foods and laws limiting liability for obesity were pinpointed in this debate. 20 states have now passed “limited” liability laws that prevent individuals from suing companies that may have contributed to their obesity. This is particularly controversial and one might be left asking how much companies can choose to disclose about their products in those cases.

Federal initiatives are using a multifaceted approach to reduce obesity. The Center for Disease Control has been the nation’s leader in obesity initiatives, with five programs targeting all aspects of obesity and demographics affected by obesity. The FDA has started labeling foods with more nutrition facts and the NIH has embarked upon a new obesity research program that studies lifestyle, medical approaches, and biological markers of obesity and health disparities between racial and ethnic groups. The private sector has also jumped on the bandwagon, with Nike starting a new fitness program and Stonyfield Farms opening vending machines with healthy foods on school campuses.

TFAH issues “Five Major Research Questions” to the research community.
1) How does obesity relate to people’s health?
2) What is success: can people be “fit and fat?”
3) What are the relationships between socio-economic and cultural issues and
obesity?
4) What are the economic costs of obesity and the benefits of possible policy
Actions?
5) Who is responsible for obesity reduction?

These questions are aimed to provide the information that would allow formulation of better policy relating to obesity. It is difficult to imagine that much headway will be made unless policymakers at all levels acknowledge the gravity of the situation. President Bush recently cut funding for two of the CDC’s new programs and only slightly increased funding for two of the programs by less than 1% each. Our hope is that America collectively realizes that through working in an organized and focused manner, this country can realize a healthier future for its individuals – while this is incredibly challenging, we’re coming from such a low base that it shouldn’t be hard to make some very constructive progress.

Amylin - very strong LAR results bode well...

Sometimes results come out and they aren't so great - other times, they are quite good. Sometimes, they are just incredible, but that's pretty rare. Yesterday was such a day. Amylin announced stellar LAR results for a small trial of 45 patients - there were two doses given of LAR and one placebo group. In the group receiving the high LAR dose, A1C went down two percent on average - astonishing, particularly given the baseline A1C of 8.5 percent - this is very low.

Significantly, these results were considered progressive, "with no evidence of a plateau after 15 weeks." 86% of the participants reached an A1C of under 7% compared to zero percent on placebo. Unheard of!

Patients receiving the high dose must not be able to believe how great this is. Very interestingly, half of the participants saw a reduction in fasting blood glucose of 50 mg/dL - this is meaningful, particularly since Byetta, great as it is, hasn't been prompting such reductions in fasting blood glucose. It may be that this is what is contributing to the better A1C drop, compared to the average drop seen for Byetta (which itself was very good, about 1 point on average). Both, obviously, are working on post-prandial levels, as well as insulin sensitivity, gastric emptying, and weight loss. WEIGHT LOSS! This is unheard of in diabetes drugs.

In the trial results announced, patients receiving the higher dose of LAR lost 9 pounds on average. Could this be any better? Three of the 14 patients experienced mild nausea in the treated group, compared to one in the placebo group. There were no severe hypos.

What an excellent day for patients. Obviously the FDA's job is safety first and last - but based on the efficacy results announced yesterday, we very much hope it can push forward its examination of LAR - patients certainly need the best meds possible and the implications on the compliance front, typically a problem with many type 2 patients, bodes very well for LAR.

For two reasons, we believe these results are a net negative for DPP-IVs and for inhaled insulin. First, we think many patients will prefer one shot a week to seven or fourteen pills. Second, we think HCPs and payors will definitely prefer it - a "Sunday night shot" in our view has much more likelihood of taking place than one or two pills a day - and since these groups care so much (appropriately) about commpliance, this may just be the way to go. Last, if weight loss is an issue (it will be for 90% of type 2s failing current therapy), Amylin will win.

We note of course, these are early results, etc. etc. If the early results are borne out, we think it is ridiculous that analysts are arguing over whether LAR is a $1.25 billion or $1.75 billion or (gasp!) $2.0 billion opportunity. It is far, far larger.

Onward!

AADE - day four - lots of enthusiasm on final day

The final day of AADE had some terrific sessions and learnings - what struck us most was how engaged educators were until the final minutes. They were in the exhibition at the very end and final sessions, especially on Byetta dynamics, were extremely well attended. A few words on exhibits ...

At the AstraZeneca booth, a fitness instructor gave demonstrations of how to use the big yellow exercise ball that AZ gave away to all who observed a complete demonstration of the ball. AZ had the same exercise/education booth at ADA. When we asked about the progress of tesaglitazar, AZ’s dual-PPAR agonist in development, there was no news to report of note. We'll be watching for posters at EASD.

The Pargluva booth looked great but offered no information that we didn’t see at ADA. We're looking forward to the FDA panel right before EASD on September 8.

GlycoMark, the new laboratory test for postprandial hyperglycemia (regardless of A1C) appears to be gaining some strength: the US-based distributor for the Japanese company that developed it was on-hand at the booth along with two Japanese representatives. The American distributor is based in North Carolina and has enlisted Dr. John Buse to work with him on some studies regarding the test. We perceive this as a potential vote of real confidence in GlycoMark. We hope that Dr. Irl Hirsch will pronounce on GlycoMark’s utility at some point in the near future – at ADA he said he was “intrigued” by the idea. If GlycoMark achieves routine use, the impact on Symlin prescriptions could be significant, that is, if abnormal postprandial hyperglycemia can be detected as a trend in people who appear to have good control otherwise, perhaps more patients will pursue Symlin.

The Insulet OmniPod booth was packed throughout AADE. Reps wearing demo pods plus a real-life type 1 diabetic Insulet employee wearing a fully operational OmniPod drew large crowds consistently. We think the novelty value of OmniPod rather than preexisting conviction regarding its utility drew most of the foot traffic, but an audience is an audience and OmniPod certainly has the attention of one of the most influential audiences in the world of diabetes care, namely, diabetes educators. Management shared with us that, to share the excitement of AADE with the employees hard at work in the company’s Bedford, Massachusetts, base, a webcam affixed to the top of the booth was transmitting images of the gathered throng to monitors in the Insulet Corp. offices. Talk about a morale boost.

AADE, day three: more excellent learning

We had another terrific day at AADE today - spent significant time walking around the booths and talking to CDEs. A few quick exhibit notes

BD – BD Diabetes appears to be doing extremely well - as we expected would happen (see April DCU, #46), supplying the pen needles for Byetta is a major positive! BD pen needles are being supplied with the Lantus OptiClik injection pen and will also be supplied as we understand it with the Apidra pen when that insulin is launched. Logic is also getting stronger.

Amylin - Interest in Byetta is very high and CDEs still appear very keen to learn, even on the third day, judging from busy booth traffic.

Lifescan – We heard some very interesting CDE answers to the question “What can be done about the diabetes epidemic?” just as at ADA. We got a free DVD training video that we look forward to checking out on the plane back to SF and a hardcover copy of Fran Kaufman’s Diabesity! Way to go LifeScan for giving out such an edifying booth favor. We are big fans of Diabesity and we hope everyone who got a copy reads it and passes it on to at least three friends and colleages. See our review of Diabesity on the website under newsletters and reports and reviews.

Novo – There is nothing new in liraglutide-land. Levemir will be in pharmacies “soon” - excellent!

Sanofi-Aventis – the rep we spoke with is very proud that Lantus is the “gold standard” against which insulin pump therapy is being compared. We are glad too since NPH studies are never comparable to real life. We personally believe that pump therapy is better (for anyone who is responsible enough to use a pump) than Lantus for most because the quality of A1C is better according to HCPs who see the detailed data. Unfortunately this doesn't always come out in the results - the power of better physiology is enormous, but it isn't always reported or even measured. As we start to see more outcomes in the form of "% in target zone" vs just A1C, this will be terrific. A1C is part but not all of the answer and too often is a shortcut. The Apidra launch in February 2006 is no longer unofficial! We hope to try it out once we can find some - we weren't lucky enough to be early samplers.

Takeda – PROactive results will be September 12 at EASD and we'll report on the blog what we hear. We certainly expect a positive study, at this stage. We think the power of earlier, more aggressive therapy and combination therapy and polypharmacy will become an order of magnitude greater as important trials unfold over the next years - PROactive, ACCORD, and others.

GSK – The real point may be not whether a TZD can raise lipid levels in the short term, but whether it offers improved outcomes on a long-term basis.

On the session front, we attended an intriguing session on telephone-based care - this really reinforced to us the importance of gaining reimbursement for e-mail and phone for endos and CDEs. We can't believe this isn't already in place ~ more to follow on this. Dr. Kaufman and her book Diabesity is seen everywhere - she was at the dLife booth, at J&J, and in session, as noted - contributing much, as usual, to AADE.

Breakout Session: Current Research and Management of Children with Type 2 Diabetes
Francine R. Kaufman, MD
Paula Jameson, MSN, ARNP, CDE
Interest rating: Extremely High

This session was nearly SRO. In an intriguing presentation, Dr. Kaufman described the pathophysiology of diabetes in children and explained the factors that lead to insulin resistance and beta cell defect in youth. Puberty is associated with increased insulin resistance, and Kaufman aptly said, “If you live with pubertal children in your home, you know that they are resistant to everything. Including insulin.” The decline in beta cell function occurs more rapidly in children than in adults. Kaufman also pointed out the characteristics of youth upon diagnosis with type 2 diabetes and discussed the long term outcome of the disease. Based on retrospective data, 36% of Japanese school children with type 2 diabetes had incipient retinopathy at diagnosis. 44% of patients diagnosed under 30 years of age had nephropathy 25 years later. This means that nearly half of 12 year old children diagnosed with type 2 diabetes would have nephropathy by the age of 37. If this doesn’t startle you, among Canadians with a mean age of 23 years and a nine year duration of diabetes, 45% had hypertension requiring treatment and 6% required dialysis – by their early 20s. Quite sobering.

Paula Jameson, from Nemours Children’s Clinic in Orlando, spoke on teaching youth with type 2 diabetes about diabetes, lifestyle management, blood glucose monitoring, medicine, and control vs. complications. She presented several innovative ideas, such as teaching in non-traditional settings like bowling alleys and grocery stores. She also discussed options such as camp for children with diabetes, “dLife” for teens, and Weight-Watchers for kids.

“Getting Paid to Answer the Questions – Making the Business”
Joan K. Bardsley, MBA, BSN, CDE
Linda Haas, Phc, RN, CDE
Linda M. Siminerio, PhD, RN, CDE
CDE interest level: Medium

This breakout session focused on both traditional and non-traditional aspects of the business of diabetes care. Coding, billing, and maintaining records ensure reimbursement are counted as “traditional” aspects of making the business; Joan K. Bardsley’s presentation on “The CDE as Study Coordinator” provided a fascinating overview of the non-traditional role that diabetes educators can play in clinical trials. Ms. Bardsley is on the staff of MedStar Research Institute in Hyattsville, MD, and has a long history of clinical trials work, ranging from the Diabetes Prevention Program to trials of HOE 901, now known as Lantus (glargine). From recruiting patients to assessing protocols, diabetes educators can use their position on the front lines of diabetes management both to increase scientific knowledge and improve their patients’ health, while bolstering their individual and collective professional reputations. Diabetes educators are getting more and more attention from drug and device company reps on the sales end of the product pipeline; we think that patients, CDEs, and industry could benefit from more CDE involvement during Phases II and III as well. This was a terrific session since we know more involvement is needed from CDEs - this is less likely to happen if reimbursement isn't favorable (extensive help is needed here!) and if overall compensation isn't lifted so we hope to see continued changes here.

“Designing and Implementing an Education Program for Today’s ‘Smart’ Pumps
Allison K. Wick, MSN, ARNP-BC, CDE
Jane L. Sparrow-Bodenmiller, RN, CDE
CDE interest level: High

This session was held in far too small a room to accommodate the number of interested CDEs (and press!) but fortunately more than enough photocopies of the slides were available. The session consisted primarily of advice on pedagogy and how to introduce topics relevant to insulin pump therapy in the most effective sequential order possible for different patients. Age, education level, lifestyle, and motivation must all be taken into account when determining a training program. While it is important to individualize education according to patients’ needs and personal situations, having a structure for group education and a basic framework from which to create personalized education programs is vital to patient and healthcare provider satisfaction with pump therapy. Though pump companies’ training materials for CDEs to use with patients are appreciated, educators must still customize pump education for each patient in order to ensure comprehension and compliance. As patients become familiar with the basic operation of the pump, techniques and strategies for getting the most out of the therapy, including extended boluses and temporary basal rates, should be introduced. Based on the perspectives shared by Ms. Wick and Ms. Sparrow-Bodenmiller, perhaps company-produced training materials should include suggested curricula for group pump classes as well as one-on-one meetings.

Breakout Session F7: The Hidden Language of Education: Nonverbal Communication in Clinical Encounters
Cecile Carson, MD
Interest Level: High

So great is the power of words that it is easy to forget the power of our gestures and expressions. Only 20% of human communication is verbal, however! Cecile A. Carson examined the nonverbal communication in clinical interactions that often affect the patients’ progress and satisfaction. She extensively discussed the four types of nonverbal communication which include kinesics, proxemics, paralanguage and autonomic responses and advised the audience on how to read body language and respond appropriately. Carson’s goal for her audience is to move her patients from a “fight or flight” to “safety,” in which the patient’s body is relaxed enough for the patient to convey information and develop a rapport with their health care provider. She outlined three necessary skills for moving patients to safety; developing nonverbal rapport, addressing mixed messages and shaping space. Using these tactics will facilitate better communication between the patient and health care provider, leading to increased quality of care in the present and future.

Breakout Session F22: Diabetes Camp Education Programs: 1995, 2005, 2015
Dennis Pillion, PhD
Interest Level: High

In 1975, the goal of diabetes camp organizer Dennis Pillion was to keep the enrollment of 25 children in his diabetes camp at 25. In 2005, not only do diabetes camps provide injections of long-acting insulin and HbA1c tests for all campers but they also form the basis for valuable social and psychological bonding networks for children with type 1 and type 2 diabetes. The rapid advances in diabetes care and management ensure that our current diabetes camps will be obsolete within the next ten years. CDE’s were asked to offer their input for developing camps to cater to the needs of children with type 2 diabetes. CDE’s predicted a large presence of “smart pumps” and continuous blood glucose monitoring at camps in 2015-and increased numbers of children with type 2 diabetes and impaired glucose tolerance. The general consensus was while camps must educate children about maintaining proper care of their diabetes and weight, children must have fun too! The final goal was to create an atmosphere of encouragement for healthy habits and bonding with other children for motivation and support. Despite Dr. Pillion’s quip “that everything we say will probably be outdated in 5 years anyway,” it is very difficult to render those goals obsolete. We know from personal experience the power of diabetes camp for children - quite amazing! This history was wonderful to witness and a strong reminder of how many amazing people are involved in diabetes.

AADE, day two: Insulet, Animas Micropump Prototype, Guardian RT and presentations of note!

Day Two - Insulet and Sessions of Note

So Insulet launched today at AADE - it's a terrific introduction for the industry, for HCPs, for patients, and for payors. We believe Insulet will expand the market for pumps and enable an outstanding option for HCPs, and that ultimately, a significantly broader lineup of patients will try the technology. Oh, and payors will see improved cash flow even as more patients move to pump therapy. This is a hard market to get right and the difficulty can't be underestimated but ... the company did steal the show today! Significant industry innovation can never be a negative for patients - by contrast, an excellent time for patients, all around. We don't see the main question as one related to share as much as one related to the size of the market - growth just got a big hit! We're off to make some revisions to our pump model market growth assumptions for 2006 ... onward and upward!

For the first time at a meeting, Animas showed prototypes of its micropump incorporating technology acquired and developed in the past year or so. We were impressed with the description of the inner workings of the pump, a beautifully simple design. We’re impressed that CDEs are being shown prototypes of products that may not be available for a few years to come – this says a lot about the significance of this audience to the diabetes care device manufacturing community.

Nipro’s booth for the newly re-launched Amigo pump was empty most of the day. ‘Nuf said.

At Medtronic, we got to handle the sensor and the display unit for the newly approved Guardian RT. We think it would be pretty easy to wear, though the display unit has a thicker housing than we might have hoped it would have for discreet wear.

Cleo samples at the Cozmo booth! Smiths Medical has gone through with the Cleo launch as planned and they’re polling booth visitors for their opinions of possible new colors for the Cozmo. We liked the spring green option.

SESSIONS OF NOTE!

Breakout session: Diagnosis and Management of Diabetic Autonomic Neuropathy
Aaron I. Vinik, PhD, MD
Interest rating: High

Dr. Vinik, from Eastern Virginia Medical School, spoke on diabetic autonomic neuropathy (DAN), which is a common diabetes complication of diabetes with a huge effect on quality of life and activities of daily living. As DAN affects all systems of the body (including the heart, GI track, the eye, and erectile dysfunction), Dr. Vinik teaches his medical students: “Know autonomic neuropathy and you will know the whole of medicine.” We were shocked to find out from Dr. Vinik that only 25% to 50% of people with symptomatic AN survive five to ten years. Dr. Vinik reported the risk factors of DAN: hypertension, raised LDL, reduced HDL, and female sex. Clearly, people with DAN are also at high risk of having a heart attack. In fact, people with autonomic neuropathy are two to three times more likely to have a silent heart attack than people without the disease.

Breakout Session: Diabetes for Life: Insulin Therapy Education for Hospital Nurses
Michelle F. Magee, MD, CDE
Sharon L. Heimiller, BSN, RN, CDE
Interest rating: Medium

Dr. Michelle Magee from the MedStar Diabetes & Research Institute spoke on the Inpatient Diabetes & Metabolic Control Position Statement 2003. Sponsored by AACE, ADA, and hospital specialist associations, this publication was intended to define goals for metabolic control in the hospital setting. The glycemic target set for ICUs were 80- 110 mg/dL hospital, while the targets for other hospital quarters were 110 mg/dL preprandial and 180 mg/dL postprandial. According to Dr. Magee (and the ADA), the key to developing and implementing a program for metabolic control in hospital patients is using a multidisciplinary approach. She also stressed the need to educate patients with diabetes rather then sending them off from the hospital without much of a clue about how to maintain glycemic control. Patients should be given medical nutrition therapy and a plan to return to their physician after discharge.

Breakout Session: Painting a Landscape for Prevention
Frank Vinicor, MD, MPH
Interest rating: high (humor rating: very high)

Frank Vinicor, Director of the CDC’s Diabetes Program, had the audience roaring with laughter throughout his cleverly titled presentation, “Painting a Landscape for Prevention.” Dr. Vinicor first commented on the state of diabetes: “It’s bad; it’s been getting bad, and it’s going to get worse.” By 2025, the five countries predicted to have the highest number of people with diabetes are India (70 million), China, USA (25-28 million), Pakistan, and Indonesia, in descending order. One out of three people born in the year 2000 is predicted to develop diabetes. On a positive note, Dr. Vinicor presented soon-to-be-released (in-press) data (Saaddine, et al.), which showed that we are doing better on the diabetes front than we were five years ago. In the U.S., the percentage of people with an A1C over 9% has dropped. The percentage of people with an A1C between 6 and 7% has increased. Hurrah!

Placing a painting of Raphael and Jackson Pollock along side each other to emphasize change in the world, Dr. Vinicor mentioned his own personal changes from 1975 to 2000. Then he wanted long hair; now he is longing for hair. Then he wanted a KEG; now he wants an EKG. Then he was growing pot; now he is growing a pot belly. More importantly, diabetes, its treatment tools, and the environment have all changed over the years.

Instead of aiming for people to live longer with diabetes, Dr. Vinicor emphasized that our goal should be to increase the quality of life by delaying the onset of morbidity and diminishing its extent. Dr. Vinicor stressed the importance of the primary prevention movement and pointed out some challenges to the movement. Health care professionals are urged to become more efficient and spend less time with patients, such that there is hardly enough time to treat existing problems, let alone prevent new ones. (As an example of pressure to become efficient, Dr. Vinicor showed a picture of his office with a toilet seat in place of his office chair. The audience became hysterical.) Dr. Vinicor insisted that our definition of treatment impact needs to be modified. Instead of focusing singly on the efficacy of a treatment program, we need to consider how many people can be exposed to the program. A good program given to many is better than the best program given to a few. Patients must take responsibility for their diabetes management and expand their sense of empowerment.

Gary Scheiner, MS, CDE
“Setting and Fine-tuning Basal Rates in Pump Users”
Interest level: High

This session was very well attended, nearly packed. Gary Scheiner thoroughly described the principles of basal insulin and offered several case studies to illustrate the importance of correctly set basal rates. Using his own clinical experience as well as his personal experience, Mr. Scheiner advocated using a patient’s total daily dose on injected insulin as a basis for setting basal rates, but cautioned that if the patient’s control is not good on injections, setting the pump basals according to that information could be risky. Mr. Scheiner discussed in detail the protocols for basal rate testing, emphasizing the necessity of testing basal rate settings when diabetes control becomes difficult or blood sugar patterns change dramatically.

We find this focus on pump education very important in light of how common but still uncommon insulin pump therapy is today. With “smarter” insulin pumps that allow smaller basal rate increments and more flexibility in basal rate profiles throughout the week, healthcare providers and patients have increased opportunities to control diabetes and more choices to make with insulin pump therapy.

Anne Peters, MD
“Conquering Unique Challenges in Diabetes Management”
Interest level: Medium

Dr. Peters shared the stories of several of her very active, athletically ambitious patients, including Gary Hall, Jr., the Olympic swimmer and several-time medalist. She focused on the need for healthcare professionals to consider the specific details of a patient’s sport and his or her lifestyle. Dr. Peters herself studied swimming in terms of exercise physiology soon after taking on Gary Hall, Jr., as a patient. She wanted to understand how the exercise and training would affect her patient’s blood sugars, and also what kinds of foods are the best fuel for a swimmer. Dr. Peters has learned to see food as not only something that must be balanced in combination with insulin, hormones, and stress, but as fuel for intense physical activity. Dr. Peters also elucidated the psychosocial aspects of a healthcare provider’s relationship with an athletic diabetes patient. Healthcare professionals have a huge role in patients’ confidence in living with diabetes: whether they believe it is possible for their patients to run marathons, win Olympic medals, or even play tennis several times per week, their support is crucial to their patients’ well-being. We like Dr. Peters’ approach. If we were ever planning to participate in elite athletic competitions, we would call her.

Merging Worlds: A Culturally-Competent Program for The Latino Population
Kirsten C. Ward, MS, RCEP, CDE
CDE Interest Level: Medium

The presentation focused on cultural competency in treating patients of all minority backgrounds, with a minor emphasis on the Latino population. With Latinos emerging as the fastest-growing ethnic population in the United States, better understanding of their physiological risk factors and treatment concerns is crucial.
A particularly striking statistic offered was that Latino children born today have a 50% chance of developing diabetes in their lifetime. Compare that to the expected diabetes incidence of roughly 33% for Caucasian children born today. Spanish terms such as personalismo, or “personal friendliness” and fatalismo (“fatalism”) were used to explain the nuances of Latino feelings towards diabetes and their diabetes educators. Many of Ward’s Latino patients confessed to not taking their insulin because it is commonly believed in many Latino communities that insulin causes blindness. Suggestions for crossing cultural and language barriers with minority patients were to use pictorial health care guides and engaging the interpreter in a dialogue with both the patient and educator at once.

Polypharmacy for Hypertension and Lipid Control: Why So Many Drugs?
Curtis D. Triplitt, PharmD, BCPS, CDE
CDE Interest Level: High

Triplitt provided a comprehensive outline for reaching ideal HDL, LDL: and blood pressure in his presentation. He admitted that there is very little clinical evidence to use in support of prescribing multiple medications for lipids but he used studies such as the UKPDS to show how multiple medications have worked more effectively than single-medications for hypertension.
Patients with diabetes showed better results on hypertension medications than did patients without diabetes.

Use of both behavior intervention and pharmacologic treatment was advocated for hypertension in patients with diabetes unless they display no risk factors other than diabetes. The combination has proven to be useful in decreasing risks of macrovascular and microvascular disease. Each increase of 10 mmHg increases risk of macrovascular or microvascular disease by 12-19%! The current goal of therapy hypertension as settled upon by the ADA and Joint National Committee for the Treatment of Hypertension is <130/80. PPAR agonists improve blood glucose control and may have effects on triglycerides that mimic those of statins.

AADE, day one: Medtronic Guardian RT approval and symposia of note!

Greetings!

-- Our team of four is at the AADE and working hard - there are well over 7000 people here in DC, with 4000 educators alone - up from 2800 last year in Indianapolis.
-- The interest is up significantly, largely, we think, due to new products on the market and new ones coming - the exhibits open tomorrow and we have posted our schedule on our site.
-- Devices are prompting significant buzz this year - we hear a lot about Insulet and think it has the potential to expand the market significantly if the device is small and hassle free - payors will certainly love it, that's for sure. Stay tuned for our take. Medtronic announced today the approval of the Guardian RT - this is the continuous glucose sensor without the pump - they have working on the combined product. Biggest quesitons to us are will this actually be launched (Guardian itself hasn't really been) and will they keep products separate, i.e., will they sell sensors alone (Guardian RT's) once their is a combined product. If not, this will limit patient choice.
-- More on that to follow, but in the meantime, here's our take on symposia of note!

Corporate Symposium: Incretin-based Therapies: Achieving Better Glycemic Control in Type 2 Diabetes (Amylin-Lilly Alliance)
John Buse, MD, PhD, FACE
Daniel J. Drucker, MD
Linda Siminerio, PhD, RN, CDE
Interest rating: High

According to Dr. John Buse, from the University of North Carolina School of Medicine, A1C rises at a rate of 0.2 to 0.3% yearly in patients on stable therapy of oral antihyperglycemic agents. This decline in the effectiveness of the oral agents is due to progressive failure of beta-cell function. Dr. Buse proposed that perhaps incretin drugs can help eliminate this progressive A1C increase. It was terrific to hear this quantification – it may help push more toward more aggressive therapy earlier.

Dr. Daniel J. Drucker, Director of the Banting and Best Diabetes Centre and Professor at the University of Toronto in Ontario, objected to the world’s “insulin-centric” stance toward diabetes treatment. He believes incretin drugs will expand the physiological tools of diabetes treatment. Scientists have known about incretins for at least 20 years, but a major delay in making them useful to patients was their rapid degradation by DPP-4 inhibitors. Fortunately, incretin mimetics that are immune to DPP-4 degradation have been developed, as well as drugs that inhibit DPP-4 itself.

Corporate Symposium: Carpe Diem! Early Intervention for Optimal outcomes (Aventis)
Stephen F. Davis, MD, FRCP
Lawrence Fisher, PhD
Susan Renda, MS, CRNP, CDE
Interest Rating: Medium

Dr. Stephen Davis, from Vanderbilt University Medical School, inspired much laughter today, from his ironic British accent (the audience expected him to sound like a Tennessean) and his joke-telling. Dr. Davis also had many serious remarks that prompted laugher – for example, he said that Glyburide is a “horrible toxic substance that should be taken off the market.” Glyburide causes gas and hypoglycemia, and hypoglycemia in turn inhibits glucose control in type 2 diabetes. He asked if any audience members deal with patients on Glyburide, and not one replied that they did – so we’re making some progress! In addition to fear of needles, he reminded us that patients fear that insulin therapy will cause them to gain weight. According to Dr. Davis, there is an average weight gain of over four pounds for each one-point drop in A1C. While we believe that extra pounds associated with lowering of A1C are sometimes outweighed by the health benefits of improved glucose control, we’d rather see lower A1C and lower weight!

Dr. Lawrence Fisher from the University of California, San Francisco, spoke on psychological insulin resistance (PIR). He reported that social class, education, and socioeconomic status are completely unrelated to a person’s willingness to take insulin. Instead, personal beliefs, values, and sentiments are the determinants. According to Dr. Fisher, for example, Latinos are over twice as likely as other ethnic groups to refuse insulin therapy. This sets up some obvious challenges.

Diabetes Makeover: Inspiring Better Self-Care (BD)
Andrea Zaldivar, MS, ANP, CDE
Ann Fittante, MS, RD, CDE
Pamela Kelly
Gary Hall, Jr.
Interest rating: High

This session was packed! Many people were turned away at the doors and every seat was taken. Perhaps people just wanted to see Gary Hall, Jr.… Not to mention that the audience was almost entirely made up of women.

The mission for the eight week BD Diabetes Makeover is to help people take control of their diabetes through “comfort, control, and collaboration.” Participant criteria include commitment to improving diabetes control and making lifestyle changes, A1C at least 9% at baseline, and absence of significant diabetes complications or other serious health conditions. BD is currently looking for new participants—a great opportunity! Participants in the Diabetes Makeover program had an average 25% reduction in fructosamine levels (A1C was not given since the program only lasted eight weeks), and all participants achieved more consistent blood glucose readings. When an audience member asked if the Diabetes Makeover can be extended to children, the audience roared in support. Unfortunately, the BD Diabetes Dream Team said they did not have an answer, but it may be something they would look at down the road.

Gary Hall, Jr. is an honorary member of the BD Diabetes Dream Team and said that the BD Diabetes Makeover program gives people the tools and support that he has been privileged enough to have had on his own. When he was diagnosed, he put together his own diabetes care team much like the BD Diabetes Dream Team. Gary’s goal is to “inspire, motivate, and support participants.”

“Sharing the Burden: The Role of Incretins in Glucose Control” (Novartis)
Interest to CDEs: Mediumish

Everyone would love there to be a very effective pill, but with so much time being spent on Byetta I think it was practically a Byetta symposium and some CDEs were into that while others were not. A lot of the audience seemed kind of curious about where this was going (those who did not know about vildagliptin) as vildagliptin did not come up until 50 minutes into the 90 min. session.

High points
i. For a symposium not sponsored by Amylin, there was a whole lot of airtime devoted to Byetta
ii. The CDEs sitting behind me thought that Symlin was an incretin mimetic at the end of the event even though there was a slide titled “Amylin is not an incretin mimetic” – clearly it is taking time to educate re the difference between Symlin and Byetta (though one of them has already prescribed Byetta to several patients and is even using it off-label in combination with insulin, she said to her friend)
iii. One of the whispered to the other when the data saying that vildagliptin is weight-neutral came up that her patients would rather lose weight and they don’t mind the shots
c. Questions focused on the same issues that arose at AACE
i. Does inhibiting DPP-4 have any negative effects?
ii. Why does exenatide cause weight loss and vildagliptin not?
iii. Are there any antibodies?
iv. Is this stuff really closely related to the gila monster?

“Overcoming Barriers and Challenges to Glycemic Control” (Novo Nordisk)
Interest rating to CDE’s (Medium)

We do not think Novo anticipated such an antagonistic response from the CDE’s about the audience exercises with medical algorithms that were included in the presentation. The CDEs sitting near me were offended that they were asked to do such “easy” exercises to calculate mixed to background insulin doses. One CDE even scoffed that these algorithms are exercises that she does “every day.” That said, some interesting points arose:

High Points

i. The emphasis on post-prandial glucose control was a refrain throughout the entire presentation. Controlling post-prandial glucose levels greatly reduces mortality and the presenters reiterated that this should be the primary focus in monitoring glucose levels.
ii. They strongly advocated switching patients to pre-mixed insulin to allow for better glycemic control “with less weight gain.” An elaborate plan for switching patients to pre-mixed insulin comprised a large segment of the presentation. The symposium, “Diabetes POEMS,” that we attended later in the afternoon claimed that insulin should not be blamed for weight gain…interesting.

“Diabetes POEMS-Seven Recent Clinically Relevant Findings That Every Health Care
Provider Can Use” (Bayer HealthCare)

Interest to CDE’s: High The presenters did a fine job of providing an informative, interesting and upbeat presentation. The CDE interest was sustained throughout the presentation with a pause for a Q&A, audience quizzes and case studies. Many CDE’s remained after the presentation to tell the presenters how much they enjoyed the presentation.

High Points

“Don’t Fix What Ain’t Broke!”- Melinda Maryniuk and Richard Jackson, two of the presenters, told CDE’s to check all of the markers of diabetes and then to tailor a patient care program that will tackle the most immediately dangerous problem. Anything that can be saved for later should be saved for later so that patients will see fast health reversals and will make lifestyle changes that they will be more likely to continue throughout their lives. For example, an obese patient with high blood pressure but a decent A1C and cholesterol levels will be asked to reduce the fat and sodium levels in his or her diet to reduce blood pressure and to focus on weight loss later.

i. Depression has a drastic effect on A1c levels, increasing levels from 1.8-3.3%! CDE’s were advised to curb the depression immediately before embarking on any lifestyle changes that were not necessary to patients’ survival.
ii. High blood pressure should be the first health concern of type 2 diabetics because improvements in cardiovascular health arrive much faster than do improvements in A1c. This will greatly reduce mortality-and will therefore allow for the time needed to improve A1c.

“…A Walking Prescription for Health” (Omron)
Interest to CDE’s-medium. The company is giving free pedometers and blood pressure monitors to all who attended the symposium ...

High points
i. Interesting statistics. Colorado, the US state with lowest incidence of obesity, showed an average of almost 7,000 steps walked per male citizen per day. The national average is about 5,000.
ii. The free pedometers were perceived as a big bonus. This will greatly increase their exhibit traffic at what might have otherwise received much lower traffic.
iii. The nice point that came across was that even an increase of 2,000 steps a day will reduce your weight. 10,000 steps is the conventional magic number to fitness-however, most of the people defined as “underweight” who responded to one of their surveys walked an average of 9,000 steps a day.