Close Concerns Weblog

Sanofi Reiterates its Insulin, Lantus, is safe. Novo Nordisk distances its products from the scare.

Both Sanofi Aventis and Novo Nordisk have been communicating with investors in the last few days, to address the backlash to four papers published in Diabetologia associating Sanofi-Aventis’ Lantus (long acting basal insulin) with increased cancer risk. Background to the controversy is here http://www.diabetologia-journal.org/cancer.html. 

Notably, all the major diabetes organizations, including the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), and the International Diabetes Federation (IDF), all suggest that patients not alter their insulin regimens. There have been a number of doctors that have pointed out weaknesses in the studies in Diabetologia, prompting Sanofi to term the studies “junk science.” 

Novo Nordisk emphasized on a conference call last Sunday night that it had taken great care in designing Levemir, its long acting insulin analog, to ensure that it had no mitogenic (cancer promoting) effects and stated that in vitro and in vivo scientific data, meta-analyses, and post-marketing pharmacovigilance studies all suggest Levemir is clean as far as cancer signals go.

We have spoken to a range of doctors over the last few days, all of whom have emphasized (along with Sanofi and Novo Nordisk) that patients should not of their own accord change their treatment plans, but should talk to their doctors carefully about their regimen. While it is still unclear what the medical community's response will be, we add that patients should always discuss with their doctors their potential cancer risks and their general treatment options.

One of our key diaTribe advisors, Dr. Steve Edelman, founder of Taking Care of Your Diabetes and a Professor at the University of California San Diego, stated that the reports associating Lantus with cancer were not “anything close to a proper scientific analysis.” Importantly, he urged patients to “stay focused on the most important issues with your health: blood sugar levels as close to goal as you can avoiding hypoglycemia and get your blood pressure and cholesterol levels in the correct range.”

“Food Inc.” - How Income Levels Affect Diet and Diabetes

Diabetes and obesity therapy has always included a focus on the importance of diet and exercise, though success on this front for most people has been elusive (an oft-cited stat: two thirds of people in the US are overweight or obese, and the highest BMI segments continue to grow the fastest). At this year’s ADA, which ended Tuesday, we noticed a focus on lifestyle interventions that reaffirmed this trend (improved diets equal improved weight and glycemic control) and shared a common plea: improve your diets! However, as noted, behavioral changes have proven to be exceedingly difficult for Americans to adopt[1]. Historically, much of the blame has been placed on the patient, widely considered a consequence of their unwillingness to wean themselves off hamburgers and lumber off the sofa. We appreciate that the reality is more complex.

 Robert Kenner’s new politically charged film Food Inc., released yesterday in New York, Los Angeles, and San Francisco, puts forward ways in which the ability to make lifestyle changes is influenced by a higher power: a highly mechanized food industry that skews the system to bad calories - unhealthy, artery-clogging, obesity and insulin resistance inducing calories.

In this documentary, author Eric Schlosser (Fast Food Nation) characterizes the food industry as one that promotes a diet that frequently leads to serious health problems. For example, in a powerful scene at a youth health community group (in which topics including diet and exercise are discussed), the group is asked how many of them have a relative or close family friend with diabetes. Then, how many had two … then, how many had three. Seeing how many in the room knew at least three people with diabetes hit home the prevalence of type 2 diabetes in a way that all the usual statistics do not. The implication of the movie is that the families of most people in the class cannot afford healthier foods. In a follow-up segment, Schlosser asserts that the biggest predictor of obesity is income level and contends that these poor eating habits have contributed to the epidemic levels of diabetes.

We found Food Inc. to be an informative, albeit one-sided, commentary on the traditional food industry and its health consequences. We were happy to hear the mention, although brief, of the industry’s effect on the current diabetes and obesity epidemics as we think it will raise further visibility of the problems. While we think this film has an important message, we would have liked to have seen more explicit emphasis on the far-reaching effects our eating habits have on healthcare costs. Ideally, we would like to see much more focus on solutions – perhaps government programs that could subsidize healthy foods like fruits and vegetables, and introduce taxation of soft drinks and other unhealthy foods that contribute to obesity.

- by Tony Sheng, Mark Sorrentino, Jessica Swienckowski, and Kelly Close

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[1] Unfortunately, although we haven’t completed our review of all posters, there was really nothing that we saw that seemed incredibly likely to change adherence problems significantly

Seven-Plus is some iteration ...

"Overall, I’m very optimistic about the SEVEN PLUS. I think that however much I loved the SEVEN, the SEVEN PLUS really represents a great improvement over the first-generation SEVEN, and both the trend arrows and the rate of change information in particular are big steps. I’ve found that the trend arrows really help me to improve my management—I got really good at not checking my blood glucose after eating cake, and then I got good at not looking at my CGM for 9 hours, but it’s awfully hard to ignore two arrows straight up (as long as you’re looking at your CGM) for 24 hours!"

-- Kelly Close's review of the SEVEN PLUS continuous glucose monitoring system - see our new issue, diaTribe #15, here.

Diabetes Alert Day ... Questions to ask!

It’s a Numbers Game – Fight Back, Sound the Alert

How many of your family members over the age of 45 know their LDL or HDL cholesterol numbers? 

How many of you know what your last blood pressure was? 

How many of you have had it checked in the last 3 months? 

How many of you know that there is a 10mm microfilament that you can use to check for foot neuropathy in 2 seconds (and it's probably less than $20)? 

How many of you know that ethnic populations including African Americans, Latinos, and Native Americans have an increased risk of type 2 diabetes? 

How many of you know that one in five Americans are at risk for developing type 2 diabetes right now?

Why don’t you tell somebody that! It’s American Diabetes Alert day – get your numbers together and find out your risk at www.diabetes.org/risk.

How great is the University of Houston!?

Wow. So this is excellent. Usually I think my alma mater Amherst College is the one that does everything right! But check this out! The University of Houston now has a required (required!) online course for freshman called Public Health Issues in Physical Activity and Obesity. How great is this. There are eight online modules with a quiz at the end of each segment - real-life forums discuss real-life issues. Each module highlights the role of obesity and physical inactivity to disease processes like CVD or, you guessed it, diabetes. Hats off to Prof Brian McFarlin and collaborator Dr. Tony Jackson - they recently published on this program in Diabetes Educator and we look for other college campuses to look to address this important education in equally innovative ways as the University of Houston has pioneered. See full text of the Medical News Today story below. 

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Required Online Course Provides Diabetes Education, Tools To Fight Obesity

There is another tool to manage diabetes and fight obesity the Internet, specifically, an online, university-based program on obesity and physical activity that can apply to diabetes education.

The University of Houston department of health and human performance developed Public Health Issues in Physical Activity and Obesity (Kinesiology 1304) because of the prevalence of obesity and physical inactivity on campus.

"One strategy to prevent the development of obesity and manage diabetes centers on the aggressive development and use of educational programs," said Brian McFarlin, assistant professor and developer of the online class. "This course was designed for freshman and has been accepted as part of the undergraduate university's core requirements."

The course consists of eight bi-weekly learning modules, which highlight the role of obesity and physical inactivity to disease processes, such as the onset of cardiovascular disease or diabetes. Each learning module is narrated by McFarlin and concludes with a quiz to determine the student's level of understanding.

Learning modules include topics such as the physiology of obesity, cardiovascular disease risk, diabetes, cancer, designing and implementing an exercise program, basic nutrition and health concerns for the 21st century.

"In addition, we've included online forums for students to discuss topics pertinent to obesity and physical activity," McFarlin said. Students have used that venue to talk about diet drugs, exercise devices and public misconceptions about dietary habits, he said.

The course has been a work-in-progress since 2005, as students have indicated the kind of technology that would be most beneficial to them. To that end, McFarlin has progressively changed the media used in his course to adapt to the ever-changing information needs of today's college students. One innovative area he is exploring is related to the use of the virtual world of Second Life as a teaching/demonstration tool. McFarlin and his key collaborator (Dr. Tony Jackson) recently published a report regarding the anti-diabetes education program in the journal, Diabetes Educator.

The course grew out of a National Institutes of Health funded project titled, Training Interventions and Genetics of Exercise Response, which examines how an individual's DNA sequence influences that person's body fatness and fitness. Dr. Molly Bray is the principal investigator of this NIH-funded project.

For more information on the UH department of health and human performance, visit http://hhp.uh.edu For more information on the research of Brian McFarlin, visithttp://hhp.uh.edu/brian

University of Houston
4800 Calhoun Rd.
Houston
TX 77204-2163
United States
http://www.uh.edu

hooray for IHOP

So yesterday was my birthday and Johnny took us all on a FULL day! We celebrated at IHOP for breakfast, Gilroy Gardens for the early evening, and Alembic on Haight Street (wow, it had just been written up in the NYT, but it was still nice and neighborhoody) for a late drink. I love all of these, but especially IHOP, it reminds me of when I was little (and before I had diabetes). There is an excellent IHOP on Lombard Street in SF, and afterwards you can take the kids up the wind-y street. So I have to say! IHOP is doing us all a big favor. Most excellent. They have carbs (and calories and fat and all that other stuff) listed on the menus for a lot of the items! AND THEY DON'T EVEN HAVE TO!! It's not like in New York, where my sense is that places are doing this a little grudgingly (begrudgingly?) ... we definitely love that too, but this was IHOP's own move and no one forced it! (In fact, the general manager told us that San Francisco may copy New York but it is sorrowfully behind in making it happen.) The carbs listed helped me SO much and after my waffle breakfast, thanks to exact carbs (54 after allowing for what Lola ate) and my CGM, my blood glucose didn't even go over 150! For an IHOP breakfast, that's pretty good. Plus I love the sausages and the kid menu and the "special treat" chocolate milk containers. Check out IHOP, it'll put you in a good mood all day ...

Reporting Bias – Insulin pumping in kids

We were disappointed with some of the headlines associated with a story on insulin pump use in teens that came out yesterday. The story was on an FDA review published in the journal, Pediatrics, on the risks of insulin pump use over 10 years (1996-2005) that found “13 deaths and more than 1500 injuries connected with pumps.”  These were attributed both to device malfunctions as well as human judgment error. 

What the AP did:

• Wrote an article on the top-line data from the study
• Described insulin pumps
• Distinguished between type 1 and type 2 diabetes
• Quoted Dr. John Buse (president of the American Diabetes Association), Dr. Judith Cope (lead author in the FDA analysis), Dr. Christina Luedke (Children’s Hospital, Boston) on their views on insulin pumping.

What the AP did right:

• Emphasized the importance of careful screening before starting children/teens on pumps – for doctors and educators, patient selection is key, and for patients, understanding the power of the therapy is really important

• Called on parents to be vigilant regarding pump use in their children

• Lauded the benefit of pumps by freeing kids from the pain/anxiety/stigma sometimes associated with injections

• Reported early in the story that the FDA study was NOT advising against the use but simply calling for more study on safe use of pumps in pediatric populations (although some headlines would have us think otherwise!)

• Mentioned the difficulty for teens (for anyone!) of good glycemic management with (multiple daily) insulin injections

What the AP forgot (in our view):

• Did not report on any of the dangers of the alternatives to pumps – for example, there are many problems that stem from MDI (multiple daily injections), such as diabetic ketoacidosis (DKA) and/or severe hypoglycemia – it would have been great to have this acknowledged in the article. Pumps enable the ability to deliver more physiologic therapy - a winner for many patients and for many, an enabler to better diabetes management.

• While it is true that mechanical devices can malfunction, we believe that real-life data would show this can be avoided - the 24/7 hotlines have enabled great advice to pump users and have given patients a feeling of well-being because they know they can call if they need to. Although I never use customer service (I virtually never have issues with my pump), I like knowing that it is there. While user error with pumps can occur, this goes back to patient selection, education, and training - indeed, user error can occur with any application of insulin! (An aside: why doesn’t someone write an article about how more diabetes education is needed and about how we need to prevent complications, not just treat them!)

• We believe that there should have been more emphasis on the fact that insulin pumping and glucose monitoring go hand in hand and that monitoring is very important in order to avoid any serious adverse event occurs.

Final thoughts

Dr. Francine Kaufman raised an excellent point when we spoke to her about this: “How many adverse events are there with MDI or traditional therapy! How many go unreported?" She emphasized that there are more under-reported adverse events with MDI and that more are reported with pump therapy. She stressed, "Done correctly, there is a real benefit perceived by patients, families, and pediatric endocrinologists and endocrinologists related to pump therapy ... A number of trials and studies have shown that in the right patients, with adequate education and patient support, pump therapy can be a major advantage.”

Virtually every trial done, for example, shows benefits related to hypoglycemia. And that alone is enough for me! I'll end by pointing you to a poignant piece written by Kerri Morrone on hypoglycemia,  "this is exactly what hypoglycemia has been like for me and yet another reason I'm so grateful to my insurance company for covering my pump. There are many, many fewer moments that I spend in hypoglycemia due to my pump and many fewer due to my CGM. Though I can't thank all insurers yet for covering this, I do send big thanks to the inventors. "

Creative ways to look at diabetes on a grey friday

1.    Create mnemonics – D.I.A.B.E.T.E.S. = Did I Ask (my) Beta cells (to) Extremely Suck?
2.    Search "diabetes song" on YouTube or click here
3.    You tend to be more aware of your state of health than the next person
4.    Injections/IVs don't quite bring the same amount of trepidation as before
5.    If you have kids, they will probably only drink 10X diluted juices
6.    You are somewhat of a whiz at carb counting and label reading
7.    Your feet tend to look better than everyone else's because you take such good care of them
8.    Your insulin pump is a great conversation starter
9.    You can always get out of awkward situations by excusing yourself to go and check your blood glucose ~ alternatively you can diffuse an awkward situation saying "this awkwardness is wreaking havoc on my sugars" after testing right there ... (Kaku came up with this one, he has diabetes envy)
10.    You gain some healthcare expertise without paying tremendous amounts of money or spending insane amounts of time to go to medical school

What! What do you mean, someone with diabetes can't be healthy?! the new york times!

As I may have mentioned, I LOVE the new york times. Living on the west coast, I receive an email message every night, late night, with the next day's headlines and I am a pretty avid follower of it. LAST night, I didn't read it but TODAY! I am aghast!

Type 2 Diabetes, Reinvented

Researchers’ understanding of type 2 diabetes is being reinvented before our eyes. Some time ago, there was a split among diabetes researchers about whether type 2 diabetes was driven by insufficient insulin production (beta-cell failure) or flawed insulin use in cells (insulin resistance). Eventually a consensus was reached: beta-cell failure and insulin resistance both contribute to the progression of type 2 diabetes, and both abnormalities emerging, typically insulin resistance first. Researchers then identified another problem in type 2 diabetes: the over-production of glucose from the liver (gluconeogensis), especially at inappropriate times such as after meals. For some time, this palpable trio – insulin resistance, beta-cell failure, and increased gluconeogenesis – encompassed the mainstream understanding of the pathology of type 2 diabetes.

This trio is expanding before our eyes to encompass a wide range of newly identified problems associated with type 2 diabetes. Suddenly researchers are paying attention to abnormalities in gut hormones (incretins), mitochondrial dysfunction and oxidative stress, inflammation, and even the brain as drivers of type 2 diabetes. The newest member of the pack, abnormal fat distribution, which has been standing on the sidelines since the earliest descriptions of type 2 diabetes, suddenly finds itself in center field.