"To parents, unless you have diabetes, you do not, will not, and cannot understand what your child with diabetes goes through .. everyday."
--Tom Karlya, Diabetes Dad, keynote presentation, July 9, Children with Diabetes Friends for Life meeting
Check out Diabetes Dad on dlife.com here
Check out our new issue of diaTribe here
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.”
Earlier this month, the FDA issued a limited recall for specific vials of insulin Levemir that may have been mishandled or stored incorrectly. The warning applies only to insulin from the following lots (the lot number should be listed on the bottle): XZF0036, XZF0037, and XZF0038. If you have insulin from these lots, you should not use it, and you should call Novo Nordisk at 1-800-727-6500 to find out how to dispose of the insulin. You can find the official recall here.
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
[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
