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On October 18, Reata and Abbott stopped their phase 3, 2,000-patient BEACON trial for the drug bardoxolone methyl, the most promising candidate in development for the treatment of chronic kidney disease (CKD). The trial was terminated due to an excessive number of serious adverse effects, including death, among those taking bardoxolone in the study. This is shocking and deeply disappointing news, particularly because the earlier phase 2 results for bardoxolone had been so encouraging – the drug showed the potential to both ease the symptoms of CKD and to actually reverse it through anti-inflammatory mechanisms.
The stakes were very high for bardoxolone since nothing of its kind is currently available, and it would have offered a sorely needed treatment for a very ill group of patients. As context for how grave a condition stage 4 CKD is (the disease state being tested in this trial), a 2004 study found that the five-year mortality rate of patients with stage 4 CKD was 46% – worse than many cancers. The companies have not released further information about why these safety problems arose, the magnitude of the problems, or the next steps with the drug. While it is possible that bardoxolone is simply not safe for use as a CKD treatment, these adverse events may be the result of unfortunate statistical variance or perhaps due to flaws in the study design. In particular, BEACON focused on patients with type 2 diabetes and stage 4 CKD, the most advanced stage of CKD before dialysis is needed. As a result, it’s possible that the participants were too ill to handle the treatment. Given that no glaring safety signals were apparent in the smaller phase 2 study (BEAM) with stage 3 and 4 CKD patients (though we note this was a much smaller study of 227 patients), we wonder if Reata and Abbott will still attempt to develop the drug for less severe forms of CKD. In any case, we will continue to monitor this story for more information on what went wrong in the BEACON trial. –AW/AB
In September, Medtronic and Bayer announced that Bayer's Contour Next Link meter became available to patients ordering new Medtronic Paradigm Revel insulin pumps and Guardian Real-Time CGMs. As a reminder, the new meter wirelessly transmits blood glucose values to the Paradigm Revel pump or the Guardian Real-Time CGM. It uses Bayer's new Contour Next strips and has a form factor and design similar to the Contour USB (essentially a blood glucose meter built in to a USB thumb drive). We got an up close look at the Contour Next Link in Medtronic's AADE 2012 booth and noticed, in addition to the reportedly greater accuracy, the integrated Medtronic CareLink USB stick (allowing upload of pump, CGM, and blood glucose meter data to Medtronic’s web-based CareLink platform), the color screen, and the easy tagging of results. Existing Medtronic customers that are not planning on getting a new pump or CGM will eventually be provided with the Contour Next Link, though they will not be contacted by Medtronic until January 2013. —AB
We recently had the opportunity to meet Christopher Angell, the founder and “Chief PWD” (person with diabetes) of GlucoLift. This took place at EASD – that’s the conference that is held each fall in Europe, that we’ll be writing more about next month. Chris has type 1 diabetes, and his company sells all-natural glucose tablets without artificial colors, flavors, or genetically modified ingredients – a welcome contribution for those looking to stay away from Yellow #6, Red #40, and other additives! We had a chance to try them while we were away (4 grams of carbs per tablet) and we love how all three flavors (cherry, wild berry, and orange cream) taste. For more information, visit www.glucolift.com or search for “GlucoLift” on Amazon.com (a 40-tablet bottle sells for $8.99). –AB/KC
On September 13, the New York City Board of Health approved Mayor Michael Bloomberg’s proposed regulation nearly unanimously. The regulation bans the sale of any soda or other sugar-sweetened drink larger than 16 ounces throughout the city. It targets the sale of such drinks in fast food restaurants like McDonald’s and Burger King as well as workplace cafeterias and both movie and Broadway theaters. The regulation was approved by eight of the nine members of the Board of Health, enacting a landmark move against obesity. One board member, Dr. Sixto R. Caro of Brooklyn’s Medspan Associates, abstained from the final vote on the grounds that the proposal doesn’t go far enough to have the desired effect. And indeed, there is a major blind spot in the regulation – New Yorkers and visitors to the city will still be able to obtain supersized sodas at supermarkets and convenience stores, where the ban doesn’t apply. It’s also worth noting that the ban specifically only deals with sugary drinks, meaning there are no restrictions on the size of diet and sugar-free sodas.
While the continued availability of large sodas in supermarkets and convenience stores may seem to blunt the impact of the regulation, there’s still significant reason for optimism. By restricting the size of sodas served in restaurants, theaters, and workplaces, the bill effectively discourages overeating in social and professional situations. These group settings represent an opportunity to change the general culture of soda-drinking – after a year or two of living with this regulation, New Yorkers may indeed be much less inclined to buy 20-oz. sodas from the convenience store.
If successful, this initiative could lead to similar regulations nationwide, such as Mayor Bloomberg’s previous regulation that required fast food restaurants to prominently display calorie information on their menus. The law is a tentative, imperfect first step – and one that faces significant public opposition and is already being challenged by lawsuits, primarily from the soda industry and its surrogates – but it’s great to see New York being so willing to take such a bold stance in the ongoing fight against obesity. –AW
In time for the beginning of this school year, DC Public Schools (DCPS) took a major step toward providing access to essential care for all its students with diabetes. DCPS, which oversees the school experience of all children living in Washington, signed an agreement with the US Department of Education requiring two employees at every school to be trained to assist any enrolled student with diabetes in case of a diabetes-related emergency. These employees will now know how to administer insulin and inject glucagon. While this resolution only affects children living in the District of Columbia, this is a great first step for all of the estimated 215,000 children (<20 years) with diabetes in the United States. The agreement is the end result of a lawsuit brought by Latesha Taylor, whose young daughter was not able to gain access to diabetes care when a school nurse was unavailable. On such occasions, Ms. Taylor was required to leave work and go to the school to ensure her daughter received insulin on time – failing that, she was forced to keep her daughter out of school as the only way to ensure proper diabetes care. We hope this will prove to be a winning model for school districts all across the country. –AW