The scientific community has been in a heated debate about xenotransplants (transplanting pig islets into humans). Although the procedures are showing to be effective - is the insulin secretion entirely pig? Some experts surmise that after the transplants, diabetic patients are actually able to produce some insulin on their own, after all.

The latest press release from Tissera, Inc (an Israeli-based company) made a statement that raises my hopes. It was, "By the fourth month after transplantation, the insulin dose needed to maintain near-normal blood sugar levels decreased by more than 90% in comparison with the insulin dose needed before transplantation, meaning that endogenous insulin production was predominantly responsible for blood sugar control."

The question of the origin of endogenous insulin was addressed by measurement of blood C-peptide. C-peptide splits from insulin and indicates the level of insulin secretion from the patient. C-peptide levels were measured both at baseline and in response to a sugar load, which brings about a rise in blood C-peptide. The measured C-peptide was shown to be predominantly of pig origin. So herein lies my question: is predominantly more than 50%? A type 1 diabetic has undetectable levels of C-peptide. Period. After the xenotransplant the C-peptide level is all of a sudden detectable? Could these islet transplants assist in regenerating the diabetics' own islets?

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Type 2 diabetes, mate? By crikey. Australia's diabetes epidemic continues to be a problem. News this week indicates the spread of obesity, and with it associated conditions like Type 2 diabetes, in rural areas is far worse than previously realized. A survey of 806 randomly selected adults (okay, not the biggest sample, admittedly) found that a great many are affected by the disease.

Based on their findings from that survey, researchers calculate that almost three-quarters of Aussie men living in rural areas are overweight. They think women in rural areas may be slightly better-off - around two-thirds may be overweight. This puts rural Australians at a very high risk for T2DM. The conclusion, stated in the Medical Journal of Australia: "urgent population-wide action is required to tackle the problem."

As is the case in the US, a big concern is how to treat all those people as they age and their overall health worses. Specifically, what will become of Australia's public healthcare system? "We might get a whole generation, now in their 40s, 50s and 60s, who will do markedly worse than their parents," predicts lead researcher for the study, Professor Edward Janus of Melbourne's Western Hospital.

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Most school cafeterias and vending programs feed our kids junk, but even worse, students with diabetes are not provided legally required care to manage the disease during school hours. Children with insulin dependent diabetes are heading to school without the assurance of regular blood glucose testing, the administration of insulin or other diabetes care tasks.

In 2005, four California families and the American Diabetes Association (ADA) filed a suit in San Francisco, alleging some California school districts were not providing adequate diabetes care. In some cases, parents were called to give aid before summoning a school nurse. Michelle Ferry was one such parent. When her son was in first grade, this widowed mother of four had to hire a babysitter so she could head to school to give her son an insulin shot. Risky business for her son, let alone expensive for the Ferry family. What if she could not secure a babysitter and her son ran high blood sugars? This is outrageous and unacceptable. This is just one example, many schools across the country are not adequately serving students with diabetes.

The lawsuit has been settled, and per the agreement, the California Department of Education will now require districts to ensure all children with diabetes have access to proper diabetes care during the school day. What took so long? Students with type 1 diabetes have been in public schools for years! Now a volunter school employee can be trained to assist a student with diabetes. San Ramon Valley school district claimed they wanted this ability, but they were following state regulations that care be provided by a health practitioner. State law outlines seven different categories of caregivers -- which includes a self-administering student, a school nurse or other health professional and family/friends. Now the agreement states if a licensed health professional is unavailable, a trained, unlicensed school employee may provide insulin shots per individual physician order. Hallelujah -- may California trigger a domino effect nationwide.

Jack O'Donnell, State Superintendent of Public Instruction, explained a lack of resources, uncertainty of how to best deliver services, and lack of clarity about state and federal requirements combined to cause hardship to some parents of children with diabetes. He said no parent should have to risk their job to care for their child. What his statement truly lacks is concern for the student with diabetes -- O'Donnell misses the point when he disregards the cumulative, tragic complications of poor blood glucose control.

A big legal team contributed to this win. Hats off to the ADA, attorneys with the Disability Rights Education and Defense Fund and the generous law firm of Reed Smith LLP (donor of $2.6 million in pro bono legal services). Here is the announcement of this landmark agreement and a story from Inside Bay Area.

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The chairman of the FDA advisory panel that reviewed the safety of rosiglitazone (Avandia) last week believes the time has come to abandon "surrogate endpoints" for approval of type 2 diabetes drugs, according to a report at www.medpagetoday.com.
Huh?

OK. English. Basically, the FDA currently approves drugs for diabetes that show great promise for controlling blood sugar. And they do it very quickly. But just because a drug controls blood sugar, doesn't mean it won't hurt your heart.

Endocrinologist Clifford J. Rosen, M.D., wrote his version of that in a perspective published online today by the New England Journal of Medicine. You can read medical jargon filled reports on it here or here. According to the reports, Rosen suggests if the FDA fails to make the shift from surrogate to clinical end points (English: make change to the criteria by which drugs are approved) "with regard to diabetes drugs, we are certain to be in the same position five years from now that we are now: we will again find ourselves in possession of a new wonder drug that is designed to treat a devastating chronic disease but that may do more harm than good."

Tags:Avandia, drug approval, DrugApproval, FDA

A new diabetes drug in the same class as Avandia has entered the final stage of its clinical trial, bringing it one step closer to government scrutiny in an effort to grab a chunk of the marketplace.

The final stage of testing for balaglitazone, known as the Phase III program, will comprise five to six studies involving different combination therapies for patients with Type 2 diabetes, as well as a long-term safety study, according to www.tmcnet.com. Philip Larsen, CEO of Rheoscience, which has partnered with Dr. Reddy's Laboratories Ltd. to develop the drug, said there are no plans to submit a new drug application until after 2009. They also don't have a commercial partner for the product. "We'd really like to see what potential the drug has before we enter a deal," he said.

But it's never too soon to envision to revenue. "I would be a wimp if I said we would only get five percent of the market," he said.

Tags:balaglitazone, Dr. Reddy's, Dr.Reddy's, Rheoscience