Competitive Bidding for Glucose Testing

This is an excellent news letter for those who are involved with diabetes on a business basis and for those who really want to “know everything”. Many behind the scenes comments and information most will never have knowledge about but is very important for those with diabetes. Here it is.

Our last topic is a bit political - the issue of competitive bidding around glucose monitoring is quietly becoming a hot topic, and this has us very concerned. Bottom line, we suddenly see a very big risk that, as a result of the new proposed rules related to Competitive Bidding for Durable Medical Equipment, that Medicare recipients (easily a third of all patients with diabetes – 20% of people over 60 have diabetes, remember…) may soon only have access to the least expensive glucose meters and strips. What?! I know. This new program is scheduled to take effect in late 2007 in 10 of the largest major metropolitan areas in the US. If this happens, people on Medicare would be stuck with the cheapest strips, not the best ones, unless the final rules are modified. In order to ensure that Medicare can consider other (read: non-price) considerations in awarding bids for glucose testing supplies (this means, in order to ensure companies will still be able to invest in patient and provider education, innovation, customer service, etc.), we urge doctors and nurses, patients, concerned individuals, and anyone who cares about patients being able to monitor their diabetes optimally to submit comments in the open-comment period that ends on June 30, 2006. We are concerned that patients, out of nowhere, are going to be wind up with the short end of the stick because they will be stuck with meters and strips made by companies who don't invest in valuable innovation, education, and other services that are important to patients and health care professionals. Please weigh in to register your thoughts.

Let them know that patients want choice and need choice and will do far better with choice! And while you’re at it, you might also let them know is that the problem is with lack of attention toward prevention and treatment, not the price of diabetes technology. We'll have a longer blog on how to make a difference here, and if you are interested in the details, please write me directly at kclose@closeconcerns.com. (BTW).

‘Til soon ~
-- Kelly L. Close
Approved by Dr. Joe, The Diabetes Doctor

Byetta Long Acting Release

The full phase II data was released on Friday for Byetta LAR. Many people feel that Byetta as we know it now and this Long Acting Release (LAR) preparation will change diabetes forever.

Based on our incomplete information it appears it will change it for type 1 and 2. This project was just for type 2 and completed in Europe. Nausea remains an issue (27%) but it is lower in severity than the present Byetta preparation. No new safety issues have arisen.

All this will be released at the Annual meeting of the American Diabetes Association in June. Two doses were used, 2 mg and 0.8 mg. The HbA1c dropped 2.1% and 1.8% respectively. Weight loss continues to be significant. It’s your time.

Endothelial Inflammation as Reation to Medications

Diabetes Care 29:291071-1076, 2006 had two articles on endothelial function and inflammatory marker response to two medications in the TDZ (thiazolidinedione) class that has been used to treat diabetes 2.

Now that there is more understanding of those who have no insulin on stimulation – therefore looking like diabetes type 1- can non-the-less be benefited by the use of these drugs, this information applies to those with type one and type two. The accelerator theory is useful in all sorts of ways.

The endothelium is a layer of thin, flat cells that line the interior surface of blood vessels, forming an interface between circulating blood and the rest of the vessel wall.

Inflammation is the body's response to injury. The markers include mediators and inhibitors of inflammations and potentially dangerous substances such as toxins.

Both Actos and Avandia had positive effects on the endothelium which means they were likely not only to improve the insulin sensitivity but prevent heart attacks, strokes and prevent all other manner of cardiovascular disease and small vessel disease. It’s your time.

Dangers of Bisphosphonates

I have been shouting about the dangers of the bisphosphonates and bones for years and now some lawsuits may get everyone’s attention.

http://www.mpowelllaw.com/zometa-aredia-fosamax.htm

http://www.valadlaw.com/

And now it is reaching the news papers. Fosamax is the target here but any bisphosphonate is in the gun sight.

http://www.latimes.com/features/health/la-he-fosamax3apr03,1,1163782.story?ctrack=1&cset=true

Dentists have been worried about the huge failure rate of dental implants in people who have received Fosamax Osteonecrosis or the jaw is unfortunately a diagnosis they have become very familiar with.

http://www.ada.org/prof/resources/topics/osteonecrosis.asp

The treatment should be preventative in anyone who has received any agents in this class. The treatment is that used in any therapy used to grow bone mass in osteoporosis or osteogenesis imperfecta is appropriate.

L-arginine therapy in Acute Myocardial Infarction

Response to JAMA 1/4/06 Vol 295, No.1, 58-64,
L-arginine therapy in Acute Myocardial Infarction

There are over 40,000 articles which are generally positive on the use of l-arginine to reverse arterial lining (endothelium) elasticity, atherosclerosis, homocysteine and viral damage. I have had 2600 patients over the last ten years with less than 0.05% having any heart disease. How did these authors come to opposite conclusions?

* They started with smaller amounts of l-arginine, 3 gm rather than the 5 grams thought to be the therapeutic amount.
* They reduced the 3 gm to lower amounts if the patients had “side effects” symptoms. They did not state who and how much.
* The source of l-arginine is from a company whose product I do not know.

Patient management had other curious notes.
* Elasticity did not change on treatment.
* Diabetes was “well controlled” – meaningless.
* Plasma l-arginine barely changed on treatment –
how little were they taking?

This is cardiologists’ research. If treatment does not change elasticity/vascular stiffness like it did for all your references shouldn't you change treatment? They quoted 6 articles in the introduction saying l-arginine improved vascular elasticity. Why not follow these articles protocol?

How long did the patients have diabetes? What were other co-morbid states? HbA1c values? What treatments were used for those with diabetes? How well were they controlled during the study? Were the cardiologists attentive to the diabetes care?

“Doctor Joe” Prendergast – January 13, 2006

Metabolic Syndrome

The world is looking at the “Metabolic Syndrome” with new eyes. Insulin resistance defined it before as one of the essential factors without which you did not have the “Metabolic Syndrome”. But the Japanese study published in Diabetes Care 29: 145-147, 2006 has opened a new question.

It appears that if the patients have insulin resistance they will have increased heart disease. But if you only use waist circumference that is supposed to signal increased brown fat and insulin resistance, you do not necessarily have increased heart disease.

It may be that you just seem to have increased fat, not brown, and that’s all.

Does this signal the “Metabolic Syndrome subgroup B”?

Vitamin D in Treating Osteoporosis

Diabetes Care 28:2850-2855, 2005 carried the information from Sweden that indicated an upswing in hip fractures for both men and women at age 40. The major drawback was that this was only dietary assessment and no measurement of blood levels were taken.

This is a fatal flaw but is a piece of information that might stalk you as yet another risk factor for having type 1 diabetes – as if there weren't enough.

A few years ago a paper in the Journal of Clinical Endocrinology and Metabolism pointed out that the Swedes had excessive Vitamin A, an antagonist of Vitamin D in high amounts, added in by the Government. They did not asses the A intake in the diet nor in the amount of vitamins. Any patient with chronic disease usually ends up taking vitamins when the Government says that is a good thing.

I measured blood levels of Vitamin A and D for about 18 months after the Swedish paper. Nobody had an elevated Vitamin A in the San Francisco Bay area and no one had levels of Vitamin D that got as high as the normal range.

You heard last week that Vitamin D is a strong anticancer agent so get it up to normal levels and forget about getting a hip fracture about at age 40. We now use large amounts of vitamin D to treat osteoporosis. It is much more effective than things like Fosamax, Actonel and the rest.

Endothelial Function

Diabetes Care 29:291071-1076, 2006 had two articles on endothelial function and inflammatory marker response to two medications in the TDZ (thiazolidinedione) class that has been used to treat diabetes 2.

Now that there is more understanding of those who have no insulin on stimulation – therefore looking like diabetes type 1- can non-the-less be benefited by the use of these drugs, this information applies to those with type one and type two. The accelerator theory is useful in all sorts of ways.

The endothelium is a layer of thin, flat cells that line the interior surface of blood vessels, forming an interface between circulating blood and the rest of the vessel wall.

Inflammation is the body's response to injury. The markers include mediators and inhibitors of inflammations and potentially dangerous substances such as toxins.

Both Actos and Avandia had positive effects on the endothelium which means they were likely not only to improve the insulin sensitivity but prevent heart attacks, strokes and prevent all other manner of cardiovascular disease and small vessel disease. It’s your time.