There is still no evidence to declare superiority of rapid-acting insulin analogues in the treatment of type 1 diabetes. These studies compared either insulin aspart (NovoLog) or insulin lispro (Humalog) with human insulin; no such study was available for glulisine (Apidra).

Based on average HbA1c values, patients treated with NovoLog had lower levels. However, statistical comparisons were so small that an effect on patients' health is not to be expected. It was also hypothesized that Humalog may prevent night time lows better than Apidra.

Even though patients have been treated with insulin analogues for 10 years, it is still unclear as to how these types of insulin affect long-term complications of type 1 diabetes. The long-term effects of insulin decisively increase the risk of heart disease and cancer, according to recent studies at Howard Hughs Medical Institute. Would you be surprised to learn that one of the insulin analogue manufacturers chose to withhold some of the results of their studies?

The CafePharma message boards are for pharmaceutical sales professionals and those interested in the pharmaceutical industry. A former Lilly sales rep started a thread about Eli Lilly and the lies they've told over the years. Pro Lilly responses flooded in, as did the anti-Lilly responses. Yesterday, however, two comments seemed to hit the message board with a vengeance.

Comments #23 and #24 epitomize the anatomy of a good old fashioned debate. Comment #23 is an Eli Lilly sales rep who claims to have helped with the successful launch of rDNA insulin, and the conversion of patients on pig and cow insulin to Humulin. He remarked from the perspective of a salesman that it was a successful venture resulting in unilateral domination. In response to his yesteryear achievement - commenter #24 raised some wonderful counter-points for modern day consideration. The following paragraph summarizes the results 25 years after the market saturation of Humulin and genetically modified human insulin.

The adverse events include: (1) Complications of diabetes are increasing. (2) Dead-in-bed syndrome is up over 300%. (3) Traffic accidents caused by people using rDNA insulins are increasing (especially in Type 2). (4) rDNA insulins are producing immunogenic responses in the same manner and numbers in the diabetic population as did pig and cow insulins. (5) No long-term studies have ever been conducted to define the dangers of the synthetic insulin hormones relative to cancer and other diseases.

Of course my favorite point is the fact that recent studies have shown that the culprit in many Type 1 diabetics may actually be the human insulin antibody produced by the diabetic. This may be self-serving beyond Type 1 diabetics needing insulin - it's giving Type 2s the very same problem.

Story time!! Today is Bastille Day. The French National holiday commemorates the storming of the Bastille, which was a mark of the French Revolution - a revolt against absolute power.

Although I am not French - I am convinced there needs to be a revolution against absolute power of the insulin cartel. You all know them very well - Lilly, Novo and Sanofi Aventis. You've been a loyal customer, in spite of the shortcomings of their products. One example of a shortcoming is the absence of C-peptide. It is found in proinsulin and protects cells from the complications resulting from long-term diabetes. The other is the possibility that another source of insulin might be better for your treatment than synthetic human insulin. The fact the US only offers genetically modified human insulin is not fair when it comes to balance of power. Does this sound like a revolution that a feisty diabetic like me is starting?

I am not here to tickle a revolution. I'm determined to achieve it. Every diabetic deserves the right to choose their insulin. This choice should not be made for you by those who profit from the sale. I'm a type 1. I am a diabetic because my body made antibodies for human insulin. Why must I use insulin that continues creating these antibodies? I'd like to use something a little different that makes antibodies for horse or cow or PIG insulin. Can I get some pork up in here, please? It's difficult to obtain. It's as difficult as Ricky Bobby trying to say something in French. This Bastille Day Blog is a proclamation. As a prisoner of the insulin cartel - I declare that there will be a choice one day soon. Given the choice - you might opt for an insulin revolution, too. Laissez-faire!

Eli Lilly has an award they give to people who have been diabetic for 25, 50 and 75 years. They call it the Lilly for Life Award. The award recognizes people who have been enslaved to the exorbitant expenses of diabetes management, in addition to the other schedules of daily life. Endearing isn't it? The award is a significant token of Lilly's appreciation for all you have endured and sacrificed.

Lilly awards people who have used insulin for 25 years with the monetary equivalent of what your diabetes management has cost. All your copays for each bottle of insulin, each box of syringes, each blood sugar testing strip, and your ability to adapt to the ever-changing technology of diabetes care (I swear, it says that in block letters) - Lilly awards you $42,500!! I told you I lived in the land of milk and honey. ACTUALLY - it's a medal and a consent form to have your face exploited in Big Pharma marketing. You should've bought the stock! The shareholders of LLY paid approximately $1.75 per share 25 years ago, when you were diagnosed. Today that share is worth approximately $56. Anybody know the math on that return? It's probably around 3,000%.

Let's go back to that statement ever-changing technology of diabetes care. Why must it be ever-changing? Doesn't that sound a lot like never-ending? We need not spend too much time on identifying how to treat this disease when we've got that down. What we need to do is spend more time and energy on preventing the disease from happening in the first place. That is what I consider achievement. Achieve that, Lilly! And by the way - I'll take 3,000% of my $42,500 while you're at it. Thanks.

Mad Money is a stock show on CNBC hosted by Jim Cramer - a well-known iron fist on Wall Street. He has a following of stock enthusiasts who regard his recommendations (buy or sell) as gospel. Why is he so good at what he does? He just wants to help you make money.

And to this end -- the reason I bring Cramer's passionate drive to The Diabetes Blog is simple: last week he called Novo Nordisk as a SELL. Cramer said he's beginning to worry about a backlash on drug stocks. He advised that viewers should not be greedy and should take gains in Novo Nordisk (NVO).

Perhaps the NY Times article raised some eyebrows at Big Pharma. It appears doctors are receiving handsome gifts and stipends for handing out samples of drugs that were not all that safe for most patients. The payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes. In light of this blood curdling synopsis Novo got a dishonorable mention. Novo Nordisk professes to operate their company in two parts: biopharmaceuticals and Diabetes Care. The Diabetes Care segment provides insulin analogues, human insulin and insulin-related products, and oral antidiabetic drugs.

The cross examination of the C-peptide disappearing act and mysterious insulin auto-antibodies appearing where they shouldn't is just getting started. Thanks for making them sweat, Cramer!

Diabetes is making a name for itself and it's spreading like wildfire. Politicians are uniting to build a $120 million campaign to educate diabetics to prevent the spread of the disease and its complications.

Senator Clinton criticizes the reaction to the problem, rather than taking measures to prevent it from occurring. She questions why current money is unquestionably $pent on treating complications from diabetes -- such as amputations and dialysis. Good point, Senator. Ask Bush if he's got any friends up at Eli Lilly. A good answer can always be found in a temporary restraining order. She and fellow politicians propose more money be spent on programs for weight-loss, nutrition education and other preventive efforts to best curtail the growing number of diabetics in the United States.

The legislation proposed would provide $90 million to the Centers for Disease Control and Prevention's Division of Diabetes Translation for diabetes surveillance, research and educational activities. It would also allot $30 million for three four-year projects that would examine how best to translate diet and exercise interventions into effective clinical practice.

Researchers defined a link between high insulin levels and defective lipid metabolism but the cause may not be exactly what you think. According to a study published in June, 2005 -- this could be due to their choice in blood sugar lowering medication.

The conclusion of the study identified obese insulin-resistant subjects taking metformin (brand names Glucophage, Diabex, Diaformin, Fortamet, Riomet, Glumetza) and rosiglitazone both improve insulin sensitivity (increase insulin production) but DO NOT improve lipid metabolism. Rosiglitazone (brand name Avandia) may have a detrimental effect on chylomicron metabolism

Blood vessels of insulin-resistant rats build up a substance called chylomicron cholesterol following a high fat meal. Because the rats are insulin-resistant, more insulin (in the form of an anti-diabetes pill) is required to clear sugars and fats from their bloodstream. Higher insulin levels reduced the rate of chylomicron removal from the blood stream following a meal. This slower clearing rate increased the chylomicron particles sticking around the blood vessels, leading to arterial plaque build up and heart disease.

Knowing that high levels of insulin are associated with elevated levels of chylomicron cholesterol, researchers will use this information to try to figure out how this happens.

Why would they do that? The answer was already explained in June, 2005. Oh it must be because arterial plaque builds differently in Australian's on anti-diabetic pills than it does in American's on anti-diabetic pills. We should all thank the good folks at GlaxoSmithKline, Bristol-Myers Squibb, Pfizer and Merck. Without their medicine -- how would anybody ever know about this stuff? First you're on an anti-diabetic pill, then you're on cholesterol lowing pill, what's next? Of course -- the blood pressure!!

How many people are Gold Star type 2 diabetic patients?

A study published in 1991, comparing the efficacy of human synthetic insulin to porcine insulin states "there is no reason to treat all insulin-requiring diabetic subjects with human insulin except those who have developed insulin allergy".

In light of this study - how was rDNA synthetic human insulin able to monopolize the US market?

The absence of highly purified porcine insulin in the US is probably (my guess) because it's cheaper to manufacture. The saturation of the US market with rDNA synthetic human insulin seems to be treating the masses with a specialized need existing in only a few individuals. But the top line of this marketing campaign must have had a good effect on the bottom-line, too. Sales reps convinced doctors to switch their patients because it was going to become nearly impossible to continue getting animal derived insulin. The insurance companies (the guys picking up the tab) must've loved this option, too. Why wouldn't they? It's better - right?

I'm going to do a self-analysis of the stuff, based on my IAA, IA and C-peptide levels. I've been on human synthetic insulin since 1985. I've never been on highly purified porcine insulin. The IAA is my insulin autoantibodies -- the antibody attacking my islets. My IA is the insulin antibody attacking the injected insulin and my c-peptide will tell me how much insulin my body is making. After 12 weeks on the highly purified porcine insulin - I'm going to do my labs again. I'm curious to see if these levels move, at all. If my c-peptide levels rise, that's a GOOD indicator what's best for Allie Beatty.

So is the best choice for me the best choice for all? Probably not. But at least I can see for myself - even if it costs me a pretty penny to get my hands on highly purified porcine insulin. Nobody said being an experimentalist was cheap. However, never exploring my options would deeply discount the value of experience.

The Wall Street Journal posted an interesting story about a man who needed a drug to treat his ALS or Lou Gehrig's disease. He could not get the funding for a large scale trial to approve the drug. I empathize, completely! See that picture of the Hulk? That's me. I'm angry. You won't like me when I'm angry.

As a type 1 diabetic, my concern for improving the lives of people affected by diabetes involves preventing and reversing the complications associated with the disease. The American Diabetes Association states the same somewhere in their mission statement. Ok ADA, put MY money where YOUR 501(C)3 is!!

When I called the American Diabetes Association and shared my excitement for the C-peptide treatment in human trials (in Sweden) reversing type 1 diabetic complications - I was floored when I heard their response.

Allie B: Can the American Diabetes Association please encourage a big pharmaceutical company to sponsor these trials here in the United States? The results in Sweden have conclusively shown reversal of complications associated with type 1 diabetes.

Mat P at the American Diabetes Association: The topic of C-peptide is very sexy in scientific forums. BUT - we don't like to tell big pharmaceutical companies what to do with their money because we don't like them to tell us what to do with ours.

Allie B (in my head): WHAT THE F%^&*)(*&^%$F do you DO as an organization to improve the lives of people affected by diabetes if you are not going to push for trials to prevent and arrest complications associated with the disease?

I'm afraid the American Diabetes Association and I do not share the same goals any longer. It was a long marriage, over 21 years - but I want a divorce. The largest diabetic organization in the United States is not willing to assist in getting a trial underway to prevent and reverse complications that could affect 2 million type 1 diabetics and between 2 and 4 million type 2 diabetics injecting insulin (without C-Peptide).

I didn't feel this way until I realized how disconnected their perception of diabetes is from the reality of the disease. What do you think?

Just like a referee to normalize play throughout the game - DiaKine Therapeutics is developing ways to normalize the body's immune system.

The new drugs modulate cytokines, part of the body's immune system, which mistakenly attack normal organs and tissue and cause diseases such as: diabetes, multiple sclerosis and inflammatory bowel disease. Research by Dr. Nadler and his collaborators published in 2006 showed that controlling certain cytokines can arrest the progression of, or reverse, type 1 diabetes in an animal model.

The company's first product, IsletLifeLSF Media 1 is designed to improve the viability and insulin producing capabilities of harvested islet cells prior to transplant. This would potentially improve the success rate of the procedure. Additional therapeutics under development by DiaKine include: adjunct therapy to islet cell transplants, halting the progression of type 1 diabetes in newly diagnosed adults, treatment and prevention of Latent Autoimmune Diabetes of Adults (LADA), treatment and prevention of insulin requiring type 2 diabetic, treatment and prevention of diabetes complications.

It all sounds like good stuff in the works. Keep an eye on the progress and press releases of DiaKine, as well as their research partner - the Diabetes Research Institute. A lot is happening these days. What else have you seen or heard about in the autoimmune arena?

At the request of the Regulatory Affairs Manager at Generex, I am posting the following to defend the accuracy of the packaging and the claim of the product. The initial blog addressed a product called Glucose RapidSpray. The reader feedback, as well as the regulatory affairs response, is listed below. In no way, does Generex imply this product is to be used to treat hypoglycemia.

The comment to the original post stated:

The nutritional label on the product (available as a PDF on their web site) says the product has 188mg of carbs (or .188g) per serving (5 sprays). A typical glucose tablet has 4g... that's about 21x more carbs in a single glucose tablet than in 5 sprays of RapidSpray. Considering you typically use at least 15g of carbs to treat hypoglycemia, you would need around 80 sprays to get 15g of carbs into your system! When you take into account the amount of sprays you need, the calorie count isn't very much different from glucose tablets.

Read the label carefully, and be very careful using this!

The response from the Manager of Generex Regulatory Affairs states:

The product, Glucose RapidSpray™, is to be taken at the first sign of needing additional glucose in the diet, either between meals, during exercise, and/or before bedtime. It is not intended to take people out of full hypoglycemic states that normally a full tube of glucose gel or a full dose of Glucose tablets would be needed for. Glucose RapidSpray™ product is meant to be a complement to meals in order to help with glucose levels. As such, a direct correlation of carbs associated with Glucose RapidSpray™ and typical glucose tablets or gel is not warranted based on the intended use of the product. If usage of the product is maintained by taking Glucose RapidSpray™ at the first sign of needing additional glucose, then the Nutritional Facts stated on the package labeling is adequate for determining caloric intake (be it 5 sprays, 10 sprays, 15 sprays or whatever is taken to address the situation).

I consider the proactive response of Generex a good sign of how a company is run. Without needing to do so, Generex went above and beyond the call to address an open forum about the efficacy and accuracy of the product. This is the kind of interaction that convinces me a company cares! Good job, Generex! Lest I NOT hold my breath for Eli Lilly to return my call about Super Insulin. Novo Nordisk was far more receptive to address my interests, as a diabetic. Stay tuned for my follow-up on the Eli Lilly vs. Novo Nordisk – Who Love You, Baby!?!

Remember the A-Game suggestions I dangled for Eli Lilly to tap for performance enhancement? Well here it comes. I called Eli Lilly headquarters to speak with the Chairman and CEO, Mr. Sidney Taurel but I was directed to their idea submission form (which consequently didn't work). Oh boy, Sid. I'm a little disappointed. So here goes - my idea is going free for all when you could've had it, first. Let's call this new and improved product Beta Juice. It delivers the essential functions of a fully operational beta cell. It produces: insulin, amylin and c-peptide. Here's why insulin should always come equipped with the other two...

Insulin brings sugar to the cells to keep our energy levels sufficient for life, homeostasis and (if we're lucky) some energy for the gym. Amylin is a controlling agent for appetite, gastric emptying and tells the liver to dispatch glucose. It is also shown to have an impact on lipolysis --- the metabolism of stored fat. Until recently C-peptide was nothing more than a number used to decipher if you were a type 1 or a type 2 diabetic. However, recent scientific studies have shown C-peptide protects small vessels from the complications associated with diabetes. The Reuters Health article is titled C-Peptide Replacement Improves Early Diabetic Neuropathy.

The American Diabetes Association promotes the ABC's of Diabetes Care in an effort to educate diabetics on controlling their disease. The ABC's of diabetes care refer to a patient's Hemoglobin A1c, blood pressure, and cholesterol. A diabetic must maintain a hemoglobin A1c less than 7%, their blood pressure must remain below 130/80 and their good and bad cholesterol must be kept in range. The ABCs of Diabetes Care were established in order to reduces the chances of developing diabetic complications like neuropathy (nerve damage), nephropathy (kidney damage) and retinopathy (eye damage).

Here comes the perfect Insulin (code name Beta Juice) -a laboratory engineered balance of insulin, amylin, and C-peptide. Insulin to balance the blood sugar level, amylin to regulate fat and cholesterol levels and C-peptide to control the damage inflicted upon the micro vessels throughout the body. This is a GREAT IDEA!! Not just because it is MY idea, but because this is a huge opportunity to mitigate the complications that insulin by itself can impose, without the checks and balances of the other beta cell hormones. What do you say, Eli Lilly? You're halfway there!! You've already partnered with Amylin Pharmaceuticals. They have one third of this patent pie. Now hop on the horn and join forces with the C-peptide patent holder and ride your stock price to the moon. The diabetic girl has spoken. I know you care, Eli Lilly. Now put your money where your mouth is and make this new and improved insulin a light at the end of the diabetes tunnel.