The American Association of Diabetes Educators has spent big bucks this year ensuring its point of view gets across to our representatives in the federal government. The AADE spent $375,000 on lobbying in just the first half of 2007, according to a Senate disclosure form that has been picked up by the media. The law requires that such disclosures be made public. Members of the organization include big Pharma names like Eli Lilly, Novartis and Merck.

The AADE is, obviously, a member organization for diabetes educators, with advocacy in Washington - for professionals and patients - coming as an additional service. The government-run site Healthfinder lists more about the AADE if you're interested. Given the amount of money involved, I'm surprised how little attention this has attracted on the Web. Many news services have featured the disclosure, but only in brief. What I'd like to know is: what issues were the AADE lobbying for and against?

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!

Lately the news has seen a lot of devastating diabetic events due to hypoglycemic unawareness. Hypoglycemic unawareness is commonly defined as an inability to recognize the symptoms (sweating, tremor, hunger, anxiety, and palpitations) of decreased blood sugar or a failure of the warning signs to occur before development of neuroglycopenia, which means a shortage of glucose in the brain. Curiously, this term was not coined for diabetes until 10 years after the introduction of genetically modified human synthetic insulin and insulin analogues.

I hate to say it but diabetes is a crapshoot. You never know what you are going to get, but you can sure try your best to keep your eye on the ball. Removing the inherent dangers of hypoglycemic unawareness would make me a happier diabetic, and improve the lives of all those I care about (diabetics like myself). The answer might lie in the only type of treatment available nowadays, insulin analogues. Diabetics who do not take any form of drug to control blood sugar do NOT have hypoglycemic unawareness.

It's called human but it is nothing like natural human insulin. It may be faster acting or longer lasting but I'm sure He didn't intend for insulin to break sound barriers or last three moons. If Big Pharmaceutical companies were asked to compare insulin analogues with natural human insulin you'd hear crickets. I promise you NO Big Pharma will fund a study that would become the antithesis of their marketing campaigns, human insulin is better. It's not better, it's just different -- totally different! Natural insulin is fat-loving. Insulin analogues are water-loving. The global command center of the body (the brain) is one big blob of fatty material. This means as your blood sugar is dropping, your brain is last fed, if it eats at all. Here in the United States we are victims of circumstance in hypoglycemic unawareness. Sorry brain, no soup for you.

For more the more than 300,000 users that once relied on animal-derived insulin, the final chapter of animal insulin is finally ending for the US market. In December 2007, Novo Nordisk has officially decided to discontinue making animal-insulin. Their explanation doesn't go into great detail why they chose to discontinue it. But the supporting evidence they use to warrant the decision is a little weak.

Novo says, animal insulin is derived from the pancreas of slaughtered animals. This statement is as true as the statement "human insulin is derived from the pancreas of slaughtered humans". Novo continues, since that time there has been significant improvement of insulin quality and formulation. Absolutely true! In fact, a Novo pork product was shown to be greater than 99% pure, while an Eli Lilly human insulin only exceeded the 97 percentile. As a consequence, demand for these old animal insulins has declined by as much 20% in the last year to a point where approximately 2% of all insulin users are currently using these products. Largely due to the fact doctor's were advising their patients they must prepare to switch to GM insulin because animal-derived insulin would be nearly impossible to obtain. True. The research that introduced GM insulin (back in the 80s) was preemptive, at best. The claims supporting it was better than the existing insulin choices was clearly debatable .A telling similarity to the discovery about Avandia.

The long-term results of GM insulin and its analogs would prove to be a nightmare if the right questions were asked, and the data properly collected. Is it fair for any of the companies to ask us to change from an insulin product we have grown to love? No, but much like the off-Broadway play suggests: We love you (as a customer). Your diabetes is perfect (for our bottom line). Now change your insulin (we don't feel like making that kind anymore). Too bad type 1 diabetics forced to change to GM insulin didn't have the outspoken advocates like those taking Avandia.

Novartis SA reports the U.S. FDA has demanded additional data, including a clinical study in patients with kidney impairment, before giving Galvus its approval. Why the holdup?

The FDA wants more data studying Galvus in patients with impaired kidneys. It had been thought that Galvus might have an advantage because it is not processed by the kidneys, while Januvia is. But another molecule created when the body metabolizes Galvus does build up in the kidney.

In the Feb. 1 issue of The New England Journal of Medicine, David M. Nathan, a Harvard Medical School endocrinologist, noted that it was surprising that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan is a consultant for Novartis and other drug makers but not Merck.

There are several potential concerns about DPP-4 drugs, clear evidence has not turned up in clinical trials so far. The medicines could affect the immune system, because a receptor on immune cells is very similar to DPP-4. Merck says that Januvia was designed to bind only to the DPP-4 enzyme, reducing the chances of these side effects. Patients with impaired kidneys have more of the drug in their bloodstream and would be more likely to experience side effects.

A Harvard Medical School scientist's experiments with fish discarded along the coast near Boston have led to a new class of diabetes drugs. The latest, from Novartis, may get U.S. approval this week.

In the late 1970s, Habener, a doctor specializing in diabetes care, began buying discarded fish to learn about the ways animals controlled blood sugar. By 1987 Habener discovered a protein in the pancreas of anglerfish that tells the pancreas to produce insulin. He called it glucagon-like peptide-1, or GLP-1. In 1995, researchers uncovered another use for Habener's discovery to treat diabetes. The scientists found an enzyme that digests GLP. By blocking the enzyme, they could increase the body's reserves of GLP, thereby raising insulin levels. Twenty years later, we will soon have the pleasure of meeting Novartis' concept for this chronology of discoveries in the form of liraglutide.

In clinical trials, patients taking liraglutide attained normal blood sugars without the common side effect of weight gain. In fact, liraglutide was more likely to make the patients slightly leaner. Depending on dosage and length of treatment, it may help patients to lose weight. The drug does not cause a change in appetite. Furthermore, none of the liraglutide patients experienced episodes of low blood sugar levels throughout the trials.

I'm no fisherman, but if all the seagulls of Big Pharma are swarming overhead - there's bound to be a school of fish below. However, this school is quite competitive. At last count, the five largest diabetic drug makers are using Habener's findings to create new medicines.

A brilliant doctor, a motivational mission, and the biggest names of the industry -- success is the only option. Taking Control Of Your Diabetes is a diabetic conference designed to educate and motivate people about diabetes.

Through informative expos, packed with field experts, enlightening workshops and crowds swarming with curiosity -- taking a more proactive role in your diabetes is as easy as showing up. A few hours at a TCOYD expo will cover a lot of territory. Whether you're interested in the latest developments in research, new medications, fresh ideas on diet and exercise, or legal and insurance guidance-- you're bound to find somebody who has an answer. TCOYD health fairs give you the chance to personally engage major manufacturers, doctors, entrepreneurs and innovators looking to help diabetics live a healthier life. Ask your questions. Try their products. They are there to help you. Tell them what you think. Tell them what you need.

Medical advances in diabetes care continue to out-pace improvements in patient care. Share something new with your doctor next visit. TCOYD delivers the information to the people who need it most. The mission of TCOYD is motivating, educating, and empowering diabetics and their loved ones. The success of this mission is defined by what you make of it.

Genomas has identified potential DNA markers for risk factors involved in diabetes-related metabolic side effects from treatment with common antipsychotic drugs. A day late and a few million dollars short, eh Eli Lilly?

The study found that DNA variations could predict a patient's likelihood for developing pre-diabetic side effects such as weight gain. Atypical antipsychotic drugs (AAPs) can induce diabetic symptoms in nearly one third of patients, most notably characterized by increased weight gain in some patients but not in others. However, the side effect profiles for these drugs even within the same drug class may differ, raising the possibility of drug-specific side effects.

Genomas develops systems for DNA-guided diagnosis and treatment of metabolic disorders induced by drugs in cardiovascular and psychiatric medicine. They have the capability to select the safest drug treatment for each patient. A company like Genomas has the right idea. The use of antipsychotic drugs is on the rise, with an estimated 14 million patients for which these drugs are increasingly being prescribed. AAPs are a dime a dozen. The million dollar question is which of these drugs is NOT the one for you?

This just in: Novartis, the multi-billion dollar drug conglomerate based on Basel Switzerland, released a statement saying that their newest drug for type 2 diabetes, Galvus, does not cause skin lesions on monkeys. Thanks for the earth-shattering info. Lord knows that we were all wondering how those monkeys were doing, so we're thrilled to hear that they're skin is silky smooth.

The other part of Navrtis' public whine session resulted from what they feel is the unnecessary delay in the FDA's review process of Galvus. The drug itself, which does not have to be injected and does not have side effects like weight gain and water retention, is part of a new wave of drugs that are designed to use the body's own physiological mechanisms to control blood sugar. Based on that information, sure, get the drug out as soon as it is deemed. I think we can all agree on that. But, to say that just because monkeys didn't get lesions that the drug is ready to be ingested into the human body doesn't exactly constitute a safe product, now does it? Oh wait, now this just came in: Novartis has research on 1,000 patients who used Galvus for as long as two years alone or in combination with other drugs -- none of which exhibited skin problems in people with type 2. Okay, now we're at least getting somewhere. Monkeys don't get lesions, and now we know that humans don't, either. Hold on a second, I'm going to crack open the champagne. Drinking it may be problem, however, since my tongue is planted far too firmly in my cheek at the moment.

Galvus may turn out to be a wonderful drug for people with type 2, but until enough research is done on its overall safety, let's be happy that the FDA is doing their job on this one. Remember Phen-Phen? Or Valtrex? Or any other drug that somehow snuck by the safety standards of the FDA, only to later be linked to a myriad of health problems. The fact is that these drug companies are only concerned with one drug: the almighty dollar. It's already estimated that Galvus could generate at least $1 billion a year in sales. By the way, that was billion with a B. B for big bucks. B for beautiful yachts and a bevy of Benzes. And B for "Better get that drug on the market pronto!!" The pharmaceuticals business is a strange one, selling drugs that can potentially help people live longer, healthier lives for amounts of money that most people will never make in their lives. It's all about the bottom line, which is why this press release was issued by Novartis -- and not because they are overly concerned with helping people with diabetes. It sucks, but it's true. But, if there's any good that we know will come out of all of this, it's that we can sleep easier at night because we now know that their test monkeys and humans are lesion-free. Thanks, Novartis. You're the best.

On Tuesday, October 17, the clouds parted and the medicinal gatekeepers welcomed the birth of a little bundle of joy from Merck & Co, named Januvia. Weighing in at $4.86 per tablet, and guaranteed to control blood sugars without the undesirable side effect of weight gain, Merck said Januvia would be in pharmacies in the near future.

This is a new class of pills called DPP-4, or dipeptidyl peptidase IV. These are inhibitors that work to enhance the body's own ability to lower blood sugar. In clinical trials, patients did not gain weight. Yippee! Taken once a day, Januvia is expected to face competition from Novartis AG's rival medicine Galvus, which is awaiting FDA approval, possibly next month. The first generation of drugs designed to combat insulin resistance notoriously caused water retention and gain weight.

The empirical evidence is shining through already. A survey of about 60 physicians, conducted by Reuters Primary Research, shows the vast majority of doctors intend to start prescribing Januvia and Galvus right away. Dr. Stuart Weiss, a New York University Medical Center endocrinologist, said the drug's ability to control blood sugar spikes without added weight gain was a big draw. "In the face of a diabetes epidemic, this drug ... is particularly an inviting choice," said Weiss, who has consulted for several Merck competitors, including Novartis. If the near $5 a day price tag doesn't send your budget into a tailspin, you might have the shelf space for a DPP-4 in your near future. Praise be the DPP, for the sugars will come down and the scales won't creep up!

Novartis has launched a new diabetes educational campaign titled How I Do Diabetes. Heading the campaign is NFL quarterback Donovan McNabb, along with his parents, Sam and Wilma. Sam McNabb was diagnosed with type 2 diabetes nine years ago. How I Do Diabetes intends to educate people about the importance of managing the condition and show how family support and a positive attitude go a long way in managing type 2 diabetes.

Living with type 2 diabetes means having to keep several plates spinning: eating right, exercising, testing your blood sugar levels, and taking your medicine. Even when you are doing it all, sometimes it still isn't enough to get your blood sugars into normal range. How I Do Diabetes provides information about nutrition and exercise, as well as coupons and special offers specifically designed for the benefit of type 2 diabetics.

Next time somebody asks you a question about type 2 diabetes management tell them to check out How I Do Diabetes and then pop your collar and say 'cause that's how I roll (for dramatic effect, of course). Donovan, you and your parents are a wonderful attribute to the diabetic community. We are lucky to have you on our team.

My previous blog was about the meeting now underway in Copenhagen of the European Association for the Study of Diabetes (EASD). More significant news from that meeting: Galvus, the diabetes drug manufactured by Novartis, appears to work as well as GlaxoSmithKline's Avandia - but without the nasty side effects.

Galvus and Avandia are both designed to lower blood sugar levels. However, in the case of Galvus, this is achieved without causing weight gain and with less incidence of fluid retention, which is seen with Avandia. This is all good news for patients, said Emanuele Bosi of Milan's San Raffaele University, while addressing the EASD meeting. Remarked Bosi, neither patients nor their physicians should accept side effects of diabetes meds as a normal part of treatment. Great - who could disagree with that?

Naturally, this represents a major coup for Novartis in the unrelenting battle for dominance of the diabetes drug market. On the other hand, Novartis is not home free: Januvia, which works in the same way as Galvus and is manufactured by Merck & Co., should also reach markets soon enough too.

Don't call your doctor just yet though. Galvus is not yet approved for sale in the United States.

Drug manufacturer Novartis claims that combining its new drug Galvus with another drug called Actos is so effective it will postpone diabetic patients' need for insulin. Galvus (vildagliptin) is designed to reduce high blood sugar levels and comes in the form of a pill, taken once a day. Novartis says that taking Galvus along with a dose of Takeda's Actos reduces blood sugar levels by an average of 1.9 percent. The company also says the combo is even more effective for people with very high blood sugar levels.

Galvus is one of the new so-called blockbuster diabetes drugs that are expected to earn big bucks for their manufacturers. Novartis will pit Galvus against Merck's Januvia, which works in a similar way to Galvus. Galvus has received a lot of media hype because Novartis says it not only stabilizes blood sugar levels, but that it does so in a way that does not cause weight gain, a common and dreaded side-effect of some diabetes meds.

In a new report from CNN, it's being predicted that drug companies Merck and Novartis are about to "lock horns." That is, they're both developing two similar diabetes drugs, both of which have the potential to have a groundbreaking impact on the market. In addition, both these drugs are now under review by the US Food and Drug Administration. The result? Analysts are saying these giant companies could be drawn into a fight for dominance of the diabetes drug market.

Merck is the second biggest drug manufacturer in the US, and is developing the drug Januvia. The Swiss company Novartis has been making great inroads into the US market in recent years, and hopes to introduce a similar drug called Galvus. Both drugs are designed to lower blood sugar in Type 2 diabetics. Says market analyst Jon LeCroy, "You really have two products battling it out. The question is: who's the winner and who's taking second share?"

The US Food and Drug Administration is going to review the oral drug Galvus in preparation for its entry to the US market. Galvus is manufactured by the Swiss company Novartis and has been developed to treat Type 2 diabetes. The brand is one of a new type of drugs that work by improving the body's ability to lower blood sugar in Type 2 diabetics. Competition is fierce among drug companies to get their own versions of the medication out, and fast. In addition to Galvus, Merck & Co., Inc., have submitted an application for review of their equivalent: Januvia. Glaxo Smith Kline and Bristol-Meyers Squibb Co. are also working on similar drugs.