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?

Shhh. Big Pharma scientists hard at work. On what, you ask? Why, on Novo's new "baby" - a drug designed to treat type 2 diabetes. Liraglutide, a hormone analogue, is supposed to improve blood sugar control. It's also supposed to get you that coveted magic bullet (a la Byetta): weight loss. Ooh, baby. Now that's medication!

Novo Nordisk has been working on Liraglutide for a while now. Here's the latest: Novo announced Monday that two Phase III studies were successful in demonstrating the aforementioned blood sugar control and weight reduction. Novo is riding high on the news: its shares rose six percent on the announcement. According to a pharmaceutical industry analyst quoted by Reuters, the shares surged so healthily because the positive news was expected.

The powers-that-be at the drug giant say they hope Liraglutide can be submitted for regulatory approval by mid-2008. They hope it will become another blockbuster, with estimated annual sales topping one billion. Stay tuned.

A year ago, competitors were out to produce their own versions of Pfizer's Exubera, the inhalable insulin. However, now it's clear that Exubera is a bomb. Yes, a slick new ad campaign might revive its fortunes, so don't count Exubera out of the race quite yet. But it's not likely to be the blockbuster product many thought it could be.

Now the fallout is hurting those companies that were scrambling to compete/cash in by producing their own inhalable insulins. According to a report in Forbes, those same companies are ready to beat a smart retreat. Meanwhile, they're trying to reassure nervous investors. Case in point: MannKind Corp. shares fell nearly ten percent on Monday after it was announced the company could take longer to line up a partner for its inhalable insulin, the Technosphere Insulin System.

Not only that, MannKind postponed the release of its second quarter financial report. Wall Street analysts downgraded the stock, saying its short-term outlook is "challenged" and cited disappointing sales of Exubera as a factor. The outlook could be even worse if it looks like insulin caps will make it to market. As I said in a previous blog on that topic, who wants to tote a bulky inhaler around if you can pop some capsules instead?

When treating diabetes, today's doctors focus on establishing blood glucose control, but often overlook the need to protect against common diabetic complications such as blindness, kidney damage, and nerve damage. The DCCT, even with a comprehensive treatment program, had a complication rate of approximately 40% of participants.

People who do not have diabetes make insulin with C-peptide. Those of us diabetics who inject synthetic insulin do not get the C-peptide. When scientists began developing insulin - they weeded out the pieces of the amino acid chain they felt were insignificant in lowering blood glucose. Synthetic insulin was designed to reduce the dangerous buildup of excess sugar in the bloodstream. Uh oh - hindsight is surprisingly clear! The long-term complications were initially thought to be caused by lack of insulin - not lack of something that should've been in it. It would make sense if insulin came equipped with this critically important element, wouldn't it?

Tada! C-peptide is the connecting peptide found on the amino acid chain of naturally produced insulin, but left on the cutting room floor in the lab. Studies have shown that C-peptide prevents the development and progression of many diabetic complications and was shown to improve glucose metabolism up to 66%.

Regardless of the potential profit decay C-peptide might cause the production of insulin - the bottom line is the salvation it will provide every man, woman, and child injecting insulin. If you're taking insulin injections, chances are you won't stop taking insulin because you're adding C-peptide to your daily lineup. Chances are - you'll be around a lot longer, and a lot healthier because you do not have the complications most often associated with long-term diabetes.

Wouldn't that be reason enough for you to celebrate the company that brings C-peptide to the drugstore nearest you? Consumer loyalty goes a long way. For those companies who knew a long time ago how beneficial C-peptide would be but didn't do a thing about it - is it really the 33% loss in insulin sales you didn't want to encounter? C'mon. We can handle the truth.

Neuropeptide regulating appetite may help in developing new diabetes treatments. The neuropeptide called melanin concentrating hormone (MCH) plays a role in the growth of insulin-producing beta cells and the secretion of insulin. MCH is found in the brain and regulates energy balance and appetite.

A previous study conducted at Joslin found an association between high levels of MCH and an increase in the number of beta cells in mice. When we eat food, our body needs more insulin. When MCH induces appetite, it simultaneously increased insulin secretion. This calls upon the beta cells and enhances their growth. If the proteins that mediate the growth mechanism can be identified, it could lead to the development of new drugs that would enhance beta cell growth to treat type 1 and type 2 diabetes.

Sounds great! However, this sounds similar to the function of SYMLIN, which is the synthetic form of amylin. Amylin is a hormone secreted by beta cells at the same time as insulin. If you've heard of Byetta - you've heard of Amylin Pharmaceuticals, the makers of SYMLIN. The researchers at Joslin and the guys at Amylin should get together and do lunch. They might have a lot to discuss between this research and the development of yet another biotechnological blockbuster drug.

The journal Diabetes Care reports obese adults who lost a substantial amount of weight through lifestyle modification and dieting regained less weight when they took the diet drug Xenical, This approach was also associated with a reduced occurrence of type 2 diabetes.

Xenical burns fat while you are eating by inhibiting the absorption of dietary fat from your food. Studies have shown that the drug promotes more weight loss than lifestyle modification alone. The study examined the effectst of Xenical in preventing weight regain in 383 obese adults who had lost an average of 31.7 pounds (14.4 kg) on an 8-week protein-rich, very-low-energy diet. The 309 participants who lost 5% or more of their bodyweight then received lifestyle counseling for 3 years while taking either Xenical or a placebo pill daily. Both groups regained some weight. Xenical patients regained an average of 10 pounds, while placebo patients put back an average of 15 pounds.

Most importantly, during the 3-year study period only 8 of 153 in the Xenical group developed type 2 diabetes compared with 17 of 156 in the placebo group. That's remarkable. Twice as many people were diagnosed with type 2 diabetes, in addition to regaining one and a half times the weight. As an aside (and not to be a whistleblower) but one of the warnings on the label says the drug should not be taken for more than 2 years. Just an FYI.

Much effort and research has been invested in finding an alternative, less painful way, to treat patients with diabetes. For years, the only method patients had to deliver insulin was by injection. However, a team of scientists discovered a technology that has the potential to revolutionize this old school way of thinking. What if I told you a company is developing an orally ingestible soft gel insulin capsule? Naysayers, allow me to introduce you to my latest find: Oramed.

Up until now, the idea of insulin in a pill was inconceivable due to the fact that insulin, which is a protein, breaks down in the digestive system. However, Oramed's patented technology overcame the problem of digestion as well as permeability to the intestine with a few organic whistles and bells. This has been a major hurdle that has inhibited the development of orally ingestible insulin for decades. Prof. Hanoch Bar-On, a leading Diabetologist, states that the route of the insulin from the swallowed pill "imitates nature" in that it passes to the liver and then to the bloodstream. Injected insulin goes straight to the bloodstream.

Oramed Pharmaceuticals' is an Israeli based company. They received the green light from the Israeli Ministry of Health, as well as the Hadassah Medical Center Institutional Review Board for phase 1 clinical trials of oral insulin in healthy humans. Here's the million dollar question for card-carrying US citizens with type 2 diabetes taking insulin injections: if you could downshift to an easier to swallow means of managing your diabetes, would you?