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?

The Rusing family of Tucson, Arizona, run a remarkably successful lemonade stand. The stand began as a way to keep the kids occupied, but turned into a bit of a money maker. It's been so successful, in fact, that it's now in the running for the title of Best Lemonade Stand in America. Yes! There is such a thing. Cute, huh?

The Rusings donate the proceeds from the stand to diabetes research. The stand is named "The Mighty Quinns" for Quinn Rusing. Quinn, who is four-years-old, was diagnosed with type 1 diabetes at age three. He helps run the lemonade stand, along with mom, Carolyn, and six-year-old twin sisters, Cali and Olivia. The secret to their success appears to be the free cookies. That's right. Free Famous Amos cookies with each 25-cent glass of lemonade purchased.

Spot anything odd about this story? Lemonade stand with free cookies as a diabetes fundraiser?? Um, what about all that sugar?! I spotted this story about the Rusings on the Tucson Citizen website. Another reader has posted this comment: "With 60 grams of sugars in a 12 ounce glass, the shareholders of Bristol-Myers-Squibb and Merck are gonna be in real good shape."

Avandia, a drug used to treat Type 2 diabetes, has been in the news of late following the release of controversial study results which concluded the drug leaves patients at an increased risk for heart trouble. My fellow blogger Bev has touched on the conundrum now facing diabetics on Avandia regimens. You can quit taking Avandia, but then what? Thousands of Americans are now facing this predicament and many have opted to switch their prescriptions to something else. The Philadelphia Inquirer is running a feature about this and talks to some diabetics who have opted for the "try something else" route.

The Inquirer profiles, among others, pharmacist Ben Briggs, 59, who switched to Merck's Januvia in the wake of the Avandia scandal, but was sorely disappointed in the results. Instead of seeing an improvement in his blood sugar levels, his health actually declined rather rapidly: he gained eight pounds and said he was "feeling awful." He promptly ditched that drug too and is now on yet another medication. According to diabetes experts interviewed by The Inquirer, patients should "tread carefully" and avoid rushing to switch to drugs such as Januvia, which do not have the proven track records of the old standbys insulin and metformin.

Bottom line: this whole dust-up over Avandia is a nightmare for its producer, GlaxoSmithKline. However, its competitors Merck and Takeda Pharmaceutical could stand to make a bundle as diabetics switch in droves from Avandia to Januvia or Takeda's Actos. According to Deutsche Bank analyst Barbara Ryan, sales of Januvia alone could be up as much as $300 million annually as a result of Avandia's troubles, while Actos profits could rise even higher than that. You have to imagine Merck and Takeda must be nervously making hay while the sun shines, hoping they don't end up testifying to Congress some day in the future.

For those of you following the Avandia story in the news, you're probably wondering how the patients currently taking Avandia are feeling. Are they flushing the pills down the toilet? What about the patients enrolled in GlaxoSmithKline's current Avandia clinical trial -- are they dropping out like flies? If you are unfamiliar with the Avandia debate, news broke last week that Avandia, a popular diabetes drug, may increase the risk of heart attack. A 43% higher risk.

It may depend on the specialty of your doctor. BusinessWeek has reported endocrinologists tend to be more skeptical of the study, noting its weaknesses compared to original, more rigorous clinical trials. Many cardiologists and drug safety experts give the study more weight, and remain worried about Avandia's potential cardiac danger. Doctors on the frontline are concerned patients may stop taking the drug without medical consultation as many are confused and frightened.

Dr. Nissen, the whistle-blower on Avandia and leader of the fight to withdraw Merck's arthritis drug Vioxx due to safety issues, acknowledges there are real limitations in his analysis, but he points out Glaxo's own data found a 30% increase in the risk of heart attack from Avandia. Nissen was alarmed enough to release his meta-analysis showing a 43% increased risk versus waiting for the results of Glaxo's 4,400-patient, eight-year clinical trial named RECORD, which is specifically measuring cardiovascular outcomes of Avandia.

Critics say Nissen went too far out on a limb this time as a meta-analysis examining 42 Avandia trials with varying research methodologies is not terribly reliable.

You will soon have role playing cards available for your doctor's visits. The conversation is scripted with four questions and the answers as to whether or not you should be on a statin. Two can play, but millions will have a chance of their very own!

The pocket cards are intended to empower patients to determine whether they should or should not take a statin. Statins are cholesterol lowering drugs that supposedly reduce the risk of heart attack. Diabetics are typically at a higher risk for heart attack. The card includes answers to four questions: (1) What is your risk of having a heart attack in 10 years? (2) What are the benefits of taking statins as compared to not taking statins? (3) What side effects can you expect from statins? (4) What do you want to do now?

If the risk of having a heart attack is very small, a pill that reduces that risk may not be worth it, but if the risk is really high, lifestyle changes (or a pill) might sound compelling. Once a patient has a sense of the potential dangers and benefits they can make an informed choice. I hope the cards come equipped with the source of the funding for this study: Mayo Clinic and the American Diabetes Association. I wonder if that's the underhanded way to say this study was funded by Merck, Pfizer, and GSK?

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?

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.

The FDA has approved sitagliptin phosphate tablets to improve blood glucose levels in patients with type 2 diabetes. The drug, named Januvia, is proudly presented to the diabetic community by Merck and Co.

JANUVIA, a once-daily pill, enhances your body's natural ability to balance blood sugar levels. Your body sends important messages to your pancreas to try to balance high blood sugar. In response, your pancreas makes more insulin and signals the liver to make less sugar. But a substance in your body called DPP-4 blocks some of these important messages. JANUVIA works by blocking DPP-4, so more of the important messages get through. It also helps your pancreas make more insulin and signal your liver to make less sugar. Another feature of this new drug is the ability to prevent your sugar from going too low. JANUVIA works only when your blood sugar levels are high, or out of balance. When your blood sugar levels are at a healthy balance, JANUVIA doesn't have an effect. Because JANUVIA stops working before your blood sugar gets too low, it is not likely to lower your blood sugar to a potentially dangerous level (hypoglycemia). One more bonus to JANUVIA is the fact that this drug did not show weight gain in most patients during clinical trials.

Could this be the answer for your diabetes dilemma? Next time you swing by your doctor's office, mention that new drug Merck released. I'm sure your doctor will be as thrilled to see your numbers controlled as you'll be to see your natural ability to control them restored. Best of luck to those who find their diabetic solution in JANUVIA!

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.

In the $20 billion diabetes market, when drugs make their way onto the scene, it's a head-turning event. So far, one drug is gaining ground and two of them are raising interest.

Januvia, manufactured by Merck, was recently approved for the treatment of diabetes. Januvia is used with diet and exercise to lower blood sugar in patients with type 2 diabetes. Januvia lowers blood sugar when blood sugar is high, especially after a meal. It also lowers blood sugar between meals and helps to improve the levels of insulin produced by your own body after a meal. The drug is unlikely to cause your blood sugar to be lowered to a dangerous level because it does not work when your blood sugar is low. Januvia faces potential competition from an experimental drug, Galvus. The drugs are similar in many respects, including their status as once-a-day pills, and their ability to lower blood-sugar levels in diabetics while helping them to lose weight, or at least to avoid gaining it. The FDA delayed its decision on Galvus, so we may be waiting till the first half of 2007 to see it in action.

Acomplia, manufactured by Sanofi-Aventis, is in hot pursuit of FDA approval. Acomplia is primarily a treatment for diabetics, but the drug is unusually multi-faceted. It was created to help people quit smoking and lose fat by blocking circuitry in the brain that gives the body cravings. The drug works by blocking the same circuitry in the brain that gives pot-smokers the munchies. The drug is expected to receive FDA approval in the first half of 2007.

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!

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?"

There are fears that a new pill under development for the treatment  of Type 2 diabetes could cause an elevated risk of heart attack and stroke. As a result, Bristol-Myers Squibb has announced it is dropping the drug, known as Pargluva. The drug was to have been the front runner in a new type of diabetes medication that controls blood sugar without the use of insulin. Bristol-Myers Squibb had been working on the drug in partnership with Merck. Basically, Bristol-Myers Squibb is quitting while it's still ahead on this one. Although the company has invested a lot in the drug (as in the development of any new drug), the work needed to iron out the wrinkles (ie. risk of heart attack and stroke) would take an estimated five years to complete, which is too long I guess in the world of pharmaceutical product development. Merck dropped out of the project a few months ago following a delay in federal approval.