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.

House Calls, a popular newsletter written by the prestigious Dr. Inglis, highlights a very important question in light of the Avandia mishap: how many other potential whistle-blowers are out there who have been silenced into submission before the Big Pharma vultures?

A medical expert testified that he agreed to sign a statement that was meant to appease the company's investors. This is not the type of behavior anyone should expect or dismiss of a doctor, entrusted with a patient's life. In his defense, he did forward a letter with his concerns to the FDA, which means they also were aware of the same threat. This same doctor is the President-elect for none other than the American Diabetes Association. Isn't that special? The ADA -- my friend, my confidant, my utter supporter of the C-peptide crusade ... sense the sarcasm? So much for advocacy, when the president-elect of this organization so willingly swept those safety concerns under the table, when he should have been throwing a tantrum on top of it! And all over the threat of litigation from a drug company more concerned about its investors than patients.

The closing comments in Dr. Inglis' newsletter say it all: There are so many vultures out there waiting to pick the bones of the American public, it disgusts me. This example goes to show why I always recommend to you -- and to all of my patients -- that you always question everything when it comes to your health. I don't care if it's your doctor you've had for 50 years or one of these nonprofit organizations -- give them all hell.

A small molecule has been identified that controls diabetes in mice and may pave the way to the development of easier treatment for adult-onset diabetes.

This key molecule, called Boc5, can stimulate insulin function and reduce body weight by 20%. The molecule stimulates the production of the glucagon-like peptide1 (GLP1), responsible for metabolizing glucose. The study intended to discover ways to sensitize insulin by stimulating production of GLP1. Boc5 is not powerful enough to become a diabetes or weight loss drug. But researchers suggest that similar compounds could join the latest generation of diabetes drugs, called "incretin mimetics." The first FDA-approved incretin mimetic was Byetta. A second such drug, with the generic name liraglutide, is in clinical trials.

The problem with the existing FDA approved incretin mimetic treatments is that they are large molecules that must be administered through injection. Boc5 is a small fry with big potential. Being a smaller molecule gives hope for a new generation in diabetes treatment in the form of a pill many of us would be happy to swallow.

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.

Generex's flagship product, Oral-lyn^TM, is an oral insulin spray for the treatment of type 1 and type 2 diabetes. Their technology permits the delivery of insulin through the oral cavity (with no deposit in the lungs). Whatever you do, don't call it an inhaler.

Oral-lyn^TM is a liquid form of human insulin that is absorbed through the buccal mucosa. Say that three times, fast. It is delivered through the RapidMist^TM device, which looks a lot like an inhaler. But because this device limits absorption to the mouth, there is no entry into the lungs. The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity which makes Oral-lyn^TM an ideal mealtime insulin, as it can be conveniently administered immediately prior to meals with little prospect of hypoglycemia. Oral-lyn^TM can be used as a preventative agent by people with pre-diabetes to delay the onset of diabetes and by patients with type-2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes.

Generex Oral-lyn^TM is expected to lead to an enormous improvement in the quality of life, with the elimination of pain and a significant increase in convenience. This will result in improved compliance with a relative decrease in complications and a significant reduction in the costs associated with treating them. Knowing now that you can non-invasively continuously monitor your blood sugars, patch on your basal rate, and puff (but not inhale) for your meals - I'm going to do my share of screaming from the hilltops to get these devices the attention they warrant.

Dear Mister FDA, please don't give any of these potential pipeline treatments any shenanigans. They deserve a bedtime story and a kiss on the forehead for the promise they bring to us in the cold, weary world of diabetes. Oh yeah-- and please put a little hustle in it! Yours truly, Allie B

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!