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.

It hasn't gone unnoticed - the cost of healthcare is rising, diabetes diagnoses are rising, the pharmaceutical industry has dramatically increased its investment in research and development -- but that has not translated into more new treatments.

Between 1993 and 2004, funding for new drug applications submitted to the FDA increased almost a 150%. However, the number of new drug applications increased only 38%. Of those applications, only 7% were for innovative drugs with new ingredients. The Government Accountability Office (yes there is such a thing) says the reason for unimpressive returns on medical research funding dollars is due to the difficulty of developing new treatments, combined with marketplace pressure to produce blockbuster new drugs.

The phenomenon known as "me too" drugs (where companies produce drugs similar to drugs already on the market) has also become much more common. These drugs offer little in the way of innovation. However, despite the economic challenges of bringing new and innovative drugs to market, the pace of scientific discovery has increased substantially in the past 10 years - 56 diabetes drugs in development, alone. As the cost of discovering new medicines rises, it becomes more difficult for drug companies to recover these costs. It seems the research dollars are plentiful but ideas for new drugs can't compete with all the profit-decaying hurdles along the way. It's not a problem of interest until it's your own. I wouldn't wish diabetes on anybody-- even those who care more about the profit margin versus the quality of life of the person taking the pill.

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.

What is all the diabetic buzz about these days? Byetta and Exubera are certainly two biggies. My intention is to tantalize your interest in these juicy topics and leave a little to the imagination. Don't fret, I have a direct route to the quickest answers to any burning questions about these monster topics.

Byetta is getting a lot of attention nowadays. It comes from a poisonous lizard, the Gila monster. So quite literally, it really is monstrous. But don't let that discourage you from looking into it as a potential enhancement to your diabetes management. Many people have been pleased with its appetite suppressing, weight reducing attributes. Call it a shot of heroism -- since you must take it by injection. Traditional drugs to treat type 2 diabetes tend to cause a surge in appetite and weight gain. Could Byetta be the brute force to reckon with these dispiriting effects?

Exubera, what do you have to say for yourself? You can start by bragging that over 90% of the patients who tested you in clinical trials have chosen to continue using you. So the question is does this stuff work? It sounds like the answer is a resounding YES. Exubera is the newest form of insulin to hit the market since the debut of insulin, around 1890 (but please, don't quote me). You inhale it! The common concerns for this delivery of insulin include: how accurate is the dosing? What will be the long-term effects on your lungs? How long does the inhaled dose last? Will it need to accompany injections of longer-acting insulin? View the dLife TV interview with Dr. David Nathan, of Massachusetts General Hospital, and Ed a type 2 diabetic who has used Exubera for 9 years.

dLifeTV clears the air with answers to some of the common questions about Byetta and Exubera. Watch dLifeTV, airing every Sunday evening on CNBC, 7:00 PM on the East coast, 6:00 PM Central time and every Sunday morning on DIRECTV channel 251 at 7.30 AM Eastern time zone.