Get Well in '05!

By Alice Park

SCANNING PHARMACY SHELVES FOR THE LATEST OFFERings from the drug industry can give you a pretty good idea of what's ailing America. Next year, then, given the sharp increase in diabetes among children, the shelves are sure to be packed with a spate of new remedies and health aids for the diabetic crowd. And with the population living longer, we'll see more and more products for oldsters, including a drug that strengthens bones and an injectable pain-killer. Here are the most promising developments in the pipeline for 2005:

o Diabetes

NAVIGATOR

For the millions of diabetics who test their glucose by pricking their finger up to eight times a day, Abbott researchers have come up with a less painful alternative-- a patch called the Navigator, which is embedded with a wireless transmitter that can read glucose levels once a minute and works for three days at a time before needing to be changed. The continuous sugar-level readings are sent to a small receiver kept in a pocket or purse, and originate from the patch's hairlike filament that penetrates ever so slightly beneath the skin. But it doesn't probe deep enough to draw blood. Instead it measures glucose levels in the body's interstitial fluid. These readings often lag behind actual blood-sugar levels by about 15 minutes, but experts say that's still plenty of time to spot a problem. Navigator's repeated readings let patients know when their glucose levels are trending dangerously high or low--or holding steady. And that's particularly liberating for Type 1 diabetics, who cannot make enough insulin to harness their sugar levels and therefore need to maintain strict control over their blood sugar. It's also helpful for Type 2 diabetics, whose bodies cannot process the insulin they have. By knowing their sugar levels, they can plan how much to eat or exercise (both of which change glucose in the blood).

EXUBERA

For 80 years, the best option for diabetics to make up for the body's inability to keep sugar in check has been to inject insulin. But by 2005, some diabetics may be able to breathe their way to better control of their disease. Exubera, already being considered for sale in Europe, would, if approved, become the first inhaled insulin for diabetics in the U.S. and would be a welcome option for Type 2 patients who may need insulin boosts before meals. One issue that the FDA will be watching carefully is how the insulin powder affects the lungs and whether it causes breathing problems, tumor growth or fibrosis. So far, studies show that after a few years of treatment patients exhibited slightly decreased lung function on certain breathing tests, although they did not report any shortness of breath.

o Cancer

CLOFARABINE

While scientists continue to design smarter drugs that can target only wayward tumor cells, few remedies are tailored specifically for children who, primarily for safety reasons, are left out of trials. But their options might expand if Genzyme and Ilex receive approval for Clofarabine, which could become the first medication in more than a decade green-lighted to treat pediatric leukemia exclusively. The drug meddles with a tumor cell's ability to replicate its DNA properly. In a small study of children who have not responded to existing treatments, 31% responded to Clofarabine.

o Osteoporosis

OPORIA

For the elderly, particularly post-menopausal women, weakened and brittle bones often lead to fractures and physical disability. Oporia, which belongs to a class of estrogen-like compounds known as selective estrogen receptor modulators (SERMs), may soon help women keep their bones strong. Early studies hint that Oporia may raise spinal bone density more and maintain its effect longer than the currently available SERM, raloxifene.

o Smoking

VARENINCLINE

From Pfizer, Varenincline is the first non-nicotine agent developed to help smokers quit. The pills activate the nicotine receptor, fooling the smoker into thinking his craving has been satisfied. In a seven-week trial, researchers reported a 50% quit rate, an improvement over the 7%-10% success with the patch or gum after six months.

o Pain

DYNASTAT

Its motto might be: No pain, no pain. Pfizer has already received approval for Dynastat--the first injectable COX-2 inhibitor--overseas, but is likely to face more scrutiny by the FDA after Vioxx, which belongs to the same family of pain-killers, was pulled off the market last week. If approved, Dynastat could be used to relieve post-op pain and reduce the need for habit-forming opiates such as morphine.