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FDA Consumer magazine

March-April 2006

 

Observations

Renaissance painter and sculptor Leonardo da Vinci described the human foot as "a masterpiece of engineering and a work of art." Comedian George Carlin offers a different take: "When you step on the brakes your life is in your foot's hands."

In any case, the feet--composed of 26 bones each and knit together by hundreds of tendons, muscles, and ligaments--are critical to health and to a sense of well-being.

The strides of an average day of walking bring the equivalent of several tons of pressure to the feet, according to the American Podiatric Medical Association (APMA). Little wonder, then, that foot ailments are among the most common health problems.

Studies indicate that 3 out of 4 Americans have some type of foot problem during their lives. And a number of diseases, such as diabetes, kidney problems, anemia, and cardiovascular disorders, often are first detected by symptoms in the feet, the APMA says. For more on foot health, including an illustrated chart showing some common foot ailments, see this issue's cover story titled "Taking Care of Your Feet."

Many researchers now believe that migraine results from genetic mutations at work in the brain. The National Institute of Neurological Disorders and Stroke (NINDS) says that studies of the more rare, familial subtypes of migraine are yielding information about specific genes and what they do, or don't do, to cause the pain of migraine headache.

According to the NINDS, there are two approaches people can use to treat migraine with drugs: preventing the debilitating headaches and relieving the symptoms during a migraine. For more on migraine, its causes, and treatments, see our feature story titled "Managing Migraines."

The Food and Drug Administration has developed three distinct approaches intended to make important treatments for serious diseases available more rapidly to those who desperately need them: "fast track" designation of drugs, "accelerated approval," and "priority review."

Independent researchers affiliated with Tufts University in Boston reported in December 2003 that the clinical development time for fast track drugs was, on average, about two and a half years shorter than that for non-fast track drugs approved between 1998 and 2003.

Accelerated approval allows the FDA to approve drugs for serious or life-threatening illnesses based on clinical trials that indicate possible beneficial results. And the FDA has set a six-month goal for review of priority drugs--those offering a significant improvement over existing treatments or providing a treatment where no adequate therapy exists. For more on the FDA's efforts to make promising treatments available more rapidly, see our feature article titled "The FDA Speeds Medical Treatments for Serious Diseases."

We also take a look at the first inhaled alternative for the 5 million Americans who inject insulin or take pills to control their diabetes, the proper use of a potent skin patch used to control severe pain, and an FDA safety alert on blood glucose meters.

Enjoy!

Raymond Formanek Jr.
Editor

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