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FDA Consumer magazine

September-October 2004 Issue

Observations

Surgery. Chemotherapy. Radiation. For decades, these have been the primary weapons used by physicians in the battle against cancer. And, while the battle is far from being won, there have been victories.

According to a recent report released by the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention, there are about 10 million cancer survivors in the United States. The report defines a survivor as someone who has been diagnosed with cancer, from the time of diagnosis through the balance of his or her lifetime.

Currently, researchers are working to develop new therapies that use the body's own defenses, called the immune system, to fight or prevent cancer. According to the NCI, the immune system generally doesn't recognize cancer cells as dangerous or foreign. That's why tumors may not stimulate an immune response. Although as of August 2004 there are no vaccines licensed by the FDA to treat cancer, there is one vaccine licensed to be used to protect against hepatitis B, an infectious agent associated with liver cancer.

Scientists continue to evaluate several different vaccines in large human clinical trials to determine which may be an effective treatment for particular kinds of cancers. In an effort to improve the review of potential cancer vaccines and imaging devices used in cancer diagnosis and treatment, the FDA is creating a new Office of Oncology Drug Products to consolidate three existing areas within the agency.

For more on the development of cancer vaccines and the hope they hold, see our cover story titled "Cancer Vaccines: Training the Immune System to Fight Cancer."

A chronic skin disease characterized by scaling and inflammation, psoriasis affects between 6 million and 7.5 million Americans, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Psoriasis involves a type of white blood cell called a T cell, which is part of the immune system. The disease occurs when skin cells rise quickly from their origin below the surface of the skin and pile up before they have a chance to mature.

Typically, the result is patches of red, inflamed skin covered with silvery flakes that can appear virtually anywhere on the body. For more on this skin disease and the latest treatments, see our feature story titled "Psoriasis: More Than Cosmetic."

Earlier this year, the FDA released a draft of its new guidelines for manufacturers of breast implants, identifying the type and amount of scientific data that will allow the agency to evaluate whether these products are safe and effective. The new recommendations include guidance on testing, modes and causes of rupture, clinical study information, and labeling.

To find out more about the risks and potential benefits of breast implants, read our feature story "Making an Informed Decision About Breast Implants."

We also take a look at the dangers of unpasteurized milk and explain the results of a new Institute of Medicine report that found no link between childhood vaccines, the preservative thimerosal, and autism.

Ray Formanek Jr.
Editor

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