The FDA and Cancer

Introduction C ancer is the second leading cause of death in the United States, exceeded only by heart disease, and it is the leading cause of death among those 35 to 64 years of age. One of every four deaths is from cancer. The federal government has spent more than $46 billion on cancer research since President Nixon declared a War on Cancer and Congress passed the National Cancer Act in 1971. In addition, states, private companies, and foundations invest billions of dollars in research and the development of new therapies.This investment recently produced the first evidence of reduced mortality from cancer. Cancer deaths declined 6 percent between 1990 and 1999 after two decades of increase between 1970 and 1990. The benefits have not been uniformly shared among all patient groups or cancer types. Against the big cancer killers, such as lung cancer, there has been little progress. Cancer treatment typically consists of a combination of surgery, radiation, and chemotherapy. Developments in scientific understanding of the basic mechanisms of cellular biology and genetics are beginning to result in newer chemotherapeutic agents. These agents target specific cell receptors to slow or stop the growth of tumors instead of killing all cells undergoing rapid growth and proliferation, both malignant and normal. 6 A handful of drugs with more directed action are used in cancer therapy now, and over 300 new drugs are currently in clinical trials. The new cancer biology presents opportunities and challenges to scientists and the Food and Drug Administration’s review and approval process. Advances in cancer biology and treatment also raise questions regarding the role of the National Cancer Institute (NCI). The Commonwealth Fund is a private foundation supporting independent research on health and social issues.The views presented here are those of the author and should not be attributed to The Commonwealth Fund or its directors, officers, or staff.