Patients with hepatitis, pneumonia and Lyme disease can be treated sooner and with greater assurance thanks to four new tests approved in 1999. They include the first home test for hepatitis C virus and an improved supplemental test to confirm screening test results for antibodies to the hepatitis C virus, which is the nation's most common blood-borne infection and a leading cause of liver damage. From the Center for Devices and Radiological Health, we have seen the new T-Scan, an imaging device that will help radiologists determine whether a woman should be evaluated further when the results of her mammograms are ambiguous. In addition, cardiac patients can benefit from three new devices approved by FDA last year. The common denominator in all these product review decisions is the importance of assuring safety and demonstrating efficacy.
Efficacy is the most obvious.
It is the safety part of the equation where the agency spends a great deal of time weighing the benefits and risks of medical products. During the course of a medical product safety review, it is simply not feasible for the agency to identify every potential risk associated with the use, and abuse, of the product. A key issue is how extensively a product should be studied to uncover adverse reactions before approval. Balancing whether knowing everything is worth keeping patients who need therapies absolutely risk-free. Obviously there is less certainty with a study of 500 people than one with 5,000 or 50,000.