Table of Contents

June 2000
Vol. 3, No. 5

FEATURES
28	Phase IV: When and why Kathleen Wong Although FDA approval bestows a license to market a drug for commercial use, it also limits the marketing claims and recommendations for the doses, formulations, medical indications, and patient populations that were tested and approved during the Phase III trials. If there is a desire to alter any of these parameters, a postmarketing, or Phase IV, study is initiated. Postmarketing studies can be initiated by a drug company, re-quested by the FDA, or conducted by third parties interested in examining a drug's application for a specific population, medical condition, or use in the home or clinic. Such studies can take from two weeks to several years to complete, but the result can be much bigger sales.
35	Redeeming thalidomide Jim Kling The infamous antinausea medication and sedative that caused tens of thousands of birth defects a half century ago, thalidomide shows promise in various therapeutic areas such as cancer and autoimmune diseases, although its side effects range from discomforting to frightening. The drug's soiled reputation presents challenges to clinical development, the most pressing of which is to guard against women taking the drug while pregnant.
40	Monitoring medications in the marketplace Carol Hart Postmarketing drug safety problems can be quite difficult to predict or prevent. It is well known, for example, that premarketing clinical trials do not have the statistical power to detect rare adverse drug reactions-those that occur at rates of 1 in 10,000 drug exposures or less. Registries and record linkage studies are two of the approaches that are being applied in safety studies by the newly formed Centers for Education and Research in Therapeutics, an independent organization.
47	Paying for "lifestyle drugs" Crispin Littlehales Drugs that treat nonacute conditions such as impotence, baldness, and obesity are a fast-growing category in the pharmacopoeia. An aging population of baby boomers with high disposable incomes is attracting pharmaceutical industry attention, but most managed care organizations resist paying for this type of therapeutic. The controversy surrounding these drugs touches on deep philosophical, political, and economic issues.
55	Drug Discovery Technology 2000: A preview Norton P. Peet The Boston meeting draws big pharma, biotech, academia, and government.