Unique role of consumer studies in nonprescription drug development.

Objective: To inform the health care community about nonprescription drug labeling and consumer studies unique and integral to the nonprescription drug development process.

Setting: Data from consumer studies are essential for many nonprescription drug approvals. These studies are conducted to help predict actual consumer behavior in the marketplace if the product is approved.

Acceleration of autoimmunity by organochlorine pesticides in (NZB x NZW)F1 mice.

Systemic lupus erythematosus (SLE) is an autoimmune disorder that affects women more frequently than men. In the (NZB times NZW)F1 mouse, a murine SLE model, the presence or absence of estrogen markedly influences the rate of progression of disease. Three organochlorine pesticides with estrogenic effects were administered chronically to ovariectomized female (NZB times NZW)F1 mice, and we measured the time to development of renal disease, the principal clinical manifestation of lupus in this model.

Randomized controlled trials in systemic lupus erythematosus: what has been done and what do we need to do?

The study of systemic lupus erythematosus (SLE) is a challenging undertaking. It is difficult to assess outcomes in SLE randomized controlled trials (RCTs), and this is illustrated by the lack of new therapies approved for use in lupus. In a disease that is waxing and waning, and requires constantly changing medications, identifying treatment effects of new therapies may be difficult, and the use of potentially toxic therapies requires a rigorous understanding of the benefit to risk ratio.