Advancing the science of medicines regulation: the role of the 21st-century medicines regulator.

The history of medicines regulation is punctuated with sudden swings in focus mandated by a public injured by medicines and skeptical of regulators' abilities to protect them. As stakeholder communities and the science that undergirds medicines have both grown more sophisticated, seemingly conflicting mission equities, such as public health protection vs. promotion or population vs. individual patient product development focus, have created new challenges to defining the mission and role of twenty-first-century medicines regulators. The role of medicines regulators as a nationally focused, retrospective assessor of data is rapidly shifting to that of a prospective generator of public data and tools to help drive what has now become a global product development and regulatory enterprise that is fast gaining recognition as an integral part of any truly effective twenty-first-century health-care system. This article discusses this evolution and describes how regulatory science will help to both drive and define it.

Bioterrorism: a challenge to public health and medicine.

Only a few years ago, an attack with a biological agent would have been considered almost unthinkable. Today, however, the threat of bioterrorism is real and growing. This article will provide a brief overview of the threat of bioterrorism, the special role of public health and medicine, and some of the critical issues that need to be addressed as this nation prepares for this disturbing and potentially catastrophic threat.

Declining HIV/AIDS mortality in New York City.

BACKGROUND: New York City has only 3% of the U.S. population but has reported nearly 16% of all AIDS cases. METHODS: This is an observational study using the New York City vital events and AIDS case surveillance registries to describe trends in HIV/AIDS mortality from 1983 through June 30, 1998. RESULTS: Annual HIV/AIDS deaths increased steadily until stabilizing at 7046 in 1995, declined 29% to 4998 in 1996, and declined 47% to 2625 in 1997. Comparing data from 1997 with those from 1995, declines occurred in all demographic groups and in all major HIV transmission categories: 74% in men who have sex with men, 68% in injecting drug users, and 64% in heterosexuals. In the first 6 months of 1998, declines were smaller than they had been in previous 6-month intervals in all demographic groups except Hispanic males and those between 35 and 44 years of age. From 1995 to the first 6 months of 1998, the number of people living with AIDS in New York City increased 22% (from 32,692 to 39,976). CONCLUSIONS: The precipitous 63% decline in HIV/AIDS deaths from 1995 to 1997 occurred at the same time that more effective antiretroviral therapies became widely available. The slowing in the mortality decline observed in 1998, however, suggests that although these new therapies may have a profound effect at the population level, deaths due to AIDS will continue.

Creating training opportunities for public health practitioners.

In response to several reports issued by the federal government and private foundations on the under-training of public health practitioners, Joseph L. Mailman School of Public Health of Columbia University (SPH) and the New York City Department of Health (NYC DOH) initiated the Public Health Scholars program (SPH-PHS) to make degree-level public health training available to NYC DOH employees. Public Health Scholars receive a 50% tuition scholarship and enroll part-time while working full-time at NYC DOH. Sixteen scholars have enrolled during the past three years. The SPH-PHS program is considered a success by both SPH and NYC DOH. This article details the history of the collaboration between the two agencies and the structure of the program and provides a critical analysis of the SPH-PHS program based on interviews with 16 scholars. It also examines the cost and benefit to other schools of public health of implementing such a program.

Tuberculosis in New York City--turning the tide.

BACKGROUND: From 1978 through 1992, the number of patients with tuberculosis in New York City nearly tripled, and the proportion of such patients who had drug-resistant isolates of Mycobacterium tuberculosis more than doubled. METHODS: We reviewed, confirmed, and analyzed data obtained during the surveillance of patients with tuberculosis. RESULTS: From 1992 through 1994, there was a 21 percent decrease in reported cases of tuberculosis in New York City. An evaluation of the surveillance system revealed very few unreported cases. The number of cases decreased by more than 20 percent among blacks and Hispanics, persons with documented human immunodeficiency virus infection, homeless persons, and patients with multidrug-resistant tuberculosis; in all these groups, tuberculosis is likely to result from recent transmission. In contrast, the number of cases of tuberculosis increased among elderly and foreign-born persons, in whom the disease is likely to result from the reactivation of an infection acquired many years earlier. Enrollment in a program of directly observed therapy, in which health workers watch patients take their medications, increased from fewer than 100 patients to nearly 1300, with more than 32,000 patient-months of observation from 1992 through 1994. CONCLUSIONS: Epidemiologic patterns strongly suggest that the decrease in cases resulted from an interruption in the ongoing spread of M. tuberculosis infection, primarily because of better rates of completion of treatment and expanded use of directly observed therapy. Another contributing factor may have been efforts to reduce the spread of tuberculosis in institutional settings, such as hospitals, shelters, and jails. Expansion of measures to prevent and control tuberculosis and support of international control efforts are needed to ensure continued progress.

Perspectives on teaching comprehensive school health.

This paper seeks to give some perspective to health education teaching as it has developed over a period of time. First, I review the source of our modern comprehensive sequential curriculum design--just to remind us of its roots. Following that, I describe current developments in teaching, highlighting some examples of widely used curricula and sources of other teaching aids for health. Finally, I review some relevant findings from a recent evaluation of comprehensive health education in U.S. public schools to show us where we are today and to help answer the questions: "Is comprehensive school health education worthwhile?"