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[The tuberculosis situation in the German Federal Republic (author's transl)].

Based on a statistical anlaysis of the records the present tuberculosis situation in Germany and how it has developed during the past years are reviewed. The main means of control are: BCG vaccination, mass radiography and public health measures. Suggestions made by the Central Committee for the Control of Tuberculosis concerning surveillance and protection against occupational exposure to tuberculous infections are discussed. Recommendations regarding the assessment of incapacity for work and degree of disablement are evaluated. The aims and plans of the Committee for the next years, also in the international field, are reviewed.

BCG Vaccine↗

[Prospective development of cancer mortality in the German Federal Republic (author's transl)].

The absolute number of cancer deaths in males will rise considerably up to the year 2070 from about 76,000 per year in 1976 to an estimated 92,000 in 2070. The numbers will then fall to an extent which is dependent on the future birth rate. The absolute number of cancer deaths among females will remain at the present level until about the third decade of the next millenium and then fall variably depending on the development of the birth rate. The expected increase in cancer deaths among males with a rate of increase of up to 20% (!) is explained by the incipient change in the age structure of the German population alone and needs no reference to carcinogens in our environment.

Adolescent↗

Industry, academia, investigator: managing the relationships.

Financial self-interests in medical research are again the subject of increasing public and government concern. Proposed new statutes and regulations would prescribe research conduct and oversight, as well as faculty behavior, in ways that would represent an unprecedented interposition of federal authority into areas of traditional university autonomy. Overly zealous regulation could also interdict a fruitful product development pathway of enormous benefit to public health. Yet, the universities and their academic medical centers have failed to respond sufficiently or credibly to the profound transformation of their research culture in the past two decades, which has witnessed a dramatic increase in the privatization of historically public biomedical research, and in the financial self-interests of investigators and institutions in the research they conduct. The author reviews the history of federal regulation of individual conflicts of interest in biomedical research, and examines the always-complex relationships and expectations of research universities with industry and society. While university oversight of individual conflicts of interest demands strengthening, the issues are long debated and well understood. In contrast, the financial interest of institutions in the medical research they conduct is recent, more complicated, poorly understood, and highly sensitive, involving investment decisions that lie at the heart of university autonomy. The author argues that institutions and professional societies must promulgate and enforce transparent standards of conduct, and strengthen oversight and management of financial self-interests, to avoid burdensome federal intervention and corrosive public skepticism. He concludes by reporting three promising responses from academia and major medical journals.

Academic Medical Centers↗

Evaluation approaches in mental health: implications of the new federalism.

Since the introduction of federal mental health legislation in 1963, there has been a changing emphasis on evaluation and accountability. With direct federal funding of community mental health services, accountability demands were met through expectations for local agency evaluation activities which were overseen by federal authorities. The advent of the New Federalism and the shift to block grant funding of mental health services to state mental health authorities have shifted responsibility for evaluation to the states and local programs. This paper reviews federal mental health statutes to trace the extent and locus of required evaluation activities and discusses two approaches to carrying out program evaluation: "top-down" where the evaluation topic, method, and data collection are mandated by an administering or funding body; and "bottom-up" approaches where the subject, method of study, and data to be collected are developed in response to a felt need at the local agency level. A case study of each approach as used at the state level in mental health is examined. Based on the literature and the case studies, conclusions are presented on the pro's and con's of each method in meeting accountability demands and the barriers which must be overcome for either method to be successful.

Community Mental Health Centers↗

[GCP inspections of clinical trials].

The new regulations on clinical trials with medicinal products for human use include rules for Good Clinical Practice (GCP) inspections. These rules pertain to such inspections as part of the surveillance program of the relevant state authorities, in preparation for a decision on the authorization of clinical trials by the federal authorities, and pre and post approval GCP-inspections as one tool of Good Regulatory Practice (GRP). The overall aim of such inspections is to verify compliance with the provisions on GCP and, thus, to ensure the protection of trial subjects, the credibility and reliability of clinical trial results, and the pro-active protection of patients. Since inspection results have to be acknowledged by other member states, there is an increasing importance for quality assurance and harmonization of inspection procedures. As in most cases a considerable number of sites are involved in the conduct of clinical trials in different member states, there is a need for coordination of GCP inspections between these states.

Clinical Protocols↗

A lesson from the smog capital of the world.

The history of air pollution control in the Los Angeles area shows a gradual transfer of authority from city and county to state and federal government. The relative role of the various levels of government is discussed. Regional control will become increasingly important with standards set or approved by state and federal authorities. Progress is noted in the control of both stationary and moving sources, but long-range planning of the development of our urban complex with an overriding regard for its effect on the environment is needed if the technological innovations are to keep pace with the demands of an ever-increasing population.

Air Pollution↗

Drug testing as part of the war on drugs.

Drug testing programs in the United States may broadly be classified as mandatory (such as under DOT or Nuclear Regulatory Commission regulation) or nonmandatory. In the first group, a regulated employer is required by federal regulations to test. In the second, the employer chooses to test for reasons other than the federal requirements. It always was intended that the federal program would be the model for testing by private employers, and that mandatory testing would be extended to private employers who are regulated by various agencies of the federal government. This has happened. In addition, private employers who are not required to test under federal authority have instituted employee drug testing programs closely modeled on the federal program. Whether mandated or not, a well-designed and implemented drug testing program is a valuable tool in the effort to fight drugs in the workplace.

Government↗

Federal grant support to general practice residency programs in dentistry: results of two years of funding.

The Health Professions Educational Assistance Act of 1976 (P.L. 94-484) authorized federal grant support to general practice residency programs. This paper reports the results of two years of funding under this authority. In this period, 46 institutions received grants totalling $7.8 million for the purpose of enlarging enrollments, hiring faculty and support staff, improving facilities, and related purposes. Three hundred eighty-six residents were enrolled in grant-supported programs; 118 of these residents received federal financial assistance. Dental departments in hospitals located in the eastern part of the country were the major recipients of these grants. Additional information related to program and trainee data, sponsorship of programs, developmental stage of programs, geographic location of programs, and funding by budget category is presented.

Academic Medical Centers↗

State services for children: an exploration of who benefits, who governs.

In recent years, equity, choice, and efficiency issues in the provision of education have received much attention and analysis. Yet, in the area of other state services for children (health, protective services, day care, etc.), there has been scant concern for equity, efficiency, or choice, despite the fact that out-of-school influences can be crucial in determining in-school performance. This paper reports on work in progress that reaches the following initial conclusions: 1. In the field of children's social services, data compilation is approximately 20 years behind the state of the art for education. Basic data on services provided is not collected for submission to state or federal authorities in any standard format on a recurring basis. 2. From the limited data available, the access of children to quantity and quality in social service programs varies enormously within states. The variations are much larger than those discovered in the public financing of education even before the recent school finance reform movement (1968-1978). 3. Federal allocations to states for social service programs comprise a substantial proportion of state Title XX budgets. For several reasons, the degree of accountability for these funds is less than that for federal education grants. 4. In all three states Title XX state allocations to localities are purported to be based on need. Closer examination of the formulas, and interviews with policy makers, revealed that Title XX allocations are determined primarily by political criteria.

California↗

Establishing remediation levels in response to a radiological dispersal event (or "dirty bomb").

The detonation of a radiological dispersal device (RDD) could produce significant social and economic damage, the extent of which would depend largely on how quickly and effectively cleanup levels were established and on public acceptance of those levels. This paper shows that current radiological cleanup laws and regulations, models for converting dose or risk goals to cleanup concentrations, and existing site-specific criteria were not designed specifically for RDD cleanups but, absent changes, would apply by default. The goals and approaches of these legal and methodological structures often conflict; using them in response to terrorism could undermine public confidence, cause delays, and produce unnecessary costs or unacceptable cleanups. RDD cleanups would involve immediate priorities not envisioned in the existing radiological cleanup framework, such as balancing radiation risks with the health, economic, and other societal impacts associated with access to the infrastructure necessary to sustain society (e.g., hospitals, bridges, utilities). To minimize the achievement of terrorism goals, the elements of an RDD cleanup response--including updating existing legal/regulatory structures to clarify federal authority, goals, and methods for developing RDD cleanup criteria--must be in place soon; given the complexity of the issues and the potential societal impact, this effort should be expedited.

Disaster Planning↗

Reform of health insurance in the Federation of Bosnia and Herzegovina.

The aim of this report is to provide an overview of the reform of health insurance in the Federation of Bosnia and Herzegovina (FBH). Health financing and resource allocation policies in the FBH are also summarized. Health financing should be ensured through three types of health insurance: compulsory, supplementary, and voluntary. The revenues for the compulsory health insurance will be ear-marked through payroll taxation. Facing the scarcity of resources, the Federation authorities have decided to raise the proportion of the payroll contribution as compared to the pre-war level and engage in various arrangements of cost-sharing and priority setting in health care. The resource allocation policy underlines two key parts of the health care reform: contracting mechanisms and payment systems. We also discuss the optimal correlation between solidarity and competition in the course of the ongoing reform of the health insurance in the Federation. The social function of a competent health system, where the well-being of the population is viewed as a sociological category of the overall society's concern, requires considerable subsidization. Incentive-based market mechanisms may be introduced into some of the segments of health care system but only under government-led control of the effects of such measures.

Bosnia and Herzegovina↗