Elements of a quality assurance program for pharmaceutical research & development 1

The four major considerations for a pharmaceutical R&D quality program are discussed—protection of resources, compliance, documentation, fitness for use. Viewing R&D as an enterprise necessitates that R&D be seen as making products—data, analysis and interpretation. The applicability of the quality program to these products is discussed.     

An introduction to research on the social impact of the therapeutic community for addiction

An introduction to the issue of research on the social impact of the Therapeutic Community for Addiction (TC) is presented. The TC is argued to originate in 1957 in the California utopian community of Synanon, although earlier antecedents are recognised. The direct scientific influence on the development of Synanon is documented and traced to the discipline of sociology and the social research tradition. The breaking with the authoritarian style of Synanon is seen as a key process in the evolution of the TC. Social innovations created by the TC movement include interracial and interethnic living groups as well as the instilling of democracy in the relations of caring in the state institutions and the civil society. The issues of after-care and the re-entry phase of the TC client to society are seen as the point where the social impact of the TC can begin to be traced. The integration of the TC into larger treatment systems is discussed, both in its positive and negative consequences to the social movement. Historical research needs to be extended beyond familiar sources into the 'grey literature' of TCs and their umbrella organisations. Also, the need to go beyond research that provides an understanding of the past history of the TC is acknowledged. A call for present-oriented sociological research on the impact of the TC on the social networks of clients in re-entry and on socially excluded segments of society that would revitalise the movement is concluded.     

The impact of the daily lottery on the numbers game: Does legalization make a difference?

There has been a profusion of state run legal lotteries over the last two decades. One justification for them has been their supposed diversion of funds from illegal games known as numbers, policy and bolita. Records obtained in a police raid in south Florida provided an opportunity to analyze the impact of Florida' legal lottery on its illegal counterpart. The records ranged over a 13 week period encompassing five weeks prior to the inception of Florida's legal daily numbers and lotto games and seven weeks afterward. While there was a 17 percent decline in monies wagered on the illegal games during the first week of the legal games, illegal wagers quickly rebounded to prelegalization levels.An earlier version of the paper was presented at the annual meeting of the Academy of Criminal Justice Sciences, Washington, D.C., March 1989. The authors wish to express their deep appreciation to the Metro-Dade Police Department, Miami, Florida, and particularly to Max Schuman and Sgt. James Boyd for their assistance in this research.     

The mystical hue in clinical practice

The notion of the mystical hue in clinical practice, viewed essentially as therapist tendency to formulate understandings and interventions from a known frame of reference, is considered from the dimensions of theoretical commitment, technical style, and similarity to psychic processes. Consideration is given to reification, the projective fallacy, and the developmental tilt, for their potential reverberations in practice. Emphasis is placed on the need to formulate experience-near interventions related to the patient's subjective state consistent with the reality that existing well reasoned theory is continually subject to revision. A case is presented in which the patient's subjective experience, imbued with a mystical flavor, was best approached from a mystical perspective familiar to both patient and therapist.