Complacent and conflicting scientific expertise in British and American drug regulation: clinical risk assessment of triazolam

This paper presents a case study in the production and interpretation of regulatory science, focusing on the conflicting British and American clinical risk assessments of triazolam (Halcion) - the most controversial sleeping pill in the world. The regulation of triazolam is shown to be more permissive in the USA than in the UK. Six principal socio-political factors are put forward to explain this; differential regulatory trust; regulators' socio-technical data selections; medico-scientific disciplinary influences; organizational and professional interests; conflicts of interest of expert advisers; and the growth of the neo-liberal regulatory state. The risk assessments of both the British and American regulatory agencies are shown to be complacent relative to technical standards which the agencies themselves later accepted. It is suggested that, when the interests of pharmaceutical manufacturers and patients diverge, regulatory assessments are crucially affected by whether regulators are predisposed to award the benefit of the scientific doubts to the manufacturers or patients, and by the balance of such predispositions both within and between regulatory institutions of scientific expertise. The triazolam case indicates that the amount of trust placed in the pharmaceutical industry by the British American regulatory systems may hamper detection of flaws in manufacturers' medical data in a timely manner and, as a consequence, compromise patients' interests. Some policy implications for drug regulation are sketched.     

The effect of submaximal exercise on recovery hemodynamics and thermoregulation in men and women

Five women and 5 men were studied to examine the effects of submaximal exercise on thermoregulatory and hemodynamic variables during recovery in two environments: (a) control (C), 22 degrees C, 33% rh; and (b) hot humid (H), 32 degrees C. The participants exercised on a cycle ergometer at 60% of peak oxygen consumption for 35 min prior to 90 min of seated recovery. Sessions were identical, except for environment. Variables evaluated (p < .05) were: core temperature (TR), mean skin temperature (Ts), sweat rate (SR), heart rate (HR), stroke index (SI), cardiac index (CI), forearm blood flow (FBF), systolic blood pressure (SBP), and diastolic blood pressure (DBP). Men and women exhibited similar patterns of TR, Ts, and SR in both environments. Ts and SR (collapsed means for gender) were higher in the H than in the C. DBP was higher in men than in women throughout recovery in both environments. With combined means for gender, HR was higher in the H than in the C. CI, SI, FBF, and SBP were similar in both environments and returned to baseline within 15 min into recovery. These data suggest that heat dissipation during extended recovery was accomplished with similar contributions of cutaneous vasodilation and sweating in M and F. Furthermore, the moderate exercise level did not influence hemodynamics beyond 15 min of recovery in either environment.     

Evaluation of a university course to promote physical activity: project GRAD

Project GRAD (Graduate Ready for Activity Daily) evaluates a university course to promote physical activity. In a randomized study, 338 university seniors participated in either an intervention or control course for academic credit, and posttest data were collected on 321. The control course was knowledge-oriented. The intervention course taught behavior change skills in weekly lectures and peer-led labs. Physical activity was assessed with 7-Day Physical Activity Recall interviews. The intervention had no significant effects on men. Among women, the intervention increased total physical activity during leisure, strengthening exercises, and flexibility exercise. This university course had the intended effects of promoting healthful patterns of physical activity among women, but no effects were observed on men, who were more active than women at baseline.     

Submaximal exercise and maturation in 12-year-olds

The aim of this study was to examine the maturation responses of young people to submaximal treadmill exercise. Body mass was controlled using both the conventional ratio standard and allometric modelling. Ninety-seven boys and 97 girls with a mean age of 12.2 years completed a discontinuous, incremental exercise test to voluntary exhaustion. We measured peak oxygen uptake (VO2peak) and VO2 when running at 8, 9 and 10 km x h(-1). Sexual maturation was assessed visually using Tanner's indices of pubic hair. Peak VO2 was significantly higher in boys (P<0.001); this was still the case when the influence of body mass was covaried out. During submaximal exercise, no significant differences in absolute VO2 were observed between the sexes (P>0.05); however, values of VO2, expressed both in ratio with body mass and adjusted for body mass using allometry, were significantly greater in boys than in girls (P<0.001). For absolute VO2, significant main effects (P<0.05) were seen for maturity at each exercise stage. With the influence of body mass controlled using either the ratio standard or allometry, no significant main effects (P>0.05) for maturity were observed. Our results indicate that boys are less economical than girls while running at 8-10 km x h(-1) and that, independently of body mass, maturation does not influence the VO2 response to submaximal exercise.     

The impact of collective efficacy beliefs on effort and persistence in a group task

Collective efficacy is an important determinant of the motivation of individuals within groups, with increases in collective efficacy producing more effort in a task and greater persistence when faced with failure. To test hypotheses concerning the impact of collective efficacy on effort and persistence, participants (n = 22) were assigned to triads (consisting of the participant and two confederates) and performed three time trials on cycle ergometers. After trial 1, the participants were assigned to either a high or low collective efficacy condition, receiving appropriate bogus performance feedback. All groups received failure feedback after trial 2. Effort was assessed by performance time and maximum heart rate (HRmax) achieved during performance. A 2 (collective efficacy condition) x 3 (trials) analysis of variance with repeated measures on trials revealed significant interaction effects for both performance time and HRmax. Fisher's least significant difference post-hoc tests indicated that, following efficacy manipulation, groups low in collective efficacy significantly reduced both their performance time and HRmax, whereas groups high in collective efficacy maintained performance and HRmax. However, predictions concerning the impact of failure on persistence were not supported. Our results provide partial support for the role of collective efficacy in team sports.     

Four-year changes in college athletes' ethical value choices in sports situations.

Positive values for fairness in competition are supposed to undergird the behavior of athletes engaged in sport. Whether athletes' values actually develop over 4 years in a college that emphasizes character development is the focus of this study. Athletes' (N = 631) use of deontological ethics (Hahm, Beller & Stoll, 1989) in 21 sports value dilemmas were evaluated. At entrance, as well as near graduation, intercollegiate athletes' value scores were lower than intramural athletes' scores. Both groups' scores declined while they were in college. Individual-sport athletes had higher scores than team-sport athletes but manifested a greater decline over 4 years. The findings are consistent with other studies that show decreases in "sportsmanship orientation" and an increase in "professional" attitudes associated with participation in sport.