Delaying approval of a critical drug: Safety,efficacy, economics,compassion

Biotechnological advance is speeding the development of drugs. The approval processes for new drugs will inevitably involve a regulatory agency in making political-economic and scientific choices. Interests of specific patients and the public in general are to be considered, and enormous stakes are involved for companies concerned. A medical regulatory authority must be at once insulated from and responsive to many different mixes of singular and general interests and pressures. Access to new drugs can be spurred by the press of patient advocacy groups, but if there are well organized groups to monitor the testing and approval process for such as AIDS or cancer drugs there is often no similar group to represent patient needs. If there is no organized patient advocacy group, compassionate responsibility by a medical regulatory authority is indeed called for. Delay in the approval of new drugs for fighting severe blood infections raises the question of how to insure the compassionate responsibility of a regulatory authority.     

Measuring and predicting the effects of alcohol consumption on contrast sensitivity for stationary and moving gratings

Contrast sensitivity was measured for 12 healthy young males while sober, after ingestion of an alcohol placebo, and after ingestion of alcohol (95% grain alcohol; mean estimated blood alcohol level = .088%). Observations were made for both stationary gratings and gratings that traveled through a circular path and required pursuit eye movements. The significant alcohol-related reduction in contrast sensitivity was 2.6 times greater for moving (.29-log-unit reduction) than for stationary gratings (.11-log-unit reduction). The loss in contrast sensitivity for the moving gratings of high spatial frequency (12 cpd) was particularly severe (.37 log unit). Estimated blood alcohol level was correlated with the loss in contrast sensitivity for moving gratings (r = .61), but not with the loss for stationary gratings. Estimated blood alcohol level was strongly correlated with the difference between the loss in contrast sensitivity to moving and stationary gratings (r = .75). These results are consistent with reports that alcohol consumption degrades the ability to make pursuit eye movements. Subjects’ perceived intoxication level was not a reliable predictor of any index of visual performance.     

Sweetness suppression in fructose/citric acid mixtures: A study of contextual effects

Twoexperiments investigated whether stimulus context affects ratings for mixtures of dissimilartasting substances (fructose/citric acid) to the same degree that it affects ratings for unmixed substances (fructose). In Experiment 1, replacing mixtures by equisweet unmixed fructose solutions produced virtually no response shifts. The proportion of mixtures in the stimulus set affected only slightly the degree of mixture suppression inferred from the responses. In Experiment 2, both the stimulus type (mixed or unmixed) and the stimulus distribution (positively versus negatively skewed) affected the responses. Several factors that determine the impact of contextual changes are identified: (a) the stage in stimulus processing affected—that of representation on the internal continuum or that of response selection; (b) the size and sources of variation in the affected process; and (c) the degree to which a stimulus is perceptually integrated in the context. In the present study, the sweetness of fructose/citric acid mixtures was largely, but not completely, integrated with the sweetness of unmixed fructose solutions. It is suggested that increased stimulus complexity makes mixture ratings more susceptible to contextual shifts. An analysis relating the size of the contextual shift to the degree of response variability suggests that response-selection processes are more important in determining the responses for unmixed stimuli than they are in determining the responses for mixtures.     

Visual slow brain potentials in children with attention deficit disorder

Using a two-stimulus reaction time paradigm, with two separate reward conditions (contingent and noncontingent), we compared slow wave brain potentials (ERPs) in 144 children with attention deficit disorder (ADD) and 30 normal control children. This article reviews the findings during the 900 msec visual warning stimulus. As we had expected, based on ERP work of Forth and Hare (1989) and Raine, Venables and Williams (1990), and on previous work from our own laboratory, the group differences were found in the negative slow wave portions of the ERP complex during the contingent reward condition but not during the noncontingent condition. Aggressive hyperactive subjects with attention deficit disorder (ADDHA) were discriminated from nonaggressive subjects (including control subjects) during the contingent reward condition in the following ways: (1) greater fronto-central negativity (640–900 msec slow wave) and (2) greater right parietal than left parietal negativity (430–750 msec slow wave). All ADD subgroups, when compared to control (CONTR) subjects, showed greater slow wave negativity (700–900 msec) at the midline occipital electrode site during the contingent reward condition. This could be explained in part as an IQ effect on ERPs reflecting the IQ difference between the ADD subgroups and the controls. These slow wave findings seem to relate to attentional problems of these children. They are discussed in terms of a psychobiological model of inhibition/disinhibition and appetitive activation.     

Matching components of self-report and peer-nomination personality measures

Two common methods of measuring personality variables are examined with respect to the ways in which they control respondent biases. A form of the mental-test theory model is developed which makes explicit differences in score components that result from different methodological constraints imposed by the two methods. From the model, it is possible to specify the operations necessary to provide equivalent information from the two sets of data. Performance of these operations in an empirical test supports the model by producing generally higher correlations between the variables having score components which are more closely matched.