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.     

A model for the study of research and education in a transdisciplinary context

In an evaluation project at the Goteborg University, we have looked at the relationship between individual and collective production of knowledge within the Health sciences in order to facilitate a common ground for a Academy of Health Sciences. We found obstacles for developing an environment which could stimulate multilateral co-operation and creativity. Some of these obstacles have their root in the different cultural backgrounds indicated in the analysis and makes it difficult to find common aims and strategies. The Model used makes the organizations’ activities visible and encouraging transdisciplinary contacts and improve organizational, structural and ideological decision making emanating from overall policies of the boards concerned.     

Modeling semantic memory: Effects of presenting semantic information in different modalities

How is semantic information from different modalities integrated and stored? If related ideas are encountered in French and English, or in pictures and sentences, is the result a single representation in memory, or two modality-dependent ones? Subjects were presented with items in different modalities, then were asked whether or not subsequently presented items were identical with the former ones. Subjects frequently accepted translations and items semantically consistent with those presented earlier as identical, although not as often as they accepted items actually seen previously. The same pattern of results was found when the items were French and English sentences, and when they were pictures and sentences. The results can be explained by the hypothesis that subjects integrate information across modalities into a single underlying semantic representation. A computer model, embodying this hypothesis, made predictions in close agreement with the data.     

Cognitive behavior therapy in treatment-naive children and adolescents with obsessive-compulsive disorder: an open trial

This work aims is to evaluate the therapeutic efficacy of cognitive behavior therapy (CBT) in pediatric patients with obsessive-compulsive disorder (OCD) who had not previously been treated with either pharmacotherapy or psychotherapy and who remained medication-free during CBT. Sixteen OCD outpatients, 8-17 years of age, were treated in a 12-week open trial with manualized CBT. Target symptoms were rated at two-week intervals with the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), the National Institute of Mental Health Global Obsessive-Compulsive Scale (NIMH Global), the Clinical Global Impression Scale (CGI), and the Hamilton Anxiety Rating Scale (Ham-A). Statistical analyses showed a significant benefit for treatment. Ten patients experienced at least a 50% reduction in symptoms on the CY-BOCS; seven were asymptomatic on the NIMH Global. These results build on previous reports that CBT may be effective in the acute treatment of pediatric OCD. Further, the results of this study suggest that CBT can be efficacious in alleviating OCD symptoms in the absence of pharmacotherapy. These results must be considered preliminary, given the small sample size and open administration of treatment.     

Cognitive deficits in major depression

Major depression is a mood disorder that is often accompanied by the impairment of cognitive functions. Although suggestive, the large range of existing neuropsychological, neuropsychiatric, and, lately, neuroimaging investigations have not yet given a consistent picture of the psychological and biological disturbances involved in this psychiatric disorder. The present study of the cognitive functions in depression was part of an extensive investigation, including neuropsychological testing, psychiatric examination, and neuroimaging. A representative sample of 40 severely depressed hospitalized patients and a group of 49 closely matched control subjects were tested with an extensive neuropsychological test battery. Results, corrected for various confounding factors, confirmed the current notion that depressed patients suffer from wide-spread cognitive impairments. The group analysis did not allow any hypothesis on a possible pattern to the dysfunctions, but heterogeneity in the test performances calls for further analysis of the data in patient subgroups in relation to neuroimaging results.     

Correlates of aggression in African American and Puerto Rican children

The authors examined a cross-sectional interrelationship of psychosocial domains as they relate to aggression in a group of African American and English-speaking Puerto Rican children living in New York City. The population included 80 biological children of African American and Puerto Rican young adults who had been participating in the authors' ongoing longitudinal study, and 77 mothers or mother substitutes (rearing mothers) of those children. The authors performed hierarchical multiple regression analysis. The results indicated that (a) the child's personality and maternal attributes were significantly related to the child's aggression, despite control on all of the other domains and (b) the ethnic identification and discrimination domain was no longer related to the child's aggression with control on the mother-child relationship domain or on the child's personality domain. The findings have implications for clinical practice and public policy.