The Commercialization of Clinical Genetics: An Analysis of Interrelations Between Academic Centers and For-Profit Clinical Genetics Diagnostics Companies

The field of clinical genetics has undergone substantial commercialization, including the development of genetics diagnostics companies. Numerous for-profit corporations now offer genetic diagnostic services; until recently, these clinical services were provided almost exclusively through academic, not-for-profit medical centers. Some of these for-profit corporations have business and/or research relationships with academia. An evaluation of the interconnections between academia and the clinical genetics industry is an important first step in analyzing the risks and benefits of commercialization. We analyzed the personnel and business affiliations of 19 major U.S. for-profit clinical genetics diagnostics companies with universities, academic medical centers, and the scientific and medical genetics communities in a 2-year period, 1991–1992. We noted extensive connections between the for-profit sector and academia. At least 17% of high-ranking personnel and 85% of consultants for the companies had one or more academic ties. At least 68% of the companies had one or more business agreements with at least one university or academic medical center. These results raise many issues regarding the delivery of genetic medicine and the structure and function of academic medical genetics centers.     

Gene therapy: ethical issues

To discern the ethical issues involved incurrent gene therapy research, to explore theproblems inherent in possible future genetherapies, and to encourage debate within thescientific community about ethical questionsrelevant to both, we surveyed American Societyof Human Genetics scientists who engage inhuman genetics research. This study of theopinions of U.S. scientific experts about theethical issues discussed in the literature ongene therapy contributes systematic data on theattitudes of those working in the field as wellas elaborative comments. Our survey finds thatrespondents are highly supportive of thepotential use of somatic cell gene therapy tocure serious diseases in adults and children aswell as prospective offspring. A clearmajority, however, believe that using suchgenetic techniques for enhancement purposes isunacceptable. Delineating the line betweendisease/disorder and improvement/enhancementposes a problem not easily resolved and oneconducive to the growth of slippery-slopeapprehensions. The majority of respondents alsoadvocate germ-line therapy, in theory at least,and under similar restrictions, but theyrecognize the roadblock that the existence ofunanticipated negative consequences currentlypresents. Another complex matter involvestrying to determine appropriate reasons forchoosing target diseases for research, forwhich the dichotomy between rare single-geneand common multifactorial diseases reveals anongoing dilemma.     

Modelling decisions to undergo genetic testing for susceptibility to common health conditions: An ancillary study of the Multiplex Initiative

New genetic tests reveal risks for multiple conditions simultaneously, although little is understood about the psychological factors that affect testing uptake. We assessed a conceptual model called the multiplex genetic testing model (MGTM) using structural equation modelling. The MGTM delineates worry, perceived severity, perceived risk, response efficacy and attitudes towards testing as predictors of intentions and behaviour. Participants were 270 healthy insured adults aged 25–40 from the Multiplex Initiative conducted within a health care system in Detroit, MI, USA. Participants were offered a genetic test that assessed risk for eight common health conditions. Confirmatory factor analysis revealed that worry, perceived risk and severity clustered into two disease domains: cancer or metabolic conditions. Only perceived severity of metabolic conditions was correlated with general response efficacy (β?=?0.13, p<0.05), which predicted general attitudes towards testing (β?=?0.24, p<0.01). Consistent with our hypothesised model, attitudes towards testing were the strongest predictors of intentions to undergo testing (β?=?0.49, p<0.01), which in turn predicted testing uptake (OR 17.7, β?=?0.97, p<0.01). The MGTM explained a striking 48% of the variance in intentions and 94% of the variation in uptake. These findings support use of the MGTM to explain psychological predictors of testing for multiple health conditions.     

Psychosocial Impact of Predictive Testing for Illness on Children and Families: Challenges for a New Millennium

Predictive testing for adult- and child-onset diseases is becoming widely available. The identification of individuals prone to develop certain illnesses is often medically advantageous in that it may afford opportunities to engage in risk reduction behaviors to detect or delay disease onset. However, sometimes the knowledge gained from these tests can be ambiguous, generate distress, and potentially affect several generations of family members. Overall, these factors create a challenging set of circumstances for persons considering genetic and other forms of predictive testing, particularly parents and children. In this article, we (1) address conceptual issues involved in determining the impact of predictive testing on child and family well-being, (2) review empirical data on this topic, and (3) provide a case example to illustrate these findings. Recommendations are made for additional psychological research on child- and family-focused outcomes associated with participation in testing, highlighting their clinical implications.     

The Impact of Changes in the Work Environment on the Place-Identity of Academics: An Exploratory Study

The study examined the impact of changes in the work environment on the construction of place-identity among university academics. Data were collected from five academics at a large distance learning university in South Africa. The institution was undergoing major structural changes at the time of the study. Unstructured questions were used for the data collection. These data were analysed using content analysis and the results suggested academics construct identities towards their place of work and changes to this place may be perceived as a threat.     

浅论医患关系中的权利冲突——以医师的诊疗权与患者的知情同意权为例

现实中医患关系呈现给人们的似乎是永远纠缠不清的利益,掩盖了医惠之间模糊的、缺失的权利。实质上引发医患矛盾的主要原因不是利益而是权利的冲突,从医师的诊疗权与患者的知情同意权的角度出发,分析了医患关系中权利冲突的成因及其表现,提出了相关解决的方法。     

Diverse knowledges and competing interests: An essay on socio-technical problem-solving

Solving complex socio-technical problems, this paper claims, involves diverse knowledges (cognitive diversity), competing interests (social diversity), and pragmatism. To explain this view, this paper first explores two different cases: Canadian pulp and paper mill pollution and siting nuclear reactors in seismically sensitive areas of California. Solving such socio-technically complex problems involves cognitive diversity as well as social diversity and pragmatism. Cognitive diversity requires one to not only recognize relevant knowledges but also to assess their validity. Finally, it is suggested, integrating the resultant set of diverse relevant and valid knowledges determines the parameters of the solution space for the problem. The author is a Professor of Philosophy at The University of Sudbury, Ontario, Canada.     

Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than “minimal risk” (§ 45CFR46.404); or 2) no more than a “minor increase over minimal risk” if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1977. Report and recommendations: Research involving children, Washington, DC: U.S. Government Printing Office.  [Google Scholar] report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.     

Parents’ Perceived Impact of the Societal Lockdown of COVID-19 on Family Well-Being and on the Emotional and Behavioral State of Walloon Belgian Children Aged 4 to 13 Years: An Exploratory Study

This exploratory study assessed parents’ perceptions of the emotional and behavioral impacts of the COVID-19 lockdown on their children. The total sample included 749 children, aged 4 to 13 years old (353 girls, 396 boys); 524 parents took part. The emotional and behavioral changes observed during the societal lockdown, family coexistence, the impact of COVID-19 on family well-being, and the frequency of social contacts before and during this lockdown were investigated. Results show that the most frequently reported difficulties were worry, agitation, anxiety, sadness, loneliness, nervousness, arguing, anger, frustration, boredom, irritability, behavioral problems, and laziness. Family coexistence declined significantly during this lockdown, and parents mentioned that COVID-19 had an impact on family well-being. Various ordinal logistic regressions showed that family coexistence, children’s nervousness due to COVID-19, the impact of COVID-19 on family well-being, age, and social contacts before and during this lockdown seemed to explain the various emotional and behavioral changes observed in children during the societal lockdown. These results are discussed and recommendations are made.