Liability of manufacturers and providers of health related goods and services: confronting the dilemma.

In this Article, Theodore Cooper, M.D., Assistant Secretary for Health at HEW, contends that the crush of lawsuits brought by aggrieved health care consumers against medical professionals and institutions, and drug and medical equipment manufacturers, may be the result, in large part, of a widely held impression--often encouraged by members of the health professions and industries themselves--that medicine has unlimited powers to heal. Dr. Cooper suggests that those involved in providing health care services and products--and members of the legal profession-have a responsibility to inform the public that this expectation is unrealistic and that everyone suffers when the number of such lawsuits and the size of damage awards are excessive.     

The Lockhart Review: where now for Australia?

In 2005 a Legislation Review Committee, known as the Lockhart Review, undertook a review of the Commonwealth legislation regulating human embryo research. The report that emanated from the review was released in December 2005. If the report recommendations are implemented by the Federal Government, Australian scientists will be permitted to create human embryo entities currently known as "human embryo clones" by the process known as somatic cell nuclear transfer to develop stem cell lines for research purposes. Many argue that stem cells have the potential to be developed into valuable medical therapies that could assist with, or cure, serious diseases such as Type 1 diabetes and Parkinson's disease. This article analyses the evidence presented to the Lockhart Review and the report recommendations. It assesses where the Lockhart recommendations would place Australia in terms of worldwide embryo research. It is argued that the Federal Government should fully embrace the recommendations so that Australia can progress stem cell research to its fullest potential.     

Validation of the Cozart Amphetamine Microplate EIA for the analysis of amphetamines in oral fluid

The purpose of this study was to determine the performance characteristics of the Cozart Amphetamine Microplate EIA for detecting amphetamine in oral fluid. Oral fluid samples were collected using the Cozart RapiScan Collection System from 135 volunteer donors from drug treatment clinics. A further 35 oral fluid samples were collected from volunteer donors who were not drug users. The samples were analyzed in the laboratory using the Cozart Amphetamine Microplate EIA and confirmed using gas chromatography-mass spectrometry (GC-MS). The samples were stored frozen until analysis by GC-MS. The intra-assay precision for the Cozart Amphetamine Microplate EIA for amphetamine in oral fluid over forty assays was 2.74-7.1% CV (within assay) and 3.4-7.0% CV (within day). A total of 78 samples were positive for various amphetamines and related designer drugs. The Cozart Amphetamine Microplate EIA, using a cutoff of 45 ng/ml amphetamine equivalents in neat oral fluid, had a sensitivity of 91.7+/-3.3% and a specificity of 95.9+/-1.9% versus GC-MS using a cutoff of 30 ng/ml. A series of potential adulterants of oral fluid were evaluated and shown not to alter the outcome of the test result.     

Elevated and similar urinary testosterone/epitestosterone ratio in all samples of a competition testing: suspicion of a manipulation

The case of seven urine samples collected for anti-doping purposes during a cycling stage race with moderately elevated testosterone and epitestosterone ratio (T/E) is reported. The very low probability of having all seven urine samples with such similar elevated T/E ratio (from 3.2 to 4.7) was very suspicious. Different pattern classification tools were tested to categorize the most similar steroid profiles, but none of the models enabled a clear classification of the different urine samples. Subsequently, genetic profiling of all urine samples was performed and demonstrated that three of the seven samples were collected from the same cyclist. Finally, the International Federation confirmed DNA profiling results. This suggests that urinary steroid data using several methodologies are not appropriate for identification purposes and to an extent not unique to individuals.     

Relinquishing custody as a requisite for receiving services for children with serious emotional disorders

A review of the literature was conducted to assess the extent and nature of the practice of requiring parents to transfer custody in order to receive public funding for intensive services needed by their child/adolescent who had a serious emotional disorder. The review focused on the legal and policy basis of this practice as well as its social and psychological impact on child and family. We conclude that the practice of transfer of custody as a requirement for receiving financial aid occurs in a majority of states, though the actual extent of this practice is not known. The major factor influencing the use of transfer of custody appears to be the absence of an appropriate and adequate system of services for children and adolescents with serious emotional disorders. We recommend that the practice of requiring custody transfer for the sole purpose of receiving services be abolished and offer several suggestions for improving acess to services.Preparation of this article was supported in part by the National Institute of Mental Health (NIMH) under contract no. 89MF761903. The authors are grateful to John Burke and Kelly Kelleher of the Division of Biometry and Applied Sciences, NIMH for their assistance on this project. Laurie Flynn, Executive Director for the National Alliance for the Mentally Ill, was very helpful during the informative stage of the project. Barbara Friesen, Director of the Research and Training Center at Portland State University, gave us useful guidance throughout the project. We thank Stephen Hill, Consultant to the National Governors' Association, for his help. We are grateful to Amy Hewitt and Carol Ishler for their assistance in preparing this report. We also would like to acknowledge several individuals who assisted us with research reported in this article. We are grateful to Governor Richard F. Celeste of Ohio for his letter of support for the state survey of custody transfer practices. We appreciate the efforts on behalf of this survey by staff from the State of Ohio, particularly Jean Ellen Stevens, Administrative Assistant to the Director of the Department of Mental Health. Margraret McNally assisted in the compilation of data for both surveys.