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.     

Elemental analysis of human cremains using ICP-OES to classify legitimate and contaminated cremains

The Tri-State Crematory Incident in Nobel, GA (February 2001) revealed limitations in traditional human cremated remains (cremains) analytical methodology. The goal of this study was to develop a method for effectively classifying questionable sets of cremains as legitimate or contaminated. Eighty-eight samples of known human cremains, concrete, mixtures of the two, and questionable sets of cremains were acid digested and analyzed for 21 elements by Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES). Variable cluster and principle component analyses identified the seven elements (Sb, B, Li, Mn, Sr, Tl, and V) used to develop discriminant functions to classify questionable sets into two groups: cremains and concrete. The discriminant analysis shows that at the 0.90 probability level, mixtures of 50% or less human content were classified as concrete. Mixtures with 90% human content classified as cremains. Sixty percent and 75% human content mixtures remained in the questionable classification, but as the concentration of human increased in the mixture, the probability of assignment to the known cremains group increased. Most of the questionable human samples classified as cremains. This is a pilot study and cannot yet satisfy Daubert standards for courtroom admissibility, but it indicates that it is possible to determine the legitimacy of cremains using elemental analysis by ICP-OES coupled with multivariate statistical analysis.     

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.