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PubMedDate not supplied

Patients' fear of genetic discrimination by health insurers: the impact of legal protections.

PURPOSE: The impact of laws restricting health insurers' use of genetic information has been assessed from two main vantage points: (1) whether they reduce the extent of genetic discrimination and (2) whether they reduce the fear of discrimination and the resulting deterrence to undergo genetic testing. A previous report from this study concluded that there are almost no well-documented cases of health insurers either asking for or using presymptomatic genetic test results in their underwriting decisions, either before or after these laws, or in states with or without these laws. This report evaluates the perceptions and the resulting behavior by patients and clinicians. METHODS: A comparative case study analysis was performed in seven states with different laws respecting health insurers' use of genetic information (no law, new prohibition, mature prohibition). Semistructured interviews were conducted in person with five patient advocates and with 30 experienced genetic counselors or medical geneticists, most of whom deal with adult-onset disorders. Also, multiple informed consent forms and patient information brochures were collected and analyzed using qualitative methods. RESULTS: Patients' and clinicians' fear of genetic discrimination greatly exceeds reality, at least for health insurance. It is uncertain how much this fear actually deters genetic testing. The greatest deterrence is to those who do not want to submit the costs of testing for reimbursement and who cannot afford to pay for testing. There appears to be little deterrence for tests that are more easily affordable or when the need for the information is much greater. Fear of discrimination plays virtually no role in testing decisions in pediatric or prenatal situations, but is significant for adult-onset genetic conditions. CONCLUSION: Existing laws have not greatly reduced the fear of discrimination. This may be due, in part, to clinicians' lack of confidence that these laws can prevent discrimination until there are test cases of actual enforcement. Ironically, there may be so little actual discrimination that it may not be possible to initiate good test cases.

Ethics, Medical↗
PubMed1995

A novel multivariate approach for estimating the degree of similarity in bioavailability between two pharmaceutical products.

Statistical assessment of bioavailability and bioequivalence of drug products is generally carried out with a univariate analysis by independently comparing each relevant parameter [such as, area under the drug concentration curve (AUC) and peak drug concentration (Cmax)] of the test and reference products. The assumption is made that AUC and Cmax are independent of each other. In reality, AUC, Cmax, and other pharmacokinetic parameters are dependent on each other. Therefore, a multivariate approach is theoretically superior. In this report, a novel multivariate approach to determine the bioavailability and bioequivalence of pharmaceutical products is described. The method determines the bivariate confidence ellipse (CE) between Cmax and AUC and the trivariate confidence ellipsoid (CED) among Cmax, AUC, and either Tmax or MRT for test and reference products. The similarity between the test and reference products can be assessed by the fraction of overlapping areas of CE and volumes of CED. The method and its comparison with conventional univariate analysis are demonstrated with data obtained from a bioequivalence study of ketoconazole tablets.

Analysis of Variance↗
PubMed2004

Erosion of regression effect in a survival study.

Lack of persistence, or erosion, of the regression effect is an alternative to proportional hazards of particular interest in many medical applications. Such a departure from proportional hazards is often the most likely direction in which the model may be inadequate. Questions such as, is the effect of treatment only transitory or to what extent does an initially measured prognostic variable maintain its impact, frequently arise. In the context of a simple changepoint model, we propose a test of the null hypothesis of proportional hazards against the specific alternative of erosion of the regression effect. The particular changepoint model used can be viewed as a first approximation to a more complex reality, an approximation that enables us to avoid specifically modeling the functional form that any erosion might take. Practical guidelines for carrying out the test are provided. The approach is illustrated in the context of a study on risk factors for breast cancer survival.

Biometry↗
PubMed1992

Bi-directional transmission of molecular information by photon or electron beams passing in the close vicinity of specific molecules, and its clinical and basic research applications: 1) Diagnosis of humans or animal patients without any direct contact; 2) Light microscopic and electron microscopic localization of neuro-transmitters, heavy metals, Oncogen C-fos (AB2), etc. of intracellular fine structures of normal and abnormal single cells using light or electro-microscopic indirect Bi-Digital O-Ring Test.

In 1985, Omura, Y. discovered that, when specific molecules were placed anywhere in the close vicinity of the path of a light beam (laser), their molecular information, as well as information on electrical & magnetic fields, is transmitted bi-directionally along the path of this light beam. Namely, this information is transmitted in the direction the light beam is projected and towards the direction from which the light beam is coming. This finding was applied to the following clinical and basic research: 1) In the past, using indirect Bi-Digital O-Ring Test, human or animal patients were diagnosed through an intermediate third person holding a good electrical conducting probe, the tip of which was touching the part of the patient to be examined. However, in order to diagnose the patient in isolation from a distance, or a dangerous or unmanagable unanesthesized animal, such as a lion or tiger, the author succeeded in making a diagnosis by replacing the metal conducting probe with a soft laser beam which is held by the one hand of the third person whose index finger is placed in close vicinity of the laser beam generated by a battery-powered penlight-type solid state laser generator. Thus, diagnosis within visible distance, without direct patient contact, became a reality. 2) Using a projection light microscope, by giving indirect Bi-Digital O-Ring Test while contacting with a fine electro-conductive probe on the magnified fine structure of normal and abnormal cells, various normal and abnormal intracellular substances were localized through a third person holding a pure reference control substance with the same hand that is holding the probe as an intermediary for the indirect Bi-Digital O-Ring Test. Instead of the photon beam in a light microscope, the author found that, using an electron beam passing through the close vicinity of specific molecules of specimens in an electron microscope, the molecular information is transmitted to the magnified fluorescent screen, and an indirect Bi-Digital O-Ring Test could be performed through a projected penlight-type solid state soft laser beam on the magnified intracellular structure through an observation glass window. Using the magnified fine structure of the cells, by either a light projection microscopic field or electron microscope, in various cancer cells of both humans and animals, Oncogen C-fos (AB2) and mercury were found inside of the nucleus. Integrin alpha 5 beta 1 was found on cell membranes and nuclear cell membranes of cancer cells. Acetylcholine was not found anywhere within cancer cells.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗
PubMed2003

Genes and gene polymorphisms associated with periodontal disease.

The scientific literature during the last ten years has seen an exponential increase in the number of reports claiming links for genetic polymorphisms with a variety of medical diseases, particularly chronic immune and inflammatory conditions. Recently, periodontal research has contributed to this growth area. This new research has coincided with an increased understanding of the genome which, in turn, has permitted the functional interrelationships of gene products with each other and with environmental agents to be understood. As a result of this knowledge explosion, it is evident that there is a genetic basis for most diseases, including periodontitis. This realization has fostered the idea that if we can understand the genetic basis of diseases, genetic tests to assess disease risk and to develop etiology-based treatments will soon be reality. Consequently, there has been great interest in identifying allelic variants of genes that can be used to assess disease risk for periodontal diseases. Reports of genetic polymorphisms associated with periodontal disease are increasing, but the limitations of such studies are not widely appreciated. While there have been dramatic successes in the identification of mutations responsible for rare genetic conditions, few genetic polymorphisms reported for complex genetic diseases have been demonstrated to be clinically valid, and fewer have been shown to have clinical utility. Although geneticists warn clinicians on the over-enthusiastic use and interpretation of their studies, there continues to be a disparity between the geneticists and the clinicians in the emphasis placed on genes and genetic polymorphism associations. This review critically reviews genetic associations claimed for periodontal disease. It reveals that, despite major advances in the awareness of genetic risk factors for periodontal disease (with the exception of periodontitis associated with certain monogenetic conditions), we are still some way from determining the genetic basis of both aggressive and chronic periodontitis. We have, however, gained considerable insight into the hereditary pattern for aggressive periodontitis. Related to our understanding that it is autosomal-dominant with reduced penetrance comes a major clinically relevant insight into the risk assessment and screening for this disease, in that we appreciate that parents, offspring, and siblings of patients affected with aggressive periodontitis have a 50% risk of this disease also. Nevertheless, we must exercise caution and proper scientific method in the pursuit of clinically valid and useful genetic diagnostic tests for chronic and aggressive periodontitis. We must plan our research using plausible biological arguments and carefully avoid the numerous bias and misinterpretation pitfalls inherent in researching genetic associations with disease.

Aggressive Periodontitis↗
PubMed2005

Real-time haptic-teleoperated robotic system for motor control analysis.

A versatile teleoperated robotic system was created as an assessment device for testing upper-extremity motor control adaptation using different control strategies. While many systems display output virtually on a computer monitor, this system was designed to output in three-dimensional physical space. The system accepts haptic force and torque input, and outputs robot end-effector displacements and rotations in three spatial dimensions. Benefits of this system include flexibility to conduct a variety of dissimilar tasks and reality of user feedback in physical space. Two separate experiments validated the teleoperated robotic system. The first experiment tested unimanual human motor control and the second tested bimanual motor control. This teleoperated robotic system can be used as an assessment device to study neuromuscular adaptability via a variety of control strategies providing a new and functional approach to human motor control analysis.

Arm↗
PubMed2004

The role of haplotypes in candidate gene studies.

Human geneticists working on systems for which it is possible to make a strong case for a set of candidate genes face the problem of whether it is necessary to consider the variation in those genes as phased haplotypes, or whether the one-SNP-at-a-time approach might perform as well. There are three reasons why the phased haplotype route should be an improvement. First, the protein products of the candidate genes occur in polypeptide chains whose folding and other properties may depend on particular combinations of amino acids. Second, population genetic principles show us that variation in populations is inherently structured into haplotypes. Third, the statistical power of association tests with phased data is likely to be improved because of the reduction in dimension. However, in reality it takes a great deal of extra work to obtain valid haplotype phase information, and inferred phase information may simply compound the errors. In addition, if the causal connection between SNPs and a phenotype is truly driven by just a single SNP, then the haplotype-based approach may perform worse than the one-SNP-at-a-time approach. Here we examine some of the factors that affect haplotype patterns in genes, how haplotypes may be inferred, and how haplotypes have been useful in the context of testing association between candidate genes and complex traits.

Genetic Predisposition to Disease↗
PubMedDate not supplied

Oral insulin and the induction of tolerance in man: reality or fantasy?

Induction of tolerance to insulin, the only beta-cell-specific antigen in Type 1 diabetes, is under testing for prevention of Type 1 diabetes in the US multicentre trial DPT1. Recently a multicentre double-blind trial with oral insulin in patients with recent onset Type 1 diabetes, conducted by our group, has been completed and showed that oral insulin administration at the dose of 5 mg daily for one year starting at the time of disease onset had no effect on residual beta-cell function as assessed by C-peptide secretion. A similar trial using different doses was carried out at the same time and similarly showed no beneficial effect on the decline of beta-cell function during the first year after diagnosis. In this study oral insulin was administered at the daily doses of 2.5 and 7. 5 mg over a one-year period. Such results challenge the current view that induction of oral tolerance can be established when the immune process is already active.

Administration, Oral↗
PubMed1997

[Future developments in genetic research. II. Psychological and social aspects].

Regarding the determination of genetic risk factors for serious diseases, the main question for a patient's young relatives is 'to know or not to know'. The answer depends among other things on the assessment of the severity of the disorder and the magnitude of the risk in relation to the population risk and on the availability of therapeutic or preventive measures. Experience with the requests for and the coping with results of the presymptomatic DNA test for untreatable neurodegenerative chorea of Huntington show that expectations about the effect of predictive DNA studies are often different from reality. A problem of a different nature arises in multifactorial diseases such as mammary or colonic carcinoma, because irrespective of the DNA study it remains uncertain whether or not the disease will occur. Nevertheless more than half of the healthy relatives of a patient with breast cancer requests DNA testing and a large majority of the proven carriers of a BCRAI and BRCA2 mutation chose for bilateral mastectomy and oophorectomy. Many questions about psychosocial consequences of predictive DNA testing remain to be answered: what will be the effect of early medicalization, how will relations be affected and which effect will carriership of genetic risk factors have on behaviour? Dutch legislation provides adequate guarantees against the use by third parties of results of genetic testing. The question remains, however, how future internationalization will work out in this respect. The possibly far-reaching social and psychological consequences of genetic research make some people feel that restraints should be imposed on this research. However, there are more grounds for curiosity and enthusiasm to constantly find new solutions for the new problems.

Adult↗
PubMed2006

Manufacturing immunity to disease in a test tube: the magic bullet realized.

Although it took over one hundred years, Ehrlich's concept of the magic bullet is now a reality. Today, therapeutic antibodies are, arguably, the most important class of new drugs for the treatment of illnesses ranging from Alzheimer's disease to cancer. The emergence of therapeutic antibodies had to wait for advances in immunochemistry that allowed construction of antibodies in vitro. The centerpiece of the new technology is the combinatorial antibody library, which essentially allows one to synthesize an artificial immune system with a diversity that exceeds that of the natural repertoire. The construction of such libraries was perceived to be difficult because, if the natural immune system was to be used as the starting material, construction of the libraries would entail protocols that are the opposite of usual cloning. In gene cloning one starts with complexity and reduces it to a singularity. In the generation of diversity by construction of combinatorial antibody libraries, one starts with a collection of clones, randomly expands their complexity, and then returns them to recoverable singularities. The methods developed to accomplish this seemingly formidable task now allow construction of antibodies in a test tube to any antigen. These synthetic antibodies may be qualitatively and quantitatively superior to those of nature.

Antibodies↗
PubMed2005

Reality orientation therapy combined with cholinesterase inhibitors in Alzheimer's disease: randomised controlled trial.

BACKGROUND: Reality orientation therapy combined with cholinesterase inhibitors has not been evaluated in patients with Alzheimer's disease. AIMS: To perform such an evaluation. METHOD: We randomly assigned 79 of 156 patients treated with donepezil to receive a reality orientation programme. Caregivers of the treatment group were trained to offer the programme at home 3 days a week, 30 min/day, for 25 consecutive weeks, and were invited to stimulate and involve patients in reality-based communication. RESULTS: The treatment group showed a slight improvement in Mini-Mental State Examination (MMSE) scores (mean change +0.2, s.e.=0.4) compared with a decline in the control group (mean change -1.1, s.e.=0.4; P=0.02). Similarly for the Alzheimer's Disease Assessment Scale--Cognition (treatment group mean change +0.4, s.e.=0.8; control group -2.5, s.e.=0.8; P=0.01). The intervention had an equal effect on cognition in those with mild (MMSE score > or = 20) and moderate (score <20) dementia. No significant effect was observed for behavioural and functional outcomes. CONCLUSIONS: Reality orientation enhances the effects of donepezil on cognition in Alzheimer's disease.

Adult↗
PubMed2006

Effectiveness of virtual reality exposure in the treatment of arachnophobia using 3D games.

Buying or creating a virtual reality (VR) software is very costly. A less expensive alternative could be to modify already existing 3D computer games. The goal of this study is to assess the effectiveness of in virtuo exposure in the treatment of arachnophobia using modified 3D games. Participants were 10 women and 1 man. Virtual worlds were created using the game editor of a 3D computer game (Half-Life), modified to offer graduals hierarchies of fearful stimuli (spiders). Analyses revealed significant improvement between pre and post results on the behavioral avoidance test, the Spider Beliefs Questionnaire, and perceived self-efficacy. These promising results suggest that therapy using virtual reality exposure via a modified computer game is useful in the treatment of arachnophobia.

Adult↗
PubMed1998

Verification of statements about story worlds that deviate from normal conceptions of time: what is true about Einstein's Dreams?

College students read chapters from a novel written by Alan Lightman (Einstein's Dreams) and later provided verification judgments on the truth/falsity of test statements. Each chapter described a different fictional village that incorporated assumptions about time that deviate from our normal TIME schema, e.g., citizens knowing exactly when the world will end, time flowing backward instead of forward. These novel assumptions about time provided interesting insights about life and reality. In two experiments, we examined whether readers could accurately incorporate these novel assumptions about time in the fictional story worlds, as manifested in the verification judgments for statements after story comprehension. The test statements included verbatim typical, verbatim atypical, inference typical, and inference atypical information from the perspective of mundane reality that meshes with a normal TIME schema. Verification ratings were collected on a 6-point scale in Experiment 1, whereas Experiment 2 used a signal-response technique in which binary true/false decisions were extracted at-.5, 1.5, 3.5, 5.5, and 10.0 s. The college students were measured on literary expertise, reading skill, working memory span, and reading time. Readers with comparatively high literary expertise showed truth discrimination scores that were compatible with a schema copy plus tag model, which assumes that readers are good at detecting and remembering atypical verbatim information; this model predicts better (and faster) truth discrimination for verbatim atypical statements than for verbatim typical statements. In contrast, fast readers with comparatively low literary expertise were compatible with a filtering model; this model predicts that readers gloss over (or suppress) atypical verbatim information and show advantages for verbatim typical information. All groups of readers had trouble inferentially propagating the novel assumptions about time in a fictional story world, but the slower readers were more accurate in their verification of the atypical inferences. A construction-integration model could explain the interactions among literary expertise, reading time, and the typicality of test statements.

Humans↗
PubMed1999

Neuronavigation.

The fact that the visualization process has been deferred since MRI and CT scanning have become the imaging standards for today's neurosurgeons has led to the importance of developing a tool for testing and teaching young pediatric neurosurgeons in the future. Navigation and teaching in a virtual reality model seems a sound solution.

Developed Countries↗
PubMedDate not supplied

Medical computers from the manufacturer's viewpoint.

The recent surge in the scope of computer applications in medical care has brought with it great strides in patient care, but it has also created a variety of concerns to manufacturers of medical software. The spate of product liability suits, with its potentially crippling effects in terms of product development, makes it increasingly vital that manufacturers engage in prospective planning, to anticipate problems and take steps before legal action ensues, so that all parties--the manufacturer, the hospital, and ultimately, the patient--benefit from the availability of new technology. The Food and Drug Administration (FDA) and Congress are similarly grappling with the implications of this new technology, to assure that patient care is not compromised by products that have not yet been fully tested. The tension between the desire to make technology available to the public and the realities of the present regulatory and litigious climate is the key dilemma facing manufacturers of medical software.

Commerce↗