Myriad genetics: Patent law and genetic testing

This paper considers the legal challenges to the legal validity of the patents held by Myriad Genetics in respect of genetic testing for breast cancer and ovarian cancer. It argues that broad-based patents on gene sequences and medical diagnostics will have a harmful effect upon access to patient care, genetic research, and the administration of public health care.

The race to patent the SARS virus: The TRIPS agreement and access to essential medicines

This article considers the race to sequence the Severe Acute Respiratory Syndrome virus ('the SARS virus') in light of the debate over patent law and access to essential medicines. Part II evaluates the claims of public research institutions in Canada, the United States, and Hong Kong, and commercial companies, to patent rights in respect of the SARS virus. It highlights the dilemma of ’defensive patenting' - the tension between securing private patent rights and facilitating public disclosure of information and research. Part III considers the race to patent the SARS virus in light of wider policy debates over gene patents. It examines the application of such patent criteria as novelty, inventive step, utility, and secret use. It contends that there is a need to reform the patent system to accommodate the global nature of scientific inquiry, the unique nature of genetics, and the pace of technological change. Part IV examines the role played by the World Trade Organization and the World Health Organization in dealing with patent law and access to essential medicines. The article contends that there is a need to ensure that the patent system is sufficiently flexible and adaptable to accommodate international research efforts on infectious diseases.

One-step homogeneous C-reactive protein assay for saliva

Background: Cardiovascular disease is the leading cause of death in the world. Human C-reactive protein (CRP) has been used in the risk assessment of coronary events. Human saliva mirrors the body's health and well-being and is non-invasive, easy to collect and ideal for third world countries as well as for large patient screening. The aim was to establish a saliva CRP reference range and to demonstrate the clinical utility of salivary CRP levels in assessing the coronary events in a primary health care setting. Methods: We have used a homogeneous bead based assay to detect CRP levels in human saliva. We have developed a rapid 15 min (vs 90 min), sequential, one-step assay to detect CRP in saliva. Saliva was collected from healthy volunteers (n = 55, ages 20-70 years) as well as from cardiac patients (n = 28, ages 43-86 years). Results: The assay incubation time was optimised from 90 min to 15 mm and generated a positive correlation (n = 29, range 10-2189 pg/mL, r2 = 0.94; Passing Bablok slope 0.885. Intercept 0, p>0.10), meaning we could decrease the incubation time and produce equivalent results with confidence. The mean CRP level in the saliva of healthy human volunteers was 285 pg/mL and in cardiac patients was 1680 pg/mL (p<0.01). Analysis of CRP concentrations in paired serum and saliva samples from cardiac patients gave a positive correlation (r2 = 0.84, p<0.001) and the salivary CRP concentration capable of distinguishing healthy from diseased patients. Conclusions: The results suggest that this minimally invasive, rapid and sensitive assay will be useful in large patient screening studies for risk assessment of coronary events. (C) 2011 Elsevier B.V. All rights reserved.

In step

In Step was a wearable artwork consisting of a pair of embroidered foot bandages and an actuator ‘cushion’ embedded with 15 electromechanical actuator pistons. The bandage was embedded with woven, soft and flexible fabric sensors - interconnected with metallic connecting threads, fasteners and a wireless interface (in a final form). When wrapped around a foot and lower leg the sensors sat on the ball of the toes and heel. This ‘wearable interface’ was then connected wirelessly to a soft sculptural form, which employed actuators to tap gently in response to the qualities of the walk detected by the soft sensors. In this way the ‘tread qualities’ of the walker could then be felt by someone else holding this device against their stomach – thereby allowing pairs of participants to ‘feel’ the tactile qualities of the other's walk. The work was presented both as a working object and via a short videorecorded performance.----- In Step generated innovative new approaches to interface and sensor embedded clothing/footware whilst also creating an evocative vehicle to comment upon contemporary Post Colonial theories of weight and groundedness – particularly the psycho-geographical ‘separation’ from the landscape that inspired Paul Carter’s “environmentally grounded poetics”. The work’s final form also suggested critical new directions for responsive clothing and footwear for the emerging genre of smart textiles.

Digital scholarship and pedagogy, the next step : cultural science.

There are two aspects to the problem of digital scholarship and pedagogy. One is to do with scholarship; the other with pedagogy. In scholarship, the association of knowledge with its printed form remains dominant. In pedagogy, the desire to abandon print for ‘new’ media is urgent, at least in some parts of the academy. Film and media studies are thus at the intersection of opposing forces – pulling the field ‘back’ to print and ‘forward’ to digital media. These tensions may be especially painful in a field whose own object of study is another form of communication, neither print nor digital but broadcast. Although print has been overtaken in the popular marketplace by audio-visual forms, this was never achieved in the domain of scholarship. Even when it is digitally distributed, the output of research is still a ‘paper.’ But meanwhile, in the realm of teaching, production- and practice-based pedagogy has become firmly established. Nevertheless a disjunction remains, between high-end scholarship in research universities and vocational training in teaching institutions; but neither is well equipped to deal with the digital challenge.

An examination of the utility of the AUDIT in people with schizophrenia

Objective: To examine the reliability and validity of the Alcohol Use Disorders Identification Test (AUDIT) compared to a structured diagnostic interview, the Composite international Diagnostic Interview (CIDI; 12-month version) in psychiatric patients with a diagnosis of schizophrenia. Method: Patients (N = 71, 53 men) were interviewed using the CIDI (Alcohol Misuse Section; 12-month version) and then completed the AUDIT. Results: The CIDI identified 32.4% of the sample as having an alcohol use disorder. Of these, 5 (7.0%) met diagnostic criteria for harmful use of alcohol, 1 (1.4%) met diagnostic criteria for alcohol abuse and 17 (23.9%) met diagnostic criteria for alcohol dependence. The AUDIT was found to have good internal reliability (coefficient = 0.85). An AUDIT cutoff of greater than or equal to 8 had a sensitivity of 87% and specificity of 90% in detecting CIDI-diagnosed alcohol disorders. All items except Item 9 contributed significantly to discriminant validity. Conclusions: The findings replicate and extend previous findings of high rates of alcohol use disorders in people with severe mental illness. The AUDIT was found to be reliable and valid in this sample and can be used with confidence as a screening instrument for alcohol use disorders in people with schizophrenia.

The utility and challenges of using ICD codes in child maltreatment research : a review of existing literature

Objective: The objectives of this article are to explore the extent to which the International Statistical Classification of Diseases and Related Health Problems (ICD) has been used in child abuse research, to describe how the ICD system has been applied and to assess factors affecting the reliability of ICD coded data in child abuse research.----- Methods: PubMed, CINAHL, PsychInfo and Google Scholar were searched for peer reviewed articles written since 1989 that used ICD as the classification system to identify cases and research child abuse using health databases. Snowballing strategies were also employed by searching the bibliographies of retrieved references to identify relevant associated articles. The papers identified through the search were independently screened by two authors for inclusion, resulting in 47 studies selected for the review. Due to heterogeneity of studies metaanalysis was not performed.----- Results: This paper highlights both utility and limitations of ICD coded data. ICD codes have been widely used to conduct research into child maltreatment in health data systems. The codes appear to be used primarily to determine child maltreatment patterns within identified diagnoses or to identify child maltreatment cases for research.----- Conclusions: A significant impediment to the use of ICD codes in child maltreatment research is the under-ascertainment of child maltreatment by using coded data alone. This is most clearly identified and, to some degree, quantified, in research where data linkage is used. Practice Implications: The importance of improved child maltreatment identification will assist in identifying risk factors and creating programs that can prevent and treat child maltreatment and assist in meeting reporting obligations under the CRC.