Big Data, Health Care, and International Human Rights Norms

Carole J. Petersen 이화여자대학교 생명의료법연구소 2017 Asia Pacific Journal of Health Law & Ethics Vol.11 No.1

In the era of “big data,” researchers manage high-volume, high-variety, and high velocity data sets, which are increasingly available to the general public. This paper explores the human rights implications of data-driven health care, focusing on the rights of persons who either live with disabilities or may be perceived as having an elevated risk of developing a disability in the future. Access to high-quality data at reasonable cost can help governments to fulfill the right to health, which is well established in international human rights law. The data revolution has also empowered individuals to take greater control over their own health and to monitor their governments’ compliance with human rights treaties, including the Convention on the Rights of Persons with Disabilities (CRPD). Yet big data can also inadvertently promote discrimination and violations of privacy. In theory, governments should ensure confidentiality and respect for the privacy of individuals’ health data. In practice, it is difficult to prevent data miners from using re-identification techniques to link anonymized health information with non-medical open data. It is therefore important to enact antidiscrimination legislation that prohibits not only discrimination on the ground of existing, past, and imputed disabilities but also discrimination on the ground of a disability that may develop in the future. Governments may also need to take a proactive approach and require employers, insurance companies and other private actors to disclose whether they are using re-identification processes or purchasing health-related data from data brokers.

Promoting the Rights of Older Persons : Addressing Adult Guardianship and Substituted Decision-Making in Health Care

Carole J. Petersen 이화여자대학교 생명의료법연구소 2016 Asia Pacific Journal of Health Law & Ethics Vol.10 No.1

Population aging has captured the attention of the international human rights movement and raised new questions regarding the legal framework for promoting and protecting human rights. Laws that promote “guardianship” of older citizens and other systems of substituted decision-making are particularly controversial. While many governments insist that these laws are necessary to protect older citizens, the disability rights movement and the UN Committee on the Rights of Persons with Disabilities has offered a strong critique of adult guardianship, viewing it as an inherent violation of an individual’s right to legal capacity. Interestingly, this debate regarding substituted decision-making has arisen while the international community is considering whether to draft a new multilateral human rights treaty dedicated to the rights of older citizens. If the UN ultimately decides to undertake this project, then the drafters of the new treaty will need to confront, directly, the ethics of adult guardianship and consider whether it can be retained (albeit with increased safeguards to prevent abuse) or must be rejected as an inherent violation of human rights.

Genetic Characterization of Indigenous Goats of Sub-saharan Africa Using Microsatellite DNA Markers

Chenyambuga, S.W.,Hanotte, O.,Hirbo, J.,Watts, P.C.,Kemp, S.J.,Kifaro, G.C.,Gwakisa, P.S.,Petersen, P.H.,Rege, J.E.O. Asian Australasian Association of Animal Productio 2004 Animal Bioscience Vol.17 No.4

Genetic diversity of sub-Saharan African goats was assessed using 19 microsatellite markers. Breeds were sampled from eastern Africa (Maasai, Kigezi, Mubende, North West Highland, Arsi-Bale), southern Africa (Ndebele, Pafuri) and West Africa (West African Dwarf, Maure, Djallonke). European breeds (Grisons Striped, Toggenburg), Asian breeds (Mongolian Cashmere, Bandipur) and a Middle East breed (Arab) were also included. The mean number of alleles per locus and average gene diversity ranged from 5.26$\pm$0.464 (Djallonke) to 7.05$\pm$0.516 (Mubende) and from 0.542$\pm$0.036 (Pafuri) to 0.672$\pm$0.031 (Ndebele), respectively. The between breeds variation evaluated using $$G_{ST}$$ and $\theta$ were found to account for 14.6% ($\theta$) and 15.7% ($$G_{ST}$$) of the total genetic variation. The $D_{A}$ measure of genetic distance between pairs of breeds indicated that the largest genetic distance was between Pafuri and Djallonke while the lowest genetic distance was between Arsi-Bale and North West Highland. A neighbour-joining tree of breed relationships revealed that the breeds were grouped according to their geographic origins. Principal component analysis supported the grouping of the breeds according to their geographic origins. It was concluded that the relationships of sub-Saharan African goat breeds were according to their geographical locations implying that the goats of eastern Africa, West Africa and southern Africa are genetically distinct. Within each sub-region, goat populations could be differentiated according to morphological characteristics.

Dynamic Expansion of Gastric Mucosal Doublecortin-Like Kinase 1-Expressing Cells in Response to Parietal Cell Loss Is Regulated by Gastrin

Choi, E.,Petersen, C.P.,Lapierre, L.A.,Williams, J.A.,Weis, V.G.,Goldenring, J.R.,Nam, K.T. American Association of Pathologists and Bacteriol 2015 The American journal of pathology Vol.185 No.8

Doublecortin-like kinase 1 (Dclk1) is considered a reliable marker for tuft cells in the gastrointestinal tract. We investigated the dynamic changes of tuft cells associated with mouse models of oxyntic atrophy and metaplasia in the stomach. Increases in the numbers of Dclk1-positive tuft cells were observed in several models of parietal cell loss. However, the expanded population of Dclk1-expressing cells showed a morphologically distinct structure in apical microvilli and acetylated microtubules, which was not seen in the tuft cells present in the normal gastric mucosa. These microvillar sensory cells (MVSCs) showed no evidence of proliferation. The expansion of the MVSCs induced by oxyntic atrophy was reversible after the return of parietal cells. More important, expansion of MVSCs after induced parietal cell loss was not observed in Gast<SUP>-/-</SUP> mice. Although the Dclk1-expressing cells in the normal gastric mucosa were in part derived from Lrig1-expressing stem cells, the Lrig1-lineaged cells did not produce the expanded Dclk1-expressing cells associated with oxyntic atrophy. These studies indicate that loss of parietal cells leads to the reversible emergence of a novel Dclk1-expressing sensory cell population in the gastric mucosa.

Daclatasvir Plus Sofosbuvir ± Ribavirin for Treating Chronic HCV Infection in Patients with Advanced Liver Disease: European Compassionate Use Program Results

( Sandzhar Abdullaev ),( T. M. Welzel ),( J. Petersen ),( K. Herzer ),( P. Ferenci ),( M. Gschwantler ),( M. Cornberg ),( P. Ingiliz ),( T. Berg ),( U. Spengler ),( O. Weiland ),( M. Van Der Valk ),( 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

Aims: The all-oral, pan-genotypic combination of daclatasvir+sofosbuvir± ribavirin (DCV+SOF±RBV) demonstrated high sustained virologic response rates at posttreatment Week 12 (SVR12) in phase 3 studies of patients with chronic HCV. We report efficacy and safety results from a large European compassionate use program that provided DCV+SOF±RBV therapy to patients with chronic HCV infection and severe liver disease. Methods: Eligible patients were adults with chronic HCV infection at a high risk of hepatic decompensation or death within 12 months if left untreated, or urgent need of viral clearance due to extrahepatic manifestations or comorbidities, and with no available treatment options. Patients received DCV(60mg)+SOF(400mg) once daily for 24 weeks; RBV addition or reduced treatment duration was the physician’s choice. The primary efficacy outcome was SVR12. Results: Efficacy data were available for 436/485 patients enrolled. Most patients were HCV treatment experienced (70%) with mean HCV RNA 5.5 log10 IU/mL. 388 (80%) patients had confirmed cirrhosis( Child-Pugh class B or C, 165 (43%); MELD scores>15, 37 (10%)) , 87 patients (18%) had received liver transplants and 55 (11%) were HIV/HCV coinfected. SVR12 was achieved by 394/436 (90%) patients (table). There were 13 relapses and 1 on-treatment virologic failure. SVR12 rates were similar with/without ribavirin and comparable across HCV GT, presence of cirrhosis, liver transplant status, HIV coinfection, and other baseline characteristics. There were 28 deaths over treatment or follow-up (none considered treatment-related), 91 experienced serious adverse events (11 considered treatment-related), and 38 discontinued treatment or died due to adverse events (10 treatment- related). Most deaths and serious adverse events were directly or indirectly associated with advanced liver disease. Adverse events (any grade) occurring in ≥5% of patients were fatigue, anaemia, headache, nausea, and diarrhoea. Conclusions: The all-oral regimen of DCV+SOF±RBV was highly effective and well tolerated in this large European real-world cohort of patients with advanced liver disease.

Risk of dementia in stroke-free patients diagnosed with atrial fibrillation: data from a community-based cohort.

Miyasaka, Yoko,Barnes, Marion E,Petersen, Ronald C,Cha, Stephen S,Bailey, Kent R,Gersh, Bernard J,Casaclang-Verzosa, Grace,Abhayaratna, Walter P,Seward, James B,Iwasaka, Toshiji,Tsang, Teresa S M Academic Press 2007 European Heart Journal Vol. No.

<P>AIMS: To estimate the incidence of dementia after the first atrial fibrillation (AF), and its impact on survival in a community-based cohort. METHODS AND RESULTS: Olmsted County, Minnesota adult residents diagnosed with first AF during 1986-2000 were identified, and followed until 2004. The primary outcome was new detection of dementia. Interim stroke was censored in the analyses. Of 2837 subjects (71 +/- 15 years old) diagnosed with first AF and without any evidence of cognitive dysfunction or stroke at the time of AF onset, 299 were diagnosed with dementia during a median follow-up of 4.6 years [interquartile (IQR) range 1.5-7.9 years], and 1638 died. The Kaplan-Meier cumulative rate of dementia was 2.7% at 1 year and 10.5% at 5 years. After adjustment for age and sex, dementia was strongly related to advancing age [hazard ratio (HR)/10 years, 2.8; 95% confidence interval (CI), 2.5-3.2], but did not vary with sex (P = 0.52). The occurrence of post-AF dementia was associated with significantly increased mortality risk (HR 2.9; 95% CI 2.5-3.3), even after adjustment for multiple comorbidities, and did not vary with age (P = 0.75) or sex (P = 0.33). CONCLUSION: Dementia appeared common following the diagnosis of first AF, and was associated with premature death.</P>

Electromagnetic Detection and Real-Time DMLC Adaptation to Target Rotation During Radiotherapy

Wu, Junqing,Ruan, Dan,Cho, Byungchul,Sawant, Amit,Petersen, Jay,Newell, Laurence J.,Cattell, Herbert,Keall, Paul J. Elsevier 2012 International journal of radiation oncology, biolo Vol.82 No.3

<P><B>Purpose</B></P> <P>Intrafraction rotation of more than 45° and 25° has been observed for lung and prostate tumors, respectively. Such rotation is not routinely adapted to during current radiotherapy, which may compromise tumor dose coverage. The aim of the study was to investigate the geometric and dosimetric performance of an electromagnetically guided real-time dynamic multileaf collimator (DMLC) tracking system to adapt to intrafractional tumor rotation.</P> <P><B>Materials/Methods</B></P> <P>Target rotation was provided by changing the treatment couch angle. The target rotation was measured by a research Calypso system integrated with a real-time DMLC tracking system employed on a Varian linac. The geometric beam-target rotational alignment difference was measured using electronic portal images. The dosimetric accuracy was quantified using a two-dimensional ion chamber array. For each beam, the following five delivery modes were tested: 1) nonrotated target (reference); 2) fixed rotated target with tracking; 3) fixed rotated target without tracking; 4) actively rotating target with tracking; and 5) actively rotating target without tracking. Dosimetric performance of the latter four modes was measured and compared to the reference dose distribution using a 3 mm/3% γ-test.</P> <P><B>Results</B></P> <P>Geometrically, the beam-target rotational alignment difference was 0.3° ± 0.6° for fixed rotation and 0.3° ± 1.3° for active rotation. Dosimetrically, the average failure rate for the γ-test for a fixed rotated target was 11% with tracking and 36% without tracking. The average failure rate for an actively rotating target was 9% with tracking and 35% without tracking.</P> <P><B>Conclusions</B></P> <P>For the first time, real-time target rotation has been accurately detected and adapted to during radiation delivery via DMLC tracking. The beam-target rotational alignment difference was mostly within 1°. Dose distributions to fixed and actively rotating targets with DMLC tracking were significantly superior to those without tracking.</P>

Vector prime protein boost vaccination in the setting of myeloablative-induced lymphopenia suppresses growth of leukemia and solid tumors

Han, T H,Tang, Y,Park, Y H,Maynard, J,Li, P,Akbulut, H,Petersen, L,Deisseroth, A Macmillan Publishers Limited 2010 Bone marrow transplantation Vol.45 No.3

We have developed a vaccine, which is designed to induce tumor-associated antigen (TAA)-specific T cells and antibodies in the setting of profound lymphopenia induced by myeloablative therapy and T-cell-depleted bone marrow transplantation. Test mice were injected subcutaneously (sc) with the 32DP210Bcr-Abl cell line, which is positive for the p210Bcr-Abl protein (Group 1). In Group 2, 7 days after injection of the 32DP210Bcr-Abl positive cell line, the mice received 900 cGy total body irradiation (TBI) followed in 1 h by the intravenous infusion of 10 million T-cell-depleted syngeneic bone marrow cells (TCDBMT) (Group 2). The leukemia-bearing group received an intravenous injection of 10 million spleen cells (donor lymphocyte infusions) from unvaccinated (Group 3) and TAA/ecdCD40L-vaccinated (Group 4) syngeneic mice 3 days after completion of the TBI and TCDBMT. Groups 3 and 4 mice received three additional sc vaccinations at 7-day intervals with the TAA/ecdCD40L vaccine, in which the TAA was taken from the junctional peptide of the P210bcr-Abl protein. The survival of Groups 3 and 4 mice was significantly longer than that in Groups 1 and 2 mice. Vaccinated mice from Group 4, which developed complete responses, survived up to 350 days post-injection of the leukemia cells without any evidence of leukemia regrowth.