Articles focusing on ethical & regulatory aspects of innovative approaches:
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Pharmacogenetics: a new challenge for health law
Ref: HD Roscam Abbing (2007) Med Law 26(4): 781-9
The medical professional standard must prevent negative effects of pharmacogenetic on individual rights; notably the right (not) to know, to privacy & to informed consent. This article discusses the challenges of pharmacogenetic data in this respect and highlights some of the issues. The article has focus on the use of pharmacogenetic data by third parties (insurers) and the potential for a disproportionate intrusion of privacy which may have adverse impact for the individual.
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Law should recognize value of interspecies embryos (Correspondence)
Ref: St John JC, Armstrong L, Minger SL & Campbell KHS (2008) Nature 451, 627 (7th Feb)
Inter-species somatic-cell nuclear transfer (human cell transfer into animal egg) - highlight aims and advantages relating to generation of interspecies embryos in relation to current debate on Human Fertilisation & Embryology Bill.
Ref: Editorial Nature 452, 388 (27 March 2008)
A cautionary note against the rush to publish w.r.t. induced pluripotent stem cell research (iPS) and negative impact on quality of research. Includes reference to key iPS article; Aoi T, Science 2008 Feb 14 [Epub ahead of print] "Generation of pluripotent stem cells from adult mouse liver and stomach cells".
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Clinical trials & healthy volunteers
Ref: Ferguson PR Medical Law Review, 16 Spring 2008, pp23-51
Article describing the TGN1412 phase 1 healthy volunteer trial, which resulted in multiple organ failure for 6 men, and the legal issues arising from this. Also reports the findings of a study the author conducted prior to this event, looking into volunteer motivations & perceptions of these trials.
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Predictive genetic testing of children for adult -onset diseases and psychological harm
Ref: Malpas PJ J Med Ethics 2008; 34: 275-278
A discussion focusing on the two key arguments against testing currently healthy, asymptomatic children for adult-onset diseases; a) future life limitations and b) damage to self-esteem in the event of a positive test result. The author suggests that these may not apply in all cases and the risks of psychological harm may be less significant if the appropriate support is in place.
General Updates:
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Rare gene defects might add up to schizophrenia
Ref: Callaway E, NewScientist.com news service 27 March 2008
News that a genetic case control study comparing subjects with schizophrenia vs healthy subjects has indicated a role for rare mutations, ie duplications and deletions in the condition, with 15% affected having such mutations compared to 5% of healthy controls.
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Umbilical cord blood cell therapy may treat cognitive decline of Alzheimer's disease, animal study suggests
Ref: ScienceDaily Mar 27 2008
News article highlighting novel strategy which may help improve pathology and cognitive decline associated with Alzheimer's disease on the basis of results published in journal article; "Peripherally administered human umbilical cord blood cells reduce parenchymal and vascular beta-amyloid deposits in Alzheimer mice" Stem Cells & Development, Nikolic WV et al, 2008 Mar 26 [Epub ahead of print]
News & Articles relating to biomarkers and diagnostics:
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FDA may soon support biomarker tests
Ref: Fernholm A, San Francisco Chronicle, Apr 17 2008 [available via http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/04/16/BU58105CNM.DTL]
An article highlighting some of the biomarker work being carried out under the FDA Critical Path Initiative at the Critical Path Institute. The article focuses on efforts to qualify 7 markers predictive of kidney toxicity but also provides background information on biomarkers.
News & Articles relating to immunotherapy and gene therapy:
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More accurate means of diagnosis & monitoring cancer offered by new technologies
Ref: Medical News Today, 17 Apr 2008 [available via www.medicalnewstoday.com/articles/104351.php]
A summary of 4 research abstracts presented at the Annual Meeting of the American Association for Cancer Research, April 12-16. Each focuses on the use of irregular molecules found within different tissue (oral epithelium, saliva, fallopian tube epithelium & serum) that may provide approaches to monitor, predict or diagnose certain cancers.
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Breakthrough in gene therapy for cancer offered by tiny magnets
Ref: Medical News Today, 18 Apr 2008 [available via www.medicalnewstoday.com/articles/104586.php]
News of a revolutionary cancer treatment to enable human monocytes to target tumours using nanomagnets. Following injection, the nanomagnet-armed monocytes are attracted to the tumour site by a magnetic field created by the placement of a magnet over the tumour. The full research will be published in the June edition of Gene Therapy.
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Immunotherapy: enlisting the immune system to fight cancer
Ref: Medical News Today, 16 Apr 2008 [available via www.medicalnewstoday.com/articles/104253.php]
A summary of 4 research abstracts presented at the Annual Meeting of the American Association for Cancer Research, April 12-16. Some of the latest research efforts have focused on different cellular strategies, including vaccine approaches, for cervical cancer, prostate cancer and various advanced cancers.
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In blood vessel stents, innovative materials allow better control, delivery of gene therapy
Ref: Medical News Today, 16 Apr 2008 [available via www.medicalnewstoday.com/articles/104148.php]
News article outlining the advanced gene therapy delivery techniques developed by cardiology researchers in Philadelphia. A synthetic material which can bind various gene therapy vectors has been shown to bind adenoviruses to bare metal stents and it is hoped that this method may be used to treat artery disease in humans. The group published their study this week online in 'Circulation'.
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