Fostering public engagement in the ethical and social implications of genetic technologies

Government seems more interested in our genes than our voices

This is a pivotal time for the future of human genetic technologies. New gene editing techniques such as CRISPR/Cas9 suggest that any limits to the uses of genetic engineering will not be due to the technology itself, but to political decisions. Given that the application of such technologies is a matter of choice, public debate about the acceptability of these practices has to rise to the occasion.   Last year, in an attempt to build consensus for the regulation of these techniques, pioneers in the field of genetic engineering called for a moratorium on human germ-line editing. The scientists argued that genetic interventions on eggs, sperm, or early embryos posed substantial risks to future generations. It was noted that even just accepting the therapeutic use of genetic engineering to fix ‘faulty’ ...
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Privacy Concerns in the Development of Personalised Medicine and the 100,000 Genome Project

With the UK launch of 23andMe’s home DNA testing kit, the legalisation of mitochondrial DNA transfer, and the 100,000 Genome Project underway, optimism abounds about the science of genetics delivering on its early promise. But there is also cause for greater caution and oversight than some biotechnology enthusiasts would like to admit. These developments are taking place with insufficient regard for their social and ethical implications. We can, however, be sure that the policies and regulatory frameworks currently being enacted will shape future decisions. A balance needs to be struck between the pro-R&D agenda that is driving a permissive regulatory regime, and sensitivity towards concerns about genetic technologies - that public consultation, if properly conducted, can alert us to. It is in the public interest that there is wider discussion ...
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23andMe: Screening a Personalised Medicine Company for Ethical Problems

With the information that our genomes hold we can make better decisions and be more proactive when it comes to our health. We can now personalise medicine. 23andMe, the Google-backed personal genetics company, are working towards exactly that. According to their co-founder, 23andMe promises nothing less than to “revolutionize health care”. They have certainly made an impression: since launching their Personal Genome Service in 2008 (initially costing £636, now £125), 23andMe has received Time magazine’s Invention of the Year award and amassed 650,000 genotypes from customers – the largest single collection of DNA in existence. But their revolution has not gone entirely as planned. With controversy following controversy, last November 23andMe were forced to stop selling their genetic testing products in the US. Consequently they have explored the possibility of marketing ...
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Care.data, Genomics, and the Launch of 'Accredited Safe Havens'

The decision to roll-out Care.data and the proposal to launch 'Accredited safe Havens' across the UK, gives compelling reasons to support the EU's strengthening of the data protection regime.  Following the announcement that Care.data will be rolled-out across England, a further, even more significant development is the proposal to launch ‘accredited safe havens’ (Ash). As a defining moment in the governance of personal information, ‘accredited safe havens’ will render obsolete the need to seek approval from the Secretary of State for Health and, in the case of medical research, by a research ethics committee or the Health Research Authority. This will make personal identifiable information easily accessible without a person’s consent and for purposes ‘other than direct care’.  Circumventing the legal instruments that have been germane ...
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Care.data and exercising our right to democracy

We have until March to opt out of the care.data initiative. The "theoretical risk" that we might be reidentified from our personal data once it is made available to third parties is a compelling reason to opt out. However, this is not the only reason. Care.data is part of a major legislative programme that includes the Clinical Practice Research Datalink (CPRD) and the 100,000 genome project – through which whole-sequenced genomes will be put to commercial use. These major infrastructural developments have been accompanied by radical changes to privacy law that have resulted in a cultural shift in the governance of information. These sweeping changes in privacy law were introduced without consultation, and the risks they entail will be borne by those whose medical records may be accessed without their consent. How did we ...
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Standing in the way of Google-backed, 23andMe, will only delay the revolution medicine needs

Genetic testing is a powerful tool. Two years ago, with the help of my colleagues, it was this tool that helped us identify a new disease. The disease, called Ogden Syndrome, caused the death of a four-month old child named Max. But the rules and regulations for genetic testing in the US, laid down in the CLIA (Clinical Laboratory Improvement Amendments), meant I could not share the results of the family’s genetic tests with them. Since that time, I have advocated performing all genetic testing involving humans such that results can be returned to research participants. This I believe should extend beyond research, and some private companies, like 23andMe, are helping to do just that. For as little as US$99, people around the world can send a sample of their saliva to 23andMe to ...
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Genetic Engineering

First coined by Jack Williamson in his1941 science fiction novel Dragon’s Island the term genetic engineering admittedly harbors an eerie connotation. In recent years, the term GMO has gained both positive and negative publicity from several different industries. Understanding the principles behind this technique along with its potential risks and benefits can help to make informed decisions about the ethical and political considerations linked to genetic engineering. By definition, genetic engineering is the process of transferring specific desirable genes from the genome of one organism into another. Genetic engineering equips the host organism with a new trait or function. The strategy improves the quality of products in many fields, including agriculture, industrial biotech, medicine and research. The process of genetic engineering is relatively straightforward. First, researchers isolate a gene of ...
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Gene Therapy

Due to improvements in lab-based technologies and a widespread availability of biomedical data, the past two decades have yielded significant progress in the field of human medicine. Despite the vast advancements, drug treatment success rates for common disorders still remain astonishingly low. According to a 2001 study by Spear et. al, drug effectiveness ranges between 25-70%, with complex disease such as cancer resting at the bottom of the spectrum. The low efficacy may be due to the fact that many drugs only mask the symptoms of a disease without working to fix the root cause. A significant proportion of conditions are created by an underlying genetic mutation. Disorders such as cancer, Alzheimer’s, Parkinson’s, cystic fibrosis, hemophilia, and muscular dystrophy are a few examples of inherited conditions with no known cures. ...
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'A Shift in Privacy law, and the Attendant Risks'

EthicsandGenetics has published ‘A Shift in Privacy Law, and the Attendant Risks'. Coverage of the report by the Guardian can be found here. In this report, we identify and explore the risks associated with the government’s plans to establish a national genetic database and commercialise personal genetic information. Furthermore, we assess changes to privacy law and practice - in particular, the recent information governance review, and demonstrate that the new privacy framework fails to adequately safeguard highly sensitive information.  Our report, reveals that the government are set to commercialise personal genetic information collected from the population, and stored on a national genetic database. As well as this, EthicsandGenetics can reveal that now, by default, NHS-users can be contacted to take part in clinical trials with private companies, without having expressed an interest ...
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Privacy, the CRPD and the Commercialisation of Personal Medical and Genomic Information

Medicine and healthcare appear to be in the midst of previously unimaginable changes. These changes might result in an improvement in our understanding of the nature of disease and, in time, assist us in predicting how a patient might respond to treatment. However, the fact remains, sweeping changes have been made to the way medical information is shared and accessed, and the cornerstones of medical law are being eroded for a science still in its infancy. The coming together of genomics, genetics and society in entirely novel ways, brings with it risks that are difficult to quantify, and must be the object of open and sustained public discussion. Genetics, genomics and advanced biotechnology are not business as usual. The public must,  therefore, be given a central role in decision-making when ...
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Moratorium on Insurers' use of Genetic Tests

The Moratorium on insurers’ use of predictive tests was recently extended and the UK Government has launched a consultation on how it is working in practice. The Moratorium is exclusively concerned with tests used to predict future illness. While EthicsandGenetics applauds these developments, as the Concordat is merely an agreement, the question remains: how long will it last for, and most importantly, the Government will eventually have to regulate this new terrain by way of legislation, when we arrive at this point, what kind of legislative measures can we expect? Can we assume that future legislation will broadly reflect the current Concordat? Let us firstly consider its substance.     In brief: The Association of British Insurers (ABI) and the Government have agreed to the following measures: A. To abide by ...
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A centralised genomic database and the risks it carries for privacy

In a recently published report for the Government, the Human Genomics Strategy Group called for the development of a national central genomic data storage facility. This would mean that genetic data collected from the population will be linked to electronic medical records. ‘Connecting for Health’ was rolled-out on opt-out basis – can we expect the same with a national genetic database? In response to a Freedom of Information request by EthicsandGenetics, Danny Lamond, Ministerial Correspondence and Public Enquiries for the Department of Health confirmed that a “central repository for storing genomic and genetic data and relevant phenotypic data from patients” will be set-up. Lamond goes on to say that “The report (by the Human Genomics Strategy Group) has been welcomed by the Secretary of State for Health and the Minister ...
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Privacy, the database state and the genomic era

In anticipation of a supposed shift in healthcare based upon genetics, New Labour, under the direction of the UK pharmaceutical sector, set about implementing a considerable legislative programme in order to gain a competitive edge in the global market for personalised medicine. This new model of healthcare requires access to massive data sets, and thus, the NHS National IT Programme, which included, ‘Connecting for Health’ – a national, set of interconnected databases, containing electronic medical records – was set up. Moreover, the Secondary Uses Service, a mechanism by which personal medical information can be shared and accessed, and makes patient-identifiable data available without individual consent, was also introduced. Lastly, Section 251 of the 2006 NHS Act circumvents the common law of confidentiality, Article 8 of the Human Rights Act 1998, ...
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The merits of 'Personalised genetic tests'

Medicine and healthcare are in the midst of previously unfathomable changes. It is clear that we are moving towards an era of ‘proactive genomics.’ As the costs of sequencing a human genome fall, more and more private clinics and companies will offer ‘personalised medicine.’ From the standpoint of developing ever more sophisticated methods in healthcare, personalised medicine is an exciting prospect. Thus far, however, we are seeing unsubstantiated promises about a science that is still in its infancy. Genomic sequencing enables physicians to identify an individual’s predisposition to disease and potentially predict how a given patient might respond to a particular drug. It may also go some way in eliminating unnecessary treatments and reduce the possibility of adverse reactions to drugs and thus increase the efficacy of treatments. The ...
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