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Technological Advances and Medical Ethics

In the contemporary world, Medical Ethics is associated with professional standards of conduct and dilemmas that arise with medical practice. Medical Ethics is the application of ethical reasoning to medical practice. As medical practice today is delivered increasingly in a multidisciplinary working environment, where the emphasis is placed strongly on team work and partnership, medical ethics is a subset of the wider ‘Healthcare Ethics’.

The turning point in medical ethics has occurred since the Second World War. This is a result of change in social attitudes, increasing plurality of cultural and religious norms and the development of a system of internationally recognised Human Rights. Hence, medical ethics had to develop towards a more analytical approach. Today there is a clear shift in the practice of medicine from the previous reliance on medical paternalism ( Doctor knows best) to a Doctor Patient (Participation) approach.

Two concepts of medical ethics are now acknowledged.

*Traditional medical ethics – seen as the professional norms and standards of medical practice

* Analytical medical ethics – seen as the critical process through which substantive ethical claims are justified or criticised in the light of argument and counter argument.

The latter is influenced by our multicultural society and various academic disciplines like Philosophy, Law, Social Sciences, History and Theology. Thus medical ethics has ceased to be the sole domain of doctors and has become a ‘part of the general moral and ethical order by which we live.’ Increasingly in practice , it is tested against the ethical principles of society.

Medical advances and ethics

Advances in medicine itself ie wider variety of more powerful technologies, the capacity to prolong life, alter psychological states, impede and enhance reproductive capacity and more recently the ability to alter genetic structure, have all influenced the adoption of this analytical approach.

Reproductive Medicine

There are many areas in modern Reproductive Medicine which pose ethical challenges. To document a few , they are, Assisted Reproduction, abortion on demand, surrogacy, selection of sex of child for termination, assisted conception for same sex couples, selective reduction of foetuses in multiple pregnancies and Genetic engineering.

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Technological Advances and Medical Ethics

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Athersys and Cell Therapy Catapult Announce Grant to Support Clinical Development of Stem Cell Therapy for Severe …

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Researchers reveal key factor in understanding elevated cancer risk linked to gene therapy

National Institutes of Health researchers have uncovered a key factor in understanding the elevated cancer risk associated with gene therapy. They conducted research on mice with a rare disease similar to one in humans, hoping their findings may eventually help improve gene therapy for humans. Researchers at the National Human Genome Research Institute (NHGRI), part of NIH, published their research in the Jan. 20, 2015, online issue of the Journal of Clinical Investigation.

“Effective and safe gene therapies have the potential to dramatically reverse diseases that are life-threatening for affected children,” said NHGRI Scientific Director Dan Kastner, M.D., Ph.D. “This study is an important step in developing gene therapies that can be safely used to benefit patients.”

Toxic side effects actually are rarely observed by researchers who have designed gene therapies using an adeno-associated virus (AAV) as a vector to deliver the corrected gene to a specific point in the cell’s DNA. AAVs are small viruses that infect humans but do not cause disease. A vector is a DNA molecule of AAV used as a vehicle to carry corrected genetic material into a cell. AAV viruses are uniquely suited for gene therapy applications.

But one prior study did find an association between AAV and the occurrence of liver cancer. The present research addresses this problem in gene therapy for an inherited disease in children called methylmalonic acidemia, or MMA.

For 10 years, NHGRI researchers have worked toward a gene therapy to treat MMA. The condition affects as many as 1 in 67,000 children born in the United States. Affected children are unable to properly metabolize certain amino acids consumed in their diet, which can damage a number of organs and lead to kidney failure. MMA patients also suffer from severe metabolic instability, failure to thrive, intellectual and physical disabilities, pancreatitis, anemia, seizures, vision loss and strokes. The most common therapy is a restrictive diet, but doctors must resort to dialysis or kidney or liver transplants when the disease progresses.

In prior MMA gene therapy studies, researchers showed that mice bred to develop the condition could be restored to health by AAV gene therapy injection shortly after birth. The mice in the study survived into adulthood and were free from the effects of MMA.

“The corrected gene delivered by AAV is the most effective therapy we have developed so far to treat MMA,” said Charles Venditti, M.D., Ph.D., senior author and investigator in NHGRI’s Genetic and Molecular Biology Branch. “However, we have identified an important safety parameter related to the AAV gene therapy in our mouse models that is critical to understand before we move to human patient trials.”

Now, in a long-term follow-up of the treated mice — after mice reached about two years of age — the researchers documented a 50-70 percent higher occurrence of liver cancer in AAV-treated mice compared with a 10 percent liver cancer rate in untreated mice. Dr. Venditti’s team determined that the AAV vector triggered the cancer.

The research team performed additional experiments to detect where in the mouse genome the AAV vector delivered the corrected gene and how that related to any cancer development. In many mice that developed liver cancer, the AAV vector targeted a region of the mouse genome called Rian, near a gene called Mir341 that codes for a microRNA molecule. MicroRNAs are small, non-coding RNA molecules involved in the regulation of gene expression. When the AAV was inserted near Mir341, the vector caused elevated expression of the gene, which the researchers believe contributed to the occurrence of liver cancer in the mice. The authors note that Mir341 is found in the mouse genome, however, it is not present in humans.

When the researchers used an alternate AAV vector to deliver the corrected gene in a study of just 10 mice, that vector did not insert where it would elevate the expression of nearby genes and it did not cause liver cancer. The researchers found that this modification was a safer gene therapy.

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Researchers reveal key factor in understanding elevated cancer risk linked to gene therapy

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TxCell to highlight success factors in cell therapy research at Cell & Gene Therapy Forum 2015

TxCell SA (FR0010127662 TXCL), a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that Dr. Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs, TxCell, will present at the Cell & Gene Therapy Forum 2015, January 26 – 28, 2015 at Grand Hayatt in Washington DC, United States.

Dr Fortes presentation will be on critical success factors for a successful transition of cell therapy candidates to the clinic. The presentation is scheduled for Monday, January 26, 2015 at 14.30 p.m. EST. A roundtable debate discussing the most important topics raised will follow the presentation.

Dr. Forte will use as examples TxCells lead product candidate, Ovasave(R) and second product candidate, Col-Treg from TxCells innovative proprietary ASTrIA technological platform. Ovasave is targeted at refractory Crohns disease and is currently evaluated in a placebo-controlled phase IIb study. Col-Treg is in development for the rare eye disease autoimmune uveitis. Col-Treg is planned to move into a first clinical study in the first half of 2015.

The key elements in the presentation include gathering strong pre-clinical and preliminary clinical data. Dr. Forte will also cover key process development activities necessary to provide the most robust and transferable manufacturing process and business model establishment and the development of a clear regulatory strategy. Dr. Forte will also present a roundup, from his perspective, on market access including economic viability and therapeutic adoption.

Patients with chronic inflammatory and autoimmune diseases that have no current therapeutic options continue to present significant unmet medical needs. As TxCell is one of the most advanced companies in the field of T-cell immunotherapy, we share our experiences regarding the development of innovative therapeutic approaches. This will benefit of the entire scientific community, said Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs, TxCell. The Cell & Gene Therapy Forum 2015 is an ideal event to position biotechnology companies developing new value-adding treatments and strategies, like TxCells personalized antigen specific Treg cell-based therapies.

The Cell & Gene Therapy Forum is a meeting designed to help advance regulatory, manufacturing, research and commercial strategies and drive cell and gene therapy products forward. The Forum enables to gather executives from biotechnology companies, representatives of big pharma and big biotech, regulators, and public and private investors.

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Study uses 'systems genetics' approach to identify potential target for epilepsy

A single gene that coordinates a network of about 400 genes involved in epilepsy could be a target for new treatments, according to research.

Epilepsy is a common and serious disease that affects around 50 million people worldwide. The mortality rate among people with epilepsy is two to three times higher than the general population. It is known that epilepsy has a strong genetic component, but the risk is related to multiple factors that are ‘spread’ over hundreds of genes. Identifying how these genes are co-ordinated in the brain is important in the search for new anti-epilepsy medications. This requires approaches that can analyse how multiple genes work in concert to cause disease.

Instead of studying individual genes, which has been the usual approach in epilepsy to date, researchers from Imperial College London developed novel computational and genetics techniques to systematically analyse the activity of genes in epilepsy. Published in Nature Communications, the study is the first to apply this ‘systems genetics’ approach to epilepsy.

The researchers studied samples of brain tissue removed from patients during neurosurgery for their epilepsy. Starting from these samples, they identified a gene network that was highly active in the brain of these patients, and then discovered that an unconnected gene, Sestrin 3 (SESN3), acts as a major regulator of this epileptic gene network. This is the first time SESN3 has been implicated in epilepsy and its co-ordinating role was confirmed in studies with mice and zebrafish.

Dr Enrico Petretto, from the Medical Research Council (MRC) Clinical Sciences Centre at Imperial College London and co-senior author of the study, said: “Systems genetics allows us to understand how multiple genes work together, which is far more effective than looking at the effect of a gene in isolation. It’s a bit like trying to tackle a rival football team. If you want to stop the team from playing well, you can’t just target an individual player; you first need to understand how the team plays together and their strategy. Likewise in systems genetics we don’t look at just one gene at a time, but a network or team of genes and the functional relationships between them in disease.

“After understanding how the team plays together, a possible approach to beating a strong side is then to identify a major control point- say the captain or the coach – who co-ordinates the players. This is like our ‘master regulator gene’, which in this case is SESN3. If we can develop medication to target this gene in the brain, then the hope is that we could influence the whole epileptic gene network rather than individual parts and in turn achieve more effective treatments.”

Using surgical samples of brain tissue provides a unique opportunity to study how genes are coordinated in the brains of people with epilepsy. Patients with severe temporal lobe epilepsy who do not respond to medication can undergo surgery to remove part of the brain to relieve their seizures. Our research was able to use brain tissue samples donated by 129 patients to analyse the genetic and functional activity underlying their epilepsy.

Co-senior author of the paper, Dr Michael Johnson from Imperial’s Department of Medicine, said: “This study is proof-of-concept for a new scientific approach in epilepsy. Existing epilepsy medications are symptomatic treatments only; that is they act to supress the seizures but they don’t treat the underlying disease.

Consequently, we find that existing medications don’t work in about one-third of people with epilepsy. Here we have taken a new approach, and identified a network of genes underlying the epilepsy itself in these patients and mapped its control to a single gene, SESN3. This offers hope that new disease-modifying therapies can be developed for the treatment of epilepsy itself.

“Imperial has pioneered the systems genetics approach to common human disease and by applying its specialism in epilepsy and working in collaboration with pharmaceutical companies and other institutes worldwide, we have identified SESN3 as a new ‘master regulatory’ gene of key inflammatory processes in the brain that could be a potential target for new and more effective treatments.”

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New potential target identified for epilepsy treatment

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Study identifies gene that may become resistant to current testicular cancer treatments

A major research study has uncovered several new genetic mutations that could drive testicular cancer – and also identified a gene which may contribute to tumours becoming resistant to current treatments.

The study is the first to use state-of-the-art sequencing technology to explore in detail testicular germ cell tumours – which make up the vast majority of testicular cancers and are the most common cancers in young men.

It was led by scientists at The Institute of Cancer Research, London, and funded by the Movember Foundation.

The researchers, whose study was published in Nature Communications today (Thursday), used a genetic technique called whole-exome sequencing to examine tumour samples from 42 patients with testicular cancer treated at the Royal Marsden NHS Foundation Trust.

They uncovered a number of new chromosome duplications and other abnormalities that could contribute to the development of this cancer, as well as confirming a previous association with the gene KIT.

Their study also found defective copies of a DNA repair gene called XRCC2 in a patient who had become resistant to platinum-based chemotherapy. They were able to verify the link between XRCC2 and platinum resistance by sequencing an additional sample from another platinum-resistant tumour.

Although generally testicular cancer responds well to treatment, resistance to platinum-based chemotherapy is associated with a poor long-term survival rate. The research provides a clue to why around 3 per cent of patients develop resistance to platinum chemotherapy, as well as new insights into testicular germ cell tumours generally.

Dr Clare Turnbull, Team Leader in Predisposition and Translational Genetics at The Institute of Cancer Research, London, and Honorary Consultant in Clinical Genetics at The Royal Marsden NHS Foundation Trust, said:

“Our study is the largest comprehensive sequencing study of testicular tumours published to date, describing their mutational profile in greater detail than has been possible using previous technologies. We have identified new potential driver mutations for this type of cancer, and provided new evidence of a link between mutations in the gene XRCC2 and platinum treatment-resistant tumours.

“We now need additional studies with a larger number of patients, focusing in particular on platinum-resistant tumours, to help our discoveries lead to new options for those unlucky men whose cancer progresses in spite of the best available treatments.”

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ENIGMA scientists discover eight genetic mutations that may erode or boost brain tissue

Published on January 22, 2015 at 1:58 AM

In the largest collaborative study of the brain to date, researchers from the Keck School of Medicine of the University of Southern California (USC) led a global consortium of 190 institutions to identify eight common genetic mutations that appear to age the brain an average of three years. The discovery could lead to targeted therapies and interventions for Alzheimer’s disease, autism and other neurological conditions.

An international team of roughly 300 scientists known as the Enhancing Neuro Imaging Genetics through Meta Analysis (ENIGMA) Network pooled brain scans and genetic data worldwide to pinpoint genes that enhance or break down key brain regions in people from 33 countries. This is the first high-profile study since the National Institutes of Health (NIH) launched its Big Data to Knowledge (BD2K) centers of excellence in 2014. The research was published Wednesday, Jan. 21, in the peer-reviewed journal Nature.

“ENIGMA’s scientists screen brain scans and genomes worldwide for factors that help or harm the brain — this crowd-sourcing and sheer wealth of data gives us the power to crack the brain’s genetic code,” said Paul Thompson, Ph.D., Keck School of Medicine of USC professor and principal investigator of ENIGMA. “Our global team discovered eight genes that may erode or boost brain tissue in people worldwide. Any change in those genes appears to alter your mental bank account or brain reserve by 2 or 3 percent. The discovery will guide research into more personalized medical treatments for Alzheimer’s, autism, depression and other disorders.”

The study could help identify people who would most benefit from new drugs designed to save brain cells, but more research is necessary to determine if the genetic mutations are implicated in disease.

The ENIGMA researchers screened millions of “spelling differences” in the genetic code to see which ones affected the size of key parts of the brain in magnetic resonance images (MRIs) from 30,717 individuals. The MRI analysis focused on genetic data from seven regions of the brain that coordinate movement, learning, memory and motivation. The group identified eight genetic variants associated with decreased brain volume, several found in over one-fifth of the world’s population. People who carry one of those eight mutations had, on average, smaller brain regions than brains without a mutation but of comparable age; some of the genes are implicated in cancer and mental illness.

In October 2014, the NIH invested nearly $32 million in its Big Data Initiative, creating 12 research hubs across the United States to improve the utility of biomedical data. USC’s two BD2K centers of excellence, including ENIGMA, were awarded a total of $23 million over four years.

“The ENIGMA Center’s work uses vast datasets as engines of biomedical discovery; it shows how each individual’s genetic blueprint shapes the human brain,” said Philip Bourne, Ph.D., associate director for data science at the NIH. “This ‘Big Data’ alliance shows what the NIH Big Data to Knowledge (BD2K) Program envisions achieving with our 12 Centers of Excellence for Big Data Computing.”

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University of Southern California

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Do Genetics Play a Role in Natural Bodybuilding ? – Video



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Stem cell researcher speaks out, defends against "inaccurate media reporting"

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Safer GMOs possible with spread-resistant bacteria

January 24, 2015

(GMO growing facility. Credit: Thinkstock)

Chuck Bednar for redOrbit.com Your Universe Online

Two teams of US scientists are currently working on a way to produce safer genetically modified organisms (GMOs) that would be unable to spread in the wild, finding a potential solution to a primary concern to critics of genetic engineering research.

According to BBC News, the researchers have altered the genetic code of bacteria so that they can only use synthetic chemicals to grow. If they escaped into nature, they would simply die out, ideally alleviating some of the fears over GMOs and opening the door for their increased use in the fields of agriculture, medicine, and environmental clean-up.

As explained in the journal Nature, the bacteria relies upon an amino acid (one of the building blocks of protein) that does not occur in nature. While the microbes can thrive in the lab as long as they have access to the unnatural amino acid, none survived an experiment in which the artificial supplement was withheld.

Genetically engineered micro-organisms are currently used in the US, Europe, and China in order to produce drugs or fuels under contained industrial conditions, the BBC said. However, scientists are looking to develop internal fail-safe measures to help keep them from spreading if used in real-world conditions.

Re-writing the genetic code

What weve done is engineered organisms so that they require synthetic amino acids for survival or for life, Yale University professor Farren J. Isaacs, who led one of the two studies, told BBC News. What were seeing here is an important proof of concept that re-coding genomes and engineering dependence on synthetic amino acids is technically feasible in not just E coli but other micro-organisms and multicellular organisms such as plants.

Our strains, to the extent that we can test them, wont escape, added Daniel J. Mandell, a synthetic biologist at Harvard. The new bacteria is also unable to exchange their DNA with the natural versions of the same bacteria, since they no longer speak each others genetic language.

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