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Posted: October 25, 2016 at 7:48 am
You have decided that you or your loved one is in need of treatment. Now what? How do you find out about treatment facilities? What level of care is needed? How do you know if a treatment center is a right fit? How do you know if you are getting what you pay for? Here are a few tips for making the best decision for treatment.
Identifying the appropriate level of care is the first step when looking for a treatment facility. Speak to your doctor or mental health provider to determine the appropriate level of care. Levels of care for treatment facilities include residential or partial hospitalization. Knowing the appropriate level of care will determine what treatment facility is appropriate.
Not all treatment facilities are created equal. So, how do you know which treatment facility to choose? The individual needs of a person is the first thing to consider when choosing a treatment facility. For example, choose a facility that can address specific addiction (gambling, substance use) and mental health needs. Check out what therapies are offered, such as evidence based-practices (Cognitive Behavioral Therapies, Dialectal Behavioral Therapies, Expressive Therapies, and Trauma Therapies). In addition, addiction treatment should include work with peer counselors (counselors who are in recovery) and provide follow up care, such as referrals for additional treatments and support in identifying recovery needs. Another way to determine if a facility can meet your needs is to check out the staff credentials and ensure that the facility has appropriate licensing. In addition to treatment needs and therapies, also consider the individual attention that is given to each patient. A low staff to patient ratio and a focus on individual sessions will ensure that you or your loved one will receive one on one attention.
Addiction and mental health treatment is expensive, making affordability a consideration when planning for treatment and for your future. It is important to consider the value of treatment when determining the cost. Are you paying for treatment or for the location and amenities? We offer the look and feel of home with the safety and security of an inpatient/residential treatment facility. Patients are surrounded by 400 acres of beautiful farmland with modern amenities and an in house chef. In addition to the beautiful surroundings and amenities, Williamsville also focuses on meeting individual needs through intensive individual and group sessions. At Williamsville, we have a 1:1 therapist patient ratio and offer 15+ individual sessions per week. The focus on individual sessions ensure that each patient is receiving individual attention, encouragement and support for processing and exploring root issues to addiction and mental health concerns. We address issues of addiction and mental health through a variety of evidence-based therapies and have on site peer counselors that support patients through the steps of AA/NA/GA. We are in-network with most major insurers which enables you to have intensive therapy in an excellent environment at the lowest possible cost.
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Posted: at 7:48 am
Ayn Rand, llam a su filosofa, “Objetivismo”, describindola como la filosofa para vivir en la tierra. El objetivismo es un sistema integrado de pensamientos, que define principios abstractos en los que el hombre debe pensar y actuar si es que quiere vivir la vida propia de un hombre. En primer lugar, Ayn Rand, present su filosofa a travs de las novelas, ambas best-sellers, “The Fountainhead” (1943), traducida al castellano como “El Manantial”, y “Atlas Shrugged” (1957), como “La Rebelin de Atlas”. En estas se presenta al hombre como un ser herico, un individuo racional digno de vivir en la tierra, ya que puede lograr lo mejor de s msmo. Posteriormente, present su filosofa en forma de no-ficcin.
La realidad, el mundo exterior, la existencia independiente de la conciencia del hombre; independiente de cualquier conocimiento, creencias, sentimientos, deseos o temores. Esto significa que A es A, los hechos son hechos, las cosas son lo que son; y la tarea de la conciencia del hombre es percibir la realidad, no crearla o inventarla. As, el objetivismo, rachaza toda creencia en lo supernatural, y cualquier aclamacin de individuales o grupos que dicen crear su propia realidad.
La razn del hombre es completamente competente de conocer los hechos de la realidad. La razn, facultad conceptual, es la facultad que identifica e integra el material provisto por los sentidos del hombre. La razn es el nico medio del hombre para adquirir conocimientos. As, el objetivismo, rechaza al misticismo (no acepta a la fe y a los sentimientos, como medios de conocimiento); y al escepticismo (que proclama la imposibilidad del conocimiento y/o estar seguro de algo). La naturaleza humana: El hombre es un ser racional. La razn, nico medio de conocimiento del hombre, es su medio de supervivencia. El hombre es un ser de conciencia volitiva, por eso el ejercicio de la razn depende de la eleccin de cada individuo. Tu conciencia es lo que sols llamar alma o espritu; y a lo que llams ‘libre albedro’, es a la libertad que tiene tu mente de pensar o no. Esta es la nica eleccin que tienes. Es la eleccin que controla tadas las otras elecciones que hacs; y determina tu vida y tu caracter . As, el objetivismo, rechaza toda forma de determinismo; la creencia de que el hombre es vctima de fuerzas que escapan a su control (como ser: dios, el destino, los genes, condiciones de nacimiento o econmicas).
La razn del hombre es la nica fuente que le permite juzgar valores y guiarlo hacia la accin. Un estndar de tica correcto es: la supervivencia del hombre como hombre, es decir, lo requerido por su naturaleza para sobrevivir como un ser racional (y, no una momentnea supervivencia fsica como un bruto sin mente). La virtud bsica del hombre es su racionalidad, y sus tres valores fundamentales son: razn, propsito, auto-estima. El hombre es un fin en s msmo, y no un medio para los fines de los dems; debe vivir por su propio propsito, sin sacrificarse para otros o sacrificar a otros para s; debe trabajar por su propio inters racional y lograr su propia felicidad como el propsito moral ms alto de su vida. As, el objetivismo, rechaza cualquier forma de altruismo (que dice que la moralidad consiste en vivir para otros o para la sociedad).
El principio social bsico de la tica objetivista es que ningn hombre tiene el derecho de buscar valores ajenos por medio de la fuerza fsica. Ningn hombre o grupo tiene el derecho de usar la fuerza fsica contra otros; con exepcin de cuando acta en propia defensa y solo contra quienes inicien su uso. Los hombres deben tratar unos con otros como comerciantes, dando valor por valor, por medio de un libre y mutuo consentimiento y mutuo beneficio. El nico sistema social que erradica de las relaciones humanas, la fuerza fsica, es el capitalismo de laissez-faire (libre comercio). El capitalismo es un sistema basado en el reconocimiento de los derechos individuales, y protege a los hombres de aquellos que inician el uso de la fuerza fsica. As, el objetivismo, rechaza cualquier forma de colectivismo, como lo son, el fasismo y el socialismo. Tambin rechaza la actual ‘economa mixta’, nocin de que el gobierno debera regular la economa y redistribuir la riqueza.
El arte es una re-creacin selectiva de la realidad, acorde al juicio metafsico del artista; es concretizar su visin fundamental de la existencia. Ayn Rand, describe su aproximacin al arte como: “Realismo Romntico”: “Yo soy Romntica en el sentido de que presento a los hombres como deberan ser. Soy Realista en el sentido de que los ubico aqu, ahora y en esta tierra”. El propsito de las novelas de Ayn Rand no es didctico; es artstico: la proyeccin de un hombre ideal: “Mi propsito, primera causa y desencadenante, es el retrato de Howard Roark o John Galt o Hank Rearden o Francisco d’Anconia como un fin en s msmo, y no como un propsito para un fin posterior”.
Dijo uno de los presentes: – Convnceme de que la lgica es til. – Quires que te lo demuestre? – S. – Entonces….es necesario que recurra a una demostracin. Y al ver que el otro asenta le dijo: – Si te engao con sofismas, cmo hars, pues, para darte cuenta? El otro guard silencio. – Ya ves como te das cuenta de que la lgica es necesaria y que, apartndote de ella, ni siquiera puedes llegar a saber si es necesaria o no. Epicteto, Conversaciones, II, 25.
La democracia es dos lobos y una oveja votando sobre que se va a comer. La Libertad es la oveja, armada, impugnando el resultado. Benjamin Franklin
info @ objetivismo . com
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Posted: at 7:41 am
Break things down to the original Latin and manufacturing is literally a matter of using your hands (manu) to make things (factura). Robots are a different story. The term comes to us from the Czech word robotnik, which means nothing short of slave labor. Don’t let science fiction and Japanese cuteness confuse you: Humans created robots to do their drudge work.
Factories first opened their doors to modern industrial robots in 1961. That’s when Unimate joined the General Motors workforce. Unimate was essentially a 4,000-pound (1,814-kilogram) arm attached to a giant steel drum. The Unimate robots boasted remarkable versatility for the time and could easily pour liquid metal into die casts, weld auto bodies together and manipulate 500-pound (227-kilogram) payloads.
In other words, Unimate could perform tasks that humans often found dangerous or boring, and it could do them with consistent speed and precision. It never called in sick, went on strike or violated company rules. It covered all three shifts in a 24-hour period without drawing a single minute of overtime. Needless to say, factory owners grew to like this no-nonsense new addition.
Robot factory workers aren’t without their limitations, however. In their simplest forms, industrial robots are mere automatons. Humans program them to perform a simple task, and they repeat that task over and over again. Tasks that require decision-making, creativity, adaptation and on-the-job learning tend to go to the humans.
But when a job’s just right for a robot, productivity tends to increase dramatically. For instance, Australia’s Drake Trailers installed a single welding robot on its production line and benefited from a reported 60 percent increase in productivity [source: ABB Australia].
The most obvious impact of industrial mechanization is that it eliminates many unskilled job positions. This has especially been the case in United States and Japan, two countries that illuminate important factors in the robot takeover.
Japan suffers from negative population growth, and the younger members of its workforce are generally disinclined to take what they may perceive as dull manufacturing jobs. Industrial robots, therefore, have been a true advantage in that they fill unwanted factory jobs and create more technical positions dedicated to their upkeep. In the same way that a computerized office depends on various techies, so too do robotic workers require technical upkeep.
The United States, on the other hand, has seen a great deal of its factory business flee to China and other countries, where human labor is simply cheaper. Even domestic factory automation, with its allure of improved productivity and efficiency, has failed to tip the scales.
What will the future bring? Despite the economic downturn in 2009, the International Federation of Robotics (IFR) observed a global surge in industrial robot demand for 2010. According to IFR estimates, the year 2013 will see Earth’s population of industrial robots exceed 1.1 million [source: IFR]
Meanwhile, roboticists continue to stretch the boundaries of what industrial robots can do, such as in the field of machine learning, tactile sensing and socially intelligent robots. The future will likely see machines working alongside humans and even learning from them to perform an increasing number of manufacturing tasks.
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Posted: at 7:41 am
Online Professional Development Courses Start this February!
Online Professional Development Courses Start this February! We are excited to announce our latest online training schedule! Classes start in February and you can enjoy the convenience of taking Robotics Academy courses without leaving your own computer workstation! Register for a class here! Benefits of Robotics Academy Online Training Courses:
The latest chapter within the VEX CORTEX Video Trainer Curriculum is now available Competition Programming!Located in the Engineering Section,this chapterincludes lessons designed to help students prepare their programs for a VEX Competition. Some of the lessons youll learn within this chapter includes: Creating a Competition Legal Program with the
The latest chapter within our VEX CORTEX Video Trainer Curriculum is now available Using the LCD!Located in the Sensing section, this chaptercovers how to configure and implement the LCD as a useful tool in your program. Some of the lessons youll learn within this chapter includes: Three steps to
We are excited to share our latest chapter available within our VEX CORTEX Video Trainer Curriculum Gyro Sensor!Located in the Sensing section, this chapter will allow you toto turn the robot by measurements of degrees. Some of the lessons youll learn within this chapter includes: How the Gyro Sensor
We are excited to announce our Fallonline training schedulethatstarts in September! The Robotics Academy is a world leader in robotics education and trains teacher internationally. Enjoy the convenience of taking Robotics Academy courses without leaving your own computer workstation. Robotics Academy online training includes: Online access to supplemental lessons from
We are excited to share our latest chapter available within out VEX CORTEX Video Trainer Curriculum Integrated Encoders! Located in the Movement section, this chapter will allow you to increase movement accuracy and automatic movement corrections. Some of the lessons youll learn within this chapter includes: Introduction to the
Our Robotics Summer of Learning (RSOL) opens today! This summer, students have the opportunity to learn how to program virtual robots using a FREE copy of Robot Virtual Worldswhere they can program VEX IQor LEGO MINDSTORMS EV3virtual robots.All RSOL courses are self-paced with e-mail support available at firstname.lastname@example.org. Sign
We are proud to announce the return of our Robotics Summer of Learning program!This summer, students have the opportunity to learn how to program robots, earn a programming certificate and badges, and play with cool software for FREE!We will provide all of the software and training materials at no cost
Our on-site (in Pittsburgh, PA) and online Summer Professional Development classes for VEX CORTEX, VEX IQ, and LEGO MINDSTORMS are filling up quickly. Register todayto make sure you get into your preferred course (listed below!) Highlights of the Robotics Academy Training: Acquire new skills with technology and new ways to
My name is Ringo Dingrando and I teach Robotics and Physics at International School Manila in the Philippines. For the past three years, high school students have been inquiring into how to program using ROBOTC and how to use their programming skills to build robots, often with VEX hardware. In
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Posted: at 7:41 am
Tom Newman Instructor 253.680.7350
Bob Traufler Career Advisor 253.680.7605
Location Downtown Campus Hours Mon – Fri, 7 a.m. – 2:45 p.m.
In the Industrial Electronics and Robotics Technician program, students learn to install, diagnose, maintain, modify, test, and calibrate electronic, electrical, and mechanical systems used in manufacturing support equipment and production machinery, including precision machine tools (CNC) and industrial robots.
The program consists of a certificate of training in Basic Electricity, a one-year Electrical Technician certificate, and a two-year Industrial Technology degree that prepares students for entry into electrical apprenticeships. The program features equipment and software from industry leaders such as Allen Bradley, Rockwell Automation, FANUC Robotics, Bosch, Siemens, Famic Technologies, and National Instruments.
Focus is on the intelligent control of machines and processes using programmable logic controllers (PLCs), embedded controllers, variable frequency drives (VFDs), industrial networks, sensors & transducers, instrumentation and robotics. The electrical curriculum is based on guidelines from the National Joint Apprenticeship Training Committee (NJATC) for electrical trades.
The program also offers in-depth career training for those interested in becoming an electronics technician in the manufacturing, scientific, aerospace, or civilian military industries.
Program Length: Seven quarters (approximate)
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Posted: at 7:37 am
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Posted: at 7:36 am
Gene therapy is the therapeutic delivery of nucleic acid polymers into a patient’s cells as a drug to treat disease. The first attempt at modifying human DNA was performed in 1980 by Martin Cline, but the first successful and approved[by whom?] nuclear gene transfer in humans was performed in May 1989. The first therapeutic use of gene transfer as well as the first direct insertion of human DNA into the nuclear genome was performed by French Anderson in a trial starting in September 1990.
Between 1989 and February 2016, over 2,300 clinical trials had been conducted, more than half of them in phase I.
It should be noted that not all medical procedures that introduce alterations to a patient’s genetic makeup can be considered gene therapy. Bone marrow transplantation and organ transplants in general have been found to introduce foreign DNA into patients. Gene therapy is defined by the precision of the procedure and the intention of direct therapeutic effects.
Gene therapy was conceptualized in 1972, by authors who urged caution before commencing human gene therapy studies.
The first attempt, an unsuccessful one, at gene therapy (as well as the first case of medical transfer of foreign genes into humans not counting organ transplantation) was performed by Martin Cline on 10 July 1980. Cline claimed that one of the genes in his patients was active six months later, though he never published this data or had it verified and even if he is correct, it’s unlikely it produced any significant beneficial effects treating beta-thalassemia.
After extensive research on animals throughout the 1980s and a 1989 bacterial gene tagging trial on humans, the first gene therapy widely accepted as a success was demonstrated in a trial that started on September 14, 1990, when Ashi DeSilva was treated for ADA-SCID.
The first somatic treatment that produced a permanent genetic change was performed in 1993.
This procedure was referred to sensationally and somewhat inaccurately in the media as a “three parent baby”, though mtDNA is not the primary human genome and has little effect on an organism’s individual characteristics beyond powering their cells.
Gene therapy is a way to fix a genetic problem at its source. The polymers are either translated into proteins, interfere with target gene expression, or possibly correct genetic mutations.
The most common form uses DNA that encodes a functional, therapeutic gene to replace a mutated gene. The polymer molecule is packaged within a “vector”, which carries the molecule inside cells.
Early clinical failures led to dismissals of gene therapy. Clinical successes since 2006 regained researchers’ attention, although as of 2014, it was still largely an experimental technique. These include treatment of retinal diseases Leber’s congenital amaurosis and choroideremia,X-linked SCID, ADA-SCID,adrenoleukodystrophy,chronic lymphocytic leukemia (CLL),acute lymphocytic leukemia (ALL),multiple myeloma,haemophilia and Parkinson’s disease. Between 2013 and April 2014, US companies invested over $600 million in the field.
The first commercial gene therapy, Gendicine, was approved in China in 2003 for the treatment of certain cancers. In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia. In 2012 Glybera, a treatment for a rare inherited disorder, became the first treatment to be approved for clinical use in either Europe or the United States after its endorsement by the European Commission.
Following early advances in genetic engineering of bacteria, cells, and small animals, scientists started considering how to apply it to medicine. Two main approaches were considered replacing or disrupting defective genes. Scientists focused on diseases caused by single-gene defects, such as cystic fibrosis, haemophilia, muscular dystrophy, thalassemia and sickle cell anemia. Glybera treats one such disease, caused by a defect in lipoprotein lipase.
DNA must be administered, reach the damaged cells, enter the cell and express/disrupt a protein. Multiple delivery techniques have been explored. The initial approach incorporated DNA into an engineered virus to deliver the DNA into a chromosome.Naked DNA approaches have also been explored, especially in the context of vaccine development.
Generally, efforts focused on administering a gene that causes a needed protein to be expressed. More recently, increased understanding of nuclease function has led to more direct DNA editing, using techniques such as zinc finger nucleases and CRISPR. The vector incorporates genes into chromosomes. The expressed nucleases then knock out and replace genes in the chromosome. As of 2014 these approaches involve removing cells from patients, editing a chromosome and returning the transformed cells to patients.
Gene editing is a potential approach to alter the human genome to treat genetic diseases, viral diseases, and cancer. As of 2016 these approaches were still years from being medicine.
Gene therapy may be classified into two types:
In somatic cell gene therapy (SCGT), the therapeutic genes are transferred into any cell other than a gamete, germ cell, gametocyte or undifferentiated stem cell. Any such modifications affect the individual patient only, and are not inherited by offspring. Somatic gene therapy represents mainstream basic and clinical research, in which therapeutic DNA (either integrated in the genome or as an external episome or plasmid) is used to treat disease.
Over 600 clinical trials utilizing SCGT are underway in the US. Most focus on severe genetic disorders, including immunodeficiencies, haemophilia, thalassaemia and cystic fibrosis. Such single gene disorders are good candidates for somatic cell therapy. The complete correction of a genetic disorder or the replacement of multiple genes is not yet possible. Only a few of the trials are in the advanced stages.
In germline gene therapy (GGT), germ cells (sperm or eggs) are modified by the introduction of functional genes into their genomes. Modifying a germ cell causes all the organism’s cells to contain the modified gene. The change is therefore heritable and passed on to later generations. Australia, Canada, Germany, Israel, Switzerland and the Netherlands prohibit GGT for application in human beings, for technical and ethical reasons, including insufficient knowledge about possible risks to future generations and higher risks versus SCGT. The US has no federal controls specifically addressing human genetic modification (beyond FDA regulations for therapies in general).
The delivery of DNA into cells can be accomplished by multiple methods. The two major classes are recombinant viruses (sometimes called biological nanoparticles or viral vectors) and naked DNA or DNA complexes (non-viral methods).
In order to replicate, viruses introduce their genetic material into the host cell, tricking the host’s cellular machinery into using it as blueprints for viral proteins. Scientists exploit this by substituting a virus’s genetic material with therapeutic DNA. (The term ‘DNA’ may be an oversimplification, as some viruses contain RNA, and gene therapy could take this form as well.) A number of viruses have been used for human gene therapy, including retrovirus, adenovirus, lentivirus, herpes simplex, vaccinia and adeno-associated virus. Like the genetic material (DNA or RNA) in viruses, therapeutic DNA can be designed to simply serve as a temporary blueprint that is degraded naturally or (at least theoretically) to enter the host’s genome, becoming a permanent part of the host’s DNA in infected cells.
Non-viral methods present certain advantages over viral methods, such as large scale production and low host immunogenicity. However, non-viral methods initially produced lower levels of transfection and gene expression, and thus lower therapeutic efficacy. Later technology remedied this deficiency.
Methods for non-viral gene therapy include the injection of naked DNA, electroporation, the gene gun, sonoporation, magnetofection, the use of oligonucleotides, lipoplexes, dendrimers, and inorganic nanoparticles.
Some of the unsolved problems include:
Three patients’ deaths have been reported in gene therapy trials, putting the field under close scrutiny. The first was that of Jesse Gelsinger in 1999. One X-SCID patient died of leukemia in 2003. In 2007, a rheumatoid arthritis patient died from an infection; the subsequent investigation concluded that the death was not related to gene therapy.
In 1972 Friedmann and Roblin authored a paper in Science titled “Gene therapy for human genetic disease?” Rogers (1970) was cited for proposing that exogenous good DNA be used to replace the defective DNA in those who suffer from genetic defects.
In 1984 a retrovirus vector system was designed that could efficiently insert foreign genes into mammalian chromosomes.
The first approved gene therapy clinical research in the US took place on 14 September 1990, at the National Institutes of Health (NIH), under the direction of William French Anderson. Four-year-old Ashanti DeSilva received treatment for a genetic defect that left her with ADA-SCID, a severe immune system deficiency. The effects were temporary, but successful.
Cancer gene therapy was introduced in 1992/93 (Trojan et al. 1993). The treatment of glioblastoma multiforme, the malignant brain tumor whose outcome is always fatal, was done using a vector expressing antisense IGF-I RNA (clinical trial approved by NIH n 1602, and FDA in 1994). This therapy also represents the beginning of cancer immunogene therapy, a treatment which proves to be effective due to the anti-tumor mechanism of IGF-I antisense, which is related to strong immune and apoptotic phenomena.
In 1992 Claudio Bordignon, working at the Vita-Salute San Raffaele University, performed the first gene therapy procedure using hematopoietic stem cells as vectors to deliver genes intended to correct hereditary diseases. In 2002 this work led to the publication of the first successful gene therapy treatment for adenosine deaminase-deficiency (SCID). The success of a multi-center trial for treating children with SCID (severe combined immune deficiency or “bubble boy” disease) from 2000 and 2002, was questioned when two of the ten children treated at the trial’s Paris center developed a leukemia-like condition. Clinical trials were halted temporarily in 2002, but resumed after regulatory review of the protocol in the US, the United Kingdom, France, Italy and Germany.
In 1993 Andrew Gobea was born with SCID following prenatal genetic screening. Blood was removed from his mother’s placenta and umbilical cord immediately after birth, to acquire stem cells. The allele that codes for adenosine deaminase (ADA) was obtained and inserted into a retrovirus. Retroviruses and stem cells were mixed, after which the viruses inserted the gene into the stem cell chromosomes. Stem cells containing the working ADA gene were injected into Andrew’s blood. Injections of the ADA enzyme were also given weekly. For four years T cells (white blood cells), produced by stem cells, made ADA enzymes using the ADA gene. After four years more treatment was needed.
Jesse Gelsinger’s death in 1999 impeded gene therapy research in the US. As a result, the FDA suspended several clinical trials pending the reevaluation of ethical and procedural practices.
The modified cancer gene therapy strategy of antisense IGF-I RNA (NIH n 1602) using antisense / triple helix anti IGF-I approach was registered in 2002 by Wiley gene therapy clinical trial – n 635 and 636. The approach has shown promising results in the treatment of six different malignant tumors: glioblastoma, cancers of liver, colon, prostate, uterus and ovary (Collaborative NATO Science Programme on Gene Therapy USA, France, Poland n LST 980517 conducted by J. Trojan) (Trojan et al., 2012). This antigene antisense/triple helix therapy has proven to be efficient, due to the mechanism stopping simultaneously IGF-I expression on translation and transcription levels, strengthening anti-tumor immune and apoptotic phenomena.
Sickle-cell disease can be treated in mice. The mice which have essentially the same defect that causes human cases used a viral vector to induce production of fetal hemoglobin (HbF), which normally ceases to be produced shortly after birth. In humans, the use of hydroxyurea to stimulate the production of HbF temporarily alleviates sickle cell symptoms. The researchers demonstrated this treatment to be a more permanent means to increase therapeutic HbF production.
A new gene therapy approach repaired errors in messenger RNA derived from defective genes. This technique has the potential to treat thalassaemia, cystic fibrosis and some cancers.
Researchers created liposomes 25 nanometers across that can carry therapeutic DNA through pores in the nuclear membrane.
In 2003 a research team inserted genes into the brain for the first time. They used liposomes coated in a polymer called polyethylene glycol, which, unlike viral vectors, are small enough to cross the bloodbrain barrier.
Short pieces of double-stranded RNA (short, interfering RNAs or siRNAs) are used by cells to degrade RNA of a particular sequence. If a siRNA is designed to match the RNA copied from a faulty gene, then the abnormal protein product of that gene will not be produced.
Gendicine is a cancer gene therapy that delivers the tumor suppressor gene p53 using an engineered adenovirus. In 2003, it was approved in China for the treatment of head and neck squamous cell carcinoma.
In March researchers announced the successful use of gene therapy to treat two adult patients for X-linked chronic granulomatous disease, a disease which affects myeloid cells and damages the immune system. The study is the first to show that gene therapy can treat the myeloid system.
In May a team reported a way to prevent the immune system from rejecting a newly delivered gene. Similar to organ transplantation, gene therapy has been plagued by this problem. The immune system normally recognizes the new gene as foreign and rejects the cells carrying it. The research utilized a newly uncovered network of genes regulated by molecules known as microRNAs. This natural function selectively obscured their therapeutic gene in immune system cells and protected it from discovery. Mice infected with the gene containing an immune-cell microRNA target sequence did not reject the gene.
In August scientists successfully treated metastatic melanoma in two patients using killer T cells genetically retargeted to attack the cancer cells.
In November researchers reported on the use of VRX496, a gene-based immunotherapy for the treatment of HIV that uses a lentiviral vector to deliver an antisense gene against the HIV envelope. In a phase I clinical trial, five subjects with chronic HIV infection who had failed to respond to at least two antiretroviral regimens were treated. A single intravenous infusion of autologous CD4 T cells genetically modified with VRX496 was well tolerated. All patients had stable or decreased viral load; four of the five patients had stable or increased CD4 T cell counts. All five patients had stable or increased immune response to HIV antigens and other pathogens. This was the first evaluation of a lentiviral vector administered in a US human clinical trial.
In May researchers announced the first gene therapy trial for inherited retinal disease. The first operation was carried out on a 23-year-old British male, Robert Johnson, in early 2007.
Leber’s congenital amaurosis is an inherited blinding disease caused by mutations in the RPE65 gene. The results of a small clinical trial in children were published in April. Delivery of recombinant adeno-associated virus (AAV) carrying RPE65 yielded positive results. In May two more groups reported positive results in independent clinical trials using gene therapy to treat the condition. In all three clinical trials, patients recovered functional vision without apparent side-effects.
In September researchers were able to give trichromatic vision to squirrel monkeys. In November 2009, researchers halted a fatal genetic disorder called adrenoleukodystrophy in two children using a lentivirus vector to deliver a functioning version of ABCD1, the gene that is mutated in the disorder.
An April paper reported that gene therapy addressed achromatopsia (color blindness) in dogs by targeting cone photoreceptors. Cone function and day vision were restored for at least 33 months in two young specimens. The therapy was less efficient for older dogs.
In September it was announced that an 18-year-old male patient in France with beta-thalassemia major had been successfully treated. Beta-thalassemia major is an inherited blood disease in which beta haemoglobin is missing and patients are dependent on regular lifelong blood transfusions. The technique used a lentiviral vector to transduce the human -globin gene into purified blood and marrow cells obtained from the patient in June 2007. The patient’s haemoglobin levels were stable at 9 to 10 g/dL. About a third of the hemoglobin contained the form introduced by the viral vector and blood transfusions were not needed. Further clinical trials were planned.Bone marrow transplants are the only cure for thalassemia, but 75% of patients do not find a matching donor.
Cancer immunogene therapy using modified anti gene, antisense / triple helix approach was introduced in South America in 2010/11 in La Sabana University, Bogota (Ethical Committee 14.12.2010, no P-004-10). Considering the ethical aspect of gene diagnostic and gene therapy targeting IGF-I, the IGF-I expressing tumors i.e. lung and epidermis cancers, were treated (Trojan et al. 2016). 
In 2007 and 2008, a man was cured of HIV by repeated Hematopoietic stem cell transplantation (see also Allogeneic stem cell transplantation, Allogeneic bone marrow transplantation, Allotransplantation) with double-delta-32 mutation which disables the CCR5 receptor. This cure was accepted by the medical community in 2011. It required complete ablation of existing bone marrow, which is very debilitating.
In August two of three subjects of a pilot study were confirmed to have been cured from chronic lymphocytic leukemia (CLL). The therapy used genetically modified T cells to attack cells that expressed the CD19 protein to fight the disease. In 2013, the researchers announced that 26 of 59 patients had achieved complete remission and the original patient had remained tumor-free.
Human HGF plasmid DNA therapy of cardiomyocytes is being examined as a potential treatment for coronary artery disease as well as treatment for the damage that occurs to the heart after myocardial infarction.
In 2011 Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia; it delivers the gene encoding for VEGF. Neovasculogen is a plasmid encoding the CMV promoter and the 165 amino acid form of VEGF.
The FDA approved Phase 1 clinical trials on thalassemia major patients in the US for 10 participants in July. The study was expected to continue until 2015.
In July 2012, the European Medicines Agency recommended approval of a gene therapy treatment for the first time in either Europe or the United States. The treatment used Alipogene tiparvovec (Glybera) to compensate for lipoprotein lipase deficiency, which can cause severe pancreatitis. The recommendation was endorsed by the European Commission in November 2012 and commercial rollout began in late 2014.
In December 2012, it was reported that 10 of 13 patients with multiple myeloma were in remission “or very close to it” three months after being injected with a treatment involving genetically engineered T cells to target proteins NY-ESO-1 and LAGE-1, which exist only on cancerous myeloma cells.
In March researchers reported that three of five subjects who had acute lymphocytic leukemia (ALL) had been in remission for five months to two years after being treated with genetically modified T cells which attacked cells with CD19 genes on their surface, i.e. all B-cells, cancerous or not. The researchers believed that the patients’ immune systems would make normal T-cells and B-cells after a couple of months. They were also given bone marrow. One patient relapsed and died and one died of a blood clot unrelated to the disease.
Following encouraging Phase 1 trials, in April, researchers announced they were starting Phase 2 clinical trials (called CUPID2 and SERCA-LVAD) on 250 patients at several hospitals to combat heart disease. The therapy was designed to increase the levels of SERCA2, a protein in heart muscles, improving muscle function. The FDA granted this a Breakthrough Therapy Designation to accelerate the trial and approval process. In 2016 it was reported that no improvement was found from the CUPID 2 trial.
In July researchers reported promising results for six children with two severe hereditary diseases had been treated with a partially deactivated lentivirus to replace a faulty gene and after 732 months. Three of the children had metachromatic leukodystrophy, which causes children to lose cognitive and motor skills. The other children had Wiskott-Aldrich syndrome, which leaves them to open to infection, autoimmune diseases and cancer. Follow up trials with gene therapy on another six children with Wiskott-Aldrich syndrome were also reported as promising.
In October researchers reported that two children born with adenosine deaminase severe combined immunodeficiency disease (ADA-SCID) had been treated with genetically engineered stem cells 18 months previously and that their immune systems were showing signs of full recovery. Another three children were making progress. In 2014 a further 18 children with ADA-SCID were cured by gene therapy. ADA-SCID children have no functioning immune system and are sometimes known as “bubble children.”
Also in October researchers reported that they had treated six haemophilia sufferers in early 2011 using an adeno-associated virus. Over two years later all six were producing clotting factor.
Data from three trials on Topical cystic fibrosis transmembrane conductance regulator gene therapy were reported to not support its clinical use as a mist inhaled into the lungs to treat cystic fibrosis patients with lung infections.
In January researchers reported that six choroideremia patients had been treated with adeno-associated virus with a copy of REP1. Over a six-month to two-year period all had improved their sight. By 2016, 32 patients had been treated with positive results and researchers were hopeful the treatment would be long-lasting. Choroideremia is an inherited genetic eye disease with no approved treatment, leading to loss of sight.
In March researchers reported that 12 HIV patients had been treated since 2009 in a trial with a genetically engineered virus with a rare mutation (CCR5 deficiency) known to protect against HIV with promising results.
Clinical trials of gene therapy for sickle cell disease were started in 2014 although one review failed to find any such trials.
In February LentiGlobin BB305, a gene therapy treatment undergoing clinical trials for treatment of beta thalassemia gained FDA “breakthrough” status after several patients were able to forgo the frequent blood transfusions usually required to treat the disease.
In March researchers delivered a recombinant gene encoding a broadly neutralizing antibody into monkeys infected with simian HIV; the monkeys’ cells produced the antibody, which cleared them of HIV. The technique is named immunoprophylaxis by gene transfer (IGT). Animal tests for antibodies to ebola, malaria, influenza and hepatitis are underway.
In March scientists, including an inventor of CRISPR, urged a worldwide moratorium on germline gene therapy, writing scientists should avoid even attempting, in lax jurisdictions, germline genome modification for clinical application in humans until the full implications are discussed among scientific and governmental organizations.
Also in 2015 Glybera was approved for the German market.
In October, researchers announced that they had treated a baby girl, Layla Richards, with an experimental treatment using donor T-cells genetically engineered to attack cancer cells. Two months after the treatment she was still free of her cancer (a highly aggressive form of acute lymphoblastic leukaemia [ALL]). Children with highly aggressive ALL normally have a very poor prognosis and Layla’s disease had been regarded as terminal before the treatment.
In December, scientists of major world academies called for a moratorium on inheritable human genome edits, including those related to CRISPR-Cas9 technologies but that basic research including embryo gene editing should continue.
In April the Committee for Medicinal Products for Human Use of the European Medicines Agency endorsed a gene therapy treatment called Strimvelis and recommended it be approved. This treats children born with ADA-SCID and who have no functioning immune system – sometimes called the “bubble baby” disease. This would be the second gene therapy treatment to be approved in Europe.
Speculated uses for gene therapy include:
Gene Therapy techniques have the potential to provide alternative treatments for those with infertility. Recently, successful experimentation on mice has proven that fertility can be restored by using the gene therapy method, CRISPR. Spermatogenical stem cells from another organism were transplanted into the testes of an infertile male mouse. The stem cells re-established spermatogenesis and fertility.
Athletes might adopt gene therapy technologies to improve their performance.Gene doping is not known to occur, but multiple gene therapies may have such effects. Kayser et al. argue that gene doping could level the playing field if all athletes receive equal access. Critics claim that any therapeutic intervention for non-therapeutic/enhancement purposes compromises the ethical foundations of medicine and sports.
Genetic engineering could be used to change physical appearance, metabolism, and even improve physical capabilities and mental faculties such as memory and intelligence. Ethical claims about germline engineering include beliefs that every fetus has a right to remain genetically unmodified, that parents hold the right to genetically modify their offspring, and that every child has the right to be born free of preventable diseases. For adults, genetic engineering could be seen as another enhancement technique to add to diet, exercise, education, cosmetics and plastic surgery. Another theorist claims that moral concerns limit but do not prohibit germline engineering.
Possible regulatory schemes include a complete ban, provision to everyone, or professional self-regulation. The American Medical Associations Council on Ethical and Judicial Affairs stated that “genetic interventions to enhance traits should be considered permissible only in severely restricted situations: (1) clear and meaningful benefits to the fetus or child; (2) no trade-off with other characteristics or traits; and (3) equal access to the genetic technology, irrespective of income or other socioeconomic characteristics.”
As early in the history of biotechnology as 1990, there have been scientists opposed to attempts to modify the human germline using these new tools, and such concerns have continued as technology progressed. With the advent of new techniques like CRISPR, in March 2015 a group of scientists urged a worldwide moratorium on clinical use of gene editing technologies to edit the human genome in a way that can be inherited. In April 2015, researchers sparked controversy when they reported results of basic research to edit the DNA of non-viable human embryos using CRISPR.
Regulations covering genetic modification are part of general guidelines about human-involved biomedical research.
The Helsinki Declaration (Ethical Principles for Medical Research Involving Human Subjects) was amended by the World Medical Association’s General Assembly in 2008. This document provides principles physicians and researchers must consider when involving humans as research subjects. The Statement on Gene Therapy Research initiated by the Human Genome Organization (HUGO) in 2001 provides a legal baseline for all countries. HUGOs document emphasizes human freedom and adherence to human rights, and offers recommendations for somatic gene therapy, including the importance of recognizing public concerns about such research.
No federal legislation lays out protocols or restrictions about human genetic engineering. This subject is governed by overlapping regulations from local and federal agencies, including the Department of Health and Human Services, the FDA and NIH’s Recombinant DNA Advisory Committee. Researchers seeking federal funds for an investigational new drug application, (commonly the case for somatic human genetic engineering), must obey international and federal guidelines for the protection of human subjects.
NIH serves as the main gene therapy regulator for federally funded research. Privately funded research is advised to follow these regulations. NIH provides funding for research that develops or enhances genetic engineering techniques and to evaluate the ethics and quality in current research. The NIH maintains a mandatory registry of human genetic engineering research protocols that includes all federally funded projects.
An NIH advisory committee published a set of guidelines on gene manipulation. The guidelines discuss lab safety as well as human test subjects and various experimental types that involve genetic changes. Several sections specifically pertain to human genetic engineering, including Section III-C-1. This section describes required review processes and other aspects when seeking approval to begin clinical research involving genetic transfer into a human patient. The protocol for a gene therapy clinical trial must be approved by the NIH’s Recombinant DNA Advisory Committee prior to any clinical trial beginning; this is different from any other kind of clinical trial.
As with other kinds of drugs, the FDA regulates the quality and safety of gene therapy products and supervises how these products are used clinically. Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects, such as clinical trials, must be reviewed and approved by the FDA and an Institutional Review Board.
Gene therapy is the basis for the plotline of the film I Am Legend and the TV show Will Gene Therapy Change the Human Race?.
Gene therapy – Wikipedia
Posted: at 7:35 am
One of the reforms designed to rein in the surveillance authorities of the National Security Agency has perhaps inadvertently solved a technical problem for the spy outfit and granted it potential access to much more data than before, a former top official told ABC News.
Before the signing of the USA Freedom Act in June 2015, one of the NSA’s most controversial programs was the mass collection of telephonic metadata from millions of Americans the information about calls, including the telephone numbers involved, the time and the duration but not the calls’ content under a broad interpretation of the Patriot Act’s Section 215. From this large “haystack,” as officials have called it, NSA analysts could get approval to run queries on specific numbers purportedly linked to international terrorism investigations.
The problem for the NSA was that the haystack was only about 30 percent as big as it should’ve been; the NSA database was missing a lot of data. As The Washington Post reported in 2014, the agency was not getting information from all wireless carriers and it also couldn’t handle the deluge of data that was coming in.
On the technical side, Chris Inglis, who served as the NSA’s deputy director until January 2014, recently told ABC News that when major telecommunications companies previously handed over customer records, the NSA “just didn’t ingest all of it.”
“[NSA officials] were trying to make sure they were doing it exactly right,” he said, meaning making sure that the data was being pulled in according to existing privacy policies. The metadata also came in various forms from the different companies, so the NSA had to reformat much of it before loading it into a searchable database.
Both hurdles meant that the NSA couldn’t keep up, and of all the metadata the agency wanted to be available for specific searches internally, only about a third of it actually was.
But then the USA Freedom Act was signed into law, and now Inglis said, all that is “somebody else’s problem.”
The USA Freedom Act ended the NSA’s bulk collection of metadata but charged the telecommunications companies with keeping the data on hand. The NSA and other U.S. government agencies now must request information about specific phone numbers or other identifying elements from the telecommunications companies after going through the Foreign Intelligence Surveillance Act (FISA) court and arguing that there is a “reasonable, articulable suspicion” that the number is associated with international terrorism.
As a result, the NSA no longer has to worry about keeping up its own database and, according to Inglis, the percentage of available records has shot up from 30 percent to virtually 100. Rather than one internal, incomplete database, the NSA can now query any of several complete ones.
The new system “guarantees that the NSA can have access to all of it,” Inglis said.
NSA general counsel Glenn Gerstell made a brief reference to the increased capacity in a post for the Lawfare blog in January after terrorist attacks at home and abroad.
“Largely overlooked in the debate that has ensued in the wake of recent attacks is the fact that under the new arrangement, our national security professionals will have access to a greater volume of call records subject to query in a way that is consistent with our regard for civil liberties,” he wrote.
Mark Rumold, a senior staff attorney at the Electronic Frontier Foundation, told ABC News he doesn’t have much of a problem with the NSA’s wider access to telephone data, since now the agency has to go through a “legitimate” system with “procedural protections” before jumping into the databases.
“Their ability to obtain records has broadened, but by all accounts, they’re collecting a far narrower pool of data than they were initially,” he said, referring to returns on specific searches. “They can use a type of legal process with a broader spectrum of providers than earlier. To me, that isn’t like a strike against it. That’s almost something in favor of it, because we’ve gone through this public process, we’ve had this debate, and this is where we settled on the scope of the authority we were going to give them.”
Rumold said he’s still concerned about the NSA’s ability to get information on phone numbers linked to a number in question up to two “hops” away but he said the USA Freedom Act “remains a step in the right direction.”
The trade-off of the new system, according to Inglis, is in the efficiency of the searches. Whereas in the past the NSA could instantaneously run approved searches of its database, now the agency must approach each telecommunications company to ask about a number and then wait for a response.
In his January post Gerstell acknowledged concerns that the new approach could be “too cumbersome to be effective” and said the NSA will report to Congress on how the arrangement is working. A representative for the NSA declined to tell ABC News if any problems have been encountered so far, and Rumold noted there has been no public evidence of any issues.
Inglis said he isn’t terribly concerned if the searches are a little slower. It’s a small price to pay, he said, for what he called an “additional safeguard” that could increase the public’s confidence in what the NSA is and how it operates.
Posted: October 23, 2016 at 4:25 am
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Posted: at 4:24 am
“Psychedelics” redirects here. For other uses, see Psychedelic.
A psychedelic drug is a drug whose primary action is to alter cognition and perception, typically by agonising serotonin receptors.
Not to be confused with psychoactive drugs, such as stimulants and opioids, which induce familiar states of consciousness, psychedelics tend to affect the mind in ways that result in the experience being qualitatively different from those of ordinary consciousness. The psychedelic experience is often compared to non-ordinary forms of consciousness such as trance, meditation, yoga, religious ecstasy, dreaming and even near-death experiences. With a few exceptions, most psychedelic drugs fall into one of the three following families of chemical compounds; tryptamines, phenethylamines, and lysergamides.
Many psychedelic drugs are illegal worldwide under the UN conventions unless used in a medical or religious context. Despite these regulations, recreational use of psychedelics is common.
The term psychedelic is derived from the Greek words (psyche, “soul, mind”) and (delein, “to manifest”), hence “soul-manifesting”, the implication being that psychedelics can access the soul and develop unused potentials of the human mind. The word was coined in 1956 by British psychiatrist, Humphry Osmond, the spelling loathed by American ethnobotanist, Richard Schultes, but championed by the American psychologist, Timothy Leary.
Aldous Huxley had suggested to Humphry Osmond in 1956 his own coinage phanerothyme (Greek “phaneroein-” visible + Greek “thymos” soul, thus “visible soul”). Recently, the term entheogenic has come into use to denote the use of psychedelic drugs in a religious/spiritual/mystical context.
Psychedelics have a long history of traditional use in medicine and religion, where they are prized for their perceived ability to promote physical and mental healing. In this context, they are often known as entheogens. Native American practitioners using mescaline-containing cacti (most notably peyote, San Pedro, and Peruvian torch) have reported success against alcoholism, and Mazatec practitioners routinely use psilocybin mushrooms for divination and healing. Ayahuasca, which contains the powerful psychedelic DMT, is used in Peru and other parts of South America for spiritual and physical healing as well as in religious festivals.
Classical or serotonergic psychedelics (agonists for the 5-HT2A serotonin receptors) include LSD (also known as “acid”), psilocin (the active constituent of psilocybin mushrooms, commonly known as “magic mushrooms” or “shrooms”), mescaline (the active constituent of peyote), and DMT (the active constituent of ayahuasca and an endogenous compound produced in the human body). Salvia divinorum is an atypical psychedelic that has been gaining popularity over the past decade, due to its legality in many US states. It is often compared to DMT due to its short and very intense trip. A few newer synthetics such as 2C-B have also enjoyed some popularity.
This class of psychedelics includes the classical hallucinogens, including the lysergamides like LSD and LSA, tryptamines like psilocybin and DMT, and phenethylamines like mescaline and 2C-B. Many of these psychedelics cause remarkably similar effects, despite their different chemical structure. However, many users report that the three families have subjectively different qualities in the “feel” of the experience, which are difficult to describe. At lower doses, these include sensory alterations, such as the warping of surfaces, shape suggestibility, and color variations. Users often report intense colors that they have not previously experienced, and repetitive geometric shapes are common. Higher doses often cause intense and fundamental alterations of sensory perception, such as synesthesia or the experience of additional spatial or temporal dimensions. Some compounds, such as 2C-B, have extremely tight “dose curves”, meaning the difference between a non-event and an overwhelming disconnection from reality can be very slight. There can be very substantial differences between the drugs, however. For instance, 5-MeO-DMT rarely produces the visual effects typical of other psychedelics and ibogaine (a ‘complex tryptamine’) is also an NMDA receptor antagonist and -opioid receptor agonist in addition to being an agonist for the 5-HT2A receptors, resulting in dissociative effects as well (see dissociatives below).
The empathogen-entactogens are phenethylamines of the MDxx class such as MDMA, MDEA, and MDA. Their effects are characterized by feelings of openness, euphoria, empathy, love, heightened self-awareness, and by mild audio and visual distortions (an overall enhancement of sensory experience is often reported). Their adoption by the rave subculture is probably due to the enhancement of the overall social and musical experience. MDA is atypical to this experience, often causing hallucinations and psychedelic effects in equal profundity to the chemicals in the 5-HT2A agonist category, but with substantially less mental involvement, and is both a serotonin releaser and 5-HT2A receptor agonist.
Certain dissociative drugs acting via NMDA antagonism are known to produce what some might consider psychedelic effects. The main differences between dissociative psychedelics and serotonergic hallucinogens are that the dissociatives cause more intense derealization and depersonalization. For example, ketamine produces sensations of being disconnected from one’s body and that the surrounding environment is unreal, as well as perceptual alterations seen with other psychedelics.
Salvia divinorum is a dissociative that is sometimes classified as an atypical psychedelic. The active molecule in the plant, salvinorin A, is a kappa opioid receptor agonist, working on a part of the brain that deals with pain. Activation of this receptor is also linked to the dysphoria sometimes experienced by users of opiates either therapeutically or recreationally. An unusual feature of S. divinorum is its high potency (dosage is in the microgram range) and extremely disorienting effects, which often include “entity contact”, complete loss of reality-perception and user’s experiencing their consciousness as being housed in different objects e.g. a pane of glass or a pencil.
Despite many psychedelic drugs being non-addictive and there being no evidence to support long term harm on mental health many of these drugs have been declared illegal under the UN Convention on Psychotropic Substances of 1971. In addition, many countries have analogue acts that automatically forbid any drugs sharing similar chemical structures to common illicit substances regardless of whether they are harmful.
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