Case 1:10-cv-01529-ESH Document 29 Filed 04/15/11 Page 1 of 11 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA VIROPHARMA, INCORPORATED, Plaintiff, Civil Action No. 10-1529 (ESH) MARGARET A. HAMBURG, M.D., in her official capacity as Commissioner, Food and Drug Administration, et al. , Defendants. MEMORANDUM OPINION Plaintiff ViroPharma Incorpo
Conversely, injection forms, though being painful and needing help of medical personnel for application, help to quickly achieve necessary concentration of preparation in blood buy antibiotics online Antibiotic is usually chosen in an empiric way (at random). But when choosing one is obligatory guided by definite rules.
Microsoft word - final paper.docIn the world that we live in today almost everything is defined by the education that we receive: the college we are accepted into, job placement, job security, wealth, and so much more. Furthering this, our education is defined by an individual’s intelligence level. Most people have a somewhat keen awareness of intelligence – whether it’s smart, dumb, bright, dull, brilliant, or stupid – the list goes on forever. Truth be told, measuring intelligence is a somewhat slippery slope. One method of measuring intelligence is through an Intelligence Quotient test, otherwise known as an IQ test. An IQ test is responsible for measuring the intelligence ability of individuals who are rather close in age. For a child, taking an IQ test can seem like a challenging feat. Not only is your future at stake based upon your test score, but the results will place you in a specified ability level. Today, whether a student is deemed gifted, average, or learning disabled is all reliant upon the results of a simple IQ test. Traditionally in most states, the minimum IQ scores to define a child as gifted will fall somewhere between 130 and 140. An average student would typically score somewhere between 90 and 110, whereas a student with a deemed learning disability would usually score somewhere under 80. Scores in between were usually judged based upon parents, teachers, and doctors. The question, however, revolves around a stranger concept – one of dual exceptionality and being able to achieve significantly above average in one sense, but fail significantly below average in a completely different sense. If this is in fact a possibility in students today, how are these exceptional students identified and what should be done? Learning disabled (LD) children are sometimes classified as having low intelligence, weird, not normal, or even ‘retarded.’ This is the wrong classification for learning disabled students. They simply seem to have a discrepancy between their ability level and their actual performance and/or achievement level. However, more than twenty years ago, criteria was proposed to describe out of the ordinary gifted students who also were diagnosed with learning disabilities. This concept seems hard to imagine, but it is actually quite simple. Imagine an individual student who, when compared to the rest of the population, has a general ability level greater than the average. Imagine this same individual showing achievement in some subject area significantly below average. This individual student “would seem to simultaneously possess giftedness and a specific learning disability” (Lovett & Lewandowski, 2006). Children with identified giftedness as well as learning disabilities are termed to have ‘dual exceptionality.’ Although psychologists only began recognizing this concept of dual exceptionality twenty years ago, it is quite plausible that there have been many intellectually gifted students with learning disabilities in our history. Take Helen Keller or Steven Hawking, for example, both of whom had some form of learning disability and intellectual giftedness. Eventually, with teachers, parents, and doctors beginning to recognize this dual exceptionality, a new gifted handicapped category was added to the Education Resources Information Center (ERIC) and case studies began to form. This gifted handicapped movement eventually led to these students being referred to with a gifted learning disabled label, or G/LD – what dual exceptionality students are referred to as today (Lovett & Lewandowski, 2006). In 1998, the National Association for Gifted Children further defined and classified G/LD students, by “describing three kinds of G/LD students: (1) identified gifted students who have subtle learning disabilities, (2) students with a learning disability but whose gift has not been identified, and (3) unidentified students whose gifts and learning disabilities may be masked by average school achievement” (Lovett & Lewandowski, 2006). The third description encompasses a label that completely defines the claim that a lot of the G/LD student population travels through elementary and middle school undetected. This masking hypothesis follows the belief that the giftedness and high intelligence level of the student in one aspect will mask out the learning disability, causing their G/LD classification to go unnoticed. There is one major criticism of using only the IQ test to identify students as G/LD. The problem is that a lot of the students will go undetected because of the masking hypothesis and that the IQ test is testing students based upon the grade-typical achievement level of a normal student. Therefore, the truly important question is how do you assess and identify gifted and learning disabled students? There have been four documents that have been published that have given almost identical guidelines for the assessment and diagnosis of the G/LD population. The four practices that have been suggested to assess the G/LD population include: scatter analysis, profile analysis, broad definitions of intelligence and giftedness, and ability-achievement discrepancy models of learning disabilities (Lovett & Lewandowski, 2006). Furthering these ideas, the documents suggest that the IQ test scores should still be analyzed, but they should be interspersed with structured interviews, teacher and parent nominations, and observations of individual student behavior, especially while participating in a classroom setting. Taking this concept of giftedness and learning disabilities in students and their capacity to have this characteristic of dual exceptionality, I would like to further examine Asperger’s syndrome and its ability to coexist with giftedness. Asperger’s syndrome, or Asperger’s disorder, is a neurobiological disorder that is typically identified as a pervasive developmental disorder (PDD) within the autism realm. A pervasive developmental disorder is a behavioral disorder that usually involves the speech, communication, social interaction, and compulsive behavior of an individual. The most common pervasive developmental disorder is autism, but there are typically five major disorders characterized and familiarized by doctors (Grossmann, 2004). Asperger’s syndrome is named for Hans Asperger, a Viennese child psychiatrist. In 1944, Asperger published a report on his case study of several young boys who were displaying several alarming characteristics. The boys seemed to demonstrate several autism-like characteristics, such as problems in social and communication skills. The difference from these young boys and children with full-fledged autism was that they also demonstrated almost normal intelligence and language development. It is only in recent years that Asperger’s syndrome has been added to the Diagnostic Statistical Manual (DSM) and even more recently that it has started being recognized by physicians, parents, In these recent years, the prevalence of Asperger’s syndrome has increased tremendously. Overall, the occurrence for young children with autism spectrum disorders is about one in one hundred and it is expected that this could account for 700,000 to 2,000,000 individuals in the United States with Asperger’s syndrome (Weber, 2008). However, of this statistical analysis, it is important to mention that Asperger’s syndrome is four times more likely to occur in males rather than in females. To put the symptoms of Asperger’s syndrome simply, Asperger’s syndrome individuals can be described as “having a dash of autism” (Kirby, 2005). Along with this, these individuals have been described as “someone who thinks and perceives the world differently than other people” (Weber, 2008). Physicians and psychologists today identify Asperger’s syndrome with six different characteristics required for diagnosis: social impairments, narrow interests, repetitive routines, speech and language peculiarities, non-verbal communication difficulties, and motor clumsiness. All of these characteristics revolve around social interaction as being the main difficulty for these individuals. Along with social interaction, individuals showing signs of a very narrow interest is a major symptom. The individual will have a tendency to become very occupied in one particular subject. This preoccupation will force the child to become somewhat of a social outcast and might lead to the child being a bit more rigid in social situations. Furthermore, this obsession will cause a child with Asperger’s syndrome to be apprehensive about change and worried about not following the usual routine. There are a few other characteristics that are easily masked as behavior problems or lack of parenting. However, in Asperger’s syndrome, this is not the case. Problems such as emotional liability and general anxiety, sensory integration problems, auditory integration problems, motor clumsiness, atypical responses to stimuli, and problems with organization are all typical characteristics of the syndrome – yet they are not clear in every individual (Weber, 2008). One of the most difficult problems revolving around Asperger’s syndrome individuals is that there is no definite treatment or intervention that will be effective for every individual. Because every child with the syndrome is different, the treatment and interventions need to be assessed and determined based upon the individual needs, as well as the strengths and weaknesses of each individual. With the help of a social mentoring aid, individuals with the syndrome can learn social skills that will aid them in specific social situations (Weber, 2008). Counselors can also provide further emotional support and assistance. It has also been proven that speech and language therapists can help with the problems that are associated with the delay in motor language development. One of the most important steps for an individual with Asperger’s syndrome (especially in young children) is to develop an individual educational plan, or IEP. An IEP is a written document that is developed at the beginning of each school year for public school children with a learning disability. The main purpose of an IEP is to develop a plan to meet each individually unique student’s need. For individuals with Asperger’s syndrome, it is obviously very important that the parents sit down and develop a plan that will be tailored exactly to meet the student’s identified needs. Along with this, several physicians have been conducting research studied on the effects of pharmacological interventions. Various medications including Melatonin, Risperidone, Olanzapine, Serotonin reuptake inhibitors, and Fluvoxamine, have been introduced to Asperger’s patients in several clinical trials (Weber, 2008). The overall treatment of individuals with Asperger’s syndrome is very difficult. Because of the recent developments with this syndrome, doctors and parents can only be hopeful that eventually a completely effective From this basic definition of Asperger’s syndrome, it seems hard and even impossible to imagine that this lesser form of autism could coexist with giftedness. As Alan Snyder explained: “So could studies of autism [including Asperger’s syndrome] reveal insights into creativity? It seems unlikely. The classical portrait of autism includes low intelligence, significant learning disabilities, memory by rote, literalness, and a rigid insistence on sameness” (2004). From Allan Snyder’s statement, it seems that dual exceptionality with Asperger’s syndrome and giftedness would be impossible. On the other hand, Michael Fitzgerald, the author of Autism and Creativity: Is There a Link between Autism in Men and Exceptional Capability, believes that many aspects of autism and especially Asperger’s syndrome will enhance the creativity in the human individual. He believes the notion that because learning disabilities are highly genetic in men, the creative ability of a genius or gifted individual is a direct result of genetic factors rather than environmental factors. He explains, “The view that geniuses began their lives made from the same material as the rest of us…is false. I support my claim by declaring that several individuals with creativity of genius proportions fit the high end of the autistic spectrum. These include Isaac Newton, the philosopher Ludwig Wittgenstein, the poet W.B. Yeats, mathematician Srinivasa Ramanujan, Lewis Carroll, and politicians Keith Joseph and Eamon de Valera. Oh – apparently Hitler too had autistic traits” (Fitzgerald, 2003). From an overall perspective of Michael Fitzgerald’s book, it is evident that he truly believes that autism might be the “necessary or crucial ingredient of human creativity” (2003). Fitzgerald and Synder were not the first to analyze the dual exceptionality possibility among Asperger’s syndrome and giftedness. Hans Asperger himself also spoke of this unique characteristic found in young male students. He talked of “autistic intelligence as being intelligence of true creativity and that it seems that for success in science or art, a dash of autism is essential” (Snyder, 2004). From this, it seems highly plausible that Asperger’s syndrome can exist with giftedness in a rare form of dual exceptionality. Looking at the characteristics and symptoms of Asperger’s syndrome, it is only logical that these would in fact enhance creativity and enhance the gifted features of a child. As stated previously, individuals with Asperger’s syndrome have the capacity to focus intently on an individual topic for very long periods of time. The capacity to sit and work intently on one topic for days and sometimes even weeks on end would definitely aid the creativity of an individual. Also, the patience that these individuals exhibit prevents them from becoming frustrated when the hoped for results are not reached. Also, Asperger’s syndrome individuals often show signs of being immature and not working well in social situations. This also enhances their creative ability. They do not like working in social settings and, therefore, will work for days alone until they reach their desired outcome. Take Albert Einstein, for example: as an inventor and an individual with high-functioning autism, he was able to use his tremendous amounts of energy and motivation to try to make ‘sense of the world.’ The most controversial problem revolving around Albert Einstein is the fact that he passed away before this condition came to be known. Upon his death, Einstein’s brain was preserved. It is hoped that in the near future physical features involving the human brain will be connected to autism and Asperger’s syndrome, which will allow for experts to identify if Einstein definitely had the condition. On the other hand, take a look at Adolf Hitler, who is expected to of had some form of autism. He led an extremely socially awkward and outcast life. His few comrades and companions stated that he was ‘contempt for mankind’ and that he had ‘no humanitarian’ feelings (Fitzgerald, 2003). In his book, Michael Fitzgerald describes the result that the autistic-Hitler had on his nation: “The combination of a person with autistic psychopathy and a nation in turmoil after the First World War caused Germany to sink into what [he] describes as ‘scarcely imaginable brutality and rapaciousness…a form of nuclear blown-out within modern society’” (2003). Comparing and contrasting Albert Einstein and Adolf Hitler will give the impression of two completely different sides of the spectrum of dual exceptionality. However, in reality, both of these men experienced dual exceptionality, in the form of autism and/or Asperger’s syndrome and giftedness. The manner in which these men chose to deal with their creativity and learning disability Therefore, there is no doubt whatsoever that individuals with dual exceptionality exist. Additionally, it is very evident that individuals with Asperger’s syndrome and giftedness can coexist. In my opinion, there is no question about the fact that gifted learning disabled students, especially in the context that no matter how high the IQ score cutoffs and how low the achievement cutoffs are, there will always be some children that will meet the criteria for both giftedness and specific learning disability. The fact that an individual can coexist in this world today with both a learning disability, such as Asperger’s syndrome, and with giftedness in a particular field, is a marvelous feat of the human brain and body. To me, it seems that this particular gifted learning disability and area of dual exceptionality is a realm that should be marveled at and celebrated. Fitzgerald, M (2003). Autism and creativity: Is there a link between autism in men and exceptional ability?. New York, N.Y.: Brunner-Routledge . Grossmann, R (2004). Childbrain.com. Retrieved July 28, 2008, from The Pediatric Neurology Site Web site: http://www.childbrain.com/pddq1.shtml Kirby, B. L. (2005). Online asperger syndrome information and support. Retrieved July 28, 2008, from What Is Asperger Syndrome? Web site: http://www.udel.edu/bkirby/asperger/aswhatisit.html Lovett, B. J., & Lewandowski, L. J. (2006). Gifted students with learning disabilities: Who are they?. Journal of Learning Disabilities. 39, 515-527. Ozbayrak, R. K. (1996, January 1). What are other psychological problems that can co- exist with asperger's disorder?. Retrieved July 22, 2008, from Asperger's Disorder Homepage Web site: http://www.aspergers.com/aspcomor.htm Ozbayrak, R. K. (1996, January 1). What is the treatment of asperger's disorder?. Retrieved July 28, 2008, from Asperger Web site: http://www.aspergers.com/asptrt.htm Snyder, A (2004). Autistic genius?. Nature Publishing Group, 428, Retrieved July 27, 2008, from http://www.nature.com/nature/journal/v428/n6982/full/428470a.html Weber, K (2008).Asperger's syndrome: From hiding to thriving. The American Journal of Nurse Practitioners. 33, 14-21. Albert Einstein. (2008). In Encyclopedia Britannica [Web]. Retrieved July 20, 2008, from http://www.britannica.com/EBchecked/topic/181349/Albert-Einstein#tab=active~checked%2Citems~checked&title=Albert%20Einstein%20--%20Britannica%20Online%20Encyclopedia Characteristics and behaviors of the gifted. Retrieved July 28, 2008, from Ri.net Web site: http://www.ri.net/gifted_talented/character.html (2008, March 19). What's unique about asperger's syndrome. Retrieved July 24, 2008, from Autism Society of America Web site: http://www.autism-society.org/site/PageServer?pagename=life_aspergers (2008, March 19). Working with individuals with asperger's disorder. Retrieved July 24, 2008, from Autism Society of America Web site: http://www.autism-society.org/site/PageServer?pagename=life_aspergers_working
Item 10.1 HARROGATE AND RURAL DISTRICT CLINICAL COMMISSIONING GROUP Minutes of the Meeting of the Harrogate and Rural District Clinical Commissioning Group Quality and Clinical Governance Committee 8 October 2013 14:00 – 16:00 Boardroom, 1 Grimbald Crag Court, St James Business Park, Knaresborough, HG5 8QB Present John Pattinson, Director of Quality/Exec