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By: James R. Bain, PhD

  • Associate Professor in Medicine
  • Member of Sarah W. Stedman Nutrition and Metabolism Center
  • Senior Fellow in the Center for Study of Aging

https://medicine.duke.edu/faculty/james-r-bain-phd

Lack of innovation and poor long-term outcomes associated with psychotropic medications arthritis relief gnc trusted 200mg plaquenil. The biomedical model of mental disorder: a critical analysis of a combined discipline of clinical neuroscience” (Insel arthritis rub buy discount plaquenil online, 2007 diet untuk rheumatoid arthritis buy plaquenil american express, p. Yet, scientists have not identified a biological cause of, or Often overlooked in the context of widespread enthusiasm for the bio even a reliable biomarker for, any mental disorder. Psychotropic medi medical model, until recently brought to light by a series of high-profile cations work by correcting the neurotransmitter imbalances that challenges to the status quo in psychiatry. However, there is no credible evidence that 2010; Whitaker, 2010a), is the fact that mental health outcomes in the mental disorders are caused by chemical imbalances, or that medicines United States are disconcertingly poor. Advances in neuroscience have between decades of pronouncements by mental health authorities ushered in an era of safer and more effective pharmacological treat about transformative advances in neuroscience and biological psychiatry ments. Conversely, modern psychiatric drugs are generally no more and the stagnant state of the clinical management of mental disorders. The aforementioned critiques of the modern biomedical model approach Biological psychiatry has made great progress in reducing the societal to mental disorder, and the popular media attention they have received burden of mental disorder. A critical analysis of public that mental disorders are biologically-based medical diseases this topic is long overdue, as is a close examination of the practical conse reduces stigma. Increased investment in neuroscience research will lead to diagnostic biological tests and curative pharmacological 2. The pharmaceutical industry has dramatically scaled back efforts to develop new psychiatric drugs due to the lack of promising the biomedical model assumes that mental disorders like schizo molecular targets for mental disorders and the frequent failure of new phrenia, major depressive disorder, attention deficit/hyperactivity compounds to demonstrate superiority to placebo. The ascendancy of the biomedical model — the notion that ders are caused by biological abnormalities principally located in the mental disorders are brain diseases1 — has yielded advances in geno brain, (b) there is no meaningful distinction between mental diseases mics, neuroscience, and molecular biology that are commonly believed and physical diseases, and (c) biological treatment is emphasized to have revolutionized our understanding of the nature and treatment (Andreasen, 1985). An atmosphere of enthusiastic anticipation has research into the nature of mental disorders is to uncover their bio surrounded biological psychiatry for decades (Deacon & Lickel, 2009; logical cause(s). Similarly, treatment research seeks to develop so Peele, 1981) driven by the faith that the field is on the verge of discov matic therapies that target underlying biological dysfunction. The eries that will transform assessment, prevention, and treatment, and ultimate goal is the discovery of magic bullets — precise therapeutic even eradicate mental disorders altogether (Wolfe, 2012). It assumes diseases to be fully 1 the phrase “biomedical model” is used throughout this article to describe the pre accounted for by deviations from the norm of measurable biological dominant approach to mental disorder in the United States. It leaves no room within its framework for the model” (Kiesler, 2000), the biomedical model is a specific manifestation of the broader medical model in which psychosocial approaches to mental disorder are eschewed in social, psychological, and behavioral dimensions of illness. Deacon / Clinical Psychology Review 33 (2013) 846–861 an entity independent of social behavior, it also demands that be established a division of publications and marketing, as well as its havioral aberrations be explained on the basis of disordered own press, and trained a nationwide roster of experts who could pro somatic (biochemical or neurophysiological) processes (p. Popular portrayal of this paradigm by Engel remains an apt characterization press articles began to describe a scientific revolution in psychiatry of the predominant approach to mental disorder in the United States. In 1985, Jon Franklin the biomedical model minimizes the relevance of psychosocial con earned a Pulitzer Prize for expository journalism for his seven-part se tributions to mental disorder and assumes the eliminative reduction ries on molecular psychiatry, published in the Baltimore Evening Sun ist position (Lilienfeld, 2007) that psychological phenomena can be (Franklin, 1984). Based on interviews with more than 50 leading psychi fully reduced to their biological causes. Any [mental] disorder is in its essence a biological today stands on the threshold of becoming an exact science, as precise process. From this perspective, the biological level of and quantifiable as molecular genetics. Ahead lies an era of psychic en analysis is inherently fundamental to the psychological, and psychol gineering, and the development of specialized drugs and therapies to ogy is relegated to the status a “placeholder science” that will eventu heal sick minds” (Franklin, 1984, p. United by their mutual interests in promotion of the biomedical model and pharmacological treatment, psychiatry joined forces with 3. Nevertheless, a brief summary of seminal working together with drug companies on medical education, events helps place the present-day dominance of the biomedical media outreach, congressional lobbying, and other endeavors. Chemical imbalance theories of mental disorder soon and the pharmaceutical industry helped solidify the “biologically-based followed. Despite these promising developments, psychiatry found itself In short, a powerful quartet of voices came together during the under attack from both internal and external forces. The field remained 1980s eager to inform the public that mental disorders were brain divided between biological psychiatrists and Freudians who rejected diseases. In response to these threats to its status as a legitimate branch of sci entific medicine, organized psychiatry embraced the biomedical model.

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The purpose of the required patent disclosures is to arthritis forecast order cheapest plaquenil and plaquenil assist rival firms to arthritis in your neck and shoulders buy plaquenil overnight delivery design around patents so that they can develop non-infringing products to arthritis in upper back and chest discount 200mg plaquenil mastercard compete with the patented 157 discovery and thus spur greater innovation. In sum, continued reliance on the patent system to stimulate biotechnology innovation is well-justified. The next two sections summarize these views and the need for a 12 to 14-year exclusivity period. Panelists’ and Commenters’ Views on the Likely Effects of a Branded Exclusivity Period Pioneer manufacturers suggested that a 12 to 14-year branded exclusivity period 158 provides certainty about recoupment when R&D investment decisions are made. To calculate the recoupment amount, pioneer manufacturers rely on an economic model (the “Nature model”) that calculates the time it takes for a manufacturer to recover 160 fully its investment to develop and commercialize a typical biologic drug. Some commenters have concluded that the Nature model supports a branded exclusivity period 161 between 12. Pioneer manufacturers suggested that a branded exclusivity period substantially 162 shorter than 14 years would be disastrous for innovation and patients. In addition, R&D would shift away from new treatments for diseases, thus depriving the public of much needed treatments 158 Phillips at 100-01 (“[I]f there is no chance to recoup the capital outlay, then the investment won’t be made. Although one panelist questioned why, if the exclusivity period were short, the pioneer manufacturer could not raise prices to make up for any shortfall in revenue and 167 thus not be any worse off. However, another panelist explained that the “the key driver of prices will be if you’re in a market where there’s competition or anticipated 168 competition. Instead, a 14-year branded exclusivity period may simply reduce the pace of 169 innovation. One commenter predicted that if the branded exclusivity period were that long then branded manufacturers would engage in minor product enhancement strategies 170 which would multiply the costs of expanding monopoly protection. Brand companies can, and routinely do, make relatively minor changes to their existing products in order to restart their monopoly-protection clocks. Panelists’ and Commenters’ Views on the Need for Branded Exclusivity to Incentivize Incremental Innovation the panelists and commenters also examined how the existence and length of an exclusivity period could affect incremental innovation. Pioneer manufacturers explained that there likely would not be incremental innovation without recoupment to recover 172 these investments. In this context, participants used the term “incremental innovation” to refer to actions such as the discovery of a new indication for a previously 173 approved product, or an improved formulation for greater safety or convenience. This commenter explained “that at the time a novel biologic is approved, little may be known of what that drug can do or of what can 174 be achieved in connection with its biological target. Another commenter explained that some extension of exclusivity for the pioneer product is necessary to effectively incentivize the development of new indications for, or other improvements to, existing products. He suggested that if additional branded exclusivity is granted, that the initial period be kept shorter to encourage the pioneer manufacturer to 177 engage in the post-approval R&D. Innovation benefits due to branded competition include a race among firms attacking an unmet medical need or investigating a promising therapy that results in increased dissemination of scientific knowledge, and a 178 greater chance of developing a breakthrough product to benefit consumers. The social value of the cumulative effects of incremental innovations can often exceed those of the 179 original breakthrough. Branded competitors also enhance their products to differentiate them from their competitors. Automatic substitution of generic drugs distorts this product enhancement dynamic such that branded manufacturers are incentivized to change their products in minor ways to defeat 180 automatic substitution. Actual Pioneer Drug Manufacturer Exclusivity Can Inform the Length of a Branded Exclusivity Period the head start that first-in-class branded products already experience against second-in-class products can inform the length of a branded exclusivity period for biologics. A subsequent branded competitor obtains limited benefits from the regulatory approval occasioned by the first-in-class product because its R&D efforts have been 181 proceeding on a parallel path with those of the first-in-class manufacturer. The head start of the first-in-class drug product has decreased over the last three decades as the average lead time of the first-in-class product shrank from 8. Although this study examined pharmaceutical products primarily, it included several biologic drugs as well. The generic drug approval process under Hatch-Waxman results in branded manufacturers enjoying 183 approximately 11 to 13 years of de facto exclusivity prior to a generic drug entry. Indeed, this length of time is attributable mainly to patent protection and patent 184 restoration. Given that the patent portfolios for biologic products are likely to include patents owned by third party entities, this time could be 188 substantially extended. Exclusivity Periods Have Been Used When Patent Protection Has Been Insufficient to Incentivize and Reward Innovation Congress has implemented exclusivity periods to encourage the development of new and innovative drug products when the drug molecule is in the public domain, and 189 therefore not patentable.

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Recall that MacDonald and Martineau manipulated participant’s moods by having them think either positive or negative thoughts knee arthritis pain location purchase online plaquenil, and after the manipulation their mood measure showed a distinct diference between the two groups arthritis treatment massage plaquenil 200mg low cost. This simultaneously provided evidence that their mood manipulation worked andthat their mood measure was valid arthritis in dogs neck purchase plaquenil mastercard. But what if your newly collected data cast doubt on the reliability or validity of your measure? It could be that there is 106 something wrong with your measure or how you administered it. For example, if a mood measure showed no diference between people whom you instructed to think positive versus negative thoughts, maybe it is because the participants did not actually think the thoughts they were supposed to or that the thoughts did not actually afect their moods. In short, it is “back to the drawing board” to revise the measure, revise the conceptual defnition, or try a new manipulation. This is accomplished both by clear and detailed thinking and by a review of the research literature. You should make this decision based on the availability of existing measures and their adequacy for your purposes. Practice: Write your own conceptual definition of self-confidence, irritability, and athleticism. If you were conducting your own study, which one (if either) would you use and why? Chapter 6 107 Chapter 6 Experimental Research Available under Creative Commons-NonCommercial-ShareAlike 4. In the late 1960s social psychologists John Darley and Bibb Latané proposed a counterintuitive hypothesis. The more witnesses there are to an accident or a crime, 1 the less likely any of them is to help the victim (Darley & Latané, 1968). They also suggested the theory that this happens because each witness feels less responsible for helping—a process referred to as the “difusion of responsibility. For example, a New York woman named Kitty Genovese was assaulted and murdered while several witnesses failed to help. But Darley and Latané also understood that such isolated cases did not provide convincing evidence for their hypothesized “bystander efect. So to test their hypothesis, Darley and Latané created a simulated emergency situation in a laboratory. Each of their college student participants was isolated in a small room and told that he or she would be having a discussion about college life with other students via an intercom system. Early in the discussion, however, one of the students began having what seemed to be an epileptic seizure. Over the intercom came the following: “I could really-er-use some help so if somebody would-er-give me a little h-help-uh er-er-er-er-er c-could somebody-er-er-help-er-uh-uh-uh (choking sounds)…I’m gonna die-er-er I’m…gonna die-er-help-er-er-seizure-er [chokes, then 2 quiet]” (Darley & Latané, 1968, p. These comments had been prerecorded and were played back to create the appearance of a real emergency. The key to the study was that some participants were told that the discussion involved only one other student (the victim), others were told that it involved two other students, and still others were told that it included fve other students. Because this was the only diference between these three groups of participants, any diference in their tendency to help the victim would have to have been caused by it. And sure enough, the likelihood that the participant left the room to seek help for the “victim” decreased from 85% to 62% to 31% as the number of “witnesses” increased. The standard version is that there were 38 witnesses to the crime, that all of them watched (or listened) for an extended period of time, and that none of them did anything to help. However, recent scholarship suggests that the standard story is 3 inaccurate in many ways (Manning, Levine, & Collins, 2007). For example, only six eyewitnesses testified at the trial, none of them was aware that he or she was witnessing a lethal assault, and there have been several reports of witnesses calling the police or even coming to the aid of Kitty Genovese. Although the standard story inspired a long line of research on the bystander effect and the diffusion of responsibility, it may also have directed researchers’ and students’ attention away from other equally interesting and important issues in the psychology of helping—including the conditions in which people do in fact respond collectively to emergency situations. The study that Darley and Latané conducted was a particular kind of study called an experiment.

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Typhi are available and should be considered for personnel regularly working with potentially infectious materials arthritis knee fluid build up order 200 mg plaquenil mastercard. Shiga toxin (Verocytotoxin)-producing Escherichia coli Escherichi coli is one of fve species in the gram-negative genus Escherichia arthritis in dogs treatment home remedies purchase plaquenil 200mg otc. This organism is a common inhabitant of the bowel fora of healthy humans and other mammals and is one of the most intensively studied prokaryotes arthritis pain at night discount plaquenil 200 mg otc. This summary statement provides recommendations for safe manipulation of Shiga toxin-producing E. Transmission usually occurs by ingestion of contaminated food, including raw milk, fruits, vegetables, and particularly ground beef. Human-to-human transmission has been observed in families, day care centers, and custodial institutions. Water-borne transmission has been reported from outbreaks 154 Biosafety in Microbiological and Biomedical Laboratories associated with swimming in a crowded lake and drinking unchlorinated municipal water. However, a variety of food specimens contaminated with the organisms including uncooked ground beef, unpasteurized dairy products and contaminated produce may present laboratory hazards. This agent may be found in blood or urine specimens from infected humans or animals. Personal protective equipment, such as splash shields, face protection, gowns, and gloves should be used in accordance with a risk assessment. Shigella the genus Shigella is composed of nonmotile gram-negative bacteria in the family Enterobacteriaceae. There are four subgroups that have been historically treated as separate species, even though more recent genetic analysis indicates that they are members of the same species. Members of the genus Shigella have been recognized since the late 19th century as causative agents of bacillary dysentery, or shigellosis. Most transmission is by fecal-oral route; infection also is caused by ingestion of contaminated food or water. Complications of shigellosis include hemolytic uremic syndrome, which is associated with S. Laboratory Safety and Containment Recommendations the agent may be present in feces and, rarely, in the blood of infected humans or animals. Accidental ingestion and parenteral inoculation of the agent are the primary laboratory hazards. The 50% infectious dose (oral) of Shigella for humans is only a few hundred organisms. The importance of proper gloving techniques and frequent and thorough hand washing is emphasized. Care in manipulating faucet handles to prevent contamination of cleaned hands or the use of sinks equipped with remote water control devices, such as foot pedals, is highly recommended. Treponema pallidum Treponema pallidum is a species of extremely fastidious spirochetes that die readily upon desiccation or exposure to atmospheric levels of oxygen, and have not been cultured continuously in vitro. No cases of laboratory animal-associated infections are reported; however, rabbit-adapted T. Venereal syphilis is a sexually transmitted disease that occurs in many areas of the world, whereas Yaws occurs in tropical areas of Africa, South America, the Caribbean, and Indonesia. Accidental parenteral inoculation, contact with mucous membranes or broken skin with infectious clinical materials are the primary hazards to laboratory personnel. Gloves should be worn when there is a likelihood Agent Summary Statements: Bacterial Agents 157 of direct skin contact with infective materials. Periodic serological monitoring should be considered in personnel regularly working with these materials. Growth of Vibrio species is stimulated by sodium and the natural habitats of these organisms are primarily aquatic environments. Although 12 different Vibrio species have been isolated from clinical specimens, V. Natural Modes of Infection the most common natural mode of infection is the ingestion of contaminated food or water. Other clinical specimens from which vibrios may be isolated include blood, arm or leg wounds, 158 Biosafety in Microbiological and Biomedical Laboratories eye, ear, and gallbladder. Yersinia pestis Yersinia pestis, the causative agent of plague, is a gram-negative, microaerophilic coccobacillus frequently characterized by a “safety pin” appearance on stained preparations from specimens.

 

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