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Benedetto Saraceno, MD Director Department of Mental Health and Substance Abuse World Health Organization 20, avenue Appia 1211 Geneva, Switzerland Phone: +41 22 791 3603/3634 Fax: +41 22 791 4160 Subject: Important Archives Of Psychiat article ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org Shankar Vedantam of The Washington Post reports (below) "a study published yesterday overturns conventional wisdom about antipsychotic drugs, which cost the United States $10 billion a year." These drugs-so-called 'atypical' antipsychotics such as Risperdal, Zyprexa, Seroquel, et al, are no more beneficial than the cheap old neuroleptics such as Haldol-both the old and new drugs cause debilitating side effects and fail to improve the quality of life. The conclusion of this major study conducted by Cambridge psychiatrist Dr. Peter Jones, [1] at the request of the British government, was published in the Archives of General Psychiatry, confirms the negative findings of at least four previous studies-[2] [3] including two US government sponsored studies--CATIE study led by Dr. Jeffrey Lieberman, [4] and the VA study led by Robert Rosenbeck. [5] In an editorial accompanying the study, Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University, who has for years defended and promoted these drugs, tried to explain how an entire medical field could have been misled into thinking that the expensive drugs, such as Zyprexa, Risperdal and Seroquel, were much better than the old: "The claims of superiority for the [newer drugs] were greatly exaggerated. This may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications. At the same time, the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical information." This is an astounding acknowledgement from one of the pillars of American psychiatry: "aggressive marketing.in the absence of empirical evidence" persuaded the psychiatric establishment "to this enhanced perception of their effectiveness." So much for psychiatry's claims about evidence-based medicine and pretense of a scientific basis for its prescribing practice. Dr. Jones, the author of the new study suggests, "We were beguiled." While Dr. Robert Rosenbeck acknowledges the wider implication of this failure to adhere to science rather than marketing hype: "The story of these newer antipsychotic drugs is a story that reveals an institutional gap. It should not have needed 10 years to get three government studies." Indeed, in the abswence of a scientific foundation psychiatry more than any other field fell under the spell of drugs, hoping to gain legitimacy. The "authorities" in psychiatry have builot their careers by promoting the latest drugs. They are entirely reliant on drug manufacturers' guidance and financial incentives. Unlike any other academic discipline, psychiatry tolerates no debate. Independent critics, such as Robert Whitaker, whose book, Mad In America (2005), laid out the evidence about the atypical antipsychotics from pre-marketing clinical trial data. In the chapter Not So Atypical, Whitaker lays out how psychiatry was "beguiled" (pp. 253-286. Whitaker's analysis was maligned and disregarded--much as other cricis were. The financially compromised pillars of psychiatry in academia refused to even examine the empirical negative findings of others. They relied instead--as Dr. Lieberman now admits--on wishful thinking and marketing hype. Psychiatry's insularity and refusal to debate has brought it to this juncture: like the Emperor's nakedness, the hazardous New Drugs' lack of efficacy can no longer be hidden.The drugs fail to benefit psychotic patients for whom they were approved. Yet, the pillars of US psychiatry (in particular) have been serving as industry's paid promoters encouraging doctors to prescribe drugs for unapproved, off-label uses--even in the knowledge that the drugs induce diabetes, hyperglycemia, and akaathisia. The academic psychiatric establishment--even more than drug manufacturers--has promoted these drugs irresponsibly. Influential leaders in psychiatry have participated in fraud and promoted the off-label use of toxic drugs prescribed for millions of children who are being damaged by professionals sworn to do no harm. The mental and physical health of children in foster care are being undermined by these inappropriately prescribed drugs. References: 1. Peter B. Jones, MD, PhD; Thomas R. E. Barnes, MD, DSc; Linda Davies, MSc; Graham Dunn, PhD; Helen Lloyd, BA; Karen P. Hayhurst, MSc; Robin M. Murray, MD, DSc; Alison Markwick, BA; Shôn W. Lewis, MD. <http://archpsyc.ama-assn.org/cgi/content/full/63/10/1079#AUTHINFO#AUTHINFO> Randomized Controlled Trial of the Effect on Quality of Life of Second- vs First-Generation Antipsychotic Drugs in Schizophrenia Arch Gen Psychiatry. 2006;63:1079-1087. 2. Geddes J, Freemantle N, Harrison P, Bebbington P. Atypical antipsychotics in the treatment of schizophrenia: systematic overview and meta-regression analysis. BMJ. 2000;321:1371-1376. 3. Bagnall AM, Jones L, Ginnelly L, Lewis R, Glanville J, Gilbody S, Davies L, Torgerson D, Kleijnen J. A systematic review of atypical antipsychotic drugs in schizophrenia. Health Technol Assess. 2003;7:1-193. 4. Jeffrey A. Lieberman Comparative Effectiveness of Antipsychotic Drugs: A Commentary on Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1) and Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Arch Gen Psychiatry. 2006;63:1069-1072. 5. Robert A. Rosenheck. Outcomes, Costs, and Policy Caution: A Commentary on the Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study Arch Gen Psychiatry. 2006;63:1074-1076 http://www.washingtonpost.com/wp-dyn/content/article/2006/10/02/AR2006100201 378_pf.html THE WASHINGTON POST In Antipsychotics, Newer Isn't Better Drug Find Shocks Researchers By Shankar Vedantam Tuesday, October 3, 2006; A01 Schizophrenia patients do as well, or perhaps even better, on older psychiatric drugs compared with newer and far costlier medications, according to a study published yesterday that overturns conventional wisdom about antipsychotic drugs, which cost the United States $10 billion a year. The results are causing consternation. The researchers who conducted the trial were so certain they would find exactly the opposite that they went back to make sure the research data had not been recorded backward. The study, funded by the British government, is the first to compare treatment results from a broad range of older antipsychotic drugs against results from newer ones. The study was requested by Britain's National Health Service to determine whether the newer drugs -- which can cost 10 times as much as the older ones -- are worth the difference in price. There has been a surge in prescriptions of the newer antipsychotic drugs in recent years, including among children. The study, published in the Archives of General Psychiatry, is likely to add to a growing debate about prescribing patterns of antipsychotic drugs. A U.S. government study last year found that one of the older drugs did as well as newer ones, but at the time, many American psychiatrists warned against concluding that all the older drugs were as good. Yesterday, in an editorial accompanying the British study, the lead researcher in the U.S. trial asked how an entire medical field could have been misled into thinking that the expensive drugs, such as Zyprexa, Risperdal and Seroquel, were much better. "The claims of superiority for the [newer drugs] were greatly exaggerated," wrote Columbia University psychiatrist Jeffrey Lieberman. "This may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications. At the same time, the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical information." Peter Jones, a psychiatrist at the University of Cambridge in England who led the study, searched yesterday for the right word to describe what had happened to his colleagues. " 'Duped' is not right," he said. "We were beguiled." One drugmaker immediately questioned the findings. Carole Puls, a spokeswoman for Eli Lilly and Co., which makes Zyprexa, said it was problematic to compare large groups of medications because there are differences between the drugs in each class. Individual patients need different medication options, she said. Janssen Pharmaceutica, which makes Risperdal, and AstraZeneca, which makes Seroquel, did not respond to requests for comment. Schizophrenia is a serious mental disorder that is believed to affect about one in 100 adults. It is characterized by psychotic symptoms such as hallucinations and delusions and negative symptoms such as social withdrawal. Especially over the past decade, older antipsychotics such as Haldol have been widely criticized for triggering uncontrolled body movements, even as the new "atypical" antipsychotics were hailed for causing fewer side effects. Recently, however, concern has grown that antipsychotics in general, and some of the newer drugs in particular, may be causing metabolic side effects. The new study randomly assigned 227 schizophrenia patients to two groups -- one received a newer antipsychotic, the other an older drug. The patients were evaluated for more than a year by experts who did not know which drug was being taken. While the researchers had expected a difference of five points on a quality-of-life scale -- showing the newer drugs were better -- the study found that patients' quality of life was slightly better when they took the older drugs. Jones said a conservative interpretation of the data suggested that there is no difference, "so the notion you would pay 10 times as much would be difficult to justify." "Why were we so convinced?" he asked, referring to the widespread opinion among psychiatrists that the new drugs were worth the great difference in cost. "I think pharmaceutical companies did a great job in selling their products. That is certainly one issue. "It became almost a moral issue on whether you would prescribe these dirty old drugs," he added. "It became the 'my son' phenomenon. What would you prescribe for your son?" In retrospect, Jones and others said, there were hints going back many years. In 2003, Robert Rosenheck, a psychiatrist at the Department of Veterans Affairs, found there was no difference between Haldol and Zyprexa -- after patients taking Haldol were treated to prevent the movement side effects. Last year, the U.S. government trial found that an older drug called perphenazine did about as well as the newer medications. Still, the belief in the newer drugs was so ingrained that many psychiatrists insisted that the results could not be extrapolated to other old drugs, said Rosenheck, who helped conduct that study. Darrel Regier, who directs research at the American Psychiatric Association, cautioned against drawing broad conclusions after the new study and said that "a thoughtful and prolonged process " is needed before treatment guidelines are changed. Not all the drugs used in the British study were available in the United States, he said, and with many of the newer medications reaching the end of their patent lives, he predicted that questions of cost would fade away. Jones and Rosenheck said the problem with many drug company studies that seemed to show that new drugs are better is that they focused on short-term results -- a symptom or side effect -- rather than the big picture: how patients fare long-term. "The story of these newer antipsychotic drugs is a story that reveals an institutional gap," Rosenheck said. "It should not have needed 10 years to get three government studies." Jones said the studies also illustrate the importance of trusting data, rather than judgment. He drew an analogy with his hobby of walking. "Sometimes the compass tells you go straight in front of you, but you somehow know it is wrong and that north is behind you," he said. "I have learned to follow the compass." 2006 The Washington Post Company

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