Follow-Up - Antidepressants shown worthless for most consumers

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ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org FYIThe comments below expand upon an Infomail about the recently published JAMAmeta-analysis (http://www.ahrp.org/cms/content/view/658/110/) After many years of controversy, the overwhelming evidence showsthat psychiatrists and general practitioners have been misprescribingantidepressants to treat minor and moderate symptoms of depression forpatients for whom the drugs don't work. Such patients comprise the vastmajority for whom these drugs are prescribed-they are, thus placed atgreater risk for harmful drug side effects without any offsetting beneficialeffect. The JAMA report is significant in that it is a patient-level meta-analysisof 6 major studies that included a full range of patients diagnosed withmajor or minor depressive disorder. The analysis examined the effects of theselective serotonin reuptake inhibiter (SSRI), paroxetine (Paxil), and thetricyclic antidepressant, imipramine (Tofranil), compared to an inertplacebo. The findings are consistent with earlier antidepressant efficacyanalyses (by Kirsch et al; Khan et al) confirming that antidepressantmedications (ADM) are ineffective in treating all but low-prevalence "verysevere" forms of depression, such as chronic dysthymia."What makes our findings surprising is the high level of depression symptomseverity that appears to be required for clinically meaningful drug/placebodifferences to emerge, particularly given the evidence that the majority ofpatients receiving ADM in clinical practice present with scores below theselevels." (http://jama.ama-assn.org/cgi/content/full/303/1/47). Depending on data source, between 1.6 percent (US Surgeon General) and 4.01percent (NIMH) of the US population is estimated to suffer this very seriousform of depression(http://www.wrongdiagnosis.com/d/dysthymia/prevalence.htm#about_prevalence_and_incidence). The latest report on the prevalence of depression by theCenters for Disease Control and Prevention estimates 1 in 20 or 5 percenthad (2005-2006) had current depression at all levels of severity (mild,moderate, severe, very severe)(http://www.cdc.gov/nchs/data/databriefs/db07.htm). If only 1.6 percent (US Surgeon General) of Americans have dysthymia and thetotal prevalence of current depression at all levels of severity is 5percent, one can conclude that antidepressant medication (ADM) is (at best)more effective than placebo in treating people with very severe depression(32 percent). Noting several subtle differences in response patterns amongearlier efficacy reports, the JAMA authors note:"it would be premature to speculate regarding whether the increasingsuperiority of ADM relative to placebo as severity increases is due to anincreasing efficacy of ADM or a declining efficacy of placebo."For the remaining 68 percent of consumers of these drugs, ADM is no moreeffective than an inert placebo. Given the frequency of adverse side-effects of varying degrees ofseverity-some life-threatening-logic tells that consumption of ADM poses fargreater risk for doing harm without any offsetting beneficial effect amongthe overwhelming majority (68 percent) of people for whom they areprescribed. The severe adverse effects of imipramine (Tofranil) include: severe allergic reactions (rash; hives; itching; difficulty breathing;tightness in the chest; swelling of the mouth, face, lips, or tongue);blurred vision or other vision changes; changes in sex drive; chest pain;confusion; constipation; fainting; fast, slow, or irregular heartbeat;fever; frequent or difficult urination; hallucinations; impulsive behavioror other unusual changes in behavior; jaw, neck, or muscle spasms; mental ormood changes (e.g., increased anxiety, mood swings, agitation, irritability,nervousness, restlessness); panic attacks; ringing in the ears; seizures;severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinkingor behavior; swelling of the testicles; tremor; trouble sleeping; troublewalking or keeping your balance; twitching of the face or tongue;uncontrolled movements of arms and legs or stiffness; unusual bleeding orbruising; worsening of depression; yellowing of the skin or eyes(http://www.drugs.com/sfx/imipramine-side-effects.html). The severe adverse effects of paroxetine (Paxil) include: loss of appetite, unusual or severe mental/mood changes, increasedsweating/flushing, unusual fatigue, uncontrolled movements (tremor),decreased interest in sex, changes in sexual ability, black stools, blurredvision, change in amount of urine, "coffee ground" vomit, easybruising/bleeding, fainting, irregular heartbeat, muscle pain, troubleswallowing, unusual swelling, seizures, tingling or numbness of thehands/feet, obsessive suicidal thoughts, suicide attempts, violence,painful, prolonged erection, serious allergic reaction, e.g., rash, itching,swelling, severe dizziness, trouble breathing(http://www.medicinenet.com/paroxetine-oral/article.htm) VIOLENCE-directed at self or others--is a significant, life-threatening risklinked to SSRI antidepressants. Manufacturers regularly coded aggression and violence occurring in clinicaltrials under the rubric of hostility. An analysis in PLoS Medicine, revealsthat the coding term, hostility, includes homicide, homicidal acts, andhomicidal ideation as well as aggressive events and "conduct disorders",although no homicides were reported from these trials. GlaxoSmithKline'sWebsite shows that when hostile events occurring in both adult and pediatrictrials are summed, both on therapy and during the 30-day drug-free phaseafter taper had finished, 60 (0.65%) of 9,219 patients overall had hostileevents. (http://www.gsk.com) A previously court sealed 2007 report by psychiatrist Joseph Glenmullen, MD,analyzing internal GSK documents-including memos and reports uncoveredduring litigation-leaves little doubt that the company had data fromcontrolled clinical trials demonstrating an increased risk of suicide asearly as 1989. Indeed, GSK's data showed that the risk of suicidal behaviorin adults increased eightfold in patients prescribed Paxil. Dr. Glenmullen's report is posted on the U.S. Senate Finance Committeewebsite: http://finance.senate.gov/press/Gpress/2008/prg020608b.pdf There are 3,500 news reports of violence, murder, suicide, self-mutilationinvolving SSRI antidepressants posted at: http://www.ssristories.com/Media reports about the recent JAMA report of results from the patient-levelmeta-analysis fail to indicate the clinical significance and trueimplications of the study, despite the authors' forceful statement ofimplications for physicians, policy makers, and consumers: "True drug effects (an advantage of ADM over placebo) were nonexistent tonegligible among depressed patients with mild, moderate, and even severebaseline symptoms, whereas they were large for patients with very severesymptoms."(http://www.nytimes.com/2010/01/06/health/views/06depress.html).Against the blitz of pharmaceutical company advertising and theself-interested arguments of prominent psychiatrists, the AHRP must ask whataction will the FDA take to protect the public from dangerous drugs whosemostly illusory benefits are far outweighed by severe risks, therebyundermining public health? Independent analyses have consistently shownthat antidepressants offer no clinical benefit for the vast majority ofpeople for whom they are prescribed. Evidence from manufacturers owndocuments show that antidepressants pose severe risks of harm.Why then, are federal drug regulators silent? Just as the Surgeon General ofthe United States forcefully warned against the dangers of smoking, federaldrug regulators need to inform the American public about the dangers ofantidepressant medications-especially because they are overwhelminglymisprescribed.References:1. Jay C. Fournier; Robert J. DeRubeis; Steven D. Hollon; et al.Patient-Level Meta-analysis. JAMA. 2010;303(1):47-53(doi:10.1001/jama.2009.1943)http://jama.ama-assn.org/cgi/content/full/303/1/472. Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria,Thomas J. Moore, Blair T. Johnson. Initial Severity and AntidepressantBenefits: A Meta-Analysis of Data Submitted to the Food and DrugAdministration. PLoS Med. 2008; 5(2):e45.http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045 3. Khan A, Leventhal RM, Khan SR, Brown WA. Severityof depression and response to antidepressants and placebo: an analysis ofthe Food and Drug Administration database. J Clin Psychopharmacol. 2002;22(1):40-45. http://www.ncbi.nlm.nih.gov/pubmed/11799341 4. Healy D, Herxheimer A, Menkes DB (2006) Antidepressants and Violence:Problems at the Interface of Medicine and Law. PLoS Med 3(9): e372.http://www.plosmedicine.org/article/info:doi%2F10.1371%2Fjournal.pmed.0030372 5. Joseph Glenmullen. Expert Report in the case of O'Neal v. SmithKlineBeecham d/b/a GlaxoSmithKline. Filed under seal, Nov. 14, 2007. UnsealedJanuary 18, 2008. http://finance.senate.gov/press/Gpress/2008/prg020608b.pdfJohn H. Noble, Jr., PhDAHRP Board member and Emeritus Professor, State University of New York at Buffalo.jhnobleVera Hassner SharavAHRP Presidentveracare212-595-8974_____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

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ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org FYIThe comments below expand upon an Infomail about the recently published JAMAmeta-analysis (http://www.ahrp.org/cms/content/view/658/110/)After many years of controversy, the overwhelming evidence showsthat psychiatrists and general practitioners have been misprescribingantidepressants to treat minor and moderate symptoms of depression forpatients for whom the drugs don't work. Such patients comprise the vastmajority for whom these drugs are prescribed-they are, thus placed atgreater risk for harmful drug side effects without any offsetting beneficialeffect. The JAMA report is significant in that it is a patient-level meta-analysisof 6 major studies that included a full range of patients diagnosed withmajor or minor depressive disorder. The analysis examined the effects of theselective serotonin reuptake inhibiter (SSRI), paroxetine (Paxil), and thetricyclic antidepressant, imipramine (Tofranil), compared to an inertplacebo. The findings are consistent with earlier antidepressant efficacyanalyses (by Kirsch et al; Khan et al) confirming that antidepressantmedications (ADM) are ineffective in treating all but low-prevalence "verysevere" forms of depression, such as chronic dysthymia."What makes our findings surprising is the high level of depression symptomseverity that appears to be required for clinically meaningful drug/placebodifferences to emerge, particularly given the evidence that the majority ofpatients receiving ADM in clinical practice present with scores below theselevels." (http://jama.ama-assn.org/cgi/content/full/303/1/47). Depending on data source, between 1.6 percent (US Surgeon General) and 4.01percent (NIMH) of the US population is estimated to suffer this very seriousform of depression(http://www.wrongdiagnosis.com/d/dysthymia/prevalence.htm#about_prevalence_and_incidence). The latest report on the prevalence of depression by theCenters for Disease Control and Prevention estimates 1 in 20 or 5 percenthad (2005-2006) had current depression at all levels of severity (mild,moderate, severe, very severe)(http://www.cdc.gov/nchs/data/databriefs/db07.htm).If only 1.6 percent (US Surgeon General) of Americans have dysthymia and thetotal prevalence of current depression at all levels of severity is 5percent, one can conclude that antidepressant medication (ADM) is (at best)more effective than placebo in treating people with very severe depression(32 percent). Noting several subtle differences in response patterns amongearlier efficacy reports, the JAMA authors note:"it would be premature to speculate regarding whether the increasingsuperiority of ADM relative to placebo as severity increases is due to anincreasing efficacy of ADM or a declining efficacy of placebo."For the remaining 68 percent of consumers of these drugs, ADM is no moreeffective than an inert placebo. Given the frequency of adverse side-effects of varying degrees ofseverity-some life-threatening-logic tells that consumption of ADM poses fargreater risk for doing harm without any offsetting beneficial effect amongthe overwhelming majority (68 percent) of people for whom they areprescribed. The severe adverse effects of imipramine (Tofranil) include: severe allergic reactions (rash; hives; itching; difficulty breathing;tightness in the chest; swelling of the mouth, face, lips, or tongue);blurred vision or other vision changes; changes in sex drive; chest pain;confusion; constipation; fainting; fast, slow, or irregular heartbeat;fever; frequent or difficult urination; hallucinations; impulsive behavioror other unusual changes in behavior; jaw, neck, or muscle spasms; mental ormood changes (e.g., increased anxiety, mood swings, agitation, irritability,nervousness, restlessness); panic attacks; ringing in the ears; seizures;severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinkingor behavior; swelling of the testicles; tremor; trouble sleeping; troublewalking or keeping your balance; twitching of the face or tongue;uncontrolled movements of arms and legs or stiffness; unusual bleeding orbruising; worsening of depression; yellowing of the skin or eyes(http://www.drugs.com/sfx/imipramine-side-effects.html). The severe adverse effects of paroxetine (Paxil) include: loss of appetite, unusual or severe mental/mood changes, increasedsweating/flushing, unusual fatigue, uncontrolled movements (tremor),decreased interest in sex, changes in sexual ability, black stools, blurredvision, change in amount of urine, "coffee ground" vomit, easybruising/bleeding, fainting, irregular heartbeat, muscle pain, troubleswallowing, unusual swelling, seizures, tingling or numbness of thehands/feet, obsessive suicidal thoughts, suicide attempts, violence,painful, prolonged erection, serious allergic reaction, e.g., rash, itching,swelling, severe dizziness, trouble breathing(http://www.medicinenet.com/paroxetine-oral/article.htm) VIOLENCE-directed at self or others--is a significant, life-threatening risklinked to SSRI antidepressants. Manufacturers regularly coded aggression and violence occurring in clinicaltrials under the rubric of hostility. An analysis in PLoS Medicine, revealsthat the coding term, hostility, includes homicide, homicidal acts, andhomicidal ideation as well as aggressive events and "conduct disorders",although no homicides were reported from these trials. GlaxoSmithKline'sWebsite shows that when hostile events occurring in both adult and pediatrictrials are summed, both on therapy and during the 30-day drug-free phaseafter taper had finished, 60 (0.65%) of 9,219 patients overall had hostileevents. (http://www.gsk.com) A previously court sealed 2007 report by psychiatrist Joseph Glenmullen, MD,analyzing internal GSK documents-including memos and reports uncoveredduring litigation-leaves little doubt that the company had data fromcontrolled clinical trials demonstrating an increased risk of suicide asearly as 1989. Indeed, GSK's data showed that the risk of suicidal behaviorin adults increased eightfold in patients prescribed Paxil. Dr. Glenmullen's report is posted on the U.S. Senate Finance Committeewebsite: http://finance.senate.gov/press/Gpress/2008/prg020608b.pdf There are 3,500 news reports of violence, murder, suicide, self-mutilationinvolving SSRI antidepressants posted at: http://www.ssristories.com/Media reports about the recent JAMA report of results from the patient-levelmeta-analysis fail to indicate the clinical significance and trueimplications of the study, despite the authors' forceful statement ofimplications for physicians, policy makers, and consumers: "True drug effects (an advantage of ADM over placebo) were nonexistent tonegligible among depressed patients with mild, moderate, and even severebaseline symptoms, whereas they were large for patients with very severesymptoms."(http://www.nytimes.com/2010/01/06/health/views/06depress.html).Against the blitz of pharmaceutical company advertising and theself-interested arguments of prominent psychiatrists, the AHRP must ask whataction will the FDA take to protect the public from dangerous drugs whosemostly illusory benefits are far outweighed by severe risks, therebyundermining public health? Independent analyses have consistently shownthat antidepressants offer no clinical benefit for the vast majority ofpeople for whom they are prescribed. Evidence from manufacturers owndocuments show that antidepressants pose severe risks of harm.Why then, are federal drug regulators silent? Just as the Surgeon General ofthe United States forcefully warned against the dangers of smoking, federaldrug regulators need to inform the American public about the dangers ofantidepressant medications-especially because they are overwhelminglymisprescribed.References:1. Jay C. Fournier; Robert J. DeRubeis; Steven D. Hollon; et al.Patient-Level Meta-analysis. JAMA. 2010;303(1):47-53(doi:10.1001/jama.2009.1943)http://jama.ama-assn.org/cgi/content/full/303/1/472. Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria,Thomas J. Moore, Blair T. Johnson. Initial Severity and AntidepressantBenefits: A Meta-Analysis of Data Submitted to the Food and DrugAdministration. PLoS Med. 2008; 5(2):e45.http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045 3. Khan A, Leventhal RM, Khan SR, Brown WA. Severityof depression and response to antidepressants and placebo: an analysis ofthe Food and Drug Administration database. J Clin Psychopharmacol. 2002;22(1):40-45. http://www.ncbi.nlm.nih.gov/pubmed/11799341 4. Healy D, Herxheimer A, Menkes DB (2006) Antidepressants and Violence:Problems at the Interface of Medicine and Law. PLoS Med 3(9): e372.http://www.plosmedicine.org/article/info:doi%2F10.1371%2Fjournal.pmed.0030372 5. Joseph Glenmullen. Expert Report in the case of O'Neal v. SmithKlineBeecham d/b/a GlaxoSmithKline. Filed under seal, Nov. 14, 2007. UnsealedJanuary 18, 2008. http://finance.senate.gov/press/Gpress/2008/prg020608b.pdfJohn H. Noble, Jr., PhDAHRP Board member and Emeritus Professor, State University of New York at Buffalo.jhnobleVera Hassner SharavAHRP Presidentveracare212-595-8974«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»§ - PULSE ON 21st CENTURY ALTERNATIVE MEDICINE! §Subscribe send email to: - «¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»GREAT VACATION RENTAL ON THE LAKE: www.vacationhomerentals.com/39833RELAXATION TECHNIQUE FOR CHRONIC PAIN, PTSD + OTHER ISSUES THAT TROUBLE YOU. http://relaxationheals.webs.com

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