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Drugs Might Be The Problem! Does Our Thinking About Mental Health Increase the Risk of Suicide? Angela Bischoff David Zitner Depression: Important ProblemImaginary Illness • The adjective mental in mental illness refers to the doctor’s mind not the patient’s. When we use the term “mental illness” we are speculating that the person suffers from a physiological derangement causing abnormal thoughts, feelings and behavior. • When the physiologic cause is known we do not classify the problem as a “mental illness” Depression is Not an Illness Using Any Conventional Definition • OED DEFINITION OF ILLNESS: bad or unhealthy condition of the body (or, formerly, of some part of it) • There is no evidence that people diagnosed with depression have a “bad or unhealthy condition of the body”. Depressed people with thyroid, Addisons or other depressing conditions are not told they have a depression (they know they feel bad!) or biochemical imbalance. When people have a real illness we tell them what it is. – When it is mere speculation we call it a biochemical imbalance How We Think About Depression Depression is a serious problem a) Depressed people are uncomfortable b) Depressed people are dysfunctional -- they accomplish less c) Depressed people are more likely to die. • • • • Cf. Blumenthal et al. for Cardiac Bypass Cf. Loberizo et al. for Stem Cell patients 8,513,000 visits for depression in 2002 Psychotherapeutic drugs second most widely prescribed class after anti-hypertensives Changes in Thinking About Depression • Paxil banned in Britain for those under 18. • Alan Metz, Vice-President for Clinical Development at Glaxo, said in court papers: – "It's not possible really to measure total serotonin." He added that "we do not know with absolute certainty about how any of the antidepressants work." • “If the drug companies can't really measure what normal serotonin levels are, and they don't know really how the drugs work, then how can we say they restore balance? “ As reported by Greg Critser, January 25/04, L.A. Times Canadian Depression Study 2003 • The top symptoms are similar to those experienced by people who are de-conditioned: those who eat poorly and don’t exercise – – – – – Fatigue Loss of Interest Depressed Mood Tense/Nervous/Irritable Impaired Concentration 96% 96% 95% 95% 93% • ABNORMAL PHYSIOLOGY/BIOCHEMISTRY IS NOT A NECESSARY CONDITION FOR FEELING BAD SSRIs: Estimated Number of Pills (000s) Dispensed from Retail Pharmacies 700,000 600,000 5 Year Growth: Nova Scotia --- 65.8% Canada --- 77.5% # Pills (000s) 500,000 400,000 300,000 200,000 100,000 0 Nova Scotia Canada 1999 2000 2001 2002 2003 MAT Sep 04 13,895 16,642 18,802 20,730 23,784 23,039 388,130 458,019 521,466 584,177 653,065 688,789 Source: IMS Health - Compuscript SSRIs: Physician Prescribing in Nova Scotia Physician Quartiles by Rx Volume – Year 2003 (Total Rxs = 422,392) A small number of docs prescribe most of these drugs Average Rx per Physician 1,200 1400 1,000 1200 Avg. Rx per Physician 1000 # of Physicians 800 800 600 600 400 400 200 200 0 0 1484 854 547 96 # of Physicians 71 124 193 1,099 % of Total Physicians 4.8 8.3 13.0 73.9 Avg. Rx per Physician Source: IMS Health - XPONENT # of Physicians per Quartile 1600 Wellbutrin Promotional Material • “The effectiveness of Buproprion in long term use-more than 8 weeks has not been systematically evaluated” • Dosing: “The full antidepressant effect may not be evident until several weeks of treatment” • A single dose “…produced amphetamine like effects compared to placebo..” • Seizures = 1/1,000 patients Drug Industry Document: Lilly -- March 29, 1985 • “The incidence rate (suicide) under fluoxetine (Prozac) therefore purely mathematically is 5.6 times higher than under the other active medication imipramine." . . . "The benefits vs. risks considerations for fluoxetine (Prozac) currently does not fall clearly in favor of the benefits. (March 29, 1985). Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine (Prozac) than to imipramine, so that the higher incidence of suicide attempts may be tolerable." Cited by Baum and Hedland Feb, 2, 2004 http://www.baumhedlundlaw.com/media/timeline.html Are Drugs Necessary? Available studies of apparently comparable subjects show similar rates of clinical response to either psychotherapy or medication. Therefore, either approach can be empirically justified, with a choice between medication and psychotherapy based on clinicians' and patients' preference. (Brent, D.A., and Birmaher, B., Adolescent depression. NEJM 347: 667-671 (August 29), 2002) Little Evidence That SSRI’s Are Effective • The degree of multiple publication, selective publication, and selective reporting differed between products. Thus, any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence. (Melander H, et al. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003 (May 31); 326: 11711173. Side Effects: General 25%+ of users have side effects • • • • • • Dry mouth Sexual dysfunction Constipation Urinary retention Nausea Greater withdrawal from drug than placebo patients • • • • • Sleep disturbance Tremor Weight gain Sweating Dizziness (orthostatic hypotension) Little Evidence That SSRIs Are Effective • When Kirch et al. reviewed material sent to the American FDA, they found poor evidence of significant benefit compared to placebo either statistically or clinically. Kirch I, et al. The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration. Prevention & Treatment, 5, Article 23, posted July 15, 2002. http://journals.apa.org/prevention/volume5/pre0050023a.html Little Evidence That SSRIs Are Effective • Moncrieff’s observations might suggest that depression is susceptible to a variety of nondisease-specific pharmacological actions such as sedation or psycho-stimulation, as well as the effects of suggestion. These effects may account for at least part of the impact of conventionally classified antidepressants. Moncrieff J: Are Antidepresssants Overrated? A Review of Methodological Problems in Antidepressant Trials. Journal of Nervous & Mental Diseases 189(5): 288-295, 2001 (May) Results • No Studies Proving that Antidepressants Actually Reduce Suicide! • Harvard http://www.baumhedlundlaw.com/media/ssri/paxil/h arvard%20doc.PDF • Studies suggest it is more likely these drugs are associated with increased suicide rates Harms of SSRIs • SSRIs Cause or Exacerbate – Obsessive preoccupations, agitation, agitated depression manic psychoses – Suicidality, Violence and Extreme Abnormal Behavior – Evidence is from clinical reports, controlled clinical trials, and epidemiological studies in children and adults. (Breggin, P.J. Suicidality, violence and mania caused by selective serotonin reuptake inhibitors: A review and analysis. International Journal of Risk & Safety in Medicine 16 (2003/2004) 31–49 31) • There are medico-legal implications as well: Physicians need to inform patients about side effects and lack of effectiveness; At least inform them about the controversy regardless of personal beliefs! (Ginn) We Harm Depressed People • Long term antidepressant use may worsen depression (Fava G et al. Can long term treatment with antidepressant drugs worsen the course of depression? Journal of Clinical Psychiatry, 2003, Feb;64(2):123-33) • A number of reported clinical findings point to the very unfavorable long-term outcomes of major depression treated by pharmacologic means, • Paradoxical (depression-inducing) effects of antidepressant drugs in some patients Purpose of Psychiatric Interventions • To change thoughts, feelings and behavior. • Methods to modify mood – Lifestyle – Psychotherapy (talking therapies) – Drugs – Surgery and other physical methods – Lobotomy, Electroconvulsive Therapy – CCT-Cranial Clunk Therapy??? Ways of Treating Depression • Lifestyle – Diet and Exercise • Talking or psychotherapies – Acceptance of context – Motivating discussion • Substances – Drugs, but which ones and when? – As the CEO of Glaxo Wellcome remarked we don’t really know what is the biochemical imbalance. More Articles Szasz, T. The psychiatric protection order for the ‘battered mental patient’. BMJ, Dec 2003; 327: 1449 - 1451.