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1. Antidepressants: ARE THEY CURES OR KILLERS?
3. SSRIs do change people,
4. Completed Suicide is the measurable tip of an iceberg of disturbing side effects:
6. Recognition of these adverse drug reactions
8. I will give you Daubert-competent science that has passes 6 Daubert Hearings.
9. The 1993 US Supreme Court Decision in Daubert v. Merrell Dow Pharmaceuticals altered the criteria by which scientific testimony is admitted as evidence in court.
11. A Relative Risk, RR, is the difference in the rate of SUICIDE*
12. If a medicine saves some patients from committing suicide, the RR between that medicine and no treatment should be less than 1.
13. Tricyclics were known to cause some depressed users to commit suicide by ‘energising’ them, but the RR was still favourable.
14. If the Relative Risk equals 1.0, the risk in treated individuals is the same as the risk in untreated ones.
17. Exposure to asbestos
18. The evidence for causality of suicide by SSRIs can be found in many areas of research
19. CLINICAL PSYCHIATRY 1990 Teicher Glod and Colefirst reported the phenomenon 15 years ago!
20. There are now scores of such reports, and few psychiatrists have not seen this happen
21. CLINICAL PSYCHIATRYReveals this side effect profile.Teicher and Cole (1993) suggested 9 “clinical mechanisms” by which SSRIs can induce or exacerbate suicidal tendencies by causing the following:(1) energizing depressed patients, (2) worsening depression, (3) akathisia, (4) panic attacks, (5) switch to mania or hypomania, (6) interfering with sleep (7) an organic obsessional state, (8) inducing personality disorder with borderline traits, (9) causing neurological disturbances with abnormal EEG.
22. Akathisia, the full catastrophe
23. SSRI overdoses are less likely to be fatal.
24. CLINICAL PSYCHIATRY19911991: Suicidal thinking (out of the blue)
25. CLINICAL PSYCHIATRYChallenge-De-challenge-Re-challenge CDR
26. SUICIDE EPIDEMIOLOGY: JICK et al 1995Britain’s most popular TCA antidepressant, Prothiaden, (toxic in overdose)was being labelled as a ‘dirty drug’ by SSRI manufacturers.
27. SUICIDE EPIDEMIOLOGY : JICK et al. RR of SUICIDE
28. FROM THE MORGUES
29. What is normal? Boardman and Healy investigated 475,000 citizens over 5 years
30. SUICIDE EPIDEMIOLOGY: Boardman and Healy
31. Fits in with other primary care suicide statistics
32. FROM THE MORGUES SUICIDE EPIDEMIOLOGY: DONOVAN
33. A&E DEPARTMENTSSUICIDAL ACTS: DONOVAN et al.
34. HEALTHY VOLUNTEERSHealy: 2 of 20 healthy volunteers ( his staff) became suicidal on Zoloft.
35. At least 3 healthy volunteers have committed suicide in SSRI Trials:
36. Result:
37. RANDOM CONTROLLED TRIALS (RCTs)SUICIDES AND SUICIDAL ACTS
38. There seemed to be no difference between placebo, the old and the new antidepressants.
39. Khan then reviewed 71,604 participants in FDA clinical trials treated with antipsychotics, SSRIs and anticonvulsants.
40. RANDOM CONTROLLED TRIALS ‘Samples of Convenience’
41. In September of 2003, Healy and Whittaker re-evaluated the same, original FDA studies. They published a watershed paper in September 2003.
42. Khan had reported in PEYs, patient exposure years. And coded as ‘placebo suicides’ all those who were ‘not taking an active drug’
43. Healy argued that counting patient exposure years (PEYs) to argue for a drug’s safety, resembled the argument that, mile for mile, a space shuttle was the safest form of transport available.
44. 40% had dropped out because they did not tolerate these drugs at all and leaving a biased sample
48. Summary: Incidence of Suicides and Suicide Attempts (combined) in Antidepressant Trials From FDA Medical Reviews
49. FDA TRIALS SUMMARY 26,000 subjects SUICIDE RATES
51. Healy and Whittaker’s conclusion was modest:
52. Any way you look at available information, clinical settings,emergency rooms, morgues, clinical trials
54. WARNING MAY 3 2004 Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and non-psychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers
55. Unlike smallpox, depression has not disappeared since a cure became available
56. 200/100,000 represents 1 death in 500 people treated with SSRIs in primary care.00,000 v 200/100,000
57. 6,664,960 prescriptions for SSRIs were written by Australian doctors in 2003.
58. I in 500 too rare for clinicians to see as being abnormal.They need advice from suicide epidemiologists and statisticians.
59. Who will warn the prescriber? Some manufacturers have now sent misspelt faxes to doctors. Product inserts have not improved.
60. It actually worse than that.
62. Lillytrials.com has all FIVE schizophrenia trials posted, after lawsuits by Elliot Spitzer, Attorney General of New York, who sued them successfully and lucratively for misleading the public and false advertising, and Congressional Hearings which followed the Healy Whittaker analysis.
63. Deaths can be quantified, but the sub lethal side effects manifest asPHARMACOLOGICAL IATROGENESIS
64. About 400 mentally ill patients in Oz under mental health care, most in their 20s and 30s –commit suicide each year
65. Murders by ‘mentally disordered’ persons (not in state Mental Health care) are running at three a month, having nearly doubled recently from
66. Prof Raphael: 2003
67. Ross Kalucy reports a similar phenomenon at Flinders Medical Centre in South Australia.
68. The Mental Health suicide rate 48 hours after discharge, is 100 times the rate for the general population
73. How common are serious adverse SSRI side effects?
74. From 1990 to 2002, antidepressant use increased by 352%, to reach 51.5 DDDs/1000/day
75. And hospitalisations for suicide attempts increased from
76. Then Mant et al talk about rates not numbers of doses, or persons treated. The HIC does not know the number of persons treated as they did not collect these statistics until 2002.
77. Mental health suicides 1989-2001
78. Separations for suicide attempts 1989-2000
79. Separations for suicide attempts
83. My hypothesis is
85. I looked 600 consecutive discharge summaries and found 150 admissions worth reporting to ADRAC, (not including psychosis or mania) and 42 more in the next 4 months.
86. They were not the usual suspects, not borderlines, but ordinary people caught up in our gung ho ‘obligation’ to treat a new socially constructed condition labelled ‘depression' the diagnosis of which has increased a thousandfold since a cure became available for it.
87. Remember: this is the side effect profile of serotonergic drugs
88. Is this the same side effects profile as Ross Kalucy reported as presenting to Flinders Medical Centre
89. This demands extra careful assessment of any patient on SSRIs or atypicals who presents for treatment.
90. Where akathisia is suspected, delirium might coexist
91. This is not trivial.
93. The subject numbers are small.
94. Only 5 Zyprexa trials were undertaken. They are not impressive.50% enrolled did not complete. 1 in 208 suicided
95. Private Centre Testing, for profit had been introduced. Very shady practices were involved in these rials.
96. The akathisia rate in these trials was 27% on 10mg olanzapine
97. Recently we have been told Zyprexa injectable is approved, in spite of ‘only’ 47 serious adverse events in 87,000 patients.
98. 84, i.e. 1 in 35 - had serious side effects.
100. RISPERDAL and ZYPREXA
101. For every completed suicide there are ten attempts and, for every ten attempts,
102. Akathisia can be a psychiatric emergency.
103. You have to ask about it. They won’t volunteer that they want to kill you or their children.
105. If the FDA figures are right, and some of these are akathisia cases,
106. Much literature was published in the1970s and 1980s on suicide and homicide associated with akathisia,
107. The madman of our nightmares is not a schizophrenic but an akathisiac.
108. The World Health Organization has been trying to tell the west for decades that problems occur when people take drugs for too long or come off these drugs suddenly and not gradually.
111. There are many Risk benefit conundrums
112. All over the world, clinicians are reviewing all their suicidal patients and finding among them chronic akathisia subjects behaving like borderlines, their lives a living hell, battling a death wish, violent, suicidal, toxic and psychotic, with homicidal impulses, ego-alien outbursts of violence, unable to articulate internal agitation, Moving attenuated, but never fully relieved, by co prescribed sedativesor worse, self -administering alcohol or whatever else is available.
113. This is about risk management. If they are making suicide attempts on SSRIs the prescriber has increased the RR of that behaviour statistically by 2.2 minimum to 10 or more.
114. Withdrawal can be tricky and that’s when we lose them,
115. The greatest satisfaction I have had in my 38 years as a psychiatrist has come from giving lives back to those who have suffered from this totally debilitating and unrecognised iatrogenic disorder for up to eight years.
116. In 1974, Ivan Illich popularised a term, iatrogenesis, for the ‘new’ epidemic of doctor-made disease it is clinical, when sickness is caused by medical care;
117. In his critique of Illich, Vicente Navarro saw that the responsibility for iatrogenesis did not lie with the medical profession
119. All Truth passes through Three Stages:
