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HIDING THE BODIES
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WheezesSwitching EndpointsSurrogate Outcomes 90%?NNT inappropriateLOCFRelative RisksShort term trialsMiscodingSplitting HazardsCo-administrationChoice of Comparator & DoseEcological fallacy
Publication Strategies
www.davidhealy.org
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screening
randomizationdrug pbo
Run-in/wash out
Stop treatment
Start treatment
FLUOXETINE – PAROXETINE - SERTRALINE ADULT TRIALSOccurrence of suicidal acts
follow-up
HealyBMJ2006
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screening
randomizationdrug pbo
Run-in/wash out
follow - up
Stop treatment
Start treatment
FLUOXETINE – PAROXETINE - SERTRALINE ADULT TRIALSReporting of suicidal acts
VioxxAvandia
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Paroxetine in treatment of intermittent brief depression[Montgomery et al 1993]
PAR PLCn = 18 n = 18
overall response [%] 38.0 50depressive episodes [n] 16.5 15.4mean MADRS score 29.7 26.8mean duration [days] 4.6 5.4suicide attempts / year 7.3 2.3
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GSK - 2006
Paroxetine Suicidal Acts 11 v 0 Placebo Suicidal Acts
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GSK - 2006
Paroxetine 43 v 35 Placebo RR – 0.74
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P=.04
Drug A
DOUBT IS OUR PRODUCT
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P=.09P=.04
Drug A Drug B
DOUBT IS OUR PRODUCT
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RR=1.9 (0.2, 16)
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SAFE TRAVEL:SPACE SHUTTLE
Mixed Messages
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THE SPIN NO DATA CAN OVERCOME
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April 15, 1991 Memo to Leigh Thompson“Upcoming TV appearance”
Section I. “MESSAGE GOALS, the three points .. are:
2. “It’s in the disease, not the drug.”
Section III “If pressed, or as a postscript to the above,then make the point that absolutely no evidenceindicates PROZAC as a cause of such behavior(violence and suicide).”, and “Prozac defense… There is simply no medical or scientific merit tothe argument.”
Exhibit 123
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screening
randomizationdrug pbo
Run-in/wash out
Stop treatment
Start treatment
RANDOMIZED CONTROLLED TRIALS
Bias 1: Suicidal Acts
follow-up
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screening
randomizationdrug pbo
Run-in/wash out
Stop treatment
Start treatment
RANDOMIZED CONTROLLED TRIALSBias 2: Suicidal Acts
follow-up
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EVIDENCE BASED MEDICINE
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EVIDENCE BASED MEDICINE
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Thalidomide
RandomizedControlled
Trials
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Alle Ding' sind Gift, und nichts ohn' Gift; allein die Dosis macht, daß ein Ding kein Gift ist.
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Objective v Subjective Certainty v Uncertainty
Mechanical v Thoughtful Autopilot v Professional
Risky Doctor v Risky Drug
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RCTS
• Are not a gold standard
• Do not demonstrate Cause and Effect
• Should never replace good evidence
• Significance testing should be about credibility
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LORDOFTHE RINGS
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“The American Psychiatric Association believes that antidepressants save lives.”
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“The American Psychiatric Association believes that psychiatrists save lives.”
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