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Antidepressants & the Politics of Health David Healy

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Antidepressants & the Politics of Health David Healy. All Trials GSK House of Common. All Trials GSK House of Common. If treatments work , they could be made available for free, they would enhance national productivity, and encourage innovation.

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slide3

All Trials

GSK

House of Common

slide4

All Trials

GSK

House of Common

If treatments work ,

they could be made available for free,

they would enhance national productivity,

and encourage innovation

slide5

We are not in favour of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner…

specific individuals sd be provided with controlled access to IPD through carefully managed and secure “safe havens”.

Access should be facilitated by an independent “gatekeeper” responsible for insuring that the data … makes a useful contribution to scientific understanding

Page 4

slide6

We are not in favour of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner…

specific individuals sd be provided with controlled access to IPD through carefully managed and secure “safe havens”.

Access should be facilitated by an independent “gatekeeper” responsible for insuring that the data … makes a useful contribution to scientific understanding

slide15

EVIDENCE

BASED

MEDICINE

slide16

Efficacy

6 Week Trials

Rating Scales

2 positive out of 10 trials

100 publications

Accentuate the positive

All effect down to alcohol

Mexican alcohol

Gin, whiskey, beer, wine & rum

Scotch, Irish & Japanese whiskey

NICE Guideline endorsed

Cost-Utility Analyses ++

Take life long - NNTs

slide17

Side Effects

6-8 week trials

10% or more?

Anecdotes – Disregard

Pregnancy

Suicide & Violence

Dependence - illness

LFTs - depression

Prescription only Med

Amphetamines

Risk laundering

Stockholm syndrome

Legal liability

slide19

All RCTs do harm

Some may also benefit

slide20

R.A Fisher,

Design of

Experiments.

Edinburgh:

1935.

Randomization

Statistical

Significance

slide21

Statistical Significance means

  • You know what you are doing
  • You get the same result each time
slide22

Statistical Significance means

  • You know what you are doing
  • You get the same result each time
slide23

DRUGS

  • 100 Effects
  • Surrogates
  • Individual Patient
  • FERTILIZERS
  • 1 Effect
  • Hard Outcomes
  • Population Effect

Logically Ungrounded

Placebo Fertilizer?

slide25

Louis Lasagna

Placebo Response

Controlled Trials

Informed Consent - Confidentiality

slide26

Thalidomide

Randomized

Controlled

Trials

Efficacy

&

Safety

slide28

The days when a company would go to skilled doctors and give them a new drug and ask them to try it on some different patients seem gone. Is this cause for celebration or depression?

In contrast to my role in the 1950s which was trying to convince people to do controlled trials, now I find myself telling people that it’s not the only way to truth.

LOUIS LASAGNA

slide29

Streptomycin – Because of RCTs

Antibiotics Penicillins

Diuretics Furosemide

Hypoglycemics Metformin

Antihypertensives Thiazides

Antihistamines Diphenhydramine,

Chlorphenamine

Antipsychotics Clozapine, Haloperidol

Antidepressants Imipramine

Minor Tranquilizers Diazepam

Stimulants Dexamphetamine, Ritalin

Steroids Prednisone

Contraceptives COC – The Pill

Chemotherapies

Anticonvulsants Valproate, Phenytoin

Analgesics Morphine, NSAIDs

Vaccines Polio, Smallpox

slide32

RANDOMIZED CONTROLLED DISEASE TRIALS

Mild-Mod Depression SSRI Suicidal Acts:

screening

Run-in/wash out

randomization

drug

pbo

Start

treatment

Stop

treatment

follow-up

slide33

RANDOMIZED CONTROLLED DISEASETRIALS

Severe Depression Imipramine Suicidal Acts:

screening

Run-in/wash out

randomization

drug

pbo

Start

treatment

Stop

treatment

follow-up

slide34

RANDOMIZED CONTROLLED DISEASE TRIALS

Mild-Mod Depression Imipramine Suicidal Acts:

screening

Run-in/wash out

randomization

drug

pbo

Start

treatment

Stop

treatment

follow-up

slide35

Every Time Drug & Illness

Produce the same Outcome

Anti-arrhythmics Arrhythmias

Anti-asthmatics Wheezing

Rosiglitazone Diabetes – heart attacks

Byetta – Januvia Diabetes – pancreatitis

Antidepressant Suicide

Benefit

It’s the Disease not the Drug if a Hazard

It’s the Drug not the Disease if a Benefit

slide36

GlaxoSmithKline - 2006

Paroxetine Suicidal Acts 11 v 0 Placebo Suicidal Acts

N = 2943 N = 1671

slide37

GlaxoSmithKline - 2006

Paroxetine Suicidal Acts 11 v 0 Placebo Suicidal Acts

N = 2943 N = 1671

RR > 6.0

Paroxetine Suicidal Acts 36 v 35 Placebo Suicidal Acts

N = 147 N = 147

slide38

GSK - 2006

Paroxetine Suicidal Acts 11 v 0 Placebo Suicidal Acts

N = 2943 N = 1671

RR > 6.0

Paroxetine Suicidal Acts 47 v 35 Placebo Suicidal Acts

N = 3090 N = 1818

RR < 0.80

slide39

Randomization controls

Fertilizer Confounders

It generates ignorance about ignorance

About Medicines

RCTs give weaker drugs

Standardized care

Fertilizers - no longer Poisons

All RCTs do harm,

some may also be of benefit

slide41

“If one came to the conclusion that the only way to find out the truth about a medication was to use a controlled clinical trial, it would mean not that the pendulum had swung too far but that it had come completely off its hook”

Louis Lasagna

Evidence Based Medicine has become synonymous with RCTs even though such trials invariably fail to tell the physician what he or she wants to know which is which drug is best for Mr Jones or Ms Smith – not what happens to a non-existent average person

slide42

Thalidomide

Randomized

Controlled

Trials

Efficacy

&

Safety

slide50

We are not in favour of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner…

specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”.

Access should be facilitated by an independent “gatekeeper” responsible for insuring that the data … makes a useful contribution to scientific understanding

slide52

Shower

  • Patents
  • Data Exclusivity
  • Prescription-only
  • Status
  • RCTs & Data
  • Evidence v Data
  • Based Medicine
  • Privacy Rights
slide53

AbbVie

V

European

Medicines

Agency

Adverse Events

slide54

Bidet

  • Data Based Medicine
  • Comparative Safety Research
  • Drug Trials
  • Patient Reporting
  • Consumer Pressure
  • [Save Money
  • New Drugs]
slide56

THE GUILDFORD FOUR

If their story is right

it is such

an appalling vista

it cannot be

Wrongfully convicted prisoners should stay in jail

rather than be freed and risk a loss of public confidence in the law.

slide57

When treatments work

they can be made available for free,

they will enhance national productivity,

and encourage innovation

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