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Through the Looking Glass: Reflections of a Research Ethicist or The Collapse of Science and Ethics?. Michael Goodyear Department of Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada MSMR Waltham MA, June 2006.

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through the looking glass reflections of a research ethicist or the collapse of science and ethics

Through the Looking Glass:Reflections of a Research EthicistorThe Collapse of Science and Ethics?

Michael Goodyear

Department of Medicine,

Queen Elizabeth II Health Sciences Centre,

Dalhousie University, Halifax,

Nova Scotia, Canada

MSMR Waltham MA, June 2006

Goodyear

slide3

Alice was sitting curled up in a corner of the great arm-chair, half talking to herself and half asleep

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learning objectives
Learning Objectives
  • I: How Did We Get Here From There?
  • II: Where are We Now?
  • III: Lessons from TGN1412
  • IV: Moving Forward

Summary

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slide6

“The aim of science is not to open a door to infinite wisdom but to set a limit to infinite error”

Brecht B. The Life of Galileo(Leben des Galilei) 1943

Bertolt Brecht (1898 –1956)

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slide7
Part I

How Did We Get Here From There?

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history
History
  • Human experimentation since time immemorial
    • Generally more vulnerable populations
      • Prisoners, slaves, patients

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history10
History
  • Thomas Percival (1740-1804)

Medical Ethics: a Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons

Russell, London 1803

Adopted by AMA 1847, modified many times

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history11
History
  • Claude Bernard (1813-1878)
    • Must have potential benefit
    • Prisoners not considered human

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history12
History
  • William Osler (1849-1918)
    • Consent
    • Animal experimentation
  • George Bernard Shaw (1856-1950)
    • “Human Guinea Pigs” (1913)*

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*Disclaimer: No Guinea Pigs were harmed in this production

history13
History
  • Germany
    • Prussian regulations 1900
    • Third Reich 1931

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slide15

Nürnberg

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slide17

Nuremberg Code

1947

Trials of war criminals before the Nuremberg military tribunals under Control Council Law,

No 10, Vol 2.

Washington DC:

US Government Printing Office, 1949: 181.

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nuremberg code 1947
Nuremberg Code 1947

1. Voluntary Consent Essential

2. Must Yield Valid Results

3. Based on Animal Experiments

4. Avoid Physical and Mental Suffering

5. Avoid Injury

6. Risk Proportional to Benefit

7. Subjects Must be Protected

8. Qualified Investigators

9. Voluntary Withdrawal

10. Must be Terminated if Necessary

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Top Secret

nuremberg code 194719
Nuremberg Code 1947

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.

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slide20

American Medical Association

Judiciary Council

  • The voluntary consent of the person on whom the experiment is to be performed must be obtained
  • The experiment must be performed under proper medical protection and management.
  • The danger of each experiment must be previously investigated by animal experimentation

December 10th, 1946

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slide21

Strangers at the Bedside:

A history of how law and bioethics

transformed medical decision makingNY Basic Books 1991

David Rothman PhD

Director, Center for the Study of Society and Medicine

Columbia College of Physicians and Surgeons

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slide22

“Neither the horrors described at the Nuremberg trial nor the ethical principles that emerged from it had a significant impact on the American research establishment” because they did not seem “directly relevant to the American Scene”Rothman p. 62

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LF Ross

slide23

“To most Americans, however, Nuremberg addressed madness, not medicine”

Shapiro HT.

Waggoner Lecture, U Michigan

Dec 5 2001

Ethical Considerations in Research on Human Subjects:

A Time for Change…Again

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slide24

Tuskegee, Alabama

Nürnberg, Germany

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slide26

“I don’t know what they used us for. I ain’t never understood the study”

Tuskegee, Alabama

(1932 – 1972)

RIP

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slide27

1965

Are humans used as guinea pigs not told?

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slide28

(1904-1976)

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slide29

“What seem to be breaches of ethical conduct in experimentation are by no means rare, but are almost, one fears, universal”

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slide30
“No physician is justified in placing science or the public welfare first and his obligation to the individual, who is his patient or subject, second”

“No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good”Maurice Pappworth

Pappworth M.H. Human Guinea Pigs Penguin 1967, p.27

Goodyear

LSwartz

the dark side
The Dark Side
  • Willowbrook Hepatitis Study
  • Jewish Hospital Cancer Study
  • Tearoom Trade Study
  • Wichita Jury Study
  • Milgram Obedience Study
  • San Antonio Contraceptive Study
  • Radiation Studies
  • etc…………..

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belmont report 1979
Belmont Report1979

Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchApril 18, 1979

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so we fixed it
So We Fixed it?

Right?

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slide35

Advisory Committee on Human Radiation Experiments (1994-5)

Human Radiation ExperimentsAssociated with theU.S. Department of Energyand Its Predecessors

(1944 – 1974)

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X-Files?

slide36

Unfortunately, however, the government's conduct with respect to some research performed in the past has left a legacy of distrust

We did find evidence of some serious problems in the conduct …of human research today

1.

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slide37

We realize, however, that regulations and policies are no guarantee of ethical conduct

It is essential that the research community come to increasingly value the ethics of research involving human subjects as central to the scientific enterprise

2.

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slide38

The revision of regulations that govern human research (and) professional ethics are necessary, but are not sufficient, means to needed reform.

Of at least equal import is the development of a more common understanding among the public of research involving human subjects

3.

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slide39

Some of what is regrettable about the past happened… because we as citizens let it happen

Let the lessons of history remind us all that the best safeguard for the future is an informed and active citizenry

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4.

slide41
Part I

Where are We Now?

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the ongoing problems
The Ongoing Problems
  • Role Confusion
    • Mission Creep
    • Administrivia
  • The Collapse of Scientific Integrity
  • Inadequate Resources
  • Increasing Complexity of Science
  • Patchwork Quilt
  • Accountabilty
  • Inflexible

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slide43

Gunsalus CK, Bruner EM, Burbules NC, Dash L, Finkin M, Goldberg JP, Greenough WT, Miller GA, Pratt MG

Mission creep in the IRB world.Science. 2006 Jun 9;312(5779):1441.

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mission creep in the irb world
Mission Creep in the IRB World
  • System endangered by excessive paperwork
    • Overregulation and underprotection
  • Overwhelmed by procedures and documentation at expense of thoughtful consideration
  • ‘Ethics Police’
  • Researchers equate ‘Human Protection’
    • with frustrating delays, expensive paperwork

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mission creep in the irb world45
Mission Creep in the IRB World
  • *Ethics a Collective Responsibility
  • IRBs not a substitute for Ethical Thinking and Behaviour
  • Should cultivate Ethical Culture
  • Researchers and IRBs need Support
    • local
    • central

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the ongoing problems46
The Ongoing Problems
  • Role Confusion
  • The Collapse of Scientific Integrity
    • A crisis in trust
  • Inadequate Resources
  • Increasing Complexity of Science
  • Patchwork Quilt
  • Accountabilty
  • Inflexible

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why is there a crisis in trust
Why is There a Crisis in Trust?

Evidence Based Medicine

Archie Cochrane

(1909-1988)

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why is there a crisis in trust49
Why is There a Crisis in Trust?
  • Evidence Based Medicine
    • Replaced Opinion, Anecdotes and Experts
    • Based on Systematic Reviews of high quality evidence (RCTs)
    • Practice Based Guidelines
      • Graded by Strength of Evidence
        • So far, so good, BUT

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why is there a crisis in trust50
Why is There a Crisis in Trust?
  • Evidence Based Medicine

A House of Cards Built on Sand?

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why is there a crisis in trust51
Why Is There a Crisis in Trust?
  • Public Perceptions (1)
    • Law Suits Against Industry
      • data suppression
    • Publication ethics

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slide52

June 3, 2004

Spitzer Sues a Drug Maker, Saying It Hid Negative Data

By GARDINER HARRIS

In a novel claim testing the way that the $400 billion worldwide pharmaceutical industry is regulated, the New York State attorney general, Eliot Spitzer, sued the British-based drug giant GlaxoSmithKline yesterday, accusing the company of fraud in concealing negative information about its popular antidepressant medicine Paxil.(Paroxetine)

The civil lawsuit, filed in State Supreme Court in Manhattan, contends that GlaxoSmithKline engaged in persistent fraud by failing to tell doctors that some studies of Paxil showed that the drug did not work in adolescents and might even lead to suicidal thoughts. Far from warningdoctors, the suit contends, the company encouraged them to prescribe the drug for youngsters.

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why is there a crisis in trust53
Why Is There a Crisis in Trust?
  • Public Perceptions (1)
    • Law suits against industry
    • Publication Ethics
      • Publication Bias
      • Outcome Bias
      • Altered outcomes
      • Publication restrictions
      • Suppressed data
      • Ghost writing

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slide54

This past year has been a bumper year for research and publication misconduct

COPE Report 2005

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why is there a crisis in trust55
Why Is There a Crisis in Trust?
  • Public Perceptions (1)
    • Law suits against industry
    • Publication Ethics
      • Publication Bias
      • Outcome Bias
      • Altered outcomes
      • Publication Restrictions
      • Suppressed data
      • Ghost writing

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industry publication restrictions facilitate selective reporting
Industry Publication Restrictions Facilitate Selective Reporting
  • “If there are disagreements with the investigators’ analyses, new or repeated analyses are required before publication. The Sponsor remains sole owner of the data.”
  • “Only the Sponsor has the right to publish results.”
  • “Any information which the Sponsor deems confidential must be deleted prior to submission.”

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AW Chan, Gøtzsche P et al JAMA 2006 295: 1645

why is there a crisis in trust58
Why Is There a Crisis in Trust?
  • Public Perceptions (1)
    • Law suits against industry
    • Publication Ethics
      • Publication Bias
      • Outcome Bias
      • Altered outcomes
      • Publication restrictions
      • Suppressed Data
      • Ghost writing

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slide59

Volume 354:1193March 16, 2006Number 11

Expression of Concern Reaffirmed

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

On December 8, 2005, we published an expression of concern regarding an article by Bombardier et al. on the Vioxx Gastrointestinal Outcomes Research (VIGOR) study that was published in the Journal on November 23, 2000. Our expression of concern was prompted by evidence that the VIGOR article did not accurately represent the safety data available to the authors when the article was being reviewed for publication.

…critical data on an array of adverse cardiovascular events that were not included in the VIGOR article. These data, which should have raised concern about potential cardiovascular toxicity of rofecoxib…

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why is there a crisis in trust60
Why Is There a Crisis in Trust?
  • Public Perceptions (1)
    • Law suits against industry
    • Publication Ethics
      • Publication Bias
      • Outcome Bias
      • Altered outcomes
      • Publication restrictions
      • Suppressed data
      • Ghost Writing
        • David Healey, Carl Elliott

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why is there a crisis in trust61
Why Is There a Crisis in Trust?

Ghost Writing

“Dear Dr …., In order to reduce your workload to a minimum we have had our Ghost Writers produce a first draft based on your published work …”

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slide62

The British Journal of Psychiatry (2003) 183: 22-27

  • Interface between authorship, industry and science in the domain of therapeutics
  • DAVID HEALY, FRCPsych and DINAH CATTELL
  • North Wales Department of Psychological Medicine, University of Wales College of Medicine, Bangor, UK
  • Unacknowledged editorial or writing assistants to academic authors – so-called ghostwriters – are often employed by medical communication agencies working for pharmaceutical companies. Efforts have been made to quantify the extent to which ghostwriting is happening, with Flanagin et al (1998)1 reporting that up to 11% of articles published in six peer-reviewed journals in 1996 involved the use of ghostwriters.
  • A. Flanagin et al.
  • Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals
  • JAMA 280 (1998): 222-24

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why is there a crisis in trust63
Why Is There a Crisis in Trust?
  • Public Perceptions (2)
    • Death and Injury of Volunteers
    • Breaches of integrity
    • Commercialisation
    • Unnecessary research

Goodyear

ellen roche
Ellen Roche

Would Ellen be Alive Today,

if all Hexamethonium Trials had been Registered?

Ellen Roche, a Healthy Volunteer

Unnecessary Research

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slide65

Jesse Gelsinger

“What's the worst

that can happen to

me? …

I die, and it's for

the babies.“1

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1 New York Times, 28 Nov 1999

why is there a crisis in trust66
Why Is There a Crisis in Trust?
  • Public Perceptions (2)
    • Death and Injury of Volunteers
    • Breaches of integrity
    • Commercialisation
    • Unnecessary research

Goodyear

slide67

Vol 435|9 June 2005 nature

COMMENTARY

Scientists behaving badly

Brian C. Martinson, Melissa S. Anderson and Raymond de Vries

Serious misbehaviour in research is important for many reasons, not least because it damages the reputation of, and undermines public support for, science.

(n=3,247)

Overall, 33% of the respondents said they had engaged in at least one of the top ten behaviours during the previous three years.

Changing the design, methodology or results of a study in response to

pressure from a funding source 16%

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why is there a crisis in trust68
Why Is There a Crisis in Trust?
  • Public Perceptions (2)
    • Death and Injury of Volunteers
    • Breaches of integrity
    • Commercialisation
      • Conflicts of interest
      • Health Care Industry
      • Globalisation
    • Unnecessary research

Goodyear

global corruption report 2006
Global Corruption Report 2006

Special focus:CORRUPTION AND HEALTH

Goodyear

slide70

Editorial

Corruption in health care costs lives

Volume 367, 11 February 2006 447

The word corruption—abuse of entrusted power for private gain—rarely enters health professionals' vocabulary and is frequently softened to unethical or unprofessional behaviour

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slide72

Testing new drugs

on the world’s poorest patients

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why is there a crisis in trust73
Why Is There a Crisis in Trust?
  • Public Perceptions (2)
    • Death and Injury of Volunteers
    • Breaches of integrity
    • Commercialisation
    • Unnecessary Research
      • Ellen Roche
      • Aprotinin

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slide74

Cumulative Meta-analysis of Aprotinin for Perioperative Bleeding1

Where was Equipoise?

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1 Fergusson, Glass, Hutton, Shapiro: Clinical Trials 2:218, 2005

why is there a crisis in trust75
Why Is There a Crisis in Trust?
  • Public Perceptions (3)
    • Inappropriate sponsor involvement
    • Safety issues
      • Paroxetine (Paxil)
      • Rofecoxib (Vioxx)
      • Class I Antiarrhythmic Drugs
    • Disease Mongering

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slide76

“Widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments”

Moynihan R, Heath I, Henry D

Selling sickness: The pharmaceutical industry and disease mongering.

BMJ 2002 324: 886–891

Vol 3(4) April 2006

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why is there a crisis in trust77
Why Is There a Crisis in Trust?
  • Public Perceptions (4)
    • Claims of large numbers of Unnecessary Deaths from inappropriate publication
    • Consumer group websites publish daily bulletins on wrongdoing in research

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slide78

Rofecoxib

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cardiovascular risk factors

Cardiovascular Risk Factors

VIGOR Trial (4%)

Increased Risk: 38% CV events

Risk Ratio: 2.5

Event Rate 1.5%

Tennessee Medicaid Study (40%)

Event Rate 11.6

NNH: 556 v 70 (8 fold)

“It is not until drugs go out into the world and they are used in real patients” EMEA

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why is there a crisis in trust80
Why Is There a Crisis in Trust?
  • Public Perceptions (4)
    • Claims of large numbers of unnecessary deaths from inappropriate publication
    • Consumer Group Websites publish daily bulletins on wrongdoing in research

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where has science gone wrong
Where Has Science Gone Wrong?
  • Has science lost its way?
    • Collaboration replaced by Secrecy
    • Obsession with Commercialisation
    • Lost Sight of Normative Values

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has science lost its way
Has Science lost its Way?
  • The majority of new products since 1990 have not improved health care compared to less costly and better understood drugs
  • Many are analogues (me-too) and reformulations designed to improve market share and prolong patents
  • Are IRBs legitimising fraud?

Goodyear

sponsor always wins
Sponsor always Wins!

Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S.

Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics.

Am J Psychiatry. 2006 Feb;163(2):185-94.

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If A > B, and B > C, then why is C > A?

slide85

Unhealthy Medicine: All Breakthrough,

No Follow-ThroughBy Steven H. WoolfSunday, January 8, 2006

We spend far more money on inventing new treatments than on research into how to deliver them

Developing new treatments often does less good than ensuring the delivery of older drugs to all those in need

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slide86

Beyond dissatisfaction, the larger problem with our focus on medical breakthroughs is that more Americans will die as a resultWe have reached a point when progress in providing good care – when needed, with compassion and skill and without errors -- would impress the public as a more meaningful "medical advance" than the rollout of the latest device or pill.Department of Family MedicineVirginia Commonwealth University

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slide87
Part III

Lessons from TGN1412

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tgn1412
TGN1412

“A Watershed Incident”

Fiona Godlee, Editor BMJ

A line in the sand?

A cautionary tale from Waltham MA

Goodyear

slide89

Hell of human guinea pigs

How the drug trial horror unfolded

By MICHAEL SEAMARK, Daily Mail 17th March 2006

We saw human guinea pigs explode

Victims tearing at shirts

By NICK PARKER, EMMA MORTON and JACQUI THORNTON

16th March 2006

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peer review
Peer Review
  • Wood AJ, Darbyshire J.

Injury to research volunteers--the clinical-research nightmare.N Engl J Med. 2006 May 4;354(18):1869-71

  • Ho MW, Cummins J.

London Drug Trial Catastrophe – Collapse of Science and Ethics: Postmortem on the TGN1412 disaster

Science in Society. 2006 Summer 30: 44-5

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slide91

SUN: A VOLUNTEER who escaped the drug test disaster told last night how he saw six healthy young men turn into wailing wrecks within minutes.

Human guinea pig Raste Khan — who did not know he had been given a harmless placebo in the test — said it was like a horror film unfolding before his eyes.

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slide92

RASTE KHAN

“The test ward turned into a living hell minutes after we were injected. The men went down like dominoes.

First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode”

“After that they started fainting, vomiting and writhing around in their beds”

“It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and didn’t know why. An Asian guy next to me started screaming and his breathing went haywire as though he was having a terrible panic attack”

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slide93

RASTE KHAN

“They put an oxygen mask on him but he kept tearing it off, shouting ‘Doctor, doctor, please help me!’ He started convulsing, shouting that he was getting shooting pains in his back.”

Goodyear

slide94

TGN1412

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tgn 1412
TGN 1412

CD28 T Cell Receptor SuperAgonist

CD28

Humanised IgG4 Monoclonal Antibody

Goodyear

tgn 141296
TGN 1412
  • By-passes Costimulation by

Antigen Presenting Cell

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tgn 141297
TGN 1412
  • First Time in Man
  • Phase I March 13 2006
  • 8 Subjects in first cohort
    • Healthy Male Volunteers
    • 2 Placebo
    • 6 Active
  • All 8 treated in rapid succession
  • Dose based on NOAEL
  • $4,000

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tgn 141298
TGN 1412

No Observed Adverse Effect Level

  • Primates tested up to 50mg/kg (NOAEL)
  • Clinical testing started at 0.1mg/kg
    • 1/500 NOAEL
  • (NOAEL ≠ Pharmacologically effect)

0.3 – 5.0mg/kg

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tgn 141299
TGN 1412
  • Rapid onset
    • Cytokine Release Syndrome
    • Angioedema
  • Testing continued
  • Multiple Organ Failure
  • All subjects admitted to ICU
  • Prolonged immunosuppression
  • 1 still hospitalised, dry gangrene

Goodyear

tgn 1412100
TGN 1412

Medicines and Healthcare Products Agency

(MHRA)

  • Suspended CTA
  • Immediate Inquiry
  • Released
    • protocol, review and inquiry

UK Government announces expert inquiry

No review of ethical review to date

Goodyear

tgn 1412101
TGN 1412

Expert Inquiry (Terms of Reference)

  • What may be necessary in transition from pre-clinical to first-in-man Phase 1 studies, specifically:
    • Biological molecules with novel mechanisms of action
    • New agents with highly species-specific action
    • New drugs for immune system targets
  • Interim report within 3 months (August)
  • Minutes of meetings and interim findings to be made public

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lessons to be learnt from tgn 1412 1
Lessons to be learnt from TGN 1412 (1)
  • Recruitment
    • Financial Incentives
  • Adequacy of Information
  • Choice of Subject in Phase I
  • Number of Subjects
  • Timing of Administration

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lessons to be learnt from tgn 1412 1105
Lessons to be learnt from TGN 1412 (1)
  • Recruitment
  • Adequacy of Information
    • Consent
  • Choice of Subject in Phase I
    • Healthy volunteers
  • Number of Subjects
  • Timing of Administration

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lessons to be learnt from tgn 1412 2
Lessons to be learnt from TGN 1412 (2)
  • Sources of Information Reviewed
    • Regulatory Review
    • Ethical Review
  • Place of Independent Expert Review
  • Relevance of Preclinical Testing
    • Interspecies difference (Maccaca)
  • Transparency in Development
    • Publishing preclinical work
  • Transparency of Reviews
  • Response to Disasters

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lessons to be learnt from tgn 1412 3
Lessons to be learnt from TGN 1412 (3)
  • Caution in
    • developing immunomodulators
    • agonists
    • bypassing regulatory mechanisms (super)
  • Assumptions about Dose-Response
    • non-linear
    • bell shaped (optimum dose was 5mg/kg)

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lessons to be learnt from tgn 1412 4
Lessons to be learnt from TGN 1412 (4)
  • Homology may not mean affinity
  • Affinity may not translate downstream
  • Even monoclonals are not specific
  • Standards for preclinical testing

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lessons to be learnt from tgn 1412 4109
Lessons to be learnt from TGN 1412 (4)

The Immune System is a Capricious Pandora’s Box!

Pandora 1898.

John William Waterhouse

British Pre-Raphaelite

1849-1917

Private collection Oil on canvas

Goodyear

lessons to be learnt from tgn 1412 5
Lessons to be learnt from TGN 1412 (5)
  • Relationships with industry
  • Adequacy of training of staff
  • Adequacy of facilities
  • Adequacy of liability insurance

Plan for the worst, hope for the best

Goodyear

the relevance of animal testing
The Relevance of Animal Testing?

Bhogal N, Combes R.

TGN1412: time to change the paradigm for the testing of new pharmaceuticals.Altern Lab Anim. 2006 May;34(2):225-3

Fund for the Replacement of Animals in Medical Experiments

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slide112

The normal co-stimulatory mechanism of T-cell activation

  • TGN1412 recognises single CD28 on receptor

Goodyear

Bhogal, Combes 2006

slide113

CD28 monomer and corresponding TGN1412 binding epitope

  • 3-D model of CD28 extracellular domain
  • TGN1412 binding epitope circled

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Bhogal, Combes 2006

slide114

Conservation of amino acid sequences of CD28.

Substitution of Glutamate (E) in Macacca mulatta (Rhesus) for Glycine (G) in human, could have profound conformal implications, and hence affect affinity binding and downstream effects.

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Bhogal, Combes 2006

the relevance of animal testing115
The Relevance of Animal Testing
  • Need to establish validity
  • Staggered timing
  • Microdosing
  • Ex-vivo

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learning from mistakes
Learning from Mistakes
  • We have been assured repeatedly that proper procedures were followed, when the the real question is whether they were the right procedures.

Goodyear M. BMJ March 25th 2006

  • Nor will a collective claim of ‘not-guilty’ likely lead to understanding and correction

Goodyear M. CMAJ In press

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slide117

"Is there any point to which you would wish to draw my attention?"

"To the curious incident of the dog in the night-time."

"The dog did nothing in the night-time."

"That was the curious incident," remarked Sherlock Holmes.

Conan-Doyle A. Silver Blaze 1892

Goodyear

slide118
Part IV

Moving Forward?

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moving forward
Moving Forward?
  • Adaptation in a Changing World
    • Regulation and ethics always lags behind technology
  • Transparency
  • Governance
  • Support

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moving forward120
Moving Forward?
  • Transparency
    • One of the biggest threats to research integrity
    • Trust and confidence can only be restored by a guaranty of transparency

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moving forward121
Moving Forward?
  • Response to TGN1412
    • This tragedy creates one more imperative for an open culture in medical research, a culture that many fear is increasingly losing its way

Goodyear M. BMJ March 25th 2006

His call for a culture of greater openness in medical research is, I think, both powerful and timely

Gunn A USA TODAY March 27th 2006

    • Maximum transparency to reaffirm trust in clinical trials and their regulation. Commercial confidentiality should not obstruct independent scrutiny

Lancet March 25th 2006

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slide123

Opening Address to World Health Assembly, May 2005

"We are ready to move forward with an International Clinical Trials Registry. This will do much to strengthen the research process and its ability to win public trust"

Dr Jong-wook Lee

WHO Director-General

died May 22

Goodyear

I Sim

slide124

Restoring Normative Values

Robert K Merton

(1910-2003)

CUDOS

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moving forward125
Moving Forward?
  • Adaptation in a Changing World
    • Regulation and ethics always lags behind technology
  • Transparency
  • Governance
  • Support

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Michael K Walsh, John J McNeil and Kerry J Breen

Improving the governance of health research

MJA 2005; 182: 468–471

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summary
Summary
  • Research ethics has come a long way
  • In many ways it is unworkable, and unable to adapt
  • The whole scientific endeavour has come off the rails
  • Collaboration must replace competition
  • The process must be transparent and accountable
  • Responsible research is a collective culture

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A Fundamental Cultural Shift is required to move from Competition to Collaboration, and from Secrecy to Transparency, if we are to move forward and restore Normative Values to Science, and Ethical Integrity to Research

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Medical hubris...has overvalued the state of our knowledge and failed to acknowledge the extent of our ignorance

McCormick J. Medical hubris and the public health: the ethical dimension.

J Clin Epidemiol. 1996 49:619

Goodyear