Clinical Pharmacology in the UK, c. 1950-2000: Industry and regulation (Wellcome Witnesses to Twentieth Century Medicine Vol 34)

149 Pages·2008·1.8 MB·English

by  L A Reynolds

CliniCal PharmaCology in the UK,
c. 1950–2000: indUstry and regUlation
The transcript of a Witness Seminar held by the Wellcome Trust Centre
for the History of Medicine at UCL, London, on 25 September 2007
edited by l a reynolds and e m tansey
Volume 34 2008
©the trustee of the Wellcome trust, london, 2008
First published by the Wellcome trust Centre
for the history of medicine at UCl, 2008
the Wellcome trust Centre for the history of medicine
at UCl is funded by the Wellcome trust, which is
a registered charity, no. 210183.
isBn 978 085484 118 9
all volumes are freely available online following the links to Publications/Wellcome Witnesses at
www.ucl.ac.uk/histmed
Technology Transfer in Britain: The case of monoclonal antibodies; Self and Non-Self:
A history of autoimmunity; Endogenous Opiates; The Committee on Safety of Drugs •
Making the Human Body Transparent: The impact of NMR and MRI; Research in General
Practice; Drugs in Psychiatric Practice; The MRC Common Cold Unit • Early Heart
Transplant Surgery in the UK • Haemophilia: Recent history of clinical management
• Looking at the Unborn: Historical aspects of obstetric ultrasound • Post Penicillin
Antibiotics: From acceptance to resistance? • Clinical Research in Britain, 1950–1980
• Intestinal Absorption • Origins of Neonatal Intensive Care in the UK • British
Contributions to Medical Research and Education in Africa after the Second World
War • Childhood Asthma and Beyond • Maternal Care • Population-based Research in
South Wales: The MRC Pneumoconiosis Research Unit and the MRC Epidemiology Unit
• Peptic Ulcer: Rise and fall • Leukaemia • The MRC Applied Psychology Unit • Genetic
Testing • Foot and Mouth Disease: The 1967 outbreak and its aftermath • Environmental
Toxicology: The legacy of Silent Spring • Cystic Fibrosis • Innovation in Pain Management
• The Rhesus Factor and Disease Prevention • The Recent History of Platelets in
Thrombosis and Other Disorders • Short-course Chemotherapy for Tuberculosis •
Prenatal Corticosteroids for Reducing Morbidity and Mortality after Preterm Birth •
Public Health in the 1980s and 1990s: Decline and rise? • Cholesterol, Atherosclerosis
and Coronary Disease in the UK, 1950–2000 • Development of Physics Applied to
Medicine in the UK, 1945–90 • The Early Development of Total Hip Replacement •
The Discovery, Use and Impact of Platinum Salts as Chemotherapy Agents for Cancer •
Medical Ethics Education in Britain, 1963–1993 • Superbugs and Superdrugs: A history
of MRSA • Clinical Pharmacology in the UK, c. 1950–2000: Influences and institutions •
Clinical Pharmacology in the UK, c. 1950–2000: Industry and regulation
Contents
illustrations and credits v
abbreviations vii
Witness seminars: meetings and publications; acknowledgements
E M Tansey and L A Reynolds ix
introduction
Professor Parveen Kumar xxiii
transcript
Edited by L A Reynolds and E M Tansey 1
references 73
Biographical notes 89
glossary 103
index 109

illUstrations and Credits
Figure 1 AstraZeneca Clinical Trials Unit, South Manchester.
Reproduced by permission of AstraZeneca. 6
Figure 2 A summary of the organization of clinical trials.
Adapted from www.clinicaltrials.gov/ct2/info/glossary
(visited 1 May 2008). 10
Figure 3 Clinical trial certificates (CTC) and clinical trial
exemption (CTX), 1972–1985. Adapted from Speirs
(1983) and Speirs (1984). 14
Figure 4 Professor Desmond Laurence and his monthly burden
of documents for a meeting of the Committee on
Safety of Medicines. Provided by, and reproduced
with permission of Professor Desmond Laurence. 65

v

Abbreviations
ABPI Association of the British Pharmaceutical Industry
BMA British Medical Association
BPS British Pharmacological Society
CDSM Committee on Dental and Surgical Materials
CHM Commission on Human Medicines
CRA Clinical research associate
CRM Committee on Review of Medicines
CRO Clinical research organization
CSD Committee on Safety of Drugs
CSM Committee on Safety of Medicines
CTX Clinical trial exemption
DHSS Department of Health and Social Security
DoH Department of Health
FDA Food and Drug Administration (US)
GMC General Medical Council
GPRD General practice research database
GSL General sales list
ICI Imperial Chemical Industries
IMP Investigational medical product
ISIS International studies of infarct survival
MCA Medicines Control Agency
MDA Medical Devices Agency
MHRA Medicines and Healthcare products Regulatory Agency
MoH Ministry of Health
vii
MRC Medical Research Council
NICE National Institute for Health and Clinical Excellence
OTC Over the counter
P medicine Pharmacy medicine
POM Prescription only medicine
PPRS Pharmaceutical price regulation scheme
SEAR Safety and Efficacy, Adverse Reactions Subcommittee
of the CSM
TCT Therapeutics and Clinical Trials Subcommittee
UCH University College Hospital
UCL University College London
WHO World Health Organization
viii
Witness seminars:
MEETINGS AND PUBLICATIONS 1
In 1990 the Wellcome Trust created a History of Twentieth Century Medicine
Group, associated with the academic unit of the Wellcome Institute for the
History of Medicine, to bring together clinicians, scientists, historians and others
interested in contemporary medical history. Among a number of other initiatives,
the format of Witness Seminars, used by the Institute of Contemporary British
History to address issues of recent political history, was adopted to promote
interaction between these different groups, to emphasize the potential benefits
of working jointly, and to encourage the creation and deposit of archival sources
for present and future use. In June 1999 the governors of the Wellcome Trust
decided that it would be appropriate for the academic unit to enjoy a more
formal academic affiliation and turned the unit into the Wellcome Trust Centre
for the History of Medicine at UCL from 1 October 2000. The Wellcome
Trust continues to fund the Witness Seminar programme via its support for
the Centre.
The Witness Seminar is a particularly specialized form of oral history, where
several people associated with a particular set of circumstances or events are
invited to come together to discuss, debate, and agree or disagree about their
memories. To date, the History of Twentieth Century Medicine Group has held
more than 50 such meetings, most of which have been published, as listed on
pages xiii–xxii.
Subjects are usually proposed by, or through, members of the Programme
Committee of the Group, which includes professional historians of medicine,
practising scientists and clinicians, and once an appropriate topic has been
agreed, suitable participants are identified and invited. This inevitably leads to
further contacts, and more suggestions of people to invite. As the organization
of the meeting progresses, a flexible outline plan for the meeting is devised,
usually with assistance from the meeting’s chairman, and some participants are
invited to ‘set the ball rolling’ on particular themes, by speaking for a short
period to initiate and stimulate further discussion.
1 The following text also appears in the ‘Introduction’ to recent volumes of Wellcome Witnesses to Twentieth
Century Medicine published by the Wellcome Trust and the Wellcome Trust Centre for the History of
Medicine at UCL.
ix