Introduction - Uppsala Monitoring Centre

§ References ....................................................................................... 372
§ Index ................................................................................................. 390
Preface
his book is not a normal history book. Several reviewers have said that this is
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a history book; but most history books that I have read are continuous
narratives reflecting the opinions of the authors. There is frequently little
primary evidence and usually there are no references, but rather a
bibliography, which itself consists of secondary sources. I want to avoid giving
subjective opinions until I have stated all the relevant primary data. I have, therefore,
based the book on the structure of a scientific paper with the aim, methods and
limitations in the preface whilst the remainder of the book forms the results and
conclusion sections. I hope that there is sufficient information for the readers to form
their own opinions and to support my own conclusions. I also hope that in using the
primary data I will avoid too much bias, however, there will be bias due my choice of
quotation. The book investigates how adverse drug reactions were discovered,
what information was given and how it was given. The progress of regulations to
control the safety of drugs is followed until the Thalidomide disaster. Thalidomide
was such a watershed that the whole approach to drug safety changed. I trust that I
can leave it to others to cover the period from1961 until the present date.The
literature published over such a long period is vast and I have only reviewed a small
amount of it, but I hope that it is sufficiently representative that it has not missed too
much. In order to link the chronologically listed pharmacovigilance events in time I
have also included some important medical events. It has been necessary to include
the sources inspected, but which yielded no information, so that the reader can draw
their own conclusions as to whether the sources are sufficiently representative as to
support the conclusions that I draw. Six marker drugs have been chosen to follow,
which seem representative of the pharmacopoeias over time. I have chosen syphilis
as a representative disease because of its many treatments and its problems over
five centuries. The terminology of the various adverse events described has
changed with the passing of time to such an extent that it is difficult to group them
for analysis. The analyses are in a tabular format, which I hope is not too daunting
for the reader.
There is a strong bias towards the English language publications and a bias
towards French, Italian and German literature in that order. Publications in other
languages have not been accessed due to language difficulties and, therefore, only
secondary English language sources have been used. For the benefit of those
whose second language is English some of the spelling has been changed to
modern British spelling. The modern Chinese transliteration called Pinyin has been