Introduction - Uppsala Monitoring Centre

(Waxman, 2003).
1956 During clinical trials of thalidomide (Chemie Grünenthal) Dr Piacenza
described a case of polyneuritis, which he had traced to the drug.
Although the manufacturers became aware that this was the case in
October 1959, they suppressed the information, and later admitted
that a neuropathy could occur, but described it as ‘reversible’ in spite
of evidence to the contrary (Sjöström and Nilsson, 1972). The first
case of thalidomide phocomelia was born on Christmas Day (Lenz,
2000).
The UK Therapeutic Substances Act 1956 this was only concerned
with standard of strength, quality and purity of the same substances
as in the 1925 act.
1957 1st October Chemie Grünenthal put Contergan (thalidomide) on
West German market as a sedative and mild hypnotic.
1958 Thalidomide on UK market as ’Distaval’ on 14th April 1958
The Drug Commission of the German Medical Association (DCGMA)
requested all doctors to report adverse drug reactions to the
Commission (www.akdac.de).
CIOMS 171 Symposium of sensitivity reactions to drugs (Rosenheim &
Moulton, 1958).
Netherlands Medicines Act 1958 established a mandatory review of
safety and efficacy for new drugs and those already on the market,
but its Medicines Evaluation Board only started to operate after 1963.
1959 The French State amended the legislation governing the issue of
marketing licences, enacting the Ordinance of 4th February 1959.
Article L.511 Code of Public Health, which set new requirements for
marketing licences. The list of data to be submitted for issuance of
the licence underwent considerable change; henceforth, applicants
must file detailed written analysis and verification of both the raw
materials and the finished product, documents that must be
corroborated by an expert’s report. The manufacturing facilities must
be inspected, and reports of clinical trials must be provided.
Senator Kefauver started investigations which three years later led in
1962 to the emasculated Kefauver-Harris Amendment of the 1938
Food, Drug and Cosmetic Act (Abraham & Lawton Smith, 2003).
The Early Clinical Drug Evaluation Unit Program was set up in the
171 CIOMS = Council for International Organisations of Medical Services