Introduction - Uppsala Monitoring Centre

of therapeutic value.’ (Green, 1944, 1945).
The UK Therapeutic Substances Act came into force on 25 th July 1931.
1932 There were several popular US books written about the dangers in
foods and drugs: ‘100,000,000 Guinea pigs, dangers in everyday
foods, drugs and cosmetics’. Written in cheap journalese with
chapter headings such as: The quack and the dead; little white lies;
to make the best of a bad law, etc. These books helped to put
pressure on the FDA. Many similar books have been published since
then on both sides of the Atlantic.
Gerhard Domagk (1895–1964) discovered the sulphonamides in
December 1932.
1933 July 15th dinitrophenol found to cause weight reduction, but caused
severe skin rashes, agranulocytosis, jaundice, and fatal
hyperthermia. This product was not covered by the 1906 law,
because it was a diet potion. (see under regulatory responses).
A group consisting of FDA officials, USDA (United States
Department of Agriculture) staff and private lawyers drafted a bill to
expand government authority to inspect manufacturers and require
firms to carry out premarketing food and safety tests. The bill
languished in the House Commerce Committee for the next five
years (Cavers, 1939).
Madison and Squier suggested that amidopyrine and other drugs
containing a benzene ring might be a cause of agranulocytosis. The
OTC (Over The Counter) sale of amidopyrine was prohibited in the
UK in 1936 and in the US in 1938, but it remains on European
markets (Wade, 1970). (see under regulatory responses).
The UK Pharmacy and Poisons Act. It contained a Fourth Schedule
which listed poisons, which could only be sold to the public in
accordance with a prescription written by a doctor, dentist or
veterinary surgeon (RPSGB).
1934 Swedish drug law required manufacturers to demonstrate the safety
and efficacy of their products prior to approval. Germany and the UK
had no pre-market safety and efficacy regulations in place until after
thalidomide. The Norwegian and Swedish law requiring drug safety
before marketing did not prevent them from authorising thalidomide.
Ciba Geigy started marketing clioquinol in 1934 for amoebic
dysentery. The company marketed it in Japan in 1953. By 1970,
10,000 Japanese citizens suffered from the adverse reaction of
subacute-myelo-optico-neuropathy (SMON). See ‘Part Three’.