Introduction - Uppsala Monitoring Centre

USA, because less than 1% of new compounds reached the market
(Prien, 1995).
The first benzodiazepine, Librium, or chlordiazepoxide, was
introduced in the US and into Britain a year later. The CRM
acknowledged that patients could be dependent on benzodiazepines
in 1980. In 1988 the Committee of Safety of Medicines (CSM)
advised against long-term use of benzodiazepines because of
dependence (Medawar, 1992). It took many years before the
dangers of barbiturates and benzodiazepines were acknowledged by
the regulatory authorities and this was partly due to their rigorous
defence by the industry.
The ABPI advocated the creation of an ‘independent’ voluntary trust
to vet new drugs (Hancher, 1990).
November 1959 A UK Working Party was set up to ‘review the
legislative provisions which relate to the control of medicinal
substances and to recommend what changes should be made to
rationalise and simplify the law with a view to ultimate amendment
and consolidation.’ The work of this group was overtaken by events
as the Thalidomide story evolved. At the same time another group,
the Interdepartmental Committee on Drug Addiction recommended
that ‘drugs having an effect on the central nervous system and liable
to produce physical or psychiatric deterioration should be confined to
supply on prescription, subject to the advice of an independent
expert body.’
During 1959 The UK Poisons Board warned of the probability of
hazard to the health of the public from widespread use of potent
medicines for self-medication.
31st December. Dr A Leslie Florence published a letter in the BMJ ‘Is
thalidomide to blame?’ describing peripheral neuropathy. He had
seen four patients, who had taken thalidomide, with parathesia of the
hands and feet, coldness of the extremities and nocturnal cramps in
leg muscles. By February 1961 Chemie Grünenthal had more than
400 cases (Sjöstrom & Nilsson, 1972).
1960 10th November 1960 Dr Frances Kelsey wrote to William S. Merrell
Co. concerning the material on the clinical trials: ‘it fails to report the
clinical studies in full detail. The report should include detailed
information relating to each individual treated, including age, sex,
conditions treated, dosage, frequency of administration of the drug,
results of clinical and laboratory examinations, and a full statement of