Act in the United Kingdom and most other
modern European states’ legislation, including
the European Community’s Directive 65/65EC,
was built, it is relevant to summarize these events.
Thalidomide first went on sale in 1956 in West
Germany and enjoyed good sales, both there and in
other countries, as a sleeping aid and as a treatment
of vomiting in early pregnancy, because of its
prompt action, lack of hangover and apparent
safety. Adverse reports of peripheral neuropathy
and myxoedema appeared in the literature in late
1958 and 1959, associated with thalidomide. In
1961, reports began to be made of a remarkable
rise, in West Germany since 1959, in the incidence
of a peculiar malformation of the extremities of
the newborn. This condition was characterized by
the defective long bones of the limbs, which had
normal to rudimentary hands or feet. Owing to its
external resemblance to a seal’s flipper, it was
given the name ‘phocomelia’. This condition had
previously been very rare in West Germany but
whereas no cases had been reported in the 10 years
1949–1959, there were 477 cases in 1961 alone. In
the United Kingdom, 400–500 cases were
reported during 1959–1961. The public and gov-
ernment were not prepared for these unforeseen
consequences of the therapeutic revolution that
had been taking place for 30 years. This compla-
cency was now shattered, public concern was
vocal, and the government was galvanized into
action.
The joint subcommittee of the English and
Scottish Standing Medical Advisory Commit-
tees, under the chairmanship of Lord Cohen of
Birkenhead, made recommendations regarding
future legislation for the control of medicines,
in addition to the immediate establishment of the
Committee on Safety of Drugs, which came into
operation in 1963 and whose function was to
review the evidence on new drugs and offer
advice on their safety. The Committee consisted
of a panel of independent experts from various
fields of pharmacy, pathology and so on. The
Committee was serviced by a professional secre-
tariat of pharmacists and medical officers, who
undertook the assessment of the submissions
and presented these to the committee and various
subcommittees.
The Committee on Safety of Drugs was set up in
June 1963 by the Health Minister, in consultation
with the medical and pharmaceutical professionals
and the British pharmaceutical industry, with the
following terms of reference:- To invite from the manufacturer or other person
developing or proposing to market a drug in the
United Kingdom any reports they may think fit
on the toxicity tests carried out on it; to consider
whether any further tests should be made and
whether the drug should be submitted to clinical
trials; and to convey their advice to those who
submitted reports. - To obtain reports of clinical trials of drugs sub-
mitted thereto. - Taking into account the safety and efficacy of
each drug, and the purposes for which it is to be
used, to consider whether it may be released for
marketing, with or without precautions or
restrictions on its use; and to convey their advice
to those who submitted reports. - To give to manufacturers and others concerned
any general advice they may think fit. - To assemble and assess reports about adverse
effects of drugs in use and prepare information
thereon which may be brought to the notice of
doctors and others concerned. - To advice the appointing ministers on any of the
above matters.
The Committee had no legal powers, but worked
with the voluntary agreement of the Associa-
tion of British Pharmaceutical Industry and the
Proprietary Association of Great Britain. They
promised that none of their members would put
on clinical trial or release for marketing a new drug
against the advice of the Committee, whose advice
they would always seek.
The joint English and Scottish Standing Medical
Advisory Committee also recommended that there
should be new legislation regarding many aspects
of drug safety, and after a review and consultation,33.3 THALIDOMIDE AND ITS AFTERMATH 425