Introduction - Uppsala Monitoring Centre

11. Mushroom poisoning
12. Gunshot wounds to the chest (Spencer et al, 1927).
These have now been whittled down to 1, 2 and 8, i.e. where there
is iron-overload, pulmonary oedema secondary to renal failure, or cor
pulmonale. So we have seen over more than 800 years the erosion
of the mythical use of blood-letting and the establishment of the
logical reasons for removing blood.
1928 Norwegian legislation developed regulations relating to drug safety
and efficacy (Abraham, 1995).
Formation of the Food, Drug and Insecticide Administration (later the
Food and Drug Administration).
Chauncey Leake suggested that the evaluation of new drugs should
entail study of the toxicity of the different members of the series and
that this required a large number of animals and much patience. He
was astonished how unreliable and meagre toxicity figures were for
even standardized preparations. The minimal lethal dose, (killing
three out of five) depended on many factors among which were:
(a) Species
(b) Condition of animal
(c) Solvent and concentration
(d) Mode and rate of administration.
He went on to say that these variables took considerable
experience to control in order to arrive at sound estimates.
He also advocated that before venturing to clinical trials one
should submit the selected substances to study in regard to their
action on normal human beings (Phase I studies).
‘Many drug firms make the mistake of believing that their chemists
can furnish trustworthy pharmacological opinion. Indeed some
eminent chemists impatient with careful pharmacologic technique,
have ventured to estimate for themselves the clinical possibilities of
their own synthetics…There is no short cut from the chemical
laboratory to the clinic except one that passes too close to the
morgue.’ (Leake, 1929).
Sir William Willcox referring to the dangers of new medicines said:
‘Recently many new drugs, a large proportion of them of foreign
manufacture, had been placed on the market, and their virtues were
highly extolled by the manufacturers and the vendors. Attention was
rarely called, however, to the toxic and other harmful effects which
were liable to follow their use. He thought it most unfortunate that the
makers of drugs did not more fully take the medical profession into