Introduction - Uppsala Monitoring Centre

knowledge of medicine and science. From the late 17th century experimental
medicine provided more specific information on adverse effects and in the early part
of the18th century Germany, and more specifically Halle University, began
producing monographs on adverse drug effects. The isolation of the active
principles extracted from herbs from 1805 onwards meant that adverse effects
discovered were peculiar to the substance rather than to the whole herb. The
French pharmacologists, Magendie and Bernard, played a major role in delineating
these. Articles and books dedicated to adverse drug reactions were now starting to
be published and increased over the coming years culminating with the superb
Meyler series. The sudden deaths with chloroform sparked of a series of official
investigations into the cause from 1864 until 1890. Inquiries into the ill-effects of
some analgesics were made by the BMA and the US Bureau of Chemistry in 1894
and 1908 respectively. From 1911 there were calls for a greater study of adverse
drug effects which resulted in laws to ensure their safety: Sweden in 1934 and 1937,
the US in 1938, Japan in 1943, France in 1959,
The progress of drug safety and medicine as a whole has been bedevilled by the
fallacy ‘Post hoc ergo propter hoc’ (After this therefore because of this).The natural
cure of an illness whilst on a medicine is frequently ascribed to the medicine and
similarly any adverse event after taking the medicine is frequently presumed to be
due to the medicine. This may have encouraged some physicians to give a
medicine when they knew that the condition would probably right itself within the
time span of the medicines action, so taking the credit and the profit. It is only since
placebo controlled trials were started that we realised the number of patients who
improved without active treatment and similarly how many patients suffered identical
adverse events on placebo as when on the active drug.
From the earliest publications until 1960 there were three main themes in the
laws and regulations:
a) Adulteration alias sophistication: mentioned from the time of Rhazes (865 -
925AD) and continues to be a problem today.
b) Protection of the rights of ‘various healers’ has been a recurring theme. Roger
II, King of the Two Scillies, passed a law in 1140 regulating who could practise
medicine. Whilst the separation of the work of the prescriber from that of the
apothecary was laid down in the Edict of Salerno in 1241. Many subsequent
laws have reinforced this separation of responsibilities
c) The first law concerning the safety of medicines prior to approval was
probably in Sweden in 1934.
The names of diseases originally covered a broad umbrella, e.g. ague, fever and
convulsions, and over time these were split into more specific diseases, e.g. fevers
- malaria, ague - gout, convulsions - epilepsy. This meant that if all agues were
treated with colchicine only those with gout would benefit and the remainder would
suffer the adverse effects, but without experiencing any benefit.