Introduction - Uppsala Monitoring Centre

This of course will add to more rapid marketing of good and safe
drugs, and protection against unsafe ones. It also increased greatly
the efforts to monitor birth defects. (Provided by the US Food and
Drug Administration).
Louis Pasteur gave the inaugural lecture as professor and dean of
the faculty of science, University of Lille, Douai, France on December
7, 1854: ‘In the fields of observation chance favours only those minds
which are prepared.’ Dr Kelsey’s mind was prepared.
Preludes to the thalidomide disaster
Following the thalidomide disaster most countries hurried to enact laws to try to
prevent any recurrence of a similar disaster and at the same time to reduce the risks
from new drugs. One must acknowledge the earlier attempts to do the latter:
Ancient Greece: Hippocrates aphorism: ‘Drugs may be administered to
pregnant women from the fourth to the seventh month of gestation.’ Had this advice
been followed the thalidomide phocomelia would not have occurred. The damage
caused by thalidomide was between the 34 th and 50 th day of gestation (Lenz, 1992).
UK: The aborted recommendation for the creation of a Medicines Commission in
1914; the ABPI avocation of the creation of an ‘independent’ voluntary trust to vet
new drugs in 1959 and the commissioning of a UK Working Party in November
1959 to ‘review the legislative provisions which relate to the control of medicinal
substances’.
France: The Ordinance of 4th February 1959. Article L.511 Code of Public
Health in response to the Stalinon disaster.
Sweden: Swedish and Norwegian drug laws in 1934 and 1928 respectively,
which required manufacturers to demonstrate the safety and efficacy of their
products prior to approval, but they still approved thalidomide.
USA: Chauncey Leake in 1929: ‘The rational introduction of new drugs requires
the close cooperation of chemists, pharmacologists and clinicians. Reliable
pharmacologic study is necessary in the development of new drugs to estimate
Toxicity
Type and mode of action
Worthiness of application to human beings
Reasonable replacement of existing drugs.
Clinical evaluation should be made under controlled conditions in research
hospitals. Physicians should not use new drugs in daily practice until favourable reports
from such sources have been published in reputable journals.’ (Leake, 1929).
Germany: The Drug Commission of the German Medical Association (DCGMA)
requesting in 1958 that all doctors should report adverse drug reactions to the
Commission.
All these efforts were to no avail and although the Bundesverfassungsgericht’s