Introduction - Uppsala Monitoring Centre

detailed laboratory data and the nuances of the quality of life, from witchcraft to the
rigours of science. Prior to Gütenberg there had been periods of great scientific
activity from the Greeks and Romans both before and after the birth of Christ,
followed by a relatively dark age, when there were few reports of new ADRs,
finishing with the Arabic enlightenment in the 9 th century. Then followed another
relatively dark age until the age of Western enlightenment in the 17 th century. The
countries which then led the world were European, especially Italy, Spain, France,
Germany and England. India, China, Africa, Scandinavia, Russia and South
America contributed little to our knowledge of drug safety. North America, when
peopled by Europeans, soon became a major contributor to medical sciences and
drug safety. The advent of synthetic drugs in 1828 soon blossomed into a torrent of
new medications and a vast number of new active drugs became available to the
developed world and produced an ever increasing number of ADRs. The
undeveloped world languished with few active herbs, but were saved from many of
the ADRs of the drugs of the Western world. However, once the new active curative
drugs became available many of them were not affordable in the undeveloped
countries and they still cannot be easily afforded in many countries.
I have not found any regulatory sources that explain why the authorities restricted
or withdrew the 50 drugs during this period. One wonders whether the regulatory
authorities shared their knowledge with each other. If we leap forward 45 years to
find out what the present state is in the UK regulatory authority then we have the UK
Parliament’s ‘Select Committee on Health. Fourth Report’ in 2005 and under
‘Conclusions’ on the regulatory system there are the following excerpts:
‘363. There is no public access to the data presented by the pharmaceutical
companies nor to the assessments undertaken by the MHRA
365. The MHRA does not routinely examine raw data submitted with the licence
application but is dependent on summaries provided by the applicant.’ Prior to
1960 there was very much less data to assess and, therefore, it is possible that
this did not apply then.
‘369. Overwhelming evidence is required by the regulator before drug warnings are
proposed or when drugs may be withdrawn, Only 19 drugs have been withdrawn
between 1993 and 2004. On the other hand, medicines can be licensed in the
absence of adequate data or investigation into possible adverse reactions and
with proof of only limited therapeutic value. We agree that it is in the public
interest to allow access to potentially life-saving therapy as quickly as possible,
but timely withdrawal or provision of strict guidance on medicines that are
dangerous if inappropriately prescribed is an equally life-saving pursuit. We
recommend that the MHRA is given the same authority to propose restrictions on
drug use as it has when approving drugs...’ It would seem likely that regulatory
authorities would vary their responses according to the pressures that they
perceived to be on them, e.g. a recent drug disaster might make them more likely