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Introduction - Uppsala Monitoring Centre

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The bill was strongly opposed by the BMA due to inadequate money<br />

for the doctors.<br />

The UK Select Committee Report on Patent Medicines<br />

recommended the creation of a Medicines Commission, that all<br />

medicines should be registered for an annual fee and that the<br />

qualifications for being on the register should be that of quality, safety<br />

and efficacy. These were not enacted because of the outbreak of the<br />

First World War (Select Committee on Patent Medicines, London:<br />

HMSO [Her Majesty’s Stationary Office]).<br />

1913 The Medical Research Council (MRC) was set-up with funding by<br />

the government under the 1911 National Insurance Act.<br />

1915 ‘The Committee (MRC) venture to urge that members of the medical<br />

profession would be performing a service of national importance, in<br />

the present emergency, by keeping accurate records of cases in<br />

which the new preparations are used, and by placing such records at<br />

the disposal of the committee for their private information and<br />

guidance. Particular stress must be laid upon the desirability of<br />

recording in every case, the name of the preparation used and the<br />

serial number applied by the manufacturer to the particular batch<br />

employed together with such details as to dosage, the precautions<br />

taken to ensure purity of the water used and finally the results of the<br />

administration, both as regards therapeutic efficacy and the presence<br />

or absence of special incidental symptoms.’ (BMJ Editorial, 1915).<br />

The first public request for spontaneous reporting of ‘incidental<br />

symptoms’.<br />

First experimental evidence of cancer by chemicals reported when<br />

repeated applications of coal tar to the ears of rabbits resulted in skin<br />

cancer (Yamagiwa & Ichikawa, 1915).<br />

Otto Seifert wrote ‘Die Nebenwirkungen der modernen arzneimittel<br />

[The side effects of modern drugs]. There are eighteen chapters in<br />

278 pages and the book covers all groups of drugs. Each drug has a<br />

section on its use followed by a list of its side-effects, which are well<br />

referenced. Of the drugs dealt with in part 3 of this book he mentions:<br />

antipyrine, Aspirin, Phenacetin, amidopyrine, phenobarbitone,<br />

phenolphthalein, cincophen, piperazine, bismuth subgallate and<br />

phenformin (Seifert, 1915).<br />

In a standard UK medical textbook, ‘Wheeler’s Handbook of<br />

Medicine’, there is no mention of ‘adverse reactions’ or ‘side effects’.<br />

Common mild adverse effects are rarely mentioned; the only ones

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