Introduction - Uppsala Monitoring Centre

groups admitted patients on alternate days. The results in a 100
patients gave a death rate as 8% in the M&B 693 group compared
with 27% in the control group. Toxic effects: cyanosis appeared in
about a quarter of the patients. Frequent white cell counts were
made but no cases of agranulocytosis were found. The attention to
adverse effects of the drug was even sparser than in the
Sulphonamide study of 1937.
Federal Food, Drug and Cosmetics Act (USA) 1938. The DEG
epidemic occurred whilst the act was under consideration, so it
was not a case of cause and effect, but no doubt gave an added
stimulus. It required that firms had to prove to the FDA that any
new drug was safe before it could be marketed. It did not specify
what kinds of tests had to be performed, but that ‘the
investigations…which are submitted… do not include adequate
tests by all methods reasonably applicable to show whether or not
such drug is safe for use under the conditions prescribed,
recommended, or suggested in the proposed labelling thereof… he
shall … issue an order refusing to permit the application to become
effective.’ The phrase ‘new drug’ was defined as ‘a drug which is not
generally recognised, by experts qualified to evaluate the safety of
drugs as safe when used as directed by its labelling.’ There were
some exemptions to the act: vaccines, serums, toxins, antitoxins and
most blood products which are licensed under the Biologic Control
Law. Later five antibiotics were also exempted: penicillin,
streptomycin, aureomycin, chloramphenicol and bacitracin and their
derivatives (Smith, 1956).
Legislation tends to prevent the industry earning money and
therefore has been resisted. The changes in the law do not always
answer the situation and, in these cases, require amendments. The
1938 law was amended in 1951 with the Durham-Humphrey
Amendment because the 1938 law was vague as to what and who
was responsible for identifying prescription versus non-prescription
drugs - dictated which drugs needed prescription drug labelling. It
was on the basis of this act that Dr Frances Kelsey refused to
approve Thalidomide.
An FDA Commissioner, GP Larrick, said of the 1938 law:
1. ‘The producer of a new drug did not have to establish that his
drug would be effective, as well as safe, for its intended uses.’
(Without knowing the effectiveness of a drug no cost-benefit
judgement can be made).