Introduction - Uppsala Monitoring Centre

and treatment. It deals with methyl salicylate, sodium salicylate and
Aspirin.
1955 ‘Reactions with Drug Therapy’ by Harry L. Alexander, WB Saunders
Company 1955. Despite its general title it only concerns type ‘B’
reactions, which reflects the authors position as editor of the ‘Journal
of Allergy’. The 301 pages give considerable details of animal studies
as well as human.
In the US there was a nation-wide campaign of poliomyelitis
vaccination using vaccine made by Cutter laboratories. In the next
two months 260 cases of poliomyelitis were reported in vaccinees
and their contacts. Two batches of the formaldehyde inactivated Salk
type Cutter vaccine were found to contain living virus (Wade, 1970).
The Council on Pharmacy and Chemistry of the American Medical
Association produced ‘New program of operation for evaluation of
drugs’. It said ‘ Pharmaceutical firms are encouraged to cooperate
with the Council by forwarding complete data or reports (published
and unpublished) of all laboratory and clinical investigations relating
to the safety and usefulness of new drugs in order that evaluation
reports may be made to the profession at the earliest possible date.’
All this data was made available to a number of recognised experts
whose views were given to the Council, who would then consider all
the evidence and then write a monograph, which would be published
in JAMA after the pharmaceutical company had offered any criticism
of the monograph to the Council (Stormont, 1955).
The FDA form (FD 356) for an NDA 170 3 contained the following
statement: ‘An application may be incomplete or may be refused
unless it includes full reports of adequate tests by all methods
reasonably applicable to show whether or not the drug is safe for use
as suggested in the proposed labelling…Reports of all clinical tests
by experts, qualified by scientific training and experience to evaluate
the safety of drugs, should be attached and ordinarily should include
detailed information pertaining to each individual treated, including
age, sex, conditions treated, dosage, frequency of administration,
duration of administration of the drug, results of clinical and
laboratory examinations made, and a full statement of any adverse
effects and therapeutic results observed’. The last clause was used
as a primary regulatory strategy to refuse marketing of drugs about
which medical officers had scepticism, including Thalidomide
170 NDA = New Drug Application (USA).