Bitter Pills:Medicines & The Third World Poor | Page 116

Ciba-Geigy did successfully register the new formulation of Spasmo-Cibalgin
without amidopyrine with the Philippines Food and Drugs Administration (FDA)
in November 1978. But preparations witfr amidopyrine continued to be imported
up to May 1978.<861 The old formulation of injectable Spasmo-Cibalgin was still
in stock in a wholesale distributor's warehouse and was being sold to retail
pharmacies in November 1980. A team from Dutch television which filmed these
stocks interviewed the Managing Director of Ciba-Geigy Philippines who said
that they had been told to deplete their existing stocks of the old formulation with
the agreement of the Philippines FDA and Ciba headquarters in Basle. In
November 1980 Dr. Arsenio Regala, the Philippines Food and Drugs
Administrator, said he knew nothing of this arrangement. The Dutch film
' 'Healthy Business'' was shown in Europe at the beginning of 1981. Subsequently
a 'to whom it may concern' letter dated 7 May 1981 arrived from the Philippines
FDA saying that permission to use up old stocks of amidopyrine had in fact been
granted, provided the manufacturers gave full information and warnings on the
product labels.(87)
In September 1980 we purchased foil strips of Cibalgin over the counter in
Bangalore in India. These contained amidopyrine and gave no dosage instructions
or warnings. The manufacturing date appeared on each strip showing that they
had been produced in Bombay in February 1980.
The delay in registering the new formulation of Cibalgin in India was apparently
partly due to reluctance from the Indian Government.(88) Whereas amidopyrine
was formulated locally, the new active ingredient, propyphenazone, would have
to be imported. The Swiss companies were not alone in continuing to market
amidopyrine. In 1981 there were reported to be 33 formulations on the Indian
market alone. (891 The Central Drug Authority issued instructions to
manufacturers in 1980 to withdraw amidopyrine "in a phased manner". But
according to an Indian newspaper report in 1981 the Government "did not specify
a deadline for the withdrawal and this seems to have been taken advantage of
by the manufacturers and druggists". (90)
There is also evidence that at least one of the major manufacturers continued
actively to promote sales of amidopyrine in a developing country two years after
the drug's withdrawal had been announced in Switzerland. In 1979 a salesman
for Ciba-Geigy was reported to be distributing free samples of Cibalgin in Maputo,
the capital of Mozambique, dismissing fears over possible toxic side-effects as
exaggerated. At that very time, a young British teacher was being rushed out of
the country for emergency treatment, one of the few recognised victims of druginduced illness in a Third World country. Carol Gates had been prescribed Cibalgin
- for a headache. Without advanced medical treatment she would have died.(9"
Dr. Burley of Ciba-Geigy informs us: "I have never defended the lack of
information in our literature about Cibalgin in Mozambique, and this matter was
settled between Carol Gates and ourselves. Because of the very great publicity that
surrounded the Carol Gates case, I think I was quite right to say that amidopyrine
drew far more attention than perhaps it warranted. Anyway the situation is now
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