Dangerous Drugs : Industry-Induced Amnesia?

In reply to a question in the Rajya Sabha, the department of drugs and pharmaceuticals has acknowledged that several products which have been on the banned list of the WHO have been allowed to be manufactured and sold in India following consultation with medical experts. Among the drugs included in this list are analgin, amidopyrine, oxyphenbutazone/phenylbutazone and hydroxyquinoline, all controversial products which were the subject of learned exchanges between the pharmaceutical industry and consumer groups the world over 20 years ago. The government's admission has serious implications, given the rapid changes occurring in the structure of the pharmaceutical industry and the evidence of lack of official interest in protecting drug consumer interests and in bringing about any rationality in the market range of products.

It may be recalled that hydroxyquinolines used extensively in diarrhoea had been recommended for a ban by the WHO on several counts. The product has been clearly shown to be associated with a number of neurological problems such as paralysis, loss of bladder control and, most importantly, sub-acute myelo-optic neuropathy or SMON which in the 1970s made headlines because it affected thousands of consumers of clioquinol in Japan. Olle Hanson, a Swedish neurologist who is widely acknowledged as the man who initiated the drug consumer movement across the world, investigated the drug and accumulated incontestable evidence of the association of clioquinol and SMON. It was only after the cases in Japan came to light that investigations revealed that the drug companies had not bothered to look into the serious side-effects that they should have known were produced by consumption of the drug. Because the drug was marketed as a sort of miracle 'cure' for diarrhoea, people often consumed it in large quantities without medical supervision. Through Hanson's efforts more than 11,000 Japanese affected with SMON sued Ciba Geigy and two other Japanese manufacturers of the drug in 1971 and the Tokyo High Court ruled that SMON was indeed caused by clioquinol. Even after this the company continued to argue that the incidence of SMON was only among Japanese which they alleged was due to ethnic and environmental factors peculiar to Japan. Parke Davis, another manufacturer of the drug, voluntarily withdrew it, but Ciba Geigy merely shifted its marketing focus to the developing countries, including India. By this time several countries, including the US and Canada and several European and Latin American countries, had banned the drug. Ciba Geigy mounted a no-holds-barred campaign to get the drug reintroduced, against the WHO's recommendation that it be banned. Enormous amounts were spent in initiating 'investigative' studies, most of which would not stand independent scientific scrutiny, to show that SMON did not occur in India. Drug consumer groups, however, pointed out that since there were no adverse reaction monitoring mechanisms in India, the incidence of SMON could easily be missed, that clioquinol products, although prescription drugs, were readily available across the counter and were consumed extensively without medical supervision, that the health system here was not such that it would be able to capture any of the side-effects of a potentially harmful drug and, most importantly, that there were several other ways to treat diarrhoea. In any case, it was pointed out that diarrhoea was better managed with no-drug treatment regimens such as oral rehydration. Following this, in 1982 the government of India issued a ban notification. However within the year, the gazette notification was modified without any explanation; hydroxyquinoline combinations were banned for all indications, "except for diarrhoea". This made a mockery of the ban, for all hydroxyquinolines were in fact for diarrhoea.