Humans as guinea pigs?
By Ajay Banerjee
Tribune News Service

CHANDIGARH / KASAULI, Nov 13 — Are humans, especially the downtrodden — in a country where reports of sale of vital organs of the body are common — likely to be used as guinea pigs? Is the country heading for a problem of sorts in the production of certain vital vaccines used on a day-to-day basis to immunise children against deadly diseases?

It sounds shocking, but in the foreseeable future these may be the harsh realities if the recommendations of the Union Environment Ministry seeking a ban or a drastic reduction on animal testing for vaccines and newer drugs are carried out in totality.

The usually passive community of researchers in the country are reacting sharply while pointing out the pitfalls of such a ban or reduction in testing on animals. Permissions for projects requiring testing on animals will have to be had from the Environment Ministry. Researchers contacted by The Tribune during the past two days opined: "Who is a babu sitting in the Environment Ministry to decide on a particular animal or on the number of animals needed for a test.?" A multi-disciplinary ethical committee of doctors could be the answer.

Apart from the long-term ramifications on the probable misuse of poor human beings, the proposed recommendations are going to effect the production of vital serums used to cure deadly diseases while quality control of several other vaccines will suffer tremendously, say sources in the scientific community.

The wheel has turned a full circle since 1881 when the legendary Louis Paster, a French scientist, invented the system of vaccination through testing on animals.

A reduction in animal testing and stricter controls will have a direct impact on the production of vital vaccines and serums that are produced in quantities of several million each at the Central Research Institute (CRI), Kasauli. The CRI is the only place in the country where vaccines for polio, rabbies, tetanus and serums for the dangerous Japanese B. Enciphalitis, snake bites etc are produced.

Each new lot of vaccines, when it is produced, needs to be tested on animals. And close to 50 per cent of the reliability in vaccines is established through testing carried out on specifically in-house bred animals like mice, rabbits, horses and guinea pigs. Specific vaccines and serums are tested and created through one of the species of animals. Some of the serums like the anti-rabbies and the one for the Japanese B. Enciphalitis cannot be produced without animals at all.

The recommendations of the Environment Ministry, which proposes stricter rules and lesser use of animals, are still being debated among scientific circles. On the other hand, the Indian Council of Medical Research (ICMR), headed by Prof N.K. Ganguly, convened a hurried meeting of researchers and suggested modifications that do not curb the use of animals where there is no other available alternative.

Though researchers at the PGI admit that some bad research in which animals were being misused was going on in the country and needs to be stopped, a blanket ban would be detrimental for human beings.

Sources in the CRI say this may be a retrograde step. It may even act as a foothold for the multi-national drug companies so that they can import the vaccines, thus leading to an almost 10-fold hike in the costs of basic vaccines.

Dr S. Majumdar of the Experimental Medicine Department, PGI, opines, "It is possible that humans may be used as guinea pigs by unscrupulous researchers to carry out risky experiments. Imagine, if blood and organs can be sold or taken out forcibly, then look at the probable risk of ignorant human beings used as guinea pigs".

Professor Ganguly, in Delhi, when contacted, said", If the modifications suggested by the ICMR are carried out by the Environment Ministry, then we should have no problem as far the new rules are concerned." He, however, refused to comment on the probable situation if the modifications are not accepted in totality by the Environment Ministry.

The ICMR, among its list of modifications, has suggested de--centralisation and formation of ethical committees in each institute where testing is carried out. It also wants proper housing for animals and a stop on needless and repetitive testing, Professor Ganguly observed.

He admitted that so far international norms of animal testing were not being carried out in India. The new rules would help prevent the misuse of animals by the cosmetics industry. He hoped that a new set rules with modifications suggested by the ICMR would be through within the coming five to six months.