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LATEST NEWS UPDATES | Malnourished tribal kids used as guinea pigs in MP

Malnourished tribal kids used as guinea pigs in MP

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published Published on Jan 2, 2012   modified Modified on Jan 2, 2012

-Daily Bhaskar

 

The malnourished children in tribal areas of Madhya Pradesh were subjected to drug trials by doctors at their clinics in defiance of set norms.

Documents accessed by DNA reveal that 20 malnourished children who suffered tuberculosis were tested for Bonnisan – an ayurvedic drug manufactured by Indian pharmaceutical company – at Nainpur in Mandla district. All the patients were in infancy or early childhood. Their age ranged from 8 months to 2½ years. The average age of children came to around 19 months.

The trial was to assess whether Bonnisan could be helpful to children with tuberculosis and malnutrition. “Although the number of cases studied was small, because of severity of malnutrition and poor general condition in them, the results were really encouraging,” report the doctors who investigated the medicine. The study report do not mention about legal permission for the trials.

All of them were treated with standard anti-tubercular drugs. Half of the cases were given Bonnisan in addition to the anti-tuberculosis treatment. The selection of patients for Bonnisan was at random. All the patients were followed up without any bias. All patients were from a similar socio-economic group, report says.

The patients were followed up clinically for six months. Weight was recorded, detailed history was taken and complete physical examination was done. Particular attention was given to the appetite and general well-being of the child. The matter was thoroughly discussed with the mother, to get a complete idea. The attitude of the child towards surroundings was observed in detail, because physical growth as well as mental and social development is equally important in the growing children.

The investigator reports — Clinical follow up showed the remarkable effect of Bonnisan in these cases of tuberculosis with malnutrition as follows: Weight-gain was significantly better in patients on Bonnisan and anti-tubercular therapy. These patients started gaining weight right from the first month and continued the progress throughout.

“The sense of well-being was remarkably better in the patients with Bonnisan right from the beginning. The smiling, healthy, look of these infants and children was a pleasant surprise in a short period. This was really unforgettable” reports the investigator adding “As compared to this, those patients on anti-tubercular drugs alone did not show satisfactory weight-gain”.

The investigator concluded his study suggesting, “It would be worth while to include Bonnisan as a very effective supplement in malnourished children with tuberculosis to achieve weight gain, increase in appetite and general sense of well-being. No side-effects of the drug were reported.

More than 100 babies of the same age were tested for the same drug in other areas of the state, their locations and other mandatory details were not disclosed. The company could not be contacted for their version.

“It shows that the necessary drug was not administered to some of the ailing children only to compare their status with children who were tested with Bonnisan,” said Dr Anand Rai, whistle-blower on illegal drug trials.

There is no law to check illegal drug trials conducted by doctors at their clinics in rural area. The poor tribals are being excploited, he said.

Every clinical trial needs to be cleared by the locally-constituted ethics committee before it is approved by the Central Drugs Standards Control Organisation. The trial should be registered with the Clinical Trials Registry of India, managed by the Indian Council of Medical Research. Clinical trials are not illegal, but most of the organisations, including reputed hospitals, take advantage of the poverty in rural areas and recruit economically disadvantaged people, said a doctor wishing anonymity.

Every year, human testers get sick or die during these drug trials, but no one knows how many because nobody tracks that number, he explained.

“The ethics of clinical research has become grim,” Dr Anand said. “I am actually frightened about it,” he said.

Daily Bhaskar, 2 January, 2012, http://daily.bhaskar.com/article/MP-BHO-malnourished-tribal-kids-used-as-guinea-pigs-in-mp-2702471.html


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