Death of four persons and hospitalization of over 30 people reported in and around the Trichy district of Tamil Nadu in the last few days are suspected to be a result of Mass Drug Administration of the controversial anti-filarial drug Diethyl Carbamzine Citrate (DEC).
Following these reports, the state health department has decided to retrieve all the DEC tablets supplied in the Trichy area during the MDA programme this week. "Volunteers have been instructed to take back all the remaining medicines in the Trichy district," said top-level state health department sources.
The MDA programme covered three crore people in 13 districts of the state, including the Chennai corporation, on September 5. The health officials in Tamil Nadu aver the deaths, all people above 60 years of age, could be either due to the ignorance of the people on the dosage and the mode of consumption of the drug, or could be natural deaths.
According to P K Rajendran, additional director of public health and preventive medicine, the volunteers entrusted to distribute the medicines were strictly instructed not to administer the drug to people above 60 and those having diabetes, blood pressure and cardiac problems. Action would be taken against the volunteers if they had violated the instructions, said the official.
According to Dr. R Ravi, deputy director of the Vector Control Research Institute in Pondichery, about 200 districts all over the country were provided with the DEC tablets so far and such a large-scale reaction was not reported from anywhere so far.
Meanwhile, sources allege the authorities had neither adequately cautioned or educated the public on the dosage nor ensured medical supervision to administer the drug. The advertisements to publicize the programme had only stated pregnant woman and children below two years should not be given the tablet.
Instead of conducting the programme on a single day with the help of SHGs, voluntary associations and social welfare department officials, the programme should have been implemented in 3-4 days with the services of trained paramedical staff who could educate people on how, who and when to consume the tablets. Sources also point out that neither the local media nor the authorities or health professionals had cautioned the public on the possible ADRs related to the drug, note sources.
Sources also point out there were allegations that a seven-year-old girl and a boy had died in the Gulbarga district and another at Bidar district of Karnataka soon after the MDA programme in Karnataka on 10th of June. Considering this, the Tamil Nadu Government should have taken adequate precautions before administering the drug.
It may be noted that Pharmabiz had extensively reported on the controversy related to the adverse drug reactions (ADRs) of DEC, when the Kerala Government decided to implement the programme in June, and on Tamil Nadu Government's move to conduct the programme.
DEC is safe, no need for panic: experts
The anti-filarial drug Diethyl Carbamazine Citrate (DEC) used in the treatment of lymphatic filaria has been a proven safe drug for many years and the controversies surrounding the adverse drug reactions are totally baseless, according to experts.
Talking to pharmabiz, experts on the subject said the drug has been used in over 37 countries for many years, and the WHO would not have included DEC in the treatment of filaria if it had any major side effects. When the drug is administered to people, if the symptoms of nausea and fever appears, it could be perceived that the person could be infected with the disease causing microfilarial bacteria, that invades the human lymphatic system to cause disease. The disease will be manifested only after many years since the infection. The principal goal of treating affected communities is to eliminate the virus from the blood stream of infected individuals so that transmission of infection causing bacteria through the mosquito can be interrupted.
The sources said companies which conforms only to the standards prescribed by the WHO, manufacture the drugs. In India, DEC is directly procured by the Central Government, which has earmarked about Rs 400 million for lymphatic filaria eradication. The WHO and other agencies involved in the fight against the disease meet the funds for the awareness campaign and for executing the MDA programme. The plans are to administer the drug to all the people in the endemic areas once in a year for the next five years.
"DEC is an old molecule and it never kills people. WHO suggests that DEC should not be administered to aged people, pregnant and lactating mothers, people using steroids, people having blood pressure and diabetes etc. only as a precautionary measure. In my 40 years of experience, what I have come across is just fever and nausea with one or two persons. This disease is incurable, and it can be only prevented. For this, people in the whole community have to consume the drug to break the cyclic process of spreading the microfilaria bacteria through mosquitoes," elaborated prof. R K Shenoy of Aalappuzha Medical College and one among the leading researchers in the field in India.
Globally 1100 million people live in 80 endemic countries with an affected 120 million population, and with disability for 40 million. India is the worst affected country with 40 per cent of the disease. Except for three states, all other region in India is endemic to the disease, and 20 million people are affected with the disease. The disease is mostly seen among poor people with wide spread prevalence in places like Varanasi, Aalappuzha, many parts of Andhra, Orissa etc.
However, the experts differ whether the disease could be completely eradicated in a vast country like India through MDA programmes. So far, the results were successful only in about five six countries having small population. According to Dr. Shenoy, less than 45 per cent of the people were ready to use the tablet during the six year-long pilot project studies even in Aalappuzha, an almost cent percent literate area. The drug has to be given to the whole of the community for the desired results. In a country like India, it is necessary to have an improved awareness programmes better strategies and planning for implementing the MDA programme to get the desired results.
The MDA programme, an ongoing project for the next five years, is a part of the national project in association with the WHO to eliminate lymphatic filariasis by year 2015. In only four years, the WHO led global program to eliminate lymphatic filariasis (LF), has done MDA programmes in about 37 endemic tropical countries. About one billion people in 80 tropical countries are at risk from the disease, and 120 million people actually carry the infection, says WHO. Two of the drugs used in the programme are being donated by their manufacturers - albendazole by GlaxoSmithKline and Mectizan (ivermectin) by Merck & Co., Inc.