EDITORIAL : THE HINDU, INDIA

For a politics of consensus

A bare legislative majority based on an expedient coalition of parties can hardly be the basis for a new government undertaking any radical restructuring of a State's political economy. In the 2011 Assembly election, Kerala voters clearly wanted an improvement in the creation of infrastructure and in the delivery of services — but not a complete change of course after five years under the government of the Left Democratic Front headed by the Communist Party of India(Marxist). The Congress-led United Democratic Front needs to try and build on the achievements of the outgoing V.S. Achuthanandan government, bridging the shortfalls in social welfare measures and hastening the completion of development projects. The UDF owed its narrow 72-68 victory in the 140-seat Assembly to the strong showing of the Muslim League, which won 20 seats, and the Kerala Congress (M), a party seeking to represent Christians, which took nine seats. The consolidation of Muslim and Christian votes, and the consequent pressures these two sectional parties could bring to bear on the Congress, are likely to pose difficulties in governance for the UDF. Like the CPI(M) in Kerala, the State Congress is faction-ridden. This UDF dispensation will, of necessity, be a balancing act, accommodating the demands of competing sections and, to an extent, conflicting interests. The danger is that in such circumstances political survival can become an end in itself.

The long-term challenge in Kerala — way and ahead India's socially most advanced State, the one State where programmes of mass employment can draw on the talents of an educated and skilled workforce — is to develop the material forces of production. This means diversifying and bringing value addition to agriculture, discovering new sources for knowledge-based, high-tech, and sustainable industrialisation, and creating suitable employment opportunities. In the social sector, the immediate need is to restore the State's famous universal Public Distribution System — which succeeded in raising the nutritional status of a whole generation but has been unfortunately replaced by a targeted system — and to find the resources to finance this re-universalisation. Building a system of universal health care will be another challenge. The UDF would do well to be modest in victory, and reach out to an opposition that is strong, active, and in good spirit as a result of the remarkable late surge created by Chief Minister Achuthanandan's anti-corruption campaign. In keeping with the character of its mandate, the UDF government must strive for a political consensus on how to move Kerala on to a higher growth trajectory while retaining and strengthening its advanced social sector.

A shockingly unethical trial

The question whether all human clinical trials undertaken in India are conducted ethically has been answered. The final report of the three-member committee appointed by the central government to go into the alleged irregularities in the conduct of the human papilloma virus (HPV) vaccine trial reveals gross ethical violations. The trial, suspended since March 2010, was carried out by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the Andhra Pradesh and Gujarat governments and the Indian Council of Medical Research. It was conducted on nearly 23,500 girls in the 10-14 years age group in Khammam district (Andhra Pradesh) and Vadodra (Gujarat). The “casual approach,” which saw the informed consent forms, the most sacrosanct trial documents, being filled “very carelessly” with “incomplete and probably inaccurate” information is shocking. In Andhra Pradesh, nearly 2,800 consent forms were signed by a hostel warden or headmaster, as the ‘guardian'. The justification: the parents were not easily reachable! That being the case, and since it was a research study and not an emergency, should such children have been enrolled at all? What ethical justification can there be for the warden or headmaster acting as a “legally acceptable representative” to meet the requirements of the 1945 Schedule Y of Drugs and Cosmetics Rules? Since students have “reduced autonomy,” the fact that teachers played a “primary role” in explaining and “obtaining consent” meant that the consent was obtained under duress, in a legally untenable way.

The trial came under scrutiny following a public outcry over the death of seven children. Although the cause of the deaths was found to be unrelated to vaccination, the incident revealed a total failure of the mechanism to monitor the ‘volunteers' for both serious and non-serious adverse events following vaccination. There was a five-month delay in reporting a death, while two deaths in Khammam district went unreported. Ironically, while measuring and reporting the adverse events after vaccination were the “primary end points of the study,” the Principal and Co-Principal investigators failed to report all such events to the sponsor within a day, as required under the Drugs and Cosmetics Rules. That widespread transgressions of prescribed procedures and norms have been detected in conducting the trial, despite the apex medical body being a part of it, and that the investigating committee has done little by way of fixing responsibility, sends out a highly damaging message.