MUMBAI, May 17: The gynaecology department of the JJ Hospital has handed in a controversial proposal to test the effects of anti-AIDS drugs on babies born to HIV positive mothers. According to the proposal, sumbitted in January this year, a combination of AZT and 3TC drugs are to be administered to the infants when they turn a month old in the Out Patient Department (OPD) by their parents. The ethical committee of the hospital has rejected the report in a recent meeting, but the department may soon re-sumbit a fresh proposal.AZT and 3TC, which will be tried out for their efficacy in reducing the infection, are still pending approval with the Drug Controller of India. They are to be administered in three month doses by the parents, and will be tested for their impact when the babies turn 18 months old. The proposal has identified three hospitals for holding the trials: JJ and Cama and Albless in Mumbai and Sassoon Hospital in Pune. Babies born to HIV infected mothers have a 33 per cent chance of being HIVpositive; thus the trials will be conducted on all babies born to such mothers in these wards.The project was initiated a year ago by the gynaecology department of JJ and BJ Medical College, Pune in collaboration with the John Hopkins University, USA; the latter will also supply the drugs for the trial. The project's clinical director is Dr KE Bharucha, who is also the professor and head of the gynaecology department at JJ. The other doctors include Dr PM Bulakh, professor of biochemistry department, BJ Medical College, Dr PJ Dalal, professor of microbiology department, JJ, and Dr MA Phadke, professor of paedriatics department, BJ Medical College.Senior doctors at JJ have raised serious objections to the proposed trial, pointing out that not only is it highly unethical, but is also likely to jeopardise the lives of the infants. The effects of a combination of AZT and 3TC are not known even abroad, pointed out a member of the ethical committee. A similiar project, the `Petra Study' in the US, hadrecently conducted trails on newborn infants, but its interim report is yet to be published, added sources.A doctor working with AIDS patients also pointed out that it is highly risky to conduct such trials in the OPD. If infants develop complications during the trial, panicky parents could rush them to pedeatricians who may be completely in the dark about the drugs or their effects, he pointed out. There is every possibility that the drugs may result in temporary or even permanent damage to the child, he added.Sources also claimed that the project is based on incorrect data that tends to give an inflated estimate of the incidence of HIV infection among infants. A study conducted by doctors at Cama and Albless in 1998 showed an incidence of 1.47 per cent of HIV among infants. This project, however, has taken the estimated incidence to be 4.25 per cent, which is a gross inflation, sources said.Confirming that the hospital's ethical committee had rejected the project in a meeting held last week, JJDean Dr AC Mohanty said he was never appraised of the details of the trial. A member of the ethical committee also revealed that a project report submitted misrepresents designations by doctors who are on the project. Dr Bharucha has been mentioned as the `chair' of the department at one place, and as `director' at another, although no such posts exist. Further, the report puts down Dr PJ Dalal as the dean of JJ Hospital since 1993, when in fact, she has only been the acting dean for a couple of days on the few ocassions when the dean was on leave, sources said.Dr Bharucha said she respected the decision of the ethical committee, but stressed that the report might be resubmitted afresh. But she refused to reveal details of either the costs or duration of the project, claiming that the matter was between the department and the state government.Dr Bharucha admitted that although results of tests being conducted in the area have not yet been published, the doctors on the project would like to see theresults of these drugs on HIV positive babies. The issue of misrepresentation of designations is being sorted out with hospital authorities, she added.Included in the children's rights as declared by the Geneva convention of the United Nations is the right to not be subjected to any research and experimentation. Even parents of a child can give consent only for accepted modes of treatment and not for trials where toxic drugs are being used.
