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Thursday, May 20, 1999

Govt orders inquiry into proposal to test drugs on babies of HIV positive mothe

Express News Service  
MUMBAI, May 19: The state government has ordered a detailed inquiry into the controversial proposal to test anti-AIDS drugs on babies born to HIV infected women at JJ, Cama Albless and Sassoon hospitals.

Express Newsline on Tuesday had reported that JJ hospital's gynaecology department had mooted testing AZT and 3TC - approval for which is pending with the Drug Controller of India - on the babies in the Out Patient Department (OPD).

According to Thomas Benjamin, secretary of the state Medical Education and Drugs department, all the doctors who were to be part of the team were summoned on Tuesday. The inquiry will be conducted by the director of the Medical Education and Research department, said Benjamin.

The drug trial was proposed in collaboration with the John Hopkins University, USA, which was to also supply the drugs. The project report was submitted by Dr KE Bharucha, professor and head of the gynaecology department at JJ to the hospital's ethical committee for approval. The committeerejected the report, and members of the committee also claimed that Dr Bharucha had been trying to influence them to approve the report.

The committee had also objected to the misrepresentation of designations by doctors who are part of the trial as well as incorrect data on HIV incidence among newborn babies, which had been done to mislead the foreign collaborator, said sources. Dr Robert Bollinger of John Hopkins has reportedly given an undertaking that the information provided in the project report is correct, and that he is aware that he can be criminally prosecuted if any of the information is found to be false, sources said.

Benjamin told Express Newsline, ``We will certainly not allow any drugs that are not cleared by the DCI or the Indian Council for Medical Research (ICMR) to be tested on children.'' Benjamin also agreed that designations had been intentionally misrepresented in the project report, and assured of proper action.

Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.


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