InterPress News Service (IPS); Thursday, 31 October 1996.
Meena Menon

The first dose, administered at a charity clinic in Mumbai (previously Bombay) in March 1994, was followed a month later by a booster dose. But before the third round, the vaccine trial was abruptly abandoned. The doctors involved did not bother to explain why to their patients.

Today one of them is dead, another is dying of blood cancer, while two of the other eight could not be traced by a group of activists campaigning to defend the rights of Indians dying of AIDS, a fatal disease caused by HIV..

ABVA, the AIDS anti-discrimination group, recently released a citizen's report on the "secret" clinical trials after a thorough investigation revealed Indian medical authorities were not aware of the experiment in Mumbai.

The human testing of the "bovine immunodeficiency vaccine" was conducted by a U.S-based doctor of Indian origin with the assistance of a controversial Indian doctor who works among sex-workers in Mumbai.

It may never have become public, but for an intrepid female reporter of 'The Times of India' newspaper who wrote on the controversial trials in September 1995.

The public outcry that followed encouraged one of the victims, whose identity has been protected by the court, to file a case in the Bombay High Court against U.S-based Dr Bhairab C. Bhattacharya and Dr I.S. Gilada of the Indian Health Organisation, which is registered as an independent trust.

In an interim order in July this year, the court ordered Gilada to procure the vaccine and administer the third dose, as demanded by the plaintiff, who requested the trial begun in 1994 should be completed.

The ABVA, meanwhile, is publicising its findings and demanding a time-bound judicial inquiry into the "bovine immunodeficiency vaccine" trials in India at the clinic run by Gilada.

Not only were the trials in complete violation of the Helsinki declaration and international ethical guidelines for biomedical research involving human subjects. But Indian Parliament was told that the experiment was not approved by the Drugs Controller of India, the only authority that can sanction clinical trials.

In its report titled 'Needle of Suspicion', ABVA states the BIV vaccine was developed by Bhattacharya, a veterinarian who works with the American Foundation for the Eradication of AIDS, Princeton. He claimed it could rid the body of the HIV virus.

The vaccine called Manisyl is manufactured by Sylka, a Florida-based company. But it is not sold in the United States as it has not been approved by the federal drug authority, whose process of validation often takes years.

ABVA says the vaccine was put to test in India without its safety on humans being established. Those who were roped into the experiment included professionals and commercial sex workers.

The clinical trial was financed by Sylka, with whom Bhattacharya had been associated as chairperson of a foundation it established for AIDS research in New Jersey. The foundation though shut down in December 1994 when funds were withdrawn by the company's owner Pierre-Emmanuel de Gaspa.

All the patients interviewed by ABVA maintain they had no idea that they were participating in an illegal scientific experiment. In fact, they believed that the vaccine would cure them.

The report quotes one patient saying: "Dr I.S. Gilada counselled us 15 days before the vaccine arrived in India. No preliminary tests were carried out to judge who was suitable and who was not. Later Dr Gilada developed cold feet when one of the patients died. We did not know we would be abandoned half-way."

The clinical trial was called off in 1994. In an affidavit, Dr Gilada has denied involvement in the testing of the vaccine -- though no case has been filed against him.

In a related development, the Bombay High Court has directed the Indian Food and Drugs Administration Commissioner to take "appropriate action" if there is a violation of rules by Gilada's trust.

The controversy has raised bigger questions about the ethics of clinical tests. ABVA activists think the state should be held responsible for having failed to protect the rights of ordinary people.

As one of the victims says, "It is a criminal breach of trust. We have been neglected purposefully. ... Besides the country's sovereignty is being challenged if vaccines can be brought in and out without anyone's knowledge."

Lawyer Nimish Pandya, who is fighting the case on behalf of the petitioner in the Bombay High Court, stresses that the issue goes beyond justice for his client.

"How can someone conduct trials with impunity. Obviously there needs to be some rules in place for HIV positive people. Someone has to be made accountable otherwise there will be a free for all," he says before asking: "Can someone from India go and conduct trials of a vaccine in the U.S." (End/IPS/mm/an/96)

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