Panos Institute, London: November 22, 1995
Rupa Chinai, a journalist with The Times of India

The experiments have been condemned as "unscientific and unethical" by the World Health Organization's chief of vaccine development, Jose Esparza.

The 10 HIV-positive Indian volunteers were injected with a strain of the Bovine Immunodeficiency Virus (BIV), a close relative of HIV that is known to cause an AIDS-like illness in cattle. Experts at WHO and the US National Institutes of Health say such an experiment may involve great risks to humans.

Dr Baihrab Bhattacharya, the US-based veterinary doctor who produced the vaccine in the basement of his house in New Jersey and conducted the Indian trial in 1994, says that he has also begun testing the vaccine in the US . He claims to have given it to 16 New Jersey residents last January.

The safety and effectiveness of the vaccine has not been scientifically established.

Only inert fragments of the virus or killed virus preparations are thought to be safe - and volunteers who have received even these vaccines are monitored very closely.

Dangers associated with the live BIV vaccine include the possibility that the living virus could mutate within the body and evolve into a new, deadlier form of HIV.

Impurities in the vaccine also may pose risks. Bhattacharya prepared the vaccine in laboratory cultures of dog cells, and the finished product might contain dog viruses or other contaminants. Some viruses, including HIV, are known to cross from one species to another, and though they may not cause disease in the species in which they originate, they may be deadly in the new host. If a person contracted an unknown dog virus from Bhattacharya's preparation, a new human disease might be created.

All the Bombay residents who received the vaccine - nine men and one woman - are young, educated, middle-class, conscious of their rights and desperate for a cure. They were infected with HIV through sexual contact. Their names are being withheld at their request.

Four commercial sex workers in Calcutta also received the vaccine, but there is no information about them.

Bhattacharya's experiment was financed by Pierre-Emanuel de Gaspe, a US citizen. They both say - as do several of the recipients - that the trial was coordinated by Dr I. S. Gilada of the non-government Indian Health Organisation. Gilada denies any role in the experiment.

The incident first came to light in August, after one of the 10 died and the rest became concerned about their health. The condition of two others was deteriorating and they were desperate for a booster shot of the BIV vaccine.

At that time, patients said they received the first vaccine dose on March 9 1994, followed on April 12 by a booster dose. But soon after, those involved in conducting the trial are reported to have fallen out over money and the experiment was abandoned. more ...

Vaccine trials are usually subject to rigorous controls and regulations established by health authorities in both the country where the vaccine is to be tested and the country where the vaccine is manufactured.

The Indian government says it was not informed that its citizens were receiving the live BIV vaccine. No official approval for the trial was given by any ethical committee within India or the US. The US Food and Drug Administration and the US National Institutes of Health claim no knowledge of Bhattacharya and his vaccine.

Bhattacharya maintains that he was following the Helsinki Declaration which permits use of experimental substances in terminally ill patients if there is a strong scientific basis for believing the treatment will help, if the patients are receiving the best possible care available and if the patients have given their informed consent.

But in this case most of the patients, though infected with HIV, were not ill. Apart from a physical examination, no baseline medical tests were conducted before the vaccine was administered. One of the patients discovered he had leukemia only after receiving the vaccine.

The vaccine has never been tested in animals, nor is there published scientific data suggesting that the vaccine is safe or that it might be effective.

Patients signed a consent form stating that their participation was voluntary. They stress, however, that they were not informed of any particular risks associated with live vaccines.

"We were told that the BIV vaccine would cure us of HIV/AIDS", said one of the trial subjects, adding that one patient reported that Gilada told him that he could get married after receiving the vaccine.

"We were the patients of Dr. Gilada, and we took part in this trial with full sincerity and trust in him. We knew that such a vaccine had not been tried on any other human being. We were told that the trial had the permission of the authorities. We did not know about the absence of clinical studies associated with live vaccines."

When the trial was abandoned, eight of the patients decided to stick together and monitor their results. They kept in touch with de Gaspe, who paid for them to have regular blood tests.

Over the past year, four such tests, known as CD4 cell counts, have been conducted at the Hinduja Hospital in Bombay. The CD4 cells, a sub-set of white blood cells (which boost the immune response against infections), decline in HIV-infected persons.

Experts say that in patients receiving products that are effective against HIV, the number of these cells in the blood ceases to decline or may increase.

The results of the tests, which were sent to de Gaspe in the US, showed that in all eight patients CD4 cell counts did not decline during the first eight months after the vaccine was administered. Thereafter, while the condition of five of the patients remained steady, the other three worsened.

One of the three died in August 1995 with full-blown AIDS. (When he received the vaccine he was the only member of the group in a late stage of HIV infection.) The second patient is terminally ill with leukemia but otherwise displays no symptoms of AIDS. The third has registered a decline in CD4 count, but otherwise remains well.

Experts who have studied the patient records express surprise at the general good health of the other five, whose CD4 counts have remained constant. They all have recorded CD4 levels averaging between 700 and 1700. A normally healthy person in Bombay records CD4 levels of 800-1200, they said.

But the patients feel they have been treated "worse than guinea pigs".

"We have been badly let down by all those who were associated with the vaccine trial," said one. "All that we now ask for is that the vaccine be scientifically tested."

Bhattacharya says two of the 16 volunteers in the US have died, one contracted lockjaw and another committed suicide.

Bhattacharya has never submitted an application to the Food and Drug Administration for permission to administer the vaccine in human subjects; he claims to have received permission to test the vaccine from the New Jersey Attorney General's Office. Contacted by Panos, a spokesman from the AIDS division of the New Jersey Department of Health denied all knowledge of the trials.

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