Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 20 Sep 1995
A World Health Organization official at an Asia-Pacific AIDS conference in Thailand on Wednesday condemned the reported tests, saying the vaccine had not even been used on animals.
"Had this happened in the United States, the persons responsible for such misconduct would have been put in jail," said Jose Esparza of WHO. "Instead of doing any good, it might actually harm the patients. We do not really know."
Lalit Kant, director of the Indian Council For Medical Research, the country's top medical research institution, also criticized the reported tests.
"We are not aware if this vaccine has been cleared for human trials anywhere in the world. This trial was illegal and unethical," he said in New Delhi, where the council is based.
Federal officials established a fact-finding commission last week to investigate the reported tests, said P. Dasgupta, who authorizes the clinical trials of experimental drugs and controls their importation into India. "We haven't given any approval for such a trial," he said in Bombay.
Nine men and one woman were given doses of the bovine immuno-deficiency virus vaccine in trials in Bombay in March and April 1994, said one of the men involved, a 30-year-old executive who spoke on condition of anonymity.
One of the men died last month, the executive said.
In Calcutta, in eastern India, four prostitutes were administered the vaccine around the same time, the Telegraph newspaper reported.
It is not clear if the people were suffering from AIDS or HIV, the virus that causes the disease.
"The participants in Bombay were paid 1,000 rupees ($31) each for expenses," the executive said.
All of them signed consent letters absolving the trial's organizers of blame in case of harm, he said.
Bhairab Bhattacharya, chairman of the Bhattacharya Foundation in the United States, is reported to have developed the vaccine.
He was unavailable for comment at his offices in New York and New Jersey, and he did not return phone calls.
Pierre-Emanuel de Gaspe, a financier who helped fund the project, said the vaccine trials in India ended abruptly last year after he withdrew from the project.
De Gaspe accused Bhattacharya of deceiving him and the Indian health authorities.
In a telephone interview from his office in Fort Lauderdale, Fla., De Gaspe said Bhattacharya had claimed he was doing the vaccine tests with the Indian Health Organization, which he identified as a government body, even though it is private.
De Gaspe said that when he traveled to India and discovered Bhattacharya had done the trials on his own initiative, "I was so disappointed by this that I canceled the balance of the scheduled program and returned to the U.S.A."
Indian health officials said little is known about the safety or efficacy of the BIV vaccine.
With an estimated 1 million or more HIV-infected people, India has Asia's worst AIDS epidemic, officials said at this week's Asia-Pacific AIDS conference in Chaing Mai, Thailand.
Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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