AIDS Trial: A Syringe Vacillates

When Bill Gates comes calling later this month, he'll be kickstarting an awareness campaign that will be the prelude to the development and testing of an AIDS vaccine in India. Here's the good news: if all goes well, a vaccine that provides immunity from the HIV virus can be accessed from any public health centre in the country in seven years. But even as the Indian chapter of the International AIDS Vaccine Initiative (IAVI) gears up for the clinical trial of the vaccine, scheduled for next year, the contentious issue of testing it on humans has surfaced. Various agencies have expressed concern that sufficient safeguards and compensation packages have not been worked out for those on whom the new vaccine is to be tested.

The preventive vaccine under development is a modified smallpox virus in which genetic material cloned from the HIV-c subtype is introduced. The virus, in this new form, will stimulate the production of HIV-killer cells in the body. The high-profile initiative is funded by the Bill and Melinda Gates Foundation, Rockefeller Foundation, the World Bank, the US and several other European nations. An agreement with the Indian government has been reached for the development of an India-specific AIDS vaccine.

Among the most common concerns being expressed by health activists is the fallout if the vaccine fails to live up to expectations. To test its efficacy, volunteers would necessarily have to be sexually active, promiscuous and be indulging in "risky" behaviour—which they might let themselves in for, feeling secure against the virus. Argues Amit Sengupta of the Delhi Science Forum and a member of the Jan Swasthya Abhiyaan, a network of over 1,000 health NGOs: "Should somebody contract the disease despite being injected with the vaccine, who'll bear the cost of anti-retroviral drugs? What compensation will be given if the person dies? Also, what happens if the volunteer infects others?"

Anjali Nayyar, India country director of the IAVI, agrees these issues must be addressed urgently. Realising the sensitivity of the issue, a 36-member advisory group including representatives from the government, UN agencies and NGOs have begun to look at all aspects of clinical trials, inlcuding ethics and the risks involved. "We have to find a solution. But remember, there is a thin dividing line between inducement and compensation," says Nayyar.

The trials will be conducted in three phases. The first two phases are expected to be completed in about three years, and the last stage will stretch to four years. In the first phase, about 25 low-risk adults are to be vaccinated. Subsequently, high-risk groups like intravenous drug users, commercial sex workers (CSW) and men who have sex with men (MSM), between 50 and 500 in all, will be administered the vaccine. In the final phase, which will determine the vaccine's efficacy, it'll be tested on a sample size going up to 10,000 volunteers. Explains Jean-Louis Excler, IAVI's medical affairs director: "The first phase will basically confirm that the vaccine is accepted by the human body and clarify the kind of immune response it generates. In the subsequent phases, besides efficacy of the vaccine in successfully avoiding infection, the best mode of administration will be determined. For example, questions like should it be injected in intra-muscular, intra-dermal modes and whether it can be administered orally in the form of a pill will be addressed."

However, health activists emphasise the need for caution, citing India's poor record in clinical trials, particularly in reproductive health. One oft-cited example is the shoddy manner in which the clinical trial of Norplant—an injectable contraceptive for women—was conducted. Says Ravi Duggal of Cehat, a Mumbai-based NGO: "Till date, the ICMR has not made public how these trials were held." Incidentally, when women's organisations took the issue to the Supreme Court, Norplant was banned from use in family planning.

The assurance that there would be informed consent from the volunteers is another area of debate. Says Purushothaman Mulloli, convenor of jack-India, an AIDS NGO: "In countries with low literacy like India, people are often under the impression that all medicines administered will benefit them. Further, the awareness about AIDS itself is very low and detection very poor."

However, IAVI officials reiterate that the entire process will be transparent. Says Nayyar: "All the volunteers will be given adequate counselling to help them understand that the vaccination does not guarantee protection and that they must take all other necessary precautions." Interestingly, those who see the vaccine as a definite step toward tackling AIDS point out that the NGOs seeing red is understandable. The success of the vaccine could render almost all of them redundant.

This is not to say that those questioning the trials don't have a point. Lawyers Collective, a Mumbai-based rights group, raises some key issues in its critique. To quote: "When testing the HIV/AIDS vaccine (in Phases 2 and 3 of trial) the first aim of the researcher would be to identify persons at a high risk of getting infected. This would be the most efficient manner by which the efficacy of the vaccine could be tested. Once subjects are identified, a researcher would then prefer that the subject continues to indulge in high-risk behaviour after being given the potential vaccine in order to conclusively demonstrate its efficacy." So the implied subtext is that counselling and asking volunteers to practice safe sex would be a farce since it would be counter-productive to the vaccine's testing. Says a lawyer: "Asking them to practice safe sex is like cigarette companies advising about the hazards of smoking."

Activists are also concerned that in all likelihood it will be the underprivileged who will end up as volunteers. Says Duggal: "Trials in India are often surreptitiously done in out-patient departments of hospitals or health centres. It is mostly the poor who are used for trials. In the US, it was mainly Black prisoners, poor Hispanics and Asian migrants who were earlier used for clinical trials. Now due to stringent laws, the trials have shifted to Third World countries."

Organisations working with high-risk groups such as MSM point out that there are various anomalies that need to be sorted out. Aditya Bondyopadhyay, legal advisor to Naz International, wonders what the government can do if a homosexual participating in the trial contracts HIV and then gives it to his partner. Asks Bondyopadhyay: "What would be the status of the partner when it comes to seeking compensation in terms of money, treatment or anti-retroviral drug therapy? Remember, practicing homosexuality is a crime under Indian law."

Meanwhile, IAVI is looking for some public figures and celebrities to come forward as volunteers. When IAVI launched its initiative in May this year, many MPs—cutting across political parties—expressed their support. So did many socialites. But IAVI officials are still waiting for a public face as volunteer. "Don't be surprised if all vocal political and social celebrities vanish when the trials begin," says Mulloli