On HIV vaccine trial in India

[Guest guest]

Petri dish India

Anjali Gopalan

November 26

When I first heard that India was going to start a process for AIDS

vaccine trials, the news sent a shiver down my spine.

I was concerned on two fronts. One was the rather disturbing history

of trials with humans in our country, and the second was the ethical

dilemma one is faced with when one has to deal with an issue that is

so sensitive and open to misconduct, manipulation and coercion. All

this made me unsure and I found myself asking the question: " Do I

really want to get involved in this process? "

The answer to that vexing question came to me as I looked at the

reality of the HIV/AIDS epidemic in India. It has been very clear to

me that to fight this epidemic we need a range of interventions among

which a preventive vaccine would be one. I, therefore, felt it

imperative that I make a commitment to ensure that whenever a vaccine

trial process takes place, I will do what it takes to ensure that the

rights of the people involved will be safeguarded and protected. This

meant having to understand the issues and concerns of those who would

eventually participate in these trials.

There are many concerns. Who will conduct the trials? Who will

participate in the trials? Will there be true access to information?

Will there be total accountability and transparency on the part of

both the government and the scientists? What about care and treatment

issues for those who sero-convert during the trial? How informed is

the informed consent for participation? Then there are issues of

reimbursement vs compensation — when does it become inducement to

participate? What about the stigma and discrimination associated with

participating in a trial for someone who wants to get a visa or find

a job? And if a vaccine is found, what about access and availability

of the vaccine?

I first heard about AIDS vaccine-related work starting in India in

2001. The International AIDS Vaccine Initiative (IAVI), a non-profit

scientific organisation, the Indian Council of Medical Research and

the National AIDS Control Organisation were coming together through a

memorandum of understanding to prepare to launch an AIDS vaccine

trial in high HIV prevalent states. As I began following the process,

I found it relieving that for the first time in India an effort was

being made to understand community concerns before conducting a trial.

As I quickly found out, this was no lip service. IAVI was willing to

set up processes that involved all stakeholders. A qualitative

research study was conducted to understand key concerns of the

community as regards participation in a trial. A National Advisory

Board comprising NGOs, the government, doctors, scientists,

ethicists, gender specialists and people living with HIV/AIDS was set

up in March 2002. The idea was to have a group of experts watching

the programme and advising it based on the interests of India and its

people. This group meets at regular intervals during the year.

Around the same time, dialogue and discussion with senior politicians

and bureaucrats was begun. The spirit behind this was to make the

discussion as broad-based as possible and also to recognise the fact

that something as sensitive as a vaccine trial could not be carried

through without political support. In May 2002, the Indian vaccine

initiative was shared at the International Policy-makers' Conference

on HIV/AIDS in New Delhi with parliamentarians from across the

country and abroad. At this juncture, the prime minister and the

leader of the opposition both reaffirmed their support for the

initiative, as did the chief ministers of the high HIV prevalent

states of Maharashtra, Andhra Pradesh and Karnataka.

Realising that the vaccine initiative could not move ahead without

creating total awareness and setting systems for the complete sharing

of information, orientation meetings with the media, scientists and

NGOs were conducted to share various issues and complex details of

what is entailed in the trials. Starting October of the same year,

state-level meetings in the above mentioned states and Tamil Nadu,

Manipur and Nagaland (the latter through Assam) involving various

stakeholders were held to hear their voices and concerns.

Concerns did emerge. But so did a need for expert groups to address

each of these concerns. It was also clear that there might be the

need to formulate a national NGO coalition that could be like a

watchdog for any clinical trials that may be conducted in India.

Still in a nascent stage, it is hoped that this body will always take

the social responsibility to ensure that the rights of our people are

never violated.

One-on-one consultations had also shown that the programme would have

to address how it could incorporate gender specific concerns

regarding the involvement of both women and men in the

trial process. There is now an expert group that is watching out for

gender-related concerns in this process.

Meanwhile, elected representatives at the state level have been

engaged in an ongoing debate so that they have all the information

they may need to look into community-based concerns as and when

trials begin. This is being done through legislators' workshops in

the high prevalence states.

The Phase 1 trial will be conducted by the National AIDS Research

Institute (NARI) in 2004. The trial will be conducted on HIV

uninfected, healthy volunteers between 18 and 50 years at low risk

for HIV infection and will take 18 months to complete. This will be

followed by a Phase 2 and 3 trial. All of this could mean anywhere up

to a decade before we come close to finding a vaccine that works. It

is not around the corner. Which is why it is very important that

communities know and have all the available information every step of

the way. More importantly, we have to ensure that the process of

informed consent for participants in the trial has no loopholes.

Keeping this in mind, an expert committee on informed consent has

been formed.

The history of trials like the Tuskegee trials in the US or the

cancer drug trial in India in 2001 involving M4N and G4N bear

testimony to the fact that if we are not ever-vigilant, people can

suffer in ways that we cannot even begin to fathom. One of the ways

to address this has been the formation of community advisory boards

where they do not exist or the need to empower existing ones to act

as strong links between the scientific researcher and the community.

These boards are meant to represent the interests of the community.

NARI already has such a board in place.

We stand at crossroads today. The questions before us are many as are

the challenges. But our people have the right to access an array of

interventions that will protect them from a life-threatening, highly

stigmatised infection.

The writer is CEO, Naz Foundation (India) Trust

http://www.hindustantimes.com/news/181_473380,00120001.htm