Risks and wrongs of AIDS vaccine trial

[Guest guest]

Risks and wrongs of AIDS vaccine

KALPANA JAIN

TIMES NEWS NETWORK [ WEDNESDAY, FEBRUARY 09, 2005 01:07:22 AM ]

NEW DELHI: If the volunteers for the preventive HIV/AIDS vaccine

start testing positive as a result of the antibodies produced by the

vaccine, will it affect their future lives? If any of them were to

get infected as a result of the known causes of infection, do they

get support and treatment all through their life?

And finally, volunteers need to be constantly told they should not

indulge in high risk behaviour by banking on the vaccine. Yet, the

paradox is that researchers would not know the vaccine's results

until some of the volunteers take behaviour risks and get infected.

As the first phase of human trials of the preventive AIDS vaccine

takes off in India, experts are discussing the moral and ethical

challenges around this promising medical step.

Some of these ethical challenges will present themselves only as the

trials progress and get into the second and third phase when

hundreds or thousands need to volunteer. The first phase of clinical

trials needs volunteers who are low-risk and healthy, to check for

any toxic effects of the vaccine, says head of microbiology

department at the All India Institute of Medical Sciences Pradeep

Seth.

Epidemiologist and expert on HIV/AIDS L M Nath points out that

volunteers who are not HIV infected may always test positive for

antibodies to the virus once the vaccine has been injected into

their bodies. This can create problems of discrimination in

insurance, travel, jobs and housing, he says.

While senior officials at the Indian Council of Medical Research

(ICMR) say that these concerns have been addressed and each

participant would be given a certificate, Nath dismisses this. ICMR

says a special test which can differentiate between vaccine induced

antibodies and HIV infection antibodies would be available to

volunteers at specialised centres in future.

However, Nath says, the responsibility of agencies has to be more

than that. First, the volunteers need to clearly understand that

they are taking a risk by participating in the trials. Second, a

certificate may or may not be recognised by all people or all

countries. And third, the authorities need to give volunteers

adequate guarantee that specialised tests would be available to them

free of cost for as long as they live.

Writing in the Indian Journal of Medical Ethics, deputy director of

the National AIDS Research Institute Sanjay Mehendale had pointed

out: " Social risks and harms to the participants should be monitored

as seriously as physical harms. " One of the peculiar paradox of HIV

will emerge as the trials move into the second and third phase. The

effectiveness of the vaccine will need to be determined at this

stage.

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