BBC News | HEALTH | Row over medical tests on humans

Current guidelines on medical experimentation on humans could be relaxed in a move that has come under attack from opponents.

The World Medical Association (WMA) began talks on Thursday that could result in individual countries amending standards governing how medical trials are conducted.

Critics say relaxing the guidelines could "open the door" for unethical research in developing countries, some of which have no policies on the subject and may not fully understand the implications of the testing.

"We should have some kind of 'gold standard' with formalised guidelines on this," said Mandeep Dhalliwall, a medical-legal consultant working on the issue.

The WMA meeting will look at a new draft of the Declaration of Helsinki.

The declaration, drawn up in the 1950s in response to medical experimentation by the Nazis on humans in World War II, is a set of guidelines on ethical practice for medical research involving human subjects.

Aids drugs

A number of ongoing testing for Aids drugs and vaccines on human subjects have generated debate on the issue. Many of these trials are taking place in developing countries.

Needle
Testing continues on humans for Aids vaccines
Critics say that participants in some of the trials have been denied on essential treatment.

The US medical consumer group, Public Citizen, has strongly condemned the trials. In 1997, it alleged that as a result of some experiments, funded by the US Government, 1,000 children had died unnecessarily from Aids.

It recently said some research had not even come up with new findings, citing a study in Thailand on the Aids drug AZT for pregnant women.

The New England Journal of Medicine also recently published an article questioning some of the ongoing trials.

However, advocates of the trials say they are essential for advances to be made that could benefit huge numbers of people.

The Treatment Action Group said the AZT trial would help stop infection among the 500,000 infants born with HIV each year.

About 12 vaccines to provide immunity against HIV, the virus that causes Aids, are currently in the final phase of tests.

Aids is now the leading killer in Africa and, according to the UN, is responsible for over 11 million deaths worldwide to date.

'Explosive' research

The WMA meeting comes after other bodies formulated new guidelines on the sensitive issue of testing on humans.

Babies
About 500,000 babies are born with HIV every year
In February, the UN body in charge of combating Aids, Unaids, issued its guidelines on research on humans for Aids vaccines.

Unaids vaccine expert Jose Esparza said argument on the issue was to be expected.

"Research on human subjects is always controversial and when you mix that with Aids, it's very explosive," he said.

"We have to be very very careful. We have to empower the local community to make decisions."

He said Unaids guidelines recommended that the trials be monitored to ensure that they are carried out ethically.

He said the volunteers in the current Aids vaccines trials were from very "vulnerable" groups.

In the US, 5,000 gay men are being tested, while in Bangkok, drug users are undergoing tests.

Mr Esparza said the current debate had moved to the standards of care that participants in the trials have received.

Participants from developing countries have been given local standards of health-care, rather than the advanced care given to participants in the US.


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