CONCERN RISES OVER DRUG TRIALS ON POOR

Critics Fear Guidelines May Be Relaxed

Drug researchers are increasingly heading for the developing world to
carry out trials on people with little understanding of their rights,
some of whom are left without treatment for the disease under study,
critics allege.

They fear this practice will go on unchecked because, they suspect,
last week's meeting of the World Medical Association may lead to the
guidelines under which medical trials are meant to take place being
diluted.

The issue has become highly contentious in the United States, where
public health doctors are privately agonising over the impossibility
of reconciling President Clinton's call to help the millions dying of
Aids in Africa with the fact that babies in Uganda and elsewhere have
been left by researchers to contract HIV. These are the babies of
mothers in the section of a trial group that were not given drugs to
stop HIV transmission. Such trials would not have been allowed in the
US; in Western countries the different test groups in a trial must
each be given some form of treatment.

The ethical battle has split the medical and scientific community, and
last week's WMA meeting in France was an attempt to reach a compromise
by starting work on a new draft of the Declaration of Helsinki. This
contains the guidelines - drawn up between 1953 and 1964, in the light
of Nazi medical experimentation - on how doctors should treat patients
involved in clinical trials. Public Citizen, the US watchdog leading
the protests against the current test regime, says researchers are
exploiting woolly wording in the Helsinki document.

It says: "In any medical study, every patient - including those of a
control group, if any -- should be assured of the best proven
diagnostic and therapeutic method."

But in the developing world there is often nothing available to give
those in the control group.

A row about the ethics of trials in the developing world on pregnant
women with HIV, which broke out three years ago, led to the decision
to rewrite not only the declaration but also the more detailed Cioms
(Council for International Organisations of Medical Sciences)
guidelines, which effectively interpret it.

But Peter Lurie and Sidney Wolfe of Public Citizen believe that the
institutions are just moving the goalposts: "Rather than bringing
their behaviour in line with the guidelines, they have set about
changing the guidelines to conform to their behaviour," Dr Lurie said.
The controversy was stoked in March by a study in 10 Ugandan villages
to find out whether people who had sexually transmitted diseases such
as syphilis were more likely to contract HIV.

Five villages were supplied with antibiotics to cure any sexually
transmitted diseases, but those in the other five got no treatment
beyond being advised to go to a government clinic. The effects when it
came to HIV were compared.

The uproar broke out in 1997, when Dr Lurie and Dr Wolfe denounced as
unethical 15 US government-funded HIV studies in developing countries.
Researchers wanted to find out if giving low doses of the drug AZT to
pregnant women could reduce the chances of the baby being infected.

Half the women got the drug, the other half got nothing. In the US
they would have been given longer courses of AZT and caesarian
sections, and told to breastfeed - techniques known to reduce
transmission.

Hundreds of infants needlessly contracted HIV, Dr Lurie and Dr Wolfe
said.