Published on Thursday, May 4, 2000 in the Guardian (UK)
US Drug Tests On Third World Poor
Leave Some To Die
by Sarah Boseley
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, the World Medical Association talks opening today may end up diluting the guidelines under which medical trials are meant to take place.

The issue has become highly contentious in the US, 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.

In a recent study of HIV and sexually transmitted diseases in Uganda antibiotics were given to half the subjects and nothing to the others. In China, people were deliberately infected with malaria to see whether this reduced the level of HIV infection - another study that would not have been permitted in the US.

The ethical battle has split the medical and scientific community, and today's WMA meeting in France is trying 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 up 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.

Marcia Angell, editor in chief of the New England Journal of Medicine, wrote of her doubts about publishing the study's findings.

"It meant that for up to 30 months, several hundred people with HIV infection were observed but not treated," she wrote.

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.

The early stages of drafting new guidelines for the WMA, Cioms and Unaids - the World Health Organisation's Aids organisation - were directed by Robert Levine, a professor at Yale University School of Medicine, who takes the opposite view to the two men.

He says that research on what works best and most cheaply in developing countries cannot be done without comparing new drugs with what there is at the moment in such places - that is, no other treatments at all.

"My reaction and that of many other people is that it is all well and good to create something in Uganda that simulates London or New York [by giving various treatments to all the groups in a trial], but what you get out of that is data that is no good anywhere other than London or New York."

He argues that babies in the AZT trials, for example, would have had to be bottle-fed under the sort of regime they would have in the west. If those arguing for western testing practices in the third world wanted to be coherent and consistent, he said, "they would have to change the prenatal care programme in the country and clean up the water supply. Now you begin to see the absurdity of the position".

Delon Human, secretary general of the WMA, strongly hinted that the changes to the Declaration of Helsinki would be minimal.

"Without any doubt the message from the WMA is that we want as little as possible change to the document and that research participants should be protected and given as much treatment as possible," he said.

"For Cioms to do anything radically out of line with that would be unlikely."

Guardian Newspapers Limited 2000