AEGiS-Bangkok Post: Top official defends AZT drug study Trials turned into issue against Clinton Bangkok PostImportant note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
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Top official defends AZT drug study Trials turned into issue against Clinton

Bangkok Post Feb 10, 1998
Aphaluck Bhatiasevi


The Public Health Ministry yesterday emphasised the importance of the controversial Aids drug study conducted in Thailand that is currently being used as a political issue in Washington.

Communicable Diseases Control Department director-general Vichai Chokeviwat said he hoped the results of the study would enable pregnant women to get access to AZT to reduce HIV transmission from pregnant women to their newborn infants.

"The results of the study would not only enable Thailand to set a standard treatment for HIV positive pregnant women, but would also benefit other developing countries of the world," said Dr Vichai.

AFP on Saturday reported that the Aids drug trials in Thailand and the Ivory Coast were being brought up as a political issue against President Bill Clinton's nomination of David Satcher, director of the US Centre for Diseases Control, as the next surgeon-general of the US.

Claiming that people under the trials were being used as guinea pigs, the report stated that conservative Republicans were hoping the US Senate would next week reject President Clinton's nominee.

The results of the study - "Phase three randomised placebo-controlled trial to evaluate the safety and efficacy of short course oral antenatal zidovudine to reduce prenatal HIV transmission, Bangkok, Thailand" involving 392 pregnant women is expected to be known in March.

The study had also been heavily criticised by US-based NGO the Public Citizen's Health Research Group for using placebo (dummy pills) despite of a known effective AZT treatment.

The Aids Clinical Trial Group (ACTG) 076 study, which showed that intake of 100 mg of AZT five times a day during the first 14-34 weeks of pregnancy, intravenously during labour and to the child for at least six weeks reduced HIV transmission from 25 to eight percent.

Critics say that the ACTG 076 regimen should be considered a standard treatment because it is being used in a number of countries including Brazil, Malaysia and Philippines, but Dr Vichai argued that it was too expensive and complicated to be used in a number of developing countries, including Thailand.

According to him, the compliance rate among the Thai people was very low. Taking the example of the treatment of tuberculosis which requires intake of drugs for a long time, Dr Vichai said the compliance rate among patients was only 50 percent.

In addition, he said most pregnant women in Thailand approached antenatal clinics during the late stage of pregnancy.

Dr Vichai said he understood the critics' concern over the Helsinki Declaration on trials in humans, which states that placebos should not be used in case of a known treatment, but in this case, the ACTG 076 should not be considered a standard treatment because it was not made available to all HIV positive pregnant women.

"We have to evaluate ourselves and see whether we can afford it. We shouldn't follow others just because they are using it," he said.
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