Bangkok Post - July 28, 2001
Aphaluck Bhatiasevi

"Only research will answer the question, not political argument or statistical analysis," said Dr Esparza, adding that available data was not good enough to say "this is it" and not bad enough to say "just drop it."

Dr Esparza made the comment after hearing about the HIV-1 Immunogen vaccine marketed as Remune by US-based Immune Response Corporation, at an international conference updating research on HIV vaccines, held in Bangkok.

The data was still marginal and strict protocols were needed to give the answer. Despite an ongoing extended phase-II study on 297 HIV-positive people nationwide, Veena Churdboonchart, of Trinity Medical Group, said her team had proposed going ahead with the phase-III trial, both as a vaccine and as a drug.

The proposal has gone before the ethical sub-committee considering vaccine trials on humans.

The extended phase-II trial of the candidate vaccine, expected to yield results by August 2003, is being held at Vajira Medical College, Phra Mongkutklao hospital, Chiang Mai University hospital, Khon Kaen University hospital and Prince of Songkhla University hospital. The therapeutic vaccine has undergone phase-I safety and phase-II immunogenicity trials in Thailand, but given problems with interpreting results obtained in the second phase, the sub-committee decided to wait for results of the phase-II study before going any further. Most members resigned and the proposal for a further trial is before a new sub-committee chaired by Medical Services Department head Seri Tuchinda. Mrs Veena said her candidate vaccine showed positive results and deserved further research.

Soyeon Kim, a biostatistician from the Harvard School of Public Health who was removed from the team looking at the Remune results, said she was concerned about "selective reporting" in presentation of the candidate vaccine. "It was found that there wasn't a significant effect." Data needed to be revised. While several Aids scientists raised concerns about the statistical theory used in interpreting results, Mrs Veena insisted that her study had resulted in more people with increased CD4 cell counts than those whose CD4 cells fell. "A significant difference was noted in the changes in CD4 cell counts that favoured the HIV-1 Immunogen-treated group compared to those for the adjuvant-related control group," she said.

On average, CD4 cell counts increased by 84 cells by the 40th week, whereas the increase for the control group was 38 cells during the same period, said Mrs Veena. Another matter still undecided was how ethical and appropriate it was to use Remune alone, said Dr Esparza. He said it would be difficult to see the use of Remune as a monotherapy, just because it was cheap. "If we have to spend some more years on the trial, we should do so rather than rush into conclusions," he said. Wisut Sukeepaisarncharoen, of Khon Kaen University, who is also the principal investigator of Remune here, accepted at the conference that Remune alone would not cure HIV/Aids.

"Remune alone couldn't cure the disease. If we want to cure the disease, we may have to use other methods like drug combinations," he said.

The trial of the candidate vaccine in Spain also involves the use of anti-retroviral drugs. Dr Esparza said that to confirm that a substance is effective, clear information was needed. "In this case, the information is not clear enough. As a doctor, what worries me is that the decision for treatment depends on statistical analysis. I think decisions can't be mathematical because we're talking about human life. We need more data," he said. He said for a disease like HIV/Aids, one has to be patient because sometimes the difference in a person's health appears only several years on, and then the difference might be modest.

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