Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
Bangkok Post - January 17, 2001
The lead researcher in the trials, Dr Vina Churdboonchart, last week petitioned Prime Minister Chuan Leekpai in his capacity as chairman of the National Aids Committee to ask that three respected members of the sub-committee on vaccine evaluation be removed.
Dr Vina claims Dr Prasert Thongcharoen and Dr Ruangpeung Suthane of Siriraj hospital and Dr Praphan Pahnuphak of Chulalongkorn hospital are ineligible to sit on the evaluation panel because they were involved in trials of other candidate Aids vaccines and this might amount to a conflict of interest.
The sub-committee, with the exception of its chairman Dr Natth Baramapravati, disapproved of Dr Vina's Phase II vaccine trial results because the study did not follow the original protocol. The sub-committee also rejected her proposal for large-scale trials of the vaccine with up to 10,000 volunteers.
The sub-committee contended that the trial results did not show any significant difference between the volunteers given Remune and those given a placebo. Its position was backed by a study of a US trial of the same vaccine conducted among 2,500 volunteers by internationally recognised researchers. The conclusion there was that the drug showed little improvement in Aids-infected volunteers. But Dr Vina insists her own results are positive.
Setting aside the differences in the trial results and looking just at the question of human rights, is it fair or humane to subject another 10,000 volunteers infected with the HIV virus to a vaccine whose efficacy is in doubt? These unfortunate people may be desperate and willing to be used as guinea pigs in the hope of some relief, but can this exploitation be justified? Will they be told the truth about the questionable properties of the vaccine before they agree to join the programme?Given the conflicting trial results, it is both appropriate and ethical for the researchers to repeat the Phase II study to determine the efficacy of Remune with new volunteers recruited for the programme and a methodology that conforms to international standards.
It is regrettable that several members of the vaccine evaluation sub-committee have resigned over the conflict with Dr Vina and due to alleged political interference. Their departure is a setback, especially for those Aids sufferers hoping desperately for a cure.
Equally disappointing is Dr Vina's resignation as the lead researcher. Her tireless dedication to vaccine trials, her valuable connections to private sponsors willing to fund the experiments and her expertise have been useful, although a question has been raised about her conflict of interest through her shareholding in the company producing the vaccine.
If Remune is proven ineffective in increasing immunity against Aids, the researchers, Dr Vina in particular, must accept the results, dump the drug and look for other candidate vaccines with potential. Trial and error is common in medical and scientific experiments. What is most important is that we learn from the errors.
Thailand of late has earned the unsavoury reputation of being a haven for international researchers to test their new vaccines or drugs on humans due to our lax research controls and low respect for the rights of those used as guinea pigs. A large-scale Remune trial with the effectiveness of the vaccine in doubt will further bathe the country in this negative light.
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