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 16, 2001
Nusara Thaitawat
Vina Churdboonchart cited conflict of interest in the refusal of the three to approve her proposal to further study the vaccine among 10,000 volunteers.
In a letter dated Jan 10, Ms Vina also asked Chuan Leekpai to consider the qualifications and conduct of the seven members of the evaluation sub-committee which, she alleged, had caused damage to her and her team.
Ms Vina wanted Dr Prasert Thongcharoen and Dr Ruangpeung Sutthane of Siriraj hospital, and Dr Praphan Phanuphak of Chulalongkorn University's faculty of medicine, who are believed to be involved in their own vaccine research, removed to ensure the neutrality of the committee.
She said she had researched HIV-1 Immunogen, marketed as Remune and developed by US-based Immune Response Corp, for eight years without state funding.
As the lead researcher, Ms Vina said she had asked her own Trinity Medical Group to cover expenses and asked Aroon Churdboonchart, the company chairman, to negotiate with Immune Response to produce the vaccine at an estimated cost of US$10 million.
She estimated the cost of research, also shouldered by Trinity, at no less than 100 million baht.
She described these as an "achievement of the private sector".
Ms Vina said she had approval in principle to further study the vaccine in a trial involving 10,000 volunteers but members of the evaluation panel had sent concerned parties a letter calling for the suspension of the proposal.
"This letter presented the research project in a negative light and was one-sided, which is not right and not fair to the researchers," she wrote.
In their letter, the panel members said they could not support the proposal without adjustments.
This followed the results of her trial involving 300 volunteers which leading researchers in Thailand and the United States insisted did not show any significant improvement on volunteers given Remune and those on a placebo. Ms Vina claimed the results were positive.
The results of a US trial involving 2,500 volunteers by internationally known researchers concluded Remune did not show a significant improvement in HIV-positive volunteers.
The sub-committee also pointed out at each of many meetings on Ms Vina's Remune trial that the methodology for the evaluation of the results, as stated in the original proposal, could not be changed without approval. The methodology was changed after the first found no significant improvement.
Members pointed out that since Ms Vina was an investor in Remune with a stock purchase agreement for one million shares in Immune Response, there was scope for conflict of interest.
In her letter to the prime minister, Ms Vina said she had been replaced as lead researcher by Dr Viraphol Chandiying from Prince of Songkhla University.
But members of the sub-committee said the move was only made recently.
Ms Vina told Mr Chuan some of the panel members had never conducted human trials nor had their work published in internationally-recognised medical journals.
"I am begging you to consider the qualifications of the sub-committee members and to appoint experts in order for the review process to be efficient and speedy," she wrote.
Dr Prasert and Dr Ruangpeung are involved in the same research on a preventive vaccine to protect against HIV infection, and Dr Praphan on the therapeutic qualities of anti-HIV medication. Ms Vina's research is on a therapeutic vaccine to help repair the immune system damaged by HIV.
Responding to the letter, Dr Prasert said he was not concerned. "I'm just doing my job and I'm doing what is right," he said. "If there is scientific merit, why wouldn't I support it?"
He said there was no conflict of interest in his research and that of Dr Praphan since the vaccine, though also against HIV, was of a different type.
Dr Praphan, who quit the evaluation panel with all other six members, declined to comment. Dr Ruangpeung could not be reached by press time.
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