Bangkok Post - April 30, 2002
Anjira Assavanonda

Trinity Medical Group (TMG), the joint developer and distributor of the vaccine in Southeast Asia, has been seeking FDA approval to register Remune as an immune moderator for treating HIV/Aids patients. The Drug Commission makes the final decision.

TMG had asked for an exemption from Certificate of Free Sale, an important document issued by the country of manufacture, in this case the US. A certificate is normally required in the FDA registration process for newly imported drugs.

FDA secretary-general Vichai Chokeviwat yesterday appeared optimistic about a decision.

He said considering unsettled problems with interpreting the results from the phase II trial of the vaccine in Thailand, FDA had decided to give the product a chance to prove itself in a straight-forward and transparent manner.

"I do insist that the consideration process will be done in transparency, based on scientific principle and without pressure from any influential parties," he said.

Dr Vichai noted it has been misconceived that all the drugs which ask for FDA registration must get through the trials in three phases.

"AZT, an anti-retroviral treatment for HIV/Aids, was allowed to register in the US though it had undergone only a phase II trial. So TMG's request in this case is reasonable, but whether it will be approved still depends on the Drug Commission," said Dr Vichai.

Vivat Rojanapitayakorn, an expert on infectious diseases, however, saw the TMG move as a strategy to escape the vaccine evaluation panel.

"Since the substance is identified as an immune moderator, not a vaccine, it doesn't need approval from the National Aids Committee," he said.

The best solution to settle the conflict would be to repeat the trial to prove the efficacy of the vaccine. Vina Churdboonchart, former lead researcher who also holds a stake in Trinity Medical Group, should refrain from taking part, he said.

Dr Vivat said the ethics sub-committee considering vaccine trials on humans chaired by Medical Services Department head Seri Tuchinda, had already approved further trials in phase III which would be held by academics at Songkhla and Khon Kaen University hospitals.

The trial, he said, could be carried out at the same time as the FDA decided whether to register the substance.

"Instead of going against Remune, we should give it a chance to prove itself. If the Drug Commission is going to give the green light, it should base its decision on clear evidence that the substance is effective in curing HIV/Aids," said Dr Vivat.

Public Health Minister Sudarat Keyuraphan, meanwhile, said she has already given policy guidelines to Dr Vichai urging that all procedures concerning drugs or vaccines must be carried out with transparency and under standard scientific principles.

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