The Thailand Centre of Excellence for Life Science (TCELS) has been assigned by the Thaksin administration to push the country as a regional centre for clinical drug tests, but its president yesterday said any testing done here would be conducted with drugs at a much later stage of development.

TCELS president Dr Thongchai Thawichachart said the concept behind the scheme would not allow such tests to be conducted here. "Tests on healthy subjects is part of an early stage of discovering [the properties of] a new drug and then further developing it - that is not our aim. Our project would cover only the very last step, phase III clinical trials, in which the drug's safety has already been approved by other countries," he said.

The International Herald Tribune on April 9 published an article dealing with the "disastrous results" of a trial of a new drug, dubbed TGN1412.

The drug was a type of immune stimulant developed by a German company and was intended to treat a rare form of leukaemia. Early tests almost killed six men involved in a trial.

After taking the drug the men wound up in the hospital's intensive care unit and did not fully recover.

The newspaper said their immune systems were now impaired. The government formed the TCELS in 2003, looking to position Thailand to take advantage of advanced biotechnology within the medical industry.

The government wanted the agency to make the country a hub for clinical trials of new drugs developed by giant pharmaceutical firms.

Looking to reassure the public, Thongchai said ethics committees already in place at each hospital in Thailand were of a high standard.

But Public Health Ministry ethics committee for human research chairman Dr Pakorn Suriyong raised concerns about the system.

He said each hospital having its own ethics committee was good, but there was no overall committee to monitor their performance and they essentially had the final say over whether a project was approved or not.

Despite the fact his committee falls under the umbrella of the Public Health Ministry, he said, he could only oversee human research conducted in government hospitals, not private institutions or medical schools.

Pakorn said the ministry was now discussing the possibility of setting up a central regulator to control human research. He said every year his committee received applications for permission for 40 to 50 tests on new drugs.

But he said he didn't know how many Thais were taking part in the trials - some might need 10, others more.

He cited HIV/Aids drug trials as an example of a disease, for which there was never any shortage of people looking to take part.

Pennapa Hongthong

The Nation