Materia Medica Malaysiana

More bite needed to ensure clinical trials meet high ethical standards

SCIENCE and Technology Minister Datuk Jamaludin Jarjis announced last week that pharmaceutical companies in the US are interested in conducting their clinical trials in Malaysia.
And Malaysia, in return, has offered these companies excellent facilities at competitive rates. Clinical trials have always been plagued with issues relating to unethical and illegal trials, especially in countries without ethical approval or where legislation may either be inadequate or not implemented.

In India, for example, an independent pharmaceutical journal, Monthly index of Medical Specialities in India, reported that last year local generic drug firm, Sun Pharmaceuticals, had tested an anti-cancer drug on 400 women without their knowledge, to see if it induced ovulation. The drug, a copy of Novartis' patented drug Letrozole, was prescribed to women who were trying in vain to have children.

The Letrozole trial is one of the many shocking examples of the extent drug companies would go to. A survey by the US National Bio Ethics Advisory Commission of more than 200 health researchers found that about 25 per cent of clinical trials conducted in developing countries do not undergo ethical review. The findings of the survey were published in the February edition of the Journal of Medical Ethics.

In Malaysia, though there is no legislation governing clinical trials in Malaysia, there is, however, the Guidelines For The Application to Conduct Drug-Related Clinical Trials in Malaysia.

Under the guidelines, principal researchers must have Good Clinical Practice Certificate approved by the National Committee for Clinical Research, says deputy director-general of Health Datuk Dr Ismail Merican. Dr Ismail, who also heads the Ministry of Health's Medical Research Ethic Committees, says the ministry is also trying to establish National Ethics Board to especially look into clinical trials on human subjects.

"Clinical trials are getting more complicated and there is an urgent need to not only safeguard the rights of human subjects, but also to ensure that trial data is credible and valid." The ethical committee of the ministry monitors clinical trials in government hospitals. Private hospitals, on the other hand, need to have their own committees for clinical trials in their hospitals. "The private hospitals, however, must disclose the composition of their ethical committees to ensure that there is some one to safeguard the interest of the human subjects." Nevertheless, Dr Ismail says, the guidelines alone aren't sufficient without the means to enforce them. "If researchers were to breach the guidelines, the most we can do is to blacklist them." He calls for legislation to regulate clinical trials conducted by foreign companies in Malaysia. "The current regulations do not have the bite," says Dr Ismail