D

Drug users in Cambodia are subject to arbitrary arrest and commitment to drug treatment facilities, but in a startling development may now also be unwilling participants in an experimental drug trial. In December 2009, police in Phnom Penh reportedly arrested at least 17 drug users and forced them into a drug trial for the experimental herbal formula Bong Sen at the military run “drug treatment center” Orksas Knyom. Bong Sen is an unlicensed treatment for opiate addiction, which, according to its Vietnamese manufacturer Ben Tre Fataco, has no side effects and enables addicts to recover in five to ten days.

Local and international NGOs, including Human Rights Watch, have expressed significant concern over the Bong Sen trials. In addition to the potentially coercive recruitment tactics, these trials were not subject to the Ministry of Health‘s ethical review process. Other ethical problems include a lack of informed consent, or safeguards for the health of participants. Moreover, after treatment, the detainees were released with no opportunity for follow-up care or counseling. Local NGOs estimate the relapse rate of drug users released from Orksas Knyom to be around one hundred percent.

If these claims are true, the trials run contrary to the World Medical Association’s Declaration of Helsinki, the definitive statement of ethical principles for human medical research. The Declaration mandates, among other things, that all human research undergo review by an ethics committee, that free and informed consent be obtained from each subject, and that the subject be able to withdraw participation at any point in the process.

Cambodia vehemently denies the claims made by NGOs. Cambodia’s National Authority for Combating Drugs, a collaborator in the trials, insists that Bong Sen is not a drug but an herbal treatment, and as such is not subject to the same ethical review procedures. Additionally, the government denies the assertions that the trials were involuntary, maintaining that all participants consented to the trial and that the treatment was effective.

In the past, the Cambodian government has been hesitant to allow drug trials on its citizens, and even halted an HIV drug trial for human rights concerns. This time, however, the government has an interest in permitting the trials. With considerable financial and technical support from Vietnam, Cambodia is planning to build the country’s first national drug rehabilitation center to help combat Cambodia’s rampant drug problem. Bong Sen, a Vietnamese drug, would be at least one of the treatments provided to patients at the proposed center. Ben Tre Fataco has been actively involved in the negotiations, including being present on at least one of the official visits of Vietnamese officials to discuss the deal.

As an increasing number of major pharmaceutical companies outsource their trials to developing countries, the prevalence of unethical drug trials in these areas has been a subject of recent interest for human rights and medical organizations. The Bong Sen trials in Cambodia highlight this concern. These trials must abide only by the host government’s standards, which are often minimal and rarely enforced. Since the people affected are already some of the most vulnerable, the ethical and legal implications of drug trials in developing countries deserve considerably more attention. While drug trials offer the possibility for new, potentially lifesaving, treatments, the human costs of involuntary and unethical medical testing must be vigilantly scrutinized.