Recently, news broke about the illegal distribution of 2,000 doses of ActRx TriAct to several public hospitals as part of its clinical trial. Dubbed a “breakthrough drug” for dengue last year, the Department of Health (DOH) ordered the suspension of the trial, citing its lack of approval from the Food and Drug Administration (FDA).
According to Acting Health Secretary Janette Garin, ActRx TriAct has no legal basis for public distribution as part of a clinical trial, as it remains unapproved by the FDA. Secretary Garin called the implementation of the trial, which had been authorized by then-Health Secretary Enrique Ona, unethical. As a result, the trial, initially approved on September 4, 2014, was suspended.
It was also revealed that ActRx TriAct had been distributed in 2012 in Palawan for treating malaria, an initiative strongly opposed by the DOH under Secretary Garin. She stated that the 2012 malaria study lacked scientific rigor and failed to provide adequate protection for participants, raising serious ethical concerns.
Further issues were uncovered in the clinical trial conducted at San Lazaro Hospital, where human participants were reportedly used without adhering to proper protocols. Moreover, there is insufficient research on the individual components of ActRx TriAct to support its effectiveness or safety for treating dengue.
ActRx TriAct is a combination therapy consisting of three drugs: Artemether (administered as an oral spray), and the tablet forms of Artesunate and Berberine. The DOH emphasized that each component requires thorough evaluation to determine its safety and efficacy before being distributed for public use.
Until robust scientific studies confirm its effectiveness and safety, ActRx TriAct remains under scrutiny, with the DOH prioritizing public health and ethical standards in research trials.
