MANILA, Philippines–A group of independent health experts and researchers tapped by the Department of Health (DOH) to investigate the use of an unproven drug for malaria and dengue in the Philippines is recommending that the agency seize the supposed “breakthrough” drug distributed to several state-run hospitals.
The recommendation is one of the highlights of a position paper the group was expected to submit to the Office of the Health Secretary, overseen by Acting Health Secretary Janette Garin while Health Secretary Enrique Ona is on an extended leave.
Ona ordered the clinical study of the drug at six DOH-retained hospitals on Sept. 24.
Aedes aegypti mosquito, carrier of the dengue virus. FILE PHOTO
When Ona went on leave, Garin suspended the clinical study following reports that the drug had no therapeutic value against malaria and dengue.
In the position paper, a copy of which was independently obtained by the Inquirer, the group said the hospitals tapped to participate in the clinical study of the efficacy and safety of ActRx Triact must “surrender” the unproven drug to the Food and Drug Administration (FDA) for the protection of public health and welfare.
At least 3,000 units of the controversial drug have been distributed to more than six hospitals in the country since the clinical trials began in November 2012.
No information is available as to how many units of the drug have been administered to subjects of the experiment.
The members of the group behind the position paper requested anonymity, as they did not want to be dragged into the rivalry between Garin and Ona, whose leave has been “extended indefinitely” by Malacañang pending a review of his explanation of his decision to buy pneumonia vaccine that was not the type recommended by the World Health Organization (WHO).
The cocktail
ActRx Triact, a two-day regimen against dengue and malaria, comprises artemether sublingual spray, artesunate and berberine tablets.
The multidrug treatment was reportedly discovered by Clark-based Preferred and Proven Therapies Inc. in collaboration with US-based ActRx Foundation.
Berberine, a compound found in herbs, has been in use in Europe and China for more than 2,500 years in treating various diseases, including intestinal infections, fever syndromes and hypertension.
Not registered with FDA
But an FDA certification stated that berberine and any of its derivatives have not been registered with the agency and therefore cannot be sold or offered for sale in the Philippines.
Before Ona went on leave, he issued Department Order No. 2014-0161, integrating ActRx Triact into the “standard of care in the management of dengue patients in the Philippines.”
Ona issued the order despite an FDA order, issued on July 3, 2013, for the termination of clinical tests involving the same drug following the death of a child in Rizal town, Palawan province, that resulted from a malaria clinical trial.
The death of the child seemed to be unrelated to the drug, the FDA said at the time, but the agency ordered the clinical trial halted because the protocol was not approved by the FDA.
Documents obtained by the Inquirer showed that in February 2012, months before the clinical study began, the ActRx Foundation offered an initial donation of 500 units of the drug as “goodwill gesture” to the DOH in view of the proposed experiment.
The following month, Ona approved the offer in principle and endorsed Preferred and Proven Therapies Inc. and ActRx Foundation to the FDA for the grant of licenses and permits.
Without the approval of the Research Institute for Tropical Medicine (RITM) for the study’s clinical trial protocol, the two entities were supposedly issued a permit to import 240 pieces of artemether sublingual spray in June 2012.
At least 1,000 pieces more of the drug were imported the following month, still without RITM approval of the protocol.
Six hospitals
ActRx Triact was distributed to six DOH-retained hospitals, where the clinical trials for the treatment of dengue were conducted: San Lazaro Hospital, East Avenue Medial Center, Dr. Jose N. Rodriguez Memorial Medical Center, Amang Rodriguez Medical Center, Quirino Memorial Medical Center and Jose B. Lingad Memorial Hospital.
The four sites tapped for the clinical study of ActRx Triact as antimalarial treatment were the towns of Bataraza and Rizal in Palawan, Leoncio General Hospital in Brooke’s Point and Ospital ng Palawan in Puerto Princesa.
In recommending the seizure of the experimental drug, the medical experts said ActRx Triact was considered “dangerous,” noting that it was unapproved by the FDA and the RITM.
They also said berberine had no proven or established medicinal effect against malaria and dengue.
Dangerous mix
They said combining arthemeter, artesunate and berberine was a potentially dangerous mix since side effects had not yet been sufficiently studied and that arthemeter and artesunate, when given in doses less than the recommended amount, could cause resistance to malaria.
Earlier, doctor Julie Hall, WHO country representative to the Philippines, wrote in a technical opinion on the study that using such multidrug combination, was against WHO policy on the global phaseout of oral artemesinin monotherapy and against WHO recommendations specifically on malaria treatment.