DOH questions Ona’s order on anti-dengue treatment

MANILA, Philippines - Two clinical trials involving human guinea pigs in 2012 and 2013 on a drug for the treatment of dengue and malaria authorized under a department order issued by Health Secretary Enrique Ona are now being questioned.

Spokesman Lyndon Lee Suy said the Department of Health (DOH) will go after the people behind the clinical trials on ActRx Triact, or arteminsin combination treatment, a multi-drug combination of artemether, artesunate and the herbal-based berberine.

The clinical trials “should have not happened” in the first place, he added.

Last Nov. 14, acting Health Secretary Janette Garin rescinded Department Order (DO) No. 2014-016, dated Sept. 24, 2014 that Ona had issued.

Ona is now on extended leave of absence.

The order provides for a national program to study  the use of ActRx Triact in the treatment of dengue.

Lee Suy said they should not have been implemented for various reasons. “Berberine was used in the studies even without specific and definitive scientific basis for the researchers’ claims that it can cure malaria or dengue,” he said.

Lee Suy said the clinical trials on ActRx Triact are “highly irregular and dangerous.”

“In not following and complying with the basic protocol of scientific experiments using human subjects, the researchers are endangering the lives of the Filipino people who were given ActRx Triac without any accountability and transparency,” he said. “If something happens now, how and where do they seek legal remedy? The people behind these researchers must be held accountable.” 

Lee Suy said the use of artemether and artesunate is considered as “artemesin monotherapy,” which increases the prevalence of resistance to anti-malarial drug.

“The combination of berberine, arthemether and artesunate may have long-term effects that have not yet been studied adequately,” he said.

“These long-term effects may possibly ruin the lives of Filipino malaria and dengue patients.” 

Since malaria is endemic to the Philippines, the “strong possible emergence of resistance to malaria via artemesin monotherapy could have devastating and fatal impact on the lives of Filipinos suffering from malaria, Lee Suy said.

ActRx Triact was first used in a clinical study for malaria treatment in Palawan in 2012 and in another study for the treatment of dengue at the San Lazaro Hospital in Manila in 2013.

Behind the dengue study are the ActRx Foundation Inc., the ActRx Operational Group Ltd. and Preferred and Proven Therapies Inc., whose president and chief executive officer, Hexilon Alvarez, is the son of former senator Heherson Alvarez.

Artemether and artesunate are made from artemesin, a drug used for treating malaria.

As an anti-malarial, artemesin is administered with other drugs, lumifantrine and primaquine, to prevent drug resistance.

By not complying with the International Conference on Harmonization Guidelines for Good Clinical Practice, the 2012 malaria study lacks strong scientific merit and study participants were not afforded due protection.