By Leilani S. Junio
MANILA, Dec. 1 (PNA) — The Department of Health (DOH) said on Monday that people behind the researches using ActRx TriAct in clinical trials for the treatment of dengue should be held liable for not following the basic principle of scientific experiments.
In an official statement read before reporters at the DOH Media Relations Unit in Tayuman, Sta. Cruz, Manila, DOH Spokesperson Lyndon Lee Suy said the studies conducted on ActRx TriAct were “highly irregular and dangerous” which caused the suspension of the clinical trials for ActRx TriAct last month.
Dr. Lee–Suy said that for not following and complying with the basic protocol of scientific experiments using human subjects, the researchers had put into risk the lives of the Filipino people who were given with ActRx TriAct without any accountability and transparency.
“If something happens to those who had taken the ActRx TriAct months or years from now, how and where do they seek legal remedy? The people behind these researches must be held accountable,” Lee-Suy added, quoting from the press statement.
It may be recalled that DOH Acting Secretary Janette Loreto-Garin ordered on Nov. 14 the suspension of the implementation of the national program studying ActRx TriAct for the treatment of dengue.
ActRx TriAct is a multi-drug combination of artemether, artesunate, and berberine.
The guidelines and rules governing the implementation of the ActRx TriAct in the national healthcare program for dengue in the different hospitals of the government were spelled out in Department Order No. 2014-0161 dated Sept. 24, 2014 and signed by (on extended leave) Health Secretary Enrique T. Ona.
In a fact sheet, the DOH cited that the use of ActRx TriAct for clinical trials in the country was not approved by the Philippine Food and Drug Administration and other concerned agencies.
“Thus, it has no legal basis to be present in the Philippines, especially for clinical trials,” Dr. Lee Suy said.
He noted that upon further review, it was found out that no other studies on the said clinical trial “have been or are being conducted” in other parts of the world.
ActRx TriAct is a combination of berberine, arthemeter, and artesunate that were first used in the clinical study for malaria treatment in selected areas in Palawan in 2012.
The DOH statement also said that ActRx TriAct was used in a clinical study for dengue treatment at the San Lazaro Hospital in 2013.
In the same statement, the DOH emphasized that the 2012 and 2013 clinical studies should not have been done for the following reasons:
First, berberine was used in the studies without specific and definitive scientific basis for the researchers’ claims that it can cure malaria or dengue.
Second, arthemether and artesunate are made from artemesin, a drug used for treating malaria.
As an anti-malarial drug, artemesin is administered with other drugs, namely lumifanterine and primaquine to prevent drug resistance.
The use of arthemeter and artesunate is considered as “artemesin monotherapy” which can result in increasing the prevalence of resistance to anti-malarial drug.
In a summary of technical consultants’ recommendations issued by the Philippine Council for Health Research and Development (PCHRD) under the Department of Science and Technology (DOST), it was stated that such resistance could jeopardize the line of defense against malaria.
In the same study, the PCHRD also cited that it was too early to recommend ActRx TriAct for widespread treatment of dengue or its inclusion in the Philippine National Drug Formulary. (PNA)