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DOH: Ona-approved anti-dengue treatment placed lives in danger


An experimental treatment for dengue and malaria patients may have placed thousands of Filipinos in danger, the Department of Health announced on Monday.

In a news conference, the DOH said the drug mixture ActRX TRIACT’s medicinal claims on malaria and dengue may have long-term harmful effects on those who were administered the treatment.

“[The] 2012 and 2013 clinical studies should not have happened. Berberine was used in the studies even without specific and definitive scientific basis for the researchers’ claims that it can cure malaria or dengue,” DOH spokesperson Dr. Lyndon Lee Suy said, reading the DOH's prepared statement on the issue.
 
Artemether and artesunate are made from artemesin, a drug used for treating malaria. As an anti-malarial, artemesin is administered with other drugs namely lumifantrine and primaquine to prevent drug resistance.
           
“The use of artemether and artesunate is considered as artemesin monotherapy, which increases the prevalence of resistance to anti-malarial drug,” Lee Suy said.
           
“The strong possible emergence of resistance to malaria via artemesin monotherapy could have devastating and fatal impact on the lives of Filipino suffering from malaria,” he added.

Sources said a few thousand units of ActRX TRIACT were given during the course of the clinical trials.

Health Secretary-on-leave Enrique T. Ona on Sept. 24 approved clinical trials for ActRX TRIACT as a treatment for dengue.

Acting Secretary Janette Garin has since suspended the experiments.

GMA News Online called and sent text messages to Ona but the official has yet to respond as of posting time.

Lee Suy said the national program using ActRX TRIACT for dengue treatment in six DOH hospitals was the third clinical study using ActRX TRIACT as “treatment for malaria or dengue.”
           
In November 2012, ActRX TRIACT, which is a combination of the compounds artemether, artesunate, and berberine, had been used in a clinical study for malaria treatment in selected areas in Palawan.

In 2013, the ActRX TRIACT was administered to patients in a clinical study for dengue treatment at the San Lazaro Hospital.
       
Malaria is endemic to the Philippines’ 52 provinces and affects thousands of Filipinos.
           
“The combination of berberine, artemether, and artesunate may have long-term effects that have not yet been studied adequately. These long-term effects may possibly ruin the lives of Filipino malaria and dengue patients,” Lee Suy said.
           
By not complying with the International Conference on Harmonization Guidelines for Good Clinical Practice, the 2012 malaria study “lacked strong scientific merit and study participants were not afforded their due protection,” he added.
           
The 2013 dengue clinical study was noted by the Philippine Council for Health Research and Development (PCHRD) to have the following deficiencies: missing baseline characteristics of study participants, lack of scientific justification for the use of artemether and artesunatef for dengue treatment, and the absence of pre-clinical studies on each of the three drugs (berberine, artemether, and artesunate) as to which drug has anti-dengue properties
           
Lee Suy said the 2013 dengue study “did not comply with the basic steps of a sound scientific research using people as subjects.” He said the ActRx TRIACT has not been registered with the Food and Drug Administration whether “as a drug or as a food or a supplement.”
           
“It has no legal basis to be present in the Philippines, especially for clinical trials,” he added.
           
“Upon further review, it has been found that no other studies on ActRx TRIACT have been or are being conducted in other parts of the world. This is highly irregular and dangerous because 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 TRIACT without any accountability and transparency,” Lee Suy said.
           
“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,” he said.

Garin suspended the trials on Nov. 14 supposedly to protect public health and welfare.
           
In a Nov. 21, 2014 letter to Garin, Dr. Julie Hall, the World Health Organization representative to the Philippines, said the WHO “considers berberine to have no anti-malarial effect and hence, it is not included in the WHO’s malaria treatment recommendations.”
           
Hall said the WHO policy “does not recommend any oral artemisinin monotherapy for malaria and that  the marketing and distribution of oral monotherapies should be stopped.” —KG/NB/KBK, GMA News
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