MANILA – The people behind the controversial dengue-malaria drug experiment must be held liable for conducting trials without accountability and transparency, according to the Department of Health (DOH) on Monday.
DOH spokesman Lyndon Lee Suy read the statement of the Office of the Secretary under acting Secretary Janette Garin saying that the trials of the “breakthrough drug” ActRx Triact were “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 Triact without accountability and transparency,” the statement said.
This is following Garin’s earlier announcement of a technical working group convening to investigate the case of the ActRx Triact which was used as treatment for dengue and malaria.
The treatment were said to have been discovered by Clark-based Preferred and Proven Therapies Inc., owned by Hexilon Alvarez, son of former Sen. Heherson Alvarez in partnership with US-based ActRx Foundation.
They began the clinical trial for malaria treatment in November 2012 at the rural health units of Bataraza and Rizal in Palawan province and Leoncio General Hospital in Brooke’s Point and Ospital ng Palawan in Puerto Princesa.
Last year, it was also used to test dengue patients at San Lazaro Hospital in Manila.
Garin, however ordered the suspension of the national program on the experimental regimen study for the
On Nov. 14, Garin ordered the suspension of the national program on the study of the experimental regimen for the treatment of dengue, a mosquito-borne disease.
The two-day regimen is composed of artemether sublingual spray, artesunate and berberine tablets.
Berberine is a compound found in herbs used for treatment of intestinal infections, fever syndromes and hypertension. It is used in Europe and China for more than 2,500 years.
Though it has been used in some parts of Europe and China for more than 2,500 years now, the Food and Drug Administration (FDA) did not gave a certification allowing its sale in the country because of the lack of scientific studies on it.
There is a need to further study ActRx and berberine had not been “scientifically studied before it was used as an experimental drug on Filipinos,” according to the documents prepared by the DOH committee conducting a probe on the issue.
The DOH enumerated reasons why the clinical trials should not have happened, including:
— Berberine was used in the studies even without specific and definitive scientific basis for the researchers’ claims that it can cure malaria or dengue.
— Artemether and artesunate are made from artemisinin, a drug used for treating malaria along with other drugs, particularly lumifantrine and primaquine to prevent drug resistance.
“The use of artemether and artesunate is considered ‘artemisinin monotherapy,’ which increases the prevalence of resistance to antimalarial drug.”
— The combination of berberine with the two artemisinin-based drugs may have long-term effects that have not yet been sufficiently studied, which “may possibly ruin the lives of Filipino malaria and dengue patients.”