Trial sought for proponents of controversial anti-dengue drug

Proponents of and researchers connected with the clinical trials of an experimental but controversial anti-dengue drug must face trial for their alleged unethical acts against children, a Filipino doctor involved in medical science research ethics said Thursday.

According to Dr. Francisco P. Tranquilino, a regent of the Philippine College of Physicians Board and a special assistant to the dean and college secretary of the UP College of Medicine, the ActRx TriAct dengue study conducted in San Lazaro Hospital in 2013 was “technically and ethically fatally flawed.”

“This study should not have been conducted in the first place,” Tranquilino, a founding member of the ASEAN Federation of Internal Medicine, said in a press conference.

He said the conduct of a clinical trial on humans, especially among children, is governed by strict internationally accepted guidelines such as the World Medical Association's (WMA) Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects.

The WMA has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects and is addressed primarily to physicians.

Specifically on vulnerable subjects such as children, the WMA said medical research with a vulnerable group “is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group.”

"Nothing wrong with ActRx TriAct"

On Wednesday, former Health Secretary Enrique T. Ona said there was nothing wrong with the ActRx TriAct clinical trials.

"To me it is so absurd na hindi mo ipagpatuloy ito, lahat tayo ngayon naghahanap ng cure it's the same thing as Ebola, naghahanap tayo ng vaccine," Ona said in a report on "24 Oras."

Acting Health Secretary Janet Garin has said children were among the patients who were in the clinical trial done in Palawan in 2012. Ona, for his part, claimed the patients who were in the clinical trials gave their full consent.

In strongly suggesting trial for those linked with the ActRx TriAct dengue clinical tests, Tranquilino said, “We cannot condone such ancient unethical acts under the guise of pseudoscience.”

“Like the Nuremberg Trial, we might need our own Manila Trial in this case,” he added, referring to a series of military trials for the prosecution of prominent members of the political, military, and economic leadership of Nazi Germany in the 1940s.

 “We cannot hide behind compassionate usage all the time, legal, ethical and moral principles must be followed,” said Tranquilino.

Considered as medical ethics expert, Tranquilino said the Nuremberg Trial was conducted because clinical trials in the 1940s were “wantonly conducted on humans during the time of Hitler.”

Senior German political and military leaders, including medical doctors were tried for their war, war crimes, and crimes against humanity. They were brought to trial before the International Military Tribunal in Nuremberg, Germany, from 1945 to 1949.

Anti-dengue

The ActRx TriAct dengue clinical trials involved the use of oral artesunate, artemether (sprayed under the tongue), and the oral herbal medication berberine.

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.

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, the Department of Health (DOH) had earlier warned.

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.

Violations?

In the same press conference, Dr. Julie Hall, World Health Organization (WHO) representative to the Philippines, said malaria is “a huge global issue” and that artemesin is at the “forefront” of the global fight against malaria.

Hall described the anti-malarial artemesin as “a precious public health drug,” while warning that Filipinos may develop widespread resistance to malaria if the drug were not used judiciously and properly.

Dr. Anthony C. Leachon, president of the Philippine College of Physicians, said that “the interest of patients take precedence over the interest of science.”

Leachon claimed that “bioethics were violated” in the Actrx Triact clinical trials.

Dr. Maria Minerva P. Calimag, president of the Philippine Medical Association, said the scientific and medical communities are “looking for proof of concepts” that artemisinin, which is a cure for malaria, may also be effective for dengue.

“We do not know whether the anti-malaria artemisinin will work for dengue. Why? Malaria is caused by protozoa while dengue is caused by a virus. These are two entirely different microorganisms,” Calimag said.

“We cannot presume that a drug which is effective for malaria, will also be effective for dengue,” she added. —KBK, GMA News