Is the anti-dengue drug trial ordered by Ona ethical?
MANILA, Philippines – When Health Secretary Enrique Ona issued the controversial department order allowing clinical trials of anti-dengue treatment ActRx TriAct in 6 government hospitals, he said it had the blessing of the Philippine Council for Health Research and Development (PCHRD).
But it turns out that what the PCHRD approved is only the technical aspect of the clinical trials.
In a December 1 letter obtained by Rappler, PCHRD Executive Director Jaime Montoya told Acting Secretary Janette Garin that their technical review "confirmed the potential of the compound as a new treatment modality for dengue."
"There were also no significant adverse effects observed among the 288 patients included in the study,” the letter read, referring to the clinical trial of ActRx TriAct in San Lazaro Hospital.
"Being illegal is different from being unethical, because…not everything legal is ethical."
"After a series of comments and revision, the PCHRD found the final version of the enhanced research protocol to be complete in form and content based on the prescribed format. Moreover, it was found to be scientifically valid and sound to be carried out in hospitals,” Montoya said, citing the evaluation report they sent to Ona.
It was this report that Ona, who is on extended leave, quoted in his department order. He said PCHRD under the Department of Science and Technology "fully endorsed the implementation of a national program" using ActRx TriAct. (READ: Anti-dengue drug: A medical mystery)
Montoya, however, clarified in the December 1 letter that while they found the study scientifically valid, it is still the researchers' responsibility to secure the appropriate ethical review and approval of the study from the participating hospitals.
"The research proponent should comply with all pertinent and relevant procedural requirements as required by the concerned regulatory and monitoring agencies," he added.
Garin earlier suspended Ona's September 24 order allowing clinical trials of 2,000 units of ActRx TriAct – an herbal-based combination of Artesunate, Berberine, and Artemether – for dengue treatment in at least 6 government hospitals:
- San Lazaro Hospital
- East Avenue Medical Center
- Dr Jose N Rodriguez Memorial Medical Center
- Amang Rodriguez Medical Center
- Quirino Memorial Medical Center
- Jose B Lingad Memorial Hospital
The suspension was made to further evaluate whether the study is complying with “established scientific and ethical standards.” (READ: The dangers of ActRx TriAct, according to DOH)
Dr Juvencio Ordoña, former director general of the Philippine Institute of Traditional and Alternative Health Care (PITAHC), said researchers were already working on securing approval from the hospitals’ research and ethics review committees before the suspension of Ona's order.
Documents obtained by Rappler showed they were able to get ethical review approvals for the clinical trials earlier done at the Ospital ng Palawan and San Lazaro Hospital.
But the DOH had said in a statement the Palawan study did not afford its participants due protection, while the San Lazaro Hospital study "did not comply with the basic steps of a sound scientific research using people as subjects."
Dr Francisco Tranquilino, an ethics consultant, said if it was improper for the researchers to conduct the clinical trials, then the trials are unethical.
"Being illegal is different from being unethical, because…not everything legal is ethical," Tranquilino, who chairs the Philippine College of Physicians' Ethics Committee, said in a forum Tuesday, December 2.
'Implicit approval' from FDA
Rebuking its own chief, the DOH earlier said ActRx TriAct has "no legal basis” for clinical trials since it has not yet been registered with the Food and Drug Administration (FDA) as food, drug, or supplement.
But Preferred and Proven Therapies Inc (PPT) – the distributor of ActRx TriAct in the Philippines – said it was able to present FDA-issued permits before the Bureau of Customs for the drug's importation and release.
"They [FDA] approved the importation for research. That is an implicit approval that the research can go on," Ordoña told Rappler in an interview Tuesday.
The Philippine Institute of Traditional and Alternative Health Care (PITAHC) is a research institute attached to the DOH, which entered into a partnership with the manufacturers of ActRx TriAct. It was PITAHC which requested PCHRD in April and July to review the clinical trial conducted in San Lazaro Hospital.
'Science vs rules'
When Tranquilino read the final report of the San Lazaro Hospital clinical trial, he noticed something unusual.
"This is now a question of science against rules. [ActRx TriAct] is beneficial for the country. Do rules have to block the beneficial?"
The study, he said, mentioned the international pharmaceutical company ActRx Foundation as "a non-profit foundation dedicated and passionate in discovering medical breakthroughs.”
"One whole paragraph in the discussion page of the clinical trial was devoted to the pharmaceutical company producing [the treatment]. That’s not ethical because that will show you that the pharma company may have an influence in the conduct of that trial,” Tranquilino explained.
Tranquilino was part of the drafting of the Mexico City Principles for voluntary codes of business ethics in the biopharmaceutical sector.
"If I’m the clinical trialist, once I make a discussion of the results of my trial, I will discuss the results; I will not discuss who’s sponsoring me in that trial," he added.
Despite all the issues surrounding ActRx TriAct, Ordoña sees the suspension of Ona's department order as a "temporary setback." The treatment, he said, will be "beneficial" to Filipinos if only regulators allowed its further testing.
"This is now a question of science against rules. This is beneficial for the country. Do rules have to block the beneficial?" the former PITAHC chief said. – Rappler.com
Mosquito image via Shutterstock