Anti-dengue drug trial ‘beneficial’ – Ona adviser

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Anti-dengue drug trial ‘beneficial’ – Ona adviser
Preferred and Proven Therapies Inc presents FDA-issued permits which authorize the importation of the controversial anti-dengue drug for clinical trials
'NO LEGAL BASIS.' The Department of Health says the controversial ActRx TriAct has no legal basis to be in the Philippines. File photo from the ActRx Operational Group website

MANILA, Philippines – A controversial drug allegedly favored by Health Secretary Enrique Ona to combat dengue in the country has been the subject of recent speculation and debate, but an adviser to the health chief considers it “beneficial” to Filipinos.

Dr Juvencio Ordoña, former director general of the Philippine Institute of Traditional and Alternative Health Care (PITAHC), said he supported the development of the so-called breakthrough drug ActRx TriAct because he knows “this could help the country.”

He said ActRx TriAct – a herbal-based combination of Artesunate, Berberine, and Artemether – has so much potential if only regulators allowed its further testing.

“If we don’t experiment on herbals, we will end up lagging behind other Southeast Asian countries, the former PITAHC chief told Rappler in a mix of Filipino and English.

PITAHC is a research institute attached to the Department of Health (DOH), which entered into a partnership with the manufacturers of ActRx TriAct.

Ordoña rose from the ranks starting in 1970 as a junior resident physician – what he called the “lowest animal in the hospital kingdom” – to eventually becoming PITAHC director-general during former Health Secretary Francisco Duque III’s term in the DOH.

Traditional and herbal-based medicine has a special place in his heart for being accessible to communities. The 71-year-old Ilocano doctor retired in January 2014 and was an adviser to Ona. 

Innovation vs assured safety, efficacy

ActRx TriAct is set to be exclusively distributed by Preferred and Proven Therapies Inc.

Ona, who is on extended leave, reportedly approved its clinical trial and eyed its eventual inclusion in the standard treatment of the mosquito-borne disease.

As in many health issues in the past, the pursuit of innovation to the exclusion of assured safety and efficacy (as many researchers put it), has put the drug in question.

Ordoña said the claims of ActRx TriAct critics are exactly why continuing research is needed.

The suspension ordered by DOH officer-in-charge Janette Garin effectively halted Phase II of the ActRx TriAct’s clinical trial, Ordoña told Rappler.

He admitted that ActRx TriAct is not yet a treatment. It is an unregistered drug, he clarified, and further testing is necessary. This, he said, was the basis of Ona’s department order 2014-0161 which expands the coverage of ActRx TriAct’s clinical trial. 

Courtesy of the US National Institutes of Health


Emerging top destination for clinical trials

Clinical trials are long and arduous. Phases of drug development are in place for a reason, foremost of which is ensuring the drug’s safety and efficacy.

They are meant to determine a drug’s proven indications, a clearly indicated therapeutic purpose. 

In June 2012, the Food and Drug Administration (FDA) recognized the country’s emergence as a “top destination for global clinical trials.”

The US National Institutes of Health records 701 clinical trials currently ongoing in the Philippines, which makes proper implementation of existing regulatory mechanisms all the more necessary.

Ordoña said the development of ActRx TriAct as a treatment intends to abide by these rules, but the suspension that Garin ordered against continued clinical trial in 6 public hospitals prevents further exploration of any medicinal effect of the drug. 

ActRx TriAct can only be registered once the clinical trial is completed, Ordoña added, which cannot happen unless the suspension is lifted.

No FDA permit for importation?

It is the FDA Special Permit Division which supposedly grants permits for the importation of investigational drug products intended for future registration.

The said FDA permit gives the Bureau of Customs (BOC) the go-signal to import an unregistered drug meant for the clinical trial, among other special purposes. 

The DOH had said in a statement that the clinical trials for ActRx TriAct were not approved by the FDA.

But the FDA Special Permit Division only issues import permits of unregistered drugs for trials it has approved, an insider earlier told Rappler.

Preferred and Proven Therapies Inc, however, was able to present FDA-issued permits before the BOC for the drug’s importation and release.

ActRx TriAct – FDA permit

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