Dec 122014

The local distributor of the ActRx TriAct, an herbal drug that is claimed to be effective against dengue and malaria, on Friday disputed assertions made by the Health Department that the clinical trials of the drug were illegal and that the drug could have long-term harmful effects.

“It is truly confusing and disheartening because the statement of DOH is founded on conjecture and has the tenor of predisposed opinions without proper verification as to the veracity of the allegations that have been hurled,” said Hexilon Alvarez, president and chief executive officer of Pampanga-based Preferred and Proven Therapies Inc. (PPTI), in an email.

Alvarez said that ActRX TriAct was proven not be harmful because the US non-profit organization ActRx Foundation Inc. had secured the approvals from the US FDA, which is under the US Department of Health and Human Services (USDHHS).

Alvarez provided GMA News Online a copy of a certification issued by the USDHHS’ Institutional Review Board (IRB) acknowledging that it had reviewed on February 22, 2012 the ActRX Foundation Inc.’s proposed protocol for the conduct of clinical trials of “Dengue Fever Treatment with Artemesia Combination Therapy (ACTRx)”.

“The ActRx Foundation Inc. proposal IORG0006761-7 Dengue Fever treatment protocol has been provisionally approved… The IRB recommends proceeding with a submission of the actual consent form to be used in the study,” the IRB certification reads.

“The US Dept of Health and Human Services and FDA would not have issued the ‘go ahead’ or approval of the protocol to conduct testing on humans unless they were not sufficiently convinced of the safety and toxicity of the products and proceed with determining actual efficacy in a large group of humans,” Alvarez argued further.

Alvarez said the USDHHS and FDA approval was valid from 2012 to 2014.

ActRx TriAct was developed and continues to manufactured by ActRX Operational Group, Ltd.

Philippine FDA-approved

In her December 1 statement, acting Health Secretary Janette Garin said that ActRx Triact had not been registered with the Philippine Food and Drug Administration, whether “as a drug or as a food or a supplement.”

Alvarez countered that a treatment or drug to be used only in a clinical trials did not need to be registered with the FDA. PPTI imported and distributed more than 2,000 ActRx TriAct packs for DOH’s human clinical trials, which began in 2012. 

“We have to make clear that the FDA approval of the treatment being used in the trials/research is not necessary yet at this stage. The approval of the treatments (for use by the public) by the FDA comes after results of trials,” Alvarez argued.

Despite this, according to Alvarez, PPTI still applied for FDA approval of its protocol, even with the protocol already having been approved by the Philippine Council for Health Research and Development (PCHRD).

“This we did out of good faith and clean intentions,” PPTI’s president and CEO said.

Alvarez also pointed out that the FDA had issued two permits to PPTI one dated June 7, 2012 and another dated July 4, 2012, allowing the release of thousands of imported packs of artesunate and berberine, two of the three components of ActRx TriAct.

“It will not also be amiss to state that prior to the FDA’s issuance of Import Permits early in June 2012, the respondents provided the FDA Pharmaceutical Data, Safety Data and Efficacy Data of these drug as prerequisites thereto,” he added.

The FDA two permits, copy of which were obtained by GMA News Online, bear the signature of then FDA director Dr. Suzette Lazo.

Safe, proven effective

Alvarez also maintained that the ActRx TriAct was safe and was effective in the treatment both of malaria and dengue as proven by the clinical trials of the drug done in 2012 and 2013.

Alvarez cited a November 2012 trial, in which ActRX TRIACT, a combination of the compounds artemether, artesunate, and berberine, had been used in a clinical study for malaria treatment in selected areas in Palawan.

He also pointed to a 2013 trial, in which ActRX TRIACT was administered to patients in a clinical study for dengue treatment at the San Lazaro Hospital.

Alvarez claimed that there were 100 malaria patients and 144 dengue patients administered with the ActRx TriAct.

“For the ActRX study for malaria conducted in Palawan, it yielded impressive results (100% success, ZERO mortality) even in serious cases. In fact, there was a case where the patient, diagnosed with cerebral malaria and was almost in a comatose state but recovered within a small amount of time after administration of the loading dose of the ActRx treatment,” Alvarez touted.

He said that the clinical trial of ActRx for dengue done at the San Lazaro hospital also yielded 100 percent success.

“There were no adverse reactions. Needless to say, there was zero mortality rate…At the San Lazaro Hospital, there were a considerable number of deaths due to dengue the year prior to the use of the treatment,” Alvarez said.

Alvarez provided GMA News Online a certified true copy of a letter dated August 7, 2014 which PCHRD executive director Dr. Jaime C. Montoya sent to Health Secretary Enrique Ona and which said that a review of the clinical trial for dengue protocol showed that it was “complete in form and content” and was “scientifically valid and sound to be carried out in hospitals.”

Quoting Montoya’s findings, currently on-leave Health Secretary Ona, through Department Order No. 2014-0161 issued on September 24, 2014 ordered the clinical trial of 2,000 units of ActRx TriAct for dengue treatment in six more government-run hospitals.

Garin, however, ordered the clinical trials to be suspended on November 14, to give way for a review on matter.

On December 1, through a statement, Garin ruled that the clinical trials in 2012 and 2013 were illegal and should not have taken place.

No anti-malarial effect 

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.”

Alvarez, however, said that “in sharp contrast to what Dr. Hall said, several studies on berberine showed that it has an anti-malarial properties and as such when taken with artemether and artesunate would mean treatment of malaria not as a monotheraphy but a combination therapy which will not only make the treatment more efficacious but patients would have less predilection to resistance.”

“It is unfortunate that a foreign-funded projects, geared towards humanitarian endeavors, wherein our country and the people are the primary beneficiaries, are the ones that are being torn apart and shelved… Let the science of this study speak for itself. Politics and clashing economic interests has no place in this humanitarian endeavor of saving lives,” Alvarez said.

Alvarez is the son of former Senator Heherson Alvarez.

GMA News Online was unable to contact acting Health Secretary Garin for comment as of posting time. — DVM, GMA News

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