MANILA, Philippines–A group of doctors has called on lawmakers to investigate an experiment that allowed the testing of a supposed “breakthrough drug” against dengue on Filipinos that was allegedly riddled with “scientific and ethical flaws.”
Dr. Anthony Leachon, president of the Philippine College of Physicians (PCP), on Tuesday said either a Senate or House inquiry should be done in order to find those responsible for the clinical trials on the efficacy of ActRx Triact on dengue patients last year.
An inquiry would also shed light on why the testing was approved by some government agencies without it having undergone the usually “long route” to the approval of a new drug, Leachon said.
ActRx Triact, a two-day regimen against dengue, is comprised of an artemether sublingual spray and artesunate and berberine tablets. The multidrug treatment was supposedly discovered by Clark, Pampanga-based Preferred and Proven Therapies Inc. in collaboration with US-based ActRx Foundation.
Tested on patients
The drug was initially tested on malaria patients in rural health units and a hospital in Palawan in 2012 before it was used in a clinical trial on dengue patients at San Lazaro Hospital in Manila.
“We can see from the documents there was a breach of protocol in the approval process… our medical experts also say the trial was not scientifically and ethically sound, so why was it approved by a government agency that is supposedly the gatekeeper and vanguard of patients?” Leachon said.
Last month, Acting Health Secretary Janette Garin ordered the suspension of the national program on the experimental regimen for the mosquito-borne disease.
It was Health Secretary Enrique Ona who had given the regimen the green light in Department Order No. 2014-0161. Ona is still on leave pending a Malacañang decision on his status at the DOH.
The Department of Health, under Garin, has said the clinical trials for ActRx Triact were “highly irregular and dangerous” for not following or complying with the basic protocols of science experiments using human subjects.
At a health forum yesterday, Dr. Francisco Tranquilino, a clinical epidemiologist, said the long route to approval of a new drug usually took 10 to 15 years and adhered to strict guidelines.
“It would start from an idea, of a possibility of a new drug, all the way to its registration with the FDA [and], in between, going through different exploratory development processes and phases of clinical trials before going into full development study,” Tranquilino, also the PCP ethics committee regent, explained.
‘Breakthrough’ drug
He noted that the “breakthrough” drug against dengue did not undergo preclinical trials, which include laboratory tests, research protocols and animal testing, before being used in full-blown clinical trial on humans, including children.
“All these steps, we believe, were not present in this case,” Tranquilino said.
But some doctors supportive of the new drug have argued that the antidengue regimen could skip the preclinical trial stage since its three components—artemether, artesunate and berberine—were existing drugs and were merely being “repurposed” or “repositioned.”
Artemether and artesunate have been proven effective against malaria. Berberine, a compound found in herbs, has been in use in Europe and China for more than 2,500 years to treat various ailments such as intestinal infections, fever and hypertension, among others.
But Tranquilino countered that since the drug components were being used for another indication, they must go through the process of approval of the Food and Drug Administration.