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At Large

That dengue/malaria drug

/ 12:44 AM December 09, 2014

One of the issues being raised against Health Secretary (on leave) Enrique Ona was the approval for testing on humans of an experimental drug that uses a combination of herbal drugs artemether, artesunate and berberine, under the name “ActRx TriAct” for the cure of both dengue and malaria.

Acting Health Secretary Janette Garin has since suspended the trials, with health department spokesperson Dr. Lyndon Lee Suy explaining that “the 2012 and 2013 clinical studies should not have happened” because the new drug, claimed to cure both malaria and dengue, “may have long-term harmful effects on those who were administered the treatment.”

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But Dr. Joven Ordonia, a former director general of the Philippine Institute of Traditional and Alternative Healthcare, which conducts studies on traditional health practices, including the use of herbal medicines, defends the trials, conducted at the San Lazaro Hospital. Of 288 subjects diagnosed with dengue and given the new drug therapy, Ordonia says all recovered.

Indeed, a summary of the final report, dated March 15, on the San Lazaro trials proclaims: “The long wait is over. There is now a treatment for Dengue.”

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If true, this should be good news for Filipinos, since dengue has become endemic in the country. “It is no longer a seasonal disease,” observes Ordonia, “and in fact health authorities have identified four strains of dengue.”

Dengue fever is caused by a family of viruses that are transmitted by mosquitoes, with symptoms ranging from “severe joint and muscle pain, swollen lymph nodes, headache, fever, exhaustion and rash.”

In the most extreme cases, dengue can lead to internal hemorrhage (thus it is also known as hemorrhagic fever) and result in death. Because it is caused by a virus, there is, at least for now, no medicine or antibiotic to treat it. So the news from the ActRx TriAct front, if true or accurate, is good news indeed.

* * *

One of the points raised questioning the efficacy of this new drug therapy is that, while it claims to be a cure for both malaria and dengue, the two diseases are quite different from each other. Dengue is caused by a virus, malaria is caused by bacteria. Though both are spread by mosquitoes, they are spread by two different types of mosquitoes—one thrives in clean water, the other in dirty water.

But, says Ordonia, the combination of herbal medications has “both antiviral and antibacterial qualities.”

Artemether and artesunate are derived from artemesin, a drug used for treating malaria. Artemesin is administered with other drugs—lumefantrine and primaquine—to prevent drug resistance. The new drug therapy combines artemether and artesunate with berberine, which, the Department of Health says, “may have long-term effects that have not yet been studied adequately” and could “possibly ruin the lives of Filipino malaria and dengue patients.”

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In its press conference, the DOH cited the observations of thePhilippine Council for Health Research and Development which found that the trials lacked “baseline characteristics of participants,” lacked sufficient scientific justification “for the use of artemether and artesunate for dengue treatment”; and did not have preclinical studies on each of the three drugs “as to which drug has antidengue properties.”

The same study, said Lee Suy, “did not comply with the basic steps of a sound scientific research using people as subjects.” The Food and Drug Administration (FDA), he added, has not recognized ActRx TriAct as either a drug or a food supplement.” “It has no legal basis to be present in the Philippines, especially for clinical trials,” Lee Suy concluded.

However, Ordonia argues that in previous years, the FDA issued to the manufacturers of ActRx TriAct a permit for “importation for research purposes.” Aren’t clinical trials precisely part of research, he asks.

Some findings of the San Lazaro study, says Ordonia, are that the combination therapy “decreased the number of days of fever” endured by patients, helped halt the alarming decrease in the number of platelets, and reduced the abdominal pain characteristic of dengue.

* * *

We can leave to medical and scientific experts the exact evaluation of efficacy and/or deficiency of this new drug.

But as some have observed, when you have dengue or malaria—or any member of your family is similarly stricken—wouldn’t you resort to finding a therapy that holds out the hope for a cure?

No one can blame a parent or spouse or relative for consenting to use an experimental drug in hopes of alleviating a serious, life-threatening illness, whose ferocity has steadily been increasing.

But still, since they are empowered by law, and equipped with the necessary scientific knowledge and clinical experience, shouldn’t health authorities be all the more rigid in their evaluations and conclusions? We are talking, after all, about the health of millions of Filipinos—and any failure or shortcoming on their part would have far-reaching consequences.

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TAGS: Dengue, Food and Drug Administration, health, Health Secretary Enrique Ona, malaria, news
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