Doctors slam 'poorly designed’ study on anti-dengue drug
MANILA, Philippines – When a San Lazaro Hospital study on anti-dengue treatment ActRx TriAct was found to be "scientifically valid," it became the basis for Health Secretary Enrique Ona's department order allowing more clinical trials of the drug in select government hospitals.
But more than a month after the order was stopped by Acting Secretary Janette Garin, medical groups criticized the study as "poorly designed," with a data analysis that is "seriously flawed."
In a statement Tuesday, December 16, the Philippine College of Physicians (PCP) and the Philippine Society for Microbiology and Infectious Diseases (PSMID) refuted claims by proponents of the drug.
They did not name ActRx TriAct – a herbal-based combination of Artesunate, Berberine, and Artemether – and only referred to it as a "novel triple-drug combination for dengue fever."
"The only basis for expanding the use of this drug combination to several DOH hospitals was a study on 290 dengue patients in one medical center. They claimed there were no deaths due to dengue among 145 patients who received this treatment in the clinical trial," said Dr Mario Panaligan, PSMID vice president and a member of the PCP Board of Regents.
"However, they are not saying in public that those who did not get this treatment also survived, which does not provide extra benefit in preventing deaths," Panaligan added.
The San Lazaro Hospital study supposedly claimed ActRx TriAct can eliminate the dengue virus faster, but PCP and PSMID said the study did not use the most accurate diagnostic test available to detect the virus in the blood of the patients.
The study was the basis for Ona's September 24 order allowing clinical trials of 2,000 units of ActRx TriAct for dengue treatment in 6 government hospitals. Garin suspended the order on November 14 to further evaluate whether the study complies with “established scientific and ethical standards.”
Ona is on extended leave, awaiting President Benigno Aquino III's assessment of his performance. He was asked to go on leave in October following a probe by the National Bureau of Investigation into complaints his department did not purchase "more cost-effective" vaccines for pneumonia. (READ: Aquino wants more answers from Ona)
To date, there is no specific treatment for dengue in the Philippines, where the disease has become an epidemic. In 2013, the Department of Health (DOH) recorded 204,906 dengue cases and 660 deaths.
ActRx TriAct was called a breakthrough drug that can kill viruses, bacteria, and parasites like malaria. But PCP and PSMID are curious why researchers are leaving out other effects of the drug, like malaria resistance. (READ: The dangers of ActRx TriAct, according to DOH)
"In the case of the malaria parasite, only artemether and artesunate have been unequivocally proven to be effective, while berberine has not," said former PSMID president Rontgene Solante.
"The proponents of this research are not telling the public that unwarranted and widespread use of artemether and artesunate in the community will promote malaria resistance to the drug – a serious public health problem that the government should address immediately."
The World Health Organization had earlier warned that if ActRx Triact is used in areas where both malaria and dengue are coendemic – such as the Philippines – resistance to malaria could develop.
'Stop use of unproven treatments'
PCP and PSMID also dubbed the researchers as unethical for using the treatment on children without first testing it on adults. (READ: Is the anti-dengue drug trial ordered by Ona ethical?)
"It is our obligation to stop the expanded use of scientifically unproven treatments," the groups said in response to the claim that stopping Ona’s order deprives dengue patients of a "promising" drug. (READ: Anti-dengue drug trial 'beneficial' – Ona adviser)
The health department itself criticized the study for not complying with “the basic steps of a sound scientific research using people as subjects.” It also said all clinical trials involving the drug have no legal basis, as they were not approved by the Food and Drug Administration.
"We call on our colleagues to conduct clinical trials in accordance with the ethical principles consistent with the Declaration of Helsinki, Good Clinical Practice Guidelines, and the applicable regulatory requirements," said Dr Francisco Tranquilino, chair of PCP's ethics committee.
Both medical groups recommended the publication of the full trial report "for public scrutiny," or for the report to be shared with "all parties concerned." – Rappler.com