DENGUE TRIPLE DRUG TREATMENT STUDY REJECTED BY PCP & PSMID

In Photo are the ff: Dr. Mario Panaligan, Dr. Francisco Tranquiluino, Dr. Tony Leachon and Dr. Rontgene Solante at the PCP Health Media Forum held every Tuesday at Annabels Restaurant in T. Morato, Q.C. (Original Photo by. Ver Garcia)

Dengue experts reject dengue treatment study;

call on doctors and government bodies  to adhere to ethics in clinical research

Members of the Philippine College of Physicians (PCP), together with the Philippine Society for Microbiology and Infectious Diseases (PSMID), criticized a clinical trial conducted in the Philippines of a novel triple-drug combination for dengue fever.  The two medical professional organizations stated the research study was poorly designed and the data analysis seriously flawed.

Controversy arose in recent weeks over the use of a proposed novel treatment that has three ingredients: oral artesunate, artemether (sprayed under the tongue), and berberine, an oral herbal medication. The triple drug combination has been recommended for use among dengue patients in several DOH hospitals under a “cohort study” protocol.

In a statement published in two newspapers yesterday, the PCP and PSMID said they fully support the global call for urgent research on new treatments for dengue but they cannot condone shortcuts in the search for a safe and effective dengue cure and raised major concerns on the trial. “The rights, safety, and well-being of the trial participants are the most important considerations and should prevail over interests of science and society,” they stated.

PCP President Dr. Anthony Leachon said it is the obligation of health professional groups to call for stopping the expanded use of scientifically unproven treatments, such as this triple drug combination, touted as a “promising” drug 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. However, they are not saying in public that those who did not get this treatment also survived, which does not provided extra benefit in preventing deaths,” said Dr. Mario Panaligan, member of the PCP Board of Regents and Vice President of PSMID.

This drug was also said to help eliminate the dengue virus faster in patients’ blood than those who did not receive the treatment. The PCP and PSMID said the diagnostic test strategy used to detect virus in the blood was not the most accurate test available.

  

Another claim that the drug combination worked in children and adults with dengue was also dismissed by PCP and PSMID. Aside from the flawed study that failed to prove it worked, the groups said it was unethical for the investigators to test drugs in children without first testing them in adults. They said increased vulnerability of children and the elderly calls for special vigilance among the concerned groups.

“The three-drug combination is said to kill viruses, bacteria and parasites. In the case of the malaria parasite, only artemether and artesunate have been unequivocally proven to be effective, while berberine has not. 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,” said Dr. Rontgene Solante, former President of PSMID and one of the experts on infectious diseases in the country today.

Dr. Francisco Tranquilino, PCP Regent for Ethics Committee added that in the interest of patients’ safety and welfare, the DOH, Food and Drug Administration, the Philippine Council for Health Research and Development, the Philippine Health Research Ethics Board, and the doctors-researchers themselves should vigorously ensure that the principles of Good Practice in clinical research are followed. 

“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,” Tranquilino said.

They also called for transparency, recommending publication of the full trial report for public scrutiny, or at least sharing it to all concerned parties. Lastly, PCP and PSMID reminded researchers and research sponsors that the design of trials should be technically sound. They stated, “The protocol should be approved by an accredited ethics review board, consisting of members who have no apparent conflict of interest.”

Worldwide, dengue fever affects over 50-100 million people a year, leading to 500,000 cases of shock, and 22,000 deaths. In the Philippines, the DOH reported close to 60,000 cases of dengue for January – September 2014, with 242 deaths (or 4 deaths among 1,000 cases), mostly in children. (VerGarcia/TeddyChoBlogs)