Ramon F. Abarquez, Jr., MD, EFACC, FAsCC, FPCP, FPCC, CSPSH
AS PHILIPPINE COLLEGE OF PHYSICIAN (PCP) past president and member of the Council of Elders, I beg for indulgence for being an “elderly but young at heart and mind” and still being involved in the “real-world” of research and echoing the concept of “balanced public information” since Medicine is not an exact science.
First, congratulation to PCP and Philippine Society of Microbiology (PSIMD) for the “Open Letter” advertisement with well conceived arguments in presenting “urgent views” anent the Department of Health (DOH) dengue research studies perceived to be a “short-cut” wherein “the rights, safety and well-being of the trial participants… should prevail over interest of science and society.”
Is DOH being a “lenient” or a “reluctant advocate” if not an obvious “non-promoter” of “high-power” universal evidence-based medicine (EBM) and ethical research methodology? Certainly not so. DOH is family in the “PRC health sector” and a PCP major ally in the HERO and Sin Tax advocacies. Is Dr. Raffy Castillo’s narration of events factual enough as proof that DOH research procedural conduct is “above board” and consistent with the Helsinki Declaration? (Dr. Abarquez was referring to Dr. Castillo’s commentary that appeared in his Medical Files column of the Philippine Daily Inquirer on December 13, 2014—Ed.)
If we agree that dengue is an “alarming morbidity-mortality risk,” that is highest among children and elderly, then a “compassionate protocol” is needed such that the ‘numbers’ game is debatable. We should wait for the PCP, Philippine Medical Association (PMA), Board of Medicine (BOM), or Professional Regulations Commission (PRC) investigation findings.
Medicine being not an exact science and medical research reaches out for the “do no harm” advantage, still research outcome interpretation has two sides of the coin, such that EBM multicenter, multinational large scale studies can still show conflicting or opposing end-points thereby requiring a “post-hoc” meta-analysis or a Cochrane systematic review for a less speculative directional clinical decision making.
More importantly, clinical practice guidelines (CPGs) has barely 20 percent high-powered EBM supporting recommendations and even CPGs’ majority consensus recommendations are finalized by merely 20 percent expert panelists without conflict of interest ‘tag’.
Since EBM studies consist of a micro-population with specific inclusion-exclusion criteria, wherein study outcome is extrapolated into a macroreal- world population, such that a 2014 JACC article raised the concern that clinical trials failed to address societies’ needs. Obviously, “high powered” studies don’t necessarily reflect “down-to-earth” scenarios such that observational results may also provide synergistic, complementary or contrary options thereby leading to a “comparative effectiveness research” format.
For example, during an acute heart attack (STEMI type) CPG, interventional procedure is an ’emergency’ and yet the Philippine Heart Association (PHA) registry is similar to ASEAN registries outcomes wherein intervention compliance is merely 30 percent compared to the about 90 percent Japan compliance. However, the hospital mortality in Japan and ASEAN countries were similar.
In medical research, therefore, a “gold standard” protocol is desirable but currently unlikely, since medical practice involves human beings with heterogeneous genetic, behavior and environment interactions, sensitivities and immunities.
Vital Signs Issue 71 Vol. 4, January 1-31 2015