i get asked why i bother to blog again and again on ActRx TriAct when no one seems to be reading, much less agreeing; mostly, the comments only echo, insist on, what kill-the-cocktail proponents feed an unthinking mediocre media.

meron naman akong readers, heh, or so my site stats tell me, and dr. stuart and i have been receiving email thanking us for the posts and the research and wishing that mainstream media would pick them up, publish them as well, so the public may know.  yeah, we wish.

but even if i had just a handful of readers, or even if no one agreed with the sentiments expressed herein, i would continue to blog, if only for the record.  i would continue to share my thoughts and reactions on an issue such as this that has national and worldwide significance.  dengue is a global public health concern, after all, and let it not be said, now and in the future, that pinoys, one and all, sat back and allowed the killing of a promising anti-dengue cocktail without question or resistance.

which is also to say that it is dismaying, nay, disturbing, nay, scandalizing! that the public discourse is so one-sided.  except for dr. tony leachon, speaking for the philippine college of physicians and the philippine medical association, and dr. sylvia claudio in her online column – both pro-garin, it would seem — we are not hearing any dissent from the medical community.  no doubt there are dissenters, but unfortunately they choose to not make public their informed opinions (along with their identities), they choose to not engage in, contribute to, an exchange of  expert views, whether for or against.  ask them why, and they’ll invoke the politics, the dirty politics; they’d rather not get involved.

but surely the good doctors know that their silence has political repercussions, too, giving the impression that they’re all okay (as in, all right) with acting DOH sec garin’s godawful decision to stop the ActRx TriAct clinical trials?

yeah, the devil is in the politics.*  and on this blog, we dare confront that devil.

Dr. Stuart:  I received anonymous emails with links to articles on the position of the Philippine Medical Association (PMA) and the Philippine College of Physicians (PCP), in support of the cancellation of the expanded clinical trials of the anti-dengue drug, ActRx TriAct. One was accompanied by a link to the WMA (World Medical Association)’s Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.

What the media reported on the PMA POSITION was a nitpicking criticism, full of text extracts from Dr. Calimag, without even the briefest elucidation on the censured design and analysis flaws.

In contrast, The WMA DECLARATION OF HELSINKI: ETHICAL PRINCIPLES FOR MEDICAL REASEARCH INVOLVING HUMAN SUBJECTS was an interesting read. I wondered which of the 37 articles the ActRx TriAct study violated. I likewise wondered if maybe it was sent in support of the ActRx TriAct study.

The last article was especially compelling: Unproven Interventions in Clinical Practice — “…where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legal representative, MAY USE AN UNPROVEN INTERVENTION IF IN THE PHYSICAN’S JUDGMENT IT OFFERS HOPE OF SAVING LIFE, RE-ESTABLISHING HEALTH OR ALLEVIATING SUFFERING.” Compelling — because it advocates the use of the medicine for compassionate use.

I don’t want to belabor the fact. The components of the ActRx TriAct anti-dengue therapy are old drugs, being repurposed or repositioned for new uses. Repositioning or repurposing drugs is one way of significantly shortening the process of drug studies and trials. Yet, criticisms continue to express incredulity on why the ActRx TriAct therapy did not take the usual 12 to 14 years of new drug development.

The PCP POSITION also slammed the people behind the clinical trial for including some children as subjects. Why are doctors so horrified or against testing the efficacy of the treatment on children? Ladies and gentlemen, it is the children who are most vulnerable, it is in the children’s sector where most fatalities are found in a 2011 study. From January to September, there were a total of 86,662 cases, with 65,000 (74%) occurring in all confirmed cases. 36% of these occurred in children aged 1-9 years, resulting in 265 deaths, representing 60% of deaths due to dengue in 2011.

CRAP?  There was also a public status on facebook posted by Dr. Claudio, that “the science supporting Ona’s anti-dengue miracle drug is crap.” In the course of public discourse, that the best argument a doctor in her position can offer is that the study is “crap,” is sad, unprofessional, disreputable, and downright juvenile. The study is crap!—and that’s it? We take her word for it? We deserve better than that. She should not have called a study “crap” based on reports she is privy to but she is not willing to divulge. Such criticism is crappier than crap.

The medical voices or the guardians of truth charged with informing the public is burdened with the responsibility of providing explanatory answers, not silently agreeing to pronouncements of “crap.”

We need a clear judgment and resolution on this controversial matter from a really independent scientific review board — if that is at all possible — not rantings from the bully pulpit or DOH press releases dutifully published by kowtowing media, repeating, ad nauseam, pronouncements from on high without looking deeper into or researching the issues.

GAME OVER?  But is it all moot now? Has the circus left town? Dr. Ona has resigned, silenced, lips politically zipped? The pneumonia vaccine issue abandoned to die a quiet death? The anti-dengue drug vilified as crap? The study criticized as unethical, diagnostically inaccurate, no endorsements, dubious paper trails, poorly designed, flawed data analysis, blah blah blah? Were these a fagot of separate political issues—of demolition, positioning, wheeling-dealing, and a clashing of government egos—really meant to get Ona out of the picture?

Or is this partly issuing from the great disdain by many in the medical community of anything that has to do with alternative medicine? Remember, many of the medicines that grace the pharmaceutical landscape are plant derived, and many more are waiting to be discovered, many a lot safer, without the toxicities of synthetic pharmaceuticals.

In the ActRx TriAct study of 290 patients — 145 received the drug treatment, 145 did not — there were no deaths in both groups of patients. The PCP concludes that because no one died in the 145 who didn’t take the drug, the “experimental drug added nothing in preventing deaths.” This is a valid scientific conclusion? Or just a position intent on seeing the cup half empty rather than half full.

In different studies, dengue deaths ranged from one for every 185 to 250 cases. In the ActRx TriAct study of 290 patients (145 with treatment, 145 without), taking the optimist position, the absence of death might suggest the benefit of prevention of at least one fatality.

Calimag also said: “the lack of adverse events in a small sample size is not conclusive evidence of the absence of harm.” Taking the optimist position, the absence of adverse effects might suggest the absence of toxicity — three drug components that have already undergone extensive toxicity evaluation — and the absence of deaths, albeit a small sample size, should support further expanded study and testing, especially in the many provinces that have attained malaria-free status.

THE CAT IS OUT OF THE BAG.  Even here in the boondocks, a local alternative healer has asked me about it. In places like these, what is to keep the local healers from accessing the separate components of the drugs for the occasional desperate families seeking any possible treatment for dengue stricken family members?

Is the study dead? I hope not—because the anti-dengue drug treatment has NOT been debunked. And calling it “crap” doesn’t kill it. Perhaps, dissenting voices from the medical community might still surface and dare to disagree with the powers that be, provide a badly needed and audible point of view.

If it is a bad study, tweaked or falsified, or in the end, proven as crap, I’ll be glad to help pull the trigger and kill it. BUT if the potential to save lives still exists, the testing and expanded use must be allowed to go forward. This year, from January to September 2014, there have been about 60,000 reported cases of dengue in the Philippines, with about 242 deaths (4 deaths for every 1,000 cases). These numbers cry out.

What a shame if in the end ActRx TriAct is taken elsewhere, and the drug is shown to work.

my pet theory is, the demolition job on ona and ActRx TriAct is in aid of that dengue vaccine for which a huge pharmaceutical company has spent $1.5 B on research and development, soon to be out in the market.  as i’ve blogged before, we could use both ActRx TriAct AND a dengue vaccine.  dr. stuart tells of the vaccine’s limitations here.

and if you’ve read this far, good for you, i saved some juicy tidbits for last.  over the holidays, different grapevines were buzzing with anti-garin stories: how she wants the post so badly, sorry na lang si ona, and how she’s not even qualified for such a high post — she’s more a politician daw than a physician, much less, a scientist (check out her wikipedia profile).

but the juiciest story, a sweet stab of sarcasm from ona himself, came via inquirer’s christmas day report, Ona: Loss of Aquino’s confidence prompted me to quit

When asked about his relationship with the acting health secretary, Ona said he thought it was “very ideal.’’

… “My personal things were brought to my house even before I officially announced my resignation and there’s only one person in DOH who could make such order,’’ Ona said.

whew, what a game she plays.  this is the same aquino-appointed acting DOH sec who brazenly disobeyed the quarantine rules imposed on families of travellers from ebola-stricken countries, the very same one, still unmasked, whom our senators welcomed to their august halls with beso-besos to boot.

the anarchy proceeds apace.  in the highest places yet.

*

* “The devil is in the politics” is how i ended the book Revolutionary Routes: Five stories of incarceration, exile, murder, and betrayal in Tayabas province, 1891-1980 (2011)