And now for Ona. . . A Manila Trial a la Nuremberg?

11 January 2015

By G. U. Stuart, MD

I thought the controversy on the ActRx Triact anti-dengue drug was going to die a quiet death—consigned to inevitable oblivion by the strong arm of politics that threatened many close to the heart of the research, nitpicked every which way, vilified as crap, with a media ensemble so eager to chorus their tsutsuwariwaps, amens and hallelujahs for the rantings of the powers that be.

But, perhaps, the controversy is far from dead. There has been a flurry of emails from the other side of the controversy—taking Garin, Claudio, and Leachon to task.

But now, a new voice from the anti-Ona trenches—Dr. Francisco Tranquilino, a regent of the Philippine College of Physicians Board and Assistant to the dean and college secretary of the UP College of Medicine. He sings the familiar line: the ActRx Triact dengue study was “technically and ethically fatally flawed.”

Dr Tranquilino draws on the  Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects.  He criticizes the inclusion of children in the Triact study as a “vulnerable” group. But how can you exclude children in a drug study for a disease where the children population is most vulnerable, where the majority of deaths happen in the same population. Also, nowhere in the Helsinki Declaration is it stated that children should be excluded in all studies. In fact, article 20 states: Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research. The article, in essence, supports the study of the drug in this vulnerable group of patients.

And again, to belabor what has been said so many times, artemisinin has been extensively studied and used in  thousands of children and has proven to have an excellent safety profile.

Not done with bully pulpit pronouncements, Dr. Tranquilino draws from history and says: “Like the Nuremberg Trial, we might need out own Manila Trial” —referring to a series of trials for the prosecution of prominent members of the political, military, and economic leadership of Nazi Germany in the 1940s. Is he insinuating an analogy with the “Doctors’ Trial” brought about by Nazi human experimentations that led to the development of the Nuremberg Code of medical ethics?

A Manila Trial akin to  the Nuremberg Trial? Are the doctors being accused of crimes against humanity? Is their research work being compared to Nazi human experimentation? That is a grievous, malicious, odious and defamatory insinuation—an insult to the Philippine medical research community. It demands an apology.

It also calls upon the community of physicians—researchers and clinicians alike—to show visible and audible umbrage. Till now, there have been only emails expressing quiet dissent, decrying the dirty and brutal politics that reigned in the Ona ouster and termination of the Actrx Triact anti-dengue drug study. To continue with silence is to risk consigning future medical research to the control of politics and politicians—to its inevitable demise or awful compromise.

And to Dr. Anthony Leachon, president of the Philippine College of Physicians: Do you agree with this position and insinuation by Dr. Tranquilino? And, lastly, let me rephrase your quote : “The interest of patients should take precedence over the interest of science.” I posit: The interest of patients should take over the interest of politics.

Posted in health, media

3 Responses to And now for Ona. . . A Manila Trial a la Nuremberg?

  1. January 12, 2015 at 11:05 pm
    manuel buencamino

    Ona was a victim of Garin’s ambition

    • January 15, 2015 at 5:14 pm

      the president’s all set to appoint her na pala, once the pope has come and gone.

  2. January 17, 2015 at 10:21 am
    Dok Margel

    Oh my, trapo (traditional politician) even at the Department of Health. Despite all of these things happening, I’m still optimistic. Let us continue investigating and tell everybody the truth.

    Dr. Stuart, I really do not believe that there is something wrong with the ActRx drug trial. In the first place, the govt. funding agency should have rejected the clinical study when they are still in the research proposal stage if it really has numerous flaws.

    Again, if the ActRx Triact dengue study was “technically and ethically fatally flawed” (according to Dr. Francisco Tranquilino)then why did the funding agency approved the group’s proposal to conduct clinical trials?

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