So who wants Dr. Ona’s post?

22 December 2014

By Katrina S.S.

Second of two parts

Clinical trials and the anti-dengue cocktail

But the bigger story is about the anti-dengue cocktail that is ActRx Triact, the clinical trials for which were started in 2012, as ordered by Dr. Ona. Acting Health Secretary Janette Garin stopped the clinical trials the moment she stepped in, declaring that it had “no legal basis” as it had yet to be approved by the Food and Drug Administration (FDA). At that point the Philippine Council for Health Research and Development (PCHRD) had questioned the soundness of the science behind the clinical trials. Since then the Philippine Medical Association (PMA), the Philippine Society for Microbiology and Infectious Diseases (PSMID), and members of the Philippine College of Physicians (PCP) have thrown their support behind Garin’s decision to stop the trials. These organizations question the science and ethics behind the clinical trials, and assert the dangers it poses to the public’s health. Dr. Sylvia Claudio has called the science behind the clinical trials “crap,” saying that it is “a medical horror story.”

Read on…

Posted in health, politics

5 Responses to So who wants Dr. Ona’s post?

  1. December 22, 2014 at 1:13 pm

    correction: Acting Health Secretary Janette Garin stopped the clinical trials the moment *soon after* she stepped in…

  2. December 22, 2014 at 5:02 pm
    baycas

    In this third column, I shall tell the story of how these trials came to be undertaken by the Department of Health. Before I begin, I will have to beg the reader’s indulgence. I will be reporting from documents leaked to me along with the request for anonymity. I must say that the leaked documents come from two or three reliable sources. None of the documents should be difficult to access because they should be public documents. But they remain inaccessible.

    Thus, I take the time to explain why I am taking the unusual step of writing 3 columns on this matter with the third column being from sources the readers cannot directly verify.

    My only motivation is that, as a medical professional, I find it abhorrent that Filipinos, and in this case even young children, were subjected to unethical testing. Furthermore, that the results of this testing were to be used to promote a drug that is potentially dangerous to those who take it and would have, in terms of creating malarial strains that would be resistant to therapy, put the health of many more of our people in danger.

    http://www.rappler.com/thought-leaders/78685-medical-ethics-doh

    • January 8, 2015 at 12:36 pm
      Dennis

      For your information, the final paper is NOT A PUBLIC DOCUMENT. It is the property of the of sponsor and that of the authors. That reason behind it not being accessible is because it is still PENDING publication. ALSO, how can you call it “LEAKED” if its a public document? Don’t you think that is contradictory to what you are saying?

      Did you know that these drugs are already established drugs to be taken by children? Artemether and Artesunate are even part of the guidelines in the management of malaria IN CHILDREN? Did you also know that berberine has been studied to treat giardiasis IN CHILDREN in the 1970’s? (Gupte, et. al. “Berberine in Treatment of Giardiasis”, 1971) did you also know that there is even a study done using berberine IN NEONATES? (Zhang et. al., in 2006, Assessment of taste development in 62 newborn infants) How can you say that this is unethical if it is already establish drugs for children?

      What is your evidence to say that this drug is dangerous? i have found NO literature saying that is dangerous.

      The study being conducted is that of a randomized CONTROLLED trial. how can it develop resistance in a control setting? Furthermore, this is just a clinical trial, this is not a policy to be used by the general public. As part of the research team, we would like to emphasize that we only want to study if it has an effect or not. We are not dealing with the policy of including it in the formulary or selling it in the market.

  3. December 22, 2014 at 5:07 pm
    baycas

    Worthy to link this here again…

    http://www.pcp.org.ph/index.php/announcement/494-position-statement-on-the-urgent-need-for-good-research-on-new-dengue-treatments

    From the Philippine College of Physicians (PCP) and the Philippine Society for Microbiology and Infectious Diseases (PSMID)

  4. January 8, 2015 at 12:37 pm
    Dennis

    If this is the case, how come we never received any letter of communication from PCP and PSMID to stop our clinical trials?

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