in defense of dr. ona (updated)

30 November 2014

poor dr. ona! indeed.  it would seem that the health secretary has been prejudged over his decision to procure the cheaper of two pneumonia vaccines when, as boo chanco explains, it was apparently a professional decision grounded on what makes the most sense, given cost and need.  dr. ona deserves a fair hearing.  the same is true with regard to the use of malaria herbal meds as treatment for dengue.

Dengue, Deaths, Drugs and Politics
By Godofredo U. Stuart M.D.

ActRx TriAct®—an herbal based treatment that combines artemether and artesunate, both used to treat malaria, and promoted as a new breakthrough treatment for Dengue— should be most welcome news, especially as a painless two-day regimen sprayed under the tongue.

Instead of celebrating a potentially life-saving treatment—for a disease that has, to date, no specific drug therapy available—Health Secretary Ona is under scrutiny for authorizing the breakthrough drug for use in dengue.

WHO Dr. Julie Hall warned the DOH against using the Artemisinin combination treatment—mainstay treatment for falcifarum malaria saving thousands of lives each year—for fear of development of resistant falcifarum malaria. She’s also concerned dengue and malaria are coendemic in some areas, and use of artemisinin in those areas could cause an emergence of malaria resistance.

Here are some numbers. In 2012, there were 187,031 cases with 921 deaths. In 2013, 204,906 cases with 660 deaths. This year, “some 24,900 cases have resulted in (at least) 100 deaths, or a ration of one fatality for every 249 cases,” Ona said. 

Malaria, on the other hand, has significantly declined since the mid-2000s, with an 83% reduction from 2005 to 2013. and deaths down from 150 in 2005 to 12 last year. A DOH report reassuringly headlines: The Philippines is on the verge of attaining malaria-free status.

And as important, of 53 known provinces endemic for the disease, 27 have already been declared malaria-free (Cavite Batangas, Marinduque, Catanduanes, Albay, Masbate, Sorsogon, Camarines Sur, Iloilo, Aklan, Capiz, Guimaras, Bohol, Cebu, Siquijor, Western Samar, Eastern Samar, Northern Samar, Northern and Southern Leyte, Biliran, Camiguin, Surigao del Norte, Benguet, Romblon, Batanes, and Dinagat Islands)—while dengue is earning epidemic status.

In 2012, in a regional surveillance report by the DOH, Cebu City topped the list with 3,081 cases of dengue with 12 deaths. Cebu is one of the 27 provinces that has been declared malaria-free. Iloilo, also designated malaria-free, reported a 71% surge in dengue cases. Aklan, also malaria-free, has seen an increase of 75%, up 1,340 cases compared to 763 last year. There are deaths buried in those numbers. Davao, although not Malaria-free (3 cases in 2013), reported 39 dengue deaths. These are compelling numbers.

I hope it’s real clinical concern that’s putting the ActRx TriAct on hold—that it’s not being stonewalled by ego and politics. Infectious disease experts should do a think-tank on the dengue health issue, devise appropriate treatment protocols. Judiciously using the treatment only for severe and lab-diagnosed cases should help avoid the emergence of resistance.

And why look to the WHO for advisement? While it suggests no specific drug therapy, it has listed dengue fever as a “neglected disease” and estimates that there may be 50 to a 100 million dengue infections worldwide each year. Rather, while others concern themselves with vector control and other public health measures, our medical community can take the initiative and embark on a pioneering treatment program that may eventually prove useful in the dengue pandemic. And if need be, until the warring factions settle their issues, the drug should be placed on “compassionate use” status.

There have been many pharmaceutical breakthroughs—studies finding new uses for old drugs. That a drug that saved lives from malaria can now be used to prevent deaths from dengue is one such breakthrough. A godsend. . . a eureka moment.

The Phase III clinical trial has concluded that ActRx TriAct is a highly efficient and successful treatment for dengue. Unless or until that is proven otherwise, if ActRx TriAct can prevent hundreds of dengue deaths a year. . . it would be medically unethical not to use it. Perhaps, criminal.

*

Ona in trouble over use of malaria-dengue drug
Ona’s fate hangs as PNoy reads report on vaccines
Was Secretary Ona let go because Usec Janet Garin, former staunch RH advocate in the House, would be more determined to push the RH Law into full implementation?

Posted in health, politics

23 Responses to in defense of dr. ona (updated)

  1. November 30, 2014 at 6:53 pm
    manuel buencamino

    Here’s a good op-ed in support of Dr Ona. http://www.bworldonline.com/content.php?section=Opinion&title=sympathy-for-health-secretary-ona&id=98445

    “In the event that Secretary Ona leaves office, let us remember the gains of the Department of Health under his leadership. Secretary Ona is not a radical reformer like his predecessors: the late Johnny Flavier, the late Quasi Romualdez, and Espie Cabral. But it was under Ona’s watch that the increase in sin tax rates, the reproductive health reform, the strengthening of the Philippine Health Insurance Corporation, and the graphic health warning on cigarettes were all legislated. These were the issues that Flavier, Romualdez and Cabral fought for.

    In sports parlance, Ona achieved a hat trick.”

  2. November 30, 2014 at 10:21 pm
    Bert

    I find it quite strange for someone holding the highest position in the Department of Health of the Philippines recommending the use of something that has no proven therapeutic value for use on patients in government institutions and hospitals. A herb doctor doing that is more understandable, but not a secretary of health. Hmmmn.

    • November 30, 2014 at 11:58 pm
      baycas

      Bert,

      The main reason why malaria is on the downtrend is because the Artemisinin-based combination drug is regulated by the government. This prevented malarial parasite resistance to the drug.

      It is only available in San Lazaro and RITM…also in Quirino Memorial (formerly Labor Hospital) yata. At mahigpit pa ang dispensing…

      • December 1, 2014 at 11:56 am
        Bert

        baycas,

        I was referring to the purported breakthrough drug for dengue, the ActRx…, being pushed by Dr. Ona to be used in government hospitals.

        • December 1, 2014 at 3:08 pm
          baycas

          Yes, so now I can say this…

          Giving that investigational drug for the purpose other than malaria (which the artemether and artesunate are known for) will promote resistance of the malarial parasite (esp. the falciparum kind) to the drugs.

          Artemisinin-based combination Co-Artem is standard of care for Falciparum malaria. Ona et al will use an similar artemisinin-based concoction for an investigational dengue study and, in fact, pointing to a direction of making it an instant first line drug for dengue. Resistance to the drug will render the first line of defense against malaria inefficient.

          The so-called “breakthrough” for dengue treatment will now be a “monkey-wrench” thrown to the success of malaria treatment here in the Philippines and flush the valid and reliable anti-malaria clinical studies down the drain.

          • December 1, 2014 at 3:29 pm
            Bert

            Right, baycas. I agree.

            Going back to Dr. Ona, I think that he cannot be defended in this anti-dengue drug fiasco until more data about the drug surfaces that can explain its efficacy and safety to patients in the treatment of dengue.

          • December 1, 2014 at 4:14 pm
            baycas

            I concur with your statement, Bert.

  3. November 30, 2014 at 11:00 pm

    updated: added last 2 paragraphs, dr. stuart’s piece, that got lost in the cut-n-paste. my bad :(

    • November 30, 2014 at 11:34 pm
      baycas

      So Dr. Butch was able to critically appraise the Phase III Clinical Trial already?

      Please upload if he has it.

    • December 1, 2014 at 10:24 am
      baycas

      Angela,

      Here is an opposite article to your blog post…

      No evidence of clinical trials

      I took some time to explain this all because, as I began to ask around about this breakthrough drug, my surprise turned to mystification and then dread.

      I could find no evidence that ActRx Triact has gone through the proper clinical trials. No evidence of PCHRD or FDA approval of any of the clinical studies cited (but never fully presented) by the manufacturer and the DOH.

      http://www.rappler.com/thought-leaders/76598-anti-dengue-drug-medical-mystery

  4. December 1, 2014 at 5:50 am
    baycas

    Angela,

    Please ask about this:

    Berberine is a bitter yellow substance with an effect on circulation. A study reported an overdose of berberine to be possibly fatal from paralysis of the central nervous system.”

    http://www.stuartxchange.com/Kachumba.html

    • December 1, 2014 at 9:21 am
      baycas

      Butch wrote:

      ActRx TriAct®—an herbal based treatment that combines artemether and artesunate…

      The mix is in combination with berberine as reported in media and as published in the web site of the drug.

    • December 1, 2014 at 10:32 am
      baycas

      Hall said WHO considers berberine to have no effect against malaria and, hence, it is not included in the malaria treatment recommendation.

      https://ph.news.yahoo.com/help-doh-handle-cases-trial-000000383.html

  5. December 1, 2014 at 11:12 am
    Bert

    “The Phase III clinical trial has concluded that ActRx TriAct is a highly efficient and successful treatment for dengue. Unless or until that is proven otherwise, if ActRx TriAct can prevent hundreds of dengue deaths a year. . . it would be medically unethical not to use it.”

    Now I’m more confused. I wonder where this Phase III clinical trial finding ActRx TriAct efficient and successful in treating dengue done? The WHO, the DOST, the FDA and the DOH were one in saying that it has no proven therapeutic value.

    From various medical sources, dengue is self-healing in one to two weeks without medication, mortality rate is very small and death is usually caused by complication such as excessive bleeding due to very low level of platelets, or very high fever that damaged the brain. Now, this questionable medicine is sprayed under the tongue of the patient who has already contracted dengue. If this medicine is really an effective treatment, it would be very interesting to know how it works on a dengue patient. Dr. Ona and the distributor of this medicine owe it to the public, and specially to the dengue patients in hospitals being supplied, to explain its full therapeutic value. If they cannot do it, then something smells here.

  6. December 1, 2014 at 4:46 pm
    baycas

    Ona’s “anti-dengue” investigational study has no legal cover and it appears that the first clinical trial done by Miranda in San Lazaro did not follow the rigors of a true clinical research (Good Clinical Practice)…

    http://www.rappler.com/nation/76618-doh-no-legal-basis-dengue-treatment

  7. December 1, 2014 at 7:17 pm
    baycas

    “The use of artemether and artesunate is considered as artemesin monotherapy, which increases the prevalence of resistance to anti-malarial drug,” Lee Suy said.

    “The strong possible emergence of resistance to malaria via artemesin monotherapy could have devastating and fatal impact on the lives of Filipino suffering from malaria,” he added.

    http://www.gmanetwork.com/news/story/390520/news/nation/doh-ona-approved-anti-dengue-treatment-placed-lives-in-danger

  8. December 2, 2014 at 9:47 am
    baycas

    In a document released Monday, December 1, DOH listed 5 reasons why it considers the use of ActRx TriAct for clinical trials as dangerous, and why the trials were not approved by FDA, the Research Institute for Tropical Medicine, and the DOH’s National Center for Disease Prevention and Control:

    Berberine, one of the components of ActRx TriAct, has no known or established medicinal effect against malaria or dengue. It needs further analysis.

    To date, Arthemeter is the only effective treatment against the deadliest form of malaria, but it must be combined with two other medicines (Lumifantrine and Primaquine) to be effective.

    Resistance to Arthemeter may occur if used as a single therapy or monotherapy medicine for malaria instead of combining it with Lumifantrine and Primaquine. The Philippines is already in the elimination phase for malaria; resistance will be “devastating and disastrous.”

    Combining Artemether as a sublingual spray with Berberine and Artesumate tablets to fight dengue poses side effects.

    There is no plausible explanation available on how Artemether and Artesunate – the treatment’s two other components – might act against dengue.

    The document mentioned the World Health Organization’s warning that if the treatment is used in areas where both malaria and dengue are co-endemic – such as the Philippines – resistance to malaria could develop.

    http://www.rappler.com/nation/76669-doh-dangers-actrx-triact

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