The Dengue Vaccine Fiasco...
Papaya Leaf Juice, Anyone?

A Case for Alternative Therapies
Dr. Godofredo U. Stuart

The Dengue Vaccine Scam
The Dengvaxia vaccine is “the biggest government funded clinical-trial-masked-as-a-public-health-program scam of an experimental drug in the history of the DOH.”

It’s a damning charge made by Dr. Susan Pineda-Mercado, former DOH undersecretary and international public health expert. it is an indictment of our health care system—the politics, the lobbying, the sway of big pharma, the conflicts of interests, and possible complicity of many in fast-tracking and green-lighting the processes of exemption, procurement and purchase of the vaccine.

Rep. Estrelita Suansing supports the charge with comments that were no less forgiving: that approval and P3B budget allocation for the vaccine purchase seemed hasty and impulsive. . . that the fund source might not have undergone Congressional scrutiny . .that the purchase was not included in the General Appropriations Act (GAA) of 2015. Others in the medical community concurred the vaccine program had misplaced priorities, procedural lapses, and conflicts of interest.

Even after the approval was criticized as hasty and impulsive, there were signs early on that the vaccine was laden with problems. The public health community has been outraged for a year, said Dr.Mercado. Why did it take so long to take it down? Why did it have to wait for Sanofi’s confessional?

Suspicious timelines
It needs to be asked: how does the dengue vaccine time-line connect with the merciless pounding and demolition campaign against Dr. Enrique Ona and the ACTRx Triact drug study? On September 24, 2014, Health Sec Ona ordered the clinical trial of 2,000 units of ActRx TriAct for dengue treatment in government-run hospitals. On November 14, 2014, Dr. Garin ordered the suspension of the expanded clinical trials.

Around those dates, reports suggest: (1) former President Aquino II met with Sanofi representatives during the Climate Change Summit in Paris on December 2, 2014. (2) The vaccine received FDA approval on December 22, 2015, within 7 months of application. (This is considered quick for an innovator drug, which otherwise requires a year or longer for approval.) (3) Formulary Executive Council defence of the economic study on January 17, 2015. (4) Signing of purchase request on January 21 , 2015, well ahead of exemption, despite the vaccine’s absence in the national drug formulary. A purchase order to Zuellig was made on the same day, despite the grant not yet approved by the PNDF. (5) Approval of budget allotment on Jan 25, 2015 by then FDA Health Sec Janette Garin. (6) February 1, 2016, the vaccine was exempted from the national drug formulary, It takes 12-18 months to enter the PNDF. (7) Actual purchase of the vaccine on March 9. (7) the mass vaccination program starts on April 4, 2016. (8) the suspected death related to the vaccine was recorded April 25, 2016.

Dr. Garin denied having negotiated a price with the vaccine supplier Sanofi-Pasteur in June 2015 and insisted that Pres. Aquino did not meet with the pharma firm in Dec 2015. Garin admitted that the dengue vaccine was already in the pipeline, announced in 2014, before she became DOH sec. (2)

Redux / The demolition of Dr. Ona
Yes, the dates are all so interesting, especially as i look back at demolition campaign waged against Dr. Ona and his endorsement of the ACTRxTriACT (artesunate-arthemether-berberine) clinical trial for dengue. The time-line suggests the campaign for the Dengue vaccine was already in the background. In fact, Dr. Garin admitted the dengue vaccine was already in the pipeline, announced in 2014, long before she became DOH secretary. (2) As soon as she stepped into office, she readily pounced on Ona and ActRx, along with all the powers that be who were intent on bringing down anything that lay in the path of the Dengue vaccine.

My sister Angela Stuart-Santiago and I blogged and took on a defense of Ona and ACTRx clinical trial. What we found was a vicious campaign of rant and rage, low on science, high on unfounded vitriol, bringing into their cauldron of responses references to the Helsinki Declaration of Ethical Principles, an analogy to the Nuremberg trial, clear-and-present-danger analogies, Dr Leachon’s position statement against the trial, a Dr. Claudio denouncing the study as crap, a railing against herbal medicine as voodoo medicine, Garin’s army nitpicking every which way they can, and many in the media so ready with their tsutsuwariwaps.

Now, hundreds of adverse effects, two deaths, and a Sanofi confessional later, there is a spate of finger pointing and accusations. I seethe at the thought that it was the machination of politics and the commerce of the vaccine that killed the ACTRx clinical trial. If the ACTRx clinical trial was green-lighted, we would have had some answers by now: a debunked hogwash of a treatment or a therapeutic option already saving lives. Instead, we have a threat of more virulent dengue infection threatening a population of vaccine recipients.

What now?
Dengvaxia is history. Even if the Japanese version of an anti-dengue vaccine proves to be safer, it will be a long time coming before a vaccine will be embraced for mass immunization.

Perhaps, the ACTRx clinical trial can be revived, resume where it left off, this time unhampered by politics and conflicts of interest. If the treatment proves to be safe and effective, the arthemeter-artesunate-berberine therapy can be a welcome option in the armamentarium of anti dengue therapies.

And, in the meantime, let’s do herbal—specifically, papaya leaf juice.

  What is surprising is why papaya leaf juice remains relatively unknown in the grapevine of rural alternative medicine in the Philippines, the way "tawa- tawa" has become the default anti-dengue herbal.

Papaya Leaf Juice
Papaya leaf juice has been found useful in the treatment of dengue. Many animal studies and a few human trials have shown efficacy in countering the low platelet count that defines the dreaded Dengue Hemorrhagic Fever. Based on evidence of clinical benefits and laboratory reversal of low platelet counts, the use of papaya leaf juice have shown great potential in saving lives. Some doctors even advocate its addition to Dengue therapy once the diagnosis has been proven by serologic testing.

There has been much written about papaya leaf juice in the past few years. The web teems with studies and how-tos on the preparation of papaya leaf leaf juice from scratch. Other countries have capsulized, tinctured, and bottled it. What surprises me is why papaya leaf juice is relatively unknown in the grapevine of rural alternative medicine in the Philippines, the way “tawa-tawa,” although underused, has become the default anti-dengue herbal.

In some countries, papaya leaf juice has caught on as alternative treatment for Dengue, Chikungunya, and Zika. India, Sri Lanka, Malaysia, and have done studies on the use of papaya leaf juice for dengue fever. The leaf juice has also been used as a natural spray to kill Aedes aegypti mosquitoes, and although toxic to mosquito larvae it is considered safe to use around people. In India and Indonesia, papaya leaf extracts are available in capsule and tincture forms.

  The DOH should send an army of health care workers to educate the rural folk, the albularyos and medicos on the preparation, use and potential life saving benefits of papaya leaf juice.

In the Philippines, especially in the rural and boondock areas, because of economic want and reliance on alternative therapies, acute febrile illnesses—whether they turn out to be dengue, trangkaso, or chikungunya—are usually relegated to watchful waiting and home therapies for the first day or two. Consultations with the albularyo, medico, or hilot are sought on the 2nd or 3rd days, sometimes later, a critical time when the dengue fever could be well on its way to progressing to the dreaded Hemorrhagic Dengue Fever or Dengue Shock Syndrome.

Besides its beneficial effects on blood platelet counts, the papaya leaf has been shown on animal studies to have antipyretic properties. In the settings of economic want and Filipino alternative health care beliefs, papaya leaf juice can be used as early mainstay therapy in acute febrile illnesses that could help relieve the fevers associated with dengue, trangkaso and chikungunya or help prevent the lowered platelet counts associated with Dengue Hemorrhagic Fever or Dengue Shock Syndrome. That's a win-win.

In 2016, while the DOH records indicated a 1.3% drop in the total number of dengue cases, from 213,930 in 2015 to 211,108 in 2016, there were 1,019 recorded deaths—more than 50% higher or 372 more than the 647 fatalities reported in 20015.

Dengue is infrequently fatal. Ninety-eight percent of dengue fever patients recover uneventfully. The deaths come from the 2% of cases that progress to the dreaded Hemorrhagic Dengue Fever or Dengue Shock Syndrome. Of the total number of cases, fatalities are less than 0.005 (<0.5%). Calculated from the theoretical 2% with DHF, that’s abut a 24% mortality for patients who progress to Dengue hemorrhagic fever or dengue shock syndrome.

As I suggested: why not go herbal. Papaya is ubiquitous, much more so than tawa-tawa. The leaf juice is easy to extract by hand, and a whole lot easier with a blender. (See: Ways to extract leaf juice/Papaya for Dengue)

Its safety profile should pass muster with the Department of Health, the herbophobes, and those in the medical communities who decry anything that is herbal or alternative. The DOH should send an army of health care workers to the boondocks to educate the rural folk, the albularyos, hilots, and medicos on its benefits and ways of extracting it.

It can save lives. It's safe. It’s cheap. It’s free—certainly of no interest to big pharma.

by Godofredo U. Stuart Jr., MD                                                                                                  December 2017
Sources and Suggested Readings

Congress scutinizes dengue vaccine program / Philippines News Agency / Dec 6, 2016 / The Manila Times
Aquino’s health chief defends speed of dengue vaccine purchase / Vince F Nonato, Reporter /
Papaya / Philippine Medicinal Plants / Dr. Godofredo Stuart / StuartXchange
Papaya for Dengue: The Case for Alternative Therapies / Dr. Godofredo Stuart / StuartXchange
Explosive / Alex Magno / Opinion: PhilStar
In Defense of the Anti-Dengue Cocktail / Dr. Godofredo Stuart
disgraceful discourse on the anti-dengue drug / Angela Stuart-Santiago

March 2017
© Godofredo U. Stuart Jr., MD
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