HOW THE PH DENGVAXIA FIASCO REALLY STARTED

pjmisa (52)in #tilphilippines • 7 years ago (edited)

In the light of Janet Garin’s ludicrous claim that the previous DOH Secretary Ona was responsible for pushing Dengvaxia, perhaps she can explain this.

In 2010 Dr. Enrique Ona was appointed DOH Secretary by President Noynoy Aquino.
Of all the Aquino Cabinet Secretaries it might be said that he was probably one of the most honest and capable. When dengue started to become an issue, he immediately attended to it using a holistic approach that addressed the matter from public education, going after the breeding ground of the mosquitoes and looking for treatments as until now there is still no real cure for dengue. The only thing even hospitalization can do to this day is alleviate the symptoms and provide support.

Perhaps it would be enlightening to first ponder on the two medical approaches to the dengue problem. The most popular approach promoted by by many Big Pharma players is the development of a vaccine for which Sanofi is apparently the most invested, having spent over 1.5B euros over the past 20 years with little to show for it.

In 2011, Sanofi started clinical trials of Dengvaxia in the Philippines involving 3,501 subjects of varying age groups.

A similar effort, however, to find a cure from Big Pharma is curiously not to be found which even the WHO seems studiously determined to ignore.

As usual, it is apparently a money game. A cure for dengue would only generate limited and declining income. On the other hand, a vaccine would be a continuing requirement for a huge number of people who would mostly not really need it anyway. This seems to give new meaning to the saying “Prevention is better than cure”. The problem is that this infatuation with vaccines has led to so much grief and human misery because of side effects which have been papered over or ignored in the rush to bring to market a drug which has not been perfected despite massive amounts of money thrown at it. . Big Pharma’s ability to make governments to require mandatory vaccination has caused epidemics of autism, ADHD and many other previously unheard of diseases before certain new vaccines were made mandatory.

On the other side of the issue, absent an effort from Big Pharma to find a “medically accepted” cure for dengue, there are testimonials galore on the local front of various simple herbal remedies such as papaya leaves or tawa-tawa that make one wonder how come these apparently effective cures are not being researched. Again, it would seem that the absence of a monetary gain would seem to be the primary hurdle.

This would perhaps explain the interest of Dr. Ona when he received a letter on February 4, 2012 from ActRx Foundation Chairman and Executive Director Robert. H Barron describing a herbal cure for dengue and malaria that the Foundation was looking for places to conduct clinical trials for.

In the meantime, the USDHHS’ Institutional Review Board (IRB) issued a certification acknowledging that it had reviewed on February 22, 2012 the ActRX Foundation Inc.’s proposed protocol for the conduct of clinical trials of “Dengue Fever Treatment with Artemesia Combination Therapy (ACTRx) (1)

This led to subsequent discussions with Robert L. Steele, Chairman of the Advisory Board of The ActRx Foundation facilitated by former Senator Heherson Alvarez.

A letter from Ona dated March 9 2012 followed wherein he stated “It is with great interest and enthusiasm that I accept and approve in principle your offer to forge a Public-Private partnership with the ActRx Foundation and Preferred and Proven Therapies, Inc. (PPTI)” The letter also stated that, “I have formally endorsed your exclusive distributor Preferred and Proven Therapies, Inc. to the FDA for the purpose of securing the appropriate licenses and permits required under Philippine law.” (2)

In a GMA news report, Hexilon Alvarez, president and chief executive officer of Pampanga-based Preferred and Proven Therapies Inc. (PPTI) showed certified true copies dated June 7, 2012 and July 4, 2012, of two permits issued by the FDA to PPTI allowing the release of thousands of imported packs of artesunate and berberine, two of the three components of ActRx TriAct.

He said that prior to the FDA’s issuance of the Import Permits, PPTI has to provide the FDA Pharmaceutical Data, Safety Data and Efficacy Data of these drugs as prerequisites thereto.

Alvarez claimed that there were 100 malaria patients and 144 dengue patients administered with the ActRx TriAct. (1)

On “October 25, 2012, Alma F. Rivera, chairman of the Ospital ng Palawan Research Ethics Committee, wrote Robert Steele that the committee has approved the study entitled, “A Study Demonstrating the Efficacy and Safety of Artemether + Artesunate in combination with Berberine in Malaria Patients Admitted in Palawan, Philippines.”

Efren M. Dimaano was named the principal investigator with Edna A. Miranda and Talitha Lea V. Lacuesta as sub-investigators. A letter by Assistant Secretary Enrique A.Tayag, Dr. Jose Llacuna, Jr. and copy furnished to Dr. Louie Ocampo, Provincial Health Officer of Palawan, said that a DOH endorsement was no longer necessary to continue with the proposed clinical trials because a Palawan review board had already approved the study. (2)

A November 2012 trial, in which ActRX TRIACT, a combination of the compounds artemether, artesunate, and berberine, were used in a clinical study for malaria treatment in selected areas in Palawan.

“For the ActRX study for malaria conducted in Palawan, it yielded impressive results (100% success, ZERO mortality) even in serious cases. In fact, there was a case where the patient, diagnosed with cerebral malaria and was almost in a comatose state but recovered within a small amount of time after administration of the loading dose of the ActRx treatment,” Alvarez touted.

He also pointed to a 2013 trial, in which ActRX TRIACT was administered to patients in a clinical study for dengue treatment at the San Lazaro Hospital.

He said that the clinical trial of ActRx for dengue done at the San Lazaro hospital also yielded 100 percent success.

“There were no adverse reactions. Needless to say, there was zero mortality rate...At the San Lazaro Hospital, there were a considerable number of deaths due to dengue the year prior to the use of the treatment,” Alvarez said. (1)

Ona’s subsequent efforts against dengue were seemingly effective with the rise in cases in 2013 only at .33 percent or practically the same as 2012. (3)

Meanwhile, on July 3, 2013, Janet Garin was appointed Undersecretary of the DOH.

On August 7, 2014, PCHRD executive director Dr. Jaime C. Montoya sent a letter to Health Secretary Enrique Ona and which said that a review of the clinical trial for dengue protocol showed that it was “complete in form and content” and was “scientifically valid and sound to be carried out in hospitals. (5)

Thus, on September 24 2014, Health Secretary Enrique Ona issued Department Order No. 2014-0161 calling for the “implementation of a national anti-dengue program utilizing ActRx TriAct for the treatment of dengue by the Philippine National Institute of Traditional and Alternative Health Care (PITAHC)”. (6)

This is where as they say “things get curioser and curioser”.

In late October 2014, Ona was accused of malfeasance in the acquisition of pneumococcal vaccines.

A report by GMA says, “The National Bureau of Investigation has been investigating since June the Department of Health's purchase of expensive vaccines in 2012 despite a recommendation to buy more cost-effective ones, Justice Secretary Leila de Lima said on Monday.

"The NBI is conducting an investigation into the procurement by the DOH of Pneumococcal Conjugate Vaccine 10 (PCV 10) contrary to the recommendation of the National Center for Pharmaceutical Access and Management (NCPAM), the Formulary Executive Council (FEC) and the World Health Organization (WHO) which recommended PCV 13 which is said to be more cost-effective," De Lima told reporters.

De Lima said Ona probably had no idea that the NBI investigating the matter as it was being done "discreetly." De Lima said investigators had also yet to speak with Tayag regarding the questioned purchases.

She said she ordered a "discreet" probe as early June, after she was informed that "certain sectors," which she did not identify, "went straight to the Office of the President" to report the procurement of the PCV 10.

De Lima said NBI agents initially were having a hard time investigating since DOH offices and units were bring "uncooperative" in providing them documents and were even giving them a "run around." (7)

In the light of the accusations, on October 29 2014 Ona took a month’s leave of office and Undersecretary Dr Janet Garin was appointed OIC/Acting Health Secretary.

In spite of the rather strident statements by De Lima, Ona was rather swiftly cleared by the NBI of the charges by January 2015, and the transaction was eventually declared above-board. In the light of subsequent events, it would appear that these charges were made simply in an effort to besmirch Ona's reputation and soften it up for the coup de grace, the media campaign against ActRx TriAct, to force Ona to resign and allow Garin to take over.

On November 10 2014, during his trip to Beijing, President Aquino met with Sanofi executives for the first time.

In his arrival speech, Aquino said that the pharmaceutical company, Sanofi is already testing vaccines against dengue fever in Asia and Latin America. “Hindi po magtatagal ay makakarating na rin ito sa Pilipinas,” (8)

Then, around November 25, 2014, even before Ona’s leave expired, then DOH OIC Janet Garin, seconded by Dr. Kenneth Hartigan-Go (FDA chief until and Dr. Anthony Leachon, president of the Philippine College of Physicians (PCP) embarked on what could only be described as a full blown campaign to discredit Dr. Ona’s ActRx TriAct initiative.

Apparently using all the resources at her disposal, supposedly incriminating documents were leaked to various MSM outlets and op-ed columnists including Ellen Tordesillas,and Rappler’s Sylvia Claudio and Jee Geronimo accompanied by speculative accusations, insinuations and twisted narratives. Curiously, all these accusations centered on supposed administrative lapses and safety what-ifs but did not once mention the efficacy of the ActRx Triact medication or the results of the modest trials.

To get an idea of how it went perhaps it would be enlightening to read the following articles. It is noteworthy how information can be maliciously twisted and half-truths and outright fabrications can be so easily made:

http://www.ellentordesillas.com/2014/11/28/corruption-in-doh-results-in-a-sickly-nation/
https://www.rappler.com/thought-leaders/78685-medical-ethics-doh
https://www.rappler.com/nation/76903-anti-dengue-drug-trial-ethical-enrique-ona
http://newsinfo.inquirer.net/657614/doctors-urge-solons-to-probe-dengue-drug-trials-on-humans

Sounds rather convincing? What the writers conveniently fail to mention is that all of the offices mentioned are under the direction of the Secretary of the DOH. It is almost unheard of that subalterns in a government office would openly defy their superiors on debatable grounds unless they had the backing of (or instructions from) someone even higher.

Here is one of the few in defense of Ona:

https://stuartsantiago.com/in-defense-of-the-anti-dengue-cocktail/

What is even more remarkable is that none of these writers seem to have come up with similar, if not more scathing denunciations of the far graver issues and clearly more deliberate disregard for public welfare raised by the Dengvaxia fiasco. And while the ActRx TriAct issue did not involve a single centavo of public funds, this one cost P3.5B.

Ona’s resignation was accepted by President Aquino on Dec 19, 2014.

In 2014, the occurrence of dengue went down by an astonishing and unprecedented 44.6% to 113,485 compared to 204,906 in 2013. (4)

(Note: The above narrative is in no way an endorsement of ActRX TriAct but simply a narration of events. There are other herbal cures for dengue such as papaya leaves and tawa-tawa that are the subject of many testimonials to their apparent efficacy despite the total disregard of the medical establishment or DOH of the matter. The narrative does tend to show that Dr. Ona was more interested in pursuing a cure for dengue rather than a vaccination program. In fact, it appears quite probable that he was considered a stumbling block to the implementation of a Dengvaxia vaccination program which resulted in his being subjected to false charges and malicious accusations in order to force his resignation and allow Janette Garin to assume his position.)

The administrative process then went forward under Garin’s watch at blazing speed.

January 17, 2015 Formulary Executive Council defence of the Dengvaxia economic study

January 21 , 2015 Signing of purchase request well ahead of exemption, despite the vaccine’s absence in the national drug formulary.

January 21 , 2015 A purchase order to Zuellig was made on the same day, despite the grant not yet approved by the PNDF.

Jan 25, 2015 Approval of budget allotment by then Acting Health Sec Janette Garin.

May 14, 2015 DOH Sec. Garin has dinner with Guillaume Leroy, Vice President of Sanofi-Pasteur’s Dengue Vaccine Program and other Sanofi officials

November 2015 The DOH requests a budget for the acquisition of dengue vaccines

December 2 2015 President Noynoy Aquino meets with Sanofi executives in France (13)

December 22, 2015 The vaccine receives FDA approval within 7 months of application. (This is considered quick for an innovator drug, which otherwise requires a year or longer for approval.)

December 29, 2015 P3,5B SARO released

December 30, 2015 Huge increase in dengue cases 2015 (64.8%) (10)

February 1, 2016, The vaccine was exempted from the national drug formulary, It takes 12-18 months to enter the PNDF.

March 9 2016. Actual purchase of the vaccine

April 4, 2016. Mass vaccination program starts

April 25, 2016 First suspected death related to the vaccine recorded (9)

December 2016 Cases rise slightly (3.1%) from 213,930 to 220,518 but CFR rises dramatically to 46% or 46 deaths per 10,000 cases compared to .3% or 30 deaths per10,000 in 2015 This corresponds to an extra 352 deaths. It is impossible to determine from the DOH report how many were from the 9 year old vaccinated group.(10)

September 30, 2017 Cases drop drastically by 41.8% from 167,102 to 97,287 for the time period but CFR rises even more to .54% or 54 deaths per 10,000. This corresponds to 233 extra deaths (11)

November 26,2017 Duterte appoints Duque as DOH Secretary

December 1, 2017 Duque suspends Dengue vaccination program

Despite the fact that the DOH has yet to definitively determine if any deaths have been caused by the vaccine, the curious statistics which seem to defy the trends of the past years seem to indicate that at this early date, perhaps as many as 580 “extra” deaths have occurred out of 317,000 cases in just the past 14 months since vaccination was implemented. This does not bode well for the future as the clinical trials indicate that the more significant adverse effects begin to manifest in the 3rd to 4th year after vaccination.

It is thus ironical and quite a stunning vindication of Dr. Ona’s push to find a cure that the prime imperative for the DOH now is to immediately find a REAL, EFFECTIVE CURE for dengue in order to stave off the impending disaster looming on the horizon.

The narrative is also a damning condemnation and a horrifyingly cautionary tale about how greed, ambition and hubris can lead to catastrophic tragedies that need never have happened. The evident use of various government agencies and cooperative MSMs and well-known opinion writers such as Ellen Tordesillas, and Rappler’s Sylvia Claudio and Jee Geronimo by parties out to destroy the reputation of what was apparently one of the very few upright Aquino appointees merely serves to highlight what is still going on up to the present.

Information sources:
http://www.gmanetwork.com/news/news/nation/392361/distributor-of-anti-dengue-actrx-triact-disputes-doh-criticisms/story/
(https://www.rappler.com/thought-leaders/78685-medical-ethics-doh)
http://www.doh.gov.ph/sites/default/files/statistics/2013%20Dengue%20Morbidity%20Week%2052.pdf
http://www.doh.gov.ph/sites/default/files/statistics/2014%20Dengue%20Morbidity%20Week%2052_0.pdf
http://vitalsigns.com.ph/final-version-of-protocol-approved-by-pchrd-describing-it-as-scientifically-sound-and-valid/
http://newsinfo.inquirer.net/645714/breakthrough-seen-in-dengue-treatment#ixzz50p3m74Pn
http://www.gmanetwork.com/news/news/nation/387380/nbi-probes-doh-vaccines-mess-involving-ona-tayag/story/
http://www.voxbikol.com/article/20141116/president-aquino-highlights-results-his-trip-china-myanmar
http://www.stuartxchange.org/DengueVaccineScamPapaya
http://www.doh.gov.ph/sites/default/files/statistics/2015%20Dengue%20Morbidity%20Week%2052.pdf
http://www.doh.gov.ph/sites/default/files/statistics/2016_Dengue_MW1-MW52.pdf
https://stuartsantiago.com/in-defense-of-the-anti-dengue-cocktail/
http://www.manilatimes.net/aquino-ordered-health-secretary-buy-p3-5-b-defective-dengue-vaccine/366550/
http://news.abs-cbn.com/news/12/07/17/an-evening-with-dengvaxia-makers-in-paris