MANILA, Philippines – Pediatric infectious disease specialist Dr Lulu Bravo said on Monday, February 5, that there must be an exhaustive scientific study before the Dengvaxia vaccine could be linked to a rare viscerotropic disease, associated years back with the yellow fever vaccine.
Bravo was responding to the announcement of the Public Attorneys Office (PAO) on Monday that the death of 10-year-old Anjielica Pestilos may have been triggered by the virus in Dengvaxia.
Based on their findings in Pestilos' death, PAO also filed on Monday its first civil case demanding damages. They are asking for more than P4 million in actual, compensatory, civil, moral and exemplary damages.
The complaint was filed against former health secretary Janette Garin, former health undersecretary Kenneth Hartigan-Go, officials of Dengvaxia makers Sanofi Pasteur, and officials of distributor Zuellig Pharma.
PAO forensics head Dr Erwin Erfe said that Pestilos had lupus at the time of vaccination. Her immediate cause of death was acute respiratory failure and extensive pulmonary hemorrhage as antecedent.
“Dalawa po ang puwedeng nangyari, either maaari siyang nagkaroon ng lupus flare o paglala ng sakit niyang lupus, or pag-uumpisa ng tinatawag nating viscerotropic disease,” Erfe said.
(Two things could have happened, either she had lupus flare or her lupus worsened, or a visceroptropic disease began.)
In their 70-page complaint filed before the Quezon City Regional Trial Court (RTC), PAO said “Dengvaxia is a lethal combination of yellow fever virus and dengue virus...that precipitated her death.”
Bravo, who has been researching pediatrics and vaccine for 43 years, however, said, "It’s an untested hypothesis needing the proper scientific method for evidence."
What is viscerotropic disease?
According to the Centers for Disease Control and Prevention (CDC), viscerotropic disease is "a rare and serious adverse event associated with administration of the yellow fever vaccine."
It is a disease “in which the vaccine virus proliferates in multiple organs, causing multiple organ dysfunction syndrome or multiorgan failure and death in at least 60% of cases,” said the CDC. (READ: Malacañang backs UP-PGH findings on Dengvaxia)
The CDC said that since 2001, only 65 cases have been reported throughout the world.
Erfe believes Pestilos’ case is among the rare types, because Dengvaxia uses the same virus as those in the yellow fever vaccine.
“To induce an immune response to dengue, certain yellow fever genes were swapped out for dengue genes,” said a Reuters report citing dengue expert Dr Scott Halstead of the Uniformed Services University of the Health Sciences in Maryland, USA.
No scientific evidence
Erfe's link is a wild one, said Bravo.
Bravo said that while a viscerotropic disease may have occurred in the child, there is no scientific evidence to link it to Dengvaxia.
According to the standard of the World Health Organization (WHO), an event can only be considered an adverse event of the vaccination if "you see it happening in more vaccinated children than in unvaccinated children."
More than the comparison in the vaccinated children vs unvaccinated children, Bravo said the children compared to each other should have "died with the same illnesses and [gone] through similar intervention procedures, taken the same drugs and medicines that can also produce various side effects in the body.”
Simply said, it takes an enormous amount of study, and thorough scientific method to be able to attribute an adverse event to a vaccine.
“Just like in a court of law, not just because you saw him near the crime scene means he killed the victim," Bravo said.
Bravo is a professor emeritus at the University of the Philippines (UP) College of Medicine and convenor of the National Institute of Health.
Who’s the expert?
Bravo said she is disappointed with the public discourse surrounding Dengvaxia and that experts like her could not speak up because they are immediately tagged as paid by Sanofi.
She said this is extremely unfair. "We studied vaccination for years and still we're not done, but we cannot speak," Bravo said.
She added: "What PAO is doing is trial by publicity and sensationalism. It is scaring the gullible and producing irreparable damage to the health system and the society in general. How I wish they will sober up and we can sit and discuss all issues in a more academic and reasonable manner."
Bravo is among the signatories in the strongly-worded statement put out by the Doctors for Public Welfare headed by former health secretary Esperanza Cabral. The group called on the PAO to stop conducting autopsies on vaccinated children.
Cabral said PAO's scores so far indicate that their investigations had yielded no useful results. Cabral's scores of PAO are based on how PAO's findings differed dramatically from the ones recently announced by the expert panel of the University of the Philippines-Philippine General Hospital (UP-PGH).
The UP-PGH said that of the 14 cases they investigated, 3 died from dengue, and that two may have died due to vaccine failure. It is a conservative finding compared to the wild claims of PAO and Erfe.
UP-PGH forensic pathologist Dr Maria Cecilia Lim said a “forensic expert” is different from a “forensic pathologist.” The latter has more training expertise, Lim said, in an apparent swipe at Erfe’s credibility.
“We take tissues, we look at them through a microscope, these findings are correlated with the clinical data, laboratory, and radiology. You do not take one finding from the autopsy and link it to one disease,” Lim said.
UP-PGH expert panel head Juliet Sio-Aguilar said that they employed a method of screening their findings through a bigger group, two smaller groups, and then a plenary.
Asked what their methods were, Erfe refused to be interviewed by Rappler and said their reports would speak for their work. Those reports have not yet been made available.
Coming to the defense of Erfe, PAO Chief Persida Acosta said no one has the monopoly of expertise.
“Tiningnan natin ang medical records, may clinical history ang parents, titingnan ang signs and symptoms, adverse reactions, fatal manifestations, tapos lab test, at forensics,” Acosta said. (We looked at medical records, clinical history from parents, signs and symptoms, adverse reactions, fatal manifestations, lab test and forensics.)
Acosta and Erfe said that pathologists from the Ospital ng Maynila helped them, through the intervention of Manila Mayor Joseph Estrada.
“May resulta naman ‘yang mga pathologist eh, ia-attach namin sa complaint (The pathologists already have results, we’ll attach them to our complaint,” Acosta said.
Cabral said that if PAO and Erfe were aided by reports, the prudent thing to do would have been to subject the report to more analysis and not "link the deaths to Dengvaxia outright."
"Make a survey and see who the medical community believes more and you should look at their credentials. There seems to be no sense in their performing more and it might be better left to more competent experts." Cabral said.
Acosta said they will not stop conducting autopsies. The Department of Justice (DOJ) confirmed on Monday that Justice Secretary Vitaliano Aguirre II has also not issued any order to PAO to stop conducting autopsies. – Rappler.com