By DR. RAYMUNDO W. LO, MD, FPSP, FCAP, FASCP
We have found ourselves in a deep hole in the aftermath, nay, the continuing mess of the Dengvaxia crisis. Vaccine confidence has plummeted and measles is once again on the rise. To understand and better manage the fallout from the crisis, we need to understand how this came about. Let us break down the elements one by one and the chronology of events to have a clear picture of the morass we are in.
The procurement of the Dengvaxia vaccine was, of course, the focal point of the investigations. The Philippines being a very political country, and there is not a time that is not political, it is sure as day follows night that this procurement would be politicized, election time or not. But public health should not be politicized or there will be consequences as we are now seeing.
The procurement started in late 2015 and the mass vaccination program started in the second quarter of 2016. There was no cry or hue about it then. Things rapidly went south when Sanofi Pasteur, Inc., announced in November, 2017, as pharmaceutical companies are required to do in the event of the slightest possibility of side effects or complications arising from a drug, vaccine, or medical device, that in dengue-naïve individuals (those who have not had dengue infection, symptomatic or not), there is the possibility of severe disease.
It was exacerbated by the knee-jerk reaction the announcement elicited from the Department of Health (DOH), which was to immediately announce the findings and to pull the Dengvaxia from the DOH vaccination program. The Food and Drug Administration without so much as an investigation pulled Dengvaxia out of the market. This was when everybody with an axe to grind and a motive to promote pounced on the issue.
What could the DOH have done better? It could have managed things more rationally by first conferring with Sanofi just exactly what its findings meant. Did “severe dengue” automatically mean death? What, if any, will the findings mean for the Philippines where dengue is hyperendemic?
Based on epidemiologic evidence on the ground, and there were several studies done on this, an overwhelming majority of Filipinos have had encounters of the close kind with the dengue virus, whether they knew it or not. If you are nine years or older, more than 90% have had exposure to dengue. The figure is almost 100% in the 14 years old and above population. These findings based on the study by the Pediatric Infectious Disease Society of the Philippines (PIDSP) were the rationale for the Dengvaxia mass vaccination program which mandated vaccination only for those 9 years of age and older.
It was by all means a very cautious approach to the issue to make sure that little or no harm can come to those vaccinated and at the same time, cover a large enough population to mitigate the impact of dengue disease in the country and its burden on the health system and the general population. The PIDSP also noted that mass screening for past dengue exposure is not practical as there is no reliable and widely available test for determining prior dengue exposure and did not recommend it.
Rather than the reflex or knee-jerk reaction, the DOH could have announced that as part of a mass vaccination program, it will form a surveillance program to monitor Dengvaxia-vaccinated persons as is being done (I hope) with other vaccination programs like polio, MMR etc. The World Health Organization (WHO) has guidelines on mass vaccination surveillance and it could have been used for launching such a program.
But it did not and all hell broke loose. As is usual in this setting, politicians of all stripes jumped on the issue. Mass media blared out the “bad” news of the Dengvaxia vaccine, causing sensationalism and widespread anxiety and hysteria in the general population. Disgruntled former DOH career officers left out in the cold joined the fray and allied themselves with the Public Attorney’s Office to exact vengeance on their former colleagues.
The government announced a billion-peso fund for “Dengvaxia victims.” The DOH opened all government hospitals to these “victims” and all medical care, from drugs to surgery, were available free. Families deluged the hospitals with complaints unrelated to the Dengvaxiato avail of vitamins and free laboratory exams. Now, it seemed like there was an epidemic of Dengvaxia illnesses and no one did anything to calm things down.
The Public Attorney’s Office (PAO) jumped on the bandwagon and announced a probe of the “Dengvaxia deaths” when there were no previous recordings of such deaths. It formed a forensic laboratory (duplicating the already superfluous presence of two forensic labs in the PNP and NBI which are the investigative bodies in the country) and promoted “autopsies” of Dengvaxia deaths by a handful of doctors untrained in the science and practice of performing autopsies, normally the province of pathologists. These “autopsies” were held in full view of invited media people and televised widely showing Erfe holding up bloody organs to the camera, which of course, exposed the media people to possible communicable disease if the body were harboring one. Never had the autopsy been thus weaponized.
Press conferences were staged with the grieving parents of children supposedly killed by the vaccine, complete with drama by PAO head Persida Acosta (who is a lawyer) wearing a white blazer, thus simulating a doctor. Rallies were held and drama maximized by photos of the dead children and crying parents egged on by Atty. Acosta herself. The press, television stations, and social media went on overdrive to announce the deaths and the demonization of the Dengvaxia vaccine.
But were they really Dengvaxia deaths? From what has been offered as the autopsy reports in cases filed against Sanofi and current and former DOH officials, it appears that the majority of those examined (I will not call the procedures autopsies as the conduct was frankly amateurish and unfit to be called such) had either pre-existing conditions, whether known or not, or developed new illnesses. A few cases appeared to have been cases of dengue in incubation right before vaccination or vaccine failures (most vaccines work on a large majority of people but a few will not develop immunity for varying reasons, among them genetics).
These illnesses were lethal. Leukemias, cancers, autoimmune disease, brain tumors, sepsis, ruptured appendicitis, severe asthma, etc., were a few of those offered as proof of death by Dengvaxia. The terms viscerotropism and neurotropism were bandied about as signifying vaccine-related diagnoses.
Let’s take a look at what constitutes vaccine-related disease by assessing these cases using the widely acknowledged reference for yellow fever vaccine related disease, the Brighton Collaboration Criteria (Viscerotropic disease: Case definition and guidelines for collection, analysis, and presentation of immunization safety data, Vaccine 2012 July 13; 30(33): 5038-5058. Doi.10.1016/j.vaccine.2012.04.067).
These criteria constitute a constellation of clinical signs and symptoms which by themselves are non-specific and to be considered related to the vaccination must arise within 28 days at most from the time of vaccination. Note that majority of these cases became symptomatic way beyond 28 days of vaccination even extending up to a year or more. Even more disconcerting was the PAO claiming these cases as Dengvaxia-related by way of autopsies when the criteria are not pathologic findings. They also conveniently ignored the footnote a that states: The case definition should be applied when there is temporal association (see Section1.3.4) with vaccination and noclear alternative diagnosis to account for the symptoms.
Indeed, all cases were dubbed Dengvaxia-related by way of “viscerotropism” and “neurotropism.” The PAO doctors even had the nerve to invent new terms as “viscerotropic-like disease” and “neurotropic-like disease” which do not exist in the real medical world of vaccine investigation. Even when the pathologist they asked to read the histopath slides stated the clear-cut diagnoses of leukemias, cancers, SLE, etc., these death-dealing diseases were relegated as “contributory” only to the deaths! Amazing chutzpah!
At any rate, with all the hullabaloo and the circus-like atmosphere of the Senate hearings covered live on public television, the stage was set for the debacle to follow. Public confidence in vaccines dove from 93% to 32% in one year’s time. Parents shied away from health centers and refused routine childhood vaccinations like DPT, MMR, polio, etc., conflating the Dengvaxia controversy with all vaccinations. Even routine deworming was spurned by suspicious parents. Public health workers are now desperately trying to reassure the public that the government health programs are safe and effective, often to no avail. Indeed, the Philippines is now facing a public health crisis the likes of which it has not seen before. Years of hard work and promotion of health measures went up in flames.
Dengue cases shot up with over 1,000 deaths reported. Measles cases are up over 350% in recent months and many deaths were reported. We were close to eliminating measles in the past few years but the resurgence of measles cases means that it’s back to the trenches for our hard-working government doctors, nurses, and midwives.
The secretary of health announced officially the measles outbreaks and the PIDSP followed suit, both ascribing the phenomenon to the Dengvaxia brouhaha. In a defensive move, PAO called a press conference to state that it is not against all vaccines, only Dengvaxia. But the damage has been done, and it is ENORMOUS.
Even then, Atty. Acosta and Dr. Erwin Erfe continued holding public “autopsies” and proclaiming the deaths as due to Dengvaxia. In one instance, they had two skeletons laid out on tables in public view for added dramatic effect (shades of Shakespeare’s Hamlet contemplating Yorrick’s skull). Well, even the most astute forensic pathologists will be hard-pressed to make anything out of the skeletons in relation to medical diagnosis of diseases. Talk about trying to squeeze blood out of stone.
Doctors for Truth and Public Safety came out with a statement decrying the misappropriation of medical matters by these doubtful characters and the continued politicalization of the matter. The affair has taken on the effect of a Pandora’s Box opening with no one seeming to know what to do next.
Cases of murder were filed with the Department of Justice based on these deaths. If the DOJ decides to send the cases to trial, it will mean years of legal wrangling, all the while holding the public hostage in respect to the public health implications of this matter.
Will epidemics start to rage? Can the health system cope with the fallout of this crisis? Where are the medical societies in this matter? The medical establishment, the Philippine Medical Association, Philippine Pediatric Society, Philippine Academy of Family Physicians, Philippine College of Physicians, etc. have all been silent on the issues burning through the health system.
A terrible blow has been dealt to the Philippine public health system. Will it survive? More importantly, will the Philippines survive a war from within?