You can’t reduce poverty without a strong public health care system. It is puzzling to us why health care, the system, and its politics, is not as prominent on the development agenda as education and agriculture. Here is a system that by many accounts is in crisis, facing shortages in manpower and infrastructure that threaten to negate the massive additional funding it has received in the last few years. Yet the public has been quiet, the press has been quiet, the candidates have been quiet.
Why have we been talking about poverty without talking much about bringing good quality health care to the poorest in the country? The poor in the rural areas have access only to rural health units that have no doctors or nurses, no medicine to provide, and no vehicles to bring them to an equipped hospital. Even middle income families are driven into poverty if a calamitous disease were to put them in a hospital in need of a complicated procedure.
Health care is central to any poverty alleviation agenda, yet we are not talking about it nearly as much as we talk about education. What is the state of the public health care system? There is money, but there are no doctors. It is not only doctors; it is also nurses, midwives, and other kinds of health care practitioners. There are only 3.5 doctors for every 10,000 Filipinos, when there should be 15. About 60-70% of all medical practitioners work in urban areas, yet the majority of the poor are in rural areas. In areas served primarily by public doctors, there are only 3 doctors for 100,000 people! The shortages are also bad for nurses and midwives. The scale of the shortage is worse if you account for medical specialties. According to a paper authored Dr. Beverly Lorraine Ho of the Ateneo Loyola School, “there are no published data on physician specialties.” We don’t even know just how short we are on the number of cardiologists, pediatricians, pulmonologists and countless other subspecialties.
The medical professionals supply chain. If the basic data on types of doctors and where they are practicing are missing, then we can assume that these are not considered in planning for health and education. The massive shortage in medical professionals is a concern for universities, colleges, and teaching hospitals, since they should be the ones who should be graduating doctors and nurses at scale. In the same way that the Department of Education knows exactly how many teachers it needs to fill all the shortages in schools, the Department of Health must also know exactly how many cardiologists, pediatricians, medical technicians, and hospital administrators it needs to fill the wide gap. But it knows only about doctors and health workers in the public facilities. It is not clear why information on specialist doctors cannot be gathered, especially those in private practice. There are specialist societies that have membership lists. We need counts and we need maps so that the DOH will know where they are needed most. With the figures in hand, the DOH, CHED, and teaching hospitals can jointly support aggressive scholarship packages for medical fields in exchange for years of service in public health. The scheme should address the urgent need for residency and fellowship positions.
There is money, but there are no hospitals. Getting the Sin Tax Law collections and giving it to the healthcare system was an exciting development. But money is only good if it is spent to maximum effect, and with an eye on efficiency. How and where it is spent is just as important as how much is there. The World Bank estimates a national ratio of 1.2 hospital beds per thousand Filipinos, the result of a steady decline over the past few years. (In Thailand it is 2.1, Singapore 2.7, and Malaysia 1.8.) A third, or 34%, of all hospital beds are in NCR. This means that the ratio of bed to people is much lower than 1.2 in the rest of the country. Worse, more than half of the country’s hospitals have incomplete critical care and emergency equipment. Dr Ho says that there are even no actual counts of primary care facilities because they are not required to register. She finds it alarming that the national health system “has no national hospital plan or national health facility plan.” So while the Department knows it is short of hospitals and primary care facilities, it does not know where these are most urgently needed, what types are needed in which places, how big they should be, and how to man them with enough medical professionals.
Let’s talk about health. It is time we put public health high up on the policy agenda, as there will be no poverty alleviation without a solid plan for fixing the health care system. It’s time to talk about health care as a system, its needs, its design, and its responsibility.
It’s time to demand of the next crop of leaders, some degree of acknowledgement that the healthcare system needs all the attention it can get. Without political commitments to fixing public health, it threatens to hold back any poverty reduction program government pursues. It is not right that a poor Filipino will die because he cannot access the nearest health facility the government can offer.
DENGVAXIA ISSUES IN THE PHILIPPINES
On April 4, 2016, the Philippines became the first country in the world to launch a mass immunization program using the first vaccine against dengue, a disease that afflicts over 200,000 and kills more than 1,000 Filipinos a year.
Let’s stop the hysteria and start with a basic fact: Dengvaxia works. It’s a remarkable vaccine that greatly reduces the chance of suffering from a severe case of dengue. A trial was conducted involving 30,000 people, including in the Philippines. In the five years after the trial, the chance of suffering from severe dengue was reduced by 93 percent; the overall reduction was 65 percent.
And for the opportunistic lawyers, Dengvaxia doesn’t cause dengue; it just, in the rare worst case, means that a seronegative person may suffer as much as a seropositive person who had not been vaccinated. If a society where the risk of dengue is high, like the Philippines, is not inoculated, 4.8 per 1,000 people are likely to suffer from a severe case. A fraction will die; the others will recover.
The data from the efficacy studies was very good: Over 90% decrease in hospitalization due to severe dengue among those vaccinated. With unprecedented efficiency, funds were appropriated and released to fund the vaccine drive. The fact that the mass vaccination program was approved prior to the official release of WHO recommendations was viewed with some suspicion among health experts. In addition, it was an election year, and administration candidates were shown schoolchildren being vaccinated for photo opportunities. Over 830,000 elementary school children in Grade 4 or older were inoculated during the mass vaccination drive.
For me, the problem isn’t the vaccine but the speed and manner in which it was introduced. One has to ask why a government noted for its lethargy rushed to sign a contract. Why was it given more importance than other equally, or more, necessary health spends? And why wasn’t greater care taken to check if the kids had had dengue? At the time there was no proof that Dengvaxia would increase the chance of severe dengue in seronegative kids. But there was some suspicion it could, so a cautious approach would have been sensible.
On November 29, 2017, Sanofi, the maker of the vaccine, announced that it was proposing a label change to reflect that the vaccine could increase the risk of hospitalization for severe disease in those who had not been previously infected by dengue. This announcement triggered mass panic, especially among the parents of the children who were vaccinated. Finally, on Dec 5, 2017, citing safety concerns, the Philippine FDA withdrew the approval of the vaccine.
Meanwhile, accusations flew thick and fast between former Department of Health officials, with reports of improper contact between the former health secretary Dr. Janette Garin and Sanofi officials prior to the inception of the vaccination program, despite denials from the former. Amidst a media firestorm, vaccine advocates and local medical societies raced to release statements in an attempt to salvage an otherwise useful vaccine, which had now become collateral damage in a high-risk game of politics.
Over 3.9 billion people live in countries at risk for dengue, a mosquito-borne virus. Ironically, the first severe dengue outbreak was described in the Philippines in 1953. It is an unusual disease, with four distinct strains, or “serotypes” of the virus. Infection with one serotype confers lifelong immunity to that strain, but paradoxically confers increased risk of severe disease to subsequent infection with another serotype.
Clinical symptoms of dengue include fever, headache, muscle aches, and a rash. Severe dengue can cause uncontrolled bleeding, a drop in blood pressure, and death. Only one out of four persons who are infected with dengue develop symptoms, and not all will need hospitalization. It is difficult to gauge who has been previously infected, and is therefore more likely to develop severe disease. In dengue-endemic countries such as the Philippines, nearly 90% of children at age 9 have been infected with at least one strain of dengue, and are at risk for developing severe disease.
The challenge in developing a vaccine for dengue lies in ensuring immunity to all four serotypes. The current vaccine, Dengvaxia, contains a mixture of all four serotypes. However, not all persons who receive the vaccine develop antibodies against all four serotypes, and some develop immunity to only three or less of the vaccine serotypes. Vaccinating a person who has never had dengue can be harmful if full immunity to all four serotypes is not achieved. This is because it may set up a patient up for severe dengue when they would otherwise not have yet been “primed” for severe infection by an initial dengue infection. On the other hand, a person who has had at least one dengue serotype infection is already at risk for severe disease, and so vaccinating that person will not harm them, and will decrease the risk of severe disease if even just one serotype “takes.”
The breakthrough dengue vaccine does not work like a traditional vaccine, which typically prevents or reduces the risk of the target disease. Instead, it is meant to reduce the risk of severe dengue infection. And it does this very well. In two phase III or clinical efficacy trials involving 30,000 patients, it decreased the risk of hospitalization for severe dengue by more than 90% in children 9 years old and older. Surprisingly, even previously uninfected patients seemed to be protected from severe disease in the first 25 months of the trial. With this in mind, Sanofi did not recommend blood testing for dengue prior to giving the vaccine, since both seropositive (with blood evidence of previous dengue infection) and seronegative (without blood evidence of previous dengue infection) children seemed to be protected.
The Philippine dengue vaccine experience represents a case study in how well-meaning safety and vaccine advocates can be caught up in a political storm and inadvertently harm vaccine programs and expose vulnerable populations to risk. As a result of this, outbreaks of measles infection was reported in South Western Mindanao. Mothers don’t want their children to be vaccinated with any kind of vaccines.
Some safety advocates led by eminent epidemiologist Dr. Antonio Dans and world-renowned dengue researcher Scott Halstead pointed out at that time that there appeared to be an increased risk of hospitalization among those younger than 9 years old, and that a “safety signal” with a possibly increased risk of hospitalization was present in seronegative children. This “safety signal” became the subject of intense debate between vaccine and safety advocates in traditional and social media.
It was one thing on top of another: complexities in understanding how the vaccine worked, highly charged political issues surrounding the vaccination program, the uncertainty. This all resulted in fewer people taking the vaccine, not just through the mass-administration program by the government, but also among private patients.
Safety advocates were vilified for having gone public with their safety concerns over an otherwise effective vaccine, and were accused of undermining the vaccination drive. In the meantime, even vaccine advocates also had misgivings about the propriety of the mass administration program, especially since the mass immunization campaign was approved prior to advice from the World Health Organization (WHO). A few weeks later, WHO (through its Strategic Advisory Group of Experts) released a conditional recommendation that it was appropriate to use the vaccine in countries where the seroprevalence, or proportion of the population with evidence of previous dengue infection, was more than 70%. Since the Philippines falls well within those parameters, the DOH officials took this as a positive sign and continued the program.
A year and a half later, Sanofi, citing new long-term safety data, announced a label change, affirming the vaccine’s efficacy, but recommending that the vaccine not be given to persons who had not had previous dengue infection. It did not release the actual data for scrutiny, and so there was much speculation of harm and even deaths in patients. Safety advocates felt vindicated, and went on a media blitz condemning the undue haste in the implementation of the mass vaccination program, decrying that politics had put the lives of hundreds of thousands of children at risk.
As distraught parents raised a huge outcry demanding answers, former and current health officials started pointing fingers at each other, and partisan legislators and government officials vowed to get to the bottom of the mess. Nearly every death in a child who had previously been given the vaccine was attributed to the inoculation, despite the fact that there were no deaths seen in the initial trial data, some timelines were untenable, and it was it not clear whether a particular child had previously had had dengue infection or not.
As the media and civil society called for blood, Sanofi belatedly organized a press conference to share the findings: there were no deaths at 72 months of follow-up in either seronegative or seropositive patients from the original phase 3 trial; the vaccine continued working well for seropositive patients, but the vaccine lost its efficacy in seronegative patients. The safety signal that was pointed out by safety advocates in seronegative patients persisted. It was not statistically significant, meaning the possibility of harm is not certain, but given the loss of efficacy in seronegatives, the label change was needed to reflect this new finding. It was too little, too late. Explanations from vaccine advocates and professional societies that attempted to calm the panic by stating that the actual children at-risk were only about 10% of the vaccinated population and therefore not the entire cohort were met by the public with suspicion, ridicule and an accusation that they were covering for the previous government and Sanofi. Despite clear benefit when used correctly, the Philippine FDA withdrew approval of the vaccine while the investigations continued.
Vaccines are still recovering from the damage unleashed by the now-discredited link to autism. In an increasingly connected age, false or misunderstood claims about safety, efficacy, and harm can be magnified and do substantial harm to public health. Part of the problem is that the discussions between these groups were highly technical, due to the complicated nature of the dengue vaccine and the disease itself. Both social media and traditional media misinterpreted many of the discussions. Unfounded accusations were hurled on both sides. Nevertheless, the bulk of the blame will likely fall on Sanofi and the politicians and officials from the previous administration who willfully ignored established norms in the conduct of mass vaccination programs. Before going on to mass vaccination programs, most vaccines after approval are typically used in individual patients where risk can be managed on a one-on-one basis, and parents and doctors can discuss the overall benefits of the vaccine with close monitoring. An industry standard Phase 4 post-marketing study is usually sponsored by the manufacturer on these early patients to watch out for any adverse effects that were not detected in the initial trials. Perhaps at best, the health officials who were responsible for implementing the mass vaccination program could claim that given the excellent data and apparent absence of harm, they were anxious to reap the benefits for Filipinos. However, this reasoning falls flat given the undue haste in which the program was implemented especially during an election year.
As for the vaccine itself, its future remains uncertain as health experts continue to debate on how to use it properly with the newly available data. Do children need to be tested for past dengue infection before they are given the vaccine? Or is a reasonably high seroprevalence (proportion of the population with blood evidence of past infection) sufficient? While a past dengue infection can be diagnosed with a blood test, the current tests on the market are used for someone with symptomatic disease, and are not optimized for detecting past infection. A new and highly sensitive test has been developed, but will not be available for wide use until it is cleared by authorities, a process than usually takes one to two years.
From a public health perspective, the decision to use the vaccine is a much easier one. In highly endemic settings such as the Philippines, where nearly 95% of children above 11 years old have evidence of past dengue infection, the risk-to-benefit ratio is clear. Sanofi estimates that for every 1,000 vaccinated seropositive children, the total number of hospitalized children is reduced by 15 cases, and severe dengue cases by 4. For every 1,000 seronegative children who are vaccinated, hospitalizations are increased by 5 cases, and severe dengue cases increase by 2. Therefore, if used in 1,000 Filipino children above 11 years old, about 950 would be seropositive and benefit from the vaccine. While only 50 would be seronegative. The benefit vastly outweighs the harm.
We need to separate the politics from the medicine. Let Congress focus on whether the decision and the order to use it were done in the right way. Let’s leave the DOH and the Food and Drug Administration to do their job, assisted, I’d suggest, by the WHO and unhampered by political interference. Particularly in the forensic analysis of the children who recently died: Was it dengue? If it was, did they have the three inoculations necessary? Were they seropositive or seronegative?.
These policy decisions where a subset of patients may be sacrificed for the greater good is unacceptable to safety advocates. Vaccine advocates counter that it is akin to sacrificing 95% of patients who would benefit for the safety of 5%. These policy discussions where life and death are treated as cold numbers used to happen behind closed doors, with a general consensus on how to proceed. In this new age of information, policy makers need to educate the general public on how these decisions are made, and they need think out of the box on how to make these difficult choices palatable. What disturbs me most about this whole sorry issue is the rush to judgment without looking first into the facts. I am sure Senators Dick Gordon and JV Ejercito will ferret that out. As to its priority over other equally urgent issues, that’s a judgment call I’ll leave to those more expert in arguing. What is very sad about all this is that people are now scared to be inoculated—for anything. What has been lost is the fact that no drug is perfect, no drug works 100 percent. If vaccination helps more than hurts people, it should be done. Dengvaxia reduces the chance of suffering a severe case of dengue by 93 percent. It is beneficial to far more than the very few it might hurt. I suggest that we follow the DOH’s call to work together in finding a solution to resolve this issue dispassionately, without further scaring a scared public. Otherwise a stalemate will occur, we lose vaccines, and we all lose.