In any scandal, there are always grandstanders, ambulance chasers, and opportunists. The Dengvaxia mess is no exception, with Senator Dick Gordon milking it for what it’s worth to advance his political career, Public Attorneys’ Office head Persida Acosta brazenly using it as an opportunity to get a plum appointment in the Duterte administration, and many Duterte partisans seeing it as a heaven-sent opportunity to score points against the previous Aquino administration.
Pests, not principals
But Gordon, Acosta, and other opportunists are minor actors in the Dengvaxia drama. They are pests, not principals. One hunts in vain in the so-called “Doctors for Truth” statement signed by selected medical professionals for a condemnation of Sanofi Pasteur and present and past top executives of the Department of Health (DOH) for what former Department of Health secretary Enrique Ona has called “a major health nightmare in the country today.”
In releasing for a mass immunization program a vaccine against dengue that had failed clinical trials for both effectiveness and safety, Sanofi Pasteur, Janette Garin, and some present and former top officials of the DOH and the Food and Drug Administration (FDA) were guilty of reckless and criminal endangerment of the health of over 800,000 children. Yet there is no acknowledgement of this in the statement.
Defending the principals
Instead there is in the “Doctors for Truth” position paper an implicit defense of the principals on the grounds that “there is no perfect vaccine.” The doctors conveniently forget that the purpose of rigorous clinical trials before a drug is brought to market is to reduce to as close to zero as possible the likelihood that a) the drug will not work, or that b) it is dangerous, or that c) it has destabilizing side effects.
Measured by the yardstick of accepted statistical probabilities, Dengvaxia failed resoundingly, an event that is rigorously documented and explained in a research report that appeared in one of the leading journals of medical research, New England Journal of Medicine (Vol 373, No. 13, Sept 24, 2015), about half of whose authors were connected with Sanofi Pasteur.
The report, which appeared before the Sanofi contract was made and the vaccination program was implemented, revealed that clinical trials showed that previously uninfected children of a certain age group showed a disturbingly higher risk than previously infected children to contract severe dengue after being vaccinated.
Indeed, so concerned were the editors that they accompanied the article with an editorial titled, “A Candidate Vaccine Walks a Tightrope.” According to the editorial, which hit the dengue research field like a thunderbolt, “Most eye-catching is the suggestion that CYD-TDV [Dengvaxia] vaccination was associated with an elevated risk of hospitalization for dengue among children younger than 9 years of age (but most markedly, among those 2 to 5 years of age) when they were naturally infected in the third year after vaccination.” [emphasis mine]
It concluded that “we still lack definitive immune correlates of protection or vaccine-associated disease risk. A lesson from these trials, and from our understanding of the natural history of dengue epidemiology, is that partial, waning immunity is a particularly unwelcome outcome after vaccination…Live vaccines need to be sufficiently potent in their infectiousness and replicative capacity to initiate immunity in both unexposed recipients and those with partial immunity…The bumpy road to a vaccine-based solution for dengue continues.” [emphasis mine].
Despite this red light from a high-powered research team that included its own researchers, Sanofi Pasteur rushed a flawed product to the market to beat the competition and the DOH authorities pushed the vaccine on over 800,000 children in 2016, with no investigation of whether or not they had been previously exposed to dengue. One does not need to be a medical expert to come to the conclusion that the haste with which this vaccine was brought to the field was simply inexplicable from a public health point of view.
It’s a safe bet that very few of the doctors who signed the statement took the time to read the New England Journal of Medicine research report and editorial, for no self-respecting medical professional with the least bit of acquaintance with these documents would have attached his or her signature to a statement that blithely defends the principals on the ground that “there is no perfect vaccine.”
The precautionary principle and Dengvaxia
The signatories compound their irresponsibility by saying that “we urge the DOH not to remove the vaccine from the market altogether,” allegedly to provide protection for those not yet found to be at risk of severe dengue infection stemming from vaccination. But contrary to its previous claim that Dengvaxia provided “consistent efficacy and longer-term safety profile in a study population 9 to16 years of age,” Sanofi retreated from this assertion and attached no age exemptions in its later, November 29, 2017, statement as to who should not be administered the vaccine.
Moreover, in banning the vaccine from the market altogether, the current DOH leadership is not panicking but simply adhering to the time-honored precautionary principle, which says, in this particular instance, that just because severe dengue infection has not yet surfaced in some categories of tested subjects that have been vaccinated does not mean that it is safe for the people in the same categories in the general population to use it.
The finding that those vaccinated who had no previous dengue infection could incur severe dengue demands that administering the drug to all age categories in the population, whether they have been previously infected by dengue or not, should be immediately withheld on the grounds that loss of immunity and susceptibility to severe dengue might take longer to emerge among some categories of the tested subjects.
This does not mean a permanent ban, but one that can only be lifted after more rigorous trials carried out over a long period of time prove that the vaccine is safe for all age groups of previously infected or non-infected people.
Experts betray public trust
The signatories bemoan the “expert bashing” that is taking place in public hearings. Have they asked themselves why this bashing is taking place in the first place? The distrust of experts stems from the fact that in the case of Dengvaxia, the experts have so spectacularly failed the people on a matter of public trust: the experts in Sanofi for rushing a dangerous vaccine to the market, and the experts at the DOH for carrying out a mass vaccination program that they knew – or should have known, given the published findings – carried grave dangers for many of its intended recipients.
Yes, grandstanders like Gordon or ambulance chasers like Acosta must be criticized for brazen opportunism, but parents don’t need Gordon or Acosta or Mocha to tell them to withdraw trust from medical experts who have endangered the lives of their children instead of prolonging them. One can understand if it will take a long time before the DOH and its program regain the trust of thousands of mothers.
Circling the wagons?
This brings us to the question of what really is the aim of the statement. The ostensible goal of the signatories is to prevent panic from spreading and affecting all immunization programs. Undoubtedly, many of them signed on with this in mind.
But with the absence of even the slightest criticism of the principals and the misplaced focus on the opportunists, one might legitimately bring up the question whether the statement is not really an attempt by some in the medical profession to circle the wagons to protect colleagues who are likely to be guilty of criminal endangerment of public health. And given the lack of any criticism of Sanofi’s breath-taking wrongdoing, one might further raise the question if the “Doctors for Truth” statement is not really an attempt by the same people to also come to the defense of the pharmaceutical industry.
This is a legitimate issue since the industry’s relations with the medical profession everywhere in the world is very tight, with doctors and hospitals enjoying perks and donations from members of the pharmaceutical cartel that is cynically called “Big Pharma.”
Medical professionals serve on the international and local boards of the drug giants, and there is a revolving door between private practice, public health service, and corporate employment. For those passing through the revolving door, this translates into very lucrative income indeed, one that could be threatened by a more guarded public response to the products of the multi-billion-dollar industry.
It is unfortunate that the signatories to the “Doctors for Truth” statement withheld their professional affiliations. One cannot but have the suspicion that one of the reasons for this might have been to not call attention to the links of many of the signatories to Sanofi and others in the pharmaceutical cartel, their local affiliates, and marketing arms.
In the interest of transparency, it might be good if the public were to demand that the “Doctors for Truth” fully disclose their professional associations, if any, to Sanofi and other members of the global pharmaceutical cartel, including their local affiliates and marketing arms.
Walden Bello, PhD, is International Adjunct Professor of Sociology at the State University of New York at Binghamton and the author or co-author of 20 books. A member of the House of Representatives from 2009 to 2015, he made the only recorded resignation on principle in the history of Congress owing to principled differences with the administration of former president Benigno Aquino III on the Disbursement Acceleration Program (DAP), the Mamasapano Raid, and the Enhanced Defense Cooperation Agreement with the United States.