On the controversy over thiomersal

The recently inflamed topic regarding inclusion of the thiomersal preservative (ethylmercury) in vaccines for parenteral use raises a series of questions at the scientific, political, and public health level, and which go beyond the controversy over risks and complications that are induced by the substance. This commentary serves as a critique of the conceptual simplicity with which it is addressed, as well as the crude black and white mindsets, which have merely reduced it to the dichotomy of toxicity/non-toxicity. This polarization unavoidably hardens positions to the point of presenting citizens with severe political differences, sustained by noisy debate devoid of any depth. Far from intending to reach a solution, this text only seeks to illustrate that the problems faced by a complex society should be addressed from various perspectives, thereby broadening the range of knowledge and citizen participation.

From the science viewpoint

Prevailing positivism is gradually coming to accept that empirical exploration is only one facet of medical knowledge, emphasized by the trend in biomedicine, and by studies conducted under the “Gold Standard” of Randomized Clinical Trials required by protocols with a randomly configured control group to justify evidence based medicine; and, more recently, empirical studies statistically backed by evidence based epidemiology.

Difficulties regarding their external validation have cast doubt on the use of Randomized Clinical Trial protocols in epidemiology. In this sense we are referring to extrapolation of the results obtained in a selectively refined universe of study¹. Only a few decades ago in Latin America did criticism develop -both in the fields of bioethics as well as in Social Studies of Science and Technology- towards scientific positivism, along with recognition of a double gap that misadjusts “progress”. These are the differing directions of politics and science, and the non-understanding between experts and citizens who aren’t as well familiarized with these topics^2,3.

Claims have arisen from the field of bioethics against the research performed by the pharmaceutical industry on account of deficiencies in three levels: epistemic, moral, and socioeconomic⁴. The scientific world is fed biased and erroneous information, created by studies that are ethically suspect (use of placebo and under-medication in control groups for random clinical trials, internal validation that restricts external validation, inappropriate selection of subjects, replacement of clinical ethics by research ethics). These are topics that have been amply discussed and continue to feed bitter controversy.

Socioeconomic improprieties have also been extensively discussed, including neglected diseases, therapeutic orphans, insistence on redundant research or me-too drugs. Less interest was aroused by the lack of scientific information, which as a whole has been called “preferential bias”(4). Such biases consist in manipulating study protocols in order for them to tend toward the desired outcomes. In sum, the experts are ill-informed, and the lay world may only know what has been agreed upon by the experts and which, according to the theory of knowledge, are called provisionally coherent truths subject to review and revocation. In medicine, we need only recall instances regarding drugs that have been researched, registered, and market-launched, only to be subsequently pulled from the market due to unacceptable toxicity.

In science, as in any subject, there are dissenting opinions, some warning of neurological complications, albeit most conclusions clear thiomersal of any negative effect. Statistics would appear to confirm that the incidence of childhood autism has increased even in countries that do not use thiomersal. In general, national experts agree that accusing publications are the least reliable. This is stated in the Declaration by the Advisory Committee for Immunization Vaccines and Strategies with regard to thiomersal in vaccines. Consequently, the discussion on the evidence that confirms or disproves the toxicity of thiomersal is of limited relevance. All coherent, consensual, or pragmatic criteria of truth argue in favor of paying heed to those who know, despite the limitations inherent to scientific knowledge. The judicial requirement of assessing the testimony of experts in terms of “relevance” and “reliability” is incompatible with science, which offers no certainty but a reasonable “weighing of evidence”. It is a language of probabilities that politicians should not underestimate^5,6. In sum, uncertainty prevails.

The precautionary principle

In situations of uncertainty, applying the precautionary principle is recommended.  Strictly speaking, it is not a principle, but rather a decision strategy when a lack of certainty exists. As a precaution, it is suggested to follow the path of least risk. Nonetheless, how does one weigh the probability and magnitude of risk in uncertainty? Is it a higher risk to ban thiomersal and discontinue use of a pentavalent vaccine? Or is it a greater threat having a case of childhood autism and for it to be blamed (on what grounds?) on a toxic effect of the substance?

Precaution is intended to be applied when the state of knowledge is deficient. However, its use lacks any ethical or technically sustainable bearing. It is sufficient to recall the H1N1 pandemic declared by the World Health Organization in 2009-2010. The mass vaccination recommendation from a council of experts shared interests with the manufacturers of an anti-flu vaccine: the so-called conflict of interests which were no more than blatant ethical offenses⁷. The “precaution” on the part of the international agency led to the unnecessary mass purchase of vaccines that met their expiry date in dark government warehouses.

Not for reasons of precaution, but rather of prudence –inherent to phronêsis or Aristotle’s practical reasoning– should the status quo of trusting the validity of vaccines preserved with thiomersal not be abandoned when there is a lack of scientific evidence and historical data proving that currently-in-use vaccines are potentially harmful or, more specifically, have a worrying risk/benefit ratio. Caution would dictate modifying the vaccination program, ignoring all compulsory or rigid recommendations, leaving the decision to use the vaccine in the hands of the affected persons.

In terms of politics

Citizens are condemned to wallow in deep disorientation when politicians arbitrarily decide to outsource in a matter of public health, taking upon themselves the technical competence, clarity of judgment, and certainty of criteria that lead to diametrically opposed conclusions between the Legislative and Executive branches, as well as wavering opinions among authorized voices.

Democracy shows its worst face when, supposedly concerned with the common good and representing the interests of the voters, a blind eye is turned to the fact that non-participatory democracy has been for a long-time dismissed. The “street”, citizen’s movements, plebiscites, intervention by the ombudsman, and support by certain NGOs are all civic procedures with which the publicly elected powers should legitimize their actions through discussion, communication, and decisive citizen participation.

Sociology has assiduously worked on the subject, proposing the formation of “hybrid forums” where average citizens and experts interact, forging public policy³ and establishing a “parliament of things”⁸. Democratization is an “effort to include ‘people’ in decisions normally made by ‘experts’”⁹. In Chile, bills put forward to set-up participatory procedures have been systematically rejected¹⁰.

Among other things, Law 20120 requires the creation of the National Bioethics Commission, which already exists in more than 100 countries, and whose mission is to act as a deliberative body between the population and public powers. For years UNESCO has been offering the Assisting Bioethics Commissions program. Aware of the crucial importance of these commissions, it provides expert help in establishing these agencies.

Chile has been unable to use this program because it has not expressed a concrete intention to implement the law enacted in 2006. Eight years have passed during which the legal mandate to create such a commission has been simply ignored, and leaving citizens without a vitally important deliberative mechanism in a democracy that has refused to establish other pathways for participation. In terms of bioethics, this equates to navigating through darkness, not facing burning issues still pending related to the extremes of life, among which we can find an equitable health system, the healthcare promised but not sufficiently fulfilled by the Universal Access with Explicit Guarantees in Health, healthcare regulation covered by an equitable insurance system, a reasonable pharmaceutical policy, a cost-containment policy to cover both public as well as private medical expenditure, and appropriately justified public health decisions.

In such complex issues of local as well as global consequence, it is unthinkable that deliberations and decisions are conducted and made behind the backs of citizens, totally ill-informed of the matters about which they intend to legislate. Here, forgotten are the thoughts of J. Habermas, who posed the need for legislation to be preceded by legitimation based on participatory democratic deliberation^11,12.

In terms of discipline

Chile’s health policies are called upon to grow above ill-informed dogmatism, substance-lacking ingenuity, and unjustified personal criteria. The colossal and multifaceted subject of immunological prevention of contagious diseases requires a multidisciplinary approach. The disciplines involved, such as public health, biomedicine, sociology, medical anthropology, and bioethics, will be distorted if cloistered within the restrictions of each specific perspective.

Transdisciplinarity consists in making the boundaries of each discipline permeable and allowing them to be nourished by other approaches, with the intention of gaining validity beyond their own borders. The transdisciplinary strategy replaces the habitual thinking of interdisciplinarity for the better, with the latter requiring a communion of thinking styles which is difficult, perhaps impossible, to achieve¹³. Interdisciplinarity is a de facto communion –unattainable and possibly undesirable‒ of schools of thought. Transdisciplinarity is a cross pollination among disciplines without losing sight of their identity.

Social sciences and bioethics are transdisciplinary by vocation. They are a reality that should be respected on account of the policy nourished between them. Within this porosity, one insistent claim is for citizen participation in the issues that affect their interests, both social and personal. This participation is all the more indispensable in nations such as ours where  the State cannot be exempted from its duty to protect a population that is afflicted by one of the worst socioeconomic inequalities in the world.

In terms of health

Public health constantly swings between ensuring public good and individual autonomy, seeking to avoid disciplinary measures whose efficacy depends on universal participation. Immunization policies have participated in this tension which is articulated in two poles: swinging between prevention policies of a paternalist demeanor, with compulsory vaccination programs and controls, against more liberal health policies that hand-down health management to individuals.  

On the other hand, mandatory vaccination has been used in a “political effort to subject populations and their minorities”¹⁴, motivating resistance movements. One clear example is the famous “Vaccine Revolution” in Rio de Janeiro (1830), vividly described by H. Cuckierman¹⁵. There have been many movements rejecting vaccination, to the point that vaccination history has come to be seen as “a privileged place to appreciate the real or apparent transformations and ruptures within a culture”¹⁴.

The reasons for controversy have been many: use of materials of animal origin, invasion of the body by scarification or injection, the duty to protect society versus the right to individual choice, ill-informed technical decisions, negligence in researching immunization against diseases such as malaria and parasitosis, the influence of socioeconomic conditions in vaccine protection susceptibility and coverage. Medical anthropology, which still has a weak voice in Chile, detects an attitude toward imposed immunological schedules, the readiness to accept vaccination as a sign of modernization, and the reluctance of neoliberal societies marked by individualism to run the risks of vaccination in the name of social good.

Vaccines have been a public health success (without a shadow of a doubt!) in the eradication of smallpox, protection against tuberculosis, diphtheria, whooping cough, polio, and measles. Nevertheless, it is these very successes that should shape the future of immunity programs, studying and weighing the risk of new outbreaks if protection is reduced in comparison to the inherent risks of intervention for diseases that, such as smallpox, have been eradicated or removed.

This mere outline aims to illustrate the complexity of vaccination history, showing the discord that becomes unsustainable between the irrecusable duty to participate and the increasing outcry of citizens for participation and to be the possible counterparty to public policies not legitimized by the involvement of those affected. Those who in the scientific and political worlds consider it necessary to take a stance and make decisions, would do well to find out in greater depth about this complex history and the social and anthropological processes that have accompanied it. The preeminence conceded by biomedical research to genetics and immunology should be reflected upon and assimilated, at the sociological as well as anthropological and bioethical levels.

In terms of bioethics

Bioethics has made its entrance into the academic world with the intention of contributing to solve problems posed by medical ethics ‒Hellegers‒ and, in a more holistic view, by the impact of technoscience on ecology ‒Potter. It is only in recent years that the need to adopt the bioethical approach to public health has been put forward, with particular urgency in regions of great socioeconomic disparities and irrecusable duties by the State which are aimed at protecting citizens¹⁶.

By making a way in search of a conceptualization that escapes the principlism schools developed in consideration of the physician-patient and researcher-subject interpersonal relationships, an approach is required for collective social processes such as public health and health policy. Latin America has pushed forward with intervention bioethics (Brazil), bioethics based on human rights (Argentina), bioethics of a bio-political slant (Colombia), and protection bioethics (Chile).

When public health proposes establishing policies and programs whose mandatory nature require ethical legitimation, protection ethics proposes a procedure based on four considerations or “conditions for application”¹⁷:

1. The community faces a harmful agent or process of unacceptable proportions.
2. There is an effective proposal for protection, proven to be the best in existence and not merely the most readily available alternative.
3. The risk of negative effects, unavoidable in any intervention at collective level, should be randomly and impartially distributed.
4. Fulfilling these requirements, and in the measure that the protective action may require, it shall be ethically legitimate to apply it in a disciplined and mandatory way, not authorizing individual attempts of resistance or non-abidance that would put the program at risk.

Conclusion

Whatever be the final outcome decreed by public authorities for thiomersal and the vaccines that contain it, they are to have negative consequences on public health policies that, at least, reincarnate the tale of “The Emperor's New Clothes”. This means that political actors, presumably informed, present with supposed sagacity contradictory conclusions that misguide citizens. In this way they put on a mask behind which lies a worrying lack of what P. Bourdieu calls “cultural capital”.

Certainly, there is no cause for requiring political actors to possess a wealth of knowledge in all matters to be seen. It is, however, all the more important then to be open to expert knowledge and to have respect for citizen participation to legitimize the decisions to be made in the midst of uncertainty.

Should thiomersal be condemned, it will be necessary to deal with those who blame vaccination programs for not allowing them to abstain from the possible risks of subjecting their children to perhaps unnecessary vaccines, through justified individual choice or not. Conversely, should the safety of thiomersal be concluded, the uneasiness of imposed decisions shall linger, casting suspicions that regulatory and legislative processes are lacking in necessary soundness.

The controversy over thiomersal is but a part of a series of deliberative and legislative insufficiencies that negatively affect Chilean society. Namely, among these, the schematic, insufficient, and unfulfilled Law 20120; the questionable and much criticized Law 20584; the ups-and-downs of legislation on organ transplants and the refusal to so much as discuss the retrograde law on abortion, the last legacy of a dictatorial regime. Few are the tools for reflection, but it is necessary to blow the whistle whenever they go unheard. Where are the guiding insights of Universities? Where is the passionate, rational-without-being-dogmatic, daring-without-being-principlism bioethics?

At another time and in another context, Emil Zola wrote in his famous text “J´accuse” (1898): “mon devoir est de parler, je ne veux pas être complice” (it is my duty to speak up; I will not be an accessory to the fact)¹⁸.

Notes

Disclosure of potential conflicts of interest
The author has completed the ICMJE conflicts of interest statement translated into Spanish by Medwave and states that he has occasionally provided consultancies to the Chilean parliament and the Superintendence of Health, not related to this article.