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Talking Back to Science?

By Stephen Rainey

In June 2017, the European Court of Justice ruled that it was legal for a French citizen to sue a drug company for damages following a vaccination, and an illness. The ruling caused some consternation as it seemed a legal vindication of anecdote over scientific rigour.

This is a dramatic case, not least owing to the position in which vaccines find themselves, post Andrew Wakefield and the rise of the anti-vaxxer movement. Nevertheless, it forms a part of a wider narrative in which scientific activity is not always very open to questions from outside science. This broader theme is worth some scrutiny.

Vaccine Injury

Shortly following a vaccination against Hepatitis B a French citizen, JW, found himself in declining health. Soon after the decline began, a diagnosis of Multiple Sclerosis (MS) was made. Having had no prior personal or family history of such an illness, and having been in good health prior to the inoculation, JW concluded that the injections must have been to blame for his developing MS. His assertion of this was not supported by scientific investigation. Rather, he could think of the vaccination as the only unusual event that preceded closely his sudden, unexpected development of the condition.

The French courts found themselves unable to agree on whether such a basis as this is sufficient to sue a pharmaceutical company. Eventually, the case was sent to the European Court of Justice (ECJ) which ruled,

“…that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof. That could be the case inter alia where that evidence leads the court to consider, first, that the administering of the vaccine is the most plausible explanation for the occurrence of the disease and, second, that the vaccine therefore does not offer the safety that one is entitled to expect.”

Some fear that this opens scientific rigour to challenge with nothing but anecdote. Peter Openshaw, president of the British Society for Immunology, notes his puzzlement with the verdict as follows,

“The scientific evidence does not support a link between the hepatitis B vaccine, or any other vaccine in current use, and multiple sclerosis,” he said. “To say that there is a link between any vaccine and multiple sclerosis and at the same time to admit that there is no scientific evidence of such a link is illogical and confusing to the public.”

The ECJ ruling appears to acknowledge that something like a ‘balance of probability’ standard ought to be considered in complaints about suspected defects in health products. It’s not that anecdote is sufficient, or that ‘no evidence’ is required, to support a complaint against scientific research. This isn’t an anti-vaxxer’s charter. Even still, why might the ECJ present a ‘confusing’ position such as this? Given that the confrontation of scientific with non-scientific discourse goes beyond vaccines, from a broader analysis, some insight can be gained.

In a context of future challenges on a global scale that might be met only through careful scientific advance, the public sphere in general becomes a kind of ‘collective experimentation’ laboratory. Areas such as climate change and air pollution require large scale responses that have implications for lots of different people, with lots of different views of the world. This being so, these publics require in principle some kind of channel of response to science. The ECJ ruling can be seen as recognition of this.

The idea of the public as a sort of laboratory may appear to be quite problematic. What is the research agenda of such a lab? Are the ‘stakes’ already defined in advance of discussing ‘an issue’, presuming that that issue is widely perceived, understood, and acknowledged as having particular social relevance? That a case such as JW’s appears in court perhaps suggests that there is no effective arena for such critical, normative discourse other than the legal. This cannot be expected to suffice, given this complex context.

Where a discursive basis for the introduction of a new technology into the public sphere is missing, there is the potential for unjustified social change — change predicated on narrow sectoral interests. The case of GM, mentioned below, demonstrates this well. Constructing a discursive basis for potential social change is a necessary condition for a just public sphere. For consistency’s sake, there cannot be exceptions to this, unless those exceptions too are grounded in a discursive manner. Such justifications will stem from communicative action rather than experimental. This means that some types of ‘non-scientific’, discursive evidence must be expected to feature in the overall evaluation of scientific outputs.


An influential report on the ‘European Knowledge Society’ notes that,

“Ethics has been used at times by EU institutions to neutralise political issues, to introduce norms outside the traditional process of law-making, to evoke society without involving it, to pay lip service to democratic concerns while only expert processes were taking place… Ethics is represented as if it is naturally a matter of expert judgment only, though this very framing has markedly shaped, and continues to shape, which ethics and whose values count in European politics.”

The criticism in the above is that politics is neutralised through the (disingenuous?) importation of extra politico-legal norms in order to smooth the path for developments of various kinds. But if the importation of such norms is problematic in that it evokes but does not involve the correct parties, then it can be corrected by involving those parties. An instrumentalist ethics, designed to be a lubricant in a policy progress machine, ought to be replaced with a discursive ethics that sets policy agendas as well as reacts to them.

Big data, human enhancement, social robotics, are among an array of fields in which scientific progress might clash with what people think of as social progress. The very nature of scientific value and its scope of application might come into question. Ethical analysis can provide a medium and a guide for this in a way that recourse to the law cannot.

The thing is, when norms or values clash in these sorts of circumstances, often what’s at stake is one conception of ‘the good life’ or another. Where accepting, or changing, norms is prompted by one set of choices rather than another, it is people who must reorient themselves in a new reality. Such reorientation can be positive, but where it is handled badly or, worse, ignored, it represents domination of one set of views by another.

The case of GM food in Europe was handled particularly badly, for instance. European regulation of genetically modified organisms has been formalised since at least 1990. GM technology, in terms of food production, was presented to the European public as a good thing. That public, though, rejected as an unnecessary deformation of well established ways of life. This confrontation was framed by policymakers and GM companies as a case of an ignorant, frightened public in need of having GM benefits explained more carefully to them. This failure to recognise the public perspective led to a hardening of public opinion further, and many years later the case of GM in Europe remains complicated.

‘Ethics’ in the GM case was exercised to the extent that GM crops were judged by expert groups to be safe. That didn’t cut it, for the reasons just described: the public weren’t necessarily all that afraid, they just weren’t that into GM.

Living Well

How the good life is envisaged; how one ought to recognise others different to oneself; when ought change to be coerced; these are clearly important areas for ethical reflection. Scientific progress, sometimes out of step with other conceptions of progress, raises all of these kinds of concerns (and more perhaps). It seems clear that science that hopes to change the world, or the lives of others, must engage with ethics in a responsive dialogical manner.

Ethical analysis is well suited to the complex challenges here. With ethics there are tools to reconstruct a discourse from what otherwise might simply be a clash. This isn’t to say that ethics researchers ought to become the powerbrokers in a brave new world of ethocracy.  Ethics is not the gatekeeper for discussions here, deciding who can say what, when. It might better be thought of as a groundskeeper, providing a critical and contextualising arena for otherwise unruly face-offs.

The sad case of JW ought not to have become a set of headlines about whether scientific progress had been disrupted by the courts. The focus in those events ought to have been on how science and society talk to each other. The case of GM ought not to have eroded into polarised positions of mutual suspicion. Such matters ought to be thought of in terms of the ethical questions they raise and discursive opportunities they present, not the legal verdicts they elicit.

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2 Comment on this post

  1. “Even still, why might the ECJ present a ‘confusing’ position such as this? Given that the confrontation of scientific with non-scientific discourse goes beyond vaccines, from a broader analysis, some insight can be gained.”

    The ECJ hardly seems interested in advancing discourse about vaccines or other scientific matters. The purpose of the court is to ensure just remediation for injury, not promote social discussion of policy matters. And the present question is a much more narrow one about standards of evidence: essentially, whether *non-scientific* evidence of causal links may be presented in pharma liability cases, just as it can be presented in other contexts. The court’s judgment sets the standards of evidence a bit lower than scientists and policy-makers would like, but this seems reasonable as a matter of parity with other cases. (There is a related suggestion that absence of evidence is not evidence of absence)

    “That a case such as JW’s appears in court perhaps suggests that there is no effective arena for such critical, normative discourse other than the legal.”

    It does not seem to be the case that the courts are the only means by which individuals can engage in social discourse over vaccine safety. Public fora have only exploded in recent years, and there are innumerable venues in which vaccine critics may express and debate their views. Perhaps in previous years newspapers served as effective gatekeepers of information dissemination (I doubt that ethicists ever have), but online communities and alternative media have effectively disrupted that. Indeed, the recent success of the anti-vaxxer movement is in part due to the discursive power of these outlets.

    1. Thanks for this.

      The purpose of the ECJ is to ensure the consistency of the application of supranational European law at the national level. While they aren’t tasked with the promotion of social discussion of policy matters, their rulings can (ought to?) prompt policy discussion of social matters.

      This is a ‘preliminary ruling’, meaning it is providing an interpretation of EU law to see if a national law is compatible. Earlier in the ruling, before the parts quoted in many of the journalistic reports it laments (reading the mood into it) that there is no definition of ‘causal link’ within the legislation, although there is one for ‘defect’. Given this is an application of product law in a medical context, with no legal definition of ‘causal link’, but a positive one for ‘defect’, the whole controversy could be seen to stem from that. Thus, the ruling establishes that, yes, the French national case is compatible with EU law overall, but that perhaps because of definitional shortcomings, EU law might want to be revisited.

      It’s not the place of the ECJ to say that, as it just operates to determine national law’s compatibility with EU treaties. But it could be seen as motivating a response from those who are empowered to revise law, that is, a combination of the European Commission, Parliament, and Council. This would be the ideal, and would be expected — ideally — to enjoy citizen participation.

      We’re in agreement on the standards of evidence point.

      The final point on the role of the law isn’t that “…the courts are the *only* means by which individuals can engage in social discourse over vaccine safety” (emphasis added) it’s that it’s the only *effective* means. the only means that can have a discussion that might end in action based on relatively public reasoning. That it’s constrained by legal standards makes it automatically a less open discourse, which is part of the unfortunate nature of things.

      We disagree that alternative media demonstrate discursive power in this kind of area. My sense is that this power is strategic and disinterested in openness to argumentation. Echo-chambers can be predicated too much on a hermeneutics of suspicion that is not reflexive enough to challenge its own basis. This is why other outlets, approaches, and media are necessary. Opening closed framings is not easy, but, I suggest, is something those skilled in ethics can facilitate — as groundskeepers rather than gatekeepers.

      This is a very tricky area where vaccines are concerned, but as I mention, one that trades on broader themes in science and technology.

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