The distinction between modal and amodal completion is ubiquitous in theperception literature. It goes back to the seminal publication “Les complémentsamodaux des structures perceptives” by A. Michotte, G. Thinès, and G. Crabbé(Publications Universitaires de Louvain: Louvain) in 1964. We review and discussthis work in this article and show commonalities and differences to today’sview. We then argue that the dichotomous distinction between modal and amodalcompletions is problematic in phenomenological, empirical, logical, andtheoretical terms. Finally, we propose alternative criteria allowing for a moredifferentiated classification scheme for completion phenomena. This scheme seemsto be consistent with all known empirical findings and can also be generalizedto nonvisual domains of perception. An important prerequisite for systematic, focused research in all scientificdisciplines is the organization of research objects in a hierarchical system ofclasses whose elements share essential characteristics. In perception psychology,there are modal and amodal completion phenomena, which belong to the class ofperceptual completion phenomena. However, this common classification seemsproblematic to us for various reasons, as we will discuss in this article. Phenomena of perceptual completion demonstrate the constructive character ofperception. In this context, the term “perceptual completion” typically refers tomental processes that lead to the perception of an entire object despite onlypartial stimulation, i.e., even though parts of the perceptually represented objecthave no actual correspondence, or “local counterparts” , p. 294,In the literature, a distinction is usually made between two types of perceptualcompletion, namely, between modal and amodal completions. This dichotomousclassification goes back to 1 In visual perception, modal completion includes, for example, “simplegap-filling” (p. 141) such as the filling of sensory holes in the blind spot or theconnection of image fragments to a unified perceptual figure that is completelyvisible  as the rest of the configuration” (p.141), and otherwise “amodal.”Although Michotte et al.'s usage of “modal” and “amodal completion” seemsstraightforward and intuitive at first sight, they do not offer a precisedefinition. More crucially, their examples of modal and amodal completions do notseem to be perfectly consistent, which makes it a bit difficult now to reconstructdefinitions that might match their real notion.occluded parts ofobjects, “using ‘amodal’ to refer to the absence of sensoryaspects, e.g., brightness or color, in the parts of objects perceived to bebehind other objects”  are present in thecompleted regions.The visibility criterion. It is met if the completedregion is visible, that is, not occluded.The Both criteria seem almost equivalent insofar as one criterion is usually metonly when the other criterion is also met. If the criteria are met, the term “modalcompletion” is used, otherwise the term “amodal completion.” In a critical review ofthe current conception of perceptual completions, we will argue that the twocriteria are actually not equivalent.The distinction between modal and amodal completions is today based on the following two phenomenological criteria: modally visible parts, for example, by the gray regions in thelower right of by the modallycompleted object, for example, the Pacmen in the upper left of Both modal completion and amodal completion often involve an interpretation ofocclusion: Amodal completion of a partly occluded object is typically induced by itsIn this article, we discuss Michotte et al.’s 1964/ conceptiFor the sake of readability, we will sometimes only mention Michotte in the followingsections. In these cases, we also refer implicitly to his collaborators on variouspublications.In this section, we give a commented summary of the famous work of Michotte et al.1964/ and showcomplement and completion pointsto the contrast between the phenomenological notion discussed by [t]he French expression “compléments amodaux” […] has been occasionallytranslated into English as “amodal complements” […], but the prevalentcontemporary usage is “amodal completion.” The difference betweenAnalogously, the expression “modal completion,” which shouldactually read as “modal complement” in most cases,cannot be taken as denoting a hypothetical process of joining inputfragments by means of illusory additions, according to what Kogo andWagemans (2013) consider a common misinterpretation found in theliterature on mid-level vision. Rather, it should be taken as denotingthe phenomenal presence of parts devoid of an obvious local counterpart but supportedby global stimulus information and functional to the overallorganization of the perceptual world.  as the rest of the configurationadditions present the same visual qualities . They point out that they use theterm “modal” in the sense of Helmholtz “to describe the special qualitativecharacter belonging to each sensory field” . Note that thiscriterion resembles the sensory-qualities criterion formulated earlier, but itis stronger in that it also includes the rest of the configuration. This meansthat modal complements can only be constructed in the presence ofmodal counterparts of the same visual quality.In the Introduction, Michotte et al. . The first examples involve filling phenomena:Filling of the blind spot and filling of tachistoscopically displayed figuresobserved in experiments with hemianopic subjects. Such phenomena are stillrepresentative of modal completion from today’s perspective.indistinguishable from the rest of thetriangle, if the displayed perimeter exceeded a critical relative length e length . Figure 5 This shows that integration is not sufficient on its own in such a caseto produce the completion [originally: complément]; other conditionshave to be satisfied; in this case, those conditions make the line ofdemarcation seem to belong to the contour of the screen.We suspect that Michotte et al. 1964/ would agComplements require integration but not viceversa.Summarized, they carefully distinguish between integration andcompletion/complements. Michotte et al. also discuss the “Rosenbach phenomenon,” which they classify as acase of apparent transparency, but which does not have much in common with thestimuli as shown in “Rosenbach transparency,” if not imagery, would be clearly understood as modalcompletion of the partially masked element today because its surface complementshave visual qualities such as brightness and color and are directly visible. For Michotte et al. 1964/, howeverFor the sake of clarity, we will use the terms “apparent transparency” and“perceptual transparency” in the following to distinguish between two differentclasses of stimuli, both of which evoke a transparency percept. With apparenttransparency, we refer to fragmented stimuli that complement each other to forma semitransparent figure with partially illusory contour and surface, as shownin 6 There is the idea that “notions like scission and layer decomposition,combined with grouping by surface colour similarity and contour goodcontinuation satisfactorily account for perception [of transparency]”  present their concept of amodal complements in connection with the“simple screen effect” , which ione object covers another without appearing to alter the integrityof the latter” . We assume that they use theterm “screen effect” because certain stimuli radically change their perceptualcharacter at the moment when a “screen”  isplaced in front of them  from the completion ofthe figure [originally: complément figural]” . While “theimpression of the unity of the whole shape and the unbroken character of itscontour is entirely compelling for the subjects” and “the shape, direction, andso on of the figural completion [original: complément figural] can be perfectlyprecise” (p. 144), the impression of the continuity of color is less compelling.“It seems rather to become established secondarily, by reason of the unity ofthe whole shape, as an overall property of it” (p. 144). Finally, theydistinguish amodal completion, which is stimulus-driven, from imagination,“which implies the presence of sensory qualities” (p. 146).Michotte et al. 1964/ explain  of them . “[C]ompWhile all of the aforementioned is consistent with today’s view, twoconsiderations need to be discussed in more detail:amodal completion occurs even when onlyone side of a figure is covered by a screen, which is undoubtedlytrue This is consistent with today’s view Michotte et al. 1964/ completeew e.g., ,2017. Wew e.g., , 1999b—ramodal complementsdo not require continuous stimulation by visible inducers. Instead,the life span of perceptual objects can also be extended amodally if(temporarily) no stimulation occurs at all ; Scherzer & Ekroll, 2009). This is consistentwith today’s view.Michotte et al.  also discuss related dynamic phenomena.They review experiments in which a moving (or stationary) target object appearsto be gradually covered and uncovered by a stationary (or moving) occluder. Thefundamental observation is that the target object continues to exist throughoutand retains its perceived shape, even if it is not visible at all for a shorttime. Summarized, these “most simple cases” , p. 150 the presence of adequate spatiotemporal cues can induce illusoryoccluders that operate in the same way as “real” occluders, thatis, the occluders induce or coincide with the amodal complement of the target.8Michotte et al. also report similar observations when the occluder wasindistinguishable from the background, that is, invisible to the subjects. Theonly difference was that the moving target now seemed to gradually disappear in(or reappear from) a modal illusory stationary slit in the background or thatthe stationary target was gradually covered and uncovered by a modal illusorymoving occluder. From our point of view, these observations show that alsoperceptual objects can continue to exist amodallyfor a while without visible inducers.9 Second, “in spite of the presence of the screen, the movement iscontinuous and uniform” and “[i]t seems that there is no differencebetween a movement of this kind and a movement exposed throughout”. The motion path in the tunnel is interpolated in asmooth, “natural” way  or“shadow movement,” which is detached from any carrier object. However, they alsoacknowledge that “[i]n other respects […] the two phenomena are quite different,particularly because of the existence in the tunnel effect of the exposed partsof the movement, which influence the apparent speed of the moving object duringthe hidden phase” , p. 153.Note that the tunnel effect is very robust, as it also occurs with static stimuli. ScherzeIt is surprising that some thoughts of Michotte et al. 1964/ about “a10 For Michotte et al., the cube “seems completely transparent andconsequently has no modal character” (p. 161), especially when a structuredbackground is visible through the (mass of the) cube. It is therefore consideredamodal.They give the example of a rotating “Necker cube” , p. 336 Michotte et al. also give stereoscopic and stereokinetic examples of outlinefigures in which surface and depth interpolation occurs, leading to the “amodal”perception of transparent objects with rigid walls.for Michotte et al., amodal perception isnot limited to cases of occlusion. However, applying the twocriteria that, in our opinion, best characterize today’s view, the exampleswould clearly fall into the category of modal completion, as the transparentindefinable substance contains material qualities and is not occluded, that is, directly visible (visibility criterion).11All these examples show that The conception of modal and amodal complements presented by Michotte et al.1964/ doesnotAccording to Michotte et al., Rosenbach transparency forms anintermediate group between simple gap-filling and amodalcomplements. Although not mentioned by the authors, the sameconsideration would probably also apply to apparent and perceptualtransparency . Today, For Michotte et al. 1964/, the comWhile Michotte et al. focused on visual complements of objects andthe interpolation of motion under occlusion, the concept ofperceptual complements/completion has been extended to texture andmotion spreading  and the Complements without cover, which Michotte et al. considered asamodal, would probably have to be considered as modal today if thesensory-qualities and the visibility criterion, which are both metin this case, were applied.Today, modal and amodal complements are  understood asdichotomous categories. Unlike Michotte et al., however, the classification intoone of the two categories is strictly based on the sensory-qualities und thevisibility criterion. Moreover, there is now a consensus that modal andespecially amodal complements are not a product of imagination but areconstructed according to fixed perceptual regularities. Compared with Michotteet al., some differences and extensions in today’s classification of certainphenomena can be observed: Taking Michotte et al. literally, visual percepts can be classified either as modal,amodal, or apparently transparent (as an intermediate group). This trichotomedivision appears suitable for figures and surfaces whose complements arecharacterized by the presence or absence of visual qualities such as brightness andcolor.To apply this categorization principle to the perception of motion, its visualqualities would have to be identified, as the visual qualities of objects such asbrightness and color are not defined for motion. Michotte et al. implicitly mentioncontinuity and uniformity as visual qualities of motion. Thus, analogous to thecategorization of perceptual complements of objects, motion would have to beconsidered modal if it is continuous and uniform, and otherwise amodal.In our opinion, however, both the trichotome classification of object percepts andthe dichotome classification of motion percepts by Michotte et al. are problematicfor different reasons, as we will briefly explain in the following subsections.Taking the strict definition of modal complements of Michotte et al. as a basisand considering perceived transparency  as a difIn our opinion, however, this division is problematic for two reasons: First, theresidual class of amodal complements is so large that it contains many phenomenathat have neither phenomenally nor structurally significant similarities . It is therefore highly questionable whetherit makes sense from a theoretical point of view to classify these differentphenomena in a common category.modal complementsonly to the locally specified surface attributes brightness and color and thusthe exclusion of globally specified object attributes such as unity,shape/contour, or surface material/quality, seems unjustified from aphenomenological point of view: Scherzer and Ekroll would have to be regarded as modal, at least with regard to certain globallyspecified attributes . However, there is a contradiction here because “in spite of thepresence of the screen, the movement is continuous and uniform” and “[i]t seemsthat there is no difference between a movement of this kind and a movementexposed throughout” , the seeming contradiction between the modal perceptionof movement on the one hand and the amodal appearance of the object on the otheris not addressed. It therefore remains unclear why the tunnel effect, which issignificantly characterized by the movement of a temporarily hidden object,should be understood as (purely) amodal phenomenon.modal complement of thevisible motion trajectories. Therefore, we disagree with Michotte et al. on this point and prefer to classifythe motion impression in the tunnel effect as modal. Motion continuity anduniformity can be summarized as motion smoothness, which is probably the mostimportant visual quality of motion and which is closely related to the (changein) speed of movement over time. Conversely, a jerky “displacement percept” with abrupt jumps  or “virtual lines” . This is how collections of dots are called,which are visually connected to a clearly defined contour in a regular manner. Thephes closed , even thAnother class of completion phenomena that do not fully meet thesensory-qualities criterion, although they meet the visibility criterion, areKanizsa-like figures with a large distance among the inducing elements as wellas “incomplete” Kanizsa-like figures as in While the surface impression near the inducers is clearly modal, the presence ofvisual attributes such as brightness (or color) decreases continuously withincreasing distance, until finally no difference to the background isdiscernible anymore. The completion of the surface can therefore in its entiretyneither be called modal nor amodal, as the type of complement obviously dependson the location on the surface. This also applies in a similar way to quasimodalpercepts . Figure The consequences of these observations and the problem of determining an exactdistinction between modal and amodal regions will be discussed furtherlater.There exist not only completion phenomena that evoke an amodal percept despitedirect visibility but also reverse cases in which a modal percept appearsdespite occlusion, that is, that the sensory-qualities criterion is met, whilethe visibility criterion is not.14 As demonstrated in Evidence of the existence of such phenomena is provided by the occlusion illusion,which cperpendicular to theoccluding edge without perceiving any difference in the positions of the regionsattached to the edge.” This would, however, imply that a modal impression wouldbe possible despite occlusion, which would lead to the paradoxical situationthat this region would appear visible and yet occluded at the same time.Up to this point one could expect a size or shape illusion, as there are many inthe literature, but it is particularly interesting to ask how the additionalspace for the modally completed stripe was released. An obvious possibilitywould be a slight displacement of one or both elements, but Palmer et al. ,but modal percepts despite occlusion are also possible in motion perception, asdiscussed earlier in the context of the tunnel effect: The motion interpolationbehind a masking screen should be considered modal, with the modal complementreferring to the  smoothness of the interpolation, ifunder appropriate conditions it is not phenomenally discernible from realmotion.The phenomena presented earlier show that the dichotomy of modal and amodalcomplements is not suitable in its current form, as in certain cases only thesensory-qualities or only the visibility criterion is met . In thes15Probably, the easiest way to solve the problem that in some cases only one of thetwo criteria applies would be to classify only those phenomena as modal (type M)that meet both criteria and those phenomena as amodal (type A) that do not meeteither criterion. For the two residual classes of phenomena, which each meetexactly one of the two criteria, there would have to be a third and fourth typeaccordingly  and in the “partially modally” completed regions in the occlusionillusion (type R1),the direct visibility of both the Kanizsa triangle (type M) andvirtual figures (type R2),the perception of occlusion both in the “amodally” and in the“partially modally” completed regions in the occlusion illusion andthe missing visual qualities of both amodal complements (type A) andvirtual figures (type R2).We therefore consider this approach inappropriate.The drawback of this solution is that it ignores essential phenomenological andpresumably structural similarities that exist between the four categories, forexample Another obvious solution would be to use only the visibility criterion, whereby aclear assignment to one of the two dichotomous categories would presumablyalways be ensured. From an empirical point of view, however, this is problematicbecause the perception of direct visibility is possible despite the impressionof occlusion visibility could be used to categorize completion phenomena, but this wouldtheoretically be unmotivated and furthermore any reference to the pervasiveperceptual concept of occlusion and completion/continuation would be lost. Froma theoretical point of view, however, such a reference seems indispensable for ameaningful classification of completion phenomena. Moreover, the objection thatthere are phenomenological and structural similarities between completionphenomena that are not captured by the classification scheme applies in partalso to a scheme based on the weakened visibility criterion.If the perceived (non)occlusion instead of perceived (in)visibility was used asan alternative criterion, similar objections would apply.Conversely, the idea could be to use only the sensory-qualities criterion toclassify completions, which would supposedly always ensure a clear assignment toone of the two dichotomous categories. With some corrections, as outlinedearlier, this would probably also largely correspond to the view of Michotteet al.However, we have already argued earlier that from a theoretical andphenomenological point of view this criterion appears suboptimal because theamodal residual class would be very large and also phenomenally heterogeneous.Accordingly, a further subdivision into suitable units would be necessary for asystematic analysis.Another problem is that for some completion phenomena the sensory-qualitiescriterion only applies in certain regions of the complement and not in others to14. IIn addition, the transition between the presence and absence of sensory qualitiescan be continuous , like theconceptions of Michotte and Kanizsa, is purely phenomenological in nature,it allows to “abandon the assumption that modal and amodal percepts arelinked to the dichotomy between unoccluded and occluded scene regions”, p 11. NThe continuity hypothesis: When modal and amodalpercepts are decoupled from the dichotomy between unoccluded andoccluded scene regions, the phenomenological attribute“modal/amodal” could be a continuous rather than a dichotomousvariable that depends continuously on the conclusiveness of thesensory evidence : The “unity class,” including attributes such as unity,connectedness, and “common fate.”16 and thus, implicitly, depth.The “shape class,” including attributes such as contours and shapeThe “quality class,” including attributes such as specificfeatures and characteristics.At first glance, the distinction between these three classes is verysimilar to the “task-oriented taxonomy of visual completion” proposed byThe CSE hypothesis not only permits a consistent classification of completionphenomena, as will be shown later, but it is also appealing because it makespredictions about the possible meaning of modal and amodal percepts, namely,that the quality of a percept represents the conclusiveness of its sensoryevidence. In this way, it may offer explanations for previously unexplainedcompletion phenomena such as the ubiquitous occlusion illusion , p. 10. Object and surface unitySurface contour, object shape, and depthSurface qualities Attributes of motion—not attributes of a moving object!—includeanalogously: Motion connectednessMotion path and depthMotion speed and smoothnessFrom these two subhypotheses, some further implications can bederived: Sensory evidence is attribute-based: Theconclusiveness of the sensory evidence regarding one perceptualattribute in a specific region of the visual field may bedifferent from that regarding a different perceptual attributein the same region. It is thereforepossible that some of the attributes pertaining to an occluded regionof the visual field may be experienced as phenomenally clearlyspecified and distinct , whereas others may be notspecified and distinct or poorly specified and distinct . , p. 11Of course, the same may also apply to some attributespertaining to unoccluded regions of the visual field.Accordingly, attributes of objects include as follows: Sensory evidence may vary with the location: Thepresence of certain perceptual attributes, that is, visualqualities, may vary abruptly or continuously across the visualfield, depending on the conclusiveness of the sensory evidenceof corresponding characteristics at different locations. Forexample, there are abrupt changes in the conclusiveness of thesensory evidence for the specific surface color of the trianglein the lower right of The conclusiveness of the sensory evidence regarding globalattributes such as the unity or the exact shape or contour also seems todepend on the local sensory evidences at critical locations in the visualfield. If the local sensory evidence regarding one attribute is weak at somecritical locations, its overall evidence cannot be very conclusive anymore.For example, the overall sensory evidence of a triangle in With respect to the situation depicted in Scherzer and Ekroll , p. 11 dphenomenologicalaspects of the percept  and the potential functional meaningof visual qualities  in a broad sense. A key concept isthe conclusiveness of the sensory evidence.The CSE hypothesis focuses on essential The important question of which stimulus characteristics provide conclusivesensory evidence is not part of the CSE hypothesis, but it builds directlyon The CSE hypothesis complements Rock’s conception with important aspectsconcerning visual qualities and their potential functional meaning. Applyingthe CSE hypothesis may therefore inspire informative deductions on the basisof pure phenomenology, as will be illustrated later. In particular, thecontinuity subhypothesis also offers an explanation for fuzzy orunderspecified properties of the percept, for example, for the “incomplete”illusory triangle in 17the illusory-contour percept provides a single explanation for whatwould otherwise be unexplained coincidence: incomplete circles whosemissing parts have edges aligned or collinear with those of otherincomplete circles and the potential presence of a triangular figurein the white central region. According to the CSE hypothesis, the extraordinary salience ofthe triangle  may beindicative of a great reliability of the underlying perceptualinferences.For example, one might wonder why the sensory evidence of a Kanizsa-liketriangle as in To illustrate the classification criteria, they will now be applied to somewell-known phenomena.Kanizsa figures: Many Kanizsa-like figures like the Kanizsatriangle , which excludes the interpretation of an unbrokencontour. This would be consistent with Michotte et al.  for whichthere does not exist a relatively sharp, relatively straight transitionbetween two more or less uniform, extended, and contrasting regions in thestimulus (a property of the image).” In this way, they linkthe phenomenal (subjective) impression with the (objective) stimulusproperties. In contrast, the proposed classification scheme intendedlyrefers only to phenomenal properties. The woman in the painting wouldtherefore rather be characterized as follows: Her unity and shape arevisually quite clearly specified, which is also supported by theexperimental results of Koenderink et al. (18 Her dress is visibly colored, that is, it contains surface qualities,but the brightening effect is much weaker than with a Kanizsa triangle.Wagemans , p. 2 caEnsemble perception: Haberman and Ulrich (d Ulrich , p. 2 prd Ulrich , p. 8fiThe common dichotomous distinction between modal and amodal percepts is problematicin phenomenological, empirical, logical, and theoretical terms.


Type 2 Diabetes (T2D) is a common long-term condition affecting the health and wellbeing of New Zealanders; one in every four New Zealanders is pre-diabetic. Māori, the Indigenous people of New Zealand, are at an increased risk of developing pre-diabetes and T2D and there are significant inequities between Māori and non-Māori for T2D complications. The purpose of this study was to explore the questions of how the strengths of Māori heath organisations may be leveraged, and how the barriers and constraints experienced by Māori health organisations may be negotiated, for the benefit of Māori; and from a systems perspective, to identify strategic opportunities that may be considered and applied by Māori health organisations, funders and policy makers to respond more effectively to pre-diabetes and reduce health inequities between Māori and non-Māori.Utilising case study methodology, a range of data sources were triangulated including nine semi-structured interviews, documents, and a diabetes system map to identify possible strategic opportunities for key stakeholders to respond more effectively to pre-diabetes.Key themes and possible actions to improve health outcomes for Māori with pre-diabetes include: (1) Recognising Māori health organisations as conduits for the community voice and influential partners in the community to effect change; (2) Strengthened partnerships with Māori health organisations for community benefit and to support measurable, evidence-based change and service delivery, particularly when Māori knowledge systems are viewed alongside a Western scientific approach; and (3) Intersectoral integration of health and social services to support provision of whānau-centred care and influence the social determinants of health and local environment.Māori health organisations are important actors in systems seeking to improve outcomes and eliminate health inequities. Support from funders and policy makers will be required to build on the strengths of these organisations and to overcome system challenges. To realise improved health outcomes for Māori, the value placed on whānau and community perspectives not only needs to be acknowledged in the implementation of health interventions, health and social policies and funding arrangements, but performance measures, service design and delivery must evolve to accommodate these perspectives in practice. Type 2 Diabetes (T2D) is a common long-term condition that significantly impacts on the health and wellbeing of New Zealanders , 2. PeopMore specifically, self-reported prevalence of T2D among Māori was about twice that of non-Māori in 2013/14   conditions.” . The need to adopt a different approach that expands beyond (largely) clinical indicators, to include quality of life and experiences of care was viewed as important by those interviewed, who felt this would ensure that measures of success are more inclusive and consistent with Te Ao Māori, a Māori worldview. A board member reiterated this point: “Because health and wellbeing to Māori is not just what health is to the health system. [Contracts] need to reflect that, because my understanding is historically contracts have been health focused but not Māori health focused.” .With today’s technological advancements there is a lot that clinicians can tell about a patient without even talking to them . However, unless patients and their whānau are asked what is important to them and how they rate their quality of life and experiences of the health care and services provided, clinicians do not actually know the whole picture , 33. StaFurthermore, this would support Poutiri Trust to demonstrate a wider range of positive outcomes back into the system in a way that is more consistent with the concept of hauora. Therefore, building capability to determine more effective outcome measures will be important for all stakeholders. As an integral part of this, there is scope for Māori organisations to utilise and further develop sets of outcome measures that demonstrate a wider range of positive outcomes that matter to Māori communities, which may be utilised in a range of ways, including to evidence how Māori organisations have effectively responded to community need, and to support contract procurement.I think partnerships are essential. Relationships are essential… it’s the whole whānau collective thing. It all makes sense, collaboration makes sense. And I don’t think it can be done without that. - Board member 2, Poutiri TrustIt’s… about creating this network of highly motivated people, passionate people, that can walk in both worlds – that can walk in the academic side and on the ground in the community and understand people’s side of things as well and can help us develop what these programs will look like. - Board member 1, Poutiri TrustWhile gaps between evidence and decision-making exist in all areas of the health system , for MāoBut Iwi settlements, where Iwi are becoming more established in their own rights and so less likely to collaborate anymore to come together as a single voice... Some of them want to get into the health space… We all have links with different Iwi but we don’t have a process to engage with Iwi to have those discussions. - Staff member 3, Poutiri TrustFurthermore, as the political landscape within New Zealand changes with more iwi settlements occurring over the coming months and years , there may be opportunities for pan tribal organisations to work in partnership to advance more explicitly the specific vision and health goals of individual iwi. One of the Poutiri staff members noted this possibility:… the bigger providers don’t necessarily have the reach into these communities. … and they don’t know the stories that happen, so they can learn from our providers but then some of our little providers or some of our providers can actually learn from the systems that national companies have. - Staff member 1, Government funding agencyThe potential for larger scale ‘alliancing’ was also discussed by funding agency staff, as a mechanism to build local capacity and to secure larger service contracts within the region, which is a strategic approach that may be considered by Māori organisations. This approach allows for Māori health providers to work with larger national providers, and non-Māori providers in the region.In sum, partnerships and alliances have the potential to offer benefits for all organisations involved and the communities they serve. For example, at the organisation level, it may be possible to make joint bids for larger contracts by strategically selecting who to work with on the basis of core organisational skills, strengths and values. Collaborative working relationships between a wider range of health professionals and health and social services, including non-Māori providers, may lead to more culturally acceptable, accessible, integrated care in the region.We need to work around the client, not around [our] contracts.” .Contracting is a mechanism to clarify roles and create accountability as well as align goals between government agencies and providers through appropriate incentives. It has been used as an attempt to meet a variety of aims, including to improve outcomes, lower costs, increase coverage of and access to services, improve service quality, and improve efficiency of resource utilisation . Unfortu[It] is an approach that DHBs  are really looking into – how can we work more collectively as multi-agencies? … that’s exciting for that integrated care and whole person kind of approach.” . The second funding agency staff member built on this perspective by providing a concrete example of integrated care:… we understand that there are a lot of players in health that contribute to the wellbeing of the community …we’ll get alliances through other different inter-agency groups; seeing how we can leverage their resources to help support, say for example, respiratory conditions… we obviously need to partner with housing. - Staff member 2, Government funding agencyNevertheless, participants reported that New Zealand government agencies are increasingly taking an inter-agency approach to health and wellbeing, which theoretically provides a mechanism for organisations to provide fully funded, more holistic care in a way that acknowledges the link between health outcomes and the social determinants of health. For example, a government funding agency staff member noted support for this approach: “It would be my hope that it was more around chronic disease prevention and management, not just one condition. It doesn’t make sense in a Māori world to think about “a condition” and “b condition”. The one thing I do like about [the focus on] prediabetes is there is a prevention focus. - Board member 2, Poutiri TrustPre-diabetes is currently being addressed by many Māori organisations as part of a broader focus on long-term conditions and a more holistic approach to health and wellbeing; although, the need for a clinical response to pre-diabetes was also seen as important because lifestyle interventions (including diet and exercise) were not always observed to be effective without the appropriate support for individuals and whānau . Both board and staff members of Poutiri Trust offered views aligning with this perspective. For example, a board member stated,In sum, an effective response to T2D will require of the ‘big picture’ promotes effective interactions across sector and organisation boundaries. This requires recognition of multiple perspectives and world views, for which Māori organisations are conduits. For most non-governmental organisations, funding sources are increasingly insufficient to meet growing health and social needs and rising costs. This makes it very difficult for these organisations to undertake long-term planning, improve their services and reach their full potential. This deserves the attention of policy makers and funders, who also have a vested interest in seeing Māori organisations continue to grow and prosper.Colonial processes have undermined Māori social, economic and political structures over time, resulting in redistribution of power and resources in favour of non-Maori, which is reflected in health inequities . There iStrengthened partnerships with Māori health organisations will support measurable, evidence-based change and service delivery, including in relation to pre-diabetes and underlying social determinants of health, particularly when Māori knowledge systems are viewed alongside a Western scientific approach, which from a systems perspective requires alignment of health messaging with every day realities and culture.Systems thinking facilitates new strategies and actions by considering multiple viewpoints within a ‘system’, and the interactions within and across organisational boundaries required to produce better outcomes . In thisIndeed, drawing on work to expand indicators beyond the (largely) clinical domain may assist with this goal. Evidence demonstrates that clinical indicators (like biomarkers) often fail to correspond with how a patient is actually feeling, further demonstrating the importance of routine and timely collection of patient’s perceptions of their health and wellbeing . This caWhile performance measures commonly prioritise a clinical perspective over the patient- and whānau-perspective, there is potential for Māori organisations to work with government funding agencies to co-design for existing and new contracts measures that are more meaningful for patients and whānau. Indeed, any attempt to measure value in health care must incorporate patient perspectives . This isTo highlight the role of Māori health organisations as critical actors within the health system, the key findings and strategic opportunities identified are summarised in Table The HPW Implementation Framework was developed to address common health service and intervention implementation challenges for Indigenous communities . The fraCurrently, the level of funding and nature of the contracts held by Māori health organisations raises questions about the relative value placed on preventing pre-diabetes, particularly given the importance of ensuring primary care provision is culturally appropriate, acceptable, and accessible . NeverthTo take an approach that is consistent with the concept of hauora and to deliver whānau-centred care that particularly addresses chronic and related conditions, inter-sectoral integration of health and social services is required , 43. SchThis case study is intended to capture the complexity of responding to pre-diabetes and the associated health inequities within the health system, which can be difficult to represent simply and is therefore a limitation of this approach. Similarly, although this case study cannot be representative, it can inform situations and approaches beyond the actual case that was studied. Therefore, this research was designed to provide detailed insight and in-depth data into the role of Māori health and/or Indigenous health organisations, who commonly face many similar challenges in their work to reduce health inequities, and is useful to understand complex inter-relationships between the qualitative data and to inform policy. Nonetheless, the focus on a single case organisation does have limits in understanding the larger healthcare system in the context of health inequities for Māori. Future research can consider the interplay of multiple organisations in the context of constructing integrated care models and implementing interventions for pre-diabetes and related conditions.Māori health organisations are important actors in the prevention of diabetes as they have influence within their communities with potential to link with marae , kura (schools), sports clubs, regional councils, urban planning functions and workplaces and other stakeholders effectively working across sectors to make ‘environmental’ changes that reduce the risk factors for several long-term conditions. The concept of hauora is of relevance when considering the overall approach to pre-diabetes and diabetes and what constitutes value in relation to the provision of health services. A primarily clinical approach to pre-diabetes can downplay the significance of social, cultural, economic, and political factors, especially because (un)healthy weight is a risk factor that is shared with diabetes and various other chronic conditions. For Māori organisations, this aligns with the approach to pre-diabetes and long-term conditions to date, which is consistent with the concept of hauora. Consideration by policy makers of how this approach may be supported by, and reflected in, funding streams warrants further attention.


Critics of the use of advanced biotechnologies in the agri-food sector  demand a strict regulation of any such method, even more severe than rules applied to so-called “Genetically Modified Organisms” (i.e. recombinant DNA processes and products). But their position is unwarranted, since it relies on faulty arguments.product and its phenotypic traits, opponents insist that the target should be certain biotech processes.While most life scientists have always explained that the trigger for regulation should be the single The antagonists maintain that NBTs are inherently risky: this belief is exactly the opposite of a long-standing, overwhelming scientific consensus. NBTs involve unpredictable effects, but it is the same for the results of any other technique. The critics wrongly equate “unintended” with “harmful” and misunderstand two meanings of “risk”: the “risk” of not achieving satisfactory results does not automatically translate into health or environment “risks”. Generic claims that allergenic or toxic properties are a hidden danger of outcomes from NBTs are unsubstantiated – as they would be for traditional techniques.Among several errors, we criticize the misuse of the Precautionary principle, a misplaced alarm about “uncontrolled spreading” of genetically engineered cultivars and the groundless comparison of  agricultural products from NBTs with known toxic substances.In order to “save” traditional techniques from “GMO”-like regulations, while calling for the enforcement of similar sectarian rules for the NBTs, the dissenters engage in baseless, unscientific distinctions.Important and necessary socio-economic, ethical and legal considerations related to the use of agri-food biotechnologies (older and newer) are outside the scope of this paper, which mostly deals with arguments from genetics, biology, and evolutionary theory that are provided by those who are suspicious of NBTs. Yet, we will provide some hints on two additional facets of the debate: the possible motivations for certain groups to embrace views which are utterly anti-scientific, and the shaky regulatory destiny of NBTs in the European Union. In this paper we aim to debunk some basic conceptual mistakes regarding criticism of the use of genome ameliorations in the “green” (i.e. agri-food) biotech area, in particular with regard to the very recent, in-progress group of methods generically indicated by the term “New Breeding Techniques” (“NBTs”), comprising CRISPR. Other biotech areas, e.g. “red” , in particular the use of gene editing to delete or correct detrimental mutations in the human DNA, or the implementation of “gene drives” to reduce populations of noxious animals (e.g. mosquitoes or rodents) or plants (e.g. invasive weeds) in open environments, raise different/additional problems, both theoretical and ethical. We circumscribe our focus to issues related to agronomy, discussing some of the underlying genetics, biology and evolutionary theory concepts.as a whole has no grounds.In order to show that skeptics of advanced agricultural biotech methods try to base their call for strict regulation on views which are unscientific, misunderstood or even plainly contradictory, we examine three documents ENSSER  recentlynot about outlining a regulation of NBTs or other groups of techniques , but rather about the life-sciences background that must be correctly set out in order to debate what regulatory approach is more adequate – which is a following step, beyond the remit of this text. In other words, we are not calling for certain ethical or normative attitudes (e.g. a cost-benefit approach) to be – or not to be – a beacon in the agri-food biotech regulation; our aim is to point out that any such (necessary) debate is warped, if basic scientific concepts are got wrong.Therefore, this paper is before any risk management perspective: if some keystones of genetics/biology and the same notion of risk are mistaken, we cannot even start discussing actual risks and how to deal with them. In other words, we are not debating values that can be related to the use/abuse/misuse of NBTs: we try to point out that anti-biotech critics are wrong in understanding what we are talking about in the first place. Therefore, the bone of contention in this paper is not whether NBTs are good or bad, risky or safe , but what life scientists explain them to be – and what biotech detractors fail to grasp.Our criticism is logically placed These opponents place an exclusive, almost obsessive emphasis on (misunderstood) risks and dangers: such a totally negative attitude reveals a biased, unescapable anti-biotechnological mindset, which seems to influence the theoretical misapprehension of the matter. We hope that our constructive criticism may encourage a rebalanced disposition.In recent years, various advanced methods of intervention for modifying the genomes, and consequently improving the phenotypic characteristics, of living objects  have been developed, with important applications also in the “green” sector: collectively, they are named “New Breeding Techniques”, “NBTs”Some of these techniques, also according to details in their different applications, may be indicated as “gene editing” or, better, “genome editing”: this expression usefully suggests an analogy between the cut-and-paste, or even deletion, of DNA sequences,In certain cases, these interventions create transgenic organisms, i.e. some sequences of exogenous DNA are permanently infused in the genome of the new organisms (only the methods – and their precision - differ from those used in former transgenic achievements); in other situations, the insertion is only provisional, in that it is useful during the lab work - the resulting phenotype is not transgenic; or there is not an insertion but a deletion of DNA portions; or the genome is not changed, but epigenetically influenced, so to say, in order to “switch on or off” certain genes; in these last three cases, the new organisms are often indistinguishable from those obtained via traditional techniques  or natural mutation. , “green” (agri-food), “white” for industrial applications, “grey” for bioremediation and “black” for biological warfare and bioterrorism.Ironically, a real danger is inherent in the use of a double agricultural biotechnology which nobody is worried about: in experiments of physical/chemical mutagenesis, operators must be very careful while using radiation and nasty chemical substances – a peril that does not exist with rDNA or NBT operations, neither in labs nor in greenhouses or open fields.product, the real thing – and/or on the process(es), i.e. the methods which have been used by experimenters to produce this or that agricultural novelty.The alleged scientific reasons which should support the demand for strict regulation of agri-food NBTs boil down to a few mistakes or misunderstandings: the first one is the somewhat worn-out issue which is called “product vs. process” debate. It is the discussion on whether regulators, when considering green biotechnologies, should focus on the actual characteristics of the phenotypic outcomes, i.e. the plant or animal or microorganism that has been endowed with new trait(s) – the The origin of this question dates back to the early 1980s, when progress in molecular biology showed the potential of using recombinant DNA techniques to change some small areas in the genomes of various cultivars , often adding nucleotide sequences which were called transgenes, in that they were “copied” from other organisms . The aim is to obtain various results: fight diseases, repel pests, provide herbicide tolerance, enhance nutritious properties, extend shelf life. Similar, even identical phenotypic effects had been obtained with existing techniques , but the new applications may allow the species barrier to be overcome. This major biotech advance was seen by breeders as a great opportunity: direct intervention on the genomes, although with methods that are imprecise , opened up a whole new scenario for the improvement of plants, for both food and non-food uses.process) was charged with vociferous accusations of hidden dangers to health and the environment. No attention was paid by opponents to the actual characteristics of genetically improved outcomes (the product), no subtleties were allowed: “In agricultural crops, products of rDNA technology were lumped together into one ominous category, regardless of trait, genetic event, or species.”  as a trigger for regulation, as regards both safety and environmental impacts, is not valid. The epistemological basis of this uncompromising position is neat: what counts is “the nature of the organism and the environment into which it will be introduced, not the method by which it was modified.” : but the established guidelines should assess the different levels of known or rationally foreseeable risks , depending on the traits and characteristics of the product. Today, instead, any rDNA cultivar is, in almost all jurisdictions, trapped inside a regulatory nightmare which exempts very similar “non-GMO” varieties (e.g. mutagenized or hybridized herbicide tolerant crops).Note that the adoption of a product-based criterion does theoretical intervention into the genome.” ’ should be considered by regulators, and no attention should be given to the processes by which these ‘events’ were created within the entire organism, whether a virus, microbe, plant or animal.” ENSSER , p. 2–3 not on the process(es), as the logical, science-based trigger for regulating the agri-food biotechnologies, is completely independent from the more or less precise character of the different applications. In other words, in the product-based approach, any organism that derives from any technique  should be evaluated on its own pros and cons: NBTs are actually more precise, but the safety and environmental impact of their outcomes (the products) must be assessed individually. Thus, the plea to consider only the product is not a call for general de-regulation, but for a shift from an incoherent perspective to a rational one.Another contorted sentence must be broken down: “the claim that the new techniques are more precise therefore more controlled, and that this justifies no regulation of the process, only of the final product, neglects all the scientific evidence” ENSSER , p. 8. WSince the appeal to regulate the process – rather: only certain arbitrarily circumscribed techniques – is invalid, one may wonder where the strenuous call to regulate NBTs as “GMOs” has its real basis: the answer is surprising, because the alleged motivation lies in the “risks inherent in the genetic modification process” ENSSER , p. 2.per se more risky than e.g. conventional plant breeding technologies.” ; but this partial ignorance is not a synonym of inability in assessing agri-food novelties. If anything, the level of unpredictability is higher with traditional methods, but this won’t discourage breeders from trying them, insofar as they appear to be promising in this or that situation. Thus, we are not downsizing the valuable contribution that can be made to agriculture by older, still widely used techniques: sometimes, non-transgenic outcomes perform better  and traditional ones  : this inconsequential remark should not create any generic, pre-emptive anxiety about breeding activities, older and newer. So, “the recognition that the process of genetic engineering itself can give rise to unintended changes at the DNA level”, contrary to the intention of the authors, will not induce us to ponder only on its “potential negative effects”  can result in missing or malformed proteins with potentially severe consequences.”these techniques are applied to some organisms and have not been excluded as happening in any organism”  to improve feed, but the preliminary tests showed possible problems  is allegedly supported by only one example of bad effects of rDNA, which is introduced by a sweeping declaration: “As first-generation GMOs already showed, the trait of herbicide tolerance can have profound impacts on the environment, human health, biodiversity, and socioeconomic conditions.” . Instead of relying on a single clumsy source, Steinbrecher and Paul could have listed several documented cases of “GMOs” which fell short: unbiased, pro-science scholars have no problem in recognizing that also rDNA breeding experiments most often fail, that unsatisfactory results are part of the game in the green biotech world.But it gets worse: the only supposed demonstration of the alleged gloomy “profound impacts” of “GMO” at various levels, which are declared as evidence, is in a study that, in the words of its authors, reports “high glyphosate pollution in association with increased frequencies of cancer in a typical argentine agricultural village, Thus, we understand that the real target of this example is glyphosate – the most hated target of the antis today. Note that: a. The product has been marketed since 1974, when HT rDNA crops were still more than twenty years away; b. Its adoption is not necessarily linked to HT rDNA varieties: in the EU, where the cultivation of “GMOs” is practically forbidden, this weed-killer – now off-patent – is largely used. In the space of a few paragraphs, we have witnessed an attempt to establish a link between a declaredly harmful pseudo-category (“GMOs”) and one trait (HT) that is not limited to rDNA, illustrated by an irrelevant paper whose shortcomings are not indicated, with the intent to attack a herbicide that has been exploited for decades before the advent of rDNA crops and that in vast agricultural areas of the world has nothing to do with “GMO”. And it is impossible to understand how the sidelong denigration of one agricultural tool can be logically linked to the generic suspicion regarding NBTs – a various group of techniques that can produce agri-food products as diverse as can be imagined.“GMO” or otherwise. Yet, this necessary action will not cast a general, unsubstantiated doubt on other products or courses of action which are very different and possibly – or certainly – beneficial: virus-immunized papaya or nutritionally-enhanced cassava or submersion-tolerant rice – all “GMO” – have nothing to do with environmental pollution; one of the most widespread rDNA traits (insect resistance) has been very advantageous to the environment and farmers, lowering the use of pesticides and requiring less work in the fields . Yet, in “green” agricultural operations, none of the traits which can be deleted  or added  – with any biotechnique - can fuel uncontrolled spread.Another “risk” which is strongly underlined is supposedly due to the fact that “GMOs” “are living systems with the ability to self-replicate and spread their genes weak, i.e. they have a hard time in surviving without human support. This ineluctable reality is linked to the fact that any such variety is a product of artificial selection, i.e. it has been singled out and taken care of, most often lowering its natural defences. Many plants have had their poisonous properties bred out through centuries of cultivation, but “reducing the content of natural toxins is a trade-off process: the lesser the content of natural toxins, the higher the susceptibility of a plant to pests and therefore the stronger the need to protect plants.” .To understand this, we have to focus on a general characteristic of domesticated species: cultivars or farmed animal strains are almost always natural species (e.g. rodents or weeds), unwillingly or willingly introduced in different environments. Transgenes may occasionally pass from some rDNA plants into relatives where they were not intended to be infused: in such cases, if and to the extent that the plant becomes invasive, the phenomenon must be contained – even with measures designed to eradicate it. Indeed, this is a problem which is not related to the origin of the cultivar which has acquired weediness, i.e. it does not depend on the process through which it was obtained.As for animals, domesticated species were chosen also for their limited aggressiveness, and their docility was amplified during millennia of farming: cattle or poultry that escape farms will be easy victims of predators. Moreover, invasive species of animal or plants have almost always been both “conventional” and rDNA canola are widespread: if the quantity of the volunteer bushes becomes a problem, actions would be put in place – whether the weeds are rDNA or not.To explain this basic point, consider canola, a modified variety of oilseed rape that was invented at the beginning of the 70s, by Canadian breeders, through selective crosses; in the 1990s and until now, several rDNA varieties of canola were created with added traits, e.g. herbicide tolerance. In North Dakota, the presence of the plant in several places outside fields was noted: which is no surprise, given the weedy characteristic of the original species and its many derivatives, that can thrive also in the wild. It was ascertained that many of those spontaneous plants were “GMO” Biello : does itquantity: the alarmist fear of “uncontrolled spread” of domesticated plants or animals is unrealistic, even if operations of gene editing have slightly changed their genome, i.e. have gifted their phenotypes with desirable traits or erased undesired ones. From an empirical point of view, how “far and wide” or “uncontrollably” has this effect occurred? After many years of cultivation of “GMOs”, “examples of spontaneous transgenic crop ×WW [Wild or Weedy] hybridization remain exceedingly few […] Transgenes in WW populations are known from three cases. Evidence for hybridization is clear for those cases but not for introgression.”  legislation”  Indeed, this link between the Precautionary principle (PP) and NBTs is baseless and the tie to the European Union is problematic.The preliminary question is: what “EU” are we talking about? It must be explained, because there is a big gap between the detailed, science-informed guidelines on the application of the PP as issued by the European Commission and the void, merely rhetoric mentions of the PP in the “GMO” Directives.The Commission specifies that a “decision to invoke the precautionary principle does not mean that the measures will be adopted on an arbitrary or discriminatory basis.”  whole – could one day be seen as a “late lesson from early warnings”, i.e. a case where “early indications of harm were neglected with serious consequences. One of the most graphic is that of asbestos” . The proposed parallel is bewildering. If we were discussing tragic mistakes that were made in the history of public health, we agree that quoting the case of asbestos would be appropriate. Instead, there isn’t the slightest This kind of outlandish analogy is not new. During the discussions that eventually led to the approval of the Cartagena Protocol on Biosafety, one of the proposed drafts was based on the structure of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal.  is a legal expert, the editor of a book which brings together the contributions of various key players in the discussions; several years after the coming into force of the first Protocol, he wrote: “unlike oil spills polluting the ocean or nuclear power plant accidents spreading radioactive material, there has not yet been a scientifically confirmed case of environmental damage caused by LMOs. The treaty negotiators were tackling a hypothetical problem of environmental damage that may eventually be caused by LMOs without any actual experience of it.” Shibata , p. 9 ThA further attempt is made to justify the disquieting narrative we are examining. Indeed, one may wonder why gloomy images of environmental turmoil and health hazards should be implied in agri-food novelties if they are obtained via NBTs (and rDNA), while products from older techniques – which may be very similar, as far as their actual characteristics are concerned - do not raise any concerns.“These risks [linked to NBTs] cannot be considered equivalent to those that emerge from conventional breeding or random mutagenesis: Here the cells and the organisms have different means of regulating changes in the genome (random mutations or new gene combinations) so that the phenotype of the plants and animals is very often not changed, or only changed within certain parameters. New biological traits that emerge can adapt over longer periods of time to the environment. These natural mechanisms of genetic regulation are overridden by methods of genetic technology e.g. through simultaneous changes at several genome locations on different chromosomes, and the mass release of organisms with biological traits that have not been tested in the evolutionary process.”  by the opponents, we must examine it carefully, distinguish several points which are improperly mixed up:* We do not see how conventional breeding methods “have different means of regulating changes in the genome (random mutations or new gene combinations)”: the fact is that traditional crossing/hybridization and physical/chemical mutagenesis are blind processes, in which the genomes are blended  or scrambled (in mutagenesis) and, if fortune favors, naturally reorganize with the possible emergence of new traits that breeders can appreciate and select. The very same biological mechanisms kick off in (much more precise) experiments with rDNA or NBTs, without triggering any different or special genotypic-phenotypic “regulation” that would make them diverse from traditional biotechnologies.always changed, of course: if no changes occurred, there would be no breeding, i.e. no new interesting organisms would be generated. It should also be evident that this happens “within certain parameters”: cucumber seeds which are bombarded with radiation will never produce apricot plants. It is not explained how unpredictable changes, which are caused by the application of older methods, should distinctly differ from those generated by newer techniques; if anything, as we have already explained, NBTs generate changes inside narrower, not wider, parameters than traditional techniques.* In all these operations, the phenotypes of the plants and animals are in the phenotype. Again, the antis fail to acknowledge that what matters is the product, not the process.* Thus, the “simultaneous changes at several genome locations on different chromosomes” that are allegedly typical of “genetic technology” may be evident in new cultivars from traditional breeding methods, which imply massive rearrangements of genomes. And, in any case, this is not a matter of concern, insofar as tests and exams – which, remember, are normally not required for enhanced organisms that are not “GMO” – show no undesired effects * As for the “longer periods of time” that cultivars obtained via traditional methods declaredly enjoy for their environmental adaptation, a quick look at the lists of registered plants, e.g. in the Mutant Variety Database FAO-IAEA , shows t* The idea that enhanced cultivars or animals obtained via traditional methods are “tested by evolutionary process” shows a perfect incomprehension of what agriculture is: evolution happens in the wild, over millennia, ages, epochs; the few natural mutations that may occur in greenhouses or fields, over years or decades, are normally irrelevant for cultivation/farming operations and results. In Darwinian terms, what is at work in breeding new plants, animals or microorganisms is not natural selection, but artificial selection: the aim of breeding efforts is to twist nature in order to modify its products according to human interests. In other words, agriculture is the realization of a highly unnatural redirection of natural, spontaneous paths toward results that humans want. Therefore, the reference to the evolutionary process is inappropriate.* Finally, note that no reference is made to scientific texts in support of the confused statements that we have dissected.Some better explanation could be hoped for from a chapter of the same document, which deals a bit longer with the “comparison” of NBTs “with random mutagenesis”  used by breeders. What we don’t understand are the alleged scientific reasons why, in the problematic document we are examining, it is maintained that tests and exams should be mandated for outcomes of genome editing – in particular when multiple and simultaneous precise changes are achieved – as if peculiar, higher risks were involved.To be clear, we are not rejecting the request for “comprehensive risk assessment” of products obtained via NBTs: on the contrary, we believe that an adequate evaluation of Ironically, we agree with the authors when they declare that “[f]rom a scientific point of view, it is not understandable why it matters how extensive the changed section is and whether DNA is inserted, changed or removed. All such changes have to undergo a detailed risk assessment.” Making a simple deduction from their own statement, they would not ask for sectarian over-regulation for products from rDNA and NBTs; rather they would call for rebalancing the under-regulation of products from conventional breeding techniques . Curiously, and certainly inadvertently, these authors declare that “GMO” means nothing, as far as a science-informed regulation is concerned.All in all, the attempt by opponents of NBTs, as it was for “GMO”, to argue for theoretical grounds that demonstrate their inevitable dangerous nature ends up in contradictions or non-sequiturs: when scientific papers are quoted, their meaning is often misunderstood; and certain statements that may appear science-sounding do not even survive a first step of scrutiny.before any debate regarding the best utilization of (products from) the NBTs.We must reaffirm that our criticism is logically placed Let’s imagine that NBT opponents correctly explain the basic science of those breeding methods: they would have every right to be against them (i.e. anti-biotechnology), for ethical, metaphysical, political or other reasons. But this is not so: their description of NBTs is mistaken in several ways, and this misapprehension pollutes any subsequent reasoning.One may wonder why anti-biotech groups present such fallacious arguments. What are the possible motivations for certain groups to embrace views which are utterly anti-scientific? What mental mechanisms are operating? In our opinion, it is not (mostly) a matter of wrong-headed reasoning, but biases are passed off as scientifically grounded arguments in the pursuit of pushing a political agenda: science has a great appeal to the public and to decision-makers, but it is difficult for non-specialists, even for scholars who are not knowledgeable in biology and genetics, to separate the wheat from the chaff. Cherry-picking half-truths or developing scientific-sounding pseudo-arguments and peddling them as sound evidence – or as indications of “risk” – is a winning strategy, if the decades-long story of the relentless opposition to so-called “GMOs” can teach us anything.Even more unfortunately, there are other examples of such biases at work: the resurgence of the anti-vaccine movement is nourished by fake news, but it originated in a scientific paper which advanced incorrect suppositions regarding possible negative effects of certain preventive treatments. As it happened, the self-correcting mechanisms which protect the scientific community led to an almost immediate rejection of the mistaken positions: but the fact the paper was retracted only fuelled the conspiracy theory of groups that are very good at exploiting pseudo-science in their propaganda.www.sciencemediacentre.org/expert-reaction-to-court-of-justice-of-the-european-union-ruling-that-gmo-rules-should-cover-plant-genome-editing-techniques. Accessed 20 September 2018). We have no evidence as to whether that ruling was influenced by incorrect presentation of scientific facts – but such a suspicion cannot be excluded.Going back to NBTs: witnessing the misplaced but effective attacks on their work, many life scientists and breeders still hope that NBTs will not suffer the regulatory destiny of “GMOs”; but the panorama is complex and ever shifting. While several countries seem unwilling to impose the “GMO” straitjacket on the newest methods, the recent ruling by the Court of Justice of the European Union (CJEU) on mutagenesis using gene edition tools is discouraging – at least for the Old Continent: contrary to the overwhelming majority of the scientific community and to the opinion of the Advocate General, the CJEU issued a binding sentence (Court of Justice


Dateline 1957. At Brentwood Elementary School, I gravely receive Jonas Salk’s miracle shots, today known as inactivated polio vaccine (IPV). Five years later, at Paul Revere Junior High, I crunch sugar cubes dotted with pink along with other Angelenos who, between 1962 and 1963, collectively ingest 7.5 million doses of Albert Sabin’s oral polio vaccine (OPV). By now, the upside is clearer. With my own eyes, I have seen children wearing awkward leg braces and read about iron lungs. Soon after my birth, the latter, boiler-like contraptions filled entire wards of Los Angeles County-USC hospital during my city’s last, great polio epidemic.At the same time, the science barely penetrated my brain. It was not until the early 1970s that I fully grasped that OPV—a product containing live attenuated poliovirus types 1, 2, and 3—proliferated in the gut. As a result, our medical school professors proclaimed, OPV not only provided long-term humoral immunity against the paralytic disease but quickly induced short-term intestinal immunity to polio! And all for a fraction of IPV’s cost! Last but not least, in unhygienic settings beyond our borders, the fecal–oral spread of OPV serendipitously protected even more children and adults who would otherwise fail to receive the vaccine.So, it was really no surprise when, in 1988, public health leaders energized by the previous decade’s success against smallpox embraced OPV as the tool by which the world would evict yet another devastating scourge. As cases plummeted, for a while it even seemed possible to eradicate polio by the year 2000. Then came the creeping awareness that OPV was neither entirely benign nor as reliably effective as hoped in children in the tropics. Bottom line: The target date for polio’s death knell continued to slide.Today, sadly, eradication is still not assured. On November 30, 2018, a WHO committee met for the 19th time in four years only to deem polio, yet again, a public health emergency of international concern—a dubious honor previously accorded to H1N1 flu (2009), Ebola (2014), and Zika (2016).The worst-case scenario in the near term? That, in 2019 and beyond, the global south will face double trouble if wild poliovirus type 1 infections in Pakistan and Afghanistan continue to stay flat or rise while circulating vaccine-derived polioviruses (VDPVs) also ratchet up and spread. In 2017 and 2018, paralytic cases caused by mutants of OPV type 2—a strain included in OPVs until 2016, when type 2 was deleted from the standard OPV mix used in 155 countries—were detected in the Democratic Republic of Congo, Niger, Nigeria, Somalia, and Syria. This confirms that neurovirulent OPV variants are still circulating, largely silent and undetected, in multiple sites worldwide where they can potentially afflict under- or unvaccinated people.Polio: The Odyssey of Eradication, recently published by Hurst and distributed by Oxford University Press, science journalist Thomas Abraham does just that, first narrating polio’s historical and virologic backstory, and then interrogating its still-elusive eradication. Along the way, the author weaves actors from past and present researchers, to global health leaders fueled by ego and dreams, to passionate, committed Rotarians and local stakeholders. All the while, Abraham pledges first and foremost to represent “the needs and aspirations of those in developing countries” and explicate “the messy reality that lies underneath an ambitious global health campaign, a reality the public rarely sees.” By quoting a rural Nigerian farmer from Kano Province who poignantly asks: “Why do you keep coming again and again to give polio vaccine? Why this polio, polio?” the author echoes the question of millions who cannot quite fathom why a seemingly rare disease commands such an inordinate investment of time, effort, and money, while children in low-income countries still die—day-in, day-out—of measles, malaria, and other deadly, ubiquitous blights.The time has come to reexamine the modern polio era. In Polio: The Odyssey of Eradication, Abraham moves to recent geopolitical events: disinformation around polio vaccine, violence unleashed on polio vaccinators, and the bitter fruit of using vaccine-related subterfuge to locate Osama bin Laden in Abbottabad, Pakistan. But by this point, many readers will have concluded that the stage was already set for a lingering (and possibly unwinnable) war against polio thanks to assorted missteps and the world’s tortoise-like response to OPV’s sporadic mutation to a neurovirulent pathogen. All of these factors have handicapped polio’s final purge.In the closing chapters of Offsetting the gloom is polio’s stunning 99 percent decline over three decades—a true cause for celebration. In Abraham’s excellent marriage of narrative, reporting, and commentary, paradoxes abound. As a result, especially for tropical medicine and global health “newbies” seeking hard, nuanced truths, this book is highly recommended.Polio: The Odyssey of Eradication, I wrote to a physician-researcher featured in its pages. Some have called Dr. T. Jacob John, an Indian pediatrician, medical virologist, and vaccine expert, “near-prophetic” for anticipating roadblocks in the polio endgame long before others either recognized or addressed them. As a record of intellectual independence, his long list of peer-reviewed publications speaks for itself.After finishing Early in our email exchange, however, one question I posed to John involved the dearth of women in the highest polio policy circles, a fact that may seem off-topic to some—to others, both significant and unfortunate. In his answer, John affirmed the gender imbalance and expressed basic philosophic principles. He also shared long-standing dismay over certain features of the Expanded Programme on Immunization [EPI] writ large and inherent flaws in the “OPV-only strategy” that, until recently, prevailed in the Global Polio Eradication Initiative [GPEI].primum non nocere.Let me start by responding to your question about women in GPEI leadership. I look at it this way. I grew up learning do no harm to any living creature—not even small animals—except for pests that are harmful. I was also taught never to exploit the “vulnerable,” namely, the ones who trust and depend on you. Then, in medical school, we learned So when I looked at IPV and OPV, all I had to ask was this: Were they equal in efficacy but unequal in safety? If OPV was more efficacious but a little unsafe, then one could justify its promotion. The answer I found for us in India was that OPV was both inefficient and universally unsafe in spite of its being branded as “one of the safest…,” while IPV was both completely safe and exquisitely efficient. The OPV-only position of GPEI, and earlier of EPI, went against my conscience and convictions. My guess is that women might have had similar lines of thinking that were more compassionate, more humane, and more ethical. If so, we would have eradicated polio quicker and cheaper.3 To date, unfortunately, there has been no progress. EPI still remains a vaccine delivery platform.As for EPI, from its earliest days, I argued that any system should have inputs, processes, and output, plus evaluations at all levels. Coverage as the only evaluation was not acceptable to me. Disease reduction and “demand creation” were two further outputs (I noticed that in Syria there was demand for OPV from parents as soon as the VDPV outbreak was detected). For the former, public health surveillance was necessary. So I designed one for Kottayam district in the state of Kerala and also tried to promote that concept in EPI.Now let’s stand back. Please summarize the “intertwined” history of the Expanded Programme on Immunization and the Global Polio Eradication Initiative. In addition, based on experience in India, what is the best way to “reach all children” with polio and/or EPI vaccines?Originally, polio eradication was to be achieved through the global EPI , an approach that would have forced all countries to find and correct flaws in the system. And, in fact, for several years polio eradication was managed by EPI, but later on the plan shifted to an independent Global Polio Eradication Initiative (GPEI) based at WHO. GPEI realized that OPV given under EPI plus an annual campaign or two would not be sufficient to eradicate polio in many tropical countries. More polio campaigns were necessary, far more than EPI would have been able to conduct. Moreover, clinical and virological surveillance was essential, but EPI had no capacity to build it in. Hence GPEI had to be de-linked from EPI.On the other hand, if IPV had been “allowed” for polio eradication, then EPI still could have played a key role and, quite likely, one or two OPV pulse campaigns per year would have been sufficient to interrupt wild poliovirus transmission. The reduction in polio cases would have been strictly proportional to IPV coverage. When necessary, OPV campaigns could be added. For such a strategy, both IPV and OPV should have been used in a relay sequence. IPV first and then OPV would have prevented vaccine-associated polio due to OPV and also retarded the evolution of virulent VDPVs.But that was not to be; GPEI remained “allergic” to the idea of using IPV until 2012. The overall result was that EPI was not strengthened when it should have been. Now that IPV is required for the conclusion and completion of eradication, the job has fallen to EPI. The worry is that we may not get high enough coverage for securing eradication in many countries, especially, as of now, in India.EPI is in urgent need of strengthening. Not only for polio eradication but also to achieve control of all EPI vaccine-preventable diseases, EPI has to be reengineered as a disease control program. Immunization should become an integral part of primary health care, for which purpose universal primary (and secondary) health care must be provided. Sri Lanka is a model.Without giving them what they need and deserve, governments cannot expect people to simply accept what is provided, and that includes immunization. Immunization costs families time and travel, but what is the benefit? The benefit is both deferred and invisible—hence the crucial need for effective health education.In your view, is there a better way to coordinate the global switch to IPV as opposed to country-by-country decision-making?I would not use the term “switch” as it was applied to the 2016 switch from trivalent OPV to bivalent OPV, which suggests globally synchronous action. IPV is already accepted in the endgame strategy, so all countries are now IPV licensed. The latest requirement is for “at least one dose.” Although GPEI has not explicitly stated so, the polio-eradicated world will have to include IPV in all national EPI schedules with a “minimum of two” well-timed doses so that immunity is both near 100% and long lasting. If a country has such a schedule and reaches very high coverage—say 90% and more—there is no reason for that country to continue to give OPV. In my mind, a schedule that results in near 100% antibody response and coverage exceeding 90% are the only two requirements for any country to unilaterally withdraw all OPV, which currently means bivalent OPV. New Zealand, Japan, and Malaysia have already done just that. However, each country should also participate in high-quality clinical surveillance for acute flaccid paralysis (AFP) as well as virological surveillance, both for the safety of the country and for the rest of the world.What I personally advocated for and was instrumental in establishing in India in the late 1980s was an IPV manufacturing company. But the government closed it down within a couple of years, misguided by global advice that IPV would never be used or required for polio eradication. Such obstinacy was indeed unfortunate. Ever since then, I declared that, without IPV, global polio eradication would not be possible.Today the main problem is an inadequate supply of IPV; the second problem is its slowly increasing price. Any country that can afford and procure sufficient vaccine must move in this direction. There is no risk involved in introducing IPV. When coverage is high, there is also no risk in removing OPV. The larger the number of countries that replace OPV with IPV, the earlier we can complete and conclude global polio eradication.Turning to contemporary challenges, what do you make of the recent surge in cases of acute flaccid myelitis (AFM) in the United States?We must always expect the unexpected. Acute flaccid paralysis due to myelitis is an example. Several enteroviruses cause CNS diseases; viral meningitis is the most common, whereas myelitis with paralysis is rare. Enterovirus 70, which emerged in 1968, causes hemorrhagic conjunctivitis and polio-like paralysis. Enterovirus 71 can cause encephalitis and acute flaccid paralysis. Enterovirus D68 has appeared in recent years and been found to cause a few cases of polio-like paralysis. In terms of causality, it’s my understanding that the cause of the current upsurge of AFM in many states in the United States remains unknown. It’s a good thing there’s no polio to confuse it with. However, the absence of polio does not prove the niche theory—that some disease will eventually occupy the niche vacated by polio. No doubt the cause will be discovered in the United States, but just imagine if this problem occurred in a country or countries with no surveillance or competence to detect and diagnose.The lesson for all of us is that new diseases will continue to appear from time to time. Universal health care, public health surveillance, and local access to diagnostic lab services are three pillars that must be established in all countries.In 1974, EPI was created in a virtual vacuum. So why, today, do we not raise the bar and establish universal health care plus public health as the reengineered EPI? EPI was meant to fill the gap in primary health care and public health. In 2018, the same gaps remain. Unless these two gaps are deliberately and by design covered, EPI will simply remain a silo of vaccine delivery.Are you beginning to see a significant “anti-vaxxer” movement in India? What’s the best way to combat this trend in low- and middle-income countries as well as industrialized nations?There have always been self-appointed opponents of anything that is good. In the vaccine arena, there are two types, starting with a few people who genuinely believe that vaccines are unwanted, harmful, and serve only to profit manufacturers. Some of this group have experienced an unfortunate event, like a child dying soon after immunization, and erroneously attribute that event to the vaccine. They seem to be in the minority.The other type are irrational. Their beliefs do not stem from the cognitive realm and are not easily overcome with factual information. They are vocal and argumentative and try to dissuade parents from immunizing their children. They work on the fear principle. We do have our share of such individuals in India. What we have done through an organization called the Child Health Foundation is to provide high-quality vaccine education for government immunization officers and pediatric academics and practitioners so that, in their own contexts, they become true experts to combat disinformation and misinformation.Perhaps school curricula should also offer histories of diseases that were controlled with vaccines so that children learn to respect vaccines. This teaching would be based on factual, recorded information. If you go beyond that and promote immunization, then I suspect the anti-vaccine zealots would cry foul.All of us have to be vigilant and prompt. Social media make it easy for misinformation to spread. Not long ago, our local high court decreed that if you forward a Whatsapp message, it will be assumed you knowingly endorse its content. This should discourage people from glibly forwarding messages and misinformation. In today’s world, vigilance and quick remedial action are required by all who know the benefits of immunization.Addendum: The following highlights key events in Dr. John’s professional career.After receiving my MBBS and DCH  in India, in 1964, I went to the United Kingdom and passed the MRCP exam, leading to membership in the Royal College of Physicians (Edinburgh). From 1964 to 1966, I completed a two-year infectious diseases fellowship at the University of Colorado while, at the same time, earning my M.Sc. degree. Training in India and the United Kingdom gave me excellent clinical skills. Training in the United States prepared me both to “think” and “write” science.Upon returning to Christian Medical College in Vellore, I originally intended to do pediatric infectious diseases but institutional need and my M.Sc. led me to Microbiology. As a result, in 1967–68 I converted a small research virology unit in Pediatrics into a full-fledged Diagnostic Virology Unit that led to many “firsts,” including detecting the failure of the original 3-dose OPV schedule, detecting HIV infection in India, and diagnosing [post-measles] subacute sclerosing pan-encephalitis, among others.In 1979, the Indian Council of Medical Research recognized our Virology Unit as a “Centre of Excellence.” In 1986, soon after we detected HIV, I had the unique opportunity to design a national, multipronged response, including annual, repetitive anonymous HIV antibody testing of men with sexually transmitted diseases and antenatal testing of women—the polar extremes of high- and low-prevalence HIV infection. As a result, India has continuous data on the prevalence of HIV infection that dates from 1986 until now, allowing us to gauge India’s success over time in controlling HIV. Our Centre of Excellence was now, in addition, the National HIV/AIDS Reference Centre.I served as Director of the ICMR Centre of Advanced Research (from 1979) and of the HIV Reference Centre (from 1986) until December 1995, when I retired as head of the Department of Clinical Virology. I was elected President of the Indian Association of Medical Microbiologists in 1994 and President of the Indian Academy of Pediatrics in 1999. I am also a Fellow of the Indian National Science Academy and the Indian Academy of Medical Sciences. Finally, I remain an active Rotarian; in 1984, I was a Founding Member of the Rotary PolioPlus Committee.At present, my professional activities in public health are reduced but some crucial ones continue, including my three-decade-old advocacy and “activism” for introducing Salk vaccine globally, which partly succeeded in 2015. Now I am working to discontinue Sabin vaccine globally and to replace it with two or three doses of Salk vaccine for every child. Next in line for elimination in India are measles and rubella. I currently chair the Expert Group for the Indian government. Our activities started two years ago; we hope the tempo will pick up in the near future.