Commentary
Translating evidence into impact: The case of ‘supermagnet’ desk toys Daniel Rosenfield MD1, Matt Strickland MD2, Charlotte Moore Hepburn MD FRCPC FAAP1
I
n the early 1980s, new discoveries in material science led to the development of neodymium-iron-boron magnets. These rareearth magnets are 10 to 20 times stronger than traditional ferrite (ie, fridge) magnets. By the 2000s, these ‘supermagnets’ were being integrated into a variety of consumer goods including children’s toys (1). Toys that incorporated these supermagnets were swiftly removed from the market in 2006, following the death of a toddler who ingested several magnets found within one particular product (2,3). When multiple magnets are swallowed, they can attract one another and link through different loops of bowel, causing pressure necrosis in the wall of the intestine. This can lead to bowel perforation, sepsis and death (4,5). Despite the recalls in 2006, the threat to children’s health re-emerged in 2009, in the form of a desk curio comprised of dozens of supermagnets, strategically sold as ‘desk toys’ for adults. Unfortunately, children who encountered these products often ingested pieces, resulting in a dramatic increase in hospital presentations requiring endoscopy and surgical removal of these multiple magnet ingestions (MMI). In 2012, various governments around the world moved to ban these desk toys. The Canadian government followed suit in June 2013 (Figure 1). The present article highlights how this novel threat was identified and how national-level policy changes were implemented.
Clinical research is often conducted with the aim of improving individual and/or population health outcomes; however, clinicians and health system leaders often do not use the best evidence in their decision-making processes. In an effort to narrow this divide, knowledge translation (KT) – ensuring that the knowledge-to-action gap is closed – has been identified as fundamental to the research endeavour (6,7). The disconnect between evidence and practice is especially apparent in health policy planning for complex systems with many stakeholders (7-10). Although many policy makers aim to integrate high-quality evidence into a rigorous, systematic and time-sensitive public administration procedure (11), policy change is often the result of a disjointed, opportunistic, multidimensional process, informed, in large part, by public opinion and political philosophy (11). For physicians and researchers to effectively translate new and important evidence into system-level health policy, they must have a thorough understanding of the current strengths, limitations and realities of the policy arena. The present article describes the experience of effecting evidence-based change at the health system level. Illustrated by a recent Canadian case study, the present review highlights the importance of primary research, and details the complex and multifaceted relationships among evidence, the media, coalition-based
Figure 1) Timeline. CCPSA Canada Consumer Product Safety Act; CHIRPP Canadian Hospitals Injury Reporting and Prevention Program; CMAJ Canadian Medical Association Journal; CPS Canadian Paediatric Society; GM General Motors 1Department of Paediatrics; 2Department of Surgery, University of Toronto, Toronto, Ontario Correspondence: Dr Daniel Rosenfield, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8. E-mail
[email protected] Accepted for publication January 7, 2015
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response. Despite the limited number of patients included in the study, the findings were statistically significant and Canadianspecific, providing concrete evidence to Health Canada that the problem was relevant to Canadian families (15). While hierarchies of medical evidence exist – tending to prioritize randomized controlled trials and systematic reviews – similar evidence standards are generally not applied in the policy arena (16). In fact, a case series can have the same impact as more authoritative forms of evidence if the data are compelling, novel or demonstrate a threat to public health. Studies reporting local data and answering questions of local concern (in this case, injury prevention and child health) are especially compelling.
Media Attention
Figure 2) The policy process, simplified: This figure represents a significant simplification of the interaction among different elements in the policy process, and is meant only to portray a basic framework for understanding a complicated process advocacy and the political environment in the course of enacting policy change. By understanding the interplay among the fundamental factors that inform the policy process, physicians and researchers can successfully build and capitalize on existing momentum to ultimately translate their findings into positive pubic policy and population health outcomes.
Case Details
Multiple magnet desk toys designed for adults (novelty toys that comprise ≥125 small magnets approximately 5 mm in diameter) were first released to the Canadian market in 2009. Soon after their introduction, numerous case reports describing MMIs among children were reported worldwide (4,12). The incidence of these ingestion events increased sharply by 2011, as the sets became more popular and sales increased globally (13). Canadian data reflected these international trends, highlighted in the publication of a case series documenting a significant increase in surgical cases at one Canadian paediatric institution (14). The publication of this case series also generated substantial media interest in the subject. Following intense media interest in the case series, and advocacy from various groups, a voluntary product recall was issued for the magnet sets on May 22, 2013. On June 21, 2013, after one of the manufacturers failed to comply, Health Canada issued its first-ever mandatory product recall, using the newly passed Canadian Consumer Product Safety Act (CCPSA). All manufacturers subsequently complied, and the products are no longer sold or distributed in Canada.
Discussion
The case of the supermagnet recall highlights fundamental factors informing the health policy process (Figure 2). The relationship between original research (potentiated by it being jurisdiction specific), media exposure and coalition-based advocacy generated the necessary political focus on this important public health issue. Collaboration with the appropriate governmental bodies enabled the rapid enactment of positive policy change. This case serves as an example of successful KT that can be used by other physicians and researchers interested in advancing their findings into policy.
Original, Jurisdiction-Specific Research Evidence
A small, single-centre case series with an illustrative index patient was sufficient to convince policy makers that the MMI problem was an issue of relevance to Canadians, and required a Canadian 176
Publication of the Canadian data generated significant media interest. In addition to national television coverage, the embargoed press release for the case report was picked up by various print, online and radio news outlets. Media monitoring revealed that >160 news outlets around the globe picked up the initial story. Importantly, 140 of these were Canadian. The role of the media in promoting public health policy has been extensively described, and is considered to be “a critical determinant of the ability to promote change” (17). Capturing media attention, however, requires an understanding of what interests and appeals to journalists and editors. In addition to clearly and effectively communicating the research findings, compelling personal stories are valuable (18). Reporters have explained their interest in the story: the magnets were a new threat, they affected children, and the index case was a photogenic toddler who was available and offered a ‘face’ for the story (19). Powerful images (such as the widely disseminated sample images of MMIrelated tissue damage) together with clear, uncomplicated policyoriented messages (such as “magnets can be hazardous products for children”) were also attractive to media outlets. While some academics may be uncomfortable interacting with the media, in this case, researchers made themselves readily available to media requests (20). Establishing both an understanding and a comfort in interacting with the media is important.
Coalition-based Advocacy
Governments are most responsive to issues that are of interest to a multitude of interested parties, and coalition building can be a successful strategy to mobilize interest and promote a particular policy aim. By leveraging the resources of one or multiple distinct groups (in this case, the Canadian Paediatric Society and Parachute Canada – formerly Safe Kids Canada), and uniting around a clear, common goal, critical momentum can build rapidly, and may focus attention on issues that may otherwise have been overlooked in the chaotic policy environment. Clinicians and researchers should actively seek partners with specific interest in similar areas. Although bureaucrats may change roles often, these partners may not only help to add voices to the chorus calling for specific changes, but often add lobbying expertise, a broader network and experienced communications departments that can amplify the message to be conveyed. In parallel, developing relationships with policy makers in the field is of paramount importance. This includes both politicians and experienced, senior-level bureaucrats. In fact, a recent metaanalysis examining the use of evidence in forming health policy revealed that two-way communication between the researcher and the policy maker is the best way to inform policy makers of emerging evidence to be linked with policy change (10). While this is a time-consuming process, relationships are essential to push agendas forward, especially if the required legislative context is not yet established. Paediatr Child Health Vol 20 No 4 May 2015
The case of ‘supermagnet’ desk toys
Legislative Environment
In the context of MMIs, the first Health Canada recall of magnetic toys was facilitated by the Hazardous Product Act, a nearly 30-year-old federal law that gave limited powers to Health Canada when dealing with consumer products that may pose a danger to human health. These powers included the ability to negotiate with manufacturers to voluntarily recall products likely to cause harm; however, they did not include the ability to launch a mandatory recall should a manufacturer refuse to participate in voluntary action. In 2011, the Canada Consumer Product Safety Act (CCPSA) was passed after nearly a decade of advocacy efforts from various organizations calling for an act giving regulators more power to protect consumers and children from potentially dangerous products. A sweeping piece of legislation, the CCPSA allows various governmental organizations (including Health Canada) to act against products deemed a “danger to human health or safety”. Its purpose, as defined in the legislation, is to “protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada, including those that circulate within Canada and those that are imported” (21). This piece of legislation allowed Health Canada to issue both voluntary and mandatory recalls of the products in 2013. According to the CCPSA (21), ...danger to human health or safety means any unreasonable hazard – existing or potential – that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual’s health – including an injury – whether or not the death or adverse effect occurs immediately after the exposure to the hazard. Familiarizing oneself with existing legislation is essential. Physicians and researchers must be aware of the legislative tools at their disposal, and must utilize them accordingly. In this context, the new CCPSA provided the exact policy lever required to enact the desired change. Indeed, had the new act not existed, it is possible that manufacturers would have continued to produce and sell the magnets in defiance of Health Canada until expanded legislative authority could be established. Compliance and enforcement actions taken by Health Canada, with respect to non-compliance with the requirements of the CCPSA or its regulations, may include: seeking voluntary commitments to product correction by industry, negotiation with industry for the voluntary removal of these products from the market, seizure, orders for recall or other measures, administrative monetary penalties and referral for prosecution. (21) In cases for which appropriate legislation does not exist, it is necessary to call for new legislation to be passed, or for existing legislation to be modified.
The Political Prerogative
Translating medical evidence, however nonpartisan, into policy requires an understanding of the political prerogative. The federal Minster of Health highlighted the mandatory recall during a press conference in June 2013 (22): “This first mandatory recall sends a strong message to industry that our Government is committed to protecting the health and safety of Canadians,” said then Health Minister Leona Aglukkaq. “We will not hesitate to use our powers Paediatr Child Health Vol 20 No 4 May 2015
under the Canada Consumer Product Safety Act to have dangerous products removed from store shelves.” While political calculus is complicated, appreciating the importance of fiscal risk, stakeholder risk and cross-jurisdictional comparators can be hugely beneficial to a physician’s or researcher’s KT efforts. In terms of the fiscal risk for the government, in this case, no significant financial resources were required to remedy the problem, and the CCPSA gave Health Canada the legislative ability to mandatorily recall the products. Stakeholder risk was considered to be high in this case. Affected citizens were children, and the potential consequences included surgery and/or fatality. Conversely, the manufacturers were primarily small, independent retailers, without industry organization or lobby groups. While this may not be the case for all initiatives, researchers must be cognizant of stakeholder issues as potential barriers to policy implementation. Finally, Canada was clearly lagging when comparing policies across jurisdictions, and no jurisdiction seeks the dubious distinction of being the ‘last’ to enact policy change widely considered to be important and effective. The United States Consumer Product Safety Commission had issued a recall nearly a year before, in June 2012, and Australia followed suit with a recall in November 2012. New Zealand enacted its recall in January 2013. Familiarity with the cross-jurisdictional environment can be particularly effective at stimulating policy change.
Conclusions
The mandatory recall of neodymium-iron-boron magnet toys in Canada offers an important case study for physicians and researchers interested in effectively translating evidence into action. While each individual research project will have different strengths and weaknesses, the general framework is the same. Researchers and granting agencies must understand the importance of investing time and resources into the generation of original policy-relevant research. Establishing rewards for this type of time-intensive, impactful KT will be important to encourage future interest in issues of importance to population health. Investments in robust, policy-relevant data systems (such as the Canadian Paediatric Surveillance Program, whose data helped inform early warnings of increasing ingestions in Canada [12]) and policy-oriented research are also required. Physicians and researchers must be encouraged and trained to effectively engage with the media, both for the enhancing public knowledge as well as stimulating public policy change. While not appropriate in every circumstance, building a strong and diverse coalition of advocates can elevate both the profile and priority of a potential policy issue. Familiarity with the legislative environment is also essential, and is facilitated by building enduring relationships with political leaders and senior government officials. Understanding the complex process that stimulates policy change allows researchers to strategize their advocacy efforts effectively and maximize the likelihood of their research informing policy. References
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