Potential risks and benefits to human health

Arms_care_check

Overview

  1. How is MycoSynVac ensuring that the potential products are not dangerous to human health, and how will potential risks be communicated to the public?
  2. How can MycoSynVac help to reduce antibiotic use? And what are the potential human health gains of such a reduction?
  3. How will MycoSynVac ensure that there are no unintended mutations, and that there will be no unintended release?

In the earlier report on public and expert opinion, it was found that the public’s main concern about MycoSynVac was about the risks it presented to human health. This worry appears to be based mainly on general concerns about new technologies, rather than specific anxieties about the methods or aims of the MycoSynVac project itself. Many respondents indicated general trust in the researchers working on the MycoSynVac project, and in the oversight and competency of governmental institutions. However, concerns remained about potential long-term side-effects that may not be discovered until it is too late.

Members of the general public also recognized a potential upside for human health in terms of a reduction in antibiotic use if MycoSynVac is successful. This insight, which the experts shared, indicates that perceptions of the impact of MycoSynVac on human health are complex and multi-faceted.

Clearly, it is important for MycoSynVac to demonstrate its engagement in efforts to determine whether any risks to human health are associated with products emerging from the project. But this is not sufficient. Several other concerns, detailed below, should also be addressed.

1. How is MycoSynVac ensuring that the potential products are not dangerous to human health, and how will potential risks be communicated to the public?

This concern presents both an empirical and an ethical challenge to the MycoSynVac project. Empirical work is needed to investigate and address public concerns regarding long-term side-effects of synthetic vaccines. As there has been no previous use of synthetic vaccines in animals for human consumption, there are currently no longitudinal data on the potential effects of such vaccines on human health. Of course, as with any other vaccine used in food animals, potential MycoSynVac products will need to be shown to be safe for both humans and animals before they can be used in food production (Grein, Papadopoulos, & Tollis, 2007), but compliance with safety regulations may not assuage the fears of consumers, who may continue to be concerned given the quality and quantity of currently available empirical studies on the long-term safety of synthetic vaccines. This is not to say that a MycoSynVac vaccine will be unsafe for humans until longitudinal studies are completed, since there already exists a wealth of studies of vaccine safety in animals for human consumption, and to varying degrees the data gathered in these studies can be applied to a MycoSynVac product. Rather, the point is that the public might perceive a synthetic vaccine as a different category of vaccine, and if they do, information about non-synthetic vaccines will not alleviate their fears. Thus, the point is not only about empirical safety, but also about perceptions of the safety of the product.

Another important factor is the transparency of the scientific environment surrounding the technology, as well as the transparency of the project specifically. It is clear from the earlier report that public worries about risks to human health do not relate to specific studies or specific effects on humans. Instead they are general worries reflecting the public’s lack of certainty that adverse consequences will not materialize. Thus, while the earlier report indicated that there is a high degree of trust in the regulatory and standards agencies in Europe which ensure that new technologies are not dangerous to humans, MycoSynVac should also be proactive in communicating the steps that have been taken to ensure that any potential product will not represent a danger to humans. To alleviate public concerns two things are therefore needed. First, a sufficient level of empirical certainty about the real long-term risks of the technology is needed: the empirical foundation for claiming that the product is safe needs to be sound. Of course, this does not mean that evidence of complete safety can be presented, nor should such a claim be made. In the past researchers have sometimes overstated the safety levels and minimized the risks of new technologies, and this created a backlash against the technologies when relatively minor harms were later identified (Torgersen, 2009). Second, information on these empirical findings needs to be transparently communicated to the general public. Without this, general anxieties and the lack of transparency can turn the public opinion against a new technology, even in the absence of empirical data backing up the belief that the technology is dangerous to humans. This happened with the attempted introduction of GMO crops into the EU.

Quick points

  • New technologies may be generally perceived as unsafe, and they may therefore meet with public resistance regardless of the specific research project
  • Scientific evidence of the safety of a MycoSynVac product will not necessarily be sufficient to create a perception that the product is safe among the public
  • MycoSynVac should aim to communicate the safety of the product efficiently, but it should also be open about any potential risks to avoid future backlash

2. How can MycoSynVac help to reduce antibiotic use? And what are the potential human health gains of such a reduction?

A major area of public interest in the synthetic vaccine technology lies in its potential to reduce antibiotic use. The hope that synthetic vaccines will reduce the use of antibiotics is also shared by both vaccine experts and synthetic biology experts. Antibiotic resistance is of considerable concern to policymakers and researchers around the world, since there is a significant potential for morbidity and mortality from future antibiotic resistance in both humans and animals. Many factors contribute to this problem, including the use (and especially the unnecessary use) of antibiotics in humans and the presence of antibiotics in the environment (which results from both production and incorrect disposal). But the use of antibiotics in livestock is a contributory factor (The Review on Antimicrobial Resistance 2016). As such, reduced use of antibiotics in livestock is of great interest around the world. The potential for MycoSynVac to contribute here is recognized by both the general public and experts, and thus opens up a significant area of common ground.

Limiting antibiotic use in food-producing animals is likely to deliver direct benefits to human health. While only a small number of studies have been conducted to date, it has been found that a reduction in antibiotic use in food-producing animals leads to a reduction in the presence of antibiotic resistant bacteria in these animals, thereby limiting the risk of resistant bacteria of animal origin infecting humans (Tang et al., 2017). This result should of course be understood in the wider context of global antibiotic use. Reduced use of antibiotics in food production is part of the solution to the risk of antibiotic resistance in humans and animals alike, but human antibiotic production and consumption also play a large part in this problem, and as such the importance of a reduction in livestock should not be overstated. However, reduced antibiotic use in animals could prove beneficial to humans, since the human and economic cost of human infection with antibiotic resistant bacteria will only grow in the future. Indeed it has been estimated that by 2050 it will lead to 10 million deaths per year at a cost of $100 trillion (The Review on Antimicrobial Resistance 2016).

Quick points

  • If a MycoSynVac vaccine reduces antibiotic use, the vaccine will benefit human health by reducing the risk of antibiotic resistance
  • Whether a real reduction is achieved should be assessed in light of the current practice of culling rather than treating animals in many cases
  • Claims of benefits to human health arising from reduced antibiotic resistance should be qualified by acknowledgement of other uses of antibiotics that are unrelated to livestock

3. How will MycoSynVac ensure that there are no unintended mutations, and that there will be no unintended release?

With regard to the unintended release of processes or products, it should be borne in mind that synthetic biology is in general a very powerful tool. As such, it can do as much damage in the wrong hands as it does good in the right hands. This so-called “dual-use dilemma” means that control of the technology is essential. The risk associated with this dilemma for the MycoSynVac project will depend on the unique capabilities of the tools and processes developed within the project. However, in general, the goal should be to minimize the potency of the tools developed while retaining their intended function, so that the risk of real cost to humans is minimized.

Even if all measures are taken to minimize the relevant risks, MycoSynVac must still assess the potential consequences of actors with malevolent intentions acquiring the knowledge that is generated by the MycoSynVac project. In cases where techniques or knowledge have dual-use, it must be assessed whether the potential benefit to be gained from using the knowledge in the ways intended justifies the risk associated with misuse of that knowledge. If the risk of misuse is sufficiently high (e.g. where techniques do not require research laboratories and equipment), then it may be concluded that the knowledge should not be developed or disseminated. Assessment of this kind should be continuous, and relevant cases should be discussed more broadly within the project. This is necessary because advances in this type of knowledge are often a one-way street. Once a technique or process has been developed, it may not be possible to limit its dissemination: the genie cannot be put back in the bottle. This problem is illustrated by the vast political and financial resources that have been expended on limiting the dissemination of nuclear technology.

Quick points

  • MycoSynVac should be aware of the risk of unintended release, not only of the product, but also of the processes, behind a synthetic vaccine’s creation
  • Synthetic biology is a powerful tool, and potent methods or processes need to be handled in a way that reduces the risk of malicious use by external actors
  • MycoSynVac should evaluate whether extremely potent processes should be researched and developed at all if the potential risks associated with unintended release are sufficiently serious

 


References

Grein, K., Papadopoulos, O., & Tollis, M. (2007). Safe use of vaccines and vaccine compliance with food safety requirements. Revue Scientifique et Technique (International Office of Epizootics), 26(2), 339–350. https://doi.org/10.20506/rst.26.2.1746

Torgersen, H. (2009). Synthetic biology in society: learning from past experience?. Systems and Synthetic Biology, 3(1–4), 9–17. https://doi.org/10.1007/s11693-009-9030-y 

The Review on Antimicrobial Resistance. (2016). Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. London: The Review on Antimicrobial Resistance

Tang, K. L., Caffrey, N. P., Nóbrega, D. B., Cork, S. C., Ronksley, P. E., Barkema, H. W., … Ghali, W. A. (2017). Restricting the use of antibiotics in food-producing animals and its associations with antibiotic resistance in food-producing animals and human beings: a systematic review and meta-analysis. The Lancet Planetary Health,1(8), e316–e327. https://doi.org/10.1016/s2542-5196(17)30141-9