Ethics

In this section we are stepping back and considering the ethical implications of our innovation, the economics of the issue and motivations for all involved to contribute to former. That is the social responsibility that carries with knowledge and technology and how much altruism.

The financial responsibility and incentives that follow with that and lastly the considerations of proposing out imperfect solutions in order to alleviate suffering.

Social and human responsibility

We have the means, we have the technology. Let us show the way

We are privileged in Denmark, so privileged that we had a challenging time finding good problems to be solved. A part of that privilege is abundant and nuanced access to a what goes on around the world.We have ample tools and opportunity to enable us to solve an issue like this. To alleviate suffering - even from the comforts of the University lab benches? We could not refuse the impact we could make. The impact of catalyzing innovation within such a new field, a field where there is potentially lives to be saved. Suffering to be alleviated.

We are aware that we are wandering into new frontiers. And that with it comes exploring the “new”, and that it with that comes the “unknown” and with the “unknown” is the the fear of it, of the unexpected. We argue that there is both a will and a way before us, and we know what they say about that.

The will is to alleviate suffering, to save lives the way; one way, is through the application of technology: If it was not for the application of we would have life expectancy significant below and mortalities significant higher than it is today. We create solutions for ourselves and others and that is one factor to what makes us great. We should keep that in mind when looking to future challenges, and to new frontiers. We have solutions and we should apply them accordingly, be it through synthetic biology or not.

In furtherance to that point, we address the issue regarding applying synthetic biology.

Technology, Synthetic biology and Safety

Taking our project into account, the application does not raise alarms. We are working with closed contained products without any living organisms. The parts we are using are safe. We are applying genetic modified organisms (GMOs) to produce the recombinant proteins going into the device, thereby preventing any exposure and release of dangerous unfavorable organisms.

However, even though our project is not utilising the most controversial tools of synthetic biology, there are still some important ethical aspects that have to be considered, and we are continuously aware of the power of technology and the responsibility that goes along with it.

We are not the only part involved. We consider two other skilled professions: The professional researcher and the doctor.

Flux of medical personnel and academic brainpower

There is a flux of competent doctors from rural areas. They move into the city where there is work and money to be made. Money to feed their families. This makes staying in a rural clinic a hard sell. What would the incentive to do so for a newly educated doctor from Ghana? Further, if inferior means of treatment, i.e no proper medical equipment or antivenom is present, would the cost of staying with his relatives in a rural city, inviting a harder life, be worth the lives he could potentially safe? How much hardship should he endure and would he be willing to accept until he, too takes the journey to an established medical practice in the city?

This means that the rural clinics are lacking competent medical personnel. The staff effectively consists of nurses that often lack the preliminary knowledge about venom treatment [1].

Furthermore, when speaking to a post-doctoral fellow working within the field of bioinformatics and comparative venomics, we sensed an expressed frustration with searching funding of research related to snake venoms as it seems to be an uphill battle. That his family suffered in the process and that he never really had time-off. He missed being able to work a nine to five and have time off, when the clock five pm. When asked about if he felt he had a duty to work, he expressed that he had responsibilities to his family as well and also felt that he had served his duty, his “conscription”.

We should utilize the motivation of students enrolling into their education of these incentives. Solving and contributing to a better world. Both the doctor and the post-doc. raises important issues. The issue of financing.

Money, Money, Money

Who will fund this?

During public engagement activities we have been put to task by the question: “Who will fund this?”

The question is justified as it is glaringly apparent that the countries, nations, societies, tribes, families and the affected individuals have little to no funds to pay for such treatment. The countries have a very challenged health budget.

For this issue to be addressed properly and our solution to be feasible, some sort of financial backing is vital.

Let us look to Uganda as a case, a country in eastern central Africa. Its main export is coffee and 10% of the $91,212 billion economy is allocated to the health sector - with a population of 41,5 million people. This is 5% below the Abuja declaration, where heads of African states agreed to spend 15% of the GDP for health care.

The current funding of $27 per capita per annum expenditure on health care is far below the $44 per capita recommended. That is a health budget that is also needed for addressing Hepatitis A, Malaria, Rabies, Typhoid and Yellow Fever [2]

This means that a course of antivenom, for a critical dose of envenoming by the commonly occurring Bitis gabonica snake will run up (based on Product: FAV-Afrique antivenin by Sanofi-Pasteur, France) $120 a vial - and many venomous bites must be treated with more than one vial. This is above what most families earn in a whole year [3].

This is the raw cost of the most effective treatment. We only speculate on how a detection device will be prioritized.

While still appealing to the higher values of social responsibility. We also ask: Who says that is can not be good business. There are potential money to be made. A report from the businesscomission.org: Better business, better world report, the solving the UN SDGs, has been estimated to have an market opportunity of $12 trillion. The issue of snake envenoming related directly to Goal 3: Good Health and Well-being, secondary to goal 1, 2, 4, and 8: No poverty, zero Hunger, Quality Education and Decent work and economic growth, respectively. The goals are related in so far as the issue debilitates the families financially thus causing further poverty or disabilities that preclude attending schools. This all in all, prevents economic growth for the family and those that society at large that rely on their productivity.

We ask global and local organizations, philanthropic or otherwise to fund this incentive. We have since our wish gotten considered in the World health organization 2020 roadmap for the treatment and management of snake envenoming.

We look for accountability of funds and full transparency that funds are spent according to the purpose, for which they were given. It is no secret that the governments of many countries are corrupted, and that the lack of oversight enables it to be viable.

We hope that this will motivate industries to partner with these organizations and compete for putting effective solutions out there, thus creating a healthy industry while still prioritizing safety.

We have so far considered potential partners, endorsers and funders such as UNDP: United Nations development programme, WHO incentive on developing a roadmap for neglected tropical disease, Doctors Without Borders (Medical sans frontiers). We project relying on academia and University research grants for funding for our research and development of the prototype. Once, developed beyond a sufficient level, we are considering getting Impact investors on board, that are facilitating investment made into companies with the intention to generate a measurable beneficial social or environmental impact alongside a financial return.

Competition, running out of effective antivenom and inferior replacements

One issue is that countries in Sub Saharan Africa rely on imports from cheaper indian and chinese pharmaceuticals. These suppliers are able to that usually carry antivenoms with inferior quality and an increased number of side effects due to the improper manufacturing process employed for the cheaper alternatives. In addition to issues of proper supply chain management of pharmaceutical in Africa [4].

This has resulted in significant casualties as in the case of Chad and Ghana that has seen a rise in envenoming related fatalities from a mere 2.3% to 15% [5].

Established quality antivenom suppliers have difficulties penetrating the marked as of late. Even with these suppliers having been endorsed and used by Non governmental organizations such as Doctors Without Borders.

A study carried out investigating the doses of antivenom both in vitro and through preclinical testing of antivenoms found that none of the six commonly employed antivenoms were effective, either due to unspecificity of the venom or due to that the dosing recommendations of the supplier were significant lower than necessary for treatment [6].

Independent testing

Taking our own solution into perspective, we will have to be very transparent with all the issues that come with such a device, such as the percentage likelihood of false positives, and -negatives, the accuracy of the test, in addition to accounting for stability and storage, as one would any other product. This means rigorous testing and declaration of any conflicting interests.

We are strongly inspired by the already established academic tradition of peer-reviewing to be taking place, as we estimate it to be the strongest means of verifying scientific research and its solutions.

We, in order to exclude financial motive, invite for more solutions that is suitable and safe and follow the World health organization guidelines on blood products and in-vitro diagnostics: biological standardization, before being put on the market [7].

Given the under-researched topic of snake venoms and their diagnostics, we see the academia as welcome opportunity to research further into this topic. This will enable for better and more well-founded solutions.

As funding these kind of incentives has been a major point in our feedback from industry and academia, we have further dedicated a section under integrated Human practice

Faulty tests

Diagnosing diseases is never going to be perfect, and our device is no different. It will create false negatives and false positives, although we hope to keep these at a minimum. If our device is to be implemented in medical procedures, we would want a period of time by which the patient should be under observation by a doctor in the case of a negative test to prevent unnecessary deaths. On the subject of false positives we do not see any treatment alternatives, since time is off the essence when dealing with snake envenomings, postponing treatment to be 100% certain would likely cost more lives than it would save. It’s important to point out that our diagnostic device should be seen as a supplement along the overall clinical picture, but not as an all encompassing replacement for the current medical procedures for snake envenomings.

In addition, these tests should not be solely relied upon, as there is a chance of false negative results which can potentially lead to deaths.

Given the imperfection and need of further development, we hope our project will serve as means for the following: catalyst further innovation. Appetize support from major partners to see and opportunity to contribute further. We hope that then lead fates as it was the case with eradicating influenza as a major cause of death, which was a major priority US army [8].

References

[1] Msuya M. et al. (2017). Descriptive study of nursing scope of practice in rural medically underserved areas of Africa, South of the Sahara International Journal of Africa Nursing Sciences, 6:74-82
[2] African Health Observatory, Analytical summary - Health financing system, World Health Organization, http://www.aho.afro.who.int/profiles_information/index.php/Uganda:Analytical_summary_-_Health_financing_system
[3]Loria K. (2016). We're about to run out of a critical antidote to some of the world's deadliest snakebites. Tech Insider
[4] Chaudhuri S., West A. (2015). Can local producers compete with low-cost imports? A simulation study of pharmaceutical industry in low-income Africa. Innovation and Development 5:23-38
[5]Schiermeier Q. (2015). Africa braced for snakebite crisis. Nature News, https://www.nature.com/news/africa-braced-for-snakebite-crisis-1.18357
[6]Harrison RA. et al. (2017) Preclinical antivenom-efficacy testing reveals potentially disturbing deficiencies of snakebite treatment capability in East Africa. PLOS Neglected Tropical Diseases 11(10):e0005969
[7]WHO Technical Report Series (2017). WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards. World Health Organization, 1004
[8] Hoyt K. (2006). Vaccine innovation: lessons from World War II. Journal of Public Health Policy, 27:38-57