Difference between revisions of "Team:Edinburgh/Safety"

 
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                       <li><a href="https://2015.igem.org/Team:Edinburgh/DNPBiosensor">DNP Biosensor</a></li>
 
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                       <li><a href="https://2015.igem.org/Team:Edinburgh/Results">Results</a></li>
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                       <li><a href="https://2015.igem.org/Team:Edinburgh/Results">Limits of Detection</a></li>
 
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                   <li><a href="https://2015.igem.org/Team:Edinburgh/MedalCriteria">Accomplishments</a></li>   
 
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Latest revision as of 18:57, 20 November 2015

Safety


Introduction

This page is divided into three sections, with each section focusing on a particular application scenario. The first section considers hypothetical situations where our biosensor provides inaccurate results, specifically in the case that it provides a false positive. The second section examines the scenario where the biosensor cannot be practically implemented in various countries due to legal constraints. The third and final section analyses the possibility that the biosensor may not be economical and therefore unable to withstand pressure from the current market. Let us consider these scenarios, and their proposed solutions, respectively.

Section 1: The biosensor provides inaccurate results.

Edinburgh’s putative biosensor could provide inaccurate results in one of two ways. Firstly, it could provide a false positive result, indicating that the drugs are contaminated when in actuality they are not. Following this, one could expect the user to not consume the drugs, and possibly discard them. This is not particularly worrisome, as the most likely consequence would be a reduction of illicit drugs in circulation.

Secondly, and more importantly, the biosensor could provide a false negative reading. In this situation, the user of the device would be in possession of contaminated, and potentially harmful, drugs. However, due to the biosensor’s inaccurate reading, she/he would be under the impression that their drug sample was safe to consume. This is particularly concerning, as the biosensor would provide a false sense of security (i.e. a ‘green light’ to use unsafe drugs), thereby placing drug users in an arguably worse situation than she/he would be in without the biosensor.

How, then, can Edinburgh safeguard against this false-negative scenario? There are a number of potential combative measures that can be taken, the first being a legal disclaimer that accompanies the biosensor. Indeed, in the same way that pregnancy tests explicitly express that they cannot provide 100 percent accurate results, so too should Edinburgh’s biosensor. This will inform the user that the device is not foolproof, and protects the manufacturer from litigation.

Furthermore, since it cannot provide perfect accuracy, health and social outreach centers that provide drug safety education should teach about the risks associated with ‘safer’ drug use. A useful analogy is that of condoms and safe sex: although condoms reduce the risks associated with sex to a large degree, they cannot provide 100 percent protection against STD’s or unplanned pregnancy (Waugh, 2010:550) and so sex education teaches that condoms make sex safer and not absolutely safe. Similarly, the biosensor can make drug consumption safer but not 100 percent safe, and so drug safety education needs to inform the public about the risks that remain constant.

Section 2: The biosensor’s implementation faces legal obstacles.

Drug law and policy varies widely from country to country. Harm reduction measures that are legal in Denmark, for example, differ greatly to those in Japan or the Philippines. This poses a potential difficulty for the implementation of the biosensor as a harm reduction tool, as, generally speaking, countries that take a prohibitive approach are unlikely to permit a biosensor that allows for the safer consumption of drugs.

Even though the biosensor may not be implemented in every country, its potential use is still significant. Countries in Europe, North America and elsewhere are becoming increasingly liberal on drug related issues, and are adopting innovative harm-reduction measures that could potentially make use of Edinburgh’s biosensor (Greenfield & Paoli, 2010:8).

A clear example of a harm reduction measure that could make use of the biosensor are drug consumption rooms, which are medically supervised social and health outreach centres that allow for users to consume drugs with legal impunity. These facilities provide clean needles, sterile injecting environments and medical supervision in the case of overdose. Currently, there are 74 drug consumption rooms operating in six countries in Europe, as well as two in Canada and Australia (EMCDDA, 2015:2).The biosensor could be used at these facilities by, or under the supervision of, medical professionals. If these governments have constructed drug consumption rooms themselves, it is highly unlikely that they would oppose (legally or otherwise) a biosensor that would allow for these facilities to operate more safely.

Still, an important question remains: can Edinburgh’s biosensor be used legally in countries that do not have drug consumption rooms? The answer is certainly yes. Take the United Kingdom as an example. Perhaps the most similar harm reduction measure to consumption rooms currently implemented in the UK are needle exchanges, where medical staff distribute clean injecting equipment to users. However, unlike consumption rooms, users are neither allowed to use or possess drugs while in needle exchanges, as it is a breach of NHS policy. Yet this does not eliminate the possibility that they could be distributed in a similar fashion as needles and be used at an individual's discretion in the privacy of his/her home.

Furthermore, since similar testing kits already exist for purchase online in the UK, there is little doubt that Edinburgh’s biosensor could not be bought legally on the free market. One may object to distributing the biosensor in this way, arguing that while supervised use of the biosensor by medical staff (in a consumption room, for example) is permissible, simply allowing individuals to buy the biosensor to use under their own discretion is irresponsible. However, this is a separate objection concerning how it ought to be implemented, and not how it can be implemented under law.

Ultimately, much of the Western World is shifting towards policies that favour increased availability of harm reduction services (Greenfield & Paoli, 2010:8), and in many of these countries (especially those that have consumption rooms), Edinburgh’s biosensor would be a welcomed augmentation to their goals. In countries that do not have consumption rooms but still have other harm reduction services, such as the UK or USA, the biosensor could be implemented in these government services, on the free market or, most likely, both.

Section 3: The biosensor cannot compete on the free market.

There already exist testing kits that provide a similar service to Edinburgh’s biosensor. Thus, it is possible that Edinburgh’s biosensor may not succeed for various reasons; namely, market oversaturation, costs of manufacturing and lack of potential investors. However, the novelty of Edinburgh’s biosensor may be enough to meet these concerns.

In the case of market oversaturation, it is useful to examine the alternatives. Current personal drug testing kits are readily available online, but are chemistry based and very inaccurate (Winstock et al., 2001:1145). By utilising synthetic biology, Edinburgh’s biosensor will have high specificity and will be very accurate, therefore separating itself from its competitors on the basis of performance.

Another benefit to Edinburgh’s biosensor is that manufacturing costs would be low because it is both cell free and paper based. The former is important because it eliminates resources spent on testing, trials and bureaucracy otherwise used if it utilised a cell-based biological system. The fact that it is paper based means that the actual production of the test would be extremely cheap, most likely less than 10 cents (USD) per test (Pelton, 2009:925).

Finally, there are potential investors if the biosensor were to be taken to market. Since it is both cheaper and more accurate than its competitors, venture capitalist and general investors may be interested in its potential to produce profit on the free market. Furthermore, since the biosensor has obvious uses for government sponsored harm reduction programs, it is likely that socialised health care services - e.g., the NHS - would be interested in subsiding a company involved in its production.

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Conclusion

Careful thought must be given to obstacles that may arise when implementing Edinburgh iGEM’s drug biosensor. False negative test results pose a serious threat to the safety of an individual who may have been better off without the biosensor in the first place. Legal and economical concerns bring into question the usefulness of the device. However, working through these scenarios provides a theoretical framework for the real-world application of the biosensor, and Edinburgh concludes that these challenges can be met.

References

EMCDDA. (2015). Drug Consumption Rooms: An Overview of Provision and Evidence. European Monitoring Centre for Drug Addiction.

Greenfield, V. and Paoli, L. (2012). If Supply-Oriented Drug Policy is Broken, Can Harm Reduction Help Fix it? Melding Disciplines and Methods to Advance International Drug-Control Policy. International Journal of Drug Policy, 23, 6-15.

Pelton, R. (2009) Bioactive Paper Provides Low Cost Platform for Diagnostics. Trends in Analytical Chemistry, 28(8), 925-942.

Waugh, M. (2010). The Role of Condom Use in Sexually Transmitted Disease Prevention: Facts and Controversies. Clinics and Dermatology, 28, 549-552.

Winstock, A. et al. (2001). Ecstasy Pill Testing: Harm Minimization Gone Too Far? Addiction, 96, 1139-1148.