Manifesto à la mode

Feature article

Aneka Larsen

 

Despite what your mother may have told you, it’s not just what’s on the inside that counts. As medical students, our external image matters greatly. We dress to impress, to show patients that we are capable and trustworthy. But how would our patients feel if they knew who made our clothes? Sustainable fashion is by no means a new idea, and most people I know support the idea, yet many of us still wear brands that are known to engage in unethical practices. Although we as medical students generally wish to improve others’ quality of life, too often we put ethics on the backburner as we convince ourselves that we are too busy, too tired, too whatever-it-happens-to-be that day, to think of the consequences of our actions. If we were truly compassionate, it would seem incongruent that we would not also express this in choosing which brands to support.

After becoming increasingly concerned, I discussed the issue with a friend who told me that given the opportunity, most people will choose to do good. That is, most people don’t want to benefit from the exploitation of others but will unthinkingly ignore the reality of how most clothes are made. Every day we are exposed to marketing on billboards, bus stops, shop windows, YouTube, Facebook, fashion blogs, and Instagram feeds. Our first thought is not ‘who made this?’, but ‘I want that’. It’s automatic, and that’s why it works. I choose to believe that my peers are not consciously deciding to fund a harmful industry, and that instead their choices simply reflect a lack of opportunity to consider their purchases. Here is said opportunity. Think carefully and buy ethically, so as to avoid a fashion faux-pas that’s more than just embarrassing— one that results in child slavery, abysmal wages and factory collapses causing thousands of deaths. If you would like to join me in protesting an industry that fuels the maltreatment and exploitation of others, then read on.

This is my manifesto to fashion, and all the illnesses, injuries and deaths that it can cause when not held accountable.

Do no harm

The famous, perhaps trite, Hippocratic oath often comes to mind when considering the part that many medical students have played in the illnesses inflicted on sweatshop workers. It is a turn of phrase strongly associated with the medical profession, and one that most doctors and medical students take very seriously. While much has changed since the oath was created 2,500 years ago, human nature is still very much the same. This oath is important because it sets clear boundaries for minimum decency. To paraphrase Hippocrates, —‘Guys, I know you’re busy and all, but at least don’t give Bangladeshi women gastric ulcers and deprive them of food and sleep for days on end.’ Bangladeshi sweatshop workers receive one of the lowest minimum wages in the world,[1] and women often feel obliged to prostitute themselves at work for extra money.[2] To help understand how severely impoverished they are, let’s take into account their average monthly wage, 3000 taka, which is approximately $50 Australian Dollars. Working 16 hours a day for 7 days a week, they have made the shirt on your back for 10 cents an hour. For an extra 7 cents an hour, they would have enough to meet the “living wage”,[3] defined as “the minimum required to provide a family with shelter, food and education”.[3] If you add on the other burdens associated with sweatshops; the cramped living, lack of maternity care, and risk of silicosis from all the sand blasting so your denim can have that worn aesthetic, Hippocrates would be turning in his grave.[4] No cause justifies the deaths of innocent people Averting the deaths of innocent civilians seems like another no-brainer, but in a globally reported disaster in April 2013, an eight-story sweatshop in Dhaka, Bangladesh, collapsed, killing over a thousand people and injuring over two thousand.[5] The sweatshop supplied clothes to international brands such as Primark and H&M. [5, 6] While this disaster was widely discussed, it is one of many examples of the deaths inflicted on Bangladeshi workers. Another 7 deadly accidents were reported to have occurred in Bangladesh between 2005 and 2015.[7] An example of the response from companies involved is the one provided by H&M after the Rana Plaza collapse. “It is important to remember that this disaster is an infrastructure problem in Bangladesh and not a problem specific to the textile industry”. [8] This response shifts the blame to a poverty-stricken country and should not absolve them from participating in the exploitation of Bangladeshi workers. Although these disasters may seem far away from our comparatively comfortable lives, the deplorable crimes committed by the fashion industry are being committed by the fashion industry in our names. Many of the clothing brands worn by my peers here in Australia have been remonstrated for their manufacture practices, including Tigerlily, UNIQLO, Gorman, Ralph Lauren, Lacoste, Boohoo, and Dotti.[9] Choosing which pretty dress or flash new suit to buy for the next ball can seem like a life or death situation, but instead of only stressing over which looks best, also ask yourself where and how it was made. There are actual lives at stake, not just social ones, and they are lives that you can help to save simply by asking the right questions.

Practice what you preach

Do what your favourite soul singer tells you to do and “Practice What You Preach” (Barry White, 1994). How could you resist that deep baritone anyway? Sustainable fashion is generally seen as an ethical “thumbs up”, and yet so many people don’t practice it. There are a range of reasons that beliefs may not necessarily transfer to action, but the difficulty in keeping track of which brands treat their workers fairly seems to be a key one. One way to combat this challenge is to refer to an organisation that conveniently does it for you, such as Ethical Clothing Australia (ECA), which maps the local supply chain of brands to ensure the fair treatment of clothing workers. It provides a list of those brands which provide fair wages and decent living conditions, and its website lists these brands for your perusal. Some included brands are Cue, Manning Cartell, Thurley, Scanlan Theodore and Nobody.[10] As a general rule, however, it helps to ask if the price tag on an item really reflects the amount of work that went into making it.[11] A Kmart t-shirt‘s $3 price tag may be appealing to some, but their supply chain is untraceable and the workers receive a “minimum wage”, less than a “living wage”, the amount required to meet basic costs of living.[11] When considering price, it is obviously very important to acknowledge that not everyone can afford to pay for organic, handmade clothes. Some ways to overcome this include participating in the events run by charities like Fashion Revolution that work at raising awareness, shopping secondhand so that your money does not go directly to exploitative companies, learning to make your own clothes and writing to companies to put pressure on them to subscribe to ethical practice. [12] Go on, make Barry proud.

There are alternatives to supporting exploitative fashion labels. Protesting the unethical choices of the fashion industry doesn’t mean you have to look like a hessian sack. Fashion is about making you feel like your best self, which is hard to accomplish when your new look endorses an industry that is directly responsible for the illnesses, injuries and deaths of women and children from third world countries. Next time you’re worried about committing a fashion fauxpas at Med Ball, remember your commitment to improving the lives of others. That commitment shouldn’t just remain within the confines of the hospital.

Acknowledgements
None

Photo credit
Ricardo Gomez Angel, accessed from https:// unsplash.com/photos/rNXy6ngoyQ0

Conflict of interest
None declared

Correspondence
alar9706@uni.sydney.edu.au

References
1. International Labour Organisation, Characteristics of minimum wage setting system and minimum wage levels, [Internet]. Available from: https://www.ilo.org/ wcmsp5/groups/public/—asia/—ro-bangkok/documents/ genericdocument/wcms_223988.pdf, (accessed 2 September 2018)

2. Inter Press Service News Agency, Women Suffer Most in Garment Sweatshops in Bangladesh, [Internet], 1998. Available from: http://www.ipsnews.net/1998/12/labour-bangladeshwomen-suffer-most-in-garment-sweatshops/, (accessed 25 August 2018).

3. War on Want, Sweatshops in Bangladesh [Internet]. Available from: http://www.waronwant.org/sweatshopsbangladesh (accessed 20 March 2017).

4. Akgun M, Araz O, Ucar EY, Karaman A, Alper F, Gorguner M, et al. Silicosis Appears Inevitable Among Former Denim Sandblasters: A 4-Year Follow-up Study. Chest. 2015;148(3):647-54.

5. The Independent, Bangladesh factory collapse: 41 charged over deadly Rana Plaza tragedy, [Internet], 2015. Available from: http://www.independent.co.uk/news/world/ asia/bangladesh-factory-collapse-41-charged-over-deadlyrana-plaza-tragedy-a6781876.html, (accessed 22 March 2016).

6. Clean Clothes Campaign, Evaluation of H&M Compliance with Safety Action Plans for Strategic Suppliers in Bangladesh, [Internet], 2015. Available from: https:// cleanclothes.org/resources/publications/hm-bangladeshseptember-2015.pdf, (accessed 25 August 2018).

7. CBC, Timeline: Deadly factory accidents in Bangladesh, [Internet]. Available from: http://www.cbc.ca/news2/ interactives/timeline-bangladesh/, (accessed 22 March 2016).

8. Business and Human Rights Resource Centre, Response by H&M: Rana Plaza factory collapse in Bangladesh; over 1100 dead, [Internet], 2013. Available from: https://business-humanrights. org/sites/default/files/media/documents/company_responses/ h&m-response-re-bangladesh-building-collapse.pdf, (accessed 20 March 2017)

9. Baptist World Aid, The 2018 Ethical Fashion Report, [Internet]. Available from: https://baptistworldaid.org.au/ resources/2018-ethical-fashion-report, (accessed 25 August 2018)

10. Ethical Clothing Australia, Brands, [Internet], 2016, http:// ethicalclothingaustralia.org.au/brands/, (accessed 20 March 2017)

11. Choice, Ethical clothing, [Internet], 2014. Available from: https://www.choice.com.au/shopping/everyday-shopping/ clothing/articles/ethical-clothing#ethically, (accessed 22 March 2016).

12. Independent, Katharine Hamnett interview: How to shop ethically on a student budget, [Internet], 2014. Available from: www.independent.co.uk/student/student-life/katharine-hamnettinterview-how-to-shop-ethically-on-a-student-budget-9882406. html, (accessed 22 March 2016).

The changing landscape of artifical neural stimulation and its introduction to the developing world

Feature article

Stephanie Kirkby

 

With Commentary from Professor Michael

Ibbotson

The artificial electrical stimulation of neurons for the treatment of neurological disease and impairment is a well-established field that is undergoing rapid development in the treatment of diseases such as Parkinson’s disease,[1] obsessive compulsive disorder,[2] epilepsy,[3]as well as auditory and visual impairments using cochlear[4] and retinal implants.[5] The basic principle underlying these treatments arises from the inherent electrical excitability of all neurons in the body. By using electrical impulses to stimulate neurons, we can attempt to manipulate their functions. Thus, if there is a dysfunction in the firing of some neurons in the network, we can seek to replace them using electrodes. Generally, this is an area of research only being explored in the context of the developed world, however, particularly in the case of cochlear implants, there may soon be an evolving role for artificial neural stimulation in the developing world.

To appreciate the potential of artificial neural stimulation, we must first appreciate the way in which the neural network operates. The communication between neurons within the brain is the primary control point of all human behaviours, ranging from the movement of our limbs to the control of our deepest thoughts and emotions. These neurons communicate via unique patterns of electrical activity within synchronousneuronal networks, which are composed of billions of cells. Different sensations and behaviours each depend upon a unique subset of neurons within this synchronous network for their function. For instance, the neurons recruited for vision differ in appearance, location, electrical signature, and distribution when compared to those required for hearing. However, when the health of these neurons is compromised, so too is their ability to produce these complex patterns of activity. Artificial neural stimulation takes advantage of the electrical potential of neurons, whose function is dependent upon the flow of charge from one cell to the next. By injecting such neurons with an electrical stimulus using electrodes, we can artificially generate new patterns of neuronal activity that can replace the role of any dysfunctional cells in the network.

Bionic vision is still in its infancy but has made significant strides in the treatment of retinitis pigmentosa, the leading cause of inherited pigmentosa, the leading cause of inherited blindness.[6] There are also plans to utilise it for the treatment of macular degeneration, the leading cause of blindness in the developed world.[7] A United States Food and Drug Administration (FDA) approved model, developed by Second Sight in the USA, has already been implanted in hundreds of patients for the treatment of retinitis pigmentosa,[8] restoring ‘functional vision’ to its recipients.

Functional vision is significantly different from normal vision and relies on ‘phosphenes’ to produce visual percepts of the surrounding world.[9] Phosphenes are ‘spots’ within the visual field that can be perceived as either light or dark, such that a recipient may be able to perceive a horizon, navigate a dining room table, or see obstacles on a street. Phosphene vision is distinct from normal vision, being unable to depict colour or fine detail, as well as being limited by the number of phosphenes that a patient can see. Each phosphene corresponds to an electrode that has been placed on the retina, so with more electrodes, the patient will be able to perceive more sections of the visual field distinctly. However, there are multiple limitations to achieving higher visual acuity with more electrodes within retinal prostheses such that phosphene vision remains ‘functional’ but rudimentary compared to normal human vision. Michael Ibbotson, Director of the National Vision Research Institute and Professor at The University of Melbourne believes that “the sky is the limit” when it comes to the potential of artificial neural stimulation. “Two key factors have driven the rapid expansion of bionics in recent years; the improvement of surgical techniques for implantation and the increased biocompatibility of the materials used. Recent advances have made it possible to both record from and stimulate neurons in different areas of the brain. For instance, we could record sensory neural information from one part of the brain and then feed it back into motor neurons to emulate more natural movements of the body.” “However, in many cases although we do not perfectly replicate the original neural network’s function, there are still significant positive outcomes for patients psychologically to have a lost sense restored.[10, 11] Despite the difficulty inherent in reading a text with bionic vision, patients would prefer to utilise that sense, which otherwise would be lost to them, rather than opt for an easier means of reading such as an audiobook.” What has been restored for these patients is much more than their sight or their hearing, but rather a restoration of their sense of self.[11]

According to Professor Ibbotson, it seems possible that the future of bionics may expand well beyond the medical world, stating that “once it becomes normal within medicine, it would not surprise me if bionics became cosmetic”. As the technology develops and becomes normalised as a treatment for various impairments and diseases, the public may eventually see an opportunity for self-improvement through artificial neural stimulation. For instance, breast implantation was originally developed for mastectomy patients before it became one of the most popular cosmetic surgeries of the modern world. [12] “If it were possible to improve memory function by selectively stimulating memory circuits at particular times, this could dramatically change the way in which students approached education, as well as in the treatment of memory disorders”. Although it seems closer to science fiction than reality, the cosmetic use of artificial neural stimulation, if it were realised, would have the potential to increase the profitability of this technology. If this were the case, it may be possible to fund its use in less developed regions, where it is currently unavailable. The expanding range of pathologies that can be treated by neural stimulation is promising, particularly for the developed world, but its implementation in the developing world is far more complex.[13] There are many obvious hurdles in utilising this technology beyond high-income countries. The first issue is the prioritisation of resources to ensure the greatest possible impact on public health outcomes. There are many other competing health priorities that require attention before advanced interventions to improve neurological health can be implemented.[14, 15] “The cochlear implant appears to be the exception to the rule” according to Professor Ibbotson. Since its initial clinical introduction for patients in 1985, the cochlear implant has undergone significant developments and is now widely utilised in the treatment of hearing impairment, particularly in paediatrics where its impact is more dramatic in younger brains due to increased neuroplasticity. The cochlear implant has also seen recent introductions into low and middle-income countries in South America, Egypt, India and China, where it has faced multiple ethical and practical challenges.[13] However, recent studies have shown that its use can remain cost-effective, even in regions where there is a scarcity of health resources.[13] This is largely due to both the use of low-cost materials and the high health benefit associated with hearing restoration in patients.

The health priorities of patients also need to be aligned with access to neural implants, regardless of the product’s availability. If patients do not feel the need for such health interventions, then such interventions are unlikely to be utilised. For instance, the cochlear implant is still met with some resistance in the deaf community due to the fear of compromising their cultural identity. [16] Visual impairment is one such example where there is a significant variation between the priorities of the developing world and the developed world. In low-income countries, cataracts are the leading cause of blindness, [17] whilst in the developed world, the leading cause of blindness is age-related macular degeneration. [7] Naturally, there is a gap in the prioritisation of treatment availability where surgical intervention is a successful treatment for cataracts but remains difficult to deliver to disadvantaged regions of the world. The treatment of age-related macular degeneration and other degenerative retinal diseases has inspired the development of the bionic eye, but is less likely to be considered a treatment priority for the developing world until it becomes far more affordable. Global health priorities are consistently evolving to reflect the needs of the wider population.

Although it may be in the distant future, the wider utility of artificial neural stimulation will remain unclear until the technology has sufficiently advanced. It will be important for patients to have an awareness and understanding of such technology in the future, so that it is more likely to be accepted as a potential treatment for future health initiatives.

At a recent public forum, Professor Ibbotson also reported that one of the primary concerns of the public surrounding the use of neural implants was the potential for ‘mind control’. This demonstrates a significant gap in the public’s understanding of what artificial neural stimulation aims to achieve, as well as what it is capable of.

The potential for this type of neural control is well beyond the capabilities of current technology, which aims to stimulate otherwise inactive local networks of the brain to restore a lost function such as vision or hearing.[18] However, these patient concerns are still important to consider if such technology is ever to be widely implemented in medicine in the future. The human brain is infinitely complex and research is only recently gaining significant momentum in our understanding of its function.

The development of artificial neural stimulation is an expanding field for the treatment of degenerative neural diseases. Although this technology is in its infancy, it has enormous potential for public health outcomes in both the developed and developing worlds, which are yet to be fully realised. The range of pathologies treated with artificial neural stimulation is expanding as rapidly as our understanding of the brain itself, making the development of this research an important area to watch in the future of medicine.

 

Acknowledgements

Commentary and revisions provided by Professor Michael Ibbotson.

Photo credits

Meo, accessed from https://www.pexels.com/photo/photo-of-head-bust-printartwork-724994/

Conflict of interest

Stephanie Kirkby is currently working with the National Vision Research Institute on a followup project relating to her Honours research with Professor Michael Ibbotson.

Correspondence

skirkby@deakin.edu.au

 

References

1. Aviles-Olmos I, Kefalopoulou Z, Tripoliti E, Candelario

J, Akram H, Martinez-Torres I, et al. Long-term outcome of

subthalamic nucleus deep brain stimulation for Parkinson’s

disease using an MRI-guided and MRI-verified approach. J Neurol

Neurosurg Psychiatry. 2014; 85: 1419-25

2. Alonso P, Cuadras D, Gabriëls L, Denys D, Goodman W,

Greenberg BD, et al. Deep brain stimulation for obsessivecompulsive

disorder: a meta-analysis of treatment outcome and

predictors of response. PloS one. 2015;10(7): e0133591

3. Cukiert A, Cukiert CM, Burattini JA, Lima AM. Seizure

outcome after hippocampal deep brain stimulation in a

prospective cohort of patients with refractory temporal lobe

epilepsy. Seizure. 2014;23(1):6-9.

4. Mäki-Torkko EM, Vestergren S, Harder H, Lyxell B. From

isolation and dependence to autonomy–expectations before and

experiences after cochlear implantation in adult cochlear implant

users and their significant others. Disability and rehabilitation.

2015;37(6):541-7.

5. Hadjinicolaou AE, Meffin H, Maturana MI, Cloherty SL,

Ibbotson MR. Prosthetic vision: devices, patient outcomes

and retinal research. Clinical & Experimental Optometry.

2015;98(5):395-410.

6. Hartong DT, Berson EL, Dryja TP. Retinitis pigmentosa.

The Lancet.

2006;368(9549):1795-809.

7. Wong WL, Su X, Li X, Cheung CMG, Klein R, Cheng C-Y, et

al. Global prevalence of age-related macular degeneration and

disease burden projection for 2020 and 2040: a systematic review

and meta-analysis. The Lancet Global Health. 2014;2(2):106-116

8. Second Sight Announces Record Number of Argus II

Retinal Prosthesis Systems Implants and Completes First-in-

Human Orion Cortical Implant [press release]. California: Second

Sight 2018.

9. Pérez Fornos A, Sommerhalder J, da Cruz L, Sahel JA,

Mohand-Said S, Hafezi F, et al. Temporal properties of visual

perception on electrical stimulation of the retina. Investigative

Ophthalmology & Visual Science. 2012;53(6):2720-31.

10. Duncan JL, Richards TP, Arditi A, da Cruz L, Dagnelie G,

Dorn JD, et al. Improvements in vision related quality of life in

blind patients implanted with the Argus II Epiretinal Prosthesis.

Clinical and Experimental Optometry. 2017;100(2):144-50.

11. Da Cruz L, Coley BF, Dorn J, Merlini F, Filley E, Christopher

P, et al. The Argus II epiretinal prosthesis system allows letter and

word reading and long-term function in patients with profound

vision loss. British Journal of Ophthalmology. 2013;97:632-6

12. Champaneria MC, Wong WW, Hill ME, Gupta SC. The

evolution of breast reconstruction: a historical perspective. World

journal of surgery. 2012;36(4):730-42.

13. Fagan JJ, Tarabichi M. Cochlear implants in developing

countries: practical and ethical considerations. Current opinion in

otolaryngology & head and neck surgery. 2018;26(3):188-9.

14. Allegranzi B, Kilpatrick C, Storr J, Kelley E, Park BJ,

Donaldson L, et al. Global infection prevention and control

priorities 2018–22: a call for action. The Lancet Global Health.

2017;5(12):1178-80.

15. Chao TE, Sharma K, Mandigo M, Hagander L, Resch SC,

Weiser TG, et al. Cost-effectiveness of surgery and its policy

implications for global health: a systematic review and analysis.

The Lancet Global Health. 2014;2(6):334-45.

16. Goldblat E, Most T. Cultural Identity of Young Deaf Adults

with Cochlear Implants in Comparison to Deaf without Cochlear

Implants and Hard-of-Hearing Young Adults. The Journal of Deaf

Studies and Deaf Education. 2018;23(3):228-39.

17. Khairallah M, Kahloun R, Bourne R, Limburg H, Flaxman

SR, Jonas JB, et al. Number of people blind or visually impaired

by cataract worldwide and in world regions, 1990 to 2010.

Investigative ophthalmology & visual science. 2015;56(11):6762-

9.

18. Lebedev MA, Nicolelis MA. Brain-machine interfaces:

From basic science to neuroprostheses and neurorehabilitation.

Physiological reviews. 2017;97(2):767-837.

Exploring the ethics and legality of conducting clinical trials in developing nations

Feature article

Rosemary B Kirk

 

The number of clinical trials conducted in developing countries has increased dramatically in recent decades due to globalisation and increased need for trial subjects. For example, between 2002 and 2007 the number of United States (US) sponsors conducting pharmaceutical research abroad increased by 15% annually, while US-based trials decreased by 5.5%.[1] All trials involving human subjects require ethical discussion, and this is of particular importance in developing nations, where risk of exploitation is high. In this article I will describe the legislation surrounding these trials, summarise the benefits of clinical trials to developing nations and researchers, analyse the ethical issues raised by this practice through a principles-based and utilitarian lens, and discuss how future legislation could align the potential benefits of these trials with reality.

Legislation surrounding clinical trials

To understand why clinical trials in developing countries are conducive to exploitation, the issues with the legislation in place must first be understood.

International

Numerous international bodies have created documents outlining clinical trial guidelines. One of the most commonly referenced documents is the Declaration of Helsinki (DoH), developed and regularly updated by the World Medical Association. International guidelines such as this are not legally binding, but are referred to in the legislation of many countries.[2] These international guidelines have been criticised for being vague and thereby allowing researchers to circumvent their recommendations.[3] For example, the DoH states that new interventions must be tested against the current best intervention, that researchers should make provisions for post-trial access to their intervention, and that medical research on a group is only justified if  it is responsive to their health needs.[4] However, the DoH lists circumstances in which placebo use is acceptable, does not specify the duration of availability or price of the intervention post-trial, and does not define how significant a health need must be for a community to justify participation in a trial.

Developed nations

Developed nations have regulations to protect subjects in trials within their country that are enforced by ethics committees. However, depending on who is funding the research, such regulations do not always have to be followed regulations do not always have to be followed when conducting research internationally.[5] It can also be problematic to apply laws from one culture to another. For example, in the US, sponsors do not have to compensate subjects for treatment of research-related injuries, but this cannot reasonably be applied to nations where subjects cannot afford treatment.[6]

Developing nations

Developing nations are less likely to have established and financially-supported clinical trial regulation, and the increase in clinical trials in developing nations in recent years has overwhelmed existing ethical review systems.[7] This makes it easy for researchers to avoid investigation, and a 2004 study found that 44% of studies in developing nations did not undergo any review from the country in which they took place.[8]

Arguments for clinical trials in developing countries

For companies

The advantages for companies of conducting clinical trials in developing countries are numerous. Costs are significantly reduced as a result of lower salaries, cheaper facilities, and less time being required to receive approval for a trial. [9] Participant recruitment is also easier, due to the higher prevalence of diseases and paucity of treatment options.[10] Finally, subjects are less likely to have received prior treatment, increasing result significance.[2]

For communities

While it can be easy to assume that clinical trials in developing nations are inherently exploitative, these trials are not without their benefits to local communities. Trials provide pharmaceuticals to people who may otherwise have extremely limited access, and if the recommendations made in the DoH are implemented, these communities may have continued access to the drugs being tested.[11] Furthermore, through conducting clinical trials, researchers can provide equipment and knowledge to advance local research, and can boost local economies.[12]

Ethical perspectives

If research is conducted ethically and following international guidelines, it is possible for all of the benefits described above to be realised. However, as long as clinical trials in developing countries are not properly policed, there are ethical issues implicit in this practice and a risk of exploitation. While there are countless ethical issues to be considered in this area, I will focus on the issues of informed consent, the dangers of trials, placebo use, testing of interventions that target health needs, and post-trial availability of interventions. These will be analysed using a principles based and a utilitarian lens.

Autonomy

Autonomy describes a state in which individuals are free to make their own decisions; one consequence of the principle of autonomy is informed consent. To make decisions, people must be provided with the relevant information in a form they can understand.[13] Informed consent has particular relevance for trials in developing nations, because gaining consent requires understanding local languages and analogies, and obtaining written consent can be difficult in the context of low education rates.[14,15] Additionally, in many communities it is essential to also obtain consent from elders, religious leaders, or heads of families. [16] Thus, in order for clinical trials in developing countries to be considered ethical from the perspective of autonomy, researchers must show cultural awareness in acquiring informed consent.

Beneficence and non-maleficence

Non-maleficence is the principle that actions should not expose individuals to unnecessary harm, while beneficence describes acting in a manner that benefits others.[13] In any clinical trial there is potential for significant harm to come to study subjects. This is particularly true when clinical trials are poorly regulated. For example, up to 2,644 people died in clinical trials of 475 new drugs over a 7-year period in India, with the majority of these trials being conducted by international sponsors.[17] In the context of murky international legislation and the potential for negligent trial structure and administration, such deaths can be considered a violation of the principle of non-maleficence by the researchers. Conversely, clinical trials can also be a force for beneficence in developing nations through the provision of medication and research infrastructure, as previously described. It is thus important that the potential harms and benefits of any trial to a community be carefully considered in order to maximise both principles of beneficence and non-maleficence. A further ethical issue relating to beneficence and non-maleficence is the use of placebos in clinical trials, a pertinent case study being the 1994 African Zidovudine trials. These trials tested Zidovudine as a means of preventing vertical transmission of HIV, with comparison to control groups who received a placebo.[18] During the trial, many women in the control group transmitted HIV to their offspring. This violates the principle of beneficence, as researchers did not act to benefit all trial subjects (which could have been achieved by giving the control group an existing intervention). Whether or not this violates the principle of non-maleficence depends on how harm is defined. If harm requires an individual to be worse-off relative to a baseline, then this placebo use could be considered ethical in a nation where women otherwise receive no treatment.[10,19] However, this creates a double standard for developing countries, as using a placebo when there is existing treatment would be unethical in developed nations, as per recommendations established in the DoH. Views on placebos from this perspective, therefore, may vary.

Justice

The principle of justice involves fair distribution of scarce resources and respect for personal rights and laws.[20] Trials in developing countries are often for ailments primarily affecting developed nations, such as overactive bladder and allergic rhinitis, rather than for diseases that disproportionately affect developing countries.[1] People in developing nations are therefore assuming the risks of research while receiving little benefit. This practice is possible because there are many health needs in developing nations and, as previously stated, the DoH does not specify how important a health need must be for it to be an appropriate research target.[21] From a justice perspective, in order for a trial to be ethical it should target a health priority, not just a health issue present in a community. If this principle is followed, clinical trials may become a means of combatting global healthcare inequalities; indeed, as it stands today, 90% of the global healthcare budget targets illnesses responsible for only 10% of the global disease burden.[22] Another issue pertaining to the principle of justice is continued access to interventions post-trial. Basic medications are often absent or expensive in developing countries; therefore, continuing to offer treatments after a trial ends is one way of fighting this distributive injustice, especially if the intervention is offered to a wider community and the researchers are allied with broader access programmes.[11]

Utilitarianism

Utilitarianism deems actions good if such actions maximise the amount of good for a maximum number of people.[13] Using a utilitarian lens, it can be argued that since clinical trials in developing countries are mutually beneficial, imposing further constraints is not justified.[23] For example, if placebo use was not permitted in the African Zidovudine trials, the trial may not have been conducted, meaning no one would receive treatment. In the context of extreme utilitarianism, it can even be argued that all clinical trials in developing countries are ethically justifiable because the results can potentially help many more people than might be harmed in the trial process. Utilitarianism thus provides a very different overall view of clinical trials in developing countries than a principles-based perspective. In practice, the views of most ethical theorists and international guidelines align with a principles-based perspective, while some developed nations follow the utilitarian perspective and favour scientific arguments and economic advantages over ethical concerns for people in developing countries.[24]

Proposed future changes

It is evident that the current guidelines and legislation surrounding international clinical trials are inadequate to protect trial subjects from exploitation. Because of deficiencies in international legal capacity and infrastructure in developing nations, the responsibility for protecting subjects of clinical trials in developing countries must fall to developed nations. Examples of beneficial changes to current legislation include adjusting laws to be culturally appropriate for developing communities,[24] enforcing governments to commit a portion of tax revenue to research that is responsive to the health priorities of developing countries,[21] and having governments provide incentives to support health policy improvement and appropriate research practices in developing nations.[25] However, such legislation is far from being realised, and is unlikely to be implemented provided that current legislation remains beneficial to developed nations and wealthy researchers.

Conclusion

There are many layers of legislation to be considered when conducting a clinical trial in a developing nation, with considerable potential for contradiction or legislative gaps. Trials can therefore result in exploitation, and require numerous ethical issues to be considered. Exploring these issues using a principles-based perspective reinforces the need for improved legislation surrounding trials; conversely, however, purely utilitarian perspectives support maintenance of the current status quo. While legislation is unlikely to change dramatically in the near future, many ethicists agree that if developed countries improve their legislation, clinical trials in developing nations can become a part of the solution to global health inequality, rather than part of the problem.

 

Acknowledgements

None

Photo credit

Louis Reed, accessed from https://unsplash.com/photos/pwcKF7L4-no

Conflict of interest

None declared

Correspondence

rosemary.kirk@unsw.edu.au

 

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