The Indian Health Service and Turning a Blind Eye

The Indian Health Service (IHS)  was founded on July 1st, 1955 and its mission is to serve the population of indigenous peoples who are members of federally recognized tribes in the United States [1]. IHS has hospitals across the country that serve the millions of people who belong to federally-recognized tribes. However, the IHS has been severely underfunded for much of its existence and has time and time again failed to provide high quality, reliable service to the indigenous population of the United States. With these observations in mind, I argue that the United States commits something larger than simply a broken promise by neglecting their relationship to tribal nations, but rather commits egregious bioethical violations. 

The obligation for the federal government to provide health services to indigenous peoples is part of the larger doctrine of trust, which was established in a series of court cases and treaties, as well as in Article 1 Section 8 of the United States Constitution, which grants the United States federal government jurisdiction over the commerce and treaties of tribal nations [2]. Within this jurisdictional declaration, tribal nations become a pseudo-subsidiary if you will of the United States, needing to conform to federal law, but still able to in-part retain their sovereignty. With the formation of this relationship, federal systems dedicated to the health and wellbeing of indigenous peoples took shape. This doctrine of trust has only been applicable to the Tribal Nations that are federally recognized and does not encompass all indigenous peoples who live within the border of the United States. This differentiation is important because during the era of termination, a period of time between 1953 and 1969, many tribal nations lost their status as federally recognized tribes, thus relieving the federal government of their obligation to recognize their sovereignty [3]. One example, of many, the Klamath people of Oregon, had their land distributed and lost their status as a federally recognized tribe, which meant the dissolution of the government of the Klamath peoples and the loss of their privileged relationship with the federal government [3]. Even those who are recognized by the federal government are not afforded the same access to health services that other citizens of the United States receive. 

The IHS and the funding for healthcare for the rest of the citizens of the United States is fundamentally different. The IHS receives the majority of its funding designated under the category of “discretionary spending” in the federal budget unlike medicare, another federally-funded health plan, which is categorized as mandatory spending [4]. This categorization opens the door for lack-luster appropriations being allocated to the Indian Health Service. The documentary Don’t Get Sick After June describes this very problem. The funding for the IHS begins on the first day of the fiscal year, the first day of October, however due to the inadequacy of funding that the IHS is given, it is financially unable to provide adequate funds to health care institutions on tribal land throughout the entire fiscal year, particularly as funding for the IHS predictably runs out in June year after year [5]. The IHS on average only has 59 percent of its annual appropriations met and in 2013, IHS per capita spending for individuals was $2,849 compared to $7,717 nationally [6]. 

In addition to the inadequacy of the funding for the IHS, the impacts of settler colonialism continue to have profound health impacts on indigenous peoples. Colonialism not only devastated and displaced indigenous communities, but broke down systems of community health such as access to traditional food sources, clean water, and land [7]. These systems of community based care dependent on the lands in which indigenous peoples were living, and the traditional practices that were tied to these lands, were replaced with systems such as the IHS. Some of the ways these impacts manifest themselves is the presence of higher mortality rates for alcoholism, which is over five times that of the national average, diabetes, which is almost double the mortality rate of the average population, cervical cancer, and maternal deaths [6]. Food insecurity also plays a large role in the disproportionate prevalence of disease and illness such as diabetes. In fact, over a quarter of the indigenous population experiences food insecurity and food deserts are common on reservations [8]. These food deserts leave people to turn to unhealthy options simply out of necessity, which in combination with the inadequate funding of the IHS, leaves people living in these areas unable to improve their health conditions. 

Clearly, discrepancies are nested in the underfunding and inadequacy of the IHS, but they are also nested within the structures and conditions within which indigenous peoples currently live. While it seems to have been easy for the United States to turn a blind eye from the needs of the indigenous peoples who live within its borders, it is clear that with regard to the health of these populations, it is carrying out gross bioethical wrongs. One of the principles of bioethics is justice, which is based upon the equal distribution of care to all groups in a society, and that a caretaker must respect and act in accordance with rights and obligations [9]. Another aspect of the justice principle of bioethics is that rights and obligations must be met, which in this case includes following through with stipulations from centuries ago that formed the basis of the “doctrine of trust.”

It would take immense structural change to correct for the health discrepancies in indigenous communities – much more than simply increasing funding for the IHS, but it may be a good place to start. Increasing funding would allow for more consistent care to be provided to these communities and could help to slow the rate at which native peoples are succumbing to disease and illness. Providing more access to food would be another way in which the health of this group of people could be improved. Broad, comprehensive investments into the health and wellbeing of these communities could go a long way, and would be a small step in the right direction on the way to correcting the federal government’s ethical wrongs. 

References

1. "If you knew the conditions..." Health Care to Native Americans: Indian Health Service Today. (2010, November 23). U.S. National Library of Medicine. https://www.nlm.nih.gov/exhibition/if_you_knew/ifyouknew_09.html#:~:text=The%20Indian%20Health%20Service%20. 

2. Basis for Health Services. Indian Health Service. (n.d.). U.S. Department of Health and Human Services. https://www.ihs.gov/newsroom/factsheets/basisforhealthservices/. 

3. 1953 to 1969: Policy of Termination and Relocation (n.d.). Stanford Medicine. https://geriatrics.stanford.edu/ethnomed/american_indian/learning_activities/learning_1/termination_relocation.html. 

4. Heisler, E. J. (2022) Indian Health Service (IHS) FY2022 Budget Request and Funding History: In Brief (CRS Report No. R47004). https://crsreports.congress.gov/product/pdf/R/R47004#:~:text=117%2D58.

5. Ritchie, C. (Director). (2010). Don’t Get Sick After June: American Indian Healthcare [Film]. Rich-Heape Films, Inc. 

6. National Congress of American Indians. (2016). Health Care: Reducing Disparities in the Federal Health Care Budget. https://www.ncai.org/policy-issues/tribal-governance/budget-and-approprations/07_FY2016_Health_NCAI_Budget.pdf. 

7. Jensen, A., & Lopez-Carmen, V. A. (2022) The “Elephants in the Room” in U.S. global health: Indigenous nations and white settler colonialism. PLOS Global Public Health. https://doi.org/10.1371/journal.pgph.0000719.

8. How Hunger Affects Native American Communities. (n.d.). Move for Hunger. https://moveforhunger.org/native-americans-food-insecure#:~:text=Overall%2C%20over%20a%20quarter%20of,of%20access%20to%20quality%20healthcare. 

9. What are the Basic Principles of Medical Ethics?. (n.d.). https://web.stanford.edu/class/siw198q/websites/reprotech/New%20Ways%20of%20Making%20Babies/EthicVoc.htm#:~:text=Bioethicists%20often%20refer%20to%20the,beneficence%2C%20and%20non%2Dmaleficence. 

Combatting Opioid-Related Deaths Ethically

According to the CDC during the 12-month period ending in April 2021, there were an estimated 100,306 drug overdose deaths in the United States, which is a 28.5% increase from the previous year (1). It has become clear that our current methods for addressing drug addiction are beyond insufficient, and we as a society have failed to recognize drug addiction for the medical condition that it is. Two solutions that have been highly debated, especially in terms of their ethicality, are needle exchange programs (NEPs) and safe injection sites. Based on the evidence from various studies and evaluations of various stances on these intervention methods, I will argue that these solutions are ethical because of the harm reduction they both provide. 

Drug addiction is a chronic disease in which an individual displays compulsive drug-seeking and drug-use behavior despite any harmful consequences. While many people initially use drugs voluntarily, the addictive aspect can quickly take effect. This development is marked by brain changes that disrupt an individual’s ability to exercise self-control, which produces behaviors commonly associated with addiction (2). Drug addiction is not a disease that discriminates; it can affect any person whether it is someone who was prescribed opioids after an invasive life-saving surgery and lost control because of the addictive nature of the medication, someone who was trying to self-medicate to withstand their mental illness, or someone who was just going to try doing drugs once at a party. There is no moral failure of those who develop drug addiction as it is a condition that alters the brains of those affected(3).  

Within the past year, 22% of males and 17% of females above age 18 participated in the use of illegal drugs or the misuse of prescription drugs in the US(4).  Furthermore, at any time there are 350,000 regular injection drug users in America all of which are at an increased risk of contracting blood-borne infectious diseases along with experiencing an overdose and various drug-related complications (5). When it comes to overdoses, over 70% of them involve some sort of opioid, whether that be prescription opioids, heroin, or synthetic opioids (like fentanyl)(6). Heroin users in particular are at a significantly higher risk of overdose because the opioid content and strength of the drug can widely vary, which means it is easy for individuals to not know how much they have taken (3). Another consequence of the opioid crisis is an increased rate of blood-borne infections including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), AIDS, and other bacterial and fungal infections (7). Thirty-five percent of AIDS infections in the US can be linked to injection drug use when mother-to-child HIV transmission is taken into account (5). These infections are primarily spread through drug use in unsanitary conditions and the sharing of injection drug equipment (7).

One way of addressing this epidemic is through needle exchange programs (NEPs).  NEPs are community-based programs created with the goal of reaching drug users, specifically intravenous drug users, to reduce a variety of risks. These programs allow for the safe disposal of used syringes and needles, dispense sterile needles and syringes, and provide other services such as referral to treatment, education about overdose prevention, wound care, and so much more (8).  In the United States, there are approximately 185 NEPs in operation in 38 states even though federal law prohibits the use of federal funds to support them (5). There are 3 primary arguments made by opponents of NEPs:  the availability of sterile drug paraphernalia would cause a rise in drug use and reduce public health, removing strong opposition and obstacles to drug use would be a corrupting influence on children; and allowing NEPs, especially through federal funding, would contradict the government's “war on drugs” by indirectly signaling governmental approval of drug use (9). 

However, these claims are highly refuted by a plethora of scientific evidence and those in support of NEPs. A study by the National Institute of Health (NIH) found that NEPs result in an estimated 80% reduction rate in risk behaviors among injection drug users (5). Furthermore, there is a decrease in blood-borne infectious disease transmission among injection drug users with the presence of NEPs (9). Around the country, NEPs have decreased the rate of transmission of HIV by between one-third and two-fifths. Not only do supporters of NEPS push back on the idea that these programs increase drug use,  but actually point ot the fact that NEP participants are about 5 times more likely to enter drug treatment services than those who had never used an exchange.(5). Finally, supporters of NEPs assert that NEPs can actually protect nonusers as well, like law enforcement officers and health care workers, by removing unsterile and potentially infected needles from rotation (9). 

To evaluate the ethicality of NEPs, we can consider the bioethical principles of beneficence and nonmaleficence. Beneficence means to do good and nonmaleficence means to do no harm (10). I believe that these principles are being met with the use of needle exchange programs because providing sterile equipment and allowing for the safe disposal of used needles reduces the harm to these addicted groups of people. This is especially the case when you consider that NEPs are not shown to increase the amount of drug use. The alternative to NEPs is that people already struggling with addiction will use unsanitary drug equipment without access to resources or education to deal with injury or overdose if they occur. We must frame addiction not as a choice or an action in need of punishment but instead as an addiction wrapped in some form of mental health issue. It is in the best interest of everyone that drug users are as safe as possible. For the moment, that means focusing on harm reduction by providing access to sterile equipment to reduce some of the negative impacts of drug use until there is a more concrete solution to address the root of drug use in America. 

An even more controversial approach to addressing the current risks experienced by those who struggle with drug addiction is safe injection sites. Safe injection sites are locations where individuals can bring their own drugs to use in the presence of trained staff without fear of receiving punishment. This setup helps to prevent accidental overdoses and the spread of infectious diseases like HIV (11). Ultimately, safe injection sites provide many of the benefits of NEPs but with the added benefit of monitoring individuals after they have used drugs in order to be able to respond to an overdose. Furthermore, it provides a safe space for people, especially vulnerable populations like women or LGBTQIA+ individuals, to take drugs without the danger of being taken advantage of while their inhibitions are lowered. These facilities are built on the principle of harm reduction, so they also provide resources to help connect those struggling with substance use disorder to treatment options and boxes of supplies (3). Boxes to reduce infectious diseases often include a variety of things like needle kits with sterile needles to reduce sharing, condoms for safe sex, bandages and topical treatments for infections and injuries, and even sometimes little sterile cups to freebase injectable drugs. Freebasing is when people boil the base form of a drug to increase potency. Safe injection sites also provide free Naloxone (overdose antidote) kits to users so that they can respond to an overdose themselves when not under supervision. It is important to note, however, that as federal law stands in the US, it is illegal for individuals to actually inject in safe injection sites. Instead, they must inject outside the building and then are welcome to come inside to be monitored (3). 

As drug-related deaths continue to rise, there is increasing consideration of amending the limitations put on safe injection sites in the US. This changing perspective can also be partially attributed to the fact that there are many examples of safe injection sites working effectively in other nations. Around the world, mainly in Europe, Canada, and Australia, there are over 100 supervised injection sites. A 2014 review of 75 studies about safe injection sites showed that they resulted in safer injection conditions and less outdoor drug use. Furthermore, there was no “honey pot effect,” meaning there was no increased drug use or crime surrounding safe injection sites. It is also significant to mention that there have been no reported deaths at a safe injection site and the fatal overdose rate has decreased in the areas surrounding safe injection sites (12). 

If we are able to recognize as a society that drug addiction is a medical disorder that requires treatment, then our methods of intervention should be centered on compassion and providing medical care. The question of this situation is whether it is better for those struggling with addiction to hide in shame, risking transmission of infectious diseases like HIV, or use in a monitored environment where they have access to treatment whenever they are ready (3). For those working in the field, their answer to the question is clear; the value of a non-judgemental supervised injection facility supersedes the unsubstantiated fears of increasing drug use and crime. As Darwin Fisher, the program coordinator of Insite, a safe injection site in Canada, said, "it's about making a space where drug users are allowed to feel like people (12)." One of the goals of providing healthcare to those struggling with disease (including addiction) is to humanize them and allow them to be defined by something more than their disease. 

It is important to reform our mentality as a society when it comes to drug use and addiction. For far too long, drug use has been painted as a crime that deserves punishment instead of the health issue that it is. As we would handle any other health issue, it is important to prioritize the safest route to treatment,  and at the moment safe injection sites and needle exchange programs are those solutions. Humans have a long history of separating from, condemning, and excluding people who are sick and appear to not be healthy out of self-preservation. However, when we overcome that gut response and care for those struggling, health outcomes increase significantly. Especially because addiction is not a disease that is transmissible, caring for those struggling with addiction is not putting ourselves at risk it is society's duty. While treatment is an important aspect of combating drug addiction, there needs to be intervention focused on harm reduction in the meantime until addicted individuals are ready to seek medical treatment. The response to drug addiction and the opioid crisis should be rooted in compassion and focused on the health of those struggling, not our own preconceived notions and fear of disease. 


Work Cited

1. Centers for Disease Control and Prevention. (2021, November 17). Drug Overdose Deaths in the U.S. Top 100,000 Annually. Www.cdc.gov. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm

2. ‌National Institute on Drug Abuse. (2018, June 6). Understanding drug use and addiction drug facts. National Institute on Drug Abuse. https://nida.nih.gov/publications/drugfacts/understanding-drug-use-addiction

3. MD, S. W. (2017, June 2). Safe injection sites and reducing the stigma of addiction. Harvard Health Blog. https://www.health.harvard.edu/blog/safe-injection-sites-reducing-stigma-addiction-2017060211826

4. National Center for Drug Abuse Statistics. (2019). NCDAS: Substance abuse and addiction statistics [2020]. National Center for Drug Abuse Statistics; National Center for Drug Abuse Statistics. https://drugabusestatistics.org/

5. Needle Exchange Programs Promote Public Safety. (n.d.). American Civil Liberties Union. Retrieved February 15, 2023, from https://www.aclu.org/fact-sheet/needle-exchange-programs-promote-public-safety#:~:text=Needle%20Exchange%20Programs%20Promote%20Public%20Safety%3A%20A%20study

6. CDC. (2019, September 4). America’s Drug Overdose Epidemic - Data to Action. Centers for Disease Control and Prevention. https://www.cdc.gov/injury/features/prescription-drug-overdose/index.html

7. Centers for Disease Control and Prevention. (2019). Persons Who Inject Drugs (PWID). Cdc.gov. https://www.cdc.gov/pwid/index.html

8. Center for Disease Control and Prevention. (2019, May 23). Syringe Services Programs (SSPs) FAQs. Www.cdc.gov. https://www.cdc.gov/ssp/syringe-services-programs-faq.html

9. Needle Exchange Programs Promote Public Safety. (n.d.). American Civil Liberties Union. Retrieved February 15, 2023, from https://www.aclu.org/fact-sheet/needle-exchange-programs-promote-public-safety#:~:text=Needle%20Exchange%20Programs%20Promote%20Public%20Safety%3A%20A%20study

10. Burks, D. (n.d.). Beauchamp and Childress The Four Principles. https://www.uc.edu/content/dam/refresh/cont-ed-62/olli/22-winter/bioethics%20four%20principles.pdf

11. Health Canada. (2017). Supervised consumption sites explained - Canada.ca. Canada.ca. https://www.canada.ca/en/health-canada/services/substance-use/supervised-consumption-sites/explained.html

12. GORDON, E. (2018, September 7). NPR Choice page. Npr.org. https://www.npr.org/sections/health-shots/2018/09/07/645609248/whats-the-evidence-that-supervised-drug-injection-sites-save-lives

Assessing the Ethicality of Unilateral DNR Orders in Covid-19 Patients

Most people have heard of the “trolley problem”– a thought experiment commonly discussed in ethics. In this fictional scenario, a trolley track splits into two paths. In the direction it is headed, the trolley would fatally hit five people; in the other direction, it would only hit one. It presents a few questions– is it morally permissible to redirect the trolley to take one in place of five lives? How can you determine who is allowed to live or die? Although this is just a hypothetical thought experiment, it’s a concept healthcare workers actually faced during the Covid-19 pandemic in 2020. 

A ‘code blue’ means a patient has gone into cardiopulmonary arrest, and anywhere from eight to 30 people immediately respond [1]. They must rush into the room, performing a variety of procedures that are critical to saving the life of the patient. As there is a positive correlation between Covid-19 cases in a community and cardiac arrests, this intensive ‘code’ became frequent in 2020 [2]. However, as an ICU physician in the Midwest said, “[a ‘code blue’ is] extremely dangerous in terms of infection risk because it involves multiple bodily fluids” [1]. These life-saving measures ultimately place a lot of healthcare providers at risk if the patient has infections or illnesses, especially Covid-19. 

Not only were exposures to Covid-19 especially deadly and dangerous in early 2020 due to the lack of a vaccine, but personal protective equipment (PPE) shortages also posed an additional danger. As the number of masks, gowns, and gloves dwindled in hospitals, it became apparent that the risk to staff “may be too great to justify the conventional response” for a code blue [1]. This idea poses an ethical question relating to the trolley problem- is it worth it to resuscitate one Covid-19 infected patient to save their life if it places many more healthcare providers in danger? If not, is it ethical for a do-not-resuscitate (DNR) order to be unilateral–without the permission of the patient or their decision-maker?

Healthcare providers are bound by oath to do everything in their power to save a patient’s life with modern technology, unless patients have previously discussed and decided on a DNR order [1]. However, as Covid-19 cases began to rise and the availability of PPE lessened, there were emergency measures implemented in hospitals. These had the power, in some cases, to completely halt certain procedures from being performed on Covid-positive patients [1]. For example, Northwestern Memorial Hospital in Chicago discussed a DNR policy for infected patients that was unilateral– it didn’t matter what the patient or their family members wished for [1]. Other large hospital systems like Atrium Health in the Carolinas chose to address coronavirus patients on a case-by-case basis, but still looked at policies allowing doctors to make unilateral decisions [1]. In 2020, all Covid-19 patients were placed on DNR status at hospitals in New York and New Jersey [3]. Ultimately, these measures and policies were formed to save and prioritize the lives of many over the one – but can this be ethically justified?

Robin Alta Charo, a bioethicist at the University of Wisconsin-Madison, justifies  the DNR unilateral order by calling it “pragmatic” [1]. Despite describing the idea of withholding treatment as “unsettling,” Charo defends his stance, saying “it doesn’t help anybody if our doctors and nurses are… not able to care for us,” and that the code process is one that puts them “at an enhanced risk” [1]. 

Additionally, it’s important to note that the possibility of discharging an ICU patient after using CPR on them is about 17% [3]. Moreover, CPR is only effective within the first 4 to 7 minutes of cardiopulmonary arrest, so it’s likely that providers either will run out of time before reaching the patient or lack crucial PPE [3]. Furthermore, most patients who have been successfully resuscitated will require a ventilator, further contributing to the scarcity of resources in hospitals during the pandemic and potentially taking these resources away from patients with a better chance of recovery [3]. Patients with other conditions or those who require surgery might also suffer as a result of limited resources like ICU beds and ventilators. For example, in Northern Italy, about 50% of beds in the hospital were occupied by Covid-19 patients, leaving minimal spots left for other patients seeking help [3]. As a result, non-Covid patients suffered greatly. Within this population, there was a sudden drop in the amount of times they visited the emergency department or were hospitalized during the lockdown period [4]. Concurrently, there was an increase in out-of-hospital mortality for these non-Covid patients – mainly driven by deaths for neoplasms, cardiovascular, and endocrine diseases [4]. This reveals how overcrowded hospitals and dwindling resources made it difficult for non-Covid patients to receive potentially life-saving care.

Despite the practical reasons to support the implementation of unilateral DNR orders, there are still many ethical aspects that complicate these policies. Refusing CPR and allowing a patient to die – while knowing something could have been done – is very difficult for a physician to grapple with. Physicians have historically faced high rates of depression, burnout, suicide, but studies have shown that the pandemic has worsened these issues. In fact, physicians of Covid-19 hospitals were shown to be “more severely depressed, stressed, and anxious than physicians of non-Covid-19 hospitals” [5]. Forcing physicians to determine whether a patient should live or die could easily compound these existing issues. 

Additionally, unilateral DNR orders seem to “violate the principle of autonomy, which honors the patients’ preferences and wishes regarding any decision for their medical care” [3]. As the different forms of consent are already discussed and learned by all healthcare providers, bypassing consent completely is radical and potentially unethical. Lastly, bioethicist Scott Halpern at the University of Pennsylvania said that a “blanket stop to resuscitations for infected patients is too ‘draconian’ and may end up sacrificing a young person who is in otherwise good health” [1]. This is why it is important for healthcare providers to look at individuals on a case-by-case basis, taking into factors such as age and pre-existing health conditions. However, these factors – potentially including race, age, gender, etc. – are subject to plenty of implicit bias, meaning that a physician’s unconscious feelings toward a certain patient could determine whether they live or die.

Although unilateral DNR orders might seem unethical and radical at first, it’s important to look at not only what is best for the patient, but what is best for the healthcare providers and society at large. Resuscitating a Covid-19 patient, even with full personal protective equipment, is not going to be successful most of the time and patients often do not fully recover. Moreover, it exposes a large number of healthcare workers – who are critical to the health and safety of many other patients – to illness and infection.

A pandemic like Covid-19 is unpredictable and dangerous, and its implications are difficult to address. In these unideal conditions, some people are bound to “lose.” This brings us back to the original trolley hypothetical – is it ethical to not resuscitate a patient, essentially directing the trolley at them, in order to protect more healthcare workers? There is truly not one right answer, and it’s also deeply affected by the case’s circumstances. Does this situation ethically change if the patient is a small child or 90-year-old? What if it were your loved one? This “back-and-forth” is just a glimpse into the moral and ethical battles that hospitals, healthcare workers, and patients have been facing during the Covid-19 pandemic. This understanding can hopefully result in more grace and empathy for the job they have done.

References

1. Cha, A. E. (2020, March 26). Hospitals consider universal do-not-resuscitate orders for coronavirus patients. The Washington Post. Retrieved February 8, 2023, from https://www.washingtonpost.com/health/2020/03/25/coronavirus-patients-do-not-resucitate/ 

2. Bharmal, M., DiGrande, K., Patel, A., Shavelle, D. M., & Bosson, N. (2022, August). Impact of coronavirus disease 2019 pandemic on cardiac arrest and emergency care. Cardiology Clinics. Retrieved February 25, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8960232/ 

3. Sultan, H., Mansour, R., Shamieh, O., Al-Tabba', A., & Al-Hussaini, M. (2021, May 12). DNR and Covid-19: The ethical dilemma and suggested solutions. Frontiers in public health. Retrieved February 8, 2023, from https://www.ncbi.nlm.nih.gov /pmc/articles/PMC8149588/

4. Santi, L., Golinelli, D., Tampieri, A., Farina, G., Greco, M., Rosa, S., Beleffi, M., Biavati, B., Campinoti, F., Guerrini, S., Ferrari, R., Rucci, P., Fantini, M. P., & Giostra, F. (2021, March 22). Non-covid-19 patients in times of pandemic: Emergency department visits, hospitalizations and cause-specific mortality in northern Italy. PloS one. Retrieved February 25, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984614/ 

5. Rahman, A., Deeba, F., Akhter, S., Bashar, F., Nomani, D., Koot, J., Koly, K. N., Salah, F. B., Haverlag, K., & Anwar, I. (2021, December 9). Mental health condition of physicians working frontline with COVID-19 patients in Bangladesh. BMC Psychiatry. Retrieved February 25, 2023, from https://bmcpsychiatry.biomedcentral. com/articles/10.1186/s12888-021-03629-w 

HeLa Cells: The Dark, Exploitative Side of Biomedical Research

From vaccines to disease treatments, behind each successful medical breakthrough is a complex research process that ensures the administration of new medical practices will be effective. At the heart of medical research is the need to test on a model that mimics the subject of interest. For humans, this may take the form of computer simulations, animals with similar biological mechanisms, human samples, and eventually, actual humans. Out of the options, human testing inevitably is the most effective in the development of medical practices, yet it carries one major caveat: the possibility of harm to a subject. The number of outcomes that can result from implementing a new medical practice is why human testing requires heavy amounts of consent screening, but the issue is that if human consent was required at each part of the research process, the rate of medical breakthroughs would be substantially hindered. Humans wouldn’t be able to overcome breakdowns in health if not for the ongoing and efficient process of research and much of this originates from the ability to test on cell lines outside of the human body. 

To avoid the need and risk of constantly testing on human subjects, medical researchers use laboratory-grown human cells to study cellular processes outside of humans. These cell lines require two main elements. First, they must be the same throughout experiments to enable scientific reproducibility or the ability of different scientists to replicate other research. For the cell lines to be the same, it also requires a cell line to grow indefinitely so it can be used universally Fortunately, the HeLA cell line exists to fit these requirements and has enabled researchers to achieve a number of successes such as the polio vaccine, drug development for HIV/AIDS, and furthering of cell research technology. 

HeLa cells were the first line of “immortal cells” that could multiply continuously, and therefore be studied infinitely by researchers, even today. Immortal cells are defined as those with the ability to divide and create new cells without dying. This differs from all of the body’s normal cells that experience aging to where cells will eventually die at varying times depending on the cell [1]. Prior to the early 1950s, researchers had attempted to grow human cell lines but encountered little success as the cells could not sustain themselves and divide for more than a few weeks [2]. This made the development of HeLa cells even more revolutionary for medical research, but because they are human cells, their origin becomes an apparent issue when evaluating the ethics of HeLa cells. 

The root of HeLa cells are written in the name, as HeLa is abbreviated from the first two letters of the full name Henrietta Lacks. Henrietta Lacks was a 31 year old Black woman being treated for cervical cancer, and while receiving treatment a biopsy sample of her cells was secretly taken and studied by Dr. George Gey without her consent. At the time, John Hopkins Hospital was a part of the few hospitals that would treat poor African-Americans, but the large disadvantage was that biospecimen exploitation increased due to the prevalence of racial prejudice at the time [3]. Regardless of the treatment she received, Lacks passed away in 1951. After, Dr. Gey discovered her cells could multiply and live infinitely, establishing a timeless line of cells that could be used for a variety of research purposes [4]. For the research field, this was a massive breakthrough and significantly convenient, yet for the Lacks family, the repercussions demonstrate the great hazard of uninformed consent. 

While John Hopkins claims that they had not profited from HeLa cells, this doesn’t mean that her unethically sourced cells haven’t been used in a capitalistic manner [5]. Since discovery, HeLa cells have initiated the multimillion dollar industry of producing and selling cell lines. One vial of HeLA cells can sell for just over $2000 [6]. The one-sided nature of the HeLa cell business becomes clear when the financial situation of the Lacks family is considered. While HeLa cells were passed around within research communities, the Lacks family lived in poverty and could not afford basic health insurance. Compensation for Henrietta’s cells never came to the family, and it wasn’t until 1971 where the family began to somewhat understand what Henrietta’s cells were truly being used for [6]. Only recently has the family received a say in how the cells are used such as approving researchers’ full access to Henrietta’s genome data [7]. However, the usage of HeLa cells and lack of compensation for the Lacks family is still ongoing as the Lacks estate filed a lawsuit against ThermoFisher Scientific Inc. in October 2021 for continuing to commercialize HeLa cells [8]. The contrast between the benefits of scientific discovery and dark origins of HeLa cells bring upon ethical questions if utilitarianism should be used and accepted in the case of consent of human samples. 

The idea of “utilitarianism” focuses on the idea that ultimately the “greater good” is worth more at the expense of few individuals. Though revolutionary medical achievements have been made with the use of HeLa cells, her case brings the problem of uninformed consent and the power that researchers have over their patients if used wrongfully. Even if the world benefits, we cannot deem this type of behavior acceptable because it allows much more complicated issues to arise. For example, biobanks are storage facilities that contain human biological material used in medical research, and generally, do not receive enough samples because patients do not willingly donate their genetic material often. However, this does not stop the collection of human samples for biobanks due to lack of regulations [9]. Not only does this mean that those in higher power are using the resources of others for their own personal gain, but the other danger behind this is the leaking of confidential, important genetic information for several individuals. DNA is what makes each human distinguishable from the other, yet giving the wrong person with malicious intent this information can make legal matters extremely difficult. 

The same matter has plagued the debate over publicly publishing patient genome sequences for research. Genetic information can affect someone’s ability to access financial backing, certain educational opportunities, or even eligibility for adoption. For instance, in cases of finance, access to genetic information may cause insurance companies to underwrite individuals as genetic information can suggest an individual’s future health prospects. The same applies to other circumstances where having an idea of someone’s genetic information can be easily exploited. Because genetic material defines each person’s identity, some of the worst possibilities public genetic material can open is the opportunity of identity theft and appropriation of people of color such as in Lacks’ case. The repercussions of uninformed consent for the broad outlook of society are simply much greater than the “good” of curing several diseases. Though, the root of the problem is from regulation of biospecimens, as it is not only Lacks who has fallen victim to the greed of the medical research industry. When the government ignores this behavior, they are indirectly allowing injustice to manifest itself in the system. Legally, the situation that allowed doctors to take Lacks’ cell line today can still occur. 

As of now, the only effective regulation on collection of biospecimens and consent is for when live samples are specifically being used for research initially. For this, the patient must consent and a plethora of processes, such as IRB (Institutional Review Board) oversight, are required before researchers can go forth with their project. However, if biospecimens were already collected for a different initial use such as treatment in medicine, they can be used for research without consent [10]. The reason this is possible is that specimens can only be used if they cannot be tied to the original patient, but there is no guarantee how regulated the anonymity of a patient is at that stage of biospecimen collection. If a researcher wanted to know the origin of a biospecimen, loopholes from loose regulation may allow for exploitation of someone’s genetic information. This brings upon several issues and puts those with diseases or cancer at risk for falling to the same exploitative fate as Henrietta Lacks. 

The most urgent change in this matter is making policy changes that require patient consent when any biospecimen is required, regardless of use. Even more IRB review could be used to ensure that the biospecimens are used in a manner not only approved by the patient but in a way that can benefit the patient. It is worthwhile to mention how certain regulations may slow the research process down, yet if proper communication is employed between the researcher and patient, projects can be carried out without much delay [11]. 

Cells make up the entirety of our identity, and to buy and sell that portion without compensation is beyond the ethical standards we should have. It is our priority to ensure those who can regulate this process—the government and other leaders—act more to protect patients in lieu of researchers. There is no need to place the overbearing desire to satiate the undying curiosity of researchers at the expense of humanity.

References

(1) Freeman, Shanna. "How HeLa Cells Work" 10 September 2012. HowStuffWorks.com. <http://science.howstuffworks.com/life/cellular-microscopic/hela-cell.htm> 21 December 2014. 

(2) Nott, Rohini, "HeLa Cell Line". Embryo Project Encyclopedia (2020-09-18). ISSN: 1940-5030 http://embryo.asu.edu/handle/10776/13166. 

(3) Butanis, Benjamin. “Role of the Johns Hopkins Hospital: Johns Hopkins Medicine.” Role of The Johns Hopkins Hospital | Johns Hopkins Medicine, 18 Feb. 2022, 

https://www.hopkinsmedicine.org/henriettalacks/role-of-the-johns-hopkins-hospital.html.

(4) Pratt, Elizabeth, "The Medical Ethics of HeLa Cells (2020-2021)" (2020). Research Inquiry. 4.https://digitalcommons.cortland.edu/rhetdragonsresearchinquiry/4 

(5) Butanis, Benjamin. “The Legacy of Henrietta Lacks.” Johns Hopkins Medicine, Based in Baltimore, Maryland, 18 Feb. 2022, https://www.hopkinsmedicine.org/henriettalacks/.

(6) “T-Rex™-Hela Cell Line.” Thermo Fisher Scientific - US, 

https://www.thermofisher.com/order/catalog/product/R71407?SID=srch-srp-R71407#/R71 407?SID=srch-srp-R71407. 

(7) Biography.com Editors. “Henrietta Lacks Biography.” Biography.com, A&E Networks Television, 

https://www.biography.com/history-culture/henrietta-lacks#:~:text=The%20Lacks%20family %20learned%20about,genetic%20information%2C%20were%20largely%20ignored.

(8) “NIH, Lacks Family Reach Understanding to Share Genomic Data of Hela Cells.” National Institutes of Health, U.S. Department of Health and Human Services, 15 Sept. 2015, https://www.nih.gov/news-events/news-releases/nih-lacks-family-reach-understanding-share-g enomic-data-hela-cells. 

(9) Press, The Associated. “Henrietta Lacks' Estate Sued a Company Saying It Used Her 'Stolen' Cells for Research.” NPR, NPR, 5 Oct. 2021, 

https://www.npr.org/2021/10/04/1043219867/henrietta-lacks-estate-sued-stolen-cells.

(10) Nisbet, Matthew C., and Declan Fahy. “Bioethics in Popular Science: Evaluating the Media Impact of The Immortal Life of Henrietta Lacks on the Biobank Debate.” BMC Medical Ethics, vol. 14, Feb. 2013, p. 10. EBSCOhost, doi:10.1186/1472-6939-14-10. 

(11) “Informed Consent.” BBRB, https://biospecimens.cancer.gov/bestpractices/elp/ic.asp. (12) Tomas Klingstrom, Erik Bongcam-Rudloff, Jane Reichel, Legal & ethical compliance when sharing biospecimen, Briefings in Functional Genomics, Volume 17, Issue 1, January 2018, Pages 1–7, https://doi.org/10.1093/bfgp/elx008.

Company Fertility Benefits Provide New Frontier of Reproductive Freedom

For 31-year-old Christine Carroll, after three years of infertility, it was time for her to begin her IVF journey with her husband Chris. After being told a single round of IVF cost $22,000 to $30,000, she also learned her employer covered up to three rounds. To her, this provided her with a unique opportunity to have peace of mind over her professional and family goals—in addition to relieving the financial pressures that accompany fertility treatments [1]. 

In recent years there has been growing popularity incorporating fertility benefits into company insurance coverage. This includes companies like Apple, Google, Facebook and other giants that cover over $20,000 worth of services to support their employees fertility and familial goals [2]. As of 2021, over 800 companies are now offering fertility benefits—and the number is only growing [3]. Fertility benefits include egg freezing, IVF treatments, and more. For Amazon employees, they are given access to over 900 physicians and fertility specialists—going beyond just covering the cost of care and allowing them the flexibility to choose their provider [4]. Now 59% of women say they would choose an employer that had fertility benefits over one that doesn’t [2]. Therefore, this new initiative not only supports women, but also allows for company expansion and popularity. 

Egg freezing begins with removing eggs and freezing them to be used at a later time, which are then fertilized and implanted back into the uterus through IVF [5]. IVF begins with the fertilization of a mature egg from the donor with a sperm. This fertilized egg is then transferred into the uterus where it implants to become an embryo. This allows heterosexual parents to both use their sperm and eggs, and for single or same-sex individuals to use a sperm donor. IVF decreases chances of miscarriages and genetic abnormalities through screening before implantation, but also increases the chances of twin or multiple pregnancies [6]. 

Both IVF and egg freezing allows people with female reproductive systems to take control of their own fertility by choosing when they get pregnant. This keeps them from being pressured by a ‘biological clock’ to begin a family. Without being concerned about a time limit for reproduction, they get more time for interests outside of having a family, such as a career, travel or hobbies. Therefore, they can dictate the trajectory of their lives and lifestyles free from the biological restrictions of reproduction and age. 

This biological factor heavily intertwines with social value, which expands with reproductive technology access. It is still difficult for women to reconcile ideals of family, while also being valued and supported in the workplace. With less fertility support, women might be pressured to work more to support themselves and may be unable to cut out time for family planning. Additionally, women without these opportunities may end up having children anyways and be stretched thin between work and trying to provide which can exacerbate financial stressors. There is a social constraint where those who do choose to have children may not experience motherhood as a real choice, and may be lacking in other opportunities for personal or professional development [7]. Alternatively, they may feel resentment as a result of having to make a ‘sacrifice’ to have a family instead of a career. This is a binary that has made women feel that they have a ‘duty’ to have children instead of prioritizing their own growth and values. This continues to place women within the rigidity of motherhood, while giving value to them only if they choose to have children. Providing these benefits begins to dismantle these social norms by expanding the flexibility of women to choose themselves, but also a family—removing their mutual exclusivity. 

Another perspective on providing these benefits would be its ability to reinforce the biological role of women by encouraging them to take advantage of IVF and other reproductive resources. There was initial concern for having to spend more money on fertility benefits, however, companies have actually decreased their spending. This is because otherwise, women doing fertility treatments would be taking paid leave—costing the company time and money [8]. Beyond this, if a patient does out of pocket IVF they may be more inclined to ask the physician to increase embryo transfer numbers, compromising their own safety and leading to more sick time taken. Therefore, with the prioritization of family planning for top companies, women’s safety and company time are both improved. 

Providing IVF support is not only a step forward in not forcing women to choose between career and family goals, but also supports LGBTQ+ individuals in having biological children. One way IVF and egg freezing allows for LGBTQ+ couples to have their own children is reciprocal IVF—having one partner donate an egg while the other acts as a gestational surrogate [2]. LGBTQ+ access to these technologies breaks down the restrictive nuclear family that often excludes and diminishes the role of same-sex parents. This expands how we view and define the parenting process, allowing each individual to take part in different aspects of the birthing process. Companies improving access to these technologies for LBGTQ+ couples legitimizes and validates their identity, while allowing partners to feel equal in the creation of a child. 

However, there continue to be ethical challenges to fertility treatments. One of the major questions regarding IVF and egg freezing treatments is the upper age limit. With women having the ability to have children older, even with a healthy pregnancy they may have an increased risk of disease or death that could hinder their ability to parent [9]. Furthermore, fetal and maternal safety—particularly for high-risk twin pregnancies that often result from IVF—may be in jeopardy as age increases. Lastly, if women are using donated eggs, there is concern for older women being prioritized over younger women struggling with infertility who may have a better chance of a successful pregnancy. Therefore, these companies would be inadvertently encouraging more dangerous or high-risk pregnancies to jeopardize the safety of the woman and the child, in addition to decreasing resource allocation to younger women. This brings into question who exactly is considered valued in their role as a mother and if we should provide donor eggs to those who want them or those who have the best chance for viable pregnancies? This would be giving medical institutions the power to decide who is best suited for reproducing—not the mothers themselves. 

As a counter to this argument, I believe it boils down to creating a space for reproductive autonomy and allowing any woman at any time to choose how and when she wants a child. In order to prevent age being something that limits reproductive access, other factors should be considered in conjunction with age that are more valuable parameters including cardiovascular health, lifestyle, and drug and alcohol use. This would expand reproductive access to older women—without age being a limiting factor—while allowing for a more scientifically-accurate analysis that would assess the safety of assisted reproductive technologies. Despite this rationale, evaluation on lifestyle or biological traits may open up more room for bias—incorporating prejudice to profile individuals as ‘unfit’ parents based on assumptions related to race, drug use, and socioeconomic status. 

Another argument that questions these policies bring into question is who exactly gets access to them. For certain employees, their job status may not entitle them to these benefits, which ostracizes low-income individuals who may not have access to the quality education needed to qualify for these jobs at top companies. This provides overwhelming access to middle-class white individuals while overlooking the gaps at companies dominated by disadvantaged individuals such as fast food giants like McDonalds and Taco Bell. At McDonalds, 1 in 5 workers makes less than $10 an hour—putting them below the poverty line, forcing them to work more, with fewer benefits and less family planning flexibility [10]. 

Despite this, the move towards supporting women’s rights and choices is inspiring a new movement towards reproductive autonomy and equality in the workplace. This creates a huge step towards dismantling the binaries of gender roles and motherhood, while also improving the safety of the birthing process. However, as someone who is a woman entering into the high-intensity and rigid field of medicine, I acknowledge my bias in wanting more flexibility in family planning with holistic considerations beyond age. These are policies that would directly affect my ability to exercise my reproductive rights, while allowing me to pursue my career goals. A question I would pose is how one might question the motivations of companies to do this—do they want to just prioritize productivity, or women’s health? A last consideration could be how this might lead to the potential enticement of women to utilize artificial wombs or surrogacy to improve company productivity. Is this the beginning of a new feminist movement, or leading to an ever-worsening emphasis on capital gain?

Resources: 

1. MFoxCNBC. (2022, October 21). Employer fertility benefits have a dramatic and 

startling expansion amid the great resignation, experts say. CNBC. Retrieved February 25, 2023, from 

https://www.cnbc.com/2022/05/27/employer-fertility-benefits-are-on-the-rise-ami d-the-great-resignation.html 

2. Vinopal, C. (2022, March 3). Large employers remain the best hope for Women Seeking 

Fertility Benefits. Quartz. Retrieved February 25, 2023, from 

https://qz.com/work/2130224/more-us-companies-are-adding-ivf-and-egg-freezin g-to-their-insurance-plans 

3. FertilityIQ. (n.d.). 2021 fertilityiq workplace index. Retrieved February 25, 2023, from 

https://www.fertilityiq.com/topics/fertilityiq-data-and-notes/fertilityiq-workplace-i ndex 

4. Amazon.jobs. (n.d.). Benefits overview for US amazon employees (excluding CT, IL, in, 

MD, NC, PA, UT, & wi). Retrieved February 25, 2023, from 

https://www.amazon.jobs/en/landing_pages/benefitsoverview-us 

5. Mayo Foundation for Medical Education and Research. (2021, April 23). Egg freezing. 

Mayo Clinic. Retrieved February 25, 2023, from https://www.mayoclinic.org/tests-procedures/egg-freezing/about/pac-20384556

6. Mayo Foundation for Medical Education and Research. (2021, September 10). In vitro fertilization (IVF). Mayo Clinic. Retrieved February 25, 2023, from https://www.mayoclinic.org/tests-procedures/in-vitro-fertilization/about/pac-2038 4716

7. OLIVER, K. (2010). Motherhood, Sexuality, and Pregnant Embodiment: Twenty-Five Years of Gestation. Hypatia, 25(4), 760–777.  http://www.jstor.org/stable/40928655 

8. Homepage | resolve: The National Infertility Association. (n.d.). Retrieved February 25,

2023, from https://www.resolve.org/wp-content/uploads/2022/01/2021-Fertility-Survey-Repo rt-Final.pdf 

9. Asplund K. (2020). Use of in vitro fertilization-ethical issues. Upsala journal of medical sciences, 125(2), 192–199. https://doi.org/10.1080/03009734.2019.1684405 

10. Crosbie, J. (2022, April 19). America's biggest companies are systematically 

short-changing workers. Rolling Stone. Retrieved February 25, 2023, from https://www.rollingstone.com/politics/politics-news/dollar-tree-mcdonalds-low-w age-workers-1339928/

Cost or Benefit? The Ethical Dilemma of CRISPR for Sickle Cell

For Victoria Gray, a common cold used to send her into a panic of whether she’d end up in a hospital because of her sickle cell anemia she was diagnosed with as a baby. According to the Mayo Clinic, sickle cell anemia is an inherited disorder that impacts the shape of red blood cells that are responsible for the transport of oxygen throughout the body [1]. Gray has been given a life changing CRISPR gene editing treatment that alleviates the effects of the disease. Now, Gray is able to live her life without pain medication and late-night hospital visits—all because of this new technological development and study [2]. However, CRISPR may present unknown challenges, such as ethical concerns surrounding bodily autonomy, an emphasis on Western perspective, and the possibility of detrimental side effects such as other congenital illnesses if used in utero.    

There is currently no cure for the condition, instead just ways to manage symptoms. Those with sickle cell anemia experience severe episodes of pain called ‘pain crises,’ anemia, swelling of hands and feet, frequent infection, delayed growth, and problems with vision [1]. The severity of these symptoms creates a high demand for researching a cure—with 100,000 Americans’ health being compromised by the disease [3]. 

On a genetic level, sickle cell anemia results from a single point substitution, which CRISPR corrects with extreme precision depending on this specific mutation. [4]. CRISPR gene editing is now being explored as a solution to alleviate the symptoms of sickle cell anemia with the Nobel prize-winning ability to change, disrupt, delete, or correct regions of DNA [4]. 

Multiple studies performed by Vertex Pharmaceuticals Inc, in collaboration with CRISPR Therapeutics and Stanford Medicine, have made CRISPR able to be administered in a single injection. Stem cells, which are unique in their ability to differentiate into a variety of specialized cells, are taken up from the patient, edited with CRISPR technology, and then injected back into the patient to produce normal, functional cells. The mutation in sickle cell affects the shape of hemoglobin, which shuttles oxygen from the lungs to tissues, and can be restored to its functional state and wild type shape. The editing targets defective cells with the DNA sickle cell anemia mutation by cutting the defective DNA and delivering the correct amino acid to the sequence [5]. Vertex Pharmaceuticals Inc hopes to get this treatment approved by the FDA in late 2023 or 2024 [2]. 

This single-injection approach to CRISPR can provide a more cost-effective and accessible form of treatment for populations living in poverty as an alternative to expenses of pain management, blood transfusions and frequent hospitalizations. CRISPR can also replace the monthly infusions of donor red blood cells that, according to the Red Cross, utilize 16 million units of blood every year [6]. Infusions are not only painful, but reducing their frequency can alleviate the strain of recent blood shortages as a result of the coronavirus pandemic, with fewer blood donors now more than ever. Therefore, CRISPR technology can eventually lower costs for the healthcare expenditures that can be allocated to other research initiatives. 

CRISPR also provides hope for treatment both during and after pregnancy for sickle cell anemia. According to a paper published in the National Library of Medicine, other gene therapies like germline therapies prevent disease through CRISPR injection into eggs and sperm. However, germline therapies are unknown in how they impact fetal development. [7].    

When used in utero, one study published in the peer-reviewed medical journal Cell found that Cas9—the enzyme used to cut the DNA—can cause major chromosome loss [8]. This potential outcome could lead to symptoms and diseases worse than what the patient originally had –  which poses notable risk to those accepting treatment. If done in utero, this could lead to other congenital disorders [9] leading to the question of if the benefits of experimental treatment, like living pain free, is worth the potential risk of irreversible disability.   

In addition, researchers have a very poor understanding of how cells are affected by CRISPR technology. With CRISPR, although created with the intention to be precise, it is often unknown if the target mutation was effectively removed or edited. The types of repair mechanisms that are initiated with CRISPR are not always accurate to create other point mutations. Alternatively, CRISPR uses generic sequences to identify the target mutation. If these nucleotides are very common and can be found in other places of the genome, CRISPR may edit the wrong gene. 

With these potential dangers, the patient is not the only one to be considered when providing treatment. We must instead weigh the potential dangers of chromosome damage or loss on the quality of life of the multiple generations impacted by the treatment. Ultimately, CRISPR gives the fetus no choice in whether to accept the treatment, whereas CRISPR modifications made in adults allow the individual to express their bodily and medical autonomy. This brings into question the role of medicine and how it designates sovereignty. 

CRISPR also poses ethical concerns due to its ability to preferably pick one gene over another. The new term ‘CRISPR babies’ has developed from concerns for human gene-editing allowing for customized children. Instead of just addressing genetic diseases, many criticize the potential for genetically modifying children to skew the natural variation that comes with sexual reproduction for the ‘ideal,’ ‘healthy’ child. Definitions of health and ‘model children’ may create artificial selection driven by prejudice that unequally values different racial identities. When heterozygous, sickle cell anemia creates a natural resistance to malaria which is prevalent in warm climates, like Africa [10]. Just the treatment of sickle cell anemia based on Western ideas of ‘health’ may create an even larger health crisis and mismanagement of health resources for malaria in Africa. So, although CRISPR can improve well-being and reverse the effects of sickle cell anemia, if done in gestation, it could produce even more vulnerability in African populations. Curing sickle cell anemia may reduce this heterozygosity that presents advantages for survival which would make them more at risk for the deadly effects of malaria. Hence, will CRISPR be used to relieve the symptoms of individuals suffering from sickle-cell, or creating another cover for mismanaged and racialized healthcare? 

There are not only unknown risks on the biological level, but also the socal level for future disease applications. However, for the immediate future, this technology could present an exciting step forward for those who suffer and live in fear of viruses and simple discomforts the general population face. This technology—despite its many unknowns and risks—could act as a step in alleviating suffering of many health-compromised populations by providing an efficient, cost-effective treatment alternative.  

However, the remaining concerns of CRISPR technologies highlight the question: ‘to what extent should a technology be used to eliminate undesirable traits?’ Who will be deciding the ethical use and removal of these traits? Although CRISPR technologies hold the potential to address global diseases that wreak havoc on the economies and welfare of populations, they also prompt concern for their future abuse and potential side effects. Overall, CRISPR presents a massive leap in the world of gene editing that has the potential to provide relief by addressing the symptoms of sickle-cell. Humanity is now entering into a new frontier of technology where survival is not just of the fittest, but left up to the powerful effects of technology. 

References

1. Mayo Foundation for Medical Education and Research. (2022, March 9). Sickle cell anemia. 

Mayo Clinic. Retrieved March 28, 2022, from

https://www.mayoclinic.org/diseases-conditions/sickle-cell-anemia/symptoms-causes/syc-20355876

2. Stein, R. (2021, December 31). First sickle cell patient treated with CRISPR gene-editing still 

thriving. NPR. Retrieved March 28, 2022, from https://www.npr.org/sections/health-shots/2021/12/31/1067400512/first-sickle-cell-patient-treated-with-crispr-gene-editing-still-thriving

3. Centers for Disease Control and Prevention. (2020, December 16). Data & statistics on Sickle 

Cell Disease. Centers for Disease Control and Prevention. Retrieved March 28, 2022, from
https://www.cdc.gov/ncbddd/sicklecell/data.html

4. CRISPR/Cas9. CRISPR. (n.d.). CRISPR Therapeutics. Retrieved March 28, 2022, from
http://www.crisprtx.com/gene-editing/crispr-cas9

5. Stanford Medicine. (n.d.). CRISPR is a gene-editing tool that's revolutionary, though not 

without risk. Stanford Medicine. Retrieved March 28, 2022, from

https://stanmed.stanford.edu/2018winter/CRISPR-for-gene-editing-is-revolutionary-but-it-comes-with-risks.html

6. US Blood Supply Facts. Facts About Blood Supply In The U.S. | Red Cross Blood Services. 

(n.d.). Retrieved March 28, 2022, from https://www.redcrossblood.org/donate-blood/how-to-donate/how-blood-donations-help/blood-needs-blood-supply.html   

7. U.S. National Library of Medicine. (2022, March 1). What are the ethical issues surrounding 

gene therapy?: Medlineplus Genetics. MedlinePlus. Retrieved March 28, 2022, from
https://medlineplus.gov/genetics/understanding/therapy/ethics/ 

8. Allele-Specific Chromosome Removal after Cas9 Cleavage in Human Embryos. Cell .
(2020,October29). Retrieved March 28, 2022, from
https://www.cell.com/cell/fulltext/S0092-8674(20)31389-1  

9. Wu, K. J. (2020, October 31). CRISPR gene editing can cause unwanted changes in human 

embryos, study finds. The New York Times. Retrieved March 28, 2022, from
https://www.nytimes.com/2020/10/31/health/crispr-genetics-embryos.html

10. Parichy, D. (2022, November). Reverse genetics. [Presentation]. University of Virginia, Charlottesville, VA, United States.   

The Reopening of Schools in a Global Pandemic: An Ethical Exploration

On March 11, 2020, the World Health Organization (WHO) declared the coronavirus to be a public health emergency of international concern (PHEIC). Following the declaration, suspension of in-person classes occurred along with the implementation of various other social distancing measures. As coronavirus numbers have come down, a shift from virtual back to in-person education has been pushed. Different states and districts have approached the issue of reopening schools in a variety of ways, trying to balance both health and educational concerns. 

For students in K-12, each grade's material builds on each other, raising concerns about the effectiveness of virtual learning in preparing students for the future. According to the Nation’s Report Card, a congressionally mandated test overseen by the Department of Education, scores in reading, writing, and mathematics declined during the pandemic. Since 2019, the average math score for fourth graders dropped 5 points and the average score for eighth graders dropped 8 points. Both grades experienced a drop of 3 points in reading tests [1].

Peggy Carr, the commissioner for the National Center for Education Statistics, said that “[These scores] are the largest declines in mathematics that we have observed in the entire history of this assessment,” [1]. However, while scores dropped drastically in math, scores in reading and writing may have been less impacted since the student’s home environment often plays a larger role in developing these skills.

These trends are concerning; however, data is otherwise too limited to make the claim that virtual learning is solely responsible for declining test performances. Remote learning looks different from state to state, district to district, and family to family. Carr emphasizes that other factors often play a role in the quality of online learning students receive, such as an unstable home environment or limited access to the internet [1].

Virtual learning does impact, though, the student’s ability to connect with others, from friends to mentors, placing additional mental and emotional strain on the child and family. Over the last few years, a trend of worsening emotional health, increased stress, and a lack of peer connection has occurred along with increasing rates of drug overdose deaths, self-harm, and eating disorders [5]. These trends raise concerns about how social isolation during virtual learning may negatively impact students, especially for those who rely on schools for support and community they can’t find at home.

For example, for students with special needs, the abrupt transition to online learning meant many students lost essential instructional time [5]. For some LGBTQ students, the closing of schools cut them off from community and essential safe spaces. In a survey conducted by EdWeek Research Center asking students if they were experiencing more problems in school after the pandemic, 83 percent of LGBTQ teenagers said they were while only 69 percent of heterosexual high schoolers also said they were [4].  

With decreased social distancing, though, comes the concern of further COVID spreading and mutation, like we saw with Omicron last year. While not as lethal as other variants, Omicron’s high transmissibility made it possible for the virus to quickly infect entire units of people, like nursing staff, flight attendants, and teachers [3]. Data through July 28, 2022 shows there have been 14 million child COVID-19 cases, 19% of all cases, with pediatric hospitalizations peaking in January 2022 during the Omicron surge [5]. 

Another concern is the possibility for school openings to cause spreading among family units and older populations. One study attempted to analyze this potential phenomenon, but could not collect enough data to suggest whether or not school openings are associated with transmissions across different age groups [2]. The study did find, though, that teachers and their significant others in open schools had higher rates of COVID-19 infections than teachers and their partners in closed schools [2]. 

Despite the concerns surrounding academic test score declines, a variety of factors also influence the necessity of opening schools or continuing virtual education. Virtual learning varies from district to district and from home to home making the process of identifying flaws within the virtual model difficult. Virtual education does, though, place additional strain on already vulnerable students cutting them off from community and vital support services. While the concern about COVID is still very real, a holistic look at students and the role schools play in their lives is essential to understanding the unique demands the pandemic has placed on students and what they need next from their school administrators. 

References:

1. Camera, Lauren. (2022, Oct. 24). Pandemic Prompts Historic Decline in Student Achievement on Nation’s Report Card. U.S. News. https://www.usnews.com/news/education-news/articles/2022-10-24/pandemic-prompts-historic-decline-in-student-achievement-on-nations-report-card#:~:text=An%20overwhelming%20majority%20of%20states,of%20the%20impact%20of%20the

2. Chernozhukov, V., Kasahara, H., & Schrimpf, P. (2021). The Association of Opening K–12 schools with the spread of covid-19 in the United States: County-level panel data analysis. Proceedings of the National Academy of Sciences, 118(42). https://doi.org/10.1073/pnas.2103420118 

3. Powell, Alvin. (2022, Oct. 11). Is the pandemic finally over? We asked the experts. Harvard Gazette. https://news.harvard.edu/gazette/story/2022/10/is-pandemic-finally-over-we-asked-the-experts/

4. Will, M. (2022, January 31). When school goes remote, many LGBTQ students lose a safe space. Education Week. https://www.edweek.org/leadership/when-school-go-remote-many-lgbtq-students-lose-a-safe-space/2021/03#:~:text=With%20remote%20learning%2C%20he%20added,build%20to%20survive%2C%20frankly.%E2%80%9D 

5. Williams, Elizabeth, & Drake, Patrick. (2022, Aug. 05). Headed Back to School: A Look at the Ongoing Effects of COVID-19 on CHildren’s Health and Well Being. Kaiser Family Foundation. https://www.kff.org/coronavirus-covid-19/issue-brief/headed-back-to-school-a-look-at-the-ongoing-effects-of-covid-19-on-childrens-health-and-well-being/

CRISPR is Revolutionary – but at What Cost?

CRISPR, the groundbreaking gene-editing tool of the last decade, has permanently altered the field of genetics for the science world. The tool efficiently targets specific sequences of genetic code and has revolutionized studies on genomes of a plethora of organisms. CRISPR has played an especially vital role in tackling diseases as the technology enables replacing harmful DNA sequences with healthy ones. 

The first cell therapy study with CRISPR was conducted just in 2019 to treat Victoria Gray’s sickle cell disease symptoms.1 Sickle cell anemia is an inherited disease that results in the formation of crescent shaped blood cells.2 For the disease’s thousands of victims, these crescent shaped blood cells can inflict episodes of pain by blocking blood flow in the body. This can make normalcy for sickle cell patients extremely challenging and prompt those like Victoria Gray to turn to new methods such as CRISPR gene editing. 

Prior to the clinical trial with Gray, the only known cure for sickle cell was a bone marrow transplant, which is where the stem cells responsible for the faulty hemoglobin in sickle cell are found. This process involves killing the stem cells through chemotherapy and replacing them with healthy cells from a donor.3 The main issue with this solution is finding a donor, and the reason why researchers began to experiment with CRISPR as an alternate treatment. 

Scientists focused on using CRISPR to edit a fetal hemoglobin gene that would produce enough healthy cells to counter the defective sickle cells. After extracting and editing Gray’s cells with this process, scientists infused billions of modified stem cells back into her body. For patients such as Gray, CRISPR is life changing – she was able to resume her daily activities without the burden that sickle cell brought upon. However, for others, the outcome can be disheartening and even deadly. 

In October of 2022, 27-year old Terry Horgan passed away during a study testing similar gene editing techniques to Victoria Gray in hopes of curing his fatal condition of Duchenne muscular dystrophy. The muscle degeneration disease is caused by a gene mutation that prevents dystrophin, a protein important for holding muscles intact, from being produced properly. Researchers at the University of Massachusetts are unsure of the exact details of what caused the death, but considering methodology, speculation points toward CRISPR possibly playing a crucial role.4

Based on what examination finds in the next few months, Terry Horgan’s death may be a large setback in research and investments towards CRISPR gene editing. The situation bears resemblance to the death of Jesse Gelsinger in 1999, which heavily set back the field of gene therapy at the time. Similar to Horgan, Gelsinger volunteered to be a part of a clinical trial that involved new gene therapy methods. Gelsinger had ornithine transcarbamylase deficiency syndrome (OTCD) where ammonia builds up to lethal levels in the blood due to a damaged or missing transcarbamylase enzyme.5 To treat OTCD, researchers developed a harmless cold virus to contain working copies of the OTC gene, which would be injected into the patient and integrate the added gene through infection of cells. While the method caused mild side effects in other patients, the viral vector caused a fatal inflammatory response for Jesse Gelsinger and dismantled the field of gene therapy for its deadly risks.6 

After nearly two decades of research, gene therapy slowly overcame its controversy with new policies requiring researchers to be cautious with human subjects.7 However, gene therapy clinical deaths still occur from time to time.8For Horgan’s case, it has called attention to how CRISPR gene therapy methods are still extremely new – and both its other abilities and long term effects are unknown.9 As CRISPR evolves and develops to have new uses, an ignorance towards its capacity to affect the human genome can lead to only more tragic deaths. 

CRISPR’s unique ability to edit almost any part of the genome holds great power, and this is what can give rise to several ethical issues. In the same year of Gray’s successful CRISPR cell therapy treatment, Chinese scientist He Jiankui was sentenced to 3 years in prison for inserting genetically modified embryos unknowingly into two women seeking in-vito fertilization.10While he had positive intentions of absolving them of HIV, an immune disease with great danger towards its victims, it is a reminder that CRISPR puts researchers in potentially-concerning positions of control. 

The controversy surrounding the case arose from how the volunteers in the study were not fully informed of the genetic modification happening to the embryos, and while it made large strides forward in gene editing, this behavior should not be tolerated due to its unpredictable risk for future generations.11 Additionally, gene editing embryos can easily be exploited for nontherapeutic methods, posing questions of autonomy in light of CRISPR. The case raises questions of who should decide what genes must or should be edited. With the wrong mindset, the abilities of CRISPR can be warped into a modern form of eugenics, embodying the same intentions to remove “undesirable” qualities but with gene editing. 

Because of the intense disciplinary action taken in Jiankui’s instance, there has not been another gene editing scandal of that caliber, but this doesn’t mean it cannot happen again. The ethical issues of editing human embryos range from its future unknown effects for the subjects to unnatural creations of mankind. While CRISPR gene editing may seem like it can improve quality of life for an individual, it is nearly impossible to evaluate whether CRISPR could make a substantial impact. In the cases of Gray and Horgan, the risk of CRISPR is understandable as the gene editing methods were utilized to help eradicate diseases they sought treatment for. 

This differs from completely eliminating genes and other genetic material that are considered “undesirable,” which would fall under the HIV case with Jiankui. The eugenic mindset may sound harmless, but it is the same that led to forced sterilization and euthanization in WWII to artificially create the Aryan race Nazis desired.12 This method of complete eradication brings forth an ableist mindset that those with disabilities have nothing to contribute to society. However, those with disabilities are human and have equal rights to life and autonomy just as those without them. Additionally, they have redeemable lessons to share and add another level of diversity to civilization. Disabilities give us the ability to explore different perspectives that pave the way towards kindness, empathy, and generosity. These qualities are essential in ensuring our relationships as human beings to one another are respectable. Beyond modern eugenics, CRISPR can pose another problem, which are lines of social inequality. 

As research with genetic diseases and CRISPR progresses, a division between those who can afford the treatment and those who must suffer will begin to emerge. For example, to treat a child with spinal muscular atrophy, the cost of a single gene therapy treatment Novartis is upwards to 2 million without insurance.13 With insurance, the price of one treatment is reduced to $10,000, but the number is still extremely unaffordable for most families. Here, the responsibilities fall on companies to make these treatments more affordable or pose a risk of alienating those with disabilities further out from society. 

This is not to say that we should do without CRISPR gene therapy, but to recognize the broader health and social effects that exist as much is unknown about the tool. While CRISPR has been able to significantly alter the lives of those who suffer from genetic diseases, it has also been responsible for deaths and exploitation. 

We must continue to acknowledge that CRISPR is a privilege full of medical uncertainties. If examined thoughtfully and integrated into the medical field carefully, CRISPR possesses the capacity to cause incredible healing. If not, it may become another point of division – decisions made today that will influence all of our shared tomorrows. 

References: 

1. Stein, Rob. “First Sickle Cell Patient Treated with CRISPR Gene-Editing Still Thriving.” NPR, NPR, 31 Dec. 2021,  https://www.npr.org/sections/health-shots/2021/12/31/1067400512/first-sickle-cell-patient-treated-w ith-crispr-gene-editing-still-thriving. 

2. “What Is Sickle Cell Disease?” National Heart Lung and Blood Institute, U.S. Department of Health and Human Services, https://www.nhlbi.nih.gov/health/sickle-cell-disease. 

3. BeTheMatch.org. “Sickle Cell Disease (SCD) .” Be The Match, https://bethematch.org/patients-and-families/about-transplant/blood-cancers-and-diseases-treated-by-t ransplant/sickle-cell-disease--scd-/. 

4. Ungar, Laura. “Death in US Gene Therapy Study Sparks Search for Answers.” AP NEWS, Associated Press, 4 Nov. 2022, https://apnews.com/article/science-technology-health-business-genetics-79f4a9b76426ec40c367957e3 bb9cf4a. 

5. “Ornithine Transcarbamylase Deficiency.” MedlinePlus Genetics , U.S. National Library of Medicine, https://medlineplus.gov/genetics/condition/ornithine-transcarbamylase-deficiency/#causes.

6. Rinder, Meir. “The Death of Jesse Gelsinger, 20 Years Later.” Science History Institute, 16 July 2019, https://www.sciencehistory.org/distillations/the-death-of-jesse-gelsinger-20-years-later. 7. Savulescu, Julian. “Harm, Ethics Committees and the Gene Therapy Death.” Journal of Medical Ethics, Institute of Medical Ethics, 1 June 2001, https://jme.bmj.com/content/27/3/148. 

8. Liu, Angus. “2 Deaths after Novartis' Zolgensma Put Gene Therapy's Liver Safety in the Spotlight Once Again.” Fierce Pharma, 12 Aug. 2022, https://www.fiercepharma.com/pharma/two-deaths-after-novartis-zolgensma-bring-gene-therapys-liver -safety-spotlight-again. 

9. “The Gene Editor Crispr Won't Fully Fix Sick People Anytime Soon. Here's Why.” Science, https://www.science.org/content/article/gene-editor-crispr-won-t-fully-fix-sick-people-anytime-soon-h ere-s-why. 

10. “Chinese Scientist Who Produced Genetically Altered Babies Sentenced to 3 Years in Jail.” Science, https://www.science.org/content/article/chinese-scientist-who-produced-genetically-altered-babies-sent enced-3-years-jail. 

11. Lanphier, Edward, et al. “Don’t Edit the Human Germ Line.” Nature, vol. 519, no. 7544, 2015, pp. 410–411., https://doi.org/10.1038/519410a. 

12. “Eugenics .” United States Holocaust Memorial Museum, United States Holocaust Memorial Museum, https://encyclopedia.ushmm.org/content/en/article/eugenics. 

13. “Paying for CRISPR Cures: The Economics of Genetic Therapies.” Innovative Genomics Institute (IGI), 18 May 2022, https://innovativegenomics.org/news/paying-for-crispr-cures/.

China's Zero-Covid Policy in Shanghai: The Pandemic's Legacy

On one side of the world, citizens peer outside strictly quarantined homes to find closed shops, empty streets, and healthcare workers armed to the teeth in personal protective equipment. On the other hand, it is almost business as usual. The way the United States has experienced and managed the COVID-19 pandemic vastly differs from China. In the U.S. today, vaccination clinics, hybrid classes, and non-mandatory masking have permanently altered the country’s landscape; many people are ready to move onto a new normal [1]. Yet, three years into the COVID pandemic, China’s dynamic zero-COVID policy still remains, defining the daily lives of an estimated 1.5 billion people. Mass public health responses should give more weight to bioethical, human impacts, and it is time to take a critical look at China’s policy from a non-western perspective to do just that. 

First, the motivations and implications of China’s dynamic zero-COVID policy must be established to understand its human impact. The policy was first created by the Chinese government to contain the initial outbreak of COVID in Wuhan during March of 2020. The policy decrees that the Chinese government will take “dynamic” action to eliminate cases that arise as necessary [2]. The implication of this statement has been two-pronged: prevention through frequent PCR testing, especially in cities, and lockdowns. Particularly in the latter, tactics can include neighborhoods to whole cities quarantining in their homes or government-controlled facilities, for weeks or even months. Now, Xi Jinping, the president of the People’s Republic of China and the general secretary of the Chinese Communist Party, stakes much of his political reputation on the policy in hopes that its success will carry him through his unprecedented third-term tenure for CCP’s general secretary position [2]. 

All this begs the question: has the policy truly been successful? From a purely statistical perspective, there is no denying that it has. According to Johns Hopkins University’s COVID mortality analyses, China has 1.12 deaths per 100,000 people [3]. On the other hand, the U.S. has the highest mortality rate in the world, with 326.74 deaths per 100,000 people [3]. Indeed, as The Atlantic science journalist Ed Yong states in his article The Pandemic’s Legacy Is Already Clear, negative responses to U.S. government-issued vaccine and mask mandates have led to less efficacy in containing it, making the country more vulnerable to new variants [4]. In comparison, China reflects its highly collectivist values in going to extreme measures to put the interest of the whole country or the “group” above the individual. 

However, from a bioethical perspective, the zero-COVID policy tells a different story. Shanghai’s lockdown this past spring demonstrates the need for public health responses to look beyond cultural values and prioritize bioethical concerns. In early April 2022, a large spike of COVID cases in Shanghai led to the entire city being shut down for two months, making this lockdown one of the most severe across the globe. Hundreds of thousands of Shanghai residents were forced to quarantine in their homes or designated facilities, relying on government-issued delivery services for medical supplies and food. People posted calls for medical help online when they could not get to the hospital they needed. In fact, facilities exacerbated the vulnerability of the elderly in this otherwise highly effective method [5]. In April, COVID spread widely among elderly Shanghai residents at the Donghai Hospital, many of whom were not vaccinated, and yet no extra protections were made for this already at-risk population. To make matters worse, families were not allowed to visit their elderly relatives in the hospital for a long time. Mr. Shen, a 45-year-old businessman, is just one example of the human cost of this policy. His father, who was already immunocompromised, died alone after running out of medication while waiting in a 400-person line [5]. 

Shanghai is not the only major Chinese city that has been in sudden mass lockdown like this. Beijing, Chengdu, and Shenzhen are just a few examples. Each lockdown equates to millions of changed lives. Even after lockdown, the daily impact of the zero-COVID policy is apparent; there is still mandatory PCR testing to get on public metro transport, and quarantines are still common even in neighborhoods that just have one or two cases. Public resistance towards the policy has been strong — with their lives clearly on the line, citizens posted their outrage, fear, and despair on social media platforms that contrasted with the cheery lockdown response that the government has tried to project in the media [6]. The usual government censorship struggled to contain public opinion that called for policymakers to rethink China’s COVID controls. 

In fact, just this past month on November 26th, 2022, protests in Shanghai in the wake of a deadly fire in a Urumqi quarantine facility added extra pressure to the Chinese government. In response, China has rapidly lifted the strictest parts of their zero-COVID policy, allowing citizens with symptoms to isolate at home instead of state-sponsored facilities and opening up free travel within the country without need for proof of negative tests [7] The immense rise in infections and sudden shift in the government’s language around COVID-19 has caused concern that the country’s healthcare system could be overwhelmed. However, from the relieved public’s response, one thing is certain: public health responses are malleable and should adjust based on the needs of a country. 

Shanghai’s reality is one that I, living on the other side of the world, could not ever imagine. I remember watching a Chinese New Years skit performed not too long before the lockdown started. In the skit, citizens young and old smiled wistfully and conversed, wearing KN95 masks, over food delivery and across apartment porches. No matter how these stringent policies have been quelling COVID mortalities, no one should have to live like this for months and years. Yet, the U.S. is a painful reminder that individualist policies downplay the truth that pandemics affect the collective, and individuals must do their part to keep everyone safe. No matter how different cultural values may be, the bottom line is that we all are humans, stumbling our way through a changed world with hope. While people across the world from each other may not live these stories, they must listen and learn from them. Inevitably, this will not be the world’s last pandemic; let these stories be what informs and strengthens public health responses to the next one.

References: 

1. John Gramlich, “Two Years Into the Pandemic, Americans Inch Closer to a New Normal,” Pew Research Center, March 3, 2022. 

2. Reuters, “Factbox: What is China's zero-COVID policy and how does it work?,” Reuters, November 3, 2022. 

3. Johns Hopkins University, “Mortality Analyses,” Johns Hopkins Coronavirus Resource Center. 

4. Ed Yong, “The Pandemic’s Legacy Is Already Clear.” The Atlantic, September 30, 2022. 

5. John Liu, Amy Chang Chien, & Paul Mozur, “Outbreak at Shanghai Hospital Exposes Covid’s Risks to China’s Seniors.” The New York Times, April 1, 2022.

6. Vivian Wang, Paul Mozur, & Isabelle Qian, “China’s Covid Lockdown Outrage Tests Limits of Triumphant Propaganda,” The New York Times, April 27, 2022.

7. Frances Mao, “China abandons key parts of zero-Covid strategy after protests,” British Broadcasting Corporation, December 7, 2022.

Ethics of Various Methods of Organ Donation for Transplantation

Ethics of Various Methods of Organ Donation for Transplantation 

In the United States and around the world we are failing to meet the demand for organ transplants. In the U.S. there are well over 100,000 patients waiting for organs in order to save their lives but fewer than 15,000 donors become available per year [1]. This shortage has caused heated debates over the best system for organ donation for the purpose of transplantation. The primarily proposed solutions include expressed consent, presumed consent, and mandated choice. This shortage has also led to the development of a highly lucrative black market for organs which is plagued with unethical and dangerous practices [1]. This is not an issue that only touches certain groups or classes of people, it is an issue that can affect almost anyone, and as a result, it should be an issue that we all commit to addressing. After a practical and ethical review of each of the proposed systems, I will show why I have come to the conclusion that with certain supports in place the most ethical and practical solution is implementing a system of mandated choice. 

In order to properly evaluate the best system for organ transplantation, it is important to understand the history of the procedure and what organ donation and transplantation actually look like. In 1954, doctors performed the first successful organ transplant of any organ using a kidney. In the 1960s organ transplant surgeries became consistently viable and since then there have been many technological advancements that have made it a truly life-saving procedure with the need for regulation [1]. Organs that have the potential to be harvested after death if viable include both kidneys, the liver, both lungs, the heart, the pancreas, the intestines, the hands and face, various tissues, the corneas of the eyes, and even in certain situations the limbs. Organs that can be donated while an individual is alive include one kidney, one lung, part of the liver, the pancreas, and the intestines. These can be donated because it is possible to survive without them, however, it is important to note that sometimes lifestyle changes are required after the removal [2]. Furthermore, there is a 5-10% risk of a surgical complication occurring and a 0.5-1% risk of death for a living donor depending on the specific procedure [3]. Even though organ donation, especially while one is still alive, is an extremely honorable action, it is important that individuals are properly educated on the risks they are taking on when they make that decision. The huge demand for this lifesaving procedure and the shortage of viable organs have created the perfect conditions for the extremely lucrative enterprise of organ trafficking to occur. There are two types of organ trafficking which are important to distinguish: the first one is human trafficking for the purpose of organ removal, and the second is organ, tissue, and cell (OTC) trafficking. Human trafficking for the purpose of organ removal is when an individual is transported and then their organs are removed. While OTC trafficking is the removal of someone's organs which are then transported and sold for transplant. In yearly revenue, the underground organ trade makes between $600 million and $1.2 billion. The organs used are generally sourced from donors in developing countries that are then bought by patients in wealthy nations like the United States. Frequently, donors in developing nations make the decision to sell their organs because they need to pay for necessities like food or shelter which makes them especially vulnerable. On the other hand, for many recipients of these illicit organs, the unsafe nature of receiving illicit medical care in a developing nation can end up making the benefits of the transplant obsolete with high rates of contraction of infectious diseases and rejection of the organs. Both patients and donors are coming from a place of extreme desperation to survive in one way or another. This need has created a prime situation for organ traffickers to take advantage of both parties and create an extremely profitable system [1]. In order to address this and end the abuse present it is necessary to pursue a more effective system of organ transplantation. 

Since organ donation is a system that has so much potential for abuse of those in need it is important to centralize bioethical principles in the conversation. In order to do this it is imperative to understand the necessary terminology. The primary pillar that organ donation is founded on is altruism [3]. This is when an individual's actions are motivated by making a positive impact on others without regard for their own benefit [3]. Along with altruism, it is extremely important to discuss the bioethical principles of autonomy, beneficence, and nonmaleficence. Nonmaleficence means to do no harm and is especially important when it comes to living donor transplants because there is a substantial risk that the donor is undertaking [3]. Beneficence as it applies to bioethics is the obligation for healthcare professionals to do good. This includes the sharing of knowledge and resources in order to ensure that a patient is able to make a decision with proper knowledge of their options, also known as informed consent [3]. Autonomy has to do with the right to freely make decisions concerning oneself. When it comes to organ donation this is extremely important, especially in regard to individuals donating organs. Nobody or no situation should put anybody in a position where they feel like they have no other choice than to donate an organ. When dealing with vulnerable populations like in systems of organ transplant it requires the utmost prioritization of ethicality. 

Now that there is a firm understanding of the problem, the procedure, and the ethical concerns that must be taken into account, an examination of each proposed system can be done. One of the proposed and most commonly practiced systems around the world, including the U.S., is expressed consent. An expressed consent system, also known as an opt-in system, relies entirely on altruistic donations from individuals who have indicated on an official form or in the presence of two adults their intention to donate after their death [1]. The primary benefit to an expressed consent model from an ethical standpoint is that it maintains the autonomy of potential donors by ensuring that every individual who donates actually wanted to donate because they took some form of official action to indicate this choice. However, in a more practical sense, a major drawback of this model is that it has proven to be extremely ineffective at meeting the demand for organs [4], which, as shown, can increase the demand for organs in the black market. This can actually create a potential counterargument to the ethicality of this system by raising the question that if a system is increasing the number of people turning to the unethical black market can it be an ethical system itself? While surveys show that a majority of citizens support organ donation, many often do not take the necessary action to become a donor and document their intention [4]. In fact, one poll found that 70% of the respondents indicated a desire to donate their organs but only 42% of Americans are registered donors and similarly in the UK only 39% of citizens are donors [5]. This causes the system to lose out on many potential organs continuing to contribute to the shortage. Some have even gone as far as to argue that US law about organ donation relies too heavily on altruism and will, therefore, worsens the shortage of organs [1]. 

An almost starkly opposing system is presumed consent. In this system, also known as an opt-out system, every individual is presumed to be an organ donor unless registered with a government database to express their opposition. A number of European countries have opt-out systems including Spain, France, Austria, Italy, and Norway. These countries that use this model have drastically higher percentages of citizens who are donors [1]. In all countries that practice this model, consent can only be presumed when it is determined that the donor was aware of the fact that not opting out meant they were deciding to donate their organs. As a result, a physician is only able to proceed with organ harvest after verifying that there is no documentation of a refusal either through the government or corroborating stories from multiple family members [7]. The primary objection to a presumed-consent policy is that some view it as a loss of autonomy because there is no affirmative choice by an individual to donate their organs. Many physicians and bioethicists view it as unethical to invade an individual's body without their expressed consent. In this model, it is incredibly possible for consent to be presumed of someone who was unaware of the need to opt out or was uneducated about the decision they were making, removing autonomous choice. Objectors to this model go on to argue that it is inherently worse to mistakenly remove someone's organs when that is against their wishes than not donate the organs of someone who wanted to because it is a blatant violation of primary ethical principles. However, those who support presumed consent respond to the argument of a loss of autonomy by countering that the model actually increases autonomy because it allows the donor instead of the family to make the final decision. Another argument in favor of presumed consent is that it is ethical because it provides the greatest good for the greatest number of people. Furthermore, some say that the burden of educating about presumed consent falls to those who object to donation rather than those who support it because the goal of donation and transplantation is overall morally good [4]. 

One extremely well-known model of the successful practice of presumed consent is in Spain. Out of any country in the world, Spain has the highest rate of organ donation with 33.5 per 1 million residents donating after death. Spain has developed an intense societal respect for organ donors which contributes to the success of the program. This policy is also extremely cost-effective because in the long run paying for a kidney transplant is cheaper than long-term dialysis. However, it is important to note that most countries that utilize a presumed consent model have universal healthcare or a combination of it with private care. This is significant because it means that all citizens are eligible to receive transplants while in a system; with entirely private health care only citizens who have insurance or money for the procedure would be eligible for transplants. While there are some countries that this model has worked well for, it is important to note that not all countries have experienced this same success. In the late 90s, Brazil adopted a policy of presumed consent but quickly repealed it because most doctors refused to harvest organs without expressed consent [4]. While the model of presumed consent is extremely effective at increasing the rate of organ donation it has many problems when it comes to respecting the autonomy of donors making it difficult to deem it a reliably ethical system. 

Another system that is less common but addresses many of the flaws with the previous two models is mandated consent. In this system, it is required that all citizens, specifically adults, indicate their preferences for donation as a part of a required activity like filing taxes. One example of the use of a mandated choice model is in the state of Illinois where residents are required to designate their desire to donate or not in order to renew their driver's license. As of 2009, there was a signup rate of 60% compared to the national rate at that time of 38%. The primary ethical benefit of this system is that since it requires a clear choice to be made it enhances individual autonomy [1]. It ensures that a person's wishes would be honored whether they would like their organs donated or not. This is in line with the generally accepted view that individuals are more suited to make decisions about organ donation than their families [6]. Other advantages of this system include eliminating the barrier of family consent, increasing public awareness about organ donation as everyone would be forced to consider it, and would eliminate current delays resulting from getting family consent which would increase the viability of donated organs [6]. One ethical challenge that has been brought up about mandated choice is how it would be possible to ethically compel someone to make this choice. For example, if someone were to refuse to make this choice how could they be forced to do so in an ethical way? The answer seems fairly simple: if a decision about whether or not to be an organ donor becomes a required part of taxes or getting a driver’s license then not making a decision would mean you did not complete the required material. As a result, the individual would experience the consequences of that. This respects all central parts of bioethics including autonomy because respecting someone’s autonomy does not mean they do not have to comply with certain regulations, it means that they are able to make a choice. There are many other required decisions on tax forms like whether or not to donate to the Presidential Election Campaign Fund. Ultimately, a system of mandated choice would be the most ethical and effective at increasing the supply of organs for transplantation. 

Systems of organ donation for the purpose of transplantation are highly dependent on the morality and central values of a society. As shown, there are countries that have been able to make each system work well enough and have it widely accepted by the general public. However, a system can be accepted by society and still be unethical or ineffective at achieving its goal. While an expressed consent model meets ethical standards it is grossly unable to meet the demand for organs. On the other hand, while a presumed consent model is extremely successful at meeting this demand, it brings up serious ethical questions about whether there is true respect for autonomy, especially in a country with an insufficient education system. The system of mandated choice is able to require an autonomous choice to be made in an ethical way while simultaneously increasing the number of donors and, therefore, the number of available organs for transplantation. While it may seem as if this is an issue that is out of the control of individuals, it is those individuals that the chosen system will most profoundly affect whether it is as a potential recipient, donor, or nondonor. As a result, it is imperative that citizens of the world evaluate both the effectiveness and ethicality of potential systems and advocate for the one that meets these standards best, which in my opinion is a model of mandated choice. This system could provide greater access to organs which can prolong the lives of so many people and allow them to live full lives and allow vulnerable populations of donors to be protected from abuse and effectively the robbery of their organs. The situation has reached a point of dire need. It requires that everyone take action through education and advocacy to ensure that as a world and individual nation there is protection for the most vulnerable and achievement of the highest standard of medical care possible.

References 

1.  Kelly, E. (2013, May 1). International organ Trafficking Crisis: Solutions Addressing the Heart of the Matter. Boston College Law Review, 1317-1349. 

2. What Can Be Donated. (2021, September). Health Resources & Service Administration. Retrieved November 25, 2022, from https://www.organdonor.gov/learn/what-can-be-donated.

3. Dalal, A. R. (2017, June 24). Philosophy of organ donation: Review of ethical facets. National Library of Medicine. Retrieved November 15, 2022, from 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4478599/

4. Zink, S., Zeehandelaar, R., & Wertlieb, S. (2005, September). Presumed vs Expressed Consent in the US and Internationally. AMA Journal of Ethics. Retrieved November 15, 2022, from 

https://journalofethics.ama-assn.org/article/presumed-vs-expressed-consent-us-and-intern ationally/2005-09#:~:text=Countries%20with%20presumed%20consent%20have%20gen erally%20seen%20higher,1986%2C%20donation%20rates%20fell%20by%2050%20perc ent%20%5B3%5D.

5. Goldman, R. (2012, May 1). States See Instant Spike in Organ Donors Following Facebook Push. ABC News. Retrieved November 25, 2022, from 

https://abcnews.go.com/Health/states-instant-spike-organ-donors-facebook-push/story?id =16255979#:~:text=More%20than%20112%2C000%20Americans%20are%20awaiting %20organs%2C%20and,support%20donation%2C%20only%2042%20percent%20are%2 0registered%20donors. 

 6. Spital, A. (1997, March 27). Mandated Choice For Organ Donation. Official Journal of Transplantation. Retrieved November 15, 2022, from 

https://journals.lww.com/transplantjournal/Fulltext/1997/03270/MANDATED_CHOICE_ FOR_ORGAN_DONATION.23.aspx. 

7. Presumed Consent & Mandated Choice for Organs from Deceased Donors. (n.d.). AMA Code of Medical Ethics. Retrieved November 15, 2022, from 

https://code-medical-ethics.ama-assn.org/ethics-opinions/presumed-consent-mandated-ch oice-organs-deceased-donors. 

Physicians Have a Duty to Treat Patients in Times of Personal Risk

Covid-19 has led to renewed interest and discussion regarding the duties of physicians in a high risk environment. The pandemic resulted in large shortages in emergency and critical care providers, and those that remained were overworked and dealing with shortages of key equipment such as personal protection devices. In one study during the pandemic, about 25% of physicians and nurses thought it was ethical for health care providers to abstain from treating patients given the personal risk to themselves and their families [1]. Those who choose healthcare as a career certainly assume certain risks relating to psychological stress, long hours, and personal risk such as exposure to harmful and potentially deadly infections. When these challenges increase dramatically, which moral and ethical duties are inherent in the jobs of physicians? I argue that there is an ethical duty for physicians to treat patients despite the personal risk involved during events such as pandemics.

An important consideration in discussing physicians’ duties and responsibilities is that of implied consent. Since it is commonly accepted that some patients are infected and contagious, it is reasonable to assume that risk is inherent in the field of medicine, and by entering the field certain risks are implied and accepted. Although this does not imply that a duty to treat exists, it establishes an accepted reality regarding physician practice.

In 1847, the American Medical Association published its first Code of Ethics stating, “When pestilence prevails, it is their [physicians’] duty to face the danger, and continue their labors for the alleviation of suffering even at the jeopardy of their own lives” [2, p. 3]. While this wording no longer exists in the AMA code, it points to the long tradition of self-sacrifice in the field of medicine, a concept which draws many to pursue the profession. In addition, pledges made by physicians such as the Hippocratic Oath reference the special nature of physicians’ duties. The World Medical Association has a similar pledge, although like the Hippocratic Oath, does not address risk to physicians [2].

When discussing the difficult concept of physician duty to treat, it is also useful to consider the ethical concept of beneficence. In their work entitled, Bioethics: The Islamic Perspective, Al-Bar and Chamsi-Pasha argue that the principle of beneficence has special meaning for health care workers, and implies unique moral obligations. They state, “beneficence is a continuum…professionally things which are considered as supererogatory for the public become obligatory for the professional, e.g., a physician or nurse in a hospital where he is tending patients with highly infectious diseases” [3, p. 132]. This perspective goes a step further in applying unique moral duties to physicians.

Making broad arguments about moral and ethical duties is particularly challenging, because physicians may face health risks that extend to others–family members at home may be especially vulnerable to an infectious disease. Although contentious, the concept of beneficence still applies: physicians have a unique commitment to provide. In the case of a future epidemic, perhaps one that is more lethal than Covid-19, a physician who pauses their labors to protect members at home may indirectly result in deaths of others. Risks that extend into a physician’s personal life should not interfere with priorities when health care is valuable and dire. These duties should be clearly outlined for prospective health care providers, as ambiguities in a code of ethics will not guarantee care from physicians.

References

1. McConnell D. (2020), “Balancing the duty to treat with the duty to family in the context of the COVID-19 pandemic”, Journal of medical ethics, April 24, 2020

1. Kirsch T. D. (2022), “Heroism Is Not a Plan-From "Duty to Treat" to "Risk and Rewards”,” The American journal of bioethics, March 4, 2022

1. Al-Bar MA, Chamsi-Pasha H. “Contemporary Bioethics: Islamic Perspective”, Cham (CH): Springer, May 28, 2015

Towards a Brave New World: The Huxleyan Reality of Using Pharmacological Neuroenhancement

Among all possible contingencies, there has been an evident progression toward the dystopian future foretold by visionary writers such as Aldous Huxley in particular. Huxley’s 1932 novel Brave New World alluded to the pre-existing epidemic that concerned the use of pharmacological neuroenhancement for improved cognitive and affective functioning (i.e., attention, memory, mood, etc.) via legal or illicit drug use [1]. But at what costs? As portrayed in the novel, the drug “soma” induces feelings of happiness while nullifying any kind of discomfort and pain [2]. Such quixotic concepts have been exploited to serve as a form of enhancement to construct the best version of our brains, especially in the postmodern era [3]. The use of pharmacological neuroenhancement, synonymously known as brain doping, by healthy subjects for non-medical purposes to enhance performance and work has been a common practice that can be traced back to the ancient Greeks who used pharmacological neuroenhancement when competing in the Olympic Games [4]. Although intense polarization has been ceaselessly ongoing between transhumanists and bioconservatives in the neuroenhancement debate.

While transhumanists argue in favor of utilizing pharmacological neuroenhancement as a form of genetic engineering to increase human cognitive abilities and thereby radically change the ways through which our species develop, bioconservatives are skeptical of such propositions and dismiss any morally permissible ideas related to modifying our natural intelligence. In their views, bioconservatives criticize the transhumanist ideal of perfection and their hubristic ambition to override the inherent principles of nature, which echoes the warning conveyed by Huxley that the perturbing influence of eugenics-inspired biotechnologies must be resisted. It is therefore imperative to critically examine and analyze the philosophical basis for both stances in relation to the ethics of using pharmacological neuroenhancement and to ultimately unveil the truth of the Huxleyan reality—a nightmarish, oppressive vision that Huxley once envisaged and feared.

In utilitarian terms, an alluring aspect as promised by the effective use of pharmacological neuroenhancement is increased cognitive functioning, which transiently improves performance in any given activity such as learning and memorization [7]. One familiar example is the use of psychostimulants like methylphenidate (brand name: Ritalin) among college and university students. Taking such neuroenhancement drugs lead to improved working memory and increased attention, which reportedly helps students study for longer hours and study more productively with reduced anxiety. Of note, however, is that the original purpose of the stimulant is meant to be prescribed to treat individuals with ADHD, [7] and not for augmenting one’s cognition for the benefit of improving the human cognitive condition [9]. All progress throughout the course of human civilization is rooted in the fundamental belief of climbing to the next step in the evolutionary hierarchy, which motivated the need to intervene and manipulate the systematic complexities of the human mind for the sake of continuing progress. In the instance of using pharmacological neuroenhancement to increase one’s cognitive abilities, an intelligence-based hierarchy as modeled after the social infrastructures that exist in the Huxleyan reality would thus be born [2]. Living under this type of hierarchy implies that even though an individual would rather prefer not to take neuroenhancement drugs, he or she would nevertheless be pressured to take the drug in an increasingly competitive environment to be on par with someone who is already conditioned to take the drug on a regular basis [5]. The aftermath would then result in the problem of, does the individual still retain his or her autonomy?

Calling transhumanism “the world’s most dangerous idea,” the political scientist Francis Fukuyama suggests that when giving in to the temptations of transhumanist thought such as in the goal of enhanced cognition, the impulse to buy into such ideas oftentimes would cause the individual to be blinded to the actual price [10]. Notwithstanding the utopian ideal, it is noteworthy to mention the health risks along with the addictive effects associated with taking neuroenhancement drugs that may pose harm to the individual, to which many of the users are oblivious [11]. By taking the use of neuroenhancement drugs out of its medical context for unintended purposes such as serving as a studying aid, the thin line that distinguishes enhancement from treatment is blurred as a result. In doing so, the individual becomes vulnerable to, among other things, increased blood pressure, nausea, and irregular palpitations from the effect of altered brain chemistry as a result of taking psychostimulants [12]. Ironically, the case of memory enhancement may also cause impairment to memory retrieval by interfering with the balance between remembering and forgetting due to information overload in the higher-order capacities of the brain [3]. Hence, while it is reasonably acceptable for individuals with mental illnesses or cognitive deficiencies to take neuroenhancement medications to reinstate normal brain functioning, the inverse is true in the case of enhancement where safety is a primary ethical concern. 

A supporting argument used to oppose bioconservatism is that pharmacological neuroenhancement promotes fairness and equity, notably for individuals who may be disadvantaged in some ways when compared to others in the context of applying to schools or finding employment [13]. Interventions by unnatural, pharmacological means thus allow underperformed individuals to have improved capabilities by elevating their lower cognitive functioning to match the normal baseline functioning [5]. However, this argument fails to take into account the socio-economic barriers that influence how justly neuroenhancement drugs will be distributed among a given population [13]. Problems would arise when disparities become apparent by considering the fact that neuroenhancement drugs may not be affordable for everyone, especially for the lower classes and those without health insurance coverages. Hypothetically, even if neuroenhancement drugs were made universally accessible through public policy solutions or government mandates, ethical concerns may be raised with regard to losing one’s liberty as a direct result of being coerced into taking neuroenhancement drugs. The likely outcomes of this hypothetical scenario have already been reflected in vaccine mandates throughout the course of the COVID-19 pandemic, where some individuals expressed antagonism in response to such mandates to protect their liberty and personal choice [5]. However, in the Huxleyan reality, liberty simply does not prevail. While coercion may be justified in the context of vaccine mandates for disease prevention, this hypothetical scenario as it applies to enhancement supports the bioconservative argument by resembling the events that were detailed in Brave New World, in which the citizens of Huxley’s dystopia all became mentally compromised by virtue of taking soma as administered by the World State [2]. Hence, when the cause for coercion is unjustifiable, it becomes worthy to ponder upon the question, is there any degree of freedom to our actions when under the influence of neuroenhancement drugs?  

Bioconservatives, moreover, continue to reinforce their objections to the use of pharmacological neuroenhancement with rationales that are beyond the preceding arguments related to safety and fairness, one that reveals the psychological horror of using pharmacological neuroenhancement. Imagine a baseball player taking neuroenhancement drugs such as steroids to increase their competitiveness on the playing field; as a result, ten home runs were hit in a single game. Contrast this with a baseball player who accomplished the same feat but without the use of neuroenhancement drugs; instead, it was the result of rigorous training and real effort [13]. The questions now present themselves as, which of the two players is more undeserving of his achievement and unworthy of praise? Does integrity not matter? The answers, of course, are obvious. Our intuition is capable of telling us what is morally responsible and what is not. In the case of the baseball player who used neuroenhancement drugs, the erosion of human agency rendered his achievement to become “hollowed” and his character to become morally “defective”, supplemented by the loss of personal dignity and overall humanity according to the foundational ethical framework that governs our morals and values [14]. Because at the end of the day, the credit does not go to the baseball player, but rather to the pharmacist who prescribed the drug or to the dealer who sold the drug.

The hubris objection as illustrated by the aforementioned example denounces the transhumanist methodology of undermining intrinsic values such as grit and tenacity and underappreciating our “gifted” character and powers with which we derived from nature, and further ridiculing the Promethean desire to be dominant over the natural order [15]. This objection was originally configured by political philosopher Michael Sandel and supported by physician-scientist Leon Kass. Kass added to Sandel’s argument of “giftedness” by emphasizing the dire consequences of substituting our moral virtues with pharmacological neuroenhancement-induced effects. Consider this thought experiment: If drugs that were originally meant to treat patients with PTSD become easily accessible to anyone, how many people without mental illnesses would be willing to take such drugs for the purpose of preventing bad memories from consolidating in their minds? While the feelings of trauma or sorrow from an unfortunate experience is undesirable, taking neuroenhancement drugs to block out those feelings and the associated painful memories of that experience would hinder our ability to develop the necessary mechanisms to cope with the myriad of negative feelings that are essential to our psychology [16]. In consequence, we would miss the opportunity for personal growth upon losing our self-control and fail to integrate the adversities of our lives to our character development. We no longer feel the sharpness of that feeling of pain, but do we still retain the courage to stand up and walk forward? This question often appears in the Huxleyan reality in which the character John “the Savage” is refused the right to be unhappy because unhappiness is not a realized concept [2]. When an individual wishes to take soma to relish in pleasure and escape from disillusionment, but in exchange, the individual would forever be trapped in a peaceful fantasy that juxtaposes the cruel reality, where does real happiness lie? To John, real happiness lies in enduring excruciating pain but knowing that it will all be worthwhile—like acing a test after hours spent studying or winning a game after the amount of effort that was spent during practice. Thus, it is within reason that taking shortcuts via artificial means offers no meaning in our pursuit of accomplishments—irrespective of the scale—and such conducts only pathologize our imperfections. 

To live with dissonance and the unanticipated are preconditions to appreciating what life has already given us and its beauty, thus enabling us to live a flourishing life that is fulfilling without external interventions that could potentially disfigure the relationship that we have with ourselves and restrict our exercise of freedom. In reference to the words of John who chose to be unhappy, we can cherish the notion that unhappiness is bliss, for it ensures that we still preserve our individual identities and the autonomy to taste the flavors of life: “I don't want comfort. I want God, I want poetry, I want real danger, I want freedom, I want goodness. I want sin” [2]. While the endeavor to advance the evolution of human cognition is appealing, one must be cautious of the dubious means represented by the unnaturalness of pharmacological neuroenhancement, as it is irresponsible to toy with our very own subjective experiences and personality traits in the midst of ambiguities [3]. Let it be known that the aspiration to enhance our cognition may lead to the inability to achieve a complete understanding of ourselves and ultimately to the downfall of our own humanity; even more so, it is at odds with our inalienable human rights in which the happiness that we would find from pharmacological neuroenhancement is only illusionary under this fallacy. The Huxleyan reality of using pharmacological neuroenhancement is not an inevitable future, and can be averted if we first consider the question: What am I willing to lose? 

References

1. Heller, S., Tibubos, A. N., Hoff, T. A., Werner, A. M., Reichel, J. L., Mülder, L. M., ... & Dietz, P. (2022). Potential risk groups and psychological, psychosocial, and health behavioral predictors of pharmacological neuroenhancement among university students in Germany. Scientific reports, 12(1), 1-10.

2. Huxley, A. (1998). Brave new world. HarperPerennial. 

3. Fuchs, T. (2006). Ethical issues in neuroscience. Current opinion in psychiatry, 19(6), 600-607.

4. Bowers, L. D. (1998). Athletic drug testing. Clinics in sports medicine, 17(2), 299-318.

5. Roskies, A. (2021, March 3). Neuroethics. Stanford Encyclopedia of Philosophy. Retrieved October 21, 2022, from https://plato.stanford.edu/entries/neuroethics/ 

6. Sandel, M. J. (2009). The case against perfection: Ethics in the age of genetic engineering. The Belknap Press of Harvard University Press. 

7. Schleim, S., & Quednow, B. B. (2018). How realistic are the scientific assumptions of the neuroenhancement debate? Assessing the pharmacological optimism and neuroenhancement prevalence hypotheses. Frontiers in Pharmacology, 9, 3.

8. Marazziti, D., Avella, M. T., Ivaldi, T., Palermo, S., Massa, L., Della Vecchia, A., ... & Mucci, F. (2021). Neuroenhancement: state of the art and future perspectives. Clinical Neuropsychiatry, 18(3), 137.

9. Liszka, J. (2021). Pragmatism and the Ethic of Meliorism. European Journal of Pragmatism and American Philosophy, 13(XIII-2).

10. McNamee, M. J., & Edwards, S. D. (2006). Transhumanism, medical technology and slippery slopes. Journal of Medical Ethics, 32(9), 513-518.

11. Shipman, M. (2019, May 8). The ethics and challenges surrounding neuroenhancement. NC State News. Retrieved October 22, 2022, from https://news.ncsu.edu/2019/05/neuroenhancement-ethics-challenges/ 

12. Nootropics. Cognitive enhancers - Alcohol and Drug Foundation. (n.d.). Retrieved October 22, 2022, from https://adf.org.au/drug-facts/cognitive-enhancers/ 

13. Forlini, C., & Hall, W. (2016). The is and ought of the ethics of neuroenhancement: mind the gap. Frontiers in Psychology, 6, 1998.

14. Faber, N. S., Savulescu, J., & Douglas, T. (2016). Why is cognitive enhancement deemed unacceptable? The role of fairness, deservingness, and hollow achievements. Frontiers in Psychology, 7, 232.

15. The president's Council on Bioethics: What's wrong with enhancement? (n.d.). Retrieved October 22, 2022, from https://bioethicsarchive.georgetown.edu/pcbe/background/sandelpaper.html 

16. Kass, L. R. (2003). Ageless bodies, happy souls: biotechnology and the pursuit of perfection. The New Atlantis, (1), 9-28.

Cryonics: The Cure for Death?

Zombies have been a popular science-fiction creation for decades, and the idea of resurrection goes back even further. How can a person be revived from death? Is it morally correct for such a thing to happen? These questions are relevant yet again due to recent interest in cryonics.

Cryonics is the technique of deep-freezing a dead body with the hopes that future scientists will be able to revive and restore it to full health. The process starts while the patient is still alive. They can sign up for the procedure through a cryonics facility, paying anywhere from tens to hundreds of thousands of dollars for a second shot at life. With this contract in place, a standby team will spring into action once a patient is pronounced legally dead, usually waiting in the hospital with the patient until it’s time. The team keeps the body stable while it is transported to the facility: supplying enough oxygen and blood to maintain minimal brain function, circulating the anticoagulant heparin to prevent blood clotting, and packing the body in ice while it is en route. A medical team awaits upon arrival [1]. 

The long-term preservation takes place on-site. Blood is drained from the patient and replaced with a mix of medical-grade antifreeze and organ-preserving chemicals, known as cryoprotective agents. If the body were to be placed directly in vats of liquid nitrogen the water in cells would expand to form ice crystals and the cells would be destroyed. With the added chemicals, organs and tissues are protected because the chemicals clump together in cryogenic temperatures. They form a solid that is molecularly similar to glass, and this new “glass” prevents the cells from bursting. Next, the body is cooled on a bed of dry ice until it reaches -130ºC (-202ºF). This completes the vitrification process, or the process of deep cooling without freezing, and allows cells to enter a state of suspended animation [2]. The body is finally inserted into an individual container and then placed into a large metal tank filled with liquid nitrogen at around -196ºC (-320ºF). It is stored head-down in these vats so that the brain will be most protected if there is ever a leak [3]. 

Currently, there are around 500 human bodies stored in vats around the world because of cryonics, with the majority being in the U.S. Major companies include the Cryonics Institute, KrioRus, Shandong Yinfeng Life Science Research Institute, and Alcor Life Extension Foundation. Alcor is the most expensive and best-known cryonics company in the U.S., charging $200,000 to handle a full human body and $80,000 to just preserve a brain (called “neuro” preservation) [3]. 

During the COVID-19 pandemic, these companies were forced to adopt new operating room rules. At Alcor, this looked like restricting the application of its medical-grade antifreeze solution to only the brain and leaving everything below the neck unprotected. It was also harder to reach clients quickly because of travel restrictions and limitations on hospital access [3]. 

Despite these more challenging circumstances, business was thriving. KrioRus and Alcor reported receiving a record number of inquiries during Covid, likely because the pandemic brought death to the forefront of people’s minds. Valeriya Udalova, chief executive of KrioRus, noted that “perhaps the coronavirus made them realize their life is the most important thing they have and made them want to invest in their own future” [3]. Jim Yount, a member of the American Cryonics Society, also commented that “something like covid brings home the fact that they are not immortal.” [3]

But how likely is it that people who “invest in their own future” by signing up for cryonics will see their money well spent? Can this process really add decades, or even centuries, to a person’s life? The quick answer is probably not. It hasn’t been proven that complex human systems can be “stored” with the help of these facilities. All we know for sure is the technology available to us right now, none of which can revive these dead bodies. In this way, the cryonics industry is built entirely on optimism since companies place the tall order of revival in the hands of future scientists.

Supporters believe death is not just the moment when the heart stops; it is a process of deterioration that humans are capable of intervening in. They generally concede there isn’t any guarantee that future science will be able to reanimate these people. Nonetheless, the odds of revival with cryonics are still better than without it. This much is certainly true: scientists can’t resuscitate a pile of ashes or bones, but at least cryonics provides a body to work with. Plus, “if you’re starting out dead, they say, you have nothing to lose.” [3]

At the same time, cryonics company websites hardly drive home the uncertainty involved in these procedures. The Alcor website advertises cryonics as “an ambulance into the future” and states that “cryonics is currently the best-known method for pausing the dying process in a way that allows for potentially restoring good health with medical technology in the future.” It also says that “cryonics sounds like science fiction, but it’s based on modern science.” [4] While the website is transparent about the procedure’s reliance on technology that doesn’t yet exist, it also advertises the success of cryonics as being only a matter of time. There are no disclaimers about the uncertainty involved or the industry’s foundations of sheer optimism. Is it misleading for websites to lack precautionary messaging? Perhaps it is within their right as private companies to advertise themselves as they wish, but it could also be considered immoral to require prospective clients to read between the lines on such important subject matter.

There are also a plethora of questions that arise when thinking about the fact that at the end of the day, these are private companies working for profit. Cryonics companies are quite literally in the business of death. Who can determine if they are acting in their client's best interest, and do they even have the incentive to do so given that the bulk of their work happens once their clients are dead? The image of these companies has already begun to tarnish, since in 2009 there were allegations that Alcor was mishandling bodies and even hastening clients’ deaths [5]. Who will hold these companies accountable in such a delicate industry?

A unique set of questions arises from assuming cryonics will be successful. Given the prohibitive pricing of these procedures, society could reach a place where wealthy people are immortal. Would this be a fair change? Wealthy people already have better access to medical care and longer life expectancies. Perhaps immortality as a result of wealth is a natural progression for society, or perhaps there is some line to be drawn as to just how much money should be able to buy.

There’s also the question of sustainability. We already struggle with overpopulation. Is it ethical to exacerbate this for our descendants by sending people from our century into the future? 

On a different note, we must examine how society as a whole would be affected by mass cryopreservation. New and old generations would eventually be living together- would society be able to progress or would it be held stagnant by the continued presence of old ideas? As USC student Anu Rajendran put it, the “advancement of culture could slow down,”making cryonics detrimental to the larger society [6].

Although it is impossible to answer these ethical questions without lived experience, they are still important to consider as the cryonics industry grows. The procedure’s allure is undisputed. If successful, patients could be treated with new cures to mend an untimely death or have decades more with loved ones (if they also partake). Most ethical dilemmas wouldn’t be realized unless millions of people were choosing to be cryopreserved, but if the process were successful and affordable that could very well be the case. Thus, it is critical to consider all possible effects of the procedure as it gains popularity.

References

1. How Cryonics Works. (2005, January 5). HowStuffWorks. https://science.howstuffworks.com/life/genetic/cryonics.htm 

2. Cryosleep - An Overview of Cryonics, Cryosleep and Cryotherapy. (2018, October 17). The Medical Futurist. https://medicalfuturist.com/are-you-going-to-wake-up-from-cryosleep/ 

3. Wilson, P. (2021, June 26). The Cryonics Industry Would Like to Give You the Past Year, and Many More, Back. The New York Times. https://www.nytimes.com/2021/06/26/style/cryonics-freezing-bodies.html 

4.  What is Cryonics? (n.d.). Alcor. Retrieved November 24, 2022, from https://www.alcor.org/what-is-cryonics/ 

5. News, A. B. C. (n.d.). Former Alcor Employee Makes Harsh Allegations Against Cryonics Foundation. ABC News. Retrieved November 24, 2022, from https://abcnews.go.com/Nightline/alcor-employee-makes-harsh-allegations-cryonics-foundation/story?id=8764331 

6. Rajendran, A. (2017, December 13). The Frozen-Undead: Ethical Implications of Suspended Animation and Cryonics. Viterbi Conversations in Ethics. https://vce.usc.edu/volume-1-issue-1/the-frozen-undead-ethical-implications-of-suspended-animation-and-cryonics/ 

Painful Justice: Botched Executions and Capital Punishment

The death penalty has been practiced as a fundamental tool in criminal and judicial systems for thousands of years and has played an integral role, both socially and punitively, in many ancient and modern societies. The practice of capital punishment in the United States began in the colony of Jamestown with the first reported execution occurring in 1608 [1]. This practice has withstood the test of time, remaining a possible sentence in twenty four states [2]. Many states, most recently, Virginia, which outlawed the practice of the death penalty in 2021, have stopped carrying out executions altogether as a form of criminal punishment. Currently in the states where the death penalty is still practiced, the most common and widely used method of execution is lethal injection, in which various medications are administered through intravenous injections resulting in the death of the prisoner. This method of execution is regarded, generally, as the most humane and is not meant to cause any pain to the person being executed [3]. 

In striving for this aversion to pain in the practice of lethal injection, legislators and advocates aim to parallel the philosophies of the medical field. In medicine, practitioners attempt to reduce the pain of patients undergoing procedures through anesthesia and control for pain in post-op recovery with pain medications as strong as morphine or fentanyl. When all goes well, lethal injection is similar to any other medical procedure where pain is managed or even completely absent for the patient. However, this is not always reality. Lethal injection has the highest rate of failure among other contemporary methods of execution sitting at 7.12%, while other methods such as electric chair or firing squad have failure rates of 1.92% and 0% respectively [4]. 

These so-called botched executions subject the person being executed to visible extreme pain, discomfort, and distress. One such execution made national news when an Oklahoma man was seen convulsing and throwing up during his execution [5]. In multiple cases, executions have failed due to prisoners who have compromised veins as a result of drug use that make it harder to insert an IV through which to inject the drugs. In these circumstances, a decision must be made to continue with the execution by finding other ways to insert IVs, such as in hands, necks, and other places on the body, causing extreme discomfort for the prisoner involved [4]. In these cases, physicians often aid technicians in establishing an IV through which to administer the drugs. And in this way, physicians play a central role in the medical killing of another human being. If the consistency of lethal injection as a mode of capital punishment requires physicians to play a role in carrying out this work, physicians must face various ethical dilemmas in weighing the benefits of both “justice” and medical ethics, similar to the ethical dilemmas of euthanasia or assisted suicide. 

 Lethal injection, the most “humane” method of execution, comes with complications not seen with other methods of executions that put into question the efficacy of lethal injection. The use of firing squads has dwindled over the years due to the sheer carnage it endows the body of the prisoner with, and execution by electric chair has similarly dwindled due to concerns over  pain and suffering during the procedure [6]. So now, we have been left with lethal injection. If the most “humane” method of execution is still having unforeseen consequences for the prisoners who are being executed, perhaps capital punishment as a whole needs to be reevaluated as a practice. 

References 

1.  “History of the Death Penalty.” Death Penalty Information Center. https://deathpenaltyinfo.org/facts-and-research/history-of-the-death-penalty/early-history-of-the-death-penalty. 

2.  “State by State,” Death Penalty Information Center. https://deathpenaltyinfo.org/state-and-federal-info/state-by-state. 

3.  “So Long as They Die: Lethal Injection in the United States,” Human Rights Watch. https://www.hrw.org/report/2006/04/23/so-long-they-die/lethal-injections-united-states#:~:text=Compared%20to%20electrocution%2C%20lethal%20gas,it%20mimics%20a%20medical%20procedure. 

4.  “Botched Executions,” Death Penalty Information Center. https://deathpenaltyinfo.org/executions/botched-executions. 

5.  “Oklahoma executes inmate who dies vomiting and convulsing,” AP, October 28, 2021. https://apnews.com/article/us-supreme-court-prisons-executions-oklahoma-oklahoma-attorney-generals-office-6e5eedd1956a38f83db96187651f145c. 

6. “South Carolina judge halts the use of firing squad, electric chair,” Washington Post, September 7, 2022. https://www.washingtonpost.com/nation/2022/09/07/south-carolina-firing-squad-electric-chair/. 

Inequitable Effects of Urban Heat Islands

It is no surprise that highly urbanized areas with little vegetation cause negative effects on their inhabitants and the local climate. These areas are called heat islands, and can be 1–7°F hotter during the daytime and 2-5°F hotter at night in comparison to more natural, vegetated land. There are two main factors that contribute to heat islands: the loss of vegetation that naturally provides cooling and the man-made structures that lead to retention of heat. 

Natural growth provides shade, which cools the land in its shadow. Trees also cool the air as the water in their leaves transpires. Bodies of water which may be covered or diverted in urban areas would also cool the air if left untouched. 

The building materials themselves in urban areas retain more heat than plants do, contributing to the rise in temperature within heat islands. Large man-made structures such as several-story buildings can also block the flow of wind, which would normally have a cooling effect in the city. These temperature differences are also greater in areas of denser populations. Increased human activity leads to increased use of all sorts of machinery, electronics, vehicles, and other industrial innovations, which all release thermal energy into the environment [1]. 

Not only are heat islands associated with increases in temperature, they can also be costly—in terms of energy, household electricity cost, and government aid. When the temperature rises in an urban area, it can cause a strain on power grids as more people use electricity to cool their homes. This leads to an energy loop, where people use electricity to cool their homes, which releases thermal energy out into the environment, which thereby makes the heat island even worse [2].

The environment also suffers because of these heat islands, because all parts of an ecosystem are interconnected, both biotic and abiotic. If the bodies of water in a heat island are heated and then flow into local rivers or lakes, it can cause harm to animals living there that have adapted to live in a cooler environment. Pollutants in heat island cities also have more severe effects, as they cannot easily be dispersed; air pollutants cannot be blown away due to disrupted air flow by tall buildings, and ground-level pollutants do not go down into the earth due to man-made non-permeable materials like roads and sidewalks [2,3]. 

These heat islands can also affect human health. “[Urban heat islands] intensify health problems in cities,” writes Professor Mattheos Santamouris, author of several books on heat islands and energy conservation, “During the 2003 heat wave in France, the excess mortality in Paris surpassed 140%, while in smaller cities it was much lower at close to 40%” [3]. Heat related illnesses like heat stroke and respiratory difficulties can be severe, and even fatal, especially in certain populations. Those who are very old or very young, those who have preexisting health issues, and those who work outside can be susceptible to increased effects from heat waves. 

Two final demographics of people who are more severely affected by heat islands stress the lack of equity in this environmental issue. Those who are low-income, and people of color. 

Per a 2021 research study on disproportionate heat island intensities, “​​We find that the average person of color lives in a census tract with higher [Surface Urban Heat Island] intensity than non-Hispanic whites in all but 6 of the 175 largest urbanized areas in the continental United States,” [4]. This disparity is theorized to be partially due to historical redlining—the denying of home sales or loans based on the area’s racial makeup. The data shows that these redlined, historically POC neighborhoods have a higher temperature makeup than other neighborhoods within the same city [4]. This racial segregation can lead to lack of funding and neglect by the local government, and “leads to people of color incurring more environmental health risks, including higher levels of exposure to pollution, hazardous waste, and urban heat” [5].

Low income households also face inequitable consequences from heat islands. The effects are dissimilar to the experiences of POC—“In nearly half the urbanized areas, the average person of color faces a higher summer daytime [Surface Urban Heat Island] intensity than the average person living below poverty”—but are still very significant [4]. Low income households are more likely to have a lack of air conditioning and shelter, and thus are more susceptible to inequitable heat related illness and death during hotter months [6]. 

Systems must be implemented in order to decrease the amount and severity of heat islands, as well as give additional help to demographics most affected by heat islands. Planting vegetation in the ground or on rooftops, as well as using lighter colored materials on buildings are two simple ways to help improve heat island intensity, but there are many more solutions out there that researchers are studying and implementing [2]. As this is a form of local climate change, it is up to local governments to notice and take charge when their communities begin to experience severe heat island effects. It is also important for governments to understand and recognize the inequitable effects of heat islands and to make sure all of their citizens are given aid and funding to help heal these local climate issues. 

References:

1: Learn About Heat Islands. (2022, September 2). US EPA. Retrieved October 9, 2022, from https://www.epa.gov/heatislands/learn-about-heat-islands

2: Urban Heat Island | National Geographic Society. (n.d.). Retrieved October 9, 2022, from https://education.nationalgeographic.org/resource/urban-heat-island/

3: Santamouris, M. (2019). Urban Heat Island and Local Climate Change. In Minimizing Energy Consumption, Energy Poverty and Global and Local Climate Change in the Built Environment: Innovating to Zero. Elsevier. https://doi.org/10.1016/B978-0-12-811417-9.00003-9

4: Hsu, A., Sheriff, G., Chakraborty, T. et al. Disproportionate exposure to urban heat island intensity across major US cities. Nat Commun 12, 2721 (2021). https://doi.org/10.1038/s41467-021-22799-5

5: Ndugga, N., & Artiga, S. (2021, September 8). Extreme Heat and Racial Health Equity. KFF. Retrieved October 9, 2022, from https://www.kff.org/policy-watch/extreme-heat-racial-health-equity/

6: Heat Island Impacts. (2022, September 2). US EPA. Retrieved October 9, 2022, from https://www.epa.gov/heatislands/heat-island-impacts

Biohacking

In 2017, an eccentric biotech CEO injected himself with a homemade herpes cure at a biohacking convention, the whole thing live streamed for the world to see. [1] What was perhaps previously only a fringe subculture in the science community immediately shot into the public eye. But what is biohacking, and how can it be treated lawfully?

Biohacking is traditionally defined as “the attempt to manipulate your brain and body in order to optimize performance, outside the realm of traditional medicine.”[2] This subculture encompasses a wide variety of people and aims: from the extremely health-conscious who wish to live to the age of 180 to those afflicted with a rare genetic condition and have become disillusioned with standard medical treatment. In its practice, biohacking can range from taking daily vitamin supplements, intermittent fasting, or meditating to completely changing the microbiome of one’s gut, implanting microchips in one’s body, and even selectively, artificially modifying one’s genome. While certainly overshadowed by events like the one that made the name famous, biohacking has provided incredible tools to increase the enjoyment of human life. For example, in 2018 a quadruple amputee had a microchip inserted under his skin in order to more easily perform daily tasks like opening doors. [3]

Arguably the most intriguing form of biohacking are procedures that involve the selective manipulation of the human genome. And while human genetic modification is still in its infancy – with examples of which, successful or unsuccessful, being few and far between – its future as a powerful technology should not be dismissed. As genetic modification technology is becoming a reality, its legality must be considered from an ethical perspective. Although home genetic editing kits may have the potential to cause harm and regulatory bodies should respect the principle of nonmaleficence (not doing harm), the adherence to the principle of autonomy, as described by the Principlist philosophy of Beauchamp and Childress, outweighs nonmaleficence and most prominently shapes the nature of the legality of genetic modification kits so as to fit an ethical criterion. 

Autonomy, as defined as “self decision that is free from the controlling interference by others and from limitations that prevent meaningful choice”[4] is a fundamental principle of not only the American bioethical philosophy, but also of our national culture. Autonomy can be further broken down into three qualities: intentionality, understanding, and non-control. For genetic modification kits to be ethically made legal, they must support these aspects of autonomy in their consumers.

Acting with intentionality refers not so much to an action as much as it does the series of events and planning leading up to said action. For an action to be intentional, there must have been some thought or planning that led up to the decision to partake in the action. However, intentionality does not prevent undesired outcomes. An act can still be intentional even if its outcome was not what the agent wanted. This detail is significant, as it separates the principles of autonomy from nonmaleficence. Whereas the principle of nonmaleficence would primarily seek to minimize any and all harm, just because an act causes harm to an agent does not mean that the action has violated the principle of autonomy. Only if the agent had not been made aware of the possibility of harm when forming their plan of action could an act be considered unintentional and not respecting autonomy. Because of this, understanding could be considered a prerequisite for intentionality.

Understanding is simply the state of having adequate knowledge of an action they are going to undertake. This is obviously a vague and subjective criteria, and it can be difficult to determine where the threshold of understanding begins. However, we as a society have decided on actual thresholds of understanding that an individual is required before we can trust that they are acting autonomously in their actions. For example, passing a driver’s test is required before we grant driver’s licenses. Yes, an understanding of road laws is essential to driving safely and preventing harm to others (driver’s test also adheres to the principle of nonmaleficence), but driver’s tests also function to ensure that a potential driver is properly informed of the action in which they are going to participate. It would not be ethical to allow for a person to get behind the wheel of a car without properly understanding both the social contract they are agreeing to between themselves and other drivers and also the dangers of driving.

Lastly, non-control refers to the lack of controlling external influences on decision making. An act can only be autonomous, and an agent can only act autonomously, if their decisions are truly self-directed. Not all forms of external influence violate the principle of non-control (ensuring understanding could be considered an external influence), rather only influences that coerce or manipulate can strip an agent of autonomy. As it regards biohacking, the decision to genetically modify oneself must be sourced internally to the agent, and biohacking must not be used as a method of violating non-control, and therefore the autonomy, in others. 

The criteria by which an action or an agent can be considered autonomous might be considered rigorous, and possibly even infringing on what some believe to be their freedom. However, ensuring people’s right to autonomy is not just allowing people to do whatever they want. Restrictions on “freedom” are in place to limit the influence of others on an individual’s decision and to ensure that an individual has a proper understanding of the action in which they are going to partake. Completely restricting access to genetic modification kits would completely violate the principle of autonomy, as it would deny people their right to self-directed actions and meaningful choice. However, legalizing genetic modification kits without any regulations or guidelines would also violate the principle of autonomy by not ensuring that intentionality, understanding, and non-control are respected. 

One way that bioethicists have succinctly ensured autonomy in medical or regulatory settings is by emphasizing the notion of informed consent. If an agent is not given adequate information about a procedure or an act they are going to perform  (i.e. the agent lacks understanding and/or intentionality), they cannot be considered as acting as autonomous agents (i.e. they are being unethically influenced and cannot give consent). Moreover, if an agent lacks the ability to develop understanding, intentionality, or resist control, they can be considered unable to give consent. An inability to give consent can be due to mental deficiencies, a vegetative state, or simply age. Children cannot be considered autonomous individuals because they can not be trusted to act with intentionality, understanding, and non-control. Buying alcohol for minors is illegal because we acknowledge that children are not developed enough to make autonomous decisions for themselves, and only a truly autonomous agent can understand the risks involved with and engage in a potentially harmful activity like alcohol consumption.

The concept of informed consent underlies the role of a regulatory agency like the FDA. Requiring clear labeling of nutritional information, side-effects of pharmaceuticals, and cancer warnings on cigarette packaging all aid in informing consumers of what exactly they are going to put in their bodies. Not only is this information essential to ensure intentionality and understanding, but it also helps prevent non-control; unequal access to information can create unhealthy, predatory relationships between those that have knowledge and those that don’t. A kit that could be used to edit one's genome must be held to the same standard of transparency. Not everyone has a Phd in molecular biology, and therefore the legality of the sale of technology that can edit human DNA for the masses is contingent on ensuring that the masses have the resources to act with intention, understanding, and non-control. 

While an agency like the FDA is trying to respect the autonomy of the people it influences, it also has a moral obligation to prevent harm, or non-maleficence as it's called. While non-maleficence is generally used in the context of a medical professional preventing the harm that a treatment or experiment could cause to their patient, regulatory bodies should also be held to a similar standard of preventing the harm that genetic modification kits could produce. However, the difference between a doctor’s and a regulatory body’s obligation to non-maleficence is distinct. Whereas doctor’s must be required to not cause harm to their patients, regulatory bodies are not necessarily obligated to keep a consumer of a genetic modification kit from harming themselves. A regulatory body does have an obligation to non-maleficence when a consumer of the product they regulate is not acting as a truly autonomous agent. Like mentioned previously, this can be due to mental deficiencies, a vegetative state, and also ignorance. The role of a regulatory body, as it regards non-maleficence, is to ensure that individuals are not harming themselves because they lacked intentionality or understanding. If an individual is truly informed and able to consent to an action, which would mean they understand the risks involved, and the individual somehow harms themselves, then the regulatory body would not be morally responsible for this harm. Ensuring informed consent is not only vital to protecting consumers’ right to autonomy, but it also underlines a regulatory body’s responsibility to non-maleficence.

One could argue that a regulatory body’s responsibility to non-maleficence extends beyond just ensuring non-maleficence in non-autonomous individuals, and that the responsibility to non-maleficence of regulatory bodies should be held to the same standard as medical professionals (i.e. preventing all harm that a treatment could cause to a patient). Overarchingly, the difference between these two takes is deciding which bioethical principles takes precedence over the other: autonomy over non-maleficence or vice versa. In a case like this, where adhering to two bioethical principles might be contradictory, one should weigh and balance the weight of these two principles in the face of each other.

Instances where the responsibility to non-maleficence outweighs the responsibility to autonomy are referred to as paternalistic. In cases like these, a regulatory body would have the moral responsibility to intervene to prevent harm, even if it meant infringing on one’s right to autonomy. However, for intervention to occur, the following conditions must be met:

1. A patient is at risk of a significant, preventable harm or failure to receive a benefit.

2. The paternalistic action will probably prevent the harm or secure the benefit.

3. The intervention to prevent harm to or to secure a benefit for the patient probably outweighs the risks to the patient of the action taken.

4. There is no morally better alternative to the limitation of autonomy that will occur.

5. The least autonomy-restrictive alternative that will prevent the harm or secure the benefit is adopted. [4]

Regulatory bodies have a more difficult time in adhering to all of these conditions because they cannot act casuistically in their decision making. Regulatory bodies and lawmakers are making broad, generalized rules that should govern all consumers of a product objectively. While a physician might be able to determine that their patient “is at risk of a significant, preventable harm or failure to receive a benefit”, regulatory bodies can not say the same about a whole population. Since regulatory bodies can not as easily meet the conditions of justifying paternalism given the magnitude of their “patients,” it is only ethical for them to favor autonomy over non-maleficence and not justify acting paternalistically.

The potential for harm that genetic modification kits can yield does not necessarily necessitate their restriction. Yes, it is absolutely possible that rational, adult human beings could use genetic editing kits to harm themselves. However, rational, adult human beings drink alcohol, don’t wear sunscreen, and eat junk food all the time. All of these acts cause a great amount of harm to both the individual and society, yet the legality of these products and its respect for autonomy is weighed over the harm that they cause. That being said, it is also the responsibility of a regulatory body to mitigate as much harm as possible without violating autonomy. In the end though, autonomous agents ought to have the right to engage in the use of genetic modification technology, even with the potential for harm present. However, to actually meet the standard of autonomy that predicates their legality, strict rules must be in place that restrict genetic modification kits solely to individuals who act with intentionality, understanding, and non-control. 

Sources: 

1. Chen, Angela. “A Biohacker Injected Himself with a DIY Herpes Treatment in Front of a Live Audience.” The Verge. The Verge, February 5, 2018. https://www.theverge.com/2018/2/5/16973432/biohacking-aaron-traywick-ascendance-biomedical-health-diy-gene-therapy. 

2. Samuel, Sigal. “How Biohackers Are Trying to Upgrade Their Brains, Their Bodies - and Human Nature.” Vox. Vox, June 25, 2019. https://www.vox.com/future-perfect/2019/6/25/18682583/biohacking-transhumanism-human-augmentation-genetic-engineering-crispr. 

3. “Quadruple Amputee Has Microchip Implant to Unlock Doors.” BBC News. BBC, January 18, 2018. https://www.bbc.com/news/av/uk-england-dorset-42725099. 

4. Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York, NY: Oxford university press, 2019.