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  • David Axon
  • 6 days ago
  • 4 min read

With 8% of people in the US in some kind of medical debt, and most of those people owing more than $1000, the American healthcare system clearly has its flaws [1]. Nevertheless, solutions continue to evade our grasp. The task of resolving this issue falls to the “politics” of medicine, which is to say the multitude of theories and attitudes directed towards the legislation of our medical system. Within this scene, the problem of debt proves particularly contentious. The idea that it is justifiable for healthcare to bankrupt patients is almost unilaterally repudiated, but that is about as far as consensus extends. Some people emphasize personal responsibility, others espouse varying degrees of support for government intervention, and still others seek to limit or eliminate medical debt as a whole. However, regardless of political orientation, these views can be boiled down to a few key ethical ideas: justice, equality, and autonomy. 

Before examining the underlying ethical principles, it is important to take a look at the state of the problem today. Across populations and geographic areas, the total medical debt owed at the end of 2021 was estimated to be “at least $220 billion.” [1] This enormous sum accrued in large part due to the American health insurance system, where patients are expected to meet deductibles and copays even with insurance. Additionally, surprise billing and ambiguous pricing can make it challenging to know what is owed. Both factors exacerbate stress and uncertainty in a situation where people are at their most vulnerable, especially for minorities and marginalized populations. Medical debt disproportionately affects people with disabilities, middle aged adults, black people, low income adults, those without health insurance, and rural, Southern communities [1]. As a result, medical expenses are cited as responsible for a striking 66.5% of bankruptcies (from a 2019 study) [2]. Looking at the statistics, one can plainly see why this issue has been garnering national attention—people’s lives and livelihoods are at stake.

Politics and healthcare both pose a host of ethical dilemmas, so it comes as no surprise that their intersection is a hotbed of debate. The first disagreement usually pertains to the role of justice in the American system. Healthcare is a necessity, and it could be argued that people should have equal access to necessities. Nevertheless, hospitals must be equipped with advanced and effective tools, and require funds in order to maintain themselves. Thus, a tension arises: financial resources drive innovation and fuel our healthcare system, but our country has a massive disparity in who possesses those resources. One position maintains that if people have the money to buy better care, they should be entitled to do so: healthcare is a necessity, but we purchase other necessities all the time (houses, food, etc.). In those situations, the rich are allowed access to higher quality goods, so it follows that the system should be consistent. In this sense, the system is “just” because it rewards individual effort and economic contribution. Nevertheless, this same system could also be called unjust because it violates the principle of equality: if all people have a right to medical treatment, then by imposing wealth-based regulation on healthcare many people are denied that right. Those without means disproportionately bear the burden of medical debt, and this translates into other areas of their life, preventing them from accessing business or housing loans. Good health is fundamental to the pursuit of work, and therefore a system which bases healthcare on wealth is cyclical, predatory, and unequal. Moreover, the problem of medical debt calls into question patient autonomy, which states that individuals should be in control of their healthcare decisions. Medical debt often undermines true autonomy by forcing individuals to choose between financial stability and necessary treatment. For example, there are many stories on the internet of people who Uber or rideshare to the hospital rather than taking an ambulance simply because they fear the bill. Autonomy is central to dignity and good patient care, and if people are forced into worse choices about their health simply because they fear being bankrupted by medical debt, their autonomy has been violated. 

In response to the ethical questions raised, politicians have come up with various measures. Shortcomings in insurance coverage increase the likelihood of debt [1], and forms of universal healthcare would combat this. However, opponents worry that it would constitute a sizable burden on the hospital system, worsening quality of care, increasing wait times, and distorting incentives. In addition to expanding coverage, politicians are focusing on ameliorating the negative effects of debt. This past January, the Biden administration finalized a bill to “[prohibit] lenders from considering medical debt when assessing the creditworthiness of borrowers,” but the Trump administration has since placed it on hold [3]. As unpaid medical bills are the “largest source of debt reported to collections agencies,” this could substantially help those with poor credit scores get their lives back after going into medical debt [3]. The unpredictability and urgency of most medical situations means that it is a poor predictor of whether or not people will actually pay back loans, so this new rule affecting lenders attempts to reinterpret how credit worthiness is assessed [3]. While the bill was put on hold by the Trump administration, so were all activities of the Consumer Financial Protection Bureau; in all likelihood, bipartisan support will help enact this rule in the near future. 

The problem of medical debt is both nebulous and perfectly clear. Though disagreements persist about the correct course of action, and the causes resist being pinned down, both sides of the aisle can agree that we need a solution. Perhaps by focusing on the ethical principles which support the broader political movements, we can understand that what seem like opposing stances share common motivations. Both parties wish to preserve justice, equality, and autonomy (in different measures); by recognizing this shared goal, we can shift the discussion to what it really is: a delicate balancing act between financial and ethical responsibility. Yet a consensus must be reached, especially because the privilege—or right—to healthcare is quite literally a question of life and death.


Designed By: Shameema Imam

Edited By: George Nathaniel,

References

[1] Shameek Rakshit, M. R. (2024, February 12). The Burden of Medical Debt in the United States. KFF. https://www.kff.org/health-costs/issue-brief/the-burden-of-medical-debt-in-the-united-states/ 

[2] Himmelstein, D. U., Lawless, R. M., Thorne, D., Foohey, P., & Woolhandler, S. (2019). Medical Bankruptcy: Still Common Despite the Affordable Care Act. American journal of public health, 109(3), 431–433. https://doi.org/10.2105/AJPH.2018.304901




 
 
 

In today’s world, science moves at a breakneck speed, constantly influenced by political and social needs. Groundbreaking medicines are developed every year, giving people an arsenal with which to fight a seemingly ever-expanding number of diseases. In light of recent crises such as COVID-19, one question has come to loom large: when it comes to drug approval, how fast is too fast? The U.S. Food and Drug Administration (FDA), tasked with protecting public health through the regulation of items such as drugs and food, sits at the center of this ethical balancing act — carefully walking the line between speed and safety. However, as commercial and societal pressures intensify, so have the ethical dilemmas surrounding the FDA’s role.



The FDA’s drug approval process is designed to be rigorous: most new treatments go through multiple phases of inspection, with each intended to verify the efficacy and potential side effects of the drug. Yet, this system can take years, delaying critical access to potential life-saving medications for patients that don’t have long to live. This paradox raises critical ethical questions: when does “caution” become harm? Who decides what level of risk is acceptable? And, perhaps most importantly, what should the FDA emphasize in its approval of drugs?

To reach conclusions, we must first understand the underlying issues. A key tension lies in the battle between non-maleficence (the principle of “do no harm”) and beneficence (the duty to help). Accelerating drug approval may help terminally-ill patients gain early access to therapies, but it can also expose them  to unknown harms if evidence and data are too limited. The FDA’s Emergency Use Authorization (EUA) system, used during the COVID-19 pandemic, serves as a key highlight of this issue. The EUA allowed for the use of vaccines and treatments without full clinical trial data, effectively expediting clinical response but raising public concerns about safety, particularly after pauses like that of the Johnson & Johnson vaccine due to rare clotting events [1].

Similarly, the Accelerated Approval Pathway (AAP)—designed for drugs treating serious or life-threatening conditions—has come under scrutiny. The 2021 approval of Aduhelm (aducanumab) for Alzheimer’s disease, despite minimal evidence of clinical benefit, sparked backlash against the AAP from scientists, ethicists, and members of the FDA advisory committee, three of whom resigned in protest [2]. Critics argued that the decision reflected not scientific rigor, but industry lobbying and political pressure. Yet, for families facing an incurable disease, even modest hope was considered justification enough. This raises a core question — how much do individual patient interests matter in the drug approval process? Should patients who are willing to suffer side effects, as long as they receive immediate care, be able to gain expedited access to a treatment?

These cases underscore how an environment of urgency can override long-standing protocols. Pharmaceutical companies, advocacy groups, and lawmakers all exert their own influences—sometimes pushing the FDA to act swiftly in ways that stretch or challenge its ethical foundations. The Right to Try Act of 2018, for example, allows terminally ill patients to access experimental treatments without FDA oversight. While it has been hailed as empowering, it bypasses safety review mechanisms designed to protect the vulnerable, and has raised questions about the importance of autonomy vs. paternalism in end-of-life care [3].

Ethical concerns also extend to justice and equity. Do fast-tracked drugs benefit all communities equally? Often, the answer is no. Marginalized populations are less likely to be represented in clinical trials and may face barriers to accessing newly approved treatments due to cost or location [4]. The risk, then, is not only approving unsafe drugs but also creating or reinforcing disparities in care availability and access.

The FDA is not static—it is an evolving, respondent entity. In response to criticism, it has tightened requirements for post-market studies under accelerated approvals and pulled back endorsements when follow-up trials fail to confirm initial suspected benefits. For example, in the case of Makena, a drug approved to prevent preterm birth, the FDA recently recommended withdrawal after post-approval data showed limited effectiveness [5]. These reversals, while controversial, reflect the agency’s efforts to balance responsiveness with accountability.

Ultimately, the FDA's decisions are more than just data-driven scientific evaluations. They are ethical judgments made under conditions of uncertainty and nuance. Carefully balancing special interests with overarching regulatory and ethical principles is essential—exceptions should not be made for cases that go against ideas of equality and accessibility. As we look to the future, the challenge is not to choose between speed and safety, but to develop a framework that better integrates both. This means improving data transparency, patient representation, and public communication, while reaffirming that ethical vigilance must serve as the ultimate guide to all regulatory action.


Designed By: Jackie No

Edited By: Alec Vazquez-Kanhere


REFERENCES

[1] U.S. Food and Drug Administration. (2021). Emergency Use Authorization for Vaccines Explained. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained


[2] Dyer, O. (2024). Aduhelm: Biogen abandons Alzheimer’s drug after controversial approval left it unfunded by Medicare. The BMJ, q281–q281. https://doi.org/10.1136/bmj.q281


[3] Brown, B., Ortiz, C., & Dubé, K. (2018). Assessment of the Right-to-Try Law: The Pros and the Cons. Journal of Nuclear Medicine, 59(10), 1492–1493. https://doi.org/10.2967/jnumed.118.216945


[4] Bibbins-Domingo, K., & Helman, A. (2022). Barriers to Representation of Underrepresented and Excluded Populations in Clinical Research. In www.ncbi.nlm.nih.gov. National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK584407/


[5] Commissioner, O. of the. (2023, April 6). FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena. FDA. https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena




 
 
 

If I had an extra hour every day, I would spend it...

 

This application classic is the Pumpkin Spice Latte of essay prompts: wildly overdone, kind of expected, and weirdly unavoidable. And yet, every time we encounter it, thousands of us pretend that this hypothetical 60 minutes will change the trajectory of humanity. We’ll finally write that novel, discover the cure to an obscure disease, win a Nobel Prize, or maybe even do all three. But let’s be honest: for most of us, that extra hour would dissolve into the background noise of daily life. We’d wake up ten minutes later, scroll through a few more TikToks, and spend a little longer debating whether to go to the gym before deciding to just go tomorrow. That’s the bonus hour, gone before it even knows it’s extra. But what if it wasn’t just an hour? What if you could get an extra month? An extra year? Maybe even ten?

 

Thanks to breakthroughs in aging research, that question is no longer just a lazy hypothetical. Scientists are beginning to ask whether aging, once considered an immutable force of nature, might actually be something we can delay, manage, or even treat. Drugs like Metformin and Rapamycin, originally developed for diabetes and immunosuppression, are now being repurposed for their potential to slow cellular aging. At the same time, pressure is mounting to reclassify aging as a disease. Together, these shifts have pushed the idea of gaining extra time beyond the realm of wishful thinking that turns bonus hours into Nobel Prizes. But what we do with that time, and who gets access to it, might expose not just what science makes possible but what society is willing, or unwilling, to make fair. Because if time really is the most valuable thing we have, then how we define it, regulate it, and distribute it might say more about us than we are ready to admit.

 

Despite growing scientific interest, aging has yet to be classified as a disease by the Food and Drug Administration (FDA), which continues to define it as a natural and biological process [6]. Similarly, other influential health bodies, such as the World Health Organization, have taken similar stances, focusing on aging healthily and age-associated decline without calling aging a condition in its own right [4]. This debate goes beyond dictionary definitions; it shapes what gets studied, funded, and ultimately delivered to patients. Such ambiguity has created a regulatory limbo: researchers cannot officially run clinical trials for anti-aging treatments because aging lacks formal recognition as a disease. Without FDA approval pathways, dedicated funding, or clear incentives, progress grinds to a halt, financial support dwindles, and the science remains stuck in preclinical gridlock [6].

 

Thus, some proponents of the classification of aging as a disease argue that the standstill movement of pharmaceuticals in biogerontology reflects a failure of policy rather than of science [1]. Certainly, the science is ready; we know cellular degeneration can be studied and potentially slowed. However, the FDA’s current system is built for discrete diseases with quick symptom onset and measurable outcomes. Aging doesn’t work like that. It’s gradual, multi-systemic, and notoriously hard to measure, making it incompatible with the approval models we currently use [6]. In a field where innovations are moving faster than the regulatory definitions meant to govern them, a regulatory reclassification would enable researchers to focus on aging itself rather than navigate complex administrative hurdles [5]. Indeed, promising drugs that already show significant efficacy in model organisms, like Rapamycin and Metformin, could finally be tested with long-term, large-scale studies instead of operating in the shadows of off-label use. Aging, defined as a disease, would transform longevity science from a patchwork of workarounds to a legitimate, regulated frontier of innovation.


Until then, scientists and biotech companies are forced to get creative. Consider studies like TAME, Targeting Aging with Metformin, which sidesteps the mention of aging altogether, instead looking at whether Metformin can delay multiple chronic diseases at once [3]. It’s regulatory rule-bending, not to deceive, but to function within a system that is not yet designed to ask the questions scientists are ready to answer. But while the system stalls, time doesn’t. Many of the researchers studying aging don’t have decades to wait for the FDA to catch up. It’s try or die. That’s why some of the same scientists who publicly urge caution about drugs like rapamycin are privately taking it themselves [7]. Simply put, it’s the research equivalent of “Do as I say, not as I do.”

 

Undoubtedly, such instances of off-label use reveal growing divides. Because aging is not classified as a disease, drugs like Rapamycin, when used preventatively, fall outside FDA-approved indications. As a result, patients must often pay out of pocket, bypassing insurance coverage entirely. These costs, combined with the need for access to longevity-focused physicians and private health networks, place anti-aging interventions firmly out of reach for most people. What emerges is a two-tiered healthcare system, where the wealthy not only receive better treatment, but they also potentially get more years of it [3]. 


Defining aging as a disease does not just risk changing how we treat older adults—it risks changing what we expect from them. As medical innovation continues to push the boundaries of life extension, choosing not to intervene has become increasingly stigmatized. In the current healthcare system, declining procedures like cardiac bypasses or transplants, even in one’s nineties, are condemned, even deemed as unnatural [3]. As sociologist Sharon Kaufman notes, what was once optional care is now standard, and what was once standard has become morally expected [3]. The technological imperative, the idea that we can intervene, has quietly become an ethical one: that we must. Framing aging itself as a disease would only deepen this shift, making it even harder for individuals to age on their own terms without being seen as irresponsible, irrational, or in decline. In the pursuit of treating aging, we may forget how to respect it.

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Ultimately, it is undeniable that science is ready to treat aging. Rather, the urgent question is whether we are, too. The stakes are higher than simply clinical trials or regulatory reform. When time becomes something to be purchased, prescribed, or postponed, it stops being a shared human experience and starts becoming a new kind of currency, one that not everyone can afford. In chasing longer lives, we risk narrowing down what it means to live well. And if we’re not careful, the future of aging won’t be defined by biology or breakthroughs but by who’s allowed to grow old with dignity and who’s quietly denied the chance.


Reviewed By: Aria Eaddy

Designed By: Sonali Patel


References:  

  1. de Grey, A. D. N. J. (2005). Resistance to debate on how to postpone ageing is delaying progress and costing lives: Open discussions in the biogerontology community would attract public interest and influence funding policy. EMBO Reports, 6(Suppl 1), S49–S53. https://doi.org/10.1038/sj.embor.7400399 

  2. Kaufman, S. R., Shim, J. K., & Russ, A. J. (2004). Revisiting the biomedicalization of aging: Clinical trends and ethical challenges. The Gerontologist, 44(6), 731–738. https://doi.org/10.1093/geront/44.6.731

  3. Lugo, N. (2024, October 8). Breakthrough research: Common medication may hold key to slowing aging. Virtue Recovery Centerhttps://www.virtuerecoverycenter.com/breakthrough-research-common-medication-may-hold-key-to-slowing-aging/

  4. Mendoza-Núñez, V. M., & Mendoza-Soto, A. B. (2024, February 24). Is aging a disease? A critical review within the framework of ageism. Cureus, 16(2), e54834. https://doi.org/10.7759/cureus.54834

  5. Newcomb, T. (2023, January 6). Humans can start living longer—Once the FDA does this. Popular Mechanicshttps://www.popularmechanics.com/science/health/a42419017/anti-aging-drugs-fda-approval/

  6. Tournas, L., & Marchant, G. E. (2019). The fountain of youth revisited: Regulatory challenges and pathways for healthspan promoting interventions. Food and Drug Law Journal, 74, 405–426.

  7. Whalen, J. (2024, March 15). A transplant drug shows promise for extending life. Should you take it? The Washington Post. https://www.washingtonpost.com/business/2024/03/15/rapamycin-longevity-drug/


 
 
 

DMEJ

   Duke Medical Ethics Journal   

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