Inaccessibility of Tissue Engineering and Regenerative Medicine

Possibly the most prevalent issue that looms over our technologically innovative society is wealth inequality, this is the unequal partitioning of resources amongst the community. Thus, with great expectations and influence comes immense inequality that permeates throughout society, yielding innumerable opportunities not obtainable by others. The upper end of resources and wealth distribution was limited to those with privilege and “importance” within society. This is highly pertinent to the issue of wealth and social inequality in the modern day world, further carrying its burdens into the medical field, and more specifically, into the realm of tissue engineering and regenerative medicine (TE-RM). 

The Oxford Dictionary defines socio-economics as “the interaction of social and economic factors”; when it comes to medicine and the advent of newly developed therapies, quite a few predicaments arise as a result of these factors. TE-RM developments are quite revolutionary and provide a sense of hope when it comes to new treatments being researched and commercialized; they provide a solution to the perennial transplantation waiting lists resulting from tissue and organ shortages. But the cost of purchasing these new treatments are highly unattainable for the majority of people that follow a “normal” career path and acquire average salaries—the “bulk” of the hierarchical pyramid. These treatments are primarily accessible to the rich and privileged—the “royalty.” According to the U.S. Bureau of Labor Statistics, the average salary of a worker in the United States is approximately $54,000/year. Meanwhile, the cost of a tissue-engineered airway transplant treatment ranged from $175,000 to $740,000 (Culme-Seymour, 2016). This transplant is one of many costly examples of tissue engineered transplants. When referring to the average salary of your typical American citizen, it would take several years to even graze the price of one treatment. Similarly, regenerative medicine, also a relatively new field that is rapidly evolving, includes stem cell therapies—specifically injections—which range from $5000 to $50,000 (Cona, 2023). Although the numbers are not nearly as dramatic as the tissue-engineered airway transplant, it is expensive nonetheless and would be incredibly debilitating to the financial stability of an individual if they were to follow through with these procedures. TE-RM is still a new subject that is being discussed in the science world despite its origins in the early 1970s, when a pediatric orthopedic surgeon, Dr. Green, began a series of experiments that attempted to generate new sets of cartilage through the use of chondrocytes that were seeded onto spicules of bone and then implanted into mice (Vacanti, 2006). The pursuit of tissue engineering and regeneration of the body through the use of the body’s own systems proceeded to take foot and accelerate in its evolution thereafter. Henceforth, due to its precarious state that continues to receive elaborate thought and research from scientists, it is sensible that the cost of treatment is set at such high prices. However, in terms of ethics and morality, the latter of the public are seldom able to afford the treatments and it is evident that only affluent people can obtain these treatments. 

Moreover, with the issue of income inequality and socioeconomic factors in TE-RM, there is the broader matter of health literacy. Health literacy is defined as the extent to which patients fully grasp the concepts of specific services offered to them by organizations in order to make informed decisions in regards to their personal health (CDC, 2023). This is especially important as medical treatments ultimately have the ability to alter your life’s trajectory for better or worse. The lack of health literacy for TE-RM treatments exemplifies a discernible imbalance in power, leaving room for physicians to abuse their knowledge and increase prices, as well as take advantage of patients. John Moore, an advocate for patients’ rights, was diagnosed with a rare form of cancer: hairy cell leukemia. Hairy cell leukemia occurs when the body produces defective lymphocytes and as a result, the body’s immune system is compromised. In Moore’s case, UCLA physicians confirmed his diagnosis through blood tests and the withdrawal of other bodily fluids. The test results exhibited substances in his blood that were of critical value for further scientific developments. Moore was required to undergo surgery and although he consented to the surgery, he did not consent to having his defective T-lymphocytes being used in research and, therefore, he did not provide “full informed consent” to the doctors’ plans, which led to the use of his spleen cells being utilized without his authorization (Nott, 2020). This reiterates the topic of health literacy as Moore was not entirely informed about the crucial details regarding his treatment and extracted bodily materials. Physicians, who have received several years of education in regards to medicinal topics and constitute the role of “scribe” in the metaphorical pyramid, clearly have the advantage over patients and are the ones responsible for ensuring their patients are aware of even the miniscule details of various procedures. It is not always the case, but because of this privilege, there is room for physicians to take advantage of marginalized communities that do not have the liberty of receiving such education and knowledge in order to make their own informed decisions. Subsequently, as TE-RM is still a newly developed practice that requires further research, it is of central importance that patients are properly informed of the details within their treatment and procedures, especially since it could mitigate the probability of being taken advantage of—akin to Moore’s scandal. 

Even so, wealth inequality and socioeconomic issues are always going to be present—especially when it comes to TE-RM—but as a community of innovative thinkers, there are ways to maneuver around these issues. The first matter to address is the incredibly bizarre prices of TE-RM treatments and how to abate these costs so they are accessible to a more extensive demographic. A fundamental aspect that will overall allow this process to bloom is government intervention; higher ranking officials and large corporations are the ones responsible for new legislation and regulations, so bringing them into medical reform is a plausible route. The Affordable Care Act (ACA), a law established in early 2010, was enacted with the initial goal of providing affordable health insurance to more people. Although it had tangible benefits that allowed underrepresented and underprivileged communities to afford healthcare, its high regulations were the prime reason for the considerable costs of treatments, especially with rising tissue engineered constructs. The Affordable Care Act has requirements set in stone, forcing insurance companies to cover large numbers of benefits in order for affordable health insurance to be integrated. As a result of the expansion of health care coverage, spending growth slowed but there was an overall increase in national health spending from $2.60 trillion in 2010 to $3.65 trillion in 2018; the second goal of reduced healthcare spending was not met (Antos, Capretta, 2020). On that account, if the government were to intervene and merely dwindle their regulations pertaining to insurance and health plans, it would moderate the cost of these treatments. Moreover, one significant case that dabbles on the consequences of healthcare insurance and spending is that of 53 year old Susan Finley. Finley was laid off from her job and as a result, no longer had health insurance coverage. She was recovering from a severe case of pneumonia while simultaneously searching for a new job. All the while, she fell victim to the health insurance system and avoided a doctor's appointment due to its unaffordability, ultimately leading to her timely death after failing to treat her surfacing flu-like symptoms (Farooq, 2019). Another similar case that indulges in TE-RM specifically is Henrietta Lacks and her surviving children. Lacks was a patient at Johns Hopkins Hospital who unfortunately passed as a result of cervical cancer. Her case was renowned for the use of her nonconsensually extracted HeLa cells in the creation of polio vaccines, in vitro fertilization techniques, cancer research, and drug manufacturing for several illnesses (McKie, 2010). But despite the profits gained by organizations within the medical industry, her children have yet to receive compensation—let alone health insurance. Their medical needs have been neglected entirely due to their inability to afford care. Cases such as these bring awareness to the harsh reality of the medical industry and its corruption. It is the amalgamation of extended healthcare coverage and new treatments that become major players in the medical treatment game. Ergo, if the government were to intervene and diminish such explicit requirements for health plans, it is possible to avoid an increase in health care expenses for patients who are unable to afford them. 

With the solution of government intervention being addressed, it is also important to acknowledge the connection between higher treatment prices and the need to focus on solely research in the interim of new developments. Essentially, an observed reason for high prices in medicine is the expansion to new treatments and procedures. In order to produce new treatments for various diseases, understanding of the body’s genomics is required. This allows us to assess the mechanisms in which the body reacts to diseases and how those diseases truly damage the body. Through that, scientists are able to find methods used to target specific issues. However, diseases are becoming increasingly complex, requiring copious effort and time to be put into these new projects. The medical industry is constantly presented with new challenges to overcome, hence leading to the large expenses. For example, cancer was identified through its cell and tissue type previously, but now there are new ways to identify them by genotype and delve into the specific arrays of genes (Burke, 2020). New cancer drugs then have to target those specificities, providing oncologists with more options to fit their patients’ needs, but also introducing the complexity factor. The same applies in TE-RM, where there is a constant complexity factor due to it being a relatively new practice. This complexity factor results in an increase in the pharmaceutical industry’s spending, where top pharmaceutical companies spend around 17% of their revenue on research and development (Burke, 2020). The early phases of development are where the bulk of the funds are invested, providing precedent as to why drugs and treatments released to the public immediately following development are especially expensive. Therefore, in order to rectify this, an approach scientists can take is increasing the time spent on TE-RM research to ensure all aspects of the developed treatments are well-prepared and fully researched prior to approval from the FDA—especially due to the harsh regulations that spur difficulty in getting approval. This would ensure companies and organizations do not lose money in the process of treatment development in TE-RM, thus leading to a palpable reduction in prices and accessibility to more people. 

Consequently, an additional benefit to increasing the time spent on research is the opportunity to ameliorate health literacy. Mary Pierce postulates, “Sometimes things aren’t clear right away. That’s where you need to be patient and persevere to see where things lead.” Time and patience are our greatest virtues; in the medical industry, time is a rudimentary factor that is inevitable and only the patience we have can determine the trajectory of our developments. If scientists and physicians allocate more time to research and development, then they will have a more elaborate record of their findings and will likely garner a deeper understanding of numerous tissue engineering constructs including tissue-engineered organs used for implants, pluripotent stem cell therapies, 3D bioprinting, and much more. Similar to an equilibrium reaction, if you apply time to acquire more knowledge on the physician’s side, then the equilibrium will shift to the patient’s end and increase their knowledge, thus increasing their health literacy accordingly. 

As the developments of TE-RM perpetually advance and evolve hereafter, the accessibility of tissue engineered therapies will undeniably adhere to unethical conditions for the “bulk” of the pyramid. However, devoting more time into the research and development process and encouraging the government to modify its ACA policies, will hopefully allow more than just the upper class to access TE-RM procedures. 

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Sophie Boeun is a graduating high school senior (Class of 2024) from California. She is incredibly passionate about medicine and literature, with a profound interest specifically in intertwining the two contrasting subjects imminently. In her free time, she enjoys reading novels of various genres (anything from mystery/thrillers to fantasy), writing stories, and baking sweet treats for friends and family!

References

Louis A. Cona, MD. “The Cost of Stem Cell Therapy in 2023.” RSS, 23 May 2023, www.dvcstem.com/post/stem-cell-therapy-cost-2020

Vacanti, Charles A. “The History of Tissue Engineering.” Journal of Cellular and Molecular Medicine, vol. 10, no. 3, 21 July 2006, pp. 569–576, https://doi.org/10.1111/j.1582-4934.2006.tb00421.x

“What Is Health Literacy?” Centers for Disease Control and Prevention, 11 July 2023, www.cdc.gov/healthliteracy/learn/index.html

Nott, Rohini. “Moore v. Regents of the University of California (1990).” The Embryo Project Encyclopedia, 18 Nov. 2020, embryo.asu.edu/pages/moore-v-regents-university-california-1990  

Antos, Joseph  R, and James C Capretta. “The ACA: Trillions? Yes. A Revolution? No. | Health Affairs.” HealthAffairs No., 10 Apr. 2020, www.healthaffairs.org/content/forefront/aca-trillions-yes-revolution-no 

Burke, Hannah. “Why Does It Cost so Much to Develop New Drugs?: Proclinical Recruitment Blogs.” Proclinical, 22 Sept. 2020, www.proclinical.com/blogs/2020-9/why-does-it-cost-so-much-to-develop-new-drugs

Farooq, Sarah. RCL, 23 Apr. 2019, sites.psu.edu/rclbysarahf/2020/04/

McKie, Robin. “Henrietta Lacks’s Cells Were Priceless, but Her Family Can’t Afford a Hospital.” The Guardian, 3 Apr. 2010, www.theguardian.com/world/2010/apr/04/henrietta-lacks-cancer-cells