Precision medicine and the fragmentation of solidarity (and justice)

See (Buyx and Prainsack 2018), especially Chapter three “What is Solidarity?”. This volume is a very thorough discussion of solidarity in the context of health care, though in a more descriptive mode, less so in a normative mode. See also Meulen (2018), who offers a useful history of the emergence of the concept of solidarity in the opening chapter, followed by an analysis of the concept and its relation to the concept of justice, concluding with some emerging challenges to solidarity, especially in the Netherlands. Though Meulen focuses on the Netherlands, the challenges will be similar across the EU (as discussed below). For other analyses and applications of the concept of solidarity in health care, see (Danis, 2018; Schindler et al, 2018; Gheaus, 2017; Butler, 2012; Wilking et al., 2017; Groot et al. 2020; Davies and Savulescu, 2019; Reichlin, 2011; Gould, 2018; Biller-Adorno and Zeltner 2015; West-Oram, 2018; Derpmann, 2018).

Four factors contribute the most to the problem of escalating health care costs in both the US and the EU: (1) costly emerging medical technologies with varying degrees of effectiveness, (2) a growing aging population, (3) an increasing burden of chronic illness related to both the aging population and emerging medical technologies, and (4) enhanced patient expectations related to the promises of those emerging medical technologies. See Aggarwal et al., (2014) and Janus and Minvielle, (2017).

Vokinger et al. (2020) write: “The prices of drugs for cancer have been shown to increase even when evidence emerges that the drug might be less effective than initially believed” (at 664). The headline from a commentary in the journal Cell captures the problem precisely: “How much longer will we put up with $100,000 cancer drugs?” (Workman et al., 2017). In 2017 there were about 70 such cancer drugs; in 2021 there were at least 150 with FDA approval. Literally hundreds of journal articles in the past three years have raised alarms regarding the cost of these drugs as part of the precision medicine initiative. Little else is comparable in the way of socio-economic concern for any class of drugs outside cancer. This is a primary reason why these drugs represent a focused threat to health care solidarity and health care justice.

The vast majority of workers will be workers for their entire life. In contrast, patients tend to be patients episodically, often with different medical needs at different times. That fact by itself makes it difficult to create a persistent identity among patients for the pursuit of a common good.

“This article argues that health care systems that are grounded in solidarity have the right to penalize some users who are responsible for their poor health” (Davies and Savulescu, 2019, at 133).

Meulen (2018) calls attention to the demand in the Netherlands for more personal responsibility regarding health maintenance as a cost control measure. He quotes one Minister of Health Care saying, “Nobody has the right to an unhealthy lifestyle” (at 133). Meulen also cites survey research in the Netherlands supporting the view that people with an unhealthy lifestyle should be forced to pay higher insurance premiums (at 134). No doubt smokers and sunworshippers who develop metastatic cancers that are very expensive to treat would be among the irresponsible imposing these costs on the responsible. This is a clear gap in solidarity that only grows wider as treatment costs become greater.

Segall (2010), for example, who is a luck egalitarian, will argue that those who are irresponsible with their health, and impose those costs on others, have no just claim to having their health needs met. Nevertheless, he adds, compassion requires that society meets those needs, at least for basic health care. In a society committed to solidarity, that reduces those individuals to second-class citizens because they will have clear limits to socially funded health care while all others will have more comprehensive access to socially funded health care.

“Confronted with the growing number of new therapies entering the market at high prices, many OECD countries have raised concerns about their ability to reconcile access to oncology treatments with spending efficiency and sustainability. Expenditure on oncology medicines has steadily increased over time, not only due to higher launch prices, but also to steady increases in the number of patients being treated (a combination of rising prevalence, new treatment options, and increasing duration of treatment)” (OECD Health Division 2020, at 9).

Carrabregu (2016) calls attention to Bayertz (1999) suggesting that solidarity ought to be understood as a supererogatory commitment. That would effectively eliminate the moral challenges posed by precision medicine and other very high-cost life-prolonging medical technologies because social financing of all these interventions would be entirely optional, i.e., non-obligatory. However, that eviscerates almost entirely the normative force of solidarity for purposes of governing the ethically defensible distribution of very costly life-prolonging technologies.

These numbers are roughly half what the costs of these targeted therapies are in the US. This is primarily the result of EU countries being able to bargain as a whole with pharmaceutical companies for extensive discounts (Vokinger et al. 2020). However, the authors emphasize that these cancer drugs will be leading contributors to health care cost escalation in both the US and the EU. They write, “The prices of drugs for cancer have been shown to increase even when evidence emerges that the drug might be less effective than initially believed” (at 664).

In all of Europe in 2018 there were 1.93 million cancer deaths, and 3.91 million new cases of cancer diagnosed. What is significant is that Europe has only 9% of the world’s population but 25% of the total world burden of cancer. See Ferlay et al. (2018).

I remind my EU readers that employers in the US have no legal obligation to provide health insurance to their employees. It is entirely voluntary, largely dependent upon the affordability of that benefit from an employer’s perspective.

Weyco, an insurance benefits administrator in Michigan, required all its employees who were smokers to quit smoking within a year or be fired. The company did random testing to enforce this rule. The no-smoking ban covered off-hours as well, not just working hours (Peters 2005).

Roughly 50% of metastatic cancer patients today would be medically eligible to receive either some targeted therapy or some immunotherapy. That fraction will continue to grow with each new cancer therapy.

See Prasad (2017a, b); Leighl et al. (2021). Leighl et al. write, “Across Europe, there are large variation in access to novel cancer medicines, with less developed countries in Eastern Europe reporting the greatest limitations” (at e2). Also, “Currently, cancer drug pricing does nor correlate with value or clinical benefit” (at e1).

Prostate cancer would be the obvious exception, where PSA levels are monitored for disease progression.

See Zhou et al. (2019); also, Mantovani et al. (2019). Both these articles precisely capture the paradox of p53, namely, that it is designed to prevent cancer but (once mutated) promotes the spread of cancer.

The ICGC/TCGA Pan-Cancer Analysis of Whole Genomes Consortium (2020). “On average, cancer genomes contained 4–5 driver mutations when combining coding and non-coding genomic elements; however, in around 5% of cases no drivers were identified, suggesting that cancer driver discovery is not yet complete.” This was an enormous piece of research that did whole genome sequencing of 2778 tumors across 38 cancer types. This allowed researchers to reconstruct the evolutionary history of each of those tumors, “revealing that driver mutations can precede diagnosis by several years to decades.” Current research suggests there might be 140 genetically distinct drivers of cancer.

There are reasons why exercising that right would be irrational. If for some biological reason in an individual patient that drug would do no good at all, or if it could be known before the fact that it would do more harm than benefit, that patient would have no right to that drug. If anything, denying a patient a targeted therapy with these considerations in mind would reinforce solidarity, not undermine it.

If nothing else, Raza should be ethically commended for requiring that resources to support broad liquid biopsy testing must come from resources currently used to treat cancer, as opposed to heart disease, or lung disease, or some other non-cancerous health need. That may be seen as being congruent with a commitment to health care justice. Potential cancer patients should not be appropriating resources now allocated for actual heart disease to meet the needs of (anxious) potential cancer patients. The relation to solidarity is less clear. Statistically, 25% of those potential cancer patients will have life-threatening heart disease sometime in their life.

This is a commitment that often gets qualified in subtle ways in a number of European countries. In Austria, for example, Grossmann et al., (2020) write, “In the inpatient sector, reimbursement decisions on (often costly) drugs are made by the regional hospital corporations. These fragmented decision-making processes can lead to unequal access between the nine Austrian federal states or even among hospital corporations.” The same is true in the Nordic countries. “This is the case in Nordic countries. For example, local or regional administrations may have variable capacity—both administrative, technical and financial—to respond to the pressures that cancer medicines pose to their systems” (OECD Health Division 2020, at 58). To be clear, coverage of various targeted therapies may have been approved at the national level, thereby honoring a commitment to national solidarity. But the practical application of that commitment below the national level might be quite variable, thereby creating inequities within the country. Are those serious inequities, given the largely marginal benefits associated with most of these targeted therapies? Maybe not, though for a small percentage of patients who might have gained extra years of life if they had had access to a non-covered targeted therapy that loss would be significant (though no one would know who they were). A number of European countries permit the purchase of private health insurance, atop or instead of some national plan. In Switzerland the purchase of heavily regulated private insurance is mandatory with a limit on health care costs of 10% of income. Individuals may purchase private insurance for services not mandated by the government. CAR T-cell therapy was approved for funding in 2020. The Dutch have been moving in the direction of a more privatized health financing arrangement. A reasonably comprehensive plan is guaranteed to everyone but the well-off can purchase additional insurance for costly health interventions not covered in the basic plan (Meulen 2018). If health costs must be controlled, then Meulen argues the package guaranteed to all may be thinned, thereby encouraging the purchase of more supplementary insurance, or, alternatively, co-pays for more expensive interventions with likely marginal benefits can be required within the national plan for everyone. This would likely result in some fragmentation of solidarity (Meulen 2018, at 135–36).

In one scoping review Paulden et al. (2015) identified nineteen such factors that would be relevant to making “value-based” decisions regarding these targeted therapies or other very expensive orphan drugs.

I (Fleck 2009) have worked out in this volume in a much more detailed fashion what a process of democratic deliberation ought to look like that is fair, reasonable, legitimate, and inclusive. In this essay I could provide only the briefest synopsis. More recently (Fleck 2022), I have addressed the complexity of the problems of distributive justice in relation to precision medicine, specifically, targeted metastatic cancer therapies.

I wish to express my deepest thanks to a very patient anonymous referee who has taken the time to offer helpful suggestions on several drafts of this essay. I believe this essay is much improved as a result of those patient efforts. I need to offer one further comment. The notion of rational democratic deliberation might seem to be at this point in time a hopeless utopian delusion, given the irrational resistance in both Europe and the United States to the public health requirements for vaccination against Covid-19. I would just add that the creation and maintenance of our liberal democratic institutions and public reason has been a three-hundred-year struggle which will need to continue with the sustained efforts of dedicated democratic citizens in solidarity.