I recently received a call from my university’s general counsel’s office, looking for health law advice about patient no-shows at a campus community health clinic. We discussed tort theories, including establishment of the physician-patient relationship and patient abandonment, as well as privacy issues with respect to contacting patients via email, phone, or a friend or relative. I then offered that the clinic might consider looking more deeply at the reasons for the patients’ lack of follow-through with appointments and treatment, including various social, economic, transportation, childcare, and other lifestyle barriers. I roughly described the concept of “social determinants of health,” which captures the problems to which I was referring. I explained how our law students working with medical-legal partnership clinics face similar challenges: clients may initially present with significant legal needs, which they are highly motivated to address, but then fail to keep follow-up appointments. The attorney was intrigued and asked me to forward some relevant literature on the various issues that I had identified.
It was easy enough to find cites for the torts and privacy topics, but surprisingly more difficult to identify a clear, definitive article describing the essential concept of social determinants of health. Given the increasing prevalence of the term within not only public health but also health law circles, I was surprised at my difficulty finding literature that explained this now-essential concept in a way that the uninitiated could understand. Thus, I was delighted last week to come across Wendy K. Mariner’s Beyond Lifestyle: Governing the Social Determinants of Health.
In her succinct article, Professor Mariner places the concept in a broader context that the specific application that I described to the attorney who called me. Social determinants of health is not a local or national problem but a global concern that calls for global solutions, on the level of other, more clearly recognized and accepted public health strategies to address the spread of infectious diseases. Although public health measures at various times have been challenged as overly coercive and paternalistic, the public now mostly accepts the need for vaccination, sanitation, quarantine, and even compelled treatment as strategies to control disease outbreaks, including highly salient recent examples of Zika and Ebola.
Despite the acceptance of those traditional public health strategies, Professor Mariner explains that health policy needs to broaden, or perhaps shift, its focus to more prevalent causes of poor health. With compelling data, she demonstrates that chronic diseases, including heart disease, stroke, and chronic obstructive pulmonary disease, have well surpassed communicable diseases as the leading causes of death internationally. The article then clearly defines the concept of social determinants of health, situating it along with biomedical and environmental causes of health, as identified in scholarly literature and international health policy declarations. Professor Mariner examines competing models of social determinants, some linear and others more interactive and layered. Regardless of the model, the essential point is the same: Health is impacted by a wide range of factors, including but not limited to discrimination, education, gender, political participation, poverty, housing, access to health care, occupation, and agricultural practices. Thus, the prescription for improving population health must address far more than contagious disease outbreaks.
Professor Mariner notes that even where health policymakers have embraced the prevalence of chronic diseases as a significant problem, their interventions have often missed the mark. The current approach to chronic, non-communicable diseases is to focus on individual lifestyle “choices,” such as substance use, diet, and physical activities. I place “choices” in quotations to emphasize Professor Mariner’s next significant point, which is that, by looking through the social determinants of a health lens, one recognizes that social, economic, and environmental factors greatly constrain individuals’ opportunities to engage in healthy behaviors. With that insight, health policy can be appropriately redirected to the underlying causes of inequality and redistribution of societal resources.
To that end, Professor Mariner proposes a human rights approach. The first step is recognizing the wider range of fundamental causes of illness and injury, as the social determinants concept does. The second step requires political forces to align in recognizing health as a fundamental human right, as a number of international covenants and treaties already do. Combining these two steps means turning policymaking attention to inequalities in access to income, education, employment, housing, political voice, clean environment, and health care, while proceeding cautiously with respect to wellness programs and other interventions that focus on individual responsibility instead of underlying causes of poor health.
The article concludes on a cautionary note, noting significant obstacles to addressing social determinants of health through the human rights approach. For one, many international human rights declarations and health policy recommendations lack enforcement mechanisms. Also, countries often resist adopting policies that would seem to impede economic progress and international trade. Those two obstacles are particularly salient in the United States, where we have yet to ratify a number of international declarations recognizing health as a human right and continue to prioritize commercial trade over social policies. But despite the challenges of implementing her prescription, Professor Mariner’s article boldly and clearly outlines an essential concept for health policy going forward. The particulars of how specific countries will incorporate social determinants into their health law and policy agendas remains to be seen.
Although the U.S. spends far more per person on medical care than any other nation, the results have been less than impressive. Relative to other developed nations, the U.S. consistently performs worse on a wide range of health measures, including infant mortality, premature deaths, life expectancy, and prevalence of heart disease, diabetes, and other chronic illnesses. Many health care experts have pointed to inefficiencies in our health care system as the cause for this paradox. Bradley and Taylor identify another culprit — too little attention to the social, environmental, and behavioral factors that impact health.
The book begins with a summary of the authors’ previous research comparing spending on health care and social services among OECD countries. This research found that when spending on health care is combined with spending on social services, the U.S only ranks in the middle of OECD countries. More importantly, the U.S. is an outlier when comparing the ratio of a nation’s social to health spending, with the U.S. allocating a far greater share of its gross domestic product to health care than to social services. This suggests that the U.S. is shortchanging the social services that help people live healthier lives, including public health, housing, education, community safety, and income support. The authors’ conclusion finds support in their recently published study comparing state spending, Variation in Heath Outcomes: The Role of Spending on Social Services, Public Health, and Health Care, 2000-09, 35 Health Affairs 760 (May 2016), which found that states with a higher ratio of social to health spending had better health outcomes. Chapter 3 of the book brings the data to life by profiling three individuals who incurred significant (and expensive) health problems when their social and behavioral health needs went unmet.
But Bradley and Taylor do not simply argue that the U.S. could get more bang for the buck if it rebalanced spending between health care and social services. Rather, they make the equally important and often overlooked point that the U.S. must do a better job of integrating health and social services. Chapter 2 provides a historical overview of the U.S. health care and social services sectors, highlighting the fragmentation plaguing both sectors. Chapter 4 compares the health and social services systems of the U.S. and Scandinavian countries. The authors make a not wholly convincing argument that cultural and political differences between the U.S. and Scandinavian countries are smaller than generally believed and that the U.S. therefore can learn much from these countries. More usefully, the Scandinavian examples concretely illustrate the value of coordinating health and social services, as well as the importance of assigning accountability for a population’s health to a centralized entity (with locally elected government officials serving this role in Scandinavian countries). Chapter 5 further underlines the potential for synergy between the health care and social services sectors with a description of four organizations in the U.S. that are successfully coordinating health care and social services.
The book also provides some useful lessons for those seeking to better integrate health care and social services. Chapter 6 analyzes previous efforts in the U.S. to integrate health care and social services, namely the push for neighborhood health centers in the 1960s and health maintenance organizations in the 1970s and 80s. The authors explain how both efforts were undermined by powerful interests opposed to these developments and an American culture that values personal responsibility. Chapter 7 highlights other challenges, most importantly how the fragmentation of health care and social services is reinforced by a political system that primarily makes decisions about social services at a local level while decisions about health care services are made at the state and federal levels. Proponents of future efforts to integrate health care and social services will need to consider how best to overcome these political forces.
While the authors do not offer specific prescriptions for how to correct the paradox they identify, their insights teach us that reforming the health care sector in isolation from the social services sector is not the solution. In doing so, they help reframe the conversation about how to improve Americans’ health.
Lisa Forman, Can Minimum Core Obligations Survive a Reasonableness Standard of Review Under the Optional Protocol to the International Covenant on Economic, Social and Cultural Rights?
, 47 Ottawa L. Rev.
(forthcoming), available at SSRN
The U.S. legal discourse on health rights is impoverished, neglected, and underinformed. The right to health is reflexively dismissed as one of the affirmative rights that our tradition of negative liberties renders irrelevant. And there (I exaggerate only slightly) conversation stops. But when we inspect this conversation-stopper, it is based on overgeneralization. The truth is more fact-dependent. Lisa Forman, in Can Minimum Core Obligations Survive a Reasonableness Standard of Review Under the Optional Protocol to the International Covenant on Economic, Social and Cultural Rights? (forthcoming in the Ottawa Law Review), gives us a window into the granular.
Managing to adjudicate an “unwieldy” health right
Although the right to health, as a right of the economic, social, and cultural variety, is often thought to be a right to some affirmative state provision rather than a negative liberty from state action, this assumption is belied by laws in the U.S. that can function as negative rights to health. For instance, some laws protect private use of plant varieties relating to essential foodstuffs against enforcement of government-granted monopolies, or provide procedural rights for a health impact assessment prior to government action that harms health. Those examples reveal statutes or regulations that restrict governmental power to infringe on individuals’ right to health. Nevertheless, once labeled as “positive rights,” health rights frequently assume a reputation as unmanageable. Forman voices this conventional wisdom succinctly: the realization of the right to health, under this skeptical view, “requir[es] extensive state action and resources, so that judicial enforcement would reallocate budgets and alter social policy, breaching the appropriate democratic separation of powers and wreck[ing] budgets.” And yet, jurisdictions outside the U.S. manage to adjudicate such rights day in and day out, handling them just as the legal system treats all kinds of other unmanageable questions, by generating thick, fact-rich jurisprudence.
Forman is among my trusted voices in the argument for a right to health with “bite.” Indeed, she is looking at the shape of the serration. The right to health operates in other contexts, justiciable in jurisdictions such as South Africa, Colombia, and Israel, but also within a body of international law binding on the global community. All countries are subject to human rights obligations under the United Nations Charter. The Universal Declaration of Human Rights (UDHR), which all U.N. members unanimously adopted in 1948, is not itself a treaty, but the common authoritative elaboration of the human rights obligations imposed by the Charter, including rights relating to health and medical care. The International Covenant on Economic, Social and Cultural Rights (ICESCR), now ratified by roughly two-thirds of countries (not including the U.S.), is a more detailed specification of the economic, social, and cultural human rights provisions of the UDHR.
In this article, Forman alerts us to a rather striking development. The Committee on Economic, Social and Cultural Rights (CESCR)—which is the UN Committee charged with overseeing the realization of the ICESCR rights—has issued an optional protocol governing individual claims that can be filed with the Committee over violations of the rights. This development makes the right to health, as Forman says, “an internationally justiciable right.” This protocol came into force in 2013, and Forman updates us on the specific questions that loom large for the practical implementation of a right to health.
Forman, in a number of contexts before, has expressed her view that giving content to a right to health should involve delineation of a minimum core. Debate continues to surround whether that core would or should be non-derogable, even in the face of resource limitations, or the “progressive” process of realizing the right. Alternatively, some view the core within a hierarchy of health interests that should be prioritized in the progressive realization of the right to health.
But Forman here flags that the optional protocol sidesteps commitment to the strongest conception of a minimum core right to health. Article 8(4) of the protocol establishes that any State’s policies will be judged not by fidelity to the minimum core, but by their adherence to a “reasonableness” standard.
Does this formulation have bite? Does it provide a manageable standard for justiciability? Forman says, “The threat of rejecting core obligations in favour of reasonableness is that as long as a state establishes that it is acting reasonably to progressively realize rights within resources, almost any extent of deprivation could be permitted.” But Forman’s tone is less that of hostile foe than friendly critic. She is vocal in holding institutions accountable against the potential weaknesses of such an approach, while hopeful that the approach can push our understanding and practice forward. Reasonableness in the health rights discourse is at least as manageable as the standard for courts’ substantive oversight of agency action, as observed before by Cass Sunstein.
It may be that this right, without more, cannot, “respond to…neoliberalism’s obliteration of the ceiling on inequality,” as suggested by Samuel Moyn. But that is not the same as saying the right cannot achieve normative significance. The right will bite if there is a body of jurisprudence specifying it further, and, with this protocol in effect, this jurisprudence will develop further; we will be able to see the conception taking shape, we can reference it, and we will crystallize our expectations around it.
We already see this process in other jurisdictions, where other jurisprudences are doing just that, and indeed they are borrowing from one another. Forman writes of how the final drafting of Article 8(4) of the optional protocol involves a direct quote from the South African Constitutional Court decision Government of the Republic of South Africa v. Grootboom, after an NGO representative looked up the language on her laptop.
Lessons for U.S.
What of the U.S. legal discourse? Our willful blindness and neglect of health rights discourse means we break faith with one of the first principles of lawyering: the primacy and richness of facts. Health rights don’t always come up in the manner we suppose (Christina Ho, Are We Suffering from an Undiagnosed Right to Health, Am. J. L. & Med. (forthcoming 2016)), and thus we underestimate how the facts can guide us by constituting case law and a jurisprudence that provides shared parameters and understandings. For now, we can see that these arguments and conceptions are in the process of being fleshed out and will be available for the conversation we may yet have one day in the U.S.
Cite as: Christina Ho, An Internationally Justiciable Right
(August 3, 2016) (reviewing Lisa Forman, Can Minimum Core Obligations Survive a Reasonableness Standard of Review Under the Optional Protocol to the International Covenant on Economic, Social and Cultural Rights?
, 47 Ottawa L. Rev.
(forthcoming), available at SSRN), https://health.jotwell.com/an-internationally-justiciable-right/
Inappropriate prescription and overconsumption of pharmaceuticals is one of the most pressing public health concerns in North America. Aggressive pharmaceutical promotion practices are widely recognized as a major contributing factor. Two recent medical journal articles provide further evidence of serious problems with the scientific record that has become an intrinsic part of pharmaceutical marketing. They document each in their own way the corruption of scientific practices in which academic scientists appear to play a significant role, but also indicate how the scientific community and civil society can help correct the record and expose misconduct. The papers further illustrate how legal tools can enable them to do so. They both affirm the importance of transparency, which many in the medical and health policy community increasingly support as essential to restore confidence in the science surrounding pharmaceuticals.
Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry’s paper in the International Journal of Risk and Safety in Medicine is a case study of how the pharmaceutical company Foster used a scientific publication to boost prescription of its blockbuster anti-depressant citalopram. A paper by Joanna Le Noury and colleagues in the British Medical Journal is the first publication produced as part of an innovative initiative by the scientific community aimed at correcting the scientific record on a host of pharmaceutical products. The study involves a reanalysis of the raw data of a Smithkline Beecham (now GSK)-sponsored published study on the efficacy of paroxetine and imipramine for the treatment of depression in adolescents.
That both publications deal with anti-depressants is not entirely surprising. They have been among the most prescribed—in fact overprescribed—drugs of the last decades. The vagueness of diagnostic criteria and the subjective nature of efficacy measurements in relation to most mental health conditions further facilitate data manipulation. Yet it should not lull us into thinking that the problems are restricted to psychiatric drugs. Both papers confirm what has been exposed in the medical and increasingly also the health law and policy literature for some time, and in relation to a variety of products: that industry control over the design, conduct, analysis, and reporting of clinical drug trials has turned many scientific publications into marketing tools. It has enabled the industry to selectively report positive results, hide negative results, manipulate statistical tools for favorable outcomes, and underplay problems.
The Jureidini et al. analysis, based on data unsealed by a U.S. court as part of a court-approved settlement in a class action litigation procedure, provides fascinating evidence of how a company can conspire with a medical writing agency and—certainly indirectly—academic scientists, to use flawed scientific publications as marketing tools. The authors obtained access to a host of documents, including correspondence, e-mail exchanges, protocols, trial results, and drafts of ghostwritten documents. They examined the original protocol and clinical trials data of a study on citalopram’s efficacy and safety for the treatment of major depression with the final published outcome. Their unsurprising conclusion is that the published paper mischaracterized primary outcomes and adverse events, hid negative secondary outcomes, and added post hoc outcomes that put a more positive spin on the data. Their analysis of the correspondence and e-mails between the medical communications agency and company marketing officials interestingly reveals that the paper was entirely written in-house and explicitly approached as a PR document. Yet, 18 academic scientists became authors of the paper, including the elected president of the American Academy of Child and Adolescent Psychiatry as the first author. The paper quotes some remarkable exchanges that should make any academic author on the paper blush, if not outright fear sanctions for violation of authorship standards. Correspondence reveals that a full draft was produced before the authors were even contacted. Yet, the academic authors later maintained that they didn’t know that a guest writer of a medical communications firm had been involved.
The Le Noury et al. study is the first study to come out of the so-called RIAT initiative: Restoring Incomplete and Abandoned Trials. The RIAT initiative was launched in 2013 with a high profile publication in the British Medical Journal. With this initiative, prominent scientists launched a public call to sponsors and investigators of unpublished (abandoned) studies to correct the published record on pharmaceutical products. They pointed out that increasing amounts of previously hidden information had become publicly available, including through access-to-information requests with the European Medicines Agency (EMA). A preliminary analysis of these data already suggested, according to the RIAT authors, that several clinical trial publications related to widely prescribed pharmaceuticals were questionable and might be in need of correction. The RIAT proposal put the sponsors and authors of these publications before an awkward dilemma: either they correct their publication themselves within a year—likely having to admit that they made “errors”—or the RIAT initiative would invite volunteers in the scientific community to conduct their own analysis based on the full data set, and submit these “restorative” publications to correct the scientific record. Several leading international medical journals explicitly supported this initiative and announced they were interested in publishing the outcomes of these studies. The 2015 Le Noury et al. article is the first of these restorative publications, written by independent authors not involved in the first study. Not surprisingly, their thorough analysis of the full data set confirms what many had already been arguing for years, namely that paroxetine is no better than placebo for the treatment of depression in children and adolescents, and is associated with a risk of serious side effects, including suicidal ideation and self-harm. Publications by leading psychiatrists had come to the opposite conclusion at the time. Also not surprisingly, these authors still maintain that their original publication remains valid.
Several commentators, including myself, have argued for a complete overhaul of the drug regulatory review system because of the significant impact of the discussed problems on public health and health care expenditures. The two papers both uniquely show what can and should be done in the absence of such reform and how legal tools can empower the scientific community to counter problems that have been created to a significant extent by ill-conceived regulatory and legal rules. The drug regulations requiring the submission of detailed clinical trials data are indeed responsible for the creation of a billion-dollar pharmaceutical knowledge industry. And trade secret rules are increasingly invoked to keep some of the data underlying regulatory submissions and scientific publications hidden. It is precisely the existence of this knowledge production industry, protected by legal rules, that has given the pharmaceutical industry enormous power over the creation, analysis, and selective distribution of research results. Since the U.S. or other governments will not likely take over the conduct of clinical trials or set up a very different and more independent clinical trials structure anytime soon, transparency can help restore the scientific record, expose problems, and provide tools for civil society to hold regulatory agencies accountable for their decision-making.
The papers also show what works best for what purpose. Both papers relied on transparency, but they obtained their data through different legal mechanisms. Jureidini et al. were dependent on a court order, and thereby had access to communications among the company, a medical writing agency, and academics for their analysis. Their paper gives unique insight into the concrete involvement of, and collaboration between, medical writers and academics in these marketing schemes. Yet, as the authors rightly point out, pharmaceutical litigation often ends up in settlements where confidentiality agreements are a part of the deal. As plaintiff lawyers may offer confidentiality of the data to obtain better compensation, a potential conflict of interest exists between plaintiffs’ lawyers and their clients, on the one hand, and the public interest in access to data, on the other. Moreover, this form of disclosure obviously happens only when someone has made the effort to go to court for the alleged harms caused by a pharmaceutical product. Court-ordered unsealing therefore cannot be relied upon as a systematic tool for public health.
Le Noury et al. obtained most of their data as a result of the EMA’s data access policy, arguably the most comprehensive data access policy by a drug regulatory agency. The new data policy starts from the premises that disclosure is the rule, clinical data submitted to the drug regulator are generally not confidential commercial information, and that exceptions to disclosure have to be justified. (This is in contrast to other countries, such as Canada, where drug regulators appear to have accepted industry’s argument that most of these data constitute confidential commercial information and that regulators are therefore under specific obligations to keep the data secret.) The EMA policy is not perfect and its implementation may often face difficulties. But the EMA’s more flexible approach to data sharing, which is reflected in this new policy but was also already present in the data sharing practices it has been following in the last couple of years, resulted in the release of more than 1.5 million pages of previously hidden data. A strong data disclosure policy, clear rules for disclosure, and a regulatory affirmation that these clinical data should generally not be considered confidential, are indeed the preferred approach to promote public health. They are not a panacea, since it still requires a significant mobilization of the scientific community and civil society to conduct these analyses. But they are an important means to restore the scientific record and to hold drug regulatory agencies also potentially accountable for their decisions.
Let me add a final note from an academic integrity perspective. Both papers reveal problems of scientific integrity in pharmaceutical industry-sponsored publications and raise serious questions about the collaboration of academic scientists. In light of what is being exposed in these and in many other related publications, it is remarkable how academic institutions remain silent about the alleged scientific misconduct by some of their researchers.
Cite as: Trudo Lemmens, Restoring the Integrity of the Pharmaceutical Science Record: Two Tales of Transparency, JOTWELL (July 14, 2016) (reviewing Jon N. Jureidini, Jay D. Amsterdam & Leemon B. McHenry, The Citalopram CIT-MD-18 Pediatric Depression on Trial: Deconstruction of Medical Ghostwriting, Data Mischaracterisation and Academic Malfeasance, 28 Int’l J. Risk & Safety Med. 33 (2016); Joanna Le Noury et al., Restoring Study 329: Efficacy and Harms of Paroxetine and Imipramine in Treatment of Major Depression in Adolescence, 351 Brit. Med. J. 4320 (2015)), https://health.jotwell.com/restoring-the-integrity-of-the-pharmaceutical-science-record-two-tales-of-transparency/.
Rachel Sachs, Prizing Insurance: Prescription Drug Insurance as Innovation Incentive
, 30 Harv. J. of L. and Tech.
(forthcoming 2016), available at SSRN
In Prizing Insurance: Prescription Drug Insurance as Innovation Incentive, Rachel Sachs brings together the often disparate worlds of intellectual property theory and health insurance design, to argue that prescription drug insurance could be structured to offer a better incentive for pharmaceutical companies to develop drugs that treat conditions primarily affecting low-income Americans. Typically, health insurance design is evaluated from an access and utilization perspective. Professor Sachs suggests we should broaden that view, at least when it comes to drug coverage, to evaluate the effect insurance coverage has on research and development incentives.
To make her point, Professor Sachs works through the example of the innovation incentives for drugs that would be primarily prescribed to low-income populations in the U.S., such as those that would treat various tropical diseases. While there are many factors that influence the development of drugs, one of those incentives is financial. And when it comes to diseases that affect primarily low-income individuals, the financial analysis disfavors significant innovation investment. After all, if the population to be treated is either uninsured or covered through only Medicaid, the “prize” for developing a treatment may be insufficient to support investment. Medicaid arguably contributes to this lack of incentive given its relatively low payment rates for pharmaceuticals, which are significantly below other market payers in the U.S. The novel argument Professor Sachs makes is that insurance design could be modified to help achieve socially desirable innovation that the market would not otherwise reward.
The article begins by explaining how the patent and FDA regulatory systems do not necessarily produce socially optimal innovation. For example, she argues that exclusivity periods and clinical trial limitations can distort the incentives for innovation, favoring certain types of drugs and interventions over others. In addition, while she acknowledges that market incentives do often reward the creation of socially desirable drugs and treatments, the mechanism is imperfect because of ability-to-pay concerns and a lack of consumer salience. In the end, the types of innovations that are incentivized are not necessarily the ones with the greatest social value or those that would address the most significant disease burdens.
After establishing the current distortions in innovation incentives, Professor Sachs moves on to discuss various policy levers that might be used to address such distortions. First, she explains why reforms aimed at the current intellectual property and FDA regimes are unlikely to be wholly effective. From there, she makes the case that insurance design itself could be used to create targeted incentives for socially desirable innovations in the pharmaceutical arena, and it is here that Professor Sachs introduces a novel way of evaluating insurance. She focuses on Medicaid, given that it is the primary source of coverage for low-income Americans and she wants to concentrate on populations for whom the usual market mechanisms would fail to produce socially optimal investment. Pursuant to federal statute, state Medicaid programs are entitled to specific percentage discounts on the average manufacturer price of all pharmaceuticals. While that pricing structure makes sense from an access and cost perspective, it lowers the incentive for pharmaceutical companies to develop drugs that primarily serve the Medicaid population. She argues that Medicaid drug pricing could be tweaked to function more like a prize for innovation, without necessarily undermining cost or access concerns.
Innovation incentives in the pharmaceutical industry in the United States are complicated by our disparate insurance markets. Medicaid pays comparatively low prices for pharmaceuticals, with Medicare and private insurance paying more. As a result, all other things being equal, pharmaceutical companies should favor innovation that will have higher utilization among the higher-paying populations – leaving the Medicaid market as the most unattractive in the U.S. While some commentators have argued that the solution is to “equalize down” – moving payment rates for non-Medicaid payers down to Medicaid levels, Professor Sachs argues that we should strategically “equalize up” – raising Medicaid rates to help achieve socially desirable innovation. She walks through possibilities for achieving this result at the federal level, and also discusses how enterprising states might implement such strategies on their own.
Professor Sachs’ article deftly brings together an understanding of patent and FDA regulation, along with insurance pricing mechanisms, to give a more complete picture of healthcare innovation than is standard. As someone who spends a lot of time thinking about health insurance regulation, I valued both the explanation of why the patent and FDA regulatory systems under-incentivize certain types of innovation, as well as Sachs’ position that evaluation of insurance design should go beyond cost, access, and utilization. While this article focuses specifically on the development of drugs to treat neglected diseases that affect primarily low-income populations, it could easily be applied to other areas in which insurance reimbursement structure impacts health care innovation.
Neal Devins, Rethinking Judicial Minimalism: Abortion Politics, Party Polarization, and the Consequences of Returning the Constitution to Elected Government
, 69 Vand. L. Rev.
_ (forthcoming 2016), available at SSRN
On March 2d, the US Supreme Court heard oral arguments in Whole Woman’s Health v. Hellerstedt, which will determine whether “TRAP laws” (targeted regulation of abortion providers) impose an unconstitutional undue burden on access to abortion, a medical or surgical procedure accessed by approximately one-third of US women of reproductive age. The Texas laws at issue require doctors who provide abortions to have admitting privileges in a hospital within 30 miles of their clinic, and abortion clinics that would otherwise operate like doctors’ offices are required to adhere to extensive ambulatory surgery center licensure requirements. The cumulative effect of these laws would be to leave 25% of Texas’s clinics operating — ten clinics for the state that is the second largest in land mass and population in the US. This opinion could decide whether the constitution protects a merely theoretical right to access abortion rather than a right that can actually be exercised by women across all parts of the nation. In Rethinking Judicial Minimalism, Professor Devins analyzes how this precipice has been reached from a judicial process and political perspective and reconsiders judicial minimalism as the superior procedural approach for contentious cases.
Planned Parenthood v. Casey and Roe v. Wade are the two key decisions interpreting the Due Process Clause to protect women seeking abortions from prohibitive state regulation. In Professor Devins’ view, Roe was a “maximalist” decision that worked legislatively by creating a formal regulatory structure, and Casey was a “minimalist” decision that correctly discarded Roe’s “trimester framework” and allowed states to follow the vaguer “undue burden” standard, which meant that states could regulate abortion if they did not place substantial obstacles in the path of a woman seeking an abortion. Professor Devins notes that the minimalist approach to judicial power that he has advocated seemed the best mechanism for allowing the deliberative democratic process to reach policy compromises on hard questions. In the wake of Roe and Casey, many notable scholars and jurists (including Justice Ginsburg) agreed that states should have reached their own conclusions without the Court crafting a decision that delineated how and when states could regulate the abortion procedure, thereby usurping states’ deliberative and political processes.
The trouble, Professor Devins writes, is that Casey’s judicial minimalist approach opened the state experimentation gates when, in hindsight, the political branches were becoming less functional. Professor Devins convincingly documents the historic moments that rendered the political parties more polarized and less able to intersect in their goals, which in turn diminished legislatures’ ability to negotiate meaningful compromises because moderate voices were removed from each party. Professor Devins claims that this polarization hinders political processes, particularly when fraught issues are at stake. Thus, Devins argues, single-issue interest groups, such as Americans United for Life (AUL), have successfully drafted legislation enacted by many states, a process that would not have been possible in a more functional political era. The political story told here is not new, but it is succinctly documented and persuasively drives the article’s conclusion that judicial minimalism may be dangerous when the political branches function sub-optimally.
The structural governmental ideas raised by Professor Devins are important for health care law and policy in the current moment. The Affordable Care Act could have acted as Professor Devins’ case study too, as it also offers an example of political polarization and backlash, having been passed with little inter-party cooperation. This arguably has contributed to the endless stream of litigation challenging everything from the law in its entirety (NFIB v. Sebelius) to seemingly minor administrative rules (Zubick v. Burwell). The challenges have forced the Court to explore what it will do with major works of “unorthodox legislation” and its role in upholding, interpreting, and otherwise exploring the constitutionality and meaning of such legislation.
Thus, Professor Devins offers a fruitful inquiry not just for the questions before the Court in Whole Women’s Health but in many other health care cases: is judicial maximalism or minimalism a better approach to hard policy questions in an era of political polarization? The article’s case study convinced me that maximalism has potential in an era of questionable democratic deliberation. But, what if the maximalist approach ultimately is not the one that Devins favors, which encompasses Professor Chemerinsky’s view that the Court should vindicate the rights of politically underrepresented minorities? I wished Professor Devins had engaged this counterfactual more deeply in Part III, as maximalism arguably has led in the modern era to decisions such as D.C. v. Heller, not just historic decisions such as Roe v. Wade, and the two are on opposite sides of ideological lines. To me, this highlights a general problem with structural arguments: they sometimes are substituted for substantive disagreement. I hope Professor Devins addresses the process over substance critique of structural theories more directly in future work.
Interestingly, striking down Texas’s TRAP laws could be deemed an act of judicial minimalism, as it would be an application of the ‘minimalist’ Casey decision that asks whether a state has legitimate reasons to regulate abortion as it regulates other medical procedures. In this instance, Texas enacted laws written by AUL to decrease access to abortion, and the briefs and oral arguments revealed that these laws will likely harm women’s health and do not address any known problem in abortion medical care (especially notable compared to riskier procedures that are significantly less regulated, such as colonoscopies). The Texas political process was allowed to proceed, and the Court need not extend itself to a maximalist approach to strike down TRAP laws. Even so, Professor Devins raises important questions about judicial process that have deeper implications for health care reform and other health care issues before the courts.
Cite as: Nicole Huberfeld, The Judiciary’s Role in Hard (Health Care) Cases
(April 7, 2016) (reviewing Neal Devins, Rethinking Judicial Minimalism: Abortion Politics, Party Polarization, and the Consequences of Returning the Constitution to Elected Government
, 69 Vand. L. Rev.
_ (forthcoming 2016), available at SSRN), https://health.jotwell.com/the-judiciarys-role-in-hard-health-care-cases/
The right to aid in dying (or physician-assisted suicide) has developed with different standards in the United States than in the Netherlands and Belgium, and a recent study suggests that the United States has gotten it right in a critical respect—on the criteria for eligibility. Patients can more easily qualify for aid in dying in the Netherlands and Belgium and that creates a potential for misuse that is not present in California, Oregon, Vermont, and the other American states that permit the practice. In particular, as a new study by Kim, De Vries, and Peteet indicates, the possibility that people with psychiatric disorders may choose aid in dying when treatment for their disorders might address their despair is a more serious problem in Europe than in the United States.
Concerns about psychiatric motivations give rise to a very important argument against a right to aid in dying. If people can choose aid in dying because of mental illness, people may opt for death when proper therapy would restore their desire to live. And anecdotal reports in both the United States and Europe reinforce this concern. In a Frontline report on underground aid in dying in the United States, filmmakers documented the death of a woman whose mental illness led her to harbor false beliefs about her health. Similarly, an article in The New Yorker described the troubling case of a Belgian woman who underwent euthanasia, which, like aid in dying, is permitted in Belgium, despite physician assessments that her psychiatric depression was not serious enough to make her eligible for assistance in dying.
Cases like this have not been described in Oregon, Washington, or the other states that have legalized aid in dying for a key reason—the right exists only for persons who are terminally ill. People exercising their right to aid in dying must have a serious and irreversible disease that will cause death within six months. As a result, in more than 75 percent of aid-in-dying deaths in Oregon, the patient had cancer, with most of the others suffering from neurologic, lung, or heart disease.
In the Netherlands and Belgium, on the other hand, the rules for aid in dying rely on a more subjective standard—people must be suffering unbearably from an incurable illness. Under this standard, psychiatric disease can provide grounds for aid in dying, and that allows for judgments that are more susceptible to error.
In the study by Kim, De Vries, and Peteet on aid in dying in the Netherlands, a number of observations are worrisome. In more than one-half of cases, social isolation or loneliness was a factor for the patients. As Paul Appelbaum observed in an editorial accompanying the study, aid in dying may have “served as a substitute for effective psychosocial intervention and support.” Indeed, in more than half of the cases in the study, patients refused treatment that might have helped, with lack of motivation a common reason for the refusals. In more than one-fourth of cases, aid in dying was provided by a physician who had not been involved previously in the treatment of the patient and might not have been able to fully understand the nature of the patient’s condition. This may help explain why in nearly one-fourth of cases, the independent physician reviewers disagreed whether the patients met the criteria for aid in dying. (In such cases, aid in dying can still take place since the treating physician has authority to decide whether to proceed.)
No study is perfect, and the authors acknowledge a number of limitations with their data. Still, the concerns raised by the findings of Kim, De Vries, and Peteet will reinforce the current reluctance to expand the right to aid in dying to patients who are not terminally ill.
Cite as: David Orentlicher, Physician Aid in Dying and Mental Illness
(March 10, 2016) (reviewing Scott Y. H. Kim, Raymond G. De Vries, & John R. Peteet, Euthanasia and Assisted Suicide of Patients With Psychiatric Disorders in the Netherlands 2011 to 2014
, JAMA Psychiatry
When anecdotes trump data, health policy can become engulfed by bad science. Alena Allen eloquently captures the pitfalls of this phenomenon in her article, Dense Women, which provides a comprehensive normative and descriptive analysis of breast density notification statutes. To my knowledge, Allen is the first legal scholar to tackle this important issue. While breast density notification statutes vary by state, they each share a common goal: ensuring that physicians provide certain information to women who have dense breast tissue and directing women (to varying degrees) to speak to their doctors about further medical tests.
Breast density notification statutes were passed in response to heart-breaking stories of women who were diagnosed with breast cancer despite initially receiving negative mammogram results. One of the leading advocates is Nancy Cappello, who was diagnosed with breast cancer despite ten years of negative mammograms, and was eventually told that only an ultrasound could detect her cancer, given her dense tissue. Following a mastectomy, chemotherapy, radiation, and hormone treatment, Cappello began advocating for legislation mandating that physicians inform women when they have dense breasts. As Allen writes: “Their message is hard to resist. They are advocating to inform and empower women. They want to standardize, improve, and promote increased doctor-patient communication. Their message is so enticing that state legislatures across the country are listening.” In 2009, Connecticut (Cappello’s home state) became the first state to pass such a law, and twenty-three states have followed. (Legislation is pending in ten states, and a bill was recently introduced in the U.S. House of Representatives.).
While acknowledging that the stories of Cappello and others are “compelling,” Allen quite firmly (and convincingly) argues that personal “narratives always militate in favor of action, without fully appreciating the downside consequences.” The data are startling; according to one recent study, for every 10,000 women with dense breasts, additional testing will result in breast cancer being prevented in four women, though 3,500 unnecessary biopsies would be performed. This represents a high false-positive rate; 99.96% of women with dense breast tissue will have undergone additional screening tests but have no cancer, and 35% of these women would have undergone a biopsy just to be sure. Biopsies are not without risks, and all the additional testing comes with financial costs and anxiety for women who are undergoing the procedures. As a recent article in the New England Journal of Medicine reports, dense breast tissue is normal and common, present in 40-50% of women. Moreover, given changes in radiological reporting systems, tissue that is deemed dense in one year may not be deemed dense in another, and there is “little evidence to support widespread supplemental screening.” In short, as Allen explains, notification laws strongly nudge physicians to order new tests not for reasons of medical necessity, but out of fear of lawsuits should their patient not be in that 99.96%.
Lurking beneath the push for breast density notification statutes is a controversial premise—that the practice of medicine can be enhanced when elected officials dictate the standard of care. As Allen illustrates, these broader questions command attention. For example, when data do not corroborate anecdotal evidence, should lawmakers tell physicians what they should, and should not, say to patients? And, should insurance companies have to foot the bill for medical treatment that is encouraged by a state but not supported by medical science?
As Allen writes, “most notification laws undermine women rather than empower them”—this is accomplished by “nudging, prodding, or pushing women to act.” Some states push women towards additional testing without requiring that insurance companies cover the costs. In fact, only two states (Connecticut and New Jersey) require that insurance companies cover the costs of additional screenings encouraged by the notification laws.
Other important contributions of Dense Women include Allen’s state-by-state analysis of breast density notification statutes. Here, Allen goes beyond merely classifying the various statutes into distinct categories; she analyzes which statutes are more likely to cause harm to women. Allen not only provides a compelling argument that questions the public health benefits of breast density notification statutes, she correctly links this debate to larger questions in health law and health policy. These include: how best to incorporate evidence-based medicine and comparative effectiveness research into health care delivery and best practices; paternalism in health care (particularly for women’s health issues); 1st Amendment issues and compelled speech on the part of the provider; and the role of medical malpractice (including doctrines such as loss of chance and negligence per se) in incentivizing sound medical care.
It’s often said that, in the realm of medicine, information is power. What Dense Women demonstrates is that this maxim ought to be qualified. This is particularly true when the evidence-based foundations of medicine are not applied to health policy. Allen’s analyses and conclusions are important, and lawmakers and health policy experts stand to gain from her thorough examination of the topic. Allen’s call for caution must be taken seriously.
Janet L. Dolgin, Unhealthy Determinations: Controlling Medical Necessity
, 22 Va. J. Soc. Pol’y & L.
435 (2015), available at SSRN
In the fight to control health care costs, the determination of whether something is “medical necessary” is of paramount importance. A clear vision of medical necessity would allow payers, regulators, and doctors to arrive at universal and understood standards regarding clinical appropriateness and appropriate reimbursement. But, even in the midst of health care reform, its importance has been lost. In Unhealthy Determinations: Controlling Medical Necessity, Janet Dolgin makes a contribution to the scholarship that examines the perplexing topic of medical necessity by robustly arguing for its recognition and restructuring. In the piece, Dolgin focuses on the history of the doctrine, particularly on the idea that the doctrine more likely reflects the characteristics of the American health care system and the will of any given decision-maker, than it presents an actual useable clinical definition.
The quest for understanding medical necessity depends on two separate queries—one that focuses on the who: which actor it is within the modern American health care regime that is the decision-maker, and, secondly, of course, the what: what the standard will look like in a given clinical scenario. Indeed, medical necessity can be characterized as a rationing tool employed by the insurance industry or as a flexible standard used by physicians to justify expensive and unnecessary medical care. Accordingly, one would have expected defining medical necessity to have been an object of attention—for insurance companies, who want to constrict it, doctors, who want to expand it, and federal administrators, who want to control it—in the effort to reform health care under the Affordable Care Act (ACA). But instead, according to Dolgin, the ACA leaves many of the rules that existed before its passage governing medical necessity in place.
Given multiple interested parties (including patients), the main thesis of Dolgin’s piece focuses on how the doctrine of medical necessity has been historically defined and dominated by the private insurance industry. Presenting obvious conflicts of interest, Dolgin argues that the industry allows cost-cutting incentives and the profit motive to trump both medical expertise of the doctors requesting the services, and the patients’ interests who would benefit from the services. Evincing a desire to vest providers with greater control over medical necessity, Dolgin pushes for more transparency and public input over a process that presently produces inconsistent and “amorphous” standards lacking in precedential power.
Dolgin’s analysis focuses on what she characterizes as the damaging effects of the Employee Retirement Income Security Act (ERISA) regime, which protects insurance companies that provide employer-sponsored health plans, arguing that these companies may make medical necessity determinations in an uneven and indefensible manner without legal consequence. She astutely highlights that, even though it could have been an effective tool, the ACA fails to define what is medically necessary, punting on an important ultimate question—and as a result, reaffirms the private insurance company as the most powerful party in American health care delivery. She does not quibble with the reliance on a so-called “medical necessity” standard or criterion, but is concerned about which party owns the ability to decide what that standard is. Finally, Dolgin’s piece is strongly supportive of the independent autonomy of doctors, arguing that “physicians’ medical decisions for their patients, assuming they do not contravene the terms of a patient’s plan, should only rarely be denied by payers.” She references other countries’ health care regimes—particularly those in Canada, Germany, and Israel—that feature additional government control and public negotiation as programs to which the U.S. should aspire.
In short, Dolgin’s piece is a strong rebuke of the private insurance industry, the ERISA regime, and in some ways, the ACA. Interestingly, she uses the story of medical necessity as an effective tool. As is the case in many health policy issues, the cost-containment problem in American health care, and the inability of the industry to agree on an understandable medical necessity standard, may have many causes. Dolgin rightly takes on the private, for-profit insurance companies as the chief concern in the medical necessity battles. However, the solution of rewarding physicians with power in determining what procedures are medically necessary may run the risk of overcompensating, bringing a new set of problems to American health care. Indeed, historically, American health care may owe its cost problems to not enough cost control by decision-makers other than physicians who are financially benefitted by increased care. Additionally, new tools imposed by the ACA—particularly the medical loss ratio (MLR) requirements that require a percentage of insurance premiums to be spent on actual care by insurance companies—are intended to blunt the private insurance companies’ incentive to limit care in order to pad profits.
Of course, Dolgin may argue that the answer to standard setting doesn’t then lie with an industry that is financially benefitted by limiting care—care that is truly needed for the health of the patient. Indeed, her piece pushes for a reexamination that features an increased public role in determining what type of health system Americans want. And with that argument, it is hard to argue.
Lindsay F. Wiley, From Patient Rights to Health Justice: Securing the Public’s Interest in Affordable, High-Quality Health Care
, Cardozo L. Rev.
(forthcoming), available at SSRN
One of the challenges of teaching Health Law is that the course covers so many distinct areas of law that it can be hard for students to find an overarching theme, beyond the obvious one that all of the issues have something to do with doctors, patients, or hospitals. I was therefore very pleased to come across Lindsay Wiley’s new article, From Patient Rights to Health Justice: Securing the Public’s Interest in Affordable, High-Quality Health Care. In this article, Wiley examines analytical models previously developed by health law scholars and proposes a new model designed to place greater emphasis on collectivist concerns. The article should appeal not only to health law scholars, but also to anyone interested in how legal analytical frameworks can be used both to explain past developments and to reshape the terms of ongoing policy debates.
Wiley begins by examining four main models of health law, which she calls “professional autonomy,” “patient rights,” “market power,” and “health consumerism.” Under the professional autonomy model, which was dominant in the first half of the twentieth century, most legal and policy questions about health care were considered to be within the exclusive competence of professionals. This model eventually gave way to the patient rights approach, which sought to use the law to protect patients’ ability to make autonomous decisions, to improve quality, and to facilitate access. The market power model, which emerged in the 1970s, began to look at health care as an economic system, with a particular focus on the unique characteristics of health care markets that can distort the normal application of market forces, such as information asymmetries and the ubiquity of insurance. Finally, the health consumerism model, which Wiley describes as a “melding” of the patient rights and market power models, aims to draw on the power of markets in the service of empowering patients and improving the quality of care.
Despite the differences between each of these models, Wiley argues that they are similar in their underlying individualistic focus. By this she means that the models’ primary object of concern is the providers and patients involved in particular health care transactions, with little or no attention to the interests of the community at large. Although the market power model “represents collectivist impulses to some extent,” the model is primarily concerned with shoring up health care markets in order to increase overall social utility, rather than to address distributional inequalities or other communitarian concerns.
Wiley argues that a variety of developments in health law have challenged the continued relevance of the four primary models by promoting greater attention to the impact of decisions about health care on collective social well-being. For example, she notes that the insurance provisions in the Affordable Care Act, including the prohibition on most types of risk-based underwriting in the individual and small group insurance markets, “represent a major shift from an actuarial fairness approach to health care financing to one premised largely on mutual aid.” Likewise, growing concerns about issues such as the cost of health care, declining immunity for vaccine-preventable diseases, increasing antibiotic resistance, and mutual vulnerability in the face of public health emergencies, has led to increasing efforts to integrate public health considerations into day-to-day clinical practice.
These and other developments, Wiley argues, create conditions for “a new approach that expressly recognizes the public — alongside the patient, the provider, and the payer — as an important stakeholder and active participant in decisions about treatment, coverage, and allocation of scarce resources.” Wiley calls this new approach the “health justice” framework. Like other “justice” movements – e.g., environmental justice, reproductive justice, and food justice – health justice is concerned about the fairness of the distributional consequences of laws and policies, in addition to their impact on individual rights and welfare. Specific characteristics of the health justice framework include the prioritization of prevention, the integration of health care and public health, and an emphasis on the role of government enforcement of rights and responsibilities of individuals and institutions.
Wiley demonstrates how the health justice model can be used both to explain new developments in health law and policy and to argue for the reinterpretation of existing doctrine to incorporate greater collectivist concerns. For example, the health justice framework helps us understand the emergence of pay-for-performance measures that focus on public health outcomes such as vaccinations or the reduction of hospital-acquired infections. Examples of its use in scholarship include Wendy Parmet’s proposal to harness informed consent doctrine to establish a provider duty to inform patients about the population consequences of antibiotic resistance, and Elizabeth Weeks Leonard’s effort to justify limits on the use of experimental treatments outside of clinical trials by appealing to the public’s interest in developing reliable knowledge about the safety and efficacy of unapproved drugs.
Wiley recognizes that the health justice approach is not the first attempt to incorporate greater collective considerations into health law analytical frameworks. In fact, she justifies her model in part by noting that it is consistent with a broader scholarly move towards recognizing collective interests in health care, particularly in the fields of bioethics and public health. However, the value of the health justice formulation is that it does not simply call for greater attention to collectivist considerations, but that it emphasizes a particular kind of collectivist approach – i.e., one in which the distribution of health benefits is at least as important as their aggregate amount.
The health justice framework offers a useful tool for reframing health law issues to highlight the long-term impact of laws and policies on larger social structures. While these collectivist considerations will not always be the decisive factors in resolving particular policy dilemmas, they deserve to be factored into the analysis alongside the traditional individualistic focus. I look forward to future scholarship applying this model to new health law proposals, as well as to further analysis of mechanisms for resolving situations in which individual and collectivist interests conflict.