Authors

At the conclusion of her fellowship year, Kelsey Berry was a PhD candidate in health policy and ethics at Harvard University. She holds a BA in political philosophy and neuroscience from Princeton University. Kelsey's research interests include theories of justice in global health, partiality and fairness in resource allocation, and ethical issues in the health of vulnerable populations. Kelsey was a 2014-2015 Student Fellow at the Petrie-Flom Center, during which she worked on a research project entitled "Rights and Duties Against Conditional Funding Agreements in Global Aid." The paper presents a normative argument for holding global health development assistance channeled through non-governmental organizations to standards of egalitarian justice, and assesses PEPFAR's "anti-prostitution pledge," which was challenged in a landmark 2013 Supreme Court case, relative to these standards. Kelsey's other work includes empirical research on issues in mental health policy, like assessing progress in achieving equitable insurance coverage for mental health disorders subsequent to the 2008 federal mental health parity law and the Affordable Care Act. She planned to continue such work with the Department of Health Care Policy at Harvard Medical School, and on a 2015-2016 training grant with the National Institute of Mental Health.

Ethics for CRISPR and the Big Leap Forward

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By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

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Despite Federal Law, Some Insurance Exchange Plans Offer Unequal Coverage for Mental Health

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By Kelsey Berry

One of my previous blogs discussed how potentially discriminatory practices in insurance design may continue to dissuade people with high-cost conditions from enrolling in insurance plans, even in a post-ACA world. Last week, colleagues Haiden A. Huskamp, Howard H. Goldman, Colleen L. Barry and I published new findings in Psychiatric Services on the same issue, except with a focus on an area that has historically been subject to considerable regulation: mental health benefits.

The Affordable Care Act shows considerable promise for extending mental health benefits with federal parity protections to several million Americans, which has been a main aim of mental health policy advocates for decades. However, insurers may still have an incentive on health insurance exchanges to avoid enrolling individuals who use mental health services because their care is more costly than average. In the study, we examined benefits information available to consumers shopping on state health insurance exchanges to assess whether the new insurance offerings were living up to the promise of mental health parity laws. We found that some plans may still be offering people with mental illness insurance benefits that are less generous than benefits for other medical conditions. Specifically, one-quarter of the health plans being sold on health insurance exchanges set up in two states through the ACA offer benefits that appear to violate the federal parity law requiring equal benefits for general medical and mental health care. Such benefit designs may dissuade people with mental health and substance abuse treatment needs from enrolling in the plans, furthering concerns about adverse selection and suggesting that some discriminatory practices persist despite efforts to equalize insurance offerings for individuals with behavioral health conditions. Read More

Discrimination, by what yardstick?

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By Kelsey Berry

It’s time to talk about discrimination again — this time, in insurance benefit design.

A recent study in NEJM by Jacobs and Sommers has coined the term “adverse tiering” to describe the use of drug formularies by insurers “not to influence enrollees’ drug utilization but rather to deter certain people from enrolling [in the plan] in the first place.” [emphasis mine] Evidence of adverse tiering includes the placement of all drugs for certain condition in the highest cost-sharing tiers of drug formularies. This practice, it turns out, occurs fairly frequently – at least when it comes to a common HIV medication, nucleoside reverse-transcriptase inhibitors (NRTIs). Jacobs and Sommers analyzed the placement of NRTIs on formularies for 48 plans in 12 states using the federally facilitated insurance marketplaces, and found evidence of adverse tiering in 25% of plans. Their conclusion? Many insurers may be using benefit design to dissuade sicker people from enrolling in their plans. This raises concerns about adverse selection, as well as discrimination on the basis of health status – a practice the ACA was meant to address via community rating and guaranteed issue requirements, among others.

The study provides an important data point as we continue to assess whether the ACA is living up to our goals for health care reform. I believe we’ll see several more studies of this nature coming down the line, drawing attention to insurer practices that fail to comply with regulations, that are creative interpretations of vague requirements, or that aren’t addressed in existing regulations and may require new scrutiny. As we digest these, I’ll raise two important points for consideration:

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“Volume to Value” Still Needs an Ethics Consult

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By Kelsey Berry

Whereas “allocation of scarce resources” is a buzz phrase that inspires a great deal of distress and desire for good ethical argument, “waste avoidance” strikes us as a relatively uncontroversial method for containing health care spending. Perhaps this is because rationing implies a trade-off between two individuals, each of whom have the potential to benefit from a possible intervention, whereas waste avoidance, on the other hand, implies a trade-off between two services – one of which has the capacity to benefit an individual, and the other which does not. Surely the latter trade-off is preferable, and perhaps even imperative, to make before we take up the former. This week U.S. Secretary of Health and Human Services Sylvia Burwell signaled a commitment to making the latter trade-off in her announcement on a complex area of health care financing: Medicare payment & payment reform. Medicare payment is one of the few levers that the federal government has relatively direct control over when it comes to controlling health care spending, and Burwell’s announcement was a welcome change in the policy discourse from the oft-lamented “doc fix”/SGR debacle (a fix for which was just bypassed again).

In her announcement and this perspectives piece in NEJM, Burwell set goals to (1) move 50% of Medicare payments to alternative payment models such as Alternative Care Organizations (ACOs) and bundled payment arrangements by 2018, and (2) tie 90% of all Medicare payments made under the traditional fee-for-service model to quality or value, through programs such as the Hospital Value Based Purchasing and the Hospital Readmissions Reduction Programs, by 2018. Notably, these are the first explicit goals for transitioning to alternative payment models and value-based payments that have been set in the history of the Medicare program – though it remains to be seen how these goals will be pursued.

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Pregnancy in the Ebola Epidemic – An update

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By Kelsey Berry

A few weeks ago, I posted on this blog a discussion of an ethical dilemma in the treatment of Ebola-infected pregnant women in West Africa. I wanted to follow-up with two brief updates concerning Ebola and pregnancy in West Africa.

First, Medecins Sans Frontieres has opened the first care center specializing in treatment for Ebola-infected pregnant women in Sierra Leone. The care center will have 80 beds once it is fully operational and at present has one patient under care. In my last post I called for greater investigation into the reasons underlying higher mortality rates among Ebola-infected pregnant women, claiming that the causes of disparate outcomes in various population groups may be important to determine the justifiability of outcome-driven resource allocation. The new care center is ideally positioned to investigate and perhaps parse out biological, practice based, and institutional factors contributing to the disparity. There are some remaining questions — for instance, will capacity be reserved solely for pregnant women or other infected individuals seeking care? Further, we have already seen that MSF is investing resources in caring for a population for whom survival rates are nearly zero in the current Ebola epidemic; will continued commitment to treating this population depend upon observed changes in survival rates or other outcomes; or will the mere provision of care continue to justify the center if outcomes don’t improve measurably? This is a development I will continue to follow.

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The ACA’s Cerberus

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By Kelsey Berry

Following the Midterm Elections, the fate of the Affordable Care Act in a Republican-controlled Congress has been much speculated about. Jonathan Oberlander just published a piece in the New England Journal of Medicine arguing that we should be less concerned about Congress, and more concerned about the Supreme Court’s potential to shake the foundations of the law.

Congress, he claims, may be wary to threaten popular provisions of the health care law now that many constituents have benefited from them. Even if ACA beneficiaries may not recognize that they are benefiting from the contentious law, the very methods available to Congress to dismantle the law — i.e., chipping away at specific provisions — may produce greater awareness of the law’s contents and even provoke opposition toward efforts to undermine it. Moreover, Obama’s veto power may keep the law stable enough through 2 more years of implementation that by the time we risk having a Chief Executive who opposes the law, the law’s benefits will be more entrenched and successes more obvious, further straining repeal or dismantle efforts. In short, it looks to Oberlander as if the core of the law (if not some of the peripheral provisions) is safe from Congressional action, and potentially even getting safer.

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Dec 8-10: Seminar Series on Social Medicine in South Africa

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By Kelsey Berry

The Harvard School of Public Health Department of Global Health and Population (GHP) is hosting what promises to be a fascinating 2-seminar series on Monday Dec 8 and Wednesday Dec 10 entitled: “A Practice of Social Medicine: South Africa and Beyond.” This event should be of interest to those thinking about models for Universal Health Coverage, community-based approaches to health, history and sociology of medicine and health care delivery, and population-level ethics.

The series will feature Professor Shula Marks, Emeritus Professor, University of London, and Fellow of the British Academy.

A word from the organizers: For just over a decade in the mid-twentieth century, perhaps somewhat surprisingly, South Africa was widely acknowledged as being in the forefront of progressive thought in health care delivery, its distinctive social conditions and developed medical practice making possible an experiment in social medicine with far-reaching implications.  These two lectures trace the story to its South African roots in the 1930s and 1940s, its propagation via the subsequent diaspora of progressive physicians, and its links to kindred developments throughout the world.  Its vision of a community-based, equitable, effective, inclusive, low cost approach to health emphasizing prevention and education may offer a distinctive model for Universal Health Coverage.

*The first lecture “South Africa’s Experiment in Social Medicine, 1940-1960: A Model to the World?“ will be held on Monday December 8th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208.

*The second lecture “Social Medicine in South Africa, 1960s to the Present“ will be held on Wednesday December 10th, from 4:30pm to 6:00pm in HSPH Building 1, Room 1208

For non-Harvard affiliated attendants, please email mclark@hsph.harvard.edu to arrange for access to the buildings in advance.

Is Pregnancy a “Disability” in the Ebola Epidemic?

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By Kelsey Berry

Much of the recent Ebola coverage has brought to the forefront principles of disaster triage and served as a reminder of the inescapability of rationing health care resources. A piece in The New Yorker recently highlighted the plight of pregnant women and their apparent exclusion from standard Ebola wards in Sierra Leone. Professor and Ethicist Nir Eyal at Harvard Medical School was quoted discussing the role of disaster triage guidelines in allocating resources for Ebola in the case of pregnant women.

Pregnant women have long been identified as more vulnerable to viral infections than other healthy adults, due perhaps to immune system changes occurring naturally during pregnancy. This may have accounted for the increased mortality rate among pregnant women during the 2009 H1N1 influenza pandemic in the US (17% in pregnant women vs. 0.02% in the general population), and it may impact Ebola survival rates as well. A smaller 1995 Ebola outbreak in Kikwit, Zaire had a case fatality rate among pregnant women of 93%, and anecdotal accounts from the current epidemic in Sierra Leone state a 100% case fatality rate. Recent figures from West Africa put the case fatality rate in the general population at 70%. These statistics, among other concerns for resource utilization, lead to an ethical dilemma: whether and how to allocate scarce resources to pregnant women in the present ebola epidemic in West Africa.

If the mortality rates from Kikwit are accurate, Dr. Eyal notes that it means that, “what’s needed to justify giving regular priority to a pregnant woman is a willingness to allow six other people to perish to save her.” But, he notes, the permissibility of excluding pregnant women is sensitive to these rates; if they are wrong, than so too may be triaging pregnant women last.  Read More

Death at 29 or 75: Are Manifestos Commitments to Die?

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By Kelsey Berry

The news media has been reporting on the role and means of one’s own death more frequently recently, buoyed along by manifestos (Ezekiel Emanuel’s “Why I Hope to Die at 75”, Brittany Maynard’s “Compassion and Choices” Campaign) that have caught the attention of a diverse audience. These declarations are perhaps more connected to one another than we may think.

Just last week on this blog, Lauren Taylor authored an excellent post on new public figure Brittany Maynard – the terminally ill 29-year old woman who relocated to Oregon for access to its death with dignity law, and to end her life with a prescription for a fatal medication. Maynard’s story seems to have struck a chord in part due to her youth. She is the youngest advocate currently featured on the website of Compassion and Choices, the largest organization advocating for end-of-life options in the US (the next youngest is 57 years old). She is also a well-educated, well-traveled, well-spoken individual, supported in her choices by her immediate family and physician. When Maynard states that the remainder of her life, if allowed to come to a natural end as a result of her cancer and without the help of medical intervention, will not be of value (and will actually be of great disvalue) to her, we are inclined to believe her evaluation – and perhaps even the normative implications that Maynard claims should follow.

Another public figure recently claimed that a particular part of life is not of (sufficient) value to him in order to keep living it, either. In September, Dr. Ezekiel Emanuel, director of the Clinical Bioethics Department at the U.S. National Institutes of Health and head of the Department of Medical Ethics & Health Policy at the University of Pennsylvania, published his essay “Why I Hope to Die at 75” in The Atlantic. The part of life he wishes to avoid? An old age marred by disability, functional loss, and relinquishment of the values and expectations of a younger individual. He proposes to adopt (for himself only) active rejection of life-sustaining and life-prolonging heath care, beginning at age 75. The effect? Ideally, death from infection untreated by antibiotics — it’s “quick and painless.”  Read More

De-Prioritizing Treatment for Mental Illness May be Due to Flaws in Reasoning

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By Kelsey Berry

In a recent article in Science Translational Medicine, former NIMH Director Steve Hyman explores possible reasons for the policy failure to prioritize treatment of mental disorders worldwide, even when evidence and cost-effective interventions are available and validated.

Hyman notes a number of potential factors, loosely falling into four categories.

  1. Stigmatization challenges;
    • Fear of the severely mentally ill
    • Superstitions about the causes of mental illness
    • Attribution of imagined moral flaws or weaknesses to sufferers or their families
    • Belief that mental health professionals are in the profession because they are similarly troubled
  2. Scientific challenges;
    • Relatively slow scientific progress and translation of discoveries into clinically useful diagnostics and therapeutics
  3. Advocacy challenges;
    • Diminished ability of the mentally ill to advocate effectively for themselves
    • Low commercial advocacy due to difficultly in discovering marketable treatments
  4. Flaws in reasoning;
    • A tendency to focus on saving lives versus improving them – a problem that puts most non-lethal disabilities at a disadvantage in priority setting
    • A tendency to distinguish mental disorders from other “biologically based” disorders that we do not control, due to the subjective experience of one’s own (healthy) mind

Though none of the categories above are without normative dimensions, the last category raises two clear points worth mentioning just now.  Read More