Petrie-Flom Student Fellow Michael Young has coauthored a new piece with Ethan Scheinberg (Harvard Law School) and Harold Bursztajn (Harvard Medical School) now available through JAMA, “Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication” The article discusses ethical and clinical implications of a 2014 HHS ruling allowing patients direct access to completed medical laboratory reports.
From the article:
Recent Center for Medicare & Medicaid regulations incentivizing reductions in 30-day hospital readmission rates have prompted a flurry of research into how clinicians and administrators can optimize patient health following hospital discharge. Preventable hospital readmissions in the U.S. are estimated to account for up to $15 billion in annual healthcare spending. In considering this problem, many analysts and innovators have focused on deficiencies in transitional care as a root cause of many preventable readmissions. While efforts to improve transitional care carry considerable promise, they tend to leave relatively underexplored a determinant of readmissions of equal if not paramount importance: the inpatient experience itself.
Writing in this week’s JAMA, Allan Detsky and Harlan Krumholz propose seven key interventions that can enhance patients’ hospital experiences and in so doing may portend improvements in patient health following discharge.
Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent. After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards’ valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014). Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.
While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.
In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.
In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.
“Mortis effare ordinem et serva vivos”
(State the facts of the death and serve the living)
It was with this incisive charge that Dr. Mark Flomenbaum concluded his lecture on forensic pathology to my medical school class on the final day of our first-year pathology course.
I was reminded of this teaching moment earlier this week when I came across a study recently published in the journal Neurology which found that the annual mortality rate from Alzheimer’s disease (AD) could be nearly six times greater than has previously been reported by the CDC from information gathered from death certificates. “Deaths from AD,” the authors conclude, “far exceed the numbers reported by the CDC and may be closer in magnitude to the number of deaths reported for heart disease and cancer.” Were the facts of death in the underreported cases simply misstated?
Earlier this month, landmark findings were published in the American Journal of Psychiatry illuminating the effect of disclosing genetic risk for Alzheimer’s disease on older adults’ cognition and memory. In a case-control study, researchers administered memory function tests to a group of known carriers of the apolipoprotein E4 allele (one of the best studied genetic risk factors for developing Alzheimer’s disease), half of whom were informed of their carrier status, and half of whom were not informed of their carrier status. They reported “[s]ignificant genotype-by-disclosure interaction effects were observed on several memory rating scales and tests of immediate and delayed verbal recall. Older adults who knew their ε4+ genotype judged their memory more harshly and performed worse on an objective verbal memory test than did ε4+ adults who did not know. In contrast, older adults who knew their ε4− genotype judged their memory more positively than did ε4− adults who did not know…informing older adults that they have an APOE genotype associated with an increased risk of Alzheimer’s disease can have adverse consequences on their perception of their memory abilities and on their performance on objective memory tests. Similar consequences might be expected if other indices of an increased risk of Alzheimer’s disease are disclosed (e.g., neuroimaging or CSF biomarkers of preclinical Alzheimer’s disease.)”
These findings raise profound questions for practitioners who must make regular decisions concerning how to communicate health risk information to patients, and more fundamentally, about what principles and policies ought to govern which findings should be disclosed or disguised.
The study and its implications bear striking correlates to a set of key issues in philosophy of language relating to the meta-descriptive aspects of speech and discourse. In a series of lectures later published as How We Do Things with Words, philosopher J.L. Austin persuasively argued against a longstanding philosophical tradition that had conceptualized language as a construct that exists solely to describe reality as it is or is imagined to be; Austin reasoned that language can serve not only to describe facts but can also serve to establish new facts by representing them as such.
Petrie-Flom Center Student Fellow Michael J. Young has published a new piece in AJOB Neuroscience on “Ethics and Ontology in Deep Brain Stimulation.” From the article:
Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems that can reliably deliver electrical, ultrasound, or magnetic impulses to specific deep cortical areas and neural circuits, with the ultimate goal of influencing abnormal patterns of neural activity implicated in disorders of the brain and nervous system (Famm et al. 2013). As knowledge of the brain’s dynamic synaptic networks and microcircuitry expands, it is anticipated that deep brain stimulation (DBS) technologies will begin to target neural activity with increasingly greater precision and functional efficiency (Warner-Schmidt 2013). While research in these domains carries tremendous promise for treating many neurologic and psychiatric conditions that have long been considered refractory to traditional treatments (Lozano and Lipsman2013; Nestler 2013; Warner-Schmidt 2013), they introduce a complex array of ethical, social, and legal questions.
Read the full article here.
The growing burden of managing chronic illness has long been a critical issue for policy makers and clinicians seeking to improve the quality, cost and efficiency of healthcare systems in the United States. According to the Institute of Medicine, the costs of treating and managing the segment of the population living with chronic illnesses currently represents nearly $1.5 trillion of the over $2 trillion in annual healthcare spending in the U.S. Over 90% of Medicare costs are allocated to beneficiaries living with two or more chronic conditions, with close to 50% of spending on individuals living with 6 or more chronic conditions (approximately 14% of beneficiaries). The immense share of healthcare spending attributable to chronic illness is expected to climb as the population ages.
Earlier this month, a bipartisan bill entitled the Better Care, Lower Cost Act was introduced in Congress which aims to address the complex issues involved in chronic care management. The legislation outlines three key innovations toward this end.
The latest edition of the Petrie-Flom Center’s bi-weekly e-newsletter is now available. Check it out for news and announcements from the Center, new scholarship from our affiliates, updates on upcoming events, and job and fellowship opportunities in health law and bioethics!
Petrie-Flom Student Fellow Michael J. Young has co-authored a new article with Dominic Sisti (Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania) and Bill of Health contributor Art Caplan (Division of Medical Ethics, NYU Langone Medical Center) in BMC Psychiatry on the ethical implications of efforts to base mental health diagnoses in biological causes.
From the abstract: Read More
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