Direct-to-Patient Laboratory Test Reporting

MJYPetrie-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:

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Preventing Post-hospital Syndrome

By Michael Young

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.

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On Patents, Patients and the Public Interest

By Michael Young

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.

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Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

By Michael Young

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.

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Quantifying Causes of Mortality and the Relative Burden of Disease

By Michael J. Young

“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?

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Disclosing Genetic Risks: Lessons from the Philosophy of Language

By Michael J. Young

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.

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Ethics and Ontology in Deep Brain Stimulation

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.

Encouraging Innovation in Chronic Care Management

By Michael Young

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.

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ICYMI: Bi-weekly Petrie-Flom Center Newsletter, 1/10/14

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!

Defining mental illnesses: can values and objectivity get along?

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.

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Capturing Value in Advanced Medical Imaging

On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients.  Structured around appropriate use criteria  developed by professional medical societies, the tools would aim to increase the value of advanced imaging studies by informing and guiding practitioners’ decisions across a variety of clinical settings.

Such tools would provide active feedback on the appropriateness and evidence base of various imaging modalities, and would require physicians to furnish rationales for ordering tests that are inconsistent with appropriate use criteria.  The bill also envisions the creation of registries that document how diagnostic tests are used in order to facilitate research and to enable feedback to clinicians on metrics related to appropriate use criteria.  In a press release, the American College of Radiology lauded the proposed legislation, stating that it would “revolutionize the specialty of radiology.”

Mandating the use of electronic clinical decision support tools portends at least three key improvements in clinical workflows and healthcare quality more broadly.

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Ethics and Oversight in Recombinant Genetic Research

By Michael Young

In 1972, biochemist Paul Berg and his student Janet Mertz published groundbreaking details of their first successful attempt at devising a procedure to cleave separate pieces of DNA and recombine them into a single novel molecule.  These innovations, dubbed recombinant DNA (rDNA) technology, spurred a flurry of concerns from members of the scientific community who worried about the safety, risks and potential drawbacks of creating recombinant DNA molecules.  Motivated by these concerns, the NIH established the Recombinant DNA Molecule Program Advisory Committee (RAC) in 1974.  The RAC was charged with the mission of overseeing research and implementation of rDNA technologies, with a particular focus on proposals involving the transfer of recombinant or synthetic DNA into humans (i.e., human gene transfer).

Last week, after nearly 40 years of providing an additional layer of oversight to this class of research, the RAC received recommendations from an independent Institute of Medicine (IOM) committee that was convened to assess “whether the current oversight of individual gene transfer protocols by the Recombinant DNA Advisory Committee (RAC) continues to be necessary.”

The committee’s report calls for significant changes to the prevailing structures of rDNA research regulation and oversight, and represents a victory for many gene transfer researchers who have challenged RAC regulations. Continue reading

Medical Advice and the Limits of Therapeutic Influence

By Michael Young

It is estimated that 500,000 patients are discharged from U.S. hospitals against the recommendations of medical staff each year.  This category of discharges, dubbed discharges against medical advice (DAMA), encompasses cases in which patients request to be discharged in spite of countervailing medical counsel to remain hospitalized.  Despite safeguards that exist to ensure that patients are adequately informed and competent to make such decisions, these cases can be ethically challenging for practitioners who may struggle to balance their commitments to patient-centered care with their impulse to accomplish what is in their view best for a patient’s health.

Writing in the most recent issue of JAMA, Alfandre et al. contend that “the term [‘discharge against medical advice’] is an anachronism that has outlived its usefulness in an era of patient-centered care.”  They argue that the concept and category of DAMA “sends the undesirable message that physicians discount patients’ values in clinical decision making.  Accepting an informed patient’s values and preferences, even when they do not appear to coincide with commonly accepted notions of good decisions about health, is always part of patient-centered care.”  The driving assumption here seems to be that if physicians genuinely include patients’ interests and values in their assessments, then the possibility of “discharge against medical advice” is ruled out ab initio, since any medical advice issued would necessarily encapsulate and reflect patients’ preferences.  They therefore propose that “[f]or a profession accountable to the public and committed to patient-centered care, continued use of the discharged against medical advice designation is clinically and ethically problematic.”

While abandoning DAMA procedures may well augment patients’ sense of acceptance among medical providers and reduce deleterious effects on therapeutic relationships that may stem from having to sign DAMA forms, it leaves relatively unaddressed the broader question of how to mitigate health risks patients may experience following medically premature or unplanned discharge.  Alfandre and Schumann’s robust interpretation of patient-centeredness also raises the question of how to handle situations in which patients refuse medically appropriate discharge.  On this interpretation, can the ideal of patient-centered care be squared with concerns for optimizing the equity and efficiency of resource allocations more broadly?

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Disruptive Innovation and the Rise of the Retail Clinic

By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

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Mental Health in the Intensive Care Unit: The Need for Early Intervention

By Michael J. Young

A prospective cohort study recently published in the New England Journal of Medicine adds to a growing body of research illuminating the neurocognitive sequelae of critical illness requiring intensive care.  Researchers reported that “one out of four patients [treated in the ICU] had cognitive impairment 12 months after critical illness that was similar in severity to that of patients with mild Alzheimer’s disease, and one out of three had impairment typically associated with moderate traumatic brain injury.”  They underscore the possible role of delirium – a syndrome of disturbed consciousness commonly seen in critically ill patients treated in the ICU – in contributing to downstream cognitive impairments.  More broadly, these findings prompt intensivists to rethink the relative priority assigned to the mental health needs of patients during ICU stays.

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Improving Outcomes by Empowering Patients: The Empirical Case for Patient-Centered Care

By Michael Young

As healthcare institutions work to meet the triple aim of reducing healthcare costs while improving quality of care and population-wide health, efforts to expand the role of patient involvement in clinical decision making have gained appreciable momentum.  Interest in increasing patient participation in clinical decision making and goal setting is premised in large part on the notion that greater patient involvement can improve health outcomes by ensuring that treatment plans align with patients’ interests, abilities and sociocultural contexts.  A recent study published in the Journal of Personality and Social Psychology adds to the growing body of empirical research supporting these efforts, suggesting that the very act of allowing patients to choose between treatment alternatives can augment the efficacy of treatment by enhancing patients’ sense of personal control.  By giving patients more opportunities to exercise autonomy at times when many are inclined to perceive their circumstances as well beyond their influence, healthcare providers can help to restore patients’ sense of self-governance and optimize patients’ perceptions of their situations and the medical care they receive.

The idea that empowering patients to choose between treatment options might itself contribute to better health outcomes invites clinicians to rethink how to approach formulating and conveying treatment plans to patients.  Whereas traditionally some clinicians might have conceptualized their roles as experts whose responsibility is to design therapeutic plans on behalf of their patients, the principle of patient-centered care encourages providers to regard patients as associates in developing shared plans to advance and sustain health.  This paradigm of care and the distinctive stance that it demands of clinicians is poetically captured by a letter penned by novelist John Steinbeck to his personal physician, in which he incisively relates “What do I want in a doctor? Perhaps more than anything else—a friend with special knowledge.”

Effectively transitioning to this horizontal model of therapeutic relationships will require careful planning and implementation.  Indeed, boosting patient involvement in clinical decision making may prove increasingly elusive as medical knowledge continues to grow exponentially complex in substance and scope.  As such, to realize the promises of patient-centered care, clinicians should work to develop concrete plans and quantifiable measures to operationalize the ideal of patient engagement within the context of day-to-day practice.  As a first step in this direction, healthcare providers might consider ways to deliver complex biomedical knowledge to patients and surrogates in ways that are more accessible, timely and actionable.  By coupling enhancements in patient education with efforts to promote patient involvement in clinical decision making, clinicians can play a pivotal role in maximizing the efficacy of healthcare innovations and delivery systems of the future.

Coupling Genetic Counseling to Test Coverage

By Michael Young

As debates surrounding genetic patent rights begin to settle, new questions and disputes have started to emerge around insurance coverage for genetic testing.  For the first time, a U.S. health insurance provider (Cigna) has decided to require evaluation by an American Board of Medical Genetics or American Board of Genetic Counseling certified counselor before covering the costs of genetic testing, including genetic tests for susceptibility to breast and ovarian cancer (e.g., BRCA1 and BRCA2).  Cigna specifies in its new coverage policy statement, which goes into effect on September 15, 2013, that coverage for such testing will require recommendation by a certified genetic counselor based on pre-test individual evaluation, pedigree analysis, and intent to engage in post-test counseling.

By mandating genetic counseling prior to testing, this requirement aims to reduce unnecessary tests and to increase the efficiency and efficacy of health risk management and service delivery. Earlier this week, however, the American Society of Clinical Oncology (ASCO) took aim at Cigna’s policy, claiming that it can “negatively impact the care of cancer patients by serving as a barrier to the appropriate use of genetic testing services.”  At least four key considerations appear to underpin ASCO’s apprehensions about Cigna’s new policy.

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Introducing the 2013-2014 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our 2013-2014 Student Fellows. During the coming year, each of the fellows will pursue independent research under the supervision of Center faculty and fellows. They will also be regular contributors at the Bill of Health on issues relating to their research.

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