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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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High Noon for Population-Wide Mammography Screening?

By Prof. Dr. med. Dr. phil. Nikola Biller-Andorno

Director, Institute of Biomedical Ethics, University of Zurich, Switzerland

Safra Network Fellow, Harvard University (13-14)

Visiting Professor, Div. Medical Ethics, Harvard Medical School (12-14)

It is amazing how much heat a report can draw that simply states what has been all over town for some time now: We do not know if mammography screening does more good than harm, we do not even know for sure if it does any good at all.

The Swiss Medical Board, an independent health technology assessment initiative that was started in 2008, stated that based on the empirical data availability the introduction of mammography screening all over Switzerland could not be recommended.

As could be expected the report drew fire. Curiously, one of the chief complaints was that it was “unethical” to upset women who might no longer know if screening was good for them or not.

This sounds just a little bit paternalistic – particularly given that we know that most women seriously overestimate the benefits of screening when making their decision, a point that my colleague Peter Juni and myself illustrate in a Perspective piece published on May 22, 2014 in the New England Journal of Medicine.

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Doctors, Lethal Injection, and Firing Squads

Yesterday JAMA published a new perspective I co-wrote with Bob Truog and Mark Rockoff  “Physicians, Medical Ethics, and Execution by Lethal Injection“. In that article we make the case that the recommendations coming out of the Oklahoma botched lethal injection executions to require physician involvement would force physicians into an untenable medical ethical position. We also argue that it supports a kind of kabuki theater of medicalization, where execution becomes normalized.

Now comes a news report of a Utah lawmaker pushing to give those set to be executed the option of firing squad which he views as more humane than lethal injection. Many people will no doubt recoil at this notion. But here is my intentionally provocative question (and this is on my behalf not my co-authors): If you are in favor of capital punishment, wouldn’t a single close range shot to the head as a form of execution be, in some ways, more defensible than lethal injection? If you recoil at the notion of this being a way of doing execution, have you perhaps fallen for the kabuki theater of medicalization? Why not choose a method of execution that is more honest about the gravity (and perhaps the horror) of what we are doing rather than present something as somewhere on a continuum with sedation?

Art Caplan on handshakes in medical settings

Art Caplan has a new opinion piece up at NBC News on the suggestion, in a recent JAMA article, that handshakes should be banned in healthcare settings. From the article:

Now, the handshake ban might make sense if it were not for the fact that the constant touching of microbe-laden things by providers and patients is likely to go on and, handshake or not, they are still likely to fist bump, shoulder pat, rub noses or whatever else they think shows love, care and concern for one another.

Health care has gotten very sterile and impersonal as more technology appears, less time is set aside for talking and more health providers find themselves chained to their computers or handheld medical devices. While not every culture values a handshake, many do, and putting the kibosh on grip and grinning just adds to the perception that caring and curing are heading down different highways.

Read the full article.

New op-ed on doctors and the death penalty, coauthored by I. Glenn Cohen

Petrie-Flom Faculty Director I. Glenn Cohen has coauthored a new opinion piece now available through JAMA, “Physicians, Medical Ethics, and Execution by Lethal Injection.” From the article:

In the wake of the recent botched execution by lethal injection in Oklahoma, however, a group of eminent legal professionals known as the Death Penalty Committee of The Constitution Project has published a sweeping set of 39 recommendations that not only tinker with, but hope to fix, the multitude of problems that affect this method of capital punishment.

Many of the recommendations this committee makes with regard to legal and administrative reforms appear worthwhile and reasonable. Their final recommendation, however, concerns the role of the medical profession in performing lethal injection. It states: “Jurisdictions should ensure that qualified medical personnel are present at executions and responsible for all medically-related elements of executions.”

In particular, the recommendation specifies that “Execution team members…are licensed, practicing doctors, nurses or emergency medical technicians who are responsible for performing functions in their day-to-day practice that are similar to those they will perform at the execution.” Regardless of this committee’s recommendations, physician participation in capital punishment is an ethical dilemma that the profession of medicine must address.

Read the full article.

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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#BELHP2014 Panel 5, Behavioral Economics and the Doctor-Patient Relationship

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

This session was kicked off by Jennifer Zamzow, Post-Doctoral Fellow, Center for Ethics and Policy, Carnegie Mellon University, with a talk called “Affective Forecasting in Medical Decision-Making: What Do Physicians Owe Their Patients?”  Jennifer began with an example of a recently paralyzed patient requesting termination of life-sustaining care on the grounds that his injury feels like a fate worse than death.  On the one hand, we feel compelled to respect the decisions of competent patients, but on the other hand, given what we know about errors in affective forecasting, we anticipate that the patient would be able to eventually adapt to his new circumstances and lead a happy, full life.  The question, then, is whether physicians have any obligation to help their patients make more accurate affective forecasts.

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A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

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FRIDAY & SATURDAY: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, & Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

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The Alexis Shapiro Case: Divergent Perspectives on Coverage Decisionmaking

Alexis Shapiro is a 12 year old girl who started gaining weight uncontrollably due to a rare condition caused by damage to her brain during the removal of a brain tumor.  Her and her parents’ struggle to get her gastric bypass surgery to curb the weight loss made national news for much of the winter in several outlets.  Happily, in March she had the surgery and she now appears to be doing well.  A good outcome, but boy was the process by which we got here a painful one, largely because the insurer understood the coverage decisionmaking process differently than the rest of us.  Here’s a timeline, and some reflections: Read More