Month: May 2015

The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

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Scale

By Michelle Meyer

A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Read More

Check out the latest news from the Petrie-Flom Center!

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pfc-web-logoCheck out the May 28th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

NEW EVENT!

glassesofwine_slidePetrie-Flom / Center for Bioethics Reception at ASLME 38th Annual Health Law Professors Conference

June 4, 2015 7:30 – 9:30 PM
Hilton St. Louis at the Ballpark
1 South Broadway, St. Louis, MO

Come learn more about the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School at this jointly-hosted dessert reception at the 2015 annual ASLME Health Law Professors Conference.

We hope to see you there!

For more information, please contact Brooke Tempesta at Brooke_Tempesta@hms.harvard.edu.

For more on news and events at Petrie-Flom, see the full newsletter.

Commil v. Cisco: Exploring the Relationship Between Patent Infringement and Validity

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By Rachel Sachs

On Tuesday, the Supreme Court issued its opinion in Commil USA, LLC v. Cisco Systems, Inc., in which it held that a defendant’s belief that a patent is invalid is not a defense to induced infringement of that patent under 35 U.S.C. § 271(b).  Four years ago, in a case called Global-Tech, the Court had held that a defendant could not be liable for induced infringement unless it had knowledge not only of the patent’s existence but also that its behavior constituted patent infringement.  In Commil, six Justices clarified that a defendant who has knowledge of a patent’s existence but believes it to be invalid may still be held liable for inducing its infringement.  (Justice Scalia dissented and was joined by Chief Justice Roberts, with Justice Breyer recused.)

Commil raises several issues for discussion, but I want to talk about just one here: the majority’s fixation on the distinction between infringement and validity.  The key passages of Justice Kennedy’s opinion, on pages 9 through 11, seem to rest heavily on preserving the separation between these two issues.  Essentially, as Justice Kennedy puts it, “because infringement and validity are separate issues under the Act, belief regarding validity cannot negate the scienter required under §271(b).”  Justice Kennedy is clearly correct as a formal matter.  We ask different legal questions when adjudicating issues of infringement and validity, we apply different burdens of proof to the two questions, and we involve different parties in their resolution.

But Justice Kennedy’s opinion ignores the close practical relationship between the two issues.  By contrast, scholars and practitioners have long recognized the tension between infringement and validity as instantiated in patent litigation.  A patentee wants its patent to be construed broadly, to ensure that the defendant’s invention falls within its bounds.  Yet at the same time, the patentee must avoid claiming too broadly, or its patent may be invalidated on precisely those grounds.  (Defendants typically advocate the opposite positions.)

Read More

The Peer Review Privilege: No Exception for Objective Facts

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By Alex Stein

The Michigan Supreme Court’s recent decision in Krusac v. Covenant Medical Center, Inc., — N.W.2d —- (Mich. 2015), 2015 WL 1809371, foiled an attempt at establishing an “objective fact” exception to the peer review privilege.  An elderly hospital patient allegedly rolled off the operating table, fell on the floor, and died shortly thereafter. As part of the hospital’s peer review procedure, one of the nurses compiled an incident report and submitted it to her superiors. The plaintiff in the ensuing wrongful death action subpoenaed that report. The trial judge ruled that the plaintiff was entitled to see the report’s first page that summarized the facts of the incident. The hospital appealed all the way to Michigan’s Supreme Court to vindicate its rights under the state’s peer review privilege, MCL 333.20175(8) & MCL 333.21515, that extends to “records, data, and knowledge collected for or by individuals or committees assigned a professional review function in a health facility or agency, or an institution of higher education in this state that has colleges of osteopathic and human medicine.” These information items are  “confidential, … are not public records, and are not subject to court subpoena.” Read More

Yale Law School Seeks Executive Director for New Health Law Center

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Solomon Center for Health Law and Policy Yale Law School

Executive Director

The Yale Law School is delighted to announce the launch of the Solomon Center for Health Law and Policy, an exciting new Center at Yale Law School dedicated to training the next generation of health law leaders—academics, CEOS, lawyers, and government officials—and having an impact today on the most important health care issues.

The Solomon Center is seeking applications for the position of Executive Director. The Solomon Center coordinates a diverse program of activities that serve students and scholars at Yale and contribute both locally and internationally to the study of health law—with a particular focus on health governance, industry and the practice of medicine.

The Executive Director, under the supervision of the Solomon Center faculty director, Professor Abbe Gluck, will be responsible for managing the day-to-day activities of the Center.  This will include working with and helping to select student and post-graduate fellows, planning events, including workshops and the annual conference, maintaining the website, building the center’s national reputation, working on grants, supervising scholarship and projects of the center, mentoring health law students, working with the many colleagues, organizations, and interested individuals with whom the Solomon Center collaborates, both within the Law School, across Yale University and outside the University.  The Executive Director will be an ambassador of the Center. He/she must be outgoing and a self-starter and will be responsible for building a broad network for the program.

Some specific responsibilities of the Executive Director/ Fellow include the following: Read More

“Medical Malpractice” vs. General Negligence: The Case of Falling Accidents

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By Alex Stein

As I wrote previously – see here, here, here, here, here, here, here, here, and here – whether a tort action sounds in “medical malpractice” as opposed to general negligence, or vice versa, can be crucial. Suits sounding in “medical malpractice” must satisfy special requirements that include shortened limitations periods, statutes of repose, and expert affidavits (or certificates of merit) at filing. In many states, those suits are also subject to special damage caps. Suits sounding in general negligence are free from these constraints. Filing and prosecuting those suits is consequently not as onerous and expensive as filing and prosecuting medical malpractice actions. For that reason, we witness many disputes over this pivotal categorization issue. Read More

Petrie-Flom is hiring a new postdoctoral fellow in clinical research ethics!

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PFC Logo-RGB-Round-Otlns-NewPetrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

Job Description

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants.  The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields.  Illustrative projects include the following: Read More

New from Bioethicist Art Caplan: How State Right-To-Try Laws Create False Expectations

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A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:

Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.

Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.

Read the full article here.

Neuroethics Seminar Videos Available Online

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In case you couldn’t attend in person, be sure to check out the videos from the Neuroethics Seminar series at the Center for Bioethics at Harvard Medical School! Topics include:

  • Hacking the Brain: Neuroenhancement with Noninvasive Brain Stimulation
  • Does Brain-Based Lie Detection Belong in American Courtrooms?
  • Does Brain Difference Affect Legal and Moral Responsibility?

View these videos and more here.

New paper on cross-disciplinary collaboration

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By Timo Minssen

The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?

Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent paper “Ten Simple Rules for a Successful Cross-Disciplinary Collaboration” published in the online open access journal PLOS Computational Biology last month. Please find below and abstract of the paper, which has inter alia been discussed and cited by Times Higher Education.

Abstract:

Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020” EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.

However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.

Proposed citation:

Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214