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

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: Continue reading

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

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

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

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

A needle in a haystack – finding the elusive solution to Indiana’s HIV Outbreak

By Nicolas Wilhelm, JD

Scott County, Indiana, which only has a few thousand residents, has historically had an average of five HIV cases per year. Since December 2014, however, the county has seen an outbreak, with more than 140 newly diagnosed cases. Dr. Jonathan Mermin, the director of the National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention at the Center for Disease Control (CDC) calls this “one of the worst documented outbreaks of HIV among IV users in the past two decades.” Dr. Joan Duwve, the chief medical consultant with the Indiana State Department of Health, explained that the abuse of the prescription drug Opana was one of the catalysts for the increase in HIV cases, with some residents injecting it as frequently as 10 times a day, and sharing syringes with other members of their community.

HIV is mainly spread either by sexual contact with another person with HIV, or by sharing needles or syringes with someone who has HIV. One way to reduce the spread of the disease is to implement syringe exchange programs (SEPs) that reduce the transmission of blood-borne pathogens like HIV by providing free sterile syringes and collecting used syringes from injection-drug users (IDUs).

Continue reading

Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

Faculty Director I. Glenn Cohen has co-authored a new Op-Ed in the New York Times:

Last week, the Food and Drug Administration released highly anticipated draft recommendations that would allow gay men to donate blood after one year of celibacy. While an improvement from the current, highly criticized lifetime ban, the new policy, which was announced in December, still caters to fear and stigma rather than science. It should be reconsidered. […]

Read the full article here.

Rutgers Journal of Bioethics: Call for Papers (8/30)

From the Rutgers Journal of Bioethics:

As members of the Bioethics Society of Rutgers University, we hope to raise general awareness of issues in bioethics within the Rutgers community by method of discussion and publication. Although the beliefs and opinions regarding bioethical issues of this group are not unanimous, we are united by our ardent belief that the student population at Rutgers should be made aware of the implications of biological research, medicine, and other topics of bioethical controversy. In order to bring to light these issues, we are now accepting any papers that fall under the vast umbrella that is bioethics. All papers will be considered for possible publication. Some example subjects are medical treatment, biological warfare, research ethics, medical sociology, social justice, history of medicine/science, medical case analysis, eugenics, gene therapy, human cloning, medical malpractice, and healthcare policy; however, you are not limited to these topics.

DEADLINE: AUGUST 30, 2015

Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we are joined by Nicole Huberfeld who brings us up to date on ACA developments including St Louis Effort for AIDS v Huff, Armstrong v Exceptional Child Center, and the situation in Florida.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Grading the ACA as Equal Protection Statute

The Affordable Care Act is sprawling.  Some of its myriad provisions may (or may not!) reduce healthcare costs.  Think of accountable care organizations, the hospital readmission reduction program, or even the preventive services mandate.  And so, the Act’s success is often evaluated by asking whether it has helped reduce healthcare costs.  (See, e.g., David Cutler here.)

Other of the ACA’s provisions are intended to promote financial security in the face of illness.  The Act’s most litigated provisions, requiring that people buy insurance, expanding Medicaid, and creating exchanges, can be understood primarily in this light.  And so, the Act’s success is also often evaluated by asking whether it has truly promoted financial security.  (See today’s New York Times piece from Margoret Sangor-Katz on the subject of underinsurance post-ACA, or Aaron E. Carroll’s take from December.)

A third way of understanding the ACA’s reforms–and evaluating its success or failure–too often gets left out (as it was by the NY Times here): The ACA can perhaps most coherently be thought of as an equal protection statute.

Continue reading

Medical Malpractice and the Middle-Ground Fallacy: Should Victims’ Families Recover Compensation for Emotional Harm?

By Alex Stein

Medical malpractice victims are generally entitled to recover compensation for emotional harm they endure: see, e.g., Alexander v. Scheid, 726 N.E.2d 272, 283–84 (Ind. 2000). But what about a victim’s close family member? Take a person who suffers emotional distress from witnessing a medical mistreatment and the consequent injury or demise of her loved one. Should the court obligate the negligent physician or hospital to compensate that person for her emotional harm?

This question has no uniform answer under our medical malpractice laws. Some states allow victims’ families to recover compensation for their emotional harm, while others do not. Three weeks ago, the Connecticut Supreme Court struck a middle ground between these two extremes. Squeo v. Norwalk Hosp. Ass’n, 316 Conn. 558, — A.3d —- (Conn. 2015). Continue reading

International Neuroethics Society Student Essay Contest: Deadline 5/20!

Remember to submit your 2000 word essay for consideration in the INS Student Essay Contest.  The top two submissions will be awarded:

  • $250 Michael Patterson Travel Stipend to attend the 2015 INS Annual Meeting in Chicago, IL (Oct 15-16), where there will be special networking opportunities,
  • One year free INS student membership,
  • Essay published in the Kopf Carrier (Newsletter of Kopf Instruments) as part of the “Neuroethics in Neuroscience Series” edited by Judy Illes (Director, National Core for Neuroethics, UBC),
  • Essay fast-tracked for peer-review if it (or a subsequent draft) is subsequently submitted to the American Journal of Bioethics Neuroscience (AJOB-N); separate submission would be required.

Who can apply: All current post-secondary students of any nationality; a student is defined as anyone enrolled in a degree granting program (undergraduate, graduate, or professional) during the 2014-2015 academic year.

Requirements: Essays must be 2000 words or less, written in English, and double spaced.  Cover page and essay should be saved as a single file in the format “Surname_INS_Student_Essay_Prize.doc” and emailed to administrator@neuroethicssociety.org with the subject line: “INS Student Essay Prize”.  Additional requirements can be found on the INS website.

Selection Criteria: Essays will be judged on originality of argument, rigor of defense, and quality of prose; a short-list will be generated by the Student Essay Prize Judging Committee and the top two selected from the shortlist through forum discussion.

Deadline: 5 p.m. ET on May 20, 2015

The Robust But Unsatisfying State Of Health Care Fraud Enforcement

By Zack Buck

Earlier this spring, the U.S. Department of Health and Human Services and Department of Justice reported they had recovered nearly $28 billion as a result of anti-health care fraud efforts in FY 2014. The federal False Claims Act played a substantial role in achieving these recoveries: the government recovered $2.3 billion in FCA settlements and judgments, and opened nearly 800 new civil health fraud investigations, in FY 2014 alone. Further, the agencies noted that these anti-fraud efforts—bolstered by increased funding and authority under the Affordable Care Act—are continuing to abandon the “pay and chase” method of fraud enforcement, relying instead on prevention and “real-time data analysis.”

Interestingly, it is no longer just the federal government driving the enforcement regime. Increasingly, facing Medicaid shortfalls, states are getting involved—and, according to practitioners, state enforcement is “exploding.” For example, in New York, its Office of Medicaid Inspector General recovered more than $1.7 billion from FY 2011 to 2013. States have also had success in litigating claims to trial, most recently illustrated by the notable South Carolina Supreme Court verdict against pharmaceutical giant Johnson and Johnson. Further, Vermont is likely to become the newest state to establish its own state false claims act, another wide-ranging and powerful statute that mirrors the federal FCA.

Continue reading

Two Cheers for Corporate Experimentation

Rubin's vase2I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading

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

Check out the May 15th 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:

brain_pain_slide_270_174_85REGISTER NOW!
Visible Solutions: How Neuroimaging Helps Law Re-envision Pain

June 30, 2015, 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West A
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain?  Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.

Agenda

The full agenda will be announced in the coming weeks. Check back here for news!

Registration

This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by the Center for Bioethics at Harvard Medical School, and with support from the Oswald DeN. Cammann Fund. 

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

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we are joined by Bill Sage. We discuss 1st Amendment challenges to FDA content regulation, NC Dental v FTC, antitrust generally and a Kentucky incident report/privilege case.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Lesley Sharp’s Transplant Imaginary

The supply of donor organs is in constant peril. But researchers around the world are working to develop spare human parts out of both machines and animals. Professor Lesley Sharp’s new book, The Transplant Imaginary, is a vivid look at how experts in “highly experimental sciences” navigate the moral world of their work—and how they think about its implications. Along with students in my course, “Healing Animals,” I recently spoke with Sharp about her new book.

The Transplant Imaginary is essential reading for anyone interested in law, ethics, and medical research. Sharp takes a look at things people cannot see and yet which factor crucially in scientific work. She recognizes that science is morally laden work, and her book helps to explain choices in a world of limited resources—and asks whether these are the only choices we have. Continue reading

New Discussion Draft of 21st Century Cures Act Released (Again)

Earlier today, the House Energy and Commerce Committee released the most recent draft of the 21st Century Cures Act, in time for it to be marked up by the Health Subcommittee tomorrow.  At 300 pages, the new draft adds back in a number of provisions that were excised from the previous, 200-page iteration of the draft.  I haven’t had time to uncover all of the new additions just yet, but given that this is my third blog post on the subject, I wanted to highlight some of the ways in which this version differs (and doesn’t differ) from the last draft.

Continue reading

The ACA, The ADA, And Wellness Program Incentives

A new post by Kristen Madison on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Wellness programs have been enthusiastically embraced by employers seeking to promote health and hoping to control costs. On April 20, 2015, program proponents received long awaited news: the Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying how the Americans with Disabilities Act (ADA) would apply to wellness programs. Many large employers likely breathed a sigh of relief upon reading the rule, but the rule is not final and may reignite a longstanding debate over the appropriate use of wellness incentives.

Wellness programs have become common in the workplace. A 2014 Kaiser Family Foundation survey found that among large employers offering health benefits, just over half offered an opportunity to complete a health risk assessment (HRA), a questionnaire that is often a gateway for the provision of health risk information and other wellness program components (Exhibit 12.8 in the Kaiser survey). A similar fraction offered biometric screenings (Exhibit 12.1), such as tests for cholesterol or blood pressure, or measurement of body mass index. Some screening programs test for cotinine, which is associated with nicotine exposure.

Some wellness programs offer financial incentives such as premium adjustments or gift cards. The 2014 survey found that more than half of large employers using HRAs provide incentives for their completion, and more than a third of these incentives equaled or exceeded $500 (Exhibit 12.10). A federally commissioned report prepared by RAND suggests that incentives are effective in increasing HRA completion. […]

Read the full article here.

LGBT Health: Recognizing Disparities and Increasing Support

by Vadim Shteyler

Amid this week’s disheartening studies highlighting discrimination of LGBT populations, the American College of Physicians (ACP) affirms its support and offers new recommendations for furthering LGBT health.

The bad “news”: is not really news. It is further evidence of how much more effort needs to be placed on ending LGBT discrimination and inequalities. A national survey published in the Ann of Intern Med found that lesbians were significantly less likely to get vaccinated for HPV than their heterosexual counterparts (adjusted prevalence of 8.5% v 28.4%). HPV is easily transmissible through contact and believed to be equally transmissible in gay and heterosexual women. The vaccine can prevent most cases of cervical cancer, which has terrible outcomes if discovered late, indicating that many deaths could have been prevented. An editorial in the same issue describes neglected health concerns affecting LGBT populations and calls for better professional education on LGBT health. The CDC’s and American Congress of Obstetrics and Gynecology’s (ACOG) efforts to inform patients about pap smear rates not been slow and inconsistent in changing medical practice. Combined with markedly lower HPV vaccination rates, cervical cancer remains a big concern. Continue reading

Bioethicist Art Caplan: A Potential Solution to the Shortage of Solid Organs for Transplantation

A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:

In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.

More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.

However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]

Read the full article here.