Biosecurity in a Globalised World Conference: The Adoption of the Revised International Health Regulations – 10 Years On

ABSTRACT SUBMISSIONS AND REGISTRATION OPEN

In 2015 it will be 10 years since the adoption of the revised International Health Regulations (IHR). To mark this important anniversary, QUT’s Australian Centre for Health Law Research is pleased to invite you to Biosecurity in a Globalised World: The Adoption of the Revised International Health Regulations – 10 Years On.

The conference will be hosted by the Australian Centre for Health Law Research at Queensland University of Technology’s Gardens Point campus in Brisbane from 27-28 July 2015.

The conference will provide a forum for scholars and policy makers to discuss and present on the progress achieved through the IHR to date, and the important work yet to be done.

The keynote address will be delivered by Professor Lawrence O. Gostin, Founding O’Neill Chair in Global Health Law, Georgetown University, USA.

Themes to be discussed at the conference include:

  • Development of IHR core capacities
  • Regulatory responses
  • Securitisation of infectious disease outbreaks
  • Human rights
  • Papers from all disciplines and areas of expertise are welcome.

For further information please visit http://ihr2015.com/

If you have any questions, or require any assistance, please contact ihr2015@qut.edu.au

The Newest Twist in the State Regulation of Off-Label Marketing

By Zack Buck

The newest chapter in the legal drama involving Johnson & Johnson, Inc. (“J&J”) and its subsidiary Janssen Pharmaceutical, Inc. (and a subsidiary previously known as Ortho-McNeil-Janssen Pharmaceuticals, Inc.) (“Janssen”) was written late last month. Specifically at issue was whether or not the alleged off-label marketing of its blockbuster antipsychotic Risperdal violated state anti-fraud and consumer protection statutes. In late February, the South Carolina Supreme Court upheld a jury verdict finding for the state under the South Carolina Unfair Trade Practices Act (“SCUTPA”), but reduced the damages award from $327 million to $136 million. In a series of cases at the state level involving the marketing of Risperdal, this is the first time that a jury verdict against J&J/Janssen has been upheld by a state supreme court. Cases in Pennsylvania, Arkansas, West Virginia, and Louisiana have ended with verdicts for the pharmaceutical company.

I’ve been following these cases for years and have undertaken further analysis on the topic here. Of course, news headlines have been dominated by the startling penalty amounts states had sought—and, in some states, had been initially imposed. Most noteworthy, an Arkansas jury imposed a $1.2 billion fine before the Arkansas Supreme Court reversed the finding; in Louisiana, the fine was $330 million before its state supreme court did the same. Indeed, these litigated claims are in addition to settled claims—the largest of which were entered into by J&J with the federal government and various states for $2.2 billion in 2013.

Continue reading

Bioethicist Art Caplan: Why a New Alzheimer’s Drug Isn’t A No-Brainer

A new piece by contributor Art Caplan on NBC News:

Biogen, a Cambridge, Massachusetts biotech company, announced last week that early tests of their new drug aducanumab, a monoclonal antibody, had shown impressive results in treating those with early stage Alzheimer’s disease. The drug significantly reduced the amyloid plaque buildup in the brain that is associated with Alzheimer’s.

In a very early stage safety test aducanumab slowed the cognitive decline and dementia associated with Alzheimer’s in people. On the Mini Mental Status Exam, a widely used measure of cognitive function, people at risk of Alzheimer’s who got a placebo lost around 3 points over a year. But those who got the lowest dose of aducanumab worsened by just two points and those who got a higher dose lost less than a point.

Biogen was so excited by the early results in 166 volunteers that it is going to try to go directly to a much bigger clinical trial of the drug. Wall Street was very excited too—Biogen’s stock price shot up 10 percent. […]

See the full article here.

Executions, Doctors, The U.S. Supreme Court, And The Breath Of Kings

A new post by I. Glenn Cohen 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.

The relationship between medicine and capital punishment has been a persistent feature of this past year in health law, both at the level of medical ethics and Supreme Court review.

Our story starts in Oklahoma, where the execution of Clayton Lockett was botched on April 28, 2014. National Institutes of Health (NIH) bioethicist Seema Shah described the events in question:

Oklahoma was administering a new execution protocol that used the drug midazolam, a sedative that is often used in combination with other anesthetic agents. Oklahoma had never used this drug in executions before; in fact, only a few states had experience with using the drug in lethal injection. Florida had previously used this drug in lethal injections, but with a dose five times higher than what was indicated in Oklahoma’s protocol. […]

See the full post here.

2015 Broad Institute Innovation & Intellectual Property Symposium

2015 Broad Institute Innovation & Intellectual Property Symposium

Monday, April 13, 2015 – Wednesday, April 15, 2015

Broad Institute, 415 Main St., Cambridge, MA

This ​symposium ​will ​bring ​together ​Broad ​scientists, ​delegates ​from ​the ​European ​and ​U.S. ​Patent ​Offices, ​and ​global ​business ​and ​legal ​thought ​leaders ​for ​discussion ​and ​information ​exchange ​on ​topics ​related ​to ​innovation ​and ​intellectual ​property ​law ​of ​interest ​to ​the ​Cambridge ​and ​Boston ​scientific, ​business ​and ​legal ​communities. ​

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week Erin Fuse Brown joins us to discuss Irrational Hospital Pricing, Price Transparency, the likely SGR Fix, and Non-Profit Tax Status.

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

NEXT WEEK (4/1): King v. Burwell and the Future of the Affordable Care Act

King v. Burwell and the Future of the Affordable Care Act

KIngApril 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is free and open to the public, but registration is required. Please register online.

This event is supported by the Oswald DeN. Cammann Fund.

Pay Disparities in Nursing

By Emily Largent

I’ve mentioned on this blog before that I had a past life as a nurse.  Therefore, I wanted to call attention to an important new study that has just come out in JAMA: Salary Differences Between Male and Female Registered Nurses in the United States.  The study found that “[m]ale RNs outearned female RNs across settings, specialties, and positions.”  On average, male nurses make $5,150 more per year than female colleagues in similar positions.  This salary gap affects 2.5 million female RNs.

There is speculation that a male nurse may be perceived as more expert simply because he is a man. This explanation is deeply ironic.  Decades  of legal barriers kept men out of the field, and historically, some nursing schools refused to admit men due to sex stereotypes that categorized caring as a feminine trait.  The Supreme Court deemed this practice unconstitutional in Mississippi University for Women v. Hogan.  While that decision came down in 1982, research suggests that men continue to face pervasive barriers in nursing school (e.g., hearing anti-male remarks from faculty).

Ongoing identification of nursing as “women’s work” and the presence of gender bias in nursing can affect male nurses in different, seemingly contradictory ways.  On the one hand, the 2000 National Sample Survey of Registered Nurses found that men leave nursing at a higher rate in their first four years of practice.  Some have attributed that attrition to the harmful effects of gender bias.  On the other hand, it has been observed that–unlike women who enter male-dominated professions–male nurses who enter this female-dominated profession typically encounter structural advantages that tend to enhance their careers.

There is a need for more nurses.  According to the Bureau of Labor Statistics’s Employment Projections, the RN workforce is expected to grow to 3.24 million in 2022.  That is a 19% increase.  Nursing is a context that highlights how gender stereotyping hurts everyone–men who encounter discrimination, women who earn less than their male counterparts, and patients who benefit most when nursing recruits and retains excellent people.

I personally found nursing to be very rewarding.  I hope this study motivates employers to scrutinize their pay structures but also to appreciate and address the broader effects of gender bias on the profession.

Ensuring Timely Approval Of Generic Drugs

By Ameet Sarpatwari and Aaron S. Kesselheim

Cross posted from Health Affairs Blog

Having saved US consumers over $1.5 trillion in the past decade, generic drugs are one of the most cost-effective interventions in our entire health care system. Using generic drugs instead of brand-name drugs, when a generic is available, has been shown to increase medication adherence and improve health outcomes for chronic conditions.

Importantly, generic drugs offer these advantages without sacrificing quality; the Food and Drug Administration’s bioequivalency standards are met and often exceeded by generic-name manufacturers, and no randomized controlled trials—the gold standard of medical evidence—have identified clinically significant variations in outcomes between brand-name and FDA-approved interchangeable generic drugs.

However, to perform the tests the Food and Drug Administration (FDA) requires before approving a generic drug, manufacturers need access to one vital component: the brand-name product. Samples of the brand-name version of a drug can be used as a comparator to demonstrate the similarity of the molecular structure, or even the clinical outcomes from the generic product. Physico-chemical details about the brand-name drug, such as its molecular structure, stability, and cross-reactions, can be even more helpful in ensuring that the generic version adheres to the highest quality standards.

Continue reading

Harvard Undergraduate Bioethics Society event: Big Brother Is Watching–Paternalism and Bioethics

 You are invited to the Harvard Undergraduate Bioethics Society 2015 Conference:

“Big Brother Is Watching: Paternalism and Bioethics”

Saturday, March 28th, 3.30-6.30pm, Harvard Hall 104

RSVP Here

Coffee and desserts will be served

A panel discussion and talks by

David Buchanan, PhD

University of Massachusetts, Amherst

Professor and Chair of the Department of Health Promotion & Policy, and Director of the Institute for Global Health

Sarah Conly, PhD

Bowdoin College

Associate Professor of Philosophy

Wendy Mariner, JD MPH LLM

Edward R. Utley Professor of Health Law at Boston University School of Public Health

Professor of Law at Boston University School of Law

Professor of Socio-Medical Sciences at Boston University School of Medicine

Steven Ralston, MD

Harvard Medical School

Associate Professor of Obstetrics, Gynecology and Reproductive Biology

 

“Error in Judgment” and Informed Consent

By Alex Stein

When conventional standards of practice allow a physician to choose between two or more ways to treat or diagnose a patient, she is free to select any of those ways. The fact that her chosen procedure subsequently proves inferior to the alternatives and works badly for the patient is of no consequence: the physician would not be liable for malpractice because malpractice accusations only attach to actions and not to consequences. Whether a physician did or did not deliver substandard treatment to the patient must be determined prospectively (ex ante) rather than by hindsight (ex post). Because a medically approved procedure that proves inferior to another recommended procedure appears negligent, jurors must receive an effective warning against this misleading appearance. How to best administer this warning is a matter of split among state courts. Continue reading

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

PFC_Banner_DrkBlueCheck out the March 20th 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:

KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

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

Should Health Lawyers Pay Attention To The Administration’s Privacy Bill?

By Nicolas Terry

Cross Posted from Health Affairs Blog

Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”

In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.

The “HIPAA clause” in the draft bill is subtly different (and noticeably narrower than its preemption of state law clause): “If a covered entity is subject to a provision of this Act and a comparable provision of a Federal privacy or security law [the list includes HIPAA] such provision of this Act shall not apply to such person to the extent that such provision of Federal privacy or security law applies to such person.” Continue reading

THIS WEEK (3/18 – 3/20): Families Matter: Ethically, Legally, and Clinically

Families Matter: Ethically, Legally, and Clinically

child_pediatrician_slide_270_200_85_c1March 18 – 20, 2015

Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

A full agenda is available on our website.

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter.

This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law.  Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.

Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

“Marlise’s Law”: Protecting the Autonomy and Dignity of Brain-Dead Pregnant Women

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

On March 12, 2015, Texas Representative Elliot Naishtat (Austin) filed HB 3183, which would repeal the Texas law that currently prohibits pregnant women from exercising their advance directives.  The existing statute includes the following language:  “I understand that under Texas law this directive has no effect if I have been diagnosed as pregnant.” The bill strikes this sentence and would allow health care providers and medical institutions to honor a woman’s wishes about end-of-life care.

The bill is known as “Marlise’s Law,” named for Marlise Muñoz of Fort Worth, Texas, who was kept on mechanical support for two months after she was declared brain dead in 2013. Muñoz collapsed in her home in November 2013 when she was 14 weeks pregnant. She was declared brain dead two days later but John Peter Smith Hospital said it was legally prevented from removing life support because she was pregnant. Continue reading

Is there an IRB inside your Phone?

Apple’s interest in the healthcare space continues to grow. Although the implications of last year’s Health app and HealthKit SDK are still unclear, the company is now entering the crowd-sourced research space with the newly announced ResearchKit.

Apple’s Health app is a powerful health platform, the full promise of which won’t be proven until the imminent launch of Watch, Apple’s first wearable, or some powerful diagnostic apps rather than more mere FitBit clones. As discussed previously Apple, while astutely navigating FDA device regulation, seems to be stepping up to the plate in its embrace of patient privacy in the HIPAA-free mobile app space.

ResearchKit is another edgy innovation. And, again, one marked by the technology giant’s ability to forge partnerships with major stakeholders. ResearchKit was announced in concert with several apps from major healthcare research institutions including Stanford and Mass. General. Early reports suggest that research subjects are signing up in droves, cutting subject recruitment times dramatically. Continue reading

REGISTER NOW: ReSourcing Big Data – A Symposium and Collaboration Opportunity (3/23)

From Harvard Catalyst:

REGISTER NOW!

March 23: Symposium
9:00 AM – 5:00 PM
Joseph B. Martin Conference Center
Harvard Medical School

Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.

Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading

Physician Aid In Dying: Whither Legalization After Brittany Maynard?

A new post by Charles Baron 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.

Brittany Maynard’s highly publicized decision to end her life under Oregon’s Death With Dignity law has given a new face to the American right to die movement. It is that of a young, attractive, athletic newlywed, who would not have considered herself as having a stake in the movement until the day she learned a brain tumor was the cause of her severe headaches. She was terminally ill and faced a future of six months of increasing pain, debilitation, and severe seizures before dying.

A video of Maynard’s story produced by the non-profit advocacy organization Compassion and Choices has reached many millions of viewers. Extended coverage of her decision-making process by People Magazine resulted in record numbers of hits to the publication’s website. During her illness, Maynard moved from California to Oregon and on November 1, 2014 took barbiturates to end her life. In her memory, her husband and mother have become prominent activists in the effort to legalize physician aid-in-dying (PAD). […]

See the full post here.

Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

I am happy to announce the following publications:

1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication)

Abstract:  

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week Lindsay Wiley joins us to discuss “New Public Health” and we debate the value and validity of wellness plans.

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 at @nicolasterry @FrankPasquale