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. ​

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.

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.

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.

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.

Bioethicist Art Caplan: UK Man, His Surrogate Mom and Their Baby Are Family

A new piece by contributor Art Caplan on NBC News:

A British high court has permitted Kyle Casson, a single man, to adopt an eight-month-old boy who was carried and delivered by a surrogate — Casson’s own mother.

To diagram this family tree, Casson, 27, technically adopted not his son but his brother because the woman who carried the baby to term is, legally, the mother. That also means that Casson’s mom gave birth, technically, to a son and a grandson at the same time.

Biologically, the child is her grandson.

The ruling traverses an array of ethical twists and turns. Let’s start with the more common fault lines. […]

Read the full article here.

TOMORROW (3/11): Identified versus Statistical Lives: An Interdisciplinary Approach Book Launch

Identified_Lives_posterBook Launch: Identified versus Statistical Lives: An Interdisciplinary Approach

March 11, 2015 12:00 PM

Wasserstein Hall, Room 2012 Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Identified versus Statistical Lives: An Interdisciplinary Approach is an edited volume that grew out of the 2012 conference “Identified versus Statistical Lives: Ethics and Public Policy,” cosponsored by the Petrie-Flom Center, Edmond J. Safra Center for Ethics, and the Harvard Global Health Institute. The essays address the identified lives effect, which describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. Such bias raises practical and ethical questions that extend to almost every aspect of human life and politics.

The book talk and discussion will feature:

  • I. Glenn Cohen, co-editor, Petrie-Flom Faculty Director, Professor of Law at Harvard Law School
  • Norman Daniels, co-editor, Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Nir Eyal, co-editor, Professor of Global Health and Social Medicine (Medical Ethics), Harvard Medical School

Co-sponsored by the Harvard Law School Library, with support from the Harvard Global Health Institute.

REGISTER NOW! 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.

Academic Fellow Rachel Sachs in the SCOTUSblog, on King v. Burwell

Academic Fellow Rachel Sachs was quoted today in the SCOTUSblog:

Wednesday’s oral arguments in King v. Burwell, the challenge to the availability of tax subsidies for individuals who purchase their health insurance on a marketplace created by the federal government, continue to dominate coverage of and commentary on the Court.  In The Wall Street Journal, Louise Radnofsky and Jess Bravin report that “Justice Samuel Alito ’s suggestion that the Supreme Court could delay for months the impact of a decision to gut the health law revives the possibility that at least a dozen states could take action to limit the effect of such a ruling.”  AtFiveThirtyEight, Oliver Roeder writes that “Solicitor General Donald Verrilli won Wednesday’s oral arguments in King v. Burwell, the latest challenge to the Affordable Care Act. Or at least that’s what the wisdom of the crowd is telling us.”

[…]  At Harvard’s Bill of Health Blog, Rachel Sachs notes that “the Court displayed a more sophisticated understanding of the consequences of a decision striking down the subsidies in states that have not established their own exchanges.”

Read the full article here. See Rachel Sachs’ original post here.

MONDAY (3/9): Gender (Re)assignment: Legal, Ethical, and Conceptual Issues

genderreassignment_slideGender (Re)assignment: Legal, Ethical, and Conceptual Issues

Monday, March 9, 2015 12:00 PM

Pound Hall, Room 102, Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion.

Panelists include:

  • Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
  • Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
  • Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
  • Matthew J.B. Lawrence, Academic Fellow, Petrie-Flom Center
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School, and Faculty Director, Petrie-Flom Center

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School and Lambda at Harvard Law School.

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

PFC_Banner_DrkBlueCheck out the March 6th 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.

Introducing New Blogger Zack Buck

Isaac BuckIsaac D. (“Zack”) Buck is joining Bill of Health as a regular contributor.

Zack is an assistant professor at Mercer University School of Law in Macon, Georgia, where he teaches torts and various health law courses.  His scholarship focuses on how the enforcement of health care fraud and abuse laws impacts American quality of care.  In 2013, he was selected as a Health Law Scholar as part of the ASLME Health Law Scholars Workshop at Saint Louis University School of Law, and he has participated in the new scholars programs at both AALS and SEALS.

Before joining Mercer, Professor Buck was a visiting assistant professor at Seton Hall University School of Law in Newark, New Jersey, where he taught bioethics, mental health law, and health care fraud and abuse.  He also has served as a visiting professor at Hamline University School of Law in St. Paul, Minnesota, where he has taught health care fraud and abuse.  He formerly practiced law at Sidley Austin LLP in Chicago.  Zack holds a J.D. from the University of Pennsylvania Law School, where he served as an Arthur Littleton and ­­H. Clayton Louderback Legal Writing Instructor and an associate editor of the University of Pennsylvania Journal of International Law.  He also holds a Masters of Bioethics from the University of Pennsylvania School of Medicine Center for Bioethics and a B.A. with highest distinction from Miami University (OH).

Recent publications:

The “Right to Try” – Compassionate Use of Experimental Medicine, 5th Annual Cathy Shine Lecture

SHINE_headerThe “Right to Try” –  Compassionate Use of Experimental Medicine

5th Annual Cathy Shine Lecture

Thursday, March 19, Noon – 1 p.m.
Boston University Medical Campus Instructional Building
Bakst Auditorium
72 East Concord Street, Boston, MA
Free and open to the public
Reception will follow

Is it fair to use social media or personal connections to get experimental drugs? Is it possible to reconcile so-called “right to try” laws—which allow patients access to novel, unapproved treatments—with evidence-based medicine and a drug-approval process charged with ensuring safe and effective medicines? Professor Caplan examines whether the duty to rescue should play a role in regulatory policies, physician advocacy, and corporate behavior in the US. Continue reading

Open Payments: Early Impact And The Next Wave Of Reform

A new post by Tony Caldwell and Christopher Robertson 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 Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.

As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.

These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. […]

Continue reading here.

Bioethicist Art Caplan: Why Are Guns a Taboo Topic on Campaign Trail?

A new piece by contributor Art Caplan on NBC News:

Guns are a medical issue — no matter how often the NRA denies it. Eight national health groups, including the American Academy of Pediatrics, just released a joint statement echoing that sentiment.

But among the barrage of media questions leveled at politicians on the presidential campaign trail, no one is asking the contenders about firearms. The topic appears to be strangely and entirely off limits.

Everything else seems to be fair game: Do you think President Obama loves this country? What do you think about vaccines? Do you believe in evolution? Did you embellish anything on your resume? Do embryos have rights? Are you too old, fat, short, ill-tempered, religious, atheistic, feminist, or in the pocket of your donors to make a good President? […]

Continue reading here.

Naturopaths — Not What The Doctor Ordered For Vaccine Exemptions

A new piece by contributor Art Caplan in Forbes:

There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.

One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. […]

Read the full article here.