Bioethicist Art Caplan: Pilots Need Mental Health Screening — And Doctors Do, Too

A new piece by contributor Art Caplan on Forbes:

The entirely predictable media obsession with the tragedy of the Germanwings jetliner that crashed into the French Alps on March 25 is moving forward full force. The media, especially cable television, love airline disasters. Once German prosecutors revealed that Andreas Lubitz, the pilot at the controls of the Germanwings jetliner when it crashed, had a mental illness but had kept the diagnosis hidden from his employer, all media hell broke loose.

One of the key questions raised by the spectre of mental illness was whether the pilot’s doctors tried to establish Lubitz’s mental fitness to fly and if they were concerned should they have revealed their worries to his employer. Despite a whole lot of talking heads jawing on these points few had anything useful to say since almost none of the experts consulted seemed familiar with the accuracy of mental health screening, or with the nature of German requirements for health screenings for crews or mechanics, or with German privacy law. When the discussion shifted to what about America, things still stayed fuzzy. […]

Continue reading here.

The Curious Case of “Mr. Oft”

by Zachary Shapiro

In the course of my year-long project with Petrie-Flom, I am studying the potential impact of neuroimaging techniques on criminal law. During the course of my research, I found a story of an individual whose case presents difficult questions for our conceptions of criminal guilt and responsibility. [1] While this may be a bit longer than a normal entry, I want to share this story with you.

In 2000, a 40 year-old man, “Mr. Oft”, found himself developing an increasing, and nearly uncontrollable, interest in child pornography.[2] Mr. Oft began collecting pornographic material, while making efforts to conceal his behavior from his family, and from those who knew him. Collecting pornography gave way to soliciting prostitution at “massage parlors,” and while Mr. Oft at first made careful attempts to conceal his actions, his aberrant behavior continued, and soon Mr. Oft was obsessively collecting and downloading child pornography, both at work and at home.[3] Before long, Mr. Oft began making subtle sexual advances toward his prepubescent stepdaughter. After several weeks, his stepdaughter informed his wife of this behavior, leading to the discovery of his newly collected child pornography.[4]

After his wife reported him, Oft was found guilty of child molestation and was ordered to either undergo inpatient rehabilitation in a 12-step program for sexual addiction or go to jail. Despite Oft’s strong and clear desire to avoid prison, he found himself unable to resist soliciting sexual favors from staff and other clients at the rehabilitation center. The center expelled him, and Mr. Oft prepared to go to jail. However, the night before his sentence was to begin, Oft was admitted to the University of Virginia Hospital emergency department complaining of severe headaches. In the course of his neurological examination, Oft made numerous sexual advances towards the hospital staff, and appeared totally unconcerned after urinating on himself. This behavior, combined with his seemingly unsteady gait, caused doctors to undertake a full neurological evaluation, eventually ordering an MRI scan of his brain.

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New browser app shines light on conflicts of interest

By: Christine Baugh

A new Google Chrome extension puts the spotlight on conflicts of interest. The browser app, available for free download here, was created at the Hacking iCorruption hackathon event held March 27-29 in Cambridge, MA. The event, co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University and the MIT Center for Civic Media (hosted at the MIT Media Lab) brought together individuals with a variety of backgrounds and skills to work toward the common mission of fighting institutional corruption, in this case by creating practical tools. This project was one of several exciting tools created at the hackathon (information about other projects available here), and it won first prize among the projects.

The Chrome extension, called Unearth, puts funding and conflict of interest information on the abstract page of PubMed research articles. Christopher Robertson, Associate Professor of Law at the University of Arizona James E. Rodgers College of Law and Edmond J. Safra Center Fellow who was a member of the Unearth team, explains the rationale for the browser extension in this Youtube video. In short, conflict of interest and funding disclosures are often placed at the end of a research article and are generally unavailable on the abstract page. This makes it impractical for physicians and other research scientists to pay appropriate attention to this important information. Research from the Cochrane Collaboration has demonstrated that research studies funded by industry generally describe “greater benefits and fewer harmful side effects” than their non-industry funded counterparts. Thus, taking the source of research funding into account when reading a new research study is critical. Although the extension currently only works for open access articles from PubMed Central, this includes several million research articles for which funding and conflict of interest information was previously much more difficult to obtain. Additionally, the developers plan on expanding the breadth of coverage in the coming weeks. Read More

Is concussion protection in Florida too much, too soon?

Today’s New York Times featured a long exploration of “Headgear Rule for Girls’ Lacrosse Ignites Outcry.” As a former lacrosse player and health policy researcher, I read the piece with interest.

Essentially what’s happened is that Florida has instituted a headgear rule ahead of the sport’s national governing body. Florida made this decision in advance of this season based on statistics that show that female lacrosse players experience the fifth-highest rate of concussions of any high school athlete. If you’ve ever held a lacrosse ball, this won’t surprise you.

Still, it is not immediately clear what the actual rate of concussions is in Florida. Identifying girls lacrosse as coming in 5th place doesn’t help the reader judge how pervasive the risk really is if we consider that there could be large gaps between the ordinal rankings. Florida officials have suggested that if even one injury is prevented by the introduction of headgear, the rule would be worth it. I’m not sure I’m so risk-averse. Read More

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.

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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

This new post by I. Glenn Cohen appears 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. ​