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.

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. Continue reading

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. Continue reading

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.

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

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

“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

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

In Memoriam: John D. Arras (1945-2015)

I am deeply saddened to report that bioethicist John D. Arras died on March 9, 2015.Arras John was the Porterfield Professor of Bioethics and Professor of Philosophy at the University of Virginia, where he directed the undergraduate bioethics program, held an additional appointment at the School of Medicine’s Center for Biomedical Ethics and Humanities, and over the years co-taught multiple courses at the Law School. He was a leading figure in the field of bioethics, and held several prestigious appointments beyond UVa including, at the time of his death, as a Fellow of The Hastings Center and a commissioner of the Presidential Commission for the Study of Bioethical Issues (whose recent report on Ebola he spoke to a journalist about just days ago). He also consulted regularly at the National Institutes of Health and was a founding member of the ethics advisory board of the Centers for Disease Control and Prevention.

John’s scholarly focus in bioethics was two-fold. First, like most bioethicists, John tackled concrete practical ethical problems involving medicine, public health, and the biosciences. His interests in this regard were fairly broad, but he focused on physician-assisted suicide, public health, human subjects research, and what justice requires in the way of access to health care. Continue reading

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.

Uncertainties in Cancer Screening

by Vadim Shteyler

A.F. was an elderly patient admitted to our service for a diagnostic work-up and management of a large pocket of pus surrounding her lungs. Until recently, she was very independent and in good health; this was her third hospitalization for the same reason in one month. Radiographic imaging was consistent with pneumonia but other causes could not be ruled out. She had not responded to antibiotics, she had no other signs of infection, and numerous cultures from her blood, pus, and sputum failed to grow microbes. Extensive testing for other possible causes was also negative. At that point, we all had the same suspicion—cancer. Some tumors in the chest can cause inflammation that may look like a pneumonia and result in a collection of pus. That inflammation can also hide the tumor on imaging. In fact, it would be a few weeks, after we drained all of the pus and the inflammation subsided, until we would have a clearer image of the lungs. Though cancer was a plausible explanation, we had no evidence at that time. Should we have discussed our concerns with A.F.? The diagnosis was not certain, so we didn’t…

In daily clinical practice, uncertainties come in many forms. Outcomes for most medical interventions are probabilistic (they are not 100% predictable). And those probabilities are often ambiguous (they are more often ranges than specific percentages) or simply unknown. At a broader level, science is underdetermined, medicine is inductive, and innumerable non-medical forces influence the medical landscape (biases, conflicts of interest, values, etc.).

How effectively providers communicate uncertainty is…well, uncertain. Continue reading

Two More Points on Federalism in King v. Burwell: A Response to Ilya Somin

And the storm rolls on… Ilya Somin has now responded to my response to him, and he correctly notes that I failed to confront his core point. (I was more focused on responding to Rick Hills and Jon Adler.) Ilya’s beef with the application of the anti-coercion argument (via the avoidance canon) in King is that he views it as nonsensical to apply anti-coercion in a way that expands federal power and limits state choice. In Ilya’s view, the plaintiffs’ interpretation in King is the one that better preserves state freedom because it allows states to pick the federal regulatory bundle that they like better. The IRS’s interpretation, by contrast, imposes a uniform regulatory bundle throughout the nation, and leaves the states free to choose only with respect to some relatively minor details of exchange implementation and management. I respond to this line of thinking at length in the JALSA brief, arguing several reasons that states’ freedom to choose under plaintiffs’ interpretation fails to mitigate the constitutional difficulties.

But in a grander sense, Ilya’s perspective is (to put it mildly) simply inconsistent with constitutional federalism doctrine (as he seems to admit). Continue reading

Despite Federal Law, Some Insurance Exchange Plans Offer Unequal Coverage for Mental Health

By Kelsey Berry

One of my previous blogs discussed how potentially discriminatory practices in insurance design may continue to dissuade people with high-cost conditions from enrolling in insurance plans, even in a post-ACA world. Last week, colleagues Haiden A. Huskamp, Howard H. Goldman, Colleen L. Barry and I published new findings in Psychiatric Services on the same issue, except with a focus on an area that has historically been subject to considerable regulation: mental health benefits.

The Affordable Care Act shows considerable promise for extending mental health benefits with federal parity protections to several million Americans, which has been a main aim of mental health policy advocates for decades. However, insurers may still have an incentive on health insurance exchanges to avoid enrolling individuals who use mental health services because their care is more costly than average. In the study, we examined benefits information available to consumers shopping on state health insurance exchanges to assess whether the new insurance offerings were living up to the promise of mental health parity laws. We found that some plans may still be offering people with mental illness insurance benefits that are less generous than benefits for other medical conditions. Specifically, one-quarter of the health plans being sold on health insurance exchanges set up in two states through the ACA offer benefits that appear to violate the federal parity law requiring equal benefits for general medical and mental health care. Such benefit designs may dissuade people with mental health and substance abuse treatment needs from enrolling in the plans, furthering concerns about adverse selection and suggesting that some discriminatory practices persist despite efforts to equalize insurance offerings for individuals with behavioral health conditions. Continue reading