What is Patient-Centered Outcomes Research? What Ethical Issues Arise in its Conduct?

By Joel Weissman

Today it is not unusual for patients to expect to be engaged in making decisions about their own health care, in consultation with their doctors. This is commonly referred to as patient-centered care, and recognizes that patients are the best source of information about their needs and preferences.

A relatively newer concept is patient involvement in research on healthcare.

Traditionally, healthcare research has focused on critical events like death or complications, or physiological data from laboratory tests. But patients may be equally (and sometimes more) concerned about harder-to-measure results like quality of life, time spent at home with their families, or the ability to return to work.

Patient-centered outcomes research (PCOR) recognizes that to better understand these kinds of issues, scientists should consult patients about the design and conduct of research. Therefore, PCOR is quickly becoming the standard.

Continue reading

What is the Role of the Judiciary in Tackling the Opioid Epidemic?

By Ryan J. Duplechin

The Judicial Panel on Multidistrict Litigation has centralized suits in the Northern District of Ohio.

As waves of opioid lawsuits have mounted in the federal courts, one district court was chosen to shepherd all the cases, and one judge is motivated to step up to stem the tide of the epidemic.

In the Northern District of Ohio, Judge Dan A. Polster was chosen by the Judicial Panel on Multidistrict Litigation, which centralized hundreds of suits, and created the Opioid MDL.

“The federal court is probably the least likely branch of government to try and tackle [the opioid epidemic], but candidly, the other branches of government, federal and state, have punted,” said Judge Polster during the first hearing of the MDL in January. “My objective is to do something meaningful to abate this crisis and to do it in 2018.”

Continue reading

Right to Try’s Problem is Funding, not Over-Regulation

By Alex Pearlman and Jonathan Darrow

Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources differently.

Continue reading

Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses

By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit

A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.

Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.

Continue reading

Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight

Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted.

Such efforts hold great promise, but also raise potential challenges for ethical oversight.

How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups?

This symposium will bring together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.

Continue reading

The German Stem Cell Network Has Compiled a Sample Text for Informed Consent

By Sara Gerke

Sara Gerke speaking

GSCN Conference in Jena in September, 2017

At the General Meeting of the German Stem Cell Network (GSCN) in Jena in September 2017, Tobias Cantz and I proposed the establishment of a new GSCN strategic working group.

This new working group, known as ELSA, focuses on the ethical, legal and social aspects of the modern life sciences. ELSA aims to serve as a country-wide interdisciplinary platform for the exchange of information and for the analysis and discussion of challenges facing basic and applied stem cell research in Germany.

Continue reading

State-Level Solutions to Discrimination in Organ Transplants 

By Emily Largent

organ transplant

Doctors in North Dakota perform a kidney transplant. (Photo by ndguard/Flickr)

In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.

In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.”  Ultimately, Rivera received a living donor kidney transplant from her mother.

Continue reading

Beyond Disadvantage: Photos from the Petrie-Flom Annual Conference

At last week’s Petrie-Flom Center Annual Conference, “Beyond Disadvantage: Disability, Law, and Bioethics,” discussed a number of topics related to the “mere difference” vs. “bad difference” disability theory debate.

Over the course of the day, six panels of experts shared their research and views on topics ranging from health care as eugenics to epistemic injustice to organ donation.

We will have the videos of the event soon, but in the meantime, enjoy the tweets from #rethinkingdisability and some photos from throughout the day by photographer Martha Stewart.

Continue reading

Medical Professionals with Disabilities Workforce and their Associated Challenges

By Paulchris Okpala

person wearing medical scrubs

Do the provisions of the 2008 Americans with Disabilities Act Amendments Act (ADAAA) address challenges faced by medical professionals with disabilities (MPD)?

A 2012 report on Americans with disabilities from the US Census Bureau suggests that it is highly unlikely. There is every reason to be alarmed by the increasing number of medical professionals with disabilities who leave their jobs, or express the intention to quit employment. There is also a rapidly decreasing number of MPD who express the desire to seek employment. Could this trend be attributed to the challenges faced by the MPD in the workplace?

Continue reading

Dementia, Disability, and Advance Medical Directives

By Rebecca Dresser

pencil drawing of a brain Anyone fortunate enough to live beyond middle age faces a risk of developing dementia. Dementia is a widely feared disability. People often say they wouldn’t want to live if they developed the condition.  

Experts in law and ethics praise advance directives, or instructions to follow on behalf of patients, as a tool giving people control over the life-sustaining medical care they later receive as mentally impaired dementia patients. Some advance directive supporters also want the law to recognize advance requests to withhold ordinary food and water in the late stages of dementia. And some argue that the U.S. should follow the Netherlands in allowing doctors to give lethal drugs to people who made advance directives asking for assisted death if dementia makes them unable to live at home or to recognize their loved ones.  

Continue reading

The EU’s GDPR in the Health Care Context 

Photo by Descrier/Flickr

By Sara Gerke 

The EU’s General Data Protection Regulation, which came into force two years ago but became directly applicable in all EU Member States only last week, aims to establish an equal level of protection for the rights and freedoms of natural persons with regard to the processing of personal data in all EU Member States.

Each of us has been inundated with emails in the last few days and weeks, informing us about the GDPR and asking us, among other things, to review updated privacy policy. This flood of emails is, in particular, the consequence of the GDPR’s imposing administrative fines for infringements.

According to its territorial scope, the GDPR can also impact US companies that process personal data of data subjects who are in the EU. For example, this is the case for newspapers and affiliated websites, where the processing activities are related to the offering of services or goods, irrespective of whether payment is required. Some papers decided to simply block users in the EU, rather than abide by the GDPR’s provisions. 

Continue reading

Epistemic Injustice, Disability Stigma and Public Health Law

long staircase

By Daniel Goldberg

Public health law can integrate medical and social understandings of disability in ways that promise to reduce disability stigma and enhance epistemic justice.

However, models of disability currently embedded in public health law do precisely the opposite, at least partly due to the fact that public health laws have historically assimilated medicalized models of disability.

Continue reading

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Continue reading

Are Ordeals a Viable Way to Improve Health Care Delivery?

By Thomas W. Feeley

We constantly hear that the American health care system is broken and badly in need of repair. Our system provides poor value in that our per capita spending is more than any other nation in the world and yet we do not have the best health outcomes.

For many years, incremental solutions have been brought forward as solutions to our health care delivery problem. Approaches such as using evidence-based guidelines, focusing on patient safety, requiring prior authorization of expensive procedures, making patients pay as customers, adopting lean, six-sigma, electronic records, and using care coordinators, to name just a few, have failed to solve the problem.

Continue reading

Introducing Blogger Nicholas Diamond

Nicholas J. Diamond, J.D., LL.M., M.B.E. is joining Bill of Health as a regular contributor.

Nick is an advisor and educator, focused on the intersection of public health, policy, and ethics. He works at an advisory firm in Washington, DC, where he helps biopharmaceutical companies, health insurers, and advocacy organizations better understand and respond to changes in the healthcare landscape. He also teaches part-time at Georgetown Law and George Washington, and holds (non-teaching) academic affiliations at the Perelman School of Medicine at the University of Pennsylvania. Continue reading

Introducing Blogger Tara Sklar

The Petrie-Flom Center is pleased to welcome Tara Sklar to Bill of Health as our newest contributor!

Tara is a Professor of Health Law and Director of the Graduate Health Sciences Programs at the University of Arizona James E. Rogers College of Law. She also holds an appointment as a Health Law Fellow in the Law and Public Health Group at the University of Melbourne, School of Population and Global Health. Prior to this she was the Founding Director of Aging Programs at the University of Melbourne, and in 2016 was awarded University of Melbourne’s Teaching Excellence in Innovation Award. She has particular interests in laws and regulations that impact population well-being, with a focus on older adults. Continue reading

Bill of Health Blog Symposium: Research Integrity and Trustworthy Science: Challenges & Solutions

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “Research Integrity and Trustworthy Science: Challenges and Solutions.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Trustworthy science is crucial to progress in scientific understanding, patient care, and product development. Yet threats to the integrity of science and to public confidence loom large. Researcher misconduct, inadequate education of new researchers, concerns over the reproducibility and rigor of scientific research, predatory journals that fail to perform thorough peer review, and oversight lapses all constitute significant threats to sound science and public trust.

A 2017 report from the National Academies on Fostering Integrity in Research carefully analyzed “detrimental research practices.” The report called for significant changes in the policies and practices of journals, research institutions, and researchers. Among the proposals was creation of a Research Integrity Advisory Board (RIAB) as an independent nonprofit. Further recommendations called for changes to allow researchers to reproduce results, including archiving datasets and code.

In March 2018, the University of Minnesota responded to the emerging research challenges and solutions by sponsoring a conference on “Research Integrity and Trustworthy Science: Challenges and Solutions.” We invited leading analysts to address the challenges for researchers, journals, and research institutions. In this blog symposium, plenary speakers from the conference examine three foundational elements of credible research:

Continue reading

Challenges for Investigators—Generating Reproducible Research Results

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By John P.A. Ioannidis, MD, DSc, C.F. Rehnborg Chair in Disease Prevention, Professor of Medicine, of Health Research and Policy, of Biomedical Data Science, and of Statistics, and Co-Director, Meta-Research Innovation Center at Stanford (METRICS), Stanford University

Generating reproducible research results is not an easy task. As discussions about a reproducibility crisis become more common and occasionally heated, investigators may feel intimidated or even threatened, caught in the middle of the reproducibility wars. Some feel that the mounting pressure to deliver (both quantity and quality) may be threatening the joy of doing science and even the momentum to explore bold ideas. However, this is a gross misunderstanding. The effort to understand the shortcomings of reproducibility in our work and to find ways to improve our research standards is not some sort of externally imposed police auditing. It is a grassroots movement that stems from scientists themselves who want to improve their work, including its validity, relevance, and utility.

As it has been clarified before, reproducibility of results is just one of many aspects of reproducibility. It is difficult to deal with it in isolation, without also considering reproducibility of methods and reproducibility of inferences. Reproducibility of methods is usually impossible to assess, because unfortunately the triplet of software, script/code, and complete raw data is hardly ever available in a complete functional form. Lack of reproducibility of inferences leads to debates, even when the evidence seems strong and well-rounded. Reproducibility of results, when considered in the context of these other two reproducibility components, is unevenly pursued across disciplines. Some fields like genetic epidemiology have long understood the importance of routinely incorporating replication as a sine qua non in their efforts. Others still consider replication as second-class, “me too” research. Nevertheless, it can be shown (see Ioannidis, Behavioral and Brain Sciences, in press), that in most circumstances replication has at least the same value—and often more value—than original discovery. However, this leads to the question: how do we reward and incentivize investigators to follow a reproducible research path?

Continue reading

Challenges for Journals—Encouraging Sound Science

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By Barbara A. Spellman, Professor of Law and Professor of Psychology, University of Virginia School of Law

Journals and scientists should be BFFs. But currently they are frenemies. Or, in adult-speak:

Journals play an important role in ensuring that the scientific enterprise is sound. Their most obvious function is to publish science—good science, science that has been peer-reviewed by experts and is of interest to a journal’s readership. But in fulfilling that mission, journals may provide incentives to scientists that undermine the quality of published science and distort the scientific record.

Journal policies certainly contributed to the replication crisis. As businesses, publishers (appropriately) want to make money; to do so they need people to buy, read, and cite their journals. To make that happen, editors seek articles that are novel, that confirm some new hypothesis, and that have clear results. Scientists know that editors want articles with these qualities. Accordingly, scientists may (knowingly or not) bias the scientific process to produce that type of result.

Continue reading