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Johns Hopkins Bioethics Films Wrap Up Award Season With Honors From Houston International Film Festival
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Tuesday, May 15, 2012
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FOR
IMMEDIATE
RELEASE
Educational documentaries from the
Vision of Hope series produced by the Johns Hopkins Berman
Institute of Bioethics have been honored by multiple awards, most recently the
Houston International Film & Video Festival, one of the oldest competitive
film festivals in the world.
“We used the
Vision of Hope films to generate
the content of curricula and spark discussions that are integral to pediatric
palliative care training sessions for clinicians working with patients and
families affected by chronic, life-limiting conditions
,”
says
Gail Geller, ScD., MHS, who co-directed the
Vision
of Hope project with Cynda Rushton, Ph.D., R.N. Both are core faculty members of the Berman
Institute.
Living With Sickle
Cell Disease: They Don’t Believe Me won the Houston festival’s Platinum
Remi Award in the Medical/Health/Fitness/Wellness category. Like all the short films in the
Vision of Hope series, it is aimed at improving
the quality of care and giving new hope to adolescents, young adults and
families affected by chronic, life-threatening diseases by training their
clinicians in the principles and practices of pediatric palliative care.
The film was produced in collaboration with Carlton Haywood,
Jr., Ph.D., M.A., and Mary
Catherine Beach, M.D., M.P.H., core faculty members of the Berman Institute
and research experts on the ethical issues surrounding Sickle Cell Disease
treatment. The film was also received a CINE
Golden Eagle Award in 2011.
“Living with the pain and other serious medical
complications of Sickle Cell Disease becomes even more frustrating and
emotionally painful when healthcare providers don’t believe the patient’s
reports of their pain experience,” says Haywood. “This film sheds light on the impact of these
added burdens on patients, and I think the awards it’s won highlight just how
powerful and moving it is to hear about these experiences from the patients
themselves. We hope to use these patient
voices as tools to enact lasting changes in the quality of the care delivered
to people suffering from Sickle Cell Disease.”
Another of the
Vision
of Hope films,
Living With Duchenne
Muscular Dystrophy: Many Faces of Hope, was also honored by a CINE Golden
Eagle, as well as a Gold Remi Award in Houston. A third film in the series,
Living With Duchenne Muscular Dystrophy: An
Uncertain Future, was honored by a Bronze Remi Award at the Houston
festival and a Bronze
Telly Award in 2011.
“What makes these palliative care training programs
innovative is that they are experiential, interdisciplinary and relational,”
Geller explains. “Relational learning
expands the notion of professional competence to encompass the moral realm of
human relationships and experience. The
Vision of Hope videos provide a means to
integrate the voices and experiences of patients and families throughout all
aspects of the training,” Geller says.
The
Vision of Hope
documentaries were directed by Nigel Noble of Magic Lantern Media.
For
more information on the films and curricula, contact Gail Geller (ggeller@jhu.edu) or Cynda Rushton (crushton@son.jhu.edu ).
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IOM Report Recommends U.S. Expand Drug Safety Monitoring After Approval
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Wednesday, May 02, 2012
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FOR
IMMEDIATE
RELEASE
Pharmaceutical drugs approved by the Food and Drug
Administration (FDA) but later re-called from the market—such as the
antidiabetic drug Avandia and pain-reliever Vioxx—were the impetus for an
Institute of Medicine committee report released yesterday, recommending that
the FDA take proactive steps to continue monitoring drugs’ safety after initial
approval and throughout their time on the market.
One of the key recommendations made by the report
, Ethical
and Scientific Issues in Studying the Safety of Approved Drugs, is that
upon approval, each drug have a single, comprehensive, publicly available Benefit
and Risk Assessment and Management Plan (BRAMP) to serve as a central,
updateable repository of side effects and other information.
“A drug’s full range of risks and benefits become apparent
after it is used widely over time, and so it is crucial that the FDA continue
to monitor drugs throughout their market life-cycle with a systematic and
transparent process,” says committee co-chair Ruth Faden, Ph.D., MPH, director
of the Johns Hopkins Berman
Institute of Bioethics.
According to the committee, the BRAMP should include a
description and benefit - risk assessment of any safety questions that exist
when a drug is approved, as well as any that emerge over the course of its
market life-cycle, with details on any regulatory actions taken and their
results.
The FDA—which asked the IOM to “convene a committee to
evaluate the scientific and ethical issues involved in conducting studies of
the safety of approved drugs”—already collects much of the suggested
information, but the data are scattered across multiple records rather than
amassed in one central location. “Decentralized records make it difficult for
physicians, policy makers and consumers to easily assess information about
risks and benefits that accrue over time,” Faden notes.
The committee recommends postmarket studies when:
·
A regulatory decision cannot be made based on
existing safety evidence
·
The research can be designed and implemented to
sufficiently reduce uncertainties about the benefit-risk balance and help
inform a regulatory decision
·
The results of the research will be used to make
a decision in a timely fashion
·
The rights and interests of the research
participants can be adequately protected
Another key recommendation in the report addresses the
significant ethical issues posed by postmarket monitoring. The committee recommends that the FDA
establish a new body to provide advice on the ethical challenges that required
observational studies and surveillance activities pose.
The report also makes recommendations about how postmarket
research should be conducted. The
committee found that while randomized controlled trials remain the gold
standard for studying drug effectiveness, observational studies have ethical
and practical benefits over clinical trials once drugs are on the market. Results can be obtained more quickly, and
thus regulatory action can be taken earlier.
The committee's recommendations build on the FDA’s increased
authority through the 2007 Food and Drug Administration Amendments Act to
monitor drugs after approval and to act if there are signals of safety issues,
Faden notes.
"Our report focuses on how the agency can be proactive,
so that when a drug’s risk outweighs its benefit, the FDA will know earlier and
respond quickly, while honoring its ethical obligations to protect both public
health and research participants,” says Faden.
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Addressing the Implementation Gap in Global Road Safety: Exploring Features of an Effective Response and Introducing a 10-Country Program
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Tuesday, April 24, 2012
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Adnan A. Hyder,MD, PhD, MPH, Katharine A. Allen,MA, MPH, Gayle Di Pietro,MEd, Claudia A. Adriazola,MA, MPA, Rochelle Sobel,MA, MEd, Kelly Larson,MPH, and Margie Peden,PhD
AJPH: First Look
Yearly, more than 1.2 million people are killed by road traffic injuries (RTIs) around the globe, and another 20 to 50 million are injured. The global burden of RTIs is predicted to rise. We explored the need for concerted action for global road safety and propose characteristics of an effective response to the gap in addressing RTIs.
We propose that a successful response includes domains such as strong political will, capacity building, use of evidence-based interventions, rigorous evaluation, increased global funding, multisectoral action, and sustainability.
We also present a case study of the global Road Safety in 10 Countries project, which is a new, 5-year, multipartner initiative to address the burden of RTIs in 10 low- and middle-income countries. (Am J Public Health. Published online ahead of print April 19, 2012: e1-e7. doi:10.2105/AJPH.2011.300563)
Read More:http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2011.300563?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
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BIOETHICISTS URGE LESS REGULATORY BURDEN FOR LOW-RISK COMPARATIVE EFFECTIVENESS HUMAN SUBJECTS RESEARCH
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Tuesday, April 17, 2012
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FOR
IMMEDIATE
RELEASE
Media Contact: Leah Ramsay
In an opinion article
published in this week’s theme edition of the Journal of the American Medical
Association focusing on comparative effectiveness research, a team of Johns
Hopkins University bioethicists argues forcefully for streamlining federal
restrictions on at least some low-risk clinical comparative effectiveness
research, instead of easing them – as is now proposed – solely for low-risk
social and behavior research involving surveys, interviews and focus groups.
Writing in the journal’s
new Viewpoint opinion section, the team supports many of the recently proposed
changes to long-standing federal rules governing human subjects research that
would allow research oversight to focus more on higher-risk research and
streamline oversight for lower risk research. The team asserts, however, that
much comparative effectiveness research is also of low-risk to patients and
also should be subject to streamlined oversight. Indeed, the proposed regulatory changes
ignore this growing and critically important category of low-risk clinical
research that compares the effectiveness and safety of different treatments
already approved by the U.S. Food and Drug Administration.
"The American public
wants and needs to know which of different widely used medications is better
for the medical problems they have," says co-author Nancy Kass, Sc.D.,
Phoebe R. Berman Professor of Bioethics and Public Health at the Johns Hopkins
Berman Institute of Bioethics. "Doing this type of comparative study poses
little if any additional risk to the patients who take part compared to their
getting usual medical care. We need to
make sure the regulatory environment makes it straightforward for doctors,
patients, and research institutions to want to do more of this kind of clinical
research," says Kass.
The failure of the
proposed changes in human subjects protections, known as the “Common Rule,” to
include clinical comparative effective research “serves to perpetuate the view
that all clinical research…involves more than minimal risk,” the Viewpoint
article states. Kass’ co-authors are Ruth Faden, Ph.D., M.P.H.,director
of the Berman Institute, and Sean Tunis, MD, MSc, President and CEO of the Center for
Medical Technology Policy, a non-profit organization that brings stakeholders together
to identify key topics for comparative effectiveness research.
In July 2011, the
Department of Health and Human Services (DHHS) issued an advance notice of proposed
changes to the Common Rule and asked for comment on suggested ways to modernize
regulations governing any use of human subjects in any kind of research. “This is the first significant proposed
change to regulations governing human subjects research in 20 years, so it is
crucial that the growing field of clinical comparative effectiveness research,
which helps doctors and patients make better treatment choices, is addressed
now as well,” says Kass.
The Viewpoint article says
revising longstanding federal regulations to focus more on high-risk research
and allowing more streamlined oversight for lower risk research ultimately will
better provide patients the careful protection they need in that smaller body
of science that poses higher risk. The
absence of attention to clinical comparative effectiveness research (CCER) in thinking through how ethics oversight should be
organized in the future, however, stands to put barriers in the way of these
important studies. “Doctors and patients alike have voiced a need for more CCER
studies that compare the relative safety and effectiveness of existing and
widely used medical options for prevention, diagnosis or treatment,” Kass says.
The proposed rule changes currently
exclude CCER, the authors say, despite the fact that “many prospective studies
of comparative effectiveness are of a low-risk equivalent to that posed by many
behavioral and social science research studies” using surveys, interviews and
focus groups. Noting an increase in federal investment recently in comparative
research of this sort, the authors agree that “significant advances in CCER
will depend on reducing the intensity and burden of oversight.”
One example of the kind of
CCER research that could be subject to streamlined review if changes to
regulations included CCER, the authors say, would be a study in which patients
treated for hypertension were asked at their regular clinical appointment to
respond to a detailed set of questions about their lifestyle and how they think
their medications are working.
“The timing of the
reconsideration of the Common Rule with the rapid increase in investments in
comparative effectiveness research highlights the importance of seizing this
opportunity to advance the shared interests in ensuring that CCER evolves
rapidly and ethically,” the authors state.
“Crafting a framework that promotes an appropriate level of oversight
for CCER studies that closely simulate routine clinical practice will be
essential for the efficient generation of the real world evidence that patients
and clinicians require.”
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JOHNS HOPKINS BIOETHICIST: "INDIVIDUAL MANDATE" IS CONSTITUTIONAL
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Friday, March 23, 2012
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FOR IMMEDIATE RELEASE
Media Contact: Leah Ramsay
On the eve of Supreme Court arguments challenging the Affordable Care Act (ACA), a legal expert and faculty member of the Johns Hopkins Berman Institute of Bioethics has vigorously defended the constitutionality of its most controversial provision, the “individual mandate” to purchase health insurance by 2014 or face a monetary penalty.
In an op-ed published today in the Baltimore Sun,
Leslie Meltzer Henry, M.Sc., J.D., and, Maxwell L. Stearns, professor of at the University of Maryland Carey School of Law declare that “The ACA is consistent with long-standing precedent allowing Congress to tackle regulatory problems affecting commerce that states are ill-suited to solve on their own.” Henry is also an assistant professor of law at the Carey School.
The real issue, the authors write, is not that the mandate violates the Commerce Clause by allowing unfettered federal regulation. Rather, striking down the individual mandate would prevent Congress’ crucial authority in matters with a ‘substantial economic effect on commerce,’ which the authors trace to the Court’s 1942 decision in
Wickard v. Filburn.
States are not capable of regulating the health insurance market on their own, the authors argue, because health insurance companies can always pull out of a state with unfavorable laws or deny coverage to high-risk applicants. “Arguments that sustaining the individual mandate would give Congress limitless power ring hollow,” the authors write.
“Striking down the individual mandate would introduce a new and deeply problematic chapter in the history of the Commerce Clause. For the first time since the New Deal, Congress would no longer hold a vital power of national concern, namely, the authority to regulate all economic subject matter substantially affecting commerce,” the authors conclude.
Henry will speak on the individual mandate at a seminar at the Johns Hopkins University on Monday, March 26, as the Supreme Court begins hearing oral arguments on the case. The seminar will be held from 12:15 – 1:30 PM at the Bloomberg School of Public Health, 615 N. Wolfe Street, Room W3008, Baltimore, MD 21205.
Stearns and Henry expand their arguments in their paper “Commerce Games and the Individual Mandate,” in the April 2012
Georgetown Law Journal.
# # #
Reporters planning to attend the seminar, or to interview Professor Henry, are asked to contact Leah Ramsay, Media Relations Officer for the Berman Institute of Bioethics, at 202.642.9640 or lramsay@jhu.edu.
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Johns Hopkins Bioethicist Contributes to IOM Report on
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Thursday, March 22, 2012
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FOR IMMEDIATE RELEASE
Media Contact: Leah Ramsay
Gail
Geller, Sc.D., MHS, core faculty of the Johns Hopkins Berman Institute of Bioethics, is
a member of the IOM Committee releasing a report Friday, March 23 on the ‘path
forward’ in translating “omics” research into useful clinical tests for
detecting disease and recommending drug treatment.
“Omics” is the general term used to describe the fields of
study within biology that look at the totality of a complex biological network.
So where genetics can focus on
individual genes, genomics looks at the complete genetic makeup of an organism.
In the
report,
Evolution
of Translational Omics: Lessons Learned and the Path Forward, Geller and the
committee make recommendations to guide the realization of the incredible
promise of the human genome sequence breakthrough for treating disease. The IOM
committee makes recommendations for better development, evaluation, and
translation of omics-based tests while also calling for stronger guidance from
the Food and Drug Administration (FDA).
Unlike other research, the huge datasets generated in omics-based
research are often not made available for independent review, and the FDA also
often declines to review omics-based clinical laboratory tests. The committee calls for both clinical
researchers to be more transparent and the FDA to provide clear guidance or
regulation that incorporates external review.
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Bioethicists Contribute to Consensus Opinion on the Responsibility of Biobanks
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Wednesday, March 21, 2012
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FOR IMMEDIATE RELEASE
Media Contact: Leah Ramsay
Bioethicists at the Johns Hopkins Berman Institute of
Bioethics are co-authors on a consensus article placing “significant
responsibility” on biobanks to report individual research results (IRRs) and incidental
findings (IFs) to the contributors of genetic material.
“The biobank should set the rules for the overall process of
recognizing (and subsequently analyzing and returning) IFs and IRRs,” the
authors write in
Genetics in Medicine.
Biobanks should define and manage a system by which “findings
that are analytically valid, reveal an established and substantial risk of a
serious health condition, and are clinically actionable should generally be
offered to consenting contributors,” the authors write.
Jeffrey Kahn, Ph.D., M.P.H, was co-investigator on the study
and is Deputy Director for Policy and Administration at the Berman Institute. Co-author Joan Scott, MS, CGC, is a faculty member at the Berman Institute and Executive
Director of the National Coalition for Health Professional Education in
Genetics. Kahn and Scott were joined by 24 colleagues on the consensus report
of a two-year study funded by the National Institutes of Health.
“This discussion of the ethical duty to research patients is
extremely important and a preview of the questions we will face as genomic
technologies such as whole genome sequencing move from the research setting to
clinical care, and patients and providers are faced with an increasing amount
of genomic information,” Scott says.
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The Associations of Clinicians’ Implicit Attitudes About Race With Medical Visit Communication and Patient Ratings of Interpersonal Care
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Monday, March 19, 2012
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Lisa A. Cooper, MD, MPH, Debra L. Roter, DrPH, Kathryn A. Carson, ScM, Mary Catherine Beach, MD, MPH, Janice A. Sabin, PhD, MSW, Anthony G. Greenwald, PhD, and Thomas S. Inui, MD
Objectives. We examined the associations of clinicians’ implicit attitudes about race with visit communication and patient ratings of care.
Methods. In a cross-sectional study of 40 primary care clinicians and 269 patients in urban community-based practices, we measured clinicians’ implicit general race bias and race and compliance stereotyping with 2 implicit association tests and related them to audiotape measures of visit communication and patient ratings.
Results. Among Black patients, general race bias was associated with more clinician verbal dominance, lower patient positive affect, and poorer ratings of interpersonal care; race and compliance stereotyping was associated with longer visits, slower speech, less patient centeredness, and poorer ratings of interpersonal care. Among White patients, bias was associated with more verbal dominance and better ratings of interpersonal care; race and compliance stereotyping was associated with less verbal dominance, shorter visits, faster speech, more patient centeredness, higher clinician positive affect, and lower ratings of some aspects of interpersonal care.
Conclusions. Clinician implicit race bias and race and compliance stereotyping are associated with markers of poor visit communication and poor ratings of care, particularly among Black patients. (Am J Public Health. Published online ahead of print March 15, 2012: e1-e9.
(Am J Public Health. Published online ahead of print March 15, 2012: e1-e9. doi:10.2105/AJPH.2011.300558)
Read More: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2011.300558
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Report Published on the Ethical Considerations Of Creating a Biorepository for Youth Pneumonia Research Project
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Thursday, March 08, 2012
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Clinical Infectious Diseases
Special Supplement: The Pneumonia Etiology Research for Child Health
CID 2012:54 (Suppl 2)
Bioethical Considerations in Developing a Biorepository for the Pneumonia Etiology Research for Child Health Project
Andrea N. DeLuca (
1), Alan Regenberg (
2), Jeremy Sugarman (
2,3,4), David R. Murdoch (
5,6) and Orin Levine (
1)
(1) Department of International Health, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health; (
2) Johns Hopkins Berman Institute of Bioethics; (
3) Johns Hopkins School of Medicine; (
4) Department of Healthy Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland;(
5) Department of Pathology, University of Otago; (
6) Canterbury Health Laboratories, Christchurch, New Zealand
Correspondence: Andrea DeLuca, MHS, Johns Hopkins Bloomberg School of Public Health, Department of International Health, 855 N Wolfe St, Ste 600, Baltimore, MD 21218 (andeluca@jhsph.edu).
Abstract
The Pneumonia Etiology Research for Child Health (PERCH) project has the potential to provide a highly valuable resource of biospecimens that may be used to inform future studies on the causes of pneumonia. Designing a biorepository for this complex project was done in collaboration with a wide range of experts including bioethicists.
In this paper, we describe the most significant ethical issues encountered related to the biorepository, focusing on its structure and informed consent. We also outline the proposed approach to the PERCH biorepository, which was designed to be sensitive to the ethical, practical, and cultural challenges inherent to the study.
Through this process, we concluded that biorepository governance plans and strategies for managing informed consent should be implemented in a way to allow for careful study in order to better understand the attitudes of and impact on the stakeholders involved in the study.
Link to article
Article will be in print April 1, 2012
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Bioethicist Calls on Congress to Protect Physicians in War Zones
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Wednesday, March 07, 2012
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FOR IMMEDIATE RELEASE
Media Contact: Leah Ramsay
Greater leadership is needed from the U.S. government to protect physicians and health facilities from increased attacks in armed conflict zones like Syria, experts told members of Congress in a special briefing today.
“Adherence to norms won’t take place unless it becomes a diplomatic priority, with the U.S. and other states using their considerable leverage to demand adherence to international law,” Leonard Rubenstein, a bioethicist at Johns Hopkins Berman Institute of Bioethics specializing in protection of human rights in areas of conflict, said in a prepared statement.
The briefing was sponsored by Rep. Jim McDermott (D-WA), who introduced the Medical Neutrality Protection Act (H.R. 2643) in July 2011.
Rubenstein, also a faculty member at the Johns Hopkins Center for Public Health and Human Rights, noted a report last year by the International Committee of the Red Cross that over 1,800 people in 16 countries have been killed or wounded as a result of violence against health care services. Such attacks violate international laws of medical neutrality included in the Geneva Conventions.
Rubenstein said there is “reason for optimism” due to proactive steps by the World Health Organization and the Obama Administration to document abuses and provide more effective protection, but more action is necessary.
“We need a far more vigorous approach, where perpetrators face consequences for their abuses,” Rubenstein told members. “It is just a matter of will.”
Also speaking at the briefing were Nils Daulaire, M.D., Director of the Office of Global Health Affairs at the Department of Health and Human Services and the U.S. Representative to the Executive Board of the World Health Organization, and Richard Sollom, Deputy Director at Physicians for Human Rights.
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Op-Ed: Individual mandate is constitutional
Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power
By Leslie Meltzer Henry and Maxwell L. Stearns
March 22, 2012,
Baltimore Sun
On Monday, the Supreme Court will commence a nearly unprecedented six hours of oral argument concerning the constitutionality of the Affordable Care Act (ACA), signed into law two years ago tomorrow. The most significant challenge to the act involves the "individual mandate," which compels most individuals to purchase health insurance by 2014 or suffer a monetary penalty. Challengers claim that the provision violates the Commerce Clause, under which Congress has broad authority to regulate interstate commerce, and that sustaining the mandate would permit Congress to enact laws requiring individuals to do whatever it chooses. Both arguments are mistaken. The ACA is consistent with long-standing precedent allowing Congress to tackle regulatory problems affecting commerce that states are ill-suited to solve on their own.
The individual mandate is the centerpiece of a complex regulatory scheme that accomplishes two objectives: obligating insurers to cover individuals with preexisting conditions, and doing so without generating prohibitively costly premiums. Achieving these goals requires what insurers call risk pooling. Broad coverage at reasonable rates is only possible when premiums of individuals least likely to require medical care offset the expected cost of care for those most likely to require it. Risk pooling does not happen by itself. In an unregulated market, healthy people do what those with pre-existing conditions cannot: They either opt out of insurance, believing they will not need costly care, or voluntarily disclose their good health to insurers to secure a low premium. The result is that low-risk individuals pay low premiums and high-risk individuals pay high premiums, defeating risk pooling.
Health insurance produces yet another separation, this one among states, which explains why the individual mandate is a proper exercise of congressional commerce power. Prior to the ACA, seven states demanded that insurance companies cover high-risk individuals but without imposing an individual mandate. The results were predictable and frustrating. Absent a meaningful quid pro quo for the additional coverage obligation, insurers pulled out. Leaving the problem of the uninsured to state regulation risked a separating (rather than a pooling) outcome in which high-regulation states drive out insurers but attract high-risk individuals, and low-regulation states attract insurers to cover those willing and able to pay. ...
...Read More
Leslie Meltzer Henry (lhenry@law.umaryland.edu) is an assistant professor of law at theUniversity of Maryland Carey School of Law and an associate faculty member at the Johns Hopkins Berman Institute of Bioethics. Maxwell L. Stearns (mstearns@law.umaryland.edu) is a professor of law and Marbury Research Professor at the University of Maryland Carey School of Law. Their article, "Commerce Games and the Individual Mandate," will be published in the Georgetown Law Journal next month.
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Friday, March 23, 2012
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Op-Ed: Individual mandate is constitutional
Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power
By Leslie Meltzer Henry and Maxwell L. Stearns
2:52 p.m. EDT,March 22, 2012,
Baltimore Sun
On Monday, the Supreme Court will commence a nearly unprecedented six hours of oral argument concerning the constitutionality of the Affordable Care Act (ACA), signed into law two years ago tomorrow. The most significant challenge to the act involves the "individual mandate," which compels most individuals to purchase health insurance by 2014 or suffer a monetary penalty. Challengers claim that the provision violates the Commerce Clause, under which Congress has broad authority to regulate interstate commerce, and that sustaining the mandate would permit Congress to enact laws requiring individuals to do whatever it chooses. Both arguments are mistaken. The ACA is consistent with long-standing precedent allowing Congress to tackle regulatory problems affecting commerce that states are ill-suited to solve on their own.
The individual mandate is the centerpiece of a complex regulatory scheme that accomplishes two objectives: obligating insurers to cover individuals with preexisting conditions, and doing so without generating prohibitively costly premiums. Achieving these goals requires what insurers call risk pooling. Broad coverage at reasonable rates is only possible when premiums of individuals least likely to require medical care offset the expected cost of care for those most likely to require it. Risk pooling does not happen by itself. In an unregulated market, healthy people do what those with pre-existing conditions cannot: They either opt out of insurance, believing they will not need costly care, or voluntarily disclose their good health to insurers to secure a low premium. The result is that low-risk individuals pay low premiums and high-risk individuals pay high premiums, defeating risk pooling.
Health insurance produces yet another separation, this one among states, which explains why the individual mandate is a proper exercise of congressional commerce power. Prior to the ACA, seven states demanded that insurance companies cover high-risk individuals but without imposing an individual mandate. The results were predictable and frustrating. Absent a meaningful quid pro quo for the additional coverage obligation, insurers pulled out. Leaving the problem of the uninsured to state regulation risked a separating (rather than a pooling) outcome in which high-regulation states drive out insurers but attract high-risk individuals, and low-regulation states attract insurers to cover those willing and able to pay. ...
...Read More
Leslie Meltzer Henry (lhenry@law.umaryland.edu) is an assistant professor of law at theUniversity of Maryland Carey School of Law and an associate faculty member at the Johns Hopkins Berman Institute of Bioethics. Maxwell L. Stearns (mstearns@law.umaryland.edu) is a professor of law and Marbury Research Professor at the University of Maryland Carey School of Law. Their article, "Commerce Games and the Individual Mandate," will be published in the Georgetown Law Journal next month.
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Friday, March 23, 2012
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January 24, 2012
Popular Science
A New Moratorium on Research Into Engineered Avian Flu: What It Means for Science
Is some
research
so dangerous it shouldn't be done at all?
In an unusual move, an international coalition of flu researchers agreed last week to a hiatus on work surrounding a highly contagious, mammal-adapted version of the avian influenza virus. Research on transmissible H5N1 flu will halt, and two manuscripts describing how to modify the virus won’t be published, at least not yet.
The voluntary pause came a few weeks after an American advisory panel recommended censoring the research in the name of security. So it raises an interesting question — is some research just too dangerous to pursue? Not just for the scientists conducting it, but for the public in a post-9/11 world?
...
“There are always concerns about misuse of the products of
research,” said Jeffrey Kahn, deputy director of the Berman Institute of Bioethics at Johns Hopkins University. “Think about nanotechnology as another example, or genetically modified food. We like the benefits of these new technologies, but we always worry about he misuse, the misapplication, or the unintended consequences. The trick is, how do we oversee and prevent problematic outcomes, while still realizing the benefits of the technology?”
...Read More
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Tuesday, January 24, 2012
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'What Happened in Guatemala'
human subjects protections and the meaning of ‘what happened in Guatemala’
By Dan O’Connor, PhD
Earlier today, President Obama’s bioethics commission released, “Moral Science“, their report on protections for human research subjects. The report was inspired by historian Susan Reverby’s expose of a 1940s research study, funded by the US government, which saw the deliberate infection of prisoners in Guatemala with syphillis. The question the report seeks to answer is, essentially,
could this happen again?
To this, commission Chair, Prof Amy Gutmann, responds: “The Commission is confident that what happened in Guatemala in the 1940s could not happen today.”
This is perhaps unsurprising, given the vast changes that have taken place in human subjects research protections since the 1940s. The 1950s saw the growth of internal hospital oversight committees, as well as the emergence of the ‘gold standard’ clinical trial – both of which developments placed constraints on the unfettered freedom of the physician researcher. The 1960s, of course, saw the first stirrings of public scandal around human experimentation – most obviously in Henry Beecher’s classic list of unethical research studies – and the federal government’s linking of funding to the existence of Institutional Review Boards. The 1970s saw the greatest scandals – Tuskegee, Willowbrook, DepoProvera – and a concerted legislative effort to regulate the conduct of research and the ethics which guide it. This culminated, in this truncated history at least, in the publication of the
Belmont Report and the enshrinement of the holy trinity of informed consent, risk/benefit balance and fair subject selection in federal regulations regarding human subjects research. Since
Belmont, ‘research ethics’ has emerged as a professional speciality within the law and public health and, most obviously, within bioethics itself. The regulatory apparatus that now surrounds human subjects research in the United States is vast, encompassing tens of thousands of lawyers, nurses, ethicists, physicians, pharmacists, community representatives, consent form specialists and compliance officers. Indeed, it would be
verysurprising if the president’s bioethics commission had come to any other conclusion than that to which they came.
And yet…
...Read More
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Thursday, December 15, 2011
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In an unprecedented move yesterday the US Secretary of Health and Human Services, Kathleen Sebelius, invoked her authority to override the recommendations of the Food and Drug Administration (FDA) and denied approval for the Plan B “morning-after pill” contraceptive to be made available to women of any age without a prescription.
FDA Commissioner Margaret Hamburg, MD, issued a press release laying out her disagreement but legally mandated compliance with Sebelius’ decision, creating a rare public conflict between government officials in what is usually an arcane bureaucratic process.
Renee Boss, MD, MHS, a faculty member at the Johns Hopkins Berman Institute of Bioethics, said the facts support Hamburg and the FDA’s position. “Nearly half of all girls in the US report that they have had sexual intercourse by age 17, with a higher rate among girls who are depressed, abuse drugs or alcohol, have poor relationships with their parents or who have limited supervision,” Boss said. “Of those girls under 17 who are sexually active, nearly one-third do not use any form of contraception, a number significantly higher than for older women,” she added.
Boss also noted the inequity of the regulation affecting only girls, and the long-lasting negative impact of a teenage pregnancy. “Boys who have unprotected sex may be able to avoid the consequences of unwanted pregnancy –girls cannot. Girls who become pregnant as adolescents are more likely to drop out of school, to become pregnant again as adolescents, and to live in a cycle of poverty,” Boss said.
In her press release Sebelius cited the need for “enough evidence to show that those who use this medicine can understand the label and use the product appropriately.” That evidence was not supplied to her satisfaction. “The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” Sebelius said.
Boss, however, said there is lack of evidence that girls under 17 cannot understand the labeling. “There are no data to support the claim that girls under 17 years old will not be able to administer the medication as directed,” Boss said. “Plan B has been shown to be safe for girls as young as 11 years old. Disregarding scientific evidence in the name of politics and paternalism is a practice that should not be tolerated. The $50 price tag that comes with Plan B is already a barrier enough.”
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Thursday, December 15, 2011
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Public Perception, Obesity and the Health of Politicians
By Jeffrey Kahn, PhD, MPH
The health status of elected officials is in the news again. Gov. Chris Christie of New Jersey is the latest name to be mentioned as a potential republican candidate for president, but along with the enthusiasm are murmurs about whether his weight is a liability.
As Eugene Robinson outlines in his recent op-ed in the Washington Post, obesity is bad for individual health as well as health care costs, and the negative effects are multiplied as the proportion of Americans who are obese increases to epidemic proportions. However, leaping from those facts to assertions about whether the Governor is a “fit” candidate or how he ought to get serious about losing weight doesn’t do much to address the public health issues or enlighten the debate about fitness for high office. And it begs the bigger questions. Discussion of the medical fitness of candidates is nothing new. Dick Cheney’s longstanding challenges with heart disease raised concerns over the course of his political career, and controversy over disease past and present have dogged candidates from Richard Nixon to Thomas Eagleton to Paul Tsongas. Gov. Christie’s case carries an added dimension in that whatever his known health issues may be, there are perceptions that someone clearly overweight is inherently less healthy than someone who appears more fit. Looks can be deceiving, however–high blood pressure, dangerous cholesterol levels, or susceptibility to cancer are invisible.
...Read More
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Monday, October 03, 2011
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Understanding Society Blog
Monday, 15 August 2011
There is a clear and reasonably uncontroversial basis for a simple theory of justice that all nations/cultures can accept. This is grounded a few core values about human development and is expressed in theUniversal Declaration of Human Rights, the Millenium Development Goals, and other founding documents of the United Nations. This conception emphasizes several key values:
- equal worth of all persons
- value of freedom
- value of democracy and self-determination
- the injustice of hunger, lack of education, lack of healthcare
- the injustice of capricious arrest and state violence (illegality)
...Read More
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Tuesday, August 16, 2011
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Informed-consent documents called too long and complex
American Medical News, 3 August, 2011
A study says clinical trial forms that run 20-plus pages are difficult to understand, and that medical liability fears may be prompting too many warnings.
Despite years of guidelines urging simpler and easier-to-understand informed-consent documents, the forms given to clinical trial participants remain too long and use language that is too complex.A review of 124 informed-consent documents used in 21 HIV clinical trials sponsored by the National Institutes of Health's Division of AIDS found that the forms were typically written above the ninth-grade level and ran longer than 22 pages. The findings were published online July 6 in the Journal of General Internal Medicine(www.ncbi.nlm.nih.gov/pubmed/21748435/).
"Very few people are going to sit down and read a document that's that long, and the goal is to have people understand," said Nancy Kass, ScD, lead author of the study. "The whole reason for putting [informed consent] in writing is with the belief that someone will read it. The longer it is, the less likely people are to read it all the way through, and then you have defeated your own purpose."
In 1998, the National Cancer Institute recommended that consent forms be written at an eighth-grade level. The institute also advised that forms be shortened, with further details provided through information sheets and explanatory videos. Most institutional review boards also recommend that consent forms be written at or below the eighth-grade level, as measured by the Flesch-Kincaid readability test.
Shorter, more readable forms are especially important when providing informed consent to participants with poor health literacy skills, said Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics in Baltimore.
Kass and her colleagues studied 21 "template" forms used in multisite trials, and they were typically shorter -- 16.8 pages long -- and more readable, scoring at the 8.7-grade level. But by the time 103 trial sites around the world were done making changes to these template forms, they ran nearly 24 pages and had a 9.4-grade level readability score.
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Tuesday, August 09, 2011
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 Faculty research scientist Joseph Ali named one of Baltimore's "10 People to Watch Under 30"
~
the
b
"I am drawn to doing something that's concrete, that's improving other people around me," Ali told the
b. "And to do that in an environment where I'm constantly learning."
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Friday, March 11, 2011
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Core faculty members
Jeremy Sugarman and
Steven Goodman are among
various experts quoted in the Feb. 12 article "Risk
and Reward in Utero," about the ethical challenges presented by a
clinical trial comparing the effectiveness of fetal surgery to treat
spina bifida, versus surgery after birth.
The article stems from a Feb. 9 story also in the Times, "Success of
Spina Bifida Study Opens Fetal Surgery Door."
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Monday, February 14, 2011
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BI Faculty Form Bioethics Working Group of New AIDS Research Center
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The National Institutes of Health (NIH) have awarded $15
million to Johns Hopkins University over the next five years to establish the
Johns Hopkins Center for AIDS Research
(CFAR), with a Bioethics and Human Rights working group led by faculty of the
Berman Institute of Bioethics (BI).
BI faculty members Nancy Kass, Sc.D., Jeremy Sugarman, M.D.,
M.P.H., and Holly
Taylor, Ph.D., M.P.H., will lead the working group, which will bring
together a broad array of investigators from across the university to collaborate
on the bioethical and human rights issues of HIV and AIDS research and
treatment.
In addition to this working group, the Center will have
other transdisciplinary groups or “cores,” including one to address Baltimore’s
HIV epidemic; Johns Hopkins University President Ronald Daniels has made
investment and engagement in the Baltimore community a priority, saying in his
installation address, “We are an island of earned privilege in a sea of
pressing need.”
Other groups will focused on Viral Eradication, Substance
Abuse, international research, and training the next generation of AIDS
researchers and biostatisticians, particularly underrepresented minority
investigators. Read more at the Johns
Hopkins Bloomberg
School of Public Health.
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Inaugural Levi Professor of Bioethics and Public Policy Installed
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Jeffrey Kahn, Ph.D., MPH, Deputy Director for Policy and
Administration at the Johns Hopkins Berman Institute of Bioethics, was
installed as the inaugural Robert Henry Levi and Ryda Hecht Levi Professor of
Bioethics and Public Policy on Tuesday, May 1, 2012. Ronald J. Daniels, President of Johns Hopkins
University was joined by Ruth Faden, Director of the Berman Institute, and
Michael Klag, Dean of the Johns Hopkins Bloomberg School of Public Health, in a
ceremony dedicating the new endowed professorship and installation of Kahn.
A professor with the Berman Institute and the Johns Hopkins
Bloomberg School of Public Health since August 2011, Kahn previously was Director
and Professor in the Center for Bioethics at the University of Minnesota,
positions he held from 1996-2011.He serves on numerous state and federal
advisory panels, including his role as chair of an Institute of Medicine
committee that issued a recent, groundbreaking report calling for an end to
most biomedical research on chimpanzees, which was immediately adopted by the
National Institutes of Health upon its release.
Kahn is also an elected Fellow of the Hastings Center and was founding
president of the Association of Bioethics Program Directors, a position he held
from 2006-2010.
The late Robert and Ryda Levi were great supporters of Johns Hopkins University, Baltimore City, and the arts. The Robert. H. Levi Leadership Program in
Bioethics and Health Policy was established in 1997.
The endowed professorship traces a long history of royal and
private support for academia, including the famous privately endowed Lucasian
Chair of Mathematics at Cambridge University, bestowed on Issac Newton in 1669,
and later on Professor Stephen Hawking.
The endowment of the Levi professorship will ensure the Berman Institute
of Bioethics will always be home to a leading mind in the field of bioethics
and public policy.
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Ethical and Scientific Issues in Studying the Safety of Approved Drugs
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via National Academies Office of News and Public Information
FOR IMMEDIATE RELEASE
Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA’s Oversight of Approved Drugs’ Safety
WASHINGTON — Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication’s effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time. Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication’s benefit-risk profile throughout its entire “life cycle” from approval until it is no longer marketed, says a new report by the Institute of Medicine. ...
...Read More
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Johns Hopkins Berman Institute of Bioethics Faculty Receive PCORI Grant
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Johns
Hopkins Berman Institute of Bioethics faculty have been awarded one of the
first grants issued by the Patient-Centered Outcomes Research Institute
(PCORI). Nancy Kass, ScD, Deputy Director of Public Health, and Ruth Faden, PhD,
MPH, Director, were awarded a pilot project grant to study “Stakeholder Views
of Streamlined Informed Consent Options for Comparative Effectiveness Research
Studies.”
With the grant, Kass and Faden will organize three day-long community
engagement sessions to gauge patient and stakeholder attitudes about
streamlined informed consent and authorization. One session will be conducted
with
patients from Geisinger Health System,
another with patients from the Johns Hopkins Health System and another with a diverse
group of stakeholders assembled by the non-profit Center for Medical Technology
Policy.
‘Diverse stakeholders’ will
include patients, clinicians, institutional review board members, PCOR
researchers, health care administrators, health system legal counsel, and
relevant government agency representatives.
The stated goal of the study
is to fill in some of the information gap about which consent options
stakeholders consider acceptable for PCOR research.
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Monday, May 14, 2012
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Berman Institute Seminar Series: Mark Hall
5/14/2012- 12:15
- 1:30
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Achieving Universal Access Without Universal Insurance:
The Role of the Safety Net
Mark Hall, JD
Fred D & Elizabeth L Turnage Professor of Law
Wake Forest School of Law
Wake Forest University
Monday, May 14, 2012, 12:15pm - 1:30pm
615 N. Wolfe Street, W3008
Open to Everyone. Lunch will be provided
Click
here
for a full list of bioethics seminars
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