Tag: federal government

Bioethics Blogs

How the FDA Produces Knowledge (and Is Not So Weird)

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that … Continue reading

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Tune Ups to Belmont & Common Rule Need to Consider Community-Engaged Research

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Eric Wat MA, Nancy Shore PhD, Sarena D Seifer MD, CCPH, Lola Sablan-Santos, Alice Park MPH, Mei-Ling Isaacs MPH, Ahahui Malama I Ka Lokahi, Kelly Edwards PhD, Elaine Drew PhD, John Cooks, Paige Castro-Reyes BS BA, CCPH

We concur with Friesen and colleagues’ (2017) assertion that the Belmont Report requires, at a minimum, a “tune-up” to better reflect the unique ethical values and demands of community-engaged research (CEnR).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Paris is Burning

June 30, 2017

by Sean Philpott-Jones, Chair, Bioethics Program of Clarkson University & Icahn School of Medicine at Mount Sinai

Paris is Burning

Earlier this month, President Trump finally honored one of his many (often contradictory) campaign promises. He formally withdrew the United States from the 2015 Paris Climate Accord. America is now one of only three countries in the world who are not party to this landmark agreement, joining Syria and Nicaragua in refusing to work collaboratively to combat the threat of global climate change.

Designed to slow and eventually reverse the release of greenhouse gases into the atmosphere, the Paris Agreement calls upon the 195 signatory nations to stabilize carbon emissions by 2030; while nearly 55 gigatonnes of carbon dioxide would still be released into the air every year, the near exponential increase in annual emissions would cease. The accord also calls for nations of the world to start reducing the overall amount of greenhouse gases in the atmosphere by 2050, offsetting anticipated emissions with compensatory sequestration and reforestation efforts. Should these ambitious goals be met, the estimated increase in the global average temperature would be limited to a manageable 1.5 – 2.0° Centigrade (2.7 – 3.6° Fahrenheit) above that of the pre-Industrial era.

Climate change is one of the most important yet, sadly, one of the most neglected problems that we face. According to the vast majority of climate scientists (over 97% of them, to be precise), mankind is irrevocably altering the environment as the result of industrial production and agricultural activity. One consequence is increasing global temperatures, but we can also expect to see changing rain and snowfall patterns, and more extreme weather events like heat waves, droughts, floods and blizzards over the coming years.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Ethics of Transparent Pharmaceutical Pricing Laws: The Harms Do Not Outweigh the Risks

by Craig Klugman, Ph.D.

Despite campaign promises that drug prices would be lowered, the current administration and Congress seem on target for giving pharmaceutical companies more power over pricing, over keeping out competition and over expanding their monopolies. The President’s “Drug Pricing Innovation Working Group” is staffed by many current and former industry lobbyists. While the federal government is deliberating, some states are already acting.

Last week, Nevada passed a law that requires pharmaceutical manufacturers to disclose the prices, profits, and discounts of insulin.…

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Trump Opioid Task Force Considers HIPAA Exception for Overdoses

by Craig Klugman, Ph.D.

Confidentiality is one of the sacrosanct principles of medicine. By keeping the secrets that patients share with health care providers, the patient trusts the provider and the provider has the information necessary to diagnose and treat. The Hippocratic Oath, American Medical Association commentaries, 1974 Federal Privacy Act and 1996 Health Insurance Portability and Accountability Act place confidentiality front and center in ethics and law.

Although we place confidentiality on a high pedestal, it does have many exceptions—some which are acceptable and some of which are required. For example, under the Tarasoff rule a provider in most states must report a specific and explicit threat to a third party. Reporting is required for concerns of public health such as abuse or infectious disease. Information must be shared if law enforcement shows a subpoena. A physician may consult colleagues about a case. Administrative assessment and quality improvement review can access patient information without specific patient consent.  In some states, a physician may inform a spouse of certain infectious diseases even when the partner does not want him/her to know. Exceptions are not made lightly since the lack of protecting secrets can decrease patient trust and thus the ability for health care providers to help patients. When exceptions are carved out they are generally because maintaining secrecy would substantially harm the patient or a third party.

A new required exception may be added to this list if New Jersey Governor Chris Christie has his way. He is asking the federal government to carve out a HIPAA exception to allow reporting to a family if a loved one has an opioid overdose.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Trump’s Attack on Science

Some time ago I began to write a blog about support of
science, and the role of science in policy and decision making under the Trump
administration. While this would seem to be a straightforward task since all of
the evidence is amazingly consistent, in fact, it has been difficult. The
reason it has been difficult is that each time I compile the sources and
information necessary to write this blog something else happens which
illustrates starkly the abandonment of the use of science by this
administration. At this time, shortly after Trump’s announcement of the United
States withdrawal from the Paris Climate Accord, I am trying to start again. I
know it may be futile to expect to cover everything but I am writing anyway.
There is no shortage of material. For the purpose of this blog I will focus on
the message sent by Trump’s science budget proposals and not seek to be all
inclusive. After all, it is the budget proposal which best states the
administrations intent. I will also try to touch on the anti-science warriors
who have been appointed to high level government positions, including cabinet
positions.

While it is attractive to think of science as non-political,
science exists in the real world and is, in fact, subject in many ways to
political considerations. We have been fortunate that the politicians in
Washington including both congress and the executive branch have recognized
both the economic and humanitarian benefits of scientific research. They have,
with a few exceptions maintained and grown the government’s support of
scientific research in both basic and applied fields in both biomedical and
other areas of research.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

In Calls for Repeal Comes Opportunity for Universal Coverage

by Craig Klugman, Ph.D.

According to the conservative press, the Affordable Care Act is failing. They point to the number of insurance companies that have withdrawn from the marketplaces including Ohio, where there are 20 counties with no plans available. They point to rising premiums and co-pays, and consider the experiment a failure that must be repealed. Of course, they are not considering the cost savings that preventive care provides in the longer term or the improved quality of life in having medical care. Those reports also ignore that the federal government has been giving confusing messages, rolling back the supportive regulations and subsidies, and that the healthcare industry is trying to adapt to a shifting landscape. Nor do they talk about the lowest rate of uninsured ever, the increase in people able to see doctors, the decrease in hospital’s unreimbursed care, the decrease in national health care spending, and the decreasing inflation rate of medical costs.

In a recent meeting between the executive and (Republican) legislative branches, there is a renewed call to repeal the Affordable Care Act. What is a state to do that has to create a budget and does not know what the health care laws will be or even what federal funds might be available for helping provide care? Some states are not waiting around for repeal and replace but are taking matters in their own hands. New York, California, and Nevada may soon be on the way to single payer health systems. And if Republicans are true to their states rights roots, then letting states design and run their own systems should be a good thing.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Four Reasons Canada Needs Universal Pharmacare

Steve Morgan gives us four reasons to support universal pharmacare and then invites us to sign the Parliamentary Petition e-959 (Health care services).

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Ontario has just announced that it will offer a publicly funded pharmacare program for children and youth in the province. This is a small step in the right direction, one that is arguably most important for its symbolism in a national debate.

Why just a small step? Because Ontario is adding universal, comprehensive pharmacare coverage to the age group that least uses medicines. Many working-age Ontarians, who are far more likely to require medicines than children, will not be insured.

Why symbolic? Ontario’s new pharmacare program is evidence of at least one government taking responsibility for this component of health care, integrating it with medical and hospital care.

Several national commissions on Canada’s health care system have recommended adding prescription drugs to our publicly funded universal medicare system. To date, however, no federal government has acted on those recommendations.

By creating ‘pharmacare-junior,’ Premier Wynne and Minister Hoskins are, in essence, calling on the federal government to help finish the job by creating a pharmacare program for all Canadians of all ages.

Here are four reasons why Canada needs a universal, public pharmacare program – and what Canadians can do to make it happen.

The most important reason for universal pharmacare in Canada is that access to essential medicines is a human right according to the World Health Organization (WHO). The WHO recommends that countries protect that right in law and with pharmaceutical policies that work in conjunction with their broader systems of universal health coverage.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Shouldn’t Dead Be Dead?: The Search for a Uniform Definition of Death

Check out “Shouldn’t Dead Be Dead?: The Search for a Uniform Definition of Death” in the latest Journal of Law Medicine & Ethics 45(1). 


NYU authors Ariane Lewis, Katherine Cahn-Fuller, and Arthur Caplan conclude:


“It is clear that variation in the definitions of death throughout the United States persists. The Hailu case introduced a medical, ethical, and legal quandary by questioning the medical determination of death and setting a legal precedent that the Harvard criteria for brain death should be treated as the only accepted medical standard for brain death determination, despite the fact that these criteria have been replaced by the AAN guidelines.  Variations in the definition of death yields uncertainty and confusion and can undermine public trust in both medicine and the law.”


“The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recognized that it was imperative that the definition of death be identical throughout the United States. While they felt that individual states should have laws about the definition of death, they noted the role of the federal government in defining death was to ‘usefully bring together experts and representatives of different streams of thought on the matter [to] clarify support,’ such as was the case in both the Hailu and McMath cases, so that practices in such situations are uniform and thus understood by families, the media and the public.”


“The Commission hoped that the UDDA would prompt homogeneous medical and legal  management of all decedents, but it is clear that this goal has not been achieved.”

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

40th Annual Health Law Professors Conference

If you teach health law, come to the 40th Annual Health Law Professors Conference, June 8-10, 2017, at Georgia State University College of Law in Atlanta.  Here is the schedule:


Thursday, June 8, 2017
8:00-12:00 AM Tour of the Centers for Disease Control and Prevention (Separate registration is required. Participants meet in the lobby of Georgia State Law to take a shuttle to the CDC.)


9:45 – 11:15 AM Tour of Grady Health System (Separate registration is required. Participants meet in the lobby of Georgia State Law and will walk over to Grady as a group.)


2:00 – 5:00 PM Conference Registration – Henson Atrium, Georgia State Law


3:00 – 5:00 PM Jay Healey Teaching Session – Knowles Conference Center, Georgia State Law
Experiential Teaching and Learning in Health Law
The format for this session is World Café roundtables, with plenty of opportunity for the collegial exchange of teaching ideas and insights among your colleagues. Come prepared for a lively, interactive workshop.
World Café Hosts:
Dayna Matthew, University of Colorado Law School
Charity Scott, Georgia State University College of Law
Sidney Watson, Saint Louis University School of Law
Invited Discussants and Participants:
Rodney Adams, Virginia Commonwealth University School of Health Administration
Christina Juris Bennett, University of Oklahoma College of Law
Amy Campbell, University of Memphis Cecil C. Humphreys School of Law
Michael Campbell, Villanova University Charles Widger School of Law
Erin Fuse Brown, Georgia State University College of Law
Cynthia Ho, Loyola University of Chicago School of Law
Danielle Pelfrey Duryea, University of Buffalo School of Law, State University of New York
Jennifer Mantel, University of Houston Law Center
Elizabeth McCuskey, University of Toledo College of Law
Laura McNally-Levine, Case Western Reserve University School of Law
Jennifer Oliva, West Virginia University College of Law and School of Public Health
Thaddeus Pope, Mitchell Hamline School of Law
Lauren Roth, St.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.