Tag: academic medical centers

Bioethics Blogs

UpToDate – Legal Aspects in Palliative and End of Life Care in the United States

I am delighted to contribute to UpToDate, starting with “Legal Aspects in Palliative and End of Life Care in the United States.”


UpToDate is an evidence-based clinical decision support resource which clinicians trust to make the right point-of-care decisions. More than 6,500 world-renowned authors, editors, and peer reviewers use a rigorous editorial process to synthesize the most recent medical information into trusted, evidence-based recommendations that are proven to improve patient care and quality. 


Over 1.3 million clinicians in 187 countries and nearly 90% of major academic medical centers in the United States rely on UpToDate to provide the best care. More than 80 research studies confirm widespread usage of UpToDate and the association of its use with improved patient care and hospital performance — including reduced length of stay, fewer adverse complications, and lower mortality.


UpToDate is a product of Wolters Kluwer Health.  I co-author a related publication for Wolters Kluwer Law and Business: the 1500-page reference Right to Die: The Law of End-of-Life Decisionmaking.

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

Rethinking The Obligation To Provide Universal Healthcare Coverage: The need for moral imagination

Healthcare is indeed complicated, in case anyone with a
speck of knowledge about it ever thought otherwise. There are many ways to
organize a healthcare system, as is evident from all the various ways advanced
industrial societies around the globe provide healthcare to their citizens.
Questions about the extent to which the private insurance system versus the
government is involved brings us back to protracted debates about the legitimate
role of government and whether or not citizens have a basic right to healthcare,
or should healthcare be assumed to be one more market service which individuals
may elect to use or not? Sadly, in the United States these questions often are
framed in abstract terms appealing to general ideological values and goals that
shape and limit the range of viable policy options. What I want to emphasize in
my blog today is the need for moral imagination—what’s it like to be in the
shoes of those who are suffering, and often without health insurance, and
without a job?  This is a first step we
all must take before we can weigh our moral obligations to provide healthcare
to everyone.

Before the passage of the Affordable Care Act (ACA) there
were over 45 million uninsured Americans who did not have access to a primary
care physician. That number has been reduced by about 18 million, but now we at
risk of seeing this number rise again with the possibility of a repeal of the
ACA and passage of a GOP led alternative. The Congressional Budget Office
(CBO), a politically independent agency, estimated that if the American
Health Care Act had past would eventually lead to 24 million people loosing
their health care insurance by 2026.

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

Rethinking The Obligation To Provide Universal Healthcare Coverage: The need for moral imagination

Healthcare is indeed complicated, in case anyone with a
speck of knowledge about it ever thought otherwise. There are many ways to
organize a healthcare system, as is evident from all the various ways advanced
industrial societies around the globe provide healthcare to their citizens.
Questions about the extent to which the private insurance system versus the
government is involved brings us back to protracted debates about the legitimate
role of government and whether or not citizens have a basic right to healthcare,
or should healthcare be assumed to be one more market service which individuals
may elect to use or not? Sadly, in the United States these questions often are
framed in abstract terms appealing to general ideological values and goals that
shape and limit the range of viable policy options. What I want to emphasize in
my blog today is the need for moral imagination—what’s it like to be in the
shoes of those who are suffering, and often without health insurance, and
without a job?  This is a first step we
all must take before we can weigh our moral obligations to provide healthcare
to everyone.

Before the passage of the Affordable Care Act (ACA) there
were over 45 million uninsured Americans who did not have access to a primary
care physician. That number has been reduced by about 18 million, but now we at
risk of seeing this number rise again with the possibility of a repeal of the
ACA and passage of a GOP led alternative. The Congressional Budget Office
(CBO), a politically independent agency, estimated that if the American
Health Care Act had past would eventually lead to 24 million people loosing
their health care insurance by 2026.

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

Lupron: Déjà Vu All Over Again

Alice Dreger raises concerns about a pervasive pattern of non-evidence based assumptions driving practices in pediatric endocrinology.

__________________________________________

You’d think that the pediatric specialty that may have given cancer to women treated with estrogen because as girls they were ‘at risk’ of growing up tall might be pretty careful with other drugs. You’d think that it would be especially cautious about treating kids with hormone blockers because they are ‘at risk’ of growing up short.

Pediatric endocrinology, I’m talking to you.

Susan Cohen and Christine Cosgrove have done a fine job tracking the history of using estrogen to prevent tallness in girls, so I won’t review it here. But their work is inevitably brought to mind because of a report published last week in California Healthline by Christina Jewett.

Jewett relays mounting health concerns among women who were given the drug Lupron as girls to stop or slow down puberty. Some were treated as children specifically to try to get them to grow taller. Lupron may increase a child’s ultimate height by lengthening the span of years in which the long bones are growing.

Leuprolide

The U.S. Food and Drug Administration (FDA) has approved Lupron (leuprolide), a hormone-blocking agent, for the treatment of precocious puberty, endometriosis, and advanced prostate cancer. Last week, Denise Grady reported in the New York Times new oncology research which suggests it can prolong the lives of some men with prostate cancer.

But in all these uses, the drug is known sometimes to cause serious side effects. As one oncologist quoted in Grady’s article put it, the side effects are serious enough, “you’d better have some decent justification” to use it.

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 News

For Loved Ones of Critically Ill Patients, Hope Often Trumps Understanding of a Physician’s Prognosis

May 19, 2016

(Los Angeles Times) – For a majority of people gathered at the bedside of a critically ill patient, new research finds that confusion and miscommunication rein, jostling for space alongside hope and fear. In more than half the cases plumbed by researchers at four major academic medical centers, the people responsible for directing the care of a critically ill patient neither agreed with nor fully understood the prognosis offered by the physician overseeing the patient’s care.

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

Clinical Trial Disaster in France

Days after receiving the experimental medication BIA 10-2474 in a first in human trial, one man was brain dead and another five hospitalized. According to recent reports, three are likely to have neurological deficits.
To my knowledge, this is the first time since 2001 that a healthy volunteer has died in a medical experiment. And it is the first major drug disaster in a phase 1 trial since 2006, when six men were hospitalized after developing a life threatening (but not ultimately fatal) immune response to the drug TGN1412.

Details surrounding the BIA 10-2474 trial are sketchy – and are likely to remain so as long as a manslaughter investigation is underway. Here is what we do know. The drug was a small molecule inhibitor of an enzyme involved in endocannabinoid metabolism, fatty acid amide hydrolase (FAAH). Other FAAH inhibitors have been tested in human beings without incident. Nor have any shown clinical activity. We also know that the men who developed life-threatening toxicities were the first to receive multiple doses of BIA 10-2474. And, based on a study protocol released by Le Figaro, multiple doses within this cohort were not staggered.
Healthy volunteer phase 1 studies are creepy. The realm of phase 1 testing is secretive, and most studies are conducted in private contract research organizations rather than academic medical centers. Few studies are ever published. Indeed, drug regulators exempt companies from even registering them in public databases. This makes it difficult to know anything about their volume, record of safety, the demographics of study participants, or the nature of study procedures.

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

Is it ok for patients to pay for their own clinical trials?

Most trials are funded by public sponsors, charities, or private drug developers. Austere research funding environments, and growing engagement of patient communities, has encouraged many to seek alternative funding.  One such alternative is patient funding. In the August 6 issue of Cell Stem Cell, my co-authors Alex London and Danni Wenner ask whether “patient funded trials” represent an opportunity for research systems, or a liability.

Our answer: liability.

Current regulatory systems train the self interest of conventional funders and scientists on the pursuit of well justified, rigorously designed, and efficient clinical trials. These regulatory systems have little purchase on patients or on clinics that offer patient funded trials.  Indeed, patient funded trials create a niche whereby clinics can market unproven interventions in the guise of a trial.  Do a few Google searches for patient funded trials and you’ll see what can flourish under this funding model.

On the other hand, our denunciation of the model is not categorical.  Provided there is a system in place for independently vetting the quality of design and supporting evidence—and for preventing such studies from pre-empting other worthy scientific efforts- patient funded trials may be ethically viable.

Until those mechanisms are in place, academic medical centers should refuse to host such studies.

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

Has the Pendulum Swung too Far in Favor of Patient Autonomy?

“Institutional Culture and Policies’ Influence on Do Not Resuscitate Decision-Making at the End of Life,” online first in JAMA Internal Medicine looks at the difference between (a) hospitals which have policies or a culture that prioritizes patient autonomy with regard to DNAR orders and (b) hospitals where doctors’ recommendations on what might be in patients’ best interests medically hold more sway.

Elizabeth Dzeng and colleagues argue that UK hospitals currently differ from the more consumer-oriented approach of their US counterparts and doctors’ recommendations still hold sway over DNAR decisions. However, they are moving more towards the US model as the recent case of Janet Tracey at Addenbrookes hospital in Cambridge shows. Tracey’s family successfully sued the hospital over a DNR order that was implemented without the family’s permission.


The authors interviewed 58 doctors and trainees at three academic medical centers in the US and one in the UK. Trainee doctors at hospitals with emphasized patient autonomy often felt compelled to offer the choice of resuscitation in a neutral way in all situations regardless of whether they believed it would be clinically appropriate. 


In contrast, trainees at hospitals where policies and culture prioritized best interest-focused approaches felt more comfortable recommending against resuscitation in situations where survival was unlikely. They felt confident, for instance, to discourage the ineffective use of CPR and found it ethically suspect to offer CPR in futile situations such as for frail elderly patients with incurable metastatic cancer where doing CPR may result in broken ribs and electric shocks as well as depriving them of a dignified death.

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

Responding to Ebola: Health Care Professionals’ Obligations to Provide Care

As health care institutions in the United States prepare for Ebola patients, many have adopted the policy that those providing hands-on care should come from a pool of volunteers. Given the mixed history of health care providers’ willingness to care for patients during epidemics and pandemics, and the need for additional training in personal protective equipment for Ebola, this may be the most pragmatic response. However, worries about the risk of transmission of the virus to those coming in contact with infectious bodily fluids may lead to insufficient personnel coming forward, putting hospitals in a position to require some professionals, including doctors, nurses, and respiratory therapists, to care for Ebola-infected patients.

Many academic medical centers have formulated policies about who might be required to participate in the care of Ebola patients and who might be exempt. In many centers, medical and nursing students have heard that they will not provide care to Ebola patients. In some centers, other trainees, such as residents and fellows, have also been excluded. 

These policies raise two important questions. First, what is the obligation of health care professionals to assume personal risk? When we look at what history shows, we find the original American Medical Association Code of Ethics, written in 1847, stated “. . . it is their duty to face the danger, and to continue their labours for the alleviation of the suffering, even at the jeopardy of their own lives.” Interestingly, this section was removed in the 1960s when the Surgeon General declared the threat of infectious diseases to be a problem of the past.

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

Here’s Why Funding Medical Education Helps Vulnerable Patients

An article in the New England Journal of Medicine in June (no one accused me of being a timely blogger!) shows that academic medical centers often provide poorly-reimbursed services that other healthcare institutions avoid. Where more general hospitals might avoid having psychiatric emergencies available, 90% of academic medical centers offer such services:

Percentage of U.S. COTH Hospitals and Nonteaching Hospitals

Whereas only 4% of nonacademic institutions offer pediatric intensive care, over half of academic medical centers do. In fact, academic medical centers have historically provided almost 40% of all charity care in the U.S. (To read the rest of this blog and leave comments, please visit Forbes.)

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.