Tag: reporting

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

Caregiving: Can It Be An Attribute of Our Healthcare System?

By David C. Leach

An old joke begins by asking that you imagine a man drowning 100 feet offshore while a conservative and a liberal are observing.  The conservative throws him a 50 foot rope and says: “swim the extra distance, it’s good for you.”  The liberal, on the other hand, throws him a 100 foot line and then promptly drops his end of the line in order to go and do another good deed.

While offering insight into our politics the story also illuminates some of our habits around caregiving in our current healthcare system and the policies supporting that system.  Certainly individual stories of near heroic caring can be found, but the system itself is designed around processes and structures that seem to diminish the importance of the caring relationships at the heart of our work.  Caregivers frequently depend on work arounds.  What would it take to develop a system that respects, rewards, or at least enables genuine caregiving?

Caregiving, of course, is an attribute of humans, not systems.  To care for another requires a voluntary opening of the heart to compassion; it requires noticing and acknowledging the uniqueness of the other and a willingness to enter into their context.  Keenan defines mercy as the willingness to enter into the chaos of the other.  (1) The biblical story of the Good Samaritan (Luke, 10:33) illuminates an interesting attribute of caregiving that may indicate why humans can care and systems cannot; the clue is in the voice of the verbs used.  The story is well known: a traveler has been assaulted and robbed.

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

Nonpublication of Neurology Trials for Stalled Drugs & the Ironic Nonpublication of Data on those Stalled Drugs

In my experience, peer review greatly improves a manuscript in the vast majority of cases. There are times, however, when peer review improves a manuscript on one less important axis, while impoverishing it in another more important one. This is the case with our recent article in Annals of Neurology.

Briefly, our manuscript created a sample of FDA-approved neurological drugs, as well as a matched sample of neurological drugs that did not receive FDA approval- but instead stalled in development (i.e. a 3 year pause in testing). We then used clinicaltrials.gov to identify trials of drugs in both groups, and determined the proportion of trials that were published for all approved drugs, as well as FDA non-approved drugs. We found- not surprisingly- that trials involving stalled neurological drugs were significantly less likely to publish. What- for us- was the bigger surprise was that the proportion of trials published at 5 years or more after closure was a mere 32% for stalled neurological drugs (56% for licensed). Think about what that means in terms of the volume of information we lose, and the disrespect we show to neurological patients who volunteer their bodies to test drugs that show themselves to be ineffective and/or unsafe.

We shopped the manuscript around numerous places- eventually landing at Annals of Neurology. The paper received glowing reviews. Referee 1: “The research is careful and unbiased and the conclusions sound and impactful.” Referee 2: “This is an excellent and very important paper. It rigorously documents a very important issue in clinical trial conduct and reporting.

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 the Journals – May 2017 by Livia Garofalo

Please enjoy the article round-up for the month of May! This post was put together in collaboration with Ann Marie Thornburg.

American Ethnologist

Plant matters: Buddhist medicine and economies of attention in postsocialist Siberia

Tatiana Chudakova

Buddhist medicine (sowa rigpa) in Siberia frames the natural world as overflowing with therapeutic potencies: “There is nothing in the world that isn’t a medicine,” goes a common refrain. An exploration of sowa rigpa practitioners’ committed relations with the plants they make into medicines challenges human-centric notions of efficacy in anthropological discussions of healing. Their work of making things medicinal—or pharmacopoiesis—centers on plants’ vital materialities and requires attention to the entanglements among vegetal and human communities and bodies. Potency is thus not the fixed property of substances in a closed therapeutic encounter but the result of a socially and ecologically distributed practice of guided transformations, a practice that is managed through the attentive labor of multiple actors, human and otherwise. In Siberia, pharmacopoiesis makes explicit the layered relations among postsocialist deindustrialization, Buddhist cosmologies, ailing human bodies, and botanical life.

Annals of Anthropological Practice

Special Issue: Continuity and Change in the Applied Anthropology of Risk, Hazards, and Disasters

Disaster vulnerability in anthropological perspective 

A.J. Faas

In the study of disasters, the concept of vulnerability has been primarily employed as a cumulative indicator of the unequal distributions of certain populations in proximity to environmental and technological hazards and an individual or group ability to “anticipate, cope with, resist and recover” from disaster (Wisner et al. 2004). This concept has influenced disaster research as a means to question how natural, temporary, and random disasters are and focused analysis on the human-environmental processes that produce disasters and subject some populations more than others to risk and hazards.

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

Inner Sense and Gender Dysphoria

Steve Phillips posted on “Caring for people with gender dysphoria” almost one year ago. In his post, he referenced a talk at a previous CBHD Summer Conference by Prof. Robert George, where Dr. George posited that the concept that the belief that one’s gender is based one’s innate or inner sense rather than one’s biological/physical sex is rooted in the Gnostic idea that human beings consist of a personal mind that lives in a non-personal body and that this stands in contrast to the longstanding Christian understanding of unity of non-material soul/spirit and material body making up the whole person. I did not attend that talk but offer a recent paper by Dr. George which covers the same ground as backdrop to this post.

The reason for the discussion of Gnosticism related to an earlier point in that same blog referencing the opinion of Dr. Paul McHugh, retired psychiatrist at Johns Hopkins University, who has over the past few years published comments arguing that gender dysphoria is a result of disordered thinking, that is, a mental disorder, requiring treatment, not surgery to complete a gender transition. Dr. McHugh has made much of the fact that Johns Hopkins, despite being an early leader in gender transition surgery, decided very early on that gender transition surgery was not sufficiently efficacious and discontinued the practice.

What a difference a year can make. Johns Hopkins has recently decided to resume what they are calling gender-affirming surgery and specifically point out that when “individuals associated with Johns Hopkins exercise the right of expression, they do not speak on behalf of the institution.”

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 & Society Newsfeed: May 5, 2017

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Politics

What Obama’s Former Ethics Counsel Thinks of Trump
Norm Eisen, former ethics counsel to President Obama and co-founder of Citizens for Responsibility and Ethics in Washington (CREW) discusses the ethical issues of the Trump administration’s first 100 days.

White House aims for Thursday signing of religious liberty executive order
A win for conservatives, especially the Vice President, the new religious liberty executive order is expected to be signed Thursday.

Ethics office says it wasn’t consulted about Ivanka Trump job
Ivanka Trump was brought on as a White House adviser without consulting the Office of Government Ethics.

State Department Promotes Ivanka Trump’s Book In Another Ethics Blunder
A State Department office retweeted post promoting Ivanka Trump’s new book despite federal rule that bars the use of public office for private gain.

Bioethics and Medical Ethics

This New App Is Tinder For Sperm And Egg Donors
“The ethical and legal complexities of egg-shopping.”

Jimmy Kimmel’s powerful, poignant Obamacare plea crystallizes the GOP’s dilemma
Late-night host Jimmy Kimmel made an emotional plea to lawmakers to fund health-care spending for preexisting conditions, discussing his newborn son Billy’s heart condition on his show.

Firestorm brewing as scientists work to create synthetic human DNA
Scientists say that synthesized human DNA could be a reality in as little as 5 years, invoking ethical questions and concerns.

Informed Consent Becoming More Difficult?
“The recent decision in Ike White v. David Beeks, M.D., has threatened to turn this consent process on its head, especially if it were to be adopted in other states.”

5 things to know about infertility treatments
Treatment for infertility can be expensive and clinics are scarce, calling into question ethics issues.

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

Self-reporting and participatory health platforms: Empowerment through sharing information about oneself online?

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Here, Dana Mahr examines claims of empowerment in participatory health platforms and the implications of this for participants and biomedical research … 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

Would You Want to be a Savant?

By John Banja
John Banja, PhD is a medical ethicist at Emory University’s Center for Ethics, a professor in the Department of Rehabilitation Medicine, and the editor of AJOB Neuroscience.
Darold Treffert (2010), a psychiatrist who has devoted the better part of his career to studying savants, notes that there are at least 3 kinds.
First, those who manifest the “savant syndrome” and display the most astonishing of savant abilities, such as Kim Peek who was the inspiration for Dustin Hoffman’s character, Raymond Babbitt, in the movie Rain Man. Peek, who died from a heart attack in 2009, was remarkable even by savant standards: He memorized more than 12,000 books and was able to read two pages simultaneously, one page with the right eye, the other page with the left. He also had a remarkably hospitable form of dyslexia where he could read words on a page turned sideways or upside down or backwards—such as reflected in a mirror. He could add a column of numbers from a telephone book page and instantly tell you the mean of those numbers, and he could do lightning calendar calculations like telling you which day of the week you were born upon knowing your birth date (Treffert, 2010, pp. 120-129). These were only a few of his talents. 

I might also mention Daniel Tammet who, on March 14th, 2004 on “International Pi Day”—get it?: 3.14—recited from memory Pi to 22,514 decimal places (p. 161). Or George Widener who can tell you what day of the week June 25th will be in the year 47,253 (p.

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

Law Changes and Slippery Slopes

Apparently, there was a TV programme in Australia the other day in which a there was a discussion of assisted dying.  It got reported in The Guardian, largely on the basis that an 81-year-old audience member kept calling Margaret Somerville “darling” and then got mildly sweary.  I’ve only seen those clips from the programme that are linked in the Graun‘s report, so I’m not going to comment on the tone of the debate in particular.  Rather, I’m interested in one of the responses to the programme, from Xavier Symons, writing in The Conversation.

Symons takes the opportunity to unpick the idea of a slippery slope argument – in this case, the claim that allowing some forms of assisted dying will commit us to allowing… well, that’s open-ended, but it’s sufficient to say that it’d be terrible.  We’d want to avoid terrible things; therefore, the argument goes, we shouldn’t allow any of it.  This is well-worn stuff in the seminar room, but it’s a mode of argument that refuses to die.  Quite correctly, Symons points out that

there is a need for empirical evidence or sound inferential reasoning to support the claim that event B will necessarily (or probably) follow on from event A.  Without this evidence, the argument is invalid. I can’t just claim, for example, that the legalisation of medicinal marijuana leads to the legalisation of ice – I need to show some empirical or logical connection between the two.

So far, so standard.  (I’d say “unsound” rather than “invalid”, because the validity of an argument doesn’t depend on its evidence – or, at least, not in the same way; but that’s a small matter.) 

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

The Deadly Business of an Unregulated Global Stem Cell Market

Guest Post: The deadly business of an unregulated global stem cell industry

Tereza Hendl and Tamra Lysaght

In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.

The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.

This case came to our attention as part of the work being done on an Australian Research Council funded Linkage Project “Regulating autologous stem cell therapies in Australia.”

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.