Tag: nonmaleficence

Bioethics Blogs

Revising the Ethical Framework for Deep Brain Stimulation for Treatment-Resistant Depression

By Somnath Das

Somnath Das recently graduated from Emory University where he majored in Neuroscience and Chemistry. He will be attending medical school at Thomas Jefferson University starting in the Fall of 2017. Studying Neuroethics has allowed him to combine his love for neuroscience, his interest in medicine, and his wish to help others into a multidisciplinary, rewarding practice of scholarship which to this day enriches how he views both developing neurotechnologies and the world around him. 

Despite the prevalence of therapeutics for treating depression, approximately 20% of patients fail to respond to multiple treatments such as antidepressants, cognitive-behavioral therapy, and electroconvulsive therapy (Fava, 2003). Zeroing on an effective treatment of “Treatment-Resistant Depression” (TRD) has been the focus of physicians and scientists. Dr. Helen Mayberg’s groundbreaking paper on Deep Brain Stimulation (DBS) demonstrates that electrical modulation an area of the brain called subgenual cingulate resulted in a “sustained remission of depression in four of six (TRD) patients” These patients experienced feelings that were described as “lifting a void,” or “a sudden calmness.” (Mayberg et al. 2005). The importance of this treatment lies in the fact participants who received DBS for TRD (DBS-TRD) often have no other treatment avenues, and thus Mayberg’s findings paved the way for DBS to have great treatment potential for severely disabling depression. 

Image courtesy of Wikimedia Commons
Because DBS involves the implantation of electrodes into the brain, Dr. Mayberg and other DBS researchers faced intense scrutiny following publication of their initial findings regarding the ethics of using what to some seems like a dramatic intervention for TRD.

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

Have I Been Cheating? Reflections of an Equestrian Academic

By Kelsey Drewry
Kelsey Drewry is a student in the Master of Arts in Bioethics program at the Emory University Center for Ethics where she works as a graduate assistant for the Healthcare Ethics Consortium. Her current research focuses on computational linguistic analysis of health narrative data, and the use of illness narrative for informing clinical practice of supportive care for patients with neurodegenerative disorders.

After reading a recent study in Frontiers in Public Health (Ohtani et al. 2017) I realized I might have unwittingly been taking part in cognitive enhancement throughout the vast majority of my life. I have been a dedicated equestrian for over twenty years, riding recreationally and professionally in several disciplines. A fairly conservative estimate suggests I’ve spent over 5000 hours in the saddle. However, new evidence from a multi-university study in Japan suggests that horseback riding improves certain cognitive abilities in children. Thus, it seems my primary hobby and passion may have unfairly advantaged me in my academic career. Troubled by the implication that I may have unknowingly spent much of my time violating the moral tenets upon which my intellectual work rests, I was compelled to investigate the issue.



The study in question, “Horseback Riding Improves the Ability to Cause the Appropriate Action (Go Reaction) and the Appropriate Self-control (No-Go Reaction) in Children,” (Ohtani et al. 2017) suggests that the vibrations associated with horses’ movement activate the sympathetic nervous system, leading to improved cognitive ability in children. Specifically, children 10 to 12 years old completed either simple arithmetic or behavioral (go/no-go) tests before and after two 10 minute sessions of horseback riding, walking, or resting.

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

When Ideology Trumps Reason, Do The Life Sciences Resist or Capitulate?

by Craig Klugman, Ph.D.

The world of the life sciences and medicine is being changed radically in 2017. The proposed Trump budget cuts funding for the CDC, NIH, NSF, NEH, NEA, EPA, and PHS will radically change how science is done, how much science is done and by whom. The US is withdrawing from the Paris Climate Treaty. Cuts to social security that traditionally pays for medical residents have also been proposed. The American Health Care Act will take affordable health insurance away from 23 million people. For the rest of us, the AHCA means higher premiums and less coverage. At the same time, we live in an era of “fake news,” “leaks,” incendiary tweets, and loyalty as the sign of someone’s worth. What might be the impact on medicine, the life sciences and bioethics in the Trumpian era? Will the dominant political ideology affect the practice of science and medicine in more ways than economics? Can ethics help steer a course around ideology?

One change that has already occurred under Trump is an anecdotal decrease in the number of immigrants (documented and undocumented) who are seeking medical care under concern that they will be deported if they show up to hospitals and doctor’s offices. In one case, a woman was forcibly removed the hospital where she was to be treated for a brain tumor and brought to a detention center.

Certainly, there is a U.S. history of medicine following the ideology of the government. Forced sterilization, the Tuskegee Syphilis study, the US radiation experiments and the Guatemala Syphilis studies were all government financed research created to prove a particular ideology: In these cases, species-level differences between the races and that a nuclear war was “winnable.”

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 ethics of conscientious objection: Caring for patients and supporting providers

Although conscientious objection arises in various
areas of medicine, notably end-of-life issues (e.g. physician assisted death), it
is ubiquitous in all aspects of reproductive medicine and women’s health care. Indeed,
it is discussed extensively in the academic bioethics literature, clinical
practice, healthcare law and policy (e.g. the Hobby Lobby Supreme Court case), and
in the popular press. Part of the reason conscientious objection is so
commonplace in reproductive medicine and women’s healthcare is because of the
controversial nature of abortion and emergency contraception.

The topic of conscientious objection forces us to
confront the boundaries of professional obligations and individual rights.
Which should be prioritized when they conflict? The common stance of most
professional medical organizations is that providers have an obligation to
refer if they oppose a practice/prescription based on personal beliefs (e.g.
providers should provide a referral if a patient requests an abortion and they
oppose abortion due to philosophical or religious reasons), but not if they
believe the practice/prescription doesn’t align with standard of care (e.g.
providers don’t have to provide a referral if a patient requests antibiotics
for the common cold).

The position of most medical organizations on
conscious objection raises some concerns. First, there are logistical and
feasibility concerns. While it may be easier to uphold providers’ conscientious
objection in densely populated areas, in rural areas where there may only be
one provider, thereby making it difficult to find someone to refer patients to.
It is burdensome for patients to travel far away to receive medical care that
they could receive locally if the provider did not have a conscientious
objection.

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

Bioethics and the Problem of Silent Neutrality in the age of Trump

by Craig Klugman, Ph.D.

One of the most contentious of all issues in bioethics has been whether as a profession, we should take a stand against issues. Arguments have raged on both sides of the issue. The American Society for Bioethics & Humanities (ASBH) only takes stands on issues of academic freedom. The thinking, as I’ve seen it, is that bioethics has something to offer all political perspectives and by not taking stands on issues, we are more likely to help further conversations among people on  all parts of the political spectrum.

This stance has been tested: When as a nation we learned that torture was regularly being practice by our military some took offense, but only Steven Miles spoke out and resigned from the organization for not taking a stand. Bioethics in general has been criticized for its lack of participation in social justice issues. In Observing Bioethics, Renee Fox and Judith Swazey criticize the bioethical enterprise for this unwillingness to take a stand.

So are there extraordinary times and issues when we as a group should stand up either individually or en masse?

I have been personally struggling with how to respond to the mass upheaval currently taking place in the United States. Plans to re-open Guantanamo Bay, CIA black sites, and torture are violations of human rights and human decency. For example, banning refugees from our shores, keeping people from returning to their jobs/homes/families; even forcing residents at US hospitals to leave the country after returning from trips abroad. Also consider efforts to silence government scientists, health care providers in other countries receiving US aid, and the diplomatic corp.

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

Two Wrongs Do Not Make A Right

by Craig Klugman, Ph.D.

A draft of a new executive order that would re-open CIA black site prisons (facilities outside the United States where more torturous forms of interrogation are not prohibited) and restart the use of enhanced interrogation techniques (which many consider to be torture) was made public on Wednesday. Trump also publicly stated that he believes torture works and thus thinks it should be reinstated.

Trump’s justification for torture is that without it “we’re not playing on an even field.” He said that since terrorists will torture people, we need to be able to do the same. Mr. Trump, two wrongs do not make a right.

Simply, torture is wrong. It is a willful infliction of harm on another human being, which violates notions of nonmaleficence. It also breaches a person’s dignity and autonomy. Torture defies Kant’s principle of humanity since torture victims are treated merely as means to achieving the end of learning information.

Legally, torture contravenes the Geneva Convention and the UN Declaration of Human Rights. Of course, some might argue that these detainees are not prisoners of war and thus are not covered. And the US is about to abandon the UN anyway (also look here). The International Criminal Court defines torture as a crime against humanity (the US is not a member of the Court). When you capture and detain people against their will and their government’s assent, and deny them basic rights of anyone living inside your own borders, that person is in fact your prisoner.

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

BioethicsTV (November 2016) Continued: Further commentary on Informed Consent

by Abhi Amarnani

Chicago Med (Season 2, Episode 8, 11/10/16).

A December 1st BIOETHICSTV blog post briefly mentioned, Season 2, Episode 8 of Chicago Med. The post notes that the episode dealt with the issues of informed consent in brief. I felt that a more in-depth discussion of these issues was warranted. Consider the storylines in the episode: A young girl with a developmental disorder needs cardiac surgery. Her condition forces her mother to question whether the girl can make decisions for surgery. Second, Nurse April was coughing at the end of episode 7, and viewers learned that she is diagnosed with multidrug resistant tuberculosis (TB). Adding to this challenge is a confirmation of pregnancy. Her colleagues question her personal autonomy when she considers refusing treatment. Third, a patient dying from kidney disease is not allowed by hospital policy and law to accept a transplant from his HIV+ brother. The message is that death from organ failure is preferable to a longer life with HIV. By the end of the episode, Dr. Manning leaves a syringe on the table stating: “If you already had HIV, the procedure would be legal,” insinuating a workaround – that if the patient infects himself with his brother’s blood, then the transplant can happen. The donor and recipient acknowledge fully informed consent that receiving an HIV positive organ will infect him, but here the informed consent consideration comes up against the “do no harm” principle of medicine and United Network for Organ Sharing (UNOS) policy.

In the first storyline, a friendly, bubbly and trusting teenage girl, Karina, enters the hospital with cardiac 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

BioethicsTV (November 2016): Informed consent, HIV organ transplants, Forgiveness, Assisted Suicide, Treating Prisoners, Undue Influence in Consent, and Failure to Vaccinate

by Craig Klugman, Ph.D.

Grey’s Anatomy (Season 13, Episode 9). A building collapses when a landlord has failed to make necessary repairs a year after an earthquake. The landlord mistakes a resident for a priest and confesses that his neglect was the cause of the tragedy that has led to much morbidity and mortality. The resident wonders if he has to preserve confidentiality like a priest or if information told to a doctor is different. A fellow resident tells him that since it’s not medically related, he has no obligation to maintain this particular confidence. Later, after surgerty the landlord tells the resident that he knows there was never a priest, but he simply needs someone to forgive him. The question then is whether the physician can offer a patient forgiveness for causing mass casualties to others. Of course, a physician must treat every patient the same irrespective of anything the patient may or may not have done in life. Thus the serial killer is treated the same as the cop. Health care professionals must make no moral judgments about choosing who to treat and how. But what if a patient admits criminal neglect? If the physician is a mental health professional, then the therapeutic privilege of confidentiality may protect the patient’s secret (unless there is an admission of fraud or abuse). But to your surgeon or anesthesiologist there is no such promise of confidentiality. In fact, the non-therapist physician may be obligated to report knowledge of the crime.

Chicago Med (Season 2, Episode 7-11/3) The main story line consists of a female patient who presents with altered mental status.

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 Ethics of Crisis Pregnancy Centers

“Pregnant? Scared? Need Help?”
read signs along major thoroughfares in the southern United States. Many
Americans have seen signs like these, often simultaneously advertising free
pregnancy and sexually transmitted infection (STI) testing. Unless experiencing
a unplanned pregnancy, most people pass by these signs without a second
thought. However, for some of our most vulnerable patients, the
establishments posting these advertisements – known as crisis
pregnancy centers – represent a significant ethical difficulty in
reproductive healthcare. Although these organizations are almost exclusively
run by community volunteers, they represent themselves as healthcare workers by
wearing lab coats and scrubs, providing lab testing and ultrasounds, and setting
up offices that look like medical clinics. This would be problematic in itself
from a legal perspective but the political and religious perspectives of these
organizations provides serious ethical questions as well. Far from
unbiased, crisis pregnancy centers (CPCs) are usually religiously
affiliated organizations with a hard right agenda of
preventing abortion at any cost. Medical evidence and scientific fact are
not considered in this equation so clients of CPCs are often told that abortion
causes breast cancer, infertility, psychiatric disorders (such as the entirely
fictitious post-abortion syndrome), and even, in one case, kidney
failure and subsequent dialysis. Furthermore, results of testing done at
CPCs are frequently fabricated or ignored – clients are given falsely
negative pregnancy test results or incorrect dating ultrasounds to prevent
those considering an abortion from pursuing other care. CPC clients are usually
unaware that these organizations do not employ trained medical providers or that
they have a political agenda. However, the intent is clearly to strongly imply
to CPC clients that they are being given information by medical personnel.

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

Response to “Do the EPA Studies Violate Do No Harm & Informed Consent”

by Nancy King, JD

I have just read your August 25 post on the EPA studies. While, I do not know that much about these particular exposure studies, I do know that EPA is taking the inquiry very seriously. I do want to question and clarify some of your discussion, principally with respect to Resnik’s 4th and 5th criteria.

You say: “Criteria 4, that the subject must “receive some benefits, such as medical evaluations” seems like a very light standard. If the medical evaluation were part of the study and data was being used for the study, would it be a benefit? I have always viewed a benefit as something that is aimed to help the subject, not the research. In the IRBs in which I have been involved, this is why receiving a study drug is not considered a benefit because it’s not intended to benefit the subject (but to gather data).”

You’re right that offering what John Lantos has called “inclusion benefits” — everybody gets a perk for joining the study — cannot be weighed against risks of harm to subjects in order to justify risk-bearing research.  Nor can you offer more than a “light” benefit in order to balance greater risks of harm.  That’s why the only benefits that count in the harm-benefit balance should be direct benefits to society from generalizable knowledge, and in some but not all research, benefits from the intervention under study.  That works for phase III randomized clinical trials (RCT) where there is clinical equipoise — and it can reasonably apply to getting the study drug in a phase III RCT that is well-supported by data from earlier phases.  But

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.