Tag: therapeutic misconception

Bioethics Blogs

Charlie Gard: Three Issues That Did Not Make Social Media

by Ann Mongoven, Ph.D., MPH

All hearts go out to the Gard family in this time of grief for their son, Charlie.

The legal wrangling over Charlie’s care became a political football–unfortunately, about many things having little to do with Charlie.

Despite the involvement of Pope Francis, this was not a case about abortion rights or the sanctity of human life. Catholic tradition warns both that quality-of-life arguments can dehumanize the disabled, and that unduly burdensome medical care can become assaultive. There is no “Catholic” view of the case, and Catholic moral theologians disagree about it.

Despite the involvement of Donald Trump, this was not a case about the relative merits of the U.K. National Health Service (NHS) versus other health systems. It was not a case of utilitarian ethics pitted against duty-based ethics or love. The NHS provided extremely expensive intensive care for Charlie for most of his life, and British courts governed cases related to his care solely by a “best interest of the child” standard– amidst heated disagreement between Charlie’s parents and doctors about his interests. The European Court of Human Rights backed the British court decision.

The case did address questions about who should decide when parents and doctors disagree about a child’s medical interest. But contrary to some portrayals in the American press, it neither changed conventional parameters for addressing those questions, nor exposed major differences in legal reasoning used to address them in the U.K. and the U.S.  Both countries appeal to “best interest” standards for resolution, and both reject an absolutist interpretation of parental rights.

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

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

BioethicsTV: Aggressive Treatment Chosen for Patients at the End of Life

by Craig Klugman, Ph.D.

This week’s Thursday night medical TV was all about end of life decision-making and delved into the questions of how much aggressive treatment is too much, what happens when physicians lose clinical distance, and who makes decisions for patients.

On Chicago Med (Season 2, Episode 18), a patient with Alzheimer’s is admitted to the ED with a fever and chills. She has pneumonia and has for several days, only being sent to the hospital that day by her long-term care facility. The patient is Dr. Bella Rowen, Halstead’s former mentor and administrator Goodwin’s former colleague (from her nursing days). As the patient is brought in, a nurse says “No advance directive, no family, and the surrogate just passed away, so it’s going to be our call.” Halstead is emotionally invested in his mentor and takes over decision-making for her care. She is frail and does not remember him. When Rowen codes, Halstead pushes CPR even though, as his colleagues tell him, he will break all of her ribs and only cause suffering. He resuscitates and intubates her. We are told that she will never get off the vent. When her kidneys fail, he orders dialysis. Goodwin talks to him and says that such measures will lead Rowen to live the rest of her days on machines, bedridden with sores, and open to infections. Goodwin tells Halstead that the woman he knew was gone and forcing this patient to live would not bring his mentor back.

One of the major ethical issues raised in this case is whether, in fact, Halstead should have been making decisions for the patient.

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.

Bioethics Blogs

Questions about Deaths in Cancer Trials using Gene-Altered Cells

In the past month, the media has reported seven patient deaths of subjects enrolled in separate gene therapy clinical trials being conducted by Juno Therapeutics and by Ziopharm Oncology, Inc., both aimed at immunotherapy-based cancer treatments that have sparked widespread hope. Despite these deaths, the trials continue to move forward.

Media coverage of trials related to gene therapy has portrayed the clinical research rollercoaster.  Just this past week, The New York Times ran an unusually lengthy and high-profile series of articles in the Sunday paper about immunotherapy treatments for cancer, some involving genetic modification of immune cells. The articles describe the promising aspects of engineering one’s own immune system to fight cancer, including dramatic stories of tumors “melting away” and promises of complete remission.  

Yet commentary on the ethical implications of these events has been scant, and these events raise a number of concerns about what bioethicists call “therapeutic misconception” – vulnerable patients seeking enrollment in a clinical trial with the mistaken belief that the gene therapy is approved by the FDA to be safe and effective. The clinical trial deaths also highlight lingering questions about transparent reporting of adverse events to the FDA and appropriately navigating financial conflicts of interest.  Instead, numerous articles have focused on how these deaths impact the bottom line: corporate stock prices

The excitement has been building for some time. In June 2015, MIT Technology Review described Juno’s experimental T-cell immunotherapy for leukemia as “Biotech’s Coming Cancer Cure” and profiled the “miracle” recovery of 20-year old leukemia patient Milton Wright III.

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

A New Edition of Journal of Empirical Research on Human Research Ethics Is Now Available

April 28, 2016

Journal of Empirical Research on Human Research Ethics (vol. 11, no. 1, 2016) is available online by subscription only.

Articles include:

  • “Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers through Evidence-Based Ethics” by Celia B. Fisher, et al.
  • “Ethics of Online Assent: Comparing Strategies to Ensure Informed Assent among Youth” by Mark S. Friedman, et al.
  • “Participants and Study Decliners’ Perspectives about the Risks of Participating in a Clinical Trial of Whole Genome Sequencing” by Jill Oliver Robinson, et al.
  • “Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?” by Tina Malan and Keymanthri Moodley

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: “Heartbeat” tackles therapeutic misconception

by Craig Klugman, Ph.D.

On episode 4 of Heartbeat, the heroine, Dr. Panttiere has received hospital funding to try an experimental cancer treatment on 5 patients. The intervention uses laparoscopic surgery to implant radioactive pellets directly into tumors. The show presents a good debate on the values of enrolling patients because the characters discuss the hope of more time versus providing patients with comfortable quality of life at the end of life. The side-by-side contrast is quite literal as the camera shows Panttiere sitting next to her paramour, Dr.…

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

Translational Science as an Ethical Imperative

An acquaintance recently sent me a copy of an article from the December 7, 2015 edition of The New Yorker magazine, describing efforts of a neurosurgeon to use an unconventional approach to treating terminal brain cancer.  Follow the link and read the article for the whole story, but the physician in question was acting on anecdotes of people whose brain tumors had improved dramatically after serious post-operative wound infections. (Surgery is the front-line, but generally inadequate, treatment for these tumors.)  The physician purposely infected the wound of one of his patients with Enterobacter aeroenes, a bacterium normally found in the bowel and in human feces.

The first patient had a dramatic improvement and lived for a few years after—a highly unusual, positive result.  The second one did not do so well.  There was a small number of people treated in this way, and results were mixed at best.

From the article, it seems clear that this was a good doctor trying to help his patients—one who had done a practice-changing clinical trial and who understood that some treatments may “work”—that is, have a biologic effect as expected—but not help the patient—that is, the effect does not translate into any actual clinical benefit against the disease.  This is a common problem in the development of new treatments, especially for cancer, where clinical trials often do no better than showing “a correlation with a correlation with something you care about,” as a former senior official of the National Cancer Institute put it to me (not about this neurosurgeon’s approach, but about something else) some years ago.

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

Welcoming the Concept of Alief to Medical Ethics

Welcoming the Concept of Alief to Medical Ethics

 by J.S. Blumenthal-Barby, Ph.D.

Philosopher Tamar Gendler has introduced (circa 2008) a new concept in the philosophical literature that could be of interest to medical ethicists. The concept is that of ‘alief’ and it is meant to contrast with the concept of ‘belief.’ An example Gendler discusses to tease out the difference between the two concepts is the example of a woman who believes African American and Caucasian people to be of equal intelligence, yet in her behavioral responses it seems as if she believes differently (e.g., she is more surprised when an African American student of hers makes an intelligent comment than she is when a Caucasian student does, she more quickly associates intelligence with her Caucasian students, when grading exams she might grade the same quality exam differently if written by an African American student than a Caucasian student, etc.). In other words, if you ask her explicitly, she says she believes P (in this case, P is “all races are of equal intelligence”), and she says it sincerely. But, you might think from the outside that she believes ~P (in this case, “all races are not of equal intelligence”). You might be tempted to say that she does not really believe P. What Gendler wants to say is that this woman does believe P, but that she has an ‘alief’ that is in tension with her belief of P (she has a “belief discordant alief”). The content of this alief is a set of associations that get activated (usually from habit) and show themselves in behavioral responses.

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

Meet the 2014-15 Pillars of PRIM&R Award Winner: Francis Kombe

We are pleased to introduce you to the 2014-15 Pillars of PRIM&R Award recipient, Francis Kazungu Kombe. Francis currently serves as a senior community facilitator in charge of training at the Kenya Medical Research Institute/Wellcome Trust Research Programme (KWTRP). Over the next year, he will be using his award for a project that explores strengthening fieldworkers’ capacity to address practical and ethical challenges in international research settings. Read on to learn more about Francis’ background and his project.

At the heart of my Pillars of PRIM&R project are fieldworkers—the front line staff who engage with prospective or actual study participants to collect data or seek consent. Fieldworkers play a vital role in maintaining a strong link between research institutions and the communities they serve.

A growing number of publications highlight the ethical dilemmas associated with fieldworkers’ involvement in studies, including the potential for them to exploit community trust in order to meet recruitment quotas, the challenges they face in maintaining privacy and confidentiality in the community, and the possibility of being exploited through unfair employment practices.1 Fieldworkers are often residents within the community in which they are employed, and their insider knowledge about the community’s socio-cultural, geographic, and leadership structures can help inform sensitivities around research implementation. However, fieldworkers can experience tension between professional expectations to adhere to ethical guidelines in the conduct of research, and the need to remain responsive and sensitive to ethical issues raised by members of their community. At worst, this tension can undermine data quality and, ultimately, the ethical standards of the 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.