Charlie Gard: An Unnecessary Tragedy?

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Leonard M. Fleck, PhD

I am writing from London, England, where I am teaching a study abroad course on medical ethics and health policy. We are located in a building just off one corner of the British Museum. More importantly, we are just a few blocks from the Great Ormond Street Hospital for Children (GOSH) where the Charlie Gard case just concluded with his death. Though this case was not part of the formal syllabus, it is difficult to imagine how it could be ignored, given the nature of the course and given that a majority of students in the course intend to pursue careers in medicine.

The case that was a formal part of the syllabus was the Lakeberg conjoined twins case from the early 1990s. These twins shared a single six-chambered heart, which would be incapable of sustaining their lives for much more than a year, possibly two. A novel surgery was proposed to reconstruct the heart into a normal four-chambered organ, which would mean that one twin would have to have its life ended through the surgery itself in order to offer “less than a 1% chance of survival” for the other twin at a cost in excess of $1 million. Loyola University Medical Center refused to do the surgery (demanded by the parents) for two ethically relevant reasons. They objected to causing the death of one child in order to save the life of the other (no matter what the chance of success), and they objected to what they regarded as an unjust use of their limited charity care budget. The surgery was performed at Philadelphia Children’s Hospital. The surviving twin lived for eleven months in the ICU, suffering one complication after another related to the surgery. Did those parents have the right to make those demands of the surgeons because they believed that was in the best interest of one (or both?) of these twins?

The students knew the end of the Lakeberg story (thanks to smartphones undermining my pedagogical objectives). However, they did not know the end of the story in the case of Charlie Gard until today (7/28/17). The pedagogical virtue of this situation is that the students (and I) had to struggle with the relevant ethical issues just as much as the health professionals and parents in this situation.

To recall the basic medical details of the case, Charlie Gard suffered from an extremely rare mitochondrial DNA depletion syndrome (infantile onset encephalomyopathy). This results in a gradual weakening of all the muscles in the body, including the lungs, which is why Charlie had his life sustained by a ventilator since October of 2016 (he had been born in early August). In addition, he suffered multiple seizures in late 2016, which resulted in massive brain damage. In early March of 2017, Charlie’s doctors recommended the removal of life-support and that he be allowed to die. Their judgment was that nothing more could be done that was in the best interest of Charlie. The brain damage and muscle damage were irreversible. That recommendation was instantly rejected by the parents. The parents had surfed the web in late 2016 and found Dr. Hirano at Columbia, whose primary area of research was mitochondrial depletion syndrome. He was prepared to offer an experimental treatment called nucleoside therapy, which had yielded some marginal benefit for children with a condition similar—but not genetically identical—to Charlie’s condition.

Readers are likely already aware that the dispute went all the way up to the UK’s highest court as well as the European Court of Human Rights. The courts all sided with the physicians and their judgment of what was in Charlie’s best interest. In the meantime, the parents created a GoFundMe account to pay the costs of taking Charlie to the U.S. for this experimental treatment. That fund accumulated $1.7 million. More importantly, petitions were circulated that gathered 350,000 signatures from individuals demanding that Charlie’s parents be allowed to take him to the U.S. for that experimental treatment.

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Image description: a photo of a blue sign with white lettering that reads “Welcome to Great Ormond Street Hospital Main Reception.” Image source: Tom Page/Flickr Creative Commons

In class, we discussed several major ethical issues generated by this case. Perhaps the central one pertained to the scope of parental authority to judge the best interests of their child in the face of medical judgment, and powerful medical evidence that supported the view that the physicians caring for Charlie had a better sense of his best interests. What the students saw in local news reports were desperate, anxious parents trying to save the life of their child. Further, these parents were up against a powerful and unyielding medical establishment that had given up in their efforts to save their child. (There is a bit of the David and Goliath narrative here.) Further, the State itself, through the courts, with all its coercive authority, had sided with the physicians and condemned their child to death. (I realize this might sound very melodramatic, but this is an accurate characterization of how it was publicly perceived by many who kept vigil outside the hospital. This characterization helps to explain the multiple death threats directed at various members of the medical staff at GOSH.)

In class, students who were sympathetic to the parents argued that the offer of an experimental treatment by Dr. Hirano represented a “last chance” therapy. This was the “only hope” that Charlie’s life could be saved. Surely, the students argued, no parent should be denied the right to pursue any medical intervention that might save the life of their child. I conceded that in these circumstances, wide scope should be given regarding parental judgment of what was in the best interest of their child, but that scope was not unlimited, and parental judgment could be askew for multiple possible reasons.

Some students seemed to think that if Charlie was doomed to die from his disorder, then there was nothing to lose from pursuing an experimental intervention. Other students noted that medical experiments can go very badly, and that Charlie could suffer seriously and unnecessarily as a result of bad science. I noted that there was no medical evidence at all to support Dr. Hirano’s suggestion that his intervention could offer reasonable hope of benefit for Charlie, though Hirano suggested at one point that there was a 16%-54% chance of some benefit. He based those numbers off his work with children with a similar condition, though “similar” in this case did not warrant the optimistic projection conveyed by Dr. Hirano.

An ethically relevant question to raise would be: “What was really in Charlie’s best interest?” The physicians caring for Charlie were concerned that the life-prolonging care they were then providing was itself causing unnecessary suffering, and hence, contrary to Charlie’s best interests. This, to my mind, was a medically disputable point. Profound brain damage had already occurred. The areas of the brain that would generate the phenomenon we would recognize as pain may have been inoperable. Further, there seemed to be no clinically visible manifestations of pain in Charlie. Perhaps he was beyond suffering. Consequently, the benefit-burden test that would typically be applied in this situation might not have been applicable. There were no benefits and there was no burden (maybe). Still, this might not be sufficient to justify yielding ultimate decisional authority to the parents, ethically speaking.

What we finally learned, once Dr. Hirano traveled to the UK, was that he had never reviewed any of the medical records, including CT and MRI scans, of Charlie’s brain while in the U.S., starting in March. He was in the UK only a matter of days in mid-July before he concluded that there was no hope for any sort of recovery for Charlie. In the meantime, he had generated the worst sort of false hope in the parents, not to mention the public passions that had been inflamed and that generated threats against the lives of those caring for Charlie. He had offered his initial judgments on the basis of no medical evidence whatsoever. Further, this was seized upon by Donald Trump for purposes of scoring points with his Right to Life constituency, though, it should be noted, Charlie Gard was not a citizen of the U.S., as would also be the case with Mexican children in the U.S. faced with life-threatening medical problems whose parents were not U.S. citizens. No record exists of Donald Trump making any passionate plea for the medical needs of those children. The following passage from the British press is worth noting: “Charlie Gard is now at peace but the agonies of his case were made far worse by a screaming U.S. right-wing media giving his parents false hope.”

In the final analysis, the Charlie Gard case should have been a private and painful misfortune. It became a political and moral tragedy when it was politicized. Dr. Hirano sought to explain his own behavior by saying that “the window of opportunity had closed,” thereby implying that at an earlier point in time his magical medical treatment might have worked. That statement represents the worst sort of self-serving disingenuousness imaginable. There was no tragedy there; it was just plain unethical.

Leonard Fleck photoLeonard M. Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Wednesday, August 16, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

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Incarcerated AND Sick: At Risk for Pain, Injury, and Death

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Karen Kelly-Blake, PhD

The U.S. project of mass incarceration reveals that more than 2 million people are jail-involved at any given time. That rate far exceeds that of any other nation in the world. Incarcerated patients are sicker, bearing an increased burden of chronic disease, namely addiction, viral infections, and mental illness. Conditions often exacerbated by solitary confinement. Moreover, those incarcerated are disproportionately from communities of color suffering from historical racial discrimination. Consider the following: Whites (non-Hispanic) comprise 64% of the U.S. population, 39% of the U.S. incarcerated population, and the national incarceration rate (per 100,000) is 450; Hispanics make up 16% of the U.S. population, 19% of incarcerated population, and the national rate is 831; Blacks are 13% of the U.S. population, 40% of the incarcerated population, and the national incarceration rate is 2,306 per 100,000.

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Image description: a black and white photograph showing a person’s hands reaching through from behind metal fencing. Their hands are grasping the fence in the foreground, and the rest of the person’s body is not visible. Image source: Tiago Pinheiro/Flickr Creative Commons

In the 1976 Estelle vs. Gamble ruling the U.S. Supreme Court established that “deliberate indifference to healthcare for inmates constituted cruel and unusual punishment, and was thus prohibited by the U.S. Constitution.” In April of this year, a class action lawsuit was filed in the State of Illinois arguing, “health care inside the Illinois Department of Corrections systematically puts inmates at risk of pain, injury, and death.” In effect, Illinois has been put on notice that the correctional health care it provides (or the lack of provision), violates the 1976 Supreme Court ruling. Of course, Illinois is not the only state faced with this problem. A recent ruling found the Alabama Department of Correction’s mental health care system to be “horrendously inadequate.”

The challenges to delivering health care in correctional institutions are similar to those experienced in delivering care in any under-resourced setting that serves vulnerable patients. Overcrowding and understaffing are oft-cited explanations for the inadequacy of correctional health care delivery. An additional, deeply concerning factor is the privatization of prisons with related underbids, cost overruns, and vast gaps in the actual services provided. With increasing numbers of women cycling in and out of prison, women prisoners have specific health needs related to the increased likelihood of being victims of domestic and sexual violence. There is a pressing need for correctional health care services to address these health issues.

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Image description: a close-up photo of the bars of a prison cell, with the bars in focus in the foreground and an empty green/yellow cell visible in the background. Image source: Dave Nakayama/Flickr Creative Commons

As a matter of justice, incarcerated patients should receive the same level of care that they would receive in a community setting. Unfortunately, this notion is not politically popular. Nevertheless, work is being done to merge correctional health and public health to ensure continuity of care once prisoners are released. Significantly, the Affordable Care Act (ACA) specifically addresses the importance of ensuring that the jail-involved have access to the same benefits as the non-incarcerated. The ACA expansion of Medicaid eligibility supplies a critical opportunity to treat prisoners once released. Untreated substance abuse and mental illness among the jail-involved increases their likelihood of future imprisonment.

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Image description: a close-up photo of part of a large metal door that reads “SOLITARY.” Image source: Shannon O’Toole/Flickr Creative Commons

Health care providers often find themselves serving two masters in correction settings. Providers have a duty to provide care that is in the best interest of the patient, but equally, they are also employed by the institution that has other, often conflicting interests, namely to confine, punish, and possibly, rehabilitate. This conflict is referred to as dual loyalty. The virtual societal silence on larger issues about the nature of the institution of incarceration is problematic and makes many correctional health providers “complicit as the United States has embarked on a vast and unprecedented social program of mass incarceration.” Given this state of affairs, providers should use their professional power and work to advocate for and insist upon substantial reforms in clinical care within prisons. A key critical reform is to eliminate solitary confinement. Medical providers also must advocate for change in the criminal justice system. The current project of mass incarceration in the U.S. harms the individual health of prisoners and the public health of the community.

Because of lawsuits or the threat of lawsuits on behalf of prisoners, as well as the dedication of committed health care professionals, activists, and advocates, the quality of health care in prisons has steadily improved. Yet there remains vast room for improvement in clinical care. Physicians hold leadership and management positions in correctional institutions. Combined with the social privilege afforded them in the U.S., physicians have the power, and I would argue the obligation, to spearhead reforms in correctional health care and ensure that the incarcerated sick are at no greater risk than the non-incarcerated of pain, injury, or death.

Karen Kelly-Blake photoKaren Kelly-Blake, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Medicine at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, August 10, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

More Bioethics in the News from Dr. Kelly-Blake: White Horse, White Faces: The Decriminalization of Heroin AddictionRacism and the Public’s Health: Whose Lives Matter?Concussion in the NFL: A Case for Shared Decision-Making?

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Dr. Fleck presents at International Bioethics Retreat in Paris

Leonard Fleck photoCenter Professor Dr. Leonard Fleck recently traveled to Paris to attend and present at the International Bioethics Retreat, held June 26-28.

Dr. Fleck chaired a session titled “Rights, Responsibilities, and Justice.” He also presented the talk “Last Chance Therapies: LVADs AND a Heart Transplant?” Dr. Fleck has provided the summary below of his talk.

In a recent review article [Journal of the American College of Cardiology 2015; 65: 2542-55] the authors assessed expanded dissemination of left ventricular assist devices [LVADs], used in late stage heart failure. About 650,000 Americans experience heart failure annually. About 5.8 million Americans are in some stage of heart failure now with 300,000 deaths annually. A heart transplant would yield more than ten extra years of life for at least half these patients, but only 2300 hearts are available for transplant annually. LVADs are now offered either as Destination Therapy [DT] or as a Bridge to Transplant [BTT]. The ethically troubling proposal suggested by these authors is that individuals in late-stage heart failure [Stage IV] in the future should first be given an LVAD; then, if complications develop, they should be a candidate for a heart transplant. This is, in fact, what was done for former Vice-President, Dick Cheney, who had suffered five heart attacks, starting at age 37. Prior to his LVAD and heart transplant at age 71 he had had bypass surgery, several stents, an implantable cardiac defibrillator, a pacemaker, and numerous cardiac drugs.

What I argued in this presentation is that the proposal in the journal article above is deeply flawed from the perspectives of fairness and health care justice. From a utilitarian perspective more life-years of higher quality would be lost rather than gained because patients needing a heart transplant after LVAD complications have poorer prospects. From an egalitarian perspective only patients with excellent insurance would be able to afford this option, which would likely have overall costs of the two transplants of almost a million dollars. As things are now, fairness is undermined when some patients get both BTT and a heart transplant, two shots at prolonged life at the expense of someone else on the transplant list. This is what happened in the case of Dick Cheney. Some relatively younger individual (who for medical reasons might not have had the LVAD option) died prematurely, having access to neither an LVAD nor a heart transplant, while Cheney had two chances for life prolongation.

I concluded the presentation with a proposal for an ethically preferable alternative. (1) Individuals below age 70 with some form of heart failure could choose either the LVAD as DT or be placed on the transplant list. They could not choose both. If they choose the transplant list, they are rolling the dice. A good match might not be available before they die. If they choose the LVAD, 30% of those patients will die within a year, and 40% will gain 4 extra years of life, though of somewhat diminished quality. The serious complication rate for the LVAD is 70% (stroke, intestinal infections, device failure). (2) Some patients are in experimental protocols with a totally implantable artificial heart. If that device fails, they are immediately moved to the transplant list with top level urgency. They too would have to choose one way or the other. (3) Some patients (often younger) have life-threatening cardiac conditions that cannot benefit from an LVAD. They need to go the transplant list. They should not have to compete for a transplant with individuals who have already had an LVAD. It is essentially unfair that some individuals would get two chances for life prolongation while others would get none.

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Drs. Eijkholt and Cabrera published in ‘Neuromodulation: Technology at the Neural Interface’

Marleen Eijkholt photoLaura Cabrera photoCenter Assistant Professor Dr. Marleen Eijkholt and Assistant Professor Dr. Laura Cabrera are co-authors of a new article in Neuromodulation: Technology at the Neural Interface. The article, “Shaking Up the Debate: Ensuring the Ethical Use of DBS Intervention Criteria for Mid-Stage Parkinson’s Patients,” was written by Dr. Eijkholt, Dr. Cabrera, Adolfo Ramirez-Zamora, MD (University of Florida), and Julie G. Pilitsis MD, PhD (Albany Medical Center).

Abstract
Objectives
Deep brain stimulation (DBS) is a well-established treatment for the management of severe motor fluctuations in advanced Parkinson’s disease (PD). Until recently, device regulation, medical, and insurance practices limited DBS to patients with advanced stages of PD. In February 2016 this changed, however, when the US Food and Drug Administration (FDA) granted formal approval for the use of brain stimulator in mid-stage PD patients. In this article, we examine whether DBS in mid-stage PD can be ethically justified beyond the FDA approval.

Materials and Methods
We scrutinize the current risk-benefit profile, the costs-benefit profile, and the capacity for informed consent requirement, to ask if use of subthalamic nucleus (STN) in mid-stage DBS is ethically appropriate.

Results
We propose that mid-stage DBS decisions could be appropriate under a shared decision-making model, which embraces a broad quality of life perspective.

Conclusion
Although it might be too premature to know how the FDA decision will affect medical and insurance practices, we conclude by arguing that revisions to persisting guidelines seems justified both on scientific and ethical grounds.

The full text is available through Wiley Online Library (MSU Library or other institutional access may be required to view this article).

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Dr. Fleck published in new ‘Ethics, Medicine and Public Health’ issue

Leonard Fleck photoCenter Professor Dr. Leonard Fleck has a new article in Ethics, Medicine and Public Health. Dr. Fleck’s article, “Just caring: Do we need philosophical foundations?,” appears in the April-June 2017 issue.

Abstract
The “Just Caring” problem asks: What does it mean to be a “just” and “caring” society when we have only limited resources (money) to meet virtually unlimited health care needs (linked to novel emerging medical technologies)? The practical implication of the “Just Caring” problem is that the need for health care rationing is inescapable. That means that some health care needs will not be met, even though those needs have moral weight, because meeting such needs is presumptively a matter of justice. How then can such rationing decisions be made justly or fairly? And who should have responsibility for making such decisions? Should such decision-making be the responsibility of legislative bodies, or administrators of health care institutions, or associations of physicians, or private insurers (in the United States), or employers (in the United States)? What should be the role of philosophers in addressing the problem of just health care rationing? After all, philosophers are supposed to be the experts when it comes to theories of justice. And, if philosophers are supposed to have such a role, are their judgments of health care justice going to be justified by appeal to ethical foundations of some sort? In this essay, I start by conceding that philosophers have had much to say about how we ought to conceptualize our understanding of the notion of justice. But the world has become enormously more complicated since Plato and Aristotle offered their reflections on justice. The same is true for Hume and Kant. Those perspectives seem remote and unhelpful about the problem of just health care rationing. The same would seem to be true about Rawls (1971) and Nozick (1974). Their theories of justice are simply too broad and too abstract to address the complex, heterogeneous problems of just health care rationing in the real world of health care we have today (though, as I show later, Rawls does have much to offer regarding the notion of public reason).1 In the first part of this essay I sketch out several concrete problems of health care rationing having to do with the allocation of targeted cancer therapies, drugs used to treat patients at risk for heart disease, drugs used to treat HIV+ patients, and drugs used to treat very rare diseases. This provides helpful context for the remainder of the essay. In the second part of this essay I argue that traditional theories of justice have only a limited role to play in addressing these problems of health care rationing. This is because no perfectly just answer can be given for the vast majority of real world problems of health care justice. Instead, what we need to settle for are non-ideal resolutions of these problems. Ultimately, I would defend a pluralistic conception of health care justice, which is another reason why we need to settle for non-ideal resolutions. Those non-ideal resolutions will have to emerge from broad, inclusive, fair processes of rational democratic deliberation. Those deliberations will be aimed at achieving a reflective balance of competing considerations of health care justice with respect to a very specific problem of health care rationing. In the third part of this essay, I argue that the role of philosophers is to protect the integrity of this public deliberative process, as opposed to seeking ethical foundations for their judgments of health care justice. This, I argue, entails three responsibilities for philosophers. First, these public deliberations need what we might call “just boundaries”. Those boundaries are defined by what I refer to as “constitutional principles of health care justice”. The role of philosophers is to articulate those constitutional principles and what counts as a reasonable balance among those principles as they are applied to specific problems of just health care rationing. Second, the role of philosophers is to articulate a specific understanding of “public reason”, which would govern those democratic deliberations. Here I have in mind the work of Rawls and his notions of “the rational” and “the reasonable” (Rawls, 1993). Third, philosophers have their traditional Socratic role of being thoughtful critics of the outcomes of these public deliberations, mindful of the fact that most outcomes will be non-ideally just. That is, philosophers must distinguish outcomes that are non-ideally “just enough” from those that are not “just enough”. Ultimately, the role of philosophers is not to construct or discover just foundations for these deliberative processes but to protect the fairness and integrity of the deliberative process itself.

The full text is available on the ScienceDirect website (MSU Library or other institutional access may be required to view this article).

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Dr. Cabrera presents at two international conferences in June

cabrera-crop-2015Center Assistant Professor Dr. Laura Cabrera recently traveled to Denmark and Germany, where she presented at two international conferences.

WCBP Photo

Photo from the 13th World Congress of Biological Psychiatry, courtesy of Dr. Cabrera.

The 13th World Congress of Biological Psychiatry was held June 18-22 in Copenhagen, Denmark. The World Federation of Societies of Biological Psychiatry (WFSBP) organizes the congress each year in a different location around the world. Dr. Cabrera presented a poster, “Psychiatric Deep Brain Stimulation: Recurrent and Neglected Ethical Issues,” which touched on key findings from her S3 grant. The conference included talks on biomarkers for psychiatric disorders, the use of electroconvulsive therapy and the use of ketamine. There were not many talks discussing deep brain stimulation, however, there was a very interesting debate about deep brain stimulation between Dr. Marwan Hariz and Dr. Thomas Schlapfer, regarding whether it is a worthwhile treatment method in psychiatry.

WSSFN Photo

Photo from the 17th Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery, courtesy of Dr. Cabrera.

The 17th Quadrennial Meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) was held June 26-29 in Berlin, Germany. This year’s theme was “Emerging Techniques and Indications.” Dr. Cabrera attended the meeting and presented a flash talk entitled “The Re-emergence of Psychiatric Neurosurgery: A Cross-National Comparison of Media Coverage.” The event included a pre-meeting workshop on “surgery for psychiatric disorders” as well as very interesting talks covering the history of stereotactic and functional neurosurgery, results from clinical trials around the world, and several techniques, including deep brain stimulation, vagal nerve stimulation, radiosurgery, and focused ultrasound, to name a few.

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Dr. Cabrera a co-author of new article in ‘Journal of Alzheimer’s Disease’

Laura Cabrera photoA new article from Center Assistant Professor Dr. Laura Cabrera and co-authors has been published in the Journal of Alzheimer’s Disease. The article, “Alzheimer’s Disease in the Latino Community: Intersection of Genetics and Social Determinants of Health,” was co-authored by Irving E.Vega, Laura Y. Cabrera, Cassandra M. Wygant, Daniel Velez-Ortiz, and Scott E. Counts.
Abstract
Alzheimer’s disease (AD) is the most common type of dementia among individuals 65 or older. There are more than 5 million diagnosed cases in the US alone and this number is expected to triple by 2050. Therefore, AD has reached epidemic proportions with significant socioeconomic implications. While aging in general is the greatest risk factor for AD, several additional demographic factors that have contributed to the rise in AD in the US are under study. One such factor is associated with the relatively fast growth of the Latino population. Several reports indicate that AD is more prevalent among blacks and Latinos. However, the reason for AD disparity among different ethnic groups is still poorly understood and highly controversial. The Latino population is composed of different groups based on nationality, namely South and Central America, Mexico, and Caribbean Hispanics. This diversity among the Latino population represents an additional challenge since there are distinct characteristics associated with AD and comorbidities. In this review, we aim to bring attention to the intersection between social determinants of health and genetic factors associated with AD within the Latino community. We argue that understanding the interplay between identified social determinants of health, co-morbidities, and genetic factors could lead to community empowerment and inclusiveness in research and healthcare services, contributing to improved diagnosis and treatment of AD patients. Lastly, we propose that inserting a neuroethics perspective could help understand key challenges that influence healthcare disparities and contribute to increased risk of AD among Latinos.

The full text is available on the IOS Press website (MSU Library or other institutional access may be required to view this article).

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