“Philosophy and ethics in the frontiers of brain science”

“With large scale international programs entering new phases, upcoming meetings and a growing debate, new discoveries in brain science always keep fostering ethical and social questions. Philosophy matters, in this field more than in any other, because it reminds us that science sometimes is not only obtaining new facts, but also engaging new ways of thinking about them.”

New Post from Dr. James Giordano on BioMed Central Blog.

Emerging Biotechnology in Genomics: An Advancing Field, Still Fraught with Questions

BY KEVIN T. FITZGERALD, SJ, PhD, SAMANTHA (SAM) WU, BS, and Fr. CHARLES BOUCHARD, OP

 

In February 2016, it was reported that the Human Fertilization and Embryology Authority (HFEA) granted limited permission for researchers in the UK to genetically modify human embryos, with the hope of elucidating which genes are necessary for successful embryological development. Although Dr. Kathy Niakan and her team at the Francis Crick Institute are only allowed to use the embryos for 14 days, and may not implant a modified embryo in the womb, this permission crossed a frontier in genetic research. It was the first time human embryonic genetic modification had been authorized. This followed the publication of the controversial paper by Liang, et al. (2015) that detailed the researchers’ attempt to modify genes that cause β-thalassaemia in non-viable human embryos using the gene-editing technique, CRISPR. The paper, published in April 2015, kicked off a heated ethical debate.

Now, Frederik Lanner at the Karolinska Institute in Sweden, who got the go-ahead on a project that will also involve gene editing in human embryos, is making preparations to begin those experiments. Earlier this month, it was also reported that another team in China, led by Yong Fan, attempted to use CRISPR to generate HIV-resistant human embryos via the introduction of precise genetic modifications. While this project involved non-viable embryos, much like the research conducted by Liang, et al., “the purpose of this study was to evaluate the technology and establish principles for the introduction of precise genetic modifications in early human embryos.” The ethics committee of Guangzhou Medical University in China approved Fan’s work, and has reported that it has since approved two more similar projects.

The rapid rate of investment of both time and money in new projects involving gene editing and CRISPR makes it clear why the novel gene-editing technique was named Science’s “2015 Breakthrough of the Year.” Indeed, the technique and the research it facilitates have the potential to lead not only to treatments, but also to the elimination of some genetic mutations from the human genome altogether. Other novel biotechnologies, such as next-generation sequencing (NGS), have contributed to the revolution in gene-editing, making sequencing of the genome faster and cheaper than ever before. Clearly, these new technologies are altering, and will alter, medicine in ways that were science fiction only a few years ago.

Scientists have hailed the advancement of these projects with enthusiasm, convinced that the recent approval of the human embryo gene-editing research by funding agencies and IRBs is indicative of wider societal approval. Lanner, for instance, is hopeful that his work will be received with more optimism and less heated debate than the paper by Liang, et al. published just a year ago. At the same time, it is worth nothing that many of the ethical and practical questions, which made and continue to make the genome-editing debate controversial, remain unanswered:

Who should guide the potential impacts of these developments in clinical practice and in broader society?  What applications are ethically permissible?  Who will own these new technologies and the information resultant from their use? How should we regulate and oversee the technology in a way that such advances in science are not prioritized at the expense of public health or to the disadvantage of the poor or marginalized? 

We argue that experts in research, medicine, industry, and policy currently dominate and guide the conversation about R&D and regulation of gene-editing technology – leaving it up to the “experts” to answer the aforementioned questions of ethical and practical importance. But one might also ask, do the “experts” have the appropriate knowledge to know what is in the public’s best interest? What is the “appropriate” or relevant knowledge to make such a judgment? Are we moving forward with these projects because we have answered those questions?

CRISPR, NGS, and many other biotechnologies are all pieces of the broader discussion regarding what the future of science, medicine, and society will look like.  The outcomes of such a discussion may affect our conceptualizations of “disease” and what it means to be a “normal” human being – things that impact every human in society, not just a gathering of experts from a particular social stratum. By restricting the debate to only the “experts” or those who have a vested interest in the technology, society risks maintaining the status quo, or worse, exacerbating existing socioeconomic and health inequalities that disproportionately affect marginalized communities.

 

gene editing

 

Recent Attempts at “Public Engagement”

Many scientists and policymakers have recognized that we are at a pivotal moment in research and health care.  They acknowledge the benefits of collaboration and communication in the effort to achieve improved health.  The FDA, for instance, launched precisionFDA, an online portal that enables “scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind…[NGS].”

With CRISPR, the international research community was prompted by growing ethical concerns to host the International Summit on Human Gene Editing in Washington, DC in December 2015.  The summit brought together experts from across disciplines and continents charged with the task of discussing the “scientific, ethical, and governance issues” central to the debate on human gene-editing research. That the scientific community organized the conference suggests that it recognizes the need to incorporate a variety of perspectives in the debate. But, recognition alone is insufficient to ensure that such diverse interests are represented in the resulting policy recommendations.

At the conclusion of the summit, Chair of the Organizing Committee, David Baltimore, proposed guidelines for regulating human gene-editing research. The guidelines, however, were crafted to reflect the perspectives of scientists and academics, along with a few members of the general public who were invited and present. The guidelines lacked input from other public groups for whom human genome editing could have many implications. Unfortunately, the inadequate model of “public engagement” employed at the Summit is actually quite common across science policy issues.

Dr. Ruha Benjamin, Princeton University professor and author of People’s Science: Bodies & Rights on the Stem Cell Frontier, notes that the processes currently used to gauge public opinion on new scientific developments often create only an “illusion of opening up the science.” Institutions acknowledge, to some degree, the importance of gauging public interests and goals when it comes to scientific progress. The list of terms and mechanisms used in an attempt to determine such interests and goals is long: “public conferences,” “public meeting,” “public comment period, “public forum,” “public engagement,” and so on. Closer inspection of these mechanisms and their outcomes reveal several issues with the scientific community’s current “public engagement” efforts: 1) there is a lack of evidence and consensus to suggest which mechanism is most appropriate and when, 2) the public’s diversity of values and goals are underrepresented by a handful of public representatives, often selected by the host organization themselves, 3) differences are often resolved with more “expert” or “technical” information, rather than deeper discussion of differences in values or goals (expert knowledge is prioritized over lay knowledge), 4) the mechanism’s design provides the public with insufficient leverage to effect change in research or policy development, and 5) more often than not, there are insufficient evaluation measures in place to reinforce accountability. While these mechanisms have the potential to inform and engage the public in policy discussions that bear directly on the common good, these obstacles often lead them to fall short and leave voices unheard.

Our ethical tradition of fostering the common good says we need broader discussions that go beyond the one-way discussion that focuses on informing the public to foster “public acceptance” — beyond this “illusion of opening up the science.” We need deliberative, two-way discussions that make values and goals explicit, and that actively involve the public as community members and participants in research, clinical practice and decision-making. With genome editing, it is imperative that these discussions happen now before boundaries are crossed, even inadvertently, that cause harm to many people which cannot be readily remedied.

Moving forward, we suggest that academic institutions – increasingly home to interdisciplinary efforts and collaborations – make a much greater effort to research and design processes that engage public stakeholders in the discussion around genome editing and, more broadly, emerging biotechnologies. Several organizations have already implemented biomedical research tools and platforms created with participant preferences, values, and communities in mind that can serve as a good starting point. We also call for greater collaboration between natural science and social science researchers, which will increase our understanding of the assumptions and factors that influence policy-making and inform the design of mechanisms intended to generate a more open, deliberative public dialogue.

Sustained public engagement is essential to ensuring that science and medicine’s advancements continue to address broad public needs, and not only those of the few. Indeed, there have been calls for greater public involvement in the genome-editing debate. Despite these calls, however, the field continues to proceed with controversial experiments while ethical and practical questions remain unanswered, with scientists presuming that IRB approval of their controversial projects means that the public is becoming more accepting with “the passage of time.” It is, thus, time to increase our efforts to “open up” the science, not just to the experts, but also to those whose lives will be impacted and whose voices have yet to be heard.

 

ABOUT THE AUTHORS

Fr. Kevin FitzGerald, S.J., is research associate professor and Samantha (Sam) Wu, B.S., is a research associate at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center; Fr. Charles Bouchard, O.P., is Senior Director, Theology and Ethics, at the Catholic Health Association of the United States.

Guiding the Tide of Neurotechnology: Coordinating the Currents of Sea-Change

BY JAMES GIORDANO, PhD

 

Recently, the Food and Drug Administration (FDA) solicited input to guide ways that the agency regards and handles “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes”, in accordance with good practices regulation (21 CFR 10.115). The FDA will use this draft guidance to “…assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes”, and “… aid industry and FDA staff in considering the benefits and risks of medical devices that target … the cause or progression of neurological disorders or conditions” (such as movement disorders, like Parkinson’s disease and dystonia; as well as other pathologies, like Alzheimer’s dementia, Tourette’s syndrome, chronic pain, and psychiatric conditions such as depression).

The goal of the FDA regulation process is to establish that drugs and devices provided for medical care are safe and technically sound and the general constructs of Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) are aligned with such aims. But like any policies that tend to entail broad concepts, the real-world utility, viability and value of these programs are contingent upon: (1) the relative appropriateness to the context(s) in which any device is employed; and (2) if and how use-in practice reflects and is supported by the scope of regulatory oversight and control.

In recent years, IDE and HDE application, review and approval has become easier and more efficient; this is a notable improvement – and a step in the right direction. However, it may be that aspects of the overall structure and certain specifics of the IDE and HDE are not well suited to meet the contingencies (and exigencies) of actual clinical use of certain neurotechnologies, like deep brain stimulation (DBS).   For example, the current regulatory framework necessitates filing and securing an IDE as a first step in investigator-initiated research (IIR) and/or other off-label use of DBS in those cases where other approaches have been shown to be ineffective or untenable, and for which DBS may prove to be viable as “humanitarian care”. In such instances, it may be that the proverbial cart precedes the horse, and the HDE might be more practical and valuable given both the nature of the disorder and treatment, and the value of the HDE in establishing a basis for further (and/or expanded) application, as supportable by an IDE.

Moreover, while both IDE and HDE establish parameters for using DBS in practice, neither regulatory mechanism creates or enforces a basis for provision of economic support necessary for right and good use-in-practice. As our recent work has demonstrated, non-payment of insurance costs for pre-certified DBS interventions has been, and remains a problem of considerable concern. Absent the resources to provide: 1) DBS as a demonstrably-important or necessary treatment option for those patients with conditions that are non-responsive to, or not candidate for other therapeutic options , and 2) continuity of clinical services as required, the sustainability of this neurotechnology may become questionable (Rossi, Okun, and Giordano, 2014). This is contrary and counter-productive to recent federal incentives to maximize benefits of translating extant and new neurotechnologies into clinically-relevant and affordable care, and to implementing precision medicine . This was the focus of much discussion at the fourth National Deep Brain Stimulation ThinkTank held last month in Gainesville, FL.

In the main, actions taken by the FDA to streamline the IDE and HDE process should be applauded. Yet, while certain aspects of the IDE and HDE mechanisms may be in order and valuable for regulating use of DBS, others may require re-examination, revision, or replacement, so as to remain apace with the rising tide of developments in the field, and needs and necessities of patients and clinicians in practice. In this vein, we recommend further study of IDE and HDE mechanisms to determine what works, what doesn’t, and what can – and should – be done to both improve these practices. It is our hope that doing this will fortify regulatory, policy and legal processes to ensure that they are aligned with, directive toward, and supportive of concomitant changes in standard of care guidelines and federal insurance structure.

Important to this endeavor would be both the development of a governmental-commercial enterprise to guide industrial efforts in neurotechnology (e.g.- a National Neurotechnology Initiative; NNTI), as well as the establishment and enactment of federal laws (e.g.- a neurological information non-discrimination act; NINA) to govern potential use(s) of information obtained through DBS and related neurotechnologies that are elements of novel big data initiatives. This might be something of a sea-change, and effecting such change will demand that the constituent currents flow in the same direction. If programs such as the BRAIN initiative and agendas of precision medicine and big data are to function as a “translational estate”, and work in ways that enable technically apt and ethically sound patient care, then what is needed is coordination of the institutions, organizations, resources and activities involved. Without doubt, this will entail considerable effort, which might make waves in the status quo; but we believe that it represents a worthwhile endeavor to achieve genuine and durable progress in the development and – right and good – use of neurotechnology in clinical practice.

 

ABOUT THE AUTHOR

James Giordano, PhD Adjunct Professor Director, Neuroethics Studies    James Giordano, PhD

James Giordano, PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.


 

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Bioethics and Fetal Tissue Hearing

BY G KEVIN DONOVAN, MD, MA

On March 2, 2016, Dr. G Kevin Donovan testified at the “Bioethics and Fetal Tissue” hearing before the Select Investigative Panel of the Committee on Energy and Commerce of the US House of Representatives. Dr. Donovan was one of six witnesses to present testimony.

 

Chairman Blackburn, and members of the panel, I thank you for the opportunity to present testimony regarding the bioethical considerations in the harvesting, transfer, and use of fetal tissues and organs.

I am a physician trained in both pediatrics and clinical bioethics. I have spent my entire professional career caring for infants and children. It was this interest and concern that led me to further study in bioethics, because I have always been concerned about the most vulnerable patients, those who need others to speak up for them, both at the beginning and at the end-of-life. I also have significant familiarity with research ethics, having spent 17 years as the chair of the IRB, a board that monitors the rightness and the wrongness of medical research in order to protect human subjects. We took this aspect of our duties so seriously that I renamed our IRB the Institutional Research Ethics Board. Four years ago, I was called by my mentor, Dr. Edmund Pellegrino, to take his place as director of the Center for Clinical Bioethics at Georgetown University. Our duties include ethics education for medical students and resident physicians, ethics consultation for patients and doctors at the hospital, as well as the promulgation of scholarly papers and public speaking. We focus on both clinical ethics, that which directly involves the good of patients, as well as addressing normative questions, those which involve right and wrong actions.

This is what we want young physicians to know: medicine is a moral enterprise. Our actions have consequences that can be good or bad for patients, and we must always focus on the patient’s good and avoid doing harm. So what does this mean for the topic at hand? We’re talking about bioethics and the fetus. In order to make any moral judgments, we would have to be clear on the moral status of the fetus. Obviously, this is an area in which society has not reached a consensus, but that does not mean we cannot make sound judgments on the topic. In a question of biomedical ethics, it is good to start with solid science. What do we know about the fetus with certainty? Well, first of all we know that it is alive, that it represents growing, developing, cells, tissues, and organs, all of which develop increasing complexity and biologic sophistication, resulting in an intact organism, a human baby. Of course, this growth and development does not cease with the production of the baby, but continues for many years afterwards. As can be seen by this description, the fetus is not only alive, but is demonstrably human. I’m not talking about a “potential human” in the way that some parents talk about their teenagers as potential adults. I am referring to the scientific fact that a fetus constitutes a live human, typically 46XX or 46XY, fully and genetically human. In fact, it is the irrefutable humanness of these tissues and organs that have made them be of interest to researchers and scientists.

So, if a fetus is clearly both alive and human, can we justify taking these tissues and organs for scientific experimentation? If so, under what circumstances, and what sort of consent or authorization should be required? In the past century, medicine has made incredible progress resulting from scientific studies involving human tissues and organs, resulting in the development of medications, vaccines, and the entire field of transplantation medicine. Is there any difference between these accomplishments and those that would require the harvesting of bod parts and tissues from the fetus? First, we would have to admit that not all scientific experimentation has been praiseworthy. Studies done by Dr. Mengele in Germany, and by American researchers in Guatemala and Tuskegee, we morally abhorrent, and any knowledge gleaned from these would be severely tainted. No one would want to associate our current scientific studies involving the human fetus with such egregious breaches of research ethics. All that it takes to avoid such a comparison is a consensus on the moral status of the fetus.

Those who have proceeded with experimentation and research on embryonic and fetal cells, tissues, and organs typically have obtained them as the result of an abortion. It is this stark fact that makes such scientific endeavors controversial, because they have proceeded without the aforementioned consensus on the moral status of the fetus. Because we know that the fetus is alive, and human, we must find some explanation for why it should not be treated with the same dignity that we accord all other human lives. The most frequent argument offered is that, although it is a human life, it is not a human person. Various criteria are offered for a definition of personhood, but none have been found universally acceptable. We thus have a standoff between those who would protect this early vulnerable human life and those that would deny that it deserves protection. In order to resolve such an ethical dilemma, the guiding principle is this: one is morally permitted to take such a life once you can demonstrate with moral certainty that the life is not human. It is a concept that can be exemplified by the situation faced by a hunter when he sees a bush shaking. He may sincerely believe that it is a deer in the bush, but if he kills it prior to determining with certainty what it is that he is killing, he will be morally responsible (as well as legally) if he has in fact killed the farmer’s cow, or worse yet, the farmer. As we can see, two deeply held, but opposing viewpoints need not be resolved unless someone intends to act upon them. Then, the one who intends to take the action resulting in the death of the disputed entity must not do so unless they can first show with moral certainty that their perception of its moral worth is irrefutable. Those who would not disturb the normal progression of its life bear no such burden. It’s my contention that such proof does not exist, and deliberate fetal destruction for scientific purposes should not proceed until it does.

Moreover, without disputing the arguable necessity of research on fetal tissue, I would also point out that harvesting it n such a way is unnecessary. Not only do cell lines already exist that were produced in such a fashion, but new cell lines could be obtained from fetal tissues harvested from spontaneous miscarriages. This is not a theoretical alternative. Georgetown University has a professor who has patented a method of isolating, processing, and cryopreserving fetal cells from second trimester (16-20 week gestation) miscarriages. These have already been obtained and are stored in Georgetown freezers.

Moreover, the present practices of obtaining fetal tissues and organs would seem to go against the procedures that have been approved for others who harvest tissues and organs donated for transplantation. First, we follow a strict rule, the dead donor rule. It states that vital unpaired organs cannot be obtained unless the donor has died a natural death. This obviously is not the case in an induced abortion. Moreover, such tissues or organs cannot be harvested without consent of the patient or their proper surrogate. In pediatrics, parents are considered the normal proper surrogate. However, this interpretation rests on the presumption that the parent is acting in the best interests of the individual. It is difficult to sustain such an interpretation when it is the same parent who has just consented to the abortive destruction of the individual from whom those tissues and organs would be obtained.

We are at a difficult time in our nation’s history. We demonstrate much moral ambiguity in our approach to the human fetus. We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home. Language has consequences, but it can also reflect our conflicts. We are a nation justly proud of the progress and achievements of our biomedical research, but lifesaving research cannot and should not require the destruction of life for it to go forward. If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction. Alternatives clearly exist that are less controversial, and moral arguments exist that support our natural abhorrence at the trafficking of human fetal parts. Surely we can, and surely we must, find a better way.

 


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.


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Testimony at Hearing on Maryland Physician-Assisted Suicide Bill

BY G KEVIN DONOVAN, MD, MA

Written testimony from Dr. G Kevin Donovan at a joint hearing of the House Health & Government Operations Committee and the Judiciary Committee of Maryland on February 19, 2016, regarding the proposed end-of-life bill.

 

Thank you for the opportunity to address this proposed legislation. I am Dr. Kevin Donovan, a physician, and the director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical School. Much of my work in the hospital setting involves consultation on patients who are nearing the end of their lives, so I have a real interest in this bill.

You will hear from others about the problems that have arisen in identical bills. You will hear about the dangers it can cause to patients, particularly the disabled or chronically ill, to the medical profession, and society at large. So I will not tell you about these things. I will tell you that I oppose this bill for two reasons: it is discriminatory, not progressive, but it is deceitful.

Okay, what are we talking about? Aren’t progressive people in favor of this bill? Perhaps some are, but if they look deeply into it, they shouldn’t be. Years ago, Sen. Hubert Humphrey said the real worth of any society can be found in the way that it cares for its most vulnerable members. That would be progressive, but we live in a society that increasingly worships autonomy, freedom, and productivity, and pushes those that don’t fit the picture to the margins. Therefore, it should come as no surprise that marginalized people, the poor, blacks, Latinos, and virtually every disability rights group are afraid of this bill. It creates by law a class of people whose lives no longer should be preserved. Of course, creating separate classes of people is discriminatory, but isn’t that what the supporters of this bill want? Yes, and we should look and see who are the supporters of this bill. It is favored by the same classes of people that have taken advantage of it in places like Oregon. Who’s the typical proponent, and patient? As published statistics show, the typical patient is a white male, usually with cancer, educated and financially comfortable. This is someone who is used to thinking that they are in control, and want to maintain the illusion of control near the end their lives. And make no mistake – the data from the Oregon health department makes it clear that this is not an issue of avoiding pain. The stated reasons for seeking a fatal prescription are primarily loss of autonomy, loss of ability to engage in enjoyable activities, or fear of being a burden to others. Pain is low on the list, because with good palliative care, pain is controllable. We’ve just described legislation that would favor the white elite, not the sort of thing that progressives usually want to get behind. And as one commentator asked, “Is anyone ashamed that we live in a culture where people believe that if they aren’t autonomous, or might be a burden on others, that they should ingest drugs and die?” I would think that Maryland should be ashamed of promoting assisted suicide for patients before palliative care is universally available?

Okay, if this bill is discriminatory not progressive, why should it be seen as deceitful? First of all, our antenna should always go up when people start using euphemisms. What started out as a movement for physician assisted suicide became physician assisted death, and now just wants to be thought of as death with dignity. Really? This can’t be the only path to dignity, and it clearly is suicide that we’re talking about. After all, the Center for Disease Control defines suicide as, and I quote “Death caused by self-directed injurious behavior with an intent to die.” What we’re talking about in this bill is clearly suicide, whether or not we’re allowed to put that on the death certificate, and by the way suicide is already legal. And when we talk about the protections in this bill, we’re not being entirely forthright either. The ones who are really being protected are the physicians, once again, members of the power elite. We may say we are placing restrictions for the patients involved, but that’s not entirely true, because they’re not entirely coherent. After all, once we redefine supporting or encouraging a patient’s death as a good thing, how can we defend limiting that benefit, that good thing, to only those who will be dead in six months? Why not 12 months? Why only terminal illness – why not suffering from chronic disease? Why only assisted suicide? What if the patient can’t lift the toxic mixture to their lips – shouldn’t someone else be able to give them a lethal dose? Shouldn’t we be willing to end the suffering in this way, even if you’re under 18, even if you’re only a child? Proponents will say that this is not what the bill says, nor what they intend, but this is the natural, logical, and really inevitable result of this redefinition of death as a medical treatment. In fact, this has already happened in Belgium and the Netherlands, countries that have been doing this longer than we have.

Finally, this brings us to an area which make legislators truly sit up and take notice: it is just not good public policy. Suggesting that suicide or euthanasia, are legitimate tools of the state is frightening. Throughout history, we have learned that granting the state legal authority to kill innocent individuals has had dreadful consequences. In Maryland, if you are convicted murderer and in no way innocent, you would be protected from the killing power of the state. Why would we want to turn that power to kill on our patients with their physicians help? A Dutch cardiologist, who has experience with this in his own country, recently stated, “the fundamental question about this is whether it is a libertarian movement for human freedom and the right of choice, or an aggressive drive to exterminate the weak, the old, and the different – this question can now be answered. It is both.“ I have no doubt that some patients with great independence will choose an early death at the end of their lives. They should not be judged, they should never be prosecuted for the attempt. As a society, we should be offering patients loving support until the very end. We shouldn’t change the law in a way that might encourage their deaths, we shouldn’t take their hands and lead them towards that, and certainly shouldn’t make them feel that they are being subtly pushed into it. The sick, the vulnerable, the suffering and dying deserve so much better, and a truly caring society will provide them with no less.

 

Addendum:

” On March 4, the bill SB 418 was withdrawn by its sponsor Senator Ron Young for lack of supporting votes, killing it for the legislative year.”


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.


 

 

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The Child in Pain, BRAIN, and Neuroethical Issues in Pediatric Pain Research and Care

BY JAMES GIORDANO, PhD

A February 4, 2016 editorial in the Boston Globe addressed the recent Food and Drug Administration (FDA) approval of the opiate analgesic oxycodone (brand named OxyContin) for use in children. This has raised concerns about the relative safety and possible effects of such compounds, as well as the roles of industry and federal government in establishing guidelines and policies for the use of drugs – or any medical intervention. Pediatric pain can incur a host of lifelong neuro-biopsychosocial effects. Moreover, pediatric pain care is complicated by practical and legal issues of long-term and often escalated dosing of opioids, and there is a paucity of safety data and information about potential long-terms risks to the developing brain associated with commonly used analgesics in this fragile population.

Both the dictates of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and invocations of the Presidential Commission for the Study of Bioethical Issues speak to the imperative to translate brain research into viable clinical uses. In light of this, it becomes important to ask if and how novel neurotechnologies can meet the challenges and opportunities of assessing and treating pediatric pain. Research to date has shown promise: For example, neuroimaging studies have sought to identify and establish brain phenotypes for pain. As well, neurogenomics and proteomics may afford an understanding of pediatric pain syndromes and sensitivities to various pharmacotherapeutics. Such studies support the capability and potential clinical utility of neurotechnologically-based assessments. Interventional neuroscientific and neurotechnological techniques, including transcranial and in-dwelling approaches to neuromodulation (such as transcranial magnetic and electrical stimulation, (Moreno-Duarte, et al.; Moisset, et al.; Avery, et al.; Fagerlund, et al.) and forms of deep brain stimulation) (Russo, et al.; Gosset, et al.; Boccard, et al.), and highly specific analgesic ligands and novel pharmaceutical delivery preparations (Tseng, et al.; Healy, et al.; Molet, et al.), may each and all have value in augmenting – or in certain circumstances, perhaps replacing – other methods of pain control.

But any such view to improved approaches to pediatric pain care must also acknowledge a host of neuroethical issues. Thus, while the use of assessment neurotechnologies may be seen as relatively low risk, we must still consider potential burdens and harms of over- or mis-reliance upon perceived objectivity, misdiagnosis, and bias and stigma (of predisposition to pain, and in the subsequent provision of care and social regard). And while interventional neurotechnologies offer great potential to effectively mitigate certain types of pain, we must acknowledge the intersection of unknowns arising from a tentative understanding of the brain, nascent neurotechnology, and the possible longitudinal effects of altering brain structure and function during development.

On one hand the need to address pediatric pain prompts calls for rapid translation of pain research to clinical assessment and care to lessen the burden of the suffering child. On the other, consideration, if not caution must be taken to avoid burdens and harms that may occur as a result of heightened expediency from bench-to-bedside. Tension between these motives could impede the scope and progress of neurotechnologically-based approaches to assessment and treatment of pediatric pain. How then to proceed?

Working in collaboration with Dr. Stefan Friedrichsdorf and his team at the Children’s Hospital and Clinics of Minneapolis, our group has called for a balance, in which we advocate prudent evaluation and use of tools and techniques of brain science that are currently and soon to be available confronting the problem of pediatric pain. Building upon prior work of Liana Buniak, current research scholars Dr. Faisal Akram and Christelle Khadra are addressing the neuroethical issues generated by neurotechnological approaches to assessment and care of pediatric pain.

We posit that priority must be given to:

  • Funding the development and articulation of prospective, longitudinal research in pediatric pain management focusing on the benefits of various types of assessment and intervention, and long-term bio-psychosocial consequences incurred by implementing – or not implementing – particular approaches.
  • Sustained discourse and deliberation focusing on the neuroethical issues associated with pain care in children;
  • Ongoing examination – and possible revision – of guidelines, policies and laws to insure the probity of pediatric pain research and clinical care.

Our group is fond of the adage “measure twice and cut once”, and we unapologetically re-assert this summons here. But it’s important to note that we do not advocate this as an “either/or” proposition, but instead as a “both/and” obligation to meet the neuroethical opportunities and challenges afforded by advancing brain science in the clinical care of those most vulnerable, and to sustain the right and good use of neuroscience and its technologies in society across generations.

James Giordano PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.

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PAS: Unwise, Uncontrollable, and Unnecessary

BY G. KEVIN DONOVAN, MD, MA

 


 

Proponents of physician-assisted suicide point to real and tragic stories of suffering in individuals at the end of life. I’ve heard the stories and found them heartbreaking, making me and others want to do something to alleviate such situations. Unfortunately their solution would not make for a better society; they offer a cure that is worse than the disease. Their plan would be to change the laws governing suicide in every state. Currently, suicide is not illegal in any of the states or the District of Columbia. What they would change is the prohibition of assistance from an outside party, specifically in this case, a physician. This would result in a profound shift in the doctor-patient relationship, and the profession of medicine. For 2 millennia, physicians have striven to separate themselves from those who would deliberately cause harm. The Hippocratic oath, still taken in some form by most medical school graduates, states specifically “I will give no deadly medicine to anyone if asked, nor suggest such counsel.” The American Medical Association still states that participating in assisted suicide or euthanasia is incompatible with the role of the physician. Given this tradition and the importance of the doctor-patient relationship, it is unclear why proponents of PAS seek to legislate the involvement of physicians in assisting with the patient’s suicide. It is likely because of the trust relationship that exists between patients and their doctors, a trust that would be eroded in many cases by even so much as an offer from the physician to bring about their patient’s death.

Those who would like to see physician-assisted suicide (PAS) legislation passed assert that it would only be done with appropriate restrictions and protections. In fact, the only real protections are for the physicians who would involve themselves, with the law protecting them from any consequences of their involvement, short of felonious behavior. It also protects from discovery the records of the activities surrounding PAS – reports are to be sent to the Health Department, which collates them, issues an anonymized report, and destroys the originals. What is missing here is the adequate protection for patients. Although the law would initially restrict PAS to those with a terminal disease with six months to live, these restrictions, if viewed closely, can be seen to be indefensible. Changing the law to legalize PAS is based on an appeal for autonomy for the patient; it redefines medical care to include, as a medical good, aiding in the death of the patient. But if we enshrine this new medical good with the power of law, we will make it logically impossible to deny that good in multiple other cases.

Why should a patient have to be expected to die in six months, rather than 12? Why must they be terminally ill rather than suffering from chronic incurable illness? Why must they be able to take the medicine themselves -what if they are too weak, too debilitated, too demented – why can’t someone else give them a lethal dose? Why even should we restrict this new “benefit” to those over 18; we know children can suffer from terminal or chronic conditions. Shouldn’t this new medical benefit include them as well?

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When a legislature undertakes to change the law, they change the moral fabric of society as well. What was previously unthinkable is now legal, and soon becomes the norm. This places all patients at risk, not solely those whom society has disadvantaged by reason of poverty, color, or physical disability. An elderly grandmother, seen by those she loves to be suffering, may hear the suggestion of assisted suicide as something she would never have considered before now. But, now that it’s legal, it must be all right, and perhaps should be considered, not so much because it is her strong desire, but because she does not want to see her loved ones or their financial resources further exhausted.

Legislators should always be cautious when considering revolutionary changes in societal norms. They should certainly have a clear and strong understanding of the effects on the majority of the citizenry. This is particularly true in PAS when so many long-term consequences are still uncertain. It is even truer when the change in the law is designed to privilege the few at the risk of many. We are repeatedly told that only a few patients would likely seek the solution annually, and some of the data from other states suggest this may be the case, at least at first. We must ask ourselves if such a drastic change in the legal landscape for such a small number is wise or is necessary. We now know that we have long suspected: patients have already been obtaining assisted suicide from physicians willing to provide it, without any legal sanction. It appears that those who want assistance in their suicides can find it, even in places where it has not been authorized by law. It would be more difficult in all likelihood, and would give people pause before proceeding. Would this be such a bad thing, if someone had to consider that step carefully and with all due deliberation?

I do not think that assisting in suicide meets the deepest and most fundamental needs of the suffering patient. I think they need physical and emotional support, the reassurance that they are never considered a burden, and a loving presence to their very end. I know that there are those individuals who would disagree, and might want to proceed with their self-inflicted deaths whether it were legalized or not. They should not be judged, they should never be prosecuted for the attempt. As a society, we shouldn’t change the law in a way that might encourage their deaths, we should not take their hand and lead them towards that, and certainly shouldn’t make them feel they are subtly being pushed into it. But overall, the sick, the vulnerable, the suffering, and dying deserve so much better, and a truly caring society would provide them with no less.


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.

 

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Reference:

Emanuel, Fairclogh, et al. “Attitudes and Practices of US Oncologists regarding Euthanasia and Physician Assisted Suicide, Ann Intern Med2000; 133:527-532,www.annals.org.

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The Child in Pain, BRAIN, and Neuroethical Issues in Pediatric Pain Research and Care

BY JAMES GIORDANO, PhD

A February 4, 2016 editorial in the Boston Globe addressed the recent Food and Drug Administration (FDA) approval of the opiate analgesic oxycodone (brand named OxyContin) for use in children. This has raised concerns about the relative safety and possible effects of such compounds, as well as the roles of industry and federal government in establishing guidelines and policies for the use of drugs – or any medical intervention. Pediatric pain can incur a host of lifelong neuro-biopsychosocial effects. Moreover, pediatric pain care is complicated by practical and legal issues of long-term and often escalated dosing of opioids, and there is a paucity of safety data and information about potential long-terms risks to the developing brain associated with commonly used analgesics in this fragile population.

Both the dictates of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and invocations of the Presidential Commission for the Study of Bioethical Issues speak to the imperative to translate brain research into viable clinical uses. In light of this, it becomes important to ask if and how novel neurotechnologies can meet the challenges and opportunities of assessing and treating pediatric pain. Research to date has shown promise: For example, neuroimaging studies have sought to identify and establish brain phenotypes for pain. As well, neurogenomics and proteomics may afford an understanding of pediatric pain syndromes and sensitivities to various pharmacotherapeutics. Such studies support the capability and potential clinical utility of neurotechnologically-based assessments. Interventional neuroscientific and neurotechnological techniques, including transcranial and in-dwelling approaches to neuromodulation (such as transcranial magnetic and electrical stimulation, (Moreno-Duarte, et al.; Moisset, et al.; Avery, et al.; Fagerlund, et al.) and forms of deep brain stimulation) (Russo, et al.; Gosset, et al.; Boccard, et al.), and highly specific analgesic ligands and novel pharmaceutical delivery preparations (Tseng, et al.; Healy, et al.; Molet, et al.), may each and all have value in augmenting – or in certain circumstances, perhaps replacing – other methods of pain control.

But any such view to improved approaches to pediatric pain care must also acknowledge a host of neuroethical issues. Thus, while the use of assessment neurotechnologies may be seen as relatively low risk, we must still consider potential burdens and harms of over- or mis-reliance upon perceived objectivity, misdiagnosis, and bias and stigma (of predisposition to pain, and in the subsequent provision of care and social regard). And while interventional neurotechnologies offer great potential to effectively mitigate certain types of pain, we must acknowledge the intersection of unknowns arising from a tentative understanding of the brain, nascent neurotechnology, and the possible longitudinal effects of altering brain structure and function during development.

On one hand the need to address pediatric pain prompts calls for rapid translation of pain research to clinical assessment and care to lessen the burden of the suffering child. On the other, consideration, if not caution must be taken to avoid burdens and harms that may occur as a result of heightened expediency from bench-to-bedside. Tension between these motives could impede the scope and progress of neurotechnologically-based approaches to assessment and treatment of pediatric pain. How then to proceed?

Working in collaboration with Dr. Stefan Friedrichsdorf and his team at the Children’s Hospital and Clinics of Minneapolis, our group has called for a balance, in which we advocate prudent evaluation and use of tools and techniques of brain science that are currently and soon to be available confronting the problem of pediatric pain. Building upon prior work of Liana Buniak, current research scholars Dr. Faisal Akram and Christelle Khadra are addressing the neuroethical issues generated by neurotechnological approaches to assessment and care of pediatric pain.

We posit that priority must be given to:

  • Funding the development and articulation of prospective, longitudinal research in pediatric pain management focusing on the benefits of various types of assessment and intervention, and long-term bio-psychosocial consequences incurred by implementing – or not implementing – particular approaches.
  • Sustained discourse and deliberation focusing on the neuroethical issues associated with pain care in children;
  • Ongoing examination – and possible revision – of guidelines, policies and laws to insure the probity of pediatric pain research and clinical care.

 

Our group is fond of the adage “measure twice and cut once”, and we unapologetically re-assert this summons here. But it’s important to note that we do not advocate this as an “either/or” proposition, but instead as a “both/and” obligation to meet the neuroethical opportunities and challenges afforded by advancing brain science in the clinical care of those most vulnerable, and to sustain the right and good use of neuroscience and its technologies in society across generations.

 

James Giordano PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.

 

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Neuroethics – Surfing the Waves of Neuroscience’s Hard Problem

BY JAMES GIORDANO, PhD

Recently, William Carroll of Blackfriars Hall at the University of Oxford reflected upon a Sunday NY Times article by Karl Ove Knausgaard about neurosurgery. Knausgaard marveled at both the subtlety of the technique (in the cases discussed, in the adept hands of noted neurosurgeon/author Dr. Henry Marsh), and at the idea that all of our thoughts, emotions, actions, if not our “self” might be nested within the folds and crevices of the brain. Carroll too appreciates the capabilities and insights of neuroscience, but ponders Knausgaard’s reductionist view, and in so doing offers the possibility for some middle ground between materialism and dualism. Caroll’s essay prompts us to confront what philosopher/cognitive scientist David Chalmers has called the ‘hard problem’ of neuroscience, namely, how the great stuff of consciousness occurs in the grey stuff of the brain. My colleagues Drs. Peter Moskovitz of George Washington University, and John Shook of the University of Buffalo and I have also been examining the “hard problem”, as well as the problem of falling into “is/ought” kinds of thinking when it comes to what the brain sciences can provide to conceptions of the self, sentience, morality and our social interactions.

Neuroscience, as a science (which possesses the tools, techniques and intent to only study the natural world) is based upon a philosophical ground of metaphysical naturalism, and as such, engages methodological naturalism. Tenets of naturalism include materialism and reductionism, but the brain sciences take some license here. Granted, neuroscience is unraveling more and more of the structure-function relationships of the brain. But the hard problem persists; and given the absence of tools or techniques to solve it at present, the most rational explanation of how the grey stuff is involved with the great stuff of consciousness and cognition relies upon token physicalism and/or inter-theoretical reduction as an explanatory model. Simply put, this posits that the contents of our subjective consciousness (i.e. – thoughts, feelings, emotions, etc.) represent tokens of some set of processes of the embodied brain (as it exists in an organism that is embedded in environments).

Any current postulate on how consciousness occurs (and what it really is) at best remains speculative. Here we could give a nod to theories of complexity and emergentism, but not too deeply, as we run risk of using one hypothetical simply to explain another (rather than actually doing justice to the explanans-explanandum relationship). As Carroll notes, from an Aristotelian-Thomistic perspective, brain science has afforded a pretty good view of material, and (especially when taken with other sciences) formal causality, but efficient causality – and final causality (if the latter is meaningful) – remain unexplained. So, let’s admit that there is much to nature that we still do not understand (else the mission of science would be moot), and that the core tenet of neuroscience, as science, is to remain self-critical and self-revising.

Is consciousness a mystery as Colin McGinn and his colleagues (“the mysterianists”) have asserted, or (as I tend to believe) a puzzle to be solved? Well, even McGinn has wavered a bit, moving from claims that we have reached a point of cognitive closure, to instead contending that our current state of understanding is best described as “approaching a cognitive cusp.” We may not solve the puzzle all at once, and I hold that like any really good puzzle, what is puzzling and important is both how the pieces or elements of the construct fit together and what they depict. But there’s arguably more to it: as we approach the puzzle it’s important to ask what it means, that is, what we will do with it, at varying stages and levels of solution. To paraphrase philosopher Hannah Arendt, what’s of real value is not just the work, but instead, is the intent of the task, and how we employ the outcomes of our labors at each step of the way.

Neuroscience can depict how brains work (albeit not completely). Putting neuroscience to work to describe what brain networks are involved in various cognitive, emotional and behavioral processes, including those involved in what individuals and communities hold to be “moral”, is noteworthy, and meaningful. But neuroscience can’t – and shouldn’t be used to – tell us how we ought to think, feel and behave, what morality is, or how to live the “good life”. Yet, the temptation to posit a purely biological basis for what is “normal”, “right”, and/or “good” looms large. Positing a “neuroscience of ethics” is fine on a descriptive level, but we must be critical of – and prepared for – attempts at using this to be prescriptive. And I perceive this as happening on a variety of levels, from the scientific to the socio-political.

Perhaps then, the really hard problem is knowing what to do with the information and capabilities we possess, what to do about the information and capabilities we lack, and knowing if we will be wise enough to know the difference, or recognize our own tendencies toward oversimplification and hubris. So, with a view to neuroscience – and neuroethics – I think that passively sitting upon a cognitive cusp is a precarious position that can foster hazardous perspectives upon the puzzles – and applications – of neuroscience. Brain science will, and arguably should, move forward, and such advancements will certainly exert effect in medical, legal and cultural domains. In light of this, I assert that we must actively “surf” a cognitive crest. This is where and why the discipline and practices of neuroethics as the “ethics of neuroscience” should come to the fore. How we surf, staying balanced and off the rocks, affords opportunity to gain insights to the task, provides a differing view of where we may be going (and from where we’ve come), and makes us better at staying afloat amongst waves of scientific discovery in an often changing, and sometimes stormy social sea.

 

James Giordano, PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.

 

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