Tag: law

Bioethics for Breakfast: Medical Legal Partnerships: A Tool to Help Address the Social Determinants of Health

Bioethics for Breakfast Seminars in Medicine, Law and Society

Megan Hoberg and Pamela Hoekwater of Legal Aid of Western Michigan presented at the December 1st Bioethics for Breakfast session, offering their insight and expertise on the topic “Medical Legal Partnerships: A Tool to Help Address the Social Determinants of Health.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman.

The session provided an overview of medical legal partnerships (MLPs) and their impact, discussing the Legal Aid of Western Michigan (LAWM) partnership with Cherry Health—Michigan’s largest Federally Qualified Health Center that operates in six counties. Speakers Hoberg and Hoekwater defined a medical legal partnership as “an integration of lawyers into the health care setting to help clinicians, case managers, and social workers address structural problems at the root of so many health inequities.” MLPs are increasing in popularity across the U.S. and can result in patient success stories, provider satisfaction, and increased recognition and reputation from organizations in the community.

They explained that a big part of MLPs involves screening for issues that might not have an obvious legal component to them. They shared four legal aid practices that relate directly to different social determinants of health: family law, housing, public benefits, and individual rights. One component of an MLP is training the health organization’s work force to help identify potential legal needs in the patient setting.

A memorandum of understanding (MOU) between the relevant stakeholders is generally a starting point to form MLPs. Hoberg and Hoekwater shared that there are a variety of ways that MLPs are funded, including AmeriCorps/Equal Justice Works, private donors, law firms, bar associations, health organizations, and foundations. They shared the evolution of their partnership with Cherry Health, which started with a pilot program and now includes a full-time on-site attorney and community health worker. The MLP currently focuses on maternal infant health and the senior population. The MLP operates as a multi-step process that begins with a referral to the MLP team through the electronic health record which leads to a meeting between the patient and attorney.

Hoberg and Hoekwater also shared challenges associated with MLPs, such as stability of funding, balancing legal and medical ethics, systems integration, and internal communication. Challenges aside, they shared both quantitative and qualitative data that supports the positive impact of MLPs. One example of a specific impact is patients reporting improved mental health and lower levels of stress and anxiety.

It was clear during the question and answer potion that attendees were interested in learning more about how they can pursue forming MLPs at their organizations, and how they can help their patients receive the legal support they need.

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About the speakers

Megan Hoberg is a Staff Attorney with Legal Aid of Western Michigan (LAWM). Previously, she worked as the Medical Legal Partnership Attorney, for the MLP LAWM maintains with Cherry Health. Megan’s perspective sheds light on how MLPs operate on a daily basis and the impact they produce for patient/client communities. Megan was drawn to MLPs during her time at Wayne State University Law School, when she served as a student attorney for The Legal Advocacy for People with Cancer Clinic and earned the 2020 Outstanding Clinical Student Team Award from the Clinical Legal Education Association (CLEA). Starting her career in healthcare and bioethics, working with MLPs and poverty law allows her to use her legal training to advance public health goals in an interdisciplinary setting. She is a member of the following organizations: State Bar of Michigan Professional Ethics Committee, Women Lawyers Association of Michigan, and American Society for Bioethics and Humanities.

Pamela Hoekwater serves as the Executive Director for Legal Aid of Western Michigan (LAWM). She has over 20 years’ experience in poverty law work since starting her legal career as a Staff Attorney in 2001 and has developed innovative partnerships with local agencies to integrate legal services in the community, including the YWCA, Goodwill Industries, and Hope Network. Having helped launch LAWM’s first medical legal partnership (MLP) in 2017, Pam holds a unique perspective and expertise as to the challenges of maintaining and advancing MLPs. Notably, she contributed to the formation of the Medical Legal Partnership with Cherry Health, which has been fully funded and staffed since 2019. Pam strives to advance social justice and equity through her participation/leadership in the following organizations: Resource Committee for Michigan Justice For All Commission, State Bar of Michigan Diversity and Inclusion Advisory Committee, Michigan State Planning Body, and Legal Services Association of Michigan.

By Liz McDaniel

Counting Women of Color: Being angry about “missing white woman syndrome” is not enough

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

By Monica List, PhD

Gwen Ifill is credited with coining the term “missing white woman syndrome” at the “Unity: Journalists of Color” conference in 2004. She used it to describe the disproportionate attention garnered by criminal investigations in which white women are victims, and in some cases, perpetrators. Discussions of this phenomenon resurfaced in the wake of recent media attention to the case of Gabby Petito, a 22-year-old white woman from Long Island, NY, reported missing on September 11th—and whose death, confirmed on September 21st was determined to be a homicide, allegedly at the hands of her fiancé.

It is not the attention on these cases themselves that is the issue, but rather how they distract focus away from similar cases occurring at a much larger scale, such as the disappearance of Black and Indigenous women. According to NPR, in 2020 nearly 100,000 Black women and girls were reported missing in the United States. In 2019, more than 5,590 Indigenous women were reported missing, although this may be a gross underestimation given the lack of adequate reporting systems. Most of us would find it difficult to name a single one of them. Yet in the past weeks, our screens, newspapers and minds were filled with Gabby Petito’s name, her story, and her images. Petito’s death is undoubtedly a tragedy, and the fact that it has been so prominently reported is not problematic in of itself, but it is symptomatic of a deeper failure.

Image description: a puzzle of solid white puzzle pieces is assembled with one missing piece remaining in the center leaving a black empty space. Image source: Willi Heidelbach/Pixabay.

From a racial justice perspective, part of the issue is the entrenched racial stereotyping underlying the belief that women of color are somehow at fault for their own disappearances and any violent acts against them. According to Dr. Ashraf Esmail, Director of the Center for Racial Justice at Dillard University, there is a perception that risky lifestyles and personal choices are a license to shift the blame to the victim and diminish social responsibility for these cases. A report published by the Urban Indian Health Institute found that 38 percent of media articles reporting on murders and disappearances of Indigenous women and girls made references to drugs or alcohol. Narratives portraying women of color as angry or hypersexual are also part of this problematic perception, says Dr. Kaye Wise Whitehead, associate professor of Communications and African American Studies at Loyola University Maryland.

But this is not simply another failure of the justice system to respect and protect the lives of Black people and other people of color. In addition to being a racial justice issue it is a public health issue. As with other public health issues, the collection, interpretation and reporting of data can be both a problem and a solution. In this case, it is one of the deep roots of a complex, systemic problem. The title of a 2020 article on the crisis of missing and murdered Indigenous women and girls summarizes it well: “They Disappear Not Once, but Three Times: In Life, In the Media, and In the Data”.

There are levels to how women and girls of color disappear in the data. First, the racial and ethnic breakdown of data categories unsurprisingly reflects the pervasive structural and systemic racism of our information management systems. The FBI’s missing person databases’ race categories are Asian, Black, Indian, unknown, and White. There is no category for Hispanic or other ethnicities, nor any subcategories for different Indigenous groups. Even within those limited categories, race misclassification is a common issue. The Missing and Murdered Indigenous Women and Girls Report found one instance in which a law enforcement agency still used an outdated coding system dating as far back as the 1960s, in which “N” was interchangeably used for “Negro” and “Native American.” This report also identified several police departments as including American Indians and Indian Americans in the same category. At least one of the databases (the FBI’s National Crime Information Center) does not allow data to be analyzed using race and gender combinations (e.g. “Black” and “woman”), making it difficult to obtain information on actual numbers of women of color reported missing.

Image description: a participant in the Greater Than Fear Rally & March in Rochester, Minnesota is shown wearing a grey knit hat, and they have a handprint on their face in red paint that covers their mouth. Image source: Lorie Shaull/Flickr Creative Commons.

Second, there is no national, unified system for the reporting of missing persons. In the United States, there are three federal missing person databases: the FBI’s National Crime Information Center (NCIC); the FBI’s National DNA Index System (NDIS), and the National Missing and Unidentified Persons System (NamUs), administered by the Department of Justice. One failure of this setup is that data on missing individuals entered into one database does not automatically populate or transfer to other databases, and access varies. NCIC and NDIS can only be accessed by local, state and federal criminal justice agencies, while NamUs is public and can be accessed by families of missing persons, law enforcement, medical examiners, and victim advocates. While NamUs seems like a good resource, especially to those victims and families who fall through the cracks of law enforcement, it is not mandatory for criminal justice agencies to report to NamUs in all states. Additionally, while almost all law enforcement agencies use NCIC, only a small fraction are registered to use NamUs. In a country with well-documented systemic racism issues, leaving federal reporting up to the good will of local law enforcement is a losing game for women of color.

The final piece of the puzzle is a lack of inclusion of relevant socioeconomic data that would allow a contextualized analysis of cases. This would not only increase chances of recovery of missing women and girls of color, but also help plan and implement preventive strategies. A first step to achieving this is making the collection and analysis of missing persons data inclusive and intersectional. This includes efforts to decolonize data, which from a public health perspective means gathering the data that a community itself finds meaningful, in ways that align with their social structures and cultural practices. But to be clear, these solutions also need good allies outside of those communities. Tomorrow, another Black or Indigenous woman will go missing, and many of us will be sad and angry again. In the meantime, the systems that continue to render missing women of color invisible and uncountable remain unchanged.

Monica List, PhD, is an assistant professor in the Center for Bioethics and Social Justice in the Michigan State University College of Human Medicine; Dr. List is Head of Research and Animal Welfare for World Animal Protection, an international non-profit animal welfare organization.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Monday, November 8, 2021. 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.

Continue reading “Counting Women of Color: Being angry about “missing white woman syndrome” is not enough” →

Abortion Restrictions and Compulsory Organ Donation

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

By Parker Crutchfield, PhD, and Emily Carroll

The Texas legislature recently passed a law prohibiting abortion of a fetus older than six weeks. The law allows abortions after six weeks in life-threatening emergencies, but not when the pregnancy results from rape or incest. The law is extraordinarily restrictive and additionally deputizes citizens to enforce the law, providing a $10,000 bounty for successful civil suits of people involved in the “aiding and abetting” of abortion. The Supreme Court of the United States recently neglected to halt the law, which meant it went into effect.

We can’t be sure of the exact thoughts of those who enact or support the bill. However, there are some claims that such people often hold. In an article set to appear in Cambridge Quarterly of Healthcare Ethics, we argue that these claims imply that if one supports restrictions on abortion, one must also support compulsory organ donation. In other words, if you support restrictions on abortion, to remain intellectually consistent you must also support a corresponding degree of compulsory organ donation.

The Duty to Protect

Our argument starts with a claim common to those who oppose a woman’s right to choose to have an abortion. This claim is that a mother has a duty to protect her fetus.

The duty to protect is supposed to be a special obligation that holds between mother and fetus. Special obligations are those that hold between people in virtue of some relation between them. We have many obligations to other people; most apply regardless of how we are related to them. But special obligations arise only in the context of certain relationships, such as those that hold between parent and child. Most people agree that a mother or father’s obligations to their child are different from those that they have to strangers. Here’s one example: a parent has a duty to protect their child, but no such duty to protect a stranger who lives in a distant locale. There are other ways to explain the duty to protect, but the one we prefer is that special obligations kick in when one person’s life is vulnerable to another person’s actions (Goodin, 1986). The more one person’s well-being is vulnerable to another person’s actions, the more the second person must protect the first. Thus, on this view the mother has such a strong duty to protect the fetus that she must allow it to use her body, willing or not.

From Prohibited Abortion to Compulsory Organ Donation

But there are other implications of this line of argument. What’s true of the mother-fetus relationship is also true of the parent-child relationship. If a fetus has full moral status, then so does a child. And children are highly vulnerable to their parents. Their well-being is significantly affected by their parents’ actions. This is true not only of their social and emotional well-being, but also of their physical well-being. This is especially true of children who need organ or tissue donation.

Children who need blood products or a kidney, liver, heart, lung, or any other organ are highly vulnerable to their parents’ actions. At a minimum, the child is vulnerable to the parent’s cooperation with the healthcare team’s treatment plan. But the child who needs an organ or tissue donation is also vulnerable to the parent’s biology. In particular, a parent may be the most biologically compatible potential donor. For parents who are a compatible donor for their child, the child’s well-being is extremely vulnerable to their parent’s actions. In a society where organs and tissues are a scarce resource, the child’s vulnerability to a biologically compatible parent is a matter of life and death.

Children who need organ or tissue donation to survive are about as vulnerable to their biologically compatible parents as a fetus is to its mother. If a mother must donate her body to her fetus unless doing so emergently threatens her life, then a parent must donate organs and tissues unless doing so emergently threatens their life. This obligation would hold for both mothers and fathers. If a child needs a kidney and their father is a match, he must donate his kidney to his child, even if he doesn’t want to. Donating a kidney is not emergently life-threatening, nor is donating a variety of other organs and tissues. If mothers shouldn’t have a choice to terminate a fetus, parents should not have a choice about whether to donate organs and tissues.

A Policy Proposal

To be clear: we are not arguing that abortion is wrong or that it should be allowed. Nor are we arguing that tissue and organ donation should be compulsory. Rather, we are drawing out the implications of the anti-choice position. There are ways out of this implication, but they are unfriendly to the anti-choice position. For example, they may wish to accept that mothers have a duty to protect the fetus, but deny that they do so in virtue of the vulnerability of the fetus to the mother. Such a strategy is not likely to help their position, as other available accounts of special obligations are even less supportive (such as the view that special obligations only arise when someone voluntarily takes them on (Brake, 2010), which clearly isn’t the case when someone seeks an abortion).

For people who support the Texas law, intellectual consistency demands they also support compulsory organ donation. Thus, supporters should also consider legislation compelling parents to donate organs and tissues to their children, even if they don’t want to, and even if doing so presents a significant risk to the parent. Indeed, they should also want to deputize citizens to enforce the law, such that there is a $10,000 bounty on biologically compatible parents who fail to donate.

But if such a policy is unacceptable, so is the Texas law.

Photo of Parker Crutchfield

Parker Crutchfield, PhD, is Associate Professor in the Department of Medical Ethics, Humanities, and Law at Western Michigan University Homer Stryker M.D. School of Medicine. His research interests include biomedical and public health ethics, moral psychology, and epistemology. His book, Moral Enhancement and the Public Good, was released by Routledge in 2021.

Emily Carroll is a third-year medical student at Western Michigan University Homer Stryker M.D. School of Medicine. She completed her undergraduate studies in psychology and biology at McGill University. Her research interests in medical school include bioethics and public health.

Join the discussion! Your comments and responses to this commentary are welcomed. The authors will respond to all comments made by Thursday, October 7, 2021. 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.

Continue reading “Abortion Restrictions and Compulsory Organ Donation” →

Human Microchip Implantation: A Bridge Too Far?

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

By Sabrina Ford, PhD

Technology. It invades every corner of our lives and for the most part improves the quality of life. From typing on a flat panel with a little TV screen attached, to a smartphone enabling users to share with others collected data that lives in the cloud. A CT/X-ray image of a C2 spinal fracture (aka Hangman’s Fracture) taken in the middle of the night at a small Midwestern rural hospital is sent to a West Coast spine surgeon, and within minutes, an expert opinion is returned to that rural hospital. Technology is convenient, pervasive, and unavoidable.

In the past 15 years, discussion and related controversy has taken place about a Radio Frequency Identification Device (RFID) or microchip that can be implanted in human bodies. That chip would contain, store, and update data about us. Might such an implant be a benefit or a risk? Some investors are betting on its appeal. The compound annual growth rate (CAGR) from 2020-2027 of the healthcare microchip is expected to grow by 22% and be valued over $6.4 million by 2027. RFID microchips (herein referred to as microchips) are already used for many things from your credit/debit card, to those efficient logistics used to move your Amazon package.

Illustrated cyborg eye with electronic circuits
Image description: An illustrated cyborg eye with electronic circuits. Image source: jemastock/Vecteezy.

Getting to the bridge

Implanted microchips are a terrifying idea to some of us—sufficiently frightening to harken images of robots and androids—the stuff of science fiction. For some of us, implanting something foreign in our bodies for the management of big data and convenience is disturbing. Another concern might be the potential breach of privacy and the surveillance of our daily life. If the chip contains medical, personal, social information, and GPS data, could we lose all autonomy? Do we maintain our autonomy if, with sufficient information, we consent to the decision? What will all the information be used or misused for? What if our employer, insurer, or a government entity decides to check on us?

These questions raise other concerns about autonomy. Enough employers considered compulsory microchips for their employees that in 2020, Michigan and several other states introduced and passed bills designed to prevent employers from forcing employees to accept microchip implants. This pre-emptive strike was against a growing technology, utilized perhaps to track safety, productivity and movement. As with many things in the United States, some vulnerable employees with microchips might be targeted, either unintentionally or intentionally, thereby putting them at further economic and social disadvantage.

Some have already crossed the bridge

It is estimated that currently approximately 10,000 people in the world have implanted microchips. Perhaps that doesn’t sound like many, but if investors are hedging their bets correctly, the technology is on its way to widespread adoption. A large number of those “cyborgs” reside in Sweden and employ the technology not for health care reasons, but instead use microchip implants to unlock their car doors, buy a coffee, or swipe into the gym. That rate of chip adoption makes sense in a society like Sweden, which is the second most cashless society (after Canada) in the world.

Photo of microchip being held between two fingers
Image description: A photo of an RFID implant held between two fingers. Image source: Dan Lane/Flickr Creative Commons.

Many argue that an RFID tag and implanted microchips can increase cybersecurity. Not being able to log into your computer without first swiping into the building and into your office door might offer a level of comforting protection against physical hacking in the workplace. In addition, many in healthcare delivery believe medical mistakes would be greatly reduced and quality of care increased if our medical charts were loaded on microchips, monitoring disease states like heart disease and diabetes, improving management of medications, and reducing surgical mistakes. If, with microchips, first responders or doctors had real-time access to accurate medical information there is potential to save lives in medical emergencies. The HITECH Act—or Health Information Technology for Economic and Clinical Health Act—calls for the interoperability of electronic health information for privacy and safety of the patient. As it is now, it doesn’t make sense for an individual to have different electronic health records in a number of physician offices. If our world were to be efficiently hyperconnected, one can argue that everyday life could be improved and streamlined.

A bridge too far

But would it be? We are covered, watched, followed, and violated through our digital footprint on a daily basis. Perhaps not necessarily with microchips, but pause to consider your actions today. You took your morning walk as public cameras captured your movement down the block, into the convenience store for a cup of coffee, where you used your debit card or smartphone to pay for the transaction, and that transaction was caught on the store camera. You then check your fitness wearable for heart rate, steps, route, and all that other good stuff. Later, you swipe in and out of the building as you stop into your office for a few hours, in and out of several doors, and log on to your computer—accessing various applications in the cloud—all the while answering your email and checking your calendar. Later in the day, you visit your doctor, either in person or via telemedicine, and she enters your ailments, diagnostic tests ordered, and electronic prescriptions into the electronic health record. As you wind down for the evening you make your market list in your favorite grocery store app, use your smart television to access your favorite shows, and access your books on a reading app. All of this is accomplished in the cloud, and on the “grid” in huge databases. Is this trek through the digital world so much different than a microchip that holds your digital footprint? You’ve left a day’s breadcrumb trail on almost every aspect of your life, and not even as consciously as Hansel and Gretel. As for implants in general, clearly Americans accept them, as witnessed by artificial joints, IUDs, cochlear implants – and don’t forget about those implants for hair and breasts.

Over the bridge

The described dilemma is that implanting a chip has the potential to be a violation of rights, yet the chip might equally offer safety and convenience. The implantable microchip is not fully developed and has a long way to go, but the technology is on its way. Microchips today are not sufficiently powerful to collect and communicate big data or to follow us all over the world the way our smartphones do. As with most technologies, the tipping point for implantable chips will come when they become so very useful that they’re simply hard to refuse.

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Sabrina Ford, PhD, is an Associate Professor in the Department of Obstetrics, Gynecology and Reproductive Biology and the Institute for Health Policy in the Michigan State University College of Human Medicine. Dr. Ford is also adjunct faculty with the Center for Ethics and Humanities in the Life Sciences.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, March 16, 2021. 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. Ford: COVID-19 Vaccine: “Not throwing away my shot”; Contemplating Fentanyl’s Double Duty

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Dr. Cabrera co-authors article in ‘Frontiers in Human Neuroscience’

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Center Assistant Professor Dr. Laura Cabrera is co-author of an article published last month in Frontiers in Human Neuroscience. Appearing in the Brain Imaging and Stimulation section of the journal, “International Legal Approaches to Neurosurgery for Psychiatric Disorders” was written by an international group of researchers.

Abstract: Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.

The full article is available online with free and open access from Frontiers.

CRISPR Dangers Highlight the Need for Continued Research on Human Gene Editing

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

By Jennifer Carter-Johnson, PhD, JD

The excitement and potential of CRISPR to treat severe genetic conditions by editing disease-causing DNA has taken an unexpected hit. A recent Wall Street Journal article highlighted the unexpected results from a CRISPR study in which attempts to edit a human gene responsible for blindness resulted in the loss of the entire chromosome from the cells in the embryos. These results echo another study conducted in human cell lines published earlier in 2019.

CRISPR is a targeted gene editing process that allows scientists to direct genetic modifications with far more precision than prior procedures. CRISPR has been touted as a gigantic leap in the ability to modify DNA by creating or repairing pinpoint DNA mutations without affecting other areas of the chromosome on which the gene resides. The recent study indicates that the technique might not be as straightforward in humans – and thus neither will be its use to fight disease.

Blue DNA double helix puzzle with missing pieces
Image description: A partially assembled puzzle that is an image of blue double helix DNA molecule structures. Image source: Arek Socha/Pixabay

CRISPR Technology – Promise and Problems

The value in CRISPR mediated genetic modification can be seen in a wide variety of biotechnology products, such as genetically modified crops and new biologics. But perhaps the most exciting and most controversial potential for CRISPR can be found in the desire to modify embryonic genomes to remove genetic abnormalities for which we currently have no cure.

This promise of embryonic gene editing is appealing not only because it would remove the condition from the child born from the gene-edited embryo, but also because the offspring of that child would also be free of the condition. CRISPR gene editing – because it is done at the embryonic stage – creates germline mutations that are passed to future generations. In a therapeutic use of CRISPR, those mutations would be cures for often untreatable diseases.

However, it is this very promise that raises many of the problems with CRISPR embryonic gene editing. Much debate has surrounded embryonic gene editing. Until this recent news, there were fears that CRISPR may make gene editing too easy. The technological development of CRISPR in embryonic gene editing is moving at a breakneck pace as scientists around the world are working on procedures. Biohackers work in their garages and livestream the use of CRISPR to edit their own genomes.

Many are debating which genes should be targeted and how fast the research into actual trials should proceed. Most agree that severe diseases would be the best place to start, but should the technology be deployed for cosmetic benefits such as eye color, or diseases for which a treatment exists? The dangers of CRISPR editing are unclear, and there has been an informal moratorium on the use of the technology to create children. Despite that, there has been at least one rogue scientist who has created genetically modified embryos and brought them to full term birth.

International Policy on Human Gene Editing

The scientific research is not occurring in a vacuum. Each country decides how CRISPR can be used in its medical system – both when the technique is safe enough and on which diseases it should be used.

An international commission recently pronounced that the technology is not ready for clinic implementation because scientists don’t understand the full safety issues surrounding its use in human embryos. The commission described some of the potential clinical uses in the future and outlined a basic safety protocol for approval.

One of the creators of CRISPR, Jennifer Doudna, has also spoken out against applying CRISPR too hastily to embryonic gene editing. 

Based on the recent studies showing loss of chromosomes, the international commission and other scientists are correct to call for a moratorium on clinical embryonic gene editing.

Blue and green DNA double helixes and binary code
Image description: An abstract image of blue and green double helix structures and binary code (zeros and ones) against a black background. Image source: Gerd Altmann/Pixabay

CRISPR – The Path Forward

The setback in CRISPR gene editing does not mean that the technology and research should be discarded. The potential to change lives is too great; however, the dangers of use with our current understanding are even greater. So how do we move forward with CRISPR in embryonic gene editing? The answer must include balance – in research strategies and in voices.

While the technology is not ready for clinical use, and we have not yet determined which uses would be appropriate if it were available, the science should not stand still. The research surrounding CRISPR gene editing will yield insights into human biology that we cannot predict. For example, the loss of chromosome length in human embryonic cells undergoing CRISPR treatment seems to be different than the response of other species of embryonic cells. And debates about the appropriate use of the technology will allow us to discover more about ourselves as humans. 

As we debate the best way to develop and deploy CRISPR technology, we should look to a variety of stakeholders. Scientists have a solid track record in understanding when recombinant DNA technology has potentially hazardous implications. In the 1970s, the Asilomar Conference allowed scientists to put together research guidelines that allowed the technology to be developed without harming public health. In fact, the international scientific consensus not to use the technology such as described above indicates that scientists are beginning that work. Such a moratorium on clinical uses gives us time to understand how to deploy the technology in the safest manner.

Additionally, there is a role for the voices of the patients whose lives could be changed by the technology. Patients may not be in the best place to judge when the technology should be deemed safe enough to deploy, but they certainly will have input about which mutations cause hardships that merit the risk of germline editing. Many of these patients already work with scientists on potential treatments for their diseases. CRISPR discussions may open another avenue for many.

Finally, there is a role for legal regulation of the use of CRISPR. Governments should listen to the voices of scientists and potential patients in drafting these regulations. But as shown by the example of at least one rogue scientist, there needs to be teeth to the moratorium on CRISPR clinical use at this time. CRISPR and its use in human gene editing raise complicated issues and hold great promise as a powerful tool to defeat genetic diseases. The development of those technologies will not be straightforward or without risk and will require more basic science research to achieve clinical efficacy. But with proper planning, we may learn more about ourselves as humans on the path to a cure.

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Jennifer Carter-Johnson, PhD, JD, is Associate Dean for Academic Affairs and Associate Professor of Law in the Michigan State University College of Law. Dr. Carter-Johnson is a member of the Michigan State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, December 15, 2020. 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. Carter-Johnson: Biohacking: How a DIY Approach to Biology Can Shape Our Future; Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult; Humanity in the Age of Genetic Modification; Defining The Spectrum of “Normal”: What is a Disease?; Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.

Continue reading “CRISPR Dangers Highlight the Need for Continued Research on Human Gene Editing” →

We Need Healthier Schools, and Student Activists Are Stepping Up

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

By Sean A. Valles, PhD

California just passed two laws that advance health in schools in ways that might not seem intuitive: pushing middle school and high school start times to after 8am, and banning school districts from “lunch shaming” that treats students differently based on whether they have unpaid school lunch debt. These laws are part of a collection of diverse efforts to make U.S. schools healthier places. The fact that some of these efforts have been led by students themselves is especially heartening.

Bioethics of school policies
The two new laws in California are worthy of attention in a bioethics blog because U.S. schools are, for many students and in many ways, unhealthy places. Not simply because they are crowded spaces infamous for spreading coughs and colds (and stress). For many students, they are also places of food insecurity, social stigma, or even fear of violence. Those problems also shed light on larger problems in society. Even as a child in Los Angeles, I grasped that the local high school having a metal detector at the door signified that something much bigger had gone horribly wrong in my community. Most student problems have their roots outside the school walls, but we can at least do our best to design schools to contend with the difficult realities of young people’s lives.

There is now compelling evidence that later start times for schools are better for adolescent health than early morning ones. As pointed out in one review of the research, adolescents’ bedtimes seem to be more or less independent of when school starts in the morning, partly due to biological clock rhythms changing during puberty. Students forced to begin school early in the morning suffer all of the resulting harms of insufficient sleep (most readers are surely aware that insufficient sleep is bad for physical and mental well-being). This change is surprising in part because the American Academy of Pediatrics has, with limited success until now, been pushing for later school start times, insisting that school start times should facilitate the 8.5-9.5 hours of sleep appropriate for adolescent biology. It will be a difficult schedule transition for some California schools and families/guardians to adjust to, but the health rationale remains powerful.

Stigmatizing and manipulating students are problems, not solutions
It is also encouraging to see California legislate against lunch shaming. Unless prohibited, U.S. schools have the freedom to intentionally or incidentally shame students for being unable to afford their lunch meals. They have done so by giving indebted students inferior meals, marking the students with wristbands or stamps, etc. This is a serious health matter because imposing a stigmatized status upon a child, or even just amplifying an existing one, is a harmful act. Research is quite clear that stigma (“the co-occurrence of labeling, stereotyping, separation, status loss, and discrimination in a context in which power is exercised”) is a powerful and pervasive cause of health injustices. Stigma stresses bodies, socially controls people, and excludes them from social opportunities and resources available to others. Being a child without enough money to pay for lunch is quite hard enough, without one’s school officials metaphorically painting a target on one’s back.

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Image description: Young person at the March for Our Lives protest, holding a placard painted with the words “AM I NEXT?” in red. Image source: Roger Jones/Public Domain.

The desirability of the California law gets clearer when one looks at a policy that goes in the opposite direction. In a widely-criticized lurch backwards, a newly-created policy in a New Jersey school district gives discretion to principals to ban students with lunch debt from participating in extracurricular activities. Which students? Under which circumstances? What goals are achieved by such exclusions? Certainly banning students from soccer practice or chess club doesn’t make money magically appear in their parents’ pockets. The policy is a setback, but I am encouraged by the backlash that gives a new sense of clarity to how remarkably regressive this policy is in light of the opposite trend.

Student advocacy should be welcomed
Most encouraging to me is the fact that students are advocating for themselves and the health of their schools. I am glad that the American Academy of Pediatrics and some California state legislators are advocating for healthier schools, but I have argued at length elsewhere that it is preferable to empower people advocate for themselves. And so students are. For instance, they have been at the forefront of a series of lobbying efforts (successful in Oregon and Utah) to get mental sick days recognized as legitimate reasons for missing school.

It is no coincidence that this push to create space for “mental health days” comes in the middle of a period of worsening mental health of young people in the U.S. Deaths from suicides just replaced deaths from homicides as the second leading cause of death among 15-19-year-olds (deaths from traffic accidents are down, but still exceed both). And homicides are also a target of student activism; after the Parkland school shooting, young people became the unexpected leaders of a new wave of gun control activism.

The late 2010s have been a time of disorienting rapid change, but I suspect that future historians will highlight one global social phenomenon: young people demanding a better world. The most prominent example is the rise of young climate change activists around the world—Greta Thunberg being the most famous—demanding action with a new sense of clarity and resolve. As I write this, Teen Vogue’s website teases an article with a link saying “Why Homeless Advocates Aren’t Happy With the 2020 Presidential Candidates” and an op-ed on radical labor organizing among nail salon workers.

Better health through better spaces
Even though lunch shaming, poor mental health, exhaustion and all sorts of other health problems still tragically afflict young people in schools, I am optimistic because it really does feel that the winds have shifted—thanks in large part to student activists, unhealthy schools are finally getting reforms they have long needed. As I argue at length in the book Philosophy of Population Health, health depends not just on whether we have good medical care, but also on whether the places where we live our everyday lives have been thoughtfully designed to support good health.

Sean Valles photo

Sean A. Valles, PhD, is an Associate Professor with an appointment in Lyman Briggs College and the Department of Philosophy at Michigan State University. His research spans a range of topics in the philosophy of population health, from the use of evidence in medical genetics to the roles played by race concepts in epidemiology. He is author of the 2018 book, Philosophy of Population Health: Philosophy for a New Public Health Era. He is also Director of the MSU Science and Society @ State Program, supporting interdisciplinary faculty collaborations that join the humanities, arts, and sciences.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 28, 2019. 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. Valles: Recognizing Menstrual Supplies as Basic Health Necessities: The Bioethics of #FreePeriods; Trump’s Attempt to Reignite the Coal Industry Is Another Health Policy Blunder; Politics and the Other Lead Poisoning: The Public Health Ethics of Gun Violence; Climate Change and Medical Risk

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Bioethics for Breakfast: Biobanking Tissue: Trash or Treasure?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyJennifer Carter-Johnson, PhD, JD, and Tom Tomlinson, PhD, presented at the Bioethics for Breakfast event on December 6, 2018, offering their perspectives and insight on the topic “Biobanking Tissue: Trash or Treasure?”

“Big data”—repositories of biological, medical and demographic information about large numbers of people—is a critical platform for discovery of the causes of disease and potential new avenues for its treatment.

This data must come from us, the general public. Data about you might end up in a biobank because you’ve generously agreed to provide it, perhaps by agreeing to join the National Institutes of Health’s All of Us project that aims to recruit a broad representative sample of one million Americans.

Or it might already have been provided for use in research without your knowledge or consent. Research using specimens and medical information collected during your clinical care, once de-identified, doesn’t count as research on a “human subject” under the Federal regulations. Thus, your consent is not required. This source probably provides the great majority of information used in big data research, and acquiring and distributing it has become a multimillion dollar business.

This practice raises a host of questions. Doesn’t my specimen and my medical information belong to me, rather than to the hospital or clinic that collects it? Or have I thrown it away like my trash sitting on the curb each week? Although many people may feel comfortable providing this information for research, others might not. So isn’t it a simple act of respect to ask first? Or are researchers simply the medical equivalent of college students dumpster diving for cheap furniture that has been thrown away? Additionally, if we ask, and too many people say “no,” won’t critical research be hampered, to the detriment of all of us?

Dr. Tomlinson asked attendees to consider this question: Should clinically-acquired specimens and other medical information be treated like the trash that you have no control of once it has left your curb?

Dr. Tomlinson referred to a national study that his research team conducted in 2014 regarding willingness to give blanket consent, focusing on the fact that people care about more than risk – they have concern about how their materials may be used, and they worry about how much they should trust the research establishment. Dr. Tomlinson’s overarching argument was that respect for persons, a fundamental bioethics principle, requires informed consent.

Dr. Carter-Johnson also offered a question: whose treasure is it? Biospecimens and related data can be donated by patients and the public, can be clinically collected de-identified materials, and they can be samples given to private companies like 23andMe or Ancestry.com. Dr. Carter-Johnson also discussed a new startup offering to sequence your genome for free, and highlighted the variety of health and fitness apps that we give our data too. “When something is free, you are the product,” she said. A show of hands revealed that a minority of the attendees had gotten their DNA sequenced.

Dr. Carter-Johnson offered a legal perspective on tissue and genetic data in relation to property and privacy rights. She explained that individuals do not own their own tissue, citing the cases Moore v. Regents of California and Greenberg v. Miami Children’s Hospital Research Institute. However, there have been exceptions, and there are legal ways to “sell” your body (think plasma, bone marrow, sperm, or clinical trials).

When discussing privacy, Dr. Carter-Johnson used 23andMe and Ancestry.com’s privacy policies as examples. These policies are contractual, they are updated frequently, and they are often ignored by the consumer. However, push from consumers as well as bioethicists have led to these policies being more available and accessible.

Audience discussion brought up the famous Henrietta Lacks case, the future of biobank donor policies, and newborn screening programs and biobanks.

Jennifer Carter-Johnson, PhD, JD
Jennifer Carter-Johnson is an Associate Professor of Law at the Michigan State University College of Law and holds both a JD and a PhD in Microbiology. Professor Carter-Johnson uses her interdisciplinary training to study the intersection of law and scientific research.

Tom Tomlinson, PhD
Tom Tomlinson was Director of the Center for Ethics and Humanities in the Life Sciences from 2000 to 2018, and is a Professor in the Department of Philosophy. He chairs the Ethics Committee at Sparrow Health System, and has published widely on the ethics of biobank-based research.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.

Dr. Stahl presents on physician-assisted suicide, opioid epidemic in November

Devan Stahl photoCenter Assistant Professor Dr. Devan Stahl gave three presentations this month at local and national events.

Dr. Stahl was invited to give a talk at Georgetown University on November 9 as part of their conference on “Physician-Assisted Suicide and Euthanasia: Theological and Ethical Responses.” In her talk, “Understanding the Voices of Disability Advocates in Physician-Assisted Suicide Debates,” she discussed the disability rights perspective on physician-assisted suicide (PAS) and how it relates to Christian ethics. The presentation argued for the importance of faithfully attending to concerns regarding PAS raised by disability advocates, and considered the ways that the Church has historically failed to offer full honor and respect to the lives of people with disabilities. By attentively listening to disability groups who oppose PAS, Christians may come to realize that they too participate in unjust structures and systems that threaten the lives and dignity of disability advocates.

On November 14, Dr. Stahl was the keynote speaker at the annual Ernest F. Krug III Symposium on Biomedical Ethics, presented by Oakland University William Beaumont School of Medicine. Her talk was titled “The Disability Rights Critique of Physician Aid in Dying Legislation.” Dr Stahl spoke to an audience of medical students and faculty about the disability rights perspective on physician aid in dying, and how it differs from the debates happening in mainstream bioethics. Over the past three decades, disability rights advocates have provided clear and consistent opposition to the legalization of physician aid in dying (PAD), which many believe threatens the lives and well-being of persons with disabilities. The presentation reviewed the common objections to PAD from disability advocates and considered what such objections reveal about the systemic failings of our current health care system.

At the American Academy of Religion Annual Meetings in Denver, CO, Dr. Stahl joined a panel of speakers discussing religious responses to the opioid epidemic. She discussed the ethical tensions that physicians experience when managing the opioid crisis, including whether and how to trust patients who request opioids, the validity of opioid contracts and drug screens, as well as the current legislative restricts on opioid prescribing.

Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult

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

By Jennifer Carter-Johnson, PhD, JD

A recent New York Times article described the problems that patients are having gaining access to a new class of cholesterol reducers, called PCSK9 inhibitors. This difficulty extends not just to the uninsured but also to patients with insurance. The drug costs are exorbitant, listing as more than $14,000 per year for a drug that may need to be taken indefinitely. Insurance companies are balking at paying so much for the new drug when cheaper cholesterol reducers are available. Patients for whom the old cholesterol reducers do not work are forced to jump through many time-consuming hoops – mountains of paperwork, proof that other drugs have failed, and appeals after initial denials of coverage – before drug coverage approval for the PCSK9 inhibitors.

It is easy to blame the drug companies in this situation. Why must they charge so much?!?! This question has become more common considering recent news stories about drug company price increases designed only to increase profits. But high drug costs are only one obstacle for patients to access drugs. Insurance coverage dictates cost of drugs to patients from nominal co-pays to out-of-pocket self-funding. Attempts to address one issue without addressing the entire web of interests is doomed to failure.

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Image description: A close-up photograph of a spider web that is covered in water droplets. The web takes up the entire frame and is in focus, the background is blurred and includes green and purple tones. Image source: nils.rohwer/Flickr Creative Commons

Drug Companies and Federal Regulations

Drugs cost money and time to develop and produce. All drugs must undergo scrutiny from the U.S. Food and Drug Administration, where drug developers must prove both the safety and efficacy of the potential drug before it is sold. The process takes on average 12 years between lead compound identification and final approval, and often costs close to a billion dollars absent streamlined approval processes for certain rare diseases. The billion-dollar cost estimate includes the cost of research for the failure of the many compounds that enter clinical trials but are deemed either unsafe or ineffective for the disease to be treated.

Thus, drug companies charge prices to recoup this huge research investment. Prices also pay for manufacturing and advertising as well as profit margins of close to 20% to fuel further investment. While there are mechanisms in place to incentivize generic drug manufacturers to enter the market and decrease prices through competition, branded drug companies have strategies to delay generic entry that have come under recent legal scrutiny.

Private Insurance and Federal/State Medical Programs

While drug costs are high due to the myriad factors described briefly above, patients are often insulated from some of those costs by insurance companies that cover the cost of drugs. Insurance comes in a variety of forms. Private insurance may be procured on the open market or through employer coverage. In the latter, the employer may cover some or all the costs of the insurance. Senior citizens rely on the Federally-sponsored Medicare program for medical coverage, though private supplements insurance policies are also the norm. Those too young for Medicare and too poor for private insurance (with or without an employer subsidy) are forced to rely on state Medicaid programs.

Unfortunately, not every insurance plan covers every drug. Insurance companies produce a formulary of covered drugs for each plan. The insurance plan negotiates a price, often significantly cheaper than the drug’s list price, that it will pay the drug manufacturer. More expensive drugs may require insurance pre-approval and multiple rounds of paperwork from the prescribing doctor.

Insurance companies have an incentive to reduce the usage of expensive drug alternatives. For private insurance companies, that incentive is profit. In fact, for-profit insurance companies know how to play this game quite well; many have profits in excess of 6 billion dollars. Medicaid and Medicare programs have limited budgets for all medical costs including drugs. While increased Medicaid funding for states offered through the Affordable Care Act was effective in decreasing uninsured rates, government funding is always in flux due to political pressures.

Doctors and Pharmacists

Doctors have great discretion in prescribing drugs. While doctors hold their patients’ health as the highest goal, knowledge of insurance (or its lack) may influence the doctor’s choice of drugs. Denial of a drug may well mean many, many more forms for a doctor who wants to make sure her patient has the best, most expensive drug. Doctors who do this for multiple patients could soon find themselves spending as much time on drug paperwork as medical care. Many doctors have taken to giving samples of drugs – left by drug companies as part of their advertising budgets – to patients who cannot afford the drug but need it.

Pharmacists exist at the epicenter of the patient’s dilemma. Patients often find out that insurance is not covering the drug when the pharmacist explains the situation. More troubling is the fact that drug prices are sometimes cheaper for a patient without insurance. For instance, a patient may have a twenty-dollar co-pay, but the drug may only cost ten dollars. For years, pharmacists have been subject to “gag clauses” in contracts between pharmacies and pharmacy benefit managers that prevent them from disclosing to the patient the cheaper alternative. Recent legislation signed this month has banned this practice.

Patients

Caught in this web of diverse and conflicting interests are the very people for whom drugs are created and vetted and prescribed – patients. Drug manufacturers must be able to recoup costs, but if no one can afford the drug how will they make sales? Additionally, drug pricing is a convoluted process that varies between insurance policies, pharmacies, and branded or generic formulations. Insurance coverage is often dictated by employer, age, or resources. Lack of coverage for a specific drug might mean the patient is faced with choosing a different drug or a different job. But asking about insurance formularies during a job interview would be quite difficult even if switching jobs in the midst of a medical crisis were possible. On the other hand, determining drug needs in advance is almost impossible. Finding a doctor with the time to work with a patient on an involved approval process is becoming more difficult given the increasing shortage of doctors in the United States.

Sitting in the center of this web of interests, patients have the most to gain and the most to lose from any overhaul of our drug system. It is impossible to fix all the problems by focusing only on the problems in one area. Unfortunately, patients are also a very small voice in the web that includes pharmaceutical companies, insurance companies, and medical professionals.

Jennifer Carter-Johnson photo

Jennifer Carter-Johnson, PhD, JD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 1, 2018. 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. Carter-Johnson: Humanity in the Age of Genetic Modification; Defining The Spectrum of “Normal”: What is a Disease?; Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.; Designing Children: Patents and the Market are not Sufficient Regulation

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