Tag: law

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’

Laura Cabrera photo

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.

Jennifer Carter-Johnson photo

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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Making Martyrs of Our Children: Religious Exemptions in Child Abuse and Neglect Cases

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

By Devan Stahl, PhD

On August 2, 2018, Seth Welch called 911 after finding his 10-month-old daughter, Mary Anne Welch, unresponsive in her crib. Mary was pronounced dead at the scene and the medical examiner determined Mary’s death was the result of malnutrition and dehydration. During interviews, Seth Welch and his wife Tatiana Fusari admitted they were aware of Mary’s skinny appearance for at least a month prior to her death, but claimed that they had fed her appropriately and did not believe her to be ill. The parents are now awaiting trial for felony murder and first-degree child abuse.

The case has made national headlines, because the parents claim their decision not to take Mary to a doctor was based, in part, on their religious beliefs. Mrs. Fusari said she failed to reach out for medical help for her daughter because she feared having her children removed by Child Protective Services, a lack of faith in the medical system, and “religious reasons.” Further, Mr. Welch claims he is being unfairly charged in Mary’s death because of his “very strong faith.” Neither Mr. Welch nor Mrs. Fusari have explained their religious beliefs, but in Facebook videos, Mr. Welch claims he is “not opposed to medicine or doctors,” but he believes some doctors are part of a “priesthood of the medical cult.” He also claims not to believe in vaccines, and expressed a desire to live in a “commune of Christian disciples living off the grid somewhere.” The reasons Mary’s parents did not take her to see a physician appear to be multifaceted, but their claims to religious liberty are a hot button issue in bioethics and politics today.

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Image description: a baby is photographed lying down, a hand is holding a stethoscope to the baby’s chest. Image source: Bread for the World/Flickr Creative Commons

The case of Mary Anne Welch is yet another in a long line of child neglect and abuse cases where a religious exemption defense is likely to be mounted. All U.S. states have laws prohibiting child abuse and neglect, but 39 states also have laws protecting parents from abuse and neglect charges (though not murder charges) when they fail to provide medical assistance to their children because of their religious beliefs. Religious exemption laws are meant to protect the religious liberty of individuals who use faith-based practices in place of medical science; although in many states the religious exemption only applies to people who are part of “recognized” religious denominations. These exemptions grew out of a Department of Health, Education, and Welfare (HEW) ruling after the 1974 passage of the Child Abuse Prevention and Treatment Act, which specified that religious exemptions be added to states’ child protection laws. In 1983, HEW adopted new regulations that removed the requirement for religious exemption, however, few states have repealed their religious exemption laws. In many states with exemptions, including Michigan where Mr. Welch and Mrs. Fusari reside, courts can order medical services to be provided to a child whose health or life are at risk without medical care.

In nearly all cases, competent adults are free to make medical decisions according to their religious beliefs, and cannot have treatment forced on them for any reason. At the same time, parents have certain obligations toward their children, which restrict their right to exercise their religious beliefs on behalf of their children. In the famous U.S. Supreme Court case Prince v. Massachusetts (1944), the court ruled that “Parents may be free to become martyrs themselves,” but they are not free “to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves.”

The case of Mary Anne Welch is a microcosm of a larger debate happening in health care around religious liberty and the rights of children. The American Academy of Pediatrics (AAP) has stated that parental desires regarding their child’s medical treatment should be followed, unless these decisions clearly go against the child’s best interests. At the same time, for decades the AAP has been opposed to religious exemption laws. In cases where parents are acting maliciously or with gross indifference to the well-being of their child, it is easy to see why overriding parental decision-making would be appropriate. Prosecuting parents for neglect and abuse if their child suffers as a result of their decisions feels appropriate as well. Knowing very little about Mr. Welch and Mrs. Fusari, however, it would be presumptuous to make any judgments about their fitness as parents, or about their care for Mary. At this point it is not clear that given Mary’s weight loss, other reasonable parents in a comparable situation would have taken their child to the doctor regardless of their religious beliefs. Time will tell if Mary’s death should have been foreseeable or if it would have been preventable with proper medical care.

What is likely to happen in the meantime, and seems to be happening already in the media, is that Mr. Welch and Mrs. Fusari’s religious beliefs will be scrutinized. (Their concerns about the dangers of hospitalization are supported by recent studies about medical errors.) Religious exemption laws regarding parental neglect are controversial, and critics are right to question the legitimacy of such laws when children die as a result of their parent’s religious beliefs. Despite their religious beliefs, we ought to hold parents to a standard where they are expected to prevent injuries to their children. At the same time, we ought not to hold parents such as Mr. Welch to a higher standard for parental care, simply because he has particular religious beliefs that are not widely held by other parents. Plenty of parents choose to opt out of certain medical treatments for religious and non-religious reasons alike, and it is not clear that medical orthodoxy should always be determinative of a child’s best interest. Time will tell if other prudent parents would have taken a child in Mary’s condition to the doctor. If that is found to be the case, then Mary’s parents should be held accountable for their decisions.

Devan Stahl photoDevan Stahl, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Pediatrics and Human Development in the Michigan State University College of Human Medicine.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, October 4, 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. Stahl: Mass Shootings, Mental Illness and Stigma; Disability and the Decisional Capacity to Vote

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Announcing the Fall 2018 Bioethics Brownbag & Webinar Series

bbag-icon-decThe Center for Ethics and Humanities in the Life Sciences at Michigan State University is proud to announce the 2018-2019 Bioethics Brownbag & Webinar Series, which features a variety of bioethics topics. The series will begin on September 19, 2018. You are invited to join us in person or watch live online from anywhere in the world! Information about the fall series is listed below. Please visit our website for more details, including the full description and speaker bio for each event.

Fall 2018 Series Flyer

sept19-bbagTherapeutic Privilege in Psychiatry? The Case of Borderline Personality Disorder
Why do behavioral health care professionals often hesitate to discuss BPD with their patients even when it is clear they have this disorder?
Wednesday, September 19, 2018; C102 Patenge Room, East Fee Hall
Dominic A. Sisti, PhD, is Director, The Scattergood Program for Applied Ethics of Behavioral Health Care; Assistant Professor, Department of Medical Ethics & Health Policy; Assistant Professor, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania.

oct-10-bbagEnding Medical Self-Regulation: Does Less Physician Control Improve Patient Safety and Protect Patient Rights?
Wednesday, October 10, 2018; E4 Fee Hall
Thaddeus Mason Pope, JD, PhD, is Director of the Health Law Institute at Mitchell Hamline School of Law.

In person: These lectures will take place from 12:00-1:00 PM (Eastern Time) in East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? Every lecture is recorded and posted for viewing in our archive. If you’d like to receive a reminder before each lecture, please subscribe to our mailing list.

Patient dumping: why are patients disposable?

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

By Karen Kelly-Blake, PhD

A public uproar ensued when a video revealed hospital staff literally dumping a woman wearing only a gown and socks in frigid weather on the streets of Baltimore. Imamu Baraka, a psychotherapist, witnessed the incident and recorded it on his cellphone. In the video, we see Mr. Baraka questioning the security personnel about their activity, and then we see them silently walking away.

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Image description: a crumpled hospital gown is pictured on the edge of a concrete ledge. The background is a concrete sidewalk. Image source: Lynn Park/Flickr Creative Commons.

The fact that the public appeared to be surprised by this event was bewildering. Patient dumping is hardly a new phenomenon, and in fact, it should not come as a surprise that those being dumped in this fashion are predominately non-white, poor, homeless, mentally ill, uninsured, and drug users. So, what is patient dumping? It is when hospitals that are capable of providing necessary medical care fail to screen, treat, or appropriately transfer a patient, or alternatively, when they turn the patient away because of the patient’s inability to pay for services.

Hospitals have long relied on this tactic as a way to offset care for those patients who cannot cover their costs, and so the hospital then is not reimbursed—it is an economic profit-loss decision. But, this blog is not about blaming hospitals. It is about recognizing that patient dumping is a symptom of larger healthcare system and societal ills. Consider the following:

Thirty million people in the U.S. remain uninsured after Affordable Care Act (ACA) implementation. Forty million adults experience mental illness in a given year. 554,000 people in the U.S. are homeless. Forty-three million live in poverty. Every day, the opioid epidemic claims 175 lives. These many data points speak to the U.S.’ combined lack of healthcare and social safety nets. Filling those gaps alone could potentially avert patient dumping.

By default, public, not-for-profit hospitals are charged with caring for such vulnerable patients. In the era of value-based, pay-for-performance, and accountable care organization (ACO) reimbursement models, those hospitals consequently will struggle to meet Centers for Medicare & Medicaid Services quality care metrics.

Federal legislation such as the Hill-Burton Act and later the Emergency Medical Treatment and Labor Act (EMTALA) were instituted to address legal and ethical concerns about patient dumping. Signed in 1946 by President Truman, Hill-Burton directed hospitals to make services available to anyone living in the geographic region of the hospital and to provide care free of charge to those individuals unable to pay. Signed in 1986 by President Reagan, EMTALA was enacted to protect all individuals seeking treatment at Medicare-participating hospital emergency departments. In addition to federal statutes, states also have passed legislation requiring hospitals to provide care irrespective of ability to pay and require that patients be medically stable before transfer. Regrettably, federal and state laws have not performed as was intended. Statutes designed to prevent patient dumping are criticized for 1) having narrow and unclear definitions of what constitutes a medical emergency; 2) failing to clarify what it means to stabilize patients before a transfer; and 3) failing to adequately provide the means for monitoring and enforcement (Ansell & Schiff, 1987).

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Image description: An aerial photo of a medical waiting area shows rows of blue chairs, and three seated individuals dispersed throughout. Image source: Erwin Morales/Flickr Creative Commons.

It would seem that patient dumping is symptomatic of larger macroeconomic and macrosocial issues. What possible solutions exist?

Suppose we actually provided health care to everyone? The ACA has greatly expanded insurance coverage by extending Medicaid, but many people remain uninsured due to prohibitive costs. Imagine having access to health insurance that was not employment dependent. Imagine that people with mild, moderate, and severe mental illness received comprehensive health services. Imagine a system of care that recognized that social determinants of health profoundly influence health outcomes. Imagine having food assistance folded in as part of a medical treatment.

Suppose we eradicated poverty and homelessness? Imagine a time when people could actually support themselves and their families because they made a living wage. Imagine that support was available for people to simultaneously work and pay for childcare.

Suppose we actually utilized comprehensive discharge planning for patients? Imagine planning documents that were easy to read and comprehend because health literacy was important. Imagine patients understanding the medications they needed to take when they got home. Imagine that prior to discharge patients had appointments scheduled for follow-up visits and had the transportation in place to get them there. Imagine providing support visits for elderly patients to make sure they were living in decreased fall risk environments.

Suppose we made the profession of medicine responsible for caring for our most vulnerable—the sickest sick and poorest poor? Imagine that all provider-patient panels included a significant number of homeless, poor, mentally ill, and uninsured individuals. Imagine an equal, fair, and just distribution of medical care service to the underserved that lightened that specific expectation on under-represented minority physicians (URMs). We know that URM physicians bear a disproportionate burden of providing care for the most vulnerable patients. Such a burden might substantially constrain their ability to meet quality care metrics for reimbursement.

Patient dumping is a harsh, cruel response to a healthcare and social system that can also be harsh and cruel. The goal for the U.S. healthcare system is to “ensure that every patient is a wanted patient regardless of ability to pay”.

Incidents of patient dumping such as the one recorded in Baltimore should not be cause for public consternation. The public protestation should instead be about macro-level systems and social ills that make such responses unsurprising. The above suppositions are probably wild-eyed idealist notions. But for a moment, just suppose they weren’t?

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

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, August 9, 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. Kelly-Blake: Incarcerated AND Sick: At Risk for Pain, Injury, and Death; White Horse, White Faces: The Decriminalization of Heroin Addiction; Racism and the Public’s Health: Whose Lives Matter?; Concussion in the NFL: A Case for Shared Decision-Making?

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